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%
19.412804580280456028090302804128280445128053500.08
29.332804772280272228037470.06
单位质量响应值RSD%判断
298124.34300508.790.57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%
5min11085678-108567836.12733.6812.8436.1333.6812.85
2981143-98114332.64932.65
31039463-103946334.59034.59
4769324-76932425.60025.60
51139750-113975037.92737.93
61057911-105791135.20335.20
10min11930765-193076564.24963.939.2364.3063.999.22
21937912-193791264.48764.54
31923753-192375364.01564.07
41730599-173059957.58857.63
51771106-177110658.93658.99
62233849-223384974.33474.39
15min12451587-245158781.58078.927.7981.7379.077.79
22329219-232921977.50877.65
32389064-238906479.49979.65
42150594-215059471.56471.69
52232275-223227574.28274.43
62678076-267807689.11789.28
20min12788668-278866892.79790.764.4693.0791.024.47
22687920-268792089.44489.71
32750694-275069491.53391.80
42618127-261812787.12287.35
52595440-259544086.36786.62
62923919-292391997.29797.60
30min13088966-3088966102.789100.533.28103.20100.943.29
23044918-3044918101.324101.72
33067576-3067576102.078102.48
42858008-285800895.10495.47
52947847-294784798.09498.48
63119767-3119767103.814104.26
45min13132531-3132531104.239101.553.64104.81102.103.65
23079543-3079543102.476103.02
33107006-3107006103.390103.95
42864600-286460095.32395.83
52974123-297412398.96899.50
63152326-3152326104.898105.50
60min13127156-3127156104.060101.363.61104.78102.063.62
23062526-3062526101.910102.61
33095181-3095181102.996103.71
42862183-286218395.24395.89
52973471-297347198.94699.63
63154983-3154983104.986105.74
极限13126360-3126360104.034101.363.61104.91102.213.62
23069097-3069097102.128102.98
33099836-3099836103.151104.02
42864560-286456095.32296.11
52964939-296493998.66299.49
63150425-3150425104.835105.75
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%
19.412797128280174428040752800333281140728029370.20
29.332807505280864328080740.03
单位质量响应值RSD%判断
297867.91300972.560.74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%
5min11319949-131994943.90833.9242.8843.9133.9242.89
21170562-117056238.93938.94
31354062-135406245.04345.04
41338473-133847344.52544.52
5370153-37015312.31312.31
6564309-56430918.77218.77
10min11944145-194414564.67263.5315.0064.7463.5815.02
22191243-219124372.89272.95
32248871-224887174.80974.88
41879108-187910862.50962.58
51499655-149965549.88649.90
61695943-169594356.41656.44
15min12672263-267226388.89380.4610.3289.0680.6110.34
22507051-250705183.39883.57
32568964-256896485.45785.64
42473705-247370582.28882.45
51966831-196683165.42765.52
62323484-232348477.29177.40
20min12831489-283148994.19089.157.8594.4989.417.87
22804521-280452193.29393.59
32768137-276813792.08392.39
42726366-272636690.69390.98
52264822-226482275.34075.53
62683701-268370189.27489.50
30min12933871-293387197.59698.815.7898.0399.215.78
23181598-3181598105.836106.27
32917181-291718197.04197.49
42879909-287990995.80196.22
52742559-274255991.23291.54
63166550-3166550105.336105.70
45min12940666-294066697.82299.725.6598.41100.275.64
23202371-3202371106.527107.12
32911307-291130796.84597.44
42876994-287699495.70496.27
52834846-283484694.30294.74
63220572-3220572107.133107.65
60min12935557-293555797.65299.535.5698.38100.235.55
23181897-3181897105.846106.60
32921091-292109197.17197.91
42871351-287135195.51696.22
52824280-282428093.95094.53
63218160-3218160107.053107.73
极限12942534-294253497.88499.565.5698.76100.405.55
23195959-3195959106.314107.22
32908733-290873396.76097.64
42872866-287286695.56696.42
52829055-282905594.10994.83
63207790-3207790106.708107.55
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%
19.412812104280781328076882811578281224528102860.09
29.332807740280738928075640.01
单位质量响应值RSD%判断
298648.88300917.900.54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%
5min11428712-142871247.46833.1133.1347.4733.1033.14
2616086-61608620.46920.47
3620175-62017520.60520.60
41163072-116307238.64238.64
5949683-94968331.55331.55
61200900-120090039.89939.90
10min12508381-250838183.34065.8321.2883.4165.8821.29
21529326-152932650.81150.84
31530047-153004750.83550.87
42289878-228987876.08076.14
51785628-178562859.32759.37
62245059-224505974.59174.65
15min12804164-280416493.16780.0016.1193.3680.1516.13
21881312-188131262.50662.61
32109857-210985770.09970.21
42489953-248995382.72782.90
52296039-229603976.28576.42
62865791-286579195.21495.39
20min13045640-3045640101.19090.6912.32101.5390.9612.34
22341878-234187877.80878.01
32475463-247546382.24682.46
42700632-270063289.72790.02
52601503-260150386.43486.68
63212116-3212116106.721107.04
30min13101861-3101861103.05898.077.98103.5598.488.01
22858855-285885594.98495.30
32653859-265385988.17388.51
42904983-290498396.51796.95
52856813-285681394.91695.30
63334023-3334023110.771111.25
45min13108116-3108116103.26599.859.87103.91100.409.88
22878543-287854395.63896.10
32742166-274216691.10791.57
42894346-289434696.16396.74
52849398-284939894.67095.19
63559539-3559539118.264118.90
60min13126082-3126082103.86299.116.81104.6699.816.84
22906306-290630696.56097.16
32798421-279842192.97693.58
42889856-288985696.01496.73
52849491-284949194.67395.34
63327822-3327822110.565111.38
极限13107626-3107626103.24999.656.79104.20100.506.82
22927020-292702097.24998.00
32874925-287492595.51896.26
42883057-288305795.78896.65
52836240-283624094.23395.04
63366289-3366289111.843112.83
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