消瘤胶囊的质量标准研究

Study on Quality Standard for Xiaoliu Capsule

目的建立消瘤胶囊的质量标准。方法采用薄层色谱法鉴别处方药材党参、丹参、三棱。采用高效液相色谱测定制剂中的斑螯素含量。结果薄层色谱鉴别在与对照药材相应的位置上，分别显相同颜色的斑点，方法专属性强，阴性对照无干扰。含量测定，斑蝥素的回归方程为：A=630．5569C-8．62857，r=0．9999。浓度在0．09725,--0．778mg／mL范围内线性关系良好。消瘤胶囊中斑蝥素含量拟控制在1．5％以上。结论本方法简便、准确、重现性好，可用于消瘤胶囊的质量控制。

Objective To establish the quality standard for Xiaoliu Capsule. Methods Codonopsis Radix, Salviae miltiorahizae Radix et Rhizoma and Sparganii Rhizoma Tuber were identified by TLC; HPLC method was used to determine the content of cantharidin. Results The TLC spots were quite clear;The calibration curve of cantharidin was linear within the range of 0.097 25 - 0.778 mg/mL,and the regression equation was A=630.556 9C - 8.628 57, （r=0.999 9）.Conclusion The method was simple, accurate and reproducible, and could be used for the quality control of Xiaoliu Caosule.