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%
112.973096426309803830969793094693309597530964220.04
212.923094681309385730942690.02
单位质量响应值RSD%判断
238737.24239494.500.23数据可信
供试品溶液-25121601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%
5min1216033-2160338.4627.847.718.467.847.69
2221966-2219668.6948.69
3190017-1900177.4437.44
4198684-1986847.7827.78
5190601-1906017.4657.47
6183893-1838937.2037.20
10min1310313-31031312.15411.476.4312.2011.526.44
2319594-31959412.51812.57
3273921-27392110.72910.77
4295516-29551611.57511.62
5281294-28129411.01811.06
6277036-27703610.85110.89
15min1396319-39631915.52314.536.3515.6414.646.34
2402466-40246615.76415.88
3348094-34809413.63413.74
4371970-37197014.56914.68
5354751-35475113.89514.00
6352269-35226913.79813.90
20min1459101-45910117.98217.225.3018.1817.415.32
2474629-47462918.59018.80
3413381-41338116.19116.37
4440111-44011117.23817.43
5423298-42329816.58016.76
6427201-42720116.73316.91
30min1580312-58031222.73021.815.6323.0322.095.63
2605954-60595423.73424.04
3523101-52310120.48920.76
4557044-55704421.81822.10
5535078-53507820.95821.23
6538753-53875321.10221.37
45min1712101-71210127.89126.974.6928.3227.374.71
2739435-73943528.96229.40
3651080-65108025.50125.88
4687105-68710526.91227.32
5672722-67272226.34926.74
6668401-66840126.18026.57
60min1812272-81227231.81531.013.9932.4031.564.03
2843192-84319233.02633.63
3754739-75473929.56130.08
4785717-78571730.77531.33
5771208-77120830.20730.74
6782533-78253330.65031.18
极限1918299-91829935.96835.533.5936.7336.263.62
2963329-96332937.73238.52
3865125-86512533.88534.57
4900288-90028835.26235.99
5894667-89466735.04235.74
6900998-90099835.29035.99
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%
143.903436936343846234370373435304343570934366900.04
243.933431390342966334305260.04
单位质量响应值RSD%判断
78284.5178090.740.18数据可信
供试品溶液-25121601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%
5min12353829-235382984.58590.755.4384.5990.765.43
22658603-265860395.53895.54
32358278-235827884.74584.75
42646014-264601495.08595.09
52585093-258509392.89692.90
62550618-255061891.65791.66
10min12367111-236711185.06391.555.6885.5392.065.68
22688439-268843996.61097.14
32368096-236809685.09885.57
42670188-267018895.95496.48
52606720-260672093.67394.19
62586069-258606992.93193.44
15min12372686-237268685.26391.165.5186.2192.185.51
22675344-267534496.13997.21
32355824-235582484.65785.60
42657828-265782895.51096.57
52593276-259327693.19094.23
62566156-256615692.21593.24
20min12344640-234464084.25590.615.6985.6792.135.69
22663506-266350695.71497.32
32342263-234226384.17085.58
42642811-264281194.97096.56
52578539-257853992.66094.21
62557529-255752991.90593.44
30min12334685-233468583.89790.145.6785.7892.165.67
22653776-265377695.36497.50
32331629-233162983.78885.67
42628489-262848994.45596.57
52562644-256264492.08994.16
62539750-253975091.26793.31
45min12317273-231727383.27289.535.6485.6292.065.64
22627678-262767894.42697.09
32318176-231817683.30485.65
42616536-261653694.02696.67
52548968-254896891.59894.18
62520491-252049190.57493.13
60min12302861-230286182.75488.955.6085.5791.975.60
22612734-261273493.88997.08
32303370-230337082.77285.58
42590959-259095993.10796.27
52528494-252849490.86293.95
62512768-251276890.29793.36
极限12286376-228637682.16188.395.4785.4391.905.48
22596216-259621693.29697.01
32300325-230032582.66385.93
42571092-257109292.39396.08
52512312-251231290.28193.87
62491708-249170889.54093.10
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%
112.973091380309727130943053089588309141630927920.10
