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%
110.073038623303763030378693037549303353730370420.07
210.083043606303475330391800.21
单位质量响应值RSD%判断
301593.05301505.950.03数据可信
供试品溶液-25010701-2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%
5min1276112-2761129.1208.345.469.128.345.46
2244100-2441008.0628.06
3236455-2364557.8107.81
4258871-2588718.5508.55
5250244-2502448.2658.27
6248557-2485578.2108.21
10min1718570-71857023.73422.484.0023.7522.494.00
2686694-68669422.68122.69
3639936-63993621.13721.15
4698359-69835923.06623.08
5671628-67162822.18322.20
6667589-66758922.05022.06
15min11153102-115310238.08636.323.7238.1436.363.73
21116454-111645436.87636.92
31052080-105208034.75034.79
41134903-113490337.48537.53
51073155-107315535.44635.49
61067784-106778435.26835.31
20min11533791-153379150.66048.263.7950.7748.363.79
21475722-147572248.74248.84
31405998-140599846.43946.53
41511291-151129149.91750.02
51441079-144107947.59847.70
61399051-139905146.21046.31
30min12103761-210376169.48666.513.4669.6766.683.46
22047798-204779867.63867.81
31940282-194028264.08664.25
42068057-206805768.30768.49
51982724-198272465.48865.66
61939191-193919164.05064.22
45min12560286-256028684.56581.962.2484.8582.242.24
22522199-252219983.30783.58
32424875-242487580.09280.35
42502325-250232582.65082.93
52453702-245370281.04481.31
62426010-242601080.13080.39
60min12739411-273941190.48188.601.3190.8989.001.32
22703510-270351089.29589.70
32647722-264772287.45387.83
42687611-268761188.77089.18
52664397-266439788.00388.39
62652797-265279787.62088.00
极限12849578-284957894.12092.581.0594.6793.101.06
22823389-282338993.25593.79
32778625-277862591.77692.29
42806449-280644992.69593.23
52778910-277891091.78692.31
62780120-278012091.82692.34
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%
110.073045825304716430555093041472303938630458710.21
210.083029998303917830345880.22
单位质量响应值RSD%判断
302469.81301050.400.34数据可信
供试品溶液-25010702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%
5min1258880-2588808.5458.276.978.548.276.98
2257065-2570658.4858.48
3236733-2367337.8147.81
4251725-2517258.3098.31
5224796-2247967.4207.42
6274097-2740979.0479.05
10min1701302-70130223.14822.056.1623.1622.076.16
2691764-69176422.83322.85
3666837-66683722.01022.02
4643004-64300421.22321.24
5599576-59957619.79019.80
6706375-70637523.31523.33
15min11132603-113260337.38335.614.5937.4335.654.60
21106713-110671336.52936.58
31096649-109664936.19736.24
41056213-105621334.86234.91
5991378-99137832.72232.76
61088835-108883535.93935.99
20min11479788-147978848.84346.823.6948.9546.923.69
21420733-142073346.89347.00
31458528-145852848.14148.24
41401579-140157946.26146.36
51329048-132904843.86743.96
61421702-142170246.92547.03
30min12018889-201888966.63763.892.9566.8164.062.94
21932955-193295563.80063.97
31980190-198019065.35965.53
41911334-191133463.08763.25
51856590-185659061.28061.44
61914677-191467763.19763.37
45min12468497-246849781.47779.212.0481.7579.472.04
22397243-239724379.12579.39
32443994-244399480.66880.94
42388701-238870178.84379.10
52341779-234177977.29477.54
62357918-235791877.82778.09
60min12634045-263404586.94185.851.3387.3486.231.33
22602215-260221585.89086.28
32641184-264118487.17687.57
42605532-260553286.00086.38
52557711-255771184.42184.78
62564798-256479884.65585.04
极限12756165-275616590.97189.800.9091.5090.310.91
22729621-272962190.09590.61
32730386-273038690.12190.64
42719963-271996389.77790.28
52686063-268606388.65889.15
62702240-270224089.19289.70
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