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目的建立受试制剂多个剂量溶出曲线与单条参考溶出曲线的比较方案。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-R|+4.82/e|D-R|×0.81+1+kS计算各时间点AV值,忽略受试制剂溶出值小于10%和大于90%的时间点,如果各时间点的AV值均小于等于15.0,则认为受试制剂与参考溶出曲线整体相似;部分时间点的AV值小于15.0,且平均AV值小于等于15.0,则认为受试制剂与参考溶出曲线基本相似;如果平均AV值大于15.0,则认为受试制剂与参考溶出曲线不相似。结论本方案可用于受试制剂多个剂量溶出曲线与单条参考曲线的比较。
OBJECTIVE To establish a comparison protocol of multiple dose dissolution curves and single reference dissolution curves of test preparations. Methods Probability and statistical methods were used to derive a comparison of dissolution profiles. Results AV value at each time point was calculated according to AV = | DR | + 4.82 / e | DR | × 0.81 + 1 + kS. When the dissolution value of the test formulation was less than 10% and greater than 90% Value of less than or equal to 15.0, then that the test preparation and the reference dissolution curve similar to the whole; part of the time point of AV value is less than 15.0, and the average AV value of less than or equal to 15.0, that the test formulation and the reference dissolution curve is similar; If the value is greater than 15.0, the test preparation is considered dissimilar to the reference dissolution curve. Conclusion This protocol can be used for the comparison of multiple dose dissolution curves and single reference curves.