五藤片的成型工艺研究

Study on the Forming Technology of Wuteng Tablets(五藤片)

目的:优化五藤片的成型工艺。方法:采用湿法制粒制备五藤片,通过单因素考察法对其辅料种类和辅料用量进行优化,结合Box-Benhnken响应面法对填充剂、崩解剂和润滑剂的用量进行考察,确定最佳的五藤片成型工艺。结果:五藤片最佳成型工艺为62%的乳糖与微晶纤维素作为填充剂与干膏粉1:1混合,65%的乙醇作为黏合剂,2%的交联聚维酮作为崩解剂和0.8%的硬脂酸镁作为润滑剂。结论:优化所得的片剂在外观、崩解时间、片重差异、脆碎度、硬度方面均符合2020年版《中华人民共和国药典》规定,表明该成型工艺稳定可行,可以作为制备五藤片的方法。

Objective:Optimization of the molding process of Wuteng tablets.Methods:Wet granulation and tablet pressing were used to optimize the types and dosage of excipients.The amount of fillers,disintegrants and lubricants were investigated by Box-Benhnken design and response surface methodology and the best molding process of Wuteng tablets was optimized.Results:The best molding process was 62%lactose and microcrystalline cellulose filler(1:1),65%ethanol binder,2%cross-linked povidone as disintegrant and 0.8%magnesium stearate lubricant.Conclusion:The appearance,disintegration time,weight difference,brittleness and hardness of the optimized tablets meet the requirements of Pharmacopoeia of the People's Republic of China,2020 Edition,indicating that the molding process is stable and feasible and that it can be used as a method for preparing Wuteng tablets.