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研究常见药用辅料-无水乳糖的固态属性变异性程度。

Investigation into the degree of variability in the solid-state properties of common pharmaceutical excipients-anhydrous lactose.

机构信息

Exploratory Biopharmaceutics R&D, Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral, CH46 1QW, UK.

出版信息

AAPS PharmSciTech. 2010 Dec;11(4):1552-7. doi: 10.1208/s12249-010-9527-4. Epub 2010 Oct 29.

DOI:10.1208/s12249-010-9527-4
PMID:21049309
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3011058/
Abstract

This paper reports the batch-to-batch and vendor-to-vendor variations in the solid-state characteristics of multiple batches of lactose anhydrous from each of three vendors and the subsequent impact of these differences on processability and/or functionality.

摘要

本文报告了三家用各自多批乳糖无水物的批次间和供应商间的固态特性差异，以及这些差异对可加工性和/或功能性的后续影响。

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本文引用的文献

1
Influence of amorphous content on compaction behaviour of anhydrous alpha-lactose.无定形含量对无水 α-乳糖压缩行为的影响。
Int J Pharm. 2010 Mar 15;387(1-2):71-8. doi: 10.1016/j.ijpharm.2009.12.009. Epub 2010 Jan 15.
2
Effect of milling and compression on the solid-state Maillard reaction.研磨和压缩对固态美拉德反应的影响。
J Pharm Sci. 2005 Nov;94(11):2568-80. doi: 10.1002/jps.20448.
3
Discoloration of tablets containing amines and lactose.含胺类和乳糖的片剂变色。
J Pharm Sci. 1962 Feb;51:106-8. doi: 10.1002/jps.2600510204.
4
Influence of physical parameters and lubricants on the compaction properties of granulated and non-granulated cross-linked high amylose starch.物理参数和润滑剂对颗粒状和非颗粒状交联高直链淀粉压实性能的影响。
Chem Pharm Bull (Tokyo). 2002 Sep;50(9):1155-62. doi: 10.1248/cpb.50.1155.
5
Analysis of the surface energy of pharmaceutical powders by inverse gas chromatography.用反相气相色谱法分析药用粉末的表面能
J Pharm Sci. 2002 Feb;91(2):571-83. doi: 10.1002/jps.10060.
6
The use of inverse phase gas chromatography to measure the surface energy of crystalline, amorphous, and recently milled lactose.使用反相气相色谱法测量结晶乳糖、无定形乳糖以及最近研磨的乳糖的表面能。
Pharm Res. 2001 May;18(5):662-6. doi: 10.1023/a:1011089511959.
7
Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine.乳糖与盐酸氟西汀（一种仲胺）的美拉德反应。
J Pharm Sci. 1998 Jan;87(1):31-9. doi: 10.1021/js9702067.
8
Studies on tabletting properties of lactose, Part I. The effect of initial particle size on binding properties and dehydration characteristics of lactose.乳糖压片性能的研究，第一部分。初始粒径对乳糖结合性能和脱水特性的影响。
Acta Pharm Suec. 1985;22(3):163-72.
9
Studies on tableting properties of lactose. VI. Consolidation and compaction of spray dried amorphous lactose.乳糖压片特性的研究。VI. 喷雾干燥无定形乳糖的固结与压实
Acta Pharm Suec. 1986;23(4):231-40.
10
The effect of the relationship between punch velocity and particle size on the compaction behaviour of materials with varying deformation mechanisms.冲头速度与颗粒尺寸之间的关系对具有不同变形机制的材料压实行为的影响。
J Pharm Pharmacol. 1986 Aug;38(8):567-71. doi: 10.1111/j.2042-7158.1986.tb03082.x.