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%
112.441576371572111575741573751575971574790.12
212.451589541591961590750.11
单位质量响应值RSD%判断
12659.0812777.110.66数据可信
供试品溶液-24112601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%
5min1120986-12098661.18870.9613.0461.1970.9613.04
2128276-12827664.87564.88
3165935-16593583.92183.92
4160142-16014280.99180.99
5134838-13483868.19468.19
6131664-13166466.58966.59
10min1173915-17391587.95791.023.2888.0591.123.29
2182832-18283292.46792.56
3183815-18381592.96493.09
4188428-18842895.29795.42
5176063-17606389.04389.15
6174743-17474388.37688.48
15min1181719-18171991.90494.382.8892.1394.622.89
2185518-18551893.82594.06
3189711-18971195.94696.21
4195940-19594099.09699.36
5184180-18418093.14893.38
6182624-18262492.36292.59
20min1186298-18629894.22096.122.9294.5896.502.92
2187111-18711194.63195.01
3192953-19295397.58597.99
4200153-200153101.227101.64
5187003-18700394.57694.95
6186816-18681694.48294.85
30min1194991-19499198.616101.043.4899.12101.573.49
2194912-19491298.57699.09
3203589-203589102.965103.52
4212342-212342107.391107.96
5197011-19701199.638100.16
6195909-19590999.08099.59
45min1196857-19685799.560101.853.54100.21102.543.55
2195629-19562998.93999.61
3205327-205327103.844104.55
4214198-214198108.330109.06
5198226-198226100.252100.92
6198122-198122100.200100.86
60min1196754-19675499.508101.963.63100.31102.803.63
2195697-19569798.97399.79
3205423-205423103.892104.76
4214822-214822108.646109.53
5198391-198391100.336101.15
6198548-198548100.415101.23
120min1197678-19767899.975102.223.64100.92103.213.65
2195805-19580599.02899.99
3206182-206182104.276105.30
4215294-215294108.884109.94
5198931-198931100.609101.58
6198834-198834100.560101.52
180min1196789-19678999.525102.023.64100.62103.163.64
2195031-19503198.63699.75
3206287-206287104.329105.51
4214444-214444108.454109.67
5199458-199458100.875101.99
6198320-198320100.300101.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1196321-19632199.289101.573.60100.54102.863.60
2194618-19461898.42799.69
3204599-204599103.475104.81
4213834-213834108.146109.52
5197470-19747099.870101.14
6198124-198124100.201101.46
360min1195197-19519798.720101.103.79100.12102.543.79
2193716-19371697.97199.38
3203349-203349102.843104.33
4213786-213786108.122109.66
5196356-19635699.306100.73
6197005-19700599.635101.05
480min1193898-19389898.063100.533.7599.61102.133.75
2192556-19255697.38598.94
3202093-202093102.208103.85
4212421-212421107.431109.13
5195641-19564198.945100.51
6196082-19608299.168100.73
600min1192431-19243197.32199.743.6699.01101.493.66
2191401-19140196.80098.50
3200975-200975101.642103.44
4210237-210237106.327108.19
5194004-19400498.11799.83
6194273-19427398.25399.97
720min1191880-19188097.04399.163.7798.88101.053.77
2189991-18999196.08797.93
3199859-199859101.078103.03
4209441-209441105.924107.95
5192578-19257897.39699.26
6192609-19260997.41199.27
极限1191367-19136796.78399.053.7298.77101.093.73
2189862-18986296.02298.01
3199605-199605100.950103.05
4209036-209036105.719107.90
5192676-19267697.44599.46
6192503-19250397.35899.36
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%
19.999199339212889221979218579221259214800.11
210.069311589312499312040.01
单位质量响应值RSD%判断
92240.2492565.010.25数据可信
供试品溶液-24112601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%
5min136771-367713.9794.9616.533.984.9616.52
249874-498745.3975.40
348174-481745.2145.21
444677-446774.8354.84
557027-570276.1726.17
638355-383554.1514.15
10min189036-890369.63610.155.829.6410.165.80
295208-9520810.30410.31
3100877-10087710.91710.92
499395-9939510.75710.76
589156-891569.6499.66
689193-891939.6539.66
15min1131689-13168914.25214.453.0614.2714.473.05
2132172-13217214.30414.33
3141100-14110015.27015.29
4135041-13504114.61414.64
5131388-13138814.21914.24
6129787-12978714.04614.07
20min1172478-17247818.66618.252.4218.7118.302.42
2166307-16630717.99818.04
3174292-17429218.86218.91
4169439-16943918.33718.38
5165076-16507617.86517.91
6164422-16442217.79417.84
30min1228376-22837624.71525.113.3624.7925.183.35
