甲磺酸多沙唑嗪片的处方工艺研究

目的:筛选甲磺酸多沙唑嗪片的最佳处方组成。方法:以辅料中乳糖、低取代羟丙基纤维素(Ls-HPC)、羟丙基甲基纤维素(HPMC)为3个因素,每个因素取3个水平,选用L9(34)正交表,以甲磺酸多沙唑嗪片的溶出度为指标进行正交试验,筛选最佳处方组成。结果:辅料中影响片剂溶出度的因素是Ls-HPC(P<0.01)和HPMC(P<0.05)。最佳处方组成为每片含甲磺酸多沙唑嗪2.43 mg(相当于多沙唑嗪2mg),乳糖110 mg,Ls-HPC 35 mg,HPMC 0.8 mg,硬脂酸镁1.5 mg。结论:采用本处方及工艺制得的甲磺酸多沙唑嗪片溶出度符合中国药典要求,与市售甲磺酸多沙唑嗪片Cardura相似,且制备工艺简单,适于工业化生产。

Study on the formulation and preparation of doxazosin mesylate tablets

Objective: To screen the optimum formulation and preparation technology of dosazosin mesylate tablets. Methods: The L9(34)orthogonal table and dissolution was employed to select the optimum formulation by taking lactose, Ls-HPC and HPMC as the three main factors, and three levels are adopted for each factors. Results: the experimental results indicated Ls-HPC and HPMC were the chief factors of influencing dissolution of tablets and lactose had no statistic significance ( P > 0. 05 ). The optimum formulation was composed of doxazosin 2 mg, Ls-HPC 35 mg, HPMC 0. 8 mg, lactose 110 mg, magnesium stearate 0. 8 mg. Conclusions: The formulation and preparing technology were reliable.