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采用水吸附和近红外光谱法研究微晶纤维素和硅化微晶纤维素在湿法制粒前后的差异。

Water sorption and near IR spectroscopy to study the differences between microcrystalline cellulose and silicified microcrystalline cellulose before and after wet granulation.

作者信息

Buckton G, Yonemochi E, Yoon W L, Moffat A C

机构信息

Centre for Materials Science, School of Pharmacy, University of London, 29-39 Brunswick Square, London, WC1N 1AX, UK.

出版信息

Int J Pharm. 1999 Apr 20;181(1):41-7. doi: 10.1016/s0378-5173(98)00413-x.

Abstract

Silicified microcrystalline cellulose (SMCC) has been shown to have advantages over conventional microcrystalline cellulose (MCC). These advantages are (i) improved tablet strength compared to that achieved with MCC, (ii) the retention of compressibility after wet granulation, whereas MCC produces weaker tablets after wet granulation, and (iii) superior flow properties than MCC. In this study gravimetric and calorimetric vapour sorption data and near IR spectroscopy have been used to study MCC and SMCC before and after wet granulation. It was found that MCC, SMCC and wet granulated SMCC had essentially identical physical structures (except for a size increase due to granulation). Wet granulated MCC had a different enthalpy of water sorption at low RH, and its near IR spectrum was different from the other samples in the region which relates to C-H bonding. It can be concluded that MCC and SMCC are of very similar structures, thus these analytical techniques cannot provide an explanation for the improvements in compressibility. However the change in compressibility in MCC after wet granulation may relate to the observed differences in internal bonding in this sample.

摘要

硅化微晶纤维素(SMCC)已被证明比传统微晶纤维素(MCC)具有优势。这些优势包括:(i)与MCC相比,片剂强度有所提高;(ii)湿法制粒后仍保留可压性,而MCC湿法制粒后片剂强度较弱;(iii)流动性能优于MCC。在本研究中,采用重量法和量热法蒸汽吸附数据以及近红外光谱对MCC和SMCC在湿法制粒前后进行了研究。结果发现,MCC、SMCC和湿法制粒后的SMCC具有基本相同的物理结构(除了因制粒导致尺寸增大)。湿法制粒后的MCC在低相对湿度下具有不同的水吸附焓,其近红外光谱在与C-H键相关的区域与其他样品不同。可以得出结论,MCC和SMCC结构非常相似,因此这些分析技术无法解释可压性的提高。然而,MCC湿法制粒后可压性的变化可能与该样品中观察到的内部键合差异有关。

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