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%
113.364551434565314552564524764510814540970.50
213.404534564531954533260.05
单位质量响应值RSD%判断
33989.3033830.300.34数据可信
长期6月-供试品溶液-2024102421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%
5min134903-349037.68113.9732.607.6813.9732.61
250864-5086411.19411.19
383069-8306918.28118.28
490430-9043019.90119.90
556275-5627512.38412.38
665353-6535314.38214.38
10min1166271-16627136.59141.549.5936.6041.579.61
2174647-17464738.43538.45
3206047-20604745.34545.38
4213595-21359547.00647.04
5185342-18534240.78840.81
6186745-18674541.09741.12
15min1245788-24578854.09158.395.3754.1658.485.39
2256027-25602756.34456.43
3277714-27771461.11761.22
4284323-28432362.57162.68
5267873-26787358.95159.04
6260258-26025857.27557.37
20min1301094-30109466.26267.883.7566.4368.073.76
2303574-30357466.80866.98
3311315-31131568.51168.72
4329394-32939472.49072.71
5296575-29657565.26765.45
6308821-30882167.96268.15
30min1339139-33913974.63480.204.4374.9180.504.44
2360441-36044179.32279.61
3375297-37529782.59282.91
4385729-38572984.88885.22
5357205-35720578.61078.91
6368853-36885381.17481.47
45min1401065-40106588.26389.801.4788.6690.241.48
2408301-40830189.85590.28
3404288-40428888.97289.43
4418669-41866992.13792.61
5409015-40901590.01290.44
6407021-40702189.57390.01
60min1411483-41148390.55592.392.1691.1092.982.15
2411914-41191490.65091.22
3423648-42364893.23293.84
4412348-41234890.74691.38
5427807-42780794.14894.72
6431827-43182795.03295.62
极限1428262-42826294.24894.681.5594.9495.421.56
2426034-42603493.75794.48
3427426-42742694.06494.83
4443701-44370197.64598.43
5428402-42840294.27995.01
6427499-42749994.08094.82
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%
113.364528974529534527284518904521724525280.11
213.404550264554554552400.07
单位质量响应值RSD%判断
33871.8633973.130.22数据可信
长期6月-供试品溶液-2024102421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%
5min182060-8206018.05217.267.5718.0517.267.57
284390-8439018.56518.56
368968-6896815.17215.17
475862-7586216.68916.69
583523-8352318.37418.37
676047-7604716.72916.73
10min1199033-19903343.78542.894.7043.8142.914.69
2205392-20539245.18445.21
3187516-18751641.25141.28
4180685-18068539.74839.78
5200570-20057044.12344.15
6196483-19648343.22443.25
15min1258099-25809956.77858.744.1456.8858.844.14
2279827-27982761.55861.66
3271461-27146159.71859.81
4251828-25182855.39955.49
5277218-27721860.98461.09
6263605-26360557.99058.09
20min1302150-30215066.46968.793.9066.6768.993.90
2315018-31501869.30069.51
3326170-32617071.75371.95
4296525-29652565.23265.42
5325980-32598071.71171.92
6310306-31030668.26368.46
30min1344211-34421175.72280.393.8776.0380.703.86
2373377-37337782.13882.46
3375302-37530282.56282.87
4351293-35129377.28077.58
5370195-37019581.43881.76
6378269-37826983.21483.52
45min1389063-38906385.58987.542.3286.0287.982.32
2391518-39151886.12986.59
3404668-40466889.02289.47
4388724-38872485.51485.94
5403580-40358088.78289.24
6409939-40993990.18190.63
60min1399723-39972387.93492.113.9488.5192.703.92
2427930-42793094.13994.74
3445995-44599598.11398.71
4414703-41470391.22991.80
5417340-41734091.80992.42
6406513-40651389.42890.03
极限1405282-40528289.15793.772.9489.8894.522.93
2441856-44185697.20397.96
3424718-42471893.43394.20
4434225-43422595.52496.24
5429815-42981594.55495.32
6421600-42160092.74793.50
