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Overview of Herbal Quality Control
Abstract
This paper outlines the importance of quality control of herbal remedies by providing an overview of the types of toxic and pathogenic contaminants which may occur. These include toxic botanicals, micro-organisms, microbial toxins, pesticides, fumigation agents, radioactivity, toxic metals, synthetic pharmaceuticals, and animal substances. Academia, government, the herbal industry, and the pharmaceutical industry must work together to develop practical methods of improving the safety of herbal remedies.
... One of such environments can be created by widespread use of HMP. HMPs have been previously implicated as a pool for such contaminations [12,13]. It is of utmost importance to both monitor and ascertain the microbial purity of HMPs given the huge medical and economic implications of any such microbial contamination especially with multiple drug resistant strains. ...
... The resistance to trimethoprim-sulphamethoxazole (co-trimoxazole) by all the isolates especially the Gramnegative isolates calls for attention. The findings of this study agree with an earlier work [12]. ...
... One of such environments can be created by widespread use of HMP. HMPs have been previously implicated as a pool for such contaminations [12,13]. It is of utmost importance to both monitor and ascertain the microbial purity of HMPs given the huge medical and economic implications of any such microbial contamination especially with multiple drug resistant strains. ...
... The resistance to trimethoprim-sulphamethoxazole (co-trimoxazole) by all the isolates especially the Gramnegative isolates calls for attention. The findings of this study agree with an earlier work [12]. ...
Objective: To determine the susceptibility and resistance pattern of bacteria and fungi isolates obtained from herbal anti-infective liquid preparations manufactured and marketed in SouthEast Nigeria to conventional antibiotics. Study Design: Experimental Place and Duration of the study: Pharmaceutical Microbiology and biotechnology Laboratory, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Agulu Campus between October 2011 and March 2012. Methodology: Isolation and characterization of contaminating microorganisms were carried out using standard procedures. A total of forty-nine (49) bacteria and forty (40) fungi isolated from the herbal products were examined for susceptibility to conventional 549 antibiotics using the disc diffusion method. The bacterial isolates were tested against ciprofloxacin, ofloxacin, amoxicillin-clavulanic acid, gentamicin, cefotaxime, ceftazidime, ceftriazone, sulphamethoxazole, tetracycline and ampicillin were employed while fungi isolates were tested against five common antifungal-griseofulvin, nystatin, ketoconazole, fluconazole and clotrimazole. The Multiple Antibiotic Resistance Index (MARI) of each of the isolated bacteria was obtained following the standard method. Result: The antimicrobial susceptibility-resistance profile of the bacteria isolates revealed that most of the bacteria were sensitive to ciprofloxacin, ofloxacin, gentamicin, and ceftriaxone, On the other hand, a good number of the isolates demonstrated high level of resistance to common antibiotics like Ampicillin, amoxycillin-clavulanic acid, trimethoprim-sulphamethoxazole, and moderate level of resistance to Tetracycline, and some of the third generation cephalosporins-ceftazidime and cefotazime. Multiple Antibiotic Resistance Index (MARI) evaluation revealed that most of the isolates were resistance to more than fifty percent (50%) of the number of antibiotics used. The fungal isolates were susceptible to nystatin, ketoconazole and clotrimazole, resistance to fluconazole and high resistance recorded against griseofulvin. Conclusion: The results of this study revealed that the herbal medications can serve as a trail of spread of antibiotic-resistance genes.
... Due to the risk of contamination with potentially toxic botanicals and other hazardous substances, including pesticide residues, bacteria, fungi, toxic metals and radioactive chemicals, the importance of strict quality control of all herbal preparations cannot be underestimated (de Smet, 1999). The large number of Scutellaria species, many of which are similar in appearance, and consequent problems of substitution or adulteration of S. lateriflora with other skullcaps or potentially harmful herbs such as germander (Teucrium) species, make its correct identification prior to commercial use particularly essential. ...
... canadense) and Wall germander (T. Chamaedrys), which contain hepatotoxic furan neoclerodane diterpenoids such as teucrin, being used in some European commercial preparations in place of S. lateriflora (de Smet, 1999; Bedir et al., 2003; Lin et al., 2009; Upton and Dayu, 2012). ...
Traditional use of American skullcap (Scutellaria lateriflora) for anxiety and related conditions is well documented. There is evidence of flavonoid instability in S. lateriflora and a high rate of substitution with other skullcap species or adulteration with potentially hepatotoxic germanders (Teucrium spp.). It is therefore essential for the identity, quality and safety of a commercial S. lateriflora product to be verified prior to clinical use.
The objective was to review the literature relating to substitution and adulteration of S. lateriflora and to present a simple, optimised high performance liquid chromatography (HPLC) method to verify the absence of adulterants in a commercial sample of S. lateriflora, by comparing its chromatographic profile with that of authenticated S. lateriflora.
S. lateriflora reference material and a freeze-dried commercial sample were extracted with methanol and water (80:20, v/v) and compared by HPLC analysis. The commercial sample showed reproducible retention times (RTs) of the flavonoid biomarkers baicalin (RT = 14.8 min; mean ± SD = 11.71 ± 1.16 mg/g); baicalein (RT = 20.4 min; 7.67 ± 0.89 mg/g); wogonin (RT = 23.7 min; 0.65 ± 0.06 mg/g). It appeared to be free from adulteration with germander (verbascoside was not detected; RT = 9.1 min) and its phytochemical profile was consistent with that of the S. lateriflora reference material.
It is crucial that commercial products are adequately identified prior to use. The reported HPLC method has shown the potential to compare non-authenticated S. lateriflora samples with authenticated voucher specimens – essential when conducting any phytochemical analysis of the herb.
... All the extracts were screened qualitatively for detection of phytoconstituents using general and specific chemical reagents [16][17][18][19] . ...
Sonchus asper also locally known as prickly sow-thistle, rough milk thistle, spiny sowthistle, spiny-leaved sow thistleordudhi, is a widespread plant an annual or biennial herb sometimes reaching a height of 200 cm. with spiny leaves and yellow flowers resembling those of the dandelion. Traditionally it has been used in the treatment of numerous disorders and many resembling plants of the genus Sonchas create confusion hence its standardization is necessary. In the present work we have tried to standardize the entire herb based on physical, chemical, microscopical, and Physico-chemical investigations to provide the proximate values for its proper identification. The present work will help the traditional healers for selecting the correct herb for treating different disorders and avoid the wrong choice of crude drugs which may lead to unsatisfactory results for intended use or it may cause discomfort for many patients. Further work is going on for the biological evaluation of this herb to provide scientific validation of its traditional claims.
