中文摘要：

目的：研究清开灵注射液引起的毒性反应。方法：单次给药毒性试验——昆明种小鼠尾静脉注射药液1次,观察14 d内动物的反应。体外溶血试验——对不同清开灵注射液及其成分进行溶血试验。结果：在给药后很短时间内,随药物剂量增加,小鼠出现乏力、抽搐、昏迷甚至死亡的不同反应;高剂量组小鼠,在血常规检测中发现红细胞、白细胞计数以及血红蛋白含量偏低,在病理切片中显示肺部充血明显;用药组与生理盐水对照组比较血清电解质（K＋、Na＋,Ca2＋）含量无显著性差异;清开灵注射液拆方后的金银花、栀子在一定浓度条件下均可引起溶血,其中金银花的溶血作用最明显;不同批号的清开灵注射液在较高浓度下也产生不同程度的溶血作用。清开灵注射液在体外对其致敏Balb/C小鼠和未经致敏Balb/C小鼠的溶血度无显著差异。结论：清开灵注射液在临床上的部分不良反应,可能是药液中金银花和栀子等引起血管内急性溶血而出现的,且溶血作用与过敏性无关。

英文摘要：

Objective：To study the toxic reaction induced by Qingkailing Injection.Methods：Kunming mice were injected single dose of Qingkailing Injection via tail vein and observed for 14 days to test the toxic reaction of the drug.According to Chinese Pharmacopoeia,hemolysis tests were conducted on the injections of different lots and each ingredient of the injection.Results：Toxic reaction induced by single dose of injection——with dose increasing,mice quickly showed different responses such as hypodynamia、convulsion、syncope and even death after injection.In the high dose group,blood routine detection showed that mice have lower counts of RBC,WBC and lower content of hemoglobin;The pulmonary pathological sections of dead mice showed significant hyperemia.And there were no significant difference in the contents of serum electrolyte（K＋,Na＋,Ca2＋） between normal saline control group and Qingkailing injection group.Hemolysis test in vitro——Honeysuckle extraction（significantly）and gardenia extraction which were components of Qingkailing injection caused hemolysis in certain dose;While gardenia、pearl shell and isatis root extraction caused RBC agglutination.With higher concentration,the Qingkailing injections of different lot caused different degree of hemolysis.There was no significant difference in the hemolysis test in vitro between the group of Balb/C mice which were sensitized by Qingkailing injection or not.Conclusion：In clinical practice some adverse reactions induced by Qingkailing injection occurred concomitantly with acute hemolysis within vessels,which might be caused by honeysuckle and gardenia.And the hemolysis was independent of allergy.