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%
112.491574371570881573261571171571631572260.10
212.581599391600141599760.04
单位质量响应值RSD%判断
12588.1512716.690.72数据可信
供试品溶液-01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%
5min1113685-11368557.79562.388.5057.7962.388.51
2129704-12970465.93865.94
3118240-11824060.11060.11
4140159-14015971.25371.25
5113405-11340557.65257.65
6121092-12109261.56061.56
10min1188545-18854595.85194.831.2795.9494.921.27
2184533-18453393.81293.91
3188295-18829595.72495.81
4183847-18384793.46393.57
5184862-18486293.97994.07
6189151-18915196.16096.25
15min1192505-19250597.86596.621.6598.1096.861.65
2187430-18743095.28595.52
3192092-19209297.65597.89
4190369-19036996.77997.03
5185145-18514594.12394.35
6192813-19281398.02198.26
20min1193141-19314198.18896.721.7498.5797.101.73
2187959-18795995.55495.94
3192498-19249897.86198.24
4187245-18724595.19195.58
5186698-18669894.91295.28
6193982-19398298.61599.00
30min1192835-19283598.03297.051.6698.5697.581.65
2188097-18809795.62496.15
3192670-19267097.94898.48
4188071-18807195.61096.15
5188339-18833995.74796.26
6195420-19542099.34799.88
45min1193055-19305598.14497.291.2198.8297.961.21
2189399-18939996.28696.95
3193037-19303798.13598.81
4188521-18852195.83996.52
5190092-19009296.63897.29
6194091-19409198.67199.35
60min1192672-19267297.94997.081.3798.7797.901.37
2188147-18814795.64996.46
3192766-19276697.99798.82
4188451-18845195.80496.63
5189420-18942096.29697.10
6194333-19433398.79499.62
120min1192899-19289998.06597.151.3999.0398.111.39
2187698-18769895.42196.38
3193293-19329398.26599.23
4188636-18863695.89896.86
5190038-19003896.61097.55
6193995-19399598.62299.60
180min1192987-19298798.11097.001.3099.2298.111.29
2187568-18756895.35596.46
3192842-19284298.03699.15
4188485-18848595.82196.93
5189924-18992496.55297.64
6192991-19299198.11299.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1192919-19291998.07596.911.3499.3498.161.34
2187478-18747895.30996.55
3192467-19246797.84599.11
4188014-18801495.58196.83
5189732-18973296.45597.69
6193161-19316198.19899.47
360min1197298-197298100.30198.951.34101.71100.351.33
2191239-19123997.22198.61
3196117-19611799.701101.11
4192160-19216097.68999.09
5193872-19387298.56099.94
6197123-197123100.212101.63
480min1196142-19614299.71498.541.40101.27100.081.39
2190243-19024396.71598.25
3195363-19536399.318100.88
4191577-19157797.39398.94
5192683-19268397.95599.48
6196944-196944100.121101.69
600min1194667-19466798.96497.891.47100.6799.581.46
2188667-18866795.91397.59
3194416-19441698.836100.54
4190271-19027196.72998.42
5191476-19147697.34199.01
6195787-19578799.533101.25
720min1193401-19340198.32097.181.48100.1899.031.47
2187729-18772995.43797.26
3192999-19299998.11699.97
4188232-18823295.69297.53
5190271-19027196.72998.55
6194367-19436798.811100.68
960min1191384-19138497.29596.211.4699.3098.201.45
2185724-18572494.41796.38
3191290-19129097.24799.25
4186662-18666294.89496.87
5188240-18824095.69697.66
6192259-19225997.74099.76
1440min1192298-19229897.75996.311.6299.9198.441.61
2186238-18623894.67996.78
3190579-19057996.88599.03
4186154-18615494.63696.76
5188104-18810495.62797.74
6193256-19325698.246100.41
极限1190947-19094797.07396.121.5399.3798.401.52
2185710-18571094.41096.66
3191508-19150897.35899.65
4185939-18593994.52796.79
