重组人皮肤模型用于评价外用液体药用高密度聚乙烯瓶的原发性皮肤刺激性研究

Study on Evaluating Primary Skin Irritation of High-density Polyethylene Bottles for Topical Liquid Preparation Using Reconstructed Human Epidermis Model

关键词:  皮肤刺激  药包材  Episkin^TM模型  Epikutis^®模型

Key words:  skin irritation  pharmaceutical packaging materials  Episkin^TM model  Epikutis^® model

摘要:

目的 探讨重组人皮肤模型用于评价外用液体药用高密度聚乙烯瓶原发性皮肤刺激的可行性。方法 采用Epikutis^®3D表皮模型和EpiSkin^TM重组人皮肤模型对6批外用液体药用高密度聚乙烯瓶的原发性皮肤刺激进行检测，并与家兔法所得的结果进行比较。结果 2种重组人皮肤模型检测结果与家兔法检测结果均为无刺激性，体内外试验的一致率为100%。结论 重组人皮肤模型可用于外用液体药用高密度聚乙烯瓶的原发性皮肤刺激性检测。

Abstract:

OBJECTIVE To explore the feasibility of evaluating primary skin irritation of High-density Polyethylene (HDPE) bottles for topical liquid preparation using reconstructed human epidermis model. METHODS Six batches of HDPE bottles for topical liquid preparation were tested to predict primary skin irritation by Epikutis^® model and EpiSkin^TM model in vitro, the datas were compared with the results of rabbit test. RESULTS The test results suggested that the classification results from rabbit test and reconstructed human epidermis test method were all non-irritation, classification consistency of in vitro and in vivo was 100%. CONCLUSION Reconstructed human epidermis models can be used to evaluate primary skin irritation potential of HDPE bottles for topical liquid preparation.