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1、中药注射剂类过敏反应临床前评价动物品系和性别差异研究［摘要］类过敏反应在首次用药后发生，与过敏反应需要抗原致敏后再次激发2个阶段的致病机制不同。该研究探讨2种中药注射剂诱导不同品系和性别小鼠发生的类过敏反应，为小鼠类过敏反应检测模型在动物品系和性别上的选择提供依据。用ICR,昆明，BALB/C,C57小鼠进行2种中药注射剂的类过敏试验，比较4种小鼠的敏感性，并比较雌雄性动物的差异。各小鼠均一次性静脉注射含有0.8%伊文思蓝(EB)的受试物，以耳廓蓝染发生率和EB渗出量作为类过敏反应评价指标。在ICR和昆明小鼠上，2种中药注射剂通过静脉
2、注射给药均在一定剂量下诱导出类过敏反应，在同种注射剂同剂量下ICR的类过敏反应更明显，说明ICR小鼠更敏感。只有1种注射剂在BALB/C小鼠上呈现出了类过敏反应，且反应程度较ICR和昆明小鼠明显减弱;2种注射剂在C57小鼠上均未诱导出类过敏反应。雌雄动物比较结果显示,1种注射剂雌雄动物未见明显差异，而另一种注射剂雄性动物比雌性动物敏感。因此，进行中药注射剂小鼠类过敏试验,ICR小鼠是较为理想的试验品系，应该作为首选动物;其次可选用昆明小鼠。BALB/C和C57小鼠敏感性较低，不建议用于中药注射剂类过敏试验。中药注射剂对小鼠类过敏反应显
3、示有一定雌雄性别差异，雄性小鼠更为敏感。［关键词］类过敏反应;中药注射剂;品系差异;性别差异;动物模型PreclinicalevaluationofpseudoallergicreactionsonChineseherbalinjections：studyonanimalstrainandgenderdifferenceZHANGYu-shi,YIYan,LIChun-ying,ZHAOYong,WANGLian-mei,HANJia-yin,LUYu-ting,TIANJing-zhuo,FENGXiao-yi,LIGui-qin,
4、LIANGAi-hua*(InstituteofChineseMateriaMedica,ChinaAcademyofChineseMedicalSciences?KeyLaboratoryofBeijingforIdentificationandSafetyEvaluationofChineseMedicine,Beijing100700,China)［AbstractJPseudoallergicreactionsoccuredafterthefirstadministrationofpatients,andthepathogen
5、icmechanismsofthemweredifferentfromtheallergicreactionswhichneededexcitationafterantigensensitization.Toprovideabasisforevaluation,clinicaluseanddrugdevelopmentofpseudoallergicreactions,themodelswereestablishedbytwokindsofChineseherbalinjections(CHI)bothondifferentstrai
6、norgendermice・WiththeuseofICR,Kunming,BALB/C,C57mice,pseudoallergictestsoftwoCHIwereconductedtocomparethesensitivityoffourstrainsmice,andcomparedthedifferencesinmaleandfemaleanimals.Testsubstancescontain0.8%Evansblue(EB)wereintravenouslyinjectedintodifferentstrainandgen
7、dermice・ScoresofearbluestainingandquantitationofearEBexudationweretheparametersforpseudoallergicreaction.ResultsofstraindifferenceindicatedthatbothCHIAandBcouldcauseseverepseudoallergicreactionsindicatedbyobviousvascularhyperpermeabilityonICRmice.Thepseudoallergicreacti
8、onsinICRmicearemoreobviousunderthethesamedoseofinjection,whichstatedthesensibilityofICRmice・AndthereactionsofK
