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。
In recent years, oral extended-release technology is developing rapidly. It is important that oral extended-release formulations increase compliance, improve drug efficacy and reduce adverse drug reactions of pa- tients with such adaptation. Thus it has increasingly become the focus of clinical attention. The higher quality re- quirement of extended-release formulations and meeting clinical demands are the driving force for the development of the pharmaceutical preparations. The different evaluation systems, including in vitro dissolution experiments, pharmacokinetic experiments in Beagle dogs, bioavailability and bioequivalence tests, and clinical trials in patients with indications were compared in this paper. The role and location of pharmacokinetic study in Beagle dogs for e- valuation system of extended-release formulations were especially analyzed. The various factors from physiology of gastrointestinal affecting the experimental results of Beagle dogs were also analyzed in this paper.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2015年第10期1134-1140,共7页
Chinese Journal of New Drugs
关键词
缓释制剂
处方优化
质量控制
Beagle犬药动学
胃肠道生理
extended-release formulations
formulation optimization
quality control
pharmacokinetics ofBeagle dogs
gastrointestinal physiology
