硫酸软骨素滴眼液抑菌剂筛选与抑菌效力研究

目的:探索硫酸软骨素滴眼液中抑菌剂的合理添加剂量,分别按中国药典2010年版和中国药典2015年版抑菌效力检查法测定硫酸软骨素滴眼液的抑菌效力。方法:对不同浓度抑菌剂的抑菌效果进行考察,筛选出抑菌剂的合理添加量。选择有代表性的挑战微生物为试验菌株进行菌落计数方法学验证,然后进行微生物的挑战试验,按验证方法测定各时间点的菌落数。结果:按2010年版中国药典,含羟苯甲酯0.03%、羟苯丙酯0.015%的硫酸软骨素滴眼液对铜绿假单胞菌、大肠埃希菌、金黄色葡萄球菌、白色念珠菌和黑曲霉5种代表试验菌的抑菌性均符合药典要求;按2015年版中国药典,均不符合药典的要求。结论:中国药典2015年版抑菌效力检查法相对中国药典2010年版抑菌效力判断标准差异较大,硫酸软骨素滴眼液目前的抑菌剂处方无法达到2015年版中国药典的要求,建议更换抑菌剂。

Objective: To explore the reasonable dose of antibacterial agents in chondroitin sulfate eye drops by ChP(2010) and ChP(2015).Methods: The antimicrobial efficacy of antimicrobial preservatives was tested at different ratio.Using challenge microorganism as test strains, the colony-count method validation was performed.According to the verified method, the preservation efficacy test was carried out, and the number of colony at each point was determined.Results: According to the ChP(2010), 0.03% methylparaben and 0.015% propylparaben chondroitin sulfate eye drops was conformable, but was not conformable to the standard of the ChP (2015).Conclusion: There are great differences for the estimate standard of preservatives-effectiveness between the ChP(2010) and the ChP(2015).The current prescription of chondroitin sulfate eye drops cannot meet the requirements of the ChP(2015).Thus, it is recommended to replace antimicrobial preservatives.

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