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 12.598057980835808158069481203808250.30
2 12.488108381089810860.01
单位质量响应值RSD%判断
6419.786497.280.85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%
5min159409-5940959.16750.7612.9059.1750.7612.91
258403-5840358.16558.17
343480-4348043.30343.30
445709-4570945.52345.52
550106-5010649.90249.90
648712-4871248.51448.51
10min187339-8733986.98386.485.3387.0786.565.32
281822-8182281.48981.58
382628-8262882.29282.36
490659-9065990.29090.36
593587-9358793.20693.28
684950-8495084.60484.68
15min190976-9097690.60692.944.8390.8293.154.82
289666-8966689.30189.51
390394-9039490.02690.21
499198-9919898.79499.00
599016-9901698.61398.83
690685-9068590.31690.52
20min190787-9078790.41793.815.1590.7794.165.14
290746-9074690.37790.72
392025-9202591.65091.97
4100313-10031399.905100.26
5100519-100519100.110100.47
690771-9077190.40190.74
30min191105-9110590.73494.785.2991.2295.275.28
296325-9632595.93396.41
393115-9311592.73693.20
4100524-100524100.115100.62
5101125-101125100.713101.23
688832-8883288.47088.94
45min191372-9137291.00094.236.5391.6394.866.52
295791-9579195.40196.02
390980-9098090.61091.21
4100981-100981100.570101.22
5102204-102204101.788102.45
686392-8639286.04086.64
60min190956-9095690.58693.327.1791.3594.097.15
295480-9548095.09195.86
389001-8900188.63989.37
4100780-100780100.370101.17
5101421-101421101.008101.82
684590-8459084.24684.98
120min191071-9107190.70091.479.7391.6092.389.68
293937-9393793.55594.46
386262-8626285.91186.78
4100824-100824100.414101.37
5101124-101124100.712101.68
677854-7785477.53778.40
180min194141-9414193.75893.6711.4994.7994.7211.42
296390-9639095.99897.05
387113-8711386.75887.76
4104961-104961104.534105.64
5104809-104809104.382105.50
676884-7688476.57177.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min194216-9421693.83292.7912.3495.0193.9812.26
295595-9559595.20696.40
386130-8613085.77986.91
4104105-104105103.681104.94
5104604-104604104.178105.45
674355-7435574.05275.14
360min193499-9349993.11891.9512.8594.4493.2812.76
295105-9510594.71896.05
384657-8465784.31285.57
4103578-103578103.156104.57
5104071-104071103.647105.08
673063-7306372.76673.97
480min193154-9315492.77591.0513.7094.2392.5213.59
293745-9374593.36394.84
384093-8409383.75185.13
4103454-103454103.033104.60
5103465-103465103.044104.63
670647-7064770.35971.67
600min192917-9291792.53990.4613.6994.1392.0613.59
293241-9324192.86194.48
383225-8322582.88684.39
4102381-102381101.964103.69
5102965-102965102.546104.29
670244-7024469.95871.37
720min191863-9186391.48989.5213.7593.2291.2613.64
291890-9189091.51693.27
382534-8253482.19883.83
4101771-101771101.357103.24
5101811-101811101.396103.29
669456-6945669.17370.69
960min191250-9125090.87888.6313.8592.7590.5013.74
291173-9117390.80292.70
381505-8150581.17382.93
4100997-100997100.586102.62
5100449-100449100.040102.09
668554-6855468.27569.90
1440min190016-9001689.65087.2813.8691.6689.2813.74
289838-8983889.47291.50
380321-8032179.99481.87
499353-9935398.948101.13
598882-9888298.479100.68
667413-6741367.13968.87
极限190150-9015089.78387.2213.8891.9389.3513.76
289604-8960489.23991.40
380296-8029679.96981.97
499121-9912198.717101.05
598970-9897098.567100.91
667305-6730567.03168.86
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%
1 10.111161550116197811622311163732116288311624750.08
