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%
112.518034480385805508054580601804850.15
212.578168781587816370.09
单位质量响应值RSD%判断
6433.656494.590.67数据可信
供试品溶液-WM1800批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147487-4748747.25249.243.5347.2549.243.53
248037-4803747.79947.80
349089-4908948.84648.85
449839-4983949.59249.59
550088-5008849.84049.84
652398-5239852.13952.14
10min183434-8343483.02179.294.5083.0979.364.49
282149-8214981.74381.81
378548-7854878.15978.23
481716-8171681.31281.39
573547-7354773.18373.26
678711-7871178.32278.40
15min190139-9013989.69387.263.4489.8987.453.44
288727-8872788.28888.48
386430-8643086.00286.19
491231-9123190.78090.98
582860-8286082.45082.63
686773-8677386.34486.54
20min191714-9171491.26090.292.6991.5990.622.69
292928-9292892.46892.80
388973-8897388.53388.85
493533-9353393.07093.40
587186-8718686.75587.06
690127-9012789.68190.01
30min192945-9294592.48592.301.4192.9592.761.42
293001-9300192.54193.01
391412-9141290.96091.41
494662-9466294.19494.67
591142-9114290.69191.13
693367-9336792.90593.36
45min193574-9357493.11194.342.0393.7294.942.03
294558-9455894.09094.69
393492-9349293.02993.62
497940-9794097.45598.07
593034-9303492.57493.15
696278-9627895.80296.40
60min193887-9388793.42394.271.4194.1795.011.41
294839-9483994.37095.12
393744-9374493.28094.01
495735-9573595.26196.02
593393-9339392.93193.64
696818-9681896.33997.08
120min194241-9424193.77594.841.2294.6695.721.22
295289-9528994.81895.70
395239-9523994.76895.64
495604-9560495.13196.03
594140-9414093.67494.53
697335-9733596.85397.74
180min194885-9488594.41695.361.3495.4496.381.33
295933-9593395.45896.49
394945-9494594.47595.49
496460-9646095.98397.03
594733-9473394.26495.26
698032-9803297.54798.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min194566-9456694.09895.211.4395.2796.381.43
295788-9578895.31496.49
394841-9484194.37295.52
496468-9646895.99197.18
594460-9446093.99395.13
697974-9797497.48998.67
360min194523-9452394.05594.771.2995.3696.081.29
295230-9523094.75996.07
394395-9439593.92895.22
495595-9559595.12296.46
594217-9421793.75195.03
697500-9750097.01898.34
480min197341-9734196.85998.131.2198.3199.581.20
298280-9828097.79499.25
397589-9758997.10698.54
498810-9881098.32199.80
599093-9909398.603100.02
6100615-100615100.117101.59
600min196638-9663896.16097.371.4397.7698.971.42
298098-9809897.61399.22
396917-9691796.43898.02
498204-9820497.71899.34
596919-9691996.44098.00
6100360-10036099.864101.48
720min196254-9625495.77896.791.3797.5298.541.37
297154-9715496.67398.42
396235-9623595.75997.48
497673-9767397.19098.96
596580-9658096.10297.81
699743-9974399.250101.02
960min194916-9491694.44695.611.4596.3397.501.45
296074-9607495.59997.49
395159-9515994.68896.56
496113-9611395.63897.55
595512-9551295.03996.89
698755-9875598.266100.19
1440min193390-9339092.92894.131.5494.9596.161.53
294431-9443193.96496.00
393436-9343692.97494.98
495148-9514894.67796.74
593946-9394693.48195.48
697237-9723796.75698.82
极限193334-9333492.87293.851.5795.0496.021.56
294135-9413593.66995.85
392944-9294492.48494.63
494592-9459294.12496.33
593794-9379493.33095.47
697094-9709496.61498.83
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%
110.069221519224289228149230819234549227860.06
210.049327999320759324370.06
单位质量响应值RSD%判断
91728.2392872.210.88数据可信
供试品溶液-WM1800批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129417-294173.1873.295.293.193.295.26
230634-306343.3193.32
327668-276682.9983.00
431313-313133.3933.39
531057-310573.3653.36
632178-321783.4863.49
10min169671-696717.5497.772.197.557.782.21
270976-709767.6907.69
371343-713437.7307.73
472425-724257.8477.85
571638-716387.7627.77
674343-743438.0558.06
15min1106919-10691911.58411.771.3911.6011.791.39
2108851-10885111.79411.81
3108090-10809011.71111.73
4110583-11058311.98112.00
5107330-10733011.62911.65
6110229-11022911.94311.96
20min1137149-13714914.86015.161.6714.8915.191.67
2142397-14239715.42815.46
3139654-13965415.13115.16
4142165-14216515.40315.44
5137230-13723014.86814.90
6140833-14083315.25915.29
30min1188191-18819120.39020.620.9320.4520.670.92
2189646-18964620.54720.60
3190217-19021720.60920.67
4193146-19314620.92720.98
5191410-19141020.73920.79
6189123-18912320.49120.55
45min1248572-24857226.93227.211.3127.0227.301.30
2252185-25218527.32327.41
3251919-25191927.29427.38
