妇科止带片药品质量标准提高研究

Study on Improving Quality Standards of Fukezhidai Tablets

目的:提高妇科止带片质量标准。方法:采用理化方法鉴别方中山药、阿胶及龟甲,取消了专属性较差的黄柏中的盐酸小檗碱、五味子中柠檬酸的理化鉴别,增加了专属性较强的五味子薄层色谱法检识,采用高效液相色谱法检测方中君药黄柏有效成分盐酸小檗碱的含量。结果:薄层色谱法鉴别五味子,斑点清晰,无干扰;盐酸小檗碱含量测定线性关系良好,重现性、精密度、稳定性良好,加样回收率平均100.8%、RSD1.7%。结论:提高后方法更有利于妇科止带片的质量控制。

Objective：To improve the quality standards of Fukezhidai tablets. Methods：The physical and chemical methods that can identify the yam,donkey - hide gelatin and shells of the compatibility had replaced those of the poor specificity of berberine hydrochloride in Huangbai and the citric acid in schisandfin;the specific TLC of schisandrin had been added and the HPLC detection of compatibility active ingredient berberine hydrochloride of drug -jun Huangbai had been used. Results： The identification of TLC of schisandrin was clear;the determination of berberine hydrochloride was in good linear relationship and its reproducibility, precision, stability were good;the average recovery was 100. 8% and RSD 1.7%. Conclusion： The method is more conducive to the quality control of Fukezhidai tablets than the former.