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目的建立测定人血浆中奥美拉唑的HPLC-UV法,测定健康志愿者口服奥美拉唑肠溶胶囊20mg后的药代动力学参数,并评价其与参比制剂的生物等效性。方法以乙醚提取血浆样品中的奥美拉唑,进行HPLC分析,20名健康志愿者交叉口服奥美拉唑肠溶胶囊试验和参比制剂20mg,用HPLC法测定血药浓度,计算主要药代动力学参数及相对生物利用度,以判断其生物等效性。结果在3.924～1962ng/ml范围内奥美拉唑与内标的峰面积比值与浓度呈良好的线性关系,以AUC0-12计算的供试制剂相对生物利用度为(99.4±13.8)%,受试奥美拉唑肠溶胶囊的相对生物利用度(99.4±13.8)%。结论本文所建立的HPLC分析方法灵敏、准确、简便,临床实验的药动学统计数据表明两种奥美拉唑胶囊生物等效。
OBJECTIVE To establish a HPLC-UV method for the determination of omeprazole in human plasma, and to determine the pharmacokinetic parameters of omeprazole enteric-coated capsules after oral administration of 20 mg omeprazole enteric-coated capsules in healthy volunteers. Methods Omeprazole was extracted from plasma samples by diethyl ether and analyzed by HPLC. Twenty healthy volunteers were given omeprazole enteric-coated capsules at a crossover point with 20 mg of reference drug and the plasma concentration was determined by HPLC. Kinetic parameters and relative bioavailability to determine their bioequivalence. Results The ratio of peak area of omeprazole to internal standard was linear in the range of 3.924 ~ 1962 ng / ml. The relative bioavailability of test compound calculated by AUC0-12 was (99.4 ± 13.8)%, The relative bioavailability of omeprazole enteric-coated capsules was (99.4 ± 13.8)%. Conclusion The analytical method of HPLC established in this paper is sensitive, accurate and simple. The pharmacokinetic statistics of clinical trials show that two kinds of omeprazole capsules are bioequivalent.