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%
110.042988343298795529856322984234298582529863980.06
210.142985234298761929864260.06
单位质量响应值RSD%判断
297450.00294519.330.71数据可信
供试品溶液-2023011111批-pH4.5(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%
5min1282640-2826409.5119.703.439.519.703.45
2302116-30211610.16710.17
3279402-2794029.4029.40
4288357-2883579.7049.70
5278512-2785129.3729.37
6297712-29771210.01810.02
10min1692569-69256923.30624.292.4123.3224.312.42
2744115-74411525.04025.06
3720413-72041324.24324.26
4717275-71727524.13724.15
5723857-72385724.35924.37
6733255-73325524.67524.69
15min11093078-109307836.78338.192.0036.8338.242.00
21147941-114794138.63038.68
31125041-112504137.85937.91
41142864-114286438.45938.51
51152919-115291938.79738.85
61147419-114741938.61238.66
20min11443720-144372048.58350.172.1248.6950.282.12
21501591-150159150.53050.64
31458544-145854449.08249.19
41514219-151421950.95551.06
51513787-151378750.94151.05
61514012-151401250.94851.06
30min11997813-199781367.22968.841.8167.4169.031.81
22035928-203592868.51168.70
32009140-200914067.61067.79
42085076-208507670.16570.35
52077322-207732269.90470.09
62069257-206925769.63369.82
45min12501064-250106484.16485.691.2384.4485.981.24
22522293-252229384.87885.17
32536065-253606585.34285.62
42574790-257479086.64586.93
52568024-256802486.41786.71
62575978-257597886.68586.98
60min12747242-274724292.44893.100.7592.8593.520.75
22747446-274744692.45592.87
32751183-275118392.58192.99
42775580-277558093.40293.82
52789933-278993393.88594.30
62789034-278903493.85494.28
极限12845897-284589795.76896.150.4796.3196.700.48
22840469-284046995.58596.14
32858643-285864396.19796.75
42853504-285350496.02496.58
52874134-287413496.71897.28
62871007-287100796.61397.17
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%
110.042979164299388129854832977656298126429834900.22
210.142993560299162029925900.05
单位质量响应值RSD%判断
297160.36295127.220.49数据可信
供试品溶液-2批-pH4.5(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%
5min1255585-2555858.5969.084.328.609.084.32
2288313-2883139.6979.70
3269969-2699699.0809.08
4268922-2689229.0459.04
5260166-2601668.7508.75
6276024-2760249.2839.28
10min1679466-67946622.85223.813.6422.8723.823.63
2739171-73917124.86024.87
3729009-72900924.51924.53
4704058-70405823.67923.69
5677284-67728422.77922.79
6719001-71900124.18224.20
15min11084985-108498536.49137.673.1136.5437.723.11
21150799-115079938.70438.76
31149377-114937738.65738.71
41099329-109932936.97337.02
51081995-108199536.39036.44
61153625-115362538.80038.85
20min11458793-145879349.06349.972.7849.1750.082.78
21522889-152288951.21951.33
31516216-151621650.99451.10
41454748-145474848.92749.03
51434092-143409248.23248.33
61528321-152832151.40251.51
30min12037709-203770968.53468.262.1668.7168.442.16
22084589-208458970.11070.30
32054537-205453769.10069.28
41997807-199780767.19267.37
51961053-196105365.95666.13
62042447-204244768.69368.88
45min12523162-252316284.86184.181.3085.1484.461.30
22514585-251458584.57284.86
32530245-253024585.09985.39
42484918-248491883.57583.85
52444720-244472082.22382.50
62519086-251908684.72485.01
60min12744955-274495592.32091.201.1392.7391.611.13
22682869-268286990.23290.65
32750363-275036392.50292.92
42706302-270630291.02091.42
52677706-267770690.05990.45
62708380-270838091.09091.51
极限12851893-285189395.91794.950.9896.4695.490.98
22799504-279950494.15594.71
32863514-286351496.30896.86
42815724-281572494.70095.24
52804193-280419394.31394.84
62803354-280335494.28494.84
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