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%
110.354262777426306442629104264526425936042625270.05
210.474282584428705642848200.08
单位质量响应值RSD%判断
411838.36409247.370.45数据可信
供试品溶液-2025081721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%
5min1164870-1648704.0163.877.934.023.887.89
2170571-1705714.1554.15
3170739-1707394.1594.16
4138295-1382953.3693.37
5151324-1513243.6863.69
6158505-1585053.8613.86
10min1348467-3484678.4888.387.058.518.407.04
2348691-3486918.4938.51
3352476-3524768.5868.61
4305815-3058157.4497.47
5330374-3303748.0478.07
6378364-3783649.2169.24
15min1495560-49556012.07111.754.0712.1311.824.06
2493170-49317012.01312.08
3484341-48434111.79811.86
4443456-44345610.80210.86
5486764-48676411.85711.92
6491946-49194611.98312.05
20min1617357-61735715.03814.822.9515.1614.942.96
2622022-62202215.15115.27
3624062-62406215.20115.32
4577775-57777514.07414.18
5596840-59684014.53814.66
6613417-61341714.94215.07
30min1818157-81815719.92919.832.7020.1320.032.71
2841288-84128820.49220.69
3825867-82586720.11720.32
4776221-77622118.90719.09
5805693-80569319.62519.82
6817554-81755419.91420.11
45min11075142-107514226.18926.012.1526.4926.302.17
21081903-108190326.35326.65
31087348-108734826.48626.79
41023964-102396424.94225.21
51063516-106351625.90526.19
61074231-107423126.16626.47
60min11295681-129568131.56131.212.1231.9931.642.13
21314037-131403732.00832.44
31291117-129111731.44931.88
41234472-123447230.07030.47
51271059-127105930.96131.38
61281695-128169531.22031.65
120min11946302-194630247.40847.472.1347.9948.052.14
22004870-200487048.83549.43
31974861-197486148.10448.69
41881328-188132845.82646.37
51934993-193499347.13347.71
61951042-195104247.52448.11
180min12429735-242973559.18459.301.6360.0160.121.63
22465651-246565160.05960.90
32494504-249450460.76261.59
42388313-238831358.17558.95
52426695-242669559.11059.92
62402992-240299258.53359.36
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12807937-280793768.39668.791.5069.5269.901.50
22854704-285470469.53670.67
32871578-287157869.94771.08
42754368-275436867.09268.16
52844243-284424369.28170.39
62810934-281093468.46969.59
360min13320589-332058980.88481.160.6682.3582.620.68
23355793-335579381.74183.23
33351705-335170581.64283.12
43304613-330461380.49581.90
53312883-331288380.69682.15
63346105-334610581.50582.96
480min13707403-370740390.30689.990.9192.1791.850.91
23710654-371065490.38592.28
33690616-369061689.89791.79
43643062-364306288.73990.54
53740032-374003291.10192.95
63674315-367431589.50091.37
600min13849257-384925793.76194.721.3096.0897.041.30
23935159-393515995.85498.20
33935216-393521695.85598.20
43826116-382611693.19795.45
53931457-393145795.76398.07
63855404-385540493.91196.23
720min13972138-397213896.75497.341.3499.54100.121.33
24071677-407167799.179102.00
34021612-402161297.959100.78
43944676-394467696.08598.80
54028976-402897698.139100.93
63936848-393684895.89598.68
极限14006108-400610897.58297.211.06100.85100.481.06
23990839-399083997.210100.53
34046012-404601298.554101.86
43916066-391606695.38898.58
53994783-399478397.306100.59
63990321-399032197.197100.46
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%
110.354339343433915843353984328955432183043329370.18
210.474348724434812243484230.01
单位质量响应值RSD%判断
418641.26415322.160.57数据可信
供试品溶液-2025081721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%
5min1164292-1642923.9403.807.863.943.807.80
2169195-1691954.0584.06
3170611-1706114.0924.09
4137812-1378123.3053.31
5151283-1512833.6283.63
6158247-1582473.7953.80
10min1344599-3445998.2648.227.108.288.247.10
2348881-3488818.3678.39
3351499-3514998.4308.45
4304879-3048797.3127.33
5329177-3291777.8947.91
6377644-3776449.0579.08
15min1493505-49350511.83511.594.5211.9011.654.51
2489465-48946511.73811.80
3499378-49937811.97612.04
4439583-43958310.54210.60
5485876-48587611.65211.71
6490819-49081911.77111.84
20min1614423-61442314.73514.552.7114.8614.672.73
2616598-61659814.78714.91
3621523-62152314.90615.03
4576834-57683413.83413.94
5599248-59924814.37114.49
6611305-61130514.66014.78
30min1813443-81344319.50819.452.6819.7019.642.69
2837737-83773720.09120.29
3817915-81791519.61519.81
4773492-77349218.55018.73
5802089-80208919.23619.42
6820615-82061519.68019.88
45min11072543-107254325.72225.512.1726.0125.802.19
21072030-107203025.71026.00
31086707-108670726.06226.36
41019605-101960524.45224.72
51062671-106267125.48525.77
61069782-106978225.65625.95
60min11293774-129377431.02830.702.3431.4531.112.34
21310868-131086831.43831.86
31288071-128807130.89131.32
41226535-122653529.41529.81
51266335-126633530.37030.78
61294090-129409031.03531.46
120min11944431-194443146.63246.612.0147.2147.182.03
21989579-198957947.71548.30
31973798-197379847.33647.92
41877333-187733345.02345.56
51929898-192989846.28346.85
61946828-194682846.68947.27
180min12420724-242072458.05458.241.5758.8659.041.58
22465216-246521659.12159.94
32482834-248283459.54460.36
42384363-238436357.18257.94
52419183-241918358.01758.81
62399241-239924157.53958.35
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12796144-279614467.05867.531.4168.1668.621.42
22847304-284730468.28569.40
32864393-286439368.69569.81
42752889-275288966.02067.07
52823876-282387667.72368.81
62810253-281025367.39668.50
360min13304811-330481179.25779.720.8580.6981.150.86
23357207-335720780.51381.97
33333660-333366079.94981.41
43293819-329381978.99380.37
53301274-330127479.17280.60
63354372-335437280.44581.88
480min13706926-370692688.90088.060.8890.7389.880.89
23696589-369658988.65390.51
33678378-367837888.21690.07
43615724-361572486.71388.49
53662654-366265487.83989.66
63669870-366987088.01289.85
600min13820979-382097991.63692.871.3893.9195.141.37
23912337-391233793.82796.13
33935448-393544894.38196.68
43805259-380525991.25993.47
53905877-390587793.67295.93
63855441-385544192.46294.74
720min13952941-395294194.80095.501.2197.5398.231.20
24055141-405514197.251100.02
33999920-399992095.92798.70
43934619-393461994.36197.02
54010901-401090196.19098.92
63938485-393848594.45497.19
极限13986267-398626795.60095.341.0298.8198.551.02
23972333-397233395.26598.52
34019307-401930796.39299.64
43899173-389917393.51196.65
53989560-398956095.67998.89
63985692-398569295.58698.80
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