| 葡萄糖注射液灭菌工艺验证性方案设计 |
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| 引用本文： | 桂双英,;郑金华.葡萄糖注射液灭菌工艺验证性方案设计[J].广东化工,2014(13):108-110. |
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| 作者姓名： | 桂双英 ;郑金华 |
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| 作者单位： | [1]安徽中医药大学,安徽合肥230031; [2]安徽双鹤药业有限责任公司,安徽芜湖241080; [3]安徽省中医药科学院药物制剂研究所,安徽合肥230031 |
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| 摘 要： | 目的验证葡萄糖注射液的灭菌工艺。方法通过对灭菌柜空载热分布实验、满载热分布实验和生物指示剂试验进行验证同时考察产品无菌状态以及主成分的变化。结果灭菌柜能够提供预定的灭菌条件,葡萄糖注射液经过灭菌操作后无菌检查合格,且其主成分改变很少。结论葡萄糖注射液通过灭菌验证。
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| 关 键 词： | 葡萄糖注射液 灭菌 验证 |
Program Design for Glucose Injection Liquid Sterilization Process Validation |
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| Affiliation: | Gui Shuangying, Zheng Jinhua (1. Anhui University of Chinese Medicine, Hefei 230031; 2. Anhui Double-Crane Pharmaceutical Co., Ltd, Wuhu 241080; 3. Anhui Academy of traditional Chinese Medicine Pharmaceutical Reserch Institute, Hefei 230031, China) |
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| Abstract: | Objective To verify a good sterilization process for glucose injection liquid. Methods Through the sterilizer is empty, full of heat distribution and heat distribution experiment of biological indicator test for validation and investigation of product sterility and changes of main components. Results Sterilization container to be able to provide pre-sterilized conditions, glucose injection liquid after sterilization operation, sterile check qualified and its main ingredients change very little. Conclusion Glucose injection liquid through sterilization validation. |
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| Keywords: | glucose injection sterilization validation |
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