异福片、胶囊与卫非宁片人体生物等效性比较  

Bioavailability of Yifu tablets,Yifu capsules and Weifei tablets in healthy volunteers

作　　者：白继锋[1] 李淑芬[1] 王厚鹏[1] 王贺玲[1] 张旻[1] 马丽莎[1] 

机构地区：[1]中国人民解放军第63880部队医院

出　　处：《中国医院药学杂志》2003年第6期347-350,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的 :评价异福片、胶囊与卫非宁片制剂的生物等效性。方法 :2 1名受试者采用随机数字分组自身交叉对照给药方案 ,单剂量口服卫非宁片 (含利福平 6 0 0mg ,异烟肼 4 0 0mg)和国产试验药异福片、异福胶囊 (均各含利福平 6 0 0mg ,异烟肼30 0mg)。用HPLC法分别测定利福平和异烟肼血药浓度。用 3P97计算机程序求药动学参数及生物利用度 ,同时对比受试制剂的生物等效性。结果 :卫非宁片与T1和T2 3种制剂中的利福平 (RFP)的主要药动学参数经方差分析、双单侧t检验和配对秩和检验 ,结果 3种制剂中RFP和INH 2种组份的lnAUC、lnCmax和Tmax差异均无显著性 (P >0 .0 5 )。结论 :国产异福片、胶囊与卫非宁片为生物等效制剂。OBJECTIVE To compare the bioavailability of Yifu tablets(T 1), Yifu capsules(T 2)and Weifei tablets(R)in healthy volunteers. METHODS An high performance liquid chromatography was used to determine the time-serum rifampin and isoniazid concentration after oral administration of Yifu tablets, Yifu capsules and Weifei tablets in separate test. Pharmacokinetics parameters were calculated and evaluated. RESULTS The T 1/2, C max, T max and AUC 0～t of rifampin in three kinds of preparations were T 1/2: ( 3.0± 0.9)h, ( 3.0± 0.8)h, ( 2.8± 0.6)h; C max: ( 14.8± 4.5)mg·L -1, ( 15.1± 4.1)mg·L -1, ( 15.1± 4.5)mg·L -1;T max: ( 1.7± 0.6)h, ( 1.8± 0.8)h, ( 1.8± 0.8)h; AUC 0～t: ( 79.3± 25.9)mg·L -1·h, ( 77.7± 23.3)mg·L -1·h, ( 78.0± 26.8)mg·L -1·h; And the parameters of isoniazid in those preparations were T 1/2: ( 2.2± 1.0)h, ( 2.3± 1.0)h, ( 2.3± 1.0)h;C max: ( 10.2± 4.0)mg·L -1, ( 8.6± 2.0)mg·L -1, ( 7.8± 3.9)mg·L -1; T max: ( 0.9± 0.5)h, ( 0.8± 0.5)h, ( 0.7± 0.3)h; AUC 0～t:( 35.3± 18.3)mg·L -1·h, ( 28.0± 14.5)mg·L -1·h and ( 25.1± 13.0)mg·L -1·h. The relative bioavailability of lifampin were ( 99.5± 15.1)% and ( 99.2± 14.1)%. The relative bioavailability of isoniazid were ( 108.4± 9.2)% and ( 95.2± 13.4)%. CONCLUSIONS The Yifu tablets, Yifu capsules and Weifei tablets are bioequivalent.

关 键 词：利福平 异烟肼 生物等效性 生物利用度 高效液相色谱法 

分 类 号：R965.1[医药卫生—药理学]