5188089-18808995.62097.87
6192236-19223697.728100.04
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%
19.839141689138709143109139739135719139780.04
29.829261469256189258820.05
单位质量响应值RSD%判断
92978.4394285.340.99数据可信
供试品溶液-01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%
5min138209-382094.0814.5412.664.084.5412.63
238462-384624.1084.11
343893-438934.6884.69
443213-432134.6154.62
539021-390214.1684.17
652272-522725.5835.58
10min188596-885969.4639.472.269.479.482.24
291931-919319.8199.82
386456-864569.2349.24
489247-892479.5329.54
589145-891459.5219.53
686705-867059.2619.27
15min1129992-12999213.88413.861.4013.9013.881.41
2132340-13234014.13514.16
3128131-12813113.68513.71
4131329-13132914.02714.05
5127826-12782613.65313.67
6128837-12883713.76113.78
20min1163755-16375517.49017.381.0417.5317.421.04
2165494-16549417.67617.72
3161749-16174917.27617.32
4162404-16240417.34617.39
5160730-16073017.16717.21
6162033-16203317.30617.35
30min1216212-21621223.09323.050.8123.1623.120.81
2218821-21882123.37123.44
3215299-21529922.99523.06
4214758-21475822.93823.01
5213673-21367322.82222.89
6216074-21607423.07823.15
45min1278840-27884029.78229.942.1429.8830.042.14
2292422-29242231.23331.34
3278435-27843529.73929.84
4278092-27809229.70229.80
5276914-27691429.57629.68
6277061-27706129.59229.70
60min1330846-33084635.33635.280.7335.4835.430.73
2334816-33481635.76135.91
3329914-32991435.23735.38
4329492-32949235.19235.34
5328892-32889235.12835.27
6327987-32798735.03135.18
120min1477676-47767651.01951.060.4751.2251.260.47
2481610-48161051.43951.64
3478649-47864951.12351.32
4478192-47819251.07451.27
5477306-47730650.97951.18
6474786-47478650.71050.91
180min1583792-58379262.35362.200.6762.6362.470.67
2586673-58667362.66062.94
3581972-58197262.15862.43
4584049-58404962.38062.66
5582227-58222762.18662.46
6575196-57519661.43561.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1663059-66305970.81970.730.5671.1971.100.56
2666337-66633771.16971.54
3660409-66040970.53670.91
4664599-66459970.98371.35
5663217-66321770.83671.20
6655842-65584270.04870.42
360min1790119-79011984.39084.430.5084.8784.910.50
2794616-79461684.87085.35
3787661-78766184.12784.60
4793613-79361384.76385.24
5792791-79279184.67585.15
6784382-78438283.77784.25
480min1858952-85895291.74291.880.4692.3492.480.46
2864041-86404192.28592.89
3856250-85625091.45392.05
4863282-86328292.20492.81
5863542-86354292.23292.83
6855221-85522191.34391.94
600min1895273-89527395.62195.930.4796.3696.670.47
2903641-90364196.51597.26
3894782-89478295.56896.31
4900532-90053296.18396.92
5901331-90133196.26897.01
6893587-89358795.44196.18
720min1912175-91217597.42697.700.5098.3198.590.50
2921124-92112498.38299.27
3911608-91160897.36698.25
4915250-91525097.75598.64
5919028-91902898.15899.04
6909446-90944697.13598.01
960min1922154-92215498.49298.500.4199.5299.540.40
2927504-92750499.063100.10
3920862-92086298.35499.38
4922683-92268398.54899.58
5924134-92413498.70399.73
6916332-91633297.87098.90
1440min1930280-93028099.36099.320.35100.54100.500.35
2935881-93588199.958101.15
3928631-92863199.184100.36
4926579-92657998.965100.15
5929959-92995999.326100.50
6927890-92789099.105100.28
极限1926303-92630398.93599.160.40100.26100.490.40
2934743-93474399.837101.18
3927763-92776399.091100.42
4925661-92566198.867100.20
