肾石通颗粒质量标准研究

Study on the Quality Standard of Shenshitong Granule

目的建立肾石通颗粒的质量标准。方法采用TLC法对处方中延胡索、丹参、王不留行、牛膝进行定性鉴别；采用HPLC法测定制剂中原儿茶醛的含量。结果TLC法可检出延胡索、丹参、王不留行、牛膝的特征斑点；原儿茶醛的线性范围为0．0143～3．6640μg（r=0．9999），平均回收率98．27％（RSD=2．6％，n=5）。结论该方法简便可靠，专属性强，重现性好，可用作肾石通颗粒的质量控制。

Objective To establish the quality standard of Shengshitong granule. Methods Corydalis yanghusuo, Salviae miltiorrhiza, vaccaria segetalis and Achyranthes bidentata were identified by TLC, and the content of protocatechuis aldehyde in the preparation was determined by HPLC. Results Corydalis yanghusuo, Salviae miltiorrhiza, Vaccaria segetalis and Achyranthes bidentata could be identified by TLC. The linear range of protocatchuis aldehyde was 0. 0143 - 3. 6640μg （r = 0. 9999）, and the average recovery was 98.27% （RSD = 2.6%, n = 5）. Conclusion The method is specific and repeatable, and can be used for the quality control of Shengshitong granule.