An overview of advances in the standardization of herbal drugs

Journal of Pharmaceutical Education and Research 01/2011; 2:55-70.

ABSTRACT Herbal formulations have reached extensive acceptability as therapeutic agents for several diseases. The
development of authentic analytical methods which can reliably profile the phytochemical composition, including
quantitative analyses of marker/bioactive compounds and other major constituents, is a major challenge to
scientists. Standardization is an important step for the establishment of a consistent biological activity, a consistent
chemical profile, or simply a quality assurance program for production and manufacturing of herbal drugs. WHO
specific guidelines for the assessment of the safety, efficacy and quality of herbal medicines as a prerequisite for
global harmonization are of utmost importance. An overview covering various techniques employed in extraction
and characterization of herbal medicines as well as herbal nanomedicines standardization is reported. In
addition, phytosomes increased bioavailability, bhasma as a metal nanocarrier drug delivery system, potential of
metabolomics in the development of improved phytotherapeutic agents, DNA based molecular markers in
distinguishing adulterants, and SCAR markers for authentication and discrimination of herbs from their
adulterants are reported. The extraction of high-valued herbal compounds using microwave–assisted extraction
and supercritical phase extraction technology followed by the standardization utilizing various spectroscopic,
chromatographic and thermogravimetric techniques individually and/or in combination has been discussed in
relation to herbal drugs. Capillary electrophoresis and polarographic techniques contributions towards
standardization of herbal drugs is also reported. Nanotechnology based Chinese herbal drugs possess improved
solubility and enhanced bioavailability.

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    ABSTRACT: Introduction: Amukkirai chooranam (A. chooranam) is an important traditional herbal preparation and its main component is the root powder of Withania somnifera Dunal (Solanaceae). It is the best remedy for rheumatism, weakness, stress, sleeping disorders, gastric ulcer, anaemia, etc. Aims: The goal of this study was to standardize this traditional herbal preparation on the basis of qualitative and quantitative methods. Study Design: Experimental laboratory study on Phytochemical and Pharmacognostic investigations. Place and Duration of Study: The Phytochemical and pharmacognostic investigations were carried out at the Herbal Technology Section, Industrial Technology Institute (ITI), Colombo, Sri Lanka, between Jan 2012 to August 2012. Methodology: The A. chooranam was prepared according to the procedure given in Traditional Text. The preparation has been standardized on the basis of macroscopic and organolepticcharacters, physicochemical properties, phytochemical screening, fluorescence analysis, and elemental analysis, aqueous and ethanol extractive values, TLC and HPLC fingerprint analysis. Data were analysed by statistical software - Statistical Package for Social Sciences (SPSS) version 17. Results: The present study reveals that the A. chooranam was light whitish brown in colour having characteristic odour with bitter taste and smooth texture. The moisture content at 105ºC in A. chooranam was found to be 9.12±0.10%. Analytical results showed total ash, water soluble, acid insoluble and sulfated ash values of 5.76±0.09%, 2.93±0.15%, 0.63±0.04% and 1.92±0.04% respectively. The percentage yields of cold and hot aqueous extractive values (15.02±0.46 & 30.82±1.09) were greater than the percentage yield of cold and hot ethanol extractive values (03.07±0.31 & 10.00±0.22) of A. chooranam. Heavy metal analysis revealed that their concentrations in A. chooranam were below the WHO/FDA permissible limits. Conclusion: A. chooranam exhibits a set of diagnostic characters, which will help to identify the standard preparation and build a monograph of the Siddha pharmacopeia of Sri Lanka.
    European Journal of Medicinal Plants. 02/2015; 5(2).
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    Indo American Journal of Pharmaceutical Research. 10/2014; Volume 4(Issue 10):4042-4046.
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    ABSTRACT: Pharmacognostical standardization of herbal formulation is essential in order to assess the quality of drugs, based on the concentration of their active principles. Vellarugu chooranam is a reputed drug mentioned in the ancient books of Siddha Medicine for the treatment of Vata diseases, arthritis, constipation, and diabetes mellitus. The main component of Vellarugu chooranam is whole plant of Enicostemma littorale Blume (Siddha Name: Vellarugu) (Gentianaceae). In the present study an attempt has been made to standardize the Vellarugu chooranam. For the standardization of this drug Organoleptic properties, Phytochemical screening, Fluorescence analysis, Elemental analysis, Physicochemical parameters such as moisture content, ash values, extractability in water and ethanol were carried out. TLC and HPLC fingerprints of the Vellarugu chooranam were also prepared to evaluate its quality. These set of parameters were found to be sufficient to evaluate authenticity of the Vellarugu chooranam and can be used as reference standards for the preparation of a standardized pharmaceutical product and further quality control researches. INTRODUCTION Plant materials are used throughout developed and developing countries as home remedies, over the counter drug products and raw materials for the pharmaceutical industry, and represent a substantial proportion of the global drug market [1] . Herbal medicines as the major remedy in traditional system of medicine have been used in medical practices since antiquity. The practices continue today because of its biomedical benefits as well as place in cultural beliefs in many parts of the world and have made a great contribution towards maintaining human health. Approximately 60% of the population use herbal medicines to treat medical illnesses. Therefore, reproducible standards of each plant are necessary for effective quality control to prevent adulteration [2] . The subject of herbal drug standardization is massively wide and deep. Standardization is an essential factor for herbal formulation in order to assess the quality of the drugs based on the concentration of their active principle and to ensure that every packet of medicine that is sold has the correct amount and will induce its therapeutic effect [3] . Thus, the present study deals with standardization of Siddha herbal preparation, Vellarugu chooranam is mentioned in the ancient books of Siddha Medicine for the treatment of Vata diseases, arthritis, constipation, and diabetes mellitus [4-5] . The term Chooranam (Powdered herbal preparation for internal use) is applied to the powder prepared by a single or a combination of two or more herbal ingredients [6-7] . Systematic protocols for standardization of Vellarugu chooranam is not available, hence it was decided to evaluate the qualitative and quantitative analysis for Vellarugu chooranam scientifically to prevent its adulteration. For the standardization of this drug Organoleptic properties, Phytochemical screening, Fluorescence analysis, Elemental analysis, and Physicochemical parameters, were carried out. TLC and HPLC fingerprints of the Vellarugu chooranam were also prepared to evaluate its quality.
    International Journal of Ayurveda and Pharma Research. 06/2014; 2(3):44-53.


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