异福酰胺片人体药代动力学及相对生物利用度研究  

Pharmacokinetics and Relative Bioqvailability of Isoniazid Rifampicin and Pyraginamide Tablet in Healthy Volunteers

作　　者：胡欣[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研究室,北京100730

出　　处：《中国临床药理学杂志》2002年第5期354-358,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的:观察18名健康志愿者单次口服异福酰胺片的人体药代动力学及相对生物利用度。方法:采用HPLC定量分析法分别测定给药后受试者血浆中利福平、异烟肼及吡嗪酰胺三种有效成分浓度。结果:被试制剂与参比制剂的药代动力学参数分别为:利福平:tmax1.04±0.32h和1.11±0.30h,Cmax13.35±4.18mg·L-1和12.67±4.18mg·L-1,AUC0-147.84±12.60mg·h·L-1和49.86±13.49mg·h·L-1,相对生物利用度为95.17％±10.58％:异烟肼:tmax0.78±0.37h和0.74±0.26h,Cmax6.13±2.01mg·L-1和6.02±1.66mg·L-1,AUC0-t14.83±5.83mg·h·L-1和15.31±6.62mg·h·L-1,相对生物利用度为92.05％±11.05％;吡嗪酰胺:tmax1.14±0.27h和1.07±0.25h,Cmax29.36±8.16mg·L-1和30.42±8.10mg·L-1,AUC0-t320.27±51.34mg·h·L-1和319.26±53.49mg·h·L-1,相对生物利用度为100.31％±14.68％。结论:被试制剂与参比制剂生物等效。OBJECTlVE:To study pharmacokinetics and relative bioavailability of Isoniazid Rifampicin and Pyrazinamide Tablet in eighteen healthy volunteers. METHOD: Rifampicin,Isoniazid and Pyrazinamide in plasma wad determined by HPLC. RESULTS:The pharmacokinetics parameters of the tested and refered drugs such as Rifampicin:tmax 1.04 ± 0.32h and 1.11 ± 0.30h, Cmax13.35 ± 4.18 mg·L-1 and 12.67±4.18 mg·L-1,AUC0-t 47.84± 12.60 mg·h·L-1 and 49.86±13.49 mg·h·L-1, the relative bioavailability of Rifampicin was 95.17 ± 10.58%;Isoniazid:tmax 0.78 ± 0. 37h and 0.74 ± 0.26h,Cmax 6.13 ± 2.01 mg·L-1 and 6.02±1.66 mg·L-1, A UC0-t 14.83 ± 5.83 mg·h·L-1 and 15.31 ± 6.62 mg·h·L-1, the relative bioavailability of Isoniazid was 92.05 ± 11.05%; Pyrazinamide:tmax 1.14 ± 0.27h and 1.07 ± 0.25h, Cmax 29.36 ± 8. 16mg·L-1 and 30.42 ± 8.10 mg·L-1, A UC0-t 320.27 ± 51.34 mg·h·L-1 and 319.26 ± 53.49 mg·h·L-1 the relative bioavailability of Pyrazinamide was 100.31 ± 14.68%. CONCLUSION: The tested and refered drugs were of bioequivalence0.

关 键 词：异福酰胺片 人体药代动力学 相对生物利用度 研究 抗结核病 

分 类 号：R978.3[医药卫生—药品] R969.1[医药卫生—药学]