Method for detecting induced anaphylactoid reaction of medicines and application thereof
A detection method and anaphylaxis technology, which is applied in the field of detection of drug anaphylaxis, can solve the problems of affecting the detection sensitivity of anaphylaxis and interfering with the detection of anaphylaxis biomarkers, and achieves objective detection indicators, low interference, and The effect of the simplicity of the test method
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Embodiment 1
[0052] Example 1 Detection Principle and Correlation Between Systemic Symptoms and Blood Biomarker Levels
[0053] 1. Experimental materials
[0054] 1.1 Experimental animals
[0055] ICR mice, clean grade, male and female, 18-22g, purchased from Shanghai Xipuer-Bikay Experimental Animal Co., Ltd., certificate number: SCXK (Shanghai) 2008-0016, the above-mentioned animals are all in the Experimental Animal Center of Shanghai University of Traditional Chinese Medicine Raised in SPF breeding room, free to drink water and ingest food during the experiment, and the indoor temperature was 20-22°C.
[0056] 1.2 Test substance
[0057] C48 / 80 (product of Sigma Company, batch number: 039K4023); Tween80 (V / V) (product of Sigma Company, batch number: BCBF4913V).
[0058] 1.3 Main reagents
[0059] Histamine ELISA kit (Demeditec product, batch number: 11411); IgE ELISA kit (ICL product, batch number: E-90E11Q1); β-hexosaminidase (Sigma company product, batch number: N9376); trypsin (...
Embodiment 2
[0160] Comparison of Example 2 and Mouse Ear Vascular Permeability Test Model in Detecting Anaphylaxis Sensitivity
[0161] 1. Experimental materials
[0162] 1.1 Experimental animals
[0163] ICR mice, clean grade, male and female, 18-22g, purchased from Shanghai Sipro-Bikay Experimental Animal Co., Ltd., certificate number: SCXK (Shanghai) 2008-0016, the above-mentioned animals are all in the Experimental Animal Center of Shanghai University of Traditional Chinese Medicine Raised in SPF breeding room, free to drink water and ingest food during the experiment, and the indoor temperature was 20-22°C.
[0164] 1.21.2 Test substances, main reagents and preparation methods
[0165] The source, batch number and preparation method of C48 / 80 and Tween80, the source and batch number of the histamine ELISA kit are the same as those under item 1.2 in Example 1.
[0166] 1.3 Main instruments
[0167] Same as item 1.3 of the experimental material part in Example 1.
[0168] 2. Exper...
Embodiment 1
[0184] Comparative Example 1 Table 10, the ratio of anaphylaxis-like symptoms and blood biomarker levels observed by the test method of the present invention to the selected auricle blue stain rate, blue stain area score and auricle Yin Indicators such as the amount of exudation of Vance blue are more sensitive and have higher sensitivity. Comparing the two, the test method of the present invention is 17 times and 2 times more sensitive to the allergy-positive drugs C48 / 80 and Tween80 than the mouse ear blood vessel permeability test method. Even in the mouse ear vascular permeability test method, the blood histamine detection in the test method of the present invention is also adopted, and the sensitivity of the test method of the present invention to C48 / 80 is also 8 times higher than that of the mouse ear vascular permeability test method.
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