小儿清肺分散片溶出度测定方法的建立

Establishment of Determination for Dissolution of Xiao'er Qingfei Dispersible Tablets

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 determining dissolution of baicalin in Xiao＇er Qingfei dispersible tablets and to provide a reference for quality control of this preparation. Method： HPLC was employed to determine the content of baicalin with mobile phase of methanol-water-phosphate （47： 53： 0.2） and detection wavelength of 280 nm. Taking dissolution of baicalin at the same time as index, single factor tests were adopted to investigate rotation rate, dissolution medium and method, difference of dissolution between Xiao＇er Qingfei dispersible tablets and Xiao＇er Qingfei tablets. Result： Baicalin had a good linear relationship in the range of 0. 025-0. 125 g ·L^-1 with r of 0. 999 9 and average recovery of 100.41%. The paddle was adopted to determine dissolution of Xiao＇er Qingfei dispersible tablets with pH 6. 8 phosphate buffer as dissolution medium, rotation rate of 75 r ·min^-1 and sampling time of 40 min. Cumulative dissolution of Xiao＇er Qingfei dispersible tablets was more than 70% in 15 min, while it was 40% for ordinary tablets. Conclusion： This method is reliable, reproducible and suitable for dissolution determination of baicalin in Xiao＇er Qingfei dispersible tablets.