氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221505401150511115053421505631150407115051110.05
211.151502963150241515026890.03
单位质量响应值RSD%判断
134145.37134770.310.33数据可信
供试品溶液-2024041521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%
60min117239-172391.1841.2711.411.181.2711.56
220932-209321.4381.44
320464-204641.4061.41
415717-157171.0801.08
517032-170321.1701.17
619464-194641.3371.34
120min150369-503693.4603.467.293.463.467.31
255519-555193.8143.82
353409-534093.6693.67
449775-497753.4193.42
547914-479143.2923.29
645348-453483.1153.12
240min1118629-1186298.1497.785.048.167.785.04
2116835-1168358.0268.03
3117008-1170088.0388.05
4113061-1130617.7677.77
5103376-1033767.1027.11
6110186-1101867.5697.58
360min1184093-18409312.64612.174.7212.6712.184.70
2179657-17965712.34212.36
3172840-17284011.87311.89
4166347-16634711.42711.45
5171317-17131711.76911.79
6188289-18828912.93512.95
480min1237274-23727416.30015.364.9816.3415.404.98
2236840-23684016.27016.31
3220838-22083815.17115.21
4220628-22062815.15615.19
5210411-21041114.45414.49
6215504-21550414.80414.84
600min1287835-28783519.77317.939.4319.8417.999.42
2271295-27129518.63718.70
3267724-26772418.39218.45
4230464-23046415.83215.89
5230533-23053315.83715.89
6278126-27812619.10619.17
720min1319825-31982521.97121.283.7022.0621.363.70
2319663-31966321.96022.05
3293822-29382220.18420.27
4313200-31320021.51621.60
5296980-29698020.40120.48
6314802-31480221.62621.71
840min1354345-35434524.34223.413.7724.4723.533.76
2328124-32812422.54122.66
3348114-34811423.91424.03
4339598-33959823.32923.44
5323101-32310122.19622.31
6351277-35127724.13124.25
960min1388188-38818826.66725.682.8526.8325.842.86
2371460-37146025.51825.68
3366857-36685725.20225.36
4370525-37052525.45425.60
5360766-36076624.78324.93
6385016-38501626.44926.61
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min1407535-40753527.99626.743.3528.2026.943.36
2388813-38881326.71026.91
3386882-38688226.57726.77
4379285-37928526.05526.24
5372484-37248425.58825.77
6400616-40061627.52127.72
1200min1416474-41647428.61027.992.7328.8528.222.73
2407964-40796428.02628.26
3401552-40155227.58527.82
4408780-40878028.08228.31
5389198-38919826.73626.96
6420359-42035928.87729.11
1320min1432874-43287429.73728.972.6330.0229.252.64
2423534-42353429.09529.37
3420618-42061828.89529.17
4414909-41490928.50328.77
5404753-40475327.80528.06
6433961-43396129.81130.09
1440min1444207-44420730.51529.772.9530.8530.092.95
2429672-42967229.51729.84
3434799-43479929.86930.19
4427163-42716329.34429.66
5414379-41437928.46628.77
6450181-45018130.92631.25
1560min1455048-45504831.26030.812.4531.6431.172.46
2448793-44879330.83031.20
3451152-45115230.99231.35
4439190-43919030.17130.53
5433016-43301629.74730.09
6463539-46353931.84332.22
1680min1469483-46948332.25231.662.7032.6832.072.70
2457147-45714731.40431.82
3458701-45870131.51131.92
4465527-46552731.98032.38
5439288-43928830.17730.57
6474669-47466932.60833.03
1800min1468574-46857432.18932.161.7232.6632.621.72
2475724-47572432.68033.14
3466168-46616832.02432.48
4473080-47308032.49932.95
5453317-45331731.14131.58
6472124-47212432.43332.90
1920min1490505-49050533.69632.892.7734.2233.402.77
2480034-48003432.97633.48
3469626-46962632.26232.76
4468450-46845032.18132.68
5465926-46592632.00732.49
6498278-49827834.23034.75
2040min1498552-49855234.24934.142.1534.8234.702.12
2492277-49227733.81834.38
3482973-48297333.17833.73
4490106-49010633.66834.21
5510656-51065635.08035.61
6507696-50769634.87735.45
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2160min1512744-51274435.22435.022.9535.8535.622.89
2499010-49901034.28034.89
3497238-49723834.15834.76
4495969-49596934.07134.67
5532817-53281736.60237.18
6520761-52076135.77436.40
极限1504112-50411234.63136.182.9335.3136.832.87
2538079-53807936.96437.62
3517636-51763635.56036.21
4518323-51832335.60736.25
5540710-54071037.14537.78
6540815-54081537.15237.83
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