塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.992961020295771129572662953038295389929565870.11
210.072930677292846129295690.06
单位质量响应值RSD%判断
295954.65290920.461.22数据可信
供试品溶液-第1批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1289209-2892099.81710.1910.239.8210.1910.23
2338990-33899011.50711.51
3258992-2589928.7918.79
4275049-2750499.3379.34
5318900-31890010.82510.83
6320236-32023610.87010.87
10min1745379-74537925.30226.346.5425.3226.366.54
2832889-83288928.27228.29
3760234-76023425.80625.82
4698676-69867623.71723.73
5799230-79923027.13027.15
6819620-81962027.82227.84
15min11183656-118365640.17941.375.0340.2341.425.03
21274470-127447043.26243.32
31205042-120504240.90540.96
41119958-111995838.01738.07
51251161-125116142.47142.53
61277357-127735743.36043.42
20min11523919-152391951.72954.124.7651.8454.244.76
21656981-165698156.24656.37
31597273-159727354.21954.33
41483057-148305750.34250.45
51635458-163545855.51655.64
61670065-167006556.69056.81
30min12040933-204093369.27972.403.8269.4772.593.82
22198046-219804674.61374.82
32143405-214340572.75872.95
42026558-202655868.79168.97
52166011-216601173.52573.73
62221534-222153475.41075.62
45min12495462-249546284.70886.092.3685.0086.392.37
22591296-259129687.96188.28
32552812-255281286.65586.96
42435942-243594282.68882.97
52554265-255426586.70487.02
62586757-258675787.80788.13
60min12672296-267229690.71191.381.2491.1391.821.25
22722025-272202592.39992.85
32697118-269711891.55491.99
42635373-263537389.45889.87
52706378-270637891.86892.31
62719625-271962592.31892.77
极限12787001-278700194.60594.790.5995.1695.360.61
22804901-280490195.21295.80
32796647-279664794.93295.50
42761627-276162793.74394.29
52799060-279906095.01495.60
62805071-280507195.21895.81
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.992955662295329829524862951302294987029525240.08
210.072955471295406929547700.04
单位质量响应值RSD%判断
295547.95293423.040.52数据可信
供试品溶液-第2批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1317807-31780710.74910.539.2610.7510.529.28
2349328-34932811.81511.82
3318497-31849710.77210.77
4322677-32267710.91410.91
5294572-2945729.9639.96
6264433-2644338.9448.94
10min1801863-80186327.12126.996.3327.1427.016.32
2859620-85962029.07429.09
3810860-81086027.42527.44
4818591-81859127.68627.70
5790096-79009626.72326.74
6707088-70708823.91523.93
15min11246710-124671042.16642.224.3242.2242.274.32
21317179-131717944.55044.61
31267729-126772942.87742.93
41263253-126325342.72642.78
51241972-124197242.00642.06
61152789-115278938.99039.04
20min11628879-162887955.09255.283.2155.2155.413.21
21702083-170208357.56857.70
31659494-165949456.12856.25
41649018-164901855.77355.90
51623717-162371754.91855.04
61544278-154427852.23152.34
30min12185046-218504673.90373.982.3874.1174.182.39
22256792-225679276.33076.54
32206296-220629674.62274.83
42202626-220262674.49874.70
52173756-217375673.52173.72
62098553-209855370.97871.16
45min12648187-264818789.56789.311.3489.8889.631.35
22691049-269104991.01791.35
32662545-266254590.05390.37
42630320-263032088.96389.28
52623585-262358588.73589.05
62588030-258803087.53387.83
60min12823486-282348695.49695.340.6995.9495.790.70
22842015-284201596.12396.59
32839941-283994196.05396.51
42799128-279912894.67295.12
52809281-280928195.01695.46
62799183-279918394.67495.10
极限12893730-289373097.87297.600.5598.4698.190.56
22900267-290026798.09398.70
32903377-290337798.19898.80
42863326-286332696.84497.44
52875094-287509497.24297.83
62878499-287849997.35797.92
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