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微晶纤维素片剂的压汞孔隙率测定法:扫描速度和水分的影响

Mercury porosimetry of microcrystalline cellulose tablets: effect of scanning speed and moisture.

作者信息

Westermarck S

机构信息

Orion Corporation, Orion Pharma, Espoo, Finland.

出版信息

Eur J Pharm Biopharm. 2000 Sep;50(2):319-25. doi: 10.1016/s0939-6411(00)00095-3.

Abstract

The effect of pretreatment and scanning speed of mercury porosimetry on the porosity result of microcrystalline cellulose tablets was studied. The porosity parameters followed were total pore volume, mean and median pore size, and volume pore size distribution. Scanning speed did not affect the total pore volume of tablets compressed from microcrystalline cellulose. With increasing speed, the smallest pores of powder tablets were not properly determined, which increased the mean pore size. The median pore size of tablets compressed from powder and granules decreased and the maximum at the pore size range 500-1000 nm changed towards smaller pores with increasing scanning speed. Scanning speed appears to affect in different ways the samples with different physical structures. In tablet samples, scanning speed affects the volume of the pores at the whole pore size range determined. Thus, it is important to use about the same, reasonably low scanning speed in the measurements when comparing the samples. Swelling of microcrystalline cellulose in tablet samples is observed by mercury porosimetry measurement; a change in the pore structure is detected after storage at 88% relative humidity as increased total pore volumes and median pore sizes. Due to swelling, the maximum at the pore size range 500-2000 nm changed towards larger pores with increasing moisture. Swelling is observed similarly in tablets manufactured from powder and granules. When storing in humid conditions, water fills the smallest pores of microcrystalline cellulose powder tablets, hinders the intrusion of mercury and, thus, the mean pore size increases. Contrary to this, the volume of the smallest pores of granule tablets compressed with the highest compression pressure increased with increasing moisture. Careful pretreatment before the measurements is important.

摘要

研究了压汞法预处理和扫描速度对微晶纤维素片剂孔隙率结果的影响。所遵循的孔隙率参数包括总孔体积、平均孔径和中值孔径以及体积孔径分布。扫描速度不影响由微晶纤维素压制的片剂的总孔体积。随着速度增加,粉末片剂的最小孔隙无法准确测定,这使得平均孔径增大。由粉末和颗粒压制的片剂的中值孔径减小,并且随着扫描速度增加,500 - 1000 nm孔径范围内的最大值向较小孔隙变化。扫描速度似乎以不同方式影响具有不同物理结构的样品。在片剂样品中,扫描速度影响所测定的整个孔径范围内的孔隙体积。因此,在比较样品时,测量中使用大致相同且合理较低的扫描速度很重要。通过压汞法测量观察到片剂样品中微晶纤维素的溶胀;在相对湿度88%下储存后,检测到孔隙结构发生变化,总孔体积和中值孔径增加。由于溶胀,随着湿度增加,500 - 2000 nm孔径范围内的最大值向较大孔隙变化。在由粉末和颗粒制成的片剂中也观察到类似的溶胀现象。当在潮湿条件下储存时,水填充微晶纤维素粉末片剂的最小孔隙,阻碍汞侵入,从而使平均孔径增大。与此相反,以最高压制压力压制的颗粒片剂的最小孔隙体积随着湿度增加而增大。测量前进行仔细的预处理很重要。

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