目的 建立测 定清开灵制剂中6个成分含量的一测多评(quantitative analysis of multi-components with a single-marker，QAMS)方法。方法 采用高效液相色谱(HPLC)法，以黄芩苷为内参物，建立与其他5个成分(R，S)-告依春、绿原酸、栀子苷、胆酸和猪去氧胆酸的相对校正因子(fk/s)，并对fk/s进行耐用性考察。分别采用外标法和QAMS法测定6批清开灵片剂和4批清开灵颗粒剂中6个成分含量，比较两者的差异。结果 各个成分fk/s的重复性良好(RSD＜5％);两种方法测定的含量结果差异无统计学意义;6个成分在片剂中的含量高于颗粒剂，同一厂家不同批号的片剂间成分含量存在差异。结论 所建立的一测多评法结果准确可靠，可用于清开灵制剂的多成分含量检测，为清开灵制剂的质量控制提供方法参考。
Simultaneous Quantitative Determination of 6 Components in Qingkailing Tablets and Qingkailing Granules by QAMS Method
Objective To establish a method of quantitative analysis of multi-components with a single-marker(QAMS)for the determination of six components in Qingkailing Preparations(清开灵制剂).Method Baicalin was used as the internal refer-ence to calculate the relative correction factors(fk/s)of the other five components(R,S)-goitrin content,chlorogenic acid,garde-noside,baicalin,cholic aid and hyodeoxy cholic acid in Qingkailing Preparations by HPLC,and the durability of fk/s was investiga-ted.The differences between QAMS method and the external standard method(ESM)were compared by determining the contents of six components in 6 batches of Qingkailing Tablets(清开灵片剂)and 4 batches of Qingkailing Granules(清开灵颗粒剂).Result The repeatability of relative correction factors for each component in Qingkailing Preparations was good.There was no sig-nificant difference(RSD＜5％)between the results of QAMS method and ESM.The contents of 6 components in the tablets were higher than those in the granules.There were significant differences in the components contents of Qingkailing Tablets from same manufacturers but different batch numbers.Conclusion The established method is accurate and reliable which can be used for the simultaneous quantitative determination of multiple components in Qingkailing Preparations will provide a reference for the com-prehensive quality control of Qingkailing Preparations.
Qingkailing Tablets(清开灵片剂)Qingkailing Granules(清开灵颗粒剂)baicalinquantitative analysis of multi-components by single marker(QAMS)
万方数据
维普
