坎地沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25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%
111.922262852263012262032257902261702261500.10
211.992253392253392253390.00
单位质量响应值RSD%判断
18972.3218793.910.67数据可信
供试品溶液-GJ031批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min179827-7982730.34733.0812.9130.3533.0812.91
271230-7123027.07927.08
392250-9225035.07035.07
491084-9108434.62634.63
584052-8405231.95331.95
6103666-10366639.40939.41
10min1147678-14767856.14158.656.6256.1958.706.63
2148409-14840956.41956.46
3157448-15744859.85559.91
4161879-16187961.54061.60
5141468-14146853.78053.83
6168813-16881364.17664.24
15min1202470-20247076.97172.007.1277.1172.157.11
2176558-17655867.12067.26
3186983-18698371.08371.24
4194221-19422173.83573.99
5171655-17165565.25665.40
6204503-20450377.74377.92
20min1220794-22079483.93778.015.5084.2178.285.50
2193040-19304073.38673.64
3199616-19961675.88676.16
4207692-20769278.95679.24
5194867-19486774.08074.33
6215230-21523081.82182.12
30min1238536-23853690.68184.964.4091.0985.364.39
2212413-21241380.75081.12
3213794-21379481.27581.68
4228203-22820386.75387.17
5221158-22115884.07584.45
6226823-22682386.22986.67
45min1251263-25126395.52091.033.4596.0891.583.44
2231140-23114087.87088.38
3229824-22982487.36987.91
4244295-24429592.87193.43
5242773-24277392.29292.81
6237433-23743390.26290.84
60min1258248-25824898.17594.413.5898.9095.103.56
2242518-24251892.19592.85
3238255-23825590.57491.26
4255120-25512096.98697.70
5255503-25550397.13197.80
6240404-24040491.39192.12
极限1260331-26033198.967100.640.9999.85101.490.96
2265273-265273100.846101.65
3264552-264552100.571101.41
4265257-265257100.839101.72
5268440-268440102.050102.88
6264475-264475100.542101.43
坎地沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.131543301544071547741549171547921546440.17
216.091542601543451543020.04
单位质量响应值RSD%判断
9587.359589.930.02数据可信
供试品溶液-GJ031批-坎地沙坦-pH6.8(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145055-4505526.37829.9414.3526.3829.9414.34
240908-4090823.95023.95
354341-5434131.81431.81
455050-5505032.22932.23
550293-5029329.44429.44
661190-6119035.82435.82
10min1105039-10503961.49663.455.9961.5463.505.99
2102437-10243759.97360.01
3114817-11481767.22167.27
4110258-11025864.55164.61
5101169-10116959.23059.28
6116541-11654168.23068.29
15min1139568-13956881.71181.355.5681.8681.505.56
2130506-13050676.40676.55
3146083-14608385.52685.69
4140471-14047182.24082.40
5129244-12924475.66775.81
6147825-14782586.54586.72
20min1154973-15497390.73089.643.7491.0189.933.75
2146264-14626485.63185.90
3158440-15844092.76093.07
4153987-15398790.15390.45
5146054-14605485.50985.78
6158978-15897893.07593.39
30min1165024-16502496.61595.611.6597.0596.051.66
2159915-15991593.62494.03
3164199-16419996.13296.59
4166948-16694897.74198.19
5160561-16056194.00294.42
6163159-16315995.52396.00
45min1166755-16675597.62897.421.3198.2298.021.30
2163740-16374095.86396.43
3165684-16568497.00197.62
4169277-16927799.10599.72
5168407-16840798.59599.17
6164553-16455396.33996.97
60min1166782-16678297.64497.361.2898.4098.121.26
2164235-16423596.15396.88
3165310-16531096.78297.57
4168800-16880098.82599.60
5168633-16863398.72899.47
6164033-16403396.03496.83
极限1166260-16626097.33898.490.6898.2699.410.69
2167737-16773798.20399.09
3168022-16802298.37099.32
4169062-16906298.97999.92
5168987-16898798.93599.84
6169263-16926399.096100.05
