对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
113.263179493318200731832503169688317123631771350.20
213.343163304315790131606020.13
单位质量响应值RSD%判断
239602.94236926.690.80数据可信
供试品溶液-25120901批-布洛芬-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1238469-2384698.9998.965.849.008.965.85
2226388-2263888.5438.54
3244407-2444079.2239.22
4249242-2492429.4069.41
5215742-2157428.1418.14
6250730-2507309.4629.46
10min1340286-34028612.84112.554.9412.8912.604.95
2318112-31811212.00412.05
3341649-34164912.89312.94
4346751-34675113.08513.14
5306183-30618311.55411.60
6342501-34250112.92512.98
15min1425544-42554416.05915.724.9616.1815.844.96
2398141-39814115.02415.14
3423170-42317015.96916.09
4433562-43356216.36116.49
5384225-38422514.49914.61
6434795-43479516.40816.53
20min1497791-49779118.78518.344.7419.0018.554.75
2467110-46711017.62717.82
3501822-50182218.93719.15
4503560-50356019.00319.22
5448044-44804416.90817.10
6498186-49818618.80019.02
30min1614419-61441923.18623.6011.2123.5023.9011.12
2579958-57995821.88622.18
3614572-61457223.19223.51
4760432-76043228.69629.02
5562240-56224021.21721.50
6620146-62014623.40223.72
45min1761323-76132328.73028.567.1729.1729.007.11
2715731-71573127.00927.43
3754174-75417428.46028.91
4761659-76165928.74229.22
5695723-69572326.25426.66
6852857-85285732.18432.63
60min1868785-86878532.78531.914.0833.3932.504.11
2803336-80333630.31530.88
3862610-86261032.55233.16
4869381-86938132.80733.45
5798926-79892630.14930.70
6869853-86985332.82533.45
极限1977654-97765436.89336.243.2137.6837.013.25
2927207-92720734.99035.73
3981866-98186637.05237.84
4982106-98210637.06137.88
5914545-91454534.51235.23
6978168-97816836.91337.72
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数50
标示量(mg)640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%
144.303516327351820335215173505869350869935141230.19
244.213497999349249534952470.12
单位质量响应值RSD%判断
79325.5879060.100.24数据可信
供试品溶液-25120901批-对乙酰氨基酚-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12664789-266478994.54495.195.3194.5495.195.31
22535904-253590489.97289.97
32789032-278903298.95398.95
42748406-274840697.51197.51
52501281-250128188.74388.74
62858564-2858564101.419101.42
10min12715016-271501696.32696.255.4296.8596.785.42
22548691-254869190.42590.93
32809504-280950499.679100.23
42762181-276218198.00098.54
52535036-253503689.94190.43
62906739-2906739103.129103.69
15min12720496-272049696.52195.925.4297.5896.985.42
22541280-254128090.16291.16
32790566-279056699.007100.11
42754852-275485297.74098.83
52519459-251945989.38890.38
62894889-2894889102.708103.84
20min12715491-271549196.34395.545.4297.9497.145.42
22527544-252754489.67591.18
32789081-278908198.954100.61
42738334-273833497.15498.78
52510091-251009189.05690.55
62876839-2876839102.068103.77
30min12697289-269728995.69894.815.3997.8396.945.39
22514061-251406189.19791.20
32764026-276402698.065100.27
42719028-271902896.46998.64
52486718-248671888.22790.21
62853309-2853309101.233103.51
45min12676624-267662494.96494.185.3797.6396.835.37
22496242-249624288.56591.06
32741254-274125497.257100.01
42708427-270842796.09398.80
52471361-247136187.68290.16
62832693-2832693100.502103.34
60min12671331-267133194.77793.695.3697.9796.865.36
22474149-247414987.78190.77
32731353-273135396.906100.19
42683377-268337795.20498.44
52467185-246718587.53490.49
62816853-281685399.940103.33
极限12649252-264925293.99393.025.3897.7196.725.38
22456746-245674687.16390.64
32720116-272011696.507100.33
42659740-265974094.36598.13
52449315-244931586.90090.35
62796288-279628899.210103.16
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
