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对照品来源中检所对照品使用方法直接使用
对照品含量(%)100.40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%
113.264368244367214376044370824374594371380.09
213.374399604404344401970.08
单位质量响应值RSD%判断
32966.6732924.230.10数据可信
供试品溶液-sjyp1批-含3%SDS的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%
5min150405-5040511.52110.0312.5911.5210.0312.58
241457-414579.4759.48
348806-4880611.15511.16
440942-409429.3589.36
535700-357008.1608.16
645908-4590810.49310.49
10min1159237-15923736.39533.796.8236.5233.906.83
2148240-14824033.88233.99
3157329-15732935.95936.08
4136924-13692431.29531.40
5135104-13510430.87930.97
6150142-15014234.31634.43
15min1243770-24377055.71653.414.1056.2553.904.13
2233362-23336253.33753.82
3242380-24238055.39855.92
4222652-22265250.88951.34
5221896-22189650.71651.15
6238105-23810554.42154.92
20min1309464-30946470.73168.303.1371.8869.383.17
2301874-30187468.99670.07
3306106-30610669.96471.10
4289546-28954666.17967.20
5285665-28566565.29266.29
6300180-30018068.60969.71
30min1377749-37774986.33883.113.0588.2884.953.08
2371322-37132284.86986.71
3370677-37067784.72286.64
4356346-35634681.44683.20
5349561-34956179.89681.62
6356162-35616281.40483.27
45min1405288-40528892.63390.841.7595.5393.601.81
2401921-40192191.86394.65
3402391-40239191.97094.83
4393943-39394390.04092.70
5386893-38689388.42891.04
6394225-39422590.10492.87
60min1418081-41808195.55694.331.1699.4898.101.24
2415144-41514494.88598.69
3416345-41634595.16099.04
4410329-41032993.78597.44
5405081-40508192.58596.18
6411238-41123893.99297.76
极限1426022-42602297.37196.411.12102.36101.231.19
2422690-42269096.610101.47
3426761-42676197.540102.48
4420553-42055396.121100.82
5413762-41376294.56999.19
6421168-42116896.262101.08
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对照品来源中检所对照品使用方法直接使用
对照品含量(%)100.40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%
113.264405054399914375354410614425544403290.42
213.374508484504984506730.06
单位质量响应值RSD%判断
33207.3233707.781.06数据可信
供试品溶液-sjyp2批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1166434-16643437.46038.186.0837.4638.186.09
2185700-18570041.79641.80
3177123-17712339.86639.87
4168219-16821937.86237.86
5156541-15654135.23335.23
6163834-16383436.87536.87
10min1292494-29249465.83369.173.5266.2569.603.53
2323853-32385372.89173.36
3314137-31413770.70471.15
4302037-30203767.98168.40
5308144-30814469.35569.75
6303326-30332668.27168.68
15min1343968-34396877.41880.933.1178.5782.133.11
2376462-37646284.73286.01
3364628-36462882.06883.30
4354282-35428279.74080.92
5363537-36353781.82382.98
6354603-35460379.81280.98
20min1371055-37105583.51587.393.3385.5289.483.33
2406898-40689891.58293.80
3395166-39516688.94291.08
4381824-38182485.93988.00
5394345-39434588.75790.83
6380293-38029385.59487.65
30min1396164-39616489.16693.363.2192.1096.423.21
2430203-43020396.827100.06
3427426-42742696.20299.33
4410679-41067992.43395.45
5419455-41945594.40897.47
6404742-40474291.09794.10
45min1408627-40862791.97195.632.5295.9099.732.54
2438448-43844898.683102.99
3428381-42838196.417100.61
4419876-41987694.50398.55
5433228-43322897.508101.61
6420663-42066394.68098.70
60min1418728-41872894.24599.663.1999.19104.823.17
2457231-457231102.911108.32
3446881-446881100.581105.85
4436528-43652898.251103.35
5455099-455099102.431107.62
6442296-44229699.549104.62
极限1438440-43844098.681100.551.61104.68106.821.68
2457563-457563102.985109.53
3449118-449118101.085107.47
4440841-44084199.222105.41
5451020-451020101.513107.84
6443445-44344599.808105.98
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对照品来源中检所对照品使用方法直接使用
对照品含量(%)100.40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%
113.264522954561444583004524034517944541870.64
213.374500494495724498100.08
单位质量响应值RSD%判断
34252.4133643.231.27数据可信
供试品溶液-sjyp3批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194865-9486521.04421.194.8621.0421.194.87
290898-9089820.16420.16
3102227-10222722.67722.68
492964-9296420.62220.62
591981-9198120.40420.40
6100157-10015722.21822.22
10min1218256-21825648.41548.933.1048.6549.163.11
2219944-21994448.79049.01
3229083-22908350.81751.07
4215880-21588047.88848.12
5211996-21199647.02747.25
6228268-22826850.63650.88
15min1299698-29969866.48266.172.3167.2566.952.31
2296590-29659065.79266.56
3302620-30262067.13067.95
4295717-29571765.59966.36
5287415-28741563.75764.51
6307639-30763968.24369.05
20min1350628-35062877.77976.362.7479.2977.872.74
2343096-34309676.10977.61
3350066-35006677.65579.22
4335666-33566674.46075.95
5330828-33082873.38774.84
6354957-35495778.74080.31
30min1410882-41088291.14589.701.7393.5292.061.74
2399889-39988988.70791.05
3404248-40424889.67492.10
4399809-39980988.68991.01
5396842-39684288.03190.30
6414556-41455691.96094.40
45min1454061-454061100.72497.281.91104.11100.641.87
2435777-43577796.668100.00
3437349-43734997.017100.44
4439864-43986497.575100.88
5429390-42939095.25198.50
6434870-43487096.46799.93
60min1455997-455997101.15398.911.57105.66103.351.56
2439637-43963797.524101.93
3440909-44090997.806102.31
4445548-44554898.835103.22
5440454-44045497.705102.01
6452702-452702100.422104.96
极限1465339-465339103.226100.621.41108.86106.161.40
2449640-44964099.743105.23
3451462-451462100.147105.73
4453785-453785100.663106.15
5447038-44703899.166104.56
6454282-454282100.773106.42
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