首页|几种壳聚糖类产品的致敏试验研究

几种壳聚糖类产品的致敏试验研究

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目的 通过豚鼠最大剂量试验(GPMT)、小鼠局部淋巴结试验(LLNA)、人细胞系激发试验(h-CLAT)探究几种壳聚糖类产品的致敏性.方法 将羧甲基壳聚糖、壳聚糖止血粉、羧甲基壳聚糖愈创膏、羧甲基壳聚糖止血纱作为试验样品,按GB/T 16886.12规定的比例浸提制备受试液,按GB/T 16886.10-2017进行GPMT、LLNA试验,按OECD442(E)进行h-CLAT 试验,对样品进行致敏性检测.结果 羧甲基壳聚糖、壳聚糖止血粉、羧甲基壳聚糖愈创膏、羧甲基壳聚糖止血纱的GPMT、LLNA试验结果均为阴性.h-CLAT试验中,羧甲基壳聚糖、羧甲基壳聚糖愈创膏、羧甲基壳聚糖止血纱的综合判定结果为阴性;壳聚糖止血粉100%、50%、25%浓度受试液CD54的相对荧光强度(RFI)均高于2.00,CD86的RFI均高于1.50,综合判定结果为阳性.结论 采用作为皮肤致敏评价体外替代方法之一的h-CLAT评估壳聚糖止血粉的致敏反应风险有待于进一步研究.
Study on Sensitization Test of Several Chitosan Products
Objective To investigate the allergenicity of several chitosan products by guinea pig maximization test(GPMT),murine local lymph node assay(LLNA)and human cell line activation test(h-CLAT).Methods The test solution of carboxymethyl chitosan,chitosan hemostatic powder,carboxymethyl chitosan wound healing ointment and carboxymethyl chitosan hemostatic gauze was prepared by extraction according to the ratio specified in GB/T 16886.12.The GPMT and LLNA tests were carried out according to GB/T 16886.10-2017,and the h-CLAT test was carried out according to OECD442(E)to test the allergenicity of the samples.Results The results of GPMT and LLNA test of carboxymethyl chitosan,chitosan hemostatic powder,carboxymethyl chitosan wound healing ointment and carboxymethyl chitosan hemostatic gauze were all negative.In h-CLAT test,carboxymethyl chitosan,carboxymethyl chitosan wound healing ointment and carboxymethyl chitosan hemostatic gauze showed negative integrated estimation results.The relative fluorescence intensity(RFI)of CD54 of the 100%,50%,and 25%of test solution of chitosan hemostatic powder were all higher than 2.00,and the RFI of CD86 were higher than 1.50.The integrated estimation result was positive.Conclusion The use of h-CLAT as one of the alternative methods for skin sensitization evaluation in vitro to evaluate the risk of hypersensitive reaction of chitosan hemostatic powder requires further research.

chitosansensitization testguinea pig maximization test(GPMT)murine local lymph node assay(LLNA)human cell line activation test(h-CLAT)

侯丽、王国伟、李非非、王鸾鸾、董传俊

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山东省医疗器械和药品包装检验研究院 国家药品监督管理局生物材料器械安全性评价重点实验室 山东省医疗器械生物学评价重点实验室,山东 济南 250101

壳聚糖 致敏试验 豚鼠最大剂量试验(GPMT) 小鼠局部淋巴结试验(LLNA) 人细胞系激发试验(h-CLAT)

山东省药品监督管理局药品医疗器械化妆品检验检测能力提升项目

SDNMPAFZLX202206

2024

10.3969/j.issn.1672-979X.2024.02.014

食品与药品
山东省生物药物研究院

食品与药品

CSTPCD
影响因子：0.537
ISSN：1672-979X
年,卷(期)：2024.26(2)
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