六味地黄苷糖片多指标成分的溶出度考察

Investigation of Dissolution of Three Components in Liuwei Dihuang Gantang Tablets

目的：建立六味地黄苷糖片中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：采用HPLC测定莫诺苷、马钱苷和芍药苷的含量,流动相水（A）-甲醇（B）-乙腈（C）梯度洗脱（0-10 min,76%A,20%B,4%C;10-30 min,76%-69%A,20%-27%B,4%C）,检测波长236 nm。采用小杯法,以水为溶出介质,对六味地黄苷糖片中莫诺苷、马钱苷和芍药苷进行溶出度测定。结果：莫诺苷、马钱苷和芍药苷的线性范围分别为4.87-155.75,4.86-155.35,2.83-180.85 mg·L^-1,平均加样回收率分别为99.88%（RSD 1.6%）,101.10%（RSD 1.8%）和100.20%（RSD 1.4%）。各成分在90 min内的累积溶出度均〉75%。结论：六味地黄苷糖片批内和批间样品中莫诺苷、马钱苷和芍药苷的累积溶出率差异较小。该溶出度测定方法简便准确、重复性好,适用于六味地黄苷糖片的质量控制。

Objective： To establish a method for determining in vitro dissolution of three components in Liuwei Dihuang Gantang tablets. Method： HPLC was adopted to determine contents of morroniside,loganin and paeoniflorin with the mobile phase of methanol-acetonitrile-water for gradient elution and the detection wavelength at236 nm. Taking water as dissolution medium,cup method was employed to determine in vitro dissolution of these three components. Result： The linear ranges of morroniside,loganin and paeoniflorin were 4. 87-155. 75,4. 86-155. 35,2. 83-180. 85 mg· L^- 1with average recoveries of 99. 88%（ RSD 1. 6%）,101. 10%（ RSD 1. 8%）and 100. 20%（ RSD 1. 4%）,respectively. The accumulation dissolution of each component in 90 minutes was more than 75%. Conclusion： Differences of the accumulation dissolution of morroniside,loganin and paeoniflorin in identical batch and different batches of samples are small. This established method is repeatable for quality control of Liuwei Dihuang Gantang tablets.