二甲双胍恩格列净片项目信息
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C033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.50对照品水分(%)0对照品稀释倍数1000
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%
113.922675462674742676492674252676202675430.04
213.962672572675062673820.07
单位质量响应值RSD%判断
19220.0419153.440.25数据可信
制剂处方摸索--供试品溶液-24012401批-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%
5min188219-8821932.94034.8516.8632.9434.8516.85
2105959-10595939.56339.56
3114253-11425342.66042.66
468820-6882025.69625.70
593072-9307234.75234.75
689723-8972333.50133.50
10min1176613-17661365.94469.4810.1166.0069.5410.11
2207979-20797977.65677.72
3201568-20156875.26275.33
4157855-15785558.94158.98
5195190-19519072.88172.94
6177279-17727966.19366.25
15min1232089-23208986.65888.213.4586.8288.383.46
2241940-24194090.33790.53
3239764-23976489.52489.72
4222721-22272183.16083.30
5245499-24549991.66591.84
6235516-23551687.93888.10
20min1246059-24605991.87493.180.9592.1893.500.94
2249310-24931093.08893.43
3248420-24842092.75693.10
4251205-25120593.79694.08
5252936-25293694.44294.77
6249480-24948093.15293.46
30min1247230-24723092.31293.961.0792.7794.431.06
2251081-25108193.75094.25
3250724-25072493.61694.12
4255009-25500995.21695.65
5253547-25354794.67095.16
6252251-25225194.18694.65
45min1247707-24770792.49094.121.1693.1194.751.14
2251289-25128993.82794.48
3251216-25121693.80094.46
4256567-25656795.79896.39
5253439-25343994.63095.28
6252145-25214594.14794.77
60min1246678-24667892.10694.051.2892.8894.841.26
2251131-25113193.76894.58
3251713-25171393.98694.80
4256564-25656495.79796.55
5253272-25327294.56895.37
6251988-25198894.08894.87
极限1248484-24848492.78094.621.3193.7095.561.30
2252127-25212794.14095.11
3253482-25348294.64695.62
4258788-25878896.62797.54
5253726-25372694.73795.70
6253788-25378894.76095.70
二甲双胍恩格列净片项目信息
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A-11412209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%)0对照品稀释倍数20
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%
119.021013097101202910141621014414101351010134420.10
219.021011726101225810119920.04
单位质量响应值RSD%判断
53282.9753206.730.11数据可信
制剂处方摸索--供试品溶液-24012401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%
5min1509561-50956143.10945.6213.8443.1145.6213.84
2597193-59719350.52250.52
3637077-63707753.89753.90
4421025-42102535.61935.62
5536397-53639745.37945.38
6534365-53436545.20745.21
10min1884443-88444374.82478.858.0774.9078.938.08
21017006-101700686.03886.12
3994429-99442984.12884.22
4814620-81462068.91768.98
5962938-96293881.46481.54
6919111-91911177.75777.83
15min11094628-109462892.60594.552.4892.8094.762.49
21129890-112989095.58895.82
31125165-112516595.18995.42
41073566-107356690.82391.00
51137620-113762096.24296.45
61144906-114490696.85997.06
20min11136693-113669396.16497.961.4196.5198.321.40
21150482-115048297.33197.72
31153615-115361597.59697.98
41168104-116810498.82199.15
51154759-115475997.69298.06
61184004-1184004100.166100.53
30min11137596-113759696.24098.241.6496.7598.771.63
21152015-115201597.46098.01
31156937-115693797.87798.43
41175902-117590299.48199.97
51154214-115421497.64698.18
61190810-1190810100.742101.28
45min11136145-113614596.11898.111.6396.7998.811.62
21149940-114994097.28598.00
31157657-115765797.93898.65
41173181-117318199.25199.91
51152260-115226097.48198.18
61189305-1189305100.615101.32
60min11131586-113158695.73297.911.6996.5698.761.67
21148490-114849097.16298.04
31155634-115563497.76698.64
41171526-117152699.11199.93
51149461-114946197.24498.10
61187056-1187056100.425101.29
极限11130563-113056395.64597.751.6896.6498.771.66
21145819-114581996.93697.97
31154460-115446097.66798.71
41169595-116959598.94799.93
51147184-114718497.05298.07
61185121-1185121100.261101.30
