| 引用本文: | 郑小玲,陈爽,章鑫萍,王知坚.地衣芽孢杆菌活菌颗粒杂菌检查方法验证[J].中国现代应用药学,2015,32(3):339-343. |
| ZHENG Xiaoling,CHEN Shuang,ZHANG Xinping,WANG Zhijian.Validation for Contaminating Microorganisms Test in Bacillus Licheniformis Particles[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(3):339-343. |
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| 摘要: |
| 目的 建立地衣芽孢杆菌活菌颗粒杂菌检查方法。方法 控制菌检查采用平皿涂布法；非致病性杂菌检查以杂菌率不得过0.1%为限度指标，采用营养琼脂平皿涂布法37 ℃培养；真菌计数采用玫瑰红钠琼脂平皿涂布法25 ℃培养。结果 控制菌检查、非致病性杂菌检查和真菌计数方法均满足中国药典2010年版验证试验的基本要求。结论 该方法可作为地衣芽孢杆菌活菌颗粒杂菌检查方法。 |
| 关键词: 地衣芽孢杆菌 活菌颗粒 杂菌检查 |
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| Validation for Contaminating Microorganisms Test in Bacillus Licheniformis Particles |
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ZHENG Xiaoling1, CHEN Shuang1, ZHANG Xinping2, WANG Zhijian1
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1.Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China;2.Zhengjiang Jingxin Pharmaceutical Co., Ltd., Shaoxing 312500, China
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| Abstract: |
| OBJECTIVE To establish a method for contaminating microorganisms test in Bacillus licheniformis particles. METHODS Spread plate method was used in the control bacteria examination; the non-pathogenic microbes was counted in nutrient agar and growth at 37 ℃, the maximum acceptable count was suggested in 0.1% of total microbes; the sodium rose Bengal agar and growth at 25 ℃ was used to do the fungi count. RESULTS The method was accepted in validation test of Chinese pharmacopoeia 2010. CONCLUSION The method can be used in contaminants test for Bacillus licheniformis particles control. |
| Key words: Bacillus licheniformis viable particles contaminating microorganisms test |
