吡嗪酰胺的质量标准研究及其应用  

Study of Quality Standard of Pyrazinamide and Its Application

作　　者：赵恂[1] 袁耀佐[1] 张玫[1] 

机构地区：[1]江苏省食品药品检验所,南京210008

出　　处：《药学与临床研究》2013年第6期630-632,共3页Pharmaceutical and Clinical Research

摘　　要：采用法定检验方法及探索性研究建立的方法,对不同来源的吡嗪酰胺原药进行检验,找出影响产品质量的关键因素。对吡嗪酰胺的现行质量标准进行了修订:增加酸度检查项,删除羧酸类化合物检查项,将原标准有关物质检查用TLC法修订为HPLC法,结果为一批样品有关物质超过限度;将含量测定用的定氮法修订为HPLC方法,测定结果与BP 2012的容量分析法比较,两者结果一致。由此表明,吡嗪酰胺原药的现行质量标准存在缺陷,亟须提高。Samples from different origins were tested by statutory and exploratory methods. Data were analyzed by a statistical software to find out the key factors affecting quality. The acidity test was added and the carboxylic acid test was deleted. The method of TLC for related substances in the original quality standard was replaced by an HPLC method,and the related substances in a batch of pyrazinamide samples were found to have exceeded the limit. The Kieldahl method was replaced by an HPLC method for content determination. The results of the potentiometric titration of BP2012 and the new HPLC method of content determination were consistent. At present the quality of domestic pyrazinamide is generally good. But exploratory study suggests that the existing quality standard is in deficiency and need to be improved.

关 键 词：吡嗪酰胺 质量标准 质量评价 

分 类 号：R926[医药卫生—药学]