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四环素混悬剂稳定性的研究

THE STABILITY OF TETRACYCLINE IN SUSPENSIONS

  • 摘要: 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。

     

    Abstract: The statistical methodology and accelerated stability tests have been employed to investigate the effects of some adjuvants and of technological process on the stability of tetracycline (TC) in aqueous suspension. A more stable new formulation for suspension B has been developed. The result of accelerated stability tests has showed that the shelf-life (t0.9) of Suspension B under room temperature (25℃) is 24.7,but that of original product A is 19 months. Both chemical kinetic theory and experiment results indicate that the solubility of TC in the liquid medium of suspension is one of the important factors which are related to the stability of TC. The degradation of TC in suspension is exhibited by pseudo-zero order reaction, while in homogeneous solution, it can be illustrated by first order reaction of which apparent active energy(Ea) is 27.73 kcal/mol.

     

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