左炔诺孕酮片人体生物等效性研究  

Study on Bioequivalence of Levonorgestrel Tablets in Healthy Volunteers

作　　者：同丽萍[1] 杨志福[1] 刘渝[1] 马忠英[1] 王志睿[1] 文爱东[1] 

机构地区：[1]第四军医大学西京医院药剂科,西安市710032

出　　处：《中国药房》2010年第42期3978-3980,共3页China Pharmacy

摘　　要：目的:比较2种左炔诺孕酮片的人体生物等效性。方法:24名健康受试者随机交叉单剂量口服左炔诺孕酮片受试制剂与参比制剂1.5mg后,以液-质联用(LC-MS)法测定左炔诺孕酮血药浓度,利用BAPP3.0软件计算药动学参数和生物利用度。结果:受试制剂与参比制剂的主要药动学参数分别为Cma(x18.00±4.33)、(18.59±4.77)ng·mL-1,tma(x1.71±0.57)、(1.85±0.62)h,AUC0～7(2229.66±66.15)、(247.33±108.19)ng·h·mL-1,AUC0～∞(257.79±65.23)、(267.77±119.87)ng·h·mL-1。受试制剂相对于参比制剂的生物利用度为(108.6±36.9)%。结论:2种左炔诺孕酮片具有生物等效性。OBJECTIVE：To compare the bioequivalence between two kinds of Levonorgestrel tablets.METHODS：In randomized crossover study,24 healthy volunteers were given single oral dose of Levonorgestrel tablets 1.5 mg（trial preparation）and reference preparation 1.5 mg.The plasma concentrations of levonorgestrel were determined by LC-MS.The pharmacokinetic parameters were calculated using BAPP3.0 software.RESULTS：Main pharmacokinetic parameters of trial preparation vs.reference preparation were as follows：C max （18.00±4.33）ng · mL-1 vs.（18.59±4.77）ng · mL-1 ;t max （1.71±0.57）h vs.（1.85±0.62）h;AUC 0～72 （229.66±66.15）ng · h · mL-1 vs.（247.33±108.19）ng · h · mL-1 ;AUC 0～∞ （257.79±65.23）ng · h · mL-1 vs.（267.77±119.87）ng · h · mL-1.The relative bioavailability of trial preparation was（108.6±36.9）%.CONCLUSION：The 2 kinds of Levonorgestrel tablets are bioequivalent.

关 键 词：左炔诺孕酮片 药动学 生物等效性 液-质联用法 

分 类 号：R969.1[医药卫生—药理学] R979.21[医药卫生—药学]