替硝唑片在健康志愿者体内的生物等效性研究

Study of the bioequivalence of Tinidazole tablets in healthy volunteers

目的研究替硝唑片的生物等效性。方法选择健康志愿者20例，用随机双交叉试验方法，单剂量口服替硝唑片的试验制剂和参比制剂，剂量分别为1g，洗净期为2周；分别于服药后60h内不同时间点抽取静脉血。用HPLC法测定血浆中替硝唑浓度，用DAS程序进行生物等效性评价。结果单剂量口服替硝唑片试验制剂和参比制剂后，血浆中替硝唑的Cmax分别为（20．49±2．03）mg／L和（1999±2．37）mg／L；Tmax分别为（1．70±0．25）h和（1．73±0.26）h；T1/2，分别为（16．06±1.77）h和（16．51±2．63）h；AUC（0-60）分别为（430．75±56．16）mg/（h·L）和（423、86±45.34）mg／（h·L）；AUC（0-Inf）分别为（468.47±63．04）mg／（h·L）和（462．32=42.70）mg／（h·L）。AUC（0-60）、AUC（0～inf）、Cmax的90％可信区间分别为9969％～10576％、98．61％～104．16％、97.79％～104．08％。相对生物利用度为（101．6±8．4）％.结论试验制剂与参比制剂具有生物学等效性．

objective It is to study the relative bioavailability and bioequivalence of Tinidazole tablets in healthy vohun teers. Methods A single oral doses （1g） of tested and reference preparations of Tinidazole were given to 20 heahhy vohunteers respectively in a randomised crossover study. The cleaning stage was 2 weeks. Venous hlood was drawn at different times within 60h after taking medicine. The concentration of Tinidazole in plasma was determined by HPLC and the bioavailability and bioequivalence of two preparations were evaluated by DAS program. Results After a single oral doses of tested and reference preparations of Tinidazole, the pharmacokinetics parameters for Tinidazole were as follows： C were （20.49 ± 2.03） mg/h and （19.99±2.37） mg/L; T were （1.70±0.25）h and （1.73±0.26）h; T1/2 were （16.06 ± 1.77）h and（16.51 ± 2.63）h; AUC（0-60） were （430.75 ± 56.16）mg/（h·L） and （423.86 ± 45.34） mg/（h·L） ; AUC（0-inf）were （468.47 ±63.04） mg/（h·L） and （462.32 ± 42.70） mg/（h·L） for T and R respectively. The 90% confidential interval of Cmax,AUC（0- 60） and AUC（0-inf） of tested formulation were 99.69 % - 105.76 % , 98.61% - 104.16 % and 97.79 % - 104.08 % respectively. The relative bioavailabillty was （101.6-8.4） %. Conclusion The test and reference preparations both have bioequivalence.