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%
112.691639181650621637621638881640441641350.33
212.681639011649711644360.47
单位质量响应值RSD%判断
12934.2012968.140.19数据可信
供试品溶液-2025070821批-达格列净-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%
5min1179574-17957489.18390.563.4189.1890.563.41
2174844-17484486.83486.83
3188229-18822993.48193.48
4176998-17699887.90387.90
5184247-18424791.50491.50
6190221-19022194.47194.47
10min1186901-18690192.82292.812.5592.9692.942.55
2179878-17987889.33489.46
3190571-19057194.64494.78
4183583-18358391.17491.31
5187159-18715992.95093.09
6193136-19313695.91896.06
15min1187710-18771093.22393.112.2593.5093.382.25
2180984-18098489.88390.15
3189464-18946494.09594.38
4185980-18598092.36492.63
5186934-18693492.83893.11
6193762-19376296.22996.51
20min1192230-19223095.46893.632.3795.8894.042.37
2182010-18201090.39390.79
3190494-19049494.60695.03
4185948-18594892.34892.76
5186588-18658892.66693.08
6193914-19391496.30596.73
30min1190577-19057794.64793.772.9695.2094.332.95
2180501-18050189.64390.18
3191035-19103594.87595.44
4186090-18609092.41992.96
5187576-18757693.15793.71
6197131-19713197.90298.48
45min1191080-19108094.89793.852.2795.6094.552.26
2182039-18203990.40791.08
3190355-19035594.53795.24
4188365-18836593.54994.23
5187243-18724392.99293.69
6194758-19475896.72497.44
60min1189047-18904793.88793.162.0294.7394.002.02
2181202-18120289.99190.80
3188587-18858793.65994.51
4187733-18773393.23594.06
5186303-18630392.52593.36
6192640-19264095.67296.54
120min1192137-19213795.42293.941.9596.4094.911.95
2183151-18315190.95991.90
3189721-18972194.22295.21
4188227-18822793.48094.44
5188023-18802393.37994.35
6193644-19364496.17097.18
180min1191479-19147995.09593.982.0496.2295.092.04
2183121-18312190.94492.02
3190219-19021994.47095.60
4188899-18889993.81494.92
5187236-18723692.98894.10
6194396-19439696.54497.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1190648-19064894.68393.741.8895.9595.001.89
2183229-18322990.99892.21
3189580-18958094.15295.43
4187274-18727493.00794.25
5187958-18795893.34794.60
6193765-19376596.23197.53
360min1193531-19353196.11495.142.0297.5296.542.02
2186514-18651492.62993.98
3193489-19348996.09497.51
4189561-18956194.14395.53
5189105-18910593.91695.31
6197166-19716697.92099.36
480min1191500-19150095.10694.561.7296.6696.101.72
2186560-18656092.65294.14
3191884-19188495.29696.85
4188664-18866493.69795.22
5188221-18822193.47795.01
6195612-19561297.14898.74
600min1191494-19149495.10394.871.9596.8096.561.96
2186051-18605192.40094.03
3192528-19252895.61697.32
4190611-19061194.66496.33
5188512-18851293.62295.30
6196984-19698497.82999.57
720min1191461-19146195.08693.991.9196.9295.821.91
2184541-18454191.65093.42
3190064-19006494.39396.24
4187193-18719392.96794.78
5187506-18750693.12294.94
6194751-19475196.72098.60
极限1190627-19062794.67294.101.7896.6596.061.78
2184809-18480991.78393.69
3190212-19021294.46696.45
4188853-18885393.79195.74
5187524-18752493.13195.08
6194810-19481096.75098.78
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%
110.139434509400769371269461669440299421690.38
210.139490319499239494770.07
单位质量响应值RSD%判断
93007.8093729.220.55数据可信
供试品溶液-2025070821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%
5min143819-438194.6935.227.114.695.227.14
254066-540665.7915.79
346780-467805.0105.01
449553-495535.3075.31
548009-480095.1425.14
650280-502805.3855.39
10min191747-917479.82610.214.109.8310.224.10
289244-892449.5589.57
396666-9666610.35310.36
498600-9860010.56010.57
597702-9770210.46410.47
698209-9820910.51910.53
15min1129817-12981713.90414.251.7613.9314.281.75
2135271-13527114.48814.51
3133042-13304214.24914.27
4130701-13070113.99914.02
5134898-13489814.44814.47
6134788-13478814.43614.46
20min1173901-17390118.62617.763.7818.6717.813.77
2157586-15758616.87816.92
3172234-17223418.44718.49
4161536-16153617.30117.35
5165839-16583917.76217.81
6163958-16395817.56117.61
30min1212443-21244322.75423.265.0722.8223.345.05
2207804-20780422.25722.33
