恩格列净二甲双胍缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
1104429374408924390434401094411134408190.33
2104355924360574358240.08
单位质量响应值RSD%判断
44081.9043582.400.81数据可信
供试品溶液-3214157批-25mg/1000mg规格-恩格列净-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%
5min1-0.0000.73159.360.000.72159.30
2-0.0000.00
38512-85121.7481.75
412682-126822.6042.60
5-0.0000.00
6-0.0000.00
10min1150489-15048930.90123.8432.0830.9023.8432.08
276091-7609115.62415.62
397380-9738019.99620.00
490807-9080718.64618.65
5172006-17200635.31935.32
6109984-10998422.58422.58
15min1287566-28756659.04751.8916.4859.1051.9316.50
2194158-19415839.86839.89
3248133-24813350.95050.99
4228395-22839546.89846.93
5310901-31090163.83963.90
6247130-24713050.74550.78
20min1363175-36317574.57372.057.7174.7272.187.73
2303963-30396362.41462.51
3348824-34882471.62671.75
4344456-34445670.72970.84
5385184-38518479.09279.26
6359674-35967473.85473.98
30min1445390-44539091.45491.882.9991.7392.123.00
2441331-44133190.62190.82
3425312-42531287.33287.57
4452370-45237092.88893.12
5462864-46286495.04295.34
6457389-45738993.91894.16
45min1476109-47610997.76298.693.2498.1999.093.23
2492754-492754101.180101.53
3451249-45124992.65793.04
4489346-489346100.480100.87
5484191-48419199.42299.88
6490048-490048100.624101.03
60min1481690-48169098.90899.824.0099.50100.393.97
2507003-507003104.106104.62
3451340-45134092.67693.22
4497369-497369102.127102.68
5484080-48408099.399100.02
6495453-495453101.734102.30
120min1496802-496802102.011101.372.96102.77102.112.96
2499822-499822102.631103.32
3464378-46437895.35396.05
4498712-498712102.403103.13
5497985-497985102.254103.04
6504479-504479103.587104.33
240min1488921-488921100.393100.712.80101.32101.612.79
2502942-502942103.272104.13
3464122-46412295.30196.15
4493706-493706101.375102.27
5496371-496371101.923102.88
6496771-496771102.005102.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1486249-48624999.844100.422.70100.94101.492.69
2496373-496373101.923102.96
3464140-46414095.30496.32
4491689-491689100.961102.02
5494872-494872101.615102.74
6501061-501061102.886103.97
480min1488983-488983100.406100.662.96101.66101.892.95
2494331-494331101.504102.71
3463559-46355995.18596.36
4489946-489946100.603101.84
5498308-498308102.320103.62
6506069-506069103.914105.17
600min1493914-493914101.418102.102.77102.84103.502.77
2504268-504268103.544104.92
3472317-47231796.98398.31
4495653-495653101.775103.17
5509263-509263104.570106.04
6508048-508048104.320105.75
720min1491691-491691100.962100.953.62102.56102.533.61
2499983-499983102.664104.21
3458193-45819394.08395.58
4488988-488988100.407101.98
5504958-504958103.686105.33
6506126-506126103.926105.53
840min1485963-48596399.78598.326.68101.55100.066.61
2497985-497985102.254103.97
3423955-42395587.05388.70
4457828-45782894.00895.74
5505530-505530103.803105.62
6501686-501686103.014104.79
960min1473632-47363297.25395.819.1699.1897.729.03
2497340-497340102.122104.01
3399513-39951382.03483.83
4429684-42968488.22990.12
5494414-494414101.521103.51
6505145-505145103.724105.67
极限1468023-46802396.10295.009.3798.1997.069.24
2494805-494805101.601103.66
3392165-39216580.52582.46
4428892-42889288.06790.11
5494812-494812101.602103.76
6497114-497114102.075104.19
恩格列净二甲双胍缓释片项目信息
介质体积(ml)900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%
111.149556779556109495389495339450279510770.48
211.149362409368229365310.05
单位质量响应值RSD%判断
85374.9684069.211.09数据可信
供试品溶液-3214157批-25mg/1000mg规格-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%
5min1-0.0000.46196.220.000.46196.04
2-0.0000.00
34778-47780.5080.51
421398-213982.2732.27
5-0.0000.00
6-0.0000.00
10min147238-472385.0181.68122.075.021.68121.92
22326-23260.2470.25
33768-37680.4000.40
43518-35180.3740.38
55284-52840.5610.56
632866-328663.4923.49
15min128002-280022.9752.9041.092.982.9140.98
220286-202862.1552.16
343331-433314.6034.60
421554-215542.2902.29
537335-373353.9663.97
613494-134941.4341.44
20min166698-666987.0866.8223.547.106.8323.55
252583-525835.5865.59
385168-851689.0489.06
462483-624836.6386.65
575182-751827.9877.99
643266-432664.5964.60
30min1137874-13787414.64714.038.8514.6714.048.87
2124428-12442813.21913.23
3141088-14108814.98915.01
4128770-12877013.68013.70
5145656-14565615.47415.49
6114359-11435912.14912.16