2228101-22810124.68624.76
3246418-24641826.66826.74
4235414-23541425.47725.55
5227324-22732424.60224.67
6226292-22629224.49024.56
45min1307761-30776133.30732.362.0433.4132.472.03
2295596-29559631.99032.10
3304000-30400032.90033.01
4300506-30050632.52132.63
5292477-29247731.65331.76
6293747-29374731.79031.90
60min1350758-35075837.96038.292.3338.1238.452.33
2350093-35009337.88838.04
3369445-36944539.98240.15
4356095-35609538.53738.70
5347149-34714937.56937.73
6349155-34915537.78637.94
120min1509927-50992755.18655.461.1655.4055.671.17
2511953-51195355.40555.62
3521237-52123756.41056.63
4517341-51734155.98856.21
5504776-50477654.62854.84
6509401-50940155.12955.34
180min1619765-61976567.07267.601.2867.3767.901.29
2615029-61502966.56066.86
3637172-63717268.95669.27
4629641-62964168.14168.44
5625960-62596067.74368.04
6620245-62024567.12467.42
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1703748-70374876.16176.501.1576.5676.901.15
2701453-70145375.91376.31
3717945-71794577.69878.11
4714786-71478677.35677.76
5696669-69666975.39575.79
6706636-70663676.47476.87
360min1819249-81924988.66188.961.1989.1789.481.19
2814030-81403088.09688.61
3832326-83232690.07690.61
4834873-83487390.35290.87
5810555-81055587.72088.23
6821078-82107888.85989.37
480min1890619-89061996.38596.751.0897.0397.401.08
2878850-87885095.11195.75
3901730-90173097.58798.25
4906428-90642898.09698.75
5892166-89216696.55297.19
6894294-89429496.78397.42
600min1925540-925540100.164100.261.41100.95101.061.41
2913229-91322998.83299.62
3938500-938500101.567102.38
4944418-944418102.207103.01
5912458-91245898.74899.53
6924492-924492100.051100.84
720min1939989-939989101.728101.881.31102.67102.821.30
2929884-929884100.634101.57
3951336-951336102.956103.92
4959959-959959103.889104.84
5928567-928567100.492101.43
6938625-938625101.580102.52
极限1940310-940310101.763101.861.32102.85102.951.32
2928623-928623100.498101.58
3952576-952576103.090104.21
4958618-958618103.744104.86
5928050-928050100.436101.52
6938908-938908101.611102.70
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%
112.441587601586711589091591121588251588550.11
212.451582191579211580700.14
单位质量响应值RSD%判断
12769.6912696.390.41数据可信
供试品溶液-24112601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%
5min177401-7740139.09937.5717.0139.1037.5717.02
280254-8025440.54040.54
353646-5364627.09927.10
486863-8686343.87943.88
564798-6479832.73232.73
683263-8326342.06042.06
10min1164279-16427982.98584.694.6283.0484.744.62
2172275-17227587.02487.08
3158361-15836179.99680.04
4179795-17979590.82390.89
5162145-16214581.90781.96
6169043-16904385.39285.45
15min1182065-18206591.97091.562.8192.1591.742.81
2181118-18111891.49191.68
3177238-17723889.53189.69
4190860-19086096.41296.61
5177920-17792089.87690.05
6178285-17828590.06090.25
20min1186671-18667194.29693.752.5694.6294.072.57
2184441-18444193.17093.50
3181926-18192691.89992.19
4194645-19464598.32498.67
5182795-18279592.33892.65
6183014-18301492.44992.78
30min1196925-19692599.47699.142.7899.9499.602.79
2193892-19389297.94498.41
3193485-19348597.73898.17
4206726-206726104.427104.92
5195161-19516198.58599.03
6191350-19135096.66097.12
45min1199897-199897100.977100.052.46101.59100.662.47
2195869-19586998.94399.56
3196874-19687499.450100.03
4206935-206935104.533105.18
5195666-19566698.84099.43
6193117-19311797.55298.16
60min1201318-201318101.695100.542.50102.46101.302.50
2196884-19688499.455100.22
3198039-198039100.039100.77
4207815-207815104.977105.78
5196505-19650599.264100.01
6193620-19362097.80798.56
120min1201564-201564101.819100.792.38102.74101.702.38
2197078-19707899.553100.47
3199598-199598100.826101.70
4207754-207754104.946105.91
5196887-19688799.457100.35
6194277-19427798.13899.04
180min1201728-201728101.902100.512.53102.97101.572.53
2196394-19639499.208100.27
3199608-199608100.831101.86
4207076-207076104.604105.73
5196287-19628799.154100.19
6192746-19274697.36598.42
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1201170-201170101.620100.462.57102.84101.672.57
2196163-19616399.091100.30
