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%
19.412816692281534928149942818124282094628172210.09
29.332805130280408728046080.03
单位质量响应值RSD%判断
299385.87300601.070.29数据可信
中间条件36月-供试品溶液-20211227批-pH12.0(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%
5min11096676-109667636.41130.0112.9536.4130.0112.95
2996126-99612633.07233.07
3828507-82850727.50727.51
4794961-79496126.39326.39
5864839-86483928.71328.71
6843124-84312427.99227.99
10min12037396-203739667.64357.869.3467.7057.919.34
21713433-171343356.88756.94
31541068-154106851.16551.21
41762554-176255458.51858.56
51710315-171031556.78456.83
61692197-169219756.18256.22
15min12468158-246815881.94576.6311.5082.1076.7611.49
22120156-212015670.39170.53
31851392-185139261.46861.59
42441858-244185881.07281.20
52523533-252353383.78383.91
62443676-244367681.13281.26
20min12760289-276028991.64488.9110.6991.9289.1610.68
22459606-245960681.66181.90
32206219-220621973.24873.46
42838089-283808994.22794.48
52959912-295991298.27298.53
62843653-284365394.41294.66
30min13153110-3153110104.686101.772.92105.10102.152.93
23050715-3050715101.286101.65
32939452-293945297.59297.91
42995023-299502399.43799.83
53168852-3168852105.209105.61
63084314-3084314102.402102.79
45min13155982-3155982104.781101.902.25105.35102.442.27
23068359-3068359101.872102.39
32986501-298650199.15499.62
43004022-300402299.736100.28
53140701-3140701104.274104.83
63060247-3060247101.603102.15
60min13135108-3135108104.088101.822.04104.82102.502.07
23053196-3053196101.369102.04
32974648-297464898.76199.38
43027190-3027190100.505101.19
53134205-3134205104.058104.77
63076145-3076145102.131102.83
极限13137534-3137534104.169101.762.40105.06102.602.42
23054300-3054300101.405102.23
32976590-297659098.82599.59
42993317-299331799.381100.22
53157858-3157858104.844105.72
63070564-3070564101.945102.79
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%
19.412802676279993127988592799584279931828000740.06
29.332796673279799927973360.04
单位质量响应值RSD%判断
297563.66299821.650.54数据可信
中间条件36月-供试品溶液-20211228批-pH12.0(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%
5min1732551-73255124.42725.2427.7824.4325.2427.78
2810943-81094327.04227.04
3867863-86786328.94028.94
41032510-103251034.43034.43
5402623-40262313.42613.43
6695577-69557723.19523.19
10min11851454-185145461.73859.6414.2661.7759.6814.26
21924844-192484464.18564.23
32130382-213038271.03971.08
41830725-183072561.04761.10
51413397-141339747.13147.15
61581046-158104652.72152.76
15min12384290-238429079.50675.2616.1279.6475.3816.13
22476241-247624182.57282.71
32668629-266862988.98889.14
42375164-237516479.20279.34
51697446-169744656.60356.69
61939238-193923864.66564.78
20min12701177-270117790.07385.1812.8590.3285.4212.86
22750988-275098891.73491.99
32901345-290134596.74897.03
42652035-265203588.43488.70
52023124-202312467.46367.64
62297745-229774576.62076.83
30min12925304-292530497.54795.553.2797.9395.923.31
22926258-292625897.57897.98
32969563-296956399.02299.45
42864737-286473795.52795.92
52736332-273633291.24591.52
62770958-277095892.40092.73
45min12922959-292295997.46897.191.6998.0097.701.72
22939892-293989298.03398.58
32994887-299488799.867100.44
42864304-286430495.51296.05
52897175-289717596.60997.02
62868977-286897795.66896.13
60min12943687-294368798.16097.901.5698.8498.551.59
22970478-297047899.05399.74
33003979-3003979100.170100.90
42886191-288619196.24296.92
52913918-291391897.16797.73
62896510-289651096.58697.19
极限12967719-296771998.96198.142.1399.7898.942.16
22965620-296562098.89199.73
33045060-3045060101.540102.42
42877428-287742895.95096.78
52912692-291269297.12697.83
62889294-288929496.34697.10
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%
19.412801663280212328041492803275280409728030610.05
29.332801119280245028017840.04
单位质量响应值RSD%判断
297881.08300298.390.58数据可信
中间条件36月-供试品溶液-20211229批-pH12.0(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%
5min1612492-61249220.39730.8723.7020.4030.8723.69
21147509-114750938.21438.21
3926246-92624630.84530.85
4713791-71379123.77023.77
51099290-109929036.60836.61
61063104-106310435.40335.40
10min11658599-165859955.23463.2111.9855.2663.2511.99
22308059-230805976.86276.92
31840181-184018161.28161.33
41733700-173370057.73557.77
51899916-189991663.27063.33
61947437-194743764.85364.91
15min12269571-226957175.58079.679.2575.6979.819.26
22769603-276960392.23292.40
32488455-248845582.86983.01
42118635-211863570.55470.68
52341561-234156177.97878.13
62366243-236624378.80078.95
20min12659776-265977688.57589.916.8888.8090.166.89
22991818-299181899.63299.94
32798511-279851193.19593.46
42438518-243851881.20781.43
52612989-261298987.01787.28
62696785-269678589.80790.08
30min12954157-295415798.37897.903.7398.7498.303.73
23009740-3009740100.229100.69
32982652-298265299.32799.73
42778133-277813392.51692.87
52842826-284282694.67195.07
63071618-3071618102.290102.69
45min12991868-299186899.63498.354.07100.1498.894.07
23019450-3019450100.552101.16
33003869-3003869100.034100.58
42787620-278762092.83293.32
52823916-282391694.04194.58
63093014-3093014103.002103.56
60min12994171-299417199.71198.434.04100.3799.114.04
23033236-3033236101.012101.77
33015521-3015521100.422101.12
42794901-279490193.07593.70
52817608-281760893.83194.51
63078016-3078016102.503103.21
极限12989054-298905499.54098.164.08100.3599.004.09
23032954-3032954101.002101.92
33005987-3005987100.104100.96
42780488-278048892.59593.36
52812489-281248993.66094.48
63063989-3063989102.036102.90
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