中国药物评价2026，Vol.43Issue(2)：124-127,4.
药食同源甘草饮片微生物限度检查方法的适用性研究
Study on the Applicability of Microbial Limit Test Methods for Licorice Decoction Pieces with Homology of Medicine and Food
牛杰振 1张原青 2韩宏昇 1何菊 1吕娟 3夏国芝4
作者信息
- 1. 云南省食品药品审核查验中心,云南 昆明 650200
- 2. 昆明医科大学第一附属医院,云南 昆明 650032
- 3. 云南经济管理学院,云南 昆明 650106
- 4. 云南新世纪药业有限公司,云南 昆明 650503
- 折叠
摘要
Abstract
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.关键词
甘草饮片/微生物限度/方法适用性/控制菌检查Key words
Licorice decoction pieces/Microbial limit/Method suitability/Control bacterial examination分类
医药卫生引用本文复制引用
牛杰振,张原青,韩宏昇,何菊,吕娟,夏国芝..药食同源甘草饮片微生物限度检查方法的适用性研究[J].中国药物评价,2026,43(2):124-127,4.
