摘要
该研究以血塞通滴丸(Xuesaitong Dropping Pills,XDP)滴制过程为例,对影响其成丸率、平均丸重和圆整度质量指标的关键影响因素进行筛选,深化了对滴制过程的理解。采用风险分析手段并结合先验知识确定XDP关键工艺单元、关键质量评价指标以及潜在关键影响因素,再进一步结合Plackett-Burman设计对其关键影响因素进行筛选。首先,由风险评估确定XDP制剂过程关键工艺为滴制,进而确定滴制工艺的关键质量评价指标为成丸率、平均丸重和圆整度。然后,结合鱼骨图(fishbone diagram)和失效模式与影响分析(failure mode and effects analysis,FMEA)确定滴制工艺的潜在关键影响因素为流量、基质比、料液比、料液温度、冷凝液顶部温度、冷凝液底部温度、滴距。最终,从这7个潜在因素中确定关键影响因素为料液比、滴距、冷凝液顶部温度及底部温度。该研究内容揭示了Plackett-Burman试验设计在筛选和理解所选因素对XDP滴制工艺过程的影响方面的潜力,可为其滴制过程研究提供参考。
With the dropping process of Xuesaitong Dropping Pills(XDP)as the study object,critical factors affecting the quality indicators of pill pass rate,average weight of drop pills and roundness were screened out,so as to deepen the understanding of the dropping process.The critical process units,critical quality attributes and potential critical process influencing factors of XDP were determined by risk analysis and prior knowledge,and then the critical influencing factors were screened out by Plackett-Burman design.First,according to the risk assessment,the critical technique of XDP preparation process was dropping,and then the critical quality attributes of dropping process were pill pass rate,average weight of drop pills and roundness.Then,according to fishbone diagram and failure mode and effects analysis(FMEA),potential critical influencing factors were determined as flow rate,matrix ratio,solid-liquid ratio,feed-liquid temperature,top temperature of condensate,bottom temperature of condensate and dropping distance.Finally,among these seven potential factors,the critical influencing factors were determined as material liquid ratio,dropping distance,top temperature of condensate,bottom temperature of condensate.This study revealed the potential of Plackett-Burman design in screening and understanding the influence of selected factors on XDP dropping process,which could provide a reference for studying the dropping process.
作者
侯一哲
黎翩
张剑
陈景丽
皮培培
李正
李文龙
HOU Yi-zhe;LI Pian;ZHANG Jian;CHEN Jing-li;PI Pei-pei;LI Zheng;LI Wen-long(College of Pharmaceutical Engineering of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Langtian Pharmaceutical(Hubei)Co.,Ltd.,Huangshi 435000,China;Huangshi Central Hospital of Edong Medical Group,Huangshi 435000,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第1期103-109,共7页
China Journal of Chinese Materia Medica
基金
国家“重大新药创制”科技重大专项(2018ZX09201011)。
