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Establishment of Microbial Limit Test Assay for Traditional Mongolian Medicine ShaoSha-7 Pills

Received: 17 August 2018     Accepted: 18 December 2018     Published: 20 December 2018
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Abstract

This study is aimed at establishing the Microbiological standard for ShaoSha-7 pills by referring to the general provisions 1105 and 1106 of part IV of “Chinese pharmacopoeia” 2015 edition, and supplying the data for improving the quality and ensuring the medical effect of ShaoSha-7 pills. Routine essay, dilution method,membrane-filter procedure and quantitative method were used to examine the microbial of ShaoSha-7 pills and the system suitability of experimental method was tested. Results showed that the recovery for the total number of strains (Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis, Monilia albican, Aspergillus niger) was 88-127% when membrane-filter method was used, and the recovery for fungus and yeasts was 87-120% while the bacteria was counted by routine method. Both recoveries met the requirement of pharmacopoeia. For the control strains experiment, Escherichia coli and Salmonella paratyphi B of ShaoSha-7 pills were detectable through routine method, and Bile salt resistant gram-negative bacteria of ShaoSha-7 pills was detectable by quantitative assay, respectively. Meanwhile, no strains were observed in the negative control of both cases, indicating the methods were feasible. Finally, the assay for checking microbial of ShaoSha-7 pills was initially established based on the above results. It supplies the data for setting up the quality control standard, especially microbiological standard for ShaoSha-7 pills.

Published in Asia-Pacific Journal of Medicine (Volume 1, Issue 1)
Page(s) 1-5
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2018. Published by Science Publishing Group

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Keywords

ShaoSha-7 Pills, Microbial Limit Test, System Adaptable Test

References
[1] 王胡格吉乐图,奥乌力吉. 蒙药七味广枣丸研究进展[J].内蒙古民族大学学报, 2013, 28 (1): 91-93。
[2] 包长山, 额尔敦其木格. 蒙成药治疗冠心病心绞痛的临床观察[J].中国民族医药杂志, 2008 (11): 14 -15。
[3] 刘萨仁, 金桃, 张春花等. 蒙药绍沙七味丸治疗稳定型劳力性心绞痛的临床研究[J]. 时珍国医国药, 2013, 4 (2): 502-503。
[4] 白清云主编. 《中国医学百科全书•蒙医学》[M]. 上海科学技术出版社, 1992, 277。
[5] 娜仁满都拉,色图雅,照日格图. 蒙药广枣七味丸治疗冠心病的体会[J]. 中国民族医药杂志, 2004, 1 (1):30。
[6] 黎明. 蒙药广枣七味丸的药理学进展[J]. 北方药学, 2011, 8 (4):70-71。
[7] 但春. 丁香和升麻的化学成分研究[D]. 中国科学院, 2006。
[8] 乌汉其木格,敖登其木格,锡林其其格,特格喜白音,阿拉腾其木格,王海荣,田吉. 蒙药绍沙-7研究进展[J].中国民族医药杂志, 2016, 12 (77-79)。
[9] 彭春梅, 夏瑶宾, 朱明. 蒙药清心广枣七味丸质量研究[J].中国民族医药杂志, 2005, (3): 33-34。
[10] 才仁•萨拉西. 蒙药广枣七味丸治疗心绞痛临床疗效观察[J].世界最新医学信息文摘, 2015, 15 (47): 200-201。
[11] 孟青春. 蒙药广枣七味丸治疗稳定劳力型心绞痛[J]中国民族医药, 2012 (5): 1-2。
[12] 孟青春. 蒙药广枣七味丸治疗稳定劳力型心绞痛的体会[J].中国民族民间医药, 2012 (6): 12。
[13] 乌汉其木格,敖登其木格, 锡林其其格,特格喜白音,阿拉腾其木格. 蒙药绍沙-7丸质量标准研究[J].时珍国医国药, 2017, 28 (4): 879-891。
Cite This Article
  • APA Style

    Song Fushun, Seyinbaoyin, Caolungaowa, Aodongtana, Bao Siqin, et al. (2018). Establishment of Microbial Limit Test Assay for Traditional Mongolian Medicine ShaoSha-7 Pills. Asia-Pacific Journal of Medicine, 1(1), 1-5.

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    ACS Style

    Song Fushun; Seyinbaoyin; Caolungaowa; Aodongtana; Bao Siqin, et al. Establishment of Microbial Limit Test Assay for Traditional Mongolian Medicine ShaoSha-7 Pills. Asia-Pac. J. Med. 2018, 1(1), 1-5.

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    AMA Style

    Song Fushun, Seyinbaoyin, Caolungaowa, Aodongtana, Bao Siqin, et al. Establishment of Microbial Limit Test Assay for Traditional Mongolian Medicine ShaoSha-7 Pills. Asia-Pac J Med. 2018;1(1):1-5.

