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%
113.214397984421794424454428404428034420130.29
213.294435274447684441480.20
单位质量响应值RSD%判断
33460.4833419.710.09数据可信
供试品溶液-5728772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%
5min160167-6016713.42711.6311.0313.4311.6311.02
248913-4891310.91510.92
352713-5271311.76311.76
453919-5391912.03312.03
542998-429989.5959.60
653866-5386612.02112.02
10min1175061-17506139.06737.355.2539.0937.375.25
2175061-17506139.06739.08
3162715-16271536.31236.33
4166508-16650837.15837.18
5152554-15255434.04434.06
6172320-17232038.45538.48
15min1249307-24930755.63554.303.7555.7254.383.75
2253378-25337856.54456.63
3237770-23777053.06153.14
4237926-23792653.09653.18
5230655-23065551.47351.55
6250860-25086055.98256.07
20min1299995-29999566.94765.662.9667.1365.842.96
2304438-30443867.93868.12
3292213-29221365.21065.38
4284858-28485863.56963.74
5283649-28364963.29963.46
6300265-30026567.00767.18
30min1358302-35830279.95978.882.3680.2579.162.36
2363144-36314481.03981.33
3356362-35636279.52679.80
4340852-34085276.06576.34
5346118-34611877.24077.50
6356159-35615979.48179.77
45min1400450-40045089.36588.721.8989.7989.131.89
2406148-40614890.63691.06
3402485-40248589.81990.23
4384637-38463785.83686.24
5394841-39484188.11388.51
6396742-39674288.53788.96
60min1420602-42060293.86293.541.5994.4494.101.59
2427937-42793795.49996.08
3424333-42433394.69495.25
4409279-40927991.33591.88
5417113-41711393.08393.62
6415635-41563592.75393.32
极限1437245-43724597.57697.711.3198.3198.431.30
2445180-44518099.347100.08
3443846-44384699.04999.77
4436278-43627897.36098.06
5434244-43424496.90697.60
6430298-43029896.02596.75
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%
113.214436734436074442534441524441454439660.07
213.294407634362134384880.74
单位质量响应值RSD%判断
33608.3332993.831.31数据可信
供试品溶液-5728772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%
5min176185-7618517.07410.6335.4117.0710.6435.38
255672-5567212.47712.48
338896-388968.7178.72
447273-4727310.59410.59
538130-381308.5458.55
628535-285356.3956.40
10min1183743-18374341.17936.618.3841.2136.638.38
2176490-17649039.55339.57
3152387-15238734.15234.17
4160918-16091836.06336.08
5156400-15640035.05135.07
6150219-15021933.66633.68
15min1248702-24870255.73753.434.2255.8353.514.23
2251983-25198356.47256.56
3227645-22764551.01851.09
4229155-22915551.35651.43
5238362-23836253.42053.49
6234711-23471152.60152.67
20min1292633-29263365.58265.043.6465.7765.203.65
2304139-30413968.16168.34
3275911-27591161.83561.99
4280727-28072762.91463.08
5298157-29815766.82066.98
6289614-28961464.90665.06
30min1345771-34577177.49179.103.1677.7979.383.15
2364937-36493781.78682.08
3345615-34561577.45677.72
4340147-34014776.23176.50
5367321-36732182.32182.59
6353902-35390279.31379.58
45min1393031-39303188.08390.292.3088.5190.702.29
2410529-41052992.00492.43
3403323-40332390.38990.78
4393513-39351388.19188.59
5416271-41627193.29193.70
6400743-40074389.81190.21
60min1416941-41694193.44195.702.0694.0296.262.05
2433381-43338197.12597.71
3429709-42970996.30296.84
4418525-41852593.79694.34
5439453-43945398.48699.05
6424137-42413795.05495.60
极限1440589-44058998.741100.492.1699.47101.212.15
2452139-452139101.329102.08
3461289-461289103.380104.08
4436746-43674697.88098.58
5456460-456460102.298103.03
6443207-44320799.328100.03
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%
113.214418924415984415234420124422104418470.07
213.294472384428614450500.70
单位质量响应值RSD%判断
33447.9233487.580.09数据可信
供试品溶液-5728772批-pH2.0(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%
5min116739-167393.7322.2580.733.732.2580.73
2-0.0000.00
317838-178383.9773.98
414966-149663.3373.34
5-0.0000.00
611077-110772.4702.47
10min162486-6248613.93312.3216.4713.9412.3216.48
252707-5270711.75211.75
360428-6042813.47413.48
461254-6125413.65813.66
538206-382068.5198.52
656479-5647912.59312.60
15min1100755-10075522.46621.3412.8622.5021.3612.87
299906-9990622.27722.30
3102478-10247822.85022.88
4102440-10244022.84222.87
570831-7083115.79415.81
697726-9772621.79121.82
20min1133655-13365529.80229.1211.6529.8729.1811.67
2139338-13933831.06931.13
3138604-13860430.90530.97
