兰索拉唑肠溶片健康人体药动学研究

目的:研究兰索拉唑肠溶片在人体内的药动学特点。方法:8名健康男性受试者单剂量口服30mg兰索拉唑肠溶片,血样加入内标(奥美拉唑)经预处理后用HPLC-UV法测定。结果:血浆中兰索拉唑浓度在20.00~2 000.00ng.mL-1范围内线性关系良好(r=0.999 9),日内、日间相对标准差均小于10%。主要药动学参数Cm ax为(876.14±278.11)ng.mL-1,tm ax为(3.81±0.70)h,t1/2为(1.68±0.70)h,AUC0~t为(2 925.04±1 110.88)ng.h.mL-1,AUC0~∞为(3 072.88±1 230.40)ng.h.mL-1。结论:本法操作简便,灵敏度高,无杂质峰干扰,测得的药动学参数可为其临床应用提供参考。

Pharmacokinetics of Lansoprazole Enteric- coated Tablets in Healthy Human Bodies

OBJECTIVE: To study pharmacokinetics profiles of lansoprazole enteric-coated tablets in human bodies.METHODS: All the 8 healthy volunteers were administered with a single oral dose of 30mg lansoprazole enteric-coated tablets,whose blood samples were determined by HPLC-UV after being pretreated with the internal standard(omeprazole).RESULTS: The linear range of lansoprazole was 20.00～ 2 000.00ng· mL-1(r=0.999 9).Both intraday and inter-day RSD were less than 10%.The main pharmacokinetic parameters were as follows: Cmax was(876.14± 278.11) ng· mL-1,tmax was(3.81± 0.70) h;t1/2 was(1.68± 0.70) h;AUC0～ t was(2 925.04± 1 110.88) ng· h· mL-1,AUC0～ ∞ was(3 072.88± 1 230.40) ng· h· mL-1.CONCLUSION: This method is simple,sensitive and without interference of impurity peaks,and the pharmacokinetic parameters obtained can serve as references for the clinical application of lansoprazole.