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目的:建立小儿清肺分散片中黄芩苷的溶出度测定方法,为该制剂的质量控制提供参考。方法:采用HPLC测定黄芩苷的含量,流动相甲醇-水-磷酸(47∶53∶0.2),检测波长280 nm。以同一时间点的溶出度为评价指标,通过单因素试验考察溶出介质、溶出方式及转速对黄芩苷溶出度的影响,比较小儿清肺分散片和小儿清肺普通片的溶出度差异。结果:黄芩苷在0.025~0.125 g·L-1与峰面积呈良好线性关系(r=0.999 9),平均加样回收率100.41%,RSD 3.0%。小儿清肺分散片的溶出度测定采用桨法,以p H 6.8磷酸盐缓冲液为溶出介质,转速75 r·min﹣1,取样时间40 min。小儿清肺分散片在15 min累计溶出度>70%,而小儿清肺片在15 min时累计溶出度刚达40%。结论:本方法操作简便、重复性好,可用于测定小儿清肺分散片中黄芩苷的溶出度。
OBJECTIVE: To establish a method for the determination of baicalin dissolution in children Qingfei Dispersible Tablets to provide a reference for the quality control of the preparation. Methods: The content of baicalin was determined by HPLC. The mobile phase was methanol - water - phosphoric acid (47:53:0.2) and the detection wavelength was 280 nm. Dissolution rate at the same time point was taken as the evaluation index. The effect of dissolution medium, dissolution method and speed on the dissolution of baicalin was investigated by single factor test. The difference of dissolution rate between Qingfei dispersible tablets and ordinary lung tablets was compared. Results: The linear range of baicalin was 0.025 ~ 0.125 g · L-1 with peak area (r = 0.999 9). The average recoveries were 100.41% and 3.0% respectively. Determination of dissolution of children Qingfei dispersible tablets paddle method to p H 6.8 phosphate buffer as dissolution medium, speed 75 r · min-1, sampling time 40 min. Pediatric Qingfei dispersible tablets in 15 min cumulative dissolution of> 70%, while children Qingfei tablets accumulated dissolution at 15 min just reached 40%. Conclusion: The method is simple, reproducible, and can be used to determine the dissolution of baicalin in children Qingfei Dispersible Tablets.