1、 , 6.6 , , , , , , 6.6 , , , , , ( ) ( ) , 3 ; ; ; ; , , , E-mail: , , , E-mail: (2014ZX09201022-004, 2014ZX09201022-005-001, 2015ZX09501004) Preclinical study on adverse reactions of Xingnaojing injection YI Yan LI Chun-ying ZHAO Yong PAN Chen LIU Su-yan WANG Lian-mei ZHANG Yu-shi HAN Jia-yin TIAN
2、Jing-zhuo LIANG Ai-hua Key Laboratory of Beijing for Identification and Safety of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences; Abstract In this study, different batches of Xingnaojing injection products were first selected for pseudoallergic mice
3、test, and the results showed that after injection of 6.6-fold clinical dose Xingnaojing injection, the mice showed a slight pseudoallergic reaction, while other mice injected with other batches of injections showed no obvious pseudoallergic reaction. Therefore, it is preliminarily believed that this
4、 mice model can effectively indicate the risk of pseudoallergic reactions in the clinical application of Xingnaojing injections. In addition, by changing some of the processes, a high concentration of Xingnaojing injection was prepared for mice pseudoallergic test and guinea pig systemic allergy tes
5、t. The results showed no significant type I allergic reaction in guinea pigs. Mild pseudoallergic reactions occurred in mice after a 6.6-fold clinical dose injection. Therefore, it is considered that for sensitive or idiosyncratic people, the concentration of certain chemical components in Xingnaoji
6、ng injection will increase after entering the body, which may increase the risk of pseudoallergic reaction. However, due to the limitations test models, the risk of Xingnaojing injection to induce allergic reactions cannot be ruled out. Finally, by increasing the content of Borneol and Tween and (so
7、dium chloride in Xingnnaojing Injection and testing its pseudoallergic reactions, the results showed that the combination of these three ingredients may produ new trace sensitization substance and induce pseudoallergic reactions. Keyword Xingnaojing injection; allergic reactions; pseudoallergic reac
8、tions; pseudoallergenic substances; (Xingnaojing injection, XNJ) 4 , , , , , , , , , 1-7 , , / (ADR/ADE) 30 min , , 20%8-11, , , , , 1 ( 160119, 160309, 160509, 151221, 160109, 161112) , 161112 (Evans blue, EB) ( 20150729, ) ; ( B15030510, ) ; ( 20150723, ) ; ( 20141119, ) ; (Sigma ) Hartley , 35040
9、0 g, ICR , 2325 g, , SCXK ( ) 2012-0001 1 , 2 d, 40%70%, 12 h , 2 2.1 (active anaphylaxis test, ASA) 2.1.1 , 70 kg 20 m L, 1020 m L 250500 m L ) , (20/70) , , 1/2 , 0.8 (1.25/1.6) 1.6 (2.5/1.6) 2.1.2 CFDA 12, 1, 3, 5 , , 0.5 mg/ (OVA) , 2.1.1 14 d 21 d, 1 2 , , 30 min, 1 , 1 Table 1All kinds of alle
10、rgic symptoms and systemic sensitization evaluation criteria 2.1.3 12 ASA , 1 , , , 2.2 2.2.1 2.1.1 , 3 , 6.6 (20/3) 2.2.2 13-14, ( 1.6% (EB) 30 min, , , , 2 , , , 48 h, ( 610 nm) , (EB) , , EB 2 Table 2 Score and judgment of outcome of pseudoallergic reaction 2 Table 2 Score and judgment of outcome
11、 of pseudoallergic reaction 2.3 , , ; , , , EB , ANOVA , SPSS 16.0 3 3.1 5 ; 6.6 , , , 3 161112 , , 6.6 , 50% , EB , 4 3 results of mice pseudoallergic reaction caused by different batches of 4 n=6) 3.2 , , , ( : , , , 15 , , , ) , , 5 , 3.1 , 2.9 , ( ) 4 5 Table 5 Xingnaojing injection liquid phase
12、 contrast of the content of each component 5 Table 5 Xingnaojing injection liquid phase contrast of the content of each component , 3.3 33.3% ( ) , 6.6 , 33.3% , EB , 152.3%, 6 , , , , 6 results of mice pseudoallergic reactions caused by high concentration 3.3 , , , , , , , , 7 7 (n=6) Table7 The po
13、sitive rate of active anaphylaxis test in guinea pigs (n=6) 3.4 ( ) 4 , 0.8% ( -80) 0.8% 2 , , , , A B A 10 , ; B 5 , , A 50% (P0.01) , EB , A 50% , 8 A 33 , B (33.3% ) , , 50% (P0.01) , , B 5.5 11 11) , A B A , , , 8 The results of mice pseudoallergic reactions caused by Xingnaojing injection which contained a high concentration of born n=6) 8 The results of mice pseudoallergic reactions caused by Xingnaojing n=6) 3.5 80 -80 , 3 5% 1% -80 , , 5% 1% -80 , 4 4.1 , , , , , 5 , 6.6 , , 6.6 , , , , , , , , 4.2 , , , , , : (1) ; (2) , , 3.3
