药食同源甘草饮片微生物限度检查方法的适用性研究OA

Objective:To explore the microbial limit test methods applicable to licorice decoction pieces.Methods:According to the requirements of Chinese Pharmacopoeia(2025 edition,Part Ⅳ)general rules 1108,the conventional method,Incremental Dilution method and direct inoculation method were adopted for applicability test of the microbial limit test method for Licorice decoction pieces from three manufacturers.Results:When the conventional method was used for total aerobic microbial count and total thermophilic microbial count,the recovery rate of Pseudomonas aeruginosa and Staphylococcus aureus failed to meet the requirements(0.5～2.0).After a 50-fold dilu-tion of the test solution,the recovery of Pseudomonas aeruginosa met the requirements.Following a 100-fold dilution,the inhibitory effect on Staphylococcus aureus was effectively eliminated,and the recovery rates of all test strains met the requirements.The conventional meth-od was employed for the determination of total combined yeasts and molds counts,and the recovery rates of all strains were within the required range.In the tests for controlled microorganisms,both the method suitability test and positive control test successfully detected the target strains,with no growth was observed in the negative control,conforming to the pharmacopoeial requirements.Conclusion:The microbial limit test methods of Licorice decoction pieces established in this research is simple and reliable,and can be used for the routine quality control of Licorice decoction pieces.It also provides a methodological reference for the microbial limit inspection of Chinese patent medicines such as Compound Glycyrrhiza Tablets.