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首页> 外文期刊>International Journal of Pharmaceutics >Measurement of surface color as an expedient QC method for the detection of deviations in tablet hardness.
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Measurement of surface color as an expedient QC method for the detection of deviations in tablet hardness.

机译：测量表面颜色，作为检测片剂硬度偏差的便捷QC方法。

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The objective of this study was to investigate whether a correlation exists between the surface color of tablets and their tensile strength. Theophylline powder blends with and without red dye were directly compressed into 600mg tablets. Applied compression pressure ranged from 9.3 to 271.2MPa. Colorimetric parameters: lightness (L), chromaticity (a, b), chroma (Cab), hue (hab) and color intensity (CI), were measured and recorded for both sides of each tablet using ColorQuest XE colorimeter in reflectance specular included mode. The tensile strength of the tablets was measured using a TA.XTPlus Texture Analyzer. A linear correlation was observed between the chroma (Cab) parameter and the tensile strength for each formulation of the tablets. For white tablets, the linearity was observed between Cab values ranging from 2.6 to 3.76 and tensile strength values ranging from 2.96 to 6.86MPa. For red tablets, the linearity was observed between a chroma range from 21.76 to 30.75 and tensile strength from 2.51 to 6.52MPa. A similar correlation was observed between the CI of red tablets and tensile strength. It was concluded that chroma could be used as suitable QC parameters to detect deviations in tablet hardness during bulk manufacturing.
机译：这项研究的目的是调查片剂的表面颜色与其抗张强度之间是否存在相关性。将有和没有红色染料的茶碱粉末混合物直接压制成600mg片剂。施加的压缩压力范围为9.3至271.2MPa。使用ColorQuest XE色度计在反射镜面反射模式下测量并记录比色参数：亮度和色度参数（L），色度（a，b），色度（Cab），色相（hab）和色强度（CI），并记录下来。使用TA.XTPlus纹理分析仪测量片剂的拉伸强度。对于每种片剂，在色度（Cab）参数和抗张强度之间观察到线性相关性。对于白色片剂，在Cab值范围为2.6至3.76和拉伸强度值范围为2.96至6.86MPa之间观察到线性。对于红色片剂，观察到的色度在21.76至30.75的色度范围和2.51至6.52MPa的抗张强度之间。在红色药片的CI和抗张强度之间观察到相似的相关性。结论是，色度可以用作合适的QC参数，以检测批量生产过程中片剂硬度的偏差。

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