3216486-21648623.18723.26
4210531-21053122.54922.62
5217603-21760323.30623.38
6238377-23837725.53125.60
45min1274500-27450029.40029.461.0329.5029.571.03
2271708-27170829.10129.20
3278178-27817829.79429.90
4272367-27236729.17229.28
5278380-27838029.81629.92
6275340-27534029.49029.60
60min1325275-32527534.83834.731.3634.9934.881.36
2319084-31908434.17534.32
3325265-32526534.83734.99
4321787-32178734.46534.61
5331788-33178835.53635.69
6322154-32215434.50434.66
120min1474637-47463750.83650.880.9551.0451.080.95
2473196-47319650.68150.88
3478860-47886051.28851.49
4469922-46992250.33150.53
5481779-48177951.60151.81
6471756-47175650.52750.73
180min1581705-58170562.30362.460.9462.5862.740.94
2581611-58161162.29362.57
3586725-58672562.84163.12
4577696-57769661.87462.15
5592316-59231663.43963.72
6578936-57893662.00662.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1666810-66681071.41871.130.8771.7971.500.87
2661889-66188970.89171.26
3667266-66726671.46771.84
4655262-65526270.18170.55
5671805-67180571.95372.33
6661712-66171270.87271.25
360min1792726-79272684.90484.911.4485.3885.391.44
2785194-78519484.09784.57
3809901-80990186.74487.23
4779294-77929483.46683.94
5802166-80216685.91586.40
6787326-78732684.32684.81
480min1856400-85640091.72492.390.9392.3393.000.92
2863814-86381492.51893.12
3872644-87264493.46494.08
4855241-85524191.60092.20
5871387-87138793.32993.94
6856058-85605891.68792.30
600min1899501-89950196.34097.360.9497.0898.100.94
2907225-90722597.16897.91
3914964-91496497.99698.75
4901422-90142296.54697.28
5922289-92228998.78199.53
6908658-90865897.32198.07
720min1932131-93213199.83599.581.02100.72100.471.02
2926116-92611699.191100.08
3934583-934583100.098101.00
4915023-91502398.00398.88
5943234-943234101.024101.93
6927488-92748899.338100.23
极限1921598-92159898.70799.510.7599.74100.550.75
2930243-93024399.633100.67
3925630-92563099.139100.19
4926413-92641399.223100.25
5941931-941931100.885101.94
6928582-92858299.455100.50
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%
112.691649321634001640631637121636451639500.37
212.681662451659971661210.11
单位质量响应值RSD%判断
12919.6213101.030.99数据可信
供试品溶液-2025070821批-达格列净-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%
5min1180163-18016389.07388.901.5289.0788.901.52
2182093-18209390.02790.03
3179556-17955688.77388.77
4182264-18226490.11190.11
5174745-17474586.39486.39
6180016-18001689.00089.00
10min1182596-18259690.27691.041.0290.4191.171.01
2186224-18622492.06992.20
3182906-18290690.42990.56
4184603-18460391.26891.40
5182155-18215590.05890.19
6186361-18636192.13792.27
15min1185709-18570991.81591.860.4792.0892.120.47
2185420-18542091.67291.94
3186296-18629692.10592.37
4185751-18575191.83592.11
5184501-18450191.21791.48
6187092-18709292.49892.77
20min1183602-18360290.77391.580.9391.1891.990.93
2187519-18751992.71093.12
3184463-18446391.19991.61
4185282-18528291.60492.01
5183497-18349790.72191.12
6187027-18702792.46692.88
30min1183875-18387590.90891.940.9891.4592.490.97
2188143-18814393.01893.57
3187573-18757392.73693.28
4184403-18440391.16991.72
5186942-18694292.42492.96
6184853-18485391.39191.94
45min1184503-18450391.21891.910.7891.9092.590.77
2185971-18597191.94492.63
3188310-18831093.10193.78
4184474-18447491.20491.89
5186527-18652792.21992.90
6185603-18560391.76292.45
60min1183679-18367990.81192.421.2191.6393.241.20
2186544-18654492.22793.05
3188027-18802792.96193.78
4185424-18542491.67492.49
5190164-19016494.01794.83
6187762-18776292.83093.65
120min1183213-18321390.58192.201.2491.5393.151.23
2186993-18699392.44993.41
3189952-18995293.91294.87
4184962-18496291.44592.40
5187499-18749992.70093.66
6186252-18625292.08393.05
180min1184311-18431191.12392.241.3192.2193.341.30
2186974-18697492.44093.54
3190599-19059994.23295.34
4183757-18375790.85091.95
5186570-18657092.24093.33
6187178-18717892.54193.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1183533-18353390.73992.341.0591.9693.581.04
2187314-18731492.60893.85
3188557-18855793.22394.47
