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对肺部吸入制剂的评价方法进行介绍,为相关研究提供理论基础和研究思路。通过中国知网,PubMed,ScienceDirect等数据库,对近12年来27篇相关文献报道进行整理、分析和归纳,将各种肺部吸入剂的评价方法按其特点进行分类。肺部吸入剂的评价方法主要有:惯性撞击器法、现代光学仪器法、药效学评价、药动学评价、肺内沉积评价法等。肺部吸入剂评价方法存在体内、外评价相关性不强,药动学、药效学评价方法单一,动物模型与实际情况不相符,安全性评价体系不完善等问题,有待于逐步改进和完善。
The evaluation methods of pulmonary inhalation preparations are introduced to provide the theoretical basis and research ideas for the related research. According to the databases of CNKI, PubMed and ScienceDirect, 27 related literatures in recent 12 years were collated, analyzed and summarized, and the evaluation methods of various pulmonary inhalants were classified according to their characteristics. Pulmonary inhalant evaluation methods are: inertial impactor method, modern optical instruments, pharmacodynamic evaluation, pharmacokinetic evaluation, lung deposition evaluation method. Pulmonary inhalant evaluation methods exist in vivo, external evaluation of the correlation is not strong, pharmacokinetic, pharmacodynamics evaluation method is single, the animal model does not match with the actual situation, the safety evaluation system is not perfect and other issues to be gradually improved and perfected .