晶型转化对药物稳定性的影响研究进展

在我国绝大多数药物晶型研究仍处于随意和偶然的自发研究状态.仿制药物疗效低于原研产品,创新药物质量不稳定的主要原因之一就是晶型问题.因此,更好地控制多晶型、利用多晶型,提高药品的稳定性,从而确保药品的安全有效性.综述了晶型对药物稳定性的影响因素、抑制转晶、亚稳定型稳定化方法等的研究进展.

Advances in study on influence of crystal transformation on drug stability

The majority of drug crystal research in China is still in the casually and occasionally spontaneous status. The curative effect of generic drug is lower than that of original one and the instability of innovative drug is mainly due to the form of crystalline. Therefore, in order to control the polymorphs, use polymorph better, and improve the stability of drugs, so that the safety and effectiveness of drugs are ensured. This paper reviewed the issues affecting crystal on the drug stability factors, inhibiting the crystallization and metastable type stabilization method and so on.