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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 sensitization effect of Astragaloside IV to animals through active systemic allergy test (ASA) and passive skin allergy test (PCA) and serum sample titer, and to provide a reference for the safety of clinical use. Methods ASA: Guinea pigs were selected as experimental animals. Astragaloside 0.4 and 1.6 mg / kg were sensitized daily for 5 times and challenged 11 and 3 times after the last sensitization to observe animal allergy symptoms within 30 min. PCA: The rats were used as experimental animals. The antisera were prepared by daily sensitization with 0.5, 2.0 mg / kg astragaloside IV injection for 5 times. The sensitized serum was diluted and sc was given to another group of rats for passive sensitization about 48 hours After 30 min, anesthesia was sacrificed to observe the skin allergic reaction. The antibody titer in the prepared antisera was detected by indirect enzyme-linked immunosorbent assay (ELISA). Results ASA: Astragaloside injection at 0.4,1.6 mg / kg dose did not show any allergic reaction in all guinea pigs, namely, anaphylactic reaction; PCA: Astragaloside injection 0.5,2.0 mg / kg dose rats passive Allergic reactions were negative, serum samples do not exist for the specific antibodies to Astragaloside. Conclusions Astragaloside IV injection has no allergic reaction to ASA and PCA in vivo. There is no specific antibody against astragaloside in animal serum, which suggests that it is less likely that allergic reactions occur in clinical use.