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Volume 32 Issue 4
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2014  >  32(4): 282-283,317

HE Jin, REN Xue, CAO Jiafu, AN Ye, LIU Ruixia. Validation for determination method of microbacteria limit of Shuitiaosan powder[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(4): 282-283,317. doi: 10.3969/j.issn.1006-0111.2014.04.011
Citation: HE Jin, REN Xue, CAO Jiafu, AN Ye, LIU Ruixia. Validation for determination method of microbacteria limit of Shuitiaosan powder[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(4): 282-283,317. doi: 10.3969/j.issn.1006-0111.2014.04.011
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Validation for determination method of microbacteria limit of Shuitiaosan powder

doi: 10.3969/j.issn.1006-0111.2014.04.011
  • 1.

    Department of Pharmacy, General Hospital of Shenyang Military Region, Shenyang 110016, China

  • 2.

    Department of Pharmacy, Shenyang Medical University, Shenyang 110016, China

  • Received Date: 2013-05-18
  • Rev Recd Date: 2013-12-02
  • Objective To validate the determination method of microbacteria limit of Shuitiaosan powder. Methods Plate counting method was used.The method of counting bacteria and mould was validated by the recovery rates with 5 control strains.The method of checking control bacteria was validated by observing cultivation of Staphylococcus aureus and Pseudomonas aeruginosa in the test group, positive control group and negative control group in the same environment. Results The recovery rate of every trail strains was higher than 70% when centrifugal sedimentation methods were used in the counting bacteria and mould.To the examination of control bacteria, Staphylococcus aureus and Pseudomonas aeruginosa were detected by the centrifugal sedimentation methods.The tested strains were observed in the test group and in the positive control group.No strains were observed in the negative control group. Conclusion The methods are simple, feasible, reliable and can be used for the examination of microbacteria limit.
  • [1] 国家药典委员会.中华人民共和国药典一部[S].北京:化学工业出版社出版,2010:附录:88.
    [2] 李晓东,李 娟,焦正花,等.我国医院中药制剂微生物限度检查存在的问题分析与建议[J].甘肃中医,2009,22(12):15-17.
    [3] 冒兴建,闫玉梅,秦 建.中药口服制剂维生素限度检查不合格的原因及解决办法[J].中国现代药物应用,2011,5(10):130-131.
    [4] 国家药典委员会.中华人民共和国药典一部[S].北京:化学工业出版社出版,2010:附录: 79-88.
    [5] 杨 静.药品微生物限度检查法的影响因素分析[J].中国药事,2008,22(12):1095-1096.
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Validation for determination method of microbacteria limit of Shuitiaosan powder

doi: 10.3969/j.issn.1006-0111.2014.04.011
  • 1. Department of Pharmacy, General Hospital of Shenyang Military Region, Shenyang 110016, China
  • 2. Department of Pharmacy, Shenyang Medical University, Shenyang 110016, China
  • Received Date: 2013-05-18
  • Rev Recd Date: 2013-12-02

Abstract: Objective To validate the determination method of microbacteria limit of Shuitiaosan powder. Methods Plate counting method was used.The method of counting bacteria and mould was validated by the recovery rates with 5 control strains.The method of checking control bacteria was validated by observing cultivation of Staphylococcus aureus and Pseudomonas aeruginosa in the test group, positive control group and negative control group in the same environment. Results The recovery rate of every trail strains was higher than 70% when centrifugal sedimentation methods were used in the counting bacteria and mould.To the examination of control bacteria, Staphylococcus aureus and Pseudomonas aeruginosa were detected by the centrifugal sedimentation methods.The tested strains were observed in the test group and in the positive control group.No strains were observed in the negative control group. Conclusion The methods are simple, feasible, reliable and can be used for the examination of microbacteria limit.

HE Jin, REN Xue, CAO Jiafu, AN Ye, LIU Ruixia. Validation for determination method of microbacteria limit of Shuitiaosan powder[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(4): 282-283,317. doi: 10.3969/j.issn.1006-0111.2014.04.011
Citation: HE Jin, REN Xue, CAO Jiafu, AN Ye, LIU Ruixia. Validation for determination method of microbacteria limit of Shuitiaosan powder[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(4): 282-283,317. doi: 10.3969/j.issn.1006-0111.2014.04.011
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