达格列净二甲双胍缓释片项目信息
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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
112.441553731555311555701555591554871555040.06
212.251561081561581561330.03
单位质量响应值RSD%判断
12500.3212745.551.38数据可信
供试品溶液-TL3539批-达格列净-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%
5min1112295-11229557.22544.3715.3557.2344.3715.35
279668-7966840.59940.60
384001-8400142.80742.81
475074-7507438.25738.26
581002-8100241.27841.28
690331-9033146.03246.03
10min1177070-17707090.23484.475.5390.3284.545.53
2153624-15362478.28678.35
3167796-16779685.50885.57
4156964-15696479.98880.05
5165471-16547184.32384.39
6173684-17368488.50988.58
15min1185125-18512594.33992.952.5194.5693.142.52
2173322-17332288.32488.50
3183032-18303293.27393.46
4183082-18308293.29893.48
5184059-18405993.79693.98
6185721-18572194.64394.84
20min1186496-18649695.03895.092.3395.4095.422.33
2178291-17829190.85791.17
3186859-18685995.22395.56
4187934-18793495.77196.09
5189960-18996096.80397.13
6190060-19006096.85497.20
30min1187943-18794395.77596.812.3696.2897.292.36
2182018-18201892.75693.20
3190529-19052997.09397.57
4191821-19182197.75198.21
5193370-19337098.54199.02
6194189-19418998.95899.45
45min1188679-18867996.15097.842.4196.8098.462.41
2184452-18445293.99694.58
3193566-19356698.64199.26
4193166-19316698.43799.04
5195006-19500699.374100.00
6197108-197108100.446101.08
60min1188671-18867196.14698.542.1096.9499.302.09
2187911-18791195.75996.49
3195604-19560499.679100.45
4194553-19455399.14499.90
5195873-19587399.816100.59
6197544-197544100.668101.46
120min1192427-19242798.06098.912.1399.0099.822.13
2186649-18664995.11695.99
3195933-19593399.847100.77
4194908-19490899.324100.23
5196272-196272100.020100.94
6198323-198323101.065102.00
180min1190067-19006796.85899.642.0097.94100.701.99
2191540-19154097.60898.62
3197213-197213100.499101.57
4196386-196386100.078101.13
5197675-197675100.735101.81
6200222-200222102.032103.12
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1190258-19025896.95599.042.3698.18100.252.35
2187535-18753595.56796.73
3196156-19615699.960101.18
4195579-19557999.666100.87
5196547-196547100.160101.38
6200015-200015101.927103.17
360min1188744-18874496.18398.962.6597.56100.322.64
2187128-18712895.36096.66
3196227-19622799.997101.37
4194946-19494699.344100.70
5199101-199101101.461102.83
6199053-199053101.437102.83
480min1194381-19438199.056101.752.40100.58103.262.39
2193070-19307098.38899.83
3201801-201801102.837104.36
4201444-201444102.655104.16
5202404-202404103.144104.67
6204947-204947104.440105.99
600min1194512-19451299.123101.152.25100.79102.822.24
2191631-19163197.65599.25
3200520-200520102.184103.86
4199921-199921101.879103.53
5201037-201037102.448104.13
6203365-203365103.634105.34
720min1191132-19113297.400100.442.4999.22102.262.48
2190801-19080197.23298.97
3199758-199758101.796103.62
4198727-198727101.271103.08
5199763-199763101.799103.63
6202419-202419103.152105.01
960min1190027-19002796.83799.982.8798.80101.942.85
2188979-18897996.30398.19
3197939-197939100.869102.85
4196467-196467100.119102.08
5201253-201253102.558104.54
6202477-202477103.182105.20
1440min1189409-18940996.52299.062.1598.63101.182.15
2189331-18933196.48298.51
3196410-196410100.090102.22
4195127-19512799.436101.55
5196349-196349100.059102.20
6199703-199703101.768103.94
极限1188455-18845596.03698.722.4798.29100.992.45
2187140-18714095.36697.54
3196205-19620599.985102.27
4195916-19591699.838102.10
5195636-19563699.695101.98
