国产噁丙嗪的人体药动学与相对生物利用度试验

Pharmacokinetics and relative bioavailability of domestic oxaprozin in healthy volunteers

采用高效液相色谱法进行丙嗪（Ｏｘａｐ）的人体药动学与相对生物利用度试验。４对正常志愿者分别随机口服国产与进口Ｏｘａｐ片剂单剂量８００ｍｇ．半月后再交叉眼药。结果发现．国产与进口制剂的血药一时间浓度曲线均符合一室模型。国产Ｏｘａｐ主要药动学参数：Ｔ９．０９±４．９ｈ．Ｃｍａｘ６２．７６±９．１２ｍｇ·Ｌ－１ＡＵＣ４８８６．６±８９２．９ｈ·ｍｇ·Ｌ－１．其相对生物利用度为１０７．９％。结果表明．国产Ｏｘａｐ除吸收较慢．达峰浓度时间较长外．其它各项指标与进口制剂无明显差异。

A single oral dose of tablets ofdomestic or imported oxaprozin(Oxap,800 mg)was given to 8 healthy volunteers in a randomiaed crossover study.Plasma levels of Oxap weredetermined with HPLC method. It was foundthat the plasma concentration-time curve fittedto one-compartment model,and the main pharmacokinetics parameters of domestic Oxap were:Tpeak9.09±4·90 h;Cmax62.7± 9.12 mg·L-1;AUC 4886.7± 892.9h·mg·L-1;F 107.9% respectively.Although the domestic Oxap could reach peak levelslower,the other pharmacokietics parameterswere not significantly different from inportedone.