二甲双胍恩格列净片项目信息
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C033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.50对照品水分(%)0对照品稀释倍数1000
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%
113.922675652675352676052671142672642674170.09
213.962665172662122663640.09
单位质量响应值RSD%判断
19210.9919080.520.49数据可信
制剂处方摸索--供试品溶液-24012402批-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%
5min135850-3585013.41513.6911.2513.4113.6911.24
234549-3454912.92812.93
343079-4307916.12016.12
437754-3775414.12714.13
537639-3763914.08414.08
630642-3064211.46611.47
10min172924-7292427.28728.057.1227.3128.087.11
274374-7437427.83027.85
384391-8439131.57831.60
474393-7439327.83727.86
575714-7571428.33128.35
668046-6804625.46225.48
15min196939-9693936.27336.593.5236.3436.663.53
297120-9712036.34136.41
3103371-10337138.68038.76
496279-9627936.02636.10
599743-9974337.32237.39
693235-9323534.88734.95
20min1104693-10469339.17539.252.3939.3039.382.40
2103599-10359938.76538.89
3106020-10602039.67139.82
4102733-10273338.44138.57
5109366-10936640.92341.06
6102995-10299538.53938.66
30min1105213-10521339.36939.632.5839.5639.822.58
2104730-10473039.18939.38
3106329-10632939.78740.00
4103192-10319238.61338.81
5111059-11105941.55741.76
6104856-10485639.23639.42
45min1105692-10569239.54939.562.5939.8139.822.59
2104537-10453739.11639.37
3106324-10632439.78540.06
4102877-10287738.49538.75
5110744-11074441.43941.71
6104203-10420338.99139.24
60min1104610-10461039.14439.502.4239.4739.832.42
2104836-10483639.22839.55
3105950-10595039.64539.99
4103261-10326138.63938.96
5110442-11044241.32641.67
6104250-10425039.00939.32
极限1106157-10615739.72339.722.3540.1140.112.34
2105451-10545139.45839.85
3106573-10657339.87840.29
4103594-10359438.76339.15
5110681-11068141.41541.82
6104380-10438039.05839.44
二甲双胍恩格列净片项目信息
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A-11412209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%)0对照品稀释倍数20
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%
119.021012001101219210120471010655101144410116680.07
219.021007785100710410074440.05
单位质量响应值RSD%判断
53189.7052967.610.30数据可信
制剂处方摸索--供试品溶液-24012402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%
5min1507489-50748943.06843.399.6943.0743.399.69
2494124-49412441.93441.93
3587775-58777549.88249.88
4528166-52816644.82344.82
5514940-51494043.70043.70
6435095-43509536.92436.92
10min1887638-88763875.32976.526.8575.4076.596.86
2904883-90488376.79376.86
31008042-100804285.54785.63
4902729-90272976.61076.68
5890925-89092575.60875.68
6815514-81551469.20969.27
15min11110462-111046294.23994.023.7194.4494.223.72
21112211-111221194.38894.59
31175773-117577399.782100.01
41099404-109940493.30193.50
51102107-110210793.53093.73
61047191-104719188.87089.05
20min11169934-116993499.28698.692.1999.6499.042.20
21160891-116089198.51998.87
31193670-1193670101.301101.69
41148737-114873797.48897.85
51181808-1181808100.294100.65
61122059-112205995.22495.55
30min11173713-117371399.60798.911.98100.1399.431.99
21160844-116084498.51599.03
31193001-1193001101.244101.80
41148398-114839897.45997.98
51185242-1185242100.586101.11
61131893-113189396.05896.54
45min11171254-117125499.39898.712.07100.0899.402.08
21156886-115688698.17998.86
31192302-1192302101.185101.91
41148515-114851597.46998.15
51183060-1183060100.400101.09
61126943-112694395.63896.28
60min11165300-116530098.89398.432.0599.7499.282.07
21157963-115796398.27199.12
31187321-1187321100.762101.66
41144137-114413797.09797.94
51181157-1181157100.239101.10
61123276-112327695.32796.13
极限11165103-116510398.87698.052.0599.8999.062.06
21150457-115045797.63498.64
31180325-1180325100.168101.23
41139113-113911396.67197.68
51177616-117761699.938100.96
61119444-111944495.00295.96
二甲双胍恩格列净片项目信息
