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%
113.541762017624176551763317663176390.11
213.601755917543175510.07
单位质量响应值RSD%判断
1302.731290.510.67数据可信
供试品溶液-2024081611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%
2min117700-1770097.69895.755.3797.7095.765.37
216434-1643490.71190.71
317595-1759597.11997.12
416504-1650491.09791.10
518908-18908104.366104.37
616944-1694493.52693.53
5min121286-21286117.492105.286.63117.49105.286.63
218121-18121100.022100.02
318857-18857104.085104.08
417676-1767697.56697.57
519011-19011104.935104.93
619492-19492107.590107.59
10min120152-20152111.233104.524.69111.23104.524.69
218106-1810699.93999.94
319101-19101105.432105.43
417756-1775698.00898.01
518978-18978104.753104.75
619525-19525107.772107.77
15min120064-20064110.747104.304.75110.75104.304.75
218049-1804999.62599.62
319189-19189105.917105.92
417668-1766897.52297.52
518924-18924104.455104.45
619481-19481107.529107.53
30min120071-20071110.786104.434.72110.79104.434.72
218060-1806099.68699.69
319263-19263106.326106.33
417712-1771297.76597.76
518912-18912104.388104.39
619498-19498107.623107.62
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%
113.541757817604175501756617567175730.12
213.601757017575175720.03
单位质量响应值RSD%判断
1297.861292.060.32数据可信
供试品溶液-2024081611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%
2min114749-1474981.51392.0410.9681.5192.0410.96
219985-19985110.451110.45
317202-1720295.07095.07
415689-1568986.70886.71
516445-1644590.88690.89
615851-1585187.60487.60
5min117894-1789498.895100.816.1198.89100.816.11
220225-20225111.777111.78
318843-18843104.139104.14
417265-1726595.41895.42
517728-1772897.97797.98
617489-1748996.65696.66
10min117938-1793899.138101.165.8999.14101.165.89
220237-20237111.844111.84
318860-18860104.233104.23
417406-1740696.19896.20
517867-1786798.74598.75
617515-1751596.80096.80
15min117947-1794799.188101.295.8399.19101.295.83
220156-20156111.396111.40
319036-19036105.206105.21
417406-1740696.19896.20
517938-1793899.13899.14
617483-1748396.62396.62
30min117885-1788598.845101.365.9698.84101.365.96
220204-20204111.661111.66
319086-19086105.482105.48
417398-1739896.15396.15
517974-1797499.33799.34
617495-1749596.68996.69
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%
113.541759817603176151760217588176010.06
213.601762017572175960.20
单位质量响应值RSD%判断
1299.931293.820.34数据可信
供试品溶液-2024081711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%
2min115309-1530984.48392.555.2584.4892.555.25
217711-1771197.73997.74
317473-1747396.42596.43
416395-1639590.47690.48
517184-1718494.83094.83
616553-1655391.34891.35
5min118037-1803799.538101.652.0699.54101.652.05
218824-18824103.881103.88
318953-18953104.593104.59
418167-18167100.255100.26
518339-18339101.204101.20
618199-18199100.432100.43
10min117986-1798699.256102.072.3299.26102.072.32
218910-18910104.355104.36
319084-19084105.316105.32
418243-18243100.674100.67
518532-18532102.269102.27
618220-18220100.548100.55
15min117971-1797199.173102.282.7599.17102.282.75
218948-18948104.565104.57
319322-19322106.629106.63
418267-18267100.807100.81
518497-18497102.076102.08
618198-18198100.426100.43
30min117966-1796699.146101.952.3499.15101.962.34
218909-18909104.350104.35
319070-19070105.238105.24
418296-18296100.967100.97
518436-18436101.740101.74
618172-18172100.283100.28
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%
113.541760317562175691759717578175820.11
213.601755517567175610.05
单位质量响应值RSD%判断
1298.521291.250.40数据可信
供试品溶液-2024081711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%
2min116228-1622889.69293.395.0089.6993.395.00
218424-18424101.830101.83
316984-1698493.87193.87
416683-1668392.20792.21
516053-1605388.72588.73
617013-1701394.03194.03
5min118685-18685103.272101.982.09103.27101.982.09
219051-19051105.295105.30
318371-18371101.537101.54
418098-18098100.028100.03
518015-1801599.56999.57
618487-18487102.178102.18
10min118607-18607102.841102.481.85102.84102.481.85
219161-19161105.903105.90
318521-18521102.366102.37
418250-18250100.868100.87
518213-18213100.664100.66
618498-18498102.239102.24
15min118560-18560102.581102.461.78102.58102.461.78
219166-19166105.931105.93
318446-18446101.951101.95
418229-18229100.752100.75
518338-18338101.354101.35
618490-18490102.195102.19
30min118531-18531102.421102.431.68102.42102.431.68
219132-19132105.743105.74
318386-18386101.620101.62
418235-18235100.785100.79
518434-18434101.885101.88
618481-18481102.145102.14
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