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%
110.069576719581349577349584519583759580730.04
210.059671879668609670240.03
单位质量响应值RSD%判断
95235.8896221.290.73数据可信
供试品溶液-25041502批-pH6.8指导原则
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128794-287943.0083.6712.203.013.6712.18
233300-333003.4793.48
337742-377423.9433.94
434403-344033.5943.59
535240-352403.6813.68
641543-415434.3404.34
10min181803-818038.5468.973.868.558.983.87
286167-861679.0019.01
382381-823818.6068.61
489003-890039.2989.30
589884-898849.3909.40
685888-858888.9728.98
15min1123483-12348312.90013.252.7312.9213.272.72
2126601-12660113.22513.24
3122589-12258912.80612.83
4130401-13040113.62213.64
5131067-13106713.69213.71
6126851-12685113.25113.27
20min1156822-15682216.38216.862.7916.4216.902.79
2164453-16445317.18017.22
3155628-15562816.25816.30
4166485-16648517.39217.43
5164615-16461517.19617.24
6160211-16021116.73616.78
30min1212843-21284322.23522.511.6322.3022.581.63
2214348-21434822.39222.46
3210889-21088922.03022.09
4219272-21927222.90622.97
5219626-21962622.94323.01
6215978-21597822.56222.63
45min1279629-27962929.21129.411.2529.3129.511.25
2279365-27936529.18429.28
3278183-27818329.06029.16
4285565-28556529.83129.93
5286363-28636329.91530.02
6280172-28017229.26829.37
60min1335328-33532835.03035.071.1835.1735.221.19
2333347-33334734.82334.96
3331794-33179434.66134.80
4339924-33992435.51035.66
5341315-34131535.65535.80
6332833-33283334.76934.91
120min1501398-50139852.37851.781.1052.5751.981.10
2492042-49204251.40151.59
3491245-49124551.31851.51
4498351-49835152.06052.26
5501743-50174352.41452.61
6489497-48949751.13551.33
180min1612691-61269164.00563.952.1264.2764.222.11
2602859-60285962.97863.25
3606394-60639463.34763.61
4610509-61050963.77764.05
5637345-63734566.58066.86
6603318-60331863.02563.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1696512-69651272.76172.261.0073.1372.631.00
2683454-68345471.39771.76
3687002-68700271.76872.13
4695364-69536472.64173.01
5701094-70109473.24073.62
6686985-68698571.76672.13
360min1840232-84023287.77587.260.8988.2587.740.89
2826757-82675786.36786.84
3829997-82999786.70587.18
4837248-83724887.46387.94
5846420-84642088.42188.91
6831056-83105686.81687.29
480min1915763-91576395.66595.170.8096.2795.780.80
2903702-90370294.40595.01
3904559-90455994.49595.10
4912049-91204995.27795.89
5922382-92238296.35696.98
6907557-90755794.80895.41
600min1958716-958716100.15299.510.75100.90100.260.75
2947091-94709198.93899.68
3944043-94404398.61999.36
4953707-95370799.629100.38
5962500-962500100.547101.31
6949406-94940699.17999.93
720min1974721-974721101.824101.490.78102.72102.390.78
2972292-972292101.570102.46
3960291-960291100.317101.21
4970070-970070101.338102.24
5983116-983116102.701103.62
6968824-968824101.208102.10
极限1985540-985540102.954101.501.07104.01102.551.07
2962900-962900100.589101.63
3960237-960237100.311101.35
4969875-969875101.318102.37
5982500-982500102.637103.71
6968418-968418101.166102.21
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%
110.069868599864059863389862939868299865450.03
210.059659319657999658650.01
单位质量响应值RSD%判断
98066.1096105.971.43数据可信
供试品溶液-25041502批-pH6.8日本药典
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136309-363093.7403.367.303.743.367.36
231108-311083.2043.20
331943-319433.2913.29
432080-320803.3053.30
534456-344563.5493.55
629744-297443.0643.06
10min187997-879979.0658.683.789.078.683.80
281818-818188.4288.43
382396-823968.4888.49
487954-879549.0609.07
584721-847218.7278.73
680606-806068.3038.31
15min1129476-12947613.33812.972.7613.3612.992.76
2122992-12299212.67012.69
3122994-12299412.67012.69
4130051-13005113.39713.42
5127205-12720513.10413.12
6122501-12250112.61912.64
20min1164485-16448516.94416.452.6416.9816.492.65
2156351-15635116.10616.14
3155757-15575716.04516.08
4164728-16472816.96917.01
5160673-16067316.55116.59
6156157-15615716.08616.12
30min1220170-22017022.68022.212.0222.7422.272.02
2212620-21262021.90221.96
3211571-21157121.79421.86
4220647-22064722.72922.79
5217417-21741722.39722.46
6211160-21116021.75221.81
45min1287757-28775729.64229.141.8129.7429.241.82
2278841-27884128.72428.82
3278022-27802228.64028.73
4289280-28928029.79929.90
5285233-28523329.38229.48
6278337-27833728.67228.76
60min1345059-34505935.54534.901.6635.6935.041.66
2334190-33419034.42634.56
3333459-33345934.35034.49
4344386-34438635.47635.62
5342139-34213935.24435.38
6333724-33372434.37834.51
120min1509358-50935852.47051.611.3652.6751.801.37
