塞来昔布片项目信息
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%
19.981463350146647414635491465436146437014646360.09
210.011465264146273814640010.13
单位质量响应值RSD%判断
146757.11146253.850.25数据可信
中间条件28月-供试品溶液-pH12.0(内含1.0%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211151196015117351511848102.78100.631.5099.05%～102.20%
214662821465614146594899.66
3148094014783851479662100.59
4148506614856441485355100.98
514472361447155144719698.39
6149052214915891491056101.37
20240302211152502114939481509484102.62101.511.8499.56%～103.46%
214657761466068146592299.66
3147668714774911477089100.42
4154006515412961540680104.74
5148013914817821480960100.68
6148419614856091484902100.95
20240303211150727115059161506594102.42103.260.93102.26%～104.26%
2150810415099131509008102.59
3152148315254601523472103.57
4150542015044421504931102.31
5152896415339951531480104.12
6153894415366101537777104.54
塞来昔布片项目信息
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%
19.982877880288536828762392884458287684528801580.16
210.012857195285531028562520.05
单位质量响应值RSD%判断
288592.99285339.860.81数据可信
中间条件28月-供试品溶液-pH12.0(内含1.0%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211293309329325232932808101.79104.201.69102.36%～106.05%
2296300429662072964606102.90
3305116430521303051647105.92
4299095429937902992372103.86
5306423930668333065536106.40
6300715230056273006390104.35
20240302211296686029712122969036103.05102.441.13101.23%～103.64%
2295648029557272956104102.60
3295241229515012951956102.46
4288789628850742886485100.19
5297850629778322978169103.37
6296817529640152966095102.95
20240303211296332329611112962217102.82102.980.53102.42%～103.55%
2295569929549942955346102.58
3299022829862932988260103.72
4296331029619242962617102.83
5295102029490952950058102.39
6298430729832942983800103.56
塞来昔布片项目信息
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%
19.981454246145525114527721450470144996214525400.16
210.011447370144843414479020.06
单位质量响应值RSD%判断
145545.09144645.550.44数据可信
中间条件28月-供试品溶液-pH1.0(内含0.5%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121113929561389972139146495.5294.331.5692.78%～95.87%
213790711378811137894194.66
313738711372066137296894.25
413384051339765133908591.92
513558051370672136323893.58
613984921399453139897296.03
2024030221114092871412402141084496.8594.942.2692.69%～97.19%
213302411327673132895791.23
313836631373257137846094.62
413717661369132137044994.07
514092661411563141041496.82
614005621397250139890696.03
2024030321114199041420034141996997.4795.172.1493.03%～97.31%
214006131401105140085996.16
313741541372722137343894.28
413791911380739137996594.73
513373541337096133722591.79
614061221408418140727096.60
塞来昔布片项目信息
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%
19.982863412286032128526022856718285610028578310.15
210.012853723285403928538810.01
单位质量响应值RSD%判断
286355.81285103.000.32数据可信
中间条件28月-供试品溶液-pH1.0(内含0.5%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121126417782643820264279992.1291.581.6390.02%～93.14%
226696902671425267055893.09
326119452614520261323291.09
425490232550721254987288.88
526293802633951263166691.74
626583732652087265523092.56
2024030221125501412551625255088388.9290.031.4688.66%～91.40%
225813402580736258103889.97
326324962631763263213091.75
425299922530282253013788.20
525920832591956259202090.35
626099862609312260964990.97
2024030321124529472456057245450285.5687.061.1885.99%～88.14%
224856652485936248580086.65
325333512530584253196888.26
425077622509307250853487.44
524796792480993248033686.46
625226812526497252458988.00
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