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100
标示量(mg)100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%
110.223065692306377430663493061798306184330638910.07
210.233051875305384630528600.05
单位质量响应值RSD%判断
299793.64298422.290.33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%
5min1204690-2046906.8167.307.216.827.307.19
2240943-2409438.0238.02
3234288-2342887.8027.80
4215389-2153897.1727.17
5201260-2012606.7026.70
6218940-2189407.2917.29
10min1572420-57242019.06119.444.8719.0719.454.86
2606102-60610220.18320.19
3620200-62020020.65220.66
4561564-56156418.70018.71
5546019-54601918.18218.19
6596228-59622819.85419.86
15min1967413-96741332.21431.874.3932.2531.904.39
2974198-97419832.44032.48
31007590-100759033.55233.59
4913418-91341830.41630.45
5898655-89865529.92429.96
6980510-98051032.65032.69
20min11322697-132269744.04543.183.9644.1343.273.96
21304916-130491643.45343.54
31361812-136181245.34745.44
41240666-124066641.31341.40
51229829-122982940.95241.03
61320867-132086743.98444.07
30min11875644-187564462.45760.802.7262.6160.952.71
21825234-182523460.77960.93
31888321-188832162.88063.04
41779588-177958859.25959.41
51764969-176496958.77258.92
61821557-182155760.65660.81
45min12283013-228301376.02275.991.1376.2776.231.14
22297615-229761576.50976.76
32313300-231330077.03177.29
42278319-227831975.86676.10
52236425-223642574.47174.70
62283086-228308676.02576.27
60min12489495-248949582.89883.350.8583.2683.710.85
22498420-249842083.19583.56
32524444-252444484.06284.43
42503095-250309583.35183.70
52473443-247344382.36482.71
62529247-252924784.22284.58
极限12678911-267891189.20689.240.5889.6989.720.57
22662556-266255688.66189.15
32681080-268108089.27889.77
42695958-269595889.77390.25
52663196-266319688.68289.15
62698059-269805989.84390.33
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100
标示量(mg)100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%
110.223050318305947630542313053663305044530536270.13
210.233052332305034930513400.05
单位质量响应值RSD%判断
298789.33298273.700.13数据可信
供试品溶液-24123102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%
5min1254458-2544588.4908.643.518.498.643.48
2266043-2660438.8768.88
3248039-2480398.2758.28
4269302-2693028.9858.98
5250138-2501388.3458.35
6264959-2649598.8408.84
10min1667661-66766122.27522.962.2822.2922.972.27
2691244-69124423.06223.08
3683265-68326522.79622.81
4704738-70473823.51223.53
5675195-67519522.52722.54
6706173-70617323.56023.57
15min11083886-108388636.16237.272.1736.2137.322.17
21107528-110752836.95137.00
31140713-114071338.05838.10
41144612-114461238.18838.24
51098858-109885836.66236.71
61126409-112640937.58137.63
20min11476206-147620649.25150.102.7349.3550.202.73
21475845-147584549.23949.34
31576270-157627052.59052.69
41495231-149523149.88649.99
51467284-146728448.95349.05
61518391-151839150.65950.76
30min12087508-208750869.64669.581.6069.8269.761.60
22069804-206980469.05669.23
32149379-214937971.71071.89
42055846-205584668.59068.77
52068413-206841369.00969.18
62081780-208178069.45569.64
45min12542505-254250584.82685.170.6685.1185.460.67
22542054-254205484.81185.09
32583672-258367286.20086.49
42543663-254366384.86585.15
52561476-256147685.45985.74
62543622-254362284.86485.15
60min12716457-271645790.63090.550.3391.0490.960.33
22706671-270667190.30490.71
32726499-272649990.96591.38
42705062-270506290.25090.66
52721618-272161890.80291.21
62707402-270740290.32890.74
极限12805402-280540293.59893.440.4794.1493.980.47
22799120-279912093.38893.93
32817364-281736493.99794.55
42789163-278916393.05693.60
52810075-281007593.75394.30
62782845-278284592.84593.39
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100
标示量(mg)100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%
110.223056626308143830631183060752305669630637260.34
210.233060053306211830610860.05
单位质量响应值RSD%判断
299777.50299226.390.14数据可信
供试品溶液-25010201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%
5min1299609-2996099.9649.296.299.969.286.28
2302008-30200810.04310.04
3272123-2721239.0509.05
4258516-2585168.5978.60
5274330-2743309.1239.12
6268970-2689708.9458.94
10min1781979-78197926.00525.283.3426.0225.293.34
2783610-78361026.05926.07
3756769-75676925.16725.18
4738294-73829424.55224.57
5777273-77727325.84825.86
6722634-72263424.03124.04
15min11238605-123860541.19040.572.5641.2440.622.56
21219346-121934640.55040.60
31224283-122428340.71440.77
41206437-120643740.12040.17
51261777-126177741.96142.01
61169258-116925838.88438.93
20min11618614-161861453.82753.422.3553.9453.542.35
21587450-158745052.79152.91
31593422-159342252.99053.10
41613921-161392153.67153.78
51668647-166864755.49155.61
61556506-155650651.76251.87
30min12163145-216314571.93671.811.9472.1372.001.94
22124307-212430770.64470.84
32141911-214191171.23071.42
42178423-217842372.44472.63
52230571-223057174.17874.38
62117993-211799370.43470.62
45min12595865-259586586.32686.461.0186.6386.761.02
22580851-258085185.82786.13
32598423-259842386.41186.71
42594630-259463086.28586.58
52650823-265082388.15488.46
62578918-257891885.76386.05
60min12792590-279259092.86892.640.7093.3093.070.70
22778077-277807792.38692.81
32781644-278164492.50492.93
42766666-276666692.00692.43
52820782-282078293.80694.25
62774210-277421092.25792.68
极限12871707-287170795.49995.520.6696.0796.090.67
22864279-286427995.25295.82
32871741-287174195.50096.07
42849277-284927794.75395.32
52906814-290681496.66797.25
62870029-287002995.44396.00
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