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目的 :观察比较健康志愿者肌注国产与进口头孢三嗪的人体相对生物利用度 ,并对其生物等效性进行评价。方法 :1 0名男性健康志愿者随机交叉自身对照的方法分别肌注国产或进口头孢三嗪注射液各 1 g ,用微生物法测定肌注各药后 0～ 36h内系列时间点的血药浓度。结果 :受试药与参比药比较 ,相对生物利用度 (F)为 93.4± 6 .3%。结论 :肌注国产头孢三嗪与进口头孢三嗪相比 ,其人体相对生物利用度为 93.4± 6 .3% ,两制剂具有生物等效性
OBJECTIVE: To observe the relative bioavailability of domestic and imported ceftriaxone in healthy volunteers and to evaluate its bioequivalence. Methods: A total of 10 healthy volunteers were randomized cross-self-control method were intramuscular injection of domestic or imported ceftriaxone injection of 1 g, respectively, by microbiological assay intramuscular injection of various drugs within 0 ~ 36h after the series of time point of plasma concentration . Results: The relative bioavailability (F) of test drug and reference drug was 93.4 ± 6.3%. CONCLUSION: Compared with the imported ceftriaxone, the relative bioavailability of domestic ceftriaxone is 93.4 ± 6.3%, and the bioavailability of the two preparations is bioequivalent