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%
110.258037480034801998012880196801860.16
210.278051180406804580.10
单位质量响应值RSD%判断
7823.027834.270.11数据可信
供试品溶液-25041001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%
5min1158694-158694130.383126.164.24130.38126.164.24
2154916-154916127.279127.28
3143727-143727118.086118.09
4149577-149577122.892122.89
5161906-161906133.022133.02
6152491-152491125.286125.29
10min1179106-179106147.153145.691.15147.35145.881.15
2178435-178435146.602146.79
3173777-173777142.775142.95
4177305-177305145.673145.86
5178945-178945147.021147.22
6176373-176373144.908145.10
15min1180482-180482148.284147.620.73148.70148.020.73
2180754-180754148.507148.92
3177937-177937146.193146.58
4179140-179140147.181147.58
5181119-181119148.807149.23
6178593-178593146.732147.14
20min1181948-181948149.488148.170.82150.13148.800.82
2181545-181545149.157149.79
3178818-178818146.917147.53
4179906-179906147.810148.43
5181292-181292148.949149.59
6178540-178540146.688147.31
30min1182108-182108149.620148.440.89150.48149.290.89
2182286-182286149.766150.62
3179614-179614147.571148.40
4179658-179658147.607148.45
5181845-181845149.404150.27
6178552-178552146.698147.54
45min1181703-181703149.287148.390.72150.37149.460.72
2181926-181926149.470150.55
3180487-180487148.288149.34
4179401-179401147.396148.46
5181357-181357149.003150.09
6178799-178799146.901147.97
60min1181936-181936149.478148.260.85150.79149.560.85
2182055-182055149.576150.88
3180016-180016147.901149.18
4179650-179650147.600148.89
5181014-181014148.721150.04
6178059-178059146.293147.58
120min1186889-186889153.548152.790.80155.08154.310.80
2187788-187788154.286155.82
3185600-185600152.489153.99
4184443-184443151.538153.05
5186931-186931153.582155.12
6184117-184117151.270152.78
180min1186386-186386153.134152.210.94154.90153.950.94
2187428-187428153.990155.75
3184955-184955151.959153.68
4183714-183714150.939152.68
5186186-186186152.970154.74
6182862-182862150.239151.97
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1185534-185534152.434151.750.78154.43153.720.78
2186535-186535153.257155.25
3184510-184510151.593153.55
4183389-183389150.672152.64
5185446-185446152.362154.36
6182760-182760150.155152.11
360min1184706-184706151.754150.950.84153.98153.160.84
2185168-185168152.134154.36
3183608-183608150.852153.03
4182458-182458149.907152.10
5185041-185041152.029154.26
6181385-181385149.026151.21
480min1183141-183141150.468149.780.84152.92152.210.84
2183939-183939151.124153.57
3182154-182154149.657152.06
4180929-180929148.651151.06
5183522-183522150.781153.24
6180119-180119147.985150.39
600min1181844-181844149.403148.900.97152.08151.560.97
2183757-183757150.974153.65
3181073-181073148.769151.40
4179599-179599147.558150.19
5182161-182161149.663152.34
6178990-178990147.058149.69
720min1181242-181242148.908147.980.92151.81150.860.91
2181933-181933149.476152.38
3180047-180047147.926150.78
4178546-178546146.693149.55
5181116-181116148.805151.71
6177790-177790146.072148.92
极限1180122-180122147.988147.660.86151.11150.760.86
2181453-181453149.081152.21
3179636-179636147.589150.67
4178143-178143146.362149.44
5181193-181193148.868152.00
6177754-177754146.042149.11
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%
110.279747709746749737269739889737899741890.06
210.259739439732409735920.06
单位质量响应值RSD%判断
94857.7494984.590.10数据可信
供试品溶液-25041001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%
5min162287-622876.5626.592.036.566.592.00
260705-607056.3956.40
364183-641836.7626.76
462306-623066.5646.56
563821-638216.7246.72
662123-621236.5456.54
10min1115528-11552812.17112.081.2512.1812.091.25
2113736-11373611.98211.99
3112571-11257111.85911.87
4116062-11606212.22712.24
5116037-11603712.22512.23
6114046-11404612.01512.02
15min1154432-15443216.27016.141.1416.3016.171.13
2151992-15199216.01216.04
3151525-15152515.96315.99
4155322-15532216.36316.39
5154569-15456916.28416.31
6151491-15149115.96015.99
20min1185815-18581519.57619.391.1919.6319.451.20
2181680-18168019.14019.19
3183676-18367619.35019.40
4186749-18674919.67419.73
5185138-18513819.50419.56
6181481-18148119.11919.17
30min1235074-23507424.76524.691.1024.8524.771.10
2231449-23144924.38324.46
3233814-23381424.63224.71
4237161-23716124.98525.07
5237234-23723424.99325.07
6231599-23159924.39924.48
45min1294354-29435431.01030.980.9431.1331.100.94
2290679-29067930.62330.74
3295369-29536931.11731.24
4297325-29732531.32331.44
5295778-29577831.16031.28
6290768-29076830.63330.75
60min1344473-34447336.29036.171.1036.4636.341.10
2339373-33937335.75335.92
3344145-34414536.25636.42
4347981-34798136.66036.83
5345694-34569436.41936.59
6338269-33826935.63735.80
120min1504994-50499453.20152.980.9253.4253.200.92
2496779-49677952.33652.55
3505399-50539953.24453.46
4506557-50655753.36653.59
5506355-50635553.34553.57
6497289-49728952.39052.61
180min1611958-61195864.47064.190.9064.7764.490.90
2603093-60309363.53663.83
3613364-61336464.61864.92
4611741-61174164.44764.75
5613877-61387764.67264.97
6601652-60165263.38463.68
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1693640-69364073.07572.760.8373.4773.160.83
2682885-68288571.94272.33
3694343-69434373.14973.55
4693467-69346773.05773.46
5695629-69562973.28573.68
6683942-68394272.05472.44
360min1812218-81221885.56884.900.8286.0785.410.82
2797292-79729283.99584.49
3809613-80961385.29385.80
4808095-80809585.13385.64
5810266-81026685.36285.87
6798044-79804484.07484.57
480min1885143-88514393.25092.590.7993.8893.220.79
2868753-86875391.52492.15
3882733-88273392.99693.63
4882198-88219892.94093.58
5882837-88283793.00793.64
6871496-87149691.81392.44
600min1924180-92418097.36396.880.6898.1497.660.68
2911024-91102495.97796.74
3925225-92522597.47398.25
4923560-92356097.29898.07
5921131-92113197.04297.82
6912660-91266096.14996.91
720min1945118-94511899.56998.890.68100.4999.800.68
2929155-92915597.88798.79
3942704-94270499.314100.23
4940756-94075699.109100.03
5941737-94173799.213100.13
6932606-93260698.25199.16
极限1943601-94360199.40998.820.63100.4899.880.63
2928606-92860697.82998.88
3941086-94108699.144100.21
4940983-94098399.133100.20
5940665-94066599.100100.17
6933069-93306998.29999.35
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