OEM项目--扑热息痛布洛芬片的转移之路  

OEM Project-the Transfer of Paracetamol and Ibuprofen Tablets

作　　者：高潇 GAO Xiao(Yiling Wanzhou International Pharmaceutical Co.,Ltd.,Shijiazhuang Hebei 050000)

机构地区：[1]以岭万洲国际制药有限公司,河北石家庄050000

出　　处：《中国科技纵横》2022年第1期163-165,共3页China Science & Technology Overview

摘　　要：产地转移项目复方制剂扑热息痛布洛芬片,采用湿法制粒工艺,使布洛芬含量低且不均匀。研究发现布洛芬原料针状结构参与制粒后静电现象增强,不易成粒游离在颗粒外并吸附于设备内壁及流化床抖袋上较多,后改变生产工艺将布洛芬外加,解决了含量问题。商业化扩批过程中批量扩大10倍,5000L混合罐出料后颗粒分层,定制出料备件后出料无粉尘、出料速度快并解决了出料分层问题,产品顺利完成商业化扩批并在多地完成注册。Item of origin transfer compound preparation paracetamol ibuprofen tablet;wet granulation process,ibuprofen assay is low and ununiformity.It was found that the needle-like structure of ibuprofen raw material was involved in granulation,and the electrostatic phenomenon was enhanced.Then the production process was changed and ibuprofen was added to solve the content problem.In the commercial batch expansion process,the batch size is expanded by 10 times.After discharging of 5000L mixing bin,particles are stratified.After customized discharging spare parts,there is no dust and the discharging speed is fast;and the problem of discharging stratification is solved.The product has successfully completed commercialization,batch expansion and registration in many places.

关 键 词：布洛芬 含量低 外加 扩批 出料分层 

分 类 号：R943[医药卫生—药剂学]