普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)75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%
116.775322253432533335314253217532690.22
216.785293753182530600.33
单位质量响应值RSD%判断
3176.453162.100.33数据可信
供试品溶液-3批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min148099-4809990.51488.632.4890.5188.622.48
246498-4649887.50187.50
347918-4791890.17490.17
447126-4712688.68388.68
547874-4787490.09190.09
645058-4505884.79184.79
5min155072-55072103.636101.421.73103.64101.421.72
253292-53292100.286100.29
353463-53463100.608100.61
452601-5260198.98698.99
554584-54584102.718102.72
654358-54358102.293102.29
10min154068-54068101.747101.091.49101.75101.091.49
253175-53175100.066100.07
353425-53425100.537100.54
452566-5256698.92098.92
554636-54636102.816102.82
654436-54436102.439102.44
15min154085-54085101.779101.001.43101.78101.001.43
252977-5297799.69499.69
353353-53353100.401100.40
452699-5269999.17199.17
554435-54435102.437102.44
654468-54468102.500102.50
30min154186-54186101.969101.790.98101.97101.790.99
253205-53205100.123100.12
354082-54082101.773101.77
453855-53855101.346101.35
554488-54488102.537102.54
654721-54721102.976102.98
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)75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%
116.775333452863530325301052998530470.33
216.785313152942530360.26
单位质量响应值RSD%判断
3163.213160.670.06数据可信
供试品溶液-3批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min144069-4406983.12283.6210.3683.1283.6210.36
246579-4657987.85787.86
346214-4621487.16887.17
435283-3528366.55066.55
547725-4772590.01890.02
646129-4612987.00887.01
5min152571-5257199.159100.021.0199.16100.021.02
253476-53476100.866100.87
352582-5258299.17999.18
452610-5261099.23299.23
553086-53086100.130100.13
653832-53832101.537101.54
10min152716-5271699.432100.551.0599.43100.551.05
253441-53441100.800100.80
353001-5300199.97099.97
453173-53173100.294100.29
553192-53192100.330100.33
654341-54341102.497102.50
15min152901-5290199.781100.950.9399.78100.950.93
253750-53750101.382101.38
353098-53098100.153100.15
453546-53546100.998101.00
553525-53525100.958100.96
654297-54297102.414102.41
30min152897-5289799.774100.690.9599.77100.690.95
253609-53609101.117101.12
352931-5293199.83899.84
453084-53084100.126100.13
553579-53579101.060101.06
654189-54189102.211102.21
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)75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%
116.775297153145530335271153250530220.39
216.785345953224533420.32
单位质量响应值RSD%判断
3161.723178.900.39数据可信
供试品溶液-3批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min142501-4250179.95478.187.9679.9578.187.95
243729-4372982.26482.26
346689-4668987.83287.83
438623-3862372.65872.66
538813-3881373.01673.02
639003-3900373.37373.37
5min150942-5094295.83395.201.8295.8395.201.82
250221-5022194.47794.48
352095-5209598.00298.00
450944-5094495.83795.84
549550-4955093.21493.21
649892-4989293.85893.86
10min152882-5288299.48398.351.3599.4898.351.35
251557-5155796.99096.99
353373-53373100.406100.41
452147-5214798.10098.10
551782-5178297.41397.41
651943-5194397.71697.72
15min153732-53732101.08299.361.23101.0899.361.22
252267-5226798.32698.33
353472-53472100.592100.59
452259-5225998.31198.31
552792-5279299.31399.31
652369-5236998.51798.52
30min153989-53989101.565100.021.23101.57100.021.23
252473-5247398.71398.71
353939-53939101.471101.47
452605-5260598.96198.96
552988-5298899.68299.68
653026-5302699.75399.75
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