复方利福平片人体生物等效性研究  

Bioequivalence of compound rifampicin tablets in healthy volunteers

作　　者：赫广威[1] 李可欣[1] 武秀忠[1] 

机构地区：[1]卫生部北京医院临床药理基地,北京100730

出　　处：《中国新药杂志》2003年第1期49-52,共4页Chinese Journal of New Drugs

摘　　要：目的 :评价国产复方利福平片剂与进口片剂在人体内药代动力学过程 ,进行生物等效性研究。方法 :1 8例健康志愿者随机分组 ,自身交叉给药 ,单剂量口服 3片试验制剂复方利福平片 (内含利福平 450mg ,异烟肼30 0mg)与 3片参比制剂卫非宁 (含有与被试制剂相同剂量的 2种成分 )。用HPLC法测定受试者血浆中利福平、异烟肼 2种有效成分的浓度。受试者血药浓度值经生物等效性计算程序 3P97处理。结果 :试验制剂与参比制剂中利福平的平均药动学参数 :Tmax分别为 (1 .1 7± 0 .44)和 (1 .2 4± 0 .46)h ,t1 /2ke分别为 (6 .55± 1 .97)和 (6 .41±1 .96)h ,Cmax分别为 (9.78± 3 .45)和 (9.71± 3 .1 7)mg·L- 1 ,AUC0～ 2 4 分别为 (35 .61± 1 3 .40 )和 (35 .1 4± 1 2 .98)mg·h·L- 1 ,试验制剂中利福平的相对生物利用度为 (1 0 1 .34± 1 3 .1 2 ) % ;试验制剂与参比制剂中异烟肼的Tmax分别为(0 .80± 0 .1 8)和 (0 .81± 0 .2 7)h ,t1 /2ke分别为 (2 .96± 0 .86)和 (3 .53± 2 .62 )h ,Cmax分别为 (5 .71± 2 .1 0 )和 (5 .31±1 .84)mg·L- 1 ,AUC0～ 1 2 分别为 (1 3 .95± 3 .43)和 (1 4 .1 1± 4 .1 1 )mg·h·L- 1 ,试验制剂中异烟肼的相对生物利用度为 (98.87± 1 2 .50 ) %。对利福平和异烟肼分别?Objective:To study the pharmacokinetic profiles and bioequivalence of domestic and imported compound rifampicin tablets in healthy volunteers.Methods:The drug concentration in plasma were assayed by RP HPLC method following a single oral of three tablets of domestic rifampicin or imported rifampicin.Results:The pharmacokinetics parameters of rifampicin were as follows: T max were(1.17±0.44) and (1.24±0.46)h, t 1/2ke were (6.55±1.97) and(6.41±1.96)h, C max were (9.78± 3.45) and (9.71±3.17)mg·L -1 ,AUC 0～24 were(35.61±13.40 ) and(35.14±12.98)mg·h·L -1 ,the relative bioavailability of rifampicin in domestic tablets were(101.34± 13.12)%. The pharmacokinetics parameters of isoniazid were as follows: T max were(0.80±0.18) and (0.81±0.27)h,t 1/2ke were(2.96±0.86) and (3.53±2.62)h, C max were(5.71±2.10) and( 5.31±1.84)mg·L -1 ,AUC 0～12 were(13.95±3.43 ) and (14.11±4.11)mg·h·L -1 ,the relative bioavailability in isoniazid of domestic tablets were(98.87±12.50)%.Two formulations of rifampicin tablets were bioequivalent by analysis of variance,two one sided test and 90% confidential interal.Conclusion:The imported and domestic compound rifampicin tablets are of bioequivalence.

关 键 词：利福平 异烟肼 高效液相色谱法 生物等效性 

分 类 号：R969[医药卫生—药理学] R978.3[医药卫生—药学]