文章摘要
廖燕萍,朱铮.六种中成药细菌数和需氧菌总数检测方法的比较[J].中国药品标准,2019,(4):350-355
六种中成药细菌数和需氧菌总数检测方法的比较
Comparison of bacterial and aerobic microbial enumeration methods for six Chinese patent medicines
投稿时间:2018-03-07  修订日期:2019-06-25
DOI:
中文关键词: 细菌数  需氧菌总数  2010版中国药典  2015版中国药典  比较
英文关键词: bacterial enumeration  aerobic microbial enumeration  Chinese Pharmacopoeia 2015 Edition  Chinese Pharmacopoeia 2010 Edition  comparison
基金项目:
作者单位E-mail
廖燕萍 福建省食品药品质量检验研究院 ypliao527@126.com 
朱铮 福建省食品药品质量检验研究院 ypliao527@126.com 
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中文摘要:
      目的:比较同一品种2015版药典需氧菌总数和2010版药典细菌数检测方法的差异。方法:以新癀片、海珠喘息定片、八宝丹锭剂、通脉降脂胶囊、大七厘散以及六味地黄丸六种中成药为研究对象分别按《中国药典》2015版需氧菌总数计数法与《中国药典》2010版细菌计数法进行相应微生物计数方法验证,并对检测方法进行比较。结果:不同版本药典的计数方法学验证过程不尽相同,最终的检测方法也各有差别。 结论:2015版《中国药典》需氧菌总数计数检查法比2010版《中国药典》细菌数计数检查法更为灵敏,并且方法更加合理和更具优越性。
英文摘要:
      Aim: To compare the aerobic microbial enumeration method in ChP 2015 and the bacterial enumeration method in ChP 2010 Edition. Method: Six types of traditional Chinese medicine patent prescription-Xinhuang Teblets、Haizhu Isoprenaline Teblets、Babaodan Lozenge、Tongmai Jiangzhi Capsule、Daqili San and Liuwei Dihuang Wan were applied for verification of microbial enumeration method. The verification testings were performed following the approaches described in ChP 2015 and ChP 2010 Edition respectively, and the corresponding methods were compared. Result: The method verification procedures in the two different editions of Chinese Pharmacopia were not the same, and the methods were also different accordingly. Conclusion: Compared with ChP 2010, the aerobic bacterial enumeration method in ChP 2015 is more sensitive, reasonable, and better.
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