212.923083496308070730821020.07
单位质量响应值RSD%判断
238457.36238552.790.03数据可信
供试品溶液-25121701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%
5min1189873-1898737.4566.5312.027.466.5412.03
2193694-1936947.6067.61
3152188-1521885.9765.98
4160176-1601766.2906.29
5151000-1510005.9295.93
6151431-1514315.9465.95
10min1245513-2455139.64110.146.539.6810.186.53
2289997-28999711.38811.43
3250965-2509659.8559.89
4264699-26469910.39410.43
5248357-2483579.7529.79
6250550-2505509.8399.87
15min1371567-37156714.59113.538.2614.6913.628.25
2381134-38113414.96615.07
3307111-30711112.06012.15
4349983-34998313.74313.84
5324318-32431812.73512.82
6332942-33294213.07413.16
20min1446996-44699617.55316.347.7417.7316.517.73
2458286-45828617.99618.18
3370639-37063914.55414.71
4414920-41492016.29316.46
5398234-39823415.63815.80
6408218-40821816.03016.19
30min1566747-56674722.25521.076.9422.5321.336.93
2583031-58303122.89423.18
3478747-47874718.79919.04
4543288-54328821.33421.59
5515376-51537620.23820.48
6532924-53292420.92721.18
45min1710849-71084927.91426.645.4528.3127.025.47
2719779-71977928.26428.68
3618240-61824024.27724.62
4684875-68487526.89427.27
5658369-65836925.85326.21
6678181-67818126.63127.00
60min1810812-81081231.83930.864.9432.3931.384.97
2838274-83827432.91733.49
3725457-72545728.48728.96
4790798-79079831.05331.58
5764254-76425430.01130.51
6785675-78567530.85231.37
极限1935707-93570736.74336.083.1637.4736.773.22
2960604-96060437.72138.48
3877992-87799234.47735.11
4923112-92311236.24936.95
5896950-89695035.22135.89
6917809-91780936.04136.73
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%
143.903428632343597034323003429250342838834309080.10
243.933420720342006134203900.02
单位质量响应值RSD%判断
78152.8077860.000.27数据可信
供试品溶液-25121701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%
5min12647962-264796295.37697.134.0395.3897.134.03
22745889-274588998.90498.90
32507971-250797190.33490.33
42755580-275558099.25399.25
52704003-270400397.39597.39
62819126-2819126101.542101.54
10min12610288-261028894.01998.493.5794.5599.033.57
22765183-276518399.599100.15
32630312-263031294.74195.24
42798278-2798278100.791101.34
52740308-274030898.70399.24
62861646-2861646103.073103.64
15min12658920-265892095.77198.383.4496.8299.463.44
22756790-275679099.296100.40
32594805-259480593.46294.49
42788419-2788419100.436101.55
52730306-273030698.34299.43
62858344-2858344102.954104.09
20min12649917-264991795.44798.153.4497.0399.783.44
22742419-274241998.779100.43
32605453-260545393.84595.39
42758461-275846199.356101.03
52718606-271860697.92199.56
62874641-2874641103.541105.25
30min12639775-263977595.08297.702.7297.2099.882.74
22723110-272311098.083100.29
32632553-263255394.82196.89
42754659-275465999.220101.44
52697200-269720097.15099.33
62828238-2828238101.870104.15
45min12624813-262481394.54397.882.6897.19100.602.68
22700398-270039897.265100.01
32678840-267884096.48999.08
42778554-2778554100.080102.85
52696251-269625197.11699.84
62826402-2826402101.804104.65
60min12609966-260996694.00896.912.2997.18100.182.31
22695335-269533597.083100.37
32662248-266224895.89199.02
42720795-272079598.000101.33
52664495-266449595.97299.23
62790813-2790813100.522103.94
极限12588987-258898793.25296.382.4596.94100.182.46
22675634-267563496.373100.20
32651246-265124695.49599.16
42704594-270459497.416101.29
52649596-264959695.43599.23
62784186-2784186100.283104.26
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%
112.973089072308826830888133089642309126230894110.04
212.923081008308224730816280.03
单位质量响应值RSD%判断
238196.68238516.100.10数据可信
