注射用灯盏花素致豚鼠主动全身过敏反应的研究  

Active systemic allergic reaction induced by breviscapine injection in guinea pigs

作　　者：周莉[1] 骆永伟[2] 王永[1] 姜娟[1] 贾玉玲[1] 桂博[1] 崇立明[1] 孙祖越[1] 

机构地区：[1]上海市计划生育科学研究所/中国生育调节药物毒理检测中心,200032 [2]复旦大学药学院

出　　处：《药物不良反应杂志》2015年第3期204-208,共5页Adverse Drug Reactions Journal

基　　金：国家科技重大专项（2011ZX09301-005）;上海市实验动物创新行动计划（14140901302）

摘　　要：目的：探讨注射用灯盏花素（灯盏花素）诱导的主动全身过敏反应与药物剂量及致敏时间的关系。方法实验方法采用豚鼠主动全身过敏试验。将48只普通级豚鼠按随机数字表法分为6组：灯盏花素1、5、25和50 mg/kg组（灯盏花素1、2、3、4组），0.9%氯化钠注射液组（阴性对照组），牛血清白蛋白（ BSA）组（阳性对照组），每组8只。致敏：灯盏花素1~4组豚鼠分别腹腔注射灯盏花素1、5、25、50 mg/kg（0.5 ml），阴性和阳性对照组豚鼠分别腹腔注射等容积0.9%氯化钠注射液和BSA 20 mg/kg，均为隔日1次，共3次。激发：已致敏各组豚鼠分别再分为2个亚组，每组4只。在末次致敏后第14、21天，灯盏花素1~4组的各亚组豚鼠分别静脉注射2倍致敏剂量灯盏花素（1.0 ml）；阴性和阳性对照组的各亚组豚鼠分别静脉注射2倍剂量阴性、阳性对照品。致敏阶段每日观察各组豚鼠是否出现过敏反应症状（竖毛、发抖、搔鼻、喷嚏、咳嗽、干呕、紫绀、呼吸困难、二便失禁、步态不稳或倒地、痉挛或抽搐、休克、死亡）；激发后详细观察静脉给药后即刻至30 min内豚鼠的反应，记录过敏反应症状出现的时间，并按中国药典“过敏反应检查法”判定是否出现过敏反应。结果致敏阶段6组豚鼠均未出现过敏反应症状。第14天激发后30 min内，灯盏花素1~4组各4只豚鼠中分别有2、4、4、4只出现过敏症状，但无一只判定为发生过敏反应；阳性对照组4只豚鼠均判定为过敏反应阳性。第21天激发后30 min内，灯盏花素1~4组各4只豚鼠中分别有4、3、4、4只出现过敏症状，其中灯盏花素4组有1只豚鼠判定发生过敏反应；阳性对照组4只豚鼠均判定为过敏反应阳性。2次激发阴性对照组均无豚鼠出现过敏症状。灯盏花素组豚鼠第21天激发后出现过敏反应症状的时间（出现在激发后20 min内）短于第14�Objective To explore the relationships between active systemic allergic reaction induced by breviscapine injection and the drug dose and the sensitization time. Methods Active systemic allergic reaction in guinea pigs was used as experimental method. Forty-eight guinea pigs were divided into 6 groups according to random number table：breviscapine injection 1,5,25 and 50 mg/kg group（ the breviscapine injection group 1,2,3,4）,0. 9% sodium chloride injection group（ the negative control group）and bovine serum albumin（ BSA）control group（ the positive control group）. Each group comprised 8 guinea pigs. Sensitization：the guinea pigs in group 1 to 4 were given the breviscapine injection at doses of 1,5,25 and 50 mg/kg（0. 5 ml）by intraperitoneal injection every other day for three times,respectively. The the guinea pigs in the negative control group and the positive control group were given 0. 9% sodium chloride injection（0. 5 ml）and bovine serum albumin（ BSA）20 mg/kg by intraperitoneal injection every Excitation：the sensitized guinea pigs in each group were divided into 2 subgroups,each subgroup comprised 4 guinea pigs. On the 14 and 21 days after the last sensitization,the guinea pigs in breviscapine 1 to 4 subgroups received 2 times of breviscapine injection intravenously（1. 0 ml）,respectively. The guinea pigs in the negative and the positive control subgroups received 2 times of control articles intravenously,respectively. The symptoms of anaphylactic reaction（ pilo-erection,shiver, scratching nose,sneeze,cough,vomiturition,cyanosis,dyspnea,urinary and fecal incontinence,instability of gait or tumble,convulsion or hyperspasmia,shock and death ） were observed every day during the sensitization phase. The guinea pigs′ reactions which appeared in 30 min after intravenous injections were observed and the occurrence time of allergic symptoms/signs were recorded attentively. The anaphylactic reaction was determined according to the Chinese Pharmacopoeia′s allergic reaction test.

关 键 词：灯盏花素 过敏反应 剂量效应关系 药物 反应时间 

分 类 号：R286.0[医药卫生—中药学]