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%
110.172468912464642468012470062465902467500.09
210.082466422467072466740.02
单位质量响应值RSD%判断
24262.5424471.630.61数据可信
供试品溶液-24092701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%
5min193380-9338038.13137.297.4438.1337.297.43
286464-8646435.30735.31
395688-9568839.07439.07
490541-9054136.97236.97
5100469-10046941.02641.03
681369-8136933.22733.23
10min1151984-15198462.06263.0214.3162.1863.1314.29
2127025-12702551.87051.98
3180417-18041773.67273.79
4163280-16328066.67566.79
5172948-17294870.62370.75
6130300-13030053.20753.31
15min1172680-17268070.51371.5311.7670.8171.8311.76
2150800-15080061.57861.84
3201503-20150382.28382.62
4184555-18455575.36275.67
5189461-18946177.36677.70
6152053-15205362.09062.35
20min1183214-18321474.81576.529.0075.3377.049.02
2169768-16976869.32469.77
3211126-21112686.21286.80
4195136-19513679.68380.22
5197130-19713080.49781.06
6168011-16801168.60769.05
30min1192489-19248978.60280.776.1779.3481.526.21
2187282-18728276.47677.13
3216265-21626588.31189.15
4202408-20240882.65283.43
5204589-20458983.54384.35
6183777-18377775.04475.70
45min1198763-19876381.16483.944.2482.1484.944.28
2202187-20218782.56283.45
3218538-21853889.23990.35
4209893-20989385.70986.73
5209398-20939885.50786.57
6194662-19466279.48980.37
60min1204908-20490883.67385.943.4884.8987.183.53
2209907-20990785.71586.85
3221525-22152590.45991.84
4214016-21401687.39288.67
5211873-21187386.51787.83
6200533-20053381.88783.00
极限1218923-21892389.39689.811.8990.8691.311.90
2217393-21739388.77190.16
3226895-22689592.65294.30
4218013-21801389.02590.57
5215619-21561988.04789.62
6222774-22277490.96992.33
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%
110.172447792451042447222445922450642448520.10
210.082451412449652450530.06
单位质量响应值RSD%判断
24075.9124310.810.69数据可信
供试品溶液-24092702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%
5min1139602-13960257.41541.0031.8857.4241.0031.87
2140401-14040157.74457.74
380229-8022932.99733.00
472126-7212629.66429.66
576092-7609231.29531.30
689650-8965036.87136.87
10min1180545-18054574.25465.2920.1974.4365.4120.20
2198867-19886781.79081.96
3170740-17074070.22270.32
4129206-12920653.14053.23
5113668-11366846.74946.84
6159481-15948165.59165.70
15min1197271-19727181.13473.6814.9381.5374.0014.96
2206631-20663184.98385.40
3197443-19744381.20481.51
4154886-15488663.70163.95
5139558-13955857.39757.63
6179108-17910873.66373.97
20min1216441-21644189.01879.7112.0189.6680.2512.05
2216125-21612588.88889.56
3208980-20898085.94986.50
4169792-16979269.83270.27
5164887-16488767.81568.22
6186598-18659876.74477.27
30min1225410-22541092.70784.528.4093.6185.298.46
2215070-21507088.45489.39
3220645-22064590.74791.56
4187040-18704076.92677.57
5185863-18586376.44277.05
6198935-19893581.81882.58
45min1230480-23048094.79289.605.9395.9890.636.02
2223988-22398892.12293.33
3229881-22988194.54595.63
4207058-20705885.15986.04
5198513-19851381.64482.48
6217159-21715989.31390.32
60min1227515-22751593.57291.194.0095.0492.494.09
2223162-22316291.78293.26
3232847-23284795.76597.13
4216927-21692789.21890.35
5207269-20726985.24586.33
6222584-22258491.54492.82
极限1243538-243538100.162100.510.73101.91102.090.72
2243781-243781100.262102.02
3244305-244305100.478102.13
4242045-24204599.548100.95
5245502-245502100.970102.31
6247201-247201101.669103.22
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