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)5补液体积(ml)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50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.204208999421286142113714214422421121642117740.05
210.274222238421391942180780.14
单位质量响应值RSD%判断
412919.02410718.400.38数据可信
加速6月-供试品溶液-2025081821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%
5min1176114-1761144.2774.585.064.284.585.02
2197043-1970434.7854.78
3191868-1918684.6594.66
4191919-1919194.6604.66
5197673-1976734.8004.80
6177438-1774384.3094.31
10min1354574-3545748.6109.064.428.639.084.44
2387704-3877049.4159.44
3367794-3677948.9318.95
4376957-3769579.1549.18
5394975-3949759.5919.62
6356404-3564048.6548.68
15min1487089-48708911.82812.504.1411.8912.574.14
2520188-52018812.63212.70
3508541-50854112.34912.42
4520696-52069612.64412.71
5550098-55009813.35813.43
6502483-50248312.20212.27
20min1614193-61419314.91415.382.3315.0415.522.35
2636821-63682115.46415.60
3625433-62543315.18715.32
4645151-64515115.66615.80
5654349-65434915.88916.03
6625333-62533315.18515.31
30min1803312-80331219.50720.302.3919.7020.512.40
2860300-86030020.89021.10
3823519-82351919.99720.20
4839160-83916020.37720.59
5847056-84705620.56920.79
6842407-84240720.45620.66
45min11054689-105468925.61126.281.6425.9126.591.65
21092627-109262726.53226.85
31068138-106813825.93726.24
41095677-109567726.60626.92
51100108-110010826.71427.03
61082569-108256926.28826.59
60min11282198-128219831.13531.761.4231.5632.201.42
21327286-132728632.23032.68
31326578-132657832.21332.65
41316094-131609431.95832.40
51304360-130436031.67332.13
61292183-129218331.37831.81
120min11934443-193444346.97447.361.1147.5547.961.12
21970167-197016747.84148.45
31925528-192552846.75747.35
41972596-197259647.90048.51
51966478-196647847.75148.36
61932795-193279546.93347.53
180min12422488-242248858.82558.461.0559.6459.301.04
22431018-243101859.03259.88
32397776-239777658.22459.05
42430522-243052259.02059.86
52396561-239656158.19559.05
62367299-236729957.48458.31
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12773787-277378767.35567.931.0568.4669.061.05
22817985-281798568.42869.57
32752700-275270066.84367.96
42830489-283048968.73269.87
52810697-281069768.25169.39
62798869-279886967.96469.08
360min13238315-323831578.63580.031.5180.0881.501.50
23320024-332002480.61982.11
33284779-328477979.76381.22
43363582-336358281.67783.16
53324556-332455680.72982.21
63242998-324299878.74980.20
480min13704671-370467189.95988.661.8391.8090.521.80
23730712-373071290.59292.48
33559563-355956386.43688.29
43622031-362203187.95389.84
53687293-368729389.53791.43
63601639-360163987.45889.31
600min13786515-378651591.94792.311.1194.2394.621.11
23856053-385605393.63595.98
33754401-375440191.16793.45
43834593-383459393.11495.45
53820045-382004592.76195.10
63757669-375766991.24693.53
720min13844434-384443493.35393.811.1296.1096.591.11
23937811-393781195.62198.43
33834593-383459393.11495.86
43888910-388891094.43397.23
53852845-385284593.55796.36
63821885-382188592.80695.55
极限13886309-388630994.37093.961.2597.5897.201.24
23924467-392446795.29798.59
33858386-385838693.69296.90
43905010-390501094.82498.09
53855888-385588893.63196.90
63787197-378719791.96395.17
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)5补液体积(ml)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12500
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.611567215784158051560415706157140.53
212.741557815549155640.14
单位质量响应值RSD%判断
1246.151221.661.41数据可信
加速6月-供试品溶液-2025081821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%
5min117120-171200.4460.452.360.450.462.31
217487-174870.4560.46
317011-170110.4430.44
417719-177190.4620.46
517096-170960.4460.45
618030-180300.4700.47
10min117843-178430.4650.471.540.470.471.75
218021-180210.4700.47
317665-176650.4600.46
418312-183120.4770.48
517596-175960.4590.46
617656-176560.4600.46
15min117536-175360.4570.461.510.460.471.91
218078-180780.4710.48
317791-177910.4640.47
