黄芪甲苷注射液动物过敏性研究  

Study on allergy of Astragaloside injection

作　　者：荆宝琴[1] 张金晓[1] 康玮 王磊[1] 熊思敏[2] 申秀萍[1] 

机构地区：[1]天津药物研究院新药评价有限公司,天津300301 [2]安徽医科大学药学院,安徽合肥230032

出　　处：《药物评价研究》2017年第8期1086-1089,1097,共5页Drug Evaluation Research

摘　　要：目的采用主动全身过敏试验(ASA)和被动皮肤过敏试验(PCA)以及血清样本效价测定,综合评价黄芪甲苷注射液对动物的致敏作用,为临床拟用的安全性提供参考。方法 ASA:选用豚鼠作为实验动物,0.4、1.6 mg/kg黄芪甲苷注射液间日致敏5次,末次致敏后11 d,3倍剂量进行激发,观察30 min内动物过敏症状;PCA:选用大鼠作为实验动物,0.5、2.0 mg/kg黄芪甲苷注射液间日致敏5次,制备抗血清;将致敏血清稀释后sc给予另一批大鼠进行被动致敏,约48 h后激发,30 min后麻醉处死,观察皮肤过敏反应;间接酶联免疫吸附测定法(ELISA)检测制备的抗血清中的抗体效价。结果ASA:黄芪甲苷注射液在0.4、1.6 mg/kg剂量下各只豚鼠均未出现任何过敏反应,即过敏反应阴性;PCA:黄芪甲苷注射液0.5、2.0 mg/kg剂量下大鼠被动过敏反应均为阴性,血清样本中不存在针对黄芪甲苷的特异性抗体。结论黄芪甲苷注射液体内ASA和PCA试验均无过敏反应,动物血清中不存在针对黄芪甲苷药物的特异性抗体,提示临床使用出现过敏反应的可能性较小。Objective To evaluate the hypersusceptibility of Astragaloside injection on animal, and provide reference for clinical use with active systemic anaphylaxis （ASA）, passive cutaneous anaphylaxis （PCA） and determination of serum sample titer. Methods ASA： Guinea pigs was ip with 0.4, 1.6 mg/kg Astragaloside injection five times every other day. On the eleventh day after the last administration, the test substance was quickly injected to fore limb vein, and animal allergy symptoms were observed within 30 min. PCA： Astragaloside injection was ip injected to rats five times every other day and antiserum was collected. The antiserum was appropriately diluted, and sc injected to another group rats for passive sensitization. About 48 hours later, Astragaloside was quickly iv to rats, and the skin allergy was observed. Meanwhile, the antibody titer of the antiserum was determined. Results ASA： Astragaloside injection of 0.4, 1.6 mg/kg in guinea pigs did not show any allergic reaction, that is, ASA was negative; PCA： Astragaloside injection of 0.5, 2.0 mg/kg in rats did not show any allergic reaction, and Astragaloside specific antibodies were not determined in serum samples. That is, PCA was negative. Conclusion The results of ASA and PCA were negative in the experimental dose, and there was no specific antibody against Astragaloside in the serum prepared by PCA, which indicated that the possibility of hypersensitivity reaction was weak in clinical use.

关 键 词：黄芪甲苷注射液 主动全身过敏试验(ASA) 被动皮肤过敏试验(PCA) 

分 类 号：R994.2[医药卫生—毒理学]