消乳散结胶囊质量标准研究

Studies on the Quality Standard for Xiaorusanjie Capsule

目的：探究消乳散结胶囊的质量控制方法。方法：使用TLC法对消乳散结胶囊中丹参、香附、当归、黄芩、玄参、牡丹皮进行鉴别;采用HPLC法对白芍及牡丹皮中芍药苷进行了含量测定。结果：在TLC中均能检识出丹参、香附、牡丹皮、当归、玄参、黄芩的色谱斑点,薄层色谱斑点显示清晰,阴性对照无干扰,分离良好;芍药苷在0.1~0.8 ug之间呈良好的线性关系,平均加样回收率为97.95%（n=5）,RSD=1.17%。结论：该方法可行、专属性强、重现性好,可作为消乳散结胶囊的质量控制方法。

Objective： To establish the quality standard for Xiaorusanjie capsule. Methods： Radix Et Rhizoma Saliviae Militiorrhizae, Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Scutellariae, Radix Scrophulariae and Cortex Moutan were identified by TLC. The content of Paeoniflorin in Xiaorusanjie capsule was determined by HPLC. Results： The chromatographic spots were distinct with good reappearance. Paeoniflorin showed a good linear relationship over the range of 0.1-0.8ug, and the average recovery was 97.95 % （n=5） with RSD of 1.I7 %. Conclusion： The methods is rapid, sinpie and accurate. It can be applied as standard for the quality control of Xiaorsanjie capsule.