药学学报, 2021, 56(9): 2513-2521
王洪亮, 董武军, 陈蕾, 叶军, 王艳宝, 刘玉玲. 叔丁醇在生物医药领域的主要应用及研究进展[J]. 药学学报, 2021, 56(9): 2513-2521.
WANG Hong-liang, DONG Wu-jun, CHEN Lei, YE Jun, WANG Yan-bao, LIU Yu-ling. Tert-butanol application and related research progress in biomedicine[J]. Acta Pharmaceutica Sinica, 2021, 56(9): 2513-2521.

王洪亮1, 董武军2, 陈蕾3, 叶军1, 王艳宝1, 刘玉玲1*
1. 中国医学科学院、北京协和医学院药物研究所, 药物传输技术及新型制剂北京市重点实验室, 北京 100050;
2. 国家食品药品监督管理总局药品审评中心, 北京 100038;
3. 国家药典委员会, 北京 100061
关键词:    叔丁醇      药物制剂      难溶性药物      冻干      安全性     
Tert-butanol application and related research progress in biomedicine
WANG Hong-liang1, DONG Wu-jun2, CHEN Lei3, YE Jun1, WANG Yan-bao1, LIU Yu-ling1*
1. Beijing Key Laboratory of Drug Delivery Technology and Novel Formulation, Institute of Materia Medica, Chinese Academy of Medical Sciences&Peking Union Medical College, Beijing 100050, China;
2. Center for Drug Evaluation, National Medical Products Administration, Beijing 100038, China;
3. Chinese Pharmacopoeia Commission, Beijing 100061, China
Tert-butanol is an organic solvent, widely used in the medical field and chemical industry. It could be characterized by high crystallization temperature and vapor pressure. It could be easily sublimed and removed during the freeze-drying process. This review mainly describes the use of tert-butanol in the lyophilized formulations of poorly soluble drugs, the lyophilization solvent of porous structure productions, and as an ice crystal growth guider. In addition, the application of tert-butanol in nano drugs and aerogels has also been reviewed, as well as the current research progress in its quality and safety.
Key words:    tert-butanol    pharmaceutical preparation    poorly water-soluble drug    freeze drying    safety   
收稿日期: 2021-05-24
DOI: 10.16438/j.0513-4870.2021-0785
基金项目: “十三五”国家科技重大专项(2018ZX09711001-002-005).
通讯作者: 刘玉玲,Tel:86-10-83160332,E-mail:ylliu@imm.ac.cn
Email: ylliu@imm.ac.cn
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董武军  在本刊中的所有文章
陈蕾  在本刊中的所有文章
叶军  在本刊中的所有文章
王艳宝  在本刊中的所有文章
刘玉玲  在本刊中的所有文章

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