Kwong K W, Tsallas G
Am J Hosp Pharm. 1980 Feb;37(2):206-10.
The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Total iron and free ferrous ion content of the preparations were measured for: (1) the dilute solutions at monthly intervals after up to three months of storage at room temperature and under refrigeration and (2) the parenteral nutrient solutions after 18 hours of storage at room temperature. Four of the seven dilute solutions were stable after two months of storage. The easiest-to-prepare dilute solution (iron dextran, benzyl alcohol, and sterile water for injection) was stable for three months; stability was greater when refrigerated. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. The study suggests that addition of recommended daily doses of iron dextran to parenteral nutrient solutions creates no stability problems; however, further study of the effects of temperature, pH, light, and storage time are recommended.
研究了稀铁右旋糖酐制剂以及一种制剂在肠外营养液中的稳定性。制备了七种稀（50mg/dl）铁右旋糖酐溶液制剂和四种每升含100mg铁右旋糖酐的肠外营养液。对制剂的总铁和游离亚铁离子含量进行了测定：（1）稀溶液在室温及冷藏条件下储存长达三个月后每月测定一次；（2）肠外营养液在室温下储存18小时后测定。七种稀溶液中有四种在储存两个月后是稳定的。最易制备的稀溶液（铁右旋糖酐、苯甲醇和注射用无菌水）在三个月内稳定；冷藏时稳定性更高。铁右旋糖酐在室温下储存18小时后在四种肠外营养液中是稳定的。该研究表明，向肠外营养液中添加推荐日剂量的铁右旋糖酐不会产生稳定性问题；然而，建议进一步研究温度、pH值、光照和储存时间的影响。