418152-181520.4730.48
517507-175070.4560.46
617837-178370.4650.47
20min117877-178770.4660.471.290.470.471.10
217758-177580.4630.47
317706-177060.4620.47
418246-182460.4760.48
517816-178160.4640.47
618173-181730.4740.48
30min117560-175600.4580.461.440.470.481.16
218049-180490.4700.48
317573-175730.4580.47
417489-174890.4560.47
518058-180580.4710.48
617875-178750.4660.48
45min118013-180130.4700.461.370.480.481.09
217796-177960.4640.48
317503-175030.4560.47
417958-179580.4680.48
517543-175430.4570.47
618050-180500.4700.48
60min117734-177340.4620.471.330.480.481.32
217960-179600.4680.48
317968-179680.4680.48
417807-178070.4640.48
517535-175350.4570.47
618238-182380.4750.49
120min117797-177970.4640.471.360.480.481.69
218020-180200.4700.49
317430-174300.4540.47
417984-179840.4690.49
517929-179290.4670.48
618062-180620.4710.49
180min118310-183100.4770.461.800.500.482.14
218042-180420.4700.49
317603-176030.4590.48
417586-175860.4580.48
517447-174470.4550.47
617817-178170.4640.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118307-183070.4770.471.470.500.491.55
217850-178500.4650.49
317538-175380.4570.48
417862-178620.4660.49
517680-176800.4610.48
617964-179640.4680.49
360min117919-179190.4670.461.020.490.481.07
217837-178370.4650.49
317428-174280.4540.48
417706-177060.4620.48
517609-176090.4590.48
617601-176010.4590.48
480min118371-183710.4790.462.860.500.482.53
217964-179640.4680.49
317097-170970.4460.47
417054-170540.4450.47
517784-177840.4640.49
617741-177410.4620.49
600min117733-177330.4620.461.310.490.481.13
217830-178300.4650.49
317258-172580.4500.48
417383-173830.4530.48
517471-174710.4550.48
617741-177410.4620.49
720min117770-177700.4630.462.090.490.482.53
217934-179340.4670.50
317017-170170.4440.47
417642-176420.4600.49
517058-170580.4450.47
617509-175090.4560.49
极限117873-178730.4660.461.670.500.491.55
217548-175480.4570.49
317258-172580.4500.48
417616-176160.4590.49
517015-170150.4440.48
617403-174030.4540.49
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)5补液体积(ml)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50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.204296432429289342904994300171428889742937780.11
210.274320310431253243164210.13
单位质量响应值RSD%判断
420958.63420294.160.12数据可信
加速6月-供试品溶液-2025081821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%
5min1199922-1999224.7534.6913.314.754.6813.33
2175022-1750224.1614.16
3177285-1772854.2154.21
4242332-2423325.7615.76
5178434-1784344.2424.24
6209607-2096074.9834.98
10min1362692-3626928.6238.737.008.658.767.00
2377047-3770478.9648.98
3340506-3405068.0958.12
4413884-4138849.8409.87
5353837-3538378.4128.43
6356415-3564158.4738.50
15min1498885-49888511.86112.153.3311.9312.223.34
2513888-51388812.21712.28
3496686-49668611.80811.87
4515388-51538812.25312.33
5499945-49994511.88611.95
6541747-54174712.88012.95
20min1625363-62536314.86715.074.6414.9915.204.63
2623487-62348714.82314.95
3628142-62814214.93315.05
4692827-69282716.47116.61
5613871-61387114.59414.72
6619082-61908214.71814.85
30min1819250-81925019.47719.611.1719.6819.821.19
2827251-82725119.66719.87
3808962-80896219.23219.43
4836492-83649219.88720.11
5829404-82940419.71819.91
6828769-82876919.70319.91
45min11072837-107283725.50625.961.9925.8026.261.97
21079956-107995625.67525.97
31101216-110121626.18026.47
41121962-112196226.67426.99
51108699-110869926.35826.65
61068028-106802825.39125.70
60min11289648-128964830.66030.480.9731.0930.900.99
21265969-126596930.09730.52
31283773-128377330.52130.94
41297533-129753330.84831.30
51268092-126809230.14830.57
61286316-128631630.58131.01
120min11941222-194122246.15146.251.0946.7346.841.10
21942824-194282446.18946.77
31942830-194283046.18946.76
41986450-198645047.22647.83
51934237-193423745.98546.56
61925466-192546645.77646.36
180min12399469-239946957.04557.361.1057.8558.181.11
22419159-241915957.51358.32
32414520-241452057.40358.21
42461011-246101158.50859.35
52397934-239793457.00957.82
