塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681433626143531214333941435218143394514342990.07
29.651432703143378414332440.06
单位质量响应值RSD%判断
148171.38148522.690.17数据可信
中间条件36月-供试品溶液-2023010511批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1209025-20902514.03413.0515.1614.0313.0515.17
2213213-21321314.31514.32
3221793-22179314.89114.89
4178377-17837711.97611.98
5142308-1423089.5559.55
6201580-20158013.53413.53
10min1511825-51182534.36432.4012.4934.3832.4212.49
2519029-51902934.84834.87
3538068-53806836.12636.15
4439259-43925929.49229.51
5380449-38044925.54325.56
6506671-50667134.01834.04
15min1779703-77970352.34949.879.9652.4249.949.96
2772718-77271851.88051.95
3802130-80213053.85553.93
4698401-69840146.89146.95
5611774-61177441.07441.13
6791885-79188553.16753.24
20min1998585-99858567.04564.908.2267.2065.058.23
2986236-98623666.21666.37
31021011-102101168.55168.71
4942488-94248863.27963.41
5817970-81797054.91855.03
61033802-103380269.40969.56
30min11288176-128817686.48884.275.2686.7484.515.27
21265528-126552884.96785.22
31311603-131160388.06188.32
41243409-124340983.48283.71
51129550-112955075.83876.03
61292778-129277886.79787.05
45min11414418-141441894.96494.221.1595.3594.591.17
21383134-138313492.86493.24
31423930-142393095.60395.99
41401328-140132894.08594.44
51386559-138655993.09493.40
61410729-141072994.71695.10
60min11434187-143418796.29195.851.0396.8296.361.04
21402590-140259094.17094.69
31442094-144209496.82297.36
41437085-143708596.48696.98
51418121-141812195.21395.66
61432027-143202796.14696.67
极限11447465-144746597.18396.781.0897.8597.431.09
21417408-141740895.16595.82
31458208-145820897.90498.58
41455070-145507097.69398.33
51430395-143039596.03796.63
61440398-144039896.70897.38
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681432263143315414323721431203143341114324810.07
29.651436714143827414374940.08
单位质量响应值RSD%判断
147983.57148963.110.47数据可信
中间条件36月-供试品溶液-2023010511批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1245403-24540316.46215.1214.3916.4615.1114.38
2257364-25736417.26517.26
3234023-23402315.69915.70
4168898-16889811.33011.33
5239698-23969816.08016.08
6206523-20652313.85413.85
10min1566607-56660738.01035.919.4138.0335.939.42
2586286-58628639.33039.36
3545924-54592436.62236.65
4447224-44722430.00130.02
5557498-55749837.39937.42
6508069-50806934.08334.10
15min1834512-83451255.98253.906.9856.0653.986.99
2863469-86346957.92558.01
3816576-81657654.77954.86
4709559-70955947.60047.66
5830683-83068355.72555.81
6765838-76583851.37551.45
20min11052090-105209070.57868.546.2570.7468.706.25
21088974-108897473.05273.22
31035689-103568969.47869.64
4912333-91233361.20261.34
51057273-105727370.92671.09
6983644-98364465.98666.14
30min11331709-133170989.33687.754.0889.6188.024.09
21359405-135940591.19491.47
31329108-132910889.16189.43
41213617-121361781.41481.64
51336321-133632189.64589.92
61278590-127859085.77286.02
45min11433234-143323496.14695.041.8196.5595.431.83
21442713-144271396.78297.20
31431983-143198396.06296.46
41374945-137494592.23692.58
51419030-141903095.19395.60
61398165-139816593.79494.17
60min11451218-145121897.35396.521.5297.9097.061.54
21462602-146260298.11698.68
31453836-145383697.52898.07
41405754-140575494.30394.79
51439516-143951696.56897.12
61420068-142006895.26395.78
极限11465827-146582798.33398.121.1199.0398.801.13
21481146-148114699.360100.07
31477310-147731099.10399.79
41437096-143709696.40597.03
51461022-146102298.01098.70
61453958-145395897.53798.20
