中国临床药学杂志

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.

AIM : To study relative bioavailability between domestic omeprazole capsule (A) and imported omeprazole capsule (B, reference drug). METHODS: A new analytical method was established for determination plasma level of omeprazole(OPZ)and its metabo-lites using HPLC. The study on bioavailability of OPZ between capsule A and B were carried out in 10 male volunteers at the oral dose of 20 mg by cross-over method. The analysis of variance and double single-side test are used to statistical analytical. RESULTS :Onecompart-ment open model could be suitable for describing the disposition of OPZ. No statistical significant differences were observed in AUC_0-∞, T_(1/2(β), C_max. The relative bioavailability of the capsule A was 98. 13% (relative to capsule B). CONCLUSION : Two capsules are bioe-quivalent.