目的 采用主動全身過敏試驗（ASA）和被動皮膚過敏試驗（PCA）以及血清樣本效價測定，綜合評價黃芪甲苷注射液對動物的致敏作用，為臨床擬用的安全性提供參考。方法 ASA：選用豚鼠作為實驗動物，0.4、1.6 mg/kg黃芪甲苷注射液間日致敏5次，末次致敏后11 d，3倍劑量進行激發(fā)，觀察30 min內(nèi)動物過敏癥狀；PCA：選用大鼠作為實驗動物，0.5、2.0 mg/kg黃芪甲苷注射液間日致敏5次，制備抗血清；將致敏血清稀釋后sc給予另一批大鼠進行被動致敏，約48 h后激發(fā)，30 min后麻醉處死，觀察皮膚過敏反應(yīng)；間接酶聯(lián)免疫吸附測定法（ELISA）檢測制備的抗血清中的抗體效價。結(jié)果 ASA：黃芪甲苷注射液在0.4、1.6 mg/kg劑量下各只豚鼠均未出現(xiàn)任何過敏反應(yīng)，即過敏反應(yīng)陰性；PCA：黃芪甲苷注射液0.5、2.0 mg/kg劑量下大鼠被動過敏反應(yīng)均為陰性，血清樣本中不存在針對黃芪甲苷的特異性抗體。結(jié)論 黃芪甲苷注射液體內(nèi)ASA和PCA試驗均無過敏反應(yīng)，動物血清中不存在針對黃芪甲苷藥物的特異性抗體，提示臨床使用出現(xiàn)過敏反應(yīng)的可能性較小。

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.