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%
113.263201481320656732064513173254317189531919300.56
213.343206084317303831895610.74
单位质量响应值RSD%判断
240718.70239097.530.48数据可信
供试品溶液-25120901批-布洛芬-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12384906-238490689.38085.953.0889.3885.953.08
22372698-237269888.92288.92
32296104-229610486.05286.05
42242080-224208084.02784.03
52233912-223391283.72183.72
62230021-223002183.57583.58
10min12507475-250747593.97391.173.2294.4791.653.22
22536946-253694695.07895.57
32454518-245451891.98992.47
42369147-236914788.78989.26
52374370-237437088.98589.45
62354017-235401788.22288.69
15min12556523-255652395.81294.082.6596.8395.062.66
22603383-260338397.56898.59
32543696-254369695.33196.32
42463088-246308892.31093.27
52448110-244811091.74892.71
62446419-244641991.68592.64
20min12558044-255804495.86996.401.7797.4297.901.77
22644864-264486499.122100.69
32572007-257200796.39297.91
42525269-252526994.64096.11
52530613-253061394.84096.31
62602391-260239197.53198.99
30min12557852-255785295.86196.811.6697.9498.851.66
22658792-265879299.644101.76
32579087-257908796.65798.71
42543285-254328595.31597.31
52555783-255578395.78497.78
62604239-260423997.60099.61
45min12524819-252481994.62396.151.8797.2498.741.86
22646876-264687699.198101.87
32559814-255981495.93598.53
42531007-253100794.85597.38
52534372-253437294.98197.51
62597165-259716597.33599.88
60min12515383-251538394.27097.884.6997.41101.004.53
22620341-262034198.203101.42
32578103-257810396.62099.74
42527050-252705094.70797.76
52848918-2848918106.770109.83
62581120-258112096.73399.82
极限12522795-252279594.54795.351.6098.2199.011.60
22605003-260500397.628101.39
32561717-256171796.00699.67
42483936-248393693.09196.67
52536906-253690695.07698.73
62555145-255514595.76099.39
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%
144.303498724350533835012293468200346673234880450.55
244.213501073346299534820340.78
单位质量响应值RSD%判断
78736.9178761.230.03数据可信
供试品溶液-25120901批-对乙酰氨基酚-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12821377-2821377100.664100.491.41100.66100.491.41
22885803-2885803102.963102.96
32831334-2831334101.019101.02
42777142-277714299.08699.09
52791549-279154999.60099.60
62791446-279144699.59699.60
10min12869692-2869692102.388102.071.25102.95102.631.25
22916443-2916443104.056104.63
32869297-2869297102.374102.93
42812802-2812802100.358100.91
52863870-2863870102.180102.73
62833135-2833135101.083101.64
15min12864865-2864865102.216102.070.98103.34103.200.99
22900782-2900782103.497104.65
32861925-2861925102.111103.24
42814320-2814320100.412101.52
52852776-2852776101.784102.91
62869835-2869835102.393103.51
20min12839672-2839672101.317101.711.04103.01103.401.04
22897310-2897310103.373105.10
32841220-2841220101.372103.07
42815820-2815820100.466102.13
52836626-2836626101.208102.89
62873918-2873918102.539104.22
30min12826757-2826757100.856101.321.10103.11103.581.09
22886601-2886601102.991105.29
32823284-2823284100.732102.99
42803462-2803462100.025102.25
52831325-2831325101.019103.27
62867695-2867695102.316104.57
45min12782341-278234199.271100.371.28102.09103.191.27
22869937-2869937102.396105.27
32800063-280006399.903102.72
42783583-278358399.315102.10
52798400-279840099.844102.65
62844513-2844513101.489104.31
60min12772487-277248798.92099.871.28102.29103.241.27
22836587-2836587101.207104.65
32808555-2808555100.206103.58
42740516-274051697.779101.11
52812561-2812561100.349103.71
62823494-2823494100.739104.13
极限12783250-278325099.30499.301.06103.22103.231.06
22804773-2804773100.071104.07
32799596-279959699.887103.82
42724991-272499197.225101.10
52796898-279689899.791103.71
