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%
110.043017539301777830191083016799301436930171190.06
210.143007189301034230087660.08
单位质量响应值RSD%判断
300509.86296722.490.90数据可信
供试品溶液-23004N1批-shui(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1641758-64175821.40621.693.7321.4121.693.72
2668936-66893622.31222.31
3611559-61155920.39920.40
4653661-65366121.80321.80
5681544-68154422.73322.73
6644751-64475121.50621.51
10min11355481-135548145.21245.962.5045.2445.992.51
21430415-143041547.71247.75
31340129-134012944.70044.73
41390808-139080846.39146.42
51398212-139821246.63846.67
61352398-135239845.10945.14
15min11871806-187180662.43463.501.4962.5363.601.49
21951355-195135565.08865.19
31886854-188685462.93663.03
41918041-191804163.97764.08
51904411-190441163.52263.63
61889794-188979463.03463.13
20min12261465-226146575.43275.550.9975.6375.740.98
22306414-230641476.93177.13
32258727-225872775.34075.53
42269624-226962475.70475.90
52245712-224571274.90675.11
62247460-224746074.96475.16
30min12625773-262577387.58386.680.9187.8987.000.90
22627074-262707487.62787.94
32597682-259768286.64686.95
42591441-259144186.43886.75
52569133-256913385.69486.01
62581854-258185486.11886.43
45min12788329-278832993.00591.940.8493.4492.380.83
22779612-277961292.71493.16
32745286-274528691.57092.00
42743503-274350391.51091.95
52728502-272850291.01091.45
62753536-275353691.84592.28
60min12858094-285809495.33294.010.9395.9194.580.93
22840681-284068194.75195.34
32810243-281024393.73694.31
42812189-281218993.80194.38
52788952-278895293.02693.60
62799898-279989893.39193.97
极限12878604-287860496.01695.220.6096.7495.940.61
22871888-287188895.79296.52
32846282-284628294.93895.65
42854660-285466095.21895.94
52837340-283734094.64095.36
62839696-283969694.71995.43
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%
110.043002864300510530027833001887300179330028860.05
210.143006449300765530070520.03
单位质量响应值RSD%判断
299092.23296553.450.61数据可信
供试品溶液-23004N1批-shui(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1742538-74253824.83323.175.4524.8323.175.45
2694414-69441423.22423.22
3717896-71789624.00924.01
4686788-68678822.96822.97
5630330-63033021.08021.08
6684475-68447522.89122.89
10min11528713-152871351.12548.133.9851.1648.173.98
21420789-142078947.51647.55
31459125-145912548.79848.83
41414275-141427547.29847.33
51357244-135724445.39145.42
61455424-145542448.67448.71
15min12039344-203934468.20265.692.1568.3265.802.16
21943780-194378065.00665.11
31970570-197057065.90266.01
41957854-195785465.47765.58
51911949-191194963.94264.04
61961727-196172765.60765.71
20min12356324-235632478.80377.141.2379.0277.341.23
22283668-228366876.37376.58
32319615-231961577.57677.78
42306080-230608077.12377.33
52288968-228896876.55176.75
62284528-228452876.40276.61
30min12655875-265587588.82187.740.9589.1688.060.95
22610148-261014887.29287.61
32635420-263542088.13788.46
42633828-263382888.08488.40
52621210-262121087.66287.97
62583919-258391986.41586.74
45min12805179-280517993.81492.750.8794.2893.200.87
22760237-276023792.31192.76
32791977-279197793.37393.83
42778081-277808192.90893.36
52766366-276636692.51692.96
62737963-273796391.56792.02
60min12873797-287379796.10994.690.9096.7295.280.91
22817122-281712294.21494.80
32837933-283793394.91095.51
42832668-283266894.73495.32
52829960-282996094.64395.22
62796783-279678393.53494.12
极限12914213-291421397.46196.170.9398.2196.900.94
22862546-286254695.73396.46
32891274-289127496.69497.43
42873435-287343596.09796.83
52877404-287740496.23096.95
62834850-283485094.80795.53
