| 引用本文: | 张国庆,程龙,杜建红,祝辉,王艳丽,刘徽,方晨.稀戊二醛溶液的微生物限度检查方法的建立及方法学验证[J].中国现代应用药学,2014,31(8):977-981. |
| ZHANG Guoqing,CHENG Long,DU Jianhong,ZHU Hui,WANG Yanli,LIU Wei,FANG Cheng.Establishment and Methodology Validation of Microbial Limit Examination for Dilute Glutaral Solution[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(8):977-981. |
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| 摘要: |
| 目的 建立稀戊二醛溶液的微生物限度检查方法，确保方法的有效性。方法 按中国药典2010年版二部附录ⅪJ对稀戊二醛溶液进行微生物限度检查法的方法学验证。结果 稀戊二醛溶液的微生物限度检查可采用薄膜过滤法进行细菌计数，可采用培养基稀释法进行霉菌和酵母菌计数，采用常规法进行控制菌的检查。结论 对本品进行微生物限度检查时，应充分考虑采用一定的方法，消除其抑菌性后再依法检查。 |
| 关键词: 稀戊二醛溶液 微生物限度 检查 方法学验证 |
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| 基金项目:军队医疗机构制剂标准提高科研专项课题面上项目(13ZJZ04-2) |
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| Establishment and Methodology Validation of Microbial Limit Examination for Dilute Glutaral Solution |
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ZHANG Guoqing, CHENG Long, DU Jianhong, ZHU Hui, WANG Yanli, LIU Wei, FANG Cheng
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Institute for Drug and Instrument Control of Chengdu Military Region, Chengdu 610017, China
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| Abstract: |
| OBJECTIVE To establish a effective method for microbial limit test of dilute glutaraldehyde solution. METHODS The methodology validation experiment for dilute glutaraldehyde solution was conducted according to the microbial limit test in the appendix ⅪJ of Chinese pharmacopoeia (second part, 2010 Edition). RESULTS In microbial limit test of dilute glutaraldehyde solution, the culture medium dilution method was used for mould and yeast count, the membrane filtration method was used for bacterial count and the routine method for control the bacteria. CONCLUSION During this article, some certain methods should be fully considered to eliminate this dilute glutaraldehyde solution’s bacteriostasis before the experiment for microbial limit test of this medicine. |
| Key words: dilute glutaraldehyde solution microbial limit examination methodology validation |
