抗痨片的粉末直压片制备工艺研究

Study on preparation technology of Kanglao powder direct compression tablets

目的:选择抗痨片粉末直接压片法的最佳制备工艺。方法:采用全粉末直接压片法,在测定直压辅料流动性、吸湿性的基础上,以崩解时限和休止角的综合评分为评价指标,选择抗痨片最优处方并验证。结果:抗痨片所用直压辅料粉末流动性好,能够满足制备工艺要求;最终制备工艺为每100片抗痨片中含浸膏粉58.5 g,辅料为预胶化淀粉∶乳糖(3∶1)40 g,十二烷基硫酸钠0.5 g,硬脂酸镁1 g。抗痨片硬度、崩解时限、外观各项指标均符合规定。结论:该工艺简便、易行,可为工业化生产提供依据。

Objective： To select the best prescription of Kanglao powder direct compression tablets. Methods： The optimal prescription of Kanglao powder was selected and verified in the use of the whole powder direct compression method and on the basis of determining the flowability and hygroscopicity of the direct compression excipients,and the comprehensive scores of the disintegration time and the angle of repose were taken as the evaluation index. Results： Direct compression excipients powder of Kanglao tablets showed the good fluidity to meet the preparation process requirements. The final preparation technology results were 58. 5g extract powder per pieces of Kanglao 100 tablets,and the excipients were pregelatinized starch∶ Lactose（ 3∶ 1） 40 g,Sodium Dodecyl Sulfate 0. 5g and Magnesium Stearate 1g. The hardness,disintegration time limit and the appearance of the indicators of Kanglao tablets all met the pharmacopoeia regulations. Conclusion： The process is simple and easy,which can provide the basis for industrial production.