Bacterial Types and Risk Assessment of Contaminated Traditional Chinese Medicine Decoction Pieces from 2015 to 2024:A Literature Review
Objective To provide a basis for the rational formulation of microbial standards in traditional Chinese medicine(TCM)decoction pieces and the microbial control in TCM decoction pieces.Methods The relevant literature in the CNKI from January 1,2015 to May 31,2024 were searched.The groups of microorganisms in contaminated TCM decoction pieces were analyzed,a failure mode and effects analysis(FMEA)model was constructed to identify,analyze and evaluate the risks of microorganisms in contaminated TCM decoction pieces.Results A total of 29 literature was included,involving 123 varieties,1 281 batches of TCM decoction pieces and 65 microbial groups(genera or species).The high-risk groups accounted for 24.24%among 33 Gram-negative bacteria,including Escherichia coli,Pseudomonas aeruginosa,Salmonella,Cronobacter sakazakii,Shigella,Yersinia pseudotuberculosis,Klebsiella pneumoniae,and Enterobacter cloacae;those accounted for 6.67%among 15 Gram-positive bacteria,involving Staphylococcus aureus;those accounted for 5.88%among 17 Bacillus,involving Bacillus cereus.There were 15.38%of high-risk groups and 73.85%of low-risk groups of bacteria in contaminated TCM decoction pieces.Conclusion The FMEA model can quantitatively evaluate the effect of microorganisms on the quality of TCM decoction pieces from a risk management perspective,which is beneficial for microbial control in TCM decoction pieces.We should pay high attention to the 10 high-risk bacterial groups such as Escherichia coli,Staphylococcus aureus,and Bacillus cereus in TCM decoction pieces,especially strengthening the control of Gram-negative bacteria.
traditional Chinese medicine decoction piecesmicrobial contaminationrisk assessmentfailure mode and effects analysis