血塞通分散片溶出曲线的测定

Determination On the Dissolution Curves of Xuesaitong Dispersible Tablets

目的:"血塞通分散片"现执行标准为国家试行标准(YBZ02702006),无溶出度测定,在转正标准研究时增加了溶出度的测定,并做了方法学验证。方法:采用小杯法,转速为50 r.m in-1,取样时间为30m in,液相法测定溶出度,C18色谱柱,乙腈-水为流动相,梯度洗脱,乙腈-水(20:80),经20m in将乙腈-水变为(40:60);检测波长为203nm;进样量10μL;流速:1mL.m in-1;柱温25℃。结果:测定了9个厂家各1批次样品中人参皂苷Rg1的溶出曲线,不同厂家的样品存在差异。结论:血塞通分散片溶出度项目测定有利于控制药品质量。

Objective ： To establish a method for determination of the dissolution curves of Xuesaitong dispersible tablets and test it. Methods： The small cup method was used with a 100mL of water as dissolution medium at a rotate speed of 50r · min ^-1, and drawing sample solution at 30min. The further determination was carried on HPLC method with Lichrospher C18 column, the mobile phase was acetonitrile （A） and water （B） with gradient elution at the flow rate of 1mL · min^-1. The gradient condition was 0 -20min, A： 20%→40%, B： 80%→60%.The detection wavelength was 203nm, column temperature： 25℃. Results ： The dissolution curves of ginsenoside Rg1 in 9 samples selected from 9 factories were determined and there were some differences in them. Conclusion：The method of the dissolution determination of Xuesaitong dispersible tablets was simple, accurate. It is important for the quality control of Xuesaitong dispersible tablets.