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%
110.042983665298263129818042983227298273029828110.03
210.142977452297804629777490.02
单位质量响应值RSD%判断
297092.73293663.610.83数据可信
供试品溶液-yd1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%
5min1637519-63751921.49822.884.8621.5022.884.87
2716922-71692224.17524.18
3703572-70357223.72523.72
4691178-69117823.30723.31
5681726-68172622.98822.99
6640014-64001421.58221.58
10min11396319-139631947.08549.413.3447.1249.443.34
21474987-147498749.73749.77
31487155-148715550.14850.18
41512862-151286251.01551.05
51506372-150637250.79650.83
61413786-141378647.67447.71
15min11933814-193381465.20967.592.5165.3167.702.51
21995540-199554067.29167.40
32022259-202225968.19268.30
42051172-205117269.16769.28
52061351-206135169.51069.62
61962363-196236366.17266.28
20min12290169-229016977.22678.811.5177.4379.021.51
22320582-232058278.25178.46
32344489-234448979.05879.27
42370823-237082379.94680.16
52382337-238233780.33480.55
62314993-231499378.06378.27
30min12598062-259806287.60888.630.7687.9288.950.76
22613319-261331988.12388.45
32644986-264498689.19189.52
42632168-263216888.75889.09
52650904-265090489.39089.73
62630128-263012888.69089.01
45min12771995-277199593.47393.960.5093.9294.420.50
22771598-277159893.46093.92
32801692-280169294.47594.94
42778837-277883793.70494.17
52798881-279888194.38094.85
62794957-279495794.24894.70
60min12837102-283710295.66996.050.5696.2696.650.56
22829479-282947995.41296.01
32867317-286731796.68897.29
42837152-283715295.67196.28
52860312-286031296.45197.06
62859579-285957996.42797.02
极限12874999-287499996.94797.050.4797.6897.790.47
22860179-286017996.44797.19
32891480-289148097.50398.25
42864768-286476896.60297.35
52886063-288606397.32098.08
62890679-289067997.47598.21
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%
110.042971354297255129750462974853297399429735600.06
210.142979581298080629801940.03
单位质量响应值RSD%判断
296171.31293904.730.55数据可信
供试品溶液-yd2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%
5min1348410-34841011.76213.2214.0311.7613.2214.03
2353580-35358011.93611.94
3396954-39695413.40113.40
4479342-47934216.18216.18
5340945-34094511.51011.51
6429963-42996314.51514.52
10min1858847-85884728.99431.548.1529.0131.568.15
2915113-91511330.89330.91
3961072-96107232.44532.46
41044398-104439835.25835.28
5845769-84576928.55228.57
6981211-98121133.12533.15
15min11305972-130597244.08847.186.3244.1547.256.33
21413917-141391747.73247.80
31441420-144142048.66148.73
41516943-151694351.21051.29
51282079-128207943.28243.34
61425285-142528548.11648.19
20min11668118-166811856.31458.684.4856.4458.824.48
21782529-178252960.17660.31
31767875-176787559.68159.82
41819411-181941161.42161.58
51617424-161742454.60254.73
61773488-177348859.87160.01
30min12097054-209705470.79471.942.4771.0172.162.48
22159770-215977072.91173.14
32172102-217210273.32873.56
42153417-215341772.69772.94
52038678-203867868.82369.03
62164638-216463873.07673.31
45min12355415-235541579.51680.461.4179.8380.791.42
22385652-238565280.53780.87
32416548-241654881.58081.92
42396221-239622180.89481.25
52332289-233228978.73579.05
62414200-241420081.50181.84
60min12481975-248197583.78984.781.0384.2385.241.04
22516141-251614184.94285.40
32547694-254769486.00786.47
42504664-250466484.55585.03
52485771-248577183.91784.35
62531887-253188785.47485.94
极限12600798-260079887.80088.450.9388.3689.030.94
22632598-263259888.87489.46
32644874-264487489.28889.88
42618817-261881788.40889.01
52582849-258284987.19487.75
62639719-263971989.11489.71
