一测多评法测定胃苏颗粒中4种成分的含量

目的: 建立以柚皮苷为内参物,同时测定胃苏颗粒中芸香柚皮苷、柚皮苷、橙皮苷、新橙皮苷的一测多评HPLC法,并进行方法学考察。方法: 以胃苏颗粒为研究对象,以柚皮苷为内参物,确定其他3种成分相对于柚皮苷的校正因子,通过相对校正因子(RCF)对芸香柚皮苷、橙皮苷、新橙皮苷进行定量,实现一测多评(计算法);同时采用外标法测定胃苏颗粒中4种成 分的含量(实测法),并比较一测多评法与外标法测定结果的差异。结果: 在一定的线性范围内,柚皮苷与芸香柚皮苷、橙皮苷、新橙皮苷的相对校正因子分别为1.146、1.018、0.987;且在不同实验条件下重现性良好(RSD分别为1.5%、1.8%、2.7%);37批胃苏颗粒中4种成分按一测多评方法与外标法测定结果基本一致(RSD<2%)。结论: 本文建立的一测多评方法操作简单,测定结果准确。在对照品缺乏的情况下,可作为一个新模式用于胃苏颗粒的多成分定量,并为全面控制胃舒颗粒的质量提供参考。

Objective: To establish a quantitative analysis of multi-components by single-marker(QAMS)for determination of four bioactive components(narirutin,naringin,hesperidin,neohesperidin)in Weishu granules with naringin as the internal reference substance,and to validate the feasibility of this method. Methods: The QAMS for Weishu granules was established and validated and naringin was selected as the internal reference substance.The relative correction factors(RCFs)of other three bioactive components were calculated.The contents of four components were determined by both external standard method and QAMS.The:AMSvalidity of the QAMS method was evaluated by comparison of the quantitative results of both methods. Results: RCFs of narirutin,hesperidin,neohesperidin with reference to naringin were 1.146,1.018,0.987 respectively,and repeatability was good in different experimental conditions(RSDs were 1.5%,1.8%,2.7%,respectively);the quantitative results of both external standard method and QAMS for the four components in 37 batches of Weishu granules were basically identical(RSD<2%). Conclusion: The QAMS method is simple,accurate and can be used as a new model for multi-component quantitation of Weishu granules in the case of lack of reference substances and it is suitable for comprehensive quality control of Weishu granules.