2 10.031161307116408011626940.17
单位质量响应值RSD%判断
114982.69115921.640.58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%
5min141405-414053.5863.503.103.593.503.08
239482-394823.4203.42
338621-386213.3453.35
441996-419963.6383.64
540284-402843.4893.49
640888-408883.5423.54
10min199528-995288.6218.283.188.638.293.19
294363-943638.1738.18
391157-911577.8967.90
495697-956978.2898.29
598459-984598.5288.53
694550-945508.1908.19
15min1151658-15165813.13612.562.9413.1512.582.93
2141264-14126412.23612.25
3140857-14085712.20112.22
4146739-14673912.71012.73
5147127-14712712.74412.76
6142289-14228912.32512.34
20min1189654-18965416.42716.002.1716.4716.042.19
2179491-17949115.54715.58
3181483-18148315.72015.75
4187717-18771716.26016.30
5187112-18711216.20716.24
6182966-18296615.84815.88
30min1254778-25477822.06821.681.4322.1321.741.44
2246303-24630321.33421.39
3248371-24837121.51321.57
4252456-25245621.86721.93
5253199-25319921.93121.99
6246998-24699821.39421.45
45min1332141-33214128.76928.441.4328.8628.531.43
2321130-32113027.81527.91
3326916-32691628.31728.41
4330917-33091728.66328.76
5333343-33334328.87328.97
6325256-32525628.17328.26
60min1396841-39684134.37333.971.1734.5134.101.17
2384768-38476833.32833.46
3392890-39289034.03134.16
4394869-39486934.20334.34
5394941-39494134.20934.35
6388712-38871233.66933.80
120min1587020-58702050.84650.310.8851.0450.500.89
2572738-57273849.60949.79
3582513-58251350.45650.64
4582244-58224450.43250.62
5583602-58360250.55050.74
6577084-57708449.98650.17
180min1749240-74924064.89764.470.7265.1664.730.72
2735835-73583563.73663.99
3748115-74811564.80065.06
4746556-74655664.66564.93
5746130-74613064.62864.89
6739756-73975664.07664.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1862512-86251274.70973.900.7875.0774.260.77
2845820-84582073.26373.62
3859255-85925574.42674.78
4851414-85141473.74774.11
5853026-85302673.88774.25
6847181-84718173.38173.74
360min11015343-101534387.94687.390.5288.4287.860.52
21007113-100711387.23487.70
31013605-101360587.79688.26
41000700-100070086.67887.15
51007490-100749087.26687.74
61009270-100927087.42087.89
480min11112887-111288796.39595.550.6697.0096.160.66
21100857-110085795.35395.95
31111036-111103696.23596.84
41097665-109766595.07795.68
51101572-110157295.41596.02
61094919-109491994.83995.44
600min11161700-1161700100.62399.790.61101.38100.530.61
21152971-115297199.867100.60
31157957-1157957100.299101.04
41144160-114416099.10499.85
51150271-115027199.633100.38
61145185-114518599.19399.93
720min11180239-1180239102.229101.110.72103.13102.000.72
21167927-1167927101.163102.05
31173456-1173456101.642102.54
41160390-1160390100.510101.40
51163536-1163536100.782101.68
61158088-1158088100.311101.20
960min11185289-1185289102.667101.410.78103.72102.460.78
21175562-1175562101.824102.86
31174268-1174268101.712102.76
41163437-1163437100.774101.82
51163047-1163047100.740101.79
61163391-1163391100.770101.81
1440min11177048-1177048101.953101.140.63103.16102.330.62
21172213-1172213101.534102.72
31172797-1172797101.585102.79
41160312-1160312100.503101.70
51160915-1160915100.555101.75
61162387-1162387100.683101.87
极限11179603-1179603102.174101.020.78103.54102.370.78
21170420-1170420101.379102.72
31172210-1172210101.534102.89
41158295-1158295100.328101.67
51157882-1157882100.293101.64
61159275-1159275100.413101.75
