何立成,张劲松,朱社敏,谢珍,匡荣.重组人皮肤模型用于评价药品包装材料原发性皮肤刺激质量标准的建立[J].中国药品标准,2018,19(6):442-447 |
重组人皮肤模型用于评价药品包装材料原发性皮肤刺激质量标准的建立 |
Establishment of primary skin irritation test standards for evaluating pharmaceutical packaging materials by using Reconstructed Human Epidermis Model |
投稿时间:2018-05-10 修订日期:2018-11-30 |
DOI: |
中文关键词: 皮肤刺激 药包材 EpiskinTM 模型 Epikutis®模型 |
英文关键词: skin irritation pharmaceutical packaging materials EpiskinTM model Epikutis® model |
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: |
摘要 目的:建立重组人皮肤模型用于评价药品包装材料原发性皮肤刺激性的标准。方法:用Epikutis?模型和EpiSkinTM模型对药品包装材料进行检测,对浸提介质、浓度、时间以及浸提液与模型的接触时间等条件进行选择,建立可行的标准。结果:取平整部位表面积600cm2,剪碎,加入大豆油100ml,37℃放置24h。使用Epikutis?模型或EpiSkinTM模型,按重组人皮肤模型皮肤刺激检测方法检测,组织活力平均值应大于80%。结论:所建立的标准可用于药品包装材料原发性皮肤刺激检测。 |
英文摘要: |
Abstract Objective:Establish primary skin irritation test standards for evaluating pharmaceutical packaging materials by using reconstructed human epidermis model. Method: Evaluate primary skin irritation of pharmaceutical packaging material by using Epikutis? model and EpiSkinTM model. Select conditions for extraction medium, concentration, time, and contact time between the extract and the model, and establish feasible standards. Result:Take a flat surface area of 600cm2, cut into pieces, add soybean oil 100ml, and place at 37°C for 24h, using Epikutis? model or EpiSkinTM model, the viability average should be higher than 80% as measured by skin irritation test method of reconstructed human epidermis. Conclusion:Established standards can be used in primary skin irritation test of pharmaceutical packaging materials. |
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