Analysis Of Adverse Reaction Of Respiratory System Of Experimental Animals Caused By Different Preparation Technologies And Different Doses Of Kudiezi Injection

Objective:Through the experiment of active systemic allergic reaction in guinea pigs and the passive skin allergic reaction in mice to study the relationship between respiratory adverse reaction and preparation process steps and dosage of Kudiezi injection,and the possible mechanism of respiratory adverse reactions induced by Kudiezi injection.Methods:1.Literature search:to search the literatures of ADR of kudiezi injection published in recent ten years,to screen out the specific cases,and to make an untoward effect analysis of the cases.2.Animal experiment:the experiment is divided into guinea pigs active systemic anaphylaxis?ASA?and SPF class C₅₇BL/6 mouse passive cutaneous anaphylaxis?PCA?.Experimental groups:group A,Kudiezi injection without ultrafiltration:carbon filter group,carbon filter 5 times group;group B,Kudiezi injection ultrafiltration group:10 thousand ultrafiltration group,30thousand ultrafiltration group,10 thousandultrafiltration 5 times with the dose group,30 thousand ultrafiltration 5 times with the dose group;group C,Ovalbumin positive control group;group D,Saline negative control group.In ASA,48 guinea pigs were randomly divided into 8 groups with 6 in each group,and half male and half female.The experiment was divided into two stages:sensitization and stimulation.Sensitization phase:each group of guinea pigs were treated with 0.5ml corresponding reagent once every other day by intraperitoneally injected,4 times in total.The excitation phase:14 days later,1ml reagent was given by toe venous injection to each animal.Observe and record the symptoms of guinea pigs 30 min,then take blood from the femoral artery,detecting the levels of IL-23 and IgE in serum.Then the pathological examination of the right lower lung was performed,number of eosinophils.In PCA,mice were divided into two groups:Immune serum preparation group and PCA group.Immune serum preparation group:32 mice were randomly divided into 8 groups with 4 in each group,and half male and half female.Each group of experimental animals were treated with 0.5ml corresponding reagent once every other day by intraperitoneally injected,4 times in total.After 14 days,isolate the serum from eyeball blood.PCA group:80 mice were randomly divided into 8 groups with 10 in each group,and half male and half female,each group of mice by subcutaneous injection of the corresponding serum.24 hours later,incorporation of1%Evans blue chlorogenic acid test solution was given by caudal vein,30min later cut back skin of mice and measure the diameter of the inner blue spot of the injection site.Results:1,A total of 19 articles were included,23 cases were included.The main adverse reaction of kudiezi injection was the systemic damage,followed by the respiratory system and cardiovascular system.Adverse reactions occurred mostly after continuous use and the patients with middle-aged and above 2.ASA results:In the evaluation of allergic reaction and the highest score of respiratory system adverse reactions in guinea pigs,the kudiezi injection without ultrafiltration was significantly higher than that of the ultrafiltration.There were significant differences in the scores of respiratory adverse reactions between the high and low dose groups and the ultrafiltration and the non-ultrafiltration group.The levels of IgE and IL-23 were increased in non-ultrafiltration group,and eosinophils were increased.Eosinophils were increased in high dose group.3.PCA results:The blue color is deeper in the non-ultrafiltration group and high dose groups,and the blue spot diameter of the ultrafiltration group,the high dose group was higher than the corresponding low dose group.Conclusion:1,The adverse reaction caused by kudiezi injection was allergic reaction;2,Ultrafiltration technology can reduce the incidence of allergic reaction caused by Kudiezi injection;3,The use of dosage in accordance with the instructions can reduce the incidence of allergic reaction caused by Kudiezi injection.