... Herbal preparations are used in different forms and normally carry a large number of various kinds of microbial contaminants. These originate from soil or normally adhere to leaves, stem, flowers, seeds and root of the herbs (Peter, 1999;Adeleye et al., 2005). The presence of diverse range of bacteria strains in LHPs poses serious public health safety. ...
In Nigeria, a large proportion of the population still uses traditional remedies in the form of liquid herbal products are sold for medicinal purposes. This study was designed to analyze antibiotics resistance and plasmid profile of bacteria species associated with selected indigenous liquid herbal products sold in Abia State, Nigeria. One millilitre of tenfold serial dilution of each liquid herbal preparation was prepared and transferred into prepared Nutrient agar and Plate count agar to culture and enumerate bacteria isolates. Antimicrobial susceptibility testing of the isolated organisms was performed by the disk diffusion technique. Double Disc Synergy Test using amoxicillin-clavulanic acid disc and ceftazidime disc was used for confirmatory test for extended spectrum β-lactamases. Plasmid profiling of multidrug isolates was determined using the alkaline lysis method and agarose gel electrophoresis. A total of 315 bacterial isolates were obtained using standard cultural and biochemical methods from 150 therapeutic liquid herbal preparations (LHPs). The most frequently isolated pathogen was S. aureus (21%) followed by Pseudomonas spp. (17%). The resistance pattern of LHP isolates shows 47(17.9%) isolates were resistant to Amoxycillin-Clavulanate, while 5(1.9%) isolates were resistant to Ciproflox. Among 98 MDR bacteria isolates from LHPs, ESBL production was identified in 4(30.8%) Salmonella spp., 4(30.8%)E. coli, 3(23.1%)P. vulgaris and 2(15.4%) Klebsiella pneumoniae. Three plasmids were isolated from P. vulgaris (P14) and 2 plasmids were isolated from P. vulgaris (P16) while Salmonella spp., (P39) had 1 plasmid. This study revealed that some tested liquid herbal preparations were grossly contaminated with Extended Spectrum β-lactamase producing and multidrug resistant bacteria.
... It is difficult to establish comprehensive quality criteria for herbal drugs due to 'professional secrecy' of herbalists, but to improve the purity and safety of the products, observation of basic hygiene during preparation, standardization of some physical characteristic such as moisture content, pH, temperature, and microbiological contamination levels are desirable. Previous studies have confirmed the presence of potential contaminants in herbal preparations (De- Smet, 1999). The contaminants that present serious health hazard are pathogenic bacteria, such Salmonella, Esherichia coli, Staphalococcus aureus, and Shigella spp (Arias et al., 1999; Plant have been used for thousands of years in the treatment of human diseases and the selection of plant for uses as medicine was probably made as result of quassipharma-cological studies. ...
... One of such environments can be an HMP. The HMPs have been previously implicated as a pool for such contaminations (Peter, 1999;Esimone et al., 2007). It is of utmost importance to both monitor and ascertain the microbial purity of these products given the huge medical and economic implications of any such microbial contamination especially with multiple drugresistant strains. ...
Herbal products are used worldwide for the treatment and
prevention of various diseases and currently represent a substantial proportion
of the global drug market. However, these products have the potential of
being contaminated by different microorganisms due to poor hygienic
practices during handling, processing and packaging. The main aim of this
study was to evaluate microbial quality of herbal products marketed to the
general population in Eldoret and Mombasa, Kenya. The study employed an
exploratory as well as laboratory based experimental design. The herbal
products were purchased from the markets and transported to Kenya Medical
Research Institute laboratories for processing and analysis. Microbial
contaminants were determined according to Pharmacopoeias and World
Health Organization standards. Microbial pathogens were isolated,
identified and drug susceptibility test was done as per National Laboratory
Standards Institute protocol. The herbal products were in-form of powders,
liquids, tablets, oils and capsules. Bacterial contamination was observed in
90% of the total samples and those with >1000×104cfu/gm or ml was
20% for Eldoret and 46% for Mombasa samples. Analysis of variance
showed that the rate of microbial contaminants for Eldoret and Mombasa
samples had no significant association (p = 0.084). Bacteria belonging to
seven genera were isolated and antibiotic susceptibility test showed that
13.2% of the bacteria isolates were resistant. Multidrug resistance was
observed with Klebsiella pneumonia, Shigella sonnei, Serratia erwinia,
Serratia liquefaciens and Proteus penneri. These findings imply that
conditions during harvest or postharvest processing of herbal products
were unsanitary. Proper handling and storage of herbs should be
observed in order to reduce the amount of microbial contaminants. Only
16% of herbal product samples evaluated met the standards for microbial
limits as specified in Pharmacopoeias. Thus, emphasis on improvement
of plant material quality and establishing better hygienic conditions
during production of herbal medicines is recommended.
... Comprehensive quality criteria for herbal drugs due to 'professional secrecy' of herbalists is difficult to establish, but in order to improve the purity and safety of the products, observation of basic hygiene during preparation, standardization of some physical characteristic such as moisture content, pH and microbiological contamination levels are desirable [7]. Earlier studies have established the presence of potential contaminants in herbal preparations [8]. The presence contaminants that serious health hazard are pathogenic bacteria such as Salmonella, Escherichia coli, Staphylococcus aureus, Shigella spp. ...
Herbal Medicines (HM) are being used in our country for a long time but the type and load of the microbial agents has not been isolated in locally produced finished products of HM. The present study was designed to assess the microbial load, genus & species of the microbes contaminating with HM. Seven different Antidiabetic Herbal Preparations (ADHPs) were purchased randomly and analyzed for microbial contaminants. Blood agar, Mac Conkey agar, Chocolate agar and Saboraud’s dextrose agar were used (Oxoid) for culturing and isolation of bacteria and fungus.Identification of organisms were done as standard ways. Total aerobic bacterial plate count was done as per the method of Brown, Poxton and Wilkinson. Out of 07 antidiabetic solid and liquid samples, except ADHP-3, Bacillus subtilis (3.5 – 4.0 x 104 cfu/g) was isolated from solid ADHPs and Enterococcus spp. (1.0x104 cfu/ml) was isolated from liquid ADHP, but all samples were free from fungi (yeasts and moulds). However presence of bacteria in these samples indicates the possibility of increased number of bacteria. So, the sample should be handled in any step maintaining standard sterility of the environment, instrument and involved personnel. The result of present study showed the contamination rate within tolerable level but the presence of bacteria in these samples was not desirable.
... Previous studies have confirmed the presence of potential contaminants in herbal preparations (De Smart, 1999). The contaminants that present serious health hazards are pathogenic bacteria such as Salmonella, Escherichia coli, Staphylococcus aureus, Shigella species and other Gram positive and Gram negative strains of bacteria (Arias et al, 1999;Okunola et al, 2007;Adeleye et al, 2008). ...
