六味地黄丸浓缩丸多指标成分体外溶出度研究

Study on Dissolution in Vitro of Multiple Index Components of Liuweidihuang Concentrated Pill

目的:建立六味地黄丸浓缩丸多指标成分的溶出度测定方法,为该制剂的质量控制提供参考。方法:按照《中国药典》2015版四部溶出测定法中的浆法,以脱气处理的pH=1.2盐酸-氯化钠溶液为溶出介质,温度保持在(37±0.5)℃,转速100r·min-1。采用HPLC测定莫诺苷、马钱苷和丹皮酚的含量,流动相乙腈(A)-0.3%磷酸(B),体积流量1mL/min,检测波长为240nm(莫诺苷)、240nm(马钱苷)、274nm(丹皮酚)。结果:莫诺苷、马钱苷和丹皮酚的累积溶出度在2h内都达到了65%以上。结论:该溶出度测定方法简便准确、重复性好,适用于六味地黄丸的质量控制。

Objective:In order to provide reference for quality control of liuwei dihuang pill,a method for determination of dissolution degree of multiple index components in concentrated pills was established.Methods:According to the"Chinese pharmacopoeia"in 2015 edition of 4 dissolution determination of the pulp method,The degitated PH1.2 hydrochloric acid-sodium chloride solution was used as the dissolution medium,and the temperature was maintained at(37±0.5)℃and the rotation speed was 100 r·min-1.HPLC was used to determine the contents of morroniside,loganin and paeonol,mobile phase acetonitrile(A)-0.3%phosphoric acid(B),volume flow rate was 1 mL/min,and the detection wavelength was 240 nm(morroniside),240 nm(loganin)and 274 nm(paeonol).Results:The cumulative dissolution rates of morroniside,loganin and paeonol all reached over 65%within 2 h.Conclusion:This method is simple,accurate and reproducible,and is suitable for quality control of liuwei dihuang pills.