Beagle犬药动学研究在缓释制剂评价体系中的作用比较

发布时间：2019-01-20 19:17

【摘要】：近年来,口服缓释技术发展迅速,口服缓释制剂在增加患者的顺应性,提高药物疗效,减少药物不良反应等方面发挥着重要作用,日益成为临床关注的重点。因此,不断提高缓释制剂的质量,满足临床需求是药物制剂发展的动力。本文综述比较了缓释制剂的评价手段,包括体外溶出试验、Beagle犬药动学实验、人体生物利用度和生物等效性试验、以适应症患者为对象的临床试验等4个层次的手段,特别对Beagle犬药动学实验在缓释制剂评价中的作用和定位进行了系统分析,并从胃肠道生理方面分析了影响Beagle犬实验结果的各种因素。
[Abstract]:In recent years, oral sustained-release technology has developed rapidly. Oral sustained-release formulations play an important role in increasing compliance of patients, improving drug efficacy and reducing adverse drug reactions, and increasingly become the focus of clinical attention. Therefore, continuous improvement of the quality of sustained-release preparations to meet clinical needs is the driving force for the development of pharmaceutical preparations. This article reviewed and compared the evaluation methods of sustained-release preparations, including in vitro dissolution test, Beagle canine pharmacokinetic test, human bioavailability and bioequivalence test, and clinical trials for patients with indications. In particular, the role and localization of Beagle canine pharmacokinetics in the evaluation of sustained-release preparations were systematically analyzed, and various factors affecting the results of Beagle canine experiments were analyzed from the aspects of gastrointestinal physiology.
【作者单位】：中国药科大学药物代谢与动力学研究中心;
【分类号】：R965

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