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片剂工艺创新及其产业化应用的思考

     

摘要

随着药物制剂新技术、新设备、新辅料的发展以及现代医疗对片剂质量要求的提高,不少企业已经开始对片剂产品进行工艺创新研究,以提高片剂产品质量与市场竞争力.然而,片剂工艺创新是一项复杂系统的工程,投入大、周期长、风险高,往往难以实现产业化应用.因此,本文就我国片剂工艺创新现状、重要性及影响因素进行分析,并从政策法规、经济性、技术要求、知识管理等多方面为我国制药企业片剂工艺创新及其产业化应用研究提供思路.%With the development of new techniques, new equipments and new excipients of pharmaceutical preparation, and improvement of requirement of modern medical treatment on tablet quality, some enterprises had started to do research on tablet technology innovation to improve product quality and market competitiveness. However, tablet technology innovation is a complicated and systematic engineering, with high research cost, long implementing period, and high risk, which is often hard to realize industrialized application. Therefore, the status, importance, and effect factors of tablet technology innovation in China were analyzed, and thoughts for the research on China's tablet technological innovation as well as its industrialized application were provided from the aspects of policies and regulations, economy, technical requirements, knowledge management, etc in this paper.

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