普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.461705417100170761709517080170810.11
213.441696616980169730.06
单位质量响应值RSD%判断
1269.021262.870.35数据可信
供试品溶液-24060402批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min115989-1598990.39292.182.7690.3992.182.76
215729-1572988.92288.92
316236-1623691.78891.79
417045-1704596.36196.36
516394-1639492.68192.68
616439-1643992.93692.94
5min117996-17996101.738102.731.73101.89102.881.73
217705-17705100.093100.24
318611-18611105.215105.37
418340-18340103.683103.84
518087-18087102.252102.41
618290-18290103.400103.55
10min118337-18337103.666103.301.92103.99103.631.92
217684-1768499.974100.29
318741-18741105.950106.28
418413-18413104.095104.43
518137-18137102.535102.86
618327-18327103.609103.94
15min118414-18414104.101103.371.85104.59103.871.85
217767-17767100.443100.92
318762-18762106.068106.57
418362-18362103.807104.31
518066-18066102.134102.63
618341-18341103.688104.19
30min118394-18394103.988103.491.82104.65104.161.82
217774-17774100.483101.13
318782-18782106.181106.86
418398-18398104.010104.69
518141-18141102.558103.22
618350-18350103.739104.41
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.461706217056170511705817028170510.08
213.441697016987169780.08
单位质量响应值RSD%判断
1266.791263.240.20数据可信
供试品溶液-24060402批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min116867-1686795.42595.903.5095.4295.903.50
216092-1609291.04091.04
316546-1654693.60993.61
417431-1743198.61698.62
517731-17731100.313100.31
617042-1704296.41596.41
5min118836-18836106.564104.462.11106.72104.622.11
218226-18226103.113103.27
317840-17840100.930101.09
418386-18386104.018104.18
518727-18727105.948106.11
618773-18773106.208106.37
10min119097-19097108.041104.672.39108.38105.002.39
218175-18175102.825103.15
317883-17883101.173101.50
418370-18370103.928104.27
518728-18728105.953106.30
618750-18750106.078106.42
15min119042-19042107.730104.672.28108.25105.182.28
218182-18182102.864103.36
317911-17911101.331101.82
418370-18370103.928104.44
518725-18725105.936106.46
618777-18777106.231106.75
30min119104-19104108.081104.612.39108.78105.292.39
218168-18168102.785103.45
317883-17883101.173101.83
418357-18357103.854104.54
518681-18681105.687106.38
618746-18746106.055106.75
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.461698816990169811698517003169890.05
213.441681716849168330.14
单位质量响应值RSD%判断
1262.181252.460.55数据可信
供试品溶液-24060402批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min116724-1672495.19693.074.0195.2093.074.01
216821-1682195.74895.75
316323-1632392.91492.91
416953-1695396.50096.50
515187-1518786.44786.45
616094-1609491.61091.61
5min118060-18060102.801104.131.34102.96104.281.34
218557-18557105.630105.79
318058-18058102.790102.94
418248-18248103.871104.03
518210-18210103.655103.80
618626-18626106.023106.18
10min118340-18340104.395104.791.20104.72105.121.20
218695-18695106.416106.75
318172-18172103.439103.76
418337-18337104.378104.71
518247-18247103.865104.18
618666-18666106.250106.58
15min118374-18374104.588104.690.98105.09105.190.98
218606-18606105.909106.42
318235-18235103.797104.30
418299-18299104.161104.67
518220-18220103.712104.20
618618-18618105.977106.48
30min118266-18266103.974104.361.05104.65105.041.05
218558-18558105.636106.33
318151-18151103.319103.99
418282-18282104.065104.75
518159-18159103.365104.03
618584-18584105.784106.47
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