复方首乌颗粒质量标准研究

Quality standard of Compound Shouwu Granule

目的:建立复方首乌颗粒(何首乌、马尾莲、冬凌草等)的质量标准.方法:采用TLC法对处方中何首乌、马尾莲、冬凌草进行鉴别;用HPLC法测定2,3,5,4‘-四羟基二苯乙烯-2-0-β-D-葡萄糖苷的含量.结果:定性鉴别分离度好,专属性强;2,3,5,4‘-四羟基二苯乙烯-2-0-β-D-葡萄糖苷的含量测定线性范围为0.04～0.72μg(r=0.9999,n=6);平均回收率为99.44%(RSD=1.3%,n=6);结论:所建立的方法简便、准确可靠,重复性好,可作为复方首乌颗粒的质量控制标准.

AIM:To establish the quality standard of Compound Shouwu Granule (Radix Polygoni multiflori,Radix et Rhizoma Thalictri Baicalensis,Herba Rabdosiae Rubescentis,etc.) METHODS:TLC was performed to identify Radix Polygoni Multiflori,Radix et Rhizoma Thalictri Baicalensis,Herba Rabdosiae Rubescentis.HPLC was used to determine 2,3,5,4'-tetrahydroxystilbene-2-0-β-D-glucoside. RESULTS:The study on the quality control showed that the characteristic of identification by TLC was distinct and highly specific.The quantitative evaluation had the linear range of 0.04-0.72 μg.The average recovery was 99.99% and RSD was 1.3%. CONCLUSION: The method for identification and quantitation was simple,accurate,realizable and reproducible.It can be used effectively for the quality control of Compound Shouwu Granule.