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  • @article{10032832,
      author = {Song Fushun and Seyinbaoyin and Caolungaowa and Aodongtana and Bao Siqin and Alatengqimuge and Wuhanqimuge},
      title = {Establishment of Microbial Limit Test Assay for Traditional Mongolian Medicine ShaoSha-7 Pills},
      journal = {Asia-Pacific Journal of Medicine},
      volume = {1},
      number = {1},
      pages = {1-5},
      url = {https://www.sciencepublishinggroup.com/article/10032832},
      abstract = {This study is aimed at establishing the Microbiological standard for ShaoSha-7 pills by referring to the general provisions 1105 and 1106 of part IV of “Chinese pharmacopoeia” 2015 edition, and supplying the data for improving the quality and ensuring the medical effect of ShaoSha-7 pills. Routine essay, dilution method,membrane-filter procedure and quantitative method were used to examine the microbial of ShaoSha-7 pills and the system suitability of experimental method was tested. Results showed that the recovery for the total number of strains (Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis, Monilia albican, Aspergillus niger) was 88-127% when membrane-filter method was used, and the recovery for fungus and yeasts was 87-120% while the bacteria was counted by routine method. Both recoveries met the requirement of pharmacopoeia. For the control strains experiment, Escherichia coli and Salmonella paratyphi B of ShaoSha-7 pills were detectable through routine method, and Bile salt resistant gram-negative bacteria of ShaoSha-7 pills was detectable by quantitative assay, respectively. Meanwhile, no strains were observed in the negative control of both cases, indicating the methods were feasible. Finally, the assay for checking microbial of ShaoSha-7 pills was initially established based on the above results. It supplies the data for setting up the quality control standard, especially microbiological standard for ShaoSha-7 pills.},
     year = {2018}
    }
    

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  • TY  - JOUR
    T1  - Establishment of Microbial Limit Test Assay for Traditional Mongolian Medicine ShaoSha-7 Pills
    AU  - Song Fushun
    AU  - Seyinbaoyin
    AU  - Caolungaowa
    AU  - Aodongtana
    AU  - Bao Siqin
    AU  - Alatengqimuge
    AU  - Wuhanqimuge
    Y1  - 2018/12/20
    PY  - 2018
    T2  - Asia-Pacific Journal of Medicine
    JF  - Asia-Pacific Journal of Medicine
    JO  - Asia-Pacific Journal of Medicine
    SP  - 1
    EP  - 5
    PB  - Science Publishing Group
    UR  - http://www.sciencepg.com/article/10032832
    AB  - This study is aimed at establishing the Microbiological standard for ShaoSha-7 pills by referring to the general provisions 1105 and 1106 of part IV of “Chinese pharmacopoeia” 2015 edition, and supplying the data for improving the quality and ensuring the medical effect of ShaoSha-7 pills. Routine essay, dilution method,membrane-filter procedure and quantitative method were used to examine the microbial of ShaoSha-7 pills and the system suitability of experimental method was tested. Results showed that the recovery for the total number of strains (Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis, Monilia albican, Aspergillus niger) was 88-127% when membrane-filter method was used, and the recovery for fungus and yeasts was 87-120% while the bacteria was counted by routine method. Both recoveries met the requirement of pharmacopoeia. For the control strains experiment, Escherichia coli and Salmonella paratyphi B of ShaoSha-7 pills were detectable through routine method, and Bile salt resistant gram-negative bacteria of ShaoSha-7 pills was detectable by quantitative assay, respectively. Meanwhile, no strains were observed in the negative control of both cases, indicating the methods were feasible. Finally, the assay for checking microbial of ShaoSha-7 pills was initially established based on the above results. It supplies the data for setting up the quality control standard, especially microbiological standard for ShaoSha-7 pills.
    VL  - 1
    IS  - 1
    ER  - 

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Author Information
  • Anesthesiology Department, Inner Mongolia International Mongolian Hospital, Hohhot, China

  • Mongolian Medicine Orthopedics Department, Inner Mongolia International Mongolian Hospital, Hohhot, China

  • Mongolian Medicine College, Inner Mongolia Medical University, Hohhot, China

  • Innovative Mongolian Pharmaceutical Preparation Laboratory, Inner Mongolia International Mongolian Hospital, Hohhot, China

  • Innovative Mongolian Pharmaceutical Preparation Laboratory, Inner Mongolia International Mongolian Hospital, Hohhot, China

  • Innovative Mongolian Pharmaceutical Preparation Laboratory, Inner Mongolia International Mongolian Hospital, Hohhot, China

  • Innovative Mongolian Pharmaceutical Preparation Laboratory, Inner Mongolia International Mongolian Hospital, Hohhot, China

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