| 谢珍,张劲松,沈琴,何立成,桑晶,匡荣.BioOcularTM角膜上皮模型EIT法评价眼用制剂包装材料的眼刺激性研究[J].中国药品标准,2018,19(3):187-190 |
| BioOcularTM角膜上皮模型EIT法评价眼用制剂包装材料的眼刺激性研究 |
| Evaluation of Eye Irritation Potential of Containers for Eye drops Using Human Cornea-like Epithelial Tissue Model BioOcularTM EIT MethodXie Zhen1, Zhang Jinsong1,Shen Qin2, He Licheng1, Sang Jing1,Kuang Rong1*(1.Zhejiang Institute of Food and Drug Control, Hangzhou, 310052；2.Shaoxing Modern Medicine Public Service Center, Shaoxing, 312073) |
| 投稿时间：2017-07-26 修订日期：2018-06-11 |
| DOI： |
| 中文关键词: 三维重组角膜上皮模型 BioOcularTM 眼刺激 包装材料 |
| 英文关键词: reconstructed human cornea-like epithelial tissue model BioOcularTM eye irritation containers for ophthalmic preparations |
| 基金项目:浙江省药品接触材料质量控制研究重点实验室(2014E10006) |
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| 中文摘要: |
| 目的：用BioOcularTM 角膜上皮模型EIT法评价眼用制剂包装材料的眼刺激性。方法：采用BioOcularTM 角膜上皮模型EIT法对6批眼用制剂包装材料的眼刺激性进行检测,并与Draize试验所得的结果相比较。结果：Draize法和BioOcularTM 角膜上皮模型EIT法所得眼刺激性结果均为无刺激性,与Draize法比较,BioOcularTM 角膜上皮模型EIT法与体内试验的分类一致性为100%(6/6)。 结论：三维重组角膜上皮模型 EIT法有潜力作为眼用制剂包装材料眼刺激性试验的替代方法。 |
| 英文摘要: |
| Objective：To evaluate eye irritation potential of containers for eye drops using human cornea-like epithelial tissue model BioOcularTM EIT method. Method： Six batches of containers for eye drops were tested to predict ocular irritation by BioOcularTM EIT method in vitro ,the datas were compared with the results of Draize assay in vivo. Result： The test results showed that the classification results from Draize assay and BioOcularTM EIT method were all non-irritation, compared with the Draize assay ,classification consistency of the two methods was 100%(6/6) . Conclusion： The results suggested that the reconstructed human cornea-like epithelial tissue model BioOcularTM could be used in eye irritation evaluation of containers for eye drops.. |
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