恩格列净二甲双胍缓释片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数400
标示量(mg)25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%
114837524848774832694841604847694841650.15
214832654830324831480.04
单位质量响应值RSD%判断
484165.00483148.000.15数据可信
供试品溶液-2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%
5min17903-79030.1470.1145.740.150.1247.55
25337-53370.0990.10
33834-38340.0710.07
44397-43970.0820.08
511147-111470.2070.21
64440-44400.0830.08
10min1125735-1257352.3401.8622.652.341.8622.57
2102035-1020351.8991.90
366460-664601.2371.24
4122990-1229902.2892.29
595983-959831.7861.79
685333-853331.5881.59
15min1309401-3094015.7574.8516.905.764.8516.91
2267000-2670004.9684.97
3187062-1870623.4813.48
4293660-2936605.4655.47
5270977-2709775.0425.05
6235069-2350694.3744.38
20min1459612-4596128.5537.3214.898.577.3414.87
2397589-3975897.3987.41
3306169-3061695.6975.71
4432221-4322218.0438.06
5424062-4240627.8917.90
6341569-3415696.3566.37
30min1549256-54925610.2219.249.0310.259.279.07
2479002-4790028.9138.94
3441580-4415808.2178.23
4519428-5194289.6669.69
5536881-5368819.99010.02
6454177-4541778.4518.47
45min1572766-57276610.6589.746.7710.709.786.79
2496972-4969729.2489.29
3492565-4925659.1669.20
4538225-53822510.01510.06
5552102-55210210.27410.32
6489439-4894399.1089.14
60min1583546-58354610.8599.916.4610.929.976.48
2508988-5089889.4719.53
3500073-5000739.3059.35
4544080-54408010.12410.18
5558077-55807710.38510.44
6502153-5021539.3449.39
120min1588727-58872710.95510.045.9411.0410.115.97
2517446-5174469.6299.70
3505484-5054849.4069.47
4549675-54967510.22810.30
5559150-55915010.40510.48
6515692-5156929.5969.66
240min1587481-58748110.93210.065.5611.0310.155.60
2521543-5215439.7059.79
3504438-5044389.3879.46
4552245-55224510.27610.37
5554841-55484110.32510.42
6523186-5231869.7369.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1588301-58830110.94710.155.1311.0610.255.15
2526381-5263819.7959.90
3510300-5103009.4969.59
4555811-55581110.34310.45
5559445-55944510.41010.52
6532231-5322319.90410.00
480min1601569-60156911.19410.225.4511.3310.345.46
2534924-5349249.95410.07
3519531-5195319.6689.78
4566204-56620410.53610.66
5531094-5310949.88310.01
6543151-54315110.10710.22
600min1600108-60010811.16710.215.4011.3210.355.42
2533538-5335389.92810.06
3517966-5179669.6389.76
4565056-56505610.51510.66
5531631-5316319.89310.04
6545100-54510010.14310.27
720min1596026-59602611.09110.185.3411.2610.335.34
2530317-5303179.86810.02
3515387-5153879.5909.73
4564466-56446610.50410.67
5531265-5312659.88610.05
6543566-54356610.11510.26
840min1594864-59486411.06910.165.1911.2610.335.21
2530306-5303069.86810.04
3517745-5177459.6349.79
4562733-56273310.47110.65
5529149-5291499.84710.02
6541519-54151910.07710.24
960min1592128-59212811.01810.075.5311.2310.265.54
2519496-5194969.6679.85
3511889-5118899.5259.70
4558479-55847910.39210.59
5525452-5254529.7789.97
6540775-54077510.06310.24
极限1588900-58890010.95810.025.4811.1910.235.49
2517228-5172289.6259.83
3509319-5093199.4789.67
4554789-55478910.32410.54
5522860-5228609.7309.94
6538018-53801810.01210.21
恩格列净二甲双胍缓释片项目信息
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100664-202507对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
111026909102769410330251033843103031010303560.31
211023870102405010239600.02
单位质量响应值RSD%判断
1030356.001023960.000.45数据可信
供试品溶液-2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%
5min11098-10980.0100.02116.820.010.02111.35
2960-9600.0080.01
36737-67370.0590.06
4833-8330.0070.01
51444-14440.0130.01
6969-9690.0080.01
10min117308-173080.1520.1617.070.150.1616.68
218530-185300.1620.16
317239-172390.1510.15
416098-160980.1410.14
524172-241720.2120.21
615748-157480.1380.14
15min156111-561110.4910.484.600.490.484.28
258243-582430.5100.51
351205-512050.4480.45
456494-564940.4950.49
556267-562670.4930.49
653418-534180.4680.47
20min1108472-1084720.9490.888.710.950.888.66
299379-993790.8700.87
390802-908020.7950.80
4113714-1137140.9951.00
598785-987850.8650.87
693336-933360.8170.82
30min1166029-1660291.4531.452.061.461.452.31
2166491-1664911.4571.46
3160138-1601381.4021.40
