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50
标示量(mg)200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%
110.043010180300386930105123011700301042330093370.11
210.143010574301134030109570.02
单位质量响应值RSD%判断
299734.76296938.560.67数据可信
供试品溶液-23004N1批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1304191-30419110.15611.418.9610.1611.418.94
2327231-32723110.92510.92
3363868-36386812.14812.15
4390133-39013313.02513.02
5326960-32696010.91610.92
6337986-33798611.28411.28
10min1816382-81638227.25628.325.1627.2728.345.16
2798067-79806726.64426.66
3843083-84308328.14728.17
4922708-92270830.80530.82
5868424-86842428.99329.01
6840733-84073328.06928.09
15min11275670-127567042.58944.566.2842.6544.626.28
21249603-124960341.71941.78
31312939-131293943.83443.89
41398103-139810346.67746.74
51471228-147122849.11849.18
61299794-129979443.39543.45
20min11674161-167416155.89357.344.6256.0157.464.62
21619637-161963754.07354.19
31711015-171101557.12457.25
41774311-177431159.23759.37
51842166-184216661.50261.64
61683452-168345256.20356.33
30min12222624-222262474.20474.962.8874.4175.172.88
22154669-215466971.93572.14
32249823-224982375.11275.32
42290291-229029176.46376.69
52340141-234014178.12878.35
62213707-221370773.90674.11
45min12628234-262823487.74687.971.5588.0688.301.56
22563235-256323585.57685.88
32664790-266479088.96689.29
42638165-263816588.07788.42
52682121-268212189.54589.89
62633483-263348387.92188.24
60min12746551-274655191.69691.641.2292.1492.101.22
22691728-269172889.86690.30
32781881-278188192.87593.33
42726418-272641891.02491.50
52776445-277644592.69493.17
62745911-274591191.67592.13
极限12839294-283929494.79294.390.7795.3894.990.77
22804249-280424993.62294.19
32852935-285293595.24895.84
42798535-279853593.43194.04
52839647-283964794.80495.42
62829551-282955194.46795.06
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50
标示量(mg)200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%
110.043013511301207230085083006645301315030107770.11
210.143012762301156730121640.03
单位质量响应值RSD%判断
299878.19297057.590.67数据可信
供试品溶液-23004N1批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1413206-41320613.78911.5215.1213.7911.5215.14
2327276-32727610.92210.92
3275228-2752289.1859.18
4303942-30394210.14310.14
5386271-38627112.89012.89
6364628-36462812.16812.17
10min1826033-82603327.56629.478.5727.5929.498.55
2935988-93598831.23531.25
3845098-84509828.20228.22
41011793-101179333.76533.78
5820173-82017327.37027.39
6859228-85922828.67328.69
15min11501532-150153250.10844.357.4850.1744.417.47
21388975-138897546.35246.41
31300379-130037943.39543.45
41285348-128534842.89442.96
51236483-123648341.26341.32
61260722-126072242.07242.13
20min11868530-186853062.35558.134.5162.4958.254.50
21728709-172870957.68957.82
31667951-166795155.66155.78
41666074-166607455.59955.73
51796499-179649959.95160.07
61723221-172322157.50657.63
30min12406223-240622380.29875.873.3680.5376.083.36
22285080-228508076.25676.48
32194655-219465573.23873.44
42211144-221114473.78874.00
52296212-229621276.62776.84
62247681-224768175.00875.22
45min12770325-277032592.44988.632.9792.8088.962.97
22719616-271961690.75791.09
32597121-259712186.66986.98
42626101-262610187.63687.96
52663565-266356588.88689.21
62558542-255854285.38285.70
60min12877088-287708896.01293.181.9496.5093.641.95
22827645-282764594.36294.83
32722930-272293090.86791.31
42764417-276441792.25292.71
52794204-279420493.24693.71
62767671-276767192.36092.81
极限12940639-294063998.13396.041.3998.7796.641.41
22901197-290119796.81697.43
32826959-282695994.33994.92
42865072-286507295.61196.20
52882185-288218596.18296.78
62851025-285102595.14295.73
