【摘要】：制劑一致性研究中如何提高效率、充分保障仿制制劑與原研藥一致,亟待發(fā)展新的技術(shù)和方法。對于具有結(jié)構(gòu)特征的固體制劑、微粒分散體系,結(jié)構(gòu)是其特定處方與工藝技術(shù)的結(jié)果,決定其遞送藥物的釋放行為及其體內(nèi)藥代動力學(xué)行為。傳統(tǒng)表征技術(shù)不能對結(jié)構(gòu)進行定量,而同步輻射成像等新一代結(jié)構(gòu)定量表征技術(shù),在揭示制劑內(nèi)部結(jié)構(gòu)方面展現(xiàn)了前所未有的能力,能定量表征制劑的靜態(tài)結(jié)構(gòu)和動態(tài)結(jié)構(gòu),實現(xiàn)制劑工藝的逆向工程剖析和制劑間結(jié)構(gòu)異同的甄別。本團隊建立了方法學(xué),采用該技術(shù)實現(xiàn)了在靜態(tài)結(jié)構(gòu)(原輔料粉體結(jié)構(gòu)、顆粒單元結(jié)構(gòu)、片劑結(jié)構(gòu)和膜結(jié)構(gòu)等)和水化等動態(tài)結(jié)構(gòu)、固體制劑工藝甄別等方面的應(yīng)用,將制劑的結(jié)構(gòu)劃分為從劑型到制劑中間體、動態(tài)結(jié)構(gòu)、分子結(jié)構(gòu)等四級結(jié)構(gòu),提出了基于制劑結(jié)構(gòu)的藥物一致性評價新策略。在制劑釋藥行為一致的基礎(chǔ)上,制劑內(nèi)部精細結(jié)構(gòu)的一致更有助于確保制劑的一致性。
[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.
【作者單位】： 安徽中醫(yī)藥大學(xué)藥學(xué)院;中國科學(xué)院上海藥物研究所;中國科學(xué)院上海應(yīng)用物理研究所;
【基金】：國家重大科技專項資助項目(2013ZX09402103) 國家自然科學(xué)基金資助項目(81430087)
【分類號】：R94

【相似文獻】

相關(guān)重要報紙文章 前2條

1 記者 任壯;建立中藥質(zhì)量一致性評價體系[N];中國中醫(yī)藥報;2013年

2 戴緒霖;質(zhì)量一致性評價應(yīng)成為嚴(yán)格的標(biāo)尺[N];醫(yī)藥經(jīng)濟報;2012年

，

本文編號：2501617