三七益肾颗粒质量标准研究

Study on quality standards of Sanqi Yishen Granule

目的:建立三七益肾颗粒的质量标准,为控制该制剂质量提供检验依据。方法:采用TLC法对三七益肾颗粒中的金银花、马鞭草、紫花地丁、甘草4味药材进行定性鉴别,采用HPLC法对三七益肾颗粒中的人参皂苷Rb1、羟基红花黄色素A和丹酚酸B进行定量测定。结果:TLC方法色谱斑点清晰,分离度好,结果明显,并且不同成分的阴性样品没有干扰;人参皂苷Rb1、羟基红花黄色素A和丹酚酸B进样量分别在0.175-16.484μg、0.03007-7.5180μg、0.09264-15.44μg范围内与峰面积线性关系良好,r>0.9999,平均加样回收率分别为100.80%、98.27%、100.63%(n=9)。结论:该方法操作过程简便,结果准确、可靠,重现性好,可有效控制三七益肾颗粒的质量。

Objective： To develop a quality standard of Sanqi Yishen Granule for quality control. Methods： Thin layer Chromatography（TLC） was used as qualitative identification for honeysuckle bud and flower, European verbena herb, Tokyo violet herb and liquorice root while high performance liquid phase（HPLC） methods were established for quantitative determination of ginsenoside Rb1, hydroxyl-safflor yellow A and salvianolic acid B in this granules. Results： TLC spots was distinct with good resolving power, and no interference was found in different components of the negative samples. Sample size of ginsenoside Rb1, hydroxyl-safflor yellow A and salvianolic acid B was within 0.175-16.484 μg, 0.03007-7.5180 μg and 0.09264-15.44 μg respectively with good linear relationship between peak area, r0.9999, and the average sample recovery rate was 100.80%, 98.27% and 100.63% respectively（n=9）. Conclusion： This method could control the quality of Sanqi Yishen Granule effectively with accurate and reliable results, as well as good reproducibility.