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%
110.043021376302180030179853022769302513830218140.09
210.143029257302927630292660.01
单位质量响应值RSD%判断
300977.49298744.180.53数据可信
供试品溶液-24123101批-shui(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1414558-41455813.77013.771.9713.7713.781.98
2404853-40485313.44813.45
3415918-41591813.81513.82
4416223-41622313.82513.83
5428387-42838714.22914.23
6407974-40797413.55113.55
10min11023253-102325333.98834.552.3734.0134.572.37
21020679-102067933.90333.92
31031172-103117234.25134.27
41071577-107157735.59335.61
51071836-107183635.60235.62
61022933-102293333.97834.00
15min11552885-155288551.58052.312.0151.6552.382.01
21545719-154571951.34251.41
31555433-155543351.66551.74
41612738-161273853.56853.64
51616818-161681853.70453.78
61565323-156532351.99452.06
20min11951489-195148964.82065.611.7164.9765.761.71
21953927-195392764.90165.05
31939648-193964864.42764.58
42004347-200434766.57666.73
52025806-202580667.28967.44
61975931-197593165.63265.78
30min12427223-242722380.62280.951.1680.8781.201.16
22438522-243852280.99881.24
32393997-239399779.51979.76
42448057-244805781.31481.57
52480646-248064682.39782.65
62434397-243439780.86181.11
45min12686332-268633289.22989.810.8789.6090.180.87
22701893-270189389.74690.11
32673384-267338488.79989.16
42708916-270891689.97990.36
52741298-274129891.05591.43
62711790-271179090.07490.44
60min12791760-279176092.73193.250.9393.2393.760.94
22816855-281685593.56494.07
32772711-277271192.09892.60
42796047-279604792.87393.38
52846796-284679694.55995.08
62820891-282089193.69894.20
极限12881512-288151295.71295.830.8796.3596.480.87
22892885-289288596.09096.73
32852956-285295694.76395.40
42863508-286350895.11495.76
52921810-292181097.05097.71
62897993-289799396.25996.90
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%
110.042991198298653529779152981946298448929844170.17
210.142962887296839729656420.14
单位质量响应值RSD%判断
297252.69292469.631.15数据可信
供试品溶液-24123102批-shui(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1409326-40932613.82714.592.8113.8314.602.80
2435446-43544614.71014.71
3434822-43482214.68914.69
4441622-44162214.91814.92
5429094-42909414.49514.50
6441981-44198114.93014.93
10min11071044-107104436.18136.411.5136.2036.431.50
21110169-111016937.50237.52
31066274-106627436.02036.04
41076919-107691936.37936.40
51069916-106991636.14336.16
61073158-107315836.25236.27
15min11600440-160044054.06454.092.0854.1454.162.07
21656981-165698155.97456.05
31558057-155805752.63252.71
41585490-158549053.55953.64
51590855-159085553.74053.82
61614804-161480454.54954.63
20min12014136-201413668.03967.861.8268.2068.021.82
22065466-206546669.77369.94
31957076-195707666.11266.27
41991500-199150067.27567.43
51998942-199894267.52667.68
62026625-202662568.46168.62
30min12464858-246485883.26583.231.1383.5283.491.13
22504593-250459384.60784.87
32421311-242131181.79482.05
42450799-245079982.79083.05
52463961-246396183.23583.49
62477743-247774383.70083.96
45min12734339-273433992.36891.650.7192.7592.040.71
22736416-273641692.43892.83
32685966-268596690.73491.11
42704606-270460691.36491.75
52710583-271058391.56691.95
62706618-270661891.43291.82
60min12836600-283660095.82394.930.6196.3495.460.60
22817391-281739195.17495.71
32787207-278720794.15494.67
42805608-280560894.77695.30
52814775-281477595.08595.61
62799876-279987694.58295.11
极限12898803-289880397.92496.820.7898.5997.480.77
22876545-287654597.17297.85
32847065-284706596.17696.83
42857535-285753596.53097.19
52876646-287664697.17597.84
62839351-283935195.91696.58
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