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%
110.17 4543774541144540174535084533414538710.10
210.124545204546034545620.02
单位质量响应值RSD%判断
44628.4244917.190.46数据可信
供试品溶液-24080601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%
5min1158194-15819435.15643.5633.2835.1643.5633.28
2211359-21135946.97146.97
399712-9971222.16022.16
4198795-19879544.17944.18
5211614-21161447.02847.03
6296432-29643265.87865.88
10min1284373-28437363.19868.079.9963.3068.2010.03
2306418-30641868.09768.24
3257267-25726757.17457.24
4334089-33408974.24674.38
5320781-32078171.28971.43
6334838-33483874.41374.61
15min1316536-31653670.34673.306.4370.6473.646.48
2328096-32809672.91573.26
3295084-29508465.57865.82
4351154-35115478.03978.39
5343507-34350776.33976.69
6344665-34466576.59777.02
20min1333210-33321074.05175.704.8674.5676.254.92
2338328-33832875.18875.75
3312185-31218569.37969.81
4356623-35662379.25479.84
5352111-35211178.25278.84
6351246-35124678.05978.71
30min1347422-34742277.20977.673.3777.9478.453.44
2349192-34919277.60378.39
3327451-32745172.77173.41
4357608-35760879.47380.30
5359042-35904279.79280.61
6356190-35619079.15880.04
45min1358858-35885879.75179.612.4780.7180.622.54
2359554-35955479.90680.93
3340919-34091975.76476.63
4361345-36134580.30481.37
5366069-36606981.35482.41
6362500-36250080.56081.68
60min1364976-36497681.11180.662.0782.3181.922.14
2365165-36516581.15382.41
3348692-34869277.49278.58
4362365-36236580.53081.84
5370720-37072082.38783.69
6365887-36588781.31382.68
极限1392883-39288387.31385.332.9488.7586.822.90
2389564-38956486.57588.08
3376458-37645883.66284.98
4364358-36435880.97382.52
5391485-39148587.00288.55
6388948-38894886.43888.05
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%
110.17 4517664520164523874525784526274522750.09
210.124519874523014521440.05
单位质量响应值RSD%判断
44471.4844678.260.33数据可信
供试品溶液-24080701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%
5min1135233-13523330.18745.7029.2430.1945.7029.24
2196143-19614343.78343.78
3304994-30499468.08168.08
4227486-22748650.78050.78
5155597-15559734.73334.73
6208852-20885246.62046.62
10min1234688-23468852.38767.8018.2452.4867.9418.26
2293865-29386565.59765.73
3367306-36730681.99082.19
4358769-35876980.08580.24
5247708-24770855.29455.40
6320177-32017771.47071.61
15min1272266-27226660.77673.4014.1861.0273.7414.22
2321604-32160471.78972.12
3381773-38177385.22085.67
4378180-37818084.41884.81
5280979-28097962.72062.99
6338214-33821475.49775.85
20min1291951-29195165.17076.5511.4965.6077.1111.54
2333000-33300074.33374.88
3386894-38689486.36387.07
4387367-38736786.46887.11
5309515-30951569.09069.55
6348788-34878877.85778.44
30min1313292-31329269.93379.798.9070.5680.588.97
2347357-34735777.53778.30
3392076-39207687.52088.48
4394264-39426488.00888.91
5336532-33653275.12175.79
6361074-36107480.59981.41
45min1333899-33389974.53382.446.9875.3783.467.07
2359155-35915580.17181.17
3397480-39748088.72689.95
4400018-40001889.29290.46
5354424-35442479.11580.01
6370815-37081582.77483.83
60min1347210-34721077.50584.205.6678.5685.485.77
2367389-36738982.00983.25
3399749-39974989.23290.73
4402412-40241289.82791.26
5366004-36600481.70082.83
6380531-38053184.94386.25
极限1404579-40457990.31191.961.0191.6093.491.15
2409907-40990791.50092.99
3415251-41525192.69394.45
4415153-41515392.67194.38
5414198-41419892.45893.83
6412708-41270892.12593.68
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%
110.17 4534134533024531724529104531334531860.05
210.124591434591364591400.01
单位质量响应值RSD%判断
44561.0645369.571.28数据可信
供试品溶液-24080702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%
5min1230588-23058851.02961.6016.3251.0361.6016.31
2223614-22361449.48649.49
3313659-31365969.41369.41
4266172-26617258.90458.90
5302562-30256266.95766.96
6333560-33356073.81773.82
10min1360340-36034079.74379.687.7479.9079.877.75
2331663-33166373.39773.55
3358840-35884079.41179.62
4326803-32680372.32172.50
5393089-39308986.99087.19
6389673-38967386.23486.46
15min1376642-37664283.35183.556.2783.7483.986.27
2366490-36649081.10481.47
3372569-37256982.44982.90
4342542-34254275.80476.20
5409485-40948590.61991.08
6397554-39755487.97988.46
20min1381749-38174984.48185.045.5385.1285.725.54
2378632-37863283.79184.40
3377812-37781283.61084.30
4352446-35244677.99678.62
5413683-41368391.54892.28
6401405-40140588.83189.57
30min1384853-38485385.16886.414.1586.0687.344.17
2387627-38762785.78286.65
3385423-38542385.29486.24
4367922-36792281.42182.28
5415101-41510191.86292.87
6401907-40190788.94289.95
45min1388816-38881686.04587.313.4587.2088.503.49
2392230-39223086.80087.92
3391551-39155186.65087.85
4375433-37543383.08384.18
5415008-41500891.84193.13
6404129-40412989.43490.71
60min1393161-39316187.00688.013.0688.4289.463.10
2395845-39584587.60088.98
3395483-39548387.52088.98
4380689-38068984.24685.59
5417265-41726592.34193.90
6403853-40385389.37290.92
极限1414947-41494791.82891.061.3793.5092.771.37
2415136-41513691.86993.51
3411064-41106490.96892.69
4403582-40358289.31390.91
5417924-41792492.48694.32
6406228-40622889.89891.71
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