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制备日服一次的盐酸氨溴索缓释片,并采用体外方法对其进行科学评价。以羟丙甲纤维素(HPMC K4M)为基本骨架材料,采用湿法制粒工艺制备盐酸氨溴索缓释片。采用高效液相色谱法测定释放度。最佳处方每片含主药盐酸氨溴索75mg,辅料HPMC K4M60mg,乳糖312 36mg,微晶纤维素101 18mg,聚维酮K30 10mg及硬脂酸镁2mg;最佳制备工艺为湿法制粒工艺。本处方工艺稳定,适用于盐酸氨溴索缓释片的工业化生产。
Ambroxol hydrochloride sustained-release tablets were prepared on a daily basis and scientifically evaluated using in vitro methods. Hydroxypropyl methylcellulose (HPMC K4M) as the basic framework material, wet granulation process preparation of ambroxol hydrochloride sustained release tablets. Determination of release by high performance liquid chromatography. The best prescription for each tablet containing the main drug ambroxol 75mg, excipients HPMC K4M60mg, lactose 312 36mg, microcrystalline cellulose 101 18mg, Povidone K30 10mg and magnesium stearate 2mg; The best preparation process for the wet granulation process . The prescription process is stable, suitable for the industrial production of ambroxol hydrochloride sustained-release tablets.