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%
110.042977033297868229767842973036297332629757720.09
210.142988093298591229870020.06
单位质量响应值RSD%判断
296391.63294576.130.44数据可信
供试品溶液-yd3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%
5min1456571-45657115.39015.601.6015.3915.601.59
2471054-47105415.87815.88
3459895-45989515.50215.50
4472710-47271015.93415.93
5455263-45526315.34615.35
6461690-46169015.56315.56
10min11092377-109237736.82237.171.8536.8437.191.84
21083779-108377936.53236.56
31082706-108270636.49636.52
41118359-111835937.69737.72
51104868-110486837.24337.27
61133561-113356138.21038.23
15min11628619-162861954.89754.902.3254.9854.982.31
21582765-158276553.35153.43
31587208-158720853.50153.58
41643011-164301155.38255.46
51652993-165299355.71955.80
61678236-167823656.57056.65
20min12013226-201322667.86168.152.2968.0268.312.29
21971392-197139266.45166.61
31969074-196907466.37366.53
42037466-203746668.67868.84
52054664-205466469.25869.42
62084860-208486070.27670.44
30min12441700-244170082.30482.571.3582.5782.841.35
22414862-241486281.40081.66
32412899-241289981.33381.59
42455831-245583182.78183.05
52479667-247966783.58483.85
62492542-249254284.01884.29
45min12671652-267165290.05590.250.7290.4490.640.73
22663588-266358889.78490.16
32651720-265172089.38389.76
42679033-267903390.30490.69
52701316-270131691.05591.45
62697138-269713890.91491.31
60min12754765-275476592.85793.020.4893.3893.550.48
22754565-275456592.85093.37
32740428-274042892.37492.89
42759976-275997693.03393.56
52772933-277293393.46994.00
62775471-277547193.55594.09
极限12932596-293259698.85198.720.3799.5199.390.37
22915672-291567298.28198.94
32918408-291840898.37399.03
42927517-292751798.68099.35
52944459-294445999.25199.92
62933955-293395598.89799.57
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%
110.042971994297026229689982968799296908029698270.05
210.142971921296934729706340.07
单位质量响应值RSD%判断
295799.50292961.930.69数据可信
供试品溶液-25020301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%
5min1284130-2841309.61310.155.179.6110.155.18
2327234-32723411.07211.07
3293598-2935989.9349.93
4307275-30727510.39710.40
5289478-2894789.7949.79
6298631-29863110.10410.10
10min1742799-74279925.13225.372.2025.1525.392.20
2757584-75758425.63225.65
3771819-77181926.11426.13
4740118-74011825.04225.06
5726427-72642724.57824.59
6760556-76055625.73325.75
15min11173949-117394939.72038.794.2739.7738.844.27
21154637-115463739.06739.12
31206300-120630040.81540.87
41106832-110683237.44937.50
51071256-107125636.24536.30
61164935-116493539.41539.47
20min11486697-148669750.30249.244.1050.4149.354.10
21451093-145109349.09749.21
31546949-154694952.34052.46
41416088-141608847.91348.02
51372628-137262846.44246.55
61458430-145843049.34549.46
30min11901765-190176564.34563.132.9564.5363.312.95
21852190-185219062.66862.86
31950126-195012665.98266.18
41846801-184680162.48662.67
51788344-178834460.50860.68
61855437-185543762.77862.96
45min12209278-220927874.75073.721.8975.0374.001.89
22169258-216925873.39673.68
32242653-224265375.87976.17
42143737-214373772.53272.81
52133540-213354072.18772.45
62174845-217484573.58573.87
60min12352662-235266279.60178.541.6080.0078.931.61
22314986-231498678.32678.72
32375967-237596780.39080.80
42285868-228586877.34177.72
52282059-228205977.21277.59
62315512-231551278.34478.74
极限12573867-257386787.08686.271.3187.6086.771.32
22554540-255454086.43286.94
32599779-259977987.96288.49
42511775-251177584.98585.48
52520590-252059085.28385.77
62537453-253745385.85486.36
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