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%
110.091698519169783716982061697590169590516976110.06
210.191719596172009117198440.03
单位质量响应值RSD%判断
168246.88168777.630.23数据可信
供试品溶液-2025031021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%
5min1829104-82910412.28811.629.6112.2911.629.60
2815004-81500412.07912.08
3631359-6313599.3579.36
4817895-81789512.12212.12
5802845-80284511.89911.90
6807206-80720611.96411.96
15min11084247-108424716.07015.575.2316.0915.595.24
21071614-107161415.88215.90
3939652-93965213.92713.94
41078313-107831315.98216.00
51063080-106308015.75615.78
61066058-106605815.80015.82
30min11221145-122114518.09817.493.3918.1517.543.40
21185994-118599417.57817.62
31104012-110401216.36216.40
41200205-120020517.78817.83
51185197-118519717.56617.61
61184113-118411317.55017.60
45min11256326-125632618.62018.312.0318.7018.382.03
21243930-124393018.43618.51
31186093-118609317.57917.65
41247308-124730818.48618.56
51240998-124099818.39318.47
61236264-123626418.32318.40
60min11286574-128657419.06818.801.5719.1818.901.59
21274441-127444118.88819.00
31230403-123040318.23618.33
41280239-128023918.97419.08
51271749-127174918.84818.95
61266240-126624018.76718.87
90min11326000-132600019.65319.371.1019.7919.511.12
21310777-131077719.42719.57
31283056-128305619.01619.14
41312295-131229519.44919.59
51309493-130949319.40819.55
61300822-130082219.27919.42
120min11351165-135116520.02619.760.9020.2019.930.92
21335927-133592719.80019.97
31314608-131460819.48419.64
41336869-133686919.81419.98
51332124-133212419.74319.91
61328309-132830919.68719.86
极限11359784-135978420.15319.940.6820.3620.140.70
21348267-134826719.98320.19
31335544-133554419.79419.98
41349685-134968520.00420.21
51341596-134159619.88420.09
61337336-133733619.82120.02
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%
110.091696679169651416967941696712169631216966020.02
210.191732486173004817312670.10
单位质量响应值RSD%判断
168146.88169898.630.74数据可信
供试品溶液-2025031021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%
5min1579453-5794538.56210.4614.898.5610.4514.88
2795960-79596011.76211.76
3630670-6306709.3199.32
4794165-79416511.73511.73
5629357-6293579.3009.30
6815754-81575412.05412.05
15min1927116-92711613.70014.737.2213.7114.747.23
21059946-105994615.66215.68
3936985-93698513.84513.86
41056361-105636115.60915.63
5929181-92918113.73013.75
61069631-106963115.80515.83
30min11102636-110263616.29316.863.9516.3316.903.98
21182954-118295417.48017.53
31101494-110149416.27616.31
41178053-117805317.40817.45
51095041-109504116.18116.22
61184258-118425817.49917.55
45min11184051-118405117.49617.832.8017.5617.902.81
21240631-124063118.33218.41
31178565-117856517.41517.48
41232639-123263918.21418.29
51166931-116693117.24317.31
61237644-123764418.28818.36
60min11231716-123171618.20018.402.1218.2918.502.15
21272332-127233218.80118.91
31215189-121518917.95618.05
41264257-126425718.68118.79
51218870-121887018.01118.10
61269252-126925218.75518.86
90min11289205-128920519.05019.091.3119.1719.221.33
21309281-130928119.34719.48
31272111-127211118.79718.92
41304311-130431119.27319.41
51272268-127226818.80018.92
61304989-130498919.28319.42
120min11319213-131921319.49319.501.0319.6519.661.04
21331173-133117319.67019.84
31306797-130679719.31019.47
41328917-132891719.63719.80
51299429-129942919.20119.36
61330812-133081219.66519.83
极限11346766-134676619.90119.790.8920.0919.980.92
21343983-134398319.85920.06
31330672-133067219.66319.85
41341868-134186819.82820.03
51319909-131990919.50419.69
61352358-135235819.98320.19
