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Volume 29 Issue 5
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2011  >  29(5): 369-371

HE Jin, SHI Guo-bing, GAO Jun, YANG Xiao-dong. Validation for determination method of microbacteria limit of compound Shenqi Wuwei chewable tables[J]. Journal of Pharmaceutical Practice and Service, 2011, 29(5): 369-371.
Citation: HE Jin, SHI Guo-bing, GAO Jun, YANG Xiao-dong. Validation for determination method of microbacteria limit of compound Shenqi Wuwei chewable tables[J]. Journal of Pharmaceutical Practice and Service, 2011, 29(5): 369-371.
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Validation for determination method of microbacteria limit of compound Shenqi Wuwei chewable tables

  • 1.

    Department of Pharmacy, General Hospital of Shenyang Military Region, Shenyang 110840, China

  • 2.

    Dalian Medical University, Dalian 116027, China

  • Received Date: 2011-03-22
  • Rev Recd Date: 2011-04-08
  • Objective To validate the determination method of microbacteria limit of compound shenqi wuwei chewable tables. Methods Plate counting method was used.The method of counting bacteria and mould was validated by the recovery rates with 5 control trains.The method of checking control bacteria was validated by observing cultivation of Escherichia coli coliform in the test group, positive control group and negetivu control group under the same environment. Results The recovery rate of every trail bacteria was higher than 70% when common methods were used in the counting bacteria and mould;To the examination of control bacteria, Escherichia coli coliform was detected in the test group and positive control group, and hadn't been detected in the negative control group. Conclusion The method was simple, feasible ,reliable and could be used for the examination of microbacteria limit.
  • [1] 中国药典.2010年版.一部[S] .2010:附录XIII C:79~88.
    [2] 中国药品生物制品检定所.中国药品检验标准操作规范[S].北京:中国医药科技出版社,2010:351~368.
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Validation for determination method of microbacteria limit of compound Shenqi Wuwei chewable tables

  • 1. Department of Pharmacy, General Hospital of Shenyang Military Region, Shenyang 110840, China
  • 2. Dalian Medical University, Dalian 116027, China
  • Received Date: 2011-03-22
  • Rev Recd Date: 2011-04-08

Abstract: Objective To validate the determination method of microbacteria limit of compound shenqi wuwei chewable tables. Methods Plate counting method was used.The method of counting bacteria and mould was validated by the recovery rates with 5 control trains.The method of checking control bacteria was validated by observing cultivation of Escherichia coli coliform in the test group, positive control group and negetivu control group under the same environment. Results The recovery rate of every trail bacteria was higher than 70% when common methods were used in the counting bacteria and mould;To the examination of control bacteria, Escherichia coli coliform was detected in the test group and positive control group, and hadn't been detected in the negative control group. Conclusion The method was simple, feasible ,reliable and could be used for the examination of microbacteria limit.

HE Jin, SHI Guo-bing, GAO Jun, YANG Xiao-dong. Validation for determination method of microbacteria limit of compound Shenqi Wuwei chewable tables[J]. Journal of Pharmaceutical Practice and Service, 2011, 29(5): 369-371.
Citation: HE Jin, SHI Guo-bing, GAO Jun, YANG Xiao-dong. Validation for determination method of microbacteria limit of compound Shenqi Wuwei chewable tables[J]. Journal of Pharmaceutical Practice and Service, 2011, 29(5): 369-371.
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