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%
110.133055133305390230562103053897305565130549590.04
210.083055209305517430551920.01
单位质量响应值RSD%判断
301575.42303094.440.36数据可信
供试品溶液-22001N1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%
5min1315370-31537010.38911.278.5610.3911.288.58
2340432-34043211.21511.22
3383584-38358412.63712.64
4330046-33004610.87310.87
5312764-31276410.30410.30
6371191-37119112.22812.23
10min1840714-84071427.69628.606.7127.7128.626.72
2841650-84165027.72727.74
3938714-93871430.92530.94
4831549-83154927.39427.41
5811530-81153026.73526.75
6945520-94552031.14931.17
15min11326637-132663743.70444.395.2543.7644.455.25
21298733-129873342.78542.84
31428275-142827547.05347.12
41293356-129335642.60842.67
51292079-129207942.56642.62
61445543-144554347.62247.69
20min11719981-171998156.66357.534.3156.7957.664.31
21685898-168589855.54055.66
31822674-182267460.04660.18
41690754-169075455.70055.82
51699464-169946455.98756.11
61859471-185947161.25861.39
30min12267142-226714274.68875.422.8374.9075.642.84
22227954-222795473.39773.60
32369333-236933378.05578.28
42239548-223954873.77973.98
52259721-225972174.44474.65
62372801-237280178.16978.40
45min12675155-267515588.13088.661.6988.4588.981.70
22645291-264529187.14687.46
32753053-275305390.69691.04
42658719-265871987.58887.90
52672194-267219488.03288.35
62742708-274270890.35590.70
60min12815121-281512192.74193.241.8893.1993.701.89
22774410-277441091.40091.85
32927036-292703696.42896.91
42802217-280221792.31692.76
52813290-281329092.68093.13
62849224-284922493.86494.35
极限12884922-288492295.04095.271.0095.6395.871.01
22846379-284637993.77194.35
32926713-292671396.41797.04
42882978-288297894.97695.56
52891345-289134595.25295.84
62919106-291910696.16696.79
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%
110.133056867305654430543023052890305367330548550.06
210.083068008306615630670820.05
单位质量响应值RSD%判断
301565.15304274.010.64数据可信
供试品溶液-22001N1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%
5min1353031-35303111.60811.782.2611.6111.782.25
2349884-34988411.50411.50
3367479-36747912.08312.08
4357592-35759211.75811.76
5352415-35241511.58811.59
6368632-36863212.12112.12
10min1884469-88446929.08229.051.4529.1029.071.45
2876454-87645428.81828.84
3882309-88230929.01129.03
4873693-87369328.72828.75
5875919-87591928.80128.82
6908169-90816929.86129.88
15min11353020-135302044.48844.451.6344.5544.511.64
21344073-134407344.19444.25
31342782-134278244.15244.21
41330688-133068843.75443.81
51346710-134671044.28144.34
61394200-139420045.84245.91
20min11748878-174887857.50457.491.4957.6357.621.49
21740429-174042957.22657.35
31725539-172553956.73756.86
41728529-172852956.83556.96
51751217-175121757.58157.71
61796997-179699759.08659.22
30min12317293-231729376.19475.641.1276.4175.861.11
22303944-230394475.75575.97
32256494-225649474.19574.41
42284895-228489575.12975.34
52321440-232144076.33176.54
62319270-231927076.25976.48
45min12750413-275041390.43589.590.7990.7689.920.79
22731362-273136289.80990.14
32692950-269295088.54688.87
42711328-271132889.15089.47
52743649-274364990.21390.54
62718983-271898389.40289.74
60min12881494-288149494.74594.060.5795.2194.520.57
22874138-287413894.50494.96
32837361-283736193.29493.75
42863630-286363094.15894.62
52858469-285846993.98894.45
62848450-284845093.65994.13
极限12924389-292438996.15695.720.4596.7696.320.44
22926928-292692896.23996.84
32909939-290993995.68196.28
42911787-291178795.74296.34
52897854-289785495.28395.89
62896089-289608995.22595.83
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%
110.133055002305565930574873054116305439830553320.05
210.083059346305786930586080.04
单位质量响应值RSD%判断
301612.24303433.330.43数据可信
供试品溶液-22001N1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%
5min1429203-42920314.13114.666.5714.1314.666.56
2423468-42346813.94213.94
3445546-44554614.66914.67
4444953-44495314.64914.65
5501577-50157716.51416.51
6426088-42608814.02814.03
10min1976912-97691232.16333.425.9532.1833.445.95
2980692-98069232.28832.31
31024468-102446833.72933.75
4996980-99698032.82432.85
51132547-113254737.28737.31
6978290-97829032.20932.23
15min11451895-145189547.80149.454.5447.8749.524.54
21463418-146341848.18148.25
31516698-151669849.93550.01
41484717-148471748.88248.95
51632542-163254253.74953.83
61461901-146190148.13148.20
20min11838567-183856760.53262.542.9760.6762.682.97
21886800-188680062.12062.26
31927647-192764763.46563.61
41879140-187914061.86862.01
51997805-199780565.77565.94
61866874-186687461.46461.61
30min12383643-238364378.47879.861.6278.7180.101.62
22424223-242422379.81480.05
32461232-246123281.03281.27
42421573-242157379.72779.96
52479127-247912781.62181.88
62383979-238397978.48978.72
45min12765893-276589391.06392.530.9591.4192.890.95
22799396-279939692.16692.52
32843444-284344493.61693.98
42809447-280944792.49792.85
52823314-282331492.95393.34
62821786-282178692.90393.25
60min12895194-289519495.32095.550.6395.8196.050.63
22907679-290767995.73196.22
32899055-289905595.44795.95
42915730-291573095.99696.49
52924012-292401296.26996.79
62872314-287231494.56695.06
极限12951294-295129497.16797.320.6397.8097.960.63
22981274-298127498.15498.79
32927742-292774296.39197.04
42953794-295379497.24997.89
52970711-297071197.80698.47
62950652-295065297.14697.78
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