盐酸坦洛新缓释滴丸的处方工艺研究

Study on Formulation and Preparation of Tamsulosin Hydrochloride Sustained-release Dropping Pills

研究了盐酸坦洛新(TSLS)缓释滴丸的处方工艺.采用聚乙二醇6000和聚乙二醇4000为速释性固体分散载体材料,硬脂酸及单硬脂酸甘油酯为缓释性骨架材料,熔融法制备缓释滴丸.以滴丸圆整度和丸重的RSD为指标,对TSLS缓释滴丸的制备工艺进行了优化.所得滴丸的圆整度好、丸重差异小,体外释放符合Higuchi模型,可持续释药24 h.

To study the formulation and preparation of tamsulosin hydrochloride（TSLS） sustained-release dropping pills,TSLS sustained-release dropping pills were prepared by melting method with PEG-6000 and PEG-4000 as quick-released material,stearic acid and glyceryl monostearate as sustained-released matrix.The preparation technology for sustained-release dropping pills was optimized by way of the spherical degree and relative standard deviation of pills weight difference were selected as evaluation indexes.The orthogonal design was used to select the optimal formulation based on the percent release.Sustained-release dropping pills made from the optimal formula had good spherical degree and smaller pills weight difference.The release percentage of optimal fomula complied with Higuchi equation,it could release erug for 24 h.