Yoshioka S, Aso Y, Takeda Y
National Institute of Hygienic Sciences, Tokyo, Japan.
Pharm Res. 1990 Apr;7(4):388-91. doi: 10.1023/a:1015875507458.
A nonisothermal method was applied to shelf-life estimation of commercial vitamin A preparations. The usefulness and limitations of the nonisothermal method, as predicted by computer simulation, were validated. Degradation of vitamin A palmitate followed zero-order kinetics, and non-Arrhenius behavior was suggested for the rate constant. The nonisothermal method predicted a higher shelf-life value than the isothermal method for a syrup preparation, and vice versa, for an injection preparation. Analysis of the results suggested that the nonisothermal method provides better estimates of shelf lives than the isothermal method when drug degradation does not follow the Arrhenius equation near ambient conditions.
一种非等温方法被应用于商业维生素A制剂的保质期估算。通过计算机模拟预测的非等温方法的实用性和局限性得到了验证。棕榈酸视黄酯的降解遵循零级动力学，且速率常数表现出非阿累尼乌斯行为。对于糖浆制剂，非等温方法预测的保质期值比等温方法更高；而对于注射剂制剂，则相反。结果分析表明，当药物降解在环境条件附近不遵循阿累尼乌斯方程时，非等温方法比等温方法能更好地估算保质期。
