Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’

Fangming Tan; Minna Huang; Suishan Qiu; Zhuanzhi Liang

doi:doi:10.11648/j.ejcbs.20210702.14

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Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’

Fangming Tan, Minna Huang, Suishan Qiu, Zhuanzhi Liang

Published in European Journal of Clinical and Biomedical Sciences (Volume 7, Issue 2)

Received: 22 April 2021 Accepted: 11 May 2021 Published: 21 May 2021

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Abstract

Background: the assessment of microbiological quality of medicinal products is one of control stages in medicinal products saft, because the holder of a manufacturing authorization must drug so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. Objective: To assess microbial limit test for hospital preparation ‘compound alum powder’. Methods: The results of strain culture and analysis were used to evaluate the drug quality of ‘compound alum powder’. The objective is ‘compound alum powder’ (approval number: Z20140229) was made by the First Affiliated Hospital of Jinan University. Their batch numbers include: 201019, 200818, 200701. Validation tests were carried out in accordance with the standards of the Chinese Pharmacopoeia (2020 edition). Three parallel independent validations were conducted to calculate the recovery rate of each test bacterium and investigate whether each test bacterium was detected in the control bacterial inspection. Result: The recovery ratio of the total number of aerobic bacteria, molds and yeast in the control group was in the range of 0.5 ~ 2, and the results of the control group were positive, and the results of each control group met the requirements. The results show that the membrane filtration method is suitable for the microbial limit test of ‘compound alum powder’. Conclusion: this microbial limit test method control and ensure the quality of drug production by solving the problem of interference of antimicrobial components in drugs. It can eliminate the bacteriostasis of boric acid, phenol and alum.

Published in	European Journal of Clinical and Biomedical Sciences (Volume 7, Issue 2)
DOI	10.11648/j.ejcbs.20210702.14
Page(s)	33-36
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

Microbial Limit Test, ‘Compound Alum Powder’, Boric Acid, Phenol, Membrane Filtration

References

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[3]	Długaszewska J, Muszyn ́ski Z, Ratajczak M. Microbiological purity of oral drugs manufactured in industrial and pharmacy environment. In: 26th Congress of the Polish Society of Microbiologists: Microbes –Challenges and Hopes. Conference Materials. Szczecin. 2018: 4–7.
[4]	National Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China: four parts of the 2020 edition. Beijing: China Medical Science and Technology Press. 2020: 160-171.
[5]	Yang XL, Li H, Ma YY, et al. Chinese Pharmacopoeia 2015 edition of the microbial limit test of non-sterile products: the introduction and countermeasures of bacterial control test [J]. Chinese Pharmacist. 2016; 19 (4): 748-752.
[6]	You SX, Wu DK, Liu SJ, et al. Research on processing of Alumen. Joumal of Chinese Medicinal Materials. 2018; 33 (7): 1192-1194.
[7]	She F, Xu ZG. Influencing factors and countermeasures of microbial limit testing error for drugs. China Health Standards Management. 2018; 9 (18): 100-102.
[8]	Ma SH, Liu P, Yang LH, et al. Experimental study on adding bacteria in the applicability test of microbial limit test method for drug. Journal of Pharmaceutical Analysis. 2018; 38 (5): 877-882.
[9]	Yang YR, Shen QL, Wang QF. Western China Journal of Traditional Chinese Medicine. 2017; 30 (11): 59-61.
[10]	Wang ZJ, Mei LQ, Wang XJ, et al. Study on the applicability of microbial limit test for six traditional Chinese medicine preparations. Pharmaceutical Care and Research. 2018; 18 (4): 300-303.
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[14]	Wei YY, He K, Wu YM, Wang XX, Pang YJ. Guangzhou Chemical Industry. 2020; 48 (19): 89-91.
[15]	Zhang XH, Liu YP, Qu GJ. Establishment of microbial limit test method for compound Danshen tablets. China Pharmaceutical Standard. 2020; 21 (05): 464-471.

