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%
112.211549071548781549091552811554431550840.17
212.201555821556381556100.03
单位质量响应值RSD%判断
12701.3912754.920.30数据可信
供试品溶液-TL3535批-达格列净-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%
5min176854-7685438.83758.2317.2138.8458.2317.21
2119888-11988860.58460.58
3132104-13210466.75766.76
4117288-11728859.27059.27
5128674-12867465.02465.02
6116591-11659158.91858.92
10min1135789-13578968.61984.4310.8968.6884.5210.89
2173667-17366787.76187.85
3186442-18644294.21694.32
4168061-16806184.92885.02
5180302-18030291.11491.21
6158180-15818079.93480.02
15min1155159-15515978.40890.247.9778.5790.457.98
2184471-18447193.22093.44
3191907-19190796.97897.22
4179045-17904590.47890.69
5191439-19143996.74296.98
6169412-16941285.61085.82
20min1161888-16188881.80891.776.5882.0992.126.60
2188361-18836195.18695.55
3192610-19261097.33397.72
4183742-18374292.85293.20
5190258-19025896.14596.52
6172749-17274987.29787.63
30min1175345-17534588.60994.084.3589.0194.564.38
2191181-19118196.61197.12
3193850-19385097.96098.49
4188249-18824995.12995.62
5191738-19173896.89397.42
6176627-17662789.25689.72
45min1181456-18145691.69795.453.5192.2396.083.53
2192887-19288797.47398.12
3194345-19434598.21098.89
4192382-19238297.21897.85
5192863-19286397.46198.13
6179425-17942590.67091.27
60min1186675-18667594.33496.222.7295.0197.002.74
2193487-19348797.77698.57
3194072-19407298.07298.90
4193776-19377697.92298.70
5192956-19295697.50898.32
6181521-18152191.73092.47
120min1192637-19263797.34797.412.3198.1698.322.31
2193902-19390297.98698.93
3194237-19423798.15599.13
4196358-19635899.227100.15
5195332-19533298.70999.67
6184075-18407593.02093.90
180min1193772-19377297.92097.352.1998.8898.412.19
2193867-19386797.96899.06
3194127-19412798.10099.22
4196879-19687999.491100.57
5192658-19265897.35898.47
6184540-18454093.25594.27
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1195701-19570198.89597.342.39100.0098.552.37
2193159-19315997.61198.85
3193424-19342497.74599.01
4197178-19717899.642100.87
5192238-19223897.14598.40
6184025-18402592.99594.15
360min1195577-19557798.83397.912.29100.0999.262.28
2194082-19408298.07799.46
3195027-19502798.55599.97
4198676-198676100.399101.77
5193635-19363597.85199.25
6185452-18545293.71695.01
480min1195758-19575898.92497.382.35100.3398.882.34
2192355-19235597.20498.73
3193952-19395298.01199.57
4197461-19746199.785101.31
5192299-19229997.17698.72
6184415-18441593.19294.63
600min1200714-200714101.429100.202.59102.98101.852.58
2198339-198339100.228101.90
3198624-198624100.372102.08
4205195-205195103.693105.37
5197319-19731999.713101.41
6189515-18951595.76997.34
720min1200143-200143101.14099.452.46102.84101.242.44
2196330-19633099.213101.04
3197960-197960100.037101.90
4201426-201426101.788103.62
5197147-19714799.626101.47
6187732-18773294.86896.59
960min1200552-200552101.34798.702.63103.20100.642.60
2194601-19460198.339100.31
3195292-19529298.689100.70
4199451-199451100.790102.77
5195888-19588898.990100.98
6186043-18604394.01595.88
1440min1194494-19449498.28596.582.31100.2998.682.29
2192167-19216797.10999.23
3191450-19145096.74798.91
4194999-19499998.541100.67
5190878-19087896.45898.60
6182786-18278692.36994.37
极限1194416-19441698.24696.821.61100.4099.051.60
2190891-19089196.46598.73
3191644-19164496.84599.15
4195228-19522898.656100.94
5190715-19071596.37698.66
6186616-18661694.30496.44
