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%
110.182475872478052480352476552475112477190.09
210.152471362469462470410.06
单位质量响应值RSD%判断
24333.8924339.010.02数据可信
供试品溶液-24102101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%
5min1113116-11311646.24847.5327.0146.2547.5427.02
2174357-17435771.28671.29
398554-9855440.29440.29
485399-8539934.91634.92
5124442-12444250.87850.88
6101700-10170041.58041.58
10min1190559-19055977.91067.8018.2078.0567.9518.21
2214863-21486387.84788.06
3147180-14718060.17560.30
4137020-13702056.02156.13
5155620-15562063.62663.78
6149805-14980561.24861.37
15min1208536-20853685.26074.9013.8485.6375.2513.86
2220542-22054290.16990.65
3162752-16275266.54166.84
4159968-15996865.40365.68
5169384-16938469.25369.60
6178006-17800672.77873.09
20min1213776-21377687.40379.4310.9288.0380.0010.96
2224688-22468891.86492.61
3175678-17567871.82672.33
4174772-17477271.45671.92
5179780-17978073.50374.05
6196935-19693580.51781.04
30min1221686-22168690.63785.147.3991.5385.957.45
2229928-22992894.00695.03
3196099-19609980.17580.89
4194526-19452679.53280.22
5194911-19491179.69080.46
6212354-21235486.82187.59
45min1229621-22962193.88190.204.7595.0491.274.84
2235442-23544296.26197.57
3215138-21513887.96088.92
4210086-21008685.89486.82
5210541-21054186.08087.09
6222928-22292891.14492.17
60min1232067-23206794.88193.262.8196.3394.602.93
2237965-23796597.29298.89
3225618-22561892.24493.47
4221130-22113090.40991.59
5222174-22217490.83692.11
6229652-22965293.89495.20
极限1236730-23673096.78796.811.2498.5298.431.33
2240462-24046298.313100.20
3238869-23886997.66299.16
4232097-23209794.89396.34
5237383-23738397.05498.60
6235229-23522996.17497.76
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%
110.182483662477162476722475482474562477520.15
210.152477942474922476430.09
单位质量响应值RSD%判断
24337.1324398.330.18数据可信
供试品溶液-24102101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%
5min1114087-11408746.58549.2017.4046.5849.2017.40
299727-9972740.72140.72
3113721-11372146.43546.44
4160547-16054765.55665.56
5122658-12265850.08550.08
6112234-11223445.82845.83
10min1158286-15828664.63371.579.9064.7771.729.90
2173463-17346370.83070.95
3156214-15621463.78663.93
4200971-20097182.06282.26
5188899-18889977.13377.28
6173863-17386370.99371.13
15min1178658-17865872.95178.117.9973.2878.478.00
2200469-20046981.85782.19
3168867-16886768.95369.28
4210881-21088186.10986.55
5197402-19740280.60580.99
6191423-19142378.16378.51
20min1191676-19167678.26781.866.9078.8282.456.91
2213620-21362087.22787.81
3178314-17831472.81173.35
4214787-21478787.70388.40
5203643-20364383.15383.78
6200743-20074381.96982.55
30min1207160-20716084.58987.334.9385.3888.174.93
2230856-23085694.26595.11
3199825-19982581.59482.35
4218764-21876489.32790.29
5213477-21347787.16988.04
6213129-21312987.02687.86
45min1221183-22118390.31591.613.4091.3692.723.40
2238333-23833397.31898.44
3215375-21537587.94488.94
4223600-22360091.30292.53
5222658-22265890.91792.05
6225037-22503791.88992.98
60min1229112-22911293.55393.992.3194.8695.372.29
2240746-24074698.30399.72
3227165-22716592.75894.02
4226582-22658292.52094.03
5227776-22777693.00794.41
6229734-22973493.80795.17
极限1234331-23433195.68496.381.9197.2898.041.83
2241596-24159698.650100.36
3240236-24023698.09599.64
4229067-22906793.53495.32
5235430-23543096.13397.82
6235561-23556196.18697.84
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%
110.182478692481692478882481112478562479790.07
210.152482992486622484800.11
单位质量响应值RSD%判断
24359.4324480.790.36数据可信
供试品溶液-24102101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%
5min1148637-14863760.56345.5325.6860.5645.5325.69
2127460-12746051.93451.93
363302-6330225.79325.79
4110478-11047845.01545.01
5101446-10144641.33541.33
6119168-11916848.55548.56
10min1183936-18393674.94567.1111.8175.1367.2511.83
2175863-17586371.65671.81
3134931-13493154.97855.06
4173138-17313870.54670.68
5146108-14610859.53259.66
6174285-17428571.01371.16
15min1199000-19900081.08375.995.3781.4976.335.40
2191030-19103077.83678.21
3180103-18010373.38473.63
4186689-18668976.06776.41
5170520-17052069.47969.78
6191703-19170378.11078.47
20min1206684-20668484.21480.733.2484.8681.303.27
2203062-20306282.73883.34
3198756-19875680.98481.45
4193376-19337678.79279.37
5188888-18888876.96377.47
6198027-19802780.68781.28
30min1211531-21153186.18984.142.1287.0984.952.14
2211552-21155286.19887.05
3207745-20774584.64685.35
4203270-20327082.82383.63
5202191-20219182.38383.13
6202755-20275582.61383.45
45min1215160-21516087.66887.101.7988.8388.161.77
2218363-21836388.97390.08
3217033-21703388.43189.39
4211636-21163686.23287.29
5212340-21234086.51987.51
6208060-20806084.77585.86
60min1216941-21694188.39388.481.4889.8289.801.43
2219491-21949189.43290.81
3220976-22097690.03791.26
4215266-21526687.71189.03
5218206-21820688.90990.16
6212019-21201986.38887.73
极限1225485-22548591.87591.900.9893.5693.480.93
2223678-22367891.13892.78
3226950-22695092.47293.97
4228081-22808192.93294.51
5226797-22679792.40993.92
6222296-22229690.57592.17
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