Abstract
OBJECTIVE: This study attempted to verify the applicability of the microbial limit test (plate culture and membrane filtration) for 10 proprietary Chinese medicines for children. METHODS: In this study, we collected 10 proprietary Chinese medicines for children as study objects and performed plate culture and membrane filtration to calculate the colony-forming unit (cfu) of microorganisms in these medicines and verify its applicability in objectionable microorganisms. RESULTS: It was found that the recovery rate of microorganisms including Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger ranged from 70% to 150%. This verification was performed by plate culture or membrane filtration. Inspection for objectionable microorganisms (Escherichia coli, Salmonella paratyphi B, and bile salt-tolerant Gram-negative bacteria) was applicable for most medicines. CONCLUSION: Microbial limit test is feasible for the determination of microorganisms in 10 proprietary Chinese medicines for children.