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%
110.051525059152569815251851524909152564415252990.03
210.101526437152538715259120.05
单位质量响应值RSD%判断
151771.04151080.400.33数据可信
供试品溶液-2023010511批-pH4.5(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%
5min1204625-20462513.45912.7011.4113.4612.7011.41
2208616-20861613.72213.72
3203312-20331213.37313.37
4153399-15339910.09010.09
5208028-20802813.68313.68
6180821-18082111.89411.89
10min1483674-48367431.81430.0311.5431.8330.0511.54
2485796-48579631.95331.97
3466248-46624830.66830.69
4358131-35813123.55623.57
5504259-50425933.16833.19
6441509-44150929.04029.06
15min1751307-75130749.41746.3711.2149.4946.4411.21
2736062-73606248.41548.48
3714633-71463347.00547.07
4561858-56185836.95637.01
5787604-78760451.80551.88
6678600-67860044.63544.70
20min1991525-99152565.21860.6810.4165.3660.8210.41
2947026-94702662.29162.43
3926018-92601860.90961.05
4753776-75377649.58049.69
51028015-102801567.61867.77
6889112-88911258.48158.61
30min11289187-128918784.79680.996.9285.0481.226.93
21255637-125563782.59082.82
31234063-123406381.17181.40
41073144-107314470.58670.77
51316147-131614786.57086.82
61219723-121972380.22780.44
45min11430825-143082594.11393.152.0094.4893.502.02
21442064-144206494.85295.21
31414490-141449093.03893.39
41362109-136210989.59389.88
51418129-141812993.27893.66
61429699-142969994.03994.38
60min11457144-145714495.84495.631.2096.3596.121.21
21471984-147198496.82097.32
31450823-145082395.42895.92
41425800-142580093.78294.20
51446285-144628595.13095.65
61471444-147144496.78497.26
极限11479080-147908097.28797.450.8497.9498.080.84
21491390-149139098.09698.74
31479919-147991997.34297.97
41470585-147058596.72897.29
51467960-146796096.55597.22
61500461-150046198.69399.32
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%
110.051520905152003215205331521959152171415210290.06
210.101526828152620815265180.03
单位质量响应值RSD%判断
151346.17151140.400.10数据可信
供试品溶液-第1批-pH4.5(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%
5min1229031-22903115.08312.5216.3015.0812.5216.30
2182397-18239712.01212.01
3212755-21275514.01114.01
4158116-15811610.41310.41
5206151-20615113.57613.58
6152259-15225910.02710.03
10min1537449-53744935.39330.4810.8935.4230.5010.90
2430234-43023428.33328.35
3495120-49512032.60632.63
4418669-41866927.57127.59
5484043-48404331.87631.90
6411567-41156727.10327.12
15min1830249-83024954.67547.159.3554.7547.219.35
2672100-67210044.26144.32
3744553-74455349.03249.10
4660857-66085743.52043.58
5730045-73004548.07748.14
6658069-65806943.33743.39
20min11083966-108396671.38461.638.6171.5461.768.61
2893022-89302258.80958.94
3956516-95651662.99163.13
4868578-86857857.20057.32
5937676-93767661.75061.89
6875300-87530057.64257.76
30min11339487-133948788.21181.904.3888.4882.134.40
21225078-122507880.67780.89
31263042-126304283.17783.41
41189320-118932078.32278.53
51245433-124543382.01782.25
61199654-119965479.00279.21
45min11445290-144529095.17894.760.4895.5895.120.50
21439476-143947694.79695.13
31438042-143804294.70195.06
41426329-142632993.93094.26
51444508-144450895.12795.48
61440342-144034294.85395.18
60min11468540-146854096.71097.090.3197.2597.580.29
21477549-147754997.30397.78
31473302-147330297.02397.53
41471313-147131396.89297.36
51473861-147386197.06097.56
61481260-148126097.54798.02
极限11480900-148090097.52398.360.5298.2199.000.49
21498640-149864098.69299.32
31493590-149359098.35999.01
41502314-150231498.93499.55
51489110-148911098.06498.71
61497221-149722198.59899.21