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 12.598067080752806608068580650806830.06
2 12.488058980838807140.22
单位质量响应值RSD%判断
6408.506467.470.65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%
5min156765-5676556.71349.2516.5356.7149.2516.53
240141-4014140.10540.10
344380-4438044.34044.34
458963-5896358.90958.91
553690-5369053.64153.64
641856-4185641.81841.82
10min187089-8708987.01083.565.8687.0983.645.86
285198-8519885.12185.18
379151-7915179.07979.15
485309-8530985.23285.32
588870-8887088.78988.87
676204-7620476.13576.20
15min194807-9480794.72191.884.6294.9492.084.62
295376-9537695.28995.48
391415-9141591.33291.52
490450-9045090.36890.58
595296-9529695.20995.42
684442-8444284.36584.54
20min195187-9518795.10193.203.7595.4693.543.75
297307-9730797.21997.55
394491-9449194.40594.73
491310-9131091.22791.58
594091-9409194.00694.36
687342-8734287.26387.57
30min196088-9608896.00195.193.7696.5095.663.75
299146-9914699.05699.53
398107-9810798.01898.48
492342-9234292.25892.75
596232-9623296.14596.64
689716-8971689.63490.07
45min196743-9674396.65595.393.4697.3096.013.45
299899-9989999.808100.43
396975-9697596.88797.50
492270-9227092.18692.81
596026-9602695.93996.58
690964-9096490.88191.45
60min196673-9667396.58595.313.4797.3796.083.46
2100059-10005999.968100.74
397168-9716897.08097.84
492120-9212092.03692.80
595138-9513895.05295.84
691235-9123591.15291.86
120min196890-9689096.80295.933.3397.7496.843.32
299781-9978199.690100.62
398993-9899398.90399.80
492614-9261492.53093.43
595737-9573795.65096.58
692086-9208692.00292.84
180min1100488-100488100.397100.503.24101.48101.553.20
2103712-103712103.618104.69
3100965-100965100.873101.92
495398-9539895.31196.35
598815-9881598.72599.80
6104194-104194104.099105.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min199436-9943699.34698.693.56100.5899.893.54
2103605-103605103.511104.74
3101455-101455101.363102.56
495120-9512095.03496.22
598412-9841298.32399.54
694632-9463294.54695.68
360min199790-9979099.69998.483.66101.0899.833.64
2103383-103383103.289104.67
3100860-100860100.768102.12
494478-9447894.39295.72
598608-9860898.51899.89
694308-9430894.22295.50
480min199451-9945199.36197.903.61100.8999.403.59
2102739-102739102.646104.19
3100419-100419100.328101.83
494203-9420394.11795.59
597264-9726497.17698.69
693876-9387693.79195.21
600min198511-9851198.42297.663.34100.1099.303.33
2102369-102369102.276103.97
399843-9984399.752101.41
495208-9520895.12296.73
597272-9727297.18498.84
693270-9327093.18594.75
720min198348-9834898.25996.983.46100.0898.773.44
2101691-101691101.599103.45
399356-9935699.266101.07
493130-9313093.04594.80
596226-9622696.13997.95
693655-9365593.57095.27
960min197961-9796197.87295.943.3299.8497.883.30
2100067-10006799.976101.98
397838-9783897.74999.70
492201-9220192.11794.01
595607-9560795.52097.47
692510-9251092.42694.27
1440min196909-9690996.82194.943.1898.9497.023.17
299014-9901498.924101.07
396504-9650496.41698.52
491230-9123091.14793.18
594533-9453394.44796.54
691976-9197691.89293.87
极限197030-9703096.94294.863.3899.2197.083.37
298274-9827498.185100.48
397575-9757597.48699.73
491430-9143091.34793.51
594475-9447594.38996.62
690891-9089190.80892.92
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%
1 10.111158957115709011573471156970115757811575880.07
2 10.031150681115496111528210.27
单位质量响应值RSD%判断