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%
113.364517794517114514994517824517014516940.03
213.404521264514784518020.11
单位质量响应值RSD%判断
33809.4333716.570.20数据可信
长期6月-供试品溶液-2024102521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%
5min188453-8845319.55018.5315.5019.5518.5315.50
297778-9777821.61221.61
372080-7208015.93215.93
480118-8011817.70817.71
597570-9757021.56621.57
666906-6690614.78814.79
10min1194394-19439442.96642.244.5343.0042.274.53
2199274-19927444.04544.08
3185269-18526940.94940.98
4189083-18908341.79241.82
5200485-20048544.31244.35
6178087-17808739.36239.39
15min1257856-25785656.99356.682.5257.1056.792.54
2261103-26110357.71157.82
3251067-25106755.49255.59
4254032-25403256.14856.25
5265965-26596558.78558.90
6248720-24872054.97455.06
20min1296553-29655365.54665.952.8665.7566.142.87
2301745-30174566.69466.90
3299074-29907466.10366.29
4295909-29590965.40465.60
5311574-31157468.86669.07
6285396-28539663.08063.26
30min1353860-35386078.21277.481.7278.5277.781.72
2359796-35979679.52479.84
3351170-35117077.61877.92
4349884-34988477.33477.64
5345692-34569276.40776.73
6342820-34282075.77276.06
45min1381253-38125384.26786.081.4484.7186.521.44
2389778-38977886.15186.60
3393623-39362387.00187.43
4389397-38939786.06786.50
5397043-39704387.75788.21
6385656-38565685.24085.65
60min1396581-39658187.65589.072.9888.2389.642.97
2406412-40641289.82890.42
3412815-41281591.24391.81
4406862-40686289.92790.50
5413337-41333791.35891.95
6381896-38189684.40984.96
极限1423685-42368593.64693.570.8494.3794.300.82
2427261-42726194.43695.18
3424343-42434393.79194.51
4420101-42010192.85393.58
5418319-41831992.46093.21
6426462-42646294.25994.96
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%
113.364528464524494525204527044524124525860.05
213.404528444519034523740.15
单位质量响应值RSD%判断
33876.2033759.250.25数据可信
长期6月-供试品溶液-2024102521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%
5min172235-7223515.94016.4011.5915.9416.4011.58
285805-8580518.93518.93
362159-6215913.71713.72
482427-8242718.18918.19
573284-7328416.17216.17
669900-6990015.42515.42
10min1180901-18090139.91941.444.0839.9541.464.08
2197309-19730943.54043.57
3183132-18313240.41240.43
4195904-19590443.23043.26
5189648-18964841.84941.88
6179803-17980339.67739.70
15min1242373-24237353.48456.643.4653.5856.733.46
2255081-25508156.28856.39
3257402-25740256.80156.89
4263883-26388358.23158.33
5267804-26780459.09659.19
6253445-25344555.92756.02
20min1284600-28460062.80266.003.1762.9866.193.17
2298068-29806865.77465.97
3304954-30495467.29467.48
4303852-30385267.05167.25
5310681-31068168.55868.75
6292318-29231864.50664.69
30min1334199-33419973.74778.343.4774.0378.643.46
2355862-35586278.52878.84
3363688-36368880.25580.55
4361633-36163379.80180.11
5367135-36713581.01581.32
6347569-34756976.69876.99
45min1376009-37600982.97485.672.6983.3886.102.69
2395826-39582687.34787.78
3401248-40124888.54388.97
4393326-39332686.79587.24
5386496-38649685.28885.73
6376486-37648683.07983.50
60min1392171-39217186.54090.212.4187.0990.792.41
2406148-40614889.62490.21
3408369-40836990.11490.69
4418214-41821492.28792.88
5419310-41931092.52993.12
6408667-40866790.18090.74
极限1413287-41328791.20093.712.0691.8994.432.05
2421611-42161193.03693.77
3422050-42205093.13393.86
4433228-43322895.60096.34
5420950-42095092.89193.63
6436794-43679496.38797.10
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%
