| Peer-Reviewed

Establishment of a Method to Allow Microbial Limit Testing of Iodine-containing Preparations

Received: 22 April 2021     Accepted: 17 May 2021     Published: 26 May 2021
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Abstract

Background: Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on the therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Iodine can inhibit and kill microorganisms in pharmaceutical preparations. The risk of microbial contamination of cellular products can be reduced when cultured in the presence of iodine. This however, may impact the sensitivity of microbiological tests. Iodine-containing Preparations does not guarantee sterility but may just reduce the proliferation rate of microorganisms, microbiological testing of medicinal products remains obligatory. Thus, an appropriate method to test for microbial contamination of iodine-containing products has to be validated. Objective: To establish a method that would allow microbial limit testing of four iodine-containing preparations (concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin). Methods: To specifically determine the degree of contamination in the four in-house iodine preparations, sodium thiosulfate was used to reduce the iodine molecules to iodide ions, thereby eliminating the intrinsic antibacterial property of the preparations. Then, the suitability of this method was evaluated according to the regulations for non-sterile microbial limit tests. Results: The neutralization method effectively eliminated the interference of the antibacterial iodine component, rendering the control bacteria detectable. The recovery ratio of the test strains met the required standards. Conclusion: The neutralization method with sodium thiosulfate as the iodine neutralizer is suitable for microbial limit testing of concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin, with the results being accurate and reliable.

Published in Journal of Drug Design and Medicinal Chemistry (Volume 7, Issue 2)
DOI 10.11648/j.jddmc.20210702.12
Page(s) 39-43
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), 2021. Published by Science Publishing Group

Keywords

Iodine-containing Preparations, Microbial Limit Test, Neutralization Method, Verification

References
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[3] S. F. Cai, J. L. Li, X. Xu, J. S. Huang. Study on Microbial Limit Test for Hospital Preparation of Onych-omycosis [J]. Strait Pharmaceutical Journal, 2021, 33 (01): 72-75.
[4] Y. Zhao, C. Shi, P. Huang. Methodology Validation of Microbial Limit Test for Iodine tincture [J]. China Pharmacist, 2011, 14 (9): 1382-1383.
[5] Cooper RA. Iodine revisited [J]. International Wound Journal, 2007, 4 (2): 124-37.
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[7] ChP 2015. Vol IV [S]. 2015: Appendix 1105, 1106.
[8] J. Ji, T. T. Liu, M. M. Niu, Z. W. Wang. Neutralization of Lecithin and Polysorbate-80 in Antibacterial Activity of Traditional Chinese Medicine Preparations [J]. China Pharmacist, 2017, 20 (3): 586-588.
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[10] Sh. Ma, P. Liu, L. H. Yang, et al. Experimental study on micro- organism introduction method in suitability test of microbial limit test [J]. Chin J Pharm Anal, 2018, 38 (5): 878-882.
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[15] W. Liu, G. Q. Zhang, L. G. Zhu. Establishment of a Microbial Limit Test Method for Two Iodine Preparations in Chinese Pharmacopoeia (2015 Edition) [J]. Chinese Journal of Rational Drug Use, 2017, 14 (2): 14-17.
Cite This Article
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    Huang Minna, Tan Fangming, Lin Shaozhu, Liang Zhuanzhi, Qiu Suishan, et al. (2021). Establishment of a Method to Allow Microbial Limit Testing of Iodine-containing Preparations. Journal of Drug Design and Medicinal Chemistry, 7(2), 39-43. https://doi.org/10.11648/j.jddmc.20210702.12

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    ACS Style

    Huang Minna; Tan Fangming; Lin Shaozhu; Liang Zhuanzhi; Qiu Suishan, et al. Establishment of a Method to Allow Microbial Limit Testing of Iodine-containing Preparations. J. Drug Des. Med. Chem. 2021, 7(2), 39-43. doi: 10.11648/j.jddmc.20210702.12

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    AMA Style

    Huang Minna, Tan Fangming, Lin Shaozhu, Liang Zhuanzhi, Qiu Suishan, et al. Establishment of a Method to Allow Microbial Limit Testing of Iodine-containing Preparations. J Drug Des Med Chem. 2021;7(2):39-43. doi: 10.11648/j.jddmc.20210702.12

