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100
标示量(mg)100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%
19.661432689143298714330331426744143330414317510.20
29.601431824143334714325860.08
单位质量响应值RSD%判断
148214.39149227.710.49数据可信
供试品溶液-2023010511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%
5min1176457-17645711.81812.6013.9611.8212.6013.97
2228275-22827515.28815.29
3177154-17715411.86411.86
4201193-20119313.47413.47
5151159-15115910.12310.12
6194298-19429813.01213.01
10min1454632-45463230.44830.7213.3830.4730.7413.38
2557285-55728537.32237.35
3426970-42697028.59528.61
4476513-47651331.91331.93
5370914-37091424.84124.86
6466054-46605431.21231.23
15min1715873-71587347.94347.9913.1448.0148.0613.14
2874547-87454758.57058.65
3669453-66945344.83444.90
4734112-73411249.16549.23
5586886-58688639.30539.36
6718841-71884148.14248.21
20min1935524-93552462.65462.5311.7562.7962.6711.75
21119871-111987175.00075.17
3883018-88301859.13759.27
4948872-94887263.54863.69
5783312-78331252.46052.57
6931584-93158462.39062.53
30min11244432-124443283.34282.308.5483.5782.538.55
21395550-139555093.46293.74
31196234-119623480.11480.33
41234354-123435482.66782.90
51067996-106799671.52671.72
61234828-123482882.69982.93
45min11423452-142345295.33193.532.9795.6993.882.99
21432265-143226595.92196.34
31393774-139377493.34493.68
41408640-140864094.33994.70
51316810-131681088.18988.49
61404046-140404694.03194.39
60min11451485-145148597.20996.211.6597.7196.701.68
21463868-146386898.03898.60
31429109-142910995.71096.19
41433091-143309195.97796.48
51395666-139566693.47093.90
61445976-144597696.84097.34
极限11467923-146792398.30998.501.0998.9599.141.12
21485764-148576499.504100.21
31474137-147413798.72699.35
41478738-147873899.03499.68
51440543-144054396.47697.05
61477883-147788398.97699.62
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100
标示量(mg)100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%
19.661436495143479414379261440777142270514345390.49
29.601421952144160114317760.98
单位质量响应值RSD%判断
148503.00149143.330.31数据可信
供试品溶液-第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%
5min1186128-18612812.45712.1219.7412.4612.1219.74
2231907-23190715.52015.52
3206242-20624213.80313.80
4174899-17489911.70511.71
5130707-1307078.7488.75
6157062-15706210.51110.51
10min1452079-45207930.25630.4812.1230.2730.5012.13
2535000-53500035.80535.83
3494225-49422533.07633.10
4446264-44626429.86629.88
5373201-37320124.97724.99
6432220-43222028.92628.94
15min1694964-69496446.51147.499.2346.5747.559.24
2807937-80793754.07154.15
3749571-74957150.16550.24
4699112-69911246.78846.85
5611674-61167440.93740.99
6693960-69396046.44446.50
20min1912347-91234761.05962.087.3461.1962.227.35
21030872-103087268.99169.15
3958340-95834064.13764.28
4916645-91664561.34761.48
5821716-82171654.99455.11
6926135-92613561.98262.11
30min11227346-122734682.14182.834.6182.3783.064.62
21323232-132323288.55888.82
31250085-125008583.66283.90
41233477-123347782.55182.78
51145026-114502676.63176.83
61246698-124669883.43683.66
45min11398397-139839793.58894.351.2093.9494.701.22
21435432-143543296.06796.46
31409761-140976194.34994.72
41414368-141436894.65795.01
51385768-138576892.74393.05
61414631-141463194.67595.02
60min11443943-144394396.63696.650.5197.1397.140.52
21455862-145586297.43497.97
31436059-143605996.10996.62
41440255-144025596.39096.88
51439551-143955196.34296.79
61449268-144926896.99397.48
极限11473222-147322298.59698.710.5599.2399.350.55
21477946-147794698.91299.60
31482096-148209699.19099.84
41459661-145966197.68898.32
51477198-147719898.86299.46
61479724-147972499.03199.67
