聚山梨酯80对药品微生物限度检查的影响

Effects of polysorbate 80 on microbiological examination of drugs

目的:分析不同来源、不同浓度的聚山梨酯80对试验菌生长的影响,为聚山梨酯80在药品微生物限度检查中的应用提供参考。方法:取不同生产厂家、不同批号的聚山梨酯80,分别加入pH7.0无菌氯化钠-蛋白胨缓冲液中,制备成3%、4%、5%、10%、15%、20%浓度(v/v)的溶液,作为供试液。按照《中国药典》2015年版四部通则1105和1106,进行需氧菌、霉菌和酵母菌计数方法适用性试验。同时进行控制菌大肠埃希菌、金黄色葡萄球菌和铜绿假单胞菌检查的方法适用性试验。结果:不同来源、不同浓度的聚山梨酯80对需氧菌计数和控制菌检查试验结果的影响差别较大,对霉菌和酵母菌计数试验结果影响差别不大。结论:不同来源、不同浓度的聚山梨酯80对试验菌的生长影响不同。药品微生物限度检查中使用聚山梨酯80时,需注意聚山梨酯80的来源不同对试验结果造成的差异。

Objective:To analyze the effects of different sources and concentrations of polysorbate 80 on the growth of test microorganisms and to provide a reference for the application of polysorbate 80 in microbiological examination of drugs. Methods:Polysorbate 80 from the different manufacturers and batches were added to pH 7.0 aseptic sodium chloride-peptone buffer solutions to prepare 3%, 4%, 5%, 10%, 15%, 20%(v/v) test solutions. According to Chinese Pharmacopoeia 2015 Volume Ⅳ general chapters 1105 and 1106, the method suitability tests for total aerobic microbial count, and total molds and yeasts count were carried out, and the method suitability tests for specified microorganisms of Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa were carried out. Results:The effects of different sources and concentrations of polysorbate 80 on total aerobic microbial count and tests for specified microorganisms had the big differences, while the effects on molds and yeasts count had less differences. Conclusion:The different sources and concentrations of polysorbate 80 have different effects on the growth of the test microorganisms. When polysorbate 80 is used in of drugs, attention should be paid to the differences of test results caused by different sources of polysorbate 80.