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本文应用数理统计方法和稳定性升温加速试验研究了一些辅料及工艺对四环素混悬剂稳定性的影响,筛选和设计了该混悬剂的新处方。新处方混悬剂的贮存期(t_(0.9))经预测从原产品的19个月提高到24.7个月。并从实验结果和理论上说明:四环素在混悬剂液相介质中的溶解度是与其稳定性有关的重要因素之一;四环素复合物在混悬剂中的降解是伪零级速度过程;在均相溶液中的降解可以近似地用一级速度过程表示,降解的表观活化能是27.73千卡/克分子。
In this paper, the effects of some excipients and processes on the stability of tetracycline suspension were studied by mathematical statistics and accelerated warming test. The new formulation of the suspension was screened and designed. The shelf-life of the new prescription suspension (t_ (0.9)) was predicted to increase from 19 months of the original product to 24.7 months. The experimental results and theoretical results show that the solubility of tetracycline in the suspension medium is one of the important factors related to its stability. The degradation of the tetracycline complex in the suspension is pseudo-zero-order speed process. Degradation in the phase solution can be approximated by a first-order rate process with an apparent activation energy of 27.73 kcal / mol.