基于制剂原料物理特性的哮喘颗粒干法制粒工艺优选  

Optimization of dry granulation prescription and technology of Xiaochuan Granules based on physical characteristics of raw materials in preparations

作　　者：周恩丽[1,2] 康小东[1,2] 付娟[1,2] 吴云[1,2] 丁岗[1,2] 王振中[1,2] 萧伟[1,2] ZHOU En-li KANG Xiao-dong FU Juan WU Yun DING Gang WANG Zhen-zhong XIAO Wei(Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China)

机构地区：[1]江苏康缘药业股份有限公司,江苏连云港222001 [2]中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《中草药》2017年第4期681-685,共5页Chinese Traditional and Herbal Drugs

基　　金：科技部重大新药创制:现在中药创新集群与数字制药科技平台(2013ZX09402203)

摘　　要：目的利用粉体的物理性质,优选哮喘颗粒干法制粒工艺。方法通过考察哮喘颗粒制剂原料的休止角、压缩度、水分等物理特性,指导干法制粒处方筛选,以颗粒一次成型率、脆碎度和制粒过程质量评分为指标,采用L9(34)正交试验方法,同时采用基于信息熵的评价方法优选哮喘颗粒干法制粒工艺参数。结果确定最佳辅料为糊精,最佳干法制粒工艺参数:轧轮压力为7 MPa,轧轮转速为10 r/min,送料速度为18 r/min。结论制剂原料的物理特性研究可指导制剂处方的筛选,制得颗粒成型性好,硬度适中,流动性好,优选的干法制粒工艺稳定合理。Objective To utilize powder physical characteristics, optimize prescription of dry granulation process of Xiaochuan Granules （XG）. Methods Filtering of granulation prescription was guided by investigating of powder material physical characteristics such as angle repose, compression degree, water content, etc; With one time forming rate, friability and quality score of granulation process as indexes, L9（3^4） orthogonal test which based on the evaluation method of information entropy was used to optimize the process parameters in XG dry granulation. Results The optimum accessory is CD, optimum dry granulation technology parameters was as follows： roll wheel pressure of 7 MPa, roll wheel speed of 10 r/min, and feed speed of 18 r/min. Conclusion Study of physical property of preparation materials could guide filtering prescription of dry granulation preparation; The prepared granules have high forming rate with moderate hardness and good flowability, and this optimized dry granulation technology is stable and reasonable.

关 键 词：哮喘颗粒 物理特性 辅料筛选 干法制粒 信息熵 

分 类 号：R283.6[医药卫生—中药学]