塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681452628143913514522981453678145463614504750.45
29.651458634145747414580540.06
单位质量响应值RSD%判断
149842.46151093.680.59数据可信
中间条件36月-供试品溶液-2023010511批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1266161-26616117.61818.1414.3617.6218.1414.36
2256082-25608216.95116.95
3247562-24756216.38716.39
4307522-30752220.35620.36
5335421-33542122.20322.20
6231937-23193715.35315.35
10min1591336-59133639.14339.1510.9039.1739.1810.91
2563926-56392637.32937.35
3546222-54622236.15736.18
4664817-66481744.00744.04
5670527-67052744.38544.42
6511821-51182133.88033.90
15min1862603-86260357.10055.938.9457.1856.028.95
2818638-81863854.18954.27
3786447-78644752.05952.14
4939546-93954662.19362.29
5917125-91712560.70960.81
6745269-74526949.33349.41
20min11060257-106025770.18368.116.9070.3568.286.91
21013731-101373167.10467.27
3974329-97432964.49564.65
41103238-110323873.02873.22
51096949-109694972.61272.80
6924880-92488061.22261.37
30min11252546-125254682.91282.043.3883.1982.323.40
21227942-122794281.28381.55
31216670-121667080.53780.79
41275635-127563584.44084.74
51288704-128870485.30585.61
61174872-117487277.77078.01
45min11353266-135326689.57989.261.3189.9889.661.34
21344590-134459089.00589.39
31338426-133842688.59788.97
41369577-136957790.65991.08
51363563-136356390.26090.69
61321338-132133887.46587.82
60min11393956-139395692.27291.800.9092.8192.330.93
21379633-137963391.32491.84
31375827-137582791.07291.58
41401132-140113292.74793.31
51398283-139828392.55993.12
61372194-137219490.83291.32
极限11408421-140842193.23093.040.8693.9093.710.88
21413293-141329393.55294.21
31395933-139593392.40393.05
41420332-142033294.01894.72
51408157-140815793.21293.91
61387435-138743591.84192.46
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681455157145613114567841450965145861614555310.20
29.651459401146215614607780.14
单位质量响应值RSD%判断
150364.77151375.960.48数据可信
中间条件36月-供试品溶液-2023010511批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1227634-22763415.02816.2819.8015.0316.2819.81
2213380-21338014.08714.09
3214518-21451814.16214.16
4296370-29637019.56619.57
5320300-32030021.14521.15
6207599-20759913.70513.71
10min1517419-51741934.15936.7115.8234.1836.7415.82
2489497-48949732.31532.34
3499196-49919632.95632.98
4648410-64841042.80742.84
5687272-68727245.37245.40
6494524-49452432.64732.67
15min1740442-74044248.88253.0014.0048.9653.0814.00
2719001-71900147.46747.54
3727431-72743148.02348.09
4912741-91274160.25760.35
5977301-97730164.51964.62
6739702-73970248.83348.90
20min1919790-91979060.72264.7810.9860.8764.9410.99
2910802-91080260.12960.27
3905913-90591359.80659.95
41089644-108964471.93672.12
51146759-114675975.70675.90
6914626-91462660.38160.52
30min11160886-116088676.63979.835.2176.8880.095.24
21162991-116299176.77877.01
31157150-115715076.39276.62
41267874-126787483.70283.99
51304844-130484486.14386.45
61201673-120167379.33279.57
45min11305979-130597986.21888.622.2186.5788.992.22
21345897-134589788.85389.20
31334877-133487788.12588.47
41317592-131759286.98487.40
51386460-138646091.53191.97
61363267-136326790.00090.35
60min11381906-138190691.23092.361.1391.7192.871.16
21392665-139266591.94192.42
31386930-138693091.56292.04
41397594-139759492.26692.81
51423760-142376093.99394.57
61411124-141112493.15993.65
极限11406107-140610792.82893.630.9293.4594.280.93
21423698-142369893.98994.61
31401969-140196992.55593.17
41414174-141417493.36094.05
51433887-143388794.66295.38
61429885-142988594.39895.02
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681449291144970714542211454345145343914522010.18
29.651458539145888614587120.02
单位质量响应值RSD%判断
150020.76151161.870.54数据可信
中间条件36月-供试品溶液-2023010611批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1304479-30447920.13819.144.3020.1419.144.30
2293632-29363219.42119.42
3294084-29408419.45119.45
4271150-27115017.93417.93
5295272-29527219.52919.53
6277672-27767218.36518.37
10min1580198-58019838.37437.234.9338.4037.264.93
