复方参金凝胶质量控制标准研究  

Quality Standard for Compound Shenjin Gel

作　　者：汤迎爽[1] 储雪蓉[1] 王倩云[1] 顾欣[2] 康阿龙[3] 

机构地区：[1]解放军第323医院,陕西西安710054 [2]陕西科技大学,陕西西安710021 [3]解放军第451医院,陕西西安710054

出　　处：《中华中医药学刊》2016年第5期1046-1049,I0003,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：全军医学科研"十二五"面上项目(CWS11C234)

摘　　要：目的:建立复方参金凝胶的质量控制标准。方法:采用薄层色谱法鉴别了方中黄柏、金银花、蛇床子、苦参、虎杖、冰片;采用高效液相色谱法测定了方中盐酸小檗碱、蛇床子素、绿原酸3个指标成分。结果:薄层鉴别专属性强,斑点清晰,阴性无干扰;盐酸小檗碱、蛇床子素、绿原酸苷分别在0.12~0.60μg(r=0.999 9)、0.056μg^0.28μg(r=0.999 9)、0.08~1.60μg(r=0.999 9)范围内呈良好的线性关系,平均加样回收率(n=6)分别为98.25%、97.04%、98.99%,RSD分别为0.97%、0.71%、0.69%。结论:所建立的定性、定量分析方法简便快速,准确,能够有效控制该制剂的质量。Objective： To establish the quality control standard of Compound Shenjin Gel. Methods： Cortex phellodendri,Flose Lonicerae Japonicae,Fructus Cnidii,Radix Sophorae Flavescentis,Rhizoma Polygoni Cuspidati and Bomeolum Syruheticum in gel were identified by TLC. The contents of berberine,osthol and chorogenic acid in gel were determined by HPLC. Result： TLC spots were clear and the blank test showed no interference. Berberine,osthol and chorogenic acid showed good linearity in the ranges of 0. 12 ~ 0. 60 μg（ r = 0. 999 9）,0. 056 ~ 0. 28 μg（ r = 0. 999 9）,0. 08 ~ 1. 60 μg（ r = 0. 999 9）,respectively. The average recoveries of berberine,osthol and chorogenic acid were 98. 25%,97. 04% and98. 99%,respectively. The RSD values were 0. 97%（ n = 6）,0. 71%（ n = 6） and 0. 69%（ n = 6）. Conclusion： The established qualitative and quantitative methods are simple and accurate,which can be used for the quality control of Compound Shenjin Gel.

关 键 词：复方参金凝胶 TLC HPLC 盐酸小檗碱 蛇床子素 绿原酸 

分 类 号：R284.1[医药卫生—中药学]