塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.083042817304480330414763043045304280530429890.04
210.093032690303432130335060.04
单位质量响应值RSD%判断
301883.83300644.800.30数据可信
供试品溶液-20211227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%
5min1724002-72400223.93632.9419.2923.9432.9419.29
21312024-131202443.37743.38
31061314-106131435.08835.09
4997880-99788032.99132.99
5924129-92412930.55230.55
6958889-95888931.70231.70
10min11555076-155507651.41252.8612.1751.4652.9212.18
21892393-189239362.56462.65
31786633-178663359.06859.14
41488405-148840549.20849.27
51428690-142869047.23447.29
61441650-144165047.66247.73
15min11882707-188270762.24461.968.7362.3962.138.74
22131846-213184670.48170.69
31995848-199584865.98466.17
41713323-171332356.64456.81
51779034-177903458.81658.97
61741994-174199457.59257.75
20min12154701-215470171.23670.306.5671.5170.596.57
22300411-230041176.05376.41
32222527-222252773.47973.80
41916333-191633363.35663.63
52147418-214741870.99571.27
62016270-201627066.66066.93
30min12576777-257677785.19082.104.5585.6182.534.56
22572971-257297185.06585.57
32563969-256396984.76785.23
42304809-230480976.19976.60
52490142-249014282.32682.74
62390938-239093879.04679.45
45min12743488-274348890.70287.383.7091.2987.983.71
22718831-271883189.88790.56
32718015-271801589.86090.50
42513713-251371383.10583.66
52613325-261332586.39986.98
62550370-255037084.31784.88
60min12783684-278368492.03190.192.9892.8090.973.01
22814717-281471793.05793.91
32802206-280220692.64393.46
42635524-263552487.13387.86
52684721-268472188.75989.51
62647520-264752087.52988.26
极限12976914-297691498.41998.251.4399.3799.201.36
22917205-291720596.44597.49
32926095-292609596.73997.74
43025185-3025185100.015100.91
53000151-300015199.187100.12
62984923-298492398.68499.59
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.083076212307399530796283079181308106830780170.10
210.093034659303595530353070.04
单位质量响应值RSD%判断
305358.83300823.291.06数据可信
供试品溶液-20211228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%
5min1842846-84284627.69927.249.2727.7027.249.27
2940894-94089430.92130.92
3776032-77603225.50325.50
4714473-71447323.48023.48
5845849-84584927.79727.80
6852680-85268028.02228.02
10min11382215-138221545.42448.776.5945.4848.826.58
21568196-156819651.53651.60
31549369-154936950.91750.97
41532159-153215950.35250.40
51338450-133845043.98644.04
61533703-153370350.40250.46
15min11635727-163572753.75559.877.6553.9060.027.64
21912063-191206362.83763.00
31922482-192248263.17963.33
41931273-193127363.46863.62
51651699-165169954.28054.42
61878190-187819061.72361.88
20min11899602-189960262.42770.506.5662.6870.776.55
22178341-217834171.58771.88
32199435-219943572.28172.56
42213108-221310872.73073.00
52077317-207731768.26768.52
62303794-230379475.71075.99
30min12392353-239235378.62080.342.5279.0080.752.51
22359606-235960677.54477.98
32425565-242556579.71280.14
42493591-249359181.94882.37
52483420-248342081.61382.00
62513360-251336082.59783.03
45min12573472-257347284.57385.142.4485.1185.712.42
22477104-247710481.40681.99
32620224-262022486.10986.69
42648461-264846187.03787.62
52640178-264017886.76587.32
62584780-258478084.94485.54
60min12647422-264742287.00387.132.5987.7187.872.56
22540371-254037183.48584.24
32654732-265473287.24388.00
42730137-273013789.72190.48
52714250-271425089.19989.92
62620671-262067186.12486.89
极限12907512-290751295.55094.573.0296.4395.483.00
22714026-271402689.19290.11
32893091-289309195.07696.01
42974980-297498097.76898.70
52896249-289624995.18096.08
62879817-287981794.64095.58
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