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%
1 12.598170381595815478166582055817130.25
2 12.488183881849818440.01
单位质量响应值RSD%判断
6490.316558.010.74数据可信
供试品溶液-WM1800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%
5min153695-5369552.93849.3712.6352.9449.3712.63
245368-4536844.72844.73
347323-4732346.65646.66
460832-6083259.97459.97
543656-4365643.04043.04
649582-4958248.88348.88
10min188859-8885987.60686.032.9387.6986.102.94
287005-8700585.77885.85
386572-8657285.35185.42
491347-9134790.05990.15
585775-8577584.56684.63
684003-8400382.81982.89
15min195323-9532393.97993.802.6594.1994.002.64
296833-9683395.46895.66
395801-9580194.45094.65
494777-9477793.44193.67
597649-9764996.27296.46
690469-9046989.19389.39
20min196159-9615994.80395.382.7495.1595.722.72
298838-9883897.44497.78
398147-9814796.76397.10
495671-9567194.32294.69
599398-9939897.99798.33
692271-9227190.97091.30
30min197293-9729395.92196.433.1096.4296.923.09
2100005-10000598.59599.08
399001-9900197.60598.09
496158-9615894.80295.31
5101434-101434100.004100.49
692966-9296691.65592.12
45min197347-9734795.97497.032.8396.6197.662.82
2100975-10097599.551100.18
399341-9934197.94098.57
496756-9675695.39296.04
5101714-101714100.280100.91
694348-9434893.01893.62
60min197324-9732495.95298.603.5196.7399.373.48
2101305-10130599.877100.66
3100255-10025598.84199.62
496602-9660295.24096.03
5106179-106179104.682105.47
698369-9836996.98297.73
120min1101962-101962100.524101.163.06101.45102.083.05
2104797-104797103.319104.25
3103854-103854102.390103.32
4100864-10086499.442100.38
5106479-106479104.978105.92
697676-9767696.29997.19
180min1101013-10101399.589100.883.17100.67101.963.16
2104889-104889103.410104.50
3103496-103496102.037103.12
4100523-10052399.106100.19
5106447-106447104.946106.04
697563-9756396.18797.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1101374-10137499.945101.073.34101.17102.303.32
2104804-104804103.326104.57
3104957-104957103.477104.71
4100252-10025298.838100.07
5106299-106299104.800106.06
697383-9738396.01097.19
360min1101592-101592100.160100.412.92101.54101.792.91
2104485-104485103.012104.41
3102784-102784101.335102.72
499906-9990698.49799.88
5105124-105124103.642105.05
697200-9720095.83097.15
480min199783-9978398.37699.743.2699.90101.273.24
2103832-103832102.368103.92
3102913-102913101.462103.00
499126-9912697.72899.26
5105007-105007103.526105.09
696357-9635794.99896.47
600min199565-9956598.16199.412.8299.83101.092.82
2103268-103268101.812103.52
3101894-101894100.457102.15
498961-9896197.56699.24
5104404-104404102.932104.66
696899-9689995.53397.14
720min198717-9871797.32598.383.0299.15100.223.01
2102848-102848101.398103.26
3100591-10059199.173101.02
498420-9842097.03298.85
5103034-103034101.581103.46
695140-9514093.79995.55
960min197566-9756696.19097.333.2098.1699.303.18
2101493-101493100.062102.07
3100360-10036098.945100.94
497040-9704095.67297.64
5102042-102042100.603102.63
693802-9380292.47994.37
1440min197145-9714595.77596.523.0097.8998.642.98
2100357-10035798.942101.10
398884-9888497.49099.63
496383-9638395.02497.13
5101325-10132599.896102.08
693289-9328991.97494.01
极限196743-9674395.37996.323.1297.6398.583.11
2100277-10027798.863101.17
398863-9886397.46999.76
495796-9579694.44596.70
5101330-10133099.901102.23
693148-9314891.83594.00
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%
