奥利司他胶囊项目信息
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5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%
113.474613394627334623664630984650554629180.30
213.494595174595174595170.00
单位质量响应值RSD%判断
34366.5934063.530.63数据可信
供试品溶液-2024102221批-pH4.5(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%
5min125478-254785.5574.1635.475.564.1635.45
225303-253035.5195.52
313881-138813.0283.03
420781-207814.5334.53
520647-206474.5034.50
68286-82861.8071.81
10min181667-8166717.81215.5114.3717.8215.5114.39
281856-8185617.85417.86
369074-6907415.06615.07
473050-7305015.93315.94
565939-6593914.38214.39
654979-5497911.99111.99
15min1143710-14371031.34528.2610.6931.3828.2910.70
2144182-14418231.44831.49
3131458-13145828.67228.70
4131452-13145228.67128.71
5115369-11536925.16325.19
6111245-11124524.26424.29
20min1198281-19828143.24740.048.4143.3440.128.42
2198258-19825843.24243.33
3189797-18979741.39741.47
4185686-18568640.50040.58
5164225-16422535.81935.89
6165126-16512636.01636.08
30min1280483-28048361.17658.735.3061.3458.885.32
2280374-28037461.15261.32
3279319-27931960.92261.07
4272610-27261059.45959.61
5248435-24843554.18654.32
6254348-25434855.47655.60
45min1356877-35687777.83876.763.0478.1077.003.06
2356365-35636577.72777.99
3363451-36345179.27279.52
4357105-35710577.88878.14
5335119-33511973.09373.32
6342657-34265774.73774.95
60min1401619-40161987.59787.221.8887.9987.591.89
2399234-39923487.07787.47
3410433-41043389.52089.90
4403744-40374488.06188.44
5388257-38825784.68385.03
6395967-39596786.36486.70
极限1427091-42709193.15393.341.7393.6993.861.74
2424296-42429692.54393.08
3438492-43849295.63996.17
4433446-43344694.53995.06
5417121-41712190.97891.46
6427255-42725593.18993.67
奥利司他胶囊项目信息
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5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%
113.474711364722384716034715974721174717380.10
213.494640514631924636220.14
单位质量响应值RSD%判断
35021.3834367.831.34数据可信
供试品溶液-2024102221批-pH4.5(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%
5min139851-398518.5725.0942.198.575.0942.19
231195-311956.7106.71
323265-232655.0055.00
415712-157123.3803.38
515407-154073.3143.31
616672-166723.5863.59
10min174198-7419815.96115.5314.6915.9815.5414.69
288667-8866719.07319.08
379679-7967917.14017.15
463837-6383713.73213.74
564694-6469413.91613.92
661998-6199813.33613.34
15min1129350-12935027.82427.4910.4727.8727.5210.48
2147294-14729431.68431.73
3139549-13954930.01830.06
4118373-11837325.46325.49
5118350-11835025.45825.49
6113803-11380324.48024.51
20min1181142-18114238.96539.047.5739.0539.127.58
2199785-19978542.97643.07
3195628-19562842.08242.17
4171579-17157936.90836.98
5175907-17590737.83937.91
6164814-16481435.45335.52
30min1263083-26308356.59257.105.3156.7457.255.32
2281764-28176460.61060.78
3281914-28191460.64360.80
4252786-25278654.37754.51
5264687-26468756.93757.07
6248528-24852853.46153.59
45min1344591-34459174.12575.313.1874.3775.543.20
2359266-35926677.28277.55
3364794-36479478.47178.73
4336670-33667072.42172.64
5354473-35447376.25176.48
6340693-34069373.28773.50
60min1390599-39059984.02285.702.6284.3986.062.62
2403342-40334286.76387.16
3412653-41265388.76689.15
4385097-38509782.83883.18
5405431-40543187.21287.57
6393310-39331084.60584.94
极限1420075-42007590.36291.922.1490.8792.422.15
2428421-42842192.15892.70
3439162-43916294.46895.01
4414725-41472589.21289.69
5435177-43517793.61194.11
6426230-42623091.68692.17
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