Background:
There is increased reliance on traditional herbal medicines by several millions of people worldwide, especially in West Africa and Nigeria in particular. This is due to escalating cost of good quality drugs and consequent proliferation of faked cheaper drugs. However, non standardization of production and handling methods have resulted in herbal medicines with varying quality and safety indices, thus resulting in possible public health concerns. This work investigated the microbial load and aflatoxin levels in herbal medicines from selected states in Nigeria.
Materials and methods:
A total of 210 samples obtained from various renowned herbal medicine practitioners from some selected states in Nigeria, based on their medicinal uses, were analyzed to determine the microbial load by the plate count method and aflatoxin contamination levels using thin layer chromatography with aflatoxin standards.
Results:
At least six bacterial genera (Bacillus, Pseudomonas, Salmonella, EPEC, EHEC, Streptococcus and other coliforms) and 6 fungal genera (Aspergillus, Penicillium, Rhizopus, Cladosporium, Geotricum and Candida) were isolated. Aflatoxin B1, B2 and G1 were detected in varying concentrations in the samples analyzed, with an average occurrence of 18.6%. Some of these herbal concoctions were found to contain unacceptably high bioload, according to WHO standards.
Conclusion:
Microbial contamination and the presence of aflatoxins in herbal medicines appear to be an endemic problem in Nigeria, as observed in this work, probably due to poor observation of basic hygiene during preparations and poor storage conditions. The findings in this work may serve in developing and instituting public health standards for the production and safety of herbal remedies in Nigeria.
... registered. [48] The method of extraction greatly influences the composition of Finally, there are reports in the literature of finished products the extract. For instance, the American Botanical Council's Ginadulterated with foreign toxic plants or synthetic drugs. ...
Physicians are increasingly recommending the use of plant-derived products, partly because of a growing dissatisfaction among consumers with conventional medicines, but also because of the progress made in the chemical, pharmacological and clinical study of herbal medicinal products, the use of innovative galenical forms and the growing importance of self medication. Quality is a key issue in the development of herbal medicinal products that have consistent safety and efficacy, and quality can only be achieved if it is prioritized from the earliest stages of the development process. Problems in the development of herbal remedies include the frequent lack of standardized products (leading to a poor reproducibility of results and lack of batch-to-batch uniformity), a lack of toxicology, pharmacokinetic and pharmacodynamic data, as well as of dose-response and interaction studies. In addition, the placebo effect in trials with herbal remedies is often very high.
Research involving herbal medicinal products must progress from the use of traditional evidence and/or open, observational trials to randomized, double-blind, placebo-controlled trials, the ‘gold standard’ of clinical and scientific research. Over time, the development process for herbal medicinal products should become more closely aligned with the development of new chemical entities. Pharmacovigilance is also slowly becoming a standard tool to monitor the safety of herbal medicinal products. Yet we should not discard the legacy of traditional wisdom because ethnopharmacology and knowledge provided by existing clinical trials (be they open, observational studies or small, double-blind investigations) is a source of invaluable insight into the safety and efficacy of herbal remedies. Ideally, a registration dossier for any herbal medicinal product should include both the results of appropriate preclinical and clinical studies, and the wealth of knowledge that has accumulated from the traditional use of the product.
Pollen viability and pollen diameter are essential criteria in plant breeding program. This study was carried out to examine the effects of sodium hypochlorite concentrations on pollen parameters of Corchorus olitorius. Seeds of Corchorus olitorius were obtained from the National Institute of Horticulture, (NIHORT) Ibadan and seeds in each case were treated with sodium hypochlorite solutions which range from 25% to 100% for six hours. Fifty seeds in each group were treated and the control was treated with distilled water. All the seeds were germinated and raised to maturity with four replicates in a randomized complete block design (RCBD). The field experiment was conducted at the garden of Centre for Preliminary and Extramural Studies, Federal University of Technology, Minna, Niger State. Pollen viability and diameter were determined using standard procedure. The result revealed significant differences (P<0.05) in pollen parameters among concentrations of sodium hypochlorite tested. The numbers of viable pollen grain (VPG) was weakly correlated (0.347) with concentrations of sodium hypochlorite increases and number of pollen diameter (PD) was strongly correlated (0.938) with concentrations of sodium hypochlorite. A positive correlation was recorded in pollen diameter (0.938). Pollens from all treatment were regular in shape and the cytoplasm stained dark brown in colour were assumed to be fertile and counted as viable while those that appeared diverted irregular in shape with a light pinkish colour or not stained at all were considered non viable. The study revealed that pollens of Corchorus olitorius could be reasonable tools for inducing genetic variability in Corchorus olitorius.
Curcuma longa (turmeric) has an extensive history of ethnomedical use for common ailments, and "curcumin"-containing dietary supplements (CDS) are a highly visible portion of today's self-medication market. Owing to raw material cost pressure, CDS products are affected by economically motivated, nefarious adulteration with synthetic curcumin ("syncumin"), possibly leading to unexpected toxicological issues due to "residual" impurities. Using a combination of targeted and untargeted (phyto)chemical analysis, this study investigated the botanical integrity of two commercial "turmeric" CDS with vitamin and other additives that were associated with reported clinical cases of hepatotoxicity. Analyzing multisolvent extracts of the CDS by 100% quantitative 1H NMR (qHNMR), alone and in combination with countercurrent separation (CCS), provided chemical fingerprints that allowed both the targeted identification and quantification of declared components and the untargeted recognition of adulteration. While confirming the presence of curcumin as a major constituent, the universal detection capability of NMR spectroscopy identification of significant residual impurities, including potentially toxic components. While the loss-free nature of CCS captured a wide polarity range of declared and unwanted chemical components, and also increased the dynamic range of the analysis, (q)HNMR determined their mass proportions and chemical constitutions. The results demonstrate that NMR spectroscopy can recognize undeclared constituents even if they represent only a fraction of the mass balance of a dietary supplement product. The chemical information associated with the missing 4.8% and 7.4% (m/m) in the two commercial samples, exhibiting an otherwise adequate curcumin content of 95.2% and 92.6%, respectively, pointed to a product integrity issue and adulteration with undeclared synthetic curcumin. Impurities from synthesis are most plausibly the cause of the observed adverse clinical effects. The study exemplifies how the simultaneously targeted and untargeted analytical principle of the 100% qHNMR method, performed with entry-level high-field instrumentation (400 MHz), can enhance the safety of dietary supplements by identifying adulterated, non-natural "natural" products.