45min1218005-21800523.16022.643.7023.2122.683.72
2209906-20990622.30022.33
3217854-21785423.14423.19
4212218-21221822.54522.59
5221353-22135323.51623.56
6199533-19953321.19821.23
60min1276936-27693629.42129.122.7729.5129.202.77
2283660-28366030.13530.21
3271960-27196028.89228.98
4274479-27447929.16029.24
5276696-27669629.39529.48
6260845-26084527.71127.78
120min1444996-44499647.27545.951.9447.4146.081.95
2427116-42711645.37545.50
3431540-43154045.84545.98
4436404-43640446.36246.49
5434615-43461546.17246.31
6420516-42051644.67444.79
240min1635046-63504667.46566.641.5167.6866.851.51
2632975-63297567.24567.44
3624090-62409066.30166.51
4629270-62927066.85167.06
5632638-63263867.20967.42
6609712-60971264.77364.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1774271-77427182.25581.541.1582.5881.861.15
2770204-77020481.82382.13
3752396-75239679.93280.25
4769815-76981581.78282.10
5776166-77616682.45782.78
6762622-76262281.01881.32
480min1876950-87695093.16492.071.0693.6392.531.05
2866509-86650992.05492.50
3851396-85139690.44990.91
4861979-86197991.57392.03
5873369-87336992.78393.24
6870007-87000792.42692.86
600min1959615-959615101.946100.831.44102.57101.441.43
2952685-952685101.209101.81
3930043-93004398.80499.41
4940132-94013299.876100.48
5967530-967530102.787103.40
6944877-944877100.380100.97
720min1992333-992333105.421104.291.93106.21105.061.91
2987008-987008104.856105.62
3945971-945971100.496101.27
4977546-977546103.851104.62
5999107-999107106.141106.93
6987963-987963104.957105.71
840min11018970-1018970108.251104.805.03109.22105.744.99
21013761-1013761107.698108.64
3907908-90790896.45397.39
4941950-941950100.069101.01
51030840-1030840109.512110.48
61005325-1005325106.802107.73
960min11004532-1004532106.717103.927.32107.86105.047.25
21034344-1034344109.885111.01
3874337-87433792.88693.99
4900409-90040995.65696.77
51027084-1027084109.113110.26
61028311-1028311109.244110.35
极限1998346-998346106.060103.587.32107.38104.887.25
21026986-1026986109.103110.41
3868809-86880992.29993.55
4902370-90237095.86497.14
51038147-1038147110.289111.62
61015431-1015431107.875109.17
恩格列净二甲双胍缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
1104283444295024296854296794305294295480.19
2104367584359844363710.13
单位质量响应值RSD%判断
42954.8043637.101.12数据可信
供试品溶液-3214157批-25mg/1000mg规格-恩格列净-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%
5min1-0.0000.28244.950.000.28244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
68141-81411.6921.69
10min1176683-17668336.73028.4118.6036.7328.4218.60
2132466-13246627.53827.54
3145801-14580130.31030.31
4144207-14420729.97829.98
5103505-10350521.51721.52
6117416-11741624.40924.41
15min1325613-32561367.69060.847.3267.7560.887.33
2297616-29761661.87061.92
3298634-29863462.08162.13
4293867-29386761.09061.14
5262213-26221354.51054.55
6277892-27789257.76957.81
20min1401846-40184683.53877.794.7483.7177.944.75
2369322-36932276.77676.93
3389012-38901280.87081.02
4369349-36934976.78276.93
5358562-35856274.53974.67
6356992-35699274.21374.35
30min1464368-46436896.53594.142.7496.8594.422.73
2447814-44781493.09493.37
3461804-46180496.00296.29
4432030-43203089.81290.09
5461795-46179596.00096.25
6449216-44921693.38593.65
45min1478307-47830799.43398.763.6199.9199.203.59
2466973-46697397.07697.51
3479314-47931499.642100.09
4445448-44544892.60293.03
5494523-494523102.804103.21
6485882-485882101.007101.43
60min1485708-485708100.97199.583.81101.61100.183.80
2468503-46850397.39597.99
3488628-488628101.578102.19
4446527-44652792.82693.41
5490312-490312101.928102.51
6494291-494291102.755103.34
120min1495495-495495103.006101.404.40103.81102.174.38
2477183-47718399.19999.96
3487751-487751101.396102.18
4452896-45289694.15094.89
5496715-496715103.259104.01
6516616-516616107.396108.16
240min1496467-496467103.208101.163.07104.19102.093.06
2481404-481404100.076101.00
3486186-486186101.071102.02
4459629-45962995.55096.45
5499317-499317103.800104.72
6496567-496567103.229104.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1493973-493973102.689101.243.13103.84102.343.12
2478755-47875599.526100.61
3486463-486463101.128102.25
4461475-46147595.93496.99
5503537-503537104.678105.77
6497741-497741103.473104.58
480min1494848-494848102.871101.303.24104.19102.573.23
2476120-47612098.978100.23
3483717-483717100.557101.85
