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%
113.181663616638165721650016595165880.35
213.281650116537165190.16
单位质量响应值RSD%判断
1258.571243.900.83数据可信
供试品溶液-HX0269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%
2min111401-1140165.21367.317.0265.2167.317.02
212258-1225870.11570.12
310572-1057260.47260.47
411267-1126764.44764.45
512315-1231570.44270.44
612792-1279273.17073.17
5min116316-1631693.32794.453.2093.3394.453.20
216201-1620192.66992.67
315910-1591091.00591.00
416958-1695896.99997.00
516358-1635893.56793.57
617330-1733099.12799.13
10min116928-1692896.82897.972.4096.8397.972.40
216914-1691496.74896.75
316686-1668695.44495.44
417770-17770101.644101.64
516982-1698297.13797.14
617483-17483100.002100.00
15min116718-1671895.62797.742.6295.6397.742.62
216841-1684196.33096.33
316743-1674395.77095.77
417853-17853102.119102.12
516989-1698997.17797.18
617378-1737899.40299.40
30min117030-1703097.41198.242.2597.4198.242.25
216866-1686696.47396.47
316836-1683696.30296.30
417790-17790101.758101.76
517018-1701897.34397.34
617507-17507100.140100.14
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%
113.181658916505166311649616498165440.38
213.281651116548165300.16
单位质量响应值RSD%判断
1255.241244.730.60数据可信
供试品溶液-HX0269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%
2min111542-1154266.08565.823.7466.0965.823.75
210754-1075461.57361.57
311880-1188068.02068.02
411928-1192868.29568.30
511314-1131464.78064.78
611553-1155366.14866.15
5min116946-1694697.02695.661.7397.0395.661.73
216563-1656394.83394.83
316320-1632093.44293.44
417120-1712098.02398.02
516707-1670795.65895.66
616584-1658494.95494.95
10min117476-17476100.06199.471.95100.0699.471.95
216954-1695497.07297.07
317058-1705897.66897.67
417882-17882102.386102.39
517537-17537100.410100.41
617332-1733299.23799.24
15min117241-1724198.71598.621.7998.7298.631.79
216835-1683596.39196.39
316985-1698597.25097.25
417723-17723101.475101.48
517339-1733999.27799.28
617228-1722898.64198.64
30min117671-17671101.17798.641.81101.1898.641.81
216957-1695797.08997.09
316861-1686196.54096.54
417153-1715398.21298.21
517498-17498100.187100.19
617226-1722698.63098.63
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%
113.181646916451164191648116341164320.35
213.281652016543165320.10
单位质量响应值RSD%判断
1246.741244.880.11数据可信
供试品溶液-HX0269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%
2min113163-1316375.61878.473.4975.6278.473.49
213779-1377979.15679.16
313392-1339276.93376.93
414495-1449583.27083.27
513359-1335976.74476.74
613772-1377279.11679.12
5min116757-1675796.264100.132.3696.26100.122.36
217723-17723101.813101.81
317292-1729299.33799.34
417906-17906102.865102.86
517282-1728299.28099.28
617617-17617101.204101.20
10min116672-1667295.776100.052.8695.78100.052.86
217640-17640101.337101.34
317388-1738899.88999.89
418109-18109104.031104.03
517078-1707898.10898.11
617605-17605101.136101.14
15min116552-1655295.086100.273.2395.09100.283.23
217603-17603101.124101.12
317381-1738199.84999.85
418165-18165104.353104.35
517174-1717498.66098.66
617856-17856102.577102.58
30min116647-1664795.632100.903.0595.63100.903.05
217835-17835102.457102.46
317534-17534100.728100.73
418180-18180104.439104.44
517334-1733499.57999.58
617849-17849102.537102.54
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%
113.181650516528163541654016586165030.54
213.281649516584165400.39
单位质量响应值RSD%判断
1252.121245.480.38数据可信
供试品溶液-HX0269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%
2min114574-1457483.52383.653.4183.5283.653.42
215482-1548288.72788.73
314091-1409180.75580.76
414232-1423281.56381.56
514777-1477784.68784.69
614416-1441682.61882.62
5min117354-1735499.45599.351.7299.4699.351.73
217862-17862102.367102.37
316954-1695497.16397.16
417327-1732799.30099.30
517325-1732599.28999.29
617192-1719298.52798.53
10min117553-17553100.59699.471.93100.6099.461.93
217795-17795101.983101.98
316795-1679596.25296.25
417397-1739799.70299.70
517261-1726198.92298.92
617334-1733499.34199.34
15min117435-1743599.91999.412.1599.9299.412.15
217919-17919102.693102.69
316772-1677296.12096.12
417446-1744699.98299.98
517251-1725198.86598.86
617252-1725298.87198.87
30min117582-17582100.76299.792.12100.7699.792.12
217979-17979103.037103.04
316947-1694797.12397.12
417473-17473100.137100.14
517083-1708397.90297.90
617408-1740899.76599.76
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%
113.181693316869167651680116976168690.53
213.281676116731167460.13
单位质量响应值RSD%判断
1279.891260.991.06数据可信
供试品溶液-HX0269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%
2min112972-1297273.07970.655.1273.0870.655.13
213215-1321574.44874.45
312650-1265071.26571.27
411549-1154965.06365.06
512877-1287772.54472.54
611982-1198267.50267.50
5min116665-1666593.88495.752.3693.8895.752.36
217727-1772799.86799.87
316769-1676994.47094.47
416756-1675694.39794.40
517181-1718196.79196.79
616875-1687595.06795.07
10min117133-1713396.52197.801.9796.5297.801.98
218036-18036101.608101.61
317170-1717096.72996.73
417225-1722597.03997.04
517379-1737997.90797.91
617215-1721596.98396.98
15min117183-1718396.80298.002.1796.8098.002.17
218125-18125102.109102.11
317183-1718396.80296.80
417141-1714196.56696.57
517468-1746898.40898.41
617272-1727297.30497.30
30min117144-1714496.58397.942.1196.5897.942.11
218110-18110102.025102.02
317165-1716596.70196.70
417245-1724597.15297.15
517389-1738997.96397.96
617258-1725897.22597.22
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%
113.181696516927168861688116924169170.21
213.281692516899169120.11
单位质量响应值RSD%判断
1283.541273.490.56数据可信
供试品溶液-HX0269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%
2min113010-1301072.82870.762.9372.8370.762.93
212733-1273371.27771.28
312289-1228968.79268.79
412281-1228168.74768.75
513123-1312373.46073.46
612406-1240669.44769.45
5min117440-1744097.62697.321.1197.6397.321.11
217562-1756298.30998.31
317039-1703995.38195.38
417510-1751098.01898.02
517295-1729596.81496.81
617468-1746897.78397.78
10min117634-1763498.71299.161.6298.7199.161.62
217932-17932100.380100.38
317627-1762798.67398.67
418169-18169101.707101.71
517372-1737297.24697.25
617553-1755398.25998.26
15min117667-1766798.89799.301.7598.9099.301.75
217932-17932100.380100.38
317469-1746997.78997.79
418174-18174101.735101.73
517336-1733697.04497.04
617851-1785199.92799.93
30min117706-1770699.11599.521.4499.1299.521.44
217847-1784799.90499.90
317729-1772999.24499.24
418212-18212101.948101.95
517429-1742997.56597.56
617745-1774599.33499.33
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