浅谈新药研发中的晶型研究

Brief Discussion on Crystal Form in New Drug Research and Development

当前国内对于1类新药的晶型研究尚处起步阶段,尚未形成一个较为统一的研究思路,因此本文总结了药用晶型选择的方法与重要性,依据药用晶型不同的热力学稳定性(热力学最稳定晶型、亚稳态晶型和无定型),从新药研发的角度阐述了一些研究与控制思路,并且综述了当前多晶型药物研究的一些成果与主要技术手段,试图从研究思路与技术难点2个方面为新药的晶型研究提供参考。

At present,the crystal form research of new drugs in China is still in its infancy,and a relatively unified research idea has not been formed.Therefore,this paper summarized the methods and importance of pharmaceutical crystal form selection.According to the different thermodynamic stability of medicinal crystal forms(thermodynamic most stable crystal form,metastable crystal form,amorphous),this paper expounded some research and control ideas from the perspective of new drug research and development,and summarized some achievements and main technical means in the current research of polycrystalline drugs.This paper attempted to provide reference for the crystal form research of new drugs from two aspects:research ideas and technical difficulties.