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国产与进口氧氟沙星注射液在健康人体内的药动学研究 被引量:1

Pharmacokinetics of Imported and Domestic Ofloxacin Injection in Healthy Subjects
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摘要 本文对10例健康志愿者静脉恒速滴注国产与进口两种氧氟沙星注射液后的药代动力学进行了研究。试验采用交叉给药的方法,30分钟静脉恒速滴注200mg氧氟沙星,用高效液相色谱(HPLC)及微生物法分别对血清及尿中氧氟沙星进行了测定,其体内过程均符合二室开放模型。实验结果表明:采用两种实验方法测得的结果无显著性差异;两种注射液的药代动力学参数也无显著性差异,两者具有生物等效性。 In ten healthy volunteers, the pharmacokinetics of ofloxacin made in China and in German Hoechst were studied after crossover administration of 200mg drug(30min constant infusion). The concentrations of ofloxacin in serum and in urine were measured by both HPLC and bioassay.The pharmacokinetic parameters of domestic and imported ofloxacin measured by HPLC were as follow:Co 5.39±1.72mg/L and 5.15±1.13mg/L,t1/2 4.86±0.26h and 486±0.18h,Vc 35.75±12.22L and 35.06±11.4L,AUC 16.00±2.99μgxh/ml and 15.89±2.86μgxh/ml;uring recovery rates(24h) 78.64±10.66%and 78.90±10.90%, respectively.The pharmacokinetic parameters obtained from our study showed that no significant differences either between two products or between two assay methods were found.
机构地区 北京医院
出处 《中国药房》 CAS CSCD 1995年第3期23-25,共3页 China Pharmacy
关键词 氧氟沙星 静脉滴注 药代动力学 高效液相色谱 ofloxacin intravenous infusion pharmacokinetics bioassay HPLC
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