有效药物成分的多态性控制

R. Terekhov, Denis I. Pankov, E. Anfinogenova, I. Selivanova
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引用次数: 0

摘要

Рolymorphism由于其在保持分子结构的同时影响活性药物成分(API)的理化和药理学性质而受到越来越多的关注。本文综述了原料药在开发阶段和药物流通期间的相状态控制问题。术语“多态性”有不同的定义取决于科学的分支。在制药行业的监管文件中也没有明确的解决方案。本文在文献资料分析的基础上,对俄罗斯、白俄罗斯、哈萨克斯坦、美国、日本国家药典以及欧洲经济联盟和欧亚经济联盟国际药典中推荐的药用物质多态性分析药典方法进行了比较。揭示了综合运用高新技术设备的趋势。基于x射线衍射、热、光谱、显微、生物和物理方法确定常数的系统分析方法,不仅可以识别原料药的多态性修饰,而且可以表征其结构、形态、理化性质和药理活性。在俄罗斯联邦,对多态现象的研究特别深入,一些控制方法,如生物方法,仅在俄罗斯药典中得到证实。进一步研究的一个有希望的方向是在这一化学和技术制药领域的框架内改进和协调监管文件。全球方法不仅有助于减少劣质产品进入市场的可能性,而且还有助于降低确定所生产的活性药物成分的真实性的成本。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Polymorphism control of active pharmaceutical ingredients
Рolymorphism is receiving increasing attention due to its influence on the physicochemical and pharmacological properties of the active pharmaceutical ingredients (API) while maintaining the molecular structure. This review is devoted to the problem of APIs phase state control both at the development stage and during the circulation of the drug. The term «polymorphism» has different definitions depending on the branch of science. There is no unambiguous solution to this issue in the regulatory documentation of pharmaceutical industry either. Based on the analysis of literary sources, the article presents a comparison of pharmacopeia methods, recommended in Russian and foreign regulatory documents for the analysis of polymorphism of medicinal substances, including state pharmacopeias of Russia, Belarus, Kazakhstan, the USA, and Japan, as well as international pharmacopeias of the European Economic Union and the Eurasian Economic Union. The trend on using a complex of high-tech equipment is revealed. A systematic approach to analysis based on X-ray diffraction, thermal, spectral, microscopic, biological, and physical methods for determining constants makes it possible not only to identify the polymorphic modification of API, but also to characterize its structure, morphology, physicochemical properties and pharmacological activity. In the Russian Federation, the phenomenon of polymorphism is being studied especially intensively, and some control methods, such as biological methods, are validated only in Russian pharmacopeia. A promising direction for further research is the improvement and harmonization of regulatory documentation within the framework of this chemical and technological field of pharmacy. A global approach will help to reduce not only the probability of poor-quality products entering the market, but also the costs of establishing the authenticity of the active pharmaceutical ingredient produced.
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