113.263177166316303231731253169231318550931736130.27
213.343167891316510731664990.07
单位质量响应值RSD%判断
239337.33237368.740.59数据可信
供试品溶液-25120901批-布洛芬-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1755198-75519828.48826.826.4628.4926.826.47
2772098-77209829.12529.13
3708764-70876426.73626.74
4696378-69637826.26926.27
5648027-64802724.44524.44
6685490-68549025.85825.86
10min1994627-99462737.51936.244.2537.6836.394.27
21016428-101642838.34238.50
3969163-96916336.55936.71
4942967-94296735.57135.72
5905548-90554834.15934.29
6935221-93522135.27835.42
15min11195432-119543245.09443.435.3945.4643.785.39
21199521-119952145.24845.62
31216738-121673845.89846.25
41121223-112122342.29542.64
51059015-105901539.94840.27
61115610-111561042.08342.42
20min11344040-134404050.70048.674.4451.3249.264.45
21358359-135835951.24051.87
31312268-131226849.50150.11
41266481-126648147.77448.35
51213785-121378545.78646.33
61246070-124607047.00447.58
30min11553762-155376258.61156.623.7959.5157.483.80
21558489-155848958.78959.70
31525263-152526357.53658.42
41493817-149381756.35057.19
51412745-141274553.29254.09
61461064-146106455.11455.95
45min11746184-174618465.87064.433.9067.0965.603.87
21719862-171986264.87766.11
31704784-170478464.30865.51
41685777-168577763.59164.75
51596534-159653460.22461.32
61794905-179490567.70768.85
60min11865528-186552870.37168.603.2071.9670.133.22
21870299-187029970.55172.15
31854132-185413269.94271.50
41811613-181161368.33869.85
51719319-171931964.85666.29
61789757-178975767.51369.03
极限11950991-195099173.59571.403.6275.5873.313.62
21972459-197245974.40576.39
31916554-191655472.29674.24
41864289-186428970.32572.21
51785330-178533067.34669.14
61866416-186641670.40572.30
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数50
标示量(mg)640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%
144.303510079349590735076253504797352173935080290.27
244.213508644350412935063860.10
单位质量响应值RSD%判断
79188.0179312.060.12数据可信
供试品溶液-25120901批-对乙酰氨基酚-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12886079-2886079102.322100.382.84102.32100.382.84
22941030-2941030104.270104.27
32836709-2836709100.571100.57
42825204-2825204100.163100.16
52706721-270672195.96395.96
62791635-279163598.97398.97
10min12880011-2880011102.106100.842.48102.67101.402.48
22948230-2948230104.525105.10
32865097-2865097101.578102.14
42825930-2825930100.189100.75
52743143-274314397.25497.79
62802752-280275299.36799.92
15min12876493-2876493101.982100.312.60103.12101.432.60
22926283-2926283103.747104.91
32857310-2857310101.302102.42
42813898-281389899.762100.88
52718743-271874396.38997.46
62784115-278411598.70799.81
20min12863490-2863490101.52199.642.66103.22101.322.66
22908349-2908349103.111104.85
32840945-2840945100.721102.41
42786816-278681698.802100.47
52704240-270424095.87597.48
62758786-275878697.80999.46
30min12844904-2844904100.86299.212.61103.13101.442.61
22896391-2896391102.687105.00
32818824-281882499.937102.18
42790014-279001498.916101.13
52688378-268837895.31297.45
62751825-275182597.56299.76
45min12817038-281703899.87498.482.48102.70101.262.48
22869111-2869111101.720104.60
32800307-280030799.281102.08
42768723-276872398.161100.93
52668877-266887794.62197.29
62742677-274267797.23799.97
60min12797799-279779999.19297.922.50102.57101.252.51
22854885-2854885101.216104.66
32790416-279041698.930102.28
42753740-275374097.630100.94
52656667-265666794.18897.38
62718246-271824696.37199.65
极限12793800-279380099.05097.182.80102.98101.052.79
22848012-2848012100.972104.98
32762749-276274997.949101.85
42717071-271707196.330100.18
52632961-263296193.34897.07