110.111106050110832811060011107696111083311077820.18
210.031105978110573711058580.02
单位质量响应值RSD%判断
109572.90110255.030.44数据可信
供试品溶液-WM1800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%
5min142483-424833.8654.9031.583.874.9031.59
244724-447244.0694.07
345408-454084.1314.13
456280-562805.1205.12
587132-871327.9277.93
646958-469584.2724.27
10min192985-929858.4608.553.828.478.563.79
295278-952788.6688.67
394963-949638.6408.65
494795-947958.6258.63
587465-874657.9587.97
698179-981798.9328.94
15min1139121-13912112.65712.882.2112.6812.902.19
2142708-14270812.98413.00
3141807-14180712.90212.92
4141935-14193512.91312.93
5137322-13732212.49412.52
6146381-14638113.31813.34
20min1177156-17715616.11816.373.2216.1616.413.20
2180907-18090716.45916.50
3187877-18787717.09317.13
4178015-17801516.19616.24
5171312-17131215.58615.63
6184079-18407916.74816.79
30min1239920-23992021.82821.871.8321.8921.931.81
2242569-24256922.06922.13
3243092-24309222.11722.18
4237933-23793321.64721.71
5233125-23312521.21021.28
6245432-24543222.33022.39
45min1312385-31238528.42128.591.9928.5228.691.98
2319257-31925729.04629.14
3314736-31473628.63528.73
4312659-31265928.44628.54
5304228-30422827.67927.78
6322155-32215529.31029.41
60min1371360-37136033.78734.553.4133.9234.693.40
2378003-37800334.39134.53
3375914-37591434.20134.34
4370013-37001333.66433.80
5378116-37811634.40134.54
6405219-40521936.86737.01
120min1571145-57114551.96351.721.0652.1551.911.06
2572030-57203052.04452.24
3569948-56994851.85552.05
4565350-56535051.43651.63
5557764-55776450.74650.94
6574376-57437652.25752.46
180min1695868-69586863.31163.320.7463.5863.580.74
2700294-70029463.71463.98
3696477-69647763.36663.64
4692675-69267563.02063.29
5687991-68799162.59462.86
6702208-70220863.88864.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1797321-79732172.54172.430.9172.9072.800.90
2796692-79669272.48472.85
3806566-80656673.38273.75
4790468-79046871.91872.28
5786051-78605171.51671.88
6799752-79975272.76273.13
360min1934592-93459285.03084.760.6785.5085.230.67
2935616-93561685.12385.60
3929080-92908084.52985.00
4932115-93211584.80585.27
5920553-92055383.75384.22
6937750-93775085.31885.80
480min11011300-101130092.00992.280.3992.6192.880.39
21017477-101747792.57193.17
31014940-101494092.34092.94
41015240-101524092.36892.96
51008045-100804591.71392.31
61018357-101835792.65193.26
600min11061453-106145396.57296.520.5097.3197.260.49
21057233-105723396.18896.93
31054639-105463995.95296.69
41065340-106534096.92697.66
51058086-105808696.26697.00
61068292-106829297.19497.94
720min11078920-107892098.16198.250.5799.0499.140.57
21083383-108338398.56799.45
31072970-107297097.62098.50
41084497-108449798.66999.55
51072857-107285797.61098.49
61087054-108705498.90199.80
960min11092271-109227199.37699.380.32100.40100.410.32
21093087-109308799.450100.48
31087756-108775698.965100.00
41095766-109576699.694100.72
51088778-108877899.058100.08
61096129-109612999.727100.77
1440min11097940-109794099.89299.590.62101.07100.760.61
21091841-109184199.337100.52
31085301-108530198.74299.92
41101496-1101496100.215101.39
51089429-108942999.117100.29
61101419-1101419100.208101.40
极限11091732-109173299.32799.260.54100.65100.590.54
21091346-109134699.292100.62
31082981-108298198.53199.86
41092973-109297399.440100.77
51086872-108687298.885100.20
61100139-1100139100.092101.43
