| 2种医院软膏制剂微生物限度检查方法学验证 |
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| 引用本文： | 黄璐敏,刘杜妙,徐文英. 2种医院软膏制剂微生物限度检查方法学验证[J]. 中国药业, 2012, 21(18): 47-49 |
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| 作者姓名： | 黄璐敏 刘杜妙 徐文英 |
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| 作者单位： | 广东省惠州市食品药品检验所,广东惠州516003 |
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| 摘 要： | 目的建立复方苯甲酸软膏和10%硫软膏的微生物限度检查方法。方法依据2010年版《中国药典(二部)》附录微生物限度检查法对样品进行方法学验证,测定阳性菌的回收率。结果在适宜的供试液制备条件下,复方苯甲酸软膏和10%硫软膏均可采用培养基稀释法消除其抑菌作用。结论经验证,培养基稀释法可用于复方苯甲酸软膏和10%硫软膏的质量监控及检测研究。
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| 关 键 词： | 医院制剂 软膏 微生物限度 方法验证 |
Methodological Validation of Microbial Limit Test in Two Kinds of Hospital Ointment Preparation |
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| Huang Lumin,Liu Dumiao,Xu Wenying. Methodological Validation of Microbial Limit Test in Two Kinds of Hospital Ointment Preparation[J]. China Pharmaceuticals, 2012, 21(18): 47-49 |
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| Authors: | Huang Lumin Liu Dumiao Xu Wenying |
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| Affiliation: | ttuang Lumtn, Ltu Dumtao , Xu Wenytng (Huizhou Municipal Institute for Food and Drug Control, Huizhou, Guangdong, China 516003) |
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| Abstract: | Objective To establish the microbial limit test method for 2 kinds of hospital ointment Compound Benzoic Acid Ointment and 10% Sulfur Ointment. Methods According to the microbial limit test method in the appendix of the Chinese Pharmacopoeia （edition 2010）,the samples were performed the methodological validation for detecting the recovery rate of positive bacteria. Results Under the proper preparing condition of the test solution,Compound Benzoic Acid Ointment and 10% Sulfur Ointment all adopted the culture medi- um dilution Methods to eliminate the bacteriostasis action. Conclusion The established microbial limit test method after validation can be used in the quality monitoring and detection research of Compound Benzoic Acid Ointment and 10% Sulfur Ointment. |
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| Keywords: | hospital preparation ointment microbial limit methodological validation |
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