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%
113.364555344547814555174552554561244554420.11
213.404556344552224554280.07
单位质量响应值RSD%判断
34089.9733987.160.22数据可信
长期6月-供试品溶液-2024102421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%
5min126316-263165.7695.7651.675.775.7651.68
234284-342847.5167.52
331480-314806.9026.90
438085-380858.3508.35
5-0.0000.00
627594-275946.0506.05
10min1110630-11063024.25421.7532.0124.2621.7632.02
2109925-10992524.10024.11
3114346-11434625.06925.08
4117514-11751425.76325.78
534763-347637.6217.62
6108161-10816123.71323.72
15min1180230-18023039.51335.7426.9139.5635.7926.93
2173282-17328237.99038.04
3190860-19086041.84441.90
4187495-18749541.10641.16
574845-7484516.40916.42
6171468-17146837.59237.64
20min1235546-23554651.64047.4417.1151.7647.5517.15
2224371-22437149.19049.31
3239253-23925352.45352.58
4234129-23412951.33051.46
5141963-14196331.12431.16
6223125-22312548.91749.03
30min1307183-30718367.34665.706.4367.5565.886.48
2299321-29932165.62265.82
3314651-31465168.98369.19
4310675-31067568.11168.32
5261872-26187257.41257.50
6304361-30436166.72766.92
45min1346744-34674476.01977.363.6076.3377.663.63
2343140-34314075.22975.54
3373325-37332581.84782.17
4355114-35511477.85478.18
5338779-33877974.27374.46
6360077-36007778.94279.25
60min1395475-39547586.70387.992.5387.1488.412.53
2386656-38665684.76985.20
3417081-41708191.44091.90
4404956-40495688.78189.24
5401487-40148788.02188.33
6402312-40231288.20288.64
极限1406704-40670489.16589.273.2389.7589.843.21
2388366-38836685.14485.72
3425345-42534593.25193.87
4411824-41182490.28790.89
5414110-41411090.78891.25
6396826-39682686.99987.58
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%
113.364546234543954549914544144544444545730.06
213.404558454564274561360.10
单位质量响应值RSD%判断
34024.9334040.000.04数据可信
长期6月-供试品溶液-2024102421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%
5min123837-238375.2277.3620.635.237.3620.65
233247-332477.2907.29
332524-325247.1327.13
444990-449909.8659.87
535915-359157.8757.88
630805-308056.7556.75
10min1103980-10398022.80025.237.0222.8125.247.03
2112471-11247124.66224.67
3115341-11534125.29225.30
4128110-12811028.09128.11
5118839-11883926.05926.07
6111670-11167024.48724.50
15min1178336-17833639.10540.524.3739.1540.574.38
2181799-18179939.86439.92
3186250-18625040.84040.89
4197586-19758643.32643.39
5189374-18937441.52541.58
6175399-17539938.46138.51
20min1222463-22246348.78150.262.8948.8950.382.89
2232762-23276251.03951.16
3231249-23124950.70750.83
4235710-23571051.68651.82
5233508-23350851.20351.33
6219445-21944548.11948.24
30min1289026-28902663.37667.964.5963.5768.174.59
2304601-30460166.79267.00
3328588-32858872.05172.26
4315209-31520969.11869.34
5320209-32020970.21470.43
6301927-30192766.20566.40
45min1355696-35569677.99679.811.2578.2980.131.25
2362686-36268679.52879.84
3365206-36520680.08180.41
4366919-36691980.45780.79
5364752-36475279.98180.31
6368545-36854580.81381.12
60min1377460-37746082.76885.512.4783.2085.972.47
2382357-38235783.84284.29
3400400-40040087.79888.26
4385487-38548784.52885.00
5400017-40001787.71488.18
6394193-39419386.43786.88
极限1402487-40248788.25690.421.9988.8291.021.99
2412330-41233090.41491.00
3425682-42568293.34293.95
4413299-41329990.62791.24
5415207-41520791.04591.65
6405223-40522388.85689.44
