普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
113.381582915768157901580315832158040.18
213.351576015797157780.17
单位质量响应值RSD%判断
1181.171181.870.05数据可信
供试品溶液-LW0489批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min112185-1218573.80871.284.0573.8171.284.05
211764-1176471.25871.26
310931-1093166.21266.21
411604-1160470.28970.29
511886-1188671.99772.00
612237-1223774.12374.12
5min116107-1610797.56599.442.4597.5699.442.45
216484-1648499.84899.85
315825-1582595.85795.86
416832-16832101.956101.96
516409-1640999.39499.39
616846-16846102.041102.04
10min116508-1650899.994102.642.1099.99102.642.10
216941-16941102.616102.62
316518-16518100.054100.05
417226-17226104.343104.34
517177-17177104.046104.05
617296-17296104.767104.77
15min116435-1643599.552102.702.3299.55102.702.32
216937-16937102.592102.59
316544-16544100.212100.21
417392-17392105.348105.35
517146-17146103.858103.86
617276-17276104.646104.65
30min116548-16548100.236103.202.48100.24103.202.48
216894-16894102.332102.33
316626-16626100.708100.71
417283-17283104.688104.69
517229-17229104.361104.36
617640-17640106.851106.85
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
113.381589915833159481591515961159110.32
213.351571915882158000.73
单位质量响应值RSD%判断
1189.161183.520.34数据可信
供试品溶液-LW0489批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min111360-1136068.53170.052.6168.5370.052.61
211579-1157969.85369.85
312063-1206372.77272.77
411396-1139668.74968.75
511369-1136968.58668.59
611900-1190071.78971.79
5min115654-1565494.43697.492.5094.4497.492.50
216043-1604396.78396.78
316791-16791101.295101.30
415879-1587995.79395.79
516416-1641699.03399.03
616181-1618197.61597.62
10min116110-1611097.187100.722.9697.19100.722.96
216617-16617100.245100.25
317526-17526105.729105.73
416311-1631198.39998.40
516749-16749101.042101.04
616859-16859101.705101.71
15min116042-1604296.77799.932.3896.7899.932.38
216467-1646799.34099.34
317200-17200103.762103.76
416348-1634898.62398.62
516767-16767101.150101.15
616564-1656499.92699.93
30min116127-1612797.289100.092.2497.29100.092.24
216401-1640198.94298.94
317081-17081103.044103.04
416319-1631998.44898.45
516922-16922102.085102.09
616695-16695100.716100.72
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
113.385138451179511455121651265512380.19
213.355110551458512820.49
单位质量响应值RSD%判断
3829.453841.350.22数据可信
供试品溶液-LR6707批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min133527-3352762.56158.695.4162.5658.685.41
232146-3214659.98459.98
331700-3170059.15259.15
432272-3227260.21960.22
528657-2865753.47453.47
630398-3039856.72256.72
5min150136-5013693.55391.881.5693.5591.881.56
249419-4941992.21592.22
348096-4809689.74789.75
449125-4912591.66791.67
549947-4994793.20193.20
648701-4870190.87690.88
10min151492-5149296.08495.171.6296.0895.171.62
251172-5117295.48695.49
349761-4976192.85492.85
450732-5073294.66594.67
552185-5218597.37797.38
650678-5067894.56594.56
15min151127-5112795.40395.551.5095.4095.551.50
251402-5140295.91695.92
350349-5034993.95193.95
451212-5121295.56195.56
552537-5253798.03498.03
650603-5060394.42594.42
30min151744-5174496.55495.801.6596.5595.801.65
251322-5132295.76695.77
350224-5022493.71893.72
451229-5122995.59395.59
552712-5271298.36098.36
650811-5081194.81394.81
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
113.385135551245514045139851372513550.13
213.355125951363513110.15
单位质量响应值RSD%判断
3838.193843.520.10数据可信
供试品溶液-LR6707批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min133814-3381463.00754.7215.3863.0154.7215.38
222646-2264642.19742.20
329330-2933054.65254.65
432872-3287261.25261.25
532218-3221860.03360.03
625304-2530447.15047.15
5min149701-4970192.61091.810.8692.6191.810.86
248691-4869190.72890.73
349212-4921291.69891.70
449684-4968492.57892.58
548875-4887591.07191.07
649465-4946592.17092.17
10min150986-5098695.00495.590.6995.0095.590.69
251712-5171296.35796.36
351528-5152896.01496.01
450789-5078994.63794.64
551485-5148595.93495.93
651293-5129395.57695.58
15min150971-5097194.97695.851.0094.9895.851.00
251944-5194496.78996.79
351600-5160096.14896.15
451492-5149295.94795.95
551930-5193096.76396.76
650691-5069194.45494.45
30min150848-5084894.74795.661.2894.7595.661.28
252178-5217897.22597.23
351414-5141495.80295.80
450656-5065694.38994.39
552057-5205797.00097.00
650888-5088894.82194.82
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