| 乙酰螺旋霉素片微生物限度检查方法验证 |
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| 引用本文： | 刘杨,王巍. 乙酰螺旋霉素片微生物限度检查方法验证[J]. 实用药物与临床, 2010, 13(3): 203-204 |
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| 作者姓名： | 刘杨 王巍 |
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| 作者单位： | 辽宁省食品药品检验所,沈阳,110023 |
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| 摘 要： | 目的建立乙酰螺旋霉素片微生物限度检查方法。方法采用常规法、离心沉淀集菌+薄膜过滤法进行方法验证。结果乙酰螺旋霉素片细菌计数采用离心沉淀集菌+薄膜过滤法,霉菌及酵母菌计数采用常规法,控制菌采用离心沉淀集菌+薄膜过滤法。结论确立了乙酰螺旋霉素片微生物限度检查方法 ,保证微生物限度检查方法的有效性。
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| 关 键 词： | 乙酰螺旋霉素片 微生物限度检查 方法验证 |
Verification of methodology on microbial limit test for acetylspiramycin tablets |
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| LIU Yang,WANG Wei. Verification of methodology on microbial limit test for acetylspiramycin tablets[J]. Practical Pharmacy and Clinical Remedies, 2010, 13(3): 203-204 |
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| Authors: | LIU Yang WANG Wei |
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| Abstract: | Objective To provide methods of microbial limit tests for acetylspiramycin tablets.Methods Routine method and centrifugal sedimentation set bacteria+membrane filtration method were used for the verification of methodology on acetylspiramycin tablets.Results Centrifugal sedimentation set bacteria+membrane filtration method were suitable for acetylspiramycin tablets on bacterial count,and routine method were applied for acetylspiramycin tablets on fungi or yeasts count,centrifugal sedimentation set bacteria+membrane filtration method were used for acetylspiramycin tablets on controlled bacteria.Conclusion Microbial limit tests for acetylspiramycin tablets are established,meanwhile the verification of methodology on the microbial limit test for acetylspiramycin tablets is assured. |
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| Keywords: | Acetylspiramycin tablets Microbial limit tests Verification of methodology |
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