溶血试验替代滴眼液眼刺激性试验的可行性研究

Feasibility Study on Hemolysis Test as an Alternative Method of Eye Irritation Test for Eye Drops

目的探索溶血试验替代体内眼刺激性试验(Draize试验)用于检测滴眼液刺激性的可行性。方法采用溶血实验(hemolysis test),对Draize数据库里的15种化学物质进行体外再评价,分析该方法的LogHC5(0HC50为50%红细胞溶血的受试物的浓度)与Draize试验评分(最大平均分值,MAS)的相关性,并采用溶血实验对11种市售滴眼液的刺激性进行体外评价。结果溶血实验的LogHC50与Draize试验评分(MAS)的相关系数为-0.639,spearman’s秩相关系数为-0.888。结论溶血实验可作为筛检滴眼液的眼刺激性的替代方法之一,为眼科制剂的开发提供参考。

Objective To investigate the feasibility of using hemolysis test as an alternative method of Draize eye irritation test （Draize test） to predict the irritation of 11 kinds of eye drops. Methods Fifteen chemical ingredients in Draize data bank were tested in vitro by hemolysis test, and the LogHC50 values （HC50, the concentrations of the test substances that induced 50 % hemolysis） were compared with maximum average Draize total seore（MAS）. And then the irritation of 11 kinds of eye drops was tested by hemolysis test in vitro. Results The correlation coefficient and Spearman＇s rank correlation coefficient between the LogHC50 value and MAS were -0.639 and -0.888, respectively. Conclusion For predicting eye irritation of eye drops, hemolysis test can be used as an effective alternative method for Draize eye irritation test, but it can＇t be the substitute for Draize eye irritation test, which will provide references for research of ophthalmic preparations.