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%
110.042996191299778629974552997108299674429970570.03
210.142998385299660129974930.05
单位质量响应值RSD%判断
298511.65295610.750.70数据可信
供试品溶液-23004N1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%
5min1347611-34761111.65511.458.9111.6611.458.92
2367783-36778312.33112.33
3375081-37508112.57612.58
4297939-2979399.9909.99
5312519-31251910.47910.48
6347415-34741511.64911.65
10min1850233-85023328.50828.246.7928.5328.266.79
2901211-90121130.21730.24
3901639-90163930.23130.25
4754063-75406325.28325.30
5803695-80369526.94726.96
6843091-84309128.26828.29
15min11313927-131392744.05543.764.7944.1243.824.80
21379908-137990846.26746.33
31364229-136422945.74245.81
41212058-121205840.63940.69
51265341-126534142.42642.48
61294608-129460843.40743.47
20min11705751-170575157.19356.893.7257.3257.023.73
21773983-177398359.48059.61
31750497-175049758.69358.83
41597390-159739053.55953.67
51665365-166536555.83855.96
61687746-168774656.58956.71
30min12243067-224306775.20874.922.0175.4275.142.01
22287553-228755376.70076.92
32278461-227846176.39576.62
42168002-216800272.69172.89
52214705-221470574.25774.46
62215611-221561174.28874.50
45min12658957-265895789.15388.181.0089.4888.501.01
22652900-265290088.95089.29
32642455-264245588.60088.93
42597391-259739187.08987.39
52626539-262653988.06688.38
62600612-260061287.19787.52
60min12780903-278090393.24293.001.0893.7093.461.09
22776779-277677993.10393.57
32825723-282572394.74495.21
42746456-274645692.08792.52
52770182-277018292.88293.33
62742823-274282391.96592.42
极限12841978-284197895.28994.850.5195.8995.440.51
22838675-283867595.17995.79
32830987-283098794.92195.53
42825113-282511394.72495.30
52833824-283382495.01695.60
62802613-280261393.96994.56
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%
110.042995844300141629983413004893299675829994500.13
210.142983484298968429865840.15
单位质量响应值RSD%判断
298750.00294534.911.01数据可信
供试品溶液-23004N1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%
5min1356373-35637311.96611.506.6611.9711.506.68
2312785-31278510.50310.50
3313596-31359610.53010.53
4356503-35650311.97011.97
5358482-35848212.03712.04
6358030-35803012.02212.02
10min1900722-90072230.24428.624.6130.2628.644.62
2796498-79649826.74426.76
3815350-81535027.37727.39
4877382-87738229.46029.48
5855694-85569428.73228.75
6868102-86810229.14929.17
15min11405056-140505647.17844.394.2947.2444.454.29
21246409-124640941.85141.91
31270580-127058042.66342.72
41335802-133580244.85344.91
51328183-132818344.59744.66
61345934-134593445.19345.25
20min11810397-181039760.78957.433.9060.9257.563.91
21614363-161436354.20654.32
31662820-166282055.83355.95
41721700-172170057.81057.94
51733115-173311558.19458.32
61720542-172054257.77157.90
30min12312019-231201977.63275.112.5477.8675.322.55
22152052-215205272.26072.46
32191835-219183573.59673.80
42254652-225465275.70675.92
52265001-226500176.05376.27
62246180-224618075.42175.64
45min12667315-266731589.56288.161.2789.9088.491.28
22580427-258042786.64486.95
32592522-259252287.05087.37
42647840-264784088.90889.24
52627590-262759088.22888.56
62637789-263778988.57088.90
60min12781508-278150893.39692.610.6893.8793.070.68
22746243-274624392.21292.65
32741177-274117792.04292.49
42770786-277078693.03693.50
52737886-273788691.93192.39
62771427-277142793.05893.52
极限12837500-283750095.27694.900.4195.8995.500.41
22833470-283347095.14195.72
32823935-282393594.82195.40
42831828-283182895.08695.69
52804919-280491994.18294.78
62826213-282621394.89795.50
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%
110.042987476298863729866882986517298535329869340.05
210.142984924298511929850220.01
单位质量响应值RSD%判断
297503.39294380.870.75数据可信
供试品溶液-25020301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%
5min1211310-2113107.1126.5311.657.116.5311.63
2182436-1824366.1406.14
3231881-2318817.8047.80
4174075-1740755.8595.86
5182813-1828136.1536.15
6181298-1812986.1026.10
10min1544000-54400018.30916.8510.0518.3216.8610.05
2476511-47651116.03816.05
3580994-58099419.55419.57
4455407-45540715.32715.34
5481823-48182316.21616.23
6464358-46435815.62915.64
15min1856708-85670828.83427.068.5128.8727.108.51
2771180-77118025.95525.99
3912435-91243530.70930.75
4735597-73559724.75724.79
5799504-79950426.90826.94
6748805-74880525.20225.23
20min11132111-113211138.10336.128.2938.1836.208.29
21025290-102529034.50734.58
31216297-121629740.93641.02
4980942-98094233.01533.08
51080884-108088436.37836.45
61004327-100432733.80233.87
30min11565011-156501152.67250.887.9052.8151.017.91
21454344-145434448.94849.07
31713837-171383757.68157.83
41377301-137730146.35546.47
51526654-152665451.38151.51
61433928-143392848.26148.38
45min11964885-196488566.13064.995.3866.3565.205.38
21876547-187654763.15763.35
32108866-210886670.97671.21
41801120-180112060.61960.81
51937651-193765165.21465.42
61897359-189735963.85864.05
60min12213700-221370074.50572.893.1074.8273.193.11
22112998-211299871.11571.41
32254866-225486675.89076.23
42070290-207029069.67869.96
52182027-218202773.43973.74
62159661-215966172.68672.98
极限12462947-246294782.89382.230.5883.3282.650.60
22422670-242267081.53881.94
32455298-245529882.63683.09
42441632-244163282.17682.56
52439262-243926282.09682.51
62438102-243810282.05782.46
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