The present study aimed to investigate the microbial populations such a bacteria and fungi contamination present in the herbal medicinal preparations (Lepidium sativum, Nigella sativa, Cuminum cyminum, Foeniculum vulgare, Pimpinella anisum, Trigoneela foenum-graecum, Cinnamomum verum, peel coffee, Alchemilla valgaris, Vitex agnus-castus) commonly available in different parts of Riyadh, Saudi Arabia. To determine the contamination of the herbal products, experiments such as total aerobic bacterial plate counts were evaluated by various plating techniques. The isolation and identification of fungi were done using czapek dox agar and potato dextrose agar. The results showed that a total of herbal remedies were contaminated with bacteria and fungi (100%). Among the contaminated products, peel of coffee and Vitex angnus-castus were noted more contamination than the other herbal medicinal plants. The results confirmed that the traditionally prepared herbal medications in Riyadh city are likely to be contaminated with a wide variety of potentially pathogenic bacteria and fungi. Therefore, before consumption, the quality assurance of these products should be thoroughly enforced and monitored in the production and distribution of herbal preparations. In conclusion, the present study gives proper evidence that the consumed herbal products contain different levels of pathogenic microbes.
Objective: Identify variables in the Theory of Planned Behavior that predict intention to use herbal medicines for health problems in the next six months and to examine the beliefs underlying these significant predictors. Design: Cross-sectional study using self-administered questionnaires. Setting: University of New Mexico Senior Health Clinic and the New Mexico Veterans Affairs Health Care System ambulatory pharmacy in Albuquerque, NM. Patients: One hundred and fifty-one ambulatory patients aged 65 years and older. Main outcome measure: Intention to use herbal medicines for health problems in the next six months. Key findings: Attitudes towards using herbal medicines was the only significant predictor of the intention to use herbal medicines for health problems in the next six months (F=70.161, p<0.001; R2=0.58; β=0.693, p<0.001). Behavioral beliefs underlying attitudes towards the use of herbal medicines differed significantly between respondents with higher and lower intentions. Conclusion: Study results provide a foundation upon which patient counseling strategies about herbal medicines for health problems could be developed for older patients.
By definition, phytomedicines are complex preparations, of which the quality is determined by a large variety of factors in the production process. The production process includes cultivation and harvesting of the plant material, the preparation of a semi-manufactured product (extract) and the preparation of a finished product. Quality assurance and quality control should take place in all of these stages. This is essential for the pharmacological, toxicological and clinical evaluation of phytomedicines and for their standardisation on biologically active constituents or marker substances with respect to a rational use and legal registration.
The quality criteria for herbal drugs are based on a clear scientific definition of the raw material. Even though global herbal resources have a great potential as natural drugs and are of great commercial importance, they are very often procured and processed without any scientific evaluation, and launched onto the market without any mandatory safety and toxicology studies. On that basis, an attempt was made on efficacy and safety studies of a well known herbal drug Foeniculum vulgare by evaluation of toxicological parameters like heavy metals and pesticide residues. Additional standardisation parameters like, physical constants, ash content, solvent residues to prove identity and purity were also carried out. Results obtained during this experiment revealed that heavy metals and pesticidal residues were variable but found within the prescribed limits. Standardisation parameters were variable in two samples under consideration which may be due to different geographical conditions. Hence, there is an urgent need for mandatory evaluation of these parameters in every crude drug before further processing to ensure safety and efficacy of Indian medicinal plants and better acceptance at International platform.
The quality of herbal medicinal products (HMP) is a challenge, mainly due to the difficulties linked to the variability and complexity of herbal drugs and herbal preparations, the limited knowledge of their active constituents, the possible adulterations and contaminations, as well as the influence of the production processes. This is a surmountable challenge. This requires having the quality as an objective from the beginning of the production chain, to establish strict controls on all stages, to improve the knowledge of the product, to optimize and to validate the production processes, to work under accepted international guidelines and to establish quality specifications. The European Pharmacopoeia, in Spain in the Royal Spanish Pharmacopoeia, is a key tool to overcome the challenge and maintaining high levels of quality of HMP in the EU. This is because the European Pharmacopoeia is an updated and transparent regulatory document, harmonized and agreed by 37 countries, which provides a unique collection of monographs and methods for the analysis of herbal drugs and preparations, and is also a provider of reference substances.
Pesticides are intended to be used to control pests, plant diseases and rival plants, causing damage during cultivation, processing, storage or transportation. They are among the most widely used chemicals in the world. Main classes include organochlorine-, organophosphorus- and pyrethroid-type pesticides. Fumigation agents may he used for decontamination and disinfection mainly at the wholesale stage. Up-to-date surveys of the contamination of herbal drugs, analytical methods, regulatory referential and health hazards study are widely documented. Plant protection products may be characterized based on three different main criteria: systemic (absorption by foliage or roots) or non-systemic (contact pesticides) behaviour, degradation speed (persistence in the environment) and pre-harvest and/or post-harvest/collection use. To estimate the pesticide contamination risks of medicinal plants and herbal drugs, different aspects may be considered: cultivated or collected plant material, part of plants (e.g. underground or above-ground parts), geographical origin, transportation and storage conditions. The general chapter "Pesticide residues" (2.8.13.) of the European Pharmacopoeia has just been revised with an extended list of 70 (instead of 34) substances or group of substances with respective limits. Most of them (67 over 70) can be analysed using a multiresidue procedure, excepted dithiocarbamates, piperonyl butoxide and bromide residues. So, SFSTP commission has focused its attention on those last three (groups of) substances. Available raw data analysis showed that optimisation of a cost-effective quality control of pesticide residues is possible via a risk evaluation. Recommendations specify in which cases testing on a routine basis can be waived, as no presence of residues is expected.
Medicinal herbs were the primary health care agent over the many centuries before development of modern medicine. The fact that herbal medicines have been employed for such a long time does not guarantee their efficacy and safety. On that basis, an attempt was made on efficacy and safety studies of a well known medicinal herb in Malaysia, Ficus deltoidea by evaluation of toxicological parameter like heavy metals and standardization parameters like, physical constants, ash content, Microbial Limit Test (MLT) and screening phytoconstituents are present in the leaves of F. deltoidea. Heavy metals analysis was done by atomic absorption spectrometry. Physicochemical determinations, including moisture, volatile and total ash content were carried out by Thermo gravimetric Analyzer. Microbial Limit Test was done as per the United State Pharmacopoeia method. Thin layer chromatography was carried out for phytochemical screening with normal silica plate using various chemical reagents. The contents of Cd, Pb and As were found to be 0.069, 0.761 and 0.422 ppm, respectively. While Hg was not detected in F. deltoidea leaves. MLT test showed 5.0×l06 and 3.3×l07cfu g-1 for Total aerobic microbial count and total combined mold and yeast respectively. However, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella sp. and Escherichia coli were found to absent. Phytochemical studies of petroleum ether, chloroform, methanol and water extracts showed presence of saponin, amino acid, flavonoids and terpenoids. Hence, there is an urgent need for mandatory evaluation of these parameters in every crude drugbefore further processing to ensure safety and efficacy of medicinal plants. In conclusion, it was shown that the extracts of F. deltoidea leaves were enriched with chemically diversified phytoconstituents which could be useful for various pharmacological activities.