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681439534143889414369731438773143862414385600.07
29.651438932143924314390880.02
单位质量响应值RSD%判断
148611.57149128.290.25数据可信
中间条件36月-供试品溶液-2023010611批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189611-18961112.68611.958.7612.6911.958.76
2156735-15673510.48610.49
3177851-17785111.89911.90
4201622-20162213.48913.49
5176973-17697311.84011.84
6169047-16904711.31011.31
10min1475719-47571931.82829.778.4031.8529.788.39
2392355-39235526.25026.27
3457277-45727730.59430.61
4492984-49298432.98333.00
5430540-43054028.80528.82
6420575-42057528.13828.16
15min1733372-73337249.06646.507.1349.1346.567.14
2623264-62326441.69941.75
3719829-71982948.16048.22
4755561-75556150.55050.62
5670012-67001244.82744.89
6667665-66766544.67044.73
20min1944419-94441963.18661.035.4863.3361.165.49
2839778-83977856.18556.30
3945049-94504963.22863.36
4973103-97310365.10565.25
5886683-88668359.32359.45
6884449-88444959.17359.30
30min11255170-125517083.97682.523.2484.2182.743.25
21170783-117078378.33078.53
31266157-126615784.71184.94
41274459-127445985.26785.51
51205398-120539880.64680.86
61228194-122819482.17182.39
45min11445405-144540596.70495.750.6997.0696.090.69
21421883-142188395.13095.45
31418764-141876494.92195.28
41436281-143628196.09396.46
51430342-143034295.69696.03
61433814-143381495.92896.27
60min11456327-145632797.43497.861.6097.9498.351.58
21462258-146225897.83198.29
31439959-143995996.33996.84
41444563-144456396.64797.16
51467881-146788198.20798.69
61505110-1505110100.698101.18
极限11467358-146735898.17298.200.6798.8298.830.65
21470074-147007498.35498.96
31456517-145651797.44798.09
41456619-145661997.45498.11
51480635-148063599.06199.69
61475021-147502198.68599.32
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681436486143645514384911438508143844314376770.08
29.651429650142818014289150.08
单位质量响应值RSD%判断
148520.35148074.090.22数据可信
中间条件36月-供试品溶液-2023010611批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193341-19334112.98511.4912.5212.9911.4912.53
2195351-19535113.12013.12
3152797-15279710.26210.26
4172204-17220411.56611.57
5141588-1415889.5099.51
6170939-17093911.48111.48
10min1482293-48229332.39228.1211.6532.4128.1411.64
2467802-46780231.41931.44
3378191-37819125.40025.42
4418352-41835228.09828.11
5358176-35817624.05624.07
6407651-40765127.37927.40
15min1763352-76335251.26944.2610.2151.3444.3210.21
2711024-71102447.75447.82
3607669-60766940.81340.87
4653295-65329543.87743.94
5582591-58259139.12839.18
6636193-63619342.72842.79
20min1999897-99989767.15658.608.7167.3058.728.71
2922339-92233961.94762.09
3823910-82391055.33655.45
4859715-85971557.74157.87
5794131-79413153.33653.44
6834646-83464656.05756.18
30min11277914-127791485.82879.075.0486.0779.285.05
21217855-121785581.79482.03
31144254-114425476.85177.05
41161211-116121177.99078.20
51120252-112025275.23975.43
61142409-114240976.72776.93
45min11413489-141348994.93494.822.0195.3195.152.02
21465561-146556198.43198.78
31404582-140458294.33594.65
41397571-139757193.86494.19
51383088-138308892.89293.19
61406724-140672494.47994.80
60min11438685-143868596.62697.170.7597.1497.650.75
21455376-145537697.74798.25
31450321-145032197.40797.86
41444105-144410596.99097.46
51431784-143178496.16296.60
61460702-146070298.10598.57
极限11456828-145682897.84498.260.7098.5198.880.70
21471781-147178198.84999.50
31464690-146469098.37298.97
41464502-146450298.36098.97
51446600-144660097.15797.74
61473961-147396198.99599.61
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681435229143577314355131435748143678214358090.05
