消霉栓的质量标准研究

Quality standard of Xiaomei suppository

目的建立消霉栓的质量标准。方法对处方中的苦参、蛇床子、地肤子3味药材采用TLC进行定性鉴别。采用HPLC对处方中的蛇床子所含有效成分（蛇床子素）的含量进行测定。结果在相应的色谱条带中各药材斑点清晰可辨,阴性对照品无干扰;蛇床子素在0.2~1μg范围内,浓度与峰面积的线性关系较好,通过实验数据整理得到其标准曲线为Y=348.08X＋13.240,r=1,平均回收率=97.96%,RSD值为1.05%。结论所建的消霉栓质量标准具有分析方法简便,准确且重现性较强等特点,可作为消霉栓的质量控制方法。

Objective To establish the quality standard of Xiaomei suppository. Methods ophorae Flavescentis Radix,Cnidii Fructus and Kochiae Fructus which in prescriptions are checked by TLC. The content of the active components in Cnidii Fructus is determinated by using HPLC. Results The qualitative discrimination is highly peculiar and the blank test showed no interference; In the range of 0. 2-1 μg linear relationship is well,through the experimental data obtained Y = 348. 08 X ＋ 13. 240,r = 1. The average recovery rate is 97. 96%. The value of RSD is 1. 05%.Conclusion The analysis methods of Xiaomei suppository are simple,feasible,accurate which can be used as the quality control methods of Xiaomei suppository.