首页|冷冻干燥技术在药品生产中的应用研究

冷冻干燥技术在药品生产中的应用研究

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冷冻干燥技术通过在低温下迅速冻结药物,在真空环境中升华去除水分,能有效保持药物的活性与稳定性,延长保质期,同时改善溶解性和生物利用度。该技术具有精准的过程控制能力,可减少添加剂使用,便于运输与储存,且有助于简化生产工艺与提高自动化水平。在优化冷冻干燥工艺方面,关键要素包括掌握预冻降温速率的调控、研究影响复溶速率的因素、深入解决冻干产品的水分问题以及制定并完善质量保障体系。随着技术的不断进步,冷冻干燥技术将在生物药物和热敏药物生产中发挥更重要作用,为制药行业的可持续发展提供新思路与方法。
Application of Freeze-dry Technology in Pharmaceutical Production
Freeze-drying technology effectively maintains the activity and stability of the drug by rapidly freezing the drug at low temperature and sublimating it in a vacuum environment to remove water,extending the shelf life while improving solubility and bioavailability.The technology provides precise process control,reduces additive use,facilitates transportation and storage,and helps streamline production processes and increase automation.In terms of optimizing the freeze-drying process,the key elements include mastering the regulation of the pre-freezing cooling rate,studying the factors affecting the reconstitution rate,deeply solving the moisture problem of the lyophilized product,and developing and improving the quality assurance system.With the continuous advancement of technology,freeze-drying technology will play a more important role in the production of biological drugs and heat-sensitive drugs,providing new ideas and methods for the sustainable development of the pharmaceutical industry.

drug productionfreeze-drying technologyapplication scheme

徐向军、耿岩、张赫宸、肖祥、刘斌

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长春生物制品研究所有限责任公司,吉林 长春 130000

药品生产 冷冻干燥技术 应用方案

2024

中国科技纵横
中国民营科技促进会

中国科技纵横

影响因子:0.102
ISSN:1671-2064
年,卷(期):2024.(17)