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 the primary skin irritation test method of pharmaceutical packaging materials with reconstructed human epidermis model

作　　者：何立成 张劲松 朱社敏 谢珍 匡荣 HE Licheng;ZHANG Jingsong;ZHU Shemin;XIE Zhen;KUANG Rong(Zhejiang Institute of Food and Drug Control,Hangzhou 310052,China)

机构地区：[1]浙江省食品药品检验研究院,杭州310052

出　　处：《中国药品标准》2018年第6期442-447,共6页Drug Standards of China

基　　金：浙江省药品接触材料质量控制研究重点实验室(2014E10006)

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EpiSkin^(TM)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600 cm^2,剪碎,加入大豆油100 mL,37℃放置24 h。使用Epikutis~?模型或EpiSkin^(TM)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。Objective:To establish the recombinant human epidermis model to evaluate primary skin irritation of pharmaceutical packaging materials.Methods:Epikutis ■model and EpiSkin^TM models were used for primary skin irritation test of pharmaceutical packaging materials,conditions The of extraction medium,concentration,temperature & time,and contact time between extraction medium and model were selected to establish the feasible test method.Results:The packaging material with the flat surface area of 600cm^2was taken and cut into pieces,100 mL of soybean oil was added,then the sample as placed for 24h at 37℃.Epikutis■ or EpiSkinTM model was used,and the average tissue viability should be higher than 80% as measured by skin irritation test method of recombinant human epidermis model.Conclusion:The established method can be used for primary skin irritation test of pharmaceutical packaging materials.

关 键 词：皮肤刺激 药包材 Episkin^TM模型 Epikutis■模型 

分 类 号：R921.2[医药卫生—药学]