塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.711459109145877014578911458376145760914583510.05
29.761453949145739614556720.17
单位质量响应值RSD%判断
150190.63149146.720.50数据可信
供试品溶液-23040N1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1138625-1386259.2259.8414.459.239.8414.47
2177415-17741511.80711.81
3159602-15960210.62110.62
4157184-15718410.46010.46
5137711-1377119.1649.16
6116336-1163367.7427.74
10min1346211-34621123.04025.139.4423.0525.159.45
2429071-42907128.55428.57
3409827-40982727.27327.29
4361945-36194524.08724.10
5379258-37925825.23925.25
6339772-33977222.61122.62
15min1563897-56389737.52641.059.1537.5741.109.16
2700024-70002446.58546.65
3660266-66026643.93944.00
4571102-57110238.00638.06
5633199-63319942.13842.19
6572691-57269138.11138.16
20min1769737-76973751.22456.078.9151.3356.198.91
2961412-96141263.98064.11
3884398-88439858.85558.98
4775598-77559851.61451.72
5866089-86608957.63657.75
6798305-79830553.12553.23
30min11099605-109960573.17678.616.7573.3678.816.76
21311271-131127187.26287.49
31213632-121363280.76580.98
41119822-111982274.52274.71
51211542-121154280.62580.83
61131625-113162575.30775.49
45min11338468-133846889.07293.022.5389.3693.342.55
21440316-144031695.85096.21
31397668-139766893.01293.34
41396497-139649792.93493.23
51426158-142615894.90895.23
61388089-138808992.37492.67
60min11386666-138666692.28095.491.9392.7095.951.95
21462060-146206097.29797.80
31426545-142654594.93395.41
41447763-144776396.34596.78
51457162-145716296.97197.44
61429251-142925195.11495.55
极限11426040-142604094.90097.001.4895.4697.601.50
21478549-147854998.39499.04
31453569-145356996.73297.35
41468615-146861597.73398.32
51478610-147861098.39899.01
61440400-144040095.85596.43
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.712913784291164829096252910142291040629111210.06
29.762907944290747529077100.02
单位质量响应值RSD%判断
299806.49297921.110.45数据可信
供试品溶液-23003N1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1347930-34793011.59511.492.7111.6011.492.69
2346389-34638911.54411.54
3350704-35070411.68811.69
4329331-32933110.97510.98
5338662-33866211.28611.29
6355211-35521111.83811.84
10min1827424-82742427.57527.582.4127.5927.602.41
2853554-85355428.44628.46
3843381-84338128.10728.12
4805277-80527726.83726.85
5804378-80437826.80726.82
6831472-83147227.71027.73
15min11252996-125299641.75842.282.4341.8242.342.43
21321930-132193044.05544.12
31287517-128751742.90842.97
41253494-125349441.77541.83
51237896-123789641.25541.31
61258123-125812341.92941.99
20min11628125-162812554.26054.932.2954.3855.062.28
21717761-171776157.24757.37
31661728-166172855.38055.50
41641393-164139354.70254.82
51614872-161487253.81853.94
61626285-162628554.19854.32
30min12172654-217265472.40772.941.7472.6173.141.73
22256223-225622375.19275.40
32210197-221019773.65873.87
42169957-216995772.31772.52
52157916-215791671.91672.12
62164121-216412172.12372.33
45min12596573-259657386.53586.671.1886.8586.981.18
22653629-265362988.43688.76
32611737-261173787.04087.36
42563929-256392985.44785.76
52594663-259466386.47186.78
62582770-258277086.07586.39
60min12754921-275492191.81291.651.0692.2592.101.06
22792279-279227993.05793.51
32748455-274845591.59792.04
42701384-270138490.02890.47
52751068-275106891.68492.12
62753034-275303491.74992.19
极限12816268-281626893.85694.181.0194.4494.761.01
22862932-286293295.41296.01
32823090-282309094.08494.67
42779127-277912792.61993.19
52843871-284387194.77695.35
62830227-283022794.32294.90
