从结构出发的制剂一致性研究策略
发布时间：2019-06-18 16:04
【摘要】：制剂一致性研究中如何提高效率、充分保障仿制制剂与原研药一致,亟待发展新的技术和方法。对于具有结构特征的固体制剂、微粒分散体系,结构是其特定处方与工艺技术的结果,决定其递送药物的释放行为及其体内药代动力学行为。传统表征技术不能对结构进行定量,而同步辐射成像等新一代结构定量表征技术,在揭示制剂内部结构方面展现了前所未有的能力,能定量表征制剂的静态结构和动态结构,实现制剂工艺的逆向工程剖析和制剂间结构异同的甄别。本团队建立了方法学,采用该技术实现了在静态结构(原辅料粉体结构、颗粒单元结构、片剂结构和膜结构等)和水化等动态结构、固体制剂工艺甄别等方面的应用,将制剂的结构划分为从剂型到制剂中间体、动态结构、分子结构等四级结构,提出了基于制剂结构的药物一致性评价新策略。在制剂释药行为一致的基础上,制剂内部精细结构的一致更有助于确保制剂的一致性。
[Abstract]:In the study of preparation consistency, how to improve the efficiency and fully ensure that the imitation preparation is consistent with the original drug, it is urgent to develop new technologies and methods. For solid preparations with structural characteristics, the structure of the particle dispersion system is the result of its specific prescription and process technology, which determines the release behavior of the delivered drugs and the pharmacokinetics behavior in vivo. The traditional characterization technology can not quantify the structure, but the new generation structure quantitative characterization technology, such as synchrotron radiation imaging, has shown unprecedented ability in revealing the internal structure of the preparation, can quantitatively characterize the static structure and dynamic structure of the preparation, and realize the reverse engineering analysis of the preparation process and the identification of the similarities and differences of the structure between the preparations. The team established the methodology and adopted this technique to realize the application in static structure (raw excipients powder structure, particle unit structure, tablet structure and membrane structure, etc.) and hydration dynamic structure, solid preparation process identification and so on. The structure of the preparation was divided into four levels of structure, from dosage form to preparation intermediate, dynamic structure, molecular structure, etc., and a new drug consistency evaluation strategy based on preparation structure was put forward. On the basis of consistent drug release behavior, the consistency of fine structure in the preparation is more helpful to ensure the consistency of the preparation.
【作者单位】： 安徽中医药大学药学院;中国科学院上海药物研究所;中国科学院上海应用物理研究所;
【基金】：国家重大科技专项资助项目(2013ZX09402103) 国家自然科学基金资助项目(81430087)
【分类号】：R94
本文编号：2501617
[Abstract]:In the study of preparation consistency, how to improve the efficiency and fully ensure that the imitation preparation is consistent with the original drug, it is urgent to develop new technologies and methods. For solid preparations with structural characteristics, the structure of the particle dispersion system is the result of its specific prescription and process technology, which determines the release behavior of the delivered drugs and the pharmacokinetics behavior in vivo. The traditional characterization technology can not quantify the structure, but the new generation structure quantitative characterization technology, such as synchrotron radiation imaging, has shown unprecedented ability in revealing the internal structure of the preparation, can quantitatively characterize the static structure and dynamic structure of the preparation, and realize the reverse engineering analysis of the preparation process and the identification of the similarities and differences of the structure between the preparations. The team established the methodology and adopted this technique to realize the application in static structure (raw excipients powder structure, particle unit structure, tablet structure and membrane structure, etc.) and hydration dynamic structure, solid preparation process identification and so on. The structure of the preparation was divided into four levels of structure, from dosage form to preparation intermediate, dynamic structure, molecular structure, etc., and a new drug consistency evaluation strategy based on preparation structure was put forward. On the basis of consistent drug release behavior, the consistency of fine structure in the preparation is more helpful to ensure the consistency of the preparation.
【作者单位】： 安徽中医药大学药学院;中国科学院上海药物研究所;中国科学院上海应用物理研究所;
【基金】：国家重大科技专项资助项目(2013ZX09402103) 国家自然科学基金资助项目(81430087)
【分类号】：R94
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1 记者 任壮;建立中药质量一致性评价体系[N];中国中医药报;2013年
2 戴绪霖;质量一致性评价应成为严格的标尺[N];医药经济报;2012年
，本文编号：2501617
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