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%
113.364554664561184538124546644545804549280.20
213.404563094552034557560.18
单位质量响应值RSD%判断
34051.5034011.640.09数据可信
长期6月-供试品溶液-2024102521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%
5min130580-305806.7068.5213.886.718.5213.86
245324-453249.9399.94
343508-435089.5419.54
436763-367638.0618.06
540493-404938.8798.88
636383-363837.9787.98
10min1109962-10996224.11326.085.8724.1226.095.88
2126661-12666127.77427.79
3123626-12362627.10927.12
4118456-11845625.97525.99
5123663-12366327.11727.13
6111260-11126024.39724.41
15min1178372-17837239.11440.954.3839.1741.004.38
2198879-19887943.61143.67
3184885-18488540.54240.60
4190314-19031441.73241.79
5190436-19043641.75941.82
6177462-17746238.91438.97
20min1226559-22655949.68051.183.9149.8051.313.91
2234238-23423851.36451.50
3238973-23897352.40252.53
4241717-24171753.00453.13
5240438-24043852.72452.85
6218601-21860147.93548.05
30min1301499-30149966.11368.282.8966.3168.492.89
2318631-31863169.87070.09
3311464-31146468.29868.51
4322123-32212370.63670.85
5314401-31440168.94269.16
6300071-30007165.80066.00
45min1354416-35441677.71780.592.4578.0380.922.45
2374507-37450782.12382.46
3369635-36963581.05481.38
4379569-37956983.23383.56
5363988-36398879.81680.15
6363074-36307479.61679.92
60min1390590-39059085.64987.231.5186.0987.691.51
2401694-40169488.08488.56
3390932-39093285.72486.19
4405268-40526888.86889.34
5400832-40083287.89588.36
6397492-39749287.16387.60
极限1409445-40944589.78490.831.8790.3791.441.87
2419707-41970792.03492.66
3412161-41216190.37990.99
4416173-41617391.25991.88
5424823-42482393.15693.77
6403080-40308088.38888.97
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%
113.364549874569054563874552284553234557660.19
213.404565794564774565280.02
单位质量响应值RSD%判断
34114.2234069.250.10数据可信
长期6月-供试品溶液-2024102521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%
5min122709-227094.9715.5152.764.975.5152.76
2-0.0000.00
334345-343457.5187.52
435335-353357.7357.73
526168-261685.7285.73
632556-325567.1267.13
10min1102740-10274022.48920.6445.3322.5020.6545.33
27641-76411.6731.67
3115735-11573525.33425.35
4115609-11560925.30625.32
5109980-10998024.07424.08
6114147-11414724.98625.00
15min1170204-17020437.25734.0237.4537.3034.0737.45
237197-371978.1428.15
3185161-18516140.53140.59
4182515-18251539.95240.01
5174833-17483338.27038.32
6182653-18265339.98240.04
20min1225286-22528649.31446.1227.4249.4246.2227.45
293514-9351420.47020.49
3244771-24477153.57953.70
4230980-23098050.56050.68
5233240-23324051.05551.17
6236263-23626351.71751.84
30min1300340-30034065.74363.8811.6365.9364.0611.70
2223502-22350248.92348.97
3316323-31632369.24169.45
4304211-30421166.59066.80
5303413-30341366.41666.61
6303176-30317666.36466.57
45min1355735-35573577.86977.943.2978.1778.233.35
2338397-33839774.07374.21
3369902-36990280.97081.30
4351997-35199777.05077.37
5368214-36821480.60080.91
6352150-35215077.08477.40
60min1395994-39599486.68186.011.7687.1186.421.74
2396629-39662986.82087.08
3403336-40333688.28888.75
4387390-38739084.79885.24
5389010-38901085.15285.60
6385120-38512084.30184.75
极限1417814-41781491.45790.802.7692.0391.362.68
2434138-43413895.03195.43
3418043-41804391.50792.12
4410375-41037589.82990.42
5401262-40126287.83488.42
6407188-40718889.13189.72
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%