Traditional Chinese medicine (TCM) is gaining popularity as a form of complementary and alternative medicine. Reports of efficacy of TCM are increasing in numbers. TCM includes both crude Chinese medicinal materials (plants, animal parts and minerals) and Chinese proprietary medicine (CPM) [final dosage forms]. Despite the belief that CPM and herbal remedies are of natural origin, unlike Western medicine, and are hence safe and without many adverse effects, there have been numerous reports of adverse effects associated with herbal remedies. Factors affecting the safety of herbal medicines include intrinsic toxicity, adulteration, substitution, contamination, misidentification, lack of standardisation, incorrect preparation and/or dosage and inappropriate labelling and/or advertising. Hence, new regulations on the control of CPM were enforced in Singapore with effect from 1 September 1999. These include licensing and labelling requirements, as well as control of microbial contamination. This article also reviews reports of excessive toxic heavy metals and undeclared drugs in CPM in Singapore between 1990 and 1997. The names, uses, toxic heavy metal or drug detected and the year of detection are tabulated. Information on the brand or manufacturer’s name are provided whenever available. The public and healthcare professionals should be better informed of the basic concept of TCM and its usefulness, as well as the potential adverse effects associated with its use. Greater control over the safety and quality of CPM could be achieved through good manufacturing practice, regulatory control, research, education, reporting usage of Chinese medicine (as in drug history) as well as reporting of adverse events.
La calidad de los medicamentos a base de plantas (MP) constituye un reto, principalmente por las dificultades ligadas a la variabilidad y complejidad de las drogas y preparados vegetales, el conocimiento limitado de sus constituyentes activos, la posibilidad de adulteraciones y contaminaciones, así como la influencia de los procesos de producción. Se trata de un reto superable. Para ello es necesario tener la calidad como objetivo desde el inicio de la cadena productiva, establecer controles estrictos de todas las etapas, mejorar el conocimiento del producto, optimizar y validar los procesos de producción, trabajar bajo las directrices internacionales aceptadas y establecer especificaciones de calidad. La Farmacopea Europea, en España dentro de la Real Farmacopea Española, constituye una herramienta clave para la superación del reto y el mantenimiento de altos niveles de calidad para los MP en la UE. Esto es así porque la Farmacopea Europea es un documento normativo actualizado, transparente, consensuado y armonizado por 37 países, que proporciona una colección singular de monografías y métodos para el análisis de drogas y preparados vegetales, siendo además un proveedor de sustancias de referencia.
Herbal medicines are more and more worldwide used. This fact certainly presents serious problems for the potential human health risks. This is due to the fact that the laws in force generally do not provide for strict quality controls of herbal medicines to certify the concentration of compounds and elements that may be hazardous for human health, and sometimes very severe or even lethal. Heavy metals have a decidedly substantial part of the contaminants in herbal medicines. The present review proposes an exhaustive focus on what are the metals of interest, and what is the state of the art about analytical methodologies suitable to detect these toxic metals in herbal medicines. This review would also be a stimulus to solicit International Organizations to fill the gap of the lack of strict and comprehensive laws regulating the maximum allowable concentrations for an increasing number of contaminants in these matrices, especially considering their enormous consumption.
Plants have long been used as herbal medicines in many countries. However, microbial contamination of these medicines may affect human health. Present study was performed to assess the pathogenic proliferation in the locally available commercial herbal oral medicines. The pathogenic load was compared with the microbiological standard given by the British Pharmacopoeia. Out of 85 oral liquid samples, 2 were found to be highly contaminated with a total aerobic bacterial load of 1.24 x 10(5) cfu/ml, 10 samples were contaminated with fungi (1.2 x 10(4)-6.3 x 10(4) cfu/ml). Tests for specific pathogens were carried out. One sample showed contamination by coliforms but none of the samples were contaminated by Salmonella spp. and Shigella spp. Among 40 semisolid samples, one showed to be contaminated with bacteria (1.93 x 10(5) cfu/g) and 5 samples consisted of fungal load ranging between 1.5 x 10(4)-2.2 x 10(4) cfu/g. The presence of bacteria and fungi in these samples thus suggest the fact that aseptic handling is necessary during processing of oral herbal medicines.
This article outlines the importance of herbal dietary supplements regulation by providing a brief overview of history of supplement regulation in the US with emphasis placed on passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and post-DSHEA enforcement actions. This review also addresses international aspects of dietary supplement regulatory processes. The controversy surrounding the separation of structure/function claims from health claims is examined. Safety issues are summarized and the following proposals are offered to improve the herbal dietary supplements regulatory system. First, herbal dietary supplements should be subject to more strict regulation by the FDA, which means treating them more like pharmaceuticals and not like food. Only pre-market approval can guarantee consumer access to safe and effective product. Second, a suggested simplified procedure allows the registration of a traditional herbal dietary supplement. Third, due to the compositional diversity and complexity of botanical substances, every new submission of nontraditional herbal supplement must be processed on a case-by-case basis. Fourth, a mandatory post-marketing reporting system of all adverse events should be established rather than the current serious adverse event reporting scheme. And finally, legislative reform is needed to change the regulatory system of dietary supplements.
Sixty-one dietary supplements are currently registered in Armenia and interest in these products has been growing. In 1996, the Armenian Drug and Medical Technology Agency of the Ministry of Health adopted the “Resolution of Licensing of Dietary Supplement Products.” This resolution is based upon the Drug Law of Armenia of 1998, which excludes from registration in Armenia any drugs that are detrimental to public health due to the uncontrolled sale of such products and the lack of information about them. The Drug and Medical Technology Agency created a product database with information about registered dietary supplements' manufacturers, ingredients, and claims.The resolution and the database demonstrate the Drug and Medical Technology Agency's dietary supplement expertise and evaluation criteria. The parameters for rejected dietary supplement applications are included and the requirements for dietary supplement labels are described. To prevent adulterated or counterfeit dietary supplements from being marketed in Armenia, special controls were introduced for some categories of dietary supplements (sedatives, hypoglycemic supplements, tonics, and arthritis supplements).
