目的:考察控释薄膜包衣对盐酸曲马多缓释片释放体外行为的影响及其制备方法。方法:采用骨架控释与控释薄膜包衣技术制备盐酸曲马多缓释片,并考察控释薄膜包衣对释放度的影响。结果:以丙烯酸酯聚合物为成膜材料的控释薄膜包衣,对以羟丙甲纤维素(HPMC)为骨架材料的亲水凝胶骨架片药物释放具有显著影响。制备的盐酸曲马多缓释片体外药物释放能够达12 h以上。结论:采用控释薄膜包衣技术和骨架控释技术可用于制备强水溶性药物控释制剂。
AIM:To study the influence of controlled release film-coated process on release of tramadol hydrochloride cores,and to prepare tramadol hydrochloride controlled release tablets.METHODS:The tramadol hydrochloride controlled release drug delivery system was prepared by matrix-controlled release technique and controlled release film-coating technology.The influence of controlled release film-coated technique on drug release was studied.RESULTS:The cumulative release of controlled release tablets with HPMC as inner matrix-controlled material was obviously influenced by controlled release film-coating with polyacrylate as the film material.The release of tramadol hydrochloride was over 12 h.CONCLUSION:The controlled release film-coated technique and the matrix technique can be used to prepare controlled release tablets for highly hydrophilic drugs.