北京生物医学工程

银离子水凝胶涂层导尿管抑菌效力定量检查方法的建立

Establishment of the antimicrobial effect quantitative test method for silver hydrogel coated catheter

作者：张娟岳卫华

单位：北京市医疗器械检验所（北京101111）

关键词：银离子水凝胶；涂层；导尿管；微生物计数；方法适用性试验；抑菌效力

分类号：R318.04

出版年·卷·期（页码）：2021·40·1（85-90）

摘要：

目的建立银离子水凝胶涂层导尿管的抑菌效力定量检查方法。方法根据《中华人民共和国药典》2015年版微生物计数法（四部通则1105），以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、表皮葡萄球菌和白色念珠菌作为试验菌株，以D/E中和肉汤作为中和剂，采用中和剂与薄膜过滤法联合使用的方式对银离子水凝胶涂层导尿管进行微生物计数方法适用性试验。根据《中华人民共和国药典》2015年版抑菌效力检查法（四部通则1121），采用经验证的微生物计数方法定量测定银离子水凝胶涂层导尿管对上述5种试验菌的抑菌效力。结果D/E中和肉汤与薄膜过滤法联合使用可以有效中和银离子的抑菌活性，银离子水凝胶涂层导尿管对上述5种试验菌均具有较好的抑菌作用，抑菌率均能达到99%，且抑菌效力可持续至14 d。结论采用D/E中和肉汤与薄膜过滤法联合使用的方式建立适用于银离子水凝胶涂层导尿管的微生物计数方法，可照此方法进行抑菌效力检查中存活菌数的测定。建立的方法可用于银离子水凝胶涂层导尿管抑菌效力的定量检查。

objective To establish the antimicrobial effect quantitative test method for silver hydrogel coated catheter. Methods According to the requirements in the 2015 version of Chinese Pharmacopoeia(General Rule 1105), Staphylococcus aureus，Pseudomonas aeruginosa，Escherichia coli，Staphylococcus epidermidis and Candida albicans were used as the test strains，D/E neutralizing broth was used as neutralizer，the microbiological counting method applicability test was carried out by combined use of neutralizer and membrane filtration method. According to the requirements in the 2015 version of Chinese Pharmacopoeia(General Rule 1121), the antimicrobial effectiveness against the above five strains was mesured by the verified microbiological counting method. Results The antimicrobial activity of silver ions could be effectively neutralized by the combination of D/E neutralizer and membrane filtration method. The silver hydrogel coated catheter had good antimicrobial effect on the above five strains，and the antimicrobial effect could reach 99% and can last up to 14d. Conclusions The microbiological counting method for silver hydrogel coated catheters is established by using D/E neutralizer combined with membrane filtration method, which can be used to determine the number of viable bacteria in antibacterial effect test. The method we established can be used in the antimicrobial effect quantitative test method for silver hydrogel coated catheter.

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