肺部吸入制剂评价方法的研究进展

Progress of Research on Evaluation Methods for Pulmonary Inhalation Preparation

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。

To provide research ideas and theoretical basis for relevant researches through summarizing on evaluation methods of pulmonary inhalation either in vivo or in vitro. Classifying various evaluation methods of pulmonary inhalation according to their characteristics after collecting, analyzing and concluding related 27 articles in last decade from the databases of CNKI, PubMed, ScienceDirect. Predominant evaluation methods were listed as follows： cascade impactor method, modern optic instruments method, pharmacodynamic evaluation method, pharmacokinetic evaluation method, intrapulmonary deposition method and so on. Currently, there were many problems yet to be solved for evaluation methods of pulmonary inhalation, for example, correlation between in vivo and in vitro evaluation methods was low, methods were single of pharmacodynamic and pharmacokinetic evaluation, animal models were not conforming to real situation of human body and safety assessment system was imperfect. All of these should be gradually improved and perfected in the future studies.