药用辅料聚乙烯醇质量标准对比研究  

Comparing and Analysis of the Quality Standards of Pharmaceutical Excipient of Polyvinyl Alcohol

作　　者：马晓黎[1] 张蕾 张娇娇[1] 宋艳霞[1] 李波[1] 

机构地区：[1]抗生素研究与再评价四川省重点实验室四川抗菌素工业研究所成都大学,成都610052 [2]四川省食品药品检验检测院,成都610097

出　　处：《海峡药学》2016年第8期89-93,共5页Strait Pharmaceutical Journal

摘　　要：目的对比研究药用辅料级聚乙烯醇国内外质量标准,为其国内质量标准的提高提供参考,对进一步规范国内厂家药用级聚乙烯醇的生产、认证、检查提出意见及建议。方法参考《中国药典》(2010版)、《美国药典》(36版)和《欧洲药典》(7.0版)及其他质量标准的要求,从溶液颜色及澄清度、砷盐、水不溶物、皂化值、水解度、残留溶剂等方面进行了研究。结果《中国药典》(2010版)在对药用聚乙烯醇标准规定上不如国外标准,本文研究内容对国内部分标准进行了修订和补充。结论药用辅料聚乙烯醇国内质量标准有待进一步的完善和提高。OBJECTIVE By comparing the quality standards of Polyvinyl Alcohol both in national and interna- tional quality standards, some modifying suggestions about the standards to the standards makers were proposed. In addition, it could provide some reference to production, certification and inspection. METHODS The samples were analyzed in Appearance and color of solution, Arsenic, Water-insoluble substances, Saponification, Hydrolysis and Re- sidual solvents by the means in the Chinese Pharmacopoeia（2010 edition）, United States Pharmacopeia（ the 36 edition）, European Pharmacopoeia（ the 7.0 edition） and other standards. RESULTS The data shown there were some differences of Polyvinyl Alcohol among the several standards, quality index in United States Pharmacopeia were the highest. CONCLUSION The domestic quality standards of Polyvinyl Alcohol need to be further improved.

关 键 词：药典 药用辅料 聚乙烯醇 砷盐 皂化值 残留溶剂 

分 类 号：R917[医药卫生—药物分析学]