29.651433315143401314336640.04
单位质量响应值RSD%判断
148327.38148566.220.12数据可信
中间条件36月-供试品溶液-2023010711批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156289-15628910.48610.639.2410.4910.629.24
2152189-15218910.21110.21
3152345-15234510.22210.22
4175190-17519011.75411.75
5175922-17592211.80311.80
6138383-1383839.2859.28
10min1400825-40082526.89327.837.5726.9127.847.57
2419163-41916328.12428.14
3391918-39191826.29626.31
4433069-43306929.05729.07
5465181-46518131.21131.23
6378551-37855125.39925.41
15min1639913-63991342.93543.965.8742.9944.025.87
2673427-67342745.18345.24
3624791-62479141.92041.97
4675503-67550345.32345.38
5711124-71112447.71347.78
6606765-60676540.71140.76
20min1855140-85514057.37558.264.4057.5058.384.40
2887852-88785259.57059.70
3841623-84162356.46956.59
4882417-88241759.20659.33
5925219-92521962.07762.21
6817592-81759254.85654.97
30min11178917-117891779.09979.833.3179.3180.043.31
21231181-123118182.60682.82
31159307-115930777.78377.99
41193553-119355380.08180.30
51237742-123774283.04683.28
61138343-113834376.37776.57
45min11413193-141319394.81894.240.9895.1494.580.99
21385747-138574792.97693.31
31396025-139602593.66693.99
41410997-141099794.67195.01
51423530-142353095.51195.87
61398408-139840893.82694.14
60min11443047-144304796.82196.590.8397.2997.060.83
21417888-141788895.13395.61
31434937-143493796.27796.74
41443395-144339596.84497.32
51446758-144675897.07097.57
61451323-145132397.37697.83
极限11464912-146491298.28898.641.8998.9099.261.87
21447453-144745397.11797.74
31525198-1525198102.333102.94
41464348-146434898.25098.88
51457821-145782197.81298.45
61461460-146146098.05698.65
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681432610143124214320911433352143247514323540.06
29.651430565143281214316880.12
单位质量响应值RSD%判断
147970.45148361.450.19数据可信
中间条件36月-供试品溶液-2023010711批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159430-15943010.71712.2111.2910.7212.2111.30
2189322-18932212.72712.73
3170507-17050711.46211.46
4190537-19053712.80812.81
5214632-21463214.42814.43
6165584-16558411.13111.13
10min1487574-48757432.77631.047.9732.7931.067.97
2451627-45162730.35930.38
3431010-43101028.97328.99
4469737-46973731.57731.60
5515171-51517134.63134.65
6415575-41557527.93627.95
15min1799525-79952553.74648.338.2053.8148.408.20
2695686-69568646.76546.83
3667239-66723944.85344.91
4715712-71571248.11248.18
5779705-77970552.41352.49
6656119-65611944.10644.16
20min11069321-106932171.88263.188.3872.0363.318.38
2905299-90529960.85660.99
3873311-87331158.70658.83
4930525-93052562.55262.69
5994562-99456266.85667.01
6865772-86577258.19958.32
30min11326316-132631689.15883.455.1589.4183.685.16
21203890-120389080.92881.15
31175721-117572179.03479.25
41245185-124518583.70483.94
51309278-130927888.01288.26
61187913-118791379.85480.07
45min11418612-141861295.36294.480.9795.7594.840.98
21401681-140168194.22494.57
31382806-138280692.95593.29
41414321-141432195.07495.43
51415612-141561295.16095.54
61400062-140006294.11594.45
60min11434693-143469396.44396.180.7496.9796.680.75
21431427-143142796.22396.71
31410414-141041494.81195.28
41441287-144128796.88697.39
51434317-143431796.41896.94
61432361-143236196.28696.76
极限11455740-145574097.85897.550.5398.5398.200.54
21458273-145827398.02898.66
31437190-143719096.61197.23
41455636-145563697.85198.50
51451351-145135197.56398.23
61449089-144908997.41198.03
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682874035287630428762832877887287696428762950.05
