硫酸软骨素滴眼液抑菌效力的研究

Studies on the antibacterial efficacy of chondroitin sulfate eye drops

目的:评价硫酸软骨素滴眼液中抑菌剂使用的合理性。方法:测定市售7个生产厂家共64批硫酸软骨素滴眼液的抑菌效力。按《中华人民共和国药典》2015年版,以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念珠菌和黑曲霉为试验菌株,进行菌落计数方法适用性试验。根据试验结果进行样品微生物挑战试验,测定样品中不同时间存活试验菌数lg值,并与初始接种lg值比较,判定抑菌效力。结果:使用尼泊金酯类抑菌剂的产品均不符合抑菌效力测定,选择醇类、季铵盐类和有机汞类抑菌剂都是可行的。结论:市售硫酸软骨素滴眼液的抑菌效力的合格率低,需重视处方中抑菌剂种类和含量的筛选以及抑菌剂稳定性的考察,确保用药安全。

Objective:To evaluate the usage rationality of antimicrobial preservatives in domestic chondroitin sulfate eye drops.Methods:To study the antibacterial efficacy of 64 batches of chondroitin sulfate eye drops from 7 manufacturers.Staphylococcus aureus,Pesudomonas aeruginosa,Escherichia coli,Candida albicans and Aspergillus niger were used as test strains,the colony-count method validation was studied following the ChP 2015.According to the verified method,the microbiological method and various time-gap colony counting lg,compared with original value,were applied to evaluate the bacteriostatic efficacy.Results:All products using Nipagin ester bacteriostat did not conform to the antibacterial efficacy.It was feasible to select alcohol,quaternary ammonium salt and organic mercury bacteriostat.Conclusion:The qualified rate of the antibacterial efficacy of chondroitin sulfate eye drops on the market is low.It is necessary to pay attention to the screening of the type and dosage of antimicrobial preservatives and the investigation on stability of preservatives so as to ensure drug safety.