药物晶型定量分析方法的研究探究进展.pdf

896 药学学报 Acta Pharmaceutica Sinica 20 11, 46 (8) : 896903 药物晶型定量分析方法的研究进展 马乐伟, 杜 葳, 赵春顺* ( 中山大学药剂学与制药工程实验室, 广东 广州 510006) 摘要: 药物的多晶型对制剂的稳定性、溶出度及生物利用度等有着不可忽视的影响, 有的甚至带来毒副作 用, 是影响药品质量的重要因素之一。因此, 仅定性分析原料药或制剂中的晶型不能满足药品的质量控制要求。 为了测定原料药或制剂中有效晶型的含量, 从而确保制剂的疗效, 需要建立适当的多晶型定量方法, 其中包括 X-射线 末衍射法、傅里叶变换拉曼光谱法、中红外光谱法、近红外光谱法、太赫兹光谱法、固态核磁共振法 和差示扫描量热法等技术。本文综述了近 10 年来这些晶型定量方法的研究进展。 关键词: 药物; 多晶型; 定量分析 中图分类号: R943 文献标识码:A 文章编号: 05 13-4870 (20 11) 08-0896-08 Advances in the quantitative analytical methods of drug polymorphism * MA Le-wei, DU Wei, ZHAO Chun-shun (Laboratory of Pharmacy and Pharmaceutical Engineering, Sun Yat-sen University, Guangzhou 510006, China) Abstract: Polymorphism of drug is known to influence the stability, dissolution, bioavailability and other performance characteristics of the products. Therefore, the crystal form of the drug must be identified and determined in order to ensure consistent product performance. Even if the identification and characterization of crystal forms are performed thoroughly and the effective crystal form is selected for preparation, it is important to ensure that the effective crystal form in the final product remains unchanged. Therefore, it is essential to quantitate the content of the effective crystal form in the product to control the quality and performance of them. X-ray powder diffraction, FT-Raman, mid-IR, near-IR, terahertz pulsed spectroscopy, solid-state NMR spectroscopy, and DSC a