葛根素及其制剂标准进展分析  

Analysis for formulating the Standards of Puerarin and its Preparations

作　　者：周怡[1] 

机构地区：[1]国家药典委员会,北京100061

出　　处：《现代预防医学》2012年第14期3652-3656,共5页Modern Preventive Medicine

摘　　要：目的阐明葛根素及其注射剂标准提高的思路与过程,为制定良好的植物提取来源药品标准提供参考。方法对葛根素、葛根素注射液、葛根素氯化钠注射液、葛根素葡萄糖注射液以及注射用葛根素标准药典收载及标准修订过程进行解析。结果葛根素及其注射剂标准增加安全性检查并修订已有检查方法,可以有效的对产品质量进行控制并保证用药安全。结论现有标准可提高产品质量可控性和安全性。OBJECTIVE To clarify the development and revision process of standards of Puerarin and its preparations for injection,and provide a reference on developing a good standards of drugs which derived from plant extracts,such as puerarin,puerarin injection,puerarin and sodium chloride injection,and puerarin and glucose injection.METHODS We analyzed the revision process of standards of Puerarin and its preparations for injection to ensure the safety use of puerarin,include monograph of ChP and National standards.RESULTS Increase safety tests and revise the method of existing test of standards of Puerarin and its preparations for injection.CONCLUSION The revised standards can ensure the drug quality control and safety.

关 键 词：葛根素及其注射剂 质量标准修订 不良反应 

分 类 号：R289[医药卫生—方剂学]