塞来昔布胶囊项目信息
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%
19.412801221280295628067472802974280305628033910.08
29.332798567279846427985160.01
单位质量响应值RSD%判断
297916.15299948.120.49数据可信
长期36月-供试品溶液-20211227批-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1767910-76791025.58629.2734.9425.5929.2834.94
2759543-75954325.30725.31
3932245-93224531.06131.06
4957004-95700431.88631.89
5463335-46333515.43815.44
61391637-139163746.36846.37
10min11627668-162766854.23261.4015.7854.2761.4415.78
21559962-155996251.97652.01
32282339-228233976.04576.09
42066873-206687368.86668.91
51620263-162026353.98654.01
61899287-189928763.28263.35
15min12034322-203432267.78276.3914.8067.9076.5314.80
21825833-182583360.83560.95
32794643-279464393.11593.28
42482943-248294382.72982.88
52276083-227608375.83775.94
62342571-234257178.05278.22
20min12400171-240017179.97187.0112.6980.1987.2612.69
22071103-207110369.00769.21
33027601-3027601100.877101.18
42723083-272308390.73091.01
52699386-269938689.94190.16
62747475-274747591.54391.82
30min12866814-286681495.51997.243.8395.8697.623.85
22805149-280514993.46593.78
33077382-3077382102.535102.99
42808481-280848193.57693.99
52940473-294047397.97498.33
63012821-3012821100.384100.80
45min12951041-295104198.32699.543.7398.81100.073.75
22884150-288415096.09796.55
33115093-3115093103.792104.40
42862144-286214495.36495.92
52991886-299188699.687100.19
63121363-3121363104.001104.57
60min12954555-295455598.443100.063.1399.07100.743.17
22900709-290070996.64997.24
33127741-3127741104.213104.97
42930999-293099997.65898.35
52999261-299926199.932100.58
63105809-3105809103.482104.21
极限12960862-296086298.653100.503.3199.43101.333.33
22955296-295529698.46799.21
33125955-3125955104.154105.07
42893492-289349296.40897.25
53021149-3021149100.662101.46
63141808-3141808104.682105.56
塞来昔布胶囊项目信息
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%
19.412792389279248527926172790818279011427916850.05
29.332824280282473328245060.02
单位质量响应值RSD%判断
296672.16302733.761.44数据可信
长期36月-供试品溶液-20211228批-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1178662-1786625.93828.5846.785.9428.5846.78
2641892-64189221.33421.33
31001054-100105433.27133.27
4891465-89146529.62929.63
51302133-130213343.27843.28
61144315-114431538.03338.03
10min11277236-127723642.45167.4123.1842.4667.4523.19
21716634-171663457.05557.09
32135282-213528270.96971.02
42097185-209718569.70369.75
52602674-260267486.50386.57
62340114-234011477.77777.83
15min12073037-207303768.90083.0411.3868.9783.1911.42
22337154-233715477.67877.80
32556826-255682684.97985.14
42460405-246040581.77581.92
52907500-290750096.63596.83
62656404-265640488.28988.46
20min12556486-255648684.96893.406.9385.1493.676.97
22725035-272503590.57090.80
32933952-293395297.51497.80
42670822-267082288.76889.04
53087206-3087206102.607102.95
62888155-288815595.99296.30
30min12845776-284577694.58398.124.4094.8998.544.43
22872424-287242495.46995.84
32960230-296023098.38798.82
42852689-285268994.81395.22
53185294-3185294105.867106.36
62997621-299762199.630100.08
45min12837399-283739994.30598.294.5694.7598.854.60
22893280-289328096.16296.68
32961580-296158098.43299.01
42845087-284508794.56095.11
53195629-3195629106.211106.86
63011366-3011366100.087100.69
60min12836170-283617094.26498.564.3494.8599.274.38
22903392-290339296.49897.16
32951505-295150598.09798.82
42883721-288372195.84496.53
53192075-3192075106.093106.90
63026577-3026577100.592101.34
极限12854025-285402594.85798.744.3895.5999.594.42
22917046-291704696.95297.75
32966127-296612798.58399.46
42854295-285429594.86695.70
53193941-3193941106.155107.13
63039339-3039339101.016101.92
塞来昔布胶囊项目信息