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%
1 12.598129681831811348168481295814480.37
2 12.488182582014819200.17
单位质量响应值RSD%判断
6469.266564.101.03数据可信
供试品溶液-WM1800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%
5min160029-6002959.25253.819.2759.2553.829.27
255322-5532254.60654.61
355884-5588455.16155.16
444908-4490844.32744.33
555005-5500554.29354.29
655972-5597255.24855.25
10min186941-8694185.81687.333.2185.9087.413.22
285765-8576584.65584.74
393140-9314091.93592.02
486029-8602984.91684.98
590129-9012988.96389.04
688856-8885687.70687.79
15min193675-9367592.46394.511.4092.6894.721.40
295064-9506493.83494.04
397540-9754096.27896.50
496242-9624294.99695.19
595447-9544794.21294.43
696533-9653395.28495.50
20min193805-9380592.59195.941.8592.9596.291.84
297965-9796596.69797.05
398322-9832297.04997.41
498484-9848497.20997.55
596548-9654895.29895.65
698044-9804496.77597.13
30min194797-9479793.57096.791.9694.0797.291.94
299060-9906097.77898.27
398797-9879797.51898.03
499543-9954398.25598.74
596693-9669395.44295.94
699485-9948598.19798.70
45min195086-9508693.85597.401.8694.4998.041.85
299675-9967598.38599.03
399749-9974998.45899.11
499855-9985598.56399.19
598449-9844997.17597.82
699261-9926197.97698.63
60min195020-9502093.79097.312.3094.5798.102.28
2100857-10085799.552100.34
398934-9893497.65498.46
4100457-10045799.15799.93
596772-9677295.52096.31
699457-9945798.17098.97
120min194998-9499893.76997.662.1994.6998.602.18
299565-9956598.27699.21
399357-9935798.07199.02
4101524-101524100.210101.14
598554-9855497.27898.21
699652-9965298.36299.31
180min198204-9820496.933100.662.2697.99101.742.25
2103703-103703102.361103.45
3102570-102570101.243102.34
4104048-104048102.701103.78
5100175-10017598.87899.96
6103164-103164101.829102.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min198459-9845997.185100.292.2298.39101.522.20
2103085-103085101.751102.99
3102181-102181100.859102.11
4104100-104100102.753103.98
599236-9923697.95299.18
6102586-102586101.258102.50
360min197573-9757396.31099.722.3097.66101.102.28
2102170-102170100.848102.24
3101992-101992100.672102.07
4103551-103551102.211103.60
598775-9877597.49798.87
6102120-102120100.798102.19
480min197094-9709495.83799.372.3497.33100.902.32
2102587-102587101.259102.80
3101388-101388100.076101.63
4102714-102714101.385102.92
598436-9843697.16298.68
6101838-101838100.520102.07
600min196837-9683795.58498.672.1797.22100.352.16
2101247-10124799.937101.63
3100807-10080799.502101.20
4102448-102448101.122102.81
597814-9781496.54898.21
6100658-10065899.355101.05
720min195723-9572394.48497.902.3296.2699.722.30
2100528-10052899.227101.07
399547-9954798.259100.11
4101868-101868100.550102.39
597161-9716195.90497.71
6100265-10026598.967100.81
960min195065-9506593.83596.682.1795.7698.662.15
299164-9916497.88199.87
398278-9827897.00699.01
4100678-10067899.375101.37
595823-9582394.58396.54
698679-9867997.40299.40
1440min192900-9290091.69895.052.1093.7697.172.09
297401-9740196.14098.28
397179-9717995.92198.07
497868-9786896.60198.74
594743-9474393.51795.61
697678-9767896.41498.56
极限192597-9259791.39994.602.1493.6096.862.12
297360-9736096.10098.38
396039-9603994.79697.08
497978-9797896.71099.00
594251-9425193.03195.27
696814-9681495.56197.85
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%
110.111100484110311111001091104010110004411015520.17
