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100
标示量(mg)96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%
113.143170321317196031825723171172317560531743260.16
213.153165318316047631628970.11
单位质量响应值RSD%判断
241577.32240524.490.31数据可信
供试品溶液-25111801批-布洛芬-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12379531-237953192.45389.301.9592.4589.291.95
22302854-230285489.47489.47
32269366-226936688.17388.17
42269316-226931688.17188.17
52309937-230993789.74989.75
62258583-225858387.75487.75
10min12635767-2635767102.40999.741.61102.92100.241.61
22560103-256010399.46999.97
32520861-252086197.94498.43
42539754-253975498.67899.17
52592790-2592790100.739101.24
62552872-255287299.18899.68
15min12678305-2678305104.062101.181.84105.14102.221.83
22586749-2586749100.504101.55
32550102-255010299.080100.11
42579760-2579760100.233101.27
52644959-2644959102.766103.82
62584694-2584694100.424101.46
20min12647625-2647625102.869101.381.33104.53102.991.33
22585653-2585653100.462102.07
32574581-2574581100.031101.62
42581036-2581036100.282101.88
52652819-2652819103.071104.70
62613557-2613557101.546103.14
30min12662476-2662476103.446101.671.66105.68103.851.65
22585210-2585210100.444102.61
32569586-256958699.837101.98
42588075-2588075100.556102.71
52673202-2673202103.863106.07
62621910-2621910101.870104.03
45min12641821-2641821102.644101.791.08105.45104.531.08
22580208-2580208100.250102.97
32611267-2611267101.457104.15
42600948-2600948101.056103.77
52657310-2657310103.246106.02
62627012-2627012102.069104.80
60min12653814-2653814103.110101.351.35106.49104.661.35
22589664-2589664100.617103.90
32564437-256443799.637102.90
42586957-2586957100.512103.78
52645175-2645175102.774106.13
62611843-2611843101.479104.77
极限12648702-2648702102.911101.570.90106.86105.440.92
22606179-2606179101.259105.10
32607093-2607093101.295105.11
42579751-2579751100.232104.06
52630734-2630734102.213106.14
62612867-2612867101.519105.38
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%
143.923500016349776835088253497271350064735009050.14
243.933501221349488934980550.13
单位质量响应值RSD%判断
79710.9579627.930.08数据可信
供试品溶液-25111801批-对乙酰氨基酚-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12815973-281597399.31098.961.2999.3198.971.29
22822953-282295399.55799.56
32801390-280139098.79698.80
42781259-278125998.08698.09
52860179-2860179100.869100.87
62755139-275513997.16597.17
10min12895022-2895022102.098101.611.17102.65102.161.17
22874345-2874345101.369101.92
32870367-2870367101.229101.78
42861273-2861273100.908101.45
52941110-2941110103.724104.28
62845153-2845153100.340100.88
15min12939295-2939295103.660103.121.24104.78104.231.23
22893251-2893251102.036103.15
32892992-2892992102.027103.14
42893737-2893737102.053103.16
52978779-2978779105.052106.19
62945698-2945698103.885104.98
20min12926692-2926692103.215103.231.08104.91104.921.07
22905917-2905917102.482104.17
32927696-2927696103.251104.93
42903686-2903686102.404104.08
52987621-2987621105.364107.08
62910699-2910699102.651104.33
30min12971870-2971870104.808104.001.29107.08106.261.28
22919200-2919200102.951105.20
32926516-2926516103.209105.46
42923021-2923021103.086105.33
53015727-3015727106.355108.66
62937128-2937128103.583105.83
45min12957120-2957120104.288104.191.13107.14107.031.12
22914179-2914179102.774105.60
32993959-2993959105.587108.41
42928959-2928959103.295106.11
52992723-2992723105.544108.44
62938809-2938809103.642106.46
60min12963786-2963786104.523103.241.12107.95106.661.11
22917236-2917236102.882106.28
32892485-2892485102.009105.42
42909327-2909327102.603105.99
52972732-2972732104.839108.32
62909449-2909449102.607106.00
极限12947313-2947313103.942102.880.88107.95106.870.87
22910189-2910189102.633106.60
32885052-2885052101.747105.73
42892813-2892813102.020105.98
