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旋转压片机模拟器上压缩的药用粉末黏附和拾取事件的图像分析定量。

Image analysis quantification of sticking and picking events of pharmaceutical powders compressed on a rotary tablet press simulator.

机构信息

Univ Paris-Sud, UFR de Pharmacie, EA 401, Matériaux et Santé5 rue Jean-Baptiste ClémentChâtenay-Malabry 92296, France.

出版信息

Pharm Res. 2013 Sep;30(9):2303-14. doi: 10.1007/s11095-013-1074-8.

Abstract

PURPOSE

The aim of this work was to develop a quantification method based on image analysis, able to characterize sticking during pharmaceutical tableting. Relationship between image analysis features and relevant mechanical parameters recorded on an instrumented tablet press simulator were investigated.

METHODS

Image analysis, based on gray levels co-occurrence matrices (GLCM), generated textural features of the tablet surface. The tableting simulator (Stylcam® 200R, Medelpharm), instrumented with force and displacement transducers, provided accurate records. The tablet defects and compaction process parameters were studied using three pharmaceutical powders (Fast-Flo® lactose, anhydrous Emcompress® and Avicel® PH200 microcrystalline cellulose), five compression pressures (60 to 250 MPa), five lubricating levels, and three types of punches (standard steel, amorphous hard carbon and anti-sticking punches).

RESULTS

Texture parameters made it possible to quantify with precision tablets’ aspect. The selected parameter IC2 (Information on Correlation 2) plotted versus the ratio between the ejection shear stress (Esh) and the compression pressure (Cp) let appear a relevant knowledge space where it was possible to identify a normal and a degraded tableting mode. A positive link between those two parameters was shown.

CONCLUSION

Since the Esh/Cp ratio was related to image analysis results, it proved to be an interesting defect tag.

摘要

目的

本工作旨在开发一种基于图像分析的定量方法,以表征药物压片过程中的粘冲现象。研究了图像分析特征与仪器化压片机模拟器上记录的相关机械参数之间的关系。

方法

基于灰度共生矩阵(GLCM)的图像分析生成了片剂表面的纹理特征。配备力和位移传感器的压片机(Stylcam® 200R,Medelpharm)提供了准确的记录。使用三种药用粉末(Fast-Flo®乳糖、无水 Emcompress®和 Avicel® PH200 微晶纤维素)、五种压缩压力(60 至 250 MPa)、五种润滑水平和三种冲头(标准钢、非晶硬碳和防粘冲头)研究了片剂缺陷和压缩过程参数。

结果

纹理参数能够精确地量化片剂的外观。选择的参数 IC2(二阶相关信息)与推出剪切应力(Esh)与压缩压力(Cp)的比值作图,显示出一个相关的知识空间,可以在其中识别正常和退化的压片模式。这两个参数之间存在正相关关系。

结论

由于 Esh/Cp 比值与图像分析结果相关,因此它被证明是一个有趣的缺陷标记。

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