塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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%
19.542826739282625528268712826461282340828259470.06
29.542828841282764828282440.03
单位质量响应值RSD%判断
296220.86296461.640.06数据可信
供试品溶液-2023010811批-pH1.0(内含%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1290404-2904049.76010.373.539.7610.373.53
2311651-31165110.47510.47
3321587-32158710.80910.81
4301916-30191610.14710.15
5312367-31236710.49910.50
6313339-31333910.53110.53
10min1781208-78120826.25627.082.8326.3127.142.82
2814756-81475627.38427.44
3836919-83691928.12928.18
4794977-79497726.71926.77
5823482-82348227.67727.73
6783344-78334426.32826.38
15min11237985-123798541.60943.392.7941.7943.582.79
21308360-130836043.97444.16
31339296-133929645.01445.21
41273258-127325842.79442.98
51312238-131223844.10444.30
61274642-127464242.84143.02
20min11651472-165147255.50656.132.0055.8956.532.01
21666318-166631856.00556.41
31720661-172066157.83158.25
41638441-163844155.06855.47
51700063-170006357.13957.55
61642641-164264155.20955.61
30min12177007-217700773.16973.701.4673.8374.381.47
22170152-217015272.93973.63
32235914-223591475.14975.86
42161353-216135372.64373.32
52230105-223010574.95475.65
62181897-218189773.33374.01
45min12639796-263979688.72388.940.9489.7590.000.95
22646378-264637888.94590.00
32664272-266427289.54690.63
42604665-260466587.54388.58
52677127-267712789.97891.05
62645777-264577788.92489.97
60min12796036-279603693.97593.880.6495.4595.370.63
22788080-278808093.70795.21
32776165-277616593.30794.84
42771774-277177493.15994.63
52814082-281408294.58196.10
62812305-281230594.52196.01
极限12860302-286030296.13496.230.5698.0898.200.55
22853150-285315095.89497.86
32847861-284786195.71697.72
42852216-285221695.86397.80
52877961-287796196.72898.72
62887686-288768697.05599.01
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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%
19.542826499282822228229152822898282335428247780.09
29.542824392282142628229090.08
单位质量响应值RSD%判断
296098.32295902.410.05数据可信
供试品溶液-2023010811批-pH1.0(内含%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1300948-30094810.12610.624.5710.1310.624.56
2316137-31613710.63810.64
3332015-33201511.17211.17
4302247-30224710.17010.17
5333672-33367211.22811.23
6308714-30871410.38810.39
10min1791690-79169026.63927.343.0626.6927.393.06
2821163-82116327.63127.68
3801061-80106126.95527.01
4783191-78319126.35326.40
5829548-82954827.91327.97
6848502-84850228.55128.60
15min11275524-127552442.92043.562.0343.1043.752.04
21308762-130876244.03844.23
31298384-129838443.68943.88
41259218-125921842.37142.55
51334445-133444544.90245.10
61291113-129111343.44443.64
20min11667535-166753556.11056.330.8656.5156.740.87
21687084-168708456.76857.18
31673467-167346756.31056.72
41654250-165425055.66356.06
51693816-169381656.99557.41
61668498-166849856.14356.55
30min12180560-218056073.37374.090.6974.0574.780.70
22204782-220478274.18874.88
32216957-221695774.59875.29
42186642-218664273.57774.25
52216177-221617774.57175.28
62206285-220628574.23874.93
45min12635574-263557488.68389.210.5389.7390.260.53
22641440-264144088.88189.95
32673844-267384489.97191.03
42646616-264661689.05590.10
52660923-266092389.53690.61
62648230-264823089.10990.17
60min12794443-279444394.02994.350.3795.5295.850.37
22790905-279090593.91095.42
32818089-281808994.82596.34
42809049-280904994.52196.01
52809071-280907194.52196.05
62801449-280144994.26595.77
极限12856313-285631396.11196.570.7298.0798.540.71
22854551-285455196.05298.03
32903715-290371597.70699.69
42874581-287458196.72698.68
52849734-284973495.89097.89
62880508-288050896.92598.91
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