6种不同来源的注射用聚氧乙烯脱水山梨醇单油酸酯致敏性和溶血性实验研究  

Study on anaphylaxis and hemocytolysis of 6 kinds of tween-80 injection from different souce

作　　者：郭琰[1] 李贻奎[2] 吴翠萍[1] 赵宜红[1] 李寅超[1] 刘学武[1] 王乃捷 黄文哲 

机构地区：[1]郑州大学药学院,河南郑州450001 [2]中国中医科学院西苑医院,北京100091 [3]中研同仁堂医药研发有限公司,北京100075 [4]键凯科技有限公司,北京100085

出　　处：《中国中药杂志》2011年第14期1879-1883,共5页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-007)

摘　　要：目的:考察6种不同来源的注射用聚氧乙烯脱水山梨醇单油酸酯(吐温80)的致敏性和体外溶血性。方法:分别以豚鼠和家兔为受试动物,给予6种不同来源的注射用吐温80,观察在豚鼠全身主动过敏试验(ASA)和被动皮肤过敏试验(PCA)中是否有过敏反应;以家兔红细胞为标本,用紫外分光光度法观察该6种注射用吐温80是否有体外溶血作用。结果:6种不同来源的注射用吐温80的ASA试验和PCA试验均呈阴性;3种注射用吐温80在观察的时间内溶血率超过5%,其余3种注射用吐温80的部分高浓度试管在观察的时间内溶血率亦超过5%。结论:本实验的条件下,6种不同来源的注射用吐温80不引起免疫介导的过敏反应,但存在不同程度的溶血性。吐温80的溶血性可能并不完全是由杂质所引起,产品本身的理化特性和使用浓度失当与溶血性的产生是否也存在着某种内在联系,值得进一步探究。Objective： To observe the anaphylaxis and hemocytolysis of 6 kinds of tween-80 injection from different source. Method： The Hartley albinism guinea pig was used to carry on the active systematic anaphylaxis（ASA） and the passive cutaneous anaphylaxis（PCA）. The in vitro hemolytic experiment and the hemocytolysis was observed by means of spectrophotometry on the domestic rabbit. Result： The result of ASA and PLA of 6 kinds of tween-80 injection from different source assumed the negative. In observation time, the temolysis rate of 3 kinds of tween-80 injection are more than 5%, while the others are also more than 5% only in the highly concentrated test tube. Conclusion： Six kinds of tween-80 injection from different source have not caused the immune-mediated anaphylaxis, but it may have hematolysis tendency on intravenous injection. The hemocytolysis of tween-80 may not be entirely caused by the impurities. It is worthy of further study that the physical and chemical properties of the product itself and the undeserved concentration is doubtful whether there is also some internal relations with the generation of hemolytic.

关 键 词：聚氧乙烯脱水山梨醇单油酸酯(吐温80) 全身主动过敏 被动皮肤过敏 溶血性 

分 类 号：R285.5[医药卫生—中药学]