113.364581684583344585544577864576884581060.08
213.404601654603924602780.04
单位质量响应值RSD%判断
34289.3734349.100.13数据可信
长期6月-供试品溶液-2024102621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%
5min134520-345207.5067.556.067.517.556.08
235317-353177.6797.68
335168-351687.6477.65
430955-309556.7316.73
537419-374198.1378.14
634904-349047.5907.59
10min1105969-10596923.04223.793.6023.0523.813.61
2104518-10451822.72722.74
3111672-11167224.28224.30
4109577-10957723.82723.84
5115450-11545025.10425.12
6109344-10934423.77623.79
15min1169404-16940436.83637.863.6036.8937.913.60
2163616-16361635.57735.63
3179658-17965839.06639.12
4177799-17779938.66138.71
5178061-17806138.71838.77
6176119-17611938.29638.35
20min1216891-21689147.16248.773.3747.2748.883.37
2213945-21394546.52146.63
3228744-22874449.73949.86
4226141-22614149.17349.29
5234132-23413250.91151.03
6225845-22584549.10949.22
30min1287079-28707962.42464.522.6962.6164.722.69
2288488-28848862.73062.92
3295008-29500864.14864.35
4307371-30737166.83667.03
5301196-30119665.49365.70
6301183-30118365.49065.69
45min1348010-34801075.67378.102.2675.9778.402.26
2353146-35314676.78977.08
3355587-35558777.32077.63
4368726-36872680.17780.49
5364272-36427279.20979.52
6365282-36528279.42879.74
60min1389019-38901984.59083.962.8085.0184.402.80
2367900-36790079.99880.42
3380987-38098782.84383.28
4391843-39184385.20485.65
5399641-39964186.89987.35
6387345-38734584.22684.67
极限1396485-39648586.21388.902.5586.7889.472.54
2402929-40292987.61488.17
3402165-40216587.44888.02
4412723-41272389.74490.33
5413359-41335989.88290.47
6425368-42536892.49493.07
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%
113.364606934609684602754595884600404603130.12
213.404634914629054631980.09
单位质量响应值RSD%判断
34454.5734567.010.24数据可信
长期6月-供试品溶液-2024102621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%
5min141449-414498.9638.4013.518.968.4013.48
242313-423139.1509.15
339009-390098.4358.44
438585-385858.3448.34
542933-429339.2849.28
628749-287496.2176.22
10min1115648-11564825.00724.776.2125.0224.786.22
2119761-11976125.89725.91
3117615-11761525.43325.45
4112769-11276924.38524.40
5120235-12023525.99926.01
6101148-10114821.87221.88
15min1173924-17392437.60938.144.6137.6738.194.61
2184466-18446639.88839.95
3178149-17814938.52238.58
4174279-17427937.68637.74
5184537-18453739.90439.96
6162807-16280735.20535.25
20min1214855-21485546.46048.204.2146.5848.324.21
2229048-22904849.52949.65
3230759-23075949.89950.02
4218134-21813447.16947.29
5233504-23350450.49250.62
6211065-21106545.64045.75
30min1285637-28563761.76563.502.4861.9663.702.48
2299272-29927264.71464.92
3300214-30021464.91765.12
4288980-28898062.48862.68
5301125-30112565.11465.32
6286767-28676762.01062.19
45min1347829-34782975.21477.712.5275.5178.022.53
2368901-36890179.77080.09
3363146-36314678.52678.84
4353544-35354476.44976.75
5369409-36940979.88080.20
6353442-35344276.42776.71
60min1366575-36657579.26782.752.7079.6983.182.70
2389793-38979384.28884.74
3394879-39487985.38885.83
4375303-37530381.15581.58
5387016-38701683.68784.14
6382521-38252182.71583.13
极限1393824-39382485.15987.582.5785.7288.152.57
2411925-41192589.07489.66
3416691-41669190.10490.69
4391181-39118184.58885.15
5411377-41137788.95589.55
6405103-40510387.59888.15
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