氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.209410899409049405959402489409319407530.04
214.189438999444409441700.05
单位质量响应值RSD%判断
66250.2166584.630.36数据可信
加速6月-供试品溶液-MU5570批-氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1667064-66706472.34265.2511.3272.3465.2611.32
2495918-49591853.78153.78
3677351-67735173.45773.46
4561851-56185160.93260.93
5618047-61804767.02667.03
6590054-59005463.99063.99
10min1819595-81959588.88388.875.1189.1089.065.11
2780925-78092584.69084.85
3865766-86576693.89194.11
4831423-83142390.16690.35
5858370-85837093.08993.29
6760666-76066682.49382.68
15min1820678-82067889.00190.053.9589.4890.513.97
2791694-79169485.85886.27
3866810-86681094.00494.51
4836775-83677590.74791.20
5867740-86774094.10594.59
6798449-79844986.59087.03
20min1817448-81744888.65189.373.8889.4090.103.89
2783958-78395885.01985.69
3860687-86068793.34094.12
4829559-82955989.96490.69
5858563-85856393.10993.87
6794215-79421586.13186.83
30min1811713-81171388.02989.053.8389.0590.053.84
2785342-78534285.16986.10
3856985-85698592.93894.00
4825989-82598989.57790.57
5857022-85702292.94293.98
6789888-78988885.66286.62
45min1809030-80903087.73888.503.8489.0289.773.85
2779078-77907884.48985.67
3851977-85197792.39593.74
4821118-82111889.04990.31
5850474-85047492.23293.55
6784889-78488985.12086.33
60min1804713-80471387.27088.024.0388.8189.564.04
2775790-77579084.13385.57
3849602-84960292.13893.76
4815973-81597388.49190.02
5847608-84760891.92193.52
6776385-77638584.19785.67
极限1806692-80669287.48488.013.8889.2989.813.89
2774085-77408583.94885.64
3850216-85021692.20494.10
4815605-81560588.45190.25
5843050-84305091.42793.30
6779692-77969284.55686.28
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.267896717899387903127904407900497900820.04
29.277915427921547918480.06
单位质量响应值RSD%判断
85322.0385420.500.09数据可信
加速6月-供试品溶液-MU5570批-贝那普利-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1-0.0000.07156.840.000.07156.64
21963-19630.2280.23
3-0.0000.00
4-0.0000.00
51514-15140.1760.18
6-0.0000.00
10min1262285-26228530.47722.5052.2330.4822.5052.23
2344555-34455540.03740.04
3198738-19873823.09323.09
4167128-16712819.42019.42
5134949-13494915.68115.68
654121-541216.2896.29
15min1704993-70499381.91980.613.4282.0180.683.44
2693784-69378480.61780.74
3718802-71880283.52483.59
4714273-71427382.99783.06
5665931-66593177.38077.43
6664446-66444677.20877.23
20min1743573-74357386.40285.672.0786.7485.982.07
2727863-72786384.57784.94
3752043-75204387.38687.71
4753240-75324087.52587.83
5714095-71409582.97783.26
6732750-73275085.14485.39
30min1754084-75408487.62387.331.4288.2287.901.41
2743455-74345586.38887.00
3757493-75749388.01988.60
4762153-76215388.56189.13
5734135-73413585.30585.83
6758079-75807988.08888.59
45min1755365-75536587.77287.740.9788.6388.560.97
2751622-75162287.33788.21
3757032-75703287.96688.81
4764678-76467888.85489.69
5743003-74300386.33687.12
6758608-75860888.14988.92
60min1751032-75103287.26987.350.9388.3988.440.93
2747651-74765186.87688.01
3755721-75572187.81488.92
4760797-76079788.40389.51
5740811-74081186.08187.12
6754525-75452587.67588.71
极限1751104-75110487.27787.080.9088.6688.430.90
2745582-74558286.63588.03
3752352-75235287.42288.80
4757252-75725287.99189.36
5738009-73800985.75587.06
6752002-75200287.38188.68
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