阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.982876702880402879432878552876882878390.06
210.962869322871842870580.07
单位质量响应值RSD%判断
26214.8526191.420.07数据可信
供试品溶液-25121101批-阿齐沙坦-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min162094-6209421.26319.949.6021.2619.949.60
253855-5385518.44218.44
349206-4920616.85016.85
461633-6163321.10621.11
559107-5910720.24120.24
663556-6355621.76421.76
10min1134175-13417545.94744.382.1646.0744.502.18
2128145-12814543.88243.98
3125646-12564643.02643.12
4130271-13027144.61044.73
5129738-12973844.42744.54
6129695-12969544.41344.53
15min1167955-16795557.51556.351.1857.8956.711.18
2165677-16567756.73457.08
3163866-16386656.11456.45
4163865-16386556.11456.48
5162869-16286955.77356.13
6163151-16315155.86956.24
20min1188965-18896564.70963.901.3465.4064.581.33
2189505-18950564.89465.56
3186285-18628563.79164.44
4186862-18686263.98964.67
5185377-18537763.48164.15
6182692-18269262.56163.24
30min1213817-21381773.21973.341.3974.2774.371.36
2218101-21810174.68775.71
3216295-21629574.06875.07
4211586-21158672.45673.49
5215162-21516273.68074.70
6210110-21011071.95072.98
45min1235981-23598180.80980.511.5982.2781.941.56
2239759-23975982.10383.54
3238981-23898181.83783.25
4231348-23134879.22380.66
5233141-23314179.83781.27
6231346-23134679.22280.65
60min1244861-24486183.85084.021.5485.7685.901.51
2251164-25116486.00987.90
3248581-24858185.12486.99
4243125-24312583.25685.13
5242953-24295383.19785.07
6241377-24137782.65784.52
极限1250930-25093085.92885.221.3288.3087.571.30
2251266-25126686.04488.41
3253021-25302186.64588.98
4246988-24698884.57986.92
5245981-24598184.23486.57
6245034-24503483.90986.23
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127219472265722017214772180721970.06
215.117189371898718960.01
单位质量响应值RSD%判断
4774.934758.170.25数据可信
供试品溶液-25121101批-氨氯地平-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min149230-4923066.96267.255.4766.9667.255.47
252700-5270071.68271.68
351026-5102669.40569.41
450967-5096769.32569.32
547399-4739964.47264.47
645331-4533161.65961.66
10min171551-7155197.32396.362.6197.7096.742.62
273509-7350999.986100.38
370497-7049795.88996.28
471584-7158497.36897.75
569909-6990995.09095.45
668028-6802892.53192.87
15min172504-7250498.61997.422.0399.5398.332.03
273643-73643100.169101.12
370170-7017095.44596.36
472099-7209998.06998.99
571515-7151597.27498.16
669816-6981694.96395.82
20min172940-7294099.21297.772.54100.6799.222.54
274029-74029100.694102.20
369908-6990895.08896.54
472684-7268498.864100.34
572331-7233198.38499.81
669405-6940594.40495.79
30min172747-7274798.95098.702.38100.96100.702.37
274426-74426101.234103.30
371275-7127596.94898.92
472667-7266798.841100.86
574299-74299101.061103.03
669986-6998695.19497.10
45min173218-7321899.59198.302.79102.15100.842.78
275142-75142102.208104.84
371444-7144497.17899.69
471728-7172897.564100.13
572915-7291599.178101.71
669154-6915494.06396.50
60min171421-7142197.14697.802.76100.26100.892.75
274772-74772101.704104.90
371319-7131997.008100.06
472762-7276298.970102.08
572384-7238498.456101.54
668772-6877293.54396.50
极限172316-7231698.36497.312.42102.02100.942.42
273653-73653100.182103.95
371320-7132097.009100.60
472152-7215298.141101.80
571336-7133697.031100.66
668481-6848193.14796.63
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