目的 通过豚鼠离体回肠模型及小鼠类致敏实验评价注射用益气复脉（冻干，YQFM）的安全性。方法 建立豚鼠离体回肠模型，依次考察0.2、0.4、0.6、0.8、1.2、1.4、1.6 mg/mL质量浓度的YQFM对静息离体肠、乙酰胆碱（Ach）及组胺（His）诱导的离体肠收缩的抑制率；雄性ICR小鼠随机分为阴性对照组，阳性对照组（C48/80，25 mg/kg），YQFM低、高剂量（780、3 135 mg/kg，分别为临床等效剂量的0.85和3.43倍）组，分为尾iv含0.4%伊文思蓝（EB）的药液及不含0.4% EB的药液两部分进行体内类致敏反应实验，依次比较各组小鼠耳廓蓝染情况；ELISA法测定血清中His和5-羟色胺（5-HT）的含量；并对耳、肺组织进行HE染色及病理检查。结果 体外实验显示，YQFM既能够抑制离体肠的自主收缩，又能抑制Ach和His导致的离体肠痉挛；体内实验表明，YQFM低剂量组耳廓蓝染率，His、5-HT含量均在正常范围，组织病理检查未见明显异常；3.43倍临床等效剂量时耳廓蓝染率，His、5-HT含量略高，病理结果见轻微炎症反应。结论 YQFM的安全性基本良好，临床使用时需对使用剂量稍加注意，以防轻微不良反应发生。
Objective To evaluate the safety of Yiqi Fumai Lyophilized Injection (YQFM) by using guinea pig isolated ileum model and pseudo-allergic reaction. Methods Isolated guinea pig ileum, resting ileum, acetylcholine (Ach) and histamine (His) load ileum were used as research models. And these models were used to detect different concentrations of YQFM (0.2, 0.4, 0.6, 0.8, 1.0, 1.2, 1.4, and 1.6 mg/mL). Male ICR mice were randomly divided into negative control group, positive control (C48/80, 25 mg/kg) group, and YQFM low and high dose (780 and 3135 mg/kg, 0.85 and 3.43 times of clinical equivalent dose respectively). Mice were divided into two parts like iv injections containing 0.4% Evans blue (EB) and injections without 0.4% EB for pseudo-allergic reaction test. This research evaluated auricular blue dye of mice in each group, the level of His and 5-hydroxytryptamine (5-HT) in serum and used HE staining to do ear and lung tissue pathological examination. Results In vitro experiments showed that YQFM could inhibit not only the voluntary contraction of ileum, but also Ach and His induced guinea pig ileum spasm. In vivo experiments showed the pinna blue dye rate, His, serotonin levels the low dose of YQFM group were in the normal range, and histopathological examination showed no significant abnormalities. Meanwhile, the high dose of YQFM could cause less pseudo-allergic reactions and His, serotonin levels were slightly higher than normal. Pathological findings showed a slight inflammatory reaction. Conclusion It was safety in the normal dose rang of YQFM. However, it was also need pay attention to the safety of using use high dose of it in clinical.