肾炎康胶囊主要原料药质量标准研究

QUALITY STANDARD OF THE MAIN CRUDE DRUGS IN NEPHRITIS CAPSULE

目的建立肾炎康胶囊原料药材(三七、黄芪、益母草、决明子、接骨木)的质量标准。方法采用薄层色谱法(TCL)对肾炎康胶囊中原料药材进行定性鉴别,采用高效液相色谱法测定三七药材中人参皂苷Rb1、Rg1和三七皂苷R1的含量。结果薄层色谱鉴别专属性强;三种皂苷的加样回收率试验的平均回收率分别为98.39%、97.15%、98.32%,RSD分别为1.45、1.17、1.47,符合质量要求。结论所用方法简便、准确,完善了肾炎康胶囊原料药材的质量标准,可作为血利康软胶囊的质量控制标准。

Objective： To establish the quality standards of nephritis capsule raw materials （three seven, astragalus root, motherwort herb, cassia seed, elderberry）.Methods： Using thin layer chromatography （TLC） for the identification of medicinal materials of nephritis capsule, using high performance liquid chromatography method for the content determination of ginseng ginsenoside Rb1, Rg1 and three seven ginsenoside R1.Results： TLC identification has high specificity. The average recovery rates of three kinds of saponins in the recovery test of the added sample are 98.39%, 97.15% and 98.32%, RSD are 1.45, 1.17 and 1.47, respectively, which meets the requirements.Conclusion： The method is simple, accurate, perfects the quality standard of the raw materials in nephritis capsule. It could be used as the control standards of blood Likang soft capsule quality.