目的 對小鼠耳廓藍染類過敏檢測法進行方法學的驗證和優(yōu)化，建立注射用益氣復脈（凍干，YQFM）質控方法。方法 小鼠1次性尾iv含0.4%依文思藍（EB）的受試物，以耳廓藍染發(fā)生率和EB滲出量作為類過敏評價指標，以Compound 48/80為陽性對照，考察了方法的重復性、鼠耳萃取時間等影響因素，并對20140105和20140804兩個批次YQFM（1 800 mg/kg）進行了耳廓藍染類過敏試驗。結果 Compound 48/80具有明顯的致類過敏反應，模型穩(wěn)定，重復性好；鼠耳在加入甲酰胺后室溫下浸泡2～5 d進行萃取，EB含量未發(fā)生顯著變化；YQFM 20140105和20140804兩個批次均未發(fā)生類過敏反應。結論 小鼠耳廓藍染類過敏檢測方法較穩(wěn)定，可用于YQFM質量控制。

Objective To develop and validate the detection method of mouse ear blue staining pseudo-allergic reactions, and establish the method of quality control for Yiqi Fumai lyophilized injection (YQFM). Method Mouse anaphylactoid reaction model was developed by tail iv injection of test substance solutions containing Evans blue (EB). Scores of ear blue staining and quantitation of ear EB exudation were the parameters for the pseudo-allergy reaction. The repeatability of the method and the extraction time of the mouse ear were investigated with Compound 48/80 as the positive control. The auricle blue anaphylactoid tests were applied to investigate two batches of YQFM (1800 mg/kg), which are 20140105 and 20140804. Results Compound 48/80 caused severe ear bluing and EB exudation by inducing obvious vascular hyperperme ability, which indicated that they can induce mouse pseudo-allergy. The model of mouse pseudo-allergy induced by YQFM was stable and repeatable. Ears can be soaked for 2~5 days in formamide, and the content of ear EB of mouse had no significant change. Moreover, no anaphylaxis was found in YQFM 20140105 and 20140804 batches. Conclusion The detection method of mouse ear blue staining pseudo-allergic reactions is stable and can be used for the quality control of YQFM.

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）