注射用硼替佐米制备及质量考察  

Paration and Quality Investigation of Desmopressin Acetate for Injection

作　　者：李远文 吕乐[1,2] Li Yuanwen;Lyu Le(Shenzhen City Polytechnic,Shenzhen 518116,China;Shenzhen Institute of Technology,Shenzhen 518116,China)

机构地区：[1]深圳城市职业学院,广东深圳518116 [2]深圳技师学院,广东深圳518116

出　　处：《山东化工》2024年第16期12-14,共3页Shandong Chemical Industry

基　　金：深圳技师学院博士科研启动金项目(项目编号:2214010);校级科研项目(项目编号:2211003)。

摘　　要：目的:建立适合注射用硼替佐米的冻干工艺。方法:采用真空冷冻干燥法,对注射用硼替佐米的工艺条件如药液装量、预冻温度、升华干燥温度、解析干燥温度等进行探讨。结果:冻干工艺为药液装量0.8 mL/瓶;选取-40℃为本产品的预冻温度;在真空状态下,以-40~-25℃进行升华干燥;35℃进行解析干燥。结论:此工艺制备的注射用硼替佐米,经验证适合批量生产,产品质量符合国家标准规定。Objective:To establish a suitable freeze-drying process for bortezomib injection.Methods:Vacuum freeze-drying process was evaluated,including conditions such as medicinal liquid volume,pre-freezing temperature,sublimation drying temperature,desorption drying temperature,etc.Results:The optimal conditions were 0.8 mL medicinal liquid per bottle,pre-freezing temperature-40℃.Under vacuum condition,sublimation drying temperature was-40~-25℃and the desorption drying temperature was 35℃.Conclusion:The bortezomib for injection prepared by this process has been verified to be suitable for mass production,and the product quality meets national standards and regulations.

关 键 词：注射用硼替佐米 真空冷冻干燥法 制备工艺 

分 类 号：TQ460[化学工程—制药化工]