| 王彪,张翠莲,刘建茹,周雨佳,李文瀚,刘鑫,唐筱婉,刘容吉.枸橼酸钾溶液微生物风险控制的改进与成效[J].中国药事,2017,(12):1494-1496 |
| 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 |
| 投稿时间：2017-06-30 |
| DOI：10.16153/j.1002-7777.2017.10.021 |
| 中文关键词: 枸橼酸钾溶液 微生物 风险控制 改进措施 成效 |
| 英文关键词: potassium citrate solution microorganism risk control improvement effects |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. Resuults: 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. |
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