超滤工艺对注射用芪红脉通药效和被动皮肤过敏反应的影响  

Effects of Ultrafiltration Process on Potency and Passive Cutaneous Anaphylaxis of Qihong Maitong Injections

作　　者：董立静 李滟[1] 吕新勇[2] 周军[2] 田恒勇[2] 周建明[2] 王伟[2] 祝倩倩[3] 王振中[2,4] 萧伟[2,4] 

机构地区：[1]天津市滨海新区汉沽中医医院,天津300457 [2]江苏康缘药业股份有限公司,江苏连云港222001 [3]南京中医药大学,南京210023 [4]中药制剂过程新技术国家重点实验室,江苏连云港222001

出　　处：《中国实验方剂学杂志》2014年第12期1-5,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家科技部重大新药创制项目(2011ZX09401-014)

摘　　要：目的:评价超滤工艺对注射用芪红脉通抗急性心肌缺血和被动皮肤过敏反应的影响。方法:选择舌静脉注射垂体后叶素(0.75 U·kg-1)构建急性心肌缺血大鼠模型,以心电图ST段变化和血清超氧化物歧化酶(SOD),丙二醛(MDA)的含量变化为药效学评价指标,比较注射用芪红脉通超滤前后对垂体后叶素致大鼠急性心肌缺血的影响,以大鼠被动皮肤过敏试验考察该制剂的安全性。结果:超滤前后注射用芪红脉通在成分上无明显变化;与模型组相比,超滤前后样品均能显著降低心电图ST段的抬升,超滤前中剂量及超滤后高剂量样品组均能显著提高血清SOD活性,各给药组均能显著降低血清MDA的产生,但超滤前后这些指标均无显著差异;超滤后样本的被动皮肤过敏呈阴性。结论:注射用芪红脉通具有显著的抗急性心肌缺血作用,超滤工艺提高了制剂的安全性,对药效无影响。Objective： To evaluate effects of ultrafiltration process on against acute myocardial ischemia and passive cutaneous anaphylaxis of Qihong Maitong injections （QM）. Method： Rat model of acute myocardial ischemia was established by vena lingualis injections of pituitrin （0.75 U ·kg-1 ） , taking electrocardiogram ST segment changes, serum superoxide dismutase （SOD） activities and malonaldehyde （MDA） levels in blood serum as indexes, effects of QM （before and after been ultrofiltraed ） on protection against pituitrin-induced myocardial ischemia in rats, passive cutaneous anaphylaxis of samples was tested to explore safety of QM. Result： No obvious changes were obsovered in compositions after ultrafiltration; compared with model group, both of ultrofihraed and un-ultrofiltraed samples could significantly reduce lifting of electrocardiogram ST segment, themiddle dose group before uhrafihration and the high dose group after uhrafihration could significantly increase serum SOD activities, every dose group could significantly reduce production of serum MDA levels, but no significant changes were obsoverd between groups administrated with uhrofihraed and unultrofihraed samples. Passive cutaneous anaphylaxis of ultrafihratded samples were negative. Conclusion： QM showed significant activties of against acute myocardial ischemia. Ultrafihration process improved security of QM, but it had not influenced their activities of anti-myocardial ischemia.

关 键 词：注射用芪红脉通 超滤工艺 抗心肌缺血作用 被动皮肤过敏反应 垂体后叶素 心电图 

分 类 号：R283.6[医药卫生—中药学] R285.5[医药卫生—中医学]