化积口服液中红花的质量控制的研究  

Study on Quality Control of Carthami Flos in Huaji Koufuye

作　　者：万林春 王琪 周国平 许妍 赵雯 

机构地区：[1]江西省药品检验检测研究院/江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《中国药物评价》2017年第5期348-350,共3页Chinese Journal of Drug Evaluation

基　　金：江西省社会发展项目(20151BBG70041);项目名称:化积口服液质量标准研究

摘　　要：目的:探讨建立化积口服液中红花的质量检测方法。方法:采用大孔吸附树脂、ODS、凝胶柱色谱法对红花的乙醇提取物进行分离纯化得到对香豆酸,利用理化性质和波谱学手段鉴定其结构;采用HPLC法对化积口服液中的对香豆酸进行测定[使用Wondasil C18色谱柱(4.6 mm×250 mm,5μm),以乙腈-0.2%磷酸(18∶82)为流动相,流速1.0 m L·min-1,检测波长为309nm,柱温30℃]。结果:制备出的对香豆酸纯度达到99.6%,可用以含量测定用;HPLC测定,对香豆酸进样量在0.007~0.35μg范围内线性关系良好,平均回收率为99.4%(RSD=0.9%,n=6)。结论:本研究的香豆酸含量测定方法经方法学考察,方法可行,可用于化积口服液的质量控制。To develop a method for the determination of Carthami Flos in Huaji Koufuye. Column chromatography of Macroporous resin、ODS and Sephadex LH-20 were used to isolate the chemical constituents from alcohol extract of Carthami Flos. Their structures were confirmed on their physic-chemical property and NMR spectroscopic analyses; The content of the active component in Huaji Koufuye,p-coumaric,was determined by HPLC,which was performed on Wondasil C18（250 mm×4.6 mm,5μm） column eluted with acetonitrile-0.2% phosphoric acid（ 18∶82） at the flow rate of 1. 0 mL·min^-1,detected at a wavelength of 309 nm. The column temperature was at 30℃.The purity of p-coumaric acid was prepared at 99.6%, can be used to determine the content. The injection sample of p-coumaric showed a good linear relationship in the range of 0. 007- 0. 35μg, the average recovery（ n = 6） was 99. 4% with RSD of 0 .9%. The p-coumaric content determination method is a feasible method,which can be used for the quality control of Huaji Koufuye.

关 键 词：化积口服液 红花 质量控制 对香豆酸 

分 类 号：R286.0[医药卫生—中药学]