首页|体内外组合法在复配防腐剂致敏性评价中的应用

体内外组合法在复配防腐剂致敏性评价中的应用

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采用直接多肽反应试验(DPRA)、氨基酸衍生化反应试验(APRA)和局部封闭斑贴试验(BT)对多组分复配防腐剂致敏性进行评价.DPRA法测得对羟基苯甲酸丙酯+甲基异噻唑啉酮组合和咪唑烷基脲+甲基异噻唑啉酮组合多肽消耗率分别为 56.25%、62.35%,预测结果均为强阳性,对羟基苯甲酸丙酯+咪唑烷基脲组合多肽消耗率为32.55%,预测结果为弱阳性,与APRA法、BT法结果相一致.DPRA法和APRA法可用于非致敏加弱致敏、非致敏加强致敏、弱致敏加强致敏 3 类组合致敏性评价.复配防腐剂中强致敏组分是多肽和氨基酸衍生物消耗主要决定性因素.体内外组合法可有效用于复配防腐剂致敏性的初步评价.
Application of in vitro and in vivo Combinatorial Methods in Sensitization Evaluation of Compound Preservatives
Evaluation of sensitization of multicomponent compound preservatives by direct peptide reaction assay(DPRA),amino acid derivatization reaction assay(APRA)and local closure patch test(BT).The DPRA method measured 56.25%and 62.35%peptide depletion for propylparaben+methylisothiazolinone and imidazolidinylurea+methylisothiazolinone combinations,respectively,with strong positive predictions,and 32.55%peptide depletion for propylparaben+imidazolidinylurea combination,which predicted weak positive results,which was consistent with the results of APRA and BT methods.The DPRA method and the APRA method could be effectively used for the 3 types of combinations,namely,non-sensitizing plus weakly sensitizing,non-sensitizing plus strongly sensitizing,and weakly sensitizing plus strongly sensitizing sensitization evaluation;the strong sensitizer component in multicomponent complex preservatives is the main determinant of the depletion of peptide and amino acid derivatives.The in vitro and in vivo combination method can be effectively used for the preliminary evaluation of the sensitization of multicomponent compound preservatives.

direct peptide reaction assayamino acid derivatization reaction assaymulticomponentcompound preservativesstrong sensitizer component

李伟、沈于兰、刘晓瑜

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无锡市药品安全检验检测中心,江苏 无锡 214000

直接多肽反应试验 氨基酸衍生化反应试验 多组分 复配防腐剂 强致敏组分

2024

香料香精化妆品
上海香料研究所

香料香精化妆品

CSTPCD
影响因子:0.341
ISSN:1000-4475
年,卷(期):2024.(6)