52940393-2940393103.698107.76
62927346-2927346103.238107.20
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100
标示量(mg)96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%
113.143151009312834631538863157231313955231460050.38
213.153138221315435031462860.37
单位质量响应值RSD%判断
239421.99239261.290.05数据可信
供试品溶液-25120901批-布洛芬-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11726316-172631667.55268.420.9467.5568.420.94
21736643-173664367.95667.96
31759759-175975968.86168.86
41765981-176598169.10469.10
51739957-173995768.08668.09
61762777-176277768.97968.98
10min12063443-206344380.74482.061.6881.1282.441.67
22063303-206330380.73981.12
32085913-208591381.62382.01
42130462-213046283.36783.75
52091605-209160581.84682.22
62148105-214810584.05784.44
15min12191317-219131785.74887.671.4986.5788.501.49
22211657-221165786.54487.37
32243012-224301287.77188.61
42268548-226854888.77089.62
52249857-224985788.03988.87
62278053-227805389.14289.99
20min12272601-227260188.92990.571.4790.2391.891.46
22288371-228837189.54690.85
32304090-230409090.16191.48
42321735-232173590.85192.19
52333321-233332191.30592.63
62367084-236708492.62693.97
30min12357025-235702592.23294.402.1694.0396.232.14
22370039-237003992.74194.55
32375033-237503392.93794.76
42460084-246008496.26598.11
52432413-243241395.18297.01
62479992-247999297.04498.90
45min12386300-238630093.37896.592.5195.6898.942.48
22423638-242363894.83997.16
32442471-244247195.57697.92
42521571-252157198.671101.05
52487198-248719897.32699.68
62548771-254877199.735102.13
60min12425231-242523194.90197.642.5097.73100.522.47
22441190-244119095.52698.37
32457164-245716496.15199.02
42560059-2560059100.177103.11
52519150-251915098.576101.48
62567824-2567824100.481103.43
极限12509701-250970198.207100.451.72101.56103.881.72
22548359-254835999.719103.10
32533473-253347399.137102.54
42606181-2606181101.982105.47
52580253-2580253100.967104.41
62623595-2623595102.663106.17
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%
143.923487921346345134901933495555347512634824490.38
243.933466397348537734758870.39
单位质量响应值RSD%判断
79290.7379123.310.15数据可信
供试品溶液-25120901批-对乙酰氨基酚-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12813102-281310299.788100.981.0099.79100.981.00
22868301-2868301101.747101.75
32813179-281317999.79199.79
42875930-2875930102.017102.02
52867440-2867440101.716101.72
62842629-2842629100.836100.84
10min12888292-2888292102.456103.031.27103.01103.591.26
22916659-2916659103.462104.03
32862858-2862858101.553102.11
42958244-2958244104.937105.50
52871533-2871533101.861102.43
62929315-2929315103.911104.47
15min12891825-2891825102.581103.691.04103.70104.821.04
22947178-2947178104.544105.68
32903740-2903740103.004104.12
42970454-2970454105.370106.52
52902862-2902862102.972104.10
62922275-2922275103.661104.80
20min12915794-2915794103.431104.491.55105.12106.201.52
22947780-2947780104.566106.29
33032803-3032803107.582109.27
42923510-2923510103.705105.44
52907728-2907728103.145104.85
62947030-2947030104.539106.25
30min12912658-2912658103.320104.801.21105.59107.091.20
22963929-2963929105.139107.44
32921535-2921535103.635105.92
43001057-3001057106.456108.77
52940171-2940171104.296106.57
62987260-2987260105.966108.26
45min12879668-2879668102.150104.521.52104.99107.391.49
22955506-2955506104.840107.73
32937107-2937107104.187107.05
42991910-2991910106.131109.03
52918653-2918653103.533106.39
62995850-2995850106.271109.15
60min12879274-2879274102.136103.891.30105.55107.341.28
22929535-2929535103.919107.39
32911303-2911303103.272106.71
42985374-2985374105.899109.39
52909072-2909072103.193106.62
62957275-2957275104.903108.38
极限12866886-2866886101.696103.290.99105.67107.320.98
22919640-2919640103.568107.61
32906532-2906532103.103107.12
