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%
110.043040616303643530349743042924303911330388120.11
210.143022716302456730236420.05
单位质量响应值RSD%判断
302670.52298189.551.06数据可信
供试品溶液-24081301批-pH4.5(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%
5min1421657-42165713.98013.8614.1213.9813.8614.12
2382548-38254812.68312.68
3468702-46870215.53915.54
4505774-50577416.76916.77
5375686-37568612.45612.46
6354065-35406511.73911.74
10min1802971-80297126.62231.7912.7826.6431.8112.78
2920864-92086430.53130.55
31084539-108453935.95735.98
41127602-112760237.38537.41
5913281-91328130.27930.30
6904212-90421229.97930.00
15min11346129-134612944.63048.638.1044.6948.708.11
21395808-139580846.27746.34
31590942-159094252.74752.82
41639936-163993654.37154.45
51418184-141818447.01947.08
61410039-141003946.74946.81
20min11761945-176194558.41662.105.6958.5462.245.70
21801357-180135759.72359.86
31997625-199762566.23066.39
42014831-201483166.80066.96
51832976-183297660.77160.91
61828858-182885860.63560.77
30min12342962-234296277.67980.393.3877.8980.633.39
22341899-234189977.64477.87
32531031-253103183.91584.17
42512527-251252783.30183.56
52394038-239403879.37379.60
62426641-242664180.45480.68
45min12751949-275194991.23992.411.3991.5792.761.41
22743972-274397290.97591.31
32837573-283757394.07894.46
42820372-282037293.50893.90
52766684-276668491.72892.07
62802949-280294992.93093.27
60min12885351-288535195.66296.061.0096.1396.551.01
22856870-285687094.71895.19
32926440-292644097.02497.55
42902521-290252196.23196.76
52880901-288090195.51496.00
62931873-293187397.20497.69
极限12945209-294520997.64697.560.8498.2698.200.84
22913253-291325396.58797.21
32961479-296147998.18698.85
42940231-294023197.48198.15
52918179-291817996.75097.38
62977099-297709998.70499.33
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%
110.043038542304273630254013045002304121330385790.26
210.143031307303247930318930.03
单位质量响应值RSD%判断
302647.31299003.250.86数据可信
供试品溶液-25020301批-pH4.5(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%
5min1202660-2026606.7105.9210.806.715.9210.80
2200122-2001226.6266.63
3181920-1819206.0236.02
4167179-1671795.5355.54
5160936-1609365.3295.33
6159461-1594615.2805.28
10min1546746-54674618.10315.758.4918.1115.768.49
2487197-48719716.13116.14
3472456-47245615.64315.65
4472141-47214115.63315.64
5433725-43372514.36114.37
6441353-44135314.61314.62
15min1893638-89363829.58826.068.2629.6326.098.27
2830572-83057227.50027.53
3776024-77602425.69425.73
4754118-75411824.96925.00
5756580-75658025.05025.08
6711391-71139123.55423.58
20min11210264-121026440.07235.088.6940.1535.158.69
21128921-112892137.37937.45
31024247-102424733.91333.98
41023333-102333333.88333.95
51009388-100938833.42133.49
6960698-96069831.80931.87
30min11625519-162551953.82149.168.0153.9649.288.01
21640267-164026754.30954.44
31390872-139087246.05246.17
41467423-146742348.58748.71
51405745-140574546.54446.66
61378403-137840345.63945.75
45min11975363-197536365.40563.124.5265.6363.324.53
22035842-203584267.40767.62
31797349-179734959.51059.70
41902428-190242862.99063.18
51868418-186841861.86462.05
61859558-185955861.57061.75
60min12177251-217725172.08971.772.4572.4172.072.45
22234434-223443473.98274.30
32073468-207346868.65368.93
42190758-219075872.53672.82
52161040-216104071.55271.83
62169531-216953171.83372.11
极限12414616-241461679.94880.021.0880.3880.421.09
22467522-246752281.70082.12
32393458-239345879.24879.63
42408700-240870079.75280.15
52402477-240247779.54679.93
62413905-241390579.92580.31
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