5930376-93037699.370100.70
6925367-92536798.835100.16
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%
112.497990279872799798003379909799390.09
212.588176581821817930.05
单位质量响应值RSD%判断
6400.246501.831.12数据可信
供试品溶液-02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%
5min170182-7018269.97970.325.8069.9870.325.80
263324-6332463.14163.14
369701-6970169.50069.50
475523-7552375.30575.30
572527-7252772.31772.32
671907-7190771.69971.70
10min175786-7578675.56775.723.6075.6775.823.60
271867-7186771.65971.75
374693-7469374.47774.58
479846-7984679.61579.73
577849-7784977.62477.73
675591-7559175.37375.48
15min176968-7696876.74677.102.8976.9677.322.89
274137-7413773.92374.13
376046-7604675.82676.04
480799-8079980.56680.80
578042-7804277.81778.04
677936-7793677.71177.93
20min177406-7740677.18277.262.4477.5277.602.45
274851-7485174.63574.95
376918-7691876.69677.03
480487-8048780.25480.61
578495-7849578.26878.61
676748-7674876.52676.86
30min177956-7795677.73178.233.1178.1878.683.11
276147-7614775.92776.35
377491-7749177.26777.71
483059-8305982.81983.29
578927-7892778.69979.16
677156-7715676.93377.39
45min178517-7851778.29078.051.7478.8678.621.75
277127-7712776.90477.44
377475-7747577.25177.81
480534-8053480.30180.90
578981-7898178.75379.33
677001-7700176.77977.35
60min178493-7849378.26679.394.3478.9580.084.32
278315-7831578.08978.74
377775-7777577.55078.23
486551-8655186.30187.02
579209-7920978.98079.68
677396-7739677.17277.85
120min179059-7905978.83178.591.4979.6379.391.49
279017-7901778.78979.56
377916-7791677.69178.48
480369-8036980.13780.98
579485-7948579.25580.07
677069-7706976.84677.64
180min179135-7913578.90678.751.6679.8379.681.66
279328-7932879.09979.99
378166-7816677.94078.85
480741-8074180.50881.48
579609-7960979.37980.31
676916-7691676.69477.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min179387-7938779.15878.851.5080.1979.881.50
279486-7948679.25680.26
378183-7818377.95778.98
480708-8070880.47581.56
579400-7940079.17180.22
677290-7729077.06778.10
360min181316-8131681.08180.691.4482.2481.851.44
281225-8122580.99082.12
380148-8014879.91681.06
482472-8247282.23483.44
581291-8129181.05682.23
679089-7908978.86180.00
480min181108-8110880.87480.862.5382.1582.142.50
284005-8400583.76285.01
379864-7986479.63380.90
482134-8213481.89783.23
581468-8146881.23382.52
677967-7796777.74279.00
600min180706-8070680.47379.741.7681.8781.141.74
280990-8099080.75682.13
379137-7913778.90880.29
481544-8154481.30882.76
579746-7974679.51680.93
677732-7773277.50778.89
720min180080-8008079.84979.231.6481.3780.761.64
280253-8025380.02181.52
378570-7857078.34379.84
481012-8101280.77882.36
579458-7945879.22880.76
677405-7740577.18178.68
960min181945-8194581.70878.613.1283.3580.253.09
278501-7850178.27479.89
377849-7784977.62479.24
481253-8125381.01882.72
578300-7830078.07479.73
675187-7518774.97076.58
1440min178396-7839678.17078.011.6179.9379.771.61
278735-7873578.50880.24
377556-7755677.33279.07
479861-7986179.63081.45
578723-7872378.49680.26
676166-7616675.94677.67
极限178587-7858778.36077.801.6480.2479.681.64
278415-7841578.18880.04
377418-7741877.19479.05
479533-7953379.30381.24
578386-7838678.16080.05
675807-7580775.58877.43
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%
19.834926454924624922324928134924154925130.05
29.824977434975694976560.03
