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%
113.474607294604974613644614184637704615560.29
213.494582664582844582750.01
单位质量响应值RSD%判断
34265.4833971.460.61数据可信
供试品溶液-24052201-2批-pH6.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135048-350487.6667.5110.437.677.5110.42
238194-381948.3548.35
330996-309966.7806.78
430664-306646.7076.71
532243-322437.0527.05
638759-387598.4788.48
10min1111231-11123124.32923.026.2524.3423.046.26
2113416-11341624.80724.82
399808-9980821.83121.84
497214-9721421.26321.27
5101849-10184922.27722.29
6108062-10806223.63623.65
15min1176416-17641638.58736.345.7138.6436.395.72
2178097-17809738.95539.01
3161003-16100335.21635.26
4153828-15382833.64633.69
5161320-16132035.28535.33
6166130-16613036.33736.39
20min1226778-22677849.60347.255.0649.7247.365.06
2230845-23084550.49250.61
3211865-21186546.34146.45
4201564-20156444.08844.19
5210169-21016945.97046.08
6214887-21488747.00247.12
30min1304927-30492766.69663.474.3066.9063.674.30
2305235-30523566.76366.97
3286257-28625762.61262.80
4273702-27370259.86660.04
5284703-28470362.27262.46
6286382-28638262.64062.83
45min1376312-37631282.31078.803.5582.6279.103.56
2375004-37500482.02482.34
3356212-35621277.91378.20
4343785-34378575.19575.47
5355390-35539077.73378.02
6354908-35490877.62877.92
60min1414877-41487790.74587.333.0391.1987.763.03
2412401-41240190.20390.66
3395666-39566686.54386.96
4383288-38328883.83684.24
5394604-39460486.31186.73
6394683-39468386.32886.75
极限1436474-43647495.46993.311.8196.0793.891.82
2433869-43386994.89995.50
3428343-42834393.69094.25
4416866-41686691.18091.72
5424114-42411492.76593.33
6420093-42009391.88692.46
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%
113.474617244618324624794626394624174622180.09
213.494617654613264615460.07
单位质量响应值RSD%判断
34314.6334213.940.21数据可信
供试品溶液-24052201-2批-pH4.5(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%
5min123545-235455.1284.5110.535.134.5110.54
219234-192344.1894.19
322191-221914.8334.83
422228-222284.8414.84
518588-185884.0484.05
618567-185674.0444.04
10min162246-6224613.55712.615.5413.5712.625.56
256647-5664712.33712.34
361304-6130413.35213.36
457324-5732412.48512.49
555607-5560712.11112.12
654200-5420011.80411.81
15min199135-9913521.59120.493.9721.6220.523.96
294386-9438620.55720.58
397122-9712221.15221.18
493245-9324520.30820.34
591733-9173319.97920.01
688753-8875319.33019.36
20min1131092-13109228.55127.223.7528.6227.283.76
2126827-12682727.62227.68
3128753-12875328.04128.11
4122687-12268726.72026.78
5121685-12168526.50226.56
6118776-11877625.86925.93
30min1186306-18630640.57639.532.7040.6939.642.70
2183468-18346839.95840.07
3185259-18525940.34840.46
4178974-17897438.97939.09
5182030-18203039.64539.75
6173025-17302537.68437.79
45min1256228-25622855.80554.782.1155.9954.952.11
2255763-25576355.70355.88
3255504-25550455.64755.83
4249021-24902154.23554.41
5249584-24958454.35854.53
6242944-24294452.91153.08
60min1309889-30988967.49266.991.3767.7767.251.37
2311144-31114467.76568.03
3311543-31154367.85268.12
4306137-30613766.67466.94
5306202-30620266.68966.95
6300495-30049565.44665.70
极限1341739-34173974.42874.201.5274.8274.571.53
2347587-34758775.70276.08
3344562-34456275.04375.43
4338518-33851873.72774.10
5338799-33879973.78874.16
6332845-33284572.49172.85
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