HPLC法测定牛黄解毒片的溶出度

Determination of the Dissolution rate of Niuhuang Jiedu Tablet by HPLC

目的:建立牛黄解毒片中黄芩苷溶出度测定方法。方法:以10%的乙醇为溶出介质,转速为100 r·min^(-1),取样时间为60 min。采用HPLC法,色谱柱为C18柱;流动相为甲醇-水-磷酸(44:56:0.2);检测波长为315nm。测定累积溶出百分率,绘制溶出曲线,并进行样品的溶出度测定。结果:黄芩苷浓度在0.0205～0.1432 mg·mL^(-1)范围内有良好的线性关系(r=0.9998);平均回收率为98.75%,RSD为0.47%。不同批次,不同片剂类型的牛黄解毒片溶出度差异大。结论:该方法简便、可行,重现性好,可用于牛黄解毒片质量控制。

Objective:To develop a method for determination of baicalin dissolution in Niuhuang Jiedu Tablets.Methods:10% ethanol was used as the dissolution medium,the rotating speed was 100 r·min-1,the sampling time was 60 minutes.The HPLC separation was performed on a Capcell Pak C18(4.5×150 mm,5 μm).The mobile phase was methanol-waterphosphoric acid(44:56:0.2);the detection wavelength was 315 nm.The cumulative dissolution curve was ploted by determinating the cumulative dissolution percentage.Results:The linear range was 0.0205~0.1432 mg·mL^-1,the average recovery was 98.75% and the RSD was 0.47%. There were considerable dissolution differences of Niuhuang Jiedu Tablet among different batches and types.Conclusion:The method is simple,viable and reproducible,which can be applied for the quality control of Niuhuang Jiedu Tablet.