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%
19.412795542279473727953892795411279257127947300.05
29.332794154279397527940640.01
单位质量响应值RSD%判断
296995.75299470.950.59数据可信
长期36月-供试品溶液-20211229批-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11223065-122306540.84736.7415.0940.8536.7415.09
21210049-121004940.41240.41
31217294-121729440.65440.65
41048614-104861435.02135.02
5793472-79347226.50026.50
61107342-110734236.98236.98
10min12185788-218578872.99970.814.7973.0670.874.79
21957305-195730565.36965.43
32098333-209833370.07970.14
42205960-220596073.67373.73
52058499-205849968.74868.79
62215524-221552473.99274.05
15min12635420-263542088.01685.233.4888.1985.383.48
22484461-248446182.97483.13
32579665-257966586.15486.32
42636784-263678488.06188.22
52411925-241192580.55280.69
62562892-256289285.59485.76
20min12883579-288357996.30492.073.2696.6192.363.26
22664272-266427288.97989.26
32794471-279447193.32893.62
42823601-282360194.30094.60
52692955-269295589.93790.20
62681263-268126389.54789.84
30min13059885-3059885102.19298.093.35102.6498.523.34
22782064-278206492.91393.33
32933726-293372697.97898.41
43007860-3007860100.454100.89
52960858-296085898.88499.28
62878108-287810896.12196.55
45min13071396-3071396102.57698.873.28103.1899.443.27
22788846-278884693.14093.70
32954215-295421598.66399.24
43028205-3028205101.134101.72
52975874-297587499.38699.93
62943197-294319798.29598.87
60min13060367-3060367102.20898.403.48102.9699.123.47
22775595-277559592.69793.39
32897674-289767496.77497.50
43030324-3030324101.204101.94
52973825-297382599.318100.01
62941019-294101998.22298.94
极限13062808-3062808102.28999.213.43103.20100.083.42
22774813-277481392.67193.51
32968513-296851399.140100.02
43014640-3014640100.681101.57
53024027-3024027100.994101.84
62979411-297941199.504100.37
塞来昔布胶囊项目信息
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%
19.412790477278703827899572790963278835327893580.06
29.332788969278890927889390.01
单位质量响应值RSD%判断
296424.87298921.650.60数据可信
长期36月-供试品溶液-DR8010批-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1890617-89061729.80022.2360.9129.8022.2260.90
2852922-85292228.53928.54
3931937-93193731.18331.18
4147285-1472854.9284.93
51016522-101652234.01334.01
6146131-1461314.8904.89
10min12069726-206972669.25367.1214.2969.3067.1614.32
21933230-193323064.68664.73
32276120-227612076.15976.21
41753949-175394958.68758.69
52365368-236536879.14579.20
61637561-163756154.79354.80
15min12561286-256128685.70184.466.7785.8584.606.79
22382113-238211379.70679.85
32728719-272871991.30391.46
42414494-241449480.78980.88
52716943-271694390.90991.08
62342372-234237278.37678.47
20min12708865-270886590.63990.844.1790.9291.104.19
22533329-253332984.76585.02
32854875-285487595.52495.82
42724367-272436791.15891.37
52806707-280670793.91394.22
62660737-266073789.02989.24
30min12798279-279827993.63194.961.6594.0495.361.65
22763082-276308292.45392.84
32866343-286634395.90896.35
42870918-287091896.06196.41
52878563-287856396.31796.76
62851130-285113095.39995.74
45min12852424-285242495.44296.661.0496.0097.201.02
22875398-287539896.21196.74
32861568-286156895.74896.33
42908307-290830797.31297.81
52927056-292705697.94098.53
62908059-290805997.30497.79
60min12854978-285497895.52896.671.2696.2297.361.24
22869411-286941196.01196.68
32848556-284855695.31396.04
42904292-290429297.17897.82
52926711-292671197.92898.67
62931226-293122698.07998.71
极限12915954-291595497.56897.800.6898.4198.630.67
22917688-291768897.62698.44
32893129-289312996.80497.68
42919638-291963897.69198.48
52943521-294352198.49099.38
62946623-294662398.59499.37
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