盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.182510972512332512712511322511372511740.03
210.152504792505772505280.03
单位质量响应值RSD%判断
24673.2824682.560.03数据可信
供试品溶液-24101402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%
5min1146657-14665759.13156.166.7259.1356.166.72
2136517-13651755.04355.04
3144089-14408958.09658.10
4139007-13900756.04756.05
5147226-14722659.36159.36
6122285-12228549.30549.30
10min1198794-19879480.15380.1513.9780.3380.3213.95
2215153-21515386.74886.91
3224071-22407190.34490.52
4165274-16527466.63866.81
5224579-22457990.54990.73
6164790-16479066.44266.59
15min1206963-20696383.44684.4611.3683.8684.8711.36
2226102-22610291.16391.59
3230550-23055092.95693.40
4183871-18387174.13674.50
5231214-23121493.22493.67
6178238-17823871.86572.21
20min1212565-21256585.70586.929.3286.3787.589.32
2231068-23106893.16593.86
3232346-23234693.68194.40
4194143-19414378.27778.87
5234020-23402094.35695.08
6189401-18940176.36576.93
30min1221589-22158989.34390.606.2890.2791.526.32
2236338-23633895.29096.27
3236002-23600295.15596.16
4209378-20937884.42085.25
5237858-23785895.90396.92
6207027-20702783.47284.26
45min1231257-23125793.24294.103.6294.4395.303.69
2241029-24102997.18298.45
3239491-23949196.56197.85
4222654-22265489.77390.85
5241336-24133697.30598.61
6224609-22460990.56191.60
60min1234042-23404294.36495.562.2195.8497.042.29
2242249-24224997.67399.23
3240530-24053096.98098.56
4229611-22961192.57893.93
5241848-24184897.51299.10
6233825-23382594.27795.59
极限1238639-23863996.21897.541.0197.9799.300.98
2243553-24355398.199100.05
3240831-24083197.10298.97
4240498-24049896.96798.59
5242512-24251297.77999.66
6245468-24546898.971100.57
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.182507862507482512112507762507002508440.09
210.152509722509892509800.01
单位质量响应值RSD%判断
24640.8624727.090.25数据可信
供试品溶液-24101402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%
5min1164295-16429566.22764.8912.9366.2364.8912.93
2164933-16493366.48466.48
3121894-12189449.13549.14
4164976-16497666.50166.50
5164666-16466666.37666.38
6185056-18505674.59574.60
10min1220802-22080289.00586.803.7289.2087.003.73
2206292-20629283.15683.36
3205002-20500282.63682.78
4216121-21612187.11887.32
5224618-22461890.54390.74
6219211-21921188.36388.59
15min1228306-22830692.02990.752.5992.5091.212.59
2215743-21574386.96587.41
3221859-22185989.43189.83
4228417-22841792.07492.53
5232150-23215093.57994.05
6224365-22436590.44190.93
20min1230707-23070792.99792.382.4493.7493.112.43
2219503-21950388.48189.19
3229001-22900192.31092.97
4233320-23332094.05194.79
5235370-23537094.87795.63
6227141-22714191.56092.32
30min1233653-23365394.18593.992.2395.2195.002.23
2224486-22448690.49091.46
3233806-23380694.24695.19
4235102-23510294.76995.79
5240422-24042296.91397.95
6231580-23158093.34994.38
45min1235450-23545094.90995.231.9296.2196.521.91
2229645-22964592.56993.82
3238484-23848496.13297.36
4236022-23602295.14096.44
5243345-24334598.09299.42
6234507-23450794.52995.84
60min1235637-23563794.98495.541.8196.5797.111.80
2231615-23161593.36394.89
3239618-23961896.58998.10
4235967-23596795.11896.71
5244043-24404398.37399.99
6235190-23519094.80496.40
极限1236215-23621595.21795.711.6497.0997.571.62
2233317-23331794.04995.85
3241113-24111397.19298.99
4235152-23515294.78996.66
5243293-24329398.07199.99
6235522-23552294.93896.82
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