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100
标示量(mg)100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%
19.661434778141912814332791416481143485914277050.64
29.601427398142729614273470.01
单位质量响应值RSD%判断
147795.55148681.980.43数据可信
供试品溶液-2023010511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%
5min1127002-1270028.5339.799.978.539.799.96
2161533-16153310.85310.85
3153606-15360610.32110.32
4159759-15975910.73410.73
5138250-1382509.2899.29
6133956-1339569.0009.00
10min1362918-36291824.38424.294.7124.4024.304.72
2376331-37633125.28525.30
3372075-37207525.00025.02
4376342-37634225.28625.30
5337680-33768022.68922.70
6343383-34338323.07223.09
15min1591405-59140539.73639.353.7339.7939.403.73
2607615-60761540.82540.88
3591588-59158839.74939.80
4595126-59512639.98640.04
5544009-54400936.55236.60
6584097-58409739.24539.29
20min1801093-80109353.82553.263.8153.9353.373.81
2834309-83430956.05756.17
3802399-80239953.91354.03
4801096-80109653.82553.94
5747337-74733750.21350.32
6769695-76969551.71551.82
30min11137510-113751076.42975.183.1176.6275.383.11
21167707-116770778.45878.66
31128720-112872075.83876.03
41119041-111904175.18875.38
51069372-106937271.85172.03
61091574-109157473.34273.53
45min11404428-140442894.36393.141.9294.6793.441.93
21414521-141452195.04195.36
31397392-139739293.89094.20
41388231-138823193.27593.58
51340803-134080390.08890.37
61371924-137192492.17992.47
60min11445640-144564097.13296.990.6897.5897.430.69
21454492-145449297.72798.19
31444174-144417497.03397.48
41443514-144351496.98997.44
51425385-142538595.77196.19
61447625-144762597.26597.70
极限11452288-145228897.57998.120.8498.1798.710.85
21481038-148103899.510100.12
31445797-144579797.14297.74
41463273-146327398.31798.91
51455413-145541397.78898.35
61464128-146412898.37498.95
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100
标示量(mg)100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%
19.661422202143330414184531425482143106514261010.44
29.601434450142328814288690.56
单位质量响应值RSD%判断
147629.50148840.520.58数据可信
供试品溶液-第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%
5min1151383-15138310.1729.448.2110.179.448.18
2132695-1326958.9168.92
3127059-1270598.5378.54
4134640-1346409.0479.05
5139944-1399449.4039.40
6156885-15688510.54110.54
10min1397419-39741926.70324.486.3426.7224.506.34
2358325-35832524.07624.09
3340748-34074822.89522.91
4365674-36567424.57024.58
5340118-34011822.85322.87
6384087-38408725.80725.82
15min1629374-62937442.28940.853.8742.3440.903.87
2608559-60855940.89040.94
3588944-58894439.57239.62
4603948-60394840.58040.63
5577374-57737438.79538.84
6639447-63944742.96643.02
20min1832922-83292255.96555.042.0356.0855.152.03
2822283-82228355.25155.36
3800527-80052753.78953.90
4812706-81270654.60754.72
5803881-80388154.01454.12
6842605-84260556.61656.74
30min11154601-115460177.58077.021.3677.7877.211.36
21158287-115828777.82778.02
31121783-112178375.37575.56
41141303-114130376.68676.88
51138188-113818876.47776.66
61163521-116352178.17978.38
45min11401771-140177194.18793.890.5094.5194.200.51
21406585-140658594.51194.82
31386354-138635493.15293.45
41393840-139384093.65593.96
51399173-139917394.01394.32
61396697-139669793.84694.17
60min11442819-144281996.94596.890.4097.4197.340.40
21438919-143891996.68397.14
31441036-144103696.82697.27
41447816-144781697.28197.73
51432996-143299696.28596.73
61448034-144803497.29697.76
极限11460878-146087898.15997.840.6298.7698.440.62
21446479-144647997.19197.79
31458596-145859698.00698.59
41463805-146380598.35698.95
51443503-144350396.99197.58
61463720-146372098.35098.96
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