乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.721735271734481725151730441726291730330.27
214.771742171739121740640.13
单位质量响应值RSD%判断
11754.9611784.970.19数据可信
供试品溶液-bc1批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min132362-3236216.41116.014.6516.4116.024.66
230581-3058115.50815.51
333239-3323916.85616.86
430385-3038515.40915.41
529883-2988315.15415.15
633025-3302516.74816.75
60min156432-5643228.61827.973.4628.6528.003.45
254777-5477727.77927.80
356811-5681128.81028.84
452592-5259226.67126.70
553262-5326227.01027.04
657018-5701828.91528.94
120min189143-8914345.20644.632.5345.2844.702.53
288483-8848344.87244.94
390522-9052245.90645.98
484350-8435042.77642.85
586471-8647143.85143.92
689105-8910545.18745.26
240min1128385-12838565.10764.291.6565.2664.441.65
2127116-12711664.46364.61
3129008-12900865.42365.58
4123109-12310962.43162.57
5126067-12606763.93164.07
6126923-12692364.36564.52
360min1154752-15475278.47877.731.3778.7477.991.37
2153515-15351577.85178.11
3155502-15550278.85979.12
4149512-14951275.82176.07
5152719-15271977.44777.70
6153655-15365577.92278.18
480min1168786-16878685.59584.961.1185.9885.341.12
2167171-16717184.77685.16
3168578-16857885.49085.88
4164181-16418183.26083.63
5167186-16718684.78485.16
6169293-16929385.85286.24
600min1177542-17754290.03589.370.9490.5789.900.95
2175817-17581789.16189.69
3178012-17801290.27490.81
4173375-17337587.92288.43
5175896-17589689.20189.72
6176741-17674189.62990.16
720min1183052-18305292.83092.231.0593.5192.911.05
2180829-18082991.70292.38
3184017-18401793.31994.01
4178753-17875390.65091.31
5181670-18167092.12992.80
6182911-18291192.75893.44
960min1191030-19103096.87697.861.1197.7198.691.11
2193866-19386698.31499.14
3195248-19524899.01599.86
4189665-18966596.18396.99
5194008-19400898.38699.21
6193986-19398698.37599.21
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1189083-18908395.88897.081.2096.8998.081.20
2191728-19172897.23098.22
3193810-19381098.28599.29
4188251-18825195.46696.43
5193510-19351098.13399.12
6192259-19225997.49998.50
1440min1188684-18868495.68696.971.1096.8498.121.10
2191872-19187297.30398.46
3193668-19366898.21399.38
4188577-18857795.63296.76
5192119-19211997.42898.58
6192348-19234897.54498.71
极限1189490-18949096.09596.941.1497.4198.251.13
2192148-19214897.44398.76
3192490-19249097.61698.95
4187599-18759995.13696.42
5193330-19333098.04299.35
6191824-19182497.27898.60
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.721730251735581732531734781730961732820.14
214.771734521733311733920.05
单位质量响应值RSD%判断
11771.8811739.470.20数据可信
供试品溶液-bc2批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min1145808-14580874.03282.565.2374.0382.565.23
2167793-16779385.19585.20
3167747-16774785.17285.17
4166752-16675284.66684.67
5162080-16208082.29482.29
6165481-16548184.02184.02
60min1166884-16688484.73390.543.2184.8690.683.21
2179596-17959691.18891.33
3181870-18187092.34292.48
4178984-17898490.87791.02
5181281-18128192.04392.18
6181277-18127792.04192.18
120min1182105-18210592.46295.091.6392.7395.381.64
2187385-18738595.14395.44
3190177-19017796.56096.86
4185475-18547594.17394.47
5189455-18945596.19496.48
6189088-18908896.00796.30
240min1188062-18806295.48696.711.0595.9197.161.05
2191534-19153497.24997.70
3192805-19280597.89598.35
4188060-18806095.48595.93
5191655-19165597.31197.76
6190716-19071696.83497.29
360min1194289-19428998.64899.750.9999.23100.360.99
2197440-197440100.248100.86
3198964-198964101.022101.64
4194083-19408398.54399.15
5197499-197499100.278100.89
6196499-19649999.770100.39
480min1194083-19408398.54399.510.9999.29100.280.99
2196791-19679199.918100.70
3198193-198193100.630101.42
4193238-19323898.11498.89
5197323-197323100.189100.97
6196272-19627299.655100.44
600min1193730-19373098.36499.210.9399.27100.150.94
2196197-19619799.617100.57
3197268-197268100.161101.12
4192606-19260697.79498.73
5196216-19621699.626100.57
6196383-19638399.711100.66
720min1192473-19247397.72698.711.1098.8099.821.10
2195624-19562499.326100.44
3196848-19684899.947101.07
4191233-19123397.09698.20
5194972-19497298.995100.11
6195344-19534499.184100.30
960min1188244-18824495.57995.430.9196.8196.700.90
2187714-18771495.31096.59
3189949-18994996.44497.73
4184974-18497493.91895.18
5187702-18770295.30496.58
6189133-18913396.03097.31
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1190996-19099696.97696.650.7498.3798.080.73
2190035-19003596.48897.93
3192439-19243997.70999.16
4188177-18817795.54596.96
5190407-19040796.67798.11
6190083-19008396.51397.95
1440min1192561-19256197.77197.730.6399.3299.320.63
2192020-19202097.49699.10
3194462-19446298.736100.35
4190783-19078396.86898.44
5192182-19218297.57899.18
6192838-19283897.91199.51
极限1191615-19161597.29097.380.7399.0199.130.73
2191722-19172297.34599.11
3193945-19394598.473100.25
4189652-18965296.29498.03
5191508-19150897.23699.00
6192301-19230197.63999.40
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