壮腰健肾片的质量标准

Quality Standard for Zhuangyaojianshen Tablets

目的:建立壮腰健肾片的质量标准。方法:建立狗脊、牛大力、黑老虎、金樱子的薄层鉴别方法和原儿茶酸的 HPLC含量测定方法。色谱柱为 Spherigel ODS C_(18)柱(250 mm×4.6 mm,5 μm),流动相为甲醇-0.4%磷酸溶液(10:90),检测波长260nm。柱温:40℃;流速:1.0ml·min^(-1)。结果:在 TCL 色谱中能够检出狗脊、牛大力、黑老虎、金樱子,阴性对照无干扰。原儿茶酸的线性关系良好,平均加样回收率为100.2%,RSD 2.1%。结论:方法简便,可靠,重现性好,可用于壮腰健肾片的质量控制。

Objective： To establish the quality standard for zhuangyaojianshen tablets. Method： The Rhizoma cibotii, Radix millettiae speciosae, Radix kadsurae coccineae and Fructus rosae in the tablets were identified by TLC, the content of protocatechuic acid in the tablets was determined by HPLC. Result： The rhizoma cibotii, rodix millettiae speciosae, radix kadsurae coccineae and fructus rosae could be identified by TLC, the linear range of protocatechuic acid was 0.12 - 0.60μg（ r = 0. 999 9 ）, the average recorery was 100.2% with RSD 2.1%. Conclusion： The method is simple, rapid and reproducible, it can be used for the quality control of zhuangyojianshen tablets.