响应面法优化加味胃炎消片的干法制粒工艺  

Optimization of dry granulation process of Jiawei Weiyanxiao tablets by response surface methodology

作　　者：钟文嘉[1] 黄益穗[1] ZHONG Wenjia;HUANG Yisui(Department of Pharmacy,The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China)

机构地区：[1]广州中医药大学第一附属医院药学部,广东广州510405

出　　处：《广东药科大学学报》2021年第6期95-99,共5页Journal of Guangdong Pharmaceutical University

基　　金：广州中医药大学第一附属医院岭南治未病专项项目(2017ZWB10)。

摘　　要：目的优化加味胃炎消片的干法制粒工艺参数,验证最佳工艺参数压片的可行性。方法采用Box-Behnken响应面法,以压辊间隙、压辊油压、螺旋送料速度、压辊转速为考察因素,颗粒一次成型率为考察指标,优化干法制粒工艺参数;以片剂的脆碎度为评价指标,考察片剂干法制粒的可行性。结果最佳制粒工艺参数:压辊间隙1.4 mm,压辊油压17.3 MPa,螺旋送料速度90 r/min,压辊转速20 r/min。颗粒一次成型率均值55.8%,RSD 1.66%;制得颗粒压片后,片剂脆碎度符合《中国药典》要求。结论加味胃炎消片干法制粒工艺简便可行,可为其他中药片剂的工业化生产提供参考。Objective To optimize the dry granulation process parameters of Jiawei Weiyanxiao tablets, and verify the feasibility of the optimal process parameters. Methods Box-Behnken response surface method was used to optimize the dry granulation process parameters, with roller clearance, roller oil pressure, screw feeding and roller speed as the factors and the one-time molding rate of particles as the index. The feasibility of dry granulation of tablets was investigated with the fragility of tablets as the evaluation index. Results The optimal granulation process parameters were as follows: press roller gap 1.4 mm, press roller oil pressure 17.3 MPa, screw feeding 90 r/min, press roller speed 20 r/min. The average one-time molding rate of granules was 55.8%, RSD was 1.66%.After the granules were pressed, the brittleness of tablets met the requirements of Pharmacopoeia. Conclusion The dry granulation process of Jiawei Weiyanxiao tablets is simple and feasible, which can provide the reference for the industrialized production of other traditional Chinese medicine tablets.

关 键 词：加味胃炎消片 Box-Behnken响应面法 干法制粒 一次成型率 

分 类 号：R282.3[医药卫生—中药学]