牛黄蛇胆川贝片质量标准研究

Study on Quality Standard for Niuhuang Shedan Chuanbei Tablet

目的：建立牛黄蛇胆川贝片的质量标准。方法：采用薄层色谱法对牛黄蛇胆川贝片中的人工牛黄、蛇胆汁、川贝母进行定性鉴定;采用高效液相色谱法对人工牛黄中胆酸的含量进行测定。结果：人工牛黄、蛇胆汁、川贝母的薄层色谱斑点清晰、分离度好,且阴性无干扰。胆酸的进样量在0.42~5.04μg范围内呈现良好的线性关系（r=0.999 7）,精密度、稳定性、重复性试验的RSD〈2%,平均加样回收率为97.75%,RSD=0.71%（n=9）。结论：所建标准可有效控制牛黄蛇胆川贝片的质量。

Objective： To establish the quality standard of Niuhuang Shedan Chuanbei Tablets. Methods： TLC was used for identify Bovis calculus artifactus, Serpatil fel and Fritillariae cirrhosae bulbus in Niuhuang Shedan Chuanbei Tablets. A HPLC method was used to determine the content, of Cholic acid in NiuHuang Shedan Chuanbei Tablets. Results： TLC spots of them were clear and well-separated without interference from negative control. The linear range of Cholic acid were 0.42 - 5.04 μg（ r = 0.999 7 ）. RSDs of precision, stability and reproducibility tests were lower than 2%. Average recovery was 97.75 % （ RSD = 0.71%, n = 9）. Conclusion： The standard can be used for quality control of Niuhuang Shedan Chuanbei Tablets.