摘要
目的旨在研究由石家庄欧意药业有限公司生产的阿奇霉素肠溶片的人体生物等效性。方法采用3×3交叉设计,将24例健康男性受试者随机分为三组,口服受试制剂(阿奇霉素肠溶片)、参比制剂(阿奇霉素片)或静脉注射参比制剂(注射用阿奇霉素)500mg,采用HPLC-MS法测定血药浓度,用DAS软件测定血药浓度参数,进行生物等效性评价。结果受试药物阿奇霉素肠溶片、对照药物阿奇霉素片和注射用阿奇霉素主要药动学参数AUC072分别为60301126ng·h/ml、61421295ng·h/ml和123592295ng·h/ml;AUC0分别为65751274ng·h/ml、66561519ng·h/ml和149672870ng·h/ml。Cmax分别为610167ng/ml、608163ng/ml和3451450ng/ml;Tmax分别为2.420.70h、2.270.68h和0.930.12h;结论阿奇霉素肠溶片与参比制剂阿奇霉素片比较,相对生物利用度为99.4%±14.3%,两者具有生物等效性。
Objective In order to assess the bioequivalence of Azithromycin Enteric-coated Tablets produced by Ouyi Pharma.Methods 24 healthy male volunteers were randomly assigned to one of three treatment guoups.Each volunteer orally received a single dose of Azithromycin Enteric-coated Tablets or Azithromycin Tablets or intravenous Azithromycin for injection 500mg. The plasma concentration of azithromycin was determined by HPLC-MS,The pharmacokinetic parameters were assessed by DAS program. Results The pharmacokinetic date of test Azithromycin Enteric-coated and reference samples Azithromycin Tablets and Azithromycin for injection were as follows： AUC0 72 6030 1126ng·h/ml,6142 1295ng·h/ml and 12359 2295ng·h/ml;AUC0 6575 1274ng·h/ml,6656 1519ng·h/ml and 14967 2870ng·h/mlo Cmax 610 167ng/ml,608 163ng/ml and 3451 450ng/ml;Tmax 2.42 0.70h,2.27 0.68h and 0.93 0.12h;Conclusion The ralative by bioavailability of the test sample was 99.4% 14.3%. The test of azithromycin dispersants bioequivalent to the reference azithromycin.
出处
《中国现代药物应用》
2009年第15期34-35,共2页
Chinese Journal of Modern Drug Application