62789402-278940299.523103.47
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%
113.263201956318235032021403188323320513831959810.32
213.343177260316027231687660.38
单位质量响应值RSD%判断
241024.21237538.681.04数据可信
供试品溶液-MXC2401批-布洛芬-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12535915-253591595.29290.543.0795.2990.543.07
22394545-239454589.98089.98
32400236-240023690.19490.19
42407795-240779590.47890.48
52412857-241285790.66890.67
62304640-230464086.60186.60
10min12580353-258035396.96293.132.4997.4993.642.49
22449944-244994492.06292.56
32471874-247187492.88693.39
42490597-249059793.58994.09
52486282-248628293.42793.93
62391730-239173089.87490.36
15min12598202-259820297.63393.912.5598.7094.932.55
22462602-246260292.53793.55
32503422-250342294.07195.09
42505997-250599794.16895.19
52518505-251850594.63895.66
62406256-240625690.42091.40
20min12601184-260118497.74593.742.7499.3695.282.74
22445260-244526091.88693.41
32505158-250515894.13695.68
42495239-249523993.76495.31
52519436-251943694.67396.22
62400749-240074990.21391.70
30min12581559-258155997.00793.822.2599.1695.892.26
22446393-244639391.92893.96
32517568-251756894.60396.67
42508972-250897294.28096.35
52502809-250280994.04896.12
62423603-242360391.07293.06
45min12575605-257560596.78393.332.2999.4895.912.30
22437915-243791591.61094.16
32494567-249456793.73896.33
42505492-250549294.14996.74
52475010-247501093.00395.60
62413293-241329390.68493.17
60min12542724-254272495.54892.792.1498.7895.902.14
22419169-241916990.90593.96
32495999-249599993.79296.90
42480165-248016593.19796.31
52479514-247951493.17396.29
62398633-239863390.13393.13
极限12544584-254458495.61893.404.2999.3897.024.20
22391121-239112189.85193.41
32484417-248441793.35796.99
42657892-265789299.876103.51
52470607-247060792.83896.47
62365233-236523388.87892.37
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%
144.303498682347775334979143484187350140634919880.30
244.213468417344924034588280.40
单位质量响应值RSD%判断
78825.9178236.330.54数据可信
供试品溶液-MXC2401批-对乙酰氨基酚-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12807147-2807147100.43696.432.33100.4496.432.33
22687708-268770896.16296.16
32695598-269559896.44596.44
42693214-269321496.35996.36
52673625-267362595.65895.66
62613899-261389993.52193.52
10min12801966-2801966100.25097.371.99100.8197.901.99
22705599-270559996.80297.34
32721994-272199497.38997.92
42748423-274842398.33598.87
52712808-271280897.06097.59
62637720-263772094.37494.89
15min12828517-2828517101.20097.612.39102.3298.682.39
22688747-268874796.19997.27
32747024-274702498.28499.36
42736633-273663397.91398.99
52734596-273459697.84098.91
62632929-263292994.20295.25
20min12823217-2823217101.01197.072.57102.6998.692.56
22672733-267273395.62697.23
32735190-273519097.86199.48
42714561-271456197.12398.75
52719454-271945497.29898.91
62613731-261373193.51595.08
30min12796200-2796200100.04496.922.20102.2899.072.20
22667191-266719195.42897.57
32737547-273754797.945100.11
42728270-272827097.61399.78
52697931-269793196.52898.68
62625449-262544993.93596.02
45min12783060-278306099.57496.162.29102.3798.862.29
22659446-265944695.15197.82
32705208-270520896.78899.50
42713544-271354497.08799.79
52662833-266283395.27297.96
62601555-260155593.08095.69
60min12746801-274680198.27695.342.16101.6298.572.16
22627200-262720093.99797.19
32701282-270128296.64899.90
42672613-267261395.62298.87
52658538-265853895.11998.34
62582022-258202292.38195.51
极限12752554-275255498.48294.692.78102.3898.462.76
22598131-259813192.95796.68
32688648-268864896.19699.98
42652074-265207494.88798.67
52650047-265004794.81598.56
62538577-253857790.82794.47
