复方大青叶注射液安全性检查方法的建立  

Establishment of a safety test method of Compound Folium Isatidis Injection

作　　者：梁玉景 孙青虎 华伟 

机构地区：[1]山东华信制药集团股份有限公司,山东菏泽274009

出　　处：《齐鲁药事》2010年第7期428-429,共2页qilu pharmaceutical affairs

摘　　要：目的建立复方大青叶注射液过敏反应检查限值及检查方法。方法通过复方大青叶注射液最大无毒性反应剂量研究,确定过敏反应检查限值;检查方法沿用中国药典2005年版一部。结果及结论限值设置合理,方法准确,能如实反应药品的安全性。OBJECTIVE To establish inspection limits and inspection methods of allergic reactions of the Compound Folium Isatidis Injection.METHODS By studying on the maximum avirulent reaction of the Compound Folium Isatidis Injection determined the detection limit;The detection methods have been using in the Chinese Pharmacopoeia 2005 Edition 1.RESULTS AND CONCLUSION The limits setted was reasonable;The method was accurate and can really response to the drug＇s safety.

关 键 词：复方大青叶注射液 安全性检查 过敏反应 

分 类 号：R927.1[医药卫生—药学]