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%
113.271676616747167871678616775167720.10
213.241678116732167560.21
单位质量响应值RSD%判断
1263.901265.560.10数据可信
供试品溶液-HH6848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%
2min111021-1102162.36565.573.5162.3765.573.51
211999-1199967.89967.90
311628-1162865.80065.80
411299-1129963.93863.94
512080-1208068.35868.36
611497-1149765.05965.06
5min116744-1674494.75095.302.8894.8595.412.88
217694-17694100.126100.24
316983-1698396.10396.21
416856-1685695.38495.49
516398-1639892.79292.91
616375-1637592.66292.77
10min117803-17803100.743100.362.38101.00100.632.38
218430-18430104.291104.57
317478-1747898.90499.17
417947-17947101.558101.82
517242-1724297.56897.84
617514-1751499.10799.37
15min117994-17994101.824101.012.37102.25101.452.37
218573-18573105.100105.55
317546-1754699.28999.72
417957-17957101.614102.05
517406-1740698.49698.93
617630-1763099.764100.19
30min117779-17779100.607100.622.26101.21101.222.26
218455-18455104.432105.06
317491-1749198.97799.58
418019-18019101.965102.57
517388-1738898.39498.99
617551-1755199.31799.91
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%
113.271688016889168521686916877168730.09
213.241682116778168000.19
单位质量响应值RSD%判断
1271.511268.880.15数据可信
供试品溶液-HH6848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%
2min113537-1353776.27374.966.0976.2774.966.09
214370-1437080.96680.97
313912-1391278.38678.39
412175-1217568.59968.60
512650-1265071.27571.28
613180-1318074.26174.26
5min117689-1768999.66799.061.5399.7999.181.53
217935-17935101.053101.19
317805-17805100.321100.45
417439-1743998.25898.37
517347-1734797.74097.86
617270-1727097.30697.43
10min117784-17784100.20299.661.67100.5099.961.67
218046-18046101.678101.98
317990-17990101.363101.66
417462-1746298.38898.67
517514-1751498.68198.96
617336-1733697.67897.96
15min117837-17837100.50199.731.61100.96100.181.62
218046-18046101.678102.15
317969-17969101.245101.71
417488-1748898.53498.98
517384-1738497.94898.39
617476-1747698.46798.92
30min117786-17786100.21399.581.45100.84100.211.45
218024-18024101.554102.20
317864-17864100.653101.29
417487-1748798.52999.14
517516-1751698.69299.30
617369-1736997.86498.48
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%
113.271681416798167901680516836168090.11
213.241677216730167510.18
单位质量响应值RSD%判断
1266.691265.180.09数据可信
供试品溶液-HH6848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%
2min19847-984755.66958.495.5855.6758.495.59
210853-1085361.35661.36
39480-948053.59453.59
410847-1084761.32261.32
510743-1074360.73460.73
610308-1030858.27558.27
5min116311-1631192.21293.221.2492.3093.321.24
216781-1678194.86994.97
316303-1630392.16792.26
416457-1645793.03793.14
516385-1638592.63092.73
616700-1670094.41194.51
10min117408-1740898.414100.060.9398.66100.320.93
217675-1767599.923100.18
317759-17759100.398100.64
417673-1767399.912100.17
517802-17802100.641100.90
617883-17883101.099101.35
15min117596-1759699.477100.330.8399.89100.750.83
217952-17952101.489101.92
317751-17751100.353100.76
417774-17774100.483100.91
517567-1756799.31399.74
617838-17838100.845101.27
30min117549-1754999.211100.770.9399.79101.360.93
217983-17983101.664102.26
317957-17957101.517102.10
417713-17713100.138100.73
517849-17849100.907101.50
617897-17897101.178101.77
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%
113.271679416801168131682616805168080.08
213.241679716742167700.24
单位质量响应值RSD%判断
1266.621266.620.00数据可信
供试品溶液-HH6848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%
2min110044-1004456.75261.654.4656.7561.654.46
211157-1115763.04163.04
310918-1091861.69061.69
411149-1114962.99663.00
511448-1144864.68564.68
610749-1074960.73560.74
5min116459-1645992.99993.852.2393.0993.962.23
216333-1633392.28792.39
316222-1622291.66091.76
417009-1700996.10696.21
516512-1651293.29893.41
617127-1712796.77396.87
10min117478-1747898.75698.652.2599.0198.912.25
217029-1702996.21996.48
317000-1700096.05696.31
417953-17953101.440101.71
517480-1748098.76899.03
617814-17814100.655100.92
15min117297-1729797.73498.671.9598.1599.101.95
217214-1721497.26597.68
317054-1705496.36196.78
417897-17897101.124101.56
517490-1749098.82499.25
617826-17826100.723101.15
30min117264-1726497.54798.742.1698.1299.332.16
217242-1724297.42398.00
317014-1701496.13596.71
417963-17963101.497102.10
517497-1749798.86499.46
617872-17872100.983101.58
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