114499.31114937.290.27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%
5min147780-477804.1653.767.664.173.767.72
240903-409033.5663.57
342270-422703.6853.68
446646-466464.0664.07
540813-408133.5583.56
640065-400653.4923.49
10min1100673-1006738.7768.465.998.788.465.98
291745-917457.9978.00
392173-921738.0358.04
4105757-1057579.2199.22
599332-993328.6598.66
692318-923188.0478.05
15min1152131-15213113.26112.705.0613.2812.725.07
2139543-13954312.16412.18
3136794-13679411.92411.94
4154955-15495513.50713.53
5149173-14917313.00313.02
6141768-14176812.35812.38
20min1191489-19148916.69216.7610.3516.7316.8010.33
2186428-18642816.25116.29
3175107-17510715.26415.30
4194528-19452816.95717.00
5229701-22970120.02320.06
6176640-17664015.39815.43
30min1257255-25725522.42521.823.1422.4921.883.15
2243984-24398421.26821.33
3244360-24436021.30121.36
4260443-26044322.70322.77
5253835-25383522.12722.19
6241978-24197821.09321.15
45min1334613-33461329.16828.512.6029.2728.602.60
2321923-32192328.06228.15
3317405-31740527.66827.76
4337537-33753729.42329.52
5331137-33113728.86528.97
6319586-31958627.85827.95
60min1400985-40098534.95434.182.0335.1034.322.04
2388606-38860633.87534.01
3382667-38266733.35733.49
4401604-40160435.00835.15
5393065-39306534.26434.41
6385531-38553133.60733.74
120min1589904-58990451.42250.791.1151.6250.981.11
2575718-57571850.18650.37
3583401-58340150.85551.04
4590054-59005451.43551.63
5580860-58086050.63450.83
6575819-57581950.19450.38
180min1751279-75127965.48965.492.6465.7665.752.63
2735702-73570264.13164.39
3734696-73469664.04464.30
4753354-75335465.67065.94
5744017-74401764.85665.13
6788581-78858168.74169.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1860866-86086675.04274.400.7075.4174.760.71
2847359-84735973.86574.22
3851115-85111574.19274.55
4860696-86069675.02775.40
5852194-85219474.28674.66
6848432-84843273.95874.32
360min11018393-101839388.77487.860.7689.2688.340.77
2998886-99888687.07387.54
31001603-100160387.31087.78
41015055-101505588.48388.97
51008739-100873987.93288.41
61005053-100505387.61188.08
480min11117032-111703297.37296.110.8497.9996.720.84
21093806-109380695.34795.95
31099569-109956995.85096.45
41110514-111051496.80497.42
51095728-109572895.51596.13
61098765-109876595.78096.38
600min11162055-1162055101.297100.551.07102.06101.301.08
21138985-113898599.286100.03
31150787-1150787100.315101.05
41173537-1173537102.298103.06
51148198-1148198100.089100.84
61147133-114713399.996100.74
720min11180643-1180643102.917101.890.87103.83102.790.87
21153105-1153105100.517101.41
31167543-1167543101.775102.67
41178067-1178067102.693103.61
51162882-1162882101.369102.27
61170693-1170693102.050102.95
960min11189386-1189386103.679102.281.00104.75103.341.00
21154218-1154218100.614101.65
31173718-1173718102.313103.36
41179167-1179167102.788103.86
51168679-1168679101.874102.93
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1440min11189911-1189911103.725102.081.02104.95103.291.03
21153639-1153639100.563101.75
31166822-1166822101.712102.91
41176472-1176472102.553103.78
51168451-1168451101.854103.06
61171202-1171202102.094103.30
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21146685-114668599.957101.30
31178687-1178687102.747104.10
41175851-1175851102.499103.88
51166204-1166204101.658103.02
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