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%
110.051522856152137715217531521373152125615217230.05
210.101524605152524915249270.03
单位质量响应值RSD%判断
151415.22150982.870.21数据可信
供试品溶液-2023010511批-pH4.5(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%
5min1131671-1316718.6749.0110.558.679.0110.56
2137857-1378579.0819.08
3119916-1199167.8997.90
4153187-15318710.09110.09
5154057-15405710.14810.15
6124066-1240668.1738.17
10min1330333-33033321.76021.815.1521.7721.835.16
2325805-32580521.46221.48
3306998-30699820.22320.23
4343527-34352722.62922.64
5356367-35636723.47523.49
6323918-32391821.33821.35
15min1538612-53861235.48034.923.4135.5334.973.40
2522118-52211834.39434.44
3499493-49949332.90332.95
4530282-53028234.93234.98
5552115-55211536.37036.42
6538290-53829035.45935.50
20min1740400-74040048.77347.632.6548.8747.732.66
2709745-70974546.75346.85
3694860-69486045.77345.86
4715402-71540247.12647.23
5738816-73881648.66848.77
6738990-73899048.68048.78
30min11064819-106481970.14368.521.6070.3268.691.60
21031531-103153167.95168.12
31022241-102224167.33967.50
41025530-102553067.55567.73
51045189-104518968.85069.03
61051345-105134569.25669.43
45min11375890-137589090.63588.781.6090.9189.061.59
21353547-135354789.16389.43
31320705-132070587.00087.26
41327623-132762387.45587.73
51343239-134323988.48488.77
61365556-136555689.95490.23
60min11478957-147895797.42496.350.5897.8496.750.58
21463858-146385896.43096.83
31457575-145757596.01696.41
41459451-145945196.13996.54
51457523-145752396.01296.43
61458144-145814496.05396.46
极限11502958-150295899.00598.050.7199.5698.600.70
21495401-149540198.50799.06
31489181-148918198.09898.63
41489920-148992098.14698.70
51477053-147705397.29997.86
61476030-147603097.23197.78
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%
110.051555494155700815578381556398155776415569000.07
210.101560237156144915608430.06
单位质量响应值RSD%判断
154915.42154538.910.18数据可信
供试品溶液-第1批-pH4.5(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%
5min1155956-15595610.0399.029.5310.049.029.54
2150883-1508839.7139.71
3138998-1389988.9488.95
4124174-1241747.9937.99
5124733-1247338.0298.03
6145703-1457039.3799.38
10min1387287-38728724.93022.417.8224.9522.427.83
2370019-37001923.81923.83
3325727-32572720.96820.98
4321913-32191320.72220.73
5327390-32739021.07521.09
6356620-35662022.95622.97
15min1611088-61108839.33736.186.2339.3936.236.23
2590528-59052838.01338.06
3523862-52386233.72233.77
4532161-53216134.25634.30
5541267-54126734.84234.89
6573499-57349936.91736.97
20min1817935-81793552.65249.155.2152.7649.265.22
2796456-79645651.26951.38
3719002-71900246.28346.38
4730374-73037447.01547.11
5739664-73966447.61347.71
6778064-77806450.08550.19
30min11138512-113851273.28870.064.4973.4870.244.49
21147593-114759373.87274.06
31040159-104015966.95767.12
41039337-103933766.90467.07
51059162-105916268.18068.35
61105837-110583771.18471.36
45min11419156-141915691.35388.792.8291.6589.072.83
21422513-142251391.56991.86
31350227-135022786.91687.18
41333193-133319385.82086.08
51351932-135193287.02687.30
61398805-139880590.04390.33
60min11466185-146618594.38093.920.8394.8294.330.84
21469472-146947294.59295.02
31438756-143875692.61593.01
41449872-144987293.33093.72
51465848-146584894.35994.76
61463606-146360694.21494.64
极限11485404-148540495.61895.390.8096.2095.940.81
21485182-148518295.60396.18
31459174-145917493.92994.46
41480754-148075495.31895.85
51492618-149261896.08296.62
61487896-148789695.77896.34
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