| 罗红霉素分散片微生物限度检查法研究 |
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| 引用本文： | 任安民,杨晓莉,周志云,彭霞. 罗红霉素分散片微生物限度检查法研究[J]. 中国药业, 2010, 19(22): 40-41 |
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| 作者姓名： | 任安民 杨晓莉 周志云 彭霞 |
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| 作者单位： | [1]陕西省食品药品检验所,陕西西安710061 [2]甘肃省医药学校,甘肃兰州730020 |
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| 摘 要： | 目的建立适合罗红霉素分散片微生物限度检查的方法。方法参照2010年版《中国药典（二部）》,采用薄膜过滤法与β-内酰胺酶法中和,进行微生物限度检查的方法学验证。结果可采用上述方法进行细菌数、霉菌和酵母菌数与控制菌的检查。结论对罗红霉素分散片进行方法学验证,结果符合药典要求。
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| 关 键 词： | 罗红霉素分散片 微生物限度检查 方法学验证 |
Study on Microbial Limit Test of Roxithromycin Dispersible Tablets |
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| Ren Anmin,Yang Xiaoli,Zhou Zhiyun,Peng Xia. Study on Microbial Limit Test of Roxithromycin Dispersible Tablets[J]. China Pharmaceuticals, 2010, 19(22): 40-41 |
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| Authors: | Ren Anmin Yang Xiaoli Zhou Zhiyun Peng Xia |
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| Affiliation: | 1.Shaanxi Provincial Institute for Food and Drug Control,Xi’an,Shaanxi,China 710061;2.Gansu Medical School,Lanzhou,Gansu,China 730020) |
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| Abstract: | Objective To establish a suitable microbial limit method of Roxithromycin Dispersible Tablet.Methods According to the Chinese Pharmacopoeia（2010 edition,volume Ⅱ）,the membrane filter procedure was neutralized with β-lactam enzymatic method to carried out the methodological validation on microbial limit tests.Results The above methods can be used to detect the number of bacteria,fungi and yeast strains and conduct the control bacteria checking.Conclusion The results of methodological validation to Roxithromycin Dispersible Tablets are in line with the demand of the Chinese Pharmacopoeia. |
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| Keywords: | Roxithromycin Dispersible Tablets microbial limit tests methodology validation |
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