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%
110.203038452304427530409713041730304067330412200.07
210.263040247303590230380740.11
单位质量响应值RSD%判断
298158.82296108.580.49数据可信
供试品溶液-6021301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%
5min1342049-34204911.46612.558.8911.4712.558.89
2349905-34990511.72911.73
3423481-42348114.19514.20
4405173-40517313.58213.58
5351426-35142611.78011.78
6373494-37349412.52012.52
10min1887627-88762729.75431.596.5629.7731.616.57
2906560-90656030.38830.41
31036081-103608134.73034.75
4989140-98914033.15733.18
5881339-88133929.54329.56
6954091-95409131.98232.00
15min11371421-137142145.97147.935.2746.0347.995.27
21397874-139787446.85846.92
31550880-155088051.98752.06
41490590-149059049.96650.04
51358291-135829145.53145.59
61409692-140969247.25447.32
20min11781729-178172959.72561.063.7559.8661.203.75
21803238-180323860.44660.58
31933185-193318564.80264.95
41874559-187455962.83662.98
51753861-175386158.79158.92
61782444-178244459.74959.89
30min12348809-234880978.73478.911.5978.9579.141.59
22329798-232979878.09678.32
32420124-242012481.12481.37
42374096-237409679.58179.82
52325381-232538177.94878.17
62326865-232686577.99878.23
45min12733598-273359891.63291.410.6191.9791.760.61
22700635-270063590.52790.87
32750107-275010792.18592.56
42722119-272211991.24791.61
52722671-272267191.26691.60
62732833-273283391.60691.95
60min12859092-285909295.83995.490.6496.3195.970.64
22819087-281908794.49894.97
32851910-285191095.59896.11
42835691-283569195.05495.55
52857679-285767995.79196.26
62868400-286840096.15196.63
极限12905963-290596397.41097.390.6398.0398.020.62
22888170-288817096.81397.43
32901478-290147897.25997.91
42885250-288525096.71597.35
52917905-291790597.81098.43
62933177-293317798.32298.95
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%
110.203024931302684430257863025812302344030253630.05
210.263023823302644630251340.07
单位质量响应值RSD%判断
296604.22294847.370.43数据可信
供试品溶液-6021302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%
5min1307802-30780210.36710.0410.9610.3710.0410.97
2342030-34203011.52011.52
3262853-2628538.8538.85
4318956-31895610.74210.74
5257784-2577848.6828.68
6298629-29862910.05810.06
10min1803979-80397927.07826.358.1827.0926.368.18
2874807-87480729.46429.48
3708255-70825523.85423.87
4805555-80555527.13127.15
5709375-70937523.89223.90
6791338-79133826.65226.67
15min11232269-123226941.50340.725.4941.5640.775.49
21301302-130130243.82843.89
31128255-112825538.00038.05
41236013-123601341.62941.69
51134783-113478338.22038.27
61221031-122103141.12541.18
20min11592970-159297053.65152.884.4053.7752.994.40
21678244-167824456.52456.65
31497432-149743250.43450.54
41572038-157203852.94653.07
51492556-149255650.27050.38
61586239-158623953.42553.54
30min12112578-211257871.15270.662.7471.3570.852.75
22184433-218443373.57273.78
32049896-204989669.04169.22
42065858-206585869.57869.78
52036123-203612368.57768.76
62138048-213804872.01072.21
45min12543313-254331385.65985.321.2385.9685.621.23
22575603-257560386.74787.07
32524314-252431485.01985.30
42510012-251001284.53884.84
52491127-249112783.90284.19
62555424-255542486.06786.37
60min12696848-269684890.83090.750.7191.2691.180.72
22717953-271795391.54191.99
32700691-270069190.96091.37
42673551-267355190.04690.48
52669772-266977289.91890.33
62707392-270739291.18591.62
极限12788548-278854893.91994.280.6094.4994.840.61
22820748-282074895.00395.59
32814528-281452894.79495.34
42785294-278529493.80994.37
52780397-278039793.64494.19
62806213-280621394.51495.08
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%
110.203019652302398530190703020601301851830203650.08
210.263036750302882630327880.19
单位质量响应值RSD%判断
296114.22295593.370.13数据可信
供试品溶液-24123101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%
5min1281609-2816099.4809.445.129.489.445.11
2292320-2923209.8419.84
3261875-2618758.8168.82
4263503-2635038.8718.87
5292514-2925149.8489.85
6290814-2908149.7909.79
10min1743866-74386625.04224.684.2825.0624.704.28
2746834-74683425.14225.16
3688907-68890723.19223.21
4713484-71348424.02024.03
5780073-78007326.26126.28
6725448-72544824.42224.44
15min11179000-117900039.69138.743.6739.7438.793.67
21144870-114487038.54238.59
31098992-109899236.99837.05
41140244-114024438.38738.44
51217927-121792741.00241.06
61123442-112344237.82137.87
20min11554833-155483352.34450.592.1652.4650.702.17
21491681-149168150.21850.33
31469880-146988049.48449.59
41496398-149639850.37750.48
51526952-152695251.40551.52
61475876-147587649.68649.79
30min12096288-209628870.57268.601.6570.7668.791.65
22023053-202305368.10768.29
32013595-201359567.78867.97
42042077-204207768.74768.93
52049539-204953968.99869.19
62002562-200256267.41767.60
45min12541740-254174085.56884.401.0685.8684.681.06
22514034-251403484.63684.92
32502637-250263784.25284.53
42494406-249440683.97584.26
52524159-252415984.97785.27
62464628-246462882.97283.26
60min12742106-274210692.31491.510.9792.7491.920.96
22735697-273569792.09892.51
32727609-272760991.82692.23
42708990-270899091.19991.61
52724530-272453091.72292.15
62670026-267002689.88790.30
极限12826488-282648895.15594.650.8595.7295.200.85
22827687-282768795.19595.75
32828649-282864995.22795.77
42806165-280616594.47095.02
52813574-281357494.72095.28
62766456-276645693.13493.68
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