滋阴生发颗粒质量标准

Quality Standard of Ziyin Shengfa Granules

目的:建立滋阴生发颗粒的质量标准。方法:采用薄层色谱(TLC)法对方中制何首乌、枸杞子、丹参进行定性鉴别,采用反相高效液相色谱(RP-HPLC)对方中二苯乙烯苷进行含量测定。结果:在TLC中能检出制何首乌、枸杞子、丹参的特征斑点,阴性样品无干扰。二苯乙烯苷在0.190 5～1.143 2μg与峰面积积分呈良好线性关系(r=0.999 9);平均加样回收率为98.60%,RSD 2.28%(n=9)。结论:方法简单、快速、精密度高、重复性好,所建标准可用于滋阴生发颗粒质量控制。

Objective：To establish the quality standard for Ziyinshengfa Granules.Method：The thinlayer chromatograph（TLC） method was used to identify Radix Polygoni Multiflori Preparata,Fructus Lycii,Radix Salviae Miltiorrhizae and the content of 2,3,4,5’-tetahyd roxy stilbence-2-O-β-D-glucoside was determined by RP-HPLC.Result：The characteristic spots of Radix Polygoni Multiflori Preparata,Fructus Lycii,Radix Salviae Miltiorrhizae appeared in the TLC,and there was no interference for the negative sample.The linear range of 2,3,4,5’-tetahyd roxy stilbence-2-O-β-D-glucoside was 0.190 5-1.143 2 mg·L-1（r = 0.999 9）.The average recovery rates were 98.60%（RSD 2.28%）（n = 9）.Conclusion：This method is simple,rapid,precise and reproducible,thus it can be used for the quality control of Ziyinshengfa Granules.