水性聚丙烯酸树脂Ⅲ制备工艺改进与包衣分析

Synthesis of enteric aqueous acrylic resin Ⅲ as enteric coating and coating analysis

以甲基丙烯酸与甲基丙烯酸甲酯为共聚单体,用乳液聚合法制备肠溶型水性聚丙烯酸树脂Ⅲ乳液,喷雾干燥成树脂粉末。采用傅立叶变换红外光谱仪测定其组成,凝胶色谱结合多角激光光散射仪测定相对分子质量及其分布,并按照国家药典2005版规定对其生物学及机械性能进行检测。在树脂粉末中加入增塑剂邻苯二甲酸二丁酯等助剂配制包衣液,利用滚转包衣法对阿司匹林素片进行包衣,然后利用智能崩解仪观察其在胃肠液中的崩解速度,考察药物体外释放度和稳定性。结果发现制得的薄膜包衣材料无论以水还是乙醇做溶剂都具有更优良的性能。且生产包衣材料过程中未使用有机溶剂,有很好的经济和环保效益,对国内水性丙烯酸树脂包衣材料生产工业化起到很好的推动作用。

Poly-acrylic acid resin was synthesized by emulsion polymerization with meth-acrylic acid（MAA） and methyl meth-acrylate （MMA） as monomers. Which used as enteric film-coating material： aqueous poly-acrylic acid resin Ⅲ. and then desiccate them to resin powder by sprayer. The polymer composing was analyzed by the infrarec absorption spectrum. The relative molecular weight and its polydispersity were determined by the gel-permeation chromatography with the multiple angle laser light scattering detection; the relative properties were tested according to the national pharmacopoeia 2005. to add plasticizer dibutyl phthalate and other things to the resin powder to make coating power, using roll- coated method to coat aspirin tablets, and then using the smart collapse equipment to observe the collapse rates in the Gastrointestinal fluid , detect drugs in vitro release and stability. The results showed that the system of film coating materials both in water or alcohol solvent do had a better performance. In the production process of coating materials no organic solvents were used, had a good economic and environmental benefits, playing a good role in promoting The industrialization of domestic water-based acrylic resin coating material production.