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%
110.001652509165175116533311652158165255216524600.04
210.431750864175055117507080.02
单位质量响应值RSD%判断
165246.00167853.121.11数据可信
影响因素30天-供试品溶液-2025031221批-含0.5%吐温20的pH6.8介质
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11197857-119785771.92672.642.0471.9372.642.04
21207730-120773072.51972.52
31215041-121504172.95872.96
41226263-122626373.63273.63
51241274-124127474.53374.53
61169844-116984470.24470.24
10min11339609-133960980.43881.201.6781.2482.001.67
21351978-135197881.18181.99
31333311-133331180.06080.87
41372732-137273282.42783.25
51385661-138566183.20384.03
61330065-133006579.86580.65
15min11388422-138842283.36985.193.1785.0686.903.14
21413760-141376084.89086.60
31385417-138541783.18984.89
41433323-143332386.06587.80
51502264-150226490.20591.96
61389314-138931483.42385.09
20min11392655-139265583.62385.321.6786.2487.981.67
21435737-143573786.21088.86
31420402-142040285.28987.91
41446175-144617586.83789.53
51438360-143836086.36889.12
61392272-139227283.60086.19
30min11426768-142676885.67287.502.2189.2291.102.19
21457383-145738387.51091.12
31432090-143209085.99189.56
41500369-150036990.09193.75
51492088-149208889.59493.31
61434520-143452086.13789.66
极限11500747-150074790.11491.191.2594.6195.761.27
21540243-154024392.48597.07
31502393-150239390.21294.74
41535424-153542492.19696.85
51531331-153133191.95096.66
61501880-150188090.18294.66
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%
110.001655763166080816607081666926166583016620070.28
210.431700711169730316990070.15
单位质量响应值RSD%判断
166200.70162896.161.43数据可信
影响因素30天-供试品溶液-2025031221批-含0.5%吐温20的pH6.8介质
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11051971-105197163.93766.132.1963.9466.132.19
21107659-110765967.32267.32
31096825-109682566.66366.66
41110855-111085567.51667.52
51065840-106584064.78064.78
61094953-109495366.55066.55
10min11262305-126230576.72179.182.1677.4379.922.16
21333848-133384881.06981.82
31290855-129085578.45679.20
41334448-133444881.10681.86
51289194-128919478.35579.08
61305714-130571479.35980.10
15min11343976-134397681.68584.161.9283.2585.771.92
21414317-141431785.96087.61
31389350-138935084.44386.06
41385627-138562784.21685.87
51365484-136548482.99284.58
61408964-140896485.63587.26
20min11375338-137533883.59186.082.0386.0688.642.02
21442607-144260787.68090.28
31391523-139152384.57587.13
41436377-143637787.30189.89
51409931-140993185.69488.21
61442327-144232787.66290.24
30min11415301-141530186.02089.342.3989.4292.842.37
21504868-150486891.46495.04
31477365-147736589.79293.28
41497404-149740491.01094.57
51439922-143992287.51690.98
61484519-148451990.22793.77
极限11498495-149849591.07693.011.3995.4397.511.41
21544302-154430293.86098.45
31543830-154383093.83298.32
41550412-155041294.23298.80
51509753-150975391.76196.20
61534848-153484893.28697.84
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%
110.001677645167695516760741672396166678216739700.27
210.431741563174158417415740.01
单位质量响应值RSD%判断
167397.00166977.370.18数据可信
影响因素30天-供试品溶液-2025031221批-含0.5%吐温20的pH6.8介质
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11277432-127743276.40776.101.6476.4176.101.63
21245306-124530674.48674.49
31296667-129666777.55877.56
41283710-128371076.78376.78
51248315-124831574.66674.67
61282374-128237476.70376.70
10min11417156-141715684.76584.790.8485.6185.640.83
21424669-142466985.21486.04
31437436-143743685.97886.84
41411598-141159884.43285.29
51405578-140557884.07284.90
61409193-140919384.28885.14
15min11473631-147363188.14387.950.4489.9389.740.44