62691303-269130395.41699.23
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
113.263178081317508931817023172195317541031764950.12
213.343167430316498131662060.06
单位质量响应值RSD%判断
239554.68237346.780.66数据可信
供试品溶液-MXC2401批-布洛芬-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1212856-2128568.0266.8012.738.036.8012.75
2191240-1912407.2117.21
3196479-1964797.4097.41
4162316-1623166.1206.12
5157848-1578485.9525.95
6161281-1612816.0816.08
10min1291378-29137810.9879.4410.9611.039.4810.97
2261205-2612059.8499.89
3268263-26826310.11510.16
4225610-2256108.5078.54
5224323-2243238.4588.49
6231612-2316128.7338.77
15min1352069-35206913.27511.669.5313.3811.759.54
2321086-32108612.10712.20
3329885-32988512.43912.54
4282941-28294110.66910.75
5280809-28080910.58810.67
6288442-28844210.87610.96
20min1414144-41414415.61613.848.6815.8014.008.72
2381679-38167914.39214.55
3386899-38689914.58914.76
4342689-34268912.92213.06
5334236-33423612.60312.74
6343116-34311612.93813.08
30min1510278-51027819.24117.317.4519.5117.547.49
2470761-47076117.75117.99
3482171-48217118.18118.43
4425965-42596516.06216.27
5429348-42934816.18916.40
6435317-43531716.41416.63
45min1631727-63172723.82021.706.4724.1922.036.51
2593436-59343622.37722.72
3593728-59372822.38822.74
4532739-53273920.08820.39
5557585-55758521.02521.32
6544430-54443020.52920.83
60min1714811-71481126.95325.225.4227.4625.675.47
2694033-69403326.17026.63
3686912-68691225.90126.37
4618760-61876023.33123.74
5660443-66044324.90325.32
6638560-63856024.07824.50
极限1843131-84313131.79230.274.4832.4530.864.54
2825257-82525731.11831.73
3828421-82842131.23731.85
4747877-74787728.20028.74
5779861-77986129.40629.96
6791430-79143029.84230.40
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数50
标示量(mg)640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%
144.303518805351581935242143511428351721935174970.14
244.213500836349849634996660.05
单位质量响应值RSD%判断
79401.7479160.050.22数据可信
供试品溶液-MXC2401批-对乙酰氨基酚-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12710130-271013096.04689.305.5196.0589.305.52
22474781-247478187.70687.71
32636190-263619093.42693.43
42364799-236479983.80883.81
52380125-238012584.35184.35
62551908-255190890.43990.44
10min12749687-274968797.44891.195.2197.9891.695.21
22499579-249957988.58489.07
32675760-267576094.82895.35
42423644-242364485.89386.36
52448458-244845886.77387.24
62641659-264165993.62094.12
15min12739840-273984097.09991.445.0198.1792.445.01
22515234-251523489.13990.12
32684709-268470995.14596.19
42431290-243129086.16487.11
52456850-245685087.07088.02
62652708-265270894.01195.03
20min12735212-273521296.93591.015.2798.5592.525.27
22491626-249162688.30389.78
32670959-267095994.65896.23
42418711-241871185.71887.14
52436377-243637786.34587.78
62654927-265492794.09095.63
30min12717692-271769296.31490.864.8498.4792.884.85
22481735-248173587.95289.92
32660033-266003394.27196.37
42423832-242383285.90087.80
52457450-245745087.09189.01
62642856-264285693.66295.73
45min12705309-270530995.87590.454.9898.5692.984.99
22464006-246400687.32489.78
32646542-264654293.79396.42
42415668-241566885.61187.99
52436994-243699486.36688.76
62645479-264547993.75596.34
60min12690336-269033695.34589.864.9698.5792.884.96
22460984-246098487.21790.16
32615487-261548792.69295.84
42391238-239123884.74587.60
52422538-242253885.85488.73
62632025-263202593.27896.39
极限12675062-267506294.80389.525.3498.5593.045.33
22438437-243843786.41889.84
32623886-262388692.99096.65
42381026-238102684.38387.70
52396325-239632584.92588.28
62641700-264170093.62197.25
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
