藏药十味诃子丸的质量控制

Quality Control of Tibetan Medicine Shiwei Hezi Pills

摘要:

目的：建立藏药十味诃子丸的质量控制方法。方法：采用显微鉴别和薄层色谱法进行定性鉴别，采用HPLC法测定羟基红花黄色素A和没食子酸的含量。结果：通过显微可鉴别出红花和诃子；TLC法可鉴别出诃子、红花、山矾叶、紫草茸、獐牙菜和藏茜草及其活性成分的特征斑点；羟基红花黄色素A回归方程为Y=2.526 3×10⁶X-1.1957×10⁴（r=0.999 7）线性范围0.013 6~0.271 7 μg；没食子酸方程Y=3.052 9×10⁶X-9.392×10³（r=0.999 7），线性范围0.157 9~0.947 5 μg；平均回收率分别为99.9%，99.1%；RSD分别为2.2%，1.6%（n=6）。结论：建立的方法可全面控制十味诃子丸的质量，鉴别方法专属性强，定量方法准确，可有效控制该制剂的质量。

Abstract:

Objective: To establish a method for quality control of Tibetan Medicine Shiwei Hezi Pills. Method: Traditional Tibetan medicine in prescription were identified by a series of Microstructure and TLC methods. Hydroxysafflor yellow A;gallic acid was determined by HPLC.The separation was performed on Phenomenex C₁₈ column (4.6 mm×250 mm, 5 μm). Result: The linear range of Hdroxysafflor yellow A and gallic acid was within the range of 0.013 6-0.271 7 μg and 0.157 9-0.947 5 μg.The average recovery was 99.9% and 99.1, the RSD was 2.2%.and 1.6%. Conclusion: The method can be applied to the quality control of Shiwei Hezi Pills.