Baoxia Fang’s research while affiliated with Hubei University of Chinese Medicine and other places

Background Accurate formulation of an intravenous infusion is critical in ensuring its smooth implementation. However, in clinical practice, owing to the diverse reasons for drug preparation, some patients cannot obtain safe and accurate medications, especially in pediatric infusion rooms. Pediatric patients often experience adverse reactions as the dosage administered does not meet the requirements or exceeds the recommended dose. Methods Finished product infusion of potassium sodium dehydroandrographolide succinate (PSDS) was used as the study drug. Drug residue samples from the finished product infusion bags were collected randomly in the pediatric infusion room and clinical wards before (from October 2022 to December 2022) and after (from May 2023 to July 2023) the plan-do-check-action (PDCA) cycle intervention. High-performance liquid chromatography (HPLC) was used to determine the drug content. Comparisons of the changes in the proportion of the drug in the infusion were made based on the monitoring results. Results After PDCA cycle intervention, the qualified rates of whole, non-whole, and overall infusions increased from 92.95%, 82.68%, and 86.59% to 97.56%, 95.12%, and 96.10% ( P < 0.05), respectively. The accuracy and uniformity of the infusion preparations significantly improved. Conclusions The combination of HPLC and PDCA cycle management can effectively improve the quality of pediatric infusion preparations and enhance their effectiveness.

Background The role of ciprofol as a novel anesthetic in gastrointestinal endoscopic surgery is unclear. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of ciprofol for gastrointestinal endoscopy in patients aged over 65 years and under 65 years, aiming to provide evidence-based information for clinical decision-making. Methods We conducted a search for RCTs(randomized controlled trials) comparing ciprofol and propofol in gastrointestinal endoscopy on databases including PubMed, Embase, Cochrane Library, Web of Science, (China National Knowledge Infrastructure)CNKI, Wanfang, and Vipro Chinese Journal Service up to September 15, 2024. The required information was screened and extracted, and the quality of the included research literatures was assessed using the Cochrane Collaboration risk of bias assessment tool, and Meta-analysis of outcome metrics was performed using Revman 5.4 and Stata software. Results A total of 17 RCTs involving 2800 patients were included, with 1,450 patients in the ciprofol group and 1350 patients in the propofol group. The results of the meta-analysis indicated that there was no statistically significant difference in the sedation success rate or recovery time between the two groups across all age categories. In patients under 65 years old, the induction time of the ciprofol group (MD = 0.41 min, 95%CI: 0.04 min ∼ 0.78 min, P = 0.03) was longer than that in the propofol group. The incidences of hypotension (OR = 0.48, 95%CI: 0.32 ∼ 0.72, P = 0.004), bradycardia (OR = 0.66, 95%CI: 0.49 ∼ 0.87, P = 0.004), injection pain (OR = 0.08, 95%CI: 0.05 ∼ 0.15, P<0.0001), respiratory depression (OR = 0.21, 95%CI: 0.15 ∼ 0.30, P<0.0001), and hypoxemia (OR = 0.29, 95%CI: 0.20 ∼ 0.43, P<0.0001), in the ciprofol group were much lower than those in the propofol group. Conclusion Meta-analysis results indicate that, across various age groups, ciprofol demonstrates a higher safety profile and effectively reduces the incidence of postoperative (ADRs)adverse reactions compared to propofol. However, there is no significant difference in the sedative effects of the two agents. This study categorized elderly patients into subgroups, thereby providing a foundation for the application of ciprofol in gastrointestinal examinations of elderly patients. Consequently, we propose that ciprofol may serve as a safer alternative to intravenous anesthesia compared to propofol; However, this conclusion requires further validation through high-quality studies.

