兰索拉唑肠溶片健康人体药动学研究

Pharmacokinetics of Lansoprazole Enteric-coated Tablets in Healthy Human Bodies

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20．00～2000．00ng·mL^-1范围内线性关系良好（r=0．9999），日内、日间相对标准差均小于10％。主要药动学参数Cmax为（876．14±278．11）ng·mL^-1tmax为（3．81±0．70）h，t1/2为（1．68±0．70）h，AUC0-1．为（2925．04±1110．88）ng·h·mL^-1AUC0-∞为（3072．88±1230．40）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。

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 entericcoated 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 ^-1tmax was （3.81 ± 0.70） h; t 1/2 was（1.68± 0.70） h; AUC0-1 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.