首批聚丙烯酸树脂Ⅱ国家标准物质的研制与建立

目的:建立药用辅料聚丙烯酸树脂Ⅱ红外光谱鉴别用首批国家标准物质。 方法:以红外光谱、核磁共振氢谱及分子量分布等方法确证结构,以容量法对甲基丙烯酸单元进行含量测定。 结果:确定了聚丙烯酸树脂Ⅱ原料的结构及组成。 结论:建立的聚丙烯酸树脂Ⅱ国家标准物质可满足国内相关产品的研究、检定以及质量控制的要求。

Objective: To develop a national reference standard of polyacrylic resin Ⅱ. Methods: The structure of polyacrylic resin Ⅱ was determined by IR,¹HNMR and GPC.The methacrylate unit content of polyacrylic resin Ⅱ was analyzed by acid-base titration. Results: The structure and the composition of the raw material have been identified. Conclusion: The national reference standard of polyacrylic resin Ⅱ has been established,which can be used for the quality control of polyacrylic resin Ⅱ and drug related products.

1 ChP(中国药典).2010.Vol Ⅱ(二部):1247
2 CHEN Yang(陈阳),WANG Bao-hua(王宝华),WU Dan(伍丹).Pharmceutical application of polyacrylic resin(聚丙烯树脂类辅料在制剂中的应用).Chin Pharm(中国药业),2007,16(14):25
3 Meltem Cetin,Alptug Atila,Yucel Kadioglu.Formulation and In vitro Characterization of Eudragit^ L100 and Eudragit^ L100-PLGA Nanoparticles Containing Diclofenac Sodium.AAPS Pharm Sci Tech,2010,11(3):1250
4 Maghsoodi M.Physicomechanical Properties of Naproxen-Loaded Microparticles Prepared from Eudragit L100.AAPS Pharm Sci Tech,2009,10(1):120
5 LIU Yu(刘羽),LIU Yan(刘燕),SUN Bei(孙备),et al.Preparation of omeprazole enteric-coated pellets with homemade polyacrylic acid resin Ⅱ(采用国产聚丙烯酸树脂Ⅱ制备奥美拉唑肠溶微丸的研究).Anhui J Med Pharm(安徽医药),2009,13(7):738
6 USP 34-NF29.2011.1584
7 EP 7.0.2011.2461
8 ChP(中国药典).1995.Vol Ⅱ(二部):1040
9 ZHENG Jun-min(郑俊民).Polymer Science in Pharmaceutics(药用高分子材料学).Beijing(北京):China Medico-Pharmaceutical Science and Thechnology Publishing House(中国医药科技出版社),2000.144