21463488-146348887.53689.31
31474504-147450488.19590.01
41478394-147839488.42890.22
51462592-146259287.48289.25
61469652-146965287.90589.69
20min11513214-151321490.51089.081.2493.2891.841.22
21479696-147969688.50591.25
31496267-149626789.49792.29
41505649-150564990.05892.83
51467356-146735687.76790.50
61473756-147375688.15090.92
30min11497500-149750089.57090.210.6993.3593.960.68
21507096-150709690.14493.87
31517527-151752790.76894.56
41512863-151286390.48994.26
51494526-149452689.39393.10
61519585-151958590.89194.64
极限11540570-154057092.14791.871.5596.9296.631.50
21524984-152498491.21495.95
31546111-154611192.47897.28
41562102-156210293.43498.21
51494223-149422389.37494.08
61548141-154814192.59997.35
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%
110.001696962169643616974681697864169816616973790.05
210.431735215173380817345120.06
单位质量响应值RSD%判断
169737.90166300.291.45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%
5min11271905-127190575.70873.701.7975.7173.701.79
21243567-124356774.02174.02
31207595-120759571.88071.88
41243694-124369474.02974.03
51220735-122073572.66272.66
61241599-124159973.90473.90
10min11384890-138489082.43381.871.2483.2782.691.24
21398978-139897883.27284.09
31355976-135597680.71281.51
41383718-138371882.36383.19
51357213-135721380.78681.59
61371766-137176681.65282.47
15min11453826-145382686.53685.351.3488.2987.081.33
21452682-145268286.46888.22
31429730-142973085.10286.80
41440084-144008485.71987.46
51423386-142338684.72586.43
61403612-140361283.54885.28
20min11454149-145414986.55686.471.2289.2789.151.21
21476472-147647287.88490.59
31456365-145636586.68889.33
41460579-146057986.93889.63
51423100-142310084.70887.35
61445839-144583986.06188.72
30min11492762-149276288.85488.361.2892.5392.001.25
21493984-149398488.92792.61
31495054-149505488.99192.59
41503623-150362389.50193.16
51463854-146385487.13390.72
61457647-145764786.76490.38
极限11558598-155859892.77390.541.9497.4495.161.89
21554526-155452692.53097.20
31512501-151250190.02994.62
41512846-151284690.05094.70
51504391-150439189.54694.10
61483963-148396388.33092.91
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%
110.001707261170893917056401703498169907317048820.23
210.431793012179270917928600.02
单位质量响应值RSD%判断
170488.20171894.530.59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%
5min11311499-131149976.61175.551.5776.6175.551.57
21283900-128390074.99975.00
31280094-128009474.77774.78
41291709-129170975.45575.46
51269635-126963574.16674.17
61323323-132332377.30277.30
10min11431078-143107883.59784.731.2384.4585.571.21
21452496-145249684.84885.68
31436683-143668383.92484.75
41447282-144728284.54385.38
51481756-148175686.55787.38
61453475-145347584.90585.76
15min11479924-147992486.45087.181.2188.2388.961.19
21512301-151230188.34190.12
31468943-146894385.80987.57
41506884-150688488.02589.80
51505319-150531987.93389.72
61480744-148074486.49888.30
20min11500039-150003987.62588.180.7790.3790.930.76
21518280-151828088.69191.45
31495742-149574287.37490.09
41506028-150602887.97590.73
51526815-152681589.18991.95
61510239-151023988.22190.98
30min11518483-151848388.70289.480.9792.4293.210.94
21558576-155857691.04494.79
31531814-153181489.48193.17
41517830-151783088.66492.40
51530970-153097089.43293.19
61532716-153271689.53493.28
极限11545874-154587490.30290.740.9295.0095.470.89
21571368-157136891.79296.55
31555295-155529590.85395.53
41542178-154217890.08794.81
51568830-156883091.64396.39
61537068-153706889.78894.53
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