Aromatic plants and spices are used throughout the world for flavouring food and beverages, as well as for food supplements, novel foods and as a source of essential oils and aromatic extracts. The non-availability or inadequacy of standards for checking and assuring the quality of aromatic plants and spices is one of the main problems that arise for industry when using such raw materials. As many aromatic plants are harvested from the wild, standardization to assure their quality is important for their safe and effective utilization in food and beverage industries. On the other hand, there are numerous parameters that influence the chemical composition of plants, which play an important role in the final quality of the product and possibly in any risk arising to the consumer. Also, from a safety point of view, aromatic plants and spices should be free of undeclared contaminants and adulterants, such as toxic botanicals, pathogenic microorganisms and excessive levels of microbial toxins, pesticides or fumigation agents. We focus on these aspects and examine ways to assure their appropriate utilization from the quality and safety standpoint. The regulatory situation of medicinal and aromatic plants (MAPs) is very complicated; several differences in standards and regulations between countries can be found, a situation that can result in more health risks arising for consumers. To clarify some of the existing problems, the major regulations of the USA and the European Union (EU) and the borderlines between food supplements and medicines and other international standards, are briefly described and discussed. Copyright © 2010 John Wiley & Sons, Ltd.
There is increasing awareness and general acceptability of the use of herbal drugs in today's medical practice. Although, most of these applications are unorthodox, it is however a known fact that over 80% of the world population depends on herbal medicines and product for healthy living. This rise in the use of herbal product has also given rise to various forms of abuse and adulteration of the products leading to consumers' and manufacturers' disappointment and in some instances fatal consequences. The challenge is innumerable and enormous, making the global herbal market unsafe. This review seeks to enlighten stakeholders in herbal medicine on the need to establish quality parameters for collection, handling, processing and production of herbal medicine as well as employ such parameters in ensuring the safety of the global herbal market. The processes of good quality assurance and standardization of herbal medicines and products were also discussed.
Anxiety is a common but potentially serious disorder as it can lead to somatic and
social dysfunction. Orthodox anxiolytics are associated with unpleasant side-effects and
dependency. American skullcap (Scutellaria lateriflora) is a popular herb in traditional
medicine systems and the western materia medica for anxiety and related disorders.
Preliminary clinical and in vitro research provides encouraging support for its potential as a safe, well-tolerated and effective alternative.
The study aimed to evaluate the bacterial contamination of powdered herbal medicinal preparations sourced from identified herbal retail outlets in different parts of Kaduna metropolis. The assessments of the contamination of the herbal products were carried out using standard procedures: total aerobic bacterial plate count, measurement of some physical parameters, isolation and characterization of selected bacterial pathogens etc. The results showed that out of a total of 150, 70 (46.67%) herbal remedies were contaminated with Salmonella typhi, twenty nine (19.33%) with Shigella spp. Eighty eight (58.67%) and 98 (65.33%) were contaminated with Escherichia coli and Staphylococcus aureus, respectively. The total aerobic plate count results showed that the highest average count of > 5x10(7) cfu/g was found in 89 (59.33%) of the preparations, while average plate count of < or = 5x10(7) cfu/g was found in 42 (28%) and no bacterial count was obtained in 19 (12.67%) of the preparations. Correlation was positive (P = 0.01; r = +0.109) between the physical parameters tested and the bacterial load. Antibacterial activities result of some common antibiotics showed that all the antibiotics had activities on the test bacterial isolates at various minimum inhibitory concentrations. Most traditionally prepared herbal medications in Kaduna state are likely to be contaminated with a wide variety of potentially pathogenic bacteria. The quality assurance of these products should be thoroughly enforced and monitored in the production and distribution of herbal preparations.
Abstract Traditional Chinese Medicine (TCM) is one of the oldest forms of medicine in the world. There has been a growing interest in TCM in Canada in terms of consumers and also among the research community. To cater for this interest, the Canadian Institute of Chinese Medicinal Research (CICMR) was established in 2004. Since its formation, CICMR has been organizing annual meetings. In 2008, the CICMR meeting, jointly organized with the Ontario Ginseng Innovation Research Centre, was held from October 16th to 19th, in London, Ontario, Canada. The meeting saw a number of participants and speakers from many countries who discussed TCM in a Canadian perspective. The talks and presentations focused on TCM practices in Asia and Canada; analytical techniques for unravelling the science behind TCM; basic and clinical research findings in the areas of cancer and cardiovascular diseases; safety and quality control issues; the regulatory and educational framework of TCM in Canada; and the latest findings in agricultural, chemical, and pharmacological research on ginseng from all over the world. The meeting successfully provided a platform for constructive discussions on TCM practices and research and education in Canada and the world.
Traditional Chinese medicine (TCM) is gaining popularity as a form of complementary and alternative medicine. Reports of efficacy of TCM are increasing in numbers. TCM includes both crude Chinese medicinal materials (plants, animal parts and minerals) and Chinese proprietary medicine (CPM) [final dosage forms]. Despite the belief that CPM and herbal remedies are of natural origin, unlike Western medicine, and are hence safe and without many adverse effects, there have been numerous reports of adverse effects associated with herbal remedies. Factors affecting the safety of herbal medicines include intrinsic toxicity, adulteration, substitution, contamination, misidentification, lack of standardisation, incorrect preparation and/or dosage and inappropriate labelling and/or advertising. Hence, new regulations on the control of CPM were enforced in Singapore with effect from 1 September 1999. These include licensing and labelling requirements, as well as control of microbial contamination. This article also reviews reports of excessive toxic heavy metals and undeclared drugs in CPM in Singapore between 1990 and 1997. The names, uses, toxic heavy metal or drug detected and the year of detection are tabulated. Information on the brand or manufacturer's name are provided whenever available. The public and healthcare professionals should be better informed of the basic concept of TCM and its usefulness, as well as the potential adverse effects associated with its use. Greater control over the safety and quality of CPM could be achieved through good manufacturing practice, regulatory control, research, education, reporting usage of Chinese medicine (as in drug history) as well as reporting of adverse events.
Polycyclic aromatic hydrocarbons (PAHs) and N-nitrosamines (NNA) are mainly activated by cytochrome P450s, and their associated enzyme activities such as aryl hydrocarbon (benzo(a)pyrene) hydroxylase (AHH), N-nitrosdimethylamine N-demethylase I (NDMA-dI), NADPH-cytochrome C reductase, and detoxified by glutathione S-transferase (GST) and glutathione (GSH). The present study shows the influence of Cymbopogon proximus (Halfa barr), Zygophyllum coccineum L. (Kammun quaramany), Lupinus albus (Termis) as herbs capable of inducing hypoglycemia on the activity of the above mentioned enzymes in the liver of diabetic rats. Alloxan was administered as a single dose (120 mg/kg body weight) to induce diabetes and the herbs were administered to diabetic rats as repeated doses for 4 weeks. Alloxan-induced diabetes significantly increased the blood glucose level by 93% compared to the control level. On the other hand, repeated-dose treatments of diabetic rats with Cymbopogon proximus and Lupinus albus are more effective than Zygophyllum coccineum in restoring the elevated blood glucose level to the normal level. Alloxan treatment increased the hepatic activity of cytochrome P450, NADPH-cytochrome C reductase, AHH, NDMA-dI, GST and GSH by 112, 122, 82, 99, 64 and 26%, respectively. These herbs decreased the activity of above mentioned enzymes in the liver of diabetic rats compared to alloxan-treated rats. We conclude that alloxan increased the activity of cytochrome P450 system and that such herbs reduced these activities. The toxic effects of PAHs (e.g. benzo(a)pyrene) and NNA (e.g. N-nitrosdimethylamine) could be increased in the liver of diabetic rats through induction of their corresponding bioactivating enzymes. On the other hand, hypoglycemic herbs could alleviate the deleterious effects of these carcinogens in the liver of diabetic rats since these herbs reduced the hepatic content of cytochrome P450 and other associated enzyme activities compared to the diabetic group. Such alterations in the activity of phase I and II drug-metabolizing enzymes should be considered when therapeutic drugs are administered to diabetic patients since most of drugs are metabolized mainly by the cytochrome P450 system.
