恩格列净二甲双胍缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数400
标示量(mg)25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%
110.014845664833394826874838064823384833470.19
29.954895964881004888480.22
单位质量响应值RSD%判断
48286.4149130.451.23数据可信
供试品溶液-3批-恩格列净-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%
5min1-0.0000.12244.950.000.12244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
54059-40590.7500.75
6-0.0000.00
10min166435-6643512.27612.2832.0812.2812.2832.08
280105-8010514.80214.80
397008-9700817.92617.93
460262-6026211.13611.14
561317-6131711.33111.33
633494-334946.1896.19
15min1258844-25884447.83144.3014.8747.8544.3214.87
2252192-25219246.60246.63
3285167-28516752.69552.72
4234893-23489343.40543.42
5227597-22759742.05742.08
6179785-17978533.22233.23
20min1430755-43075579.59873.406.5279.7073.506.53
2409233-40923375.62175.72
3411547-41154776.04876.17
4381280-38128070.45670.55
5393333-39333372.68372.77
6357125-35712565.99266.06
30min1540744-54074499.92295.893.66100.1696.113.67
2531005-53100598.12398.35
3505574-50557493.42393.67
4506650-50665093.62293.83
5535061-53506198.87299.08
6494617-49461791.39991.57
45min1554146-554146102.399100.913.50102.80101.293.50
2558723-558723103.245103.64
3527633-52763397.50097.90
4535420-53542098.93999.30
5573798-573798106.030106.41
6526767-52676797.34097.67
60min1558896-558896103.277102.113.46103.85102.663.45
2563997-563997104.219104.78
3534840-53484098.83199.39
4546482-546482100.983101.51
5580983-580983107.358107.91
6530437-53043798.01898.51
120min1557627-557627103.042102.443.11103.78103.153.11
2563535-563535104.134104.87
3539189-53918999.635100.36
4553153-553153102.215102.91
5580220-580220107.217107.95
6532338-53233898.36999.02
240min1557153-557153102.955102.602.58103.87103.482.59
2561207-561207103.704104.61
3548439-548439101.344102.24
4554417-554417102.449103.32
5576676-576676106.562107.47
6533374-53337498.56099.38
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
360min1554948-554948102.547102.542.79103.63103.592.80
2561856-561856103.824104.91
3544063-544063100.536101.60
4555566-555566102.661103.70
5579121-579121107.014108.10
6533799-53379998.63999.62
480min1568063-568063104.971104.862.74106.23106.092.74
2574469-574469106.154107.41
3556896-556896102.907104.14
4563562-563562104.139105.35
5593376-593376109.648110.91
6548480-548480101.352102.50
600min1565181-565181104.438104.232.44105.87105.632.45
2571367-571367105.581107.02
3551790-551790101.964103.36
4560817-560817103.632105.01
5586356-586356108.351109.80
6548803-548803101.412102.73
720min1560685-560685103.607103.712.51105.21105.292.52
2570090-570090105.345106.96
3549348-549348101.512103.08
4556683-556683102.868104.42
5584282-584282107.968109.60
6546483-546483100.983102.47
840min1555339-555339102.619102.972.37104.40104.722.36
2564243-564243104.265106.05
3543410-543410100.415102.16
4551316-551316101.876103.60
5580036-580036107.183108.99
6548973-548973101.443103.10
960min1553122-553122102.210102.432.31104.16104.352.32
2560803-560803103.629105.59
3544586-544586100.632102.54
4546663-546663101.016102.91
5576881-576881106.600108.59
6543678-543678100.465102.29
极限1553113-553113102.208102.272.33104.33104.362.32
2555053-555053102.566104.70
3539464-53946499.686101.76
4556081-556081102.756104.82
5575343-575343106.316108.48
6541589-541589100.079102.07
恩格列净二甲双胍缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202507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10
标示量(mg)1000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%
110.059123999134589113419143679128939128920.13
210.109295699245919270800.38
单位质量响应值RSD%判断
90835.0291790.100.74数据可信
供试品溶液-3批-二甲双胍-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%
5min1-0.0000.02244.950.000.02244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
51000-10000.0980.10
6-0.0000.00
10min16636-66360.6530.6517.430.650.6517.69
26562-65620.6460.65
38793-87930.8660.87
45419-54190.5340.53
56369-63690.6270.63
65959-59590.5870.59
15min131371-313713.0893.0914.683.093.0914.64
233169-331693.2663.27
339219-392193.8623.86
426576-265762.6172.62
530956-309563.0483.05
627114-271142.6702.67
20min176736-767367.5566.9310.937.566.9410.90
271132-711327.0047.01
381210-812107.9968.00
463686-636866.2716.28
568769-687696.7716.78
660886-608865.9956.00
30min1145511-14551114.32813.794.4814.3513.804.49
2140879-14087913.87213.89
3147791-14779114.55214.57
4132644-13264413.06113.08
5140358-14035813.82113.84
6132896-13289613.08613.10
45min1209707-20970720.64920.432.7820.6920.482.80
2209043-20904320.58420.63
3215100-21510021.18021.23
4199838-19983819.67719.71
5209897-20989720.66820.71
6201489-20148919.84019.88
60min1261577-26157725.75725.582.3225.8325.662.33
2261452-26145225.74425.82
3267688-26768826.35826.44
4252175-25217524.83124.90
5262846-26284625.88225.96
6253052-25305224.91724.99
120min1403413-40341339.72339.541.7839.8439.651.79
2403230-40323039.70539.82
3410211-41021140.39240.52
4393441-39344138.74138.85
5406449-40644940.02240.14
6392422-39242238.64038.75
240min1589376-58937658.03457.891.9858.2258.071.99
2586173-58617357.71957.90
3609091-60909159.97560.17
4578991-57899157.01157.19
5587838-58783857.88258.07
6575918-57591856.70956.88
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
360min1713966-71396670.30269.961.4970.5870.241.49
2711386-71138670.04870.33
3725852-72585271.47271.76
4704167-70416769.33769.61
5713156-71315670.22270.50
6694417-69441768.37768.65
480min1821025-82102580.84480.421.4681.2480.821.46
2818045-81804580.55080.95
3833774-83377482.09982.51
4804062-80406279.17379.56
5821449-82144980.88581.28
6802282-80228278.99879.38
600min1889107-88910787.54786.701.5188.0887.231.51
2883014-88301486.94787.48
3897848-89784888.40888.96
4861794-86179484.85885.38
5882659-88265986.91387.45
6868610-86861085.52986.05
720min1929116-92911691.48791.061.0892.1791.731.09
2925004-92500491.08291.76
3940333-94033392.59193.29
4910694-91069489.67390.33
5924462-92446291.02991.71
6918939-91893990.48591.14
840min1951430-95143093.68493.691.0594.5294.521.05
2947670-94767093.31494.14
3965783-96578395.09795.95
4935805-93580592.14692.96
5951903-95190393.73194.56
6956485-95648594.18294.99
960min1971341-97134195.64595.501.4596.6396.481.45
2961460-96146094.67295.66
3991168-99116897.59798.61
4949369-94936993.48194.44
5969905-96990595.50396.49
6975700-97570096.07497.04
极限1975468-97546896.05196.001.0097.2097.140.99
2958001-95800194.33195.47
3986458-98645897.13398.30
4979566-97956696.45597.57
5971645-97164595.67596.82
6978696-97869696.36997.50
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