Safety Monitoring

Bacterial contamination status and traceability analysis of Aurantii Fructus*

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  • 1. Jiangxi Institute for Drug Control, NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine, Jiangxi Province Engineering Research Center of Drug and Medical Device Quality, Nanchang 330029, China;
    2. Jiangxi University of Chinese Medicine, Nanchang 330004, China

Received date: 2022-06-29

  Online published: 2024-06-24

Abstract

Objective: To investigate the level of microbial contamination in the fruits, herbs and tablets of Aurantii Fructus, and to isolate, identify and trace the source of contaminated bacteria. Methods: According to the microbial limit test method of the fourth part of Chinese Pharmacopoeia (2020 edition), the total number of aerobic bacteria, fungi and yeast, heat-resistant bacteria and control bacteria in Aurantii Fructus were examined. The bacterial strains detected in Aurantii Fructus were identified by PCR and RP technology and traced by BN software. Results: The total number of microorganisms, aerobic bacteria, fungi and yeasts in each stage were as follows: sliced slices, the fruit, bran fried slices, medicinal materials. Cholestate-resistant gram-negative bacteria were detected in 10 batches, but none of them exceeded 1×104 cfu·g-1. Escherichia coli and salmonella were not detected in 10 batches. A total of 50 strains were identified, among which Bacillus is the dominant strain in the herb. The conditional pathogenic bacteria such as Cronobacter sakazakii, Pseudomonas aeruginosa and Klebsiella pneumoniae were also detected. Conclusion: To reduce the microbial load in the tablets, attempts can be made to prevent microbial blooms by controlling the moistening process parameters such as temperature and water activity. Pseudomonas were present in the fruit and the medicinal material, but not in the slices which can be due to heat intolerance from isolating. Cronobacter sakazakii was only present in the tablets and accounted for up to 50% of the total, which might be caused by contamination of production equipment or environment or water during processing; in addition, it is noteworthy that the conditional pathogenic bacteria Klebsiella pneumoniae were present in all three batches of tablets after bran-frying Klebsiella pneumoniae, and attention should be paid to control this type of microbial contamination to ensure the quality and safety of Aurantii Fructus.

Cite this article

HUO Xiao-fei, LIU Wei-de, LIU Xu-ping, ZHANG Hong . Bacterial contamination status and traceability analysis of Aurantii Fructus*[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(2) : 324 -333 . DOI: 10.16155/j.0254-1793.2023.02.16

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