Traditional herbal remedies are used as alternative medicine by a large proportion of people worldwide. Herbals are generally perceived as safe, harmless, and free from side effects, but there have been reports of adulteration of Asian herbal remedies with Western pharmaceuticals, a practice that has not hitherto been observed in Africa. The authors present 2 cases from South Africa in which herbal remedies, consumed by patients admitted to hospital, were found to be adulterated with commercially available Western medicines. The adulterants were identified using high-performance liquid chromatography with a photodiode array detector and gas chromatography-mass spectrometry. The authors alert clinicians to the fact that adulteration of herbal remedies may become more common and should be considered, especially in cases where the symptoms are confusing in light of the history.
Little is known about the underlying intentions to use herbal medicines among Hispanic older adults. Understanding these intentions is critical to the provision of effective counseling.
The objectives were to (1) identify predictors of the intention to use herbal medicines for health problems in the next 6 months among Hispanic and non-Hispanic older adults using the Theory of Planned Behavior (TPB); and (2) compare their beliefs underlying significant predictors of intention with use herbal medicines for health problems in the next 6 months.
Using a cross-sectional research design, data were collected via self-administered questionnaires from convenience samples at a Senior Health Clinic and a Veterans Affairs Hospital outpatient pharmacy. Study subjects were community dwelling adults aged 65 years and older and able to complete the survey in English. Multiple regression analysis was used to identify the significant predictors of intention to use herbal medicines in the TPB within each ethnicity. Independent t tests were used to compare the beliefs underlying the significant predictors of intention with use herbal medicines across the 2 groups.
For both Hispanic (N=80) and non-Hispanic (N=171) patients, attitudes toward using herbal medicines was the only significant predictor of the intention to use herbal medicines in the next 6 months (Hispanics, Adj. R(2)=0.59, beta=0.78, P<.001; non-Hispanics, Adj. R(2)=0.57, beta=0.66, P<.001). The magnitude of the beta coefficients did not differ significantly between the 2 ethnicities. Compared with non-Hispanics, Hispanics believed that herbal medicines are cheaper, have fewer side effects, work better, and are more convenient to use than other medicines.
Understanding ethnic differences in behavioral beliefs underlying attitudes toward the use of herbal medicines can help pharmacists and other health care professionals in educating and formulating appropriate counseling strategies specific to older patients of different ethnicities.
The alkaloid pattern of Spartium junceum has been investigated. Cytisine, N-methylcytisine, anagyrine, rhombifoline and epi-baptifoline occur as major compounds in most of the samples studied. Considerable quantitative differences were found between various parts of the plant. The alkaloid content changed strongly dependent on the seasons. Only a limited variation can be ascribed to geographical origin.
EDITOR, - We wish to express our concern about the availability of yohimbe preparations on the health food market. We submitted capsules that contained yohimbe extracts (imported from France by Nutramin, Amsterdam) to thin layer chromatography and high performance liquid chromatography and recovered, besides several other alkaloids, at least l mg of yohimbine per capsule. The recommended daily dose of 8-10 capsules would therefore provide at least 8-10 mg of yohimbine a day, and the other alkaloids might also …
A patient with acute interstitial nephritis secondary to ingestion of a Chinese herbal medicine adulterated with mefenamic acid is presented. Following hemodialysis and cessation of the medication the patient's renal function returned to normal. ( Arch Intern Med. 1995;155:211-212 )
Alkaloid content variations were studied in four Spartium junceum populations in different dynamic stages. The highest alkaloid content was found in young plants, in reproductive organs, particularly in seeds, and in the twigs with primary structure. In addition, among the four populations, the highest alkaloid values were noted in the pioneer population, the lowest in the more vigorous population. These alkaloid contents can be interpreted as a defensive strategy of the species, and more specifically, of individuals in the pioneer population, which are the most vulnerable to predators and parasites.
"NATURAL" foods and herbal medicines have gained substantial popularity in the United States during the past two decades. These products often are assumed to be free of toxic side effects and are used in an effort to improve general health and well-being. This report describes a young woman in whom abnormal clotting function and mild clinical bleeding developed as a result of ingestion of an herbal tonic.Report of a Case
A 25-year-old woman consulted her gynecologist because of menometrorrhagia. A small mass was palpated on pelvic examination, and the patient was admitted to the hospital for laparoscopy. A small amount of endometriosis was found, and the mass effect was thought to result from an unusually placed ovary. She was discharged from the hospital but continued to have abnormal menstrual bleeding. Her condition was reevaluated three weeks later, and she was found to have a prothrombin time of 53.4 s
An outbreak of cholinergic poisoning occurred in New York City during a 3-day period. Seven individuals from three families of South American origin were affected. Signs and symptoms of illness included dry skin, hyperthermia, tachycardia, dilated pupils, agitation, and hallucinations. Onset of illness in all cases was temporally associated with consumption of a tea that was labeled "Paraguay Tea" and was purchased from a grocery store specializing in South American foods. Paraguay tea, made from the leaves of the holly, Ilex paraguariensis, contains caffeine and theophylline and is a popular beverage in South America. Samples of the tea analyzed with gas chromatography contained belladonna alkaloids but neither caffeine nor theophylline. An investigation by the New York City Department of Health personnel determined that the tea was from a single lot, imported by one distributor, and sold at one grocery store. Unsold inventories of the tea were quarantined, and no further cases of anticholinergic poisoning were reported.
Hepatitis E is endemic in developing countries and may occur as imported hepatitis in industrialized countries. A 46-year-old Japanese man developed immunoserologically diagnosed acute hepatitis E in Japan 4 months after he had made a trip to China. He had bought a Chinese herbal medicine there, taking it occasionally until approximately 6 weeks prior to the onset of acute hepatitis. Nucleotide sequencing of the 3' terminal region of the viral cDNA amplified from the patient's serum by polymerase chain reaction revealed a high degree of homology (99.8% of 752 nucleotides) with the Chinese strain. Thus, the results of sequencing suggest that his hepatitis E was caused by infection with the Chinese strain, via the Chinese herbal medicine.
