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%
110.152976161297375929725052974584297715629748330.07
210.192963427296622529648260.07
单位质量响应值RSD%判断
293087.00290954.470.52数据可信
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%
5min11081493-108149336.88736.6219.4336.8936.6219.43
21151142-115114239.26339.26
31209147-120914741.24141.24
4763802-76380226.05126.05
51334106-133410645.50345.50
6902844-90284430.79430.79
10min12067687-206768770.52470.7414.1870.5870.7914.17
22496775-249677585.15985.22
31919130-191913065.45765.52
42336062-233606279.67879.72
51920287-192028765.49665.56
61703468-170346858.10158.15
15min12536758-253675886.52386.8410.2786.6887.0010.26
22730465-273046593.13093.32
32509272-250927285.58585.75
42930424-293042499.950100.11
52179508-217950874.33874.50
62390188-239018881.52481.66
20min12775538-277553894.66797.085.3394.9697.375.32
22839560-283956096.85197.18
32927587-292758799.853100.14
43082387-3082387105.133105.44
52630031-263003189.70489.98
62822434-282243496.26796.52
30min12795526-279552695.349100.923.2295.78101.363.21
22917693-291769399.51699.99
32982539-2982539101.727102.17
43079572-3079572105.037105.50
52991803-2991803102.043102.46
62986884-2986884101.876102.28
45min12789175-278917595.132101.563.9495.71102.153.92
22912694-291269499.34599.97
33116867-3116867106.309106.90
43073643-3073643104.835105.46
52992812-2992812102.078102.64
62980461-2980461101.656102.21
60min12778862-277886294.780100.563.3295.50101.303.31
22907092-290709299.15499.92
32967289-2967289101.207101.96
43068123-3068123104.646105.43
52989449-2989449101.963102.68
62979499-2979499101.624102.33
极限12774825-277482594.643100.753.2695.50101.643.26
22961076-2961076100.995101.91
32967272-2967272101.207102.11
43068030-3068030104.643105.58
52981994-2981994101.709102.58
62969473-2969473101.282102.14
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%
110.152968878296966529763742971507296479329702430.15
210.192989123298756029883420.04
单位质量响应值RSD%判断
292634.78293262.220.16数据可信
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%
5min1988998-98899833.62540.9216.8733.6340.9216.86
21233640-123364041.94341.94
31303520-130352044.31944.32
41543568-154356852.48052.48
51093814-109381437.18937.19
61057548-105754835.95635.96
10min12091098-209109871.09671.9413.4771.1572.0013.47
22040679-204067969.38169.44
32113904-211390471.87171.94
42577857-257785787.64587.72
51689348-168934857.43657.49
62182393-218239374.20074.25
15min12269063-226906377.14683.949.0777.3084.119.07
22373626-237362680.70180.87
32562613-256261387.12787.30
42815135-281513595.71295.92
52220153-222015375.48375.63
62572832-257283287.47487.64
20min12688002-268800291.39096.036.8791.6696.336.88
22710136-271013692.14292.43
32944894-2944894100.124100.43
43168825-3168825107.737108.09
52703850-270385091.92992.18
62731527-273152792.87093.17
30min13011489-3011489102.388101.744.31102.80102.184.33
22908468-290846898.88699.31
33036146-3036146103.227103.68
43220998-3220998109.511110.03
52887283-288728398.16598.56
62890648-289064898.28098.72
45min13009338-3009338102.315101.914.33102.88102.504.35
22910478-291047898.95499.53
33058479-3058479103.986104.60
43221989-3221989109.545110.22
52884883-288488398.08498.62
62900031-290003198.59999.18
60min13002702-3002702102.089101.794.51102.81102.544.53
22907896-290789698.86699.59
33055368-3055368103.880104.65
43228976-3228976109.783110.63
52872087-287208797.64998.34
62896320-289632098.47399.20
极限12999936-2999936101.995101.584.32102.87102.484.34
22900033-290003398.59999.47
33043188-3043188103.466104.39
43213748-3213748109.265110.27
52880267-288026797.92798.76
62889368-288936898.23699.11
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