盐酸伊托必利片在健康受试者中的生物等效性研究  

Study on the Bioequivalence of Itopride Hydrochloride Tablets in Healthy Subjects

作　　者：谢斌 刘杰 陈新民 杨沛欣 杨琼 陆司司 蔡金兰 钟克凤 XIE Bin;LIU Jie;CHEN Xinmin;YANG Peixin;YANG Qiong;LU Sisi;CAI Jinlan;ZHONG Kefeng(Zhuhai Rundu Pharmaceutical Co.,Ltd.,Zhuhai 519041,China)

机构地区：[1]珠海润都制药股份有限公司,广东珠海519041

出　　处：《中国现代应用药学》2022年第16期2145-2150,共6页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的 评价盐酸伊托必利片的生物等效性。方法 采用 HPLC-MS/MS 测定血浆中伊托必利的浓度。64 例健康受试者(空腹 32 例,餐后 32 例)随机交叉单剂量口服盐酸伊托必利片受试制剂和参比制剂 50 mg,测定不同时间血药浓度,采用 Phoenix WinNonlin 软件对药动学参数进行计算。结果 空腹试验 C_(max)、AUC_(0-t)、AUC_(0-∞)几何均数比值的 90%置信区间分别为 89.42%~118.95%、93.25%~117.27%、92.78%~117.33%;餐后试验 90%置信区间分别为 90.53%~104.83%、96.72%~99.77%、96.76%~99.88%。结论 盐酸伊托必利片受试制剂和参比制剂具有生物等效性。OBJECTIVE To evaluate the bioequivalence of itopride hydrochloride tablets.METHODS The concentration of itopride in plasma was measured by HPLC-MS/MS.Sixty-four healthy subjects(32 on fasting and 32 after meal)were randomly assigned to take a single dose of itopride hydrochloride tablets 50 mg orally as test preparation and reference preparation.The plasma concentrations of itopride hydrochloride tablets were determined at different times and the pharmacokinetic parameters were calculated by Phoenix WinNonlin software.RESULTS Under fasting conditions,the 90% confidence intervals of C_(max),AUC_(0-t) and AUC_(0-∞) for the test/reference geometric mean ratio were 89.42%-118.95%,93.25%-117.27%,92.78%-117.33%.Under fed conditions,the 90% confidence intervals of C_(max),AUC_(0-t) and AUC_(0-∞) for the test/reference geometric mean ratio were 90.53%-104.83%,96.72%-99.77%,96.76%-99.88%.CONCLUSION The test preparation and reference preparation of itopride hydrochloride tablets are bioequivalent.

关 键 词：盐酸伊托必利片 生物等效性 药动学 高效液相色谱-串联质谱法 

分 类 号：R969.1[医药卫生—药理学]