地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP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100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.991697883169160816848221687210168443016891910.34
2 10.041698374169259116954820.25
单位质量响应值RSD%判断
169088.19168872.710.10数据可信
供试品溶液-ACSB24005批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11120520-112052066.24467.273.6866.2467.263.68
21107448-110744865.47265.47
31185431-118543170.08270.08
10min11267086-126708674.90978.293.7975.6579.043.77
21345166-134516679.52580.25
31360513-136051380.43381.21
15min11288773-128877376.19176.040.4977.7677.660.50
21279027-127902775.61577.23
31290795-129079576.31177.98
20min11518609-151860989.77989.051.2192.1991.521.18
21485556-148555687.82590.28
31514891-151489189.55992.08
30min11344374-134437479.47879.300.3882.8982.750.39
21335457-133545778.95182.38
31344030-134403079.45882.97
45min11465628-146562886.64789.562.8390.9493.892.73
21538151-153815190.93495.24
31541039-154103991.10595.50
60min11367972-136797280.87482.323.5986.1387.653.45
21359600-135960080.37985.69
31449909-144990985.71891.13
90min11500506-150050688.70990.571.9194.8796.821.88
21537597-153759790.90297.11
31557987-155798792.10798.47
120min11435744-143574484.88084.661.7192.0291.911.66
21405937-140593783.11890.34
31454364-145436485.98193.37
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min11468033-146803386.78989.352.6394.8797.542.53
21520424-152042489.88698.03
31545748-154574891.38499.73
极限11443753-144375385.35486.301.3494.4095.491.38
21454301-145430185.97795.12
31481415-148141587.58096.94
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP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100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.991702001169961516987621694974169841416987530.15
2 10.041715514171131617134150.18
单位质量响应值RSD%判断
170045.35170658.860.26数据可信
供试品溶液-ACSB24005批-pH7.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1590593-59059334.63434.890.7134.6334.890.72
2598969-59896935.12635.13
3595251-59525134.90834.91
10min1563343-56334333.03633.292.4833.4233.682.46
2556245-55624532.62033.01
3583317-58331734.20834.60
15min1692900-69290040.63440.892.2241.3941.652.16
2714446-71444641.89842.65
3684558-68455840.14540.91
20min1734766-73476643.08943.811.6544.2945.021.62
2747122-74712243.81445.03
3759333-75933344.53045.74
30min1740477-74047743.42444.101.3745.1145.801.34
2759980-75998044.56846.27
3755754-75575444.32046.03
45min1830049-83004948.67748.640.8850.8450.830.84
2821865-82186548.19750.40
3836373-83637349.04851.25
60min1810907-81090747.55446.192.5950.2648.922.40
2773346-77334645.35248.09
3778511-77851145.65548.40
90min1868928-86892850.95751.340.6854.1954.580.66
2877230-87723051.44454.68
3880317-88031751.62554.88
120min1818124-81812447.97847.760.5251.7851.570.48
2809770-80977047.48851.30
3815116-81511647.80151.63
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1962186-96218656.42656.290.4160.7660.630.36
2961912-96191256.41060.75
3955305-95530556.02260.38
极限1871116-87111651.08550.700.8756.0555.670.78
2866234-86623450.79955.76
3856404-85640450.22255.20
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