供试品溶液-25111801批-布洛芬-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11288872-128887250.64348.914.7650.6448.914.75
21333673-133367352.40352.40
31254436-125443649.29049.29
41202281-120228147.24147.24
51214600-121460047.72547.72
61175183-117518346.17646.18
10min11632622-163262264.15063.213.2464.4363.493.24
21699812-169981266.79067.08
31605180-160518063.07263.35
41582256-158225662.17162.43
51580349-158034962.09662.36
61552679-155267961.00961.27
15min11850046-185004672.69372.262.6573.3372.882.66
21930156-193015675.84176.50
31832828-183282872.01672.64
41821377-182137771.56772.17
51802273-180227370.81671.43
61797474-179747470.62771.22
20min12011043-201104379.01978.912.1080.0679.932.11
22089880-208988082.11783.20
31997761-199776178.49779.52
41993095-199309578.31479.32
51984902-198490277.99279.00
61972243-197224377.49478.48
30min12172602-217260285.36786.121.9386.8587.581.94
22276773-227677389.46091.00
32179267-217926785.62987.09
42180802-218080285.68987.13
52162091-216209184.95486.39
62178425-217842585.59687.01
45min12276324-227632489.44390.531.4891.4092.471.49
22367112-236711293.01095.05
32298694-229869490.32292.26
42287355-228735589.87691.79
52279713-227971389.57691.48
62314815-231481590.95592.85
60min12302821-230282190.48491.791.5792.9494.241.57
22396877-239687794.17996.73
32317216-231721691.04993.49
42325345-232534591.36993.78
52310642-231064290.79193.20
62363526-236352692.86995.27
极限12316420-231642091.01893.192.2393.9796.142.19
22436297-243629795.72898.80
32342154-234215492.02994.97
42354721-235472192.52395.45
52340948-234094891.98294.89
62439263-243926395.84598.76
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%
143.903425558342476834230743425138342609234249260.04
243.933420993342333334221630.05
单位质量响应值RSD%判断
78016.5477900.360.11数据可信
供试品溶液-25111801批-对乙酰氨基酚-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12616780-261678094.31197.482.6894.3197.482.68
22792754-2792754100.653100.65
32657633-265763395.78395.78
42671935-267193596.29996.30
52698714-269871497.26497.26
62790211-2790211100.562100.56
10min12649068-264906895.47598.972.7496.0099.512.74
22824613-2824613101.801102.36
32694105-269410597.09897.63
42726642-272664298.27198.81
52738673-273867398.70499.24
62843408-2843408102.479103.04
15min12644865-264486595.32399.212.8296.38100.302.81
22816031-2816031101.492102.62
32693731-269373197.08498.16
42731824-273182498.45799.54
52778496-2778496100.139101.23
62851180-2851180102.759103.89
20min12640319-264031995.15998.912.8196.74100.552.80
22815816-2815816101.484103.17
32695494-269549497.14898.76
42730155-273015598.397100.03
52735557-273555798.592100.24
62848989-2848989102.680104.38
30min12634386-263438694.94698.532.7597.06100.722.75
22811508-2811508101.329103.58
32688646-268864696.90199.05
42716669-271666997.911100.09
52719466-271946698.012100.20
62832447-2832447102.084104.35
45min12614959-261495994.24597.962.7096.89100.702.70
22791560-2791560100.610103.43
32685654-268565496.79399.48
42696715-269671597.19299.91
52705598-270559897.512100.25
62813897-2813897101.415104.25
60min12603755-260375593.84297.332.7997.01100.612.78
22776746-2776746100.076103.45
32651458-265145895.56198.79
42680473-268047396.60799.87
52689215-268921596.922100.20
62801045-2801045100.952104.35
极限12589089-258908993.31396.802.9397.00100.622.92
22762072-276207299.547103.48
32637444-263744495.05698.81
42662891-266289195.97399.77
52666409-266640996.10099.92
62797192-2797192100.813104.77
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%
112.973096609309916130982233097061309625330974610.04
212.923073369307232430728460.03