A green, rapid, and simple HPLC-External standard method (ESM) and a quantitative analysis of multi- components with a single-marker (QAMS) method were established for the simultaneous determination of five nitroimidazole antimicrobials (Metronidazole sodium chloride injection, Tinidazole injection, Ornidazole sodium chloride injection, Morinidazole sodium chloride injection, Secnidazole tablets) in pharmaceutical preparations. The five specified drugs were chromatographed via HPLC on a ZORBAX SB-C18 (150 mm×4.6 mm, 5 μm particle size) analytical column using a mobile phase consisting of methanol-0.1% v/v triethylamine (26:74 v/v, pH adjusted to 3.0 with phosphoric acid) with isocratic elution and monitored by photodiode array detector at 316 nm. The chromatographic separation was accomplished within a short run time (less than 20 min) for the studied analyte. Using metronidazole as internal reference, the relative correction factors of each constituent were calculated were established, and the contents of each component of 5 nitroimidazole were calculated to achieve QAMS. The measured results were verified by the ESM. The methods were validated in terms of linearity, intra- and inter-batch precision, accuracy, stability, and recovery. The proposed ESM and QAMS methods could simultaneously determination of the studied analyte, and they were successfully applied to the analysis of the above cited drugs in pharmaceutical preparations with excellent accuracy and precision. In addition, the analytical greenness (AGREE) and blue applicability grade index (BAGI) metric tools were used to evaluate the greenness and environmental friendliness of the developed methods. AGREE scores of QAMS and EMS were 0.66 and 0.59, and BAGI scored 82.5 and 77.5, respectively.

Introduction: Antitussive and expectorant drugs such as aminophylline (APL), doxofylline (DXL), bromhexine hydrochloride (BXH), and ambroxol hydrochloride (AXH), either individually or in combination, are widely used in the prevention and treatment of respiratory diseases. The study aimed to establish a high-performance liquid chromatography (HPLC) method for the simultaneous determination of these four drugs and to investigate their stability in 0.9% sodium chloride injection or 5% glucose injection over 48 hours. Methods: An InertSustain C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile and 50 mmol·L⁻¹ potassium dihydrogen phosphate solution (pH 4.0) with gradient elution. The flow rate was 0.8 mL·min⁻¹, and the column temperature was maintained at 30°C. The stability of APL, DXL, BXH, and AXH in 0.9% sodium chloride and 5% glucose injections over 48 h was determined using HPLC. Results: APL, DXL, BXH, and AXH showed good linearity within the ranges of 0.01 to 0.20, 0.003–0.06, 0.015–0.30, and 0.016–0.16 mg·mL⁻¹, respectively (r > 0.999). The intraday and interday relative standard deviations were <2%, with recovery rates between 98.4% and 102.2%. The four drugs remained colorless and clear in infusion mixtures. The pH value fluctuated within ±0.3 over 48 hours, and the relative percentage content of the drugs ranged from 95.0% to 105.0%. Conclusion: The established HPLC method is simple, reliable, and stable, allowing for the simultaneous determination of the four antitussive and expectorant drugs. APL, DXL, BXH, and AXH were stable within 48 hours when mixed with 0.9% sodium chloride and 5% glucose injections.

Background Dexamethasone in conjunction with type 3 serotonin receptor antagonists are being used to the prevention and treatment of chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting in clinic. The present study aimed to investigates the stability of ramosetron with dexamethasone in infusions, with the goal of enhancing the safety and clinical applicability of their combined use. Methods Ramosetron hydrochloride (3.0 μg/mL) combining with dexamethasone (0.05, 0.1, 0.2 mg/mL) were prepared with 0.9% sodium chloride injection and then packaged in polyolefin bags or glass bottles. The stability were investigated kept in the dark at refrigeration for 14 days and at room temperature for 48 h. Results The concentration of both drugs maintained at least 97% in the various solutions for both storage conditions with light protection. In the light exposure conditions, as the extension of storage time, the concentration of both drugs had declined. All antiemetic mixture solutions remained clear and no changes in color, turbidity, precipitation, and the pH remained stable. The insoluble particles were in line with Chinese Pharmacopoeia. Conclusion Our findings suggest that combinations of ramosetron hydrochloride with dexamethasone sodium phosphate in 0.9% sodium chloride injection remain stable for 14 days at 4°C and 48 h at 25°C when protected from light.

