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%
113.214650054653394602544642894642704638310.45
213.294628064620564624310.12
单位质量响应值RSD%判断
35112.1134795.410.65数据可信
供试品溶液-24051001批-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%
5min159853-5985312.89412.9113.9312.8912.9113.93
262486-6248613.46113.46
373443-7344315.82215.82
458625-5862512.63012.63
547594-4759410.25310.25
657669-5766912.42412.42
10min1207897-20789744.78842.987.0144.9343.127.02
2209264-20926445.08245.23
3213007-21300745.88846.06
4202588-20258843.64443.78
5179514-17951438.67338.79
6184702-18470239.79139.93
15min1295609-29560963.68464.053.9864.3264.674.01
2309150-30915066.60167.25
3311042-31104267.00867.69
4300105-30010564.65265.28
5283426-28342661.05961.60
6284454-28445461.28061.86
20min1356174-35617476.73177.573.2678.0878.903.30
2373618-37361880.48981.88
3373409-37340980.44481.87
4361439-36143977.86579.21
5345630-34563074.46075.68
6350033-35003375.40876.67
30min1401855-40185586.57290.403.6288.7792.603.61
2446004-44600496.08398.37
3422957-42295791.11893.44
4423043-42304391.13793.35
5411824-41182488.72090.77
6412073-41207388.77490.87
45min1436611-43661194.06096.272.9397.2299.472.92
2471785-471785101.638104.99
3441496-44149695.11298.45
4450326-45032697.015100.24
5442109-44210995.24498.28
6438838-43883894.54097.62
60min1435868-43586893.90097.163.7998.11101.423.76
2482323-482323103.908108.39
3456050-45605098.248102.64
4449587-44958796.855101.15
5438094-43809494.37998.47
6443998-44399895.65199.79
极限1439361-43936194.65296.723.6599.90102.063.62
2481487-481487103.728109.36
3447133-44713396.327101.81
4445830-44583096.046101.42
5442461-44246195.320100.46
6437418-43741894.23499.43
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%
113.214618514611764610754608884606004611180.11
213.294605564612334608940.11
单位质量响应值RSD%判断
34906.7434679.760.47数据可信
供试品溶液-24051002批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114754-147543.1933.3313.513.193.3313.48
219457-194574.2114.21
315256-152563.3023.30
414997-149973.2463.25
513954-139543.0203.02
613850-138502.9973.00
10min188305-8830519.11119.797.3219.1519.837.33
2100363-10036321.72121.77
399160-9916021.46121.50
490003-9000319.47919.51
584896-8489618.37318.41
685978-8597818.60818.64
15min1171250-17125037.06337.866.0637.3138.126.06
2183201-18320139.64939.94
3190074-19007441.13641.41
4177264-17726438.36438.62
5162875-16287535.25035.49
6164987-16498735.70735.95
20min1240487-24048752.04752.573.9152.7153.253.94
2248047-24804753.68354.41
3258407-25840755.92556.66
4243584-24358452.71753.40
5233599-23359950.55651.19
6233387-23338750.51051.15
30min1334756-33475672.44970.864.1373.6972.124.13
2333647-33364772.20973.53
3346729-34672975.04076.39
4312484-31248467.62968.89
5312737-31273767.68468.87
6324269-32426970.17971.38
45min1402574-40257487.12784.872.8389.1786.922.82
2389963-38996384.39786.52
3402201-40220187.04689.23
4395880-39588085.67887.69
5389704-38970484.34186.28
6372662-37266280.65382.63
60min1413198-41319889.42689.071.4292.4492.061.48
2409827-40982788.69691.76
3421760-42176091.27994.43
4412367-41236789.24692.21
5406484-40648487.97390.85
6405764-40576487.81790.69
极限1416328-41632890.10389.175.3994.1193.155.22
2397812-39781286.09690.15
3431774-43177493.44697.61
4427518-42751892.52596.48
5424732-42473291.92295.78
6373951-37395180.93284.78
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