6199015-199015101.417103.74
达格列净二甲双胍缓释片项目信息
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100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.559369249364889371939360439363059365910.05
210.509400859404799402820.03
单位质量响应值RSD%判断
88776.4089550.670.62数据可信
供试品溶液-TL3539批-二甲双胍-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%
5min125630-256302.8752.942.962.872.942.89
225817-258172.8962.90
326067-260672.9242.92
425550-255502.8662.87
526613-266132.9852.98
627587-275873.0943.09
10min164542-645427.2396.873.347.246.883.34
258848-588486.6006.60
360204-602046.7526.76
460256-602566.7586.76
561165-611656.8606.86
662731-627317.0367.04
15min1100105-10010511.22710.672.9311.2410.682.93
291980-9198010.31610.33
393266-9326610.46010.47
494530-9453010.60210.62
595454-9545410.70610.72
695514-9551410.71210.73
20min1128442-12844214.40513.892.4014.4413.922.41
2120876-12087613.55713.59
3120481-12048113.51313.54
4124301-12430113.94113.97
5125416-12541614.06614.10
6123684-12368413.87213.90
30min1177964-17796419.96019.382.2520.0119.432.23
2169812-16981219.04519.10
3167857-16785718.82618.88
4176083-17608319.74919.80
5173770-17377019.48919.54
6171046-17104619.18419.24
45min1234192-23419226.26625.971.6526.3526.051.66
2230645-23064525.86825.95
3225516-22551625.29325.37
4236230-23623026.49526.58
5233235-23323526.15926.24
6229621-22962125.75325.83
60min1282051-28205131.63431.772.3431.7631.892.33
2293363-29336332.90233.02
3274744-27474430.81430.93
4287923-28792332.29232.41
5282720-28272031.70931.83
6278650-27865031.25231.37
120min1429996-42999648.22647.901.6048.4048.061.60
2430260-43026048.25648.42
3415685-41568546.62146.78
4434682-43468248.75248.92
5429207-42920748.13848.31
6422598-42259847.39747.56
180min1533673-53367359.85460.251.8060.1060.491.80
2550186-55018661.70661.95
3523365-52336558.69858.93
4545549-54554961.18661.43
5538078-53807860.34860.59
6532338-53233859.70559.94
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1623767-62376769.95969.481.4070.2969.811.40
2626139-62613970.22570.56
3603703-60370367.70968.03
4626853-62685370.30570.64
5619638-61963869.49669.83
6616924-61692469.19169.52
360min1729350-72935081.80182.841.4782.2483.281.47
2747197-74719783.80284.24
3724450-72445081.25181.67
4745293-74529383.58984.03
5751342-75134284.26784.70
6734224-73422482.34782.78
480min1827809-82780992.84393.881.1193.4094.441.11
2848646-84864695.18095.74
3826644-82664492.71393.26
4846035-84603594.88895.45
5839525-83952594.15794.72
6833533-83353393.48594.04
600min1880231-88023198.72398.950.7899.4299.640.78
2890135-89013599.834100.54
3871696-87169697.76698.45
4888207-88820799.617100.32
5884643-88464399.21899.92
6878368-87836898.51499.21
720min1888159-88815999.612101.121.02100.46101.961.01
2913000-913000102.398103.25
3894406-894406100.313101.14
4908240-908240101.864102.72
5904606-904606101.457102.31
6901037-901037101.056101.90
960min1903542-903542101.337102.901.02102.33103.901.02
2925001-925001103.744104.75
3908942-908942101.943102.92
4919671-919671103.146104.16
5927184-927184103.989104.99
6920557-920557103.246104.24
1440min1908353-908353101.877103.040.97103.03104.190.96
2933647-933647104.714105.88
3911191-911191102.195103.33
4920419-920419103.230104.39
5918951-918951103.065104.23
6919534-919534103.131104.28
极限1906095-906095101.624102.720.81102.93104.030.81
2924191-924191103.653104.97
3909056-909056101.956103.24
4923709-923709103.599104.92
5915222-915222102.647103.96
6916972-916972102.844104.15
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