“一测多评”法测定腰痹通胶囊中5种皂苷类成分的含量  

Simultaneous Determination of Five Saponins in Yao-Bi-Tong Capsules by QAMS

作　　者：代百东[1] 孙莉琼[1] 李艳静[1] 丁岗[1] 李欣[1] 王振中[1] 毕宇安[1] 萧伟[1] 

机构地区：[1]江苏康缘药业股份有限公司/中药制药过程新技术国家重点实验室,连云港222001

出　　处：《世界科学技术-中医药现代化》2014年第10期2227-2232,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科学技术部国家重大新药创制专项(2013ZX09402203):现代中药创新集群与数字制药技术平台;负责人:王振中

摘　　要：目的:建立"一测多评"法测定腰痹通胶囊中皂苷类成分含量的分析方法。方法:以腰痹通胶囊为研究对象,建立参照物人参皂苷Rg1与三七皂苷R1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd的相对校正因子,分别采用外标法和"一测多评"法测定腰痹通胶囊中5种皂苷类成分的含量,并将两种测定方法的结果进行对比分析,以验证"一测多评"法的合理性、可行性和可重复性。结果:腰痹通胶囊中皂苷类成分间的相对校正因子分别为:f人参皂苷Rg1/三七皂苷R1=0.999、f人参皂苷Rg1/人参皂苷Re=1.228、f人参皂苷Rg1/人参皂苷Rb1=0.990、f人参皂苷Rg1/人参皂苷Re=1.094。"一测多评"法的计算结果与外标法的实测值之间无显著性差异,实验所得的相对校正因子可信。结论:本实验建立的"一测多评"法可行准确,可以更合理、快速地实现腰痹通胶囊中多种皂苷类成分的质量控制。This study was aimed to establish a quality evaluation method, quantitative analysis of multi-components with a single-marker（QAMS） to determine the contents of five saponins in Yao-Bi-Tong（YBT） capsules. Ginsenoside Rg1 was used as the internal standard; the relative correction factor（RCF） of notoginsenoside R1, ginsenoside Re, ginsenoside Rb1 and ginsenoside Rd were calculated and evaluated. The contents of 5 saponins were determined by the external standard method and QAMS, respectively. Rationality, feasibility and repeatability of the QAMS method were verified by comparing the results obtained from two different methods. The results showed that RCFs of notoginsenoside R1, ginsenoside Re and ginsenoside Rb1 to ginsenoside Rg1 against YBT capsules were 0.999, 1.228, 0.990 and 1.094, respectively, indicating good reproducibility. These results of two methods had no significant difference. It was concluded that the QAMS method can be accurately, rapidly and reasonably used as a new quality assessment model for ginsenosides in YBT capsules.

关 键 词：一测多评 相对校正因子 人参皂苷 三七皂苷 腰痹通胶囊 

分 类 号：R284[医药卫生—中药学]