用无水葡萄糖生产葡萄糖注射液的工艺验证  

Process Validation of Glucose Injection Used Anhydrous Glucose as Material

作　　者：杨善彬[1] 梁桂兆[1] 江有 潘元[3] 杨娟[3] 李志良[1] 

机构地区：[1]重庆大学生物工程学院,重庆400030 [2]成都青山制药有限公司,四川成都611844 [3]重庆大学化学化工学院药物化学研究所,重庆400030

出　　处：《重庆大学学报（自然科学版）》2008年第2期206-208,共3页Journal of Chongqing University

基　　金：重庆大学研究生创新团队科技创新基金资助项目(200711CIA0010260);重庆直辖市应用基础基金资助项目(01-3-6)

摘　　要：为验证用无水葡萄糖生产葡萄糖注射液的工艺可行性,验证标准考察工艺。结果表明用无水葡萄糖取代一水葡萄糖生产葡萄糖注射液的工艺质量稳定。所以用无水葡萄糖取代一水葡萄糖生产葡萄糖注射液的工艺可行。OBJECTIVE To validate the feasibility of using anhydrous glucose as material to produce glucose injection. METHODS The validation standard was built according to the method on Chinese Pharmacopoeia （1995 or 2000 edition）. RESULTS The procedure of glucose injection used anhydrous glucose as material was found to have good stability and high quality. CONCLUSION The procedure validation showed that production of glucose injection used anhydrous glucose as material was feasible . Glucose monohydrate could be replaced by anhydrous glucose to produce glucose injection.

关 键 词：无水葡萄糖 一水葡萄糖 葡萄糖注射液 工艺验证 

分 类 号：R944.11[医药卫生—药剂学]