| 苯海拉明软膏微生物限度检查方法的验证 |
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| 引用本文： | 余晓霞,朱桦,区杰彬.苯海拉明软膏微生物限度检查方法的验证[J].中国实用医药,2014(23):32-33. |
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| 作者姓名： | 余晓霞 朱桦 区杰彬 |
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| 作者单位： | 中山大学孙逸仙纪念医院药学部,510120 |
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| 摘 要： | 目的：建立苯海拉明软膏微生物限度检查方法。方法采用常规法进行细菌、霉菌及酵母菌计数方法的验证和控制菌检查的验证。结果采用常规法，细菌、霉菌及酵母菌的回收率均〉70%，并可检出铜绿假单胞菌和金黄色葡萄球菌。结论经方法学验证，结果符合现行《中国药典》2010年版的要求。
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| 关 键 词： | 苯海拉明软膏 微生物限度 验证 |
Validation of microbial limit tests of diphenhydramine ointment |
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| YU Xiao-xia,ZHU Hua,OU Jie-bin.Validation of microbial limit tests of diphenhydramine ointment[J].China Practical Medical,2014(23):32-33. |
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| Authors: | YU Xiao-xia ZHU Hua OU Jie-bin |
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| Affiliation: | (Department of Pharmacy, Sun-Yat-Sen Memorial Hospital of Sun Yat-sen University, Guangzhou 510120, China) |
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| Abstract: | Objective To establish a method to test microbial limit in diphenhydramine ointment. Methods Conventional method was adopted to verify bacteria, mold and yeast count method and control bacteria check.Results By conventional method, all of the recoveries of bacteria, mold and yeast were above 70%, pseudomonas aeruginosa and staphylococcus aureus were detected.Conclusion Through the technological validation, the result is consistent with the requirement of “Chinese Pharmacopoeia”（edition 2010） in force. |
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| Keywords: | Diphenhydramine ointment Microbial limit Validation |
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