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目的:建立肾复康胶囊的质量标准。方法:采用显微鉴别法对肾复康胶囊中大黄、当归和全蝎进行定性鉴别;采用TLC法对肾复康胶囊中的大黄、何首乌、山茱萸、丹参、川牛膝、黄芪进行定性鉴别;采用HPLC法对制剂中大黄酚的含量。结果:大黄、何首乌、山茱萸、丹参、川牛膝、黄芪薄层色谱斑点清晰、重现性好、专属性强、阴性对照无干扰。含量测定中大黄酚在1.712~17.120μg·ml~(-1)范围内线性关系良好(r=0.999 9),平均回收率为101.2%,RSD=0.34%(n=6)。结论:所建立的定性、定量方法简便易行,重复性好,为肾复康胶囊提供了质量控制方法。
Objective: To establish the quality standard of Shenfukang capsule. Methods: The rhubarb, Angelica sinensis and Scorpio were identified qualitatively by using the method of microscopic identification. The TLC was used to qualitatively identify the Rhubarb, Polygonum multiflorum, Fructus Corni, Radix Salviae Miltiorrhizae, HPLC method for the preparation of chrysophanol content. Result: Rhubarb, Polygonum multiflorum, Fructus Corni, Radix Salviae Miltiorrhizae, Radix Astragali and Radix Astragali have clear spots, good reproducibility, strong specificity and no interference with negative control. The determination of the content of chrysophanol in the range of 1.712 ~ 17.120μg · ml ~ (-1) good linear relationship (r = 0.999 9), the average recovery was 101.2%, RSD = 0.34% (n = 6). Conclusion: The established qualitative and quantitative methods are simple, reproducible, and provide a quality control method for Shenfukang capsule.