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%
19.662900114290173828998792898868289670628994610.07
29.602905474290562929055520.01
单位质量响应值RSD%判断
300151.24302661.670.59数据可信
供试品溶液-2023010811批-pH6.8(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%
5min1341805-34180511.29511.9110.1611.3011.9110.14
2352906-35290611.66211.66
3335786-33578611.09611.10
4429546-42954614.19514.19
5331952-33195210.97010.97
6370278-37027812.23612.24
10min1870950-87095028.78129.926.8728.8029.946.88
2926073-92607330.60330.62
3857600-85760028.34028.36
41012804-101280433.46933.49
5844829-84482927.91827.93
6921076-92107630.43830.46
15min11344815-134481544.44046.165.5744.5046.225.57
21431168-143116847.29447.36
31340848-134084844.30944.37
41524518-152451850.37950.45
51317680-131768043.54443.60
61421266-142126646.96747.03
20min11755803-175580358.02259.674.3358.1559.804.33
21841899-184189960.86761.00
31755036-175503657.99658.12
41930508-193050863.79563.94
51717413-171741356.75356.88
61833818-183381860.60060.73
30min12343672-234367277.44878.451.7677.6678.681.77
22398770-239877079.26979.49
32333377-233337777.10877.32
42437257-243725780.54180.78
52339720-233972077.31877.53
62391840-239184079.04079.27
45min12782974-278297491.96591.790.5692.3092.130.57
22787263-278726392.10792.45
32756011-275601191.07491.40
42799472-279947292.51092.87
52768071-276807191.47391.80
62772799-277279991.62991.97
60min12919372-291937296.47396.060.2996.9496.540.29
22911616-291161696.21696.70
32897006-289700695.73396.20
42908566-290856696.11596.62
52905217-290521796.00596.47
62899758-289975895.82496.31
极限12969464-296946498.12897.920.7198.7498.550.70
22954861-295486197.64598.27
32946728-294672897.37797.99
42952815-295281597.57898.22
52953175-295317597.59098.20
63002853-300285399.23199.86
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%
19.662901442290263429003222898597290199929009990.06
29.602897090289743428972620.01
单位质量响应值RSD%判断
300310.46301798.120.35数据可信
供试品溶液-第1批-pH6.8(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%
5min1388515-38851512.85412.3110.4812.8512.3010.49
2369780-36978012.23412.23
3350249-35024911.58811.59
4340439-34043911.26311.26
5340939-34093911.28011.28
6441835-44183514.61814.62
10min1935132-93513230.93830.156.1330.9630.176.12
2952315-95231531.50631.52
3879838-87983829.10929.13
4850824-85082428.14928.17
5860843-86084328.48028.50
6989652-98965232.74232.76
15min11414405-141440546.79446.355.4846.8646.425.48
21480002-148000248.96449.03
31358327-135832744.93945.00
41318333-131833343.61643.67
51334782-133478244.16044.22
61500791-150079149.65249.72
20min11818500-181850060.16360.263.4860.3060.393.48
21895166-189516662.70062.84
31773772-177377258.68358.81
41829002-182900260.51160.64
51729151-172915157.20757.33
61882306-188230662.27462.42
30min12384064-238406478.87478.242.5979.1078.472.60
22444482-244448280.87381.11
32366102-236610278.28078.50
42280520-228052075.44975.66
52308392-230839276.37176.58
62406512-240651279.61779.86
45min12805321-280532192.81192.091.3793.1692.431.38
22818518-281851893.24893.60
32814761-281476193.12393.46
42737064-273706490.55390.88
52735016-273501690.48590.81
62790070-279007092.30692.66
60min12936324-293632497.14596.511.0697.6396.991.06
22929294-292929496.91397.41
32960469-296046997.94498.42
42897857-289785795.87396.34
52874177-287417795.08995.55
62904969-290496996.10896.60
极限12979979-297997998.58997.940.7899.2298.560.78
22964152-296415298.06698.71
32990977-299097798.95399.57
42951089-295108997.63498.24
52927713-292771396.86097.46
62948319-294831997.54298.18
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%
19.662902211290424729013782904315290300029030300.05
29.602906034290028829031610.14
单位质量响应值RSD%判断
300520.70302412.600.45数据可信
供试品溶液-2023010811批-pH6.8(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%
5min1364900-36490012.05612.033.6312.0612.033.63
2386040-38604012.75412.75
3371286-37128612.26712.27
4350491-35049111.58011.58
5352449-35244911.64411.64
6359867-35986711.89011.89
10min1915286-91528630.24029.822.7030.2629.842.70
2944127-94412731.19331.21
3895710-89571029.59329.61
4882932-88293229.17129.19
5877402-87740228.98829.01
6899802-89980229.72829.75
15min11390916-139091645.95445.742.1646.0245.812.17
21442363-144236347.65447.72
31373619-137361945.38345.45
41367483-136748345.18045.24
51362850-136285045.02745.09
61370149-137014945.26845.33
20min11788772-178877259.09959.111.6659.2359.241.66
21842790-184279060.88461.02
31785244-178524458.98259.11