29.652867942287037928691600.07
单位质量响应值RSD%判断
297137.91297322.280.05数据可信
中间条件36月-供试品溶液-2023010811批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1332561-33256111.14411.234.1311.1411.234.15
2337925-33792511.32411.32
3327943-32794310.98910.99
4329932-32993211.05611.06
5360990-36099012.09712.10
6321202-32120210.76310.76
10min1863564-86356428.93829.192.8528.9529.212.84
2887391-88739129.73629.75
3849691-84969128.47328.49
4857052-85705228.71928.74
5913949-91394930.62630.64
6855281-85528128.66028.68
15min11351963-135196345.30345.302.5645.3645.362.56
21383681-138368146.36646.43
31321307-132130744.27644.34
41328042-132804244.50244.56
51403380-140338047.02647.09
61323533-132353344.35144.41
20min11755811-175581158.83659.193.0558.9659.323.05
21841353-184135361.70361.83
31698507-169850756.91657.04
41735142-173514258.14458.27
51819241-181924160.96261.10
61748272-174827258.58458.71
30min12335605-233560578.26577.631.5678.4877.841.56
22352402-235240278.82879.05
32249863-224986375.39275.60
42320871-232087177.77177.98
52333291-233329178.18778.41
62307394-230739477.31977.53
45min12750830-275083092.17991.811.2092.5192.141.20
22753223-275322392.25992.60
32682982-268298289.90590.23
42776835-277683593.05093.38
52722775-272277591.23991.58
62752076-275207692.22092.55
60min13016550-3016550101.08397.492.70101.5597.962.70
23001167-3001167100.567101.05
32836992-283699295.06695.52
42879828-287982896.50196.97
52852476-285247695.58596.06
62869676-286967696.16196.63
极限12913917-291391797.64497.681.0698.2798.301.05
22922050-292205097.91698.55
32882126-288212696.57897.18
42971131-297113199.561100.18
52900502-290050297.19497.82
62901059-290105997.21397.82
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682865589286756928684212868000286538528669930.05
29.652861318286300828621630.05
单位质量响应值RSD%判断
296176.96296597.200.11数据可信
中间条件36月-供试品溶液-2023010811批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1335009-33500911.25811.142.3611.2611.142.34
2336630-33663011.31211.31
3322528-32252810.83810.84
4342323-34232311.50411.50
5324549-32454910.90610.91
6327125-32712510.99310.99
10min1865505-86550529.08528.571.5529.1028.581.56
2861784-86178428.96028.98
3830987-83098727.92527.94
4855770-85577028.75828.78
5842637-84263728.31728.33
6843741-84374128.35428.37
15min11336078-133607844.89944.181.0244.9644.241.02
21319666-131966644.34744.41
31297886-129788643.61543.67
41319307-131930744.33544.40
51307292-130729243.93143.99
61307968-130796843.95444.01
20min11736879-173687958.36757.550.9758.5057.680.98
21718372-171837257.74557.87
31694098-169409856.93057.05
41724387-172438757.94858.07
51703432-170343257.24357.37
61698913-169891357.09157.22
30min12310135-231013577.63176.341.0777.8576.561.07
22270132-227013276.28776.50
32235327-223532775.11875.33
42262291-226229176.02476.24
52275163-227516376.45676.67
62278040-227804076.55376.76
45min12742774-274277492.17090.950.7892.5091.280.78
22704005-270400590.86791.20
32676971-267697189.95990.28
42703503-270350390.85091.18
52705032-270503290.90291.23
62707333-270733390.97991.30
60min12867578-286757896.36495.930.5696.8396.390.56
22847686-284768695.69696.16
32835117-283511795.27395.73
42842988-284298895.53896.00
52856895-285689596.00596.47
62877614-287761496.70197.16
极限12908036-290803697.72497.390.2398.3497.990.23
22897981-289798197.38697.99
32892613-289261397.20597.80
42889538-288953897.10297.71
52898242-289824297.39598.00
62901600-290160097.50798.11
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682866916287174328753412877693287686628737120.16
