Huber H E, Streng W H, Tan H G
J Pharm Sci. 1979 Aug;68(8):1028-32. doi: 10.1002/jps.2600680829.
Osmolality-concentration profiles for individual and mixed solute systems are presented. Linear relationships between osmolality and concentration held true in all systems examined at concentrations below 0.2 molal levels. At higher concentrations, linearity existed only in select systems. Deviations from linearity can be greater or less than extrapolated values. In view of the need to determine an osmolarity conversion factor for each parenteral formulation and the many errors possible in the use of these values, adoption of osmolality values for labeling parenteral products rather than osmolarity, as stipulated in USP XIX-NF XIV third supplement, strongly recommended.
本文给出了单个溶质和混合溶质系统的渗透压浓度曲线。在浓度低于0.2摩尔浓度水平的所有测试系统中,渗透压与浓度之间的线性关系均成立。在较高浓度下,只有特定系统存在线性关系。与线性关系的偏差可能大于或小于外推值。鉴于需要为每种肠胃外制剂确定一个渗透压转换因子,以及使用这些值时可能出现的许多误差,强烈建议按照《美国药典》第十九版-《国家处方集》第十四版第三次增补的规定,在肠胃外产品标签中采用重量摩尔渗透压浓度值而非渗透压。