单位质量响应值RSD%判断
50103.0550677.800.81数据可信
供试品溶液-02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%
5min138575-385757.6558.095.577.668.095.59
239368-393687.8137.81
339366-393667.8127.81
440302-403027.9988.00
544475-444758.8268.83
642507-425078.4368.44
10min176676-7667615.21715.632.3615.2315.642.36
276634-7663415.20915.22
378469-7846915.57315.58
480365-8036515.94915.96
579395-7939515.75615.77
681065-8106516.08816.10
15min1104992-10499220.83621.777.2620.8721.817.26
2105406-10540620.91920.95
3106574-10657421.15021.19
4108813-10881321.59521.63
5106761-10676121.18721.22
6125730-12573024.95224.99
20min1127710-12771025.34525.861.7425.4125.921.75
2128405-12840525.48325.55
3130792-13079225.95726.02
4131904-13190426.17726.25
5129244-12924425.64925.72
6133654-13365426.52526.60
30min1164636-16463632.67333.402.1232.7833.512.13
2165578-16557832.86032.96
3169029-16902933.54533.65
4173144-17314434.36234.47
5165734-16573432.89133.00
6171789-17178934.09334.21
45min1209173-20917341.51241.961.1641.6642.121.17
2210573-21057341.79041.94
3213243-21324342.32042.48
4212438-21243842.16042.32
5208416-20841641.36241.52
6214699-21469942.60842.77
60min1244754-24475448.57349.291.3148.7949.501.32
2246991-24699149.01749.23
3250176-25017649.64949.87
4251546-25154649.92150.14
5244816-24481648.58548.80
6251809-25180949.97350.20
120min1345753-34575368.61769.310.8068.9069.600.81
2350506-35050669.56069.85
3352108-35210869.87870.17
4348266-34826669.11669.41
5346606-34660668.78669.08
6352232-35223269.90370.21
180min1410238-41023881.41582.440.7881.8182.840.78
2418129-41812982.98183.37
3418686-41868683.09183.49
4414736-41473682.30782.71
5413457-41345782.05382.45
6417190-41719082.79483.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1450852-45085289.47590.600.8789.9991.120.86
2461312-46131291.55192.07
3459325-45932591.15691.68
4454351-45435190.16990.69
5454448-45444890.18890.71
6458791-45879191.05091.58
360min1499056-49905699.04199.890.8099.69100.540.79
2509154-509154101.045101.70
3505508-505508100.322100.98
4499732-49973299.17599.83
5501044-50104499.436100.09
6505359-505359100.292100.96
480min1508688-508688100.953102.291.76101.75103.101.75
2533361-533361105.849106.66
3514892-514892102.184102.99
4510308-510308101.274102.08
5513327-513327101.873102.68
6512127-512127101.635102.46
600min1512336-512336101.677102.330.94102.62103.290.94
2524736-524736104.137105.10
3516712-516712102.545103.51
4512135-512135101.637102.60
5512492-512492101.708102.66
6515287-515287102.262103.23
720min1510515-510515101.315101.980.83102.41103.100.83
2521481-521481103.491104.61
3515225-515225102.250103.37
4509970-509970101.207102.32
5511996-511996101.609102.72
6514083-514083102.023103.15
960min1514422-514422102.091101.570.82103.34102.830.81
2518033-518033102.807104.08
3511158-511158101.443102.71
4512496-512496101.708102.97
5507761-507761100.769102.03
6506860-506860100.590101.87
1440min1504106-504106100.043101.080.92101.45102.500.91
2516859-516859102.574104.01
3510888-510888101.389102.81
4505423-505423100.305101.72
5507673-507673100.751102.16
6511096-511096101.431102.86
极限1503838-50383899.990100.830.97101.54102.400.96
2516774-516774102.557104.14
3509357-509357101.085102.66
4503666-50366699.956101.52
5505875-505875100.394101.96
6508769-508769100.969102.55
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