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%
110.283057916305601330567543058788305520330569350.05
210.253055876305538030556280.02
单位质量响应值RSD%判断
297367.22298110.050.18数据可信
供试品溶液-25110901批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1122289-1222894.09129.4850.144.0929.4850.15
21019207-101920734.09534.09
31300614-130061443.50843.51
41062404-106240435.54035.54
51185549-118554939.65939.66
6598185-59818520.01120.01
10min12267916-226791675.86769.5215.9775.8769.5615.97
21976709-197670966.12566.18
32281515-228151576.32276.39
41987337-198733766.48166.53
52443543-244354381.74281.80
61511572-151157250.56550.60
15min12867196-286719695.91486.0512.6596.0386.1912.64
22466599-246659982.51382.66
32643818-264381888.44288.62
42604946-260494687.14187.29
52861819-286181995.73495.92
61988847-198884766.53166.64
20min13011028-3011028100.72694.609.14100.9994.889.14
22937071-293707198.25298.53
32822316-282231694.41394.73
42913111-291311197.45097.73
52967791-296779199.27999.60
62316937-231693777.50777.71
30min13039496-3039496101.67899.563.19102.0999.983.22
23037635-3037635101.616102.04
32983468-298346899.804100.26
42993644-2993644100.144100.57
53014840-3014840100.853101.33
62788338-278833893.27693.60
45min13039158-3039158101.667100.930.86102.23101.500.83
23041727-3041727101.752102.33
32985693-298569399.878100.48
42989583-2989583100.008100.59
53008815-3008815100.652101.28
63037566-3037566101.613102.08
60min13031454-3031454101.409100.921.07102.13101.641.02
23038482-3038482101.644102.37
32980856-298085699.716100.47
42983947-298394799.820100.55
53005161-3005161100.529101.31
63061126-3061126102.401103.02
极限13036027-3036027101.562101.091.72102.43101.961.66
23026427-3026427101.241102.12
32974610-297461099.507100.41
42980939-298093999.719100.60
52997372-2997372100.269101.20
63115478-3115478104.220104.99
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%
110.283059129305382930517973056170305475530551360.09
210.253050485305729430538900.16
单位质量响应值RSD%判断
297192.22297940.490.18数据可信
供试品溶液-25110902批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1777096-77709626.01128.3019.9026.0128.3019.90
2995746-99574633.32933.33
3548727-54872718.36718.37
4914781-91478130.61930.62
5844559-84455928.26928.27
6991582-99158233.19033.19
10min12224971-222497174.47364.9512.3374.5164.9912.32
21990138-199013866.61366.66
31644109-164410955.03155.06
42027403-202740367.86067.91
52100606-210060670.31170.35
61655193-165519355.40255.45
15min12745662-274566291.90287.169.2692.0587.309.26
22834984-283498494.89195.04
32241446-224144675.02575.13
42835045-283504594.89395.04
52443104-244310481.77581.92
62523777-252377784.47584.61
20min12947870-294787098.67097.842.5698.9698.112.58
23024708-3024708101.242101.53
32841019-284101995.09395.32
42981408-298140899.792100.08
52843517-284351795.17795.45
62899361-289936197.04697.31
30min13014217-3014217100.891100.561.02101.33100.981.04
23036402-3036402101.633102.08
32949323-294932398.71899.08
42992439-2992439100.162100.60
53014612-3014612100.904101.32
63018918-3018918101.048101.45
45min13015313-3015313100.927100.350.93101.52100.920.95
23023048-3023048101.186101.78
32947531-294753198.65999.17
42985386-298538699.926100.52
53006708-3006708100.639101.20
63010910-3010910100.780101.34
60min13006566-3006566100.635100.141.00101.37100.861.02
23021685-3021685101.141101.89
32938132-293813298.34499.01
42978891-297889199.708100.45
53006354-3006354100.627101.34
62999934-2999934100.413101.12
极限13002681-3002681100.504100.001.04101.39100.871.06
23018430-3018430101.032101.93
32932549-293254998.15798.97
42971053-297105399.446100.34
52998952-2998952100.380101.25
63001793-3001793100.475101.33
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