非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.961947731195802419642181974644197841919646070.64
210.081954457195571919550880.05
单位质量响应值RSD%判断
197249.70193957.141.20数据可信
供试品溶液-3786A批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11141156-114115652.51048.0516.3652.5148.0516.37
21088280-108828050.07750.08
3698793-69879332.15532.15
41138848-113884852.40452.40
51089875-108987550.15050.15
61109005-110900551.03151.03
10min11777347-177734781.78478.994.6381.9079.104.64
21681640-168164077.38077.49
31571111-157111172.29472.37
41776261-177626181.73481.85
51743044-174304480.20680.32
61750058-175005880.52880.64
15min11958309-195830990.11188.591.9390.4188.871.94
21879040-187904086.46486.75
31886245-188624586.79587.03
41967471-196747190.53390.83
51918689-191868988.28888.58
61941762-194176289.35089.64
20min12048852-204885294.27792.881.5394.7893.361.53
21973578-197357890.81491.29
32019773-201977392.93993.36
42054980-205498094.55995.06
51997414-199741491.91092.40
62016471-201647192.78793.28
30min12144359-214435998.67297.211.5299.3897.901.50
22066734-206673495.10095.78
32135648-213564898.27198.90
42134959-213495998.24098.95
52081886-208188695.79796.49
62111747-211174797.17197.87
45min12183700-2183700100.48299.431.99101.41100.331.97
22113576-211357697.25698.14
32182668-2182668100.435101.28
42164422-216442299.595100.52
52105696-210569696.89397.80
62214378-2214378101.894102.81
60min12185750-2185750100.57799.001.49101.73100.121.48
22116107-211610797.37298.48
32182445-2182445100.425101.50
42170722-217072299.885101.03
52118187-211818797.46898.59
62135158-213515898.24999.39
极限12183366-2183366100.46798.851.45101.84100.191.43
22120262-212026297.56398.88
32177596-2177596100.201101.50
42163160-216316099.537100.91
52109162-210916297.05398.39
62135449-213544998.26299.62
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.961964478196890619555251967284196698219646350.28
210.082023341202315920232500.01
单位质量响应值RSD%判断
197252.51200719.251.24数据可信
供试品溶液-3786A批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1949899-94989942.96743.1022.9942.9743.1022.99
21140929-114092951.60751.61
31150119-115011952.02352.02
41053863-105386347.66947.67
5572473-57247325.89525.89
6849789-84978938.43838.44
10min11626561-162656173.57473.915.0973.6774.005.12
21716336-171633677.63577.75
31709740-170974077.33677.45
41671234-167123475.59575.70
51501721-150172167.92767.98
61578143-157814371.38471.47
15min11880213-188021385.04784.731.4385.3185.001.46
21903454-190345486.09986.39
31883232-188323285.18485.47
41888883-188888385.43985.71
51829621-182962182.75982.97
61854298-185429883.87584.12
20min11983715-198371589.72989.370.9090.1889.820.92
21976173-197617389.38889.87
31968502-196850289.04189.52
42002253-200225390.56791.03
51948449-194844988.13488.53
61975931-197593189.37789.81
30min12078518-207851894.01793.781.0194.6694.421.03
22067448-206744893.51694.19
32065529-206552993.43094.10
42108003-210800395.35196.02
52044111-204411192.46193.05
62076057-207605793.90694.53
45min12112419-211241995.55195.561.0496.4196.421.04
22104274-210427495.18296.07
32102818-210281895.11696.00
42146331-214633197.08597.96
52083091-208309194.22495.02
62126525-212652596.18997.03
60min12128362-212836296.27295.701.1897.3496.771.19
22107087-210708795.30996.41
32114278-211427895.63596.73
42157466-215746697.58898.68
52085555-208555594.33595.34
62102014-210201495.08096.13
极限12123272-212327296.04195.611.2097.3296.891.21
22098881-209888194.93896.25
32107993-210799395.35096.66
42158464-215846497.63398.94
52084735-208473594.29895.51
62108644-210864495.38096.64
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