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%
112.471632931634471633101633251631561633060.07
212.531655791656171655980.02
单位质量响应值RSD%判断
13095.9113216.120.65数据可信
供试品溶液-TL3539批-达格列净-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1115205-11520556.32550.8813.8156.3350.8813.81
275883-7588337.10037.10
3106143-10614351.89551.89
4108704-10870453.14753.15
5113359-11335955.42355.42
6105095-10509551.38251.38
10min1167958-16795882.11787.693.4282.2087.773.41
2177411-17741186.73886.79
3184536-18453690.22290.30
4182345-18234589.15189.23
5183393-18339389.66389.75
6180514-18051488.25588.33
15min1186979-18697991.41694.741.8491.6294.941.84
2194807-19480795.24395.43
3195479-19547995.57295.79
4193751-19375194.72794.94
5197403-19740396.51396.73
6194191-19419194.94295.15
20min1189580-18958092.68896.232.0593.0396.582.05
2197634-19763496.62696.95
3197336-19733696.48096.84
4197037-19703796.33496.69
5202063-20206398.79199.15
6197272-19727296.44996.80
30min1191761-19176193.75497.582.3794.2498.072.36
2205251-205251100.350100.82
3198409-19840997.00597.51
4199265-19926597.42397.92
5203627-20362799.556100.07
6199170-19917097.37797.87
45min1193148-19314894.43297.731.8995.0698.371.88
2200383-20038397.97098.59
3198790-19879097.19197.84
4201945-20194598.73399.38
5204212-20421299.842100.50
6200879-20087998.21298.85
60min1194613-19461395.14997.911.6795.9198.701.67
2200735-20073598.14298.91
3199709-19970997.64098.43
4200659-20065998.10598.90
5205023-205023100.238101.05
6200822-20082298.18498.97
120min1198155-19815596.880100.662.0497.79101.602.03
2207374-207374101.388102.31
3205581-205581100.511101.45
4206382-206382100.903101.84
5210759-210759103.043104.00
6207106-207106101.257102.19
180min1197909-19790996.760100.512.0697.81101.592.06
2207369-207369101.385102.46
3205166-205166100.308101.40
4205516-205516100.479101.57
5210664-210664102.996104.11
6206802-206802101.108102.20
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1198101-19810196.854100.531.9898.05101.761.98
2206519-206519100.970102.19
3208292-208292101.836103.08
4205081-205081100.267101.51
5209797-209797102.572103.84
6205895-205895100.665101.91
360min1196323-19632395.98599.962.1897.33101.352.17
2205693-205693100.566101.94
3204207-20420799.839101.23
4204632-204632100.047101.44
5209814-209814102.581104.00
6206060-206060100.745102.14
480min1195620-19562095.64199.612.1597.13101.152.14
2205492-205492100.468101.99
3203816-20381699.648101.19
4203557-20355799.521101.07
5208603-208603101.989103.57
6205342-205342100.394101.94
600min1194867-19486795.27399.192.1796.90100.882.17
2206120-206120100.775102.45
3202177-20217798.847100.54
4202895-20289599.198100.89
5207446-207446101.423103.15
6203776-20377699.629101.32
720min1193780-19378094.74198.572.0896.52100.412.07
2202932-20293299.216101.04
3202160-20216098.838100.68
4201426-20142698.480100.32
5206278-206278100.852102.73
6203145-20314599.320101.16
极限1193064-19306494.39198.252.1296.31100.232.11
2202696-20269699.101101.08
3200672-20067298.111100.10
4200987-20098798.265100.25
5205647-205647100.543102.58
6202623-20262399.065101.06
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 10.131082440108540810852921086546108697210853320.17
2 10.081094061109488710944740.06
单位质量响应值RSD%判断
107140.38108578.770.95数据可信
供试品溶液-TL3539批-二甲双胍-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min139215-392153.6363.1912.073.643.1912.04
239411-394113.6543.65
331663-316632.9362.94
432547-325473.0183.02
534184-341843.1693.17
629233-292332.7102.71
10min186598-865988.0297.405.748.037.405.70
275093-750936.9626.97
378029-780297.2357.24
481001-810017.5107.51
582879-828797.6847.69
675095-750956.9636.97
15min1129908-12990812.04511.393.6512.0611.413.66
2118046-11804610.94510.96
3121702-12170211.28411.30
4125025-12502511.59211.61
5124133-12413311.50911.53
6118395-11839510.97710.99
20min1164453-16445315.24814.722.5815.2814.752.57
2153815-15381514.26114.29
3158608-15860814.70614.74
4159766-15976614.81314.85
5161468-16146814.97115.00
6154507-15450714.32514.36
30min1222115-22211520.59420.353.0120.6520.413.01
2230774-23077421.39721.45
3217511-21751120.16720.22
4218318-21831820.24220.30
5217458-21745820.16220.22
6210883-21088319.55219.60
45min1293600-29360027.22226.682.5327.3126.772.53
2280322-28032225.99126.08
3286904-28690426.60126.69
4298784-29878427.70227.79
5286528-28652826.56626.65
6280555-28055526.01226.09
60min1348600-34860032.32131.801.4832.4531.921.48
2337088-33708831.25431.38
3345319-34531932.01732.14
4345915-34591532.07232.20
5344514-34451431.94232.07
6336233-33623331.17531.30
120min1525927-52592748.76348.580.8648.9448.760.86
2519730-51973048.18848.36
3528149-52814948.96949.14
4527973-52797348.95249.13
5524927-52492748.67048.84
6517309-51730947.96348.13
180min1651408-65140860.39760.160.7060.6560.400.70
2646541-64654159.94660.19
3652603-65260360.50860.75
4652997-65299760.54460.79
5648293-64829360.10860.35
6641309-64130959.46059.70
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1749462-74946269.48869.150.9269.8369.480.93
2741294-74129468.73169.06
3755237-75523770.02470.36
4749466-74946669.48869.83
5743185-74318568.90669.24
6736253-73625368.26368.59
360min1884523-88452382.01181.940.5282.4682.380.52
2881284-88128481.71082.15
3889970-88997082.51682.96
4887238-88723882.26282.71
5882260-88226081.80182.24
6877256-87725681.33781.77
480min1969811-96981189.91890.060.4290.4990.620.42
2971867-97186790.10990.67
3977050-97705090.58991.15
4974680-97468090.37090.94
5968452-96845289.79290.36
6966123-96612389.57690.13
600min11020945-102094594.65994.770.3895.3695.460.38
21026563-102656395.18095.87
31024181-102418194.95995.66
41025199-102519995.05495.76
51018714-101871494.45295.15
61016991-101699194.29394.98
720min11043125-104312596.71697.040.3597.5697.880.35
21050191-105019197.37198.21
31049628-104962897.31998.16
41049922-104992297.34698.19
51042964-104296496.70197.54
61044132-104413296.80997.64
极限11042766-104276696.68297.050.3797.6798.040.37
21050465-105046597.39698.38
31050391-105039197.38998.38
41049931-104993197.34798.34
51043148-104314896.71897.70
61043940-104394096.79197.77
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