目的 对基于Heckel和Kawakita方程建立的通用压缩模型在药物粉体压缩特性中应用进行对比研究,得到2种模型的适用范围和精确度。方法 分别对乳糖、淀粉、微晶纤维素3种常用辅料和含有不同质量百分比的乳糖、淀粉、微晶纤维素、硬脂富马酸钠4种药用辅料混合物进行单向圆片直压实验,对2种不同压缩模型的密度-压力变化规律和模型误差进行分析。结果 在压力值大于80 MPa时,Heckel和Kawakita模型密度误差绝对值均在4%之内,且Kawakita模型的方差小于Heckel模型的方差;当压力值大于60 MPa时,Heckel和Kawakita模型误差绝对值均在3.73%之内,且Kawakita模型的方差小于Heckel模型的方差。结论 应用2种通用压缩模型对药物粉体压缩特性进行分析时,当压力处于80~240 MPa时,2种模型均适用,但Kawakita压缩模型精确度高于Heckel压缩模型。
Abstract
OBJECTIVE To conduct the contrastive studies of universal compression model to pharmaceutical powder compression characteristics effect base on Heckel and Kawakita equation founded.METHODS The uniaxial compression tests were developed with three excipients of lactose, starch, microcrystalline cellulose and four mixture excipients of lactose, starch, microcrystalline cellulose with different mass fraction. The change rules between density and pressure and model error are analyzed of two different compression models respectively.RESULTS The absolute density error value of Heckel and Kawakita compression model is within 4%, when the pressure is greater than 80 MPa,and the variance of Kawakita model is less than Heckel model.The absolute error value of Heckel and Kawakita compression model is within 3.73%, when the pressure is larger than 60 MPa, and the variance of Kawakita compression model less than Heckel model.CONCLUSION During applying two universal compression models to analyze pharmaceutical powder compression characteristics, two models are suitable, when the pressure is between 80 and 240 MPa.
关键词
Heckel模型 /
Kawakita模型 /
药物压缩 /
误差分析 /
方差分析
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Key words
Heckel model /
Kawakita model /
pharmaceutical compression /
error analysis /
variance analysis
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中图分类号：
R944.4
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参考文献
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脚注
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基金
上海市联盟计划项目资助(LM201750)
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