41781432-178143258.85658.99
51751596-175159657.87158.00
61784590-178459058.96159.09
30min12337056-233705677.21477.530.9777.4377.750.98
22351398-235139877.68777.92
32368969-236896978.26878.49
42362674-236267478.06078.28
52305880-230588076.18476.40
62354287-235428777.78378.00
45min12738260-273826090.46991.541.0690.8191.881.06
22821193-282119393.20993.55
32773420-277342091.63091.97
42774711-277471191.67392.01
52745084-274508490.69491.02
62771057-277105791.55291.89
60min12864351-286435194.63595.501.1395.1195.971.13
22901163-290116395.85196.34
32896516-289651695.69796.17
42875414-287541495.00095.47
52858724-285872494.44994.91
62947057-294705797.36797.84
极限12901254-290125495.85496.430.6696.4797.040.66
22924365-292436596.61897.25
32942561-294256197.21997.84
42906741-290674196.03596.65
52898878-289887895.77596.38
62937708-293770897.05897.68
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%
19.662904968290569029063462907072290599429060140.03
29.602908036291051229092740.07
单位质量响应值RSD%判断
300829.61303049.380.52数据可信
供试品溶液-第1批-pH6.8(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%
5min1383837-38383712.66211.974.0812.6611.974.08
2362904-36290411.97111.97
3369023-36902312.17312.17
4343280-34328011.32411.32
5349206-34920611.51911.52
6369484-36948412.18812.19
10min1943866-94386631.13529.743.1331.1529.763.12
2902811-90281129.78129.80
3913844-91384430.14530.16
4861587-86158728.42128.44
5881527-88152729.07929.10
6905510-90551029.87029.89
15min11450906-145090647.86145.912.3447.9345.982.35
21388512-138851245.80345.87
31399617-139961746.16946.23
41356075-135607544.73344.79
51371924-137192445.25645.32
61383803-138380345.64845.71
20min11854309-185430961.16859.092.1661.3159.222.16
21802553-180255359.46159.59
31804985-180498559.54159.67
41745658-174565857.58457.71
51760018-176001858.05858.19
61780415-178041558.73158.86
30min12428264-242826480.10277.831.6780.3378.051.67
22356196-235619677.72477.94
32362009-236200977.91678.14
42367759-236775978.10678.32
52316892-231689276.42876.64
62326142-232614276.73376.95
45min12830482-283048293.37091.401.7293.7291.741.72
22826080-282608093.22493.56
32773410-277341091.48791.83
42730070-273007090.05790.39
52727868-272786889.98590.32
62737129-273712990.29090.62
60min12930193-293019396.65995.170.9297.1595.650.93
22898058-289805895.59996.08
32889232-288923295.30895.78
42866435-286643594.55695.02
52866290-286629094.55195.02
62860618-286061894.36494.83
极限12965415-296541597.82196.510.7998.4697.130.79
22936771-293677196.87697.50
32926147-292614796.52597.14
42913284-291328496.10196.71
52904900-290490095.82496.43
62907856-290785695.92296.53
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%
19.662903914290474029027442904562290225329036430.04
29.602907385290689129071380.02
单位质量响应值RSD%判断
300584.16302826.880.53数据可信
供试品溶液-2023011011批-pH6.8(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%
5min1361911-36191111.94811.892.0811.9511.892.07
2366530-36653012.10012.10
3363884-36388412.01312.01
4360246-36024611.89311.89
5363232-36323211.99111.99
6345569-34556911.40811.41
10min1902604-90260429.79729.002.8929.8229.022.90
2897099-89709929.61629.63
3879281-87928129.02829.05
4885781-88578129.24229.26
5875008-87500828.88628.90
6831299-83129927.44327.46
15min11382882-138288245.65345.232.1145.7245.292.11
21389238-138923845.86345.93
31376343-137634345.43745.50
41394697-139469746.04346.10
51360122-136012244.90144.96
61316377-131637743.45743.52
20min11752249-175224957.84758.161.5557.9858.291.55
21791492-179149259.14259.27
31765330-176533058.27858.41
41782067-178206758.83158.96
51765960-176596058.29958.43
61713846-171384656.57956.70
30min12328144-232814476.85977.061.2077.0877.281.20
22367602-236760278.16178.38
32327903-232790376.85177.07
42361982-236198277.97678.19
52329274-232927476.89677.11
62290615-229061575.62075.83
45min12743742-274374290.57991.160.9190.9191.490.91
22799115-279911592.40792.74
32748575-274857590.73891.07
42787118-278711892.01192.35
52744643-274464390.60890.94
62744528-274452890.60490.93
60min12883639-288363995.19795.740.6895.6796.220.68
22916492-291649296.28296.76
32920885-292088596.42796.90
42915021-291502196.23396.71
52875343-287534394.92395.39
62890020-289002095.40895.87
极限12929691-292969196.71797.340.7797.3397.950.76
22959099-295909997.68898.31
32984257-298425798.51999.13
42952988-295298897.48698.10
52921271-292127196.43997.05
62943658-294365897.17897.78
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