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一测多评法在舒肝益脾颗粒中的应用
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作者单位
颜瑞琪,栗建明,顾利红,侯惠婵,袁震霆 广州市药品检验所国家药品监督管理局中成药质量评价重点实验室 
基金项目:国家药典委员会2019年国家药品标准提高中药立项品种(2019Z073)
中文摘要:建立了舒肝益脾颗粒一测多评(QAMS)的高效液相色谱(HPLC)测定方法,并验证该方法在质量控制中的适用性与准确性。该方法能较好地分离舒肝益脾颗粒中3种主要成分(五味子醇甲、五味子甲素、五味子乙素),并以五味子醇甲为内参物,建立五味子甲素、五味子乙素与其之间的相对校正因子(fs/k),用fs/k计算各代表性成分含量,实现一测多评。在各自线性范围内,采用多点校正法得到五味子醇甲与甲素、五味子乙素之间的fs/k分别为0.94、0.95,且在不同品牌色谱仪、色谱柱下有较好的重复性。同时将一测多评的计算值(多点校正法与斜率校正法)与外标法实测值进行比较,两者结果无差异。一测多评法可同时对舒肝益脾颗粒中上述3种成分进行含量测定,方法简便、准确、可靠,可有效控制舒肝益脾颗粒的质量。
中文关键词:一测多评  舒肝益脾颗粒  相对校正因子  五味子醇甲  五味子甲素  五味子乙素
 
Application of Quantitative Analysis on Multi-components with a Single-marker in Shuganyipi Granules
Abstract:A high performance liquid chromatography(HPLC) for quantitative analysis of multi components with a single marker(QAMS) was established for the quality control of Shuganyipi granules.Meanwhile,the applicability and accuracy of the method in quality control were also verified.Three main effective components,i.e.schisandrol,deoxyschisandrin and schisandrin B in Shuganyipi granules were simultaneously separated by HPLC.With schisandrol as the internal reference,the relative correction factors(RCFs) fs/k for other two components were set up and calculated to achieve QAMS.In a certain linear range,the RCFs(fs/k) for deoxyschisandrin and schisandrin B were calculated by multipoint correction method to be 0.94 and 0.95,respectively,with good repeatability under the experimental conditions such as different instruments and chromatographic columns.Moreover,the results of QAMS were compared with those obtained by the external standard method,and there were no significant differences existed.Therefore,the QAMS method is simple,reliable and accurate,and could be used for the simultaneous detection of contents of three components in Shuganyipi granules and the effective control of the quality of Shuganyipi granules.
Key Words:multi-component with a single marker  Shuganyipi granules  relative correction factor  schisandrol  deoxyschisandrin  schisandrin B
引用本文:颜瑞琪,栗建明,顾利红,侯惠婵,袁震霆.一测多评法在舒肝益脾颗粒中的应用[J].分析测试学报,2021,40(1):126-131.
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