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%
19.542844442284203928416632841598284073328420950.05
29.542877632284352128605760.85
单位质量响应值RSD%判断
297913.52299850.730.46数据可信
供试品溶液-2023010811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%
5min1280122-2801229.3359.9610.389.339.9610.40
2297976-2979769.9309.93
3329382-32938210.97610.98
4271443-2714439.0469.05
5343810-34381011.45711.46
6271361-2713619.0439.04
10min1717942-71794223.92525.247.6423.9425.267.65
2753309-75330925.10425.12
3804550-80455026.81126.83
4710026-71002623.66123.67
5849222-84922228.30028.32
6710019-71001923.66123.67
15min11136263-113626337.86539.536.5437.9239.586.54
21176379-117637939.20239.25
31226476-122647640.87240.93
41120425-112042537.33837.39
51323385-132338544.10144.16
61134261-113426137.79937.85
20min11504401-150440150.13351.755.9950.2451.866.00
21547345-154734551.56551.68
31587647-158764752.90853.03
41467630-146763048.90849.01
51721013-172101357.35257.48
61489258-148925849.62949.73
30min12071379-207137969.02870.234.3169.2170.424.32
22097897-209789769.91170.10
32116763-211676370.54070.74
42027897-202789767.57967.76
52280937-228093776.01176.22
62050245-205024568.32368.50
45min12566987-256698785.54485.731.7385.8386.021.74
22575718-257571885.83586.13
32558977-255897785.27785.58
42538065-253806584.58084.86
52657431-265743188.55888.88
62537833-253783384.57284.85
60min12722917-272291790.74090.610.8491.1591.030.84
22730884-273088491.00591.43
32680021-268002189.31089.74
42728622-272862290.93091.34
52744464-274446491.45891.92
62706432-270643290.19190.60
极限12807989-280798993.57593.300.8094.1293.860.80
22817272-281727293.88494.44
32758515-275851591.92692.49
42810646-281064693.66394.21
52813905-281390593.77294.37
62789998-278999892.97593.52
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%
19.542862993286316328656912865588286448528643840.05
29.542840458284156628410120.03
单位质量响应值RSD%判断
300249.90297800.000.58数据可信
供试品溶液-2023010811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%
5min1286535-2865359.5449.875.459.549.875.45
2286729-2867299.5519.55
3324556-32455610.81110.81
4286972-2869729.5599.56
5307558-30755810.24410.24
6286112-2861129.5309.53
10min1760198-76019825.32125.904.4725.3425.924.47
2742624-74262424.73624.75
3840776-84077628.00528.02
4768811-76881125.60825.62
5791190-79119026.35426.37
6761714-76171425.37225.39
15min11178667-117866739.26040.874.7639.3140.934.76
21182711-118271139.39539.45
31333928-133392844.43244.49
41217598-121759840.55740.61
51249359-124935941.61541.67
61200461-120046139.98640.04
20min11548896-154889651.59253.643.9051.7053.753.91
21560968-156096851.99452.10
31720955-172095557.32357.45
41614638-161463853.78253.90
51633124-163312454.39754.51
61583280-158328052.73752.85
30min12098593-209859369.90272.142.6370.0972.342.64
22125965-212596570.81371.00
32257508-225750875.19575.41
42177731-217773172.53872.73
52195025-219502573.11473.31
62139945-213994571.27971.47
45min12581176-258117685.97687.111.1386.2787.411.13
22591205-259120586.31086.60
32655158-265515888.44088.76
42626829-262682987.49787.80
52638403-263840387.88288.19
62597837-259783786.53186.83
60min12723500-272350090.71791.390.7591.1491.820.76
22723998-272399890.73391.16
32763388-276338892.04592.50
42767465-276746592.18192.62
52754798-275479891.75992.20
62728956-272895690.89891.33
极限12807522-280752293.51593.830.5194.0794.400.52
22807435-280743593.51294.07
32838799-283879994.55795.15
42812329-281232993.67594.25
52830520-283052094.28194.86
62804797-280479793.42493.99
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