苦参片质量标准的研究  

Study on Quality Standard for Kushen Tablets

作　　者：吕海鸿[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药品标准》2015年第5期353-356,共4页Drug Standards of China

摘　　要：目的：修订完善苦参片的质量标准。方法：修订现行标准的显微鉴别和薄层鉴别；增订高效液相色谱法测定苦参片中苦参碱和氧化苦参碱的总量。结果：显微鉴别中苦参组织特征均易察见；薄层色谱中斑点清晰，专属性强；苦参碱，氧化苦参碱分别在24．2～4840μg（r=0．9999）、20．8～4160μg（r=0．9999）范围内线性关系良好，平均回收率分别为97．53％（RSD为1．17％）、96．97％（RSD为1．35％）。结论：修订后的标准简便、准确，可用于苦参片的质量控制。Objective： To improve the quality standard of Kushen Tablets. Methods ： The micro-identification and TLC identification of the working standard were revised and HPLC determination of total contents of matrine and oxymatrine in Kushen Tablets were added. Results ：The micro-characters of sophora flaveseens radix were easily observed. The sports were fairly clear and visible in TLC. The contents of matrine and oxymatrine showed a good linear relationship in the range of 24. 2 -4 840 μg（ r = 0. 999 9 ） and 20. 8 -4 160 μg （r =0. 999 9） , respectively. The average recoveries were 97.53% with RSD of 1.17% and 96. 97% with RSD of 1.35% , respectively. Conclusion：The revised standard is simple, accurate and can be usd to control the quality of Kushen Tablets.

关 键 词：苦参片 薄层色谱 高效液相色谱 苦参碱 氧化苦参碱 

分 类 号：R921.2[医药卫生—药学]