4188334-18833493.11294.34
5187566-18756692.73393.97
6185385-18538591.65492.89
360min1187037-18703792.47193.721.2893.8395.091.27
2190939-19093994.40095.78
3190696-19069694.28095.66
4186151-18615192.03393.40
5190224-19022494.04795.42
6192332-19233295.08996.47
480min1186628-18662892.26993.371.1493.7794.891.13
2188069-18806992.98194.50
3192943-19294395.39196.92
4188029-18802992.96294.47
5188593-18859393.24194.75
6188905-18890593.39594.91
600min1185545-18554591.73492.891.1993.3794.541.18
2188922-18892293.40395.07
3191019-19101994.44096.11
4185103-18510391.51593.16
5188493-18849393.19194.84
6188219-18821993.05694.72
720min1182230-18223090.09592.351.4391.8794.151.42
2188338-18833893.11494.92
3189556-18955693.71795.53
4185146-18514691.53693.32
5188061-18806192.97794.77
6187465-18746592.68394.48
极限1181253-18125389.61292.101.5891.5294.031.56
2187276-18727692.58994.53
3189840-18984093.85795.81
4184928-18492891.42993.35
5186721-18672192.31594.25
6187663-18766392.78194.72
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%
110.139507239513539476789456279496029489970.25
210.139617189617519617340.01
单位质量响应值RSD%判断
93681.8494939.190.95数据可信
供试品溶液-2025070821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%
5min153609-536095.6855.3211.935.685.3211.95
247462-474625.0335.03
360809-608096.4486.45
446126-461264.8914.89
547371-473715.0235.02
645465-454654.8214.82
10min197468-9746810.33510.015.2610.3410.025.24
298730-9873010.46910.48
385886-858869.1079.12
495111-9511110.08510.09
591420-914209.6949.70
698051-9805110.39710.40
15min1136885-13688514.51513.974.0214.5414.004.02
2134213-13421314.23214.25
3123897-12389713.13813.16
4137443-13744314.57414.60
5128862-12886213.66413.69
6129443-12944313.72613.75
20min1167069-16706917.71617.103.1417.7617.153.13
2165814-16581417.58217.63
3153198-15319816.24516.29
4162571-16257117.23917.28
5159019-15901916.86216.90
6160059-16005916.97217.02
30min1217328-21732823.04522.492.2523.1222.562.24
2216814-21681422.99023.06
3204906-20490621.72821.80
4212132-21213222.49422.56
5212609-21260922.54522.61
6208671-20867122.12722.20
45min1279346-27934629.62128.951.6729.7329.051.67
2276764-27676429.34729.45
3267567-26756728.37228.47
4273535-27353529.00529.11
5272118-27211828.85528.96
6268785-26878528.50128.60
60min1329995-32999534.99234.792.9335.1434.942.92
2329930-32993034.98535.13
3316454-31645433.55633.70
4324348-32434834.39334.54
5344845-34484536.56636.71
6323089-32308934.26034.40
120min1483012-48301251.21750.311.4751.4250.501.47
2483143-48314351.23151.43
3468548-46854849.68449.88
4468753-46875349.70549.90
5473554-47355450.21450.41
6469529-46952949.78849.98
180min1592967-59296762.87761.771.0863.1662.051.08
2586745-58674562.21762.50
3576388-57638861.11961.39
4580200-58020061.52361.80
5577797-57779761.26861.54
6581115-58111561.62061.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1672670-67267071.32870.501.3171.7070.861.31
2671926-67192671.24971.62
3655470-65547069.50469.86
4672880-67288071.35071.72
5661329-66132970.12670.49
6654788-65478869.43269.80
360min1803098-80309885.15884.231.0985.6484.701.09
2795184-79518484.31984.80
3784323-78432383.16883.63
4786266-78626683.37483.85
5791596-79159683.93984.41
6805460-80546085.40985.88
480min1872710-87271092.54091.590.7193.1592.180.70
2859409-85940991.13091.74
3869740-86974092.22592.81
4861421-86142191.34391.94
5857654-85765490.94391.54
6861349-86134991.33591.93
600min1911295-91129596.63195.980.4297.3896.710.42
2905333-90533395.99996.74
3905201-90520195.98596.71
4900891-90089195.52896.26
5906553-90655396.12996.86
6901536-90153695.59796.33
720min1917841-91784197.32698.010.5498.2298.890.53
2928319-92831998.43799.32
3927387-92738798.33899.21
4919990-91999097.55398.43
5922186-92218697.78698.66
6929925-92992598.60799.48
极限1918986-91898697.44798.050.6298.4999.080.60
2924775-92477598.06199.09
3926086-92608698.20099.22
4925218-92521898.10899.13
5918832-91883297.43198.46
6934176-93417699.058100.08
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