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%
110.174173639417173641705864170316417038441713320.04
210.104151767415451841531420.05
单位质量响应值RSD%判断
410160.47411202.180.18数据可信
供试品溶液-2025070821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%
5min1160651-1606513.9123.468.603.913.468.58
2153156-1531563.7293.73
3131689-1316893.2073.21
4132256-1322563.2203.22
5133556-1335563.2523.25
6141081-1410813.4353.44
10min1308851-3088517.5207.788.697.547.808.68
2299501-2995017.2937.31
3374235-3742359.1139.13
4321333-3213337.8247.84
5305208-3052087.4327.45
6307910-3079107.4987.51
15min1442861-44286110.78410.813.1410.8410.863.12
2433997-43399710.56810.62
3444259-44425910.81810.88
4435786-43578610.61110.67
5470812-47081211.46411.52
6435141-43514110.59610.65
20min1572764-57276413.94713.762.7214.0613.872.73
2552215-55221513.44613.55
3592244-59224414.42114.54
4560496-56049613.64813.76
5551713-55171313.43413.54
6561338-56133813.66813.78
30min1771489-77148918.78618.620.6918.9718.800.70
2764289-76428918.61018.79
3768843-76884318.72118.91
4759660-75966018.49818.67
5766765-76676518.67118.85
6758093-75809318.45918.64
45min1981318-98131823.89524.501.3124.1724.771.29
21013241-101324124.67224.94
31019211-101921124.81825.10
41006803-100680324.51524.78
51010795-101079524.61324.88
61005702-100570224.48924.76
60min11195554-119555429.11229.491.0929.5129.881.09
21220823-122082329.72730.12
31228639-122863929.91730.32
41214936-121493629.58329.98
51209655-120965529.45529.85
61196584-119658429.13729.53
120min11836207-183620744.71145.532.0445.2546.072.02
21820113-182011344.31944.86
31892297-189229746.07746.63
41917413-191741346.68947.23
51856616-185661645.20845.75
61896060-189606046.16946.71
180min12356756-235675657.38757.041.1858.1557.811.17
22298555-229855555.96956.73
32321430-232143056.52657.31
42374930-237493057.82958.60
52351539-235153957.26058.03
62351732-235173257.26458.03
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12711405-271140566.02254.8348.9767.0755.8848.03
22642397-264239764.34265.38
32412-24120.0591.13
42745443-274544366.85167.91
52727219-272721966.40767.46
62680908-268090865.28066.33
360min13287981-328798180.06279.291.3581.4480.611.44
23275616-327561679.76181.12
33194789-319478977.79378.86
43255311-325531179.26680.66
53308473-330847380.56181.95
63214377-321437778.26979.65
480min13585419-358541987.30486.931.2789.0888.651.34
23515451-351545185.60187.36
33517700-351770085.65587.11
43583146-358314687.24989.04
53586568-358656887.33289.12
63631672-363167288.43190.20
600min13802905-380290592.60077.4248.9894.8279.5847.61
23794948-379494892.40694.60
33877432-387743294.41596.30
43790376-379037692.29594.52
51527-15270.0372.26
63810602-381060292.78795.00
720min13938364-393836495.89895.141.5698.5897.691.57
23855108-385510893.87196.52
33838064-383806493.45695.81
43995535-399553597.29199.98
53942329-394232995.99598.22
63875137-387513794.35997.04
极限13908532-390853295.17279.0548.8898.3382.0746.99
23852211-385221193.80196.92
33874409-387440994.34197.17
47765-77650.1893.37
53921789-392178995.49598.20
63912697-391269795.27398.42
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%
110.174201946420840842092314209557420714542072570.08
210.104203970420353642037530.01
单位质量响应值RSD%判断
413692.92416213.170.43数据可信
供试品溶液-2025070821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%
5min1159120-1591203.8353.1848.883.833.1848.85
2171527-1715274.1344.13
3151478-1514783.6513.65
41152-11520.0280.03
5151595-1515953.6533.65
6157052-1570523.7853.78
10min1323522-3235227.7977.772.867.827.782.91
2325156-3251567.8367.86
3337982-3379828.1458.16
4312646-3126467.5357.53
5313730-3137307.5617.58
6321203-3212037.7417.76
15min1472194-47219411.38012.2412.9211.4412.3012.88
2482428-48242811.62611.69
3640584-64058415.43815.50
4483607-48360711.65511.69
5495578-49557811.94312.00
6472880-47288011.39611.45
20min1589402-58940214.20414.9913.7214.3215.1013.65
2591786-59178614.26214.38
3615827-61582714.84114.98
4565725-56572513.63413.73
5792549-79254919.10019.22
6575925-57592513.87913.99
30min1778266-77826618.75618.761.7518.9418.951.77
2791462-79146219.07419.26
3795708-79570819.17619.39
4762550-76255018.37718.54
5764339-76433918.42018.63
6778789-77878918.76818.95
45min11096627-109662726.42825.122.8426.7125.412.81
21013055-101305524.41424.70
31045868-104586825.20525.51
41039060-103906025.04125.30
51041073-104107325.08925.39
61019197-101919724.56224.84
60min11272671-127267130.67130.302.2631.0830.712.28
21263595-126359530.45230.86
31296593-129659331.24731.68
41213847-121384729.25329.63
51239642-123964229.87530.30
61258171-125817130.32130.72
120min11898421-189842145.75145.951.8746.3246.521.88
21931253-193125346.54247.10
31959528-195952847.22347.81
41861485-186148544.86145.39
51878333-187833345.26745.84
61912285-191228546.08546.64
180min12401253-240125357.86957.461.8358.6658.251.83
22372649-237264957.17957.97
32464749-246474959.39960.22
42353857-235385756.72657.48
52350377-235037756.64357.45
62362631-236263156.93857.72
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12771701-277170166.79666.860.9967.8867.941.00
22798649-279864967.44668.52
32814904-281490467.83768.96
42752891-275289166.34367.38
52762836-276283666.58367.67
62744680-274468066.14567.21
360min13330347-333034780.25980.151.1581.6881.561.15
23336553-333655380.40981.82
33388113-338811381.65183.11
43320399-332039980.01981.39
53271996-327199678.85380.27
63307749-330774979.71581.11
480min13620315-362031587.24774.6349.3089.0776.4548.14
24063604-406360497.93099.75
33654418-365441888.06989.94
43596327-359632786.66988.44
53644770-364477087.83789.65
61459-14590.0351.83
600min13853171-385317192.85993.341.1795.1195.521.05
23887830-388783093.69496.00
33881286-388128693.53695.85
43799275-379927591.56093.76
53879994-387999493.50595.76
63936459-393645994.86696.66
720min13976217-397621795.82480.3649.1898.5483.0147.84
23897361-389736193.92496.70
34296027-4296027103.531106.31
43940977-394097794.97597.63
53895384-389538493.87696.60
61274-12740.0312.30
极限13808948-380894891.79394.592.1194.9997.652.01
23930051-393005194.71297.96
33973561-397356195.76099.05
43845332-384533292.67095.80
54025263-402526397.006100.20
63967916-396791695.62497.90
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