29.652861426287934628703860.45
单位质量响应值RSD%判断
296871.07297449.330.14数据可信
中间条件36月-供试品溶液-2023011011批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1369694-36969412.39112.4310.8712.3912.4310.89
2445382-44538214.92814.93
3346098-34609811.60011.60
4382128-38212812.80812.81
5337722-33772211.32011.32
6343850-34385011.52511.52
10min1883165-88316529.60131.088.9029.6231.108.89
21090411-109041136.54836.57
3879587-87958729.48129.50
4933587-93358731.29131.31
5896968-89696830.06430.08
6880374-88037429.50829.53
15min11371387-137138745.96547.236.8146.0347.306.81
21600770-160077053.65353.73
31339531-133953144.89744.96
41402480-140248047.00747.07
51366913-136691345.81545.88
61374360-137436046.06546.13
20min11739020-173902058.28760.145.5858.4260.285.59
21992129-199212966.77166.93
31731556-173155658.03758.17
41793049-179304960.09860.23
51733735-173373558.11058.24
61776519-177651959.54459.67
30min12310106-231010677.42978.243.0177.6578.473.02
22469824-246982482.78283.04
32274168-227416876.22476.44
42290738-229073876.77977.01
52325014-232501477.92878.15
62335722-233572278.28778.51
45min12704747-270474790.65691.941.4690.9992.291.47
22802409-280240993.92994.31
32693561-269356190.28190.61
42741974-274197491.90492.25
52751145-275114592.21192.55
62765338-276533892.68793.02
60min12776256-277625693.05395.262.2393.5295.742.23
22907525-290752597.45297.98
32760729-276072992.53293.00
42829777-282977794.84795.33
52881546-288154696.58297.05
62897503-289750397.11697.59
极限12874208-287420896.33696.861.6196.9597.491.59
22848564-284856495.47696.15
32862822-286282295.95496.56
42856819-285681995.75396.37
52955796-295579699.07099.69
62941467-294146798.59099.21
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682850875286903928761042887492288503628737090.52
29.652877394288242928799120.13
单位质量响应值RSD%判断
296870.76298436.480.38数据可信
中间条件36月-供试品溶液-2023011011批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1369813-36981312.37512.209.5012.3712.209.49
2331665-33166511.09811.10
3358262-35826211.98811.99
4339567-33956711.36311.36
5358503-35850311.99612.00
6429173-42917314.36114.36
10min1924821-92482130.94630.786.6130.9630.806.61
2880260-88026029.45529.47
3893388-89338829.89429.91
4883206-88320629.55429.57
5898111-89811130.05330.07
61039743-103974334.79234.81
15min11416941-141694147.41446.555.8347.4846.615.83
21343574-134357444.95945.02
31365775-136577545.70145.76
41335067-133506744.67444.74
51340355-134035544.85144.91
61544498-154449851.68251.76
20min11825126-182512661.07260.043.9661.2160.183.97
21759467-175946758.87559.00
31747091-174709158.46158.59
41752752-175275258.65058.78
51754801-175480158.71958.85
61926594-192659464.46864.62
30min12356523-235652378.85478.121.6379.0878.341.64
22314049-231404977.43377.65
32296383-229638376.84177.06
42306485-230648577.17977.40
52335257-233525778.14278.36
62398450-239845080.25780.50
45min12755423-275542392.20291.330.5692.5591.680.56
22710373-271037390.69491.03
32732783-273278391.44491.78
42723897-272389791.14791.48
52731899-273189991.41591.75
62722366-272236691.09691.46
60min12872056-287205696.10595.330.7496.5995.810.73
22836588-283658894.91895.39
32858498-285849895.65196.12
42840166-284016695.03795.51
52868611-286861195.98996.46
62818156-281815694.30194.81
极限12908397-290839797.32196.611.2497.9597.231.24
22858964-285896495.66696.28
32889243-288924396.68097.29
42830343-283034394.70995.32
52918748-291874897.66798.28
62916554-291655497.59498.24
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682839512287008328802702880543287768228696180.61
