Studies On Detecting Anaphylaxis Induced By Gegensu And Qingkailing Injection And Screening Of Potential Anaphylactogens

Traditional Chinese Medicine Injection (TCMI), the new style of preparation originally invented in our states, have been widely used in regular and emergency treatments of infection and cardiovascular diseases, etc. However, its adverse drug reaction (ADR), especially the appearance of anaphylactic shock, has limited its use in clinic. As the representatives of TCMI, Gegensu Injection (GGSI) and Qingkailing Injection (QKLI) also have been proved to cause severe anaphylaxis in clinic, and both of which have been notified in national ADR communications.Currently, Passive Cutaneous Anaphylaxis (PCA) and Active Systemic Anaphylaxis (ASA) tests in nonclinical animals are recommended in detecting type I anaphylaxis induced by TCMI, but neither of them is reliable in accuracy and sensitivity, there is a discordance lieing between nonclinic tests and clinic diagnoses.In our previous study, modified BN rats PCA have been established, and this model would be applied to detect the anaphylaxis induced by GGSI and QKLI, so as to screen the potential anaphylactogens. Meanwhile, the method used in contraction test of guinea pig ileum would be introduced into guinea pig ASA test, which would bring a new strategy for detecting anaphylaxis induced by TCMI.1. BN rats PCA tests for GGSI and QKLIAim:BN rats PCA would used to test the anaphylaxis induced by GGSI and QKLI in3levels, so as to screen the potential anaphylactogens. Methods:BN rats would be sensitized to harvest antiserum, which then would be transferred into normal BN rats, and these transferred animals would be challenged so as to determine the anaphylaxis according to the degree of dyeing. Results:Puerarin-protein conjugations and protein extracted from Honeysuckle Flower showed positive results. Conclusion: Conjugated antigen formed by puerarin and particular protein might cause the anaphylaxis of GGSI, while the potential anaphylactogen in QKLI might be the remaining protein extracted from Honeysuckle Flower.2. Guinea pig ileum model tests for GGSI and QKLIAim:Guinea pig ileum model would be established to detect the anaphylaxis of GGSI and QKLI. Methods:Hartley guinea pigs would be sensitized according to the demands of ASA, and ileums would be prepared for challenge at particular time points. After challenged by drugs with previously selected concentration, the degree of anaphylaxis would be indicated by the alteration of ileum tension. Results:GGSI and QKLI showed negative results. Conclusion:The model of guinea pig ileum is successful in detecting anaphylaxis induced by OVA, and along with guinea pig ASA, it would bring a new strategy for detecting anaphylaxis induced by TCMI; Both GGSI and QKLI showed negative results in this test.