奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703对照品来源中检所对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数200
标示量(mg)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.464598794600084597814593814595124597120.06
213.484670504668054669280.04
单位质量响应值RSD%判断
34153.9434638.581.00数据可信
供试品溶液-24061201批-含3%SDS的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%
5min125471-254715.5765.4911.755.585.4911.76
228338-283386.2046.20
323377-233775.1185.12
420530-205304.4954.49
524685-246855.4045.40
628053-280536.1426.14
10min1114801-11480125.13325.543.1825.2025.603.19
2120433-12043326.36626.44
3119388-11938826.13826.19
4110401-11040124.17024.22
5118690-11869025.98526.04
6116335-11633525.46925.54
15min1205029-20502944.88744.462.5345.2344.802.54
2205652-20565245.02345.39
3206258-20625845.15645.50
4192952-19295242.24342.56
5205906-20590645.07945.43
6202540-20254044.34244.69
20min1261064-26106457.15558.091.8357.9958.931.84
2270987-27098759.32760.19
3269240-26924058.94559.79
4259611-25961156.83757.62
5268688-26868858.82459.67
6262441-26244157.45658.30
30min1344149-34414975.34575.881.7276.8277.361.71
2346574-34657475.87577.40
3356689-35668978.09079.59
4340526-34052674.55175.97
5349620-34962076.54278.05
6341917-34191774.85676.34
45min1402950-40295088.21888.820.9190.5391.150.91
2403554-40355488.35090.71
3412883-41288390.39292.76
4404099-40409988.46990.72
5405848-40584888.85291.21
6404876-40487688.64090.95
60min1423248-42324892.66292.790.6395.9596.100.62
2423936-42393692.81296.16
3427445-42744593.58196.96
4426257-42625793.32096.55
5420649-42064992.09395.43
6421341-42134192.24495.54
极限1436513-43651395.56695.000.8599.8999.350.81
2431964-43196494.57098.95
3438098-43809895.913100.33
4436610-43661095.58799.85
5428709-42870993.85798.22
6431702-43170294.51398.84
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703对照品来源中检所对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数200
标示量(mg)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.464537894554544556054537764545804546410.20
213.484600474593024596740.12
单位质量响应值RSD%判断
33777.1934100.450.68数据可信
供试品溶液-23102701批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min146080-4608010.22410.719.6310.2210.719.64
253003-5300311.76011.76
354230-5423012.03212.03
443649-436499.6859.68
543482-434829.6489.65
649285-4928510.93510.94
10min1151586-15158633.63334.584.2633.7534.704.27
2165589-16558936.74036.87
3159582-15958235.40735.54
4149597-14959733.19233.30
5149453-14945333.16033.27
6159419-15941935.37135.49
15min1236256-23625652.41953.722.6952.9154.222.71
2252530-25253056.03056.57
3246053-24605354.59355.12
4236238-23623852.41552.89
5238125-23812552.83453.31
6243554-24355454.03954.55
20min1297956-29795666.10967.252.5067.1868.352.51
2318174-31817470.59571.76
3298927-29892766.32467.46
4300157-30015766.59767.66
5300468-30046866.66667.73
6302829-30282967.19068.31
30min1373718-37371882.91983.641.9484.7285.491.94
2387395-38739585.95387.90
3378447-37844783.96885.84
4366873-36687381.40083.20
5382225-38222584.80686.61
6373240-37324082.81384.67
45min1406583-40658390.21192.732.6392.9495.512.60
2429197-42919795.22898.13
3424620-42462094.21397.02
4412480-41248091.51994.22
5429041-42904195.19397.94
6405679-40567990.01092.79
60min1419065-41906592.98094.122.7196.7197.932.68
2437269-43726997.019100.98
3426807-42680794.69898.55
4414029-41402991.86395.58
5437310-43731097.028100.83
6410731-41073191.13194.91
极限1428744-42874495.12895.452.3499.89100.302.25
2429225-42922595.234100.27
3431119-43111995.654100.56
4432122-43212295.877100.62
5445753-44575398.901103.78
6414202-41420291.90196.70
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