奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数200
标示量(mg)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.854723724734324732844733924737244732410.11
213.864729164727474728320.03
单位质量响应值RSD%判断
34169.0334114.860.12数据可信
供试品溶液-24042801批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100517-10051722.16922.0811.6922.1722.0811.70
2115709-11570925.52025.52
382362-8236218.16518.16
492879-9287920.48420.48
5108687-10868723.97123.97
6100464-10046422.15722.16
10min1245293-24529354.09958.435.8554.3558.685.86
2288205-28820563.56463.85
3252569-25256955.70455.91
4260077-26007757.36057.59
5272277-27227760.05160.32
6271238-27123859.82260.07
15min1329798-32979872.73763.9549.1073.5864.8448.40
2375800-37580082.88383.87
3345962-34596276.30277.12
4333698-33369873.59774.46
51307-13070.2881.22
6353096-35309677.87578.79
20min1352273-35227377.69485.665.0579.3587.274.90
2406578-40657889.67191.58
3391725-39172586.39588.06
4384708-38470884.84786.53
5404406-40440689.19290.13
6390739-39073986.17787.95
30min1372826-37282682.22791.295.7084.7593.855.67
2445890-44589098.341101.25
3421899-42189993.05095.68
4414996-41499691.52794.15
5414058-41405891.32093.25
6413804-41380491.26494.00
45min1409823-40982390.38694.943.2493.8298.513.21
2448660-44866098.952102.95
3430932-43093295.04298.70
4435898-43589896.13799.78
5438271-43827196.66199.60
6419302-41930292.47796.22
60min1415428-41542891.62394.003.1696.0698.623.16
2449582-44958299.155104.25
3425843-42584393.92098.64
4425509-42550993.84698.56
5429721-42972194.77598.79
6411062-41106290.66095.43
极限1406780-40678089.71594.192.5195.1799.862.54
2438376-43837696.684102.88
3430556-43055694.959100.72
4428414-42841494.487100.24
5431230-43123095.108100.18
6426946-42694694.16399.95
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数200
标示量(mg)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.854726064727954725834725374725054726050.03
213.864722514709044715780.21
单位质量响应值RSD%判断
34123.1034024.390.21数据可信
供试品溶液-24042802批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116293-11629325.70025.524.3225.7025.524.31
2123321-12332127.25327.25
3118603-11860326.21026.21
4111667-11166724.67724.68
5109858-10985824.27824.28
6113058-11305824.98524.98
10min1274243-27424360.60561.393.1160.8961.673.11
2287263-28726363.48363.79
3287125-28712563.45263.74
4280940-28094062.08562.36
5270012-27001259.67059.94
6267188-26718859.04659.32
15min1364059-36405980.45479.621.6781.4180.581.67
2355356-35535678.53179.54
3366901-36690181.08282.08
4365660-36566080.80881.77
5352691-35269177.94278.87
6356921-35692178.87779.81
20min1397297-39729787.79988.341.3089.6590.191.29
2399263-39926388.23490.11
3409037-40903790.39492.29
4395745-39574587.45689.32
5395209-39520987.33889.14
6401830-40183088.80190.61
30min1421740-42174093.20193.511.9296.0396.341.89
2423888-42388893.67696.54
3438246-43824696.84999.75
4415920-41592091.91594.75
5422380-42238093.34296.11
6416546-41654692.05394.85
45min1418988-41898892.59394.841.4096.4698.721.35
2431164-43116495.28499.19
3432972-43297295.68399.66
4426230-42623094.19398.05
5429527-42952794.92298.73
6436105-43610596.376100.20
60min1415968-41596891.92593.951.5996.8298.881.50
2420598-42059892.94997.91
3424367-42436793.78298.82
4435335-43533596.205101.11
5425191-42519193.96498.82
6429440-42944094.90399.79
极限1422943-42294393.46794.861.0799.38100.831.04
2430927-43092795.231101.22
3429886-42988695.001101.08
4432747-43274795.634101.60
5424570-42457093.82699.73
6434472-43447296.015101.96
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