目的 通過BN大鼠全身主動過敏實驗考察注射用丹參多酚酸的過敏反應癥狀，檢測致敏后BN大鼠血清中的IgE、組胺及β-氨基己糖苷酶含量，考察注射用丹參多酚酸是否產生速發(fā)型過敏反應。方法 以卵白蛋白為陽性藥物、生理鹽水為對照，注射用丹參多酚酸分為低、中、高（13.43、26.86、134.30 mg/kg）3個劑量組分別直接對BN大鼠進行致敏和激發(fā)，觀察過敏反應癥狀；酶聯(lián)免疫吸附法（ELISA）法檢測致敏后動物血清中的IgE、β-氨基己糖苷酶及組胺的含量變化；激發(fā)后的BN大鼠立即處死，取肺組織進行HE染色。結果 BN大鼠全身主動過敏實驗中僅卵白蛋白組有明顯過敏反應；與對照組比較，BN大鼠致敏血清IgE水平僅卵白蛋白組顯著升高（P<0.05），組胺檢測各組間均無顯著性差異，注射用丹參多酚酸中、高劑量組β-氨基己糖苷酶釋放量顯著降低（P<0.05）；BN大鼠激發(fā)后，肺部組織病理結果僅陽性藥組肺泡壁凝固性壞死，肺間質有大量炎癥因子浸潤。結論 注射用丹參多酚酸未產生由IgE介導的I型過敏反應。

Objective Investigating the allergic reaction of Salvianolic Acids for Injection (SAFI) by active systemic anaphylaxis in BN rats. detecting the content of IgE, histamine and β-hexosaminidase in the serum of BN rats after sensitization for investigating whether the allergic reaction is immediate hypersensitivity. Methods ovalbumin (OVA) was used as positive drug group, strokephysiological saline solution was used as negative control group, and injection dose of SAFI was divided into low, medium and high (13.43, 26.86, 134.30 mg/kg) groups to sensitize and stimulate BN rats directly, then observing the symptoms of allergic reaction. Enzyme linked immunosorbent assay (ELISA) was used to detect the content of IgE, β-hexosaminidase and histamine in serum of sensitized animals. After stimulation, BN rats were immediately sacrificed to obtain lung tissue for pathological study. Results BN rats had no significant difference between drug groups and negative control group in allergic reaction except positive group. In the sensitized serum of BN rats, The result of Enzyme linked immunosorbent assay show that IgE content of positive has significant difference from the rest of the groups. And there was no significant difference among all test groups in detecting the content of histamine. The release content of β -hexosaminidase test in the medium dose group and the high dose group was significantly different with other groups. And the concentration of SAFI was negatively correlated with the release content of β-hexosaminidase. The results of Hematoxylin-Eosin show that the positive group had coagulation necnosis of alveolar wall and extensive inflammatory factor infiltration in the lung stroma, while all the other groups were normal. Conclusion The results indicated the SAFI may not cause anaphylaxis reaction in BN rats modle, long-term administration of the drug will not cause increasing (IgE, histamine and β-hexosaminidase) indexes in vivo.

R965.3

天津市科技重大專項與工程（18ZXXYSY00120）