非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.651875975188806418677311863736186081918712650.59
29.821873606187399118737980.02
单位质量响应值RSD%判断
193913.47190814.461.14数据可信
供试品溶液-20200722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%
5min1192909-1929099.0267.7738.239.037.7738.21
2186373-1863738.7208.72
3191690-1916908.9698.97
436674-366741.7161.72
5197074-1970749.2219.22
6191538-1915388.9628.96
10min1383475-38347517.94316.2221.9517.9616.2421.98
2378758-37875817.72217.74
3385965-38596518.05918.08
4192156-1921568.9918.99
5374795-37479517.53617.56
6365368-36536817.09517.12
15min1475734-47573422.25921.188.0622.3221.238.09
2473252-47325222.14322.20
3471346-47134622.05422.11
4380259-38025917.79217.82
5462212-46221221.62721.69
6452593-45259321.17721.23
20min1531773-53177324.88124.144.2724.9924.244.32
2528187-52818724.71424.82
3530420-53042024.81824.93
4474081-47408122.18222.25
5520645-52064524.36124.47
6510003-51000323.86323.97
30min1596741-59674127.92127.501.5428.0927.661.58
2595947-59594727.88428.05
3594101-59410127.79827.96
4579650-57965027.12127.23
5584677-58467727.35727.52
6575803-57580326.94127.10
45min1648968-64896830.36530.131.2730.5930.341.26
2652509-65250930.53030.76
3644168-64416830.14030.37
4647395-64739530.29130.46
5640811-64081129.98330.21
6629361-62936129.44729.67
60min1681084-68108431.86731.501.2632.1631.791.22
2668396-66839631.27431.57
3675416-67541631.60231.90
4681862-68186231.90432.14
5673799-67379931.52731.82
6659387-65938730.85231.14
90min1709685-70968533.20633.081.0933.5733.441.07
2711585-71158533.29533.66
3704941-70494132.98433.35
4714960-71496033.45333.76
5708253-70825333.13933.50
6692911-69291132.42132.77
120min1729758-72975834.14533.951.8434.5834.371.78
2730713-73071334.19034.63
3719685-71968533.67434.11
4744333-74433334.82735.21
5724372-72437233.89334.33
6704314-70431432.95433.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1735647-73564734.42034.331.8434.9434.831.83
2734941-73494134.38734.90
3756583-75658335.40035.91
4732619-73261934.27934.74
5726873-72687334.01034.52
6715656-71565633.48533.98
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.651905830190132719049311900487189651319018180.20
29.821902377190466919035230.09
单位质量响应值RSD%判断
197079.59193841.451.18数据可信
供试品溶液-20200722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%
5min1213139-2131399.8155.6248.389.815.6248.41
2168583-1685837.7637.76
363079-630792.9052.90
496952-969524.4644.46
5122251-1222515.6295.63
668514-685143.1553.15
10min1381808-38180817.58214.8316.8917.6014.8416.92
2370291-37029117.05117.07
3239423-23942311.02511.03
4311157-31115714.32814.34
5344830-34483015.87915.89
6284340-28434013.09313.10
15min1466910-46691021.50020.357.5121.5620.407.54
2483735-48373522.27522.33
3394516-39451618.16718.20
4437662-43766220.15420.20
5453720-45372020.89320.94
6415079-41507919.11419.15
20min1524905-52490524.17123.602.7224.2823.692.76
2523319-52331924.09824.20
3488732-48873222.50522.58
4510376-51037623.50223.59
5521560-52156024.01724.11
6505647-50564723.28423.36
30min1589807-58980727.16027.031.1827.3227.171.21
2591005-59100527.21527.37
3585880-58588026.97927.10
4587815-58781527.06827.21
5593048-59304827.30927.46
6573738-57373826.42026.55
45min1643185-64318529.61829.832.4329.8430.042.41
2636902-63690229.32829.55
3648682-64868229.87130.05
4649491-64949129.90830.11
5676816-67681631.16631.37
6632034-63203429.10429.29
60min1672913-67291330.98631.051.3131.2831.321.29
2672253-67225330.95631.24
3684785-68478531.53331.78
4683655-68365531.48131.75
5671490-67149030.92131.20
6660991-66099130.43730.69
90min1707063-70706332.55932.600.7932.9232.940.78
2710180-71018032.70333.06
3715242-71524232.93633.25
4708323-70832332.61732.95
5708361-70836132.61932.97
6698261-69826132.15432.48
120min1718011-71801133.06333.280.7733.4933.680.76
2725314-72531433.39933.82
3729599-72959933.59733.99
4723249-72324933.30433.71
5725205-72520533.39433.81
6714408-71440832.89733.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1727692-72769233.50933.470.5834.0133.950.58
2726050-72605033.43333.93
3733020-73302033.75434.22
4726061-72606133.43433.92
5727740-72774033.51134.00
6720000-72000033.15533.62
