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%
110.344254238425254542566524273042427046242613880.23
210.474306630431000143083160.06
单位质量响应值RSD%判断
412126.50411491.500.11数据可信
供试品溶液-2025081621批-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%
5min1181414-1814144.4054.237.074.414.237.11
2161541-1615413.9233.92
3176974-1769744.2974.30
4193092-1930924.6894.69
5170208-1702084.1334.13
6161437-1614373.9203.92
10min1352340-3523408.5568.404.888.588.424.84
2328593-3285937.9798.00
3364592-3645928.8538.87
4330592-3305928.0288.05
5365381-3653818.8738.89
6335068-3350688.1368.16
15min1487545-48754511.83911.741.6311.9011.801.64
2484362-48436211.76211.82
3492753-49275311.96612.03
4486990-48699011.82611.89
5479809-47980911.65111.72
6470024-47002411.41411.47
20min1610037-61003714.81414.501.9614.9414.631.98
2587495-58749514.26614.38
3611166-61116614.84114.97
4590371-59037114.33614.46
5600667-60066714.58614.71
6584188-58418814.18614.30
30min1799018-79901819.40319.440.8819.6019.630.88
2794755-79475519.29919.49
3813742-81374219.76019.96
4797384-79738419.36319.56
5802004-80200419.47519.67
6795960-79596019.32819.52
45min11061651-106165125.78025.331.5626.0825.621.55
21034463-103446325.12025.41
31057677-105767725.68425.98
41033842-103384225.10525.40
51051117-105111725.52425.82
61020130-102013024.77225.06
60min11247613-124761330.29630.581.8330.7231.001.83
21262953-126295330.66831.08
31292618-129261831.38931.82
41270873-127087330.86131.28
51257790-125779030.54330.96
61224004-122400429.72330.13
120min11899461-189946146.12545.971.6646.7046.541.65
21882772-188277245.72046.28
31947056-194705647.28147.86
41901325-190132546.17046.74
51857617-185761745.10945.68
61870578-187057845.42345.98
180min12430183-243018359.01258.671.2459.8259.481.23
22416963-241696358.69159.49
32435297-243529759.13759.96
42366300-236630057.46158.26
52449176-244917659.47460.27
62399314-239931458.26359.05
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12818742-281874268.44867.660.8369.5568.750.83
22760671-276067167.03868.12
32791354-279135467.78368.90
42805536-280553668.12769.22
52773867-277386767.35868.45
62767075-276707567.19368.27
360min13342692-334269281.17181.690.4782.6183.120.45
23366412-336641281.74783.17
33360202-336020281.59683.05
43354146-335414681.44982.88
53372985-337298581.90783.34
63388037-338803782.27283.68
480min13780851-378085191.81190.630.7193.6692.470.70
23707956-370795690.04191.87
33731886-373188690.62292.48
43736144-373614490.72592.56
53726849-372684990.50092.34
63710698-371069890.10791.93
600min13909346-390934694.93195.200.2797.2497.500.26
23910719-391071994.96497.25
33915084-391508495.07097.39
43932928-393292895.50497.79
53931809-393180995.47797.77
63923181-392318195.26797.54
720min13974673-397467396.51797.760.7299.30100.530.69
24031974-403197497.909100.66
34039384-403938498.089100.88
44059418-405941898.575101.34
54033721-403372197.951100.72
64016776-401677697.540100.29
极限13974105-397410596.50497.690.8999.77100.950.86
24061533-406153398.627101.87
34027854-402785497.809101.09
44059658-405965898.581101.84
54024686-402468697.732100.99
63989699-398969996.882100.12
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%
110.344329855433024343271504321851431453343247260.16
210.474356687433301643448520.39
单位质量响应值RSD%判断
418252.03414981.090.56数据可信
供试品溶液-2025081621批-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%
5min1181722-1817224.3624.176.934.364.186.88
2161449-1614493.8753.88
3176296-1762964.2324.23
4192119-1921194.6114.61
5170826-1708264.1004.10
6161130-1611303.8683.87
10min1352246-3522468.4558.294.818.488.314.81
2328328-3283287.8817.90
3364136-3641368.7408.76
4329859-3298597.9187.94
5363602-3636028.7288.75
6334615-3346158.0328.05
15min1491285-49128511.79211.611.9311.8611.681.93
2484753-48475311.63611.69
3492316-49231611.81711.88
4488260-48826011.72011.78
5478375-47837511.48311.55
6467803-46780311.22911.29
20min1609499-60949914.63014.331.8214.7514.451.82
2584843-58484314.03814.16
3607942-60794214.59314.72
4597871-59787114.35114.47
5598130-59813014.35714.48
6584345-58434514.02614.14
30min1796294-79629419.11419.190.9019.3119.380.92
2796253-79625319.11319.30
3813570-81357019.52819.73
4795204-79520419.08719.28
5800309-80030919.21019.40
6795269-79526919.08919.27
45min11062525-106252525.50425.041.6725.8025.321.67
21039815-103981524.95925.24
31058809-105880925.41525.71
41034480-103448024.83125.12
51047114-104711425.13425.42
61015287-101528724.37024.65
60min11246993-124699329.93230.181.8730.3530.591.86
21270601-127060130.49930.91
31287094-128709430.89431.32
41268564-126856430.45030.86
51250914-125091430.02630.44
61219671-121967129.27629.68
120min11902825-190282545.67445.571.4146.2446.131.41
21894072-189407245.46446.02
31936635-193663546.48647.06
41917591-191759146.02846.59
51874951-187495145.00545.57
61864391-186439144.75145.30
180min12432384-243238458.38557.931.2659.1858.721.25
22416296-241629657.99958.79
32434855-243485558.44459.25
42363193-236319356.72457.52
52441399-244139958.60259.39
62391958-239195857.41558.19
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12815641-281564167.58566.940.7968.6768.020.79
22783636-278363666.81667.89
32810409-281040967.45968.56
42792454-279245467.02868.11
52770761-277076166.50767.59
62760132-276013266.25267.31
360min13368720-336872080.86080.920.6882.2982.340.66
23391034-339103481.39682.81
33365530-336553080.78482.22
43360221-336022180.65682.07
53338674-333867480.13981.55
63402661-340266181.67583.07
480min13799328-379932891.19689.570.9893.0391.390.97
23736052-373605289.67791.50
33729593-372959389.52291.36
43720632-372063289.30791.12
53708679-370867989.02090.84
63694959-369495988.69190.49
600min13915037-391503793.97494.410.6696.2696.680.64
23955693-395569394.95097.22
33926434-392643494.24796.54
43917928-391792894.04396.31
53973870-397387095.38697.65
63910673-391067393.86996.11
720min13949939-394993994.81196.721.2897.5799.461.24
24064250-406425097.555100.30
34054270-405427097.316100.08
44093563-409356398.259100.99
54005580-400558096.14798.89
64009446-400944696.24098.95
极限14021890-402189096.53897.171.0199.77100.400.99
24091905-409190598.219101.45
34081606-408160697.972101.22
44068888-406888897.667100.89
54041307-404130797.005100.22
63984702-398470295.64698.84
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