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%
112.211540241542151540491542781539691541070.09
212.201544311544561544440.02
单位质量响应值RSD%判断
12621.3812659.340.22数据可信
供试品溶液-TL3535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%
5min1113335-11333557.67048.5621.6657.6748.5621.66
2107752-10775254.82954.83
364867-6486733.00733.01
4111717-11171756.84756.85
574475-7447537.89637.90
6100388-10038851.08251.08
10min1184790-18479094.03084.6214.3294.1284.6914.33
2177526-17752690.33490.42
3130186-13018666.24566.29
4188576-18857695.95696.04
5143536-14353673.03873.09
6173148-17314888.10688.18
15min1198451-198451100.98193.0110.71101.2193.2110.72
2193035-19303598.22598.44
3153752-15375278.23678.39
4198634-198634101.074101.30
5162501-16250182.68882.85
6190360-19036096.86497.07
20min1198467-198467100.98995.228.31101.3795.568.33
2194613-19461399.02899.39
3164436-16443683.67383.94
4200596-200596102.073102.45
5170473-17047386.74587.04
6194173-19417398.80499.16
30min1199454-199454101.49297.386.25102.0297.866.28
2195215-19521599.33599.85
3174018-17401888.54988.94
4202396-202396102.989103.52
5178681-17868190.92191.34
6198509-198509101.011101.51
45min1201533-201533102.55099.084.54103.2399.714.58
2196059-19605999.764100.43
3182775-18277593.00593.53
4203570-203570103.586104.27
5184823-18482394.04794.60
6199539-199539101.535102.19
60min1200006-200006101.773100.203.62102.61100.983.66
2196759-196759100.120100.93
3188787-18878796.06496.73
4203685-203685103.645104.49
5188034-18803495.68196.38
6204224-204224103.919104.72
120min1199899-199899101.718100.911.98102.71101.842.03
2197239-197239100.365101.33
3195746-19574699.605100.41
4203954-203954103.781104.78
5192790-19279098.10198.94
6200279-200279101.911102.87
180min1199758-199758101.646101.171.53102.79102.251.57
2196044-19604499.756100.87
3197891-197891100.696101.65
4203342-203342103.470104.62
5195254-19525499.354100.34
6200647-200647102.099103.21
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1199389-199389101.459101.131.41102.75102.361.44
2195787-19578799.626100.89
3198665-198665101.090102.20
4203216-203216103.406104.72
5195758-19575899.611100.75
6199613-199613101.573102.84
360min1202405-202405102.993102.281.32104.44103.661.34
2197597-197597100.547101.96
3201266-201266102.414103.67
4204949-204949104.288105.75
5198590-198590101.052102.34
6201201-201201102.381103.80
480min1200057-200057101.798101.671.27103.40103.211.28
2196305-19630599.889101.45
3201123-201123102.341103.75
4203445-203445103.522105.14
5197693-197693100.596102.03
6200243-200243101.893103.47
600min1205490-205490104.563104.731.29106.32106.421.29
2201784-201784102.677104.39
3207494-207494105.583107.15
4209449-209449106.578108.35
5204263-204263103.939105.53
6206432-206432105.042106.77
720min1203983-203983103.796104.001.20105.71105.851.20
2200872-200872102.213104.08
3206342-206342104.997106.72
4207755-207755105.716107.65
5202852-202852103.221104.97
6204552-204552104.086105.97
960min1202493-202493103.038102.931.39105.10104.931.38
2197815-197815100.658102.68
3204439-204439104.028105.91
4205802-205802104.722106.82
5200788-200788102.170104.07
6202351-202351102.966105.01
1440min1198064-198064100.784101.081.45103.01103.241.43
2194161-19416198.798100.97
3201300-201300102.431104.47
4201680-201680102.624104.88
5196862-196862100.173102.23
6199816-199816101.676103.87
极限1198700-198700101.108100.941.40103.48103.251.38
2193667-19366798.547100.87
3200693-200693102.122104.32
4201346-201346102.454104.86
