健康志愿者口服两种螺旋霉素片剂的相对生物利用度

BOTH SPIRAMYCIN TABLETS RELATIVE BIOAVAILABILITY IN HEALTHY VOLUNTEERS

用微生物法测定了10名健康志愿者单剂量交叉口服1g 国产和进口螺旋霉素片剂后的血药浓度,比较了它们的相对生物利用度。所有数据都经计算机拟合处理和统计分析,结果表明:这两种片剂的血药高峰浓度(Cmax)、达峰时间(Tmax)和药时曲线下面积(AUC_(0→10h))等药物动力学参数间均尢显著差异(P>0.3),其相对生物利用度 F(国产片 AUC_(0→10h)/进口 AUC_(0→10h))为124.57%。

In this study,the relative bioavailability of domestic spiramycin tablet(Ⅰ)and import commercially available tablet(Ⅱ)was compared by a crossover orally administered single dose spiramycin 1 g in 10 healthy male volunteers.The spiramycinconcentrations in serum were determined by microbial assay.All data were calculatedand analysed with computer.These results showed,that the pharmacokinetic parametersTmax,Cmax,AUC_(0→10h)and the bioavailability were not significantly different(P>0.3)between the Ⅰ and Ⅱ.The relative bioavailability F was 124.57%.