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聚山梨酯80刺激肥大细胞RBL-2H3脱颗粒作用的评价
引用本文:李佳,金晶,关翠雯,李萍,涂家生,孙会敏,黄芝瑛.聚山梨酯80刺激肥大细胞RBL-2H3脱颗粒作用的评价[J].药物评价研究,2010(5):379-383.
作者姓名:李佳  金晶  关翠雯  李萍  涂家生  孙会敏  黄芝瑛
作者单位:[1]中山大学药学院,广东广州510006 [2]中国药科大学药剂学教研室,江苏南京210009 [3]中国药品生物制品检定所,北京100050
基金项目:科技部“十一五”国家科技支撑计划重点项目——药用新辅料临床前安全性评价及药品与包装材料的相容性安全研究(2008BAI55B03)
摘    要:目的:研究不同类别及厂家的聚山梨酯80直接刺激肥大细胞RBL-2H3脱颗粒的作用,为建立完善的注射用辅料引发类过敏反应的筛选评价体系提供依据。方法:以不同剂量的聚山梨酯80处理RBL-2H3细胞,测定β-氨基己糖苷酶释放量,并通过MTT法进一步研究有脱颗粒作用的受试物对RBL-2H3细胞的毒性作用。结果:8种聚山梨酯80样品具有不同程度的直接刺激RBL-2H3细胞脱颗粒的作用,且呈浓度依赖性,其中上海试剂采购供应站提供的受试物作用极强,威尔制药口服级受试物作用较强,威尔制药A、威尔制药B、威尔制药注射级、威尔制药4个受试物作用相近,2个进口品种的作用略弱。在产生直接刺激RBL-2H3细胞脱颗粒作用的浓度下,上海试剂采购供应站的聚山梨酯80有明显的细胞毒性,并呈浓度依赖性。结论:聚山梨酯80能够直接刺激RBL-2H3细胞脱颗粒,其作用强度不同反映了产品的质量差异;上海试剂采购供应站提供的聚山梨酯80直接刺激RBL-2H3细胞脱颗粒的作用可能由其细胞毒性引起。

关 键 词:聚山梨酯80  类过敏反应  肥大细胞  β-氨基己糖苷酶  MTT

Study of degranulation in mast cell RBL-2H3 induced by Tween 80
LI Jia,JIN Jing,GUAN Cui-wen,LI Ping,TU Jia-sheng,SUN Hui-min,HUANG Zhi-ying.Study of degranulation in mast cell RBL-2H3 induced by Tween 80[J].Drug Evaluation Research,2010(5):379-383.
Authors:LI Jia  JIN Jing  GUAN Cui-wen  LI Ping  TU Jia-sheng  SUN Hui-min  HUANG Zhi-ying
Institution:1 School of Pharmaceutical Science, Sun Yat-sen University, Guangzhou 510006, China; 2 Department of Pharmaceutics, China Pharmaceutical University, Nanjing 210009, China; 3 National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China. )
Abstract:Objective:To study directive effects of multiple kinds of injective excipients on the degranualation in rat mast cell line RBL-2H3 and to provide some indications for establishing a screening and evaluating method for pseudoallergy induced by different Tween 80.Methods:RBL-2H3 cells were cultured and treated with varying dose of Tween 80, and then the amount of releasing β-hexosaminidase was detected.MTT assay was demonstrated to determine the cytotoxicity of injective excipients which causing RBL-2H3 cells degranulation.Results:All of eight different Tween 80 products directly induced RBL-2H3 cells degranulation in a concentration-dependent manner while the degree of this effect was varying (ShanghaiWeier (oral)〉Weier (A)=Weier (B)=Weier (injective)=Weier〉Nof=Croda).Tween 80 (Shanghai) showed cytotoxicity effect in a concentration-dependent manner.Conclusion:Tween 80 can induce RBL-2H3 cells degranulation directly, and the degree of effect is related to the different quality among these products.Cell degranulation induced by Tween 80 (Shanghai) dues to its cytotoxicity.
Keywords:Tween 80  pseudoallergy  mast cells  β-hexosaminidase  MTT
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