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  • @article{10.11648/j.jddmc.20210702.12,
      author = {Huang Minna and Tan Fangming and Lin Shaozhu and Liang Zhuanzhi and Qiu Suishan and He Xiaomin},
      title = {Establishment of a Method to Allow Microbial Limit Testing of Iodine-containing Preparations},
      journal = {Journal of Drug Design and Medicinal Chemistry},
      volume = {7},
      number = {2},
      pages = {39-43},
      doi = {10.11648/j.jddmc.20210702.12},
      url = {https://doi.org/10.11648/j.jddmc.20210702.12},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.jddmc.20210702.12},
      abstract = {Background: Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on the therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Iodine can inhibit and kill microorganisms in pharmaceutical preparations. The risk of microbial contamination of cellular products can be reduced when cultured in the presence of iodine. This however, may impact the sensitivity of microbiological tests. Iodine-containing Preparations does not guarantee sterility but may just reduce the proliferation rate of microorganisms, microbiological testing of medicinal products remains obligatory. Thus, an appropriate method to test for microbial contamination of iodine-containing products has to be validated. Objective: To establish a method that would allow microbial limit testing of four iodine-containing preparations (concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin). Methods: To specifically determine the degree of contamination in the four in-house iodine preparations, sodium thiosulfate was used to reduce the iodine molecules to iodide ions, thereby eliminating the intrinsic antibacterial property of the preparations. Then, the suitability of this method was evaluated according to the regulations for non-sterile microbial limit tests. Results: The neutralization method effectively eliminated the interference of the antibacterial iodine component, rendering the control bacteria detectable. The recovery ratio of the test strains met the required standards. Conclusion: The neutralization method with sodium thiosulfate as the iodine neutralizer is suitable for microbial limit testing of concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin, with the results being accurate and reliable.},
     year = {2021}
    }
    

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  • TY  - JOUR
    T1  - Establishment of a Method to Allow Microbial Limit Testing of Iodine-containing Preparations
    AU  - Huang Minna
    AU  - Tan Fangming
    AU  - Lin Shaozhu
    AU  - Liang Zhuanzhi
    AU  - Qiu Suishan
    AU  - He Xiaomin
    Y1  - 2021/05/26
    PY  - 2021
    N1  - https://doi.org/10.11648/j.jddmc.20210702.12
    DO  - 10.11648/j.jddmc.20210702.12
    T2  - Journal of Drug Design and Medicinal Chemistry
    JF  - Journal of Drug Design and Medicinal Chemistry
    JO  - Journal of Drug Design and Medicinal Chemistry
    SP  - 39
    EP  - 43
    PB  - Science Publishing Group
    SN  - 2472-3576
    UR  - https://doi.org/10.11648/j.jddmc.20210702.12
    AB  - Background: Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on the therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Iodine can inhibit and kill microorganisms in pharmaceutical preparations. The risk of microbial contamination of cellular products can be reduced when cultured in the presence of iodine. This however, may impact the sensitivity of microbiological tests. Iodine-containing Preparations does not guarantee sterility but may just reduce the proliferation rate of microorganisms, microbiological testing of medicinal products remains obligatory. Thus, an appropriate method to test for microbial contamination of iodine-containing products has to be validated. Objective: To establish a method that would allow microbial limit testing of four iodine-containing preparations (concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin). Methods: To specifically determine the degree of contamination in the four in-house iodine preparations, sodium thiosulfate was used to reduce the iodine molecules to iodide ions, thereby eliminating the intrinsic antibacterial property of the preparations. Then, the suitability of this method was evaluated according to the regulations for non-sterile microbial limit tests. Results: The neutralization method effectively eliminated the interference of the antibacterial iodine component, rendering the control bacteria detectable. The recovery ratio of the test strains met the required standards. Conclusion: The neutralization method with sodium thiosulfate as the iodine neutralizer is suitable for microbial limit testing of concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin, with the results being accurate and reliable.
    VL  - 7
    IS  - 2
    ER  - 

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Author Information
  • Department of Pharmacy, The First Affiliated Hospital of Jinan University, Guangzhou, China

  • Department of Pharmacy, The First Affiliated Hospital of Jinan University, Guangzhou, China

  • Department of Pharmacy, The First Affiliated Hospital of Jinan University, Guangzhou, China

  • Department of Pharmacy, The First Affiliated Hospital of Jinan University, Guangzhou, China

  • Department of Pharmacy, The First Affiliated Hospital of Jinan University, Guangzhou, China

  • Department of Pharmacy, The First Affiliated Hospital of Jinan University, Guangzhou, China

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