溶出曲线相似性因子f2-差异因子f1自动计算表格

PercentageDissolved(%)-AmpicillinCap250mg(R)MeanPercentageDissolved(%)Time(t)(mins)Sample1Sample2Sample3Sample4Sample5Sample6Sample7Sample8Sample9Sample10Sample11Sample12AverageSDCV(%)CVlimitallowed(%)Time(t)(mins)AmpicillinCap250mg(R)AmpicillinCap250mg(T)Difference(Rt-Tt)000000000000000#DIV/0!200000526.727.026.826.726.626.726.926.727.127.126.726.826.816666670.16966990.632703220526.8166666729.452.63333331065.865.665.965.565.96666.165.467.265.365.966.265.90.49543370.7517962201065.965.483333330.41666671575.275.876.475.378.680.479.675.678.177.175.371.676.583333332.37327293.0989418101576.5833333378.872727272.28939393086.085.787.585.586.482.987.385.78286.285.484.385.408333331.63009111.9085855103085.4083333390.658333335.254591.391.090.491.49290.493.292.090.389.191.092.891.241666671.14610671.2561221104591.2416666792.2250.98333336093.089.992.489.692.094.593.490.292.892.390.290.591.733333331.59962121.7437731106091.7333333392.050.3166667#DIV/0!#DIV/0!#DIV/0!100#DIV/0!#DIV/0!#DIV/0!#DIV/0!#DIV/0!#DIV/0!100#DIV/0!#DIV/0!#DIV/0!#DIV/0!#DIV/0!#DIV/0!100#DIV/0!#DIV/0!#DIV/0!COMPARISIONCALCULATIONSPercentageDissolved(%)-AmpicillinCap250mg(T)n6Time(t)(mins)Sample1Sample2Sample3Sample4Sample5Sample6Sample7Sample8Sample9Sample10Sample11Sample12AverageSDCV(%)CVlimitallowed(%)Sumof(Rt-Tt)11.88939394000000000000000#DIV/0!20SumofRt437.6833333529.028.831.028.528.529.528.728.528.631.431.929.029.451.24425954.2249920Sumof(Rt-Tt)240.979102391066.165.563.366.765.563.367.566.767.664.865.563.365.483333331.55670592.3772552201577.677.978.676.878.876.381.678.677.681.182.776.678.872727272.05674062.6076702103090.791.691.691.591.890.491.190.587.985.891.193.990.658333332.04470862.255400610f12.716437441Iff115,fail(Redtext)4591.891.491.491.791.592.192.392.493.891.692.394.492.2250.95358181.033973210f277.65616339Iff2=50or100,fail(Redtext)6091.791.791.891.892.592.493.989.691.690.793.293.792.051.21318511.317963210#DIV/0!#DIV/0!#DIV/0!10#DIV/0!#DIV/0!#DIV/0!10#DIV/0!#DIV/0!#DIV/0!10该自动计算表格用于非模型依赖法或模型依赖方法进行溶出曲线的比较，同时计算差异因子（f1）和相似因子（f2）。受试样品和参比样品各12片或6片均可，直接用溶出度的数据代替表格中的数据即可自动计算出f1和f2。（一）非模型依赖法非模型依赖的相似因子法1、采用差异因子（f1）或相似因子（f2）来比较溶出曲线是一种简单的非模型依赖方法。差异因子（f1）法是计算两条溶出曲线在每一时间点的差异（%），是衡量两条曲线相对偏差的参数。2、相似因子（f2）是衡量两条溶出曲线相似度的参数。差异因子和相似因子的具体测定步骤如下：（1）分别取受试（变更后）和参比样品（变更前）各12片（粒），测定其溶出曲线。（2）取两条曲线上各时间点的平均溶出度值，根据上述公式计算差异因子（f1）或相似因子（f2）。（3）f1值越接近0，f2值越接近100，则认为两条曲线相似。一般情况下，f1值小于15或f2值高于50，可认为两条曲线具有相似性，受试（变更后）与参比产品（变更前）具有等效性。SquareofDifference(Rt-Tt)206.9344444440.1736111115.2413246127.56250.9669444440.100277778#DIV/0!#DIV/0!#DIV/0!Iff115,fail(Redtext)Iff2=50or100,fail(Redtext)