4256685-25668527.81127.90
5247524-24752426.81826.91
6249912-24991227.07727.17
60min1298380-29838032.32832.601.1132.4632.731.11
2302604-30260432.78632.92
3301643-30164332.68232.81
4306215-30621533.17733.31
5297146-29714632.19532.32
6299165-29916532.41332.54
120min1446211-44621148.34548.780.8948.5248.960.89
2452981-45298149.07949.26
3455181-45518149.31749.49
4453256-45325649.10949.29
5446373-44637348.36348.54
6447505-44750548.48548.66
180min1556305-55630560.27460.790.7360.5261.040.73
2566641-56664161.39361.65
3560288-56028860.70560.96
4565406-56540661.26061.51
5558472-55847260.50860.76
6559296-55929660.59860.85
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1640646-64064669.41269.970.6469.7570.320.64
2651664-65166470.60570.95
3645195-64519569.90470.25
4649670-64967070.38970.74
5643567-64356769.72870.07
6644258-64425869.80370.14
360min1759453-75945382.28483.080.6582.7383.530.65
2774135-77413583.87584.32
3765533-76553382.94383.39
4769621-76962183.38683.84
5764573-76457382.83983.28
6767456-76745683.15183.60
480min1862386-86238693.43694.690.7394.0095.260.73
2880814-88081495.43396.01
3872150-87215094.49495.07
4876889-87688995.00895.58
5876964-87696495.01695.58
6874352-87435294.73395.30
600min1905758-90575898.13599.390.7798.84100.100.77
2926851-926851100.421101.14
3915099-91509999.14899.86
4917904-91790499.451100.17
5917024-91702499.356100.07
6921457-92145799.836100.55
720min1925266-925266100.249101.540.75101.10102.400.75
2945948-945948102.490103.36
3935003-935003101.304102.17
4937229-937229101.545102.41
5937975-937975101.626102.49
6941551-941551102.014102.88
960min1930884-930884100.858102.180.80101.86103.200.80
2952849-952849103.238104.26
3940879-940879101.941102.95
4941001-941001101.954102.97
5944718-944718102.357103.37
6948383-948383102.754103.77
1440min1921993-92199399.894101.190.79101.05102.360.79
2942640-942640102.132103.31
3931886-931886100.966102.13
4932500-932500101.033102.21
5934138-934138101.210102.38
6940648-940648101.916103.09
极限1921488-92148899.840100.980.75101.14102.300.75
2940526-940526101.902103.23
3929250-929250100.681102.00
4929744-929744100.734102.06
5932352-932352101.017102.33
6938945-938945101.731103.05
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%
112.518127081089810298130081199811770.15
212.578141481458814360.04
单位质量响应值RSD%判断
6488.976478.600.12数据可信
供试品溶液-WM1800批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148960-4896048.56940.6725.7448.5740.6725.74
228164-2816427.93927.94
351174-5117450.76550.77
450980-5098050.57350.57
535353-3535335.07135.07
631340-3134031.09031.09
10min181054-8105480.40770.2116.9880.4870.2716.99
258637-5863758.16958.21
380365-8036579.72379.80
483560-8356082.89382.97
561552-6155261.06061.11
659468-5946858.99359.04
15min190116-9011689.39681.6610.4489.5981.8310.46
274109-7410973.51773.65
387777-8777787.07687.27
492059-9205991.32491.52
576770-7677076.15776.30
673078-7307872.49472.63
20min192615-9261591.87586.417.6392.2086.707.65
281831-8183181.17781.42
390097-9009789.37789.70
495611-9561194.84795.18
583739-8373983.07083.33
678751-7875178.12278.37
30min194033-9403393.28290.364.6093.7590.784.64
288355-8835587.64988.01
392435-9243591.69792.16
497066-9706696.29196.77
588976-8897688.26588.65
685653-8565384.96985.33
45min194886-9488694.12892.693.0094.7393.253.03
292804-9280492.06392.56
393551-9355192.80493.40
497857-9785797.07697.70
591938-9193891.20491.72
689597-8959788.88189.37
60min194762-9476294.00593.753.2394.7594.443.25
294440-9444093.68694.32
393739-9373992.99093.73
4100091-10009199.292100.06
592986-9298692.24392.90
691002-9100290.27590.90
120min194928-9492894.17094.172.0195.0695.012.04
295699-9569994.93595.71
394292-9429293.53994.42
498074-9807497.29198.21
594267-9426793.51494.30
692337-9233791.60092.36
180min195840-9584095.07595.391.9196.1096.371.94
297358-9735896.58097.49
395020-9502094.26195.28
499183-9918398.39199.46
595528-9552894.76595.70
694041-9404193.29094.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min195467-9546794.70595.271.8095.8896.391.82
297641-9764196.86197.92
394841-9484194.08495.24
498621-9862197.83399.05
595557-9555794.79495.87
694121-9412193.36994.40
360min194918-9491894.16094.972.0095.4796.242.01
297412-9741296.63497.84
394327-9432793.57494.87
498718-9871897.93099.29
595249-9524994.48895.70
693812-9381293.06394.24
