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%
110.043045242304822030579143046363305350530502490.18
210.173046422304434230453820.05
单位质量响应值RSD%判断
303809.66299447.591.03数据可信
供试品溶液-6031901批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1319927-31992710.56510.057.4010.5610.057.38
2269176-2691768.8898.89
3328259-32825910.84010.84
4295194-2951949.7489.75
5320800-32080010.59410.59
6293197-2931979.6829.68
10min1784900-78490025.91925.694.5225.9425.714.52
2728871-72887124.06924.08
3831997-83199727.47527.49
4764163-76416325.23525.25
5796335-79633526.29726.31
6761779-76177925.15625.17
15min11212183-121218340.02940.293.7740.0840.343.78
21172525-117252538.72038.77
31294514-129451442.74842.81
41194736-119473639.45339.51
51255272-125527241.45241.51
61191269-119126939.33939.39
20min11588256-158825652.44853.173.8152.5653.283.82
21556971-155697151.41551.52
31689113-168911355.77955.90
41589557-158955752.49152.60
51683964-168396455.60955.73
61551948-155194851.24951.36
30min12165192-216519271.50071.631.7271.6971.821.73
22120948-212094870.03970.22
32211204-221120473.01973.22
42177008-217700871.89072.08
52207337-220733772.89273.09
62133024-213302470.43870.63
45min12691641-269164188.88586.891.5289.1987.201.52
22615522-261552286.37186.66
32611925-261192586.25286.57
42627943-262794386.78187.08
52662116-266211687.91088.22
62578965-257896585.16485.46
60min12856423-285642394.32693.210.6894.7693.640.68
22824791-282479193.28293.70
32805437-280543792.64293.09
42813741-281374192.91793.35
52829068-282906893.42393.86
62806510-280651092.67893.10
极限12934636-293463696.90996.290.3497.4896.860.34
22913607-291360796.21496.77
32912257-291225796.17096.75
42916642-291664296.31596.88
52906867-290686795.99296.57
62911593-291159396.14896.71
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%
110.043058233305299530501633052226305092330529080.11
210.173081099309210030866000.26
单位质量响应值RSD%判断
304074.50303500.490.14数据可信
供试品溶液-6031902批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1220949-2209497.2447.667.717.247.667.74
2250099-2500998.2008.20
3227995-2279957.4757.48
4206605-2066056.7746.77
5246641-2466418.0868.09
6249694-2496948.1868.19
10min1600257-60025719.68020.267.7119.6920.277.71
2684384-68438422.43822.45
3577440-57744018.93218.94
4567213-56721318.59718.61
5666626-66662621.85621.87
6612204-61220420.07220.08
15min1976436-97643632.01433.049.3532.0533.089.35
21133260-113326037.15537.20
3919357-91935730.14230.18
4922147-92214730.23430.27
51115768-111576836.58236.63
6979148-97914832.10232.14
20min11340196-134019643.94044.748.4944.0344.848.49
21540411-154041150.50450.61
31255200-125520041.15341.24
41259096-125909641.28141.36
51468505-146850548.14748.25
61324718-132471843.43243.52
30min11904834-190483462.45262.994.8862.6163.154.89
22050028-205002867.21267.39
31818269-181826959.61459.76
41832698-183269860.08760.23
52012897-201289765.99566.17
61908516-190851662.57362.73
45min12446932-244693280.22579.891.4380.4780.141.45
22490123-249012381.64181.92
32385043-238504378.19678.43
42417402-241740279.25779.49
52444470-244447080.14580.42
62435789-243578979.86080.11
60min12647219-264721986.79286.890.4887.1687.260.49
22658197-265819787.15287.55
32629008-262900886.19586.55
42650375-265037586.89587.25
52648860-264886086.84687.24
62666721-266672187.43187.80
极限12764273-276427390.63091.510.5791.1392.010.56
22791627-279162791.52792.06
32786577-278657791.36191.84
42807631-280763192.05192.54
52789900-278990091.47091.99
62806171-280617192.00392.50
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