基于溶出-液相在线联用系统研究藿香正气丸(浓缩丸)中两种成分体外释放行为

Study on the in vitro release behavior of two components in Huoxiang Zhengqi pills(concentrated pills)by dissolution-liquid phase on-line coupled system

目的:探讨研究并建立藿香正气丸(浓缩丸)体外溶出测定方法,并对其溶出情况进行评价,为该品种的体外溶出评价提供依据。方法:采用溶出-液相联用方法测定藿香正气丸(浓缩丸)中橙皮苷和甘草酸铵两种目标成分的累积溶出量并绘制溶出曲线图,利用不同的数据模型对溶出数据进行模型拟合,确定藿香正气丸(浓缩丸)的最佳溶出模型。结果:在人工肠液和pH 6.8磷酸盐缓冲液中,不同批次的藿香正气丸(浓缩丸)两种目标标成分溶出行为差异性较小,藿香正气丸(浓缩丸)中两种目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:藿香正气丸(浓缩丸)在pH 6.8磷酸盐缓冲液中更有利于考察目标成分的溶出情况,该研究准确可靠,可用于藿香正气丸(浓缩丸)的质量控制,同时也为其质量一致性评价研究及工艺的分析改进提供了数据支撑。

The article explores and establishes a method for determination of dissolution in vitro of Huoxiang Zhengqi pills(concentrated pills),and evaluates their dissolution status,so as to provide a basis for evaluation.The cumulative dissolution of hesperidin and ammonium glycyrrhizinate in Huoxiang Zhengqi pills(concentrated pills)is determined by dissolution-liquid chromatography,and the dissolution curves are drawn.The dissolution data are fitted by different data models to determine the best dissolution model for Huoxiang Zhengqi pills(concentrated pills).The results show that there is little difference in the dissolution behavior of the two target components in different batches of Huoxiang Zhengqi pills(concentrated pills)in artificial intestinal fluid and pH 6.8 phosphate buffer solution,and the Weibull model is the best.Huoxiang Zhengqi Pills(concentrated pills)in pH 6.8 phosphate buffer solution are more conducive to investigating the dissolution of target components.This study is accurate and reliable,and can be used for quality control of Huoxiang Zhengqi Pills(concentrated pills),and also provides data support for its quality consistency evaluation research and process analysis and improvement.