枸橼酸钾溶液微生物风险控制的改进与成效  

Improvement and Effects of Microbiological Risk Control of Potassium Citrate Solution

作　　者：王彪[1] 张翠莲[1] 刘建茹[1] 周雨佳 李文瀚 刘鑫[1] 唐筱婉 刘容吉[1] 

机构地区：[1]中国医学科学院中国协和医科大学北京协和医院,北京100730

出　　处：《中国药事》2017年第12期1494-1496,共3页Chinese Pharmaceutical Affairs

摘　　要：目的:为医疗机构制剂微生物风险控制提供参考。方法:回顾性分析我院对枸橼酸钾溶液微生物风险研判的过程,探索性地采取了生产改进后微生物限度检查结果呈现的效果。结果:增加着色剂(5%柠檬黄溶液)储备液的终端灭菌措施,可保证枸橼酸钾溶液微生物检查符合规定。结论:对着色剂溶液采取终端灭菌措施,是确保枸橼酸钾溶液微生物限度达标的有效手段。Objective： To provide references for microbiological risk control of preparations of medical institutions. Methods： The process of investigating the microorganism risk of potassium citrate solution was retrospectively analyzed. The effects of microbial limit test after improvement were explored. Results： Terminal sterilization by adding coloring agent （5% tartrazine solution） could ensure the microbial limit of potassium citrate solution. Conclusion： Terminal sterilization for coloring agent was an effective way to ensure the microbial limit of potassium citrate solution.

关 键 词：枸橼酸钾溶液 微生物 风险控制 改进措施 成效 

分 类 号：TQ658[化学工程—精细化工] R95[医药卫生—药学]