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水分对羟丙基淀粉钠可压性和压缩成型性的影响。

Effect of moisture on the compressibility and compactibility of sodium starch glycolate.

作者信息

Young Paul M, Edge Stephen, Staniforth John N, Steele D Fraser, Traini Daniela, Price Robert

机构信息

Pharmaceutical Technology Research Group, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK.

出版信息

Pharm Dev Technol. 2007;12(2):217-22. doi: 10.1080/10837450601168797.

Abstract

The relationship between the apparent moisture content and compactibility of sodium starch glycolate was compared to similarly obtained data for pregelatinized starch. Samples of sodium starch glycolate (SSG) and pregelatinised starch (PGS) were stored at 44% or 75% relative humidity (RH), producing samples exhibiting moisture contents of up to 14% w/w, as determined by loss on drying (LOD). Increasing the moisture content of SSG and PGS resulted in an increase in compressibility and compactibility for both materials. However, the effect was more dramatic for SSG with unlubricated compactibilities of 2.0 MPa and 0.9 MPa at approximately 11.5% LOD for SSG and PGS, respectively, which was further exemplified in the compactibility of lubricated materials and in blends with microcrystalline cellulose. These results suggested that moisture content had a greater effect on the compactibility of SSG compared with PGS and that the interactions of water with the components of the SSG starch granules may be different from those within the PGS starch granules at comparable LOD values.

摘要

将羟丙基二淀粉磷酸酯的表观水分含量与可压性之间的关系,与预胶化淀粉以类似方式获得的数据进行了比较。羟丙基二淀粉磷酸酯(SSG)和预胶化淀粉(PGS)样品在44%或75%相对湿度(RH)下储存,通过干燥失重(LOD)测定,得到水分含量高达14% w/w的样品。SSG和PGS水分含量的增加导致两种材料的可压缩性和可压性均增加。然而,这种影响对SSG更为显著,对于未润滑的可压性,SSG和PGS在约11.5% LOD时分别为2.0 MPa和0.9 MPa,这在润滑材料以及与微晶纤维素的混合物的可压性中得到了进一步体现。这些结果表明,与PGS相比,水分含量对SSG的可压性影响更大,并且在相当的LOD值下,水与SSG淀粉颗粒成分的相互作用可能与PGS淀粉颗粒内的相互作用不同。

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