4167325-1673251.4651.47
5169380-1693801.4831.49
6162466-1624661.4221.42
45min1237682-2376822.0812.070.932.092.081.05
2236834-2368342.0732.08
3236316-2363162.0692.07
4235010-2350102.0572.06
5240310-2403102.1042.11
6234200-2342002.0502.05
60min1293529-2935292.5692.571.392.582.581.36
2296418-2964182.5952.60
3293184-2931842.5662.57
4288695-2886952.5272.54
5299577-2995772.6222.63
6289774-2897742.5362.54
120min1449855-4498553.9383.931.143.953.941.13
2451132-4511323.9493.96
3450710-4507103.9453.96
4440995-4409953.8603.87
5454633-4546333.9803.99
6443838-4438383.8853.90
240min1647798-6477985.6705.660.895.695.680.93
2655271-6552715.7365.76
3648334-6483345.6755.69
4639239-6392395.5955.61
5649795-6497955.6885.71
6641909-6419095.6195.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1784810-7848106.8706.880.586.906.910.62
2793606-7936066.9476.98
3788149-7881496.8996.93
4780972-7809726.8366.86
5788607-7886076.9036.93
6783129-7831296.8556.88
480min1905601-9056017.9277.950.297.977.990.29
2912401-9124017.9878.03
3905722-9057227.9287.97
4909517-9095177.9618.00
5907191-9071917.9417.98
6908340-9083407.9517.99
600min1978573-9785738.5668.600.268.628.650.26
2982493-9824938.6008.65
3979779-9797798.5768.63
4985574-9855748.6278.68
5982812-9828128.6038.66
6983192-9831928.6068.66
720min11020717-10207178.9358.990.509.009.060.49
21027133-10271338.9919.06
31026404-10264048.9849.05
41022363-10223638.9499.02
51030360-10303609.0199.09
61034583-10345839.0569.12
840min11046810-10468109.1639.250.529.259.330.49
21053852-10538529.2259.31
31060277-10602779.2819.36
41055749-10557499.2419.32
51060039-10600399.2799.36
61060885-10608859.2869.37
960min11064748-10647489.3209.340.639.429.440.63
21059538-10595389.2759.37
31067246-10672469.3429.44
41061249-10612499.2899.39
51071744-10717449.3819.48
61077380-10773809.4319.53
极限11061559-10615599.2929.330.829.419.440.80
21055062-10550629.2359.35
31065583-10655839.3279.44
41059423-10594239.2749.39
51074497-10744979.4059.52
61077005-10770059.4279.54
恩格列净二甲双胍缓释片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数400
标示量(mg)25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%
114832504834634835174844254846564838620.14
214886054882964884500.05
单位质量响应值RSD%判断
483862.00488450.000.67数据可信
供试品溶液-1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%
5min1311964-3119645.7755.867.485.785.867.45
2285094-2850945.2785.28
3357180-3571806.6126.61
4306126-3061265.6675.67
5321796-3217965.9575.96
6316487-3164875.8595.86
10min1455947-4559478.4418.835.008.458.845.02
2471736-4717368.7338.74
3520970-5209709.6459.66
4456383-4563838.4498.46
5478911-4789118.8668.88
6478952-4789528.8678.88
15min1490472-4904729.0809.685.419.109.705.42
2539573-5395739.98910.01
3566578-56657810.48910.52
4496609-4966099.1949.22
5527560-5275609.7679.79
6516756-5167569.5679.59
20min1498389-4983899.2279.925.289.279.965.26
2564165-56416510.44410.48
3571185-57118510.57410.62
4514558-5145589.5269.56
5540567-54056710.00810.05
6527715-5277159.7709.81
30min1504228-5042289.33510.005.829.3910.055.81
2576138-57613810.66610.72
3574725-57472510.64010.70
4508798-5087989.4199.47
5547090-54709010.12810.19
6529207-5292079.7979.85
45min1504326-5043269.33710.045.489.4110.125.46
2574342-57434210.63310.71
3572708-57270810.60310.68
4514563-5145639.5269.60
5555059-55505910.27610.35
6533117-5331179.8709.94
60min1514200-5142009.51910.125.299.6010.215.32
2578751-57875110.71410.81
3577310-57731010.68810.79
4515772-5157729.5489.63
5557365-55736510.31810.41
6537722-5377229.95510.04
120min1514454-5144549.52410.155.239.6310.265.20
2579241-57924110.72310.83
3577962-57796210.70010.82
4518747-5187479.6049.71
5560435-56043510.37510.48
6538483-5384839.96910.08
240min1512078-5120789.48010.115.339.6010.245.32
2576442-57644210.67210.80
3576058-57605810.66510.80
4518274-5182749.5959.71
5562725-56272510.41810.54
6531678-5316789.8439.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1513501-5135019.50610.154.979.6410.294.97
2578088-57808810.70210.85
3573531-57353110.61810.77
4525992-5259929.7389.87
5564615-56461510.45310.60
6534176-5341769.88910.03
480min1520705-5207059.64010.375.349.7910.525.32
