摘要
本文报道８例健康青年志愿者交叉口服两个药厂生产的吉非罗齐胶囊的生物利用度研究。用反相高效液相色谱法测定人血浆中吉非罗齐的浓度。单剂量口服两种胶囊９００ｍｇ后，体内过程符合单室模型。达峰时间为１．７８１±０．５５０和１．９９５±０．６９２ｈ；峰浓度为１７．４５７±５．３０４和１６．６４６±６．４７４ｍｇ·Ｌ－１；曲线下面积为７９．６４１±１６．８１６和８１．８１７±２１．５７３ｍｇ·Ｌ－１·ｈ。以对照制剂为标准，样品制剂的相对生物利用度为１０２．７３２％，两药的主要药代动力学参数无显著性差异（ｐ＜０．０５）。
A study on bioavailability of gemfibroxzil was performed in 8 young healthy volunteers. Acoording to the cross-over design, each volunteer was orally given two different products of gemfibrozil capsules produced by different pharmaceutical factories in single dosage of 900mg alternatively.The plasma concentrations were determined by RP-HPLC method.The pharmacokinetics of gemfibrozil could be described by single compartment model.The Tmax, Cmax, AUC0～∞ of two products were 1.78l±0.550h and 1.995±0.692h; 17.457±5.304mg·L-1; 16.646±6.474mg·L-1; 79.641±16.816mg·L-1·h and 81.817±21.573mg·L-1·h respectively.The relative bioavailiability of sample capsule was 102.732% compared with standard capsule. There was no singificant difference of pharmacokinetic parameters of two products.
出处
《中国药房》
CAS
CSCD
1996年第1期33-34,共2页
China Pharmacy
