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

Huang Minna; Tan Fangming; Lin Shaozhu; Liang Zhuanzhi; Qiu Suishan; He Xiaomin

doi:doi:10.11648/j.jddmc.20210702.12

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

Huang Minna, Tan Fangming, Lin Shaozhu, Liang Zhuanzhi, Qiu Suishan, He Xiaomin

Published in Journal of Drug Design and Medicinal Chemistry (Volume 7, Issue 2)

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), 2024. Published by Science Publishing Group

Keywords

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

References

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[2]	W. Y. Zhang, F. Q. Guo. Results of Microbial Limit Tests and Quality Analysis of Hospital Preparation Sampling Inspection of Tianjin [J]. Chinese Pharmaceutical Affairs, 2019, 33 (01): 100-107.
[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.
[6]	J. Li, H. Cai, H. M. Cao, Q. He, Establishment of Microbial Limit Test for Iodine Glycerin [J]. China Pharmaceuticals, 2019, 28 (27): 30-33.
[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.
[9]	L. N. Li. Methodology Validation of Microbial Limit Test for compound iodine oral solution [J]. Inner Mongolia Journal of Traditional Chinese Medicine, 2016, 10 (13): 143-144.
[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.
[11]	X. L. Yang, H. Li, Y. Y. Ma, et al. Interpretation of the microbio-logical examination of nonsterile products: microbial enumeration test of Chinese pharmacopoeia 2015 edition [J]. Chin J Pharm A- nal, 2016, 36 (6): 1101-1107.
[12]	X. L. Yang, H. Li, Y. Y. Ma, et al. Interpretation and Countermea-sure of the Microbiological Examination for Nonsterile Products: Tests for Specified Microorganisms in Chinese Pharma- copoeia 2015 Edition [J]. China Pharm, 2016, 19 (4): 748-752.
[13]	Y. J. Pang, W. Y. Fan, J. Liang. Research progress on methodological validation of microbial limit test for pharmaceuticals [J]. Chinese Traditional Patent Medicine, 2017, 39 (10): 2137-2140.
[14]	H. L. Ma, Y. Y. Tao, Ch. F. Xu, Y. M. Zhang. Study on applicability of microbial limit test methods for three kinds of hospital preparations [J]. International Journal of Traditional Chinese Medicine, 2020, 42 (5): 469-474.
[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.

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APA Style

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

Huang Minna

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

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

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

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

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

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

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APA Style

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

Copy | Download

@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}
}

Copy | Download

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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