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APA Style

Fangming Tan, Minna Huang, Suishan Qiu, Zhuanzhi Liang. (2021). Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’. European Journal of Clinical and Biomedical Sciences, 7(2), 33-36. https://doi.org/10.11648/j.ejcbs.20210702.14

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ACS Style

Fangming Tan; Minna Huang; Suishan Qiu; Zhuanzhi Liang. Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’. Eur. J. Clin. Biomed. Sci. 2021, 7(2), 33-36. doi: 10.11648/j.ejcbs.20210702.14

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AMA Style

Fangming Tan, Minna Huang, Suishan Qiu, Zhuanzhi Liang. Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’. Eur J Clin Biomed Sci. 2021;7(2):33-36. doi: 10.11648/j.ejcbs.20210702.14

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@article{10.11648/j.ejcbs.20210702.14,
  author = {Fangming Tan and Minna Huang and Suishan Qiu and Zhuanzhi Liang},
  title = {Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’},
  journal = {European Journal of Clinical and Biomedical Sciences},
  volume = {7},
  number = {2},
  pages = {33-36},
  doi = {10.11648/j.ejcbs.20210702.14},
  url = {https://doi.org/10.11648/j.ejcbs.20210702.14},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ejcbs.20210702.14},
  abstract = {Background: the assessment of microbiological quality of medicinal products is one of control stages in medicinal products saft, because the holder of a manufacturing authorization must drug so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. Objective: To assess microbial limit test for hospital preparation ‘compound alum powder’. Methods: The results of strain culture and analysis were used to evaluate the drug quality of ‘compound alum powder’. The objective is ‘compound alum powder’ (approval number: Z20140229) was made by the First Affiliated Hospital of Jinan University. Their batch numbers include: 201019, 200818, 200701. Validation tests were carried out in accordance with the standards of the Chinese Pharmacopoeia (2020 edition). Three parallel independent validations were conducted to calculate the recovery rate of each test bacterium and investigate whether each test bacterium was detected in the control bacterial inspection. Result: The recovery ratio of the total number of aerobic bacteria, molds and yeast in the control group was in the range of 0.5 ~ 2, and the results of the control group were positive, and the results of each control group met the requirements. The results show that the membrane filtration method is suitable for the microbial limit test of ‘compound alum powder’. Conclusion: this microbial limit test method control and ensure the quality of drug production by solving the problem of interference of antimicrobial components in drugs. It can eliminate the bacteriostasis of boric acid, phenol and alum.},
 year = {2021}
}

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TY  - JOUR
T1  - Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’
AU  - Fangming Tan
AU  - Minna Huang
AU  - Suishan Qiu
AU  - Zhuanzhi Liang
Y1  - 2021/05/21
PY  - 2021
N1  - https://doi.org/10.11648/j.ejcbs.20210702.14
DO  - 10.11648/j.ejcbs.20210702.14
T2  - European Journal of Clinical and Biomedical Sciences
JF  - European Journal of Clinical and Biomedical Sciences
JO  - European Journal of Clinical and Biomedical Sciences
SP  - 33
EP  - 36
PB  - Science Publishing Group
SN  - 2575-5005
UR  - https://doi.org/10.11648/j.ejcbs.20210702.14
AB  - Background: the assessment of microbiological quality of medicinal products is one of control stages in medicinal products saft, because the holder of a manufacturing authorization must drug so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. Objective: To assess microbial limit test for hospital preparation ‘compound alum powder’. Methods: The results of strain culture and analysis were used to evaluate the drug quality of ‘compound alum powder’. The objective is ‘compound alum powder’ (approval number: Z20140229) was made by the First Affiliated Hospital of Jinan University. Their batch numbers include: 201019, 200818, 200701. Validation tests were carried out in accordance with the standards of the Chinese Pharmacopoeia (2020 edition). Three parallel independent validations were conducted to calculate the recovery rate of each test bacterium and investigate whether each test bacterium was detected in the control bacterial inspection. Result: The recovery ratio of the total number of aerobic bacteria, molds and yeast in the control group was in the range of 0.5 ~ 2, and the results of the control group were positive, and the results of each control group met the requirements. The results show that the membrane filtration method is suitable for the microbial limit test of ‘compound alum powder’. Conclusion: this microbial limit test method control and ensure the quality of drug production by solving the problem of interference of antimicrobial components in drugs. It can eliminate the bacteriostasis of boric acid, phenol and alum.
VL  - 7
IS  - 2
ER  -

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Author Information

Fangming Tan

Department of Medicine, The First Affiliated Hospital of Jinan University, Guangzhou, China
Minna Huang

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

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

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

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APA Style

Fangming Tan, Minna Huang, Suishan Qiu, Zhuanzhi Liang. (2021). Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’. European Journal of Clinical and Biomedical Sciences, 7(2), 33-36. https://doi.org/10.11648/j.ejcbs.20210702.14

