塞来昔布片项目信息
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%
19.402799518279855227972042796240279602527975080.06
29.332788938278870527888220.01
单位质量响应值RSD%判断
297607.23298909.110.31数据可信
供试品溶液-1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%
5min1357837-35783711.95011.551.8211.9511.551.82
2342908-34290811.45111.45
3344127-34412711.49211.49
4341173-34117311.39311.39
5347979-34797911.62011.62
6341982-34198211.42011.42
10min1886800-88680029.61428.691.7929.6428.711.79
2846706-84670628.27528.30
3864021-86402128.85328.88
4849715-84971528.37528.40
5859675-85967528.70828.73
6847303-84730328.29528.32
15min11362473-136247345.49844.351.6145.5844.431.61
21322602-132260244.16744.25
31328611-132861144.36844.45
41315835-131583543.94144.02
51338977-133897744.71444.79
61300094-130009443.41543.49
20min11744721-174472158.26357.581.1158.4457.751.11
21734677-173467757.92858.10
31722418-172241857.51957.69
41710500-171050057.12157.29
51738063-173806358.04158.21
61694427-169442756.58456.75
30min12283526-228352676.25676.160.6676.5576.450.66
22305147-230514776.97877.26
32275730-227573075.99676.28
42282732-228273276.23076.51
52279191-227919176.11176.40
62258431-225843175.41875.70
45min12700123-270012390.16890.260.6690.6190.700.66
22730667-273066791.18891.63
32712814-271281490.59291.03
42703976-270397690.29790.73
52683213-268321389.60390.04
62686023-268602389.69790.13
60min12839011-283901194.80694.820.5195.4395.430.51
22860359-286035995.51996.14
32850922-285092295.20495.82
42835925-283592594.70395.32
52824596-282459694.32594.94
62824845-282484594.33394.94
极限12894310-289431096.65396.530.4797.4797.340.47
22906772-290677297.06997.88
32902893-290289396.93997.75
42888643-288864396.46397.27
52879637-287963796.16396.97
62871473-287147395.89096.69
塞来昔布片项目信息
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%
19.402797880279851127977622794704279833327974380.06
29.332784402278304227837220.04
单位质量响应值RSD%判断
297599.79298362.490.19数据可信
供试品溶液-1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%
5min1289918-2899189.6919.621.529.699.621.50
2287312-2873129.6039.60
3288847-2888479.6559.65
4279920-2799209.3569.36
5293007-2930079.7949.79
6287275-2872759.6029.60
10min1699055-69905523.36623.561.0923.3923.581.09
2715599-71559923.91923.94
3706687-70668723.62123.64
4705183-70518323.57123.59
5708525-70852523.68223.70
6693502-69350223.18023.20
15min11102702-110270236.85837.070.8736.9237.140.88
21120124-112012437.44037.51
31098692-109869236.72436.79
41118336-111833637.38037.45
51114406-111440637.24937.32
61100141-110014136.77236.84
20min11463857-146385748.92949.040.6649.0749.180.66
21476192-147619249.34249.48
31460193-146019348.80748.95
41477837-147783749.39749.54
51470993-147099349.16849.31
61453517-145351748.58448.72
30min12010991-201099167.21767.200.8567.4667.440.85
22023397-202339767.63267.87
32019001-201900167.48567.72
42017037-201703767.41967.66
52015303-201530367.36167.60
61976688-197668866.07166.31
45min12510760-251076083.92283.970.7584.2984.340.75
22531844-253184484.62785.00
32512698-251269883.98784.36
42524598-252459884.38584.76
52515876-251587684.09384.47
62477812-247781282.82183.19
60min12770885-277088592.61791.760.8193.1692.300.80
22756841-275684192.14792.69
32725605-272560591.10391.64
42756310-275631092.13092.67
52750321-275032191.92992.47
62712217-271221790.65691.19
极限12832890-283289094.68994.800.9895.4195.520.97
22838906-283890694.89095.62
32803232-280323293.69894.42
42885396-288539696.44497.17
52836841-283684194.82195.55
62819509-281950994.24294.96
塞来昔布片项目信息
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%
19.402787538278800327867252784798278344327861010.07
29.332780041278064727803440.02
单位质量响应值RSD%判断
296393.72298000.430.39数据可信
供试品溶液-1批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1391154-39115413.10913.191.8613.1113.191.88
2389672-38967213.05913.06
3391912-39191213.13413.13
4385641-38564112.92412.92
5396783-39678313.29813.30
6406567-40656713.62513.63
10min1911899-91189930.56131.332.2530.5931.362.25
2928831-92883131.12831.15
3949209-94920931.81131.84
4909888-90988830.49330.52
5951799-95179931.89831.92
6957903-95790332.10332.13
15min11353582-135358245.36346.041.6745.4546.131.67
21378998-137899846.21546.30
31359528-135952845.56245.65
41354796-135479645.40445.49
51412548-141254847.33947.43
61384053-138405346.38446.48
20min11732799-173279958.07258.021.5958.2558.201.59
21732109-173210958.04958.23
31693255-169325556.74756.93
41712828-171282857.40357.58
51774427-177442759.46759.65
61742092-174209258.38358.57
30min12262856-226285675.83675.461.2276.1375.761.22
22268672-226867276.03176.33
32209657-220965774.05374.35
42241753-224175375.12975.42
52287986-228798676.67876.98
62239602-223960275.05775.36
45min12686435-268643590.03189.610.5190.4890.060.51
22681621-268162189.87090.32
32656113-265611389.01589.46
42672121-267212189.55289.99
52687519-268751990.06890.53
62660057-266005789.14789.60
60min12849983-284998395.51394.660.4796.1495.280.47
22822184-282218494.58195.21
32817062-281706294.40995.03
42813208-281320894.28094.90
52819625-281962594.49595.13
62824793-282479394.66895.30
极限12905705-290570597.38096.810.4298.2097.630.42
22884691-288469196.67697.49
32890333-289033396.86597.67
42869915-286991596.18096.99
52886400-288640096.73397.56
62895270-289527097.03097.85
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