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目的比较普拉洛芬滴眼液原研药与仿制药对人角膜上皮细胞(HCEC)的毒性差异。方法常规培养HCEC,分别在培养液中添加按1∶1、1∶10、1∶100、1∶1 000稀释的滴眼液,采用四甲基偶氮唑盐(MTT)法检测各组药物处理后HCEC的存活率,采用线性回归分析滴眼液浓度与细胞存活率的相关性;分别在培养液中添加不同浓度的苯扎氯铵(BAK),采用MTT法检测BAK处理后HCEC的存活率,采用非线性回归分析BAK浓度与细胞存活率的相关性。结果普拉洛芬滴眼液原研药与仿制药对HCEC存活率的影响均存在剂量依赖性(原研药r=0.893,P<0.05;仿制药r=0.888,P<0.05),两组药物相同浓度、相同时间下对HCEC存活率的影响差异无统计学意义(P>0.05);BAK对HCEC存活率的影响具有剂量依赖性(r~2=0.951,P<0.05)。结论普拉洛芬滴眼液降低HCEC存活率,具有细胞毒性,原研药与仿制药对HCEC毒性的差异无统计学意义(P>0.05)。
Objective To compare the toxicity of pranoprofen eye drops with original and generic drugs on human corneal epithelial cells (HCECs). Methods HCECs were cultured routinely. Eye drops diluted 1: 1, 1: 10, 1: 100 and 1: 1000 respectively were added to the culture medium. The effects of each group of drugs The survival rate of HCEC after treatment was analyzed by linear regression analysis of the correlation between eye drops concentration and cell viability; different concentrations of benzalkonium chloride (BAK) were added to the culture medium, and the survival of HCEC after BAK treatment was measured by MTT assay Rates, using non-linear regression analysis of BAK concentration and cell survival correlation. Results The effects of the original drug and the generic drug of pranoprofen eye drops on the survival rate of HCEC were dose-dependent (r = 0.893, P <0.05; r = 0.888, P <0.05) (P> 0.05). The effect of BAK on the survival rate of HCEC was dose-dependent (r ~ 2 = 0.951, P <0.05). Conclusion Pranoprofen ophthalmic solution can reduce the survival rate of HCECs and has cytotoxicity. There is no significant difference in HCEC toxicity between the original drug and the generic drug (P> 0.05).