目的 通過BN大鼠全身主動(dòng)過敏（ASA）、被動(dòng)皮膚過敏（PCA）和比格犬類過敏模型考察注射用益氣復(fù)脈（凍干）（YQFM）的致敏性。方法 ASA和PCA過敏試驗(yàn)：BN大鼠隨機(jī)分成5組，即陰性對照組、卵白蛋白（陽性藥，2%）組和YQFM低、中、高劑量（230.30、460.60、921.20 mg/kg，460.60 mg/kg為臨床等效劑量）組，每組9只，ip給藥，隔日注射1次，共致敏5次。致敏結(jié)束后隨機(jī)每組取3只用于取血得血清混勻后用于PCA試驗(yàn)；另外6只用于ASA試驗(yàn)的激發(fā)，激發(fā)30 min內(nèi)，觀察BN大鼠的全身過敏反應(yīng)癥狀，評分并記錄；觀察結(jié)束后取血得血清用于IgE、組胺及β-氨基己糖苷酶水平檢測。比格犬類過敏試驗(yàn)：比格犬隨機(jī)分為陰性對照組、吐溫-80（陽性藥，2%）組、YQFM（460.60 mg/kg，臨床等效劑量）組，每組4只。iv給藥1次，分別于給藥前、給藥后30 min取血，檢測血中組胺、IgE、β-氨基己糖苷酶的含量變化；觀察給藥后比格犬的行為學(xué)變化。結(jié)果 ASA試驗(yàn)結(jié)果顯示，除陽性藥組外，其他組別BN大鼠未出現(xiàn)陽性過敏反應(yīng)癥狀；PCA試驗(yàn)結(jié)果顯示，除陽性藥組外，其他各組大鼠均未出現(xiàn)陽性藍(lán)斑；與陰性對照組比較，陽性藥組中的BN大鼠致敏血清IgE、β-氨基己糖苷酶、組胺水平均顯著升高（P<0.05、0.01），YQFM各組無顯著性變化。比格犬類過敏試驗(yàn)結(jié)果顯示，與陰性對照組比較，給藥后吐溫-80組的組胺、β-氨基己糖苷酶顯著升高（P<0.05），IgE未見明顯升高，個(gè)別犬出現(xiàn)流涎、嗜睡等現(xiàn)象；YQFM組別均無明顯變化。結(jié)論 YQFM在ASA、PCA試驗(yàn)中過敏反應(yīng)為陰性，對犬類過敏反應(yīng)也為陰性。

Objective To investigate sensitization of Yiqi Fumai Lyophilized Injection (YQFM) on BN rats systemic active allergy (ASA) passive skin allergy (PCA) and Beagle dogs allergy models. Methods Allergic test of ASA and PCA:BN rats were randomly divided into five groups:negative control group, ovalbumin (positive drug, 2%) group, YQFM low, medium and high dose (230.30, 460.60, 921.20 mg/kg, 460.60 mg/kg as clinical equivalent dose) groups, nine rats in each group, ip administration, injection once every other day, a total of five times. At the end of sensitization, three rats in each group were randomly selected for taking blood, and the serum was mixed for PCA test; the other six rats were used for the stimulation of ASA experiment, and the systemic allergic reaction symptoms of BN rats were observed, scored and recorded within 30 min after stimulation; after the observation, the serum was taken for the detection of IgE, histamine and β-aminohexosidase levels. Beagle dog allergy test:Beagle dogs were randomly divided into negative control group, Tween-80 (positive drug, 2%) group and YQFM (460.60 mg/kg, clinical equivalent dose) group, with four dogs in each group. Blood samples were taken before and 30 min after administration to detect the changes of histamine, IgE and β-aminohexosidase in blood, and the behavioral changes of beagle dogs after administration were observed. Results ASA test showed that BN rats in other groups did not show positive allergic reaction symptoms except the positive drug group; PCA:Rats in other groups did not show positive blue spots except the positive drug group; Compared with the negative control group, the contents of IgE, β-hex and histamine in the sensitized serum of BN rats in the positive drug group were significantly increased (P<0.05 and 0.01), and there was no significant difference between YQFM groups. The results of Beagle allergy test showed that compared with the negative control group, the histamine and β-aminohexosidase of Tween-80 group were significantly increased (P<0.05), IgE was not significantly increased, salivation and drowsiness were observed in some dogs; there was no significant change in YQFM group. Conclusion In ASA and PCA tests, the allergic reaction of YQFM was negative, and the allergic reaction in dogs of YQFM was also negative.

R965.3

天津市科技計(jì)劃項(xiàng)目（18YFCZZC00430）