480min197931-9793197.14998.222.1198.6099.622.11
2101562-101562100.751102.10
397110-9711096.33497.77
4101635-101635100.823102.33
598666-9866697.87899.23
697134-9713496.35897.67
600min197504-9750496.72597.691.9398.3399.241.93
2100340-10034099.539101.04
396915-9691596.14197.73
4101276-101276100.467102.12
598106-9810697.32398.83
696709-9670995.93797.40
720min196778-9677896.00597.122.0597.7598.822.05
299962-9996299.164100.81
396179-9617995.41197.14
4100855-100855100.050101.86
597309-9730996.53298.18
696319-9631995.55097.15
960min196492-9649295.72196.281.8697.6198.121.86
299048-9904898.257100.05
395378-9537894.61696.49
499449-9944998.655100.61
596676-9667695.90497.70
695266-9526694.50596.25
1440min194682-9468293.92694.612.0295.9696.602.02
297109-9710996.33398.28
393226-9322692.48194.50
498216-9821697.43299.54
595095-9509594.33696.27
693885-9388593.13595.02
极限194397-9439793.64394.442.1795.8296.572.16
297569-9756996.79098.88
393115-9311592.37194.52
497916-9791697.13499.39
594776-9477694.01996.10
693428-9342892.68294.71
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%
110.069300669303199307959306059305929304750.04
210.049299199294199296690.04
单位质量响应值RSD%判断
92492.5492596.510.08数据可信
供试品溶液-WM1800批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129759-297593.2163.335.923.223.335.92
233192-331923.5873.59
331059-310593.3563.36
427939-279393.0193.02
532024-320243.4603.46
630740-307403.3223.32
10min172845-728457.8717.425.127.887.435.13
267171-671717.2587.26
373152-731527.9057.91
467174-671747.2597.26
567285-672857.2717.28
664439-644396.9636.97
15min1110298-11029811.91811.065.5211.9411.085.54
297320-9732010.51610.53
3107566-10756611.62311.64
4103577-10357711.19211.21
598344-9834410.62710.64
697201-9720110.50310.52
20min1141430-14143015.28214.145.7815.3214.185.76
2125105-12510513.51813.55
3136878-13687814.79114.82
4133700-13370014.44714.48
5125939-12593913.60813.64
6122384-12238413.22413.26
30min1191302-19130220.67119.414.5420.7319.464.55
2173123-17312318.70718.76
3184903-18490319.98020.04
4183283-18328319.80519.86
5174617-17461718.86818.92
6170314-17031418.40318.45
45min1253203-25320327.36025.913.6127.4525.993.61
2233164-23316425.19525.28
3244176-24417626.38526.47
4243214-24321426.28126.36
5234424-23442425.33125.41
6230331-23033124.88924.97
60min1303446-30344632.78931.313.0332.9231.433.03
2283306-28330630.61330.73
3293531-29353131.71831.84
4293996-29399631.76831.89
5283958-28395830.68330.80
6280314-28031430.29030.41
120min1450637-45063748.69447.291.7448.8747.461.74
2432339-43233946.71746.88
3440441-44044147.59247.77
4439112-43911247.44947.62
5433942-43394246.89047.05
6429456-42945646.40546.57
180min1563245-56324560.86259.481.2561.1159.721.25
2545672-54567258.96359.20
3550714-55071459.50859.75
4550173-55017359.45059.69
5549276-54927659.35359.59
6543630-54363058.74358.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1647068-64706869.92068.700.9570.2669.030.96
2631173-63117368.20268.52
3634341-63434168.54468.88
4636355-63635568.76269.09
5635648-63564868.68669.01
6630301-63030168.10868.43
360min1768822-76882283.07681.880.7783.5282.310.78
2754213-75421381.49781.92
3754042-75404281.47981.92
4756223-75622381.71582.15
5759230-75923082.03982.47
6753800-75380081.45381.87
480min1875502-87550294.60393.600.6395.1894.160.63
2867912-86791293.78394.33
3859309-85930992.85493.41
4863775-86377593.33693.89
5866685-86668593.65194.20
6864287-86428793.39293.93
600min1919963-91996399.40898.480.50100.1299.180.50
2910157-91015798.34899.04
3906659-90665997.97098.67
4909332-90933298.25998.96
5910373-91037398.37199.06
6912017-91201798.54999.23
720min1937647-937647101.319100.550.48102.18101.390.48
2929866-929866100.478101.31
3926841-926841100.151101.00
4927874-927874100.262101.11
5926927-926927100.160101.00
6933953-933953100.919101.75
960min1942207-942207101.811101.230.49102.83102.230.49
2937747-937747101.329102.32
3933359-933359100.855101.85
4933305-933305100.849101.84
5932287-932287100.739101.73
6942209-942209101.811102.79
1440min1935256-935256101.060100.390.53102.23101.540.53
2931989-931989100.707101.85
3925960-925960100.056101.20
4923534-92353499.794100.94
5924882-92488299.939101.08
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2929730-929730100.463101.75
3924569-92456999.905101.20
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