国产头孢泊肟酯片剂人体生物等效性

Bioequivalence of Domestic Cefpodoxime Proxetil Tablets in Healthy Volunteers

目的评价国产及进口头孢泊肟醋片剂的生物等效性试验。方法：采用随机交叉试验方法进行试验设计，２０名受试者按体重指数进行分层随机服用头孢泊肟酯片被试制剂或参比制剂。结果：被试制剂与参比制剂的ｔ──（ｍａｘ）。分别为：３．００±０．３２ｈ和３．００±０．４０ｈ，Ｃ＿（ｍａｘ）分别为：３．４５９±０．４４４ｍｇ．Ｌ～（－１）和３．４１５±０．３８６ｍｇ．Ｌ～（－１），用梯形法计算所得的ＡＵＣＯ；分别为：１７．３６５± ２．５ｌ６ｍｇ．Ｌ～（－１）和１７．７３８± ２·１９７ｍｇ．Ｌ～（－１）头抱泊脂酯被试制剂的相对生物利用度为９８．１％±１０．３％。结论：对ｔ＿（ｍａｘ）及经对数转换后的 Ｃ＿（ｍａｘ）、ＡＵＣ＿（０－ｔ）进行统计分析，方差分析后进行双单侧检验及 ９０％可信限判断，两制剂具有生物等效性。

OBJECTIVE: The bioequivalence of domestic and imported cefpodoxime proxetil was studied in 20 healthy male volunteers. METHODS:A single oral domestic and imported cefpodoxime proxetil tablets were given according to a randomized 2 way cross-over design.Plasma cefpodoxime was determined by HPLC. RESULTS: The pharmacokinetics parameters were as follow:t_(max) were :3.00 ±0.32h and 3.00 ±0.40h,C were:3.459±0.444mg.L^(-1)and 3.415 ±0.386mg.L^(-1) AUC_(0-t) were: 17.365 ±2.5 l6mg.h.L^(-1)and 17.738 ±2.197mg.h.L^(-1) respectively. The relative bioavaila b:lity domestic were 98.1% ±10.3%. CONCLUSION:The result demonstrated that two formations of cefpodoxime proxetil were bioequivalent by analysis of variance, two-one sided test and 90% confidential interal.