异福酰胺片(Ⅱ)人体生物等效性评价

Bioequivalence study on Yifuxianan tablets (Ⅱ) in healthy volunteers

目的研究20名健康志愿者单剂量经口给予异福酰胺片(Ⅱ)受试制剂和参比制剂后的人体生物等效性。方法采用反相高效液相色谱法分别测定给药后受试者血浆中利福平、异烟肼、吡嗪酰胺3种有效成分的质量浓度,用DAS软件求其药动学参数及相对生物利用度。结果利福平、异烟肼、吡嗪酰胺的线性范围分别为0.40～25.0 mg·L-1、0.10～10.0 mg·L-1、0.30～60.0 mg·L-1,相关系数均大于0.99,日内和日间精密度均小于15%,提取回收率均大于70%,受试制剂中利福平、异烟肼、吡嗪酰胺的相对生物利用度分别为(97.5±25.5)%、(108.7±24.0)%、(109.0±17.4)%。结论受试制剂与参比制剂生物等效。

Objective To study the bioequivalence of Yifuxianan tablets（II）（compound preparation of rifampicin,isoniazid and pyrazinamide） after a single oral dose of the tested and referred preparations to 20 healthy volunteers.Methods Concentrations of rifampicin,isoniazid and pyrazinamide in plasma were determined by RP-HPLC,pharmacokinetic parameters and relative bioavailability were calculated by using DAS software.Results The linear ranges of rifampicin,isoniazid and pyrazinamide were 0.40-25.0 mg · L-1,0.10-10.0 mg · L-1 and 0.30-60.0 mg · L-1,with good linearity（r0.99）,intra-and inter-day precisions were below 15%,average recoveries of three drugs were above 70%,the relative bioavailability of rifampicin,isoniazid and pyrazinamide were（97.5±25.5）%,（108.7±24.0）% and（109.0±17.4）%,respectively.Conclusions The tested preparation is bioequivalent with the referred preparation.