一测多评法同时测定妇科调经片中7个成分的含量  

Simultaneous determination of seven components in Fuke Tiaojing tablets by quantitative analysis of multi-components by single marker

作　　者：张文静 王晓燕[1] 李向阳[1] 李海燕[1] ZHANG Wen-jing;WANG Xiao-yan;LI Xiang-yang;LI Hai-yan(Henan Province Institute for Food and Drug Control,Zhengzhou 450008,China)

机构地区：[1]河南省食品药品检验所,郑州450008

出　　处：《药物分析杂志》2020年第2期329-336,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：国家食品药品监督管理总局《2017年国家药品抽验计划》。

摘　　要：目的:建立一测多评法同时测定妇科调经片中芍药内酯苷、芍药苷、阿魏酸、洋川芎内酯Ⅰ、去氢紫菫碱、洋川芎内酯A和藁本内酯7个成分的含量。方法:采用Phenomenex Luna C18色谱柱(4.6 mm×250mm,5μm),以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速1.0 mL·min-1,柱温30℃,检测波长为230nm(0~25 min,检测芍药内酯苷、芍药苷)、322 nm(25~40 min,检测阿魏酸)、280 nm(40~50 min,60~80min,检测洋川芎内酯Ⅰ、洋川芎内酯A、藁本内酯)、335 nm(50~60 min,检测去氢紫堇碱)。以阿魏酸为内参物,建立其与芍药苷、洋川芎内酯Ⅰ、去氢紫菫碱、洋川芎内酯A和藁本内酯的相对校正因子;同时采用一测多评法和外标法测定妇科调经片中7个成分的含量,并将2种方法的测定结果进行比较。结果:在一定线性范围内,阿魏酸与芍药内酯苷、芍药苷、洋川芎内酯Ⅰ、去氢紫菫碱、洋川芎内酯A和藁本内酯的相对校正因子分别为5.6、3.2、1.0、3.3、2.7、2.4,且在不同实验条件下重现性良好;一测多评法与外标法测定结果无明显差异。结论:同时建立了妇科调经片中7个成分的一测多评法,经方法学验证,该法可用于妇科调经片的质量控制。Objective:To establish a quantitative analysis of multi-components by single marker(QAMS)method for simultaneous determination of seven components(albiflorin,paeoniflorin,ferulic acid,senkyunolide Ⅰ, dehydrocorydaline,senkyunolide A and ligustilide)in Fuke Tiaojing tablets.Method:Phenomenex Luna C18 column(4.6 mm×250 mm,5 μm)was chosen,the mobile phase consisted of acetonitrile-0.1% phosphoric acid water with gradient elution at a flow of 1.0 mL·min-1,and the column temperature was 30 ℃.The detection wavelengths were set at 230 nm(0-25 min for albiflorin and paeoniflorin),322 nm(25-40 min for ferulic acid),280 nm(40-50 min,60-80 min for senkyunolide Ⅰ senkyunolide A and ligustilide)and 335 nm(50-60 min for dehydrocorydaline).Ferulic acid was used as the internal reference standard,and 6 relative correction factors(RCFs)to ferulic acid were calculated.The contents of seven components in Fuke Tiaojing Tablets were determined by both QAMS and external standard method.Results:The RCFs of albiflorin,paeoniflorin,senkyunolide Ⅰ,dehydrocorydaline,senkyunolide A and ligustilide with reference to ferulic acid were 5.6,3.2,1.0,3.3,2.7 and 2.4,respectively and the reproducibility was good under different experimental conditions.There was no significant difference observed between the quantitative results of the two methods.Conclusions:The method of QAMS for seven components in Fuke Tiaojing tablets was established.The methodology validation showed that the method can be used for quality control of Fuke Tiaojing tablets.

关 键 词：妇科调经片 芍药内酯苷 芍药苷 阿魏酸 洋川芎内酯 去氢紫菫碱 藁本内酯 一测多评 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]