论中药工业中的中试放大验证

Verification via pilot magnification,key of Traditional Chinese Medicine modernization

本文对中药制药工程技术的四要素之一———中试放大与验证进行探讨,从中药研究成果转化为大规模生产的过程中一般都将发生质的变化,许多重大工程技术问题也往往出现在这一阶段。因此,中试放大验证至关重要,也是中药现代化的关键。本文论述了在实现中药大规模生产过程中进行中试放大验证的必要性、主要技术内容、应达到的目标,并就中试放大验证平台的建设、基本功能与任务、运行等进行了详细介绍。

In the article'Theory and Practice of Pharmaceutical Engineering of Traditional Chinese Medicine(TCM)',the authors of this article have exposed that the pharmaceutical engineering of TCM lays the theoretical and practical foundation which supports TCM industry to step onto the road of healthy development.This article explores one of the four factors-pilot magnification and verification in the pharmaceutical engineering of TCM.Qualitative changes usually occur in the transformation of research results made in TCM into large-scale production and quite a lot of major problems in engineering and technology emerge in it.Therefore,verification via pilot magnification is significantly important and the key of TCM modernization.This article discusses the necessity,the main contents and the goals to be attained of the verification via pilot magnification during the process of large-scale production of TCM,and makes a detailed introduction of the construction,the basic functions and tasks and the operation of the platform of the verification via pilot magnification.