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首次提出了药物有效期与温度的线性模型。该模型以药物有效期的对数(lnt0.9)对温度的倒数(1/T)作回归,只需几个较高温度下所测定的药物贮藏期,即可根据此模型计算出药物在室温下的贮藏期。运用MonteCarlo方法分别模拟了0级、1级、2级、3/2级反应数据,结果表明,对于在贮藏期内发生降解反应,其降解规律又符合Arhenius公式的药物,无论其反应级数为多少,lnt0.9与1/T之间都呈现出良好的线性关系。应用此模型能够有效、直观地预测药物在室温下的有效期,且无需知道反应的活化能。
For the first time, a linear model of drug expiration and temperature was proposed. The model regresses the reciprocal of the temperature (l / T) with the logarithm of drug expiration (lnt0.9), and simply measures the shelf-life of the drug at several higher temperatures to calculate the drug at room temperature Under the storage period. The Monte Carlo method was used to simulate the data of 0, 1, 2 and 3/2 levels, respectively. The results showed that for the degradation reaction occurring during the storage period, the degradation was in accordance with the Arhenius formula, no matter the reaction order was How much, lnt0.9 and 1 / T showed a good linear relationship between. Applying this model can effectively and intuitively predict the drug’s expiration date at room temperature without knowing the activation energy of the reaction.