塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.223066471306603030682663066420306638530667140.03
210.223058412306233230603720.10
单位质量响应值RSD%判断
300069.86299449.320.15数据可信
供试品溶液-1批-pH2.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128947-289470.9627.4681.610.967.4681.63
2530311-53031117.62017.62
3229004-2290047.6097.61
440687-406871.3521.35
5255757-2557578.4988.50
6263093-2630938.7428.74
10min11212446-121244640.28641.7617.0440.2941.7817.06
21346006-134600644.72344.76
31249005-124900541.50041.52
4862535-86253528.65928.66
51432869-143286947.60947.63
61438158-143815847.78547.80
15min11842592-184259261.22362.9810.0761.3163.0810.08
22085952-208595269.30969.43
31816268-181626860.34960.45
41580336-158033652.50952.57
51977102-197710265.69365.80
62070151-207015168.78468.90
20min12205419-220541973.27975.414.4073.4875.634.43
22456841-245684181.63381.90
32279992-227999275.75775.98
42170220-217022072.10972.27
52251118-225111874.79775.04
62253000-225300074.86075.11
30min12567494-256749485.30985.461.7385.6685.841.75
22642571-264257187.80488.23
32608399-260839986.66887.04
42534844-253484484.22484.53
52534285-253428584.20684.60
62545044-254504484.56384.96
45min12727037-272703790.61091.841.1591.1392.381.15
22728337-272833790.65491.26
32765250-276525091.88092.42
42766269-276626991.91492.39
52795588-279558892.88893.45
62801422-280142293.08293.65
60min12827269-282726993.94193.850.9994.6494.580.97
22773086-277308692.14092.92
32820044-282004493.70194.43
42828764-282876493.99094.65
52850789-285078994.72295.47
62846794-284679494.58995.35
极限12857158-285715894.93495.131.2695.8396.051.22
22794059-279405992.83793.81
32876041-287604195.56196.48
42891776-289177696.08496.93
52887161-288716195.93196.87
62871777-287177795.42096.36
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.223064951306235830624273060508306386530628220.06
210.223117182307218730946841.03
单位质量响应值RSD%判断
299689.04302806.650.74数据可信
供试品溶液-1批-pH6.8(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11050465-105046534.73228.9429.9034.7328.9429.90
21094857-109485736.20036.20
31159136-115913638.32538.32
4508894-50889416.82616.83
5728875-72887524.09924.10
6709943-70994323.47323.47
10min11658425-165842554.83358.8312.5654.9058.8912.56
21823088-182308860.27760.35
31998822-199882266.08866.16
41498232-149823249.53749.57
52067763-206776368.36768.42
61629535-162953553.87853.92
15min12160966-216096671.44978.338.9371.6378.518.92
22328035-232803576.97377.17
32549286-254928684.28884.50
42525853-252585383.51383.65
52568168-256816884.91285.10
62082830-208283068.86569.02
20min12606542-260654286.18189.263.3286.5089.603.33
22675483-267548388.46088.81
32760127-276012791.25991.64
42792088-279208892.31692.62
52777292-277729291.82792.18
62587294-258729485.54585.84
30min12901569-290156995.93695.630.4596.4396.140.46
22896229-289622995.75996.28
32888486-288848695.50396.06
42868585-286858594.84595.33
52904408-290440896.02996.57
62894016-289401695.68696.15
45min12913660-291366096.33596.270.4197.0296.980.42
22911328-291132896.25896.97
32928533-292853396.82797.58
42892822-289282295.64696.32
52907778-290777896.14196.87
62916804-291680496.43997.09
60min12915412-291541296.39396.520.6597.2797.420.65
22941652-294165297.26198.17
32931688-293168896.93197.88
42889919-288991995.55096.42
52907539-290753996.13397.06
62929348-292934896.85497.70
极限12944249-294424997.34797.440.5298.4298.520.52
22951793-295179397.59698.70
32960672-296067297.89099.03
42925270-292527096.71997.78
52934556-293455697.02698.14
62965132-296513298.03799.08
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