4463424-46342496.33997.55
5501894-501894104.336105.61
6503671-503671104.705105.99
600min1501307-501307104.214102.902.50105.71104.342.50
2484385-484385100.696102.12
3494720-494720102.845104.30
4477057-47705799.173100.55
5502073-502073104.373105.82
6510444-510444106.113107.57
720min1500305-500305104.006102.602.04105.67104.212.05
2481485-481485100.093101.68
3490540-490540101.976103.60
4482582-482582100.321101.86
5502441-502441104.450106.07
6503899-503899104.753106.39
840min1497998-497998103.526102.032.38105.37103.822.37
2475597-47559798.869100.62
3487903-487903101.427103.23
4480807-48080799.952101.66
5495569-495569103.021104.81
6507067-507067105.411107.22
960min1495752-495752103.059101.622.28105.07103.582.27
2475369-47536998.822100.74
3482698-482698100.345102.31
4479891-47989199.762101.64
5495449-495449102.996104.96
6503877-503877104.748106.73
极限1491534-491534102.182101.371.91104.37103.501.90
2473266-47326698.385100.47
3480560-48056099.901102.04
4487776-487776101.401103.44
5494461-494461102.791104.93
6498303-498303103.589105.75
恩格列净二甲双胍缓释片项目信息
介质体积(ml)900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%
111.149255979265269277029225949282019261240.24
211.149370149392859381500.18
单位质量响应值RSD%判断
83135.0184214.540.92数据可信
供试品溶液-3214157批-25mg/1000mg规格-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%
5min1-0.0000.22244.950.000.22244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
612409-124091.3351.33
10min14899-48990.5270.4647.120.530.4646.91
23155-31550.3390.34
36307-63070.6780.68
46634-66340.7140.71
52882-28820.3100.31
61661-16610.1790.18
15min136016-360163.8743.8531.313.873.8531.24
246033-460334.9514.95
322545-225452.4252.43
440769-407694.3854.39
547407-474075.0995.10
622070-220702.3742.38
20min177785-777858.3677.3613.938.377.3613.91
267787-677877.2917.30
359635-596356.4156.42
480996-809968.7128.72
567078-670787.2157.22
657078-570786.1406.15
30min1148035-14803515.92315.065.5115.9415.085.53
2142858-14285815.36615.39
3131870-13187014.18414.20
4147289-14728915.84315.87
5140219-14021915.08215.10
6129748-12974813.95613.97
45min1223380-22338024.02823.382.5824.0823.422.59
2220608-22060823.72923.78
3213730-21373022.99023.03
4214904-21490423.11623.17
5222213-22221323.90223.95
6209153-20915322.49722.54
60min1278846-27884629.99429.441.9630.0829.531.95
2277824-27782429.88429.97
3275778-27577829.66429.74
4266252-26625228.63928.73
5275890-27589029.67629.76
6267732-26773228.79828.88
120min1434157-43415746.70046.652.2646.8446.792.25
2438954-43895447.21647.35
3433053-43305346.58146.71
4416960-41696044.85044.99
5432518-43251846.52346.66
6446739-44673948.05348.18
240min1637391-63739168.56067.561.8868.7867.771.88
2644466-64446669.32169.54
3627427-62742767.48867.69
4613138-61313865.95166.16
5628655-62865567.62167.83
6617503-61750366.42166.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1781101-78110184.01882.701.7784.3583.031.77
2781022-78102284.01084.34
3767249-76724982.52882.85
4750415-75041580.71781.04
5778427-77842783.73184.06
6755146-75514681.22681.54
480min1878098-87809894.45293.261.3294.9293.721.32
2881316-88131694.79895.27
3861174-86117492.63193.09
4850437-85043791.47691.93
5863051-86305192.83393.30
6868115-86811593.37893.83
600min1962538-962538103.534102.481.23104.16103.101.23
2969536-969536104.287104.92
3950607-950607102.251102.86
4952815-952815102.488103.10
5939710-939710101.079101.70
6941294-941294101.249101.86
720min11014042-1014042109.074107.201.21109.87107.981.21
21007173-1007173108.335109.14
3990414-990414106.533107.31
4990357-990357106.527107.30
5996023-996023107.136107.92
6981698-981698105.595106.37
840min11028222-1028222110.599109.430.82111.58110.400.83
21025841-1025841110.343111.33
31014626-1014626109.137110.09
41013978-1013978109.067110.02
51015739-1015739109.257110.22
61005741-1005741108.181109.13
960min11035932-1035932111.429110.440.83112.59111.580.83
21038744-1038744111.731112.90
31021518-1021518109.878111.02
41023672-1023672110.110111.25
51021552-1021552109.882111.03
61018849-1018849109.591110.72
极限11031167-1031167110.916110.411.28112.27111.751.27
21040042-1040042111.871113.22
31014453-1014453109.118110.44
41037881-1037881111.638112.96
51028334-1028334110.611111.94
61007124-1007124108.330109.65
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