Objective: Patient-controlled intravenous analgesia (PCIA) can alleviate pain to some extent, and several randomized controlled trials (RCTs) have examined the efficacy of esketamine-assisted sufentanil in postoperative PCIA. In this research, we conducted a meta-analysis of relevant RCTs to compare the effect and safety of esketamine-sufentanil versus sufentanil alone for postoperative PCIA. Methods: We systematically searched the Cochrane Library, PubMed, Embase, Web of Science, CNKI, and other libraries up to December 2023 to screen out RCTs examining the use of esketamine combined with sufentanil for PCIA. We analysed analgesia scores, sedation scores, adverse drug reactions and postpartum depression scores as outcome indicators. Results: This meta-analysis included 32 RCTs. The results of the meta-analysis were as follows. 1) Visual Analog Scale: The VAS scores at 6, 12, 24, and 48 h were lower in the esketamine-sufentanil group than in the sufentanil alone group, and significant differences were found at all time points (p < 0.05). 2) Ramsay Sedation Scale: The sedation score of the esketamine-sufentanil group at 48 h after surgery was higher than that of the sufentanil group alone [mean difference (MD) = −0.09 points, confidence interval (CI): (−0.26, −0.07), p = 0.27], but this difference was not significant (p > 0.05). 3) Safety: Compared with sufentanil alone, the incidence rates of postoperative nausea-vomiting, dizziness-headache, skin pruritus and respiratory depression were significantly lower in the esketamine-sufentanil group. 4) Postartum depression: The reduction in postpartum depression scores were significantly greater in the esketamine-sufentanil group than in the sufentanil alone group at 3 days [MD = −1.35 points, CI: (−1.89, −0.81), p < 0.00001] and 7 days [MD = −1.29 points, CI: (−2.42, −0.16), p = 0.03]. Conclusion: The meta-analysis showed that the use of esketamine combined with sufentanil for postoperative PCIA could improve postoperative analgesia, alleviate postpartum depression and reduce the rate of postoperative adverse reactions, but there was no significant difference in sedation.

A green, efficient, sensitive and accurate detection method by HPLC–DAD and LC–MS/MS was developed and validated for the quantification of morphine, hydromorphone, oxycodone, ketamine tramadol, dezocine, ropivacaine, remifentanil, butorphanol, bupivacaine, droperidol, fentanyl, lornoxicam and sufentanil. The 14 mixtures were chromatographed via HPLC–DAD method which employed 0.05 mol/L potassium dihydrogen phosphate solution-acetonitrile as the mobile phase, the analytes were gradient elution on a SinoChrom ODS-BP C18 column with a total separation time of 35 min, and 14 mixtures showed a good linear relationship in the linear range. The Limit of Quantitation (LOQ) ranged from 0.10 to 20.0 µg/mL, the inter-day and intra-day precision of each analyte is within 1.1–2.0% and 0.4–1.3%, and the average absolute recovery of all compounds was above 98%. The LC–MS/MS method was used to successfully separate the 14 mixtures within 10 min which employed 0.1% formic acid-acetonitrile as the mobile phase, the analytes were gradient elution on a ACQUITY UPLC-BEH C18 column with a total separation time of 13 min, and 14 mixtures showed a good linear relationship in the linear range. The LOQ ranged from 0.005 to 0.2 ng/mL, the inter-day and intra-day precision of each analyte is within 1.2–4.1% and 0.6–3.3%, and the average absolute recovery of all compounds was above 93%. The proposed method has been successfully applied in the clinic and provides a strong technical basis for the quantitative detection of these 14 mixtures for detecting drug abuse, and for studying the stability and compatibility of analgesic solutions. The proposed methods were validated against ICH guidelines. Supplementary Information The online version contains supplementary material available at 10.1186/s13065-024-01113-6.

