Microbiological Quality Analysis and Evaluation of Cod Liver Oil Emulsion Based on Commercial Samples
- Author:
- No author available
- Journal Title:
- Drug Evaluation
- Issue:
- 10
- DOI:
- 10.19939/j.cnki.1672-2809.2023.10.04
- Key Word:
- 鱼肝油乳;微生物限度检查;方法验证;质量分析;Cod liver oil emulsion;Microbial test method;Validation of method;Quality assessment
Abstract： Objective To analyze the microbial contamination and provide a basis for standardizing microbial test method of non-sterile drug cod liver oil emulsion in the market.Methods The total aerobic microbial count,the total combined yeasts and molds count,and specified microorganisms were tested by the methods in the 2020 edition of Chinese Pharmacopoeia(VolⅣ).Microbes isolated from drug samples were identified and characterized by Gram staining,microscope examination,and 16S rDNA sequencing.Results A total of 27 batches samples obtained from two manufacturers of cod liver oil emulsion were detected in this report.One of them was exceeded because gluconacetobacter aggeris were detected in the yeasts and molds count,while 26 batches samples were qualified.Results of strain identification revealed that 15 kinds of strains were detected including bacillus,staphylococcus,micrococcus and gluconacetobacter.Conclusion The research work showed that the microbial contaminants were found in cod liver oil emulsion during manufacturing and over product shelf life.Increased focus on should be placed on controlling of microbial populations from excipients,manufacturing environment and personnel,and refining microbiological examination and acceptance criteria for non-sterile products.
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