29.652877800290360828907040.64
单位质量响应值RSD%判断
296448.14299554.820.74数据可信
中间条件36月-供试品溶液-2023011111批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1330401-33040111.04310.923.7811.0410.923.79
2315766-31576610.55410.55
3327710-32771010.95310.95
4348798-34879811.65811.66
5316631-31663110.58310.58
6320793-32079310.72210.72
10min1832907-83290727.83927.512.1827.8627.532.18
2798125-79812526.67626.69
3846028-84602828.27728.29
4833182-83318227.84827.87
5807199-80719926.97927.00
6821878-82187827.47027.49
15min11288303-128830343.06043.131.7243.1243.191.72
21286283-128628342.99243.05
31331373-133137344.49944.56
41293004-129300443.21743.28
51277676-127767642.70442.76
61266454-126645442.32942.39
20min11656845-165684555.37855.991.1055.5056.111.10
21673126-167312655.92256.04
31710131-171013157.15957.28
41675913-167591356.01556.14
51669073-166907355.78655.91
61665963-166596355.68255.80
30min12231162-223116274.57374.541.3074.7874.741.30
22234198-223419874.67574.88
32276291-227629176.08276.29
42240754-224075474.89475.10
52200592-220059273.55273.76
62197616-219761673.45273.66
45min12682847-268284789.67090.090.6889.9990.400.67
22667030-266703089.14289.46
32705260-270526090.41990.74
42715924-271592490.77691.10
52707651-270765190.49990.81
62692904-269290490.00690.32
60min12829153-282915394.56095.000.6795.0195.460.66
22833446-283344694.70495.15
32820385-282038594.26794.73
42851194-285119495.29795.75
52872696-287269696.01696.47
62847666-284766695.17995.63
极限12902413-290241397.00997.341.0397.6097.941.03
22897005-289700596.82897.42
32931296-293129697.97498.58
42864566-286456695.74496.34
52933681-293368198.05498.65
62945012-294501298.43399.03
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682888551286709528603152867704287105628709440.37
29.652888443289955028939960.28
单位质量响应值RSD%判断
296585.12299895.960.79数据可信
中间条件36月-供试品溶液-2023011111批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1383331-38333112.80211.519.6912.8011.519.67
2387908-38790812.95512.95
3323194-32319410.79410.79
4335172-33517211.19411.19
5305570-30557010.20510.21
6333452-33345211.13611.14
10min1894394-89439429.87028.484.8229.8928.504.82
2912782-91278230.48430.50
3815508-81550827.23527.25
4839074-83907428.02228.04
5816937-81693727.28327.30
6837651-83765127.97527.99
15min11355487-135548745.26944.034.1945.3344.094.20
21408527-140852747.04047.11
31296608-129660843.30343.36
41309338-130933843.72843.79
51254042-125404241.88141.94
61286225-128622542.95643.01
20min11751858-175185858.50756.423.8658.6456.553.86
21784101-178410159.58359.72
31682285-168228556.18356.31
41655592-165559255.29255.42
51643475-164347554.88755.01
61618497-161849754.05354.18
30min12276649-227664976.03374.902.4476.2575.112.44
22272283-227228375.88776.11
32233250-223325074.58474.79
42312641-231264177.23577.44
52194278-219427873.28273.48
62167974-216797472.40472.61
45min12680699-268069989.52789.501.4989.8689.821.49
22709497-270949790.48990.83
32720489-272048990.85691.17
42701970-270197090.23790.56
52616521-261652187.38487.69
62650211-265021188.50988.82
60min12768268-276826892.45294.041.3392.9294.501.32
22856462-285646295.39795.87
32860850-286085095.54396.00
42785418-278541893.02493.48
52817539-281753994.09794.54
62806241-280624193.72094.17
极限12861104-286110495.55296.371.4396.1696.971.42
22904153-290415396.99097.61
32921725-292172597.57798.17
42877981-287798196.11696.71
52928605-292860597.80698.39
62819907-281990794.17694.76
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