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.653777374376106037729543762380376038437668300.21
29.823795775379395637948660.04
单位质量响应值RSD%判断
390345.08386442.570.72数据可信
供试品溶液-20200712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%
5min1332029-3320297.6947.2121.437.697.2121.43
2330928-3309287.6697.67
3330107-3301077.6507.65
4371966-3719668.6208.62
5179955-1799554.1704.17
6321911-3219117.4607.46
10min1596322-59632213.81913.289.8713.8413.309.87
2595242-59524213.79413.81
3586869-58686913.59913.62
4617138-61713814.30114.32
5460267-46026710.66610.68
6583039-58303913.51113.53
15min1676191-67619115.66915.553.4415.7215.603.48
2677132-67713215.69115.74
3679754-67975415.75215.80
4690759-69075916.00716.06
5625220-62522014.48814.52
6676778-67677815.68315.73
20min1701449-70144916.25516.241.7516.3416.321.76
2712544-71254416.51216.59
3693294-69329416.06616.15
4717967-71796716.63716.72
5686278-68627815.90315.97
6694062-69406216.08316.16
30min1734927-73492717.03016.821.1317.1516.931.15
2717247-71724716.62116.74
3725372-72537216.80916.93
4736509-73650917.06717.19
5719975-71997516.68416.78
6720272-72027216.69116.81
45min1739887-73988717.14517.060.8317.3017.210.84
2737609-73760917.09317.25
3728773-72877316.88817.04
4743374-74337417.22617.39
5737850-73785017.09817.24
6728416-72841616.88017.03
60min1746030-74603017.28817.191.4317.4817.381.43
2744374-74437417.24917.44
3737539-73753917.09117.28
4756892-75689217.53917.74
5741102-74110217.17417.35
6724835-72483516.79716.99
90min1753524-75352417.46117.361.2317.6917.591.22
2753755-75375517.46717.70
3734690-73469017.02517.26
4760917-76091717.63317.87
5749419-74941917.36617.58
6743295-74329517.22417.45
120min1754404-75440417.48217.361.0217.7517.631.01
2755599-75559917.50917.78
3741140-74114017.17417.44
4755477-75547717.50717.78
5750784-75078417.39817.65
6738473-73847317.11317.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1744161-74416117.24417.341.3217.5617.651.34
2759190-75919017.59317.90
3748896-74889617.35417.66
4759153-75915317.59217.91
5733590-73359016.99917.29
6744451-74445117.25117.56
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.653894517389836838913023891601386361038878800.36
29.823891285388501738881510.12
单位质量响应值RSD%判断
402889.12395942.061.23数据可信
供试品溶液-20200712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%
5min1278741-2787416.2817.0711.516.287.0711.54
2370896-3708968.3588.36
3270458-2704586.0956.09
4322004-3220047.2567.26
5321250-3212507.2397.24
6318057-3180577.1677.17
10min1555834-55583412.52612.964.6412.5412.984.65
2614802-61480213.85413.87
3538650-53865012.13812.15
4576352-57635212.98813.00
5573774-57377412.93012.95
6591629-59162913.33213.35
15min1662776-66277614.93515.091.4514.9815.131.45
2678955-67895515.30015.35
3664327-66432714.97015.01
4680718-68071815.34015.38
5656693-65669314.79814.84
6673212-67321215.17115.22
20min1699886-69988615.77215.751.6415.8515.831.64
2704814-70481415.88315.97
3710527-71052716.01116.09
4707633-70763315.94616.03
5686656-68665615.47415.55
6682895-68289515.38915.47
30min1718329-71832916.18716.241.0416.3016.351.02
2726465-72646516.37116.49
3724819-72481916.33416.44
4724523-72452316.32716.44
5706613-70661315.92316.04
6723202-72320216.29716.41
45min1733392-73339216.52716.381.7516.6716.521.73
2730411-73041116.46016.61
3739616-73961616.66716.81
4727760-72776016.40016.55
5702692-70269215.83515.98
6726255-72625516.36616.52
60min1734488-73448816.55116.591.6016.7316.771.60
2741442-74144216.70816.90
3747389-74738916.84217.02
4740004-74000416.67616.86
5713659-71365916.08216.26
6739944-73994416.67416.86
90min1745021-74502116.78916.671.7617.0116.891.75
2747622-74762216.84717.08
3746803-74680316.82917.05
4750207-75020716.90617.13
5716772-71677216.15216.37
6731871-73187116.49216.72
120min1742417-74241716.73016.711.8216.9916.961.81
2740062-74006216.67716.94
3754069-75406916.99317.25
4747554-74755416.84617.11
5715794-71579416.13016.38
6748077-74807716.85817.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1742417-74241716.73016.601.3817.0216.891.38
2740887-74088716.69617.00
3734418-73441816.55016.85
4743165-74316516.74717.05
5716859-71685916.15416.44
6741322-74132216.70517.00
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