吉非罗齐胶囊剂的相对生物利用度及其生物等效性评价  

Assesment of Relative Bioavailability of Gemfibrozil Capsule and Its Bioequivalence

作　　者：李俊杰[1] 王宇[1] 

机构地区：[1]暨南大学医学院

出　　处：《暨南大学学报（自然科学与医学版）》1998年第4期23-26,共4页Journal of Jinan University(Natural Science & Medicine Edition)

摘　　要：１０名健康受试者口服两种不同厂家生产的吉非罗齐胶囊，以高效液相色谱法（ＨＰＬＣ）测定其血药浓度经时过程，经“ＰＫＢＰ－Ｎ１”药动学程序计算表明，湘江制药厂生产的吉非罗齐胶囊与金晓制药厂生产的吉非罗齐胶囊的吸收半衰期ｔ１／２ｋａ分别为（０４２±０１９）和（０４９±０２８）ｈ；消除半衰期ｔ１／２分别为（１４８±０８４）和（１２６±０４５）ｈ；达峰时间ｔｍａｘ分别为（１４５±０３７）和（１６０±０７８）ｈ；达峰浓度ｃｍａｘ分别为（６１８８±１５５１）和（６１５１±１０３４）μｇ／ｍＬ；ＡＵＣ０－∞分别为（２１２９１±４７１６）和（１９９８５±２４９１）μｇ·ｈ／ｍＬ，以湘江制药厂生产的吉非罗齐胶囊为参比测得金晓制药厂生产的吉非罗齐胶囊的相对生物利用度为０９３９。经双单侧ｔ检验法统计分析，表明两制剂间ＡＵＣ无显著差异，两制剂具有生物等效性。Bioavailability of gemfibrozil capsule(GC) was invesitgated in a crossover trial in 10 healthy volunteers after oral administration of 900 mg GC made by two manufacturers. Gemfibrozil plasma concentration was measured by HPLC method,pharmacokinetics parameters were estimated by pharmacokinetic program“PKBP-N 1”. The peak concentration of GC made by Xiang Giang manufacturer was (61 88±15 51)μg/mL,reached at (1 45±0 37)h,its elimination T 1/2 was (1 48±0 84)h。That made by Jin Xiao manufacturer was(61 51±10 34) μg/mL,reached at (1 26±0 45)h,its elimination T 1/2 was (1 60±0 78)h The relative bioavailabiligy of GC by Jin Xiao manufacturer was 0 939,wihich was estimated according to gemfibrozil capsule by Xiangjiang manufacturer. This two kinds of gemfibrozil were bioequivalent by two one-sidet test analysis.

关 键 词：吉非罗齐胶囊剂 相对生物利用度 生物等效性 

分 类 号：R972.6[医药卫生—药品]