In this study, a new strategy for the simultaneous quantization of five serotonin 5-hydroxytryptamine receptor antagonists—ondansetron, azasetron, ramosetron, granisetron, and tropisetron—either in infusion samples or in injection dosage form was first established based on high-performance liquid chromatography combined with a quantitative analysis of multiple components by a single marker. The quantitative analysis of multicomponents by a single marker method was conducted with ondansetron as an internal reference substance and performed using relative retention time and ultraviolet spectral similarity as the double indicator. The quantitative analysis of the 5-HT3 receptor antagonists was calculated and investigated based on the relative correction factors. Chromatographic separation was achieved using a C18 column (150 mm × 4.6 mm, 5.0 μm), and the mobile phase was composed of acetonitrile-0.05 mol·L−1 potassium dihydrogen phosphate (pH 4.0) (25 : 75) at a flow rate of 1.0 mL·min−1 and detection wavelengths of 307 nm (ondansetron, azasetron, ramosetron), 302 nm (granisetron), and 285 nm (tropisetron). In addition, the accuracy of the quantitative analysis of multicomponents by a single marker method was compared with an external standard method, and no significant difference was observed between the two methods. The established method is rapid, is easy, and does not require many reference substances, and it can been successfully applied as part of the quality control of the five 5-HT3 receptor antagonists in their injection dosage form and infusion sample drugs in hospitals.

Background Loop diuretics are commonly used in clinical practice to manage high fluid loads and to control fluid balance. In this paper, a novel quantitative analysis method for multiple components with a single marker (QAMS) was developed for the simultaneous determination of 5 diuretic drugs furosemide, torasemide, azosemide, etacrynic acid, and bumetanide, by HPLC. Qualitative analysis was performed using relative retention time and ultraviolet (UV) spectral similarity as the double indicator. The QAMS method was conducted with etacrynic acid as an internal reference substance. The quantities of the other four diuretics were calculated by using the relative correction factors for etacrynic acid. The quantities of the 5 diuretic drugs were also determined by the external standard method (ESM). Chromatographic separation was achieved on a Shimadzu HC-C 18 column (150 mm × 4.6 mm, 5 µm) using 50 mM potassium dihydrogen phosphate (pH adjusted to 4.0 with phosphoric acid) with acetonitrile (64:36, v/v) as the mobile phase at a flow rate of 1.0 mL/min and a column temperature of 30 ℃. Results Under these conditions, the 5 diuretic drugs were well separated, showing linear relationships within certain ranges. The quantitative results showed that there was no significant difference between the QAMS and ESM methods. Conclusions Overall, the HPLC-QAMS analytical scheme established in this study is a simple, efficient, economical, and accurate method for the quantitative evaluation of 5 diuretic drugs.

Background: Loop diuretics are commonly used in clinical practice to manage high fluid loads and to control fluid balance. In this paper, a novel quantitative analysis method for multiple components with a single marker (QAMS) was developed for the simultaneous determination of 5 diuretic drugs furosemide, torasemide, azosemide, etacrynic acid, and bumetanide, by HPLC. Qualitative analysis was performed using relative retention time and ultraviolet (UV) spectral similarity as the double indicator. The QAMS method was conducted with etacrynic acid as an internal reference substance. The quantities of the other four diuretics were calculated by using the relative correction factors for etacrynic acid. The quantities of the 5 diuretic drugs were also determined by the external standard method (ESM). Chromatographic separation was achieved on a Shimadzu HC-C18 column (150 mm× 4.6 mm, 5µm) using 50 mM potassium dihydrogen phosphate (pH adjusted to 4.0 with phosphoric acid) with acetonitrile (64:36, v/v) as the mobile phase at a flow rate of 1.0 mL/min and a column temperature of 30 ℃. Results: Under these conditions, the 5 diuretic drugs were well separated, showing linear relationships within certain ranges. The quantitative results showed that there was no significant difference between the QAMS and ESM methods. Conclusions: Overall, the HPLC-QAMS analytical scheme established in this study is a simple, efficient, economical, and accurate method for the quantitative evaluation of 5 diuretic drugs.