62385412-238541256.71157.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12718737-271873764.63565.701.4965.7366.801.48
22828703-282870367.25068.35
32779932-277993266.09067.18
42781178-278117866.12067.26
52727970-272797064.85565.95
62744242-274424265.24266.34
360min13266242-326624277.65277.920.6879.0779.350.68
23299951-329995178.45379.89
33273919-327391977.83479.26
43292479-329247978.27679.74
53240350-324035077.03678.45
63291330-329133078.24879.67
480min13580331-358033185.11985.661.1686.9387.481.15
23612126-361212685.87587.70
33632904-363290486.36988.18
43666226-366622687.16189.02
53568812-356881284.84586.65
63558729-355872984.60686.42
600min13803315-380331590.42089.910.8092.6592.150.78
23800508-380050890.35492.61
33821125-382112590.84493.09
43756104-375610489.29891.59
53758414-375841489.35391.58
63750442-375044289.16391.40
720min13857276-385727691.70392.230.9694.3994.920.93
23872212-387221292.05894.76
33949743-394974393.90296.60
43849911-384991191.52894.27
53858808-385880891.74094.41
63888274-388827492.44095.12
极限13865437-386543791.89792.141.4095.0495.291.35
23874558-387455892.11495.28
33898232-389823292.67795.84
43837519-383751991.23394.43
53966995-396699594.31297.44
63810070-381007090.58193.73
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)5补液体积(ml)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12500
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.611588215825159131595215992159130.41
212.741603416188161110.68
单位质量响应值RSD%判断
1261.931264.600.15数据可信
加速6月-供试品溶液-2025081821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%
5min117471-174710.4450.441.500.440.441.44
217406-174060.4430.44
316876-168760.4300.43
417559-175590.4470.45
517476-174760.4450.44
617142-171420.4360.44
10min117843-178430.4540.451.860.460.451.99
218094-180940.4610.46
317307-173070.4410.44
417502-175020.4460.45
517703-177030.4510.45
617231-172310.4390.44
15min117436-174360.4440.461.540.450.461.65
217630-176300.4490.45
318102-181020.4610.47
417999-179990.4580.46
518022-180220.4590.46
618062-180620.4600.46
20min117876-178760.4550.451.300.460.461.38
217905-179050.4560.46
317944-179440.4570.46
418101-181010.4610.47
517451-174510.4440.45
617707-177070.4510.46
30min117594-175940.4480.451.230.460.461.38
217373-173730.4420.45
317901-179010.4560.46
417689-176890.4500.46
517962-179620.4570.47
617753-177530.4520.46
45min117541-175410.4470.451.780.460.471.75
217493-174930.4450.46
317807-178070.4530.46
417835-178350.4540.47
518049-180490.4590.47
618358-183580.4670.48
60min117523-175230.4460.450.910.460.460.89
217469-174690.4450.46
317911-179110.4560.47
417524-175240.4460.46
517694-176940.4500.46
617633-176330.4490.46
120min118045-180450.4590.460.740.480.481.09
217931-179310.4560.47
318047-180470.4590.48
418056-180560.4600.48
518290-182900.4660.48
617991-179910.4580.47
180min117423-174230.4440.451.930.460.471.60
217719-177190.4510.47
318153-181530.4620.48
417566-175660.4470.47
518315-183150.4660.48
617681-176810.4500.47
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min117103-171030.4350.452.140.460.471.73
217944-179440.4570.48
317682-176820.4500.47
417688-176880.4500.47
518077-180770.4600.48
618108-181080.4610.48
360min117275-172750.4400.451.020.460.471.35
217728-177280.4510.47
317658-176580.4500.47
417666-176660.4500.47
517797-177970.4530.48
617682-176820.4500.47
480min117034-170340.4340.451.900.460.471.73
217627-176270.4490.47
317968-179680.4570.48
417965-179650.4570.48
517717-177170.4510.48
617576-175760.4470.47
600min117358-173580.4420.451.610.470.481.72
217449-174490.4440.47
317694-176940.4500.48
417443-174430.4440.47
517985-179850.4580.49
617971-179710.4580.48
720min116940-169400.4310.452.080.460.481.77
217520-175200.4460.48
317802-178020.4530.48
417357-173570.4420.47
517874-178740.4550.48
617845-178450.4540.48
极限117407-174070.4430.452.430.470.482.45
217350-173500.4420.47
317719-177190.4510.48
417060-170600.4340.47
518287-182870.4660.50
617578-175780.4470.48
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