热毒宁注射液及其降解产物的安全性研究  

Safety of Reduning Injection and their degradation products

作　　者：邱喜龙[1] 任晓亮[1] 张慧杰[1] 萧伟[2,3] 戚爱棣[1] 

机构地区：[1]天津中医药大学中药学院,天津300193 [2]江苏康缘药业股份有限公司,江苏连云港222001 [3]中药制药过程新技术国家重点实验室(筹),江苏连云港222001

出　　处：《中成药》2013年第10期2108-2112,共5页Chinese Traditional Patent Medicine

基　　金：国家自然科学基金青年基金项目(81102732);高等学校博士学科点专项科研基金项目(20111210120006);中药制药过程新技术国家重点实验室开放基金课题(SKL2010Z0401)

摘　　要：目的评价热毒宁注射液(金银花、栀子及青蒿)及其降解产物的过敏性和溶血反应。方法选用豚鼠、大鼠和新西兰兔静脉注射热毒宁注射液及其降解产物后观察豚鼠主动全身过敏反应、大鼠被动皮肤过敏反应和新西兰兔溶血反应的影响。结果在实验剂量下,热毒宁注射液及其降解产物对豚鼠的主动全身过敏反应、大鼠的皮肤过敏反应及溶血试验均为阴性。结论热毒宁注射液及其降解产物的动物实验表明临床用药安全。AIM To evaluate the possible allergic reaction and hemolyzation in Reduning Injection （Lonicerae japonicae Flos, Gardeniae Fructus and Artemisiae annuae Herba ） and their degradation products. METHODS Active systemic anaphylaxis （ASA） in guinea pigs and passive cutaneous anaphylaxis （PCA） in rats and rabbits inhemolytic test were performed respectively. RESULTS The results of animal experiments showed that the data on Reduning Injection and their degradation products were all negative as compared with those on the control group. No allergic reaction on passive cutaneous anaphylaxis in guinea pigs and active systemic anaphylaxis in rats, and no evidences of hemolyzation and aggregation on rabbit erythrocytein in vitro were observed. CONCLUSIONS Re- duning Injection and their degradation products are safe at the animal level.

关 键 词：热毒宁注射液 降解产物 主动全身过敏反应 被动皮肤过敏反应 溶血试验 

分 类 号：R285.5[医药卫生—中药学]