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%
110.439301219302769305969305209312679305560.05
210.449310719321049315880.08
单位质量响应值RSD%判断
89219.1889232.570.02数据可信
供试品溶液-TL3535批-二甲双胍-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%
5min130833-308333.4563.434.053.463.444.04
230035-300353.3663.37
329732-297323.3323.33
429323-293233.2863.29
532721-327213.6673.67
631249-312493.5023.50
10min176008-760088.5198.242.358.528.242.32
274412-744128.3408.34
372972-729728.1788.18
470873-708737.9437.95
573842-738428.2768.28
672829-728298.1628.17
15min1108323-10832312.14012.394.2112.1612.404.19
2111591-11159112.50712.52
3110974-11097412.43712.45
4106089-10608911.89011.91
5118981-11898113.33513.35
6107274-10727412.02312.04
20min1122892-12289213.77315.395.3613.8115.435.35
2142387-14238715.95815.99
3141532-14153215.86215.90
4137837-13783715.44815.48
5141655-14165515.87615.91
6137846-13784615.44915.48
30min1175669-17566919.68821.093.6419.7421.153.64
2194542-19454221.80321.86
3192590-19259021.58521.64
4188155-18815521.08721.15
5191868-19186821.50421.57
6186235-18623520.87220.93
45min1231127-23112725.90427.873.7425.9927.963.74
2256670-25667028.76628.86
3253992-25399228.46628.56
4249789-24978927.99528.08
5253719-25371928.43628.53
6246745-24674527.65427.74
60min1282685-28268531.68233.573.0431.8133.703.04
2308216-30821634.54334.68
3305111-30511134.19534.33
4300156-30015633.64033.77
5303712-30371234.03934.18
6297149-29714933.30333.43
120min1436743-43674348.94850.591.9649.1250.771.97
2460247-46024751.58251.77
3458258-45825851.35951.55
4452640-45264050.73050.91
5454948-45494850.98851.18
6445459-44545949.92550.11
180min1548603-54860361.48562.751.5261.7363.011.52
2571488-57148864.05064.31
3565348-56534863.36163.62
4561407-56140762.92063.18
5560720-56072062.84363.11
6551750-55175061.83762.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1635841-63584171.26272.101.1571.6072.461.15
2653151-65315173.20273.56
3648352-64835272.66473.02
4645948-64594872.39572.75
5642608-64260872.02072.38
6634130-63413071.07071.42
360min1769313-76931386.22172.1148.9186.6772.5748.59
2781151-78115187.54888.02
31243-12430.1390.61
4778297-77829787.22887.69
5767682-76768286.03886.50
6762723-76272385.48285.94
480min1852518-85251895.54695.120.9596.1295.680.94
2856588-85658896.00296.60
3851922-85192295.47995.95
4853787-85378795.68896.28
5840470-84047094.19694.79
6836817-83681793.78694.37
600min1921954-921954103.328102.760.97104.05103.480.96
2924889-924889103.657104.40
3918301-918301102.919103.53
4924437-924437103.606104.34
5906433-906433101.589102.33
6905496-905496101.484102.21
720min1943418-943418105.734104.751.01106.61105.611.00
2939627-939627105.309106.21
3935915-935915104.893105.66
4942692-942692105.652106.54
5923696-923696103.523104.41
6922387-922387103.377104.25
960min1959185-959185107.501105.721.18108.53106.741.17
2946183-946183106.044107.10
3943589-943589105.753106.68
4949280-949280106.391107.44
5931785-931785104.430105.47
6929759-929759104.203105.23
1440min1938813-938813105.218104.341.05106.41105.521.04
2938405-938405105.172106.39
3933264-933264104.596105.68
4937733-937733105.097106.31
5917035-917035102.777103.98
6920595-920595103.176104.36
极限1937049-937049105.020104.330.92106.37105.660.91
2935460-935460104.842106.22
3932591-932591104.520105.76
4938935-938935105.231106.60
5917383-917383102.816104.17
6923682-923682103.522104.86
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%
