洛索洛芬钠细粒剂项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.811172822117307211727201173568117289111730150.03
213.761170683117079911707410.01
单位质量响应值RSD%判断
84939.5485082.920.12数据可信
影响因素30天-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025020621批112813491283528128243899.0098.661.5397.08%～100.24%
212480631247149124760696.31
312704021270755127057898.08
412735751273465127352098.31
5130601013056541305832100.80
612899701287104128853799.47
2025020621批1131239713108451311621101.2599.221.6297.54%～100.91%
2130780013077181307759100.95
312780071277852127793098.65
412690571269866126946298.00
512591361259842125948997.23
612854651286363128591499.27
2025020621批112853901284811128510099.2099.500.7898.70%～100.31%
2129826812980811298174100.21
312945991294821129471099.95
412766921276990127684198.57
5129952813004831300006100.35
612802661277993127913098.74
洛索洛芬钠细粒剂项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.811171058117221611718551170688117208211715800.06
213.761167401116900211682020.10
单位质量响应值RSD%判断
84835.6384898.400.06数据可信
影响因素30天-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025020621批1129588012967031296292100.2499.801.5098.23%～101.36%
2130401613027641303390100.79
3131637113156331316002101.76
412917161290225129097099.83
512646011264871126473697.80
612721031271612127185898.35
2025020621批1130100112997241300362100.55100.090.8099.26%～100.92%
212790161278195127860698.87
3129452312967601295642100.19
4130547013032401304355100.86
512861411284394128526899.39
6130114013026781301909100.67
2025020621批1130299213031351303064100.76100.190.6599.51%～100.87%
2129464412945181294581100.11
3129635212970301296691100.27
412857891284976128538299.39
5130762513060361306830101.05
612872041288160128768299.57
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