4138433-13843330.86730.93
599983-9998322.29422.33
6133506-13350629.76929.83
30min1184531-18453141.14641.1910.5941.2641.3010.60
2198516-19851644.26444.37
3193901-19390143.23543.35
4196476-19647643.80943.93
5146228-14622832.60532.68
6188679-18867942.07142.18
45min1238165-23816553.10553.608.3953.2953.788.39
2254904-25490456.83757.02
3250624-25062455.88356.07
4255014-25501456.86257.05
5201751-20175144.98645.12
6241968-24196853.95354.13
60min1273669-27366961.02261.926.3361.3062.186.35
2290055-29005564.67564.95
3286742-28674263.93764.22
4291714-29171465.04565.33
5244647-24464754.55054.76
6279246-27924662.26562.54
极限1328773-32877373.30873.533.6773.6873.903.70
2338498-33849875.47775.86
3335575-33557574.82575.22
4338867-33886775.55975.95
5306629-30662968.37168.67
6330208-33020873.62874.00
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%
113.214527214457384456944456444459024471400.70
213.294428754428154428450.01
单位质量响应值RSD%判断
33848.6033321.671.11数据可信
供试品溶液-5728772批-pH6.8(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%
5min1114280-11428025.39415.6758.3025.3915.6758.31
288197-8819719.59819.60
390923-9092320.20420.20
484419-8441918.75918.76
545246-4524610.05410.05
6-0.0000.00
10min1228163-22816350.70042.1526.0850.7442.1826.10
2206412-20641245.86745.90
3219415-21941548.75648.79
4210747-21074746.83046.86
5178663-17866339.70139.72
694688-9468821.04121.04
15min1307635-30763568.36061.2912.3868.4961.3912.42
2287316-28731663.84563.95
3299580-29958066.57066.68
4287023-28702363.77963.89
5258429-25842957.42657.51
6215050-21505047.78647.82
20min1337306-33730674.95369.127.7375.1969.327.77
2317000-31700070.44170.66
3327840-32784072.84973.08
4317610-31761070.57670.79
5295565-29556565.67865.86
6271064-27106460.23360.35
30min1379954-37995484.43081.553.4684.8081.863.51
2369751-36975182.16282.50
3376329-37632983.62483.97
4370868-37086882.41182.74
5359715-35971579.93280.22
6345262-34526276.72176.94
45min1412169-41216991.58890.681.5692.0991.131.61
2408733-40873390.82591.29
3413016-41301691.77692.26
4412980-41298091.76892.24
5404651-40465189.91890.34
6396963-39696388.20988.55
60min1427387-42738794.97095.041.0995.6395.641.14
2426857-42685794.85295.47
3430727-43072795.71296.35
4434518-43451896.55497.18
5426081-42608194.68095.25
6420676-42067693.47893.97
极限1438145-43814597.36098.531.1598.1899.291.15
2439366-43936697.63298.41
3446411-44641199.197100.00
4451844-451844100.404101.19
5441119-44111998.02198.75
6443491-44349198.54899.19
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%
113.214428634427934427724426234423384426780.05
213.294386564425554406060.63
单位质量响应值RSD%判断
33510.8333153.200.76数据可信
供试品溶液-5728772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%
5min152822-5282211.8269.0251.1511.839.0251.15
241364-413649.2619.26
355265-5526512.37312.37
4-0.0000.00
550990-5099011.41611.42
641189-411899.2229.22
10min1133259-13325929.83525.5323.1829.8625.5523.20
2122237-12223727.36827.38
3124696-12469627.91827.94
461105-6110513.68113.68
5125433-12543328.08328.10
6117572-11757226.32326.34
15min1194801-19480143.61440.4611.0143.6840.5211.04
2187791-18779142.04542.11
3188311-18831142.16142.23
4141308-14130831.63731.66
5191577-19157742.89242.96
6180592-18059240.43340.49
20min1246833-24683355.26452.326.2555.4152.446.29
2240672-24067253.88454.02
3237693-23769353.21753.35
4206319-20631946.19346.27
5241382-24138254.04354.18
6229162-22916251.30751.43
30min1312564-31256469.98067.772.9070.2167.982.92
2308168-30816868.99669.22
3306480-30648068.61868.84
4290363-29036365.00965.16
5305033-30503368.29468.52
6293551-29355165.72365.94
45min1370053-37005382.85180.832.2083.2081.162.20
2367271-36727182.22882.56
3363847-36384781.46281.80
4358561-35856180.27880.54
5358515-35851580.26880.61
6347914-34791477.89578.22
60min1400364-40036489.63888.682.2390.1389.142.22
2402782-40278290.17990.65
3396833-39683388.84789.32
4398020-39802089.11389.51
5399931-39993189.54190.02
6378627-37862784.77185.22
极限1433676-43367697.09696.282.1497.7396.892.12
2438532-43853298.18398.81
3432700-43270096.87797.50
4437402-43740297.93098.47
5422830-42283094.66895.29
6415159-41515992.95093.54
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