尤特奇RS-PO/RL-PO制备缓释片的工艺研究

Technical study on sustained release tablets preparation of Eudragit RS-PO/RL-PO

比较尤特奇RS-PO和RL-PO的缓释性能,为更好地应用提供依据。以茶碱为模型药物,选用尤特奇RS-PO,RL-PO为缓释材料,制备了茶碱骨架缓释片和包衣缓释片,通过体外释放度试验考察尤特奇RS-PO和RL-PO的缓释性能。结果表明,RS-PO的阻滞作用较强,不宜单独作为骨架缓释材料使用;RL-PO的缓释作用强,对药物释放的控制作用好,是理想的骨架缓释材料。RS-PO衣膜的成型性、韧性均不理想,对药物的渗透作用极差,不宜用做包衣材料;RL-PO衣膜的成型性、塑性及韧性均较好,释药过程衣膜始终保持完整,对药物渗透性较好,可作为渗透泵制剂的缓释包衣材料。

For better application of Eudragit RS-PO and RL-PO,the sustained release properties are compared.Using theophylline as a model drug and Eudragit RS-PO and RL-PO as sustained release materials for preparation of theophyline sustained release tablets and coated sustained released tablets,Eudragit RS-PO and RL-PO release properties are tested through in vitro release test.RS-PO has a relatively strong retard property,which is not recommended to be used alone as a skeleton sustained-release material.RL-PO is considered as an ideal release material with relatively strong release property and strong controlling effect on release.Formability of film coating and toughness of RS-PO is not ideal,and the drug penetration is extremely poor,therefore,it is not recommended to be used as a coating material.RL-PO can be chosen as a sustained release material for osmotic pump preparation,for it has better coating film formation property and relative better plasticity toughness.The film membranes remain intact through the release process and it has good drug penetration property.