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%
113.461731317325173231731417324173200.04
213.441722117224172220.02
单位质量响应值RSD%判断
1286.781281.400.30数据可信
供试品溶液-24060403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%
2min115809-1580988.11191.714.7388.1191.724.73
216869-1686994.01994.02
315198-1519884.70684.71
417210-1721095.92095.92
516916-1691694.28194.28
616731-1673193.25093.25
5min118892-18892105.294101.072.82105.44101.222.81
218355-18355102.301102.46
317424-1742497.11297.25
418353-18353102.290102.45
517945-17945100.016100.17
617837-1783799.41499.57
10min118805-18805104.809101.252.50105.13101.572.50
218416-18416102.641102.97
317554-1755497.83798.14
418366-18366102.362102.69
518046-18046100.579100.90
617807-1780799.24799.57
15min118837-18837104.988101.032.45105.48101.522.45
218051-18051100.607101.11
317618-1761898.19498.66
418406-18406102.585103.09
518088-18088100.813101.30
617758-1775898.97499.46
30min118760-18760104.558101.212.28105.23101.872.28
218326-18326102.140102.81
317705-1770598.67899.31
418402-18402102.563103.24
518028-18028100.479101.14
617731-1773198.82399.47
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%
113.461719617200172041719717192171980.03
213.441715017233171920.35
单位质量响应值RSD%判断
1277.711279.170.09数据可信
供试品溶液-24060403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%
2min116843-1684394.28894.354.5194.2994.354.51
216395-1639591.78091.78
316427-1642791.96091.96
418358-18358102.770102.77
516702-1670293.49993.50
616402-1640291.82091.82
5min118871-18871105.641103.442.35105.80103.602.35
217881-17881100.099100.25
318273-18273102.294102.45
419063-19063106.716106.89
518507-18507103.604103.76
618275-18275102.305102.46
10min118758-18758105.009103.552.29105.34103.882.29
217853-1785399.942100.26
318450-18450103.285103.61
419090-19090106.867107.22
518562-18562103.912104.24
618271-18271102.282102.61
15min118808-18808105.289103.572.06105.80104.072.06
217890-17890100.150100.64
318469-18469103.391103.89
418966-18966106.173106.70
518549-18549103.839104.34
618319-18319102.551103.05
30min118747-18747104.947103.282.17105.63103.962.17
217836-1783699.847100.50
318391-18391102.954103.62
418963-18963106.156106.86
518541-18541103.794104.47
618217-18217101.980102.65
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%
113.461721217196172331718517214172080.11
213.441727617290172830.06
单位质量响应值RSD%判断
1278.451285.940.42数据可信
供试品溶液-24060403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%
2min115433-1543386.14390.843.8386.1490.843.83
216053-1605389.60389.60
316390-1639091.48491.48
417334-1733496.75496.75
516084-1608489.77689.78
616358-1635891.30691.31
5min118096-18096101.007102.972.41101.15103.122.41
218432-18432102.882103.03
318635-18635104.015104.17
418331-18331102.319102.48
517973-17973100.320100.47
619216-19216107.258107.41
10min118284-18284102.056103.692.27102.37104.012.26
218586-18586103.742104.06
318915-18915105.578105.90
418365-18365102.508102.84
518094-18094100.996101.31
619213-19213107.242107.57
15min118239-18239101.805103.622.34102.29104.112.34
218612-18612103.887104.38
318926-18926105.640106.14
418343-18343102.386102.89
518064-18064100.828101.31
619199-19199107.163107.67
30min118241-18241101.816103.562.17102.47104.232.17
218546-18546103.519104.19
318862-18862105.282105.96
418309-18309102.196102.87
518170-18170101.420102.07
619193-19193107.130107.82
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