42939439-2939439104.270108.35
52895768-2895768102.721106.72
62942702-2942702104.386108.44
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100
标示量(mg)96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%
113.143143297315245531522263147189315315231496640.14
213.153133404314456931389860.26
单位质量响应值RSD%判断
239700.46238706.160.30数据可信
供试品溶液-5122101批-布洛芬-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11316526-131652651.54750.461.4951.5550.471.49
21259995-125999549.33349.33
31285358-128535850.32650.33
41291278-129127850.55850.56
51300257-130025750.91050.91
61279972-127997250.11550.12
10min11704814-170481466.75064.881.7067.0465.161.70
21643600-164360064.35364.63
31673614-167361465.52865.81
41648727-164872764.55464.83
51646712-164671264.47564.76
61624796-162479663.61763.89
15min11957306-195730676.63674.261.8977.2974.901.89
21895548-189554874.21774.85
31915723-191572375.00775.65
41882976-188297673.72574.36
51871439-187143973.27473.91
61857203-185720372.71673.35
20min12122363-212236383.09881.151.6284.1882.201.62
22076510-207651081.30382.35
32097314-209731482.11783.18
42055567-205556780.48381.53
52053708-205370880.41081.46
62029544-202954479.46480.50
30min12321182-232118290.88389.091.3292.4390.601.32
22289083-228908389.62691.12
32290857-229085789.69591.21
42253139-225313988.21889.71
52244115-224411587.86589.36
62254178-225417888.25989.74
45min12439850-243985095.52993.431.2097.5895.431.21
22382394-238239493.27995.27
32392171-239217193.66295.68
42367776-236777692.70794.69
52359995-235999592.40294.39
62374995-237499592.99094.96
60min12435276-243527695.35094.570.6897.9397.080.69
22427003-242700395.02697.54
32421118-242111894.79597.33
42403719-240371994.11496.62
52390029-239002993.57896.07
62414354-241435494.53197.01
极限12479441-247944197.07996.410.71100.1999.460.71
22453755-245375596.07399.11
32472694-247269496.81599.88
42432314-243231495.23498.26
52462033-246203396.39799.41
62474307-247430796.87899.89
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%
143.923471484348057134836513476113348322734790090.15
243.933461773347061834661960.19
单位质量响应值RSD%判断
79212.4178902.710.28数据可信
供试品溶液-5122101批-对乙酰氨基酚-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12774582-277458298.60897.890.5998.6197.890.59
22745087-274508797.56097.56
32739170-273917097.35097.35
42737589-273758997.29497.29
52771262-277126298.49098.49
62758917-275891798.05298.05
10min12826852-2826852100.466100.170.51101.01100.710.50
22798796-279879699.469100.01
32826497-2826497100.453100.99
42807951-280795199.794100.33
52836908-2836908100.823101.37
62813524-281352499.992100.54
15min12863511-2863511101.769100.950.57102.87102.050.56
22818577-2818577100.172101.27
32847604-2847604101.204102.30
42826518-2826518100.454101.55
52843099-2843099101.043102.15
62843077-2843077101.043102.14
20min12844483-2844483101.093101.240.69102.76102.900.68
22827046-2827046100.473102.12
32880082-2880082102.358104.02
42833226-2833226100.693102.35
52861698-2861698101.704103.37
62844896-2844896101.107102.77
30min12837775-2837775100.854100.820.60103.09103.040.59
22818278-2818278100.161102.37
32861083-2861083101.683103.91
42819851-2819851100.217102.43
52850448-2850448101.305103.54
62833465-2833465100.701102.92
45min12843517-2843517101.058100.280.81103.85103.060.80
22786187-278618799.021101.79
32844239-2844239101.084103.88
42810296-281029699.878102.65
52832625-2832625100.671103.47
62812528-281252899.957102.74
60min12797097-279709799.40999.680.44102.76103.020.44
22792008-279200899.228102.54
32824117-2824117100.369103.73
42797018-279701899.406102.73
52814539-2814539100.028103.38
62803429-280342999.634102.97
极限12788271-278827199.09599.120.81103.00103.020.80
22758122-275812298.023101.89
32807497-280749799.778103.69
42775777-277577798.651102.53
