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%
19.402812614281144528086502815118281214628119950.09
29.332822514282614728243300.10
单位质量响应值RSD%判断
299148.40302714.900.84数据可信
供试品溶液-23003N1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1288764-2887649.5589.476.129.569.486.14
2295076-2950769.7679.77
3262884-2628848.7018.70
4283082-2830829.3709.37
5313462-31346210.37510.38
6273908-2739089.0669.07
10min1788084-78808426.08425.316.4226.1025.326.42
2770198-77019825.49225.51
3707520-70752023.41823.43
4747699-74769924.74824.76
5845760-84576027.99328.01
6728354-72835424.10724.12
15min11246630-124663041.26140.385.2441.3140.445.25
21214847-121484740.20940.26
31144911-114491137.89537.94
41201207-120120739.75839.81
51330861-133086144.04944.11
61182298-118229839.13239.18
20min11627900-162790053.88153.314.2954.0053.424.29
21591032-159103252.66152.77
31539281-153928150.94851.05
41589018-158901852.59452.70
51738913-173891357.55557.68
61577350-157735052.20852.32
30min12173308-217330871.93371.532.7972.1371.722.80
22134759-213475970.65770.85
32100618-210061869.52769.71
42128251-212825170.44270.63
52273088-227308875.23675.45
62155932-215593271.35871.54
45min12593964-259396485.85685.581.4886.1685.881.49
22584837-258483785.55485.85
32536094-253609483.94184.23
42556702-255670284.62384.92
52647618-264761887.63287.95
62594123-259412385.86186.16
60min12738936-273893690.65490.781.0791.0991.201.07
22750019-275001991.02191.45
32715885-271588589.89190.30
42704472-270447289.51489.94
52781481-278148192.06392.52
62764799-276479991.51091.93
极限12825245-282524593.51193.440.9194.0894.000.92
22813350-281335093.11793.68
32804893-280489392.83793.38
42790033-279003392.34692.90
52852997-285299794.43095.02
62852064-285206494.39994.96
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%
19.402822442282223028247572823402282205128229760.04
29.332809675281328728114810.10
单位质量响应值RSD%判断
300316.60301337.730.25数据可信
供试品溶液-23003N1批-pH4.5(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1333754-33375411.05011.054.4511.0511.054.44
2336875-33687511.15411.15
3336756-33675611.15011.15
4352521-35252111.67211.67
5335663-33566311.11311.11
6306816-30681610.15810.16
10min1851942-85194228.20727.522.8228.2227.542.81
2808687-80868726.77526.79
3835438-83543827.66027.68
4845875-84587528.00628.02
5849083-84908328.11228.13
6795943-79594326.35326.37
15min11328486-132848643.98542.443.5144.0442.503.50
21224193-122419340.53240.59
31288625-128862542.66542.72
41299430-129943043.02343.08
51320846-132084643.73243.79
61229611-122961140.71140.77
20min11695325-169532556.13054.982.1056.2655.102.10
21598520-159852052.92553.04
31675591-167559155.47755.60
41677222-167722255.53155.65
51673795-167379555.41755.54
61643284-164328454.40754.52
30min12238070-223807074.10073.002.6374.3173.212.63
22145584-214558471.03871.23
32277978-227797875.42175.63
42250062-225006274.49774.70
52175494-217549472.02872.24
62142334-214233470.93071.13
45min12673136-267313688.50487.461.1588.8287.771.14
22651078-265107887.77488.08
32654835-265483587.89888.22
42662267-266226788.14488.46
52608394-260839486.36186.68
62599764-259976486.07586.38
60min12832482-283248293.78092.231.0094.2392.671.00
22783091-278309192.14592.58
32798679-279867992.66193.11
42779846-277984692.03792.49
52754540-275454091.20091.64
62764787-276478791.53991.97
极限12966443-296644398.21595.061.6498.8195.641.64
22849820-284982094.35494.93
32855655-285565594.54795.14
42858112-285811294.62995.22
52852933-285293394.45795.04
62843160-284316094.13494.70
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%
19.402807851281180728108192811806280644828097460.09
29.332816976281553828162570.04
单位质量响应值RSD%判断
298909.15301849.620.70数据可信
供试品溶液-23003N1批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1366908-36690812.16611.922.8112.1711.922.82
2371751-37175112.32712.33
3346862-34686211.50211.50
4361607-36160711.99011.99
5361866-36186611.99912.00
6347947-34794711.53811.54
10min1893394-89339429.62429.011.9729.6429.021.97
2875921-87592129.04529.06
3856381-85638128.39728.41
4867517-86751728.76628.78
5896750-89675029.73529.75
6858687-85868728.47328.49
15min11342248-134224844.50744.521.4444.5744.581.44
21339829-133982944.42744.49
31330262-133026244.11044.17
41324521-132452143.92043.98
51379363-137936345.73845.80
61338842-133884244.39444.45
20min11719181-171918157.00657.471.2157.1457.591.21
21729741-172974157.35657.48
31725841-172584157.22757.35
41709244-170924456.67756.80
51767160-176716058.59758.73
61747161-174716157.93458.06
30min12264720-226472075.09675.931.0375.3176.141.03
22288416-228841675.88176.10
32290639-229063975.95576.17
42264575-226457575.09175.30
52324241-232424177.06977.29
62306727-230672776.48876.70
45min12664438-266443888.35089.701.0388.6890.031.03
22703202-270320289.63589.96
32706905-270690589.75890.08
42686469-268646989.08089.40
52730073-273007390.52690.86
62739905-273990590.85291.18
60min12793543-279354392.63193.980.9693.0994.440.96
22829943-282994393.83894.30
32838201-283820194.11294.57
42821980-282198093.57494.03
52846548-284654894.38894.86
62874894-287489495.32895.79
极限12851551-285155194.55495.640.8995.1596.240.88
22881065-288106595.53396.14
32879886-287988695.49496.10
42882459-288245995.57996.18
52880637-288063795.51996.13
62930271-293027197.16497.77
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