112.211559151561031561221559001566491561380.20
212.201571691574781573240.14
单位质量响应值RSD%判断
12787.7112895.410.60数据可信
供试品溶液-TL3535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%
5min169442-6944234.78243.6518.8334.7843.6418.83
296627-9662748.39948.40
362946-6294631.52931.53
499209-9920949.69249.69
595720-9572047.94447.94
698875-9887549.52549.52
10min1123298-12329861.75878.4618.9961.8178.5218.98
2172199-17219986.25186.32
3113864-11386457.03257.08
4175387-17538787.84887.92
5179863-17986390.09090.16
6175231-17523187.77087.84
15min1140746-14074670.49786.1215.7670.6486.3015.77
2186321-18632193.32593.53
3133783-13378367.01067.14
4186273-18627393.30193.51
5193636-19363696.98997.20
6190867-19086795.60295.81
20min1151501-15150175.88489.1713.3376.1389.4813.35
2190596-19059695.46695.81
3144022-14402272.13872.37
4189621-18962194.97895.32
5197020-19702098.68499.04
6195427-19542797.88698.24
30min1164342-16434282.31692.3010.0182.6892.7510.04
2192898-19289896.61997.10
3157555-15755578.91779.26
4192588-19258896.46496.95
5200366-200366100.360100.86
6197947-19794799.14899.64
45min1174676-17467687.49294.536.8087.9895.116.85
2193991-19399197.16797.80
3170337-17033785.31985.78
4194887-19488797.61598.25
5200054-200054100.204100.85
6198399-19839999.375100.02
60min1180183-18018390.25195.845.0890.8796.565.14
2194811-19481197.57798.35
3178031-17803189.17389.76
4195775-19577598.06098.84
5199886-199886100.119100.92
6199366-19936699.859100.65
120min1186319-18631993.32497.642.7694.0898.512.83
2194668-19466897.50698.43
3191262-19126295.80096.52
4197617-19761798.98399.91
5199884-199884100.118101.07
6199885-199885100.119101.06
180min1187477-18747793.90497.982.4694.8099.002.53
2194895-19489597.61998.69
3193545-19354596.94397.81
4197492-19749298.920100.00
5200185-200185100.269101.37
6200091-200091100.222101.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1188003-18800394.16798.262.5795.2099.422.62
2193905-19390597.12498.34
3194312-19431297.32798.34
4200582-200582100.468101.69
5199769-199769100.061101.31
6200477-200477100.415101.66
360min1192114-19211496.22799.612.1397.40100.922.16
2195975-19597598.16099.52
3200748-200748100.551101.71
4198937-19893799.644101.02
5203692-203692102.026103.43
6201771-201771101.064102.46
480min1189872-18987295.10499.052.4296.42100.512.44
2194653-19465397.49899.01
3200530-200530100.442101.75
4197948-19794899.149100.67
5202870-202870101.614103.17
6200602-200602100.478102.02
600min1195883-19588398.114101.591.9599.58103.201.99
2200883-200883100.619102.27
3204003-204003102.182103.64
4203652-203652102.006103.68
5205820-205820103.092104.80
6206652-206652103.508105.21
720min1195043-19504397.694101.121.9599.30102.881.98
2199627-19962799.990101.79
3204041-204041102.201103.81
4202541-202541101.449103.27
5204775-204775102.568104.43
6205306-205306102.834104.69
960min1193259-19325996.800100.001.8798.56101.911.91
2197209-19720998.779100.73
3201259-201259100.807102.57
4200733-200733100.544102.52
5202318-202318101.338103.35
6203070-203070101.714103.72
1440min1190146-19014695.24198.431.9197.14100.501.94
2193922-19392297.13299.24
3198682-19868299.516101.43
4197576-19757698.962101.09
5199257-19925799.804101.97
6199542-19954299.947102.11
极限1189648-18964894.99198.322.0997.04100.532.12
2193129-19312996.73598.98
3198148-19814899.249101.31
4197287-19728798.818101.09
5200441-200441100.397102.72
6199129-19912999.740102.05
