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一测多评法测定六神丸中5种蟾毒配基类成分含量
引用本文:李宗云,刘莉,何世学,赵越,张春宝. 一测多评法测定六神丸中5种蟾毒配基类成分含量[J]. 中国医院药学杂志, 2020, 40(2): 184-188. DOI: 10.13286/j.1001-5213.2020.02.11
作者姓名:李宗云  刘莉  何世学  赵越  张春宝
作者单位:1. 哈励逊国际和平医院国家药物临床试验机构, 河北 衡水 053000;2. 哈励逊国际和平医院制剂科, 河北 衡水 053000
基金项目:河北省中医药管理局科研计划项目(编号:2018545);哈励逊国际和平医院研究生科研基金课题项目(编号:2015-06)
摘    要:目的:建立一测多评法测定六神丸中蟾毒配基类成分含量的分析方法,并验证此方法在六神丸中的可行性和适应性。方法:采用高效液相色谱法,以华蟾酥毒基(S)为内参物,建立日蟾毒它灵(A)、蟾毒它灵(B)、蟾毒灵(C)和脂蟾毒配基(D)的相对校正因子。分别采用外标法和一测多评法测定六神丸中5种蟾毒配基类成分的含量,并比较测定值和计算值之间的差异。结果:六神丸中蟾毒配基类成分间的相对校正因子分别为fA/S=1.06,fB/S=0.896,fC/S=1.09,fD/S=0.914,一测多评法的计算值与外标法的实测值的相对误差小于1%。结论:以华蟾酥毒基为内参物建立的相对校正因子准确、可行,一测多评法可用于六神丸中蟾毒配基类成分的质量评价。

关 键 词:一测多评法(QAMS)  相对校正因子  蟾毒配基  六神丸  
收稿时间:2019-06-21

Simultaneous determination of five bufadienolides in Liushen pills by QAMS
LI Zong-yun,LIU Li,HE Shi-xue,ZHAO Yue,ZHANG Chun-bao. Simultaneous determination of five bufadienolides in Liushen pills by QAMS[J]. Chinese Journal of Hospital Pharmacy, 2020, 40(2): 184-188. DOI: 10.13286/j.1001-5213.2020.02.11
Authors:LI Zong-yun  LIU Li  HE Shi-xue  ZHAO Yue  ZHANG Chun-bao
Affiliation:1. Department of Clinical Trial Institution, Harrison International Peace Hospital, Hebei Hengshui 053000, China;2. Department of Pharmaceutical Preparations, Harrison International Peace Hospital, Hebei Hengshui 053000, China
Abstract:OBJECTIVE To establish a analytical method of multi-components with a single-marker (QAMS), to simultaneously determine the contents of five bufadienolides in Liushen pills, and evaluate the adaptation and application of QAMS method in the evaluation of Liushen pills. METHODS Cinobufagin was chosen as the internal reference substance. The relative correlation factors (RCF) of gamabufotalin (A), bufotalin (B), bufalin (C) and resibufogenin (D) to cinobufagin (S) were calculated and established. The contents of these five bufadienolides were determined by the external standard method and QAMS respectively. The QAMS method was validated through comparison of the results obtained by the two different methods. RESULTS RCFs of gamabufotalin(A), bufotalin(B), bufalin(C) and resibufogenin(D) to cinobufagin(S) in Liushen pills were 1.06, 0.896, 1.09 and 0.914, respectively. The relative error between the calculated value and the measured value of the QAMS was less than 1%. CONCLUSION The RCF established in the QAMS method with cinobufagin as the internal reference substance is accurate and feasible. The QAMS method can be used for the quality evaluation of multiple bufadienolides in Liushen pills.
Keywords:QAMS  relative correlation factor (RCF)  bufadienolides  Liushen pills  
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