曾嘉炜,吴海燕,何秋毅,李佳,陈杰,陈孝
ZENG Jiawei,WU Haiyan,HE Qiuyi,LI Jia,CHEN Jie,CHEN Xiao

• 1:中山大学附属第一医院药学部

摘要(Abstract)：

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 drug cytotoxicity between brand-name and generic pranoprofen eye drops. METHODS Human corneal epithelial cells( HCEC) were used in this study and were treated with 1 ∶1,1 ∶10,1 ∶100,1 ∶1 000 diluted original and generic pranoprofen eye drops. The cytotoxicity effects of different eye drops were detected with MTT assay. The correlation between drug concentration and cell viability was analyzed with linear regression. The cytotoxicity effect of benzalkonium chloride( BAK) was detected with MTT assay,the correlation between BAK concentration and cell viability was analyzed with nonlinear regression. RESULTS Both brand-name and generic pranoprofen eye drops performed cell cytotoxicity in a dose dependent manner( brand-name group r = 0.893,P<0.05; generic group r = 0. 888,P < 0. 05),no obvious differences of drug cytotoxicity were detected between groups at the same drug concentration or time( P> 0. 05). BAK reduced cell viability in a dose dependent manner( r~2= 0. 951,P < 0. 05). CONCLUSION Pranoprofen eye drops reduce HCEC cell viability,no obvious differences are detected between brand-name and generic pranoprofen eye drops( P>0.05).

关键词(KeyWords)： 普拉洛芬;人角膜上皮细胞;细胞毒性
pranoprofen;human corneal epithelial cells;cytotoxicity

Abstract:

Keywords:

基金项目(Foundation): 广东省药学会临床用药研究基金(2015RL15);; 广东省省级科技计划项目(2015A30302012)

作者(Author): 曾嘉炜,吴海燕,何秋毅,李佳,陈杰,陈孝
ZENG Jiawei,WU Haiyan,HE Qiuyi,LI Jia,CHEN Jie,CHEN Xiao

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