| 内容提要: |
This report is used to show the whole experiment of assessing the security of Yiqi Fumai Lyophilized Injection which is displayed as following. 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. |