210.031103260110605011046550.18
单位质量响应值RSD%判断
108956.68110135.090.77数据可信
供试品溶液-WM1800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%
5min140323-403233.6814.3728.543.684.3728.52
274949-749496.8426.84
338889-388893.5503.55
443584-435843.9793.98
541169-411693.7583.76
648564-485644.4334.43
10min196255-962558.7878.775.758.798.785.76
295412-954128.7108.72
3101455-1014559.2629.27
485694-856947.8237.83
598368-983688.9808.99
699257-992579.0619.07
15min1148252-14825213.53413.202.3313.5513.222.31
2141773-14177312.94212.97
3140978-14097812.87012.89
4144513-14451313.19213.21
5148948-14894813.59713.62
6142845-14284513.04013.06
20min1184659-18465916.85716.882.9516.9016.922.94
2179950-17995016.42716.47
3179801-17980116.41416.45
4194146-19414617.72317.76
5187883-18788317.15217.19
6182971-18297116.70316.74
30min1242935-24293522.17722.142.2022.2422.212.19
2243479-24347922.22722.29
3241765-24176522.07022.13
4233137-23313721.28321.35
5249366-24936622.76422.83
6244786-24478622.34622.41
45min1316030-31603028.85029.234.3028.9529.334.28
2316637-31663728.90529.01
3318609-31860929.08529.18
4305158-30515827.85727.95
5346322-34632231.61531.71
6318446-31844629.07029.17
60min1375889-37588934.31434.471.7934.4634.621.79
2380914-38091434.77334.92
3374679-37467934.20434.34
4367385-36738533.53833.68
5387362-38736235.36235.51
6379540-37954034.64834.79
120min1551290-55129050.32650.892.2650.5251.082.25
2551301-55130150.32750.52
3549494-54949450.16350.35
4553479-55347950.52650.71
5582602-58260253.18553.38
6556597-55659750.81151.00
180min1699511-69951163.85763.920.9264.1364.200.92
2701361-70136164.02664.30
3695204-69520463.46463.73
4691240-69124063.10263.37
5708638-70863864.69164.97
6705423-70542364.39764.67
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1803991-80399173.39572.870.7973.7673.240.79
2799637-79963772.99873.37
3789275-78927572.05272.41
4791549-79154972.25972.62
5802494-80249473.25973.64
6802383-80238373.24873.62
360min1934535-93453585.31285.080.5385.7985.560.53
2932317-93231785.11085.59
3922657-92265784.22884.70
4931561-93156185.04185.51
5936315-93631585.47585.96
6934567-93456785.31585.79
480min11013730-101373092.54292.610.7193.1493.220.71
21018359-101835992.96593.57
31002075-100207591.47892.07
41012421-101242192.42293.02
51022867-102286793.37693.99
61017576-101757692.89393.50
600min11064925-106492597.21696.810.7497.9697.550.74
21063850-106385097.11797.86
31044822-104482295.38096.11
41060938-106093896.85297.58
51065050-106505097.22797.98
61063378-106337897.07497.82
720min11081910-108191098.76698.670.8199.6599.560.81
21088581-108858199.375100.27
31064480-106448097.17598.05
41081756-108175698.75299.63
51087613-108761399.287100.19
61080951-108095198.67899.57
960min11094427-109442799.90999.560.79100.94100.600.78
21096770-1096770100.123101.16
31073883-107388398.03399.06
41093173-109317399.794100.82
51095497-1095497100.006101.06
61089959-108995999.501100.54
1440min11093367-109336799.81299.770.80101.00100.960.80
21097805-1097805100.217101.41
31075936-107593698.22199.39
41093818-109381899.853101.03
51100207-1100207100.436101.64
61096207-1096207100.071101.26
极限11089436-108943699.45399.290.78100.79100.630.78
21089357-108935799.446100.79
31070885-107088597.76099.08
41090531-109053199.553100.88
51094466-109446699.912101.26
61091378-109137899.630100.97
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