LC-MS/MS法测定人血浆中的甘草次酸并评价两种甘草酸二铵胶囊的生物等效性  

Determination of glycyrrhetic acid in human plasma by LC-MS/MS and study on the bioavailability of two Diammonium glycyrrhizinate capsules

作　　者：南峰 陈朝霞 唐诗韵[1] 丁红[1] 曾洁萍[1] 阎博华[1] NAN Feng;CHEN Zhaoxia;TANG Shiyun;DING Hong;ZENG Jieping;YAN Bohua(GCP Centre,Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu,Sichuan,610072 P.R.China)

机构地区：[1]成都中医药大学附属医院GCP中心,四川成都610072

出　　处：《华西药学杂志》2020年第4期424-427,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用LC-MS/MS法测定人血浆中的甘草次酸,并评价两种甘草酸二铵胶囊在人体内的生物等效性。方法采用自身对照设计,将20位健康受试者随机分组后,交叉口服同剂量的受试制剂和参比制剂,采用LC-MS/MS法测定血浆中甘草次酸的经时血药浓度,用WinNonlin软件计算药动学参数,并比较两种制剂的生物利用度。结果经对数转换后,受试制剂/参比制剂的Cmax、AUC0-t、AUC0-∞的相对生物利用度分别为113.0%、106.1%、105.2%,且其90%置信区间均符合80%~125%的生物等效标准。结论受试制剂与参比制剂生物等效。OBJECTIVE To establish a LC-MS/MS method for the determination of glycyrrhetic acid in human plasma,and to study the bioavailability of two Diammonium glycyrrhizinate capsules.METHODS In a randomized and crossover study,20 healthy volunteers were administrated with test capsule and reference capsule.The plasma concentration of glycyrrhetic acid were measured by LC-MS/MS.The concentration-time data were treated with Win Nonlin pharmacokinetic software.RESULTS The relative bioavailability of Cmax,AUC0-tand AUC0-∞were 113.0%,106.1%,105.2%,respectively,and the 90%confidence intervals conformed to the bioequivalence standard of 80%-125%.CONCLUSION The test capsule is bioequivalence to the reference capsule.

关 键 词：甘草酸二铵 甘草次酸 人血浆 血药浓度 液质联用技术 药动学 生物等效性 

分 类 号：R917[医药卫生—药物分析学]