血塞通滴丸溶出行为研究

Study on Dissolution Behavior of Xuesaitong Dropping Pills

关键词:  血塞通滴丸  溶出行为  溶出曲线  相似因子

Key words:  Xuesaitong dropping pills  dissolution behavior  dissolution curve  similarity factor

摘要:

目的 考察血塞通滴丸中三七皂苷R¹、人参皂苷Rg¹、人参皂苷Re、人参皂苷Rb¹、人参皂苷Rd在不同溶出介质中的溶出行为。方法 采用小杯法,以水、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液为溶出介质,体积200 mL,转速50 r?min_-1。采用HPLC测定血塞通滴丸中5种成分的累积溶出量。绘制溶出曲线图,并通过f²相似因子法进行溶出度比较。对溶出数据进行模型拟合,确定血塞通滴丸的最佳溶出模型。结果 在水中,不同厂家及批号的血塞通滴丸5种指标成分溶出行为差异性较小,15 min溶出达到平衡,同一样品5种指标成分的溶出呈现同步性。在pH 4.5醋酸盐缓冲液中,同一种成分批次间差异较小;同一样品中人参皂苷Rb¹与人参皂苷Rd较其他3种成分溶出量低。在pH 6.8磷酸盐缓冲液中,其溶出行为存在显著性差异。各厂家及批次血塞通滴丸指标成分的溶出数据拟合结果略有不同,主要以Weibull模型最佳。结论 血塞通滴丸在水中更有利于其指标成分的溶出,偏碱性溶液对指标成分的溶出影响较大。该研究准确可靠,可用于血塞通滴丸的质量控制,同时也为其质量一致性评价研究及工艺改进提供了数据基础。

Abstract:

OBJECTIVE To investigate the dissolution behavior of notoginsenoside R₁, ginsenoside Rg₁, ginsenoside Re,ginsenoside Rb₁ and ginsenoside Rd in Xuesaitong dropping pills in different dissolution mediums. METHODS The small cup method was adopted with 200 mL water, pH 4.5 acetate buffer and pH 6.8 phosphate buffer as dissolution medium at a rotate speed of 50 r?min^–1. The cumulative dissolution of 5 components in Xuesaitong dropping pills was determined by HPLC. The dissolution curves were drawn and the dissolution rates was evaluated by f₂ similarity factor. The dissolution data were fitted to determine the optimal dissolution model of Xuesaitong dropping pills. RESULTS The dissolution behavior in water had little difference in the dissolution behavior of 5 components in Xuesaitong drop pills from different manufacturers and batches, and reached equilibrium in 15 minutes. The dissolution of 5 index components in the same sample was synchronous. In pH 4.5 acetate buffer solution, there was little difference between batches of the same component. The contents of ginsenoside Rb₁ and ginsenoside Rd in the same sample were lower than those of the other three components. In pH 6.8 phosphate buffer solution,there were significant differences in the dissolution behavior. The dissolution data fitting results of Xuesaitong dropping pills from different manufacturers and batches were slightly different and the best one was Weibull model. CONCLUSION Xuesaitong dropping pills in water was more conducive to the dissolution of indicators. The partial alkaline solution has a great influence on the dissolution of index components. The study was accurate and reliable, and can be used for the quality control of Xuesaitong dropping pills. It also provided a data base for the study of quality consistency evaluation and process improvement.