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C033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.50对照品水分(%)0对照品稀释倍数1000
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%
113.922657122671212667792660472668042664930.23
213.962651832664572658200.34
单位质量响应值RSD%判断
19144.6119041.550.39数据可信
制剂处方摸索--供试品溶液-206397批-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%
5min147483-4748317.81615.4010.5117.8215.4010.52
236942-3694213.86113.86
345018-4501816.89216.89
438874-3887414.58614.59
540630-4063015.24515.25
637297-3729713.99413.99
10min190172-9017233.83431.117.5633.8631.137.57
277038-7703828.90628.93
389861-8986133.71733.75
478828-7882829.57829.60
584946-8494631.87331.90
676583-7658328.73528.76
15min1104122-10412239.06838.123.3139.1538.203.31
298732-9873237.04637.12
3105514-10551439.59139.68
4101234-10123437.98538.06
5103287-10328738.75538.83
696756-9675636.30536.38
20min1105668-10566839.64839.720.7639.8039.860.76
2105716-10571639.66639.80
3106254-10625439.86840.02
4107059-10705940.17040.31
5105852-10585239.71739.86
6104621-10462139.25639.39
30min1105411-10541139.55239.940.9039.7740.140.89
2107108-10710840.18940.39
3106629-10662940.00940.23
4107832-10783240.46040.66
5105429-10542939.55939.77
6106194-10619439.84640.04
45min1105751-10575139.68039.900.7139.9640.170.70
2107407-10740740.30140.57
3105789-10578939.69439.98
4107096-10709640.18440.46
5105671-10567139.65039.92
6106292-10629239.88340.15
60min1105429-10542939.55939.910.9439.9140.250.92
2107231-10723140.23540.57
3105819-10581939.70540.05
4107556-10755640.35740.70
5105222-10522239.48139.82
6106931-10693140.12240.45
极限1105133-10513339.44839.830.9439.8640.240.92
2107180-10718040.21640.62
3106095-10609539.80940.22
4107477-10747740.32740.73
5105151-10515139.45439.86
6105928-10592839.74640.14
二甲双胍恩格列净片项目信息
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A-11412209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%)0对照品稀释倍数20
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%
119.021012258101142710102871012255100671010105870.23
219.021010344100746610089050.21
单位质量响应值RSD%判断
53132.8653044.430.12数据可信
制剂处方摸索--供试品溶液-206397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%
5min1622210-62221052.79446.898.7752.7946.898.77
2506506-50650642.97642.98
3599125-59912550.83550.83
4530793-53079345.03745.04
5550811-55081146.73646.74
6506471-50647142.97342.97
10min11020540-102054086.59281.335.9786.6881.415.98
2901998-90199876.53376.60
31023518-102351886.84486.93
4924103-92410378.40978.48
5980857-98085783.22483.30
6900167-90016776.37876.45
15min11130269-113026995.90294.512.4796.1394.722.48
21093884-109388492.81593.01
31145540-114554097.19897.43
41114737-111473794.58494.79
51128274-112827495.73395.95
61070379-107037990.82091.02
20min11139735-113973596.70597.090.7697.1097.460.76
21140984-114098496.81197.16
31146152-114615297.25097.64
41160734-116073498.48798.85
51141679-114167996.87097.25
61136260-113626096.41096.76
30min11138065-113806596.56397.340.8797.1297.880.85
21154269-115426997.93898.45
31140965-114096596.80997.36
41163174-116317498.69499.22
51139184-113918496.65897.20
61147997-114799797.40697.92
45min11136630-113663096.44297.130.8297.1697.830.81
21150439-115043997.61398.29
31146105-114610597.24697.96
41156581-115658198.13498.83
51130987-113098795.96396.66
61147731-114773197.38398.06
60min11135109-113510996.31396.970.7897.1997.830.77
21153034-115303497.83398.67
31141757-114175796.87797.75
41151766-115176697.72698.58
51130715-113071595.94096.80
61144976-114497697.15097.99
极限11135825-113582596.37396.770.7097.4197.790.69
21146482-114648297.27898.28
31138808-113880896.62697.66
41152362-115236297.77698.79
51129676-112967695.85296.87
61139927-113992796.72197.72
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