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%
113.004161728416275241639744164271415418941613830.10
213.024217388421685542171220.01
单位质量响应值RSD%判断
320106.38323895.700.84数据可信
供试品溶液-YA0011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%
5min1100701-1007013.1273.335.483.133.335.46
2105330-1053303.2713.27
3101403-1014033.1493.15
4114339-1143393.5513.55
5113645-1136453.5293.53
6107817-1078173.3483.35
10min1222987-2229876.9257.919.406.947.939.38
2284504-2845048.8368.85
3233420-2334207.2497.27
4256939-2569397.9808.00
5277273-2772738.6118.63
6252955-2529557.8567.87
15min1364451-36445111.31912.217.3811.3712.277.35
2420520-42052013.06013.12
3366889-36688911.39411.45
4396016-39601612.29912.36
5434179-43417913.48413.54
6377441-37744111.72211.78
20min1464403-46440314.42315.887.6414.5316.007.63
2556549-55654917.28517.41
3477775-47777514.83814.95
4520059-52005916.15116.27
5554852-55485217.23217.36
6494822-49482215.36815.48
30min1662560-66256020.57721.964.9620.7622.164.98
2750404-75040423.30523.52
3680144-68014421.12321.31
4718340-71834022.30922.51
5740967-74096723.01223.23
6690283-69028321.43821.63
45min1906354-90635428.14929.744.2728.4330.044.29
21007322-100732231.28431.61
3918958-91895828.54028.83
4977369-97736930.35430.67
5991518-99151830.79331.12
6943554-94355429.30429.60
60min11135597-113559735.26836.292.5535.6936.742.59
21204627-120462737.41237.90
31138234-113823435.35035.78
41183385-118338536.75237.22
51194699-119469937.10437.59
61154029-115402935.84136.29
120min11773953-177395355.09356.492.1655.6957.132.19
21882252-188225258.45759.13
31780880-178088055.30955.92
41826517-182651756.72657.37
51831571-183157156.88357.55
61818888-181888856.48957.11
180min12204032-220403268.45071.062.3369.3271.982.34
22345324-234532472.83873.80
32255690-225569070.05570.94
42335722-233572272.54073.47
52307413-230741371.66172.61
62280505-228050570.82571.73
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12573185-257318579.91582.922.4381.1384.192.44
22711654-271165484.21685.54
32616719-261671981.26782.50
42715280-271528084.32885.62
52739525-273952585.08186.39
62662342-266234282.68483.94
360min13124730-312473097.044100.181.7698.66101.871.78
23272767-3272767101.642103.39
33206680-320668099.589101.23
43264086-3264086101.372103.09
53266352-3266352101.443103.18
63219253-321925399.980101.65
480min13515493-3515493109.180111.611.43111.28113.801.44
23635796-3635796112.916115.17
33565677-3565677110.739112.88
43652429-3652429113.433115.65
53573567-3573567110.984113.23
63619034-3619034112.396114.57
600min13745904-3745904116.336118.241.79118.98120.981.80
23891102-3891102120.845123.67
33742477-3742477116.230118.92
43885824-3885824120.682123.47
53814303-3814303118.460121.26
63762720-3762720116.858119.59
720min13862809-3862809119.967121.721.60123.20125.061.62
24006636-4006636124.434127.86
33861967-3861967119.941123.21
43963218-3963218123.085126.48
53951324-3951324122.716126.11
63869568-3869568120.177123.50
极限13865881-3865881120.062121.771.44123.89125.711.46
23979457-3979457123.590127.64
33861292-3861292119.920123.79
43962914-3962914123.076127.08
53971988-3971988123.358127.36
63883207-3883207120.600124.52
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%
113.004232666423605642342854234545423437642343860.03
213.024230927423167442313000.02
单位质量响应值RSD%判断
325722.00324984.640.17数据可信
供试品溶液-YA0011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%
5min1165086-1650865.0744.0213.755.074.0213.72
2135222-1352224.1564.16
3118219-1182193.6343.63
4125562-1255623.8593.86
5119285-1192853.6663.67
6120818-1208183.7133.71
10min1309932-3099329.5269.333.979.559.353.99
2291470-2914708.9598.98
3306093-3060939.4089.43
4318395-3183959.7869.81
5286505-2865058.8068.82
6308097-3080979.4709.49
15min1465827-46582714.31813.733.3514.3913.793.36
2442389-44238913.59713.66
3424741-42474113.05513.12
4452316-45231613.90213.97
5436610-43661013.42013.48
6457546-45754614.06314.13
20min1583962-58396217.94917.552.3018.0917.692.31
2561754-56175417.26617.40
3548951-54895116.87217.00
4578851-57885117.79117.93
5576044-57604417.70517.83
6576891-57689117.73117.87
30min1781315-78131524.01423.501.5124.2523.721.52
2761425-76142523.40323.62
3746249-74624922.93723.15
4765033-76503323.51423.74
5762697-76269723.44223.66
6770085-77008523.66923.89
45min11026930-102693031.56431.252.7731.9231.592.76
21028606-102860631.61531.95
3992879-99287930.51730.85
41025277-102527731.51331.86
5974070-97407029.93930.27
61051934-105193432.33232.68
60min11250440-125044038.43338.112.0038.9538.612.00
21230877-123087737.83238.33
31209805-120980537.18437.67
41245663-124566338.28738.79
51223233-122323337.59738.08
61280422-128042239.35539.86
120min11880304-188030457.79358.321.3758.5059.011.37
21887892-188789258.02658.71
31865096-186509657.32557.99
41908166-190816658.64959.34
51903782-190378258.51459.19
61939257-193925759.60560.31
180min12300958-230095870.72270.311.4071.7271.291.40
22300504-230050470.70871.68
32265735-226573569.63970.59
42282464-228246470.15371.14
52242096-224209668.91369.88
62334371-233437171.74972.75
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12662199-266219981.82581.010.9983.1782.340.98
22667062-266706281.97483.30
32623109-262310980.62481.93
42611253-261125380.25981.60
52606603-260660380.11681.43
62643710-264371081.25782.62
360min13201514-320151498.40198.081.34100.1699.821.33
23204434-320443498.491100.23
33212842-321284298.749100.46
43138529-313852996.46598.20
53141800-314180096.56698.28
63247246-324724699.807101.57
480min13606836-3606836110.859109.471.05113.11111.701.04
23598825-3598825110.613112.84
33547230-3547230109.027111.23
43519877-3519877108.186110.41
53524378-3524378108.325110.52
63572737-3572737109.811112.07
600min13737139-3737139114.864115.620.62117.67118.390.61
23790402-3790402116.501119.28
33775812-3775812116.053118.80
43749508-3749508115.244118.01
53738049-3738049114.892117.63
63779239-3779239116.158118.97
720min13859400-3859400118.622118.810.91122.00122.160.90
23882471-3882471119.331122.70
33903097-3903097119.965123.29
43836837-3836837117.928121.27
53814798-3814798117.251120.56
63896906-3896906119.775123.17
极限13856690-3856690118.539119.650.76122.51123.600.74
23897276-3897276119.786123.75
33909263-3909263120.155124.08
43867572-3867572118.873122.80
53888931-3888931119.530123.43
63937723-3937723121.029125.02
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