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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 the determination of the dissolution of multi-index components in the six-flavored glycosides, which provides a reference for the quality control of the preparation. Methods: The contents of morroniside, loganin and paeoniflorin were determined by HPLC. The mobile phase was eluted with gradient elution of water (A) -methanol (B) -acetonitrile (0-10 min, 76% A, 20% B , 4% C; 10 ~ 30 min, 76% ~ 69% A, 20% ~ 27% B, 4% C). The detection wavelength was 236 nm. Using small cup method, taking water as the dissolution medium, the dissolution rate of morroniside, loganin and paeoniflorin in the six-flavored glycosides tablets was determined. RESULTS: The linear ranges of morroniside, loganin and paeoniflorin were 4.87 ~ 155.75, 4.86 ~ 155.35 and 2.83 ~ 180.85 mg · L -1, respectively. The average recoveries were 99.88% (RSD 1.6%) and 101.10 % (RSD 1.8%) and 100.20% (RSD 1.4%). The cumulative dissolution of each component within 90 min were> 75%. CONCLUSION: The cumulative dissolution rates of morroniside, loganin and paeoniflorin in the samples of lotin and glycosides from Liuweidihuang glycosides are small. The dissolution method is simple and accurate, good repeatability, and is suitable for the quality control of six-glycosides glycosides.