| 硫酸沙丁胺醇吸入气雾剂微生物限度检查方法的建立和验证 |
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| 引用本文： | 雷春华,王明巧,黄洁瑕,肖海文,李雪梅,林文辉.硫酸沙丁胺醇吸入气雾剂微生物限度检查方法的建立和验证[J].中国药业,2020(7):98-101. |
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| 作者姓名： | 雷春华 王明巧 黄洁瑕 肖海文 李雪梅 林文辉 |
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| 作者单位： | 广东同德药业有限公司;国家中药现代化工程技术研究中心·药用植物油研究<湛江>分中心;湛江市明德医药科技有限公司 |
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| 摘 要： | 目的建立和验证硫酸沙丁胺醇吸入气雾剂的微生物限度检查方法。方法根据2015年版《中国药典(四部)》非无菌产品微生物限度检查方法,采用薄膜过滤法测定试验菌株的回收率,确立需氧菌总数、霉菌和酵母菌总数计数方法、控制菌检查方法,并进行验证。结果需氧菌、霉菌和酵母菌总数计数采用薄膜过滤法时,回收率均在0.5~2.0范围内;控制菌的检查采用常规法,结果均符合2015年版《中国药典(四部)》的规定。结论该方法准确、可靠,可用于硫酸沙丁胺醇吸入气雾剂的微生物限度检查。
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| 关 键 词： | 硫酸沙丁胺醇吸入气雾剂 微生物限度 薄膜过滤法 方法学验证 质量控制 |
Establishment and Validation of Microbial Limit Test Methods for Salbutamol Sulfate Inhalation Aerosol |
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| LEI Chunhua,WANG Mingqiao,HUANG Jiexia,XIAO Haiwen,LI Xuemei,LIN Wenhui.Establishment and Validation of Microbial Limit Test Methods for Salbutamol Sulfate Inhalation Aerosol[J].China Pharmaceuticals,2020(7):98-101. |
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| Authors: | LEI Chunhua WANG Mingqiao HUANG Jiexia XIAO Haiwen LI Xuemei LIN Wenhui |
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| Affiliation: | (Guangdong Tonde Pharmaceutical Co.,Ltd.,Zhanjiang,Guangdong,China 524018;National Engineering Research Center for Modernization of Traditional Chinese Medicine Medicinal Plant Oil ResearchBranch,Zhanjiang,Guangdong,China 524018;Zhanjiang Mingde Pharmaceutical Technology Co.,Ltd.,Zhanjiang,Guangdong,China 524018) |
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| Abstract: | Objective To establish and validate microbial limit test methods for salbutamol sulfate inhalation aerosols.Methods According to the microbial limit test method of four non-sterile products of the Chinese Pharmacopoeia 2015 Edition,the recovery rate of the test strain was determined by membrane filtration method,and the total number of aerobic bacteria,the total number of molds and yeasts,the control method of the control bacteria were established,and authenticated.Results The total aerobic bacteria count,the total number of molds and yeasts were counted in the range of 0.5-2.0 by membrane filtration method,and the control bacteria were tested by conventional methods.The results were in compliance with the Chinese Pharmacopoeia 2015 Edition.Conclusion The method is accurate and reliable,which is suitable for microbial limit inspection of salbutamol sulfate inhalation aerosol. |
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| Keywords: | salbutamol sulfate inhalation aerosol microbial limit membrane filtration method methodological validation quality control |
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