单位质量响应值RSD%判断
238817.35237836.380.30数据可信
供试品溶液-5122101批-布洛芬-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1721312-72131228.34626.106.5128.3526.106.51
2710824-71082427.93427.93
3639311-63931125.12325.12
4655559-65555925.76225.76
5648959-64895925.50325.50
6609716-60971623.96023.96
10min1974796-97479638.30736.554.0838.4636.704.08
2968337-96833738.05338.21
3873561-87356134.32934.47
4915473-91547335.97636.12
5935689-93568936.77036.91
6912855-91285535.87336.01
15min11182437-118243746.46744.304.1346.8444.654.13
21158918-115891845.54345.91
31051611-105161141.32641.66
41101966-110196643.30543.65
51146758-114675845.06545.41
61121586-112158644.07644.41
20min11309176-130917651.44750.343.5352.0850.943.53
21309538-130953851.46252.08
31197194-119719447.04747.61
41260496-126049649.53450.12
51308355-130835551.41552.01
61301612-130161251.15051.73
30min11517771-151777159.64558.843.8060.5659.723.80
21530449-153044960.14361.05
31393531-139353154.76255.58
41469787-146978757.75958.62
51542714-154271460.62561.51
61529902-152990260.12160.98
45min11728932-172893267.94367.303.9869.1968.513.97
21753198-175319868.89670.14
31587260-158726062.37563.50
41688861-168886166.36867.55
51777073-177707369.83571.05
61740847-174084768.41169.61
60min11856728-185672872.96573.064.1074.5974.644.08
21901563-190156374.72776.35
31718800-171880067.54569.02
41845519-184551972.52474.07
51936162-193616276.08677.69
61896587-189658774.53176.11
极限11985953-198595378.04378.873.5880.0780.843.56
22029970-202997079.77381.81
31880033-188003373.88175.73
42009266-200926678.95980.91
52091806-209180682.20384.23
62044266-204426680.33582.32
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%
143.903438905344131234390063438897343678834389820.05
243.933412749341295834128540.01
单位质量响应值RSD%判断
78336.7277688.460.59数据可信
供试品溶液-5122101批-对乙酰氨基酚-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12786917-2786917100.375101.761.47100.37101.761.47
22821339-2821339101.615101.61
32808981-2808981101.170101.17
42803975-2803975100.989100.99
52905002-2905002104.628104.63
62826802-2826802101.811101.81
10min12813617-2813617101.336103.181.58101.89103.741.58
22836066-2836066102.145102.71
32853757-2853757102.782103.34
42864491-2864491103.169103.73
52945888-2945888106.100106.68
62874279-2874279103.521104.09
15min12808902-2808902101.167103.351.84102.29104.491.83
22824972-2824972101.745102.88
32855826-2855826102.857103.99
42876256-2876256103.593104.73
52954494-2954494106.410107.58
62896668-2896668104.328105.47
20min12784812-2784812100.299103.002.07101.98104.712.06
22805686-2805686101.051102.75
32847697-2847697102.564104.27
42872920-2872920103.472105.18
52937238-2937238105.789107.55
62910125-2910125104.812106.53
30min12776557-2776557100.002102.712.24102.24104.992.22
22799392-2799392100.824103.08
32827225-2827225101.827104.10
42856135-2856135102.868105.15
52939917-2939917105.885108.23
62910877-2910877104.839107.14
45min12757327-275732799.309102.012.33102.10104.862.31
22774493-277449399.927102.75
32812143-2812143101.283104.12
42837541-2837541102.198105.05
52932065-2932065105.603108.54
62880218-2880218103.735106.62
60min12738065-273806598.615101.562.30101.96104.992.29
22774703-277470399.935103.31
32795263-2795263100.675104.08
42822381-2822381101.652105.08
52909583-2909583104.793108.32
62879670-2879670103.715107.18
极限12725799-272579998.174100.992.30102.07104.982.28
22754422-275442299.204103.13
32776459-277645999.998103.96
42813061-2813061101.316105.31
52892484-2892484104.177108.28
62862508-2862508103.097107.13
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