113.364525164522104524084526264530034525530.07
213.404575184569394572280.09
单位质量响应值RSD%判断
33873.7334121.490.52数据可信
长期6月-供试品溶液-2024102621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%
5min168720-6872015.08416.4610.5115.0816.4610.52
268118-6811814.95214.95
385447-8544718.75618.76
467730-6773014.86714.87
577551-7755117.02317.02
682427-8242718.09318.09
10min1177144-17714438.88439.613.4538.9139.643.45
2175690-17569038.56538.59
3191186-19118641.96642.00
4174957-17495738.40438.43
5179616-17961639.42639.45
6184097-18409740.41040.44
15min1233892-23389251.34053.032.6551.4353.132.65
2238352-23835252.31952.41
3249842-24984254.84154.94
4236045-23604551.81351.90
5245412-24541253.86953.96
6246134-24613454.02754.12
20min1285428-28542862.65263.012.2462.8363.192.24
2289002-28900263.43763.61
3291515-29151563.98964.18
4275686-27568660.51460.69
5286627-28662762.91663.10
6294127-29412764.56264.75
30min1332447-33244772.97374.952.2073.2575.242.20
2335176-33517673.57273.85
3345793-34579375.90376.20
4346196-34619675.99176.27
5337444-33744474.07074.36
6351618-35161877.18177.48
45min1380416-38041683.50384.870.8983.9085.280.90
2388447-38844785.26685.67
3388413-38841385.25885.68
4384970-38497084.50284.90
5387756-38775685.11485.53
6389784-38978485.55985.98
60min1401278-40127888.08289.821.6088.6290.381.60
2415166-41516691.13091.68
3404598-40459888.81189.38
4408408-40840889.64790.19
5407226-40722689.38889.94
6418629-41862991.89192.46
极限1419565-41956592.09694.452.1192.7895.152.11
2434219-43421995.31396.01
3444363-44436397.53998.26
4422219-42221992.67993.37
5427793-42779393.90294.61
6433534-43353495.16295.88
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%
113.364581454578214579544573614580914578740.07
213.404591484592204591840.02
单位质量响应值RSD%判断
34272.0134267.460.01数据可信
长期6月-供试品溶液-2024102621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%
5min172174-7217415.71615.133.7415.7215.133.73
272292-7229215.74215.74
368252-6825214.86214.86
466396-6639614.45814.46
570772-7077215.41115.41
667073-6707314.60614.61
10min1176095-17609538.34638.102.8038.3738.122.81
2180986-18098639.41139.44
3178286-17828638.82338.85
4171104-17110437.25937.28
5175753-17575338.27238.30
6167500-16750036.47436.50
15min1240924-24092452.46352.422.1852.5552.512.18
2246685-24668553.71853.81
3244270-24427053.19253.28
4239197-23919752.08752.17
5241931-24193152.68252.77
6231467-23146750.40450.49
20min1278217-27821760.58461.571.8460.7661.751.84
2290299-29029963.21563.40
3285852-28585262.24662.42
4278881-27888160.72860.90
5285501-28550162.17062.35
6277727-27772760.47760.65
30min1333201-33320172.55773.762.2772.8474.042.27
2338595-33859573.73274.02
3346347-34634775.42075.70
4343099-34309974.71274.99
5344773-34477375.07775.36
6326446-32644671.08671.36
45min1378900-37890082.50882.451.6982.9182.851.68
2382167-38216783.22083.63
3375827-37582781.83982.25
4389075-38907584.72485.12
5374944-37494481.64782.05
6370932-37093280.77381.16
60min1398863-39886386.85688.961.8987.3989.501.88
2413524-41352490.04890.60
3411995-41199589.71590.26
4419072-41907291.25691.80
5405959-40595988.40188.94
6401660-40166087.46587.99
极限1413444-41344490.03192.362.8490.7193.042.83
2422693-42269392.04592.74
3433716-43371694.44595.14
4440889-44088996.00796.70
5425184-42518492.58793.28
6408847-40884789.03089.70
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