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%
110.184186475417898341843374182276417920841822560.08
210.194218706421974142192240.02
单位质量响应值RSD%判断
410830.65414055.350.56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%
5min1156412-1564123.7923.7817.323.793.7817.32
2181639-1816394.4044.40
3123763-1237633.0013.00
4124984-1249843.0303.03
5163017-1630173.9533.95
6186713-1867134.5274.53
10min1303659-3036597.3637.0911.067.387.1111.12
2301341-3013417.3067.33
3251161-2511616.0906.10
4254050-2540506.1606.17
5318812-3188127.7307.75
6326502-3265027.9167.94
15min1438270-43827010.62610.066.4710.6810.116.49
2417371-41737110.12010.18
3379802-3798029.2099.25
4384101-3841019.3139.36
5441489-44148910.70410.76
6427238-42723810.35910.42
20min1549886-54988613.33312.499.2013.4412.609.19
2527005-52700512.77812.89
3465832-46583211.29511.39
4445697-44569710.80610.90
5553713-55371313.42513.54
6548728-54872813.30513.42
30min1708302-70830217.17416.517.8317.3516.687.83
2679883-67988316.48516.66
3624898-62489815.15115.30
4621582-62158215.07115.22
5762925-76292518.49818.68
6687480-68748016.66916.85
45min1954242-95424223.13722.098.8623.4022.348.85
2901953-90195321.86922.12
3832265-83226520.17920.40
4824376-82437619.98820.21
51040842-104084225.23625.51
6911771-91177122.10722.37
60min11122071-112207127.20626.418.6227.5826.778.62
21094248-109424826.53126.90
31005092-100509224.37024.69
4993588-99358824.09124.41
51251372-125137230.34130.74
61068574-106857425.90926.28
120min11728363-172836341.90640.987.0042.4241.487.01
21656553-165655340.16540.66
31599359-159935938.77839.22
41573200-157320038.14438.59
51902955-190295546.13946.69
61681398-168139840.76741.27
180min12229769-222976954.06351.476.9254.7952.176.93
22091594-209159450.71351.41
31994483-199448348.35949.00
41985422-198542248.13948.77
52362824-236282457.28958.07
62073947-207394750.28550.99
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12649679-264967964.24560.357.0165.2461.307.02
22462274-246227459.70160.65
32329117-232911756.47257.35
42333722-233372256.58457.46
52751722-275172266.71967.79
62406558-240655858.35059.31
360min13233511-323351178.40075.316.4479.7176.576.44
23154459-315445976.48377.73
32859945-285994569.34370.51
42861569-286156969.38270.54
53337787-333778780.92882.33
63189493-318949377.33378.58
480min13676408-367640889.13986.334.9590.8487.964.97
23667577-366757788.92590.56
33330292-333029280.74782.26
43335844-333584480.88182.38
53668155-366815588.93990.74
63683963-368396389.32290.96
600min13859834-385983493.58693.143.8495.7495.213.87
24000206-400020696.99099.07
33685712-368571289.36491.28
43638697-363869788.22490.13
53907377-390737794.73996.99
63957580-395758095.95698.04
720min13959986-395998696.01495.772.1298.6398.292.21
24011967-401196797.27599.84
33877383-387738394.01296.37
43819311-381931192.60494.95
54026962-402696297.638100.36
64002723-400272397.05199.61
极限13932148-393214895.33995.922.4198.4498.932.45
24083007-408300798.997102.05
33893150-389315094.39497.23
43818328-381832892.58095.39
53984396-398439696.60699.82
64025370-402537097.600100.65
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%
112.653224331997320253204032001320610.33
212.623237932341323600.09
单位质量响应值RSD%判断
2534.472564.180.83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%
5min134337-3433786.63688.174.4086.6488.174.40
236808-3680892.87192.87
335594-3559489.80789.81
432579-3257982.20082.20
536136-3613691.17591.17
634225-3422586.35386.35
10min135605-3560589.83591.323.3890.2791.763.38
237366-3736694.27894.74
337291-3729194.08994.54
434999-3499988.30688.72
537172-3717293.78994.24
634728-3472887.62288.05
15min135768-3576890.24691.953.1391.1392.853.14
237539-3753994.71595.65
337809-3780995.39696.32
435719-3571990.12390.98
536894-3689493.08794.01
634941-3494188.16089.03
20min135730-3573090.15191.632.8891.4892.992.88
237375-3737594.30195.71
337550-3755094.74396.14
435443-3544389.42690.73
536728-3672892.66994.06
635083-3508388.51889.83
30min135423-3542389.37692.023.3491.1693.843.33
237022-3702293.41095.29
338104-3810496.14098.01
436428-3642891.91293.66
537095-3709593.59595.45
634752-3475287.68389.44
45min135643-3564389.93192.283.2292.1694.553.21
237381-3738194.31696.66
338281-3828196.58798.94
436412-3641291.87194.08
536707-3670792.61694.94
635014-3501488.34490.54
60min135201-3520188.81692.323.5891.5095.063.56
237645-3764594.98297.80
338223-3822396.44199.27
436086-3608691.04993.72
537263-3726394.01996.80
635121-3512188.61491.25
120min135669-3566989.99793.624.1393.1296.824.09
237567-3756794.78698.08
339694-39694100.152103.47
437199-3719993.85796.98
537047-3704793.47496.73
635451-3545189.44792.52
180min136067-3606791.00193.183.5994.5896.843.56
237549-3754994.74098.51
339137-3913798.747102.56
436957-3695793.24696.84
536558-3655892.24095.96
635305-3530589.07892.60
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min136260-3626091.48893.423.8395.5297.563.79
237851-3785195.50299.74
339184-3918498.865103.18
437059-3705993.50497.56
536792-3679292.83097.01
635019-3501988.35792.33
360min136050-3605090.95893.193.2395.4597.793.22
237478-3747894.56199.28
338951-3895198.278103.08
436699-3669992.59597.12
536866-3686693.01797.66
635561-3556189.72494.14
480min136712-3671292.62893.182.6997.5798.252.71
237414-3741494.40099.59
338591-3859197.369102.67
436808-3680892.87197.86
536406-3640691.85696.97
635663-3566389.98294.84
600min136288-3628891.55893.123.0296.9698.663.02
237404-3740494.374100.04
338853-3885398.030103.81
436672-3667292.52797.98
536596-3659692.33697.91
635640-3564089.92495.23
720min135921-3592190.63392.353.1696.5098.343.14
236489-3648992.06698.20
338635-3863597.480103.75
436622-3662292.40198.32
536763-3676392.75798.79
635171-3517188.74094.50
极限135531-3553189.64891.973.0795.9698.433.07
237030-3703093.431100.03
338361-3836196.789103.55
436200-3620091.33697.72
536281-3628191.54198.04
635309-3530989.08895.29
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