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ACS Style

Fangming Tan; Minna Huang; Suishan Qiu; Zhuanzhi Liang. Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’. Eur. J. Clin. Biomed. Sci. 2021, 7(2), 33-36. doi: 10.11648/j.ejcbs.20210702.14

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AMA Style

Fangming Tan, Minna Huang, Suishan Qiu, Zhuanzhi Liang. Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’. Eur J Clin Biomed Sci. 2021;7(2):33-36. doi: 10.11648/j.ejcbs.20210702.14

Copy | Download

@article{10.11648/j.ejcbs.20210702.14,
  author = {Fangming Tan and Minna Huang and Suishan Qiu and Zhuanzhi Liang},
  title = {Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’},
  journal = {European Journal of Clinical and Biomedical Sciences},
  volume = {7},
  number = {2},
  pages = {33-36},
  doi = {10.11648/j.ejcbs.20210702.14},
  url = {https://doi.org/10.11648/j.ejcbs.20210702.14},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ejcbs.20210702.14},
  abstract = {Background: the assessment of microbiological quality of medicinal products is one of control stages in medicinal products saft, because the holder of a manufacturing authorization must drug so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. Objective: To assess microbial limit test for hospital preparation ‘compound alum powder’. Methods: The results of strain culture and analysis were used to evaluate the drug quality of ‘compound alum powder’. The objective is ‘compound alum powder’ (approval number: Z20140229) was made by the First Affiliated Hospital of Jinan University. Their batch numbers include: 201019, 200818, 200701. Validation tests were carried out in accordance with the standards of the Chinese Pharmacopoeia (2020 edition). Three parallel independent validations were conducted to calculate the recovery rate of each test bacterium and investigate whether each test bacterium was detected in the control bacterial inspection. Result: The recovery ratio of the total number of aerobic bacteria, molds and yeast in the control group was in the range of 0.5 ~ 2, and the results of the control group were positive, and the results of each control group met the requirements. The results show that the membrane filtration method is suitable for the microbial limit test of ‘compound alum powder’. Conclusion: this microbial limit test method control and ensure the quality of drug production by solving the problem of interference of antimicrobial components in drugs. It can eliminate the bacteriostasis of boric acid, phenol and alum.},
 year = {2021}
}

Copy | Download

TY  - JOUR
T1  - Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’
AU  - Fangming Tan
AU  - Minna Huang
AU  - Suishan Qiu
AU  - Zhuanzhi Liang
Y1  - 2021/05/21
PY  - 2021
N1  - https://doi.org/10.11648/j.ejcbs.20210702.14
DO  - 10.11648/j.ejcbs.20210702.14
T2  - European Journal of Clinical and Biomedical Sciences
JF  - European Journal of Clinical and Biomedical Sciences
JO  - European Journal of Clinical and Biomedical Sciences
SP  - 33
EP  - 36
PB  - Science Publishing Group
SN  - 2575-5005
UR  - https://doi.org/10.11648/j.ejcbs.20210702.14
AB  - Background: the assessment of microbiological quality of medicinal products is one of control stages in medicinal products saft, because the holder of a manufacturing authorization must drug so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. Objective: To assess microbial limit test for hospital preparation ‘compound alum powder’. Methods: The results of strain culture and analysis were used to evaluate the drug quality of ‘compound alum powder’. The objective is ‘compound alum powder’ (approval number: Z20140229) was made by the First Affiliated Hospital of Jinan University. Their batch numbers include: 201019, 200818, 200701. Validation tests were carried out in accordance with the standards of the Chinese Pharmacopoeia (2020 edition). Three parallel independent validations were conducted to calculate the recovery rate of each test bacterium and investigate whether each test bacterium was detected in the control bacterial inspection. Result: The recovery ratio of the total number of aerobic bacteria, molds and yeast in the control group was in the range of 0.5 ~ 2, and the results of the control group were positive, and the results of each control group met the requirements. The results show that the membrane filtration method is suitable for the microbial limit test of ‘compound alum powder’. Conclusion: this microbial limit test method control and ensure the quality of drug production by solving the problem of interference of antimicrobial components in drugs. It can eliminate the bacteriostasis of boric acid, phenol and alum.
VL  - 7
IS  - 2
ER  -

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