Research progress in quality control of Bufonis Venenum in preparations / 中国中药杂志

Bufonis Venenum, an animal medicinal material, is widely used for treating cardiovascular diseases and pain induced by rheumatics or malignant tumors. In view of the high activity and high toxicity, it is of great significance to pay attention to the quality control of Bufonis Venenum to ensure the safety and effectiveness of its preparations. China's drug standards involve 102 preparations(474 batch numbers) containing Bufonis Venenum approved for sale, including 14 preparations in the Chinese Pharmacopoeia(2020 edition) and 68 preparations in the standards issued by the Ministry of Health Drug Standard of the People's Republic of China. Bufonis Venenum is mostly used in pill and powder preparations in the form of raw powder, with the main functions of clearing heat, removing toxin, relieving swelling and pain, replenishing qi, activating blood, opening orifice, and awakening brain. Except the high level of quality control for Bufonis Venenum in the preparations in the Chinese Pharmacopoeia(2020 edition), the quality control standards of Bufonis Venenum in other preparations are low or even absent. Therefore, it is urgent to conduct research on the improvement of quality standards for the preparations containing Bufonis Venenum. This study retrieved the reports focusing on the quality evaluation and quality control of the preparations containing Bufonis Venenum from CNKI, PubMed, and Web of Science. Qualitative and quantitative analysis methods for 64 preparations containing Bufonis Venenum have been reported, mainly including thin-layer chromatography, HPLC fingerprint, and multi-component content determination. The index components mainly involved bufadienolides, such as gamabufalin, arenobufagin, bufotalin, bufalin, cinobufagin, and resibufogenin. According to the literature information, this paper suggests that attention should be paid to the correlations between the analysis methods and detection indexes of medicinal materials, decoction pieces and preparations, the monitoring of indole alkaloids, and the content uniformity inspection for further improving the quality standards for the preparations containing Bufonis Venenum.

Rapid and quantitative determination of multiple quality indicators (indole alkaloids, etc.) in concentration process of Bufo bufo gargarizans Cantor extract using fourier transform near infrared spectroscopy and chemometrics / 中国药学杂志

OBJECTIVE: To investigate the application of near infrared spectroscopy in rapid and quantitative determination of multiple quality indicators in concentration process of Bufo bufo gargarizans Cantor extract. METHODS: NIR transmission spectra of concentrated solutions were collected in rectangular quartz cuvette with different optical pathlengths (2 and 5 mm). Calibration models of density, water content and indole alkaloids were developed by partial least squares regression (PLSR). The established models were applied to predict the unknown samples to test the performance of the models. RESULTS: The correlation coefficients of the density, water content and indole alka. The residual predictive deviations (RPD) were all above 3, and the relative standard errors of predictions(RSEP) were less than 10%, indicating the satisfactory model performance and predictive ability. Moreover, better calibration results were obtained with an optical path length of 2 mm for density and water content, and 5 mm for indole alkaloids. The results revealed that the optical path length has influence on the NIR analysis results, and the appropriate path length for the NIR analysis should be determined by comparison analysis. CONCLUSION: NIR spectroscopy technique provides a novel efficient and environmental friendly approach for the fast simultaneous determination of three key quality indicators (density, water content and indole alkaloids) in the concentration process of Bufo bufo gargarizans Cantor extract. Copyright 2012 by the Chinese Pharmaceutical Association.