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随着抗菌药物的不断发展和临床应用的日益普遍,各种抗菌药物的不同制剂越来越多。临床实践发现,含有同量活性成分的药物,由于其剂型、配方、工艺等不同,口服或肌注后可显著影响其吸收,从而影响临床疗效。因此产生了生物利用度测定,即于给药后不同时间测定血药浓度,以确定药物的吸收速率和吸收程度。由于药物的疗效主要决定于到达感染部位的药浓度,当体内药物分布达到稳态时,感染部位的药物浓度与血药浓度直接相关,因此生物利用度测定可以作为测定药物疗效的一项指标。根据这一指标,1968年美国FDA命令收回8种市售不同来源的氯霉素胶囊2亿粒,这些药品全部符合药典和美国FDA(食品药物管理局)规定的质量标准,但经生物利用度测定证实吸收不良,生物利用度差。根据同样理由,1974年美国FDA命令Preno制药公司收回其全部四环素制剂。
With the continuous development of antibacterial drugs and the increasingly widespread clinical application, a variety of different preparations of antibacterial drugs more and more. Clinical practice found that the same amount of active ingredients of the drug, due to its formulations, formulations, processes and other differences, oral or intramuscular injection can significantly affect their absorption, thus affecting the clinical efficacy. Thus, a bioavailability assay was developed that measures the plasma concentration at different times after administration to determine the rate of absorption and extent of absorption of the drug. As drug efficacy depends primarily on the concentration of drug arriving at the site of infection, the drug concentration at the site of infection is directly related to plasma concentration as the drug distribution in the body reaches steady state, and bioavailability can be used as an indicator of the efficacy of the drug. According to this indicator, in 1968, the U.S. FDA ordered the recovery of 200 million chloramphenicol capsules from eight different sources, all of which meet the quality standards set forth in the Pharmacopoeia and the U.S. Food and Drug Administration (FDA). However, the bioavailability Measurement confirmed that malabsorption, poor bioavailability. By the same token, in 1974, the U.S. FDA ordered Preno Pharma to withdraw all its tetracycline preparations.