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%
113.484534784535534536174535794537574535970.03
213.434509234518104513660.14
单位质量响应值RSD%判断
33649.6333608.790.09数据可信
供试品溶液-2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%
5min134990-349907.7645.6721.797.765.6721.73
224605-246055.4605.46
329300-293006.5026.50
422218-222184.9304.93
520619-206194.5754.58
621619-216194.7974.80
10min1130231-13023128.89924.618.7028.9124.628.70
2105370-10537023.38223.39
3109701-10970124.34324.35
4108605-10860524.10024.11
5105218-10521823.34823.36
6106236-10623623.57423.58
15min1207982-20798246.15242.265.0246.2142.305.02
2184417-18441740.92340.97
3184446-18444640.93040.98
4194732-19473243.21243.26
5187525-18752541.61341.66
6183429-18342940.70440.75
20min1267439-26743959.34655.244.8759.4855.364.87
2251110-25111055.72355.84
3239624-23962453.17453.29
4256473-25647356.91357.03
5233765-23376551.87451.99
6245203-24520354.41254.53
30min1342895-34289576.09073.322.6776.3373.532.67
2330684-33068473.38173.59
3315277-31527769.96270.17
4330791-33079173.40473.62
5331492-33149273.56073.76
6331326-33132673.52373.73
45min1399473-39947388.64585.642.7589.0185.982.74
2394809-39480987.61087.94
3377459-37745983.76084.09
4372586-37258682.67983.02
5390443-39044386.64186.97
6380735-38073584.48784.82
60min1416513-41651392.42691.741.7392.9492.221.73
2419276-41927693.04093.52
3399280-39928088.60289.07
4414786-41478692.04392.52
5416141-41614192.34492.81
6414535-41453591.98892.46
极限1419619-41961993.11694.261.6893.7894.891.66
2430130-43013095.44896.08
3413300-41330091.71492.33
4426280-42628094.59495.22
5432442-43244295.96196.58
6426884-42688494.72895.35
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%
113.484536534536354537884538664540544537990.04
213.434495254513964504600.30
单位质量响应值RSD%判断
33664.6133541.330.26数据可信
供试品溶液-6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%
5min123020-230205.1125.168.195.115.168.19
222243-222434.9404.94
320074-200744.4584.46
424360-243605.4105.41
525422-254225.6465.65
624241-242415.3835.38
10min190584-9058420.11720.085.4620.1320.085.46
288224-8822419.59319.60
383882-8388218.62818.64
498014-9801421.76721.78
593669-9366920.80220.81
688000-8800019.54319.55
15min1161007-16100735.75635.355.8035.8035.395.80
2153813-15381334.15934.20
3148842-14884233.05533.09
4172338-17233838.27338.32
5167051-16705137.09937.14
6152016-15201633.76033.80
20min1221196-22119649.12348.215.3949.2248.315.40
2207111-20711145.99546.09
3204931-20493145.51145.60
4235741-23574152.35352.46
5222752-22275249.46949.57
6210761-21076146.80646.90
30min1298853-29885366.36965.844.7066.5566.024.70
2284739-28473963.23563.41
3283984-28398463.06763.24
4316744-31674470.34270.54
5308583-30858368.53068.72
6285905-28590563.49463.67
45min1377708-37770883.88182.103.1984.1882.393.20
2363779-36377980.78881.07
3354052-35405278.62878.90
4380373-38037384.47384.79
5381877-38187784.80785.11
6360303-36030380.01680.30
60min1398534-39853488.50688.594.1688.9489.024.16
2383580-38358085.18585.60
3382257-38225784.89185.30
4423555-42355594.06394.52
5413329-41332991.79292.24
6392123-39212387.08287.50
极限1421834-42183493.68194.282.7094.2694.852.71
2416141-41614192.41692.97
3413223-41322391.76892.32
4442650-44265098.30398.91
5434121-43412196.40997.01
6419186-41918693.09393.65
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