坎地沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25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%
111.924462774465934465454462434462364463790.04
211.994470034471184470600.02
单位质量响应值RSD%判断
37447.9037286.070.31数据可信
供试品溶液-24030701批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1348296-34829666.91065.9215.0066.9165.9215.00
2314201-31420160.36060.36
3348349-34834966.92066.92
4375198-37519872.07872.08
5261513-26151350.23850.24
6411419-41141979.03679.04
10min1435791-43579183.71885.256.5083.8385.366.51
2429115-42911582.43682.54
3456616-45661687.71987.83
4457444-45744487.87888.00
5399920-39992076.82776.91
6483711-48371192.92493.06
15min1474778-47477891.20890.993.3191.4691.243.33
2469530-46953090.20090.44
3478187-47818791.86392.12
4477097-47709791.65391.92
5446970-44697085.86686.08
6495147-49514795.12195.41
20min1489337-48933794.00592.972.6694.4193.372.68
2486543-48654393.46893.86
3486164-48616493.39593.81
4486081-48608193.37993.80
5458968-45896888.17188.53
6496494-49649495.38095.82
30min1502063-50206396.44995.012.4597.0195.572.46
2503157-50315796.66097.20
3493973-49397394.89595.46
4495380-49538095.16695.74
5471189-47118990.51891.02
6501724-50172496.38496.99
45min1513880-51388098.72096.602.4499.4497.322.44
2516626-51662699.24799.95
3498917-49891795.84596.57
4502030-50203096.44397.18
5482345-48234592.66293.31
6503411-50341196.70897.47
60min1522912-522912100.45597.372.85101.3498.242.84
2523332-523332100.535101.41
3501178-50117896.27997.16
4504561-50456196.92997.82
5485421-48542193.25294.06
6503581-50358196.74197.67
极限1528475-528475101.523102.390.82102.58103.430.84
2533564-533564102.501103.54
3533132-533132102.418103.46
4533506-533506102.490103.55
5528856-528856101.597102.56
6540438-540438103.822104.91
坎地沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.133089443090783091053087673088333089450.05
216.093091903092763092330.02
单位质量响应值RSD%判断
19153.4419218.960.25数据可信
供试品溶液-24030701批-坎地沙坦-pH6.8(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1113617-11361733.24433.8613.0933.2433.8613.09
2107273-10727331.38731.39
3117821-11782134.47434.47
4129115-12911537.77837.78
592323-9232327.01327.01
6134147-13414739.25139.25
10min1203851-20385159.64660.887.1559.7060.947.15
2201758-20175859.03359.09
3208120-20812060.89560.95
4218809-21880964.02264.09
5186376-18637654.53254.58
6229534-22953467.16067.23
15min1258413-25841375.61075.714.0675.7675.874.08
2253114-25311474.06074.21
3256826-25682675.14675.30
4261404-26140476.48576.65
5245672-24567271.88272.02
6277137-27713781.08981.27
20min1289611-28961184.73884.062.8085.0284.352.81
2284527-28452783.25183.53
3283505-28350582.95283.24
4287505-28750584.12284.42
5277331-27733181.14581.40
6301285-30128588.15488.47
30min1319711-31971193.54692.312.2493.9792.742.25
2316919-31691992.72993.14
3310213-31021390.76691.19
4313597-31359791.75792.19
5306345-30634589.63590.03
6326194-32619495.44295.90
45min1336365-33636598.41896.382.0699.0096.962.06
2335697-33569798.22398.79
3323588-32358894.68095.25
4326657-32665795.57896.17
5320413-32041393.75194.29
6333695-33369597.63798.26
60min1342272-342272100.14797.492.28100.8998.222.28
2341072-34107299.796100.53
3326453-32645395.51896.25
4330606-33060696.73397.48
5323772-32377294.73495.43
6334885-33488597.98598.77
极限1343248-343248100.432100.830.82101.34101.730.84
2344875-344875100.908101.81
3344009-344009100.655101.55
4345210-345210101.006101.92
5340912-34091299.749100.60
6349421-349421102.238103.18
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