清肺平喘颗粒制备工艺研究  

Study on preparation technology of Qingfei Pingchuan granules

作　　者：刘冬菊 孟凡志 刘新丰 郭情情 LIU Dongju;MENG Fanzhi;LIU Xinfeng;GUO Qingqing(Department of Pharmacy,Feng County Hospital of TCM,Xuzhou,Jiangsu 221700,China)

机构地区：[1]丰县中医医院药剂科,江苏徐州221700

出　　处：《安徽医药》2020年第6期1094-1097,I0003,共5页Anhui Medical and Pharmaceutical Journal

摘　　要：目的制备清肺平喘颗粒并优化其制粒工艺参数。方法采用干法制粒工艺制备清肺平喘颗粒,并通过单因素实验考察清肺平喘颗粒的处方和制备工艺;以送料速度、轧轮压力、轧轮转速作为考察因素,以清肺平喘颗粒一次成型率和溶化时间作为评判指标,利用Box-Behnken实验设计优化制粒工艺参数。结果通过实验优化得到清肺平喘颗粒的制粒工艺参数设计空间,在设计空间内任取一点:送料速度为22 r/min、轧轮压力为10 MPa、轧轮转速为15 r/min,经连续3批生产验证,制备的清肺平喘颗粒成型率高、为(75.8±2.8)%,溶化时间短、为(25±2)s。结论Box-Behnken实验设计优化得到的清肺平喘颗粒制粒工艺参数,生产工艺稳健,质量可控,有望进一步放大生产。Objective To prepare Qingfei Pingchuan granules and to optimize its granulation process parameters.Methods Qingfei Pingchuan granules were prepared by dry granulation process.The formulation and preparation process of Qingfei Pingchuan granules were investigated by single factor experiment.Taking feeding speed,rolling wheel pressure,and rolling wheel speed as factors to consider,and the primary forming rate and the dissolution time of Qingfei Pingchuan granules as the evaluation indexes,the Box-Behnken experimental design was used to optimize the granulation process parameters.Results By the experimental optimization,the granulation process parameter design space of Qingfei Pingchuan granules was obtained,and one point was taken in the design space:feeding speed was 22 r/min,rolling wheel pressure was 10 MPa,and rolling wheel speed was 15 r/min.Three consecutivebatches of production verified that the primary forming rate was(75.8±2.8)% and the dissolution time was(25±2)s.Conclusion The Box-Behnken experimental design optimizes the granulation process parameters of Qingfei Pingchuan granules.The production process is stable and the quality is controllable.It is expected to further increase the production.

关 键 词：中草药 药物调剂 清肺平喘 复合混合物 膏剂 干法制粒 Box-Behnken实验设计 

分 类 号：R283.6[医药卫生—中药学]