113.263180828317530331596793177063317491831735580.26
213.343147681315436831510240.16
单位质量响应值RSD%判断
239333.18236208.700.93数据可信
供试品溶液-MXC2401批-布洛芬-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1617634-61763423.35620.858.2023.3620.858.20
2570742-57074221.58321.58
3562652-56265221.27721.28
4548011-54801120.72320.72
5526251-52625119.90019.90
6483050-48305018.26718.27
10min1839136-83913631.73229.714.9731.8629.834.98
2823242-82324231.13131.25
3768779-76877929.07229.19
4781112-78111229.53829.65
5769510-76951029.09929.21
6732901-73290127.71527.82
15min1997863-99786337.73536.693.0538.0436.973.07
21005213-100521338.01238.31
3968046-96804636.60736.89
4976355-97635536.92137.20
5944686-94468635.72436.00
6929181-92918135.13735.39
20min11178414-117841444.56242.733.9945.0843.223.98
21149245-114924543.45943.96
31085953-108595341.06641.55
41178610-117861044.57045.05
51110640-111064041.99942.47
61077625-107762540.75141.20
30min11400734-140073452.96951.502.1853.7352.222.20
21380434-138043452.20252.95
31323328-132332850.04250.75
41379032-137903252.14952.88
51350620-135062051.07451.78
61337243-133724350.56851.25
45min11647741-164774162.31060.801.9163.3761.811.93
21617501-161750161.16662.20
31574864-157486459.55460.54
41637189-163718961.91162.93
51584755-158475559.92860.92
61585132-158513259.94260.90
60min11392647-139264752.66364.439.0354.0765.788.80
21777453-177745367.21568.59
31731250-173125065.46866.79
41789707-178970767.67869.04
51766064-176606466.78468.10
61766374-176637466.79668.09
极限11915681-191568172.44271.590.9774.1473.290.95
21881146-188114671.13672.88
31863261-186326170.46072.14
41900316-190031671.86173.60
51896248-189624871.70773.40
61901785-190178571.91773.58
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数50
标示量(mg)640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%
144.303514915351269434953933512626351117535093610.23
244.213489673349648534930790.14
单位质量响应值RSD%判断
79218.0879011.060.19数据可信
供试品溶液-MXC2401批-对乙酰氨基酚-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12589651-258965191.96990.682.0391.9790.682.03
22547457-254745790.47190.47
32551966-255196690.63190.63
42629070-262907093.36993.37
52521751-252175189.55889.56
62480750-248075088.10288.10
10min12627595-262759593.31793.061.2993.8393.571.29
22599761-259976192.32892.83
32608320-260832092.63293.14
42677110-267711095.07595.59
52630535-263053593.42193.92
62579325-257932591.60392.09
15min12640707-264070793.78394.091.3694.8195.121.35
22615856-261585692.90093.92
32646616-264661693.99395.01
42711616-271161696.30197.35
52665210-266521094.65395.67
62616737-261673792.93193.93
20min12654717-265471794.28094.331.6195.8395.881.60
22594007-259400792.12493.66
32660684-266068494.49296.03
42720345-272034596.61198.19
52676291-267629195.04696.59
62630988-263098893.43794.95
30min12632495-263249593.49194.461.6995.5796.531.68
22590083-259008391.98594.03
32669519-266951994.80696.87
42717111-271711196.49698.61
52692820-269282095.63397.70
62656667-265666794.34996.38
45min12644086-264408693.90394.151.7296.5096.741.71
22572385-257238591.35693.91
32652639-265263994.20696.80
42713563-271356396.37099.02
52660380-266038094.48197.08
62662714-266271494.56497.12
60min12621153-262115393.08893.691.5896.2096.801.56
22564947-256494791.09294.15
32639261-263926193.73196.85
42682482-268248295.26698.46
52659511-265951194.45097.58
62660711-266071194.49397.58
极限12591816-259181692.04693.001.8695.6896.641.82
22552268-255226890.64294.21
32594731-259473192.15095.79
42679254-267925495.15298.87
52627817-262781793.32596.98
62666888-266688894.71298.32
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