塞来昔布片项目信息
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%
110.223055696306128430700643085264310593130756480.66
210.233024750302157730231640.08
单位质量响应值RSD%判断
300944.03295519.451.29数据可信
供试品溶液-24123101批-pH6.8(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%
5min1321722-32172210.7459.995.5110.759.995.51
2296834-2968349.9149.91
3300553-30055310.03810.04
4312728-31272810.44510.44
5279513-2795139.3369.34
6282715-2827159.4439.44
10min1856635-85663528.61126.814.9728.6326.824.98
2792153-79215326.45826.47
3774760-77476025.87725.89
4847631-84763128.31128.33
5760678-76067825.40625.42
6783920-78392026.18326.20
15min11358788-135878845.38342.734.7445.4442.784.74
21277366-127736642.66442.72
31230618-123061841.10241.16
41344525-134452544.90744.96
51209785-120978540.40640.46
61254824-125482441.91141.96
20min11754046-175404658.58456.023.8358.7156.143.83
21683414-168341456.22556.34
31624142-162414254.24654.36
41749622-174962258.43758.56
51599649-159964953.42853.54
61653279-165327955.21955.34
30min12243666-224366674.93873.232.4575.1573.432.45
22219616-221961674.13474.34
32115935-211593570.67170.87
42247687-224768775.07275.29
52149063-214906371.77871.97
62178946-217894672.77672.98
45min12560054-256005485.50584.601.4785.8384.911.48
22584438-258443886.31986.63
32484634-248463482.98683.29
42547295-254729585.07985.40
52511750-251175083.89184.19
62509540-250954083.81884.13
60min12693854-269385489.97489.441.0890.4389.881.08
22727301-272730191.09191.53
32660041-266004188.84489.27
42669243-266924389.15289.61
52646537-264653788.39388.82
62669371-266937189.15689.59
极限12816772-281677294.07993.140.7794.6793.710.78
22814629-281462994.00894.59
32778238-277823892.79293.35
42778747-277874792.80993.40
52774752-277475292.67693.23
62768209-276820992.45793.02
塞来昔布片项目信息
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%
110.223046723304850630454803053562304296430474470.14
210.233044348304619430452710.05
单位质量响应值RSD%判断
298184.64297680.450.12数据可信
供试品溶液-24123102批-pH6.8(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%
5min1323789-32378910.8249.826.1610.829.826.15
2303584-30358410.14910.15
3286605-2866059.5819.58
4295828-2958289.8909.89
5276599-2765999.2479.25
6276726-2767269.2519.25
10min1863811-86381128.87825.966.8228.8925.976.81
2815932-81593227.27727.29
3736978-73697824.63724.65
4768375-76837525.68725.70
5733146-73314624.50924.52
6740478-74047824.75424.77
15min11297279-129727943.36940.664.8243.4340.714.82
21280532-128053242.80942.86
31167451-116745139.02839.08
41194052-119405239.91839.97
51158994-115899438.74638.80
61198664-119866440.07240.12
20min11713053-171305357.26853.784.6157.3953.894.61
21680944-168094456.19556.31
31539511-153951151.46651.58
41564403-156440352.29952.41
51541025-154102551.51751.63
61612873-161287353.91954.03
30min12275147-227514776.05972.782.7376.2772.982.74
22214724-221472474.03974.24
32132214-213221471.28171.47
42138623-213862371.49571.69
52121226-212122670.91371.10
62180680-218068072.90173.09
45min12620674-262067487.61086.980.7887.9387.280.79
22628526-262852687.87388.19
32587616-258761686.50586.80
42582597-258259786.33786.64
52582727-258272786.34286.63
62608534-260853487.20487.51
60min12726738-272673891.15691.570.5991.6192.000.59
22763707-276370792.39292.84
32734164-273416491.40491.83
42730022-273002291.26691.69
52725546-272554691.11691.54
62753961-275396192.06692.50
极限12805545-280554593.79194.300.3894.3894.870.38
22834484-283448494.75895.34
32824319-282431994.41894.98
42825567-282556794.46095.03
52811277-281127793.98294.54
62823739-282373994.39994.97
塞来昔布片项目信息
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%
110.223058822306047930610713063248305996430607170.06
210.233045282304317530442280.05
单位质量响应值RSD%判断
299483.07297578.490.46数据可信
供试品溶液-25010201批-pH6.8(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%
5min1351683-35168311.73311.936.4711.7311.936.45
2345891-34589111.54011.54
3403272-40327213.45513.45
4358127-35812711.94811.95
5344963-34496311.50911.51
6341702-34170211.40011.40
10min1937194-93719431.26831.205.2331.2931.225.23
2906705-90670530.25130.27
31027457-102745734.28034.30
4936444-93644431.24331.26
5916474-91647430.57730.59
6887454-88745429.60929.63
15min11456637-145663748.59948.313.6048.6648.383.60
21410662-141066247.06547.13
31545846-154584651.57551.65
41435900-143590047.90747.97
51438342-143834247.98848.05
61400435-140043546.72446.79
20min11863298-186329862.16762.152.2462.3062.292.24
21827465-182746560.97161.10
31942489-194248964.80964.96
41846687-184668761.61261.75
51862311-186231162.13462.27
61834841-183484161.21761.35
30min12428311-242831181.01880.641.3481.2580.871.35
22378430-237843079.35379.58
32471185-247118582.44882.69
42398511-239851180.02380.25
52425455-242545580.92281.15
62400607-240060780.09380.32
45min12801796-280179693.47893.040.8893.8393.390.89
22770208-277020892.42492.77
32832167-283216794.49294.86
42767347-276734792.32992.68
52781031-278103192.78693.14
62779334-277933492.72993.07
60min12899715-289971596.74597.210.5997.2497.700.60
22918018-291801897.35697.84
32943017-294301798.19098.70
42900547-290054796.77397.26
52900112-290011296.75997.25
62920235-292023597.43097.91
极限12956947-295694798.65598.900.5399.2999.540.54
22974405-297440599.23799.87
32986565-298656599.643100.30
42954227-295422798.56499.20
52943447-294344798.20498.84
62970505-297050599.10799.74
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