塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.542828694283156828287942829271283201628300690.06
29.542823215282322128232180.01
单位质量响应值RSD%判断
296652.94295934.800.18数据可信
供试品溶液-2023010811批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1285199-2851999.5879.5013.069.599.5013.06
2317817-31781710.68410.68
3275028-2750289.2459.25
4244042-2440428.2048.20
5242578-2425788.1548.15
6331814-33181411.15411.15
10min1783214-78321426.32826.128.7226.3526.148.72
2828103-82810327.83727.86
3773203-77320325.99126.01
4703609-70360923.65223.67
5701211-70121123.57123.59
6872464-87246429.32829.35
15min11248451-124845141.96741.836.3942.0441.906.39
21302600-130260043.78743.86
31247936-124793641.95042.02
41151237-115123738.69938.76
51160247-116024739.00239.07
61355615-135561545.56945.65
20min11638810-163881055.08955.045.1255.2455.205.13
21698345-169834557.09057.26
31637471-163747155.04455.20
41539180-153918051.74051.88
51552478-155247852.18752.33
61757655-175765559.08459.26
30min12189632-218963273.60573.133.2473.8773.403.26
22233078-223307875.06675.34
32177316-217731673.19173.46
42079613-207961369.90770.15
52109913-210991370.92571.17
62263876-226387676.10176.39
45min12650777-265077789.10787.591.9889.5288.011.99
22636599-263659988.63089.06
32578282-257828286.67087.08
42524246-252424684.85385.24
52588055-258805586.99887.39
62656844-265684489.31189.75
60min12795789-279578993.98192.921.3894.5793.511.39
22786188-278618893.65994.26
32734281-273428191.91492.50
42704478-270447890.91291.47
52765335-276533592.95893.52
62800041-280004194.12494.75
极限12860520-286052096.15795.491.1296.9496.261.13
22849908-284990895.80196.59
32806070-280607094.32795.09
42798351-279835194.06794.80
52850551-285055195.82296.57
62878466-287846696.76197.57
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.542820686282253028224832821366282069428215520.04
29.542808412281022328093180.05
单位质量响应值RSD%判断
295760.17294477.780.31数据可信
供试品溶液-2023010811批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1282097-2820979.52110.1710.279.5210.1710.27
2324373-32437310.94710.95
3252717-2527178.5298.53
4295086-2950869.9599.96
5316598-31659810.68510.68
6336688-33668811.36311.36
10min1750475-75047525.32827.328.6925.3527.348.69
2855307-85530728.86628.89
3712886-71288624.05924.08
4793573-79357326.78326.80
5843164-84316428.45628.48
6901164-90116430.41430.44
15min11245723-124572342.04243.597.0342.1143.677.04
21355321-135532145.74145.82
31152858-115285838.90838.97
41252854-125285442.28342.36
51344306-134430645.36945.45
61398954-139895447.21447.30
20min11655765-165576555.88157.295.0856.0357.455.09
21767950-176795059.66759.84
31575897-157589753.18553.33
41641628-164162855.40455.56
51744537-174453758.87759.05
61798963-179896360.71460.89
30min12184866-218486673.73874.913.8374.0075.183.84
22281233-228123376.99077.28
32125041-212504171.71971.97
42133610-213361072.00872.28
52257156-225715676.17776.46
62335186-233518678.81179.11
45min12636649-263664988.98589.291.6289.4089.721.64
22688636-268863690.73991.18
32594272-259427287.55587.95
42600832-260083287.77688.19
52659475-265947589.75590.19
62694740-269474090.94591.40
60min12747924-274792492.74094.211.0893.3394.811.09
22823509-282350995.29195.92
32797257-279725794.40594.97
42761236-276123693.19093.78
52808429-280842994.78295.40
62810164-281016494.84195.48
极限12878541-287854197.14997.050.5697.9397.850.56
22890376-289037697.54898.36
32883688-288368897.32298.08
42845271-284527196.02696.80
52881840-288184097.26098.07
62874702-287470297.01997.85
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