根黄分散片溶出度测定方法的研究

目的建立根黄分散片中黄芩苷溶出度的测定方法。方法依据《中国药典》2010版溶出度测定法第1法(篮法),以蒸馏水为溶出介质,转速为100 r.min-1,于不同时间取样,采用RP-HPLC法在波长为280 nm处测定黄芩苷的含量,计算根黄分散片的累积释放度。结果该法加样回收率为97.27%,RSD为0.74%,在1.018~50.9μg.m l-1范围内浓度和峰面积呈良好的线性关系。使用该试验确定的方法,10 min时测定根黄分散片的累积溶出百分率达到标示量的99.10%。结论根黄分散片批内和批间黄芩苷的溶出累积释放百分率差异小,说明该方法简便易行、准确可靠且重现性好,可用于根黄分散片的质量控制。

Determination of the Dissolution of Genhuang Dispersible Tablets

Objective To establish a method for the determination of baicalin dissolution in Genhuang dispersible tablets.Methods According to the Chinese Pharmacopoeia,water was used as the dissolution medium,with speed of 100r·min-1.The content of baicalin was determined at a wavelength of 280nm by RP-HPLC method,and the cumulative release of Genhuang dispersible tablet was calculated.Results The average recovery rate was 97.27% and the RSD was 0.74%.The calibration curve of baicalin was linear in the range of 1.018～50.9 μg·ml-1.With this method,the accumulation dissolution rate of the baicalin in Genhuang dispersible tablets reached 99.10% at 10 minute.Conclusion The difference in the cumulative release percentage of Genhuang dispersible tablets is not significant,so this method is simple,accurate,repeatable,which can be used for the quality control of Genhuang dispersible tablets.