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%
110.439405869401099399709402079400159401770.03
210.449423259435949429600.10
单位质量响应值RSD%判断
90141.6190321.840.15数据可信
供试品溶液-TL3535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%
5min125494-254942.8252.6911.662.832.6911.59
224220-242202.6842.68
325854-258542.8652.87
421434-214342.3752.38
520467-204672.2682.27
627924-279243.0953.09
10min154089-540895.9946.387.616.006.387.58
260378-603786.6916.70
354087-540875.9946.00
464413-644137.1397.14
553644-536445.9455.95
658677-586776.5036.51
15min181170-811708.9969.575.679.019.585.66
291632-9163210.15510.17
379442-794428.8048.82
488321-883219.7889.80
587754-877549.7259.74
689743-897439.9469.96
20min1105608-10560811.70412.616.8911.7312.646.89
2120893-12089313.39813.43
3102257-10225711.33311.36
4116907-11690712.95612.99
5117140-11714012.98213.01
6119756-11975613.27213.30
30min1150014-15001416.62517.896.8816.6717.946.87
2169631-16963118.80018.85
3144857-14485716.05416.10
4165725-16572518.36718.42
5170828-17082818.93218.98
6167491-16749118.56218.61
45min1205890-20589022.81824.235.8922.8924.315.88
2228811-22881125.35825.44
3198848-19884822.03822.11
4225235-22523524.96225.04
5227019-22701925.16025.23
6226129-22612925.06125.14
60min1254418-25441828.19629.685.2728.3029.795.27
2280496-28049631.08631.20
3245899-24589927.25227.35
4274048-27404830.37230.48
5276100-27610030.59930.71
6275950-27595030.58230.70
120min1398397-39839744.15345.793.3544.3045.953.36
2421867-42186746.75446.92
3392713-39271343.52343.66
4422637-42263746.83947.00
5422739-42273946.85047.01
6420859-42085946.64246.80
180min1503316-50331655.78057.432.6255.9957.662.63
2525148-52514858.20058.43
3498450-49845055.24155.45
4526831-52683158.38758.62
5528260-52826058.54558.77
6527313-52731358.44058.67
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1584920-58492064.82466.532.2565.1266.842.26
2605010-60501067.05167.37
3581581-58158164.45464.74
4612249-61224967.85368.17
5608758-60875867.46667.78
6609444-60944467.54267.86
360min1714946-71494679.23580.911.4079.6381.321.40
2729293-72929380.82581.24
3723264-72326480.15680.54
4736081-73608181.57782.00
5744109-74410982.46782.88
6732821-73282181.21681.63
480min1791897-79189787.76389.411.2388.2789.941.23
2803385-80338589.03689.58
3803846-80384689.08789.59
4813105-81310590.11390.65
5821028-82102890.99191.53
6807389-80738989.48090.02
600min1872996-87299696.75197.360.6897.3998.020.69
2877178-87717897.21497.89
3871127-87112796.54397.18
4886699-88669998.26998.95
5882724-88272497.82998.51
6880068-88006897.53498.21
720min1898845-89884599.615100.210.49100.40101.020.50
2901869-90186999.950100.77
3902247-90224799.992100.78
4911055-911055100.968101.79
5907470-907470100.571101.40
6903972-903972100.183101.01
960min1915307-915307101.440101.920.57102.38102.880.58
2916347-916347101.555102.53
3916012-916012101.518102.45
4928492-928492102.901103.88
5923114-923114102.305103.28
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1440min1911703-911703101.040101.690.62102.13102.800.63
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3915141-915141101.421102.51
4927385-927385102.778103.91
5920831-920831102.052103.18
6915438-915438101.454102.58
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2911561-911561101.025102.30
3912710-912710101.152102.39
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6913234-913234101.210102.49
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