| 谢珍.基于BioOcularTM角膜上皮模型EIT法对眼用制剂包装材料眼刺激性的再研究[J].中国药品标准,2019,20(6):469-473 |
| 基于BioOcularTM角膜上皮模型EIT法对眼用制剂包装材料眼刺激性的再研究 |
| Re-evaluation on Eye Irritation of containers for the ophthalmic preparation based on Human Cornea-like Epithelial Tissue Model BioOcularTM EIT Method |
| 投稿时间：2019-01-23 修订日期：2019-11-21 |
| DOI： |
| 中文关键词: BioOcularTM 眼刺激 Draize试验 包装材料 |
| 英文关键词: BioOcularTM eye irritation Draize test containers for ophthalmic preparation |
| 基金项目:国家药品监督管理局化妆品动物替代试验技术重点实验室（国药监科外函[2019]82号）；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：探讨用BioOcularTM 角膜上皮模型EIT法评价眼用制剂包装材料眼刺激性的可行性。方法：在眼用制剂包装材料的浸提液中加入不同浓度的阳性物质，同时进行BioOcularTM 角膜上皮模型EIT试验和Draize试验，比较两种方法所得结果的一致性。 结果：与Draize法比较，BioOcularTM 角膜上皮模型EIT法对含不同浓度阳性物质浸提液的眼刺激性分级与体内试验的一致程度为100%。 结论：BioOcularTM 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 study the possibility of human cornea-like epithelial tissue model BioOcularTM EIT method as an alternative method to evaluate eye irritation potential of containers for the ophthalmic preparation . METHODS Different concentrations of positive control substance were added into the extracts of containers for the ophthalmic preparation, they were tested by BioOcularTM EIT method and Draize test, then compared the consistency of the results obtained by the two methods. RESULTS Compared with Draize test, the correspondence of rank classification of BioOcularTM EIT method for the extracts of containers for the ophthalmic preparation which were added into different concentrations of positive control substance was 100%. CONCLUSION The results suggested that the human cornea-like epithelial tissue model BioOcularTM EIT method could be used in eye irritation evaluation of containers for the ophthalmic preparation. |
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