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Volume 34 Issue 2
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2016  >  34(2): 177-178

CHEN Yalin, FENG Xu, CHEN Hong, LUAN Jie, ZHAO Long, WANG Jiachun. Validation of microbial limit tests for compound Hongjingtian oral liquid[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(2): 177-178. doi: 10.3969/j.issn.1006-0111.2016.02.020
Citation: CHEN Yalin, FENG Xu, CHEN Hong, LUAN Jie, ZHAO Long, WANG Jiachun. Validation of microbial limit tests for compound Hongjingtian oral liquid[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(2): 177-178. doi: 10.3969/j.issn.1006-0111.2016.02.020
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Validation of microbial limit tests for compound Hongjingtian oral liquid

doi: 10.3969/j.issn.1006-0111.2016.02.020
  • 1.

    Naval Medical Research Institute of PLA, Shanghai 200433, China

  • 2.

    Tianjin University of Science and Technology, Tianjin 300457, China

  • Received Date: 2015-01-05
  • Rev Recd Date: 2015-07-15
  • Objective To establish a method of microbial limit tests for compound Hongjingtian oral liquid and to perform the validation of the method. Methods The validation on the microbial limit test method was conducted according to the counting method of bacteria,mycetes and yeasts and the control bacteria test method stated in the appendix of China pharmacopoeia(2010 edition). Results The recoveries were over 70% when culture diluting method was used for staphylococcus aureus and routine test method was used for Escherichia coli, Bacillus subtilis,Candida albicans and Aspergillus niger. In the test of positive control bacteria, the growth was detected, while the negative control was no growth detected. Conclusion The microbial limit test for compound Hongjingtian oral liquid is validated in this study. The amount of staphylococcus aureus can be determined using diluted culture method; while the amounts of Escherichia coli, Bacillus subtilis,Candida albicans, Aspergillus niger can be determined by conventional method.
  • [1] 国家药典委员会. 中华人民共和国药典2010年版一部[S].北京:中国医药科技出版社,附录, 79-88,138.
    [2] 宋永熙, 刘世萍, 马妍妍,等. 安神宁口服液微生物限度检查方法的研究[J]. 中国药学杂志, 2012, 47(13):1074-1076.
    [3] 谭梅英, 张诚光, 范宋玲. 中风复元口服液微生物限度检查法验证[J]. 江西中医学院学报,2012, 24(1):48-49.
    [4] 何进,顾明业,高军,等.桃红四物口服液微生物限度检查的方法验证[J].解放军药学学报,2010,26(4):371.
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通讯作者: 陈斌, [email protected]
  • 1. 

    沈阳化工大学材料科学与工程学院 沈阳 110142

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Validation of microbial limit tests for compound Hongjingtian oral liquid

doi: 10.3969/j.issn.1006-0111.2016.02.020
  • 1. Naval Medical Research Institute of PLA, Shanghai 200433, China
  • 2. Tianjin University of Science and Technology, Tianjin 300457, China
  • Received Date: 2015-01-05
  • Rev Recd Date: 2015-07-15

Abstract: Objective To establish a method of microbial limit tests for compound Hongjingtian oral liquid and to perform the validation of the method. Methods The validation on the microbial limit test method was conducted according to the counting method of bacteria,mycetes and yeasts and the control bacteria test method stated in the appendix of China pharmacopoeia(2010 edition). Results The recoveries were over 70% when culture diluting method was used for staphylococcus aureus and routine test method was used for Escherichia coli, Bacillus subtilis,Candida albicans and Aspergillus niger. In the test of positive control bacteria, the growth was detected, while the negative control was no growth detected. Conclusion The microbial limit test for compound Hongjingtian oral liquid is validated in this study. The amount of staphylococcus aureus can be determined using diluted culture method; while the amounts of Escherichia coli, Bacillus subtilis,Candida albicans, Aspergillus niger can be determined by conventional method.

CHEN Yalin, FENG Xu, CHEN Hong, LUAN Jie, ZHAO Long, WANG Jiachun. Validation of microbial limit tests for compound Hongjingtian oral liquid[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(2): 177-178. doi: 10.3969/j.issn.1006-0111.2016.02.020
Citation: CHEN Yalin, FENG Xu, CHEN Hong, LUAN Jie, ZHAO Long, WANG Jiachun. Validation of microbial limit tests for compound Hongjingtian oral liquid[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(2): 177-178. doi: 10.3969/j.issn.1006-0111.2016.02.020
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