[关键词]
[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。
[Key word]
[Abstract]
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(34) 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.
[中图分类号]
[基金项目]
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)