2497226-49722651.22051.41
3494446-49444650.93451.12
4505397-50539752.06252.26
5506118-50611852.13652.33
6493396-49339650.82651.01
180min1622662-62266264.14263.351.2164.4263.621.22
2610953-61095362.93563.20
3610295-61029562.86863.13
4618733-61873363.73764.01
5622738-62273864.14964.42
6604716-60471662.29362.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1706375-70637572.76571.901.1973.1472.271.19
2692700-69270071.35671.72
3693444-69344471.43371.79
4702529-70252972.36972.74
5706313-70631372.75973.13
6686543-68654370.72271.08
360min1852449-85244987.81286.691.0688.2987.161.06
2834405-83440585.95486.42
3840371-84037186.56887.03
4843860-84386086.92887.41
5849135-84913587.47187.95
6829036-82903685.40185.86
480min1926446-92644695.43594.320.9396.0594.920.93
2908632-90863293.60094.20
3917364-91736494.49995.10
4916814-91681494.44395.05
5921203-92120394.89595.50
6903132-90313293.03393.62
600min1963266-96326699.22898.350.8299.9899.100.82
2947448-94744897.59898.33
3957544-95754498.63899.38
4954764-95476498.35299.10
5961754-96175499.07299.82
6943897-94389797.23397.96
720min1980296-980296100.98299.880.87101.89100.770.87
2962294-96229499.128100.01
3971946-971946100.122101.01
4968322-96832299.749100.65
5976447-976447100.586101.48
6958181-95818198.70499.58
极限1979654-979654100.91699.800.94101.97100.840.94
2965615-96561599.470100.50
3972855-972855100.216101.25
4967223-96722399.635100.68
5974072-974072100.341101.39
6953525-95352598.22499.25
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%
110.069653379655889646289638589634259645670.10
210.059605129602439603780.02
单位质量响应值RSD%判断
95881.4195560.000.24数据可信
供试品溶液-192E42406批-pH6.8中国药典
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137089-370893.8754.4735.083.874.4735.04
233192-331923.4683.47
335867-358673.7473.75
434349-343493.5883.59
543859-438594.5824.58
672488-724887.5737.57
10min185451-854518.9279.056.038.939.066.01
280575-805758.4188.42
386183-861839.0049.01
495407-954079.9679.97
589370-893709.3379.34
682947-829478.6668.68
15min1129555-12955513.53513.073.4013.5513.093.39
2119553-11955312.49012.51
3127199-12719913.28913.31
4121313-12131312.67412.69
5129408-12940813.51913.54
6123587-12358712.91112.94
20min1158882-15888216.59916.592.8016.6416.632.80
2153115-15311515.99616.03
3163866-16386617.11917.16
4154510-15451016.14216.18
5163488-16348817.08017.12
6158897-15889716.60016.64
30min1213348-21334822.28922.191.7822.3522.261.78
2208455-20845521.77721.84
3214917-21491722.45322.52
4208445-20844521.77621.84
5218002-21800222.77522.84
6211381-21138122.08322.15
45min1277749-27774929.01728.951.4329.1129.041.44
2274540-27454028.68128.77
3279282-27928229.17729.28
4272116-27211628.42828.52
5283332-28333229.60029.70
6275455-27545528.77728.88
60min1330626-33062634.54134.531.8134.6834.671.81
2325686-32568634.02534.16
3331642-33164234.64734.79
4324685-32468533.92034.06
5341349-34134935.66135.81
6329245-32924534.39734.54
120min1480460-48046050.19450.370.9450.3950.560.94
2480271-48027150.17450.36
3483358-48335850.49750.69
4476752-47675249.80750.00
5490152-49015251.20751.41
6481793-48179350.33350.53
180min1593007-59300761.95262.010.8362.2262.280.84
2591034-59103461.74662.01
3596678-59667862.33562.61
4587106-58710661.33561.60
5601315-60131562.82063.10
6592144-59214461.86262.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1678169-67816970.84970.890.8771.2171.260.87
2685506-68550671.61571.97
3679248-67924870.96271.33
4668981-66898169.88970.25
5683705-68370571.42771.80
6676049-67604970.62770.99
360min1816551-81655185.30685.300.6585.7785.770.65
2815003-81500385.14485.61
3815328-81532885.17885.65
4808814-80881484.49884.96
5825031-82503186.19286.67
6818338-81833885.49385.96
480min1888042-88804292.77592.780.5093.3793.380.51
2886492-88649292.61393.20
3887068-88706892.67393.27
4881984-88198492.14292.73
5895506-89550693.55494.16
6889666-88966692.94493.54
600min1926700-92670096.81396.630.5497.5597.360.54
2920932-92093296.21196.94
3923135-92313596.44197.18
4918418-91841895.94896.67
5931242-93124297.28898.03
6929280-92928097.08397.82
720min1942768-94276898.49298.140.4799.3799.020.48
2935185-93518597.70098.57
3936783-93678397.86798.75
4934377-93437797.61598.49
5944498-94449898.67399.57
6942526-94252698.46799.35
极限1944158-94415898.63798.150.4499.6699.180.44
2936204-93620497.80698.83
3937531-93753197.94598.97
4935384-93538497.72098.74
5945010-94501098.72699.77
6938700-93870098.06799.10
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