口服罗红霉素颗粒剂的相对生物利用度

Bioavailability of Roxithromycin Granules in Healthy Volunteers

以藤黄八叠球菌 2 80 0 1为试验菌 ,用微生物琼脂扩散法测定血清中罗红霉素浓度 ,最低检测浓度为 0 .2 5μg/ ml,线性范围 0 .2 5～ 1 0 .0 0 μg/ ml。 8名健康志愿者 ,随机口服单剂量(30 0 mg)罗红霉素片 (罗力得 )和罗红霉素颗粒剂 ,用面积法估算的罗红霉素颗粒剂的相对生物利用度为 93± 1 3% ,经统计分析 。

Roxithromycin concentrations in serum in 8 healthy male volunteers were assayed by the microbiological agar diffusion method with Sarcina lutea CMCC28001 as the organism. A single oral dose of 300 mg roxithromycin granules or tablets was given according to a crossover design. The pharmacokinetic parameters obtained from this studies showed no significant difference between tablets and granules. The relative bioavailability of granules and tablets were 93±13%. It demonstrated that both formations had bioequivalence.