52821286-2821286100.268104.18
62783500-278350098.925102.82
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100
标示量(mg)96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%
113.143132870313719631328503099475312696831258720.49
213.153143934315065031472920.16
单位质量响应值RSD%判断
237889.80239337.790.43数据可信
供试品溶液-MXC2401批-布洛芬-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11488280-148828058.41658.481.5558.4258.481.56
21501806-150180658.94758.95
31515125-151512559.46959.47
41489615-148961558.46858.47
51447201-144720156.80356.80
61497644-149764458.78358.78
10min11859378-185937872.98274.071.7173.3174.401.70
21909855-190985574.96375.29
31907726-190772674.87975.21
41897887-189788774.49374.82
51835496-183549672.04472.36
61912812-191281275.07975.41
15min12050429-205042980.48080.991.5881.2181.731.58
22093646-209364682.17782.92
32064341-206434181.02681.77
42086638-208663881.90282.64
52005470-200547078.71679.43
62080289-208028981.65282.40
20min12156324-215632484.63784.991.8085.8186.181.80
22196600-219660086.21887.42
32177516-217751685.46986.67
42182105-218210585.64986.84
52091013-209101382.07383.23
62188759-218875985.91087.11
30min12298971-229897190.23690.411.4191.8892.061.41
22325100-232510091.26192.94
32304978-230497890.47292.14
42338796-233879691.79993.47
52244428-224442888.09589.70
62307580-230758090.57492.25
45min12400076-240007694.20494.400.8596.3596.560.86
22424907-242490795.17997.37
32391535-239153593.86996.04
42420692-242069295.01397.19
52373260-237326093.15295.25
62419216-241921694.95597.13
60min12435563-243556395.59794.453.3298.2797.143.26
22449957-244995796.16298.88
32425807-242580795.21497.91
42444242-244424295.93898.65
52244375-224437588.09390.71
62438071-243807195.69698.40
极限12489046-248904697.69697.240.27100.90100.450.28
22478849-247884997.296100.55
32475618-247561897.169100.39
42474007-247400797.106100.35
52469726-246972696.938100.04
62476661-247666197.210100.45
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%
143.923461924347664734771113435996346660534636570.49
243.933458653347192634652900.28
单位质量响应值RSD%判断
78862.8678882.090.02数据可信
供试品溶液-MXC2401批-对乙酰氨基酚-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12347965-234796583.64283.481.5883.6483.481.58
22350763-235076383.74283.74
32397537-239753785.40885.41
42358953-235895384.03384.03
52290775-229077581.60581.60
62315026-231502682.46982.47
10min12484312-248431288.49989.002.1488.9689.472.13
22509053-250905389.38089.85
32585935-258593592.11992.59
42518844-251884489.72990.20
52433457-243345786.68787.14
62459030-245903087.59888.06
15min12575250-257525091.73991.431.6492.6992.381.64
22572776-257277691.65092.61
32616783-261678393.21894.20
42600477-260047792.63793.60
52511220-251122089.45890.39
62522467-252246789.85890.80
20min12620113-262011393.33793.351.7094.8094.821.71
22616743-261674393.21794.69
32687134-268713495.72497.23
42645078-264507894.22695.71
52553655-255365590.96992.40
62600957-260095792.65494.10
30min12672876-267287695.21695.771.5097.2097.761.50
22672034-267203495.18697.18
32734752-273475297.42199.46
42741620-274162097.66599.67
52641813-264181394.11096.05
62668064-266806495.04597.00
45min12689083-268908395.79496.850.9198.3199.370.92
22716440-271644096.76899.29
32745841-274584197.816100.39
42748018-274801897.893100.44
52694852-269485295.99998.46
62718996-271899696.85999.35
60min12692686-269268695.92296.720.5998.9799.780.60
22709810-270981096.53299.59
32728500-272850097.198100.32
42737620-273762097.523100.61
52714616-271461696.70399.70
62707402-270740296.44699.47
极限12720470-272047096.91296.660.64100.49100.260.67
22703829-270382996.31999.91
32732917-273291797.355101.02
42731845-273184597.317100.95
52691473-269147395.87999.41
62700587-270058796.20399.76
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