3199017-199017100.533101.71
4207579-207579104.858106.14
5196479-19647999.251100.44
6192852-19285297.41998.61
360min1200067-200067101.063100.002.42102.44101.362.41
2194963-19496398.48599.84
3197965-197965100.001101.33
4206025-206025104.073105.51
5196534-19653499.279100.62
6192188-19218897.08398.43
480min1198490-198490100.26799.282.51101.79100.792.51
2194002-19400297.99999.51
3197186-19718699.608101.09
4204781-204781103.444105.04
5194290-19429098.14599.63
6190427-19042796.19497.68
600min1196936-19693699.48298.602.54101.16100.262.54
2192555-19255597.26998.92
3196084-19608499.051100.68
4203613-203613102.854104.60
5192621-19262197.30298.94
6189324-18932495.63697.27
720min1195232-19523298.62197.942.48100.4599.752.47
2191393-19139396.68298.48
3194597-19459798.300100.08
4202196-202196102.139104.04
5191630-19163096.80198.58
6188227-18822795.08296.86
极限1194989-19498998.49897.652.46100.4799.612.46
2190872-19087296.41898.36
3194361-19436198.181100.11
4201165-201165101.618103.67
5191247-19124796.60898.53
6187251-18725194.58996.51
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%
19.999275329275039275319279179278049276570.03
210.069203479209919206690.05
单位质量响应值RSD%判断
92858.5691517.791.03数据可信
供试品溶液-24112601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%
5min150193-501935.4454.3314.175.444.3214.16
235613-356133.8633.86
337090-370904.0244.02
438675-386754.1954.20
542304-423044.5894.59
635418-354183.8423.84
10min186081-860819.3389.196.669.359.196.63
282962-829629.0009.01
378751-787518.5438.55
493261-9326110.11710.12
578902-789028.5598.57
688077-880779.5559.56
15min1127897-12789713.87413.513.6713.9013.533.66
2126261-12626113.69713.72
3119265-11926512.93812.96
4130412-13041214.14714.17
5119344-11934412.94612.97
6123976-12397613.44913.47
20min1162999-16299917.68217.263.3917.7317.303.40
2161436-16143617.51217.55
3152517-15251716.54516.58
4165968-16596818.00418.05
5153342-15334216.63416.67
6158517-15851717.19617.24
30min1238600-23860025.88324.304.1525.9524.364.15
2223442-22344224.23924.30
3214159-21415923.23223.29
4231285-23128525.09025.16
5217694-21769423.61523.68
6218666-21866623.72123.79
45min1294390-29439031.93531.362.3132.0431.462.31
2291356-29135631.60631.71
3282654-28265430.66230.76
4298447-29844732.37532.48
5282652-28265230.66230.76
6284813-28481330.89631.00
60min1350722-35072238.04637.603.2038.2037.743.19
2346898-34689837.63137.78
3338668-33866836.73936.88
4366476-36647639.75539.91
5338269-33826936.69536.84
6338378-33837836.70736.86
120min1507955-50795555.10354.591.5455.3254.801.55
2504544-50454454.73354.94
3500836-50083654.33054.53
4515221-51522155.89156.11
5496539-49653953.86454.06
6494228-49422853.61453.82
180min1620864-62086467.35166.641.6167.6566.931.62
2616292-61629266.85567.14
3613147-61314766.51466.79
4628072-62807268.13368.43
5607347-60734765.88566.17
6600120-60012065.10165.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1703353-70335376.29975.761.5476.7076.151.54
2697706-69770675.68776.08
3698196-69819675.74076.12
4715327-71532777.59878.00
5692313-69231375.10275.48
6683335-68333574.12874.51
360min1815396-81539688.45488.211.2588.9788.711.25
2813530-81353088.25188.75
3811842-81184288.06888.56
4829878-82987890.02590.54
5809663-80966387.83288.32
6798561-79856186.62887.12
480min1882082-88208295.68895.701.5296.3396.341.52
2889221-88922196.46297.10
3879258-87925895.38196.01
4903396-90339698.00098.65
5875451-87545194.96995.59
6863883-86388393.71494.34
600min1916172-91617299.38699.641.56100.17100.421.56
2923148-923148100.143100.92
3916379-91637999.408100.18
4943417-943417102.341103.14
5911963-91196398.92999.70
6900294-90029497.66398.43
720min1931611-931611101.061101.251.28102.00102.181.28
2935254-935254101.456102.39
3930565-930565100.947101.87
4954648-954648103.560104.51
5929287-929287100.809101.72
6918587-91858799.648100.56
极限1930821-930821100.975101.131.43102.06102.211.43
2934507-934507101.375102.46
3931771-931771101.078102.15
4954257-954257103.517104.63
5929602-929602100.843101.91
6912624-91262499.001100.06
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