2593418-59341810.98611.15
3586384-58638410.85611.02
4533705-5337059.88010.03
5576765-57676510.67810.84
6548443-54844310.15310.31
600min1517816-5178169.58610.335.419.7510.515.41
2591232-59123210.94511.13
3582960-58296010.79210.98
4532958-5329589.86710.03
5578631-57863110.71210.89
6545354-54535410.09610.27
720min1515090-5150909.53610.265.329.7210.455.31
2589332-58933210.91011.11
3576514-57651410.67310.88
4530290-5302909.81710.00
5572307-57230710.59510.79
6540834-54083410.01210.20
840min1513270-5132709.50210.215.309.7010.425.28
2586094-58609410.85011.07
3574847-57484710.64210.86
4528167-5281679.7789.98
5568566-56856610.52610.74
6536717-5367179.93610.14
960min1508997-5089979.42310.285.049.6410.514.97
2583772-58377210.80711.04
3571169-57116910.57410.81
4569733-56973310.54710.76
5564251-56425110.44610.68
6534986-5349869.90410.13
极限1508207-5082079.40810.285.079.6410.525.02
2583767-58376710.80711.06
3571861-57186110.58710.84
4567182-56718210.50010.73
5565017-56501710.46010.71
6534889-5348899.90210.14
恩格列净二甲双胍缓释片项目信息
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100664-202507对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
111022017102210510221301022059102604110228700.18
211024659102466710246630.01
单位质量响应值RSD%判断
1022870.001024663.000.13数据可信
供试品溶液-1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%
5min118138-181380.1590.167.150.160.165.22
216659-166590.1460.15
319872-198720.1750.17
418280-182800.1610.16
516864-168640.1480.15
616880-168800.1480.15
10min171764-717640.6300.624.690.630.624.37
265602-656020.5760.58
374259-742590.6520.65
473918-739180.6490.65
569014-690140.6060.61
669335-693350.6090.61
15min1116533-1165331.0231.022.901.021.022.95
2111695-1116950.9810.98
3120589-1205891.0591.06
4119522-1195221.0501.05
5113773-1137730.9991.00
6117162-1171621.0291.03
20min1150176-1501761.3191.367.681.321.367.58
2148568-1485681.3051.31
3154137-1541371.3541.36
4178721-1787211.5701.57
5147749-1477491.2981.30
6149969-1499691.3171.32
30min1205444-2054441.8041.781.151.811.791.26
2201853-2018531.7731.78
3205265-2052651.8031.81
4203010-2030101.7831.79
5199252-1992521.7501.75
6201992-2019921.7741.78
45min1261317-2613172.2952.310.602.302.320.61
2262942-2629422.3092.32
3265245-2652452.3292.34
4264712-2647122.3252.33
5262971-2629712.3092.32
6261641-2616412.2982.31
60min1318323-3183232.7962.760.962.812.780.97
2315375-3153752.7702.78
3317918-3179182.7922.80
4312532-3125322.7452.76
5311025-3110252.7322.74
6312910-3129102.7482.76
120min1464973-4649734.0844.060.884.104.080.92
2462634-4626344.0634.08
3465566-4655664.0894.11
4464799-4647994.0824.10
5454940-4549403.9954.01
6460646-4606464.0464.06
240min1660392-6603925.8005.741.125.825.771.11
2656320-6563205.7645.79
3663735-6637355.8295.85
4645166-6451665.6665.69
5648071-6480715.6925.71
6650701-6507015.7155.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1804990-8049907.0706.951.157.106.981.14
2794743-7947436.9807.01
3797130-7971307.0017.03
4784281-7842816.8886.92
5780111-7801116.8516.88
6789350-7893506.9326.97
480min1918397-9183978.0667.961.268.118.011.26
2910996-9109968.0018.05
3915922-9159228.0448.09
4895740-8957407.8677.91
5889837-8898377.8157.86
6907917-9079177.9748.02
600min1988596-9885968.6828.591.048.748.651.04
2981096-9810968.6168.67
3991414-9914148.7078.77
4968679-9686798.5078.57
5967402-9674028.4968.55
6974602-9746028.5598.62
720min11033211-10332119.0748.970.919.159.040.89
21025449-10254499.0069.08
31027192-10271929.0219.09
41010377-10103778.8738.95
51011793-10117938.8868.96
61016975-10169758.9319.00
840min11058079-10580799.2929.200.849.389.290.85
21050877-10508779.2299.32
31057048-10570489.2839.37
41038993-10389939.1259.21
51039281-10392819.1279.21
61042136-10421369.1529.24
960min11068686-10686869.3869.340.789.499.440.78
21062505-10625059.3319.43
31066945-10669459.3709.47
41074328-10743289.4359.54
51052269-10522699.2419.34
61056115-10561159.2759.38
极限11070059-10700599.3989.350.649.529.470.64
21061666-10616669.3249.44
31072527-10725279.4199.54
41070216-10702169.3999.52
51057765-10577659.2909.41
61057645-10576459.2899.41
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