药学学报, 2021, 56(5): 1301-1313
引用本文:
曹秋芳, 饶小勇, 张尧, 张爱玲, 李敏, 李哲, 罗晓健. 玻璃化转变现象在药剂学中的应用研究进展[J]. 药学学报, 2021, 56(5): 1301-1313.
CAO Qiu-fang, RAO Xiao-yong, ZHANG Yao, ZHANG Ai-ling, LI Min, LI Zhe, LUO Xiao-jian. Research progress in the application of glass transition phenomenon in pharmaceutics[J]. Acta Pharmaceutica Sinica, 2021, 56(5): 1301-1313.

玻璃化转变现象在药剂学中的应用研究进展
曹秋芳1, 饶小勇1, 张尧1, 张爱玲1, 李敏2, 李哲1*, 罗晓健1*
1. 江西中医药大学, 中药固体制剂制造技术国家工程中心, 现代中药制剂教育部重点实验室, 江西 南昌 330004;
2. 扬子江药业集团有限公司, 江苏 泰州 225300
摘要:
近年来,玻璃化转变现象逐渐应用到药剂学领域,对药物制剂的多个操作单元、制剂中间体与产品的性质及贮存有重要影响。目前已在干燥、制粒和包衣等制剂制备环节中广泛应用,同时对固体分散体、微囊、脂质体、微粒和片剂等制剂中间体及其产品的制备具有指导意义。因此,本文对玻璃化转变现象在制剂过程中的应用及其对制剂中间体和制剂产品的影响,进行详细分析和系统总结,为制剂生产和产品贮存提供理论指导。
关键词:    玻璃化转变      无定形      温度      含水量      药剂      稳定性     
Research progress in the application of glass transition phenomenon in pharmaceutics
CAO Qiu-fang1, RAO Xiao-yong1, ZHANG Yao1, ZHANG Ai-ling1, LI Min2, LI Zhe1*, LUO Xiao-jian1*
1. National Pharmaceutical Engineering Research Center for Solid Preparation in Chinese Herbal Medicine, Ministry of Education, Jiangxi University of Chinese Medicine, Nanchang 330004, China;
2. Yangzijiang Pharmaceutical Group Co., LTD., Taizhou 225300, China
Abstract:
In recent years, the phenomenon of glass transition has been gradually applied to the field of pharmaceutics. And it exhibits important influences on multiple operating units of pharmaceutical preparations, and the properties and storage of pharmaceutical intermediates and products. At present, it has been widely used in the process of preparations such as drying, granulation, coating, tableting, holt-melt extrusion, cryogenic comminution, and so on. Meanwhile, it showed guiding significance for the process of preparation intermediates and their products, such as solid dispersion, microcapsule, liposome, particle, tablet, and other preparation intermediates and their products. Therefore, this article conducts a detailed analysis and systematic summary of the application guidance of the phenomenon of glass transition in the preparation process, and its influence on the preparation intermediates and products, so as to provide theoretical guidance for preparation production and product storage.
Key words:    glass transition    amorphous    temperature    moisture content    pharmaceutics    stability   
收稿日期: 2020-11-17
DOI: 10.16438/j.0513-4870.2020-1755
基金项目: 国家重点研发计划“中医药现代化研究”重点专项(2018YFC1706901);国家自然科学基金资助项目(82003953);中国博士后科学基金面上资助项目(2019M662278);江西省青年科学基金资助项目(20202BAB216039);江西省教育厅科学技术研究项目(GJJ190688).
通讯作者: 李哲,Tel:86-791-87119027,E-mail:lizhezd@163.com;罗晓健,Tel:86-791-87119619,E-mail:luoxj98@126.com
Email: lizhezd@163.com;luoxj98@126.com
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