| 8种医院制剂微生物限度检查法验证 |
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| 引用本文： | 殷生楠,柳冬梅.8种医院制剂微生物限度检查法验证[J].现代医药卫生,2010,26(16):2432-2434. |
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| 作者姓名： | 殷生楠 柳冬梅 |
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| 作者单位： | 南京中医药大学泰州附属医院,江苏,泰州,225300 |
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| 摘 要： | 目的:分析8种医院制剂的微生物限度检查方法.方法:对8种医院制剂进行了微生物限度检查方法验证.结果:8种医院制剂对4株阳性代表菌株有不同程度的抑菌活性.结论:通过方法验证实验建立医院制剂微生物限度检查极为必要,根据方法验证实验结果建议顺气通腑合剂采用培养基稀释法、痱子洗剂采用薄膜过滤法及另6种医院制剂采用常规法进行微生物限度检查.
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| 关 键 词： | 微生物限度 方法验证 培养基稀释法 薄膜过滤法 回收率 |
Limit inspection method confirmation for eight kinds of hospital preparation microorganism |
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| YIN Sheng-nan
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LIU Dong-mei.Limit inspection method confirmation for eight kinds of hospital preparation microorganism[J].Modern Medicine Health,2010,26(16):2432-2434. |
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| Authors: | YIN Sheng-nan LIU Dong-mei |
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| Institution: | (Affiliated Taizhou Hospital,Nanjing University of Traditional Chinese Medicine,Taizhou,Jiangsu 225300,China) |
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| Abstract: | Objective：To analyze the microorganism limit inspection method for eight kinds of hospital preparation.Methods：According to the stipulations in the Chinese pharmacopoeia（2005 edition）,to carry on the microorganism limit inspection method confirmation to eight kinds of hospital preparations.Results：Eight kinds of hospital preparations had the varying degrees of bacteriostasis activity to 4 strains of positive representative strain.Conclusion：It is extremely essential to establish the hospital preparation microorganism limit inspection through the method confirmation experiment.According to the method confirmation experimental results,it is suggested that the culture medium dilution method is adopted for Shunqi Tongfu Mixture,the thin film filtration method for Miliaria Lotion and the conventional method for other six kinds of hospital preparation in the microorganism limit inspection. |
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| Keywords: | Microorganism limit Method confirmation Culture medium dilution method Thin film filtration method Recovery rate |
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