一种新的溶出曲线比较方案

目的: 建立简便实用的溶出曲线比较方案。 方法: 用概率论和统计学方法推导溶出曲线比较方案。 结果: 按AV=|D|+kS=|D_R -D_T |+ 4.85 e^{|D_R -D_T |×0.75+1 +k S2_<em>R+S2_<em>T 计算各时间点AV值,忽略参比制剂溶出值小于10%和大于90%的时间点,如果所有有效时间点的AV值均小于等于15.0,则认为2个产品溶出曲线整体相似;如果部分有效时间点的AV值小于等于15.0,但所有有效时间点AV的平均值小于等于15.0,则认为2个产品溶出曲线基本相似;如果AV的平均值大于15.0,则认为2个产品溶出曲线不相似。 结论: 本方案可用于溶出曲线比较。}

Objective: To establish a simple evaluation for drug dissolution profiles. Methods: To derive evaluation method by using probability theory and statistics. Results: To calculate AV values for every point by AV=|D|+kS=|D_R -D_T |+ 4.85 e^{|D_R -D_T |×0.75+1 +k S2_<em>R+S2_<em>T ,ignore the points of the dissolution below 10% and over 90% of reference preparation.The dissolution profiles are globally similar when all the AV values are less than 15.0.The dissolution profiles are locally similar when any AV values are larger than 15.0,but the average AV value is less than 15.0.If the average AV value is large than 15.0,the dissolution Profiles are not similar. Conclusion: This evaluation can be used for comparing dissolution profiles.}