Koshiro A, Fujita T
Drug Intell Clin Pharm. 1981 May;15(5):331-7. doi: 10.1177/106002808101500503.
A new method for predicting pharmaceutical stability in parenteral admixtures was studied using meclofenoxate hydrochloride injection as a model preparation. The pH and temperature of clinical parenteral admixtures are not constant, unlike experimental buffer solutions, and it is impossible to predict the accurate degradation ratio by the preceding method described by many authors. This study provides a solution to this problem making possible the accurate prediction of degradation ratios of pharmaceuticals even in such complicated systems.
以盐酸氯酯醒注射液作为模型制剂,研究了一种预测肠外混合液中药物稳定性的新方法。与实验缓冲溶液不同,临床肠外混合液的pH值和温度并不恒定,因此无法通过许多作者之前描述的方法准确预测降解率。本研究为解决这一问题提供了一种方法,即使在如此复杂的体系中也能准确预测药物的降解率。