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DRm0341024-D对照品来源自制对照品对照品使用方法直接使用
对照品含量(%)100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%
110.001655971164207916411391638850164153916439160.42
210.431758476173596817472220.92
单位质量响应值RSD%判断
164391.60167518.891.34数据可信
影响因素30天-供试品溶液-ACSB24025批-含0.5%吐温20的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%
5min11491150-149115089.86190.481.9189.8690.481.91
21463899-146389988.21888.22
31519701-151970191.58191.58
41506126-150612690.76390.76
51483425-148342589.39589.39
61544768-154476893.09293.09
10min11566023-156602394.37395.372.0995.3796.382.08
21551090-155109093.47394.45
31622229-162222997.76098.78
41605217-160521796.73497.74
51544121-154412193.05394.05
61606977-160697796.84197.87
15min11543725-154372593.02995.063.1295.0897.133.09
21536659-153665992.60394.62
31605624-160562496.75998.86
41606878-160687896.83598.92
51524920-152492091.89693.92
61647089-164708999.258101.37
20min11534904-153490492.49793.822.5495.5896.942.52
21555913-155591393.76396.81
31581903-158190395.33098.51
41559479-155947993.97897.14
51496634-149663490.19193.24
61612201-161220197.155100.37
30min11536346-153634692.58493.682.3596.6997.842.35
21513703-151370391.22095.31
31577160-157716095.04499.28
41566886-156688694.42598.63
51523222-152322291.79395.84
61609440-160944096.989101.28
极限11537365-153736592.64693.482.4297.7898.682.41
21528270-152827092.09797.20
31556991-155699193.82899.12
41563266-156326694.20699.46
51506119-150611990.76395.83
61615207-161520797.337102.71
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DRm0341024-D对照品来源自制对照品对照品使用方法直接使用
对照品含量(%)100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%
110.001720957169236416910501695444170103017001690.72
210.431804682177978117922320.99
单位质量响应值RSD%判断
170016.90171834.320.76数据可信
影响因素30天-供试品溶液-ACSB24025批-含0.5%吐温20的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%
5min11532078-153207889.63788.761.3589.6488.761.35
21516675-151667588.73688.74
31477816-147781686.46286.46
41528311-152831189.41689.42
51517022-151702288.75688.76
61530712-153071289.55789.56
10min11571016-157101691.91593.180.9892.9194.170.98
21597795-159779593.48294.47
31576703-157670392.24893.21
41595091-159509193.32394.32
51608230-160823094.09295.08
61607366-160736694.04295.04
15min11576174-157617492.21793.903.0194.2395.922.97
21593005-159300593.20195.23
31532464-153246489.65991.64
41619602-161960294.75796.79
51667212-166721297.54399.57
61641236-164123696.02398.06
20min11573941-157394192.08693.191.1695.1396.251.11
21600750-160075093.65496.71
31603649-160364993.82496.81
41611514-161151494.28497.37
51565484-156548491.59194.71
61601213-160121393.68296.79
30min11572489-157248992.00191.672.4696.0795.772.40
21548712-154871290.61094.71
31504197-150419788.00692.03
41609596-160959694.17298.30
51563286-156328691.46395.60
61602562-160256293.76197.91
极限11576790-157679092.25391.671.6697.3496.791.62
21531685-153168589.61494.72
31539098-153909890.04795.05
41599090-159909093.55798.73
51578329-157832992.34397.49
61576287-157628792.22397.41
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DRm0341024-D对照品来源自制对照品对照品使用方法直接使用
对照品含量(%)100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%
110.001695655167146116773611671111166798816767150.67
210.431782266175843817703520.96
单位质量响应值RSD%判断
167671.50169736.530.87数据可信
影响因素30天-供试品溶液-ACSB24025批-含0.5%吐温20的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%
5min11575337-157533793.38290.892.2593.3890.892.24
21564484-156448492.73992.74
31520121-152012190.10990.11
41519048-151904890.04690.05
51539955-153995591.28591.28
61480924-148092487.78687.79
10min11619469-161946995.99896.441.9097.0497.451.89
21664471-166447198.66699.70
31653913-165391398.04099.04
41587563-158756394.10795.11
51638872-163887297.14898.16
61597316-159731694.68595.66
15min11620665-162066596.06996.030.9698.1798.110.96
21624836-162483696.31698.44
31613366-161336695.63797.73
41621203-162120396.10198.15
51643523-164352397.42499.52
61596239-159623994.62196.65
20min11615035-161503595.73595.651.3798.9198.801.36
21631252-163125296.69799.89
31641428-164142897.300100.45
41603188-160318895.03398.15
51612099-161209995.56198.74
61578575-157857593.57496.65
30min11614610-161461095.71094.271.4199.9598.481.40
21592236-159223694.38498.66
31603842-160384295.07299.31
41572947-157294793.24197.41
51603568-160356895.05699.29
61554867-155486792.16996.29
极限11609352-160935295.39993.481.69100.7098.741.65
21578245-157824593.55598.87
31599899-159989994.838100.13
41546438-154643891.66996.88
51582663-158266393.81799.11
61545815-154581591.63296.77
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DRm0341024-D对照品来源自制对照品对照品使用方法直接使用
对照品含量(%)100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%
110.001699739169832816977761695268169632116974860.11
210.431767503176732517674140.01
单位质量响应值RSD%判断
169748.60169454.840.13数据可信
影响因素30天-供试品溶液-2025031221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11302690-130269076.80977.672.5076.8177.662.50
21345340-134534079.32479.32
31344070-134407079.24979.25
41304333-130433376.90676.91
51343120-134312079.19379.19
61263767-126376774.51474.51
10min11471723-147172386.77585.873.1687.6386.733.14
21401934-140193482.66083.54
31535606-153560690.54291.42
41434793-143479384.59885.45
51461867-146186786.19487.07
61432008-143200884.43485.26
15min11500607-150060788.47888.891.8590.3090.711.85
21489128-148912887.80289.60
31560961-156096192.03793.92
41490559-149055987.88689.68
51513833-151383389.25891.10
61490720-149072087.89589.66
20min11546130-154613091.16289.411.9593.9692.211.94
21477628-147762887.12389.90
31552615-155261591.54594.45
41508604-150860488.95091.72
51520776-152077689.66892.50
61492419-149241987.99690.74
30min11515194-151519489.33890.442.3693.1594.242.33
21494975-149497588.14691.89
31597095-159709594.16798.09
41511132-151113289.09992.86
51544976-154497691.09494.92
61540338-154033890.82194.54
极限11537950-153795090.68091.713.6195.4996.523.52
21510790-151079089.07993.80
31667514-166751498.319103.29
41533511-153351190.41895.17
51540428-154042890.82695.66
61542565-154256590.95295.68
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