地拉罗司颗粒项目信息
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.091694484169487216924731691480169027316927160.12
210.191700140170143917007900.06
单位质量响应值RSD%判断
167761.74166907.750.37数据可信
供试品溶液-2025031221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%
5min1576673-5766738.6078.563.138.618.563.13
2574715-5747158.5788.58
3560669-5606698.3688.37
4596458-5964588.9028.90
5546839-5468398.1628.16
6587393-5873938.7678.77
15min1885062-88506213.21013.312.1313.2213.322.12
2925031-92503113.80613.82
3900118-90011813.43513.45
4890805-89080513.29613.31
5876547-87654713.08313.10
6873182-87318213.03213.05
30min11082757-108275716.16016.843.8016.2016.873.79
21136455-113645516.96217.00
31109409-110940916.55816.59
41131250-113125016.88416.92
51102412-110241216.45416.49
61205560-120556017.99318.03
45min11168888-116888817.44618.314.9117.5118.374.90
21231694-123169418.38318.45
31200797-120079717.92217.99
41229719-122971918.35418.42
51188658-118865817.74117.80
61339007-133900719.98520.05
60min11218434-121843418.18519.054.7418.2819.154.72
21279031-127903119.09019.19
31247105-124710518.61318.71
41283180-128318019.15219.25
51242383-124238318.54318.64
61389681-138968120.74120.84
90min11276651-127665119.05419.794.3219.1819.914.31
21331745-133174519.87720.00
31297710-129771019.36919.49
41335818-133581819.93720.07
51281570-128157019.12819.25
61431011-143101121.35821.49
120min11310703-131070319.56320.193.6319.7220.353.63
21354199-135419920.21220.37
31325268-132526819.78019.94
41353336-135333620.19920.36
51325471-132547119.78319.94
61446376-144637621.58821.76
极限11324695-132469519.77120.303.2019.9620.493.19
21360404-136040420.30420.50
31333192-133319219.89820.09
41358876-135887620.28220.48
51338462-133846219.97720.17
61443533-144353321.54521.75
地拉罗司颗粒项目信息
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.091716194171409717137631713927169896017113880.42
210.191721603172140717215050.01
单位质量响应值RSD%判断
169612.29168940.630.29数据可信
供试品溶液-2025031221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%
5min1572723-5727238.4508.247.228.458.247.22
2554391-5543918.1808.18
3529421-5294217.8117.81
4501004-5010047.3927.39
5617635-6176359.1139.11
6574075-5740758.4708.47
15min1904760-90476013.34913.092.0413.3613.112.04
2898926-89892613.26313.28
3867170-86717012.79412.81
4900531-90053113.28613.30
5862718-86271812.72912.74
6890893-89089313.14413.16
30min11122745-112274516.56516.342.8216.6016.382.80
21106577-110657716.32616.36
31077760-107776015.90115.94
41161042-116104217.13017.16
51078600-107860015.91415.95
61100024-110002416.23016.27
45min11180761-118076117.42117.804.7217.4817.864.71
21192921-119292117.60017.66
31169967-116996717.26217.32
41321010-132101019.49019.55
51177886-117788617.37917.44
61196502-119650217.65317.72
60min11261840-126184018.61718.654.6218.7118.744.62
21235336-123533618.22618.32
31223374-122337418.05018.14
41379307-137930720.35020.45
51229679-122967918.14318.23
61253841-125384118.49918.59
90min11315817-131581719.41419.464.1319.5419.594.12
21291193-129119319.05019.17
31283287-128328718.93419.05
41426801-142680121.05121.18
51286071-128607118.97519.10
61311809-131180919.35419.48
120min11340912-134091219.78419.803.7019.9419.963.69
21313032-131303219.37319.53
31311457-131145719.34919.50
41439320-143932021.23621.40
51310504-131050419.33519.49
61335978-133597819.71119.87
极限11347367-134736719.87919.913.3920.0720.103.38
21322653-132265319.51419.70
31319105-131910519.46219.65
41438997-143899721.23121.43
51322273-132227319.50919.69
61346649-134664919.86820.06
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