吡诺克辛滴眼液的抑菌效力评价

Study on the Preservatives-effectiveness of Pirenoxine Ophthalmic Solution

关键词:  诺克辛滴眼液  抑菌效力  评价

Key words:  pirenoxine ophthalmic solution  preservatives-effectiveness  evaluation

摘要:

目的 分别按中国药典2010年版和中国药典2015年版通则公示稿1121抑菌效力检查法测定吡诺克辛滴眼液的抑菌效力。方法 以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、黑曲霉和白色念珠菌为试验菌株，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 吡诺克辛滴眼液中抑菌剂的抑菌效力符合中国药典2010年版的规定，但不符合中国药典2015年版通则公示稿1121抑菌效力检查法的规定。结论 中国药典2010年版和中国药典2015年版通则公示稿1121抑菌效力判断标准差异较大，部分已上市品种的抑菌剂效力达不到中国药典2015年版抑菌效力的要求。

Abstract:

OBJECTIVE To study the evaluation of preservatives-effectiveness of pirenoxine ophthalmic solution respectively by the Ch.P (2010) and the general public draft 1121 of Ch.P (2015). METHODS using Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Aspergillus and Candida albicans as test strains, the colony-count method validation was studied. According to the verified method, the preservation efficacy test was carried out, the number of colony at each point was determined. RESULTS the effect of bacteriostatic agent of pirenoxine ophthalmic solution was confoumable to the standard of Ch.P (2010), but was not confoumable to the standard of the general public draft 1121 of Ch.P (2015). CONCLUSION there are great differences for the estimate standard of preservatives-effectiveness between the Ch.P (2010) and the general public draft 1121 of Ch.P (2015), and the preservatives-effectiveness in part of the listed varieties do not meet requirement of the latter.