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目的:为了解国产奥美拉唑(OPZ)胶囊的质量,抽取市售进口和国产OPZ胶囊进行生物利用度再评价.方法:以市售进口品为对照,用高效液相色谱法(HPLC)对国产品的OPZ胶囊进行生物利用度研究,选择10名健康志原者进行双交叉试验,用新建立的OPZ体内分析方法测定血药浓度,方差分析和双单侧检验用于统计分析.结果:AUC_(o-∞)、峰浓度、消除半衰期两个供试品间无差异,但个体间存在极显著差异,两者具生物等效,国产品的平均相对生物利用度约为进口品的98.13%;但国产品的达峰时和吸收迟滞时间比进口品显著慢.结论:国产仿制品质量与进口品相仿.
OBJECTIVE: To understand the quality of OPZ capsule made in China and to evaluate the bioavailability of imported OPZ capsule and domestic commercial OPZ capsule.METHODS: Commercially available imported products were used as controls, The bioavailability of OPZ capsules was studied, 10 healthy volunteers were selected for cross test, and the newly established OPZ in vivo assay was used to determine plasma concentration, variance analysis and double unilateral test for statistical analysis.Results : AUC_ (o-∞), peak concentration, elimination half-life of two samples without any difference, but there are significant differences between individuals, both bioequivalent, the average relative bioavailability of domestic products is about imported 98.13%, but the peak time of domestic products and absorption delay time were significantly slower than that of imported ones.Conclusion: The quality of domestic imitation products is similar to the imported ones.