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%
113.541708417146170561719017214171380.40
213.601716417093171280.30
单位质量响应值RSD%判断
1265.731259.410.36数据可信
供试品溶液-2024081211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%
2min114913-1491384.53487.813.1884.5387.803.18
215891-1589190.07890.08
315800-1580089.56289.56
414809-1480983.94483.94
515802-1580289.57389.57
615726-1572689.14289.14
5min118300-18300103.733100.242.17103.73100.242.17
217273-1727397.91197.91
317401-1740198.63798.64
417498-1749899.18799.19
517953-17953101.766101.77
617676-17676100.196100.20
10min118162-18162102.951100.932.28102.95100.932.28
217311-1731198.12798.13
317373-1737398.47898.48
417747-17747100.598100.60
518297-18297103.716103.72
617940-17940101.692101.69
15min118278-18278103.608100.262.42103.61100.262.43
217118-1711897.03397.03
317420-1742098.74598.74
417556-1755699.51699.52
518080-18080102.486102.49
617672-17672100.173100.17
30min118395-18395104.271100.672.32104.27100.672.32
217171-1717197.33397.33
317564-1756499.56199.56
417737-17737100.542100.54
517986-17986101.953101.95
617705-17705100.360100.36
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%
113.541721717378171551732017199172540.54
213.601716117234171980.31
单位质量响应值RSD%判断
1274.301264.560.55数据可信
供试品溶液-2024081211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%
2min114748-1474883.14883.923.8383.1583.923.83
214548-1454882.02082.02
314696-1469682.85582.85
414226-1422680.20580.20
515815-1581589.16389.16
615278-1527886.13686.14
5min117745-17745100.04497.281.74100.0497.281.74
217148-1714896.67996.68
317158-1715896.73596.74
416860-1686095.05595.05
517417-1741798.19598.20
617201-1720196.97796.98
10min117594-1759499.19398.171.3199.1998.161.31
217150-1715096.69096.69
317659-1765999.56099.56
417132-1713296.58896.59
517391-1739198.04998.05
617544-1754498.91198.91
15min117629-1762999.39098.000.9099.3998.000.90
217443-1744398.34298.34
317334-1733497.72797.73
417158-1715896.73596.74
517409-1740998.15098.15
617323-1732397.66597.67
30min117670-1767099.62298.670.8699.6298.670.86
217577-1757799.09799.10
317582-1758299.12599.13
417551-1755198.95198.95
517314-1731497.61597.61
617316-1731697.62697.63
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%
113.541704317083173251714517050171290.69
213.601721817375172960.65
单位质量响应值RSD%判断
1265.071271.760.38数据可信
供试品溶液-2024081511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%
2min114293-1429380.64689.257.6280.6589.257.62
215490-1549087.40087.40
315291-1529186.27786.28
417542-1754298.97898.98
515320-1532086.44186.44
616967-1696795.73495.73
5min117052-1705296.21398.705.0396.2198.705.04
217254-1725497.35397.35
316719-1671994.33594.33
419050-19050107.487107.49
516898-1689895.34495.34
617984-17984101.472101.47
10min116522-1652293.22399.375.2093.2299.375.20
217549-1754999.01899.02
317054-1705496.22596.22
418947-18947106.906106.91
517157-1715796.80696.81
618443-18443104.062104.06
15min116514-1651493.17898.755.0393.1898.755.03
217480-1748098.62898.63
316902-1690295.36795.37
418935-18935106.838106.84
517106-1710696.51896.52
618074-18074101.980101.98
30min117059-1705996.25399.044.7396.2599.044.73
217351-1735197.90097.90
316790-1679094.73594.74
418924-18924106.776106.78
517005-1700595.94895.95
618184-18184102.601102.60
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%
113.541730017115170831709517276171740.62
213.601711817213171660.40
单位质量响应值RSD%判断
1268.391262.210.35数据可信
供试品溶液-2024081511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%
2min115213-1521386.04993.655.5486.0593.655.54
217889-17889101.185101.18
316525-1652593.47093.47
416023-1602390.63090.63
517138-1713896.93796.94
616555-1655593.63993.64
5min117239-1723997.508102.223.8697.51102.223.86
219144-19144108.283108.28
317946-17946101.507101.51
417505-1750599.01399.01
518564-18564105.003105.00
618033-18033101.999102.00
10min116699-1669994.454101.435.1694.45101.435.17
219378-19378109.607109.61
317859-17859101.015101.01
417413-1741398.49298.49
518522-18522104.765104.77
617725-17725100.257100.26
15min116684-1668494.369101.315.0094.37101.315.00
219253-19253108.900108.90
317873-17873101.094101.09
417399-1739998.41398.41
518540-18540104.867104.87
617716-17716100.206100.21
30min116596-1659693.871101.154.8493.87101.154.84
219026-19026107.616107.62
318035-18035102.010102.01
417266-1726697.66197.66
518491-18491104.590104.59
617882-17882101.145101.15
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