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T12B-A020-230703对照品来源自制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100
标示量(mg)120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%
113.489204709177889197929190809181359190530.13
213.509162489156329159400.05
单位质量响应值RSD%判断
68179.0167847.410.35数据可信
供试品溶液-24041501-1批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116559-165591.8332.2527.701.832.2527.70
230920-309203.4233.42
321859-218592.4202.42
415537-155371.7201.72
518893-188932.0922.09
618164-181642.0112.01
10min169112-691127.6528.246.457.658.246.46
282428-824289.1269.13
377530-775308.5848.59
471567-715677.9247.93
572395-723958.0158.02
673496-734968.1378.14
15min1122980-12298013.61614.124.4713.6314.144.49
2136713-13671315.13615.16
3132314-13231414.64914.67
4126132-12613213.96513.98
5124314-12431413.76313.78
6122851-12285113.60113.62
20min1170834-17083418.91419.433.5918.9519.473.60
2185107-18510720.49420.54
3181406-18140620.08420.13
4174365-17436519.30519.34
5171289-17128918.96419.00
6170049-17004918.82718.87
30min1254946-25494628.22628.773.0528.3028.853.05
2269869-26986929.87829.96
3268802-26880229.76029.84
4259841-25984128.76828.84
5255626-25562628.30128.37
6250325-25032527.71527.79
45min1359773-35977339.83240.522.6639.9540.642.66
2377011-37701141.74141.87
3377172-37717241.75841.88
4366869-36686940.61840.74
5361722-36172240.04840.17
6353100-35310039.09339.21
60min1445101-44510149.27950.062.2749.4650.242.28
2462811-46281151.24051.44
3464147-46414751.38851.58
4454461-45446150.31550.50
5448004-44800449.60149.79
6438164-43816448.51148.69
极限1516313-51631357.16357.842.0257.4358.112.03
2533433-53343359.05959.34
3534270-53427059.15159.43
4524020-52402058.01758.29
5519769-51976957.54657.81
6506681-50668156.09756.36
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T12B-A020-230703对照品来源自制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100
标示量(mg)120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%
113.489114629119419121419125979124579121200.05
213.509115689112479114080.03
单位质量响应值RSD%判断
67664.6967511.700.17数据可信
供试品溶液-24041501-1批-pH6.8(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%
5min130662-306623.4163.267.353.423.267.40
228901-289013.2203.22
326946-269463.0023.00
430096-300963.3533.35
532182-321823.5853.59
626724-267242.9772.98
10min1111758-11175812.45113.055.5312.4613.065.54
2112322-11232212.51412.52
3115983-11598312.92212.93
4116879-11687913.02213.03
5129604-12960414.43914.45
6116253-11625312.95212.96
15min1200769-20076922.36822.702.4022.3922.722.41
2200819-20081922.37322.40
3206389-20638922.99423.02
4201991-20199122.50422.53
5212531-21253123.67823.71
6199925-19992522.27422.30
20min1274735-27473530.60830.792.0430.6730.862.05
2273055-27305530.42130.48
3279871-27987131.18031.25
4272360-27236030.34430.41
5286242-28624231.89031.96
6272037-27203730.30830.37
30min1394549-39454943.95743.941.5144.0744.061.51
2395036-39503644.01144.13
3399967-39996744.56044.68
4387114-38711443.12843.24
5401631-40163144.74644.87
6388160-38816043.24543.36
45min1529097-52909758.94759.091.3159.1359.281.31
2533464-53346459.43359.62
3535703-53570359.68359.87
4520144-52014457.94958.14
5538696-53869660.01660.21
6525134-52513458.50558.69
60min1630572-63057270.25270.171.2670.5470.461.26
2634475-63447570.68770.97
3634291-63429170.66670.96
4616616-61661668.69768.98
5638103-63810371.09171.39
6624755-62475569.60469.89
极限1707160-70716078.78578.581.0179.1978.991.01
2709993-70999379.10079.50
3707204-70720478.79079.20
4692857-69285777.19177.59
5712910-71291079.42579.84
6701915-70191578.20078.60
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T12B-A020-230703对照品来源自制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100
标示量(mg)120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%
113.489112109125009122119127539110259119400.09
213.508969468992628981040.19
单位质量响应值RSD%判断
67651.3466526.221.19数据可信
供试品溶液-24041501-1批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17421-74210.8330.719.880.830.719.66
26333-63330.7110.71
36035-60350.6770.68
46486-64860.7280.73
55511-55110.6190.62
66323-63230.7100.71
10min110299-102991.1561.123.871.161.124.06
210197-101971.1451.15
310296-102961.1561.16
49793-97931.0991.10
59358-93581.0501.05
69717-97171.0911.09
15min111957-119571.3421.292.831.351.302.97
211761-117611.3201.32
311569-115691.2991.30
411467-114671.2871.29
511026-110261.2381.24
611332-113321.2721.27
20min114246-142461.5991.542.701.601.552.57
214033-140331.5751.58
313793-137931.5481.55
413761-137611.5451.55
513193-131931.4811.49
613520-135201.5181.52
30min117988-179882.0191.952.612.031.962.65
217712-177121.9882.00
317529-175291.9681.98
417306-173061.9431.95
516749-167491.8801.89
617030-170301.9121.92
45min125125-251252.8202.712.832.832.722.83
224483-244832.7482.76
324379-243792.7362.75
424256-242562.7232.73
523222-232222.6072.62
623549-235492.6432.65
60min130340-303403.4063.292.653.423.312.63
229635-296353.3263.34
329648-296483.3283.34
429494-294943.3113.33
528196-281963.1653.18
628629-286293.2143.23
极限135151-351513.9463.773.093.973.803.11
234067-340673.8243.85
333866-338663.8013.82
433701-337013.7833.80
532258-322583.6213.64
632666-326663.6673.69
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