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国产克林霉素磷酸酯正常人药物动力学及生物利用度研究
Pharmacokinetics and relative bioavailability studies of clindamycin phosphate in heaIthy volunteers
【摘要】 对8名健康男性志愿受试者进行了国产克林霉素磷酸酯与进口制剂的药物动力学随机交叉对比试验和国产克林霉素磷酸酯注射液肌注给药的绝对生物利用度研究。用微生物法测定血药浓度。结果国产品与进口品药动学性质一致,静脉注射5分钟后,血药浓度分别为6.81和5.85mg/L;清除半衰期为2.30和2.31h;表现分布容积为33.80和35.01L;总体清除率为19.52和21.01ml/min;曲线下面积为16.00和14.96h·mg/L。国产克林霉素磷酸酯肌注药动学参数与静注相似。生物利用度达111.38%。
【Abstract】 healthy volunteers receivect the clindamycin phosphate injection made byshandong Xinhua Pharmacetitical plant and the same drugs imported from U,S.A,Theserum concentration v s,time curve following a single iv or im fldministration of thoseinjection were well fitted for two compartments open model.The pharmacokineticparameters of domestic and imported clindamycin phosphate by iv were:Cmax 6.81 and 5.85mg/L,T1/2β,2.30 and 2. 3lh,Vd 33.80 and 35.01 L,Cls 19.52 and 21.01 ml/min,AUC16.00 and 14.96 h· mg/L。The pharmacokinetic parameters of domestic clindamycinphosphate by im were similar with iv,Relative bioavailabilty of domestic im injection was111.4%compared with imported iv injection;
【Key words】 Clindamycin phosphate; Pharmacokinetics; Relative bioavailability;
- 【文献出处】 中国抗生素杂志 ,CHINESE JOURNAL OF NATIBIOTICS , 编辑部邮箱 ,1995年03期
- 【分类号】R978.1
- 【被引频次】8
- 【下载频次】236