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%
110.184223113422296942170194218607421649542196410.08
210.194214205422141542178100.13
单位质量响应值RSD%判断
414503.05413916.580.11数据可信
供试品溶液-2025081521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%
5min1129420-1294203.1253.179.733.123.179.78
2134819-1348193.2553.25
3112845-1128452.7242.72
4152424-1524243.6803.68
5127692-1276923.0833.08
6131469-1314693.1743.17
10min1288376-2883766.9627.314.686.987.334.70
2317867-3178677.6747.69
3285855-2858556.9016.91
4319415-3194157.7117.73
5301255-3012557.2737.29
6304043-3040437.3407.36
15min1411303-4113039.93010.374.669.9810.424.67
2449273-44927310.84710.90
3403948-4039489.7529.80
4454474-45447410.97211.03
5428775-42877510.35210.40
6429138-42913810.36010.41
20min1524813-52481312.67013.424.4912.7713.524.48
2593806-59380614.33614.44
3533770-53377012.88612.98
4569977-56997713.76113.87
5554402-55440213.38513.49
6558157-55815713.47513.58
30min1736436-73643617.77918.364.7017.9418.534.69
2822554-82255419.85820.04
3732178-73217817.67717.84
4744570-74457017.97618.16
5742285-74228517.92118.09
6784172-78417218.93219.10
45min11000059-100005924.14424.614.7924.4024.884.78
21096003-109600326.46026.74
3960021-96002123.17723.43
41036662-103666225.02725.30
5982855-98285523.72823.99
61041268-104126825.13925.41
60min11220505-122050529.46629.412.5229.8429.802.54
21253910-125391030.27230.68
31176105-117610528.39428.76
41235280-123528029.82330.22
51186515-118651528.64529.02
61237084-123708429.86630.26
120min11957418-195741847.25745.243.3747.7845.773.36
21919271-191927146.33646.90
31805346-180534643.58544.09
41825380-182538044.06944.61
51824718-182471844.05344.57
61911640-191164046.15246.69
180min12374389-237438957.32356.675.1158.0857.435.08
22504369-250436960.46161.26
32175505-217550552.52253.25
42314923-231492355.88856.65
52268714-226871454.77255.51
62445457-244545759.03959.81
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12755217-275521766.51765.734.3767.5666.784.36
22889173-288917369.75170.85
32559455-255945561.79162.78
42652571-265257164.03965.08
52670229-267022964.46665.48
62809628-280962867.83168.90
360min13277299-327729979.12279.154.3780.5080.524.35
23505753-350575384.63786.08
33216040-321604077.64378.94
43103267-310326774.92076.28
53194997-319499777.13578.47
63374402-337440281.46682.87
480min13591026-359102686.69687.446.1088.4789.206.05
23989703-398970396.32198.19
33342963-334296380.70782.39
43544043-354404385.56287.30
53523340-352334085.06286.79
63739503-373950390.28092.09
600min13947914-394791495.31294.145.7997.5296.345.75
24226329-4226329102.034104.38
33643446-364344687.96190.05
43816700-381670092.14494.31
53690485-369048589.09791.25
64070852-407085298.280100.55
720min14123320-412332099.54797.534.51102.23100.214.51
24286451-4286451103.485106.35
33838810-383881092.67895.21
43919382-391938294.62397.25
53889402-388940293.89996.49
64182541-4182541100.976103.73
极限13799947-379994791.74091.713.9594.9294.873.96
24033586-403358697.380100.76
33625769-362576987.53590.53
43702568-370256889.38992.49
53721988-372198889.85892.92
63908366-390836694.35797.62
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)5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%
112.653250232234323563220632480323560.43
212.623201831817319180.45
单位质量响应值RSD%判断
2557.792529.160.80数据可信
供试品溶液-2025081521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%
5min133649-3364985.09585.408.2485.1085.408.24
237077-3707793.76493.76
329275-2927574.03474.03
435389-3538989.49589.50
532057-3205781.06981.07
635159-3515988.91488.91
10min135982-3598290.99591.432.8391.4291.852.85
237724-3772495.40095.87
334923-3492388.31788.69
435955-3595590.92791.37
535398-3539889.51889.92
636931-3693193.39593.84
15min136382-3638292.00790.583.4192.8991.473.43
237081-3708193.77494.72
333698-3369885.21986.03
436229-3622991.62092.52
535107-3510788.78289.64
636415-3641592.09093.00
20min136633-3663392.64192.963.8193.9894.303.81
239047-3904798.746100.16
334920-3492088.30989.55
436110-3611091.31992.68
536345-3634591.91393.21
637507-3750794.85296.22
30min137647-3764795.20693.965.1197.0195.765.08
239854-39854100.787102.70
335396-3539689.51391.19
435301-3530189.27391.09
535977-3597790.98292.74
638741-3874197.97299.82
45min138316-3831696.89895.094.6999.1897.364.68
239803-39803100.658103.07
335181-3518188.96991.10
437470-3747094.75897.02
535972-3597290.97093.18
638873-3887398.306100.64
60min138882-3888298.32993.713.94101.0996.453.93
237583-3758395.04497.96
334953-3495388.39390.96
436759-3675992.96095.70
535950-3595090.91493.58
638197-3819796.59799.42
120min140604-40604102.68494.385.28105.9497.595.19
237492-3749294.81498.20
335303-3530389.27892.29
435771-3577190.46193.66
536348-3634891.92195.04
638397-3839797.102100.41
180min138832-3883298.20294.215.58101.9797.905.52
238859-3885998.271102.14
334029-3402986.05689.52
436325-3632591.86295.52
536189-3618991.51995.10
639280-3928099.335103.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min138939-3893998.47394.174.80102.7398.334.77
238540-3854097.464101.82
334482-3448287.20291.09
436078-3607891.23895.35
536689-3668992.78396.82
638698-3869897.864102.16
360min138126-3812696.41793.704.45101.1798.334.41
238802-3880298.127102.97
335826-3582690.60194.93
434810-3481088.03192.60
536227-3622791.61596.12
638520-3852097.413102.20
480min137700-3770095.34093.485.83100.5798.575.74
239924-39924100.964106.30
333699-3369985.22290.00
435914-3591490.82395.83
536287-3628791.76696.73
638254-3825496.741102.01
600min138625-3862597.67994.565.57103.39100.125.50
239648-39648100.266106.11
334691-3469187.73092.94
436366-3636691.96697.43
535679-3567990.22995.65
639332-3933299.467105.22
720min139272-3927299.31594.994.65105.52101.034.63
239028-3902898.698105.04
335367-3536789.44095.08
436085-3608591.25697.18
536581-3658192.51098.38
639041-3904198.731104.98
极限135797-3579790.52788.783.9897.2295.304.00
236693-3669392.79399.63
333046-3304683.57089.66
434075-3407586.17292.55
534783-3478387.96394.30
636250-3625091.67398.42
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