5197116-197116100.302102.51
6198666-198666101.091103.44
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%
110.439424799436299429279425649441359431470.08
210.449440179465299452730.19
单位质量响应值RSD%判断
90426.3790543.390.10数据可信
供试品溶液-TL3535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%
5min125998-259982.8732.996.752.872.996.78
226348-263482.9122.91
329429-294293.2523.25
424363-243632.6922.69
528143-281433.1103.11
628020-280203.0973.10
10min168155-681557.5327.117.307.547.127.32
266199-661997.3167.32
360589-605896.6966.70
462682-626826.9276.93
558071-580716.4186.42
670346-703467.7747.78
15min1143997-14399715.91411.8419.2315.9311.8619.21
2103082-10308211.39211.41
390436-904369.99510.01
498658-9865810.90310.92
589825-898259.9279.94
6116919-11691912.92112.94
20min1140672-14067215.54614.267.1215.5914.307.13
2133038-13303814.70314.74
3118447-11844713.09013.12
4128344-12834414.18414.21
5118342-11834213.07913.11
6135607-13560714.98715.02
30min1184874-18487420.43119.535.6020.4919.595.62
2181846-18184620.09720.15
3162001-16200117.90417.95
4178106-17810619.68419.74
5167408-16740818.50118.55
6186286-18628620.58820.65
45min1254211-25421128.09426.325.2828.1926.405.29
2240825-24082526.61526.70
3220571-22057124.37724.45
4237245-23724526.21926.30
5227577-22757725.15125.23
6248249-24824927.43527.52
60min1294132-29413232.50631.673.7732.6431.793.78
2291084-29108432.16932.29
3269620-26962029.79729.91
4288066-28806631.83631.96
5277880-27788030.71030.82
6298397-29839732.97833.11
120min1444782-44478249.15548.342.3249.3448.512.33
2440304-44030448.66148.83
3421680-42168046.60246.76
4437839-43783948.38848.56
5430107-43010747.53447.69
6449579-44957949.68649.87
180min1550517-55051760.84160.231.7461.1060.481.75
2543700-54370060.08760.33
3530546-53054658.63458.86
4544703-54470360.19860.44
5541598-54159859.85560.09
6559011-55901161.78062.03
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1634026-63402670.07069.421.3870.4269.751.39
2625177-62517769.09269.43
3617430-61743068.23668.55
4627373-62737369.33569.67
5623005-62300568.85269.17
6641829-64182970.93271.28
360min1763875-76387584.42083.710.9384.8784.140.94
2751218-75121883.02183.46
3751549-75154983.05883.48
4754967-75496783.43683.87
5754654-75465483.40183.83
6768213-76821384.90085.35
480min1839776-83977692.80892.070.7393.3992.640.74
2826604-82660491.35391.92
3833353-83335392.09992.64
4826913-82691391.38791.95
5831540-83154091.89892.45
6840628-84062892.90393.48
600min1911264-911264100.70999.980.75101.43100.680.75
2894164-89416498.81999.52
3909340-909340100.496101.18
4898929-89892999.346100.04
5905333-905333100.054100.74
6909166-909166100.477101.20
720min1931035-931035102.894102.410.76103.77103.260.75
2917266-917266101.372102.22
3936297-936297103.476104.31
4920173-920173101.694102.54
5927200-927200102.470103.31
6927788-927788102.535103.41
960min1946950-946950104.653103.930.94105.68104.940.93
2927812-927812102.538103.54
3951864-951864105.196106.18
4933528-933528103.170104.17
5942370-942370104.147105.14
6940082-940082103.894104.92
1440min1943193-943193104.238103.540.98105.42104.700.97
2924840-924840102.209103.36
3949918-949918104.981106.13
4929007-929007102.670103.82
5938000-938000103.664104.81
6936385-936385103.485104.67
极限1944227-944227104.352103.521.09105.69104.841.08
2922313-922313101.930103.24
3949879-949879104.977106.28
4928095-928095102.569103.88
5937246-937246103.580104.88
6938512-938512103.720105.06
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