目的 通過小鼠類過敏實驗，對注射用益氣復脈（凍干）（YQFM）與9種臨床常用藥物配伍的類過敏安全性進行評估。方法 ①小鼠耳廓藍染類過敏實驗，尾iv含有0.4%伊文思藍（EB）的受試物：陽性對照組給予Compound 48/80-0.4%伊文思藍（EB）的生理鹽水溶液，陰性對照組給予0.4% EB生理鹽水溶液，單獨藥物組給予“藥物-0.4% EB的生理鹽水溶液”（包括注射用輔酶A、注射用環(huán)磷酰胺、維生素C、維生素B6、奧扎格雷注射液、氨茶堿注射液、呋塞米注射液、注射用鹽酸納洛酮、注射用泮托拉唑鈉9種藥物），配伍藥物組給予用“藥物-0.4% EB的生理鹽水溶液”配制的YQFM。對小鼠耳廓藍染面積進行評估，并測定小鼠耳廓EB滲出量。②小鼠血液組胺檢測實驗，除0.4% EB生理鹽水溶液均換做生理鹽水外，分組給藥方法與耳廓藍染實驗均相同。給藥30 min后取血，化學法測定小鼠血液組胺釋放率。結果 ①陽性對照、單獨給藥的維生素B6、注射用輔酶A、注射用鹽酸納洛酮、呋塞米注射液，配伍給藥的維生素B6、注射用鹽酸納洛酮、呋塞米注射液小鼠耳廓藍染類過敏實驗結果為陽性；其他結果均為陰性；且9種藥物配伍給藥的EB含量升高率較單獨給藥有下降的趨勢；②小鼠血液中的組胺的釋放在配伍前后也無明顯變化。結論 YQFM與9種臨床常用藥物配伍給藥組分別與單獨給藥組比較，小鼠耳廓藍染類過敏考察指標和組胺檢測指標無增加類過敏發(fā)生的風險。

Objective To evaluate the pseudo-allergic safety of Yiqi Fumai Lyophilized Injection (YQFM) in combination with nine common injections by pseudo-allergic test in mouse. Methods ① The mouse pseudo-allergic reaction model was developed by injecting test substance in 0.4% Evans blue (EB) solutions via tail vein. The positive control group was given Compound 48/80- 0.4% EB saline solution, the negative control group was given 0.4% EB saline solution, and the drug compatibility group was given "drug-0.4% EB" saline solution. According to the standard of mice ear blue staining test, the scores of ear blue staining was evaluated, and the EB exudation of mice ear was measured. ② In the concentration test of histamine in mice, except that 0.4% EB saline solution was replaced by saline solution, the administration method was the same as that of mice with ear blue staining test. Blood was collected after 30 min, and the histamine content in blood of mice was determined by chemical method. The histamine content in blood of mice was determined by a similar method. Result ① Positive drug, vitamin B6, coenzyme A for injection, naloxone hydrochloride for injection, and furosemide injection in single dose groups, and vitamin B6, furosemide injection and naloxone hydrochloride for injection administered in combination with YQFM showed positive results in ear blue staining test in mice; the other results were negative. Moreover, the increase rate of EB content in nine drug compatibility group was lower than that in the single administration. ② There was no significant change in histamine content in the blood of mice before and after compatibility.Conclusion Comparing nine kinds of commonly used drugs in combination group with single group respectively, there was no increase in the risk of pseudo-allergic reaction in mice with mice ear blue staining test and histamine detection.

天津市中藥注射劑關鍵技術校企協(xié)同創(chuàng)新實驗室建設項目（17PTSYJC00090）