Objective: To classify the microbiological examination methods of live microecological products according to the results of suitability test for the enumeration method, and establish the decision-making method for microbiological examination of live microecological products. Methods: The suitability test of the microbiological examination method of live microecological products was performed according to the requirements of the General Chapter 1105 in the Chinese Pharmacopoeia Vol Ⅳ. Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger were used as the test strains. Tryptic Soy Agar, Sabouraud Dextrose Agar, Rose Bengal Agar and Rose Bengal Agar Ⅱ were used as medium. Results: For live microecological products composed of anaerobic bacteria or microorganisms with growth characteristics significantly different from the test strains, the suitability test for the method could be performed according to General Chapter 1105. For live microecological products containing Bacillus and enterococcus, the suitability test for the fungal enumeration method could be performed according to General Chapter 1105. Live microecological products could not be tested for suitability of the method due to the influence of the component microorganisms, gram-negative bacteria could be controlled using selective medium. In addition, some potentially harmful microorganisms could be controlled based on risk assessment according to the route of administration and the population of drug users. Conclusion: This study provides a basis for the selection of the microbiological examination methods for live microecological products, and further complements and improves the quality standard system of live microecological products.
FENG Dan-yang, MENG Xiao-li, SHEN Zhen, REN Li-hong, DING Bo
. Microbiological examination method suitability study and decision-making method establishment of live microecological products[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(8)
: 1415
-1429
.
DOI: 10.16155/j.0254-1793.2023-0716
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