Herbal remedies can result in indirect health risks when they delay or replace a more effective form of conventional treatment or when they compromise the efficacy of conventional medicines. Herbal remedies can also be associated with direct health risks. Long-standing traditional experience may tell much about striking and predictable symptoms of acute toxicity but it is a less reliable tool for the detection of reactions which are inconspicuous, develop gradually or have a prolonged latency period, or which occur uncommonly. Another reason why safety claims cannot always be based on traditional empiricism is that not all herbal remedies are firmly rooted in traditional medicine.
The risk of a herbal remedy producing an adverse reaction depends not only on the remedy and its dosage but also on consumer-related parameters, such as age, genetics, concomitant diseases and concurrent use of other drugs. Another important determinant of the toxicity of herbal remedies is their quality.
What is already known about the risks of herbal remedies must be systematically collected, disseminated and acted upon. What is yet unknown must be found out by herbal postmarketing surveillance and experimental research.
Herbal medication use is common in many cultural groups. Because these products are unregulated, the potential for significant toxicity exists. We report a case of aplastic anemia associated with the use of an herbal medication by a 12-year-old boy. On analysis, the herbal medication was found to contain phenylbutazone, which has been strongly associated with the production of similar hematologic abnormalities. The medication was not listed as an ingredient and no warning was present on the box.
Many patients with chronic disease use alternative therapies. Our objective was to investigate complications resulting from the use of Chinese herbal medications containing undeclared prescription drugs, and to analyze these pills.
Medical records of 5 patients with complications were reviewed. Pills from symptomatic and asymptomatic individuals were analyzed for possible content of undeclared prescription drugs.
All pills analyzed contained mefenamic acid and diazepam. Complications related to the presence of these substances included, among others, massive gastrointestinal bleeding.
Chinese herbal medications may contain undeclared prescription drugs including nonsteroidal antiinflammatory drugs and benzodiazepines.
To describe the hepatotoxicity associated with ingestion of the Chinese herbal product Jin Bu Huan Anodyne Tablets (Lycopodium, serratum) and to propose possible mechanisms of injury.
Retrospective analysis.
Academic hepatology units and private practice facilities.
Seven previously healthy patients.
Clinical, laboratory, radiologic, and histologic studies.
Acute hepatitis occurred after a mean of 20 weeks (range, 7 to 52 weeks) of Jin Bu Huan ingestion and resolved in six patients within a mean of 8 weeks (range, 2 to 30 weeks); another patient is currently improving. Hepatitis was associated with symptoms of fever, fatigue, nausea, pruritus, and abdominal pain and with signs of jaundice and hepatomegaly. Biopsy specimens showed that one patient had hepatitis with eosinophils (consistent with a drug reaction) and the other had mild hepatitis, moderate fibrosis, and microvesicular steatosis. Decreasing the Jin Bu Huan dose in one patient improved liver test results. Reusing Jin Bu Huan in two other patients caused abrupt recrudescence of hepatitis.
Jin Bu Huan can cause liver injury. Although the hepatotoxic mechanisms are not defined, they may include hypersensitive or idiosyncratic reactions or direct toxicity to active metabolites. Hepatotoxicity caused by herbal products underscores the toxicity caused by herbal products underscores the importance of national surveillance programs and quality control of the manufacture of these products.
Former reports about too high and from batch to batch changing endotoxin contents in mistletoe preparations and phytopharmaceuticals for parenteral administration correlated with clinically observed side effects led to investigations of the endotoxin content of ABNOBA-viscum. For that purpose the endotoxin levels of the raw materials, the equipment and the production steps were observed by using the limulus amebocyte lysate (LAL) test. The mean value found in the preparation containing the highest available concentration (dilution level 2 containing 15 mg of plant extract from 20 mg of fresh mistletoe in 1 ml) came to 66.7 endotoxin units (EU) per ml, corresponding to about one fifth of the commonly accepted limit value of 350 EU/ml, the human pyrogenic dose. Depending on their dilution level, lower concentrated preparations led also to lower LAL test results. It could be proved that lectins contained in mistletoe preparations cause false positive LAL tests. Such results implicate false too high contents of endotoxin. Different lysates, i.e. Limusate, Pyrogel, Pyrogent, and Pyroquant showed approximately the same results. Microbiological and LAL test results indicate that only 10% of the total amount of the LAL test result was caused by endotoxins. So it is necessary to form a new estimation of the former results of determination of the endotoxin content of mistletoe preparations.
In this manuscript the chemical and pharmacokinetic evaluation of a doping case associated with the use of an Ephedra-labelled dietary supplement is reported. The urine of a Dutch professional cyclist was found to be positive for norpseudoephedrine at a doping control. An inquiry revealed that the cyclist had consumed a liquid herbal food supplement with Ephedra as one of its 15 declared ingredients. Chemical analysis revealed concentrations of 6.8-8.2 mg/ml of norpseudoephedrine and 0.02-0.03 mg/ml of ephedrine in several batches, which could have caused the positive doping test. Since the International Olympic Committee (IOC) list of doping substances comprises several substances which occur naturally in botanicals, doping agents like ephedrines and/or caffeine may be taken unwittingly in the form of herbal food supplements. In this case, the predominance of norpseudoephedrine over ephedrine was explained by spiking with norpseudoephedrine, showing that adulteration of herbal food supplements with undeclared agents also have to be taken into account. Our report demonstrates a need for improved quality control of herbal food supplements.
Links-draaiend tetrahydropalmatine in Chinese tablet
- De Smet
- Pagm Elferink
- F Verpoorte
- PAGM Smet De
Drug development from natural products
- Anonymous
- Anonymous
Listeriosis traced to the consumption of alfalfa tablets and soft cheese
- J M Farber
- A O Carter
- P V Varughese
- F E Ashton
- E P Ewan
- JM Farber
Lethal ingestion of Chinese herbal tea containing Ch’an Su
- R J Ko
- M S Greenwald
- S M Loscutoff
- A M Au
- Br
- R A Kreutzer
- W F Haddon
- T Y Jackson
- F O Boo
- G Presicek
- RJ Ko
Anthranoid-containing human medicines
- Anonymous
- Anonymous
Hemorrhagic diathesis caused by drinking an herbal tea
- Iii Hogan
- Rp
- RP Hogan III
Remedies may contain cocktail of active drugs
- B I Van Der Stricht
- O E Parvais
- R J Vanhaelen-Fastré
- M H Vanhaelen
- BI Stricht Van der