乳癖克胶囊质量标准的研究

A Study on Quality Control of Rupike Capsule

目的建立乳癖克胶囊的质量标准。方法用薄层色谱法对处方中的穿山甲、当归、山楂进行定性分析;用高效液相色谱法对赤芍中的芍药苷进行含量测定。结果在薄层色谱中可检出穿山甲、当归、山楂的特征斑点;芍药苷在0.16~0.80μg范围内线性关系良好,r=0.9999,平均回收率为97.3%,RSD为0.89%。结论所建鉴别方法专属性强,定量方法简便、准确,能有效控制制剂的质量。

Objective To establish a method for the quality standard of Rupike Capsule.Methods Squama Manis,Radix angelicae Sinesis,Fructus Crategi were identified by thin layer chromatography.The content of paeoniflorin in Radix Paeoniae Rubra was determined by high performance liquid chromatography.Results Squama Manis,Radix angelicae Sinesis,Fructus Crategi could be identified by thin layer chromatography.The study showed that spots on high performance liquid chromatography could be well separated.The paeoniflorin result revealed good linearity between the injecion concentration range of 0.16-0.80 μg.The average recovery rate was 97.3%,and RSD was 0.89%.Conclusion This method is simple,accurate,specific and can control the quality of this preparation effectively.