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.711455398145463714546281453121145319014541950.07
29.761446516144304814447820.17
单位质量响应值RSD%判断
149762.62148030.940.83数据可信
供试品溶液-23040N1批-pH4.5(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1134338-1343388.9869.777.378.999.777.34
2154966-15496610.36610.37
3140492-1404929.3989.40
4139892-1398929.3589.36
5163006-16300610.90410.90
6143767-1437679.6179.62
10min1350275-35027523.43124.977.3523.4424.987.36
2405929-40592927.15427.17
3346155-34615523.15623.17
4366500-36650024.51724.53
5408736-40873627.34227.36
6361978-36197824.21424.23
15min1571332-57133238.21940.577.4838.2740.627.47
2667599-66759944.65944.71
3555664-55566437.17137.22
4590842-59084239.52439.57
5655393-65539343.84243.90
6597798-59779839.98940.04
20min1761631-76163150.94954.876.6951.0554.986.70
2886003-88600359.26859.39
3760237-76023750.85550.96
4809810-80981054.17254.28
5879964-87996458.86558.99
6823496-82349655.08755.20
30min11091075-109107572.98777.364.4173.1777.564.41
21211028-121102881.01181.22
31099477-109947773.54973.73
41160145-116014577.60777.80
51202426-120242680.43580.65
61174649-117464978.57778.77
45min11368763-136876391.56294.302.4191.8594.622.42
21457941-145794197.52897.86
31374817-137481791.96792.26
41407559-140755994.15894.47
51418259-141825994.87395.21
61431077-143107795.73196.04
60min11403375-140337593.87895.491.1594.3195.941.17
21442072-144207296.46696.95
31410181-141018194.33394.76
41435672-143567296.03896.49
51433965-143396595.92496.40
61439263-143926396.27896.73
极限11442391-144239196.48897.540.8397.0698.140.83
21464679-146467997.97998.60
31452159-145215997.14197.71
41477304-147730498.82399.42
51453265-145326597.21597.83
61458898-145889897.59298.19
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.712897046289864129004842897141290064128987910.06
29.762896724289923428979790.07
单位质量响应值RSD%判断
298536.66296924.080.39数据可信
供试品溶液-23003N1批-pH4.5(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1341232-34123211.41510.956.5911.4210.956.60
2354390-35439011.85611.86
3310420-31042010.38510.38
4322778-32277810.79810.80
5338930-33893011.33811.34
6296401-2964019.9169.92
10min1854603-85460328.58927.645.1628.6127.655.16
2872372-87237229.18429.20
3794998-79499826.59526.61
4814886-81488627.26127.28
5857153-85715328.67528.69
6762465-76246525.50725.52
15min11283519-128351942.93842.443.7543.0042.503.76
21339040-133904044.79544.86
31246348-124634841.69441.75
41257771-125777142.07742.13
51288184-128818443.09443.15
61196995-119699540.04340.10
20min11657723-165772355.45654.902.6955.5855.032.68
21707319-170731957.11657.24
31617462-161746254.10954.23
41633221-163322154.63754.76
51655363-165536355.37755.50
61576318-157631852.73352.85
30min12182072-218207272.99872.851.2573.2173.061.26
22201358-220135873.64373.86
32166174-216617472.46672.66
42189688-218968873.25273.45
52198373-219837373.54373.75
62128888-212888871.21871.41
45min12603944-260394487.11187.090.9487.4387.400.94
22611910-261191087.37787.70
32611148-261114887.35287.66
42607411-260741187.22787.54
52628862-262886287.94488.26
62557164-255716485.54685.84
60min12710922-271092290.68991.681.5791.1492.121.56
22731659-273165991.38391.84
32821874-282187494.40194.84
42724751-272475191.15291.59
52748875-274887591.95992.41
62704563-270456390.47790.90
极限12831806-283180694.73395.160.4695.3295.740.46
22851962-285196295.40896.00
32853501-285350195.45996.04
42847431-284743195.25695.84
52857130-285713095.58196.17
62825297-282529794.51695.08
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