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葛连解糖颗粒的质量标准研究

         

摘要

目的:建立葛连解糖颗粒的定性鉴别和含量测定方法.方法:采用薄层色谱法对葛连解糖颗粒中葛根、黄连、胡芦巴、枸杞子、地黄等进行定性分析;采用高效液相法,建立葛连解糖颗粒中葛根素、盐酸小檗碱的含量测定方法.结果:建立的薄层色谱鉴别方法,分别能检出葛根、黄连、枸杞子、地黄、胡芦巴药材,薄层斑点清晰,阴性对照均无干扰.葛根素进样量在21.1 ~337.6ng(r=0.9999),盐酸小檗碱进样量在43.1 ~ 689.9 ng范围内线性关系良好(r =0.999 9);葛根素平均回收率为97.21%,RSD为1.41%(n=6),盐酸小檗碱平均回收率为96.18%,RSD为1.22%(n=6).结论:所建方法定性专属性强,定量准确度高,可用于葛连解糖颗粒的质量控制.%Objective: To establish the quality standards of Gelian Jietang granules. Methods: Puerariae labatae radix, Coptidis rhizome, Trigonellae semen, Lycii fructus and Rehmanniae radix were identified by TLC. The contents of puerarin and berberine hydrochloride were determined by HPLC. Results: Puerariae labatae radix, Coptidis rhizome, Trigonellae semen, Lycii fructus. and Rehmanniae radix were identified by TLC in Gelian Jietang granules. The calibration curves of puerarin and berberine hydrochloride were linear in the ranges of 21. 1 -337.6 ng (r =0. 999 9) and 43. 1 ~ 689. 9 ng ( r = 0. 999 9) , respectively. The average recoveries of puerarin and berberine hydrochloride were 97.21% (RSD = 1.41%, n=6) and 96. 18% (RSD=1.22%, n=6), respectively. Conclusion: The established method is specific and accurate, and can be used for the quality control of Gelian Jietang granules.

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