一测多评法评价川射干配方颗粒的质量

Quality control of Iridistectori Rhizoma Dispensing Granules by QAMS

目的建立同时测定川射干配方颗粒中射干苷、野鸢尾苷、鸢尾黄素、鸢尾甲黄素A、鸢尾甲黄素B 5种成分含量的一测多评法(quantitative analysis of multi-components with single-marker,QAMS),并验证该方法在川射干配方颗粒质量控制中应用的可行性。方法以射干苷为内参物,确定其他4种成分的相对校正因子(f_(k/s));同时采用外标法(external standard method,ESM)测定各成分的含量,并比较QAMS计算值与实测值的差异,验证QAMS的可行性和准确性。结果川射干配方颗粒中野鸢尾苷、鸢尾黄素、鸢尾甲黄素A、鸢尾甲黄素B的f_(k/s)分别为0.865、1.359、1.209、1.158;4种成分QAMS计算值与实测值之间无明显差异。结论QAMS能准确地测定川射干配方颗粒中4种化学成分的含量,可用于川射干配方颗粒多指标质量控制。

Objective To establish a quantitative analysis of multi-components with single-marker(QAMS)for the contents of tectoridin,lridin,tectorigenin,iristectorigenin A and iristectorigenin B in Iridistectori Rhizome Dispensing Granules,and to verify the feasibility of this method in quality control.Methods The relative correction factors(f_(k/s))of other 4 components were determined by using tectoridin as an internal reference.At the same time,the 4 components were determined by using external standard method(ESM).The results were compared between the calculated values of QAMS and the measured value of ESM to validate the feasibility and accuracy of QAMS.Results Relative correction factors of tectoridin,lridin,tectorigenin,iristectorigenin A and iristectorigenin B were established.The values are 0.865,1.359,1.209 and 1.158,respectively.There was no significant difference between the calculated values by QAMS and the measured values by ESM.Conclusion The QAMS method can accurately determine the contents of the 4 chemical components in Iridistectori Rhizome Dispensing Granules,and can be used for multi index quality control of Iridistectori Rhizome Dispensing Granules.