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%
113.263185725317784331856123170765318764431815180.23
213.343158805317694431678740.41
单位质量响应值RSD%判断
239933.48237471.810.73数据可信
供试品溶液-25120901批-布洛芬-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1720504-72050427.13924.197.9727.1424.197.97
2656478-65647824.72824.73
3656724-65672424.73724.74
4648143-64814324.41424.41
5589139-58913922.19122.19
6581623-58162321.90821.91
10min11010524-101052438.06435.115.6538.2135.245.65
2965393-96539336.36436.50
3932207-93220735.11435.25
4933445-93344535.16035.30
5866887-86688732.65332.78
6884105-88410533.30233.42
15min11215883-121588345.79943.333.7546.1643.663.76
21170159-117015944.07744.42
31144141-114414143.09643.43
41156253-115625343.55343.88
51086672-108667240.93241.24
61128891-112889142.52242.83
20min11390472-139047252.37549.763.2652.9950.333.28
21321515-132151549.77850.36
31297760-129776048.88349.45
41342795-134279550.57951.15
51263473-126347347.59148.12
61310319-131031949.35649.90
30min11607919-160791960.56658.002.8361.4758.852.84
21535480-153548057.83758.70
31512576-151257656.97457.82
41569460-156946059.11759.97
51484422-148442255.91456.71
61529469-152946957.61158.43
45min11793926-179392667.57266.042.4868.8267.212.49
21754395-175439566.08367.27
31745759-174575965.75866.92
41772782-177278266.77667.96
51671969-167196962.97864.09
61780181-178018167.05468.19
60min11917141-191714172.21370.132.5873.8371.662.58
21859526-185952670.04371.59
31816803-181680368.43469.96
41896189-189618971.42472.98
51794368-179436867.58969.05
61886923-188692371.07572.58
极限12017565-201756575.99673.383.2278.0275.303.21
21927595-192759572.60774.55
31920110-192011072.32574.23
41986904-198690474.84176.79
51846373-184637369.54871.38
61989421-198942174.93676.84
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%
144.303484246346847234807723454610348354434743290.37
244.213441701347047534560880.59
单位质量响应值RSD%判断
78427.2978174.350.23数据可信
供试品溶液-25120901批-对乙酰氨基酚-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12856326-2856326102.49596.914.05102.4996.914.05
22685713-268571396.37296.37
32608867-260886793.61593.61
42803798-2803798100.610100.61
52577041-257704192.47392.47
62672498-267249895.89895.90
10min12900296-2900296104.07298.233.98104.6498.773.98
22712349-271234997.32897.86
32648594-264859495.04095.56
42828398-2828398101.492102.05
52611734-261173493.71894.23
62723364-272336497.72398.26
15min12873304-2873304103.10498.063.65104.2599.143.65
22708563-270856397.19298.27
32640455-264045594.74895.80
42824936-2824936101.368102.49
52622523-262252394.10595.14
62726746-272674697.84598.92
20min12874121-2874121103.13397.763.99104.8599.383.98
22682498-268249896.25797.87
32620046-262004694.01695.59
42817958-2817958101.118102.80
52604085-260408593.44395.00
62746813-274681398.565100.18
30min12836709-2836709101.79197.133.75104.0899.303.75
22682663-268266396.26398.41
32605799-260579993.50595.60
42803829-2803829100.611102.86
52588735-258873592.89294.97
62723668-272366897.73499.90
45min12840604-2840604101.93096.903.99104.7999.613.99
22665137-266513795.63498.32
32597801-259780193.21895.83
42787635-2787635100.030102.84
52569130-256913092.18994.78
62742350-274235098.405101.11
60min12801838-2801838100.53996.073.87103.9699.323.86
22658696-265869695.40398.62
32564236-256423692.01395.15
42764865-276486599.213102.57
52553697-255369791.63594.74
62721215-272121597.646100.90
极限12805149-2805149100.65895.664.07104.6499.444.06
22624597-262459794.17997.93
32571585-257158592.27795.92
42744745-274474598.491102.40
52526946-252694690.67594.29
62722510-272251097.693101.49
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