复方首乌颗粒质量标准研究  

Quality Standard for Compound Shouwu Granule

作　　者：刘敏芳[1] 付萍萍[1] 张月寒[1] 董秋香[1] 景浩然[1] 

机构地区：[1]河北省保定市药品检验所,河北保定071051

出　　处：《中国药业》2008年第1期15-17,共3页China Pharmaceuticals

基　　金：河北省中医药管理局科研计划课题;项目编号:2004035

摘　　要：目的探讨复方首乌颗粒(何首乌、葛根、丹参)的质量标准。方法用薄层色谱法鉴别复方首乌颗粒中的何首乌、葛根及丹参;用高效液相色谱法分别对制剂中的2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷及葛根素进行定量分析。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-O-β-D-葡萄糖苷进样量线性范围为0.01752～0.3504μg(r=0.9999,n=6),平均回收率为100.23%,RSD=1.2%(n=9);葛根素进样量线性范围为0.08160～1.224μg(r=1.0000,n=5),平均回收率为99.75%,RSD=1.3%(n=9)。结论所用方法可靠、准确、专属性强,可有效控制复方首乌颗粒的质量。Objective To establish the quality standard for Compound Shouwu Granule （Radix Polygoni Muhiflori,Radix Salviae Muhiorrhiae, Radix Purerariae）. Methods Radix Polygoni Muhiflori, Radix Salviae Muhiorrhiae, Radix Purerariae in Compound Shouwu Granule were identified by TLC. 2, 3, 5, 4＇-tetrahedroxystilbene- 2- O- β- D- glucoside and puerarin were determined by HPLC. Results The characteristic identification by TLC was distict and highly specific. 2, 3, 5, 4＇-tetrahedroxystilbene-2-O-β-D-glucoside had the linear range of 0. 017 52 - 0. 350 4μg （ r = 0. 999 9, n = 6）. The average recovery rate was 100. 23% and RSD was 1, 2%. Puerarin had the linear range of 0. 08160 -1. 224μg （r=1. 0000, n=5）.The average recovery rate was 99.75% and RSD was 1.3%.Conclusion The method is reliable, accurate and specific. It can be used for quality control of Compound Shouwu Granule. Key words- HPLC;Compound Shouwu Granule;2, 3, 5, 4＇ - tetrahedroxystilbene - 2 - O - β - D - glucoside;puerarin

关 键 词：高效液相色谱法 复方首乌颗粒 2 3 5 4’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷 葛根素 

分 类 号：R286.0[医药卫生—中药学] R284.1[医药卫生—中医学]