A survey of microbial contamination for ten processed pieces of Chinese materia medica in Shanghai / 中草药

ABSTRACT

Objective: To investigate the microbial contamination of ten kinds of processed pieces of Chinese materia medica (CMM) manufactured in Shanghai. Methods: The bio-burden of 94 samples was analyzed for microbial enumeration, heat-resistant strains enumeration and detection of seven pathogens according to microbiology methods in Chinese Pharmacopeia 2015 (the third draft for public release). Results: The range of total aerobic microbial count was from 10-108 CFU/g. The range of total combined yeasts and molds count was from 10-107 CFU/g. The detection rate for bile-tolerant Gram-negative bacteria (MPN method) and heat-resistant strains were 22.3% (21/94) and 76.6% (72/94), respectively. Meanwhile, Escherichia coli was detected in one sample (100 < N < 103 MPN/g). However, other pathogens such as Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Shigella (GB 4789.5) and hemolytic Streptococcus (GB 4789.11) were not detected. In this study, 5.3%, 18.1%, and 23.4% of the total samples were not consistent with the microbiology requirement of EP 8.0, JP 16, and USP 37, respectively. Conclusion: This study shows that processed pieces of CMM is contaminated by varied microorganisms. Further research on risk assessment should be carried out to re-evaluate the test method and process system of processed pieces of CMM for the sake of reducing patients' risk.