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%
110.091719110171773117140301711844171118417147800.21
210.191723160172902117260900.25
单位质量响应值RSD%判断
169948.46169390.580.24数据可信
供试品溶液-2025031121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%
5min1596122-5961228.7758.712.888.778.712.84
2586744-5867448.6378.64
3578702-5787028.5188.52
4572377-5723778.4258.43
5597178-5971788.7908.79
6620429-6204299.1339.13
15min1886181-88618113.04413.140.8213.0613.160.80
2887583-88758313.06513.08
3895262-89526213.17813.19
4888182-88818213.07413.09
5894098-89409813.16113.18
6905548-90554813.33013.34
30min11058811-105881115.58615.730.5715.6215.770.57
21066184-106618415.69415.73
31074608-107460815.81815.85
41067821-106782115.71815.75
51070709-107070915.76115.80
61074997-107499715.82415.86
45min11144447-114444716.84616.960.4616.9117.030.46
21150551-115055116.93617.00
31160665-116066517.08517.15
41152315-115231516.96217.02
51152524-115252416.96517.03
61154159-115415916.98917.05
60min11191995-119199517.54617.680.9417.6417.770.94
21203390-120339017.71417.80
31210824-121082417.82317.91
41183031-118303117.41417.50
51208366-120836617.78717.88
61208965-120896517.79617.89
90min11246384-124638418.34718.650.8918.4718.780.87
21266976-126697618.65018.77
31274668-127466818.76318.88
41265528-126552818.62818.75
51273762-127376218.75018.87
61276562-127656218.79118.91
120min11283106-128310618.88719.130.7419.0419.280.73
21299398-129939819.12719.28
31307711-130771119.24919.40
41296123-129612319.07919.23
51302403-130240319.17119.32
61309275-130927519.27219.43
极限11306107-130610719.22619.470.6719.4119.650.67
21323865-132386519.48719.67
31330289-133028919.58219.77
41320623-132062319.43919.62
51324670-132467019.49919.68
61329275-132927519.56719.75
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%
110.091703390170255217021491703255170567417034040.09
210.191755062175352217542920.07
单位质量响应值RSD%判断
168821.01172158.191.39数据可信
供试品溶液-2025031121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%
5min1610000-6100008.9378.851.378.948.851.40
2603709-6037098.8458.84
3603860-6038608.8478.85
4594754-5947548.7138.71
5596597-5965978.7408.74
6616820-6168209.0379.04
15min1905244-90524413.26213.240.7613.2813.250.76
2907228-90722813.29113.31
3911860-91186013.35913.37
4892537-89253713.07613.09
5898609-89860913.16513.18
6905708-90570813.26913.28
30min11077520-107752015.78615.750.7015.8215.780.71
21078814-107881415.80515.84
31086708-108670815.92115.96
41066572-106657215.62615.66
51067998-106799815.64715.68
61072735-107273515.71615.75
45min11166187-116618717.08516.980.8117.1517.050.80
21162430-116243017.03017.09
31172562-117256217.17817.24
41148164-114816416.82116.88
51155128-115512816.92316.99
61151622-115162216.87216.94
60min11217885-121788517.84217.710.8517.9317.800.84
21212261-121226117.76017.85
31222458-122245817.90918.00
41196931-119693117.53617.63
51205181-120518117.65617.75
61199221-119922117.56917.66
90min11277925-127792518.72218.630.6718.8418.750.66
21269562-126956218.60018.72
31285301-128530118.83018.95
41263396-126339618.50918.63
51267401-126740118.56818.69
61265351-126535118.53818.66
120min11312920-131292019.23519.150.6519.3919.300.65
21305629-130562919.12819.28
31320701-132070119.34919.50
41298648-129864819.02619.18
51304155-130415519.10619.26
61299615-129961519.04019.19
极限11293930-129393018.95719.321.0919.1419.511.09
21325723-132572319.42219.61
31336592-133659219.58219.77
41321683-132168319.36319.55
51322166-132216619.37019.55
61314184-131418419.25319.44
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