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50
标示量(mg)200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%
110.043012829300790630156943013938301020130121140.11
210.143015217301358330144000.04
单位质量响应值RSD%判断
300011.35297278.110.65数据可信
供试品溶液-yd3批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1306372-30637210.21810.372.1610.2210.372.15
2319873-31987310.66810.67
3307919-30791910.27010.27
4301830-30183010.06610.07
5315704-31570410.52910.53
6314033-31403310.47310.47
10min1778103-77810325.95126.432.3725.9726.442.35
2810096-81009627.01827.03
3790102-79010226.35126.37
4766103-76610325.55125.57
5794837-79483726.50926.52
6815518-81551827.19927.21
15min11225001-122500140.85541.342.9640.9141.402.96
21271318-127131842.40042.46
31246724-124672441.58041.63
41177545-117754539.27339.33
51237214-123721441.26341.32
61279498-127949842.67342.73
20min11613135-161313553.80054.133.3953.9254.253.39
21671655-167165555.75255.87
31635940-163594054.56154.68
41529671-152967151.01751.13
51606099-160609953.56653.68
61681893-168189356.09356.21
30min12162156-216215672.11172.722.8072.3172.922.80
22249248-224924875.01575.22
32180211-218021172.71372.91
42086658-208665869.59369.78
52158740-215874071.99772.19
62245286-224528674.88375.09
45min12606607-260660786.93487.121.8187.2487.431.81
22650375-265037588.39488.71
32613641-261364187.16887.48
42551965-255196585.11285.40
52572464-257246485.79586.10
62678689-267868989.33889.65
60min12774204-277420492.52392.081.6492.9692.521.64
22777492-277749292.63393.08
32766069-276606992.25292.69
42701406-270140690.09690.52
52719514-271951490.69991.13
62827433-282743394.29994.75
极限12862550-286255095.47094.841.3096.0495.411.30
22859036-285903695.35395.94
32845300-284530094.89595.47
42805393-280539393.56494.12
52796001-279600193.25093.82
62893067-289306796.48897.08
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50
标示量(mg)200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%
110.043017611301655830181233020185301763030180210.05
210.143002191300497630035840.07
单位质量响应值RSD%判断
300599.70296211.441.04数据可信
供试品溶液-25020301批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1218928-2189287.3087.123.567.317.123.57
2224602-2246027.4977.50
3203617-2036176.7976.80
4208213-2082136.9506.95
5213581-2135817.1297.13
6210301-2103017.0207.02
10min1588508-58850819.64418.564.2119.6518.574.20
2571460-57146019.07519.09
3554061-55406118.49418.50
4554102-55410218.49518.51
5549306-54930618.33518.35
6518726-51872617.31517.33
15min1947363-94736331.62230.084.4331.6630.124.43
2929442-92944231.02431.06
3884975-88497529.54029.58
4900565-90056530.06030.10
5911336-91133630.42030.46
6832942-83294227.80327.84
20min11196261-119626139.93039.593.4040.0239.673.40
21229978-122997841.05641.14
31151591-115159138.43938.52
41220349-122034940.73440.82
51191984-119198439.78739.87
61125608-112560837.57237.65
30min11618428-161842854.02254.703.1754.1754.853.16
21678297-167829756.02056.17
31604785-160478553.56653.71
41724853-172485357.57457.72
51616600-161660053.96154.10
61589962-158996253.07253.21
45min12039534-203953468.07868.592.3968.3168.822.39
22107061-210706170.33270.56
32016298-201629867.30267.52
42124943-212494370.92971.16
52033706-203370667.88368.11
62007816-200781667.01967.23
60min12280885-228088576.13476.561.4276.4776.891.43
22316370-231637077.31977.66
32273134-227313475.87576.20
42347868-234786878.37078.71
52283515-228351576.22276.55
62259712-225971275.42775.74
极限12487307-248730783.02482.641.0083.4783.081.01
22491075-249107583.15083.60
32461296-246129682.15682.59
42511083-251108383.81884.27
52445938-244593881.64382.08
62457629-245762982.03482.46
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