痤疮胶囊质量标准的制定

Quality standard of Cuochuang Capsule

目的：建立痤疮胶囊质量标准。方法：用TLC法对痤疮胶囊中的黄柏、大黄、丹参进行鉴别；用HPLC法对痤疮胶囊中盐酸小檗碱的含量进行测定：结果：薄层色谱中，供试品溶液色谱在与对照药材或对照品色谱相应位置上出现相同颜色的斑点，阴性对照无干扰；高效液相色谱中，盐酸小檗碱在0．02094—0．3141μg范围内线性关系良好，r=0．9998，平均回收率98．37％，RSD=1．1％（n=6）。结论：TLC法呈现斑点清晰、特异性强，可用于痤疮胶囊的鉴别；HPLC法简便、快速、精密度高、准确度好，可用于痤疮胶囊的质量控制。

Objective： To establish the quality standard of Cuochuang Capsule. Methods： Cotex Phellodendri ehinesis, Redix Rhizoma Salviae mihiorrhizae and Radix Et Rhizoma Rhei in this prescription were identified by TLC. The content of berberine hydrochloride in Cuochuang Capsules were determined by HPLC. Results： Spots obtained from the test solutions had the same color in reference solution and medical material in the same location, and blank solution had no interference. Berberine hydroehloride showed a good linear relationship at a range of 0. 020 94 -0. 314 1 μg, r = 0. 999 8. The average recovery was 98.37%, RSD = 1.1% （n =6）. Conclusion： In TLC, the spots are very clear and specific to identify the herbal medicines in Cuochuang Capsule. It is simple, quick, highly precise and accurate for HPLC to control the quality of Cuochuang Capsules.