[關(guān)鍵詞]
[摘要]
我國化學(xué)創(chuàng)新藥物產(chǎn)業(yè)正蓬勃發(fā)展，藥物創(chuàng)新體系不斷完善，國產(chǎn)創(chuàng)新藥及高端制劑處于快速發(fā)展階段，將為我國新藥研發(fā)格局帶來深刻變革?；瘜W(xué)藥物質(zhì)量控制是藥物研發(fā)的重點，是藥品安全有效的前提。圍繞化學(xué)藥物產(chǎn)業(yè)發(fā)展戰(zhàn)略，攻堅關(guān)鍵核心技術(shù)，要重視科技創(chuàng)新。結(jié)合當(dāng)前國內(nèi)外前沿理念及技術(shù)，未來我國化藥制造將持續(xù)發(fā)展。從化藥制造關(guān)鍵質(zhì)量屬性辨識、化藥生產(chǎn)質(zhì)量源于設(shè)計和化藥質(zhì)量控制與劑型改良3個角度展開論述，以近10余年國內(nèi)外相關(guān)研究為參考，圍繞化藥產(chǎn)業(yè)發(fā)展戰(zhàn)略，緊扣關(guān)鍵質(zhì)量屬性與質(zhì)量源于設(shè)計理念對化藥質(zhì)量控制相關(guān)內(nèi)容進(jìn)行歸納總結(jié)，以期為化藥質(zhì)量控制提供方向和參考。
[Key word]
[Abstract]
The chemical innovative drug industry of China is booming, the drug innovation system is constantly improving, and domestic innovative drugs and high-end preparations are in the stage of rapid development, which will bring profound changes to new drug research and development pattern of China. The quality control of chemical drugs is the key point of drug research and development, and is the premise of drug safety and effectiveness. Centering on the development strategy of the chemical drug industry, we should focus on scientific and technological innovation by tackling key core technologies. Combined with the current domestic and foreign cutting-edge concepts and technologies, chemical medicine manufacturing of China will continue to develop in the future. This paper discusses the identification of critical quality attributes, quality by design of chemical pharmaceutical production, chemical pharmaceutical quality control and dosage form improvement from three perspectives. Based on the relevant literature at home and abroad in the past decade, the relevant content of chemical pharmaceutical quality control is summarized around the development strategy of chemical pharmaceutical industry and closely related to the critical quality attribute and quality by design concept. In this paper, the identification of critical quality attribute, the concept of quality by design and the improvement of dosage form were reviewed in order to provide reference for the quality control of chemical drugs.
[中圖分類號]
R914
[基金項目]
2022年江蘇省產(chǎn)教融合《藥物分析》一流課程；江蘇海洋大學(xué)專業(yè)學(xué)位研究生課程《藥品質(zhì)量控制》案例庫建設(shè)項目（YJSZY202102）；江蘇海洋大學(xué)2023年一流課程《藥物儀器分析》建設(shè)項目；連云港市政策引導(dǎo)產(chǎn)學(xué)研項目（CYX2202）
