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%
19.912428472426232428302428352427012427670.05
29.992423732421532422630.07
单位质量响应值RSD%判断
24497.1724250.550.72数据可信
供试品溶液-2095120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%
5min1226320-22632092.39292.794.0092.3992.794.00
2233106-23310695.16295.16
3230009-23000993.89893.90
4230766-23076694.20794.21
5234039-23403995.54395.54
6209597-20959785.56585.56
10min1231737-23173794.60395.082.9694.8895.362.96
2239259-23925997.67497.96
3233855-23385595.46895.75
4234701-23470195.81396.10
5237850-23785097.09997.39
6220014-22001489.81790.07
15min1231606-23160694.55095.222.9295.1195.782.92
2239440-23944097.74898.33
3234538-23453895.74796.31
4235238-23523896.03296.60
5238129-23812997.21397.79
6220577-22057790.04790.57
20min1231099-23109994.34395.023.0695.1995.873.06
2239561-23956197.79798.67
3234078-23407895.55996.41
4234790-23479095.84996.71
5237489-23748996.95197.82
6219530-21953089.62090.42
30min1229701-22970193.77294.583.0694.9095.723.07
2238668-23866897.43398.60
3233126-23312695.17096.31
4233348-23334895.26196.41
5236621-23662196.59797.76
6218681-21868189.27390.34
45min1229272-22927293.59794.353.1695.0195.773.16
2238047-23804797.17998.64
3232295-23229594.83196.26
4233687-23368795.39996.83
5235891-23589196.29997.75
6217567-21756788.81890.15
60min1228270-22827093.18894.003.0694.8895.703.06
2237050-23705096.77298.52
3231685-23168594.58296.29
4232228-23222894.80496.52
5235030-23503095.94797.69
6217276-21727688.70090.30
极限1227496-22749692.87293.683.1094.8495.663.11
2236290-23629096.46298.50
3230801-23080194.22196.22
4231719-23171994.59696.60
5234199-23419995.60897.64
6216319-21631988.30990.17
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%
19.912411252412012414132414632416362413680.09
29.992414152410962412560.10
单位质量响应值RSD%判断
24356.0024149.750.61数据可信
供试品溶液-2185663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%
5min1230698-23069894.64893.212.4794.6593.212.47
2233203-23320395.67695.68
3230441-23044194.54394.54
4223267-22326791.59991.60
5227418-22741893.30293.30
6218101-21810189.48089.48
10min1226798-22679893.04895.153.3193.3395.433.31
2235162-23516296.47996.77
3235226-23522696.50696.79
4235700-23570096.70096.97
5239799-23979998.38298.66
6218868-21886889.79590.06
15min1236772-23677297.14095.313.1197.7095.873.10
2237422-23742297.40797.98
3235958-23595896.80697.38
4235859-23585996.76597.33
5228721-22872193.83794.41
6219100-21910089.89090.43
20min1235702-23570296.70195.202.9797.5696.052.97
2238446-23844697.82798.70
3233707-23370795.88396.75
4234395-23439596.16597.02
5231066-23106694.79995.66
6218873-21887389.79790.60
30min1232338-23233895.32194.772.7796.4795.912.77
2236243-23624396.92398.09
3234586-23458696.24397.39
4233724-23372495.88997.03
5230514-23051494.57395.71
6218589-21858989.68090.76
45min1234907-23490796.37594.673.0197.8196.093.00
2236107-23610796.86798.32
3233852-23385295.94297.38
4233391-23339195.75397.18
5228602-22860293.78895.21
6217609-21760989.27890.62
60min1230875-23087594.72193.942.7996.4495.652.78
2235417-23541796.58498.33
3231309-23130994.89996.63
4232712-23271295.47497.19
5225966-22596692.70794.41
6217607-21760789.27790.89
极限1232798-23279895.51093.833.1597.5195.823.14
2234498-23449896.20798.24
3231676-23167695.04997.06
4232443-23244395.36497.37
5225396-22539692.47394.46
6215483-21548388.40690.29
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%
19.912410912411952413792413152411202412200.06
29.992414002415012414500.03
单位质量响应值RSD%判断
24341.0724169.170.51数据可信
供试品溶液-2180621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%
5min1230523-23052394.56793.603.7294.5793.603.72
2219569-21956990.07390.07
3216111-21611188.65588.65
4238104-23810497.67797.68
5232563-23256395.40495.40
6232102-23210295.21595.21
10min1234485-23448596.19295.613.4196.4895.893.41
2226726-22672693.00993.28
3220635-22063590.51190.78
4242341-24234199.41599.71
5237058-23705897.24897.53
6237117-23711797.27297.56
15min1236599-23659997.05995.723.9697.6396.293.95
2224526-22452692.10792.66
3219797-21979790.16790.70
4244272-244272100.207100.80
5237083-23708397.25897.84
6237764-23776497.53798.11
20min1235574-23557496.63995.443.8797.5096.293.87
2223216-22321691.56992.39
3220003-22000390.25191.06
4243067-24306799.713100.60
5237374-23737497.37798.25
6236627-23662797.07197.94
30min1234740-23474096.29795.124.0097.4596.264.00
2222538-22253891.29192.39
3219013-21901389.84590.92
4243731-24373199.985101.18
5235761-23576196.71697.88
6235466-23546696.59597.76
45min1233594-23359495.82794.723.9897.2796.153.98
2222202-22220291.15392.53
3217673-21767389.29690.64
4242518-24251899.488100.98
5234341-23434196.13397.59
6235033-23503396.41797.87
60min1232858-23285895.52594.503.8697.2596.213.86
2218055-21805589.45291.10
3221439-22143990.84092.46
4241776-24177699.183100.97
5234426-23442696.16897.91
6233607-23360795.83297.57
极限1232399-23239995.33794.083.7897.3596.083.78
2220844-22084490.59692.51
3217063-21706389.04590.93
4240299-24029998.577100.66
5232552-23255295.39997.43
6232909-23290995.54697.57
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