药物多态性是影响药物质量和临床疗效的重要因素。因此,药物的晶体分析及其研究和评价部分应引起高度重视。近年来,随着拉曼光谱技术的蓬勃发展,越来越多的晶体分析研究基于振动光谱。本文主要讨论了拉曼光谱对药物活性成分(API)和药物制剂的定性和定量分析。在药物分子振动模式测定和化学结构分析的基础上,这种方法具有普适性的优点,非破坏性的,快速测定,低样品和成本,等。本综述为晶体结构提供了理论和技术支持,值得推广。预计对政府相关管理机构有所帮助,制药科研机构和药品生产企业。
Drug polymorphism is an important factor affecting the drugs quality and clinical efficacy. Therefore, great attention should be paid to the crystal analysis of drugs with their researching and evaluating part. With the booming development of Raman spectroscopy in recent years, more and more crystal analysis investigations were based on vibrational spectroscopy. This
review mainly discussed the qualitative and quantitative analysis of active pharmaceutical ingredients (API) and pharmaceutical preparation with Raman spectroscopy. On basis of the determination of the vibration mode of drug molecules and the analysis of their chemical structure, this method had the advantages of universal, non-destructive, fast determination, low samples and cost, etc. This
review provides theoretical and technical support for crystal structure, which are worth popularizing. It is expected that it will be helpful to relevant government management institutions, pharmaceutical scientific research institutions and pharmaceutical manufacturers.