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%
113.461704317121170951709817080170870.17
213.441704417087170660.18
单位质量响应值RSD%判断
1269.471269.790.02数据可信
供试品溶液-24060401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%
2min117296-1729697.49694.222.5697.5094.222.57
216748-1674894.40794.41
317088-1708896.32496.32
416162-1616291.10491.10
516362-1636292.23192.23
616637-1663793.78293.78
5min118684-18684105.320103.061.77105.48103.221.77
217864-17864100.698100.86
318523-18523104.413104.57
417981-17981101.358101.51
518194-18194102.558102.71
618454-18454104.024104.18
10min118718-18718105.512103.221.85105.85103.551.84
217890-17890100.845101.17
318549-18549104.559104.89
417946-17946101.160101.48
518274-18274103.009103.33
618495-18495104.255104.58
15min118734-18734105.602103.281.96106.12103.781.96
217866-17866100.709101.20
318536-18536104.486104.99
417955-17955101.211101.70
518246-18246102.851103.35
618597-18597104.830105.33
30min118731-18731105.585103.221.96106.28103.901.96
217828-17828100.495101.16
318511-18511104.345105.03
417956-17956101.217101.87
518281-18281103.049103.72
618562-18562104.633105.31
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%
113.461706617077170861703417043170610.13
213.441690217037169700.57
单位质量响应值RSD%判断
1267.531262.650.28数据可信
供试品溶液-24060401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%
2min117621-1762199.68593.763.6299.6893.763.62
216416-1641692.86892.87
315759-1575989.15189.15
416585-1658593.82493.82
516496-1649693.32193.32
616562-1656293.69493.69
5min118382-18382103.990103.130.98104.16103.280.98
218139-18139102.615102.77
318074-18074102.248102.40
418063-18063102.185102.34
518217-18217103.057103.21
618501-18501104.663104.82
10min118388-18388104.024103.321.05104.36103.651.05
218174-18174102.813103.14
318126-18126102.542102.86
418030-18030101.999102.33
518317-18317103.622103.95
618550-18550104.940105.27
15min118389-18389104.030103.481.12104.54103.981.11
218176-18176102.825103.32
318362-18362103.877104.37
417982-17982101.727102.22
518263-18263103.317103.82
618578-18578105.099105.60
30min118348-18348103.798103.081.05104.48103.751.05
218151-18151102.683103.35
318072-18072102.236102.90
418016-18016101.919102.59
518212-18212103.028103.70
618528-18528104.816105.50
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%
113.461701417005169781700416996169990.08
213.441698116987169840.03
单位质量响应值RSD%判断
1262.931263.690.05数据可信
供试品溶液-24060401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%
2min115277-1527786.54689.704.1386.5589.704.13
215271-1527186.51286.51
315235-1523586.30886.31
416091-1609191.15891.16
516651-1665194.33094.33
616477-1647793.34493.34
5min117963-17963101.763101.700.88101.91101.850.88
217906-17906101.440101.58
317981-17981101.865102.01
418004-18004101.995102.15
518168-18168102.924103.08
617687-17687100.199100.35
10min118162-18162102.890102.131.01103.20102.451.00
218079-18079102.420102.73
317968-17968101.791102.10
418012-18012102.040102.36
518230-18230103.275103.60
617716-17716100.363100.69
15min118233-18233103.292102.130.98103.78102.620.98
218060-18060102.312102.80
317967-17967101.785102.27
417991-17991101.921102.41
518175-18175102.964103.46
617737-17737100.482100.97
30min118214-18214103.185101.981.03103.84102.641.02
218067-18067102.352103.01
317941-17941101.638102.29
417940-17940101.632102.29
518149-18149102.816103.49
617700-17700100.273100.93
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%
113.461701317042170461703117043170350.08
213.441704417016170300.12
单位质量响应值RSD%判断
1265.601267.110.09数据可信
供试品溶液-24060401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%
2min116093-1609390.94989.362.9590.9589.362.95
215411-1541187.09587.10
316523-1652393.38093.38
415944-1594490.10790.11
515611-1561188.22588.23
615284-1528486.37786.38
5min118237-18237103.066103.251.46103.22103.401.46
217790-17790100.540100.69
318526-18526104.699104.86
418502-18502104.564104.71
518313-18313103.496103.64
618254-18254103.162103.31
10min118308-18308103.467103.531.17103.79103.851.17
217928-17928101.320101.63
318468-18468104.372104.70
418546-18546104.812105.14
518345-18345103.677104.00
618315-18315103.507103.82
15min118212-18212102.925103.291.27103.42103.791.27
217892-17892101.116101.60
318439-18439104.208104.71
418529-18529104.716105.22
518407-18407104.027104.52
618183-18183102.761103.25
30min118221-18221102.976103.511.13103.64104.171.13
217937-17937101.371102.02
318387-18387103.914104.59
418477-18477104.423105.10
518434-18434104.180104.85
618434-18434104.180104.84
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