摘要
目的:考察世界银行贷款项目中抗结核药国际招标的部分国产利福平胶囊相对生物利用度,以此作为评标的重要指标之一,以保证该项目所用药物安全、有效。方法:采用5对或6对交叉设计,测定了6个厂家的产品。采用反相高效液相色谱法测定健康志愿者口服国产和进口利福平胶囊的血药浓度,用3P87程序求算各药代动力学参数,用新药数据统计处理软件N DST 程序对血药浓度峰值(Cmax)、达峰时间(Tmax)、半衰期(t1/2)、药-时曲线下面积(AUC0→n)进行生物等效性检验。结果:Cmax为11.91～16.25μg /m L,Tmax为1.42～2.16h,t1/2为3.33～3.68h,AUC0→n为85.70～101.79μg·h /mL。以进口产品为标准参比制剂,测得国内各厂家利福平胶囊的相对生物利用度分别为(100.2±16.2)%,(108.1±21.4)%,(108.5±13.7)%,(103.4±12.4)%,(101.2±14.2)%,(92.6±13.6)%。结论:经生物等效性检验,国内各厂家产品与进口产品为等效制剂。
Objective:To study the relative bioavailability and assess the inherit quality of the domestic rifampicin capsules for World Bank Loans International Bidding Tuberculosis Project.As one of the important indexes,to ensure the drugs used in the project being safe and effective.Methods:In this 5 or 6 pairs randomized designed crossover study,6 producers were determined.The drug concentrations in serum of healthy volunteers given domestic and imported rifampicin were determined by HPLC.The pharmacokinetic parameters were calculated with 3P87 and the bioquivalence of AUC0→n,Tmax,Cmax,t1/2 were assessed with NDST program.Results:The major pharmacokinetic parameters were Cmax=11.91～16.25 μg/mL,Tmax=1.42～2.16 h,t1/2=3.33～3.68 h,AUC0→n=85.70～101.79 μg·h/mL.The standard reference drugs were provided by Italid Lepetit S.P.A or Islituto biochimico Pirri S.P.A,the relative bioavailability of 6 patches of rifampicin were (100.2±16.2)%,(108.1±21.4)%,(108.5±13.7)%,(103.4±12.4)%,(101.2±14.2)%,(92.6±13.6)%,respectively.Conclusion:Domestic rifampicin capsules were bioquivalent with the imported same kinds of products.
出处
《中国药业》
CAS
2005年第3期29-31,共3页
China Pharmaceuticals
