盐酸氨溴索缓释颗粒的制备和释放度的研究

Study on Preparation and Release of Ambroxol Hydeochloride Sustained Release Granules

为了建立一种盐酸氨溴索缓释颗粒的制备方法,以累积释放度为主要指标对其质量和工艺稳定性进行评价。采用以阳离子交换树脂法制备盐酸氨溴索药物树脂微囊,并以此微囊制备盐酸氨溴索缓释颗粒;按照《中国药典》规定的释放度测定法进行释放度检查,采用紫外分光光度法进行测定,计算盐酸氨溴索缓释颗粒的累积释放度,对累积释放度曲线进行拟合,以考察其释放特性。结果表明:按照本法制备的盐酸氨溴索缓释颗粒的释放度符合要求,累计释放度曲线符合Higuchi方程,制备工艺稳定,重现性良好。

In order to establish a method for the preparation of ambroxol hydrochloride sustained release granules, the accumulative release rate was used to evaluate its quality and process stability. Ambroxol hydrochloride drug resin microcapsules were prepared by the cation exchange resin method, ambroxol hydrochloride sustained-release pellets were prepared by the microcapsule. According to the ＂ Chinese Pharmacopoeia＂ provisions of the release determination method for the release test,mensurate using ultraviolet spectrophotometry, calculate the accumulative release rate of ambroxol hydrochloride sustained release granules, and fit the cumulative release curve, to study its release characteristics. The results showed that ambroxol hydrochloride sustained release particles were prepared by the release of the demand,the release curve accorded with Higuchi equation,the preparation process was stable.