奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.754639364639464651164630594629184637950.19
213.724623844624144623990.01
单位质量响应值RSD%判断
33730.5533702.550.06数据可信
供试品溶液-6000597批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136767-367678.13810.0429.798.1410.0429.77
253987-5398711.94911.95
340119-401198.8808.88
447343-4734310.47810.48
566070-6607014.62314.62
627903-279036.1766.18
10min1123757-12375727.39130.6811.0627.4030.6911.07
2156160-15616034.56334.58
3135451-13545129.97929.99
4135073-13507329.89629.91
5158115-15811534.99635.02
6123027-12302727.23027.24
15min1184362-18436240.80546.548.3840.8646.618.39
2232910-23291051.55051.63
3211469-21146946.80546.87
4204583-20458345.28045.35
5226419-22641950.11350.20
6201835-20183544.67244.73
20min1231370-23137051.20958.377.4551.3458.527.46
2286433-28643363.39663.56
3267669-26766959.24359.39
4257419-25741956.97557.12
5280680-28068062.12362.29
6258789-25878957.27857.41
30min1293743-29374365.01473.326.3365.2373.566.33
2349849-34984977.43277.70
3340491-34049175.36175.60
4323498-32349871.60071.84
5348458-34845877.12477.39
6331554-33155473.38373.61
45min1355802-35580278.75085.494.3279.0785.864.33
2390193-39019386.36286.76
3397335-39733587.94288.31
4381386-38138684.41284.77
5403164-40316489.23289.63
6389753-38975386.26486.61
60min1390202-39020286.36492.253.4686.8292.763.47
2419926-41992692.94293.48
3428318-42831894.80095.31
4413055-41305591.42291.92
5429651-42965195.09595.64
6419613-41961392.87393.36
极限1455614-455614100.841100.762.21101.44101.422.18
2439427-43942797.25997.96
3463224-463224102.526103.20
4467992-467992103.581104.23
5455080-455080100.723101.43
6450190-45019099.641100.29
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.754619264621854628174623194620604622610.08
213.724629464627614628540.03
单位质量响应值RSD%判断
33618.9833735.710.25数据可信
供试品溶液-6000597批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158478-5847812.95811.8810.0712.9611.8810.09
251024-5102411.30611.31
353637-5363711.88511.89
460772-6077213.46613.47
545777-4577710.14410.14
652001-5200111.52311.52
10min1148817-14881732.97633.957.4633.0033.987.46
2152403-15240333.77133.79
3158925-15892535.21635.24
4169052-16905237.46037.48
5134678-13467829.84329.86
6155502-15550234.45734.48
15min1219819-21981948.70950.076.0848.7950.156.08
2226052-22605250.09150.17
3238104-23810452.76152.84
4244188-24418854.10954.19
5205810-20581045.60545.67
6221772-22177249.14249.22
20min1272904-27290460.47261.704.7760.6361.864.77
2280624-28062462.18362.34
3294061-29406165.16165.33
4292320-29232064.77564.95
5259616-25961657.52857.67
6271153-27115360.08460.24
30min1337233-33723374.72776.764.0774.9977.034.07
2353593-35359378.35278.61
3367196-36719681.36781.64
4352951-35295178.21078.49
5328216-32821672.72972.97
6339386-33938675.20475.46
45min1386241-38624185.58788.033.7385.9788.423.73
2408406-40840690.49890.89
3419327-41932792.91893.33
4397973-39797388.18688.60
5378784-37878483.93484.29
6392912-39291287.06587.45
60min1410871-41087191.04493.962.8691.5794.502.86
2433301-43330196.01596.56
3443597-44359798.29698.86
4420463-42046393.17093.73
5416745-41674592.34692.85
6419208-41920892.89293.42
极限1436132-43613296.64299.992.3997.32100.682.37
2454294-454294100.666101.37
3458820-458820101.669102.40
4439461-43946197.38098.10
5461807-461807102.331102.98
6456914-456914101.247101.93
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