2557962-55796236.90436.93
3541893-54189335.84135.87
4537060-53706035.52135.55
5610262-61026240.36340.39
6549934-54993436.37336.40
15min1807942-80794253.43752.885.2153.5352.965.20
2784100-78410051.86151.95
3776034-77603451.32751.41
4760744-76074450.31650.40
5878176-87817658.08358.17
6789720-78972052.23252.31
20min1990475-99047565.51065.334.5865.6865.504.58
2959048-95904863.43263.59
3966433-96643363.92064.08
4953889-95388963.09063.25
51075632-107563271.14371.32
6981371-98137164.90865.07
30min11217477-121747780.52480.652.1580.7980.922.16
21196995-119699579.17079.43
31208812-120881279.95180.21
41198628-119862879.27879.53
51267589-126758983.83984.12
61227155-122715581.16481.42
45min11352033-135203389.42489.540.7589.8189.920.75
21335866-133586688.35488.73
31354974-135497489.61889.99
41355056-135505689.62489.99
51366236-136623690.36390.77
61358813-135881389.87290.25
60min11402771-140277192.78092.590.5993.3093.110.59
21384776-138477691.58992.10
31404560-140456092.89893.41
41403315-140331592.81693.32
51407358-140735893.08393.63
61396850-139685092.38892.90
极限11405959-140595992.99093.830.5293.6594.490.52
21422244-142224494.06894.71
31420365-142036593.94394.59
41424950-142495094.24794.89
51424289-142428994.20394.89
61414325-141432593.54494.20
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681460489146047114596611459950145875514598650.05
29.651451740144909514504180.13
单位质量响应值RSD%判断
150812.50150302.380.24数据可信
中间条件36月-供试品溶液-2023010611批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1243235-24323516.09116.128.6816.0916.128.67
2223657-22365714.79614.80
3236464-23646415.64315.64
4231592-23159215.32115.32
5284096-28409618.79418.79
6242690-24269016.05516.05
10min1498802-49880232.99833.215.5833.0233.235.57
2476537-47653731.52531.55
3488760-48876032.33432.36
4482941-48294131.94931.97
5553178-55317836.59536.62
6511825-51182533.85933.88
15min1727526-72752648.12948.514.2648.2048.584.27
2702772-70277246.49146.56
3717264-71726447.45047.52
4713006-71300647.16847.24
5787132-78713252.07252.16
6751693-75169349.72849.80
20min1919078-91907860.80161.033.7860.9561.183.79
2889953-88995358.87459.01
3902850-90285059.72759.87
4895033-89503359.21059.35
5977668-97766864.67764.84
6951042-95104262.91663.07
30min11173822-117382277.65376.791.4177.8977.031.42
21154311-115431176.36376.59
31139488-113948875.38275.61
41148273-114827375.96376.19
51182821-118282178.24978.51
61165791-116579177.12277.37
45min11295001-129500185.67086.361.2286.0286.721.22
21302763-130276386.18386.53
31280336-128033684.70085.05
41317725-131772587.17387.52
51316273-131627387.07787.45
61320918-132091887.38487.74
60min11368730-136873090.54791.881.2891.0392.361.28
21387082-138708291.76192.23
31372971-137297190.82891.30
41393642-139364292.19592.67
51392130-139213092.09592.60
61418353-141835393.83094.32
极限11385185-138518591.63693.341.4192.2593.961.41
21413005-141300593.47694.09
31395576-139557692.32392.93
41413877-141387793.53494.15
51414512-141451293.57694.22
61443100-144310095.46796.10
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681402358140848414130911421506142599514142870.68
29.651424906143054814277270.28
单位质量响应值RSD%判断
146104.03147950.980.89数据可信
中间条件36月-供试品溶液-2023010711批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1251478-25147817.03616.2213.0117.0416.2213.01
2217496-21749614.73414.73
3241468-24146816.35816.36
4290970-29097019.71219.71
5235207-23520715.93415.93
6200154-20015413.55913.56
10min1644330-64433043.65041.429.0543.6841.449.05
2563184-56318438.15338.18
3600722-60072240.69640.72
4693221-69322146.96246.99
5625363-62536342.36542.39
6541547-54154736.68736.71
15min1786968-78696853.31351.3810.2753.4051.4610.27
2693412-69341246.97547.05
3753972-75397251.07851.16
4892765-89276560.48060.58
5749304-74930450.76250.85
6674122-67412245.66845.74
20min1952361-95236164.51863.358.1964.6963.528.20
2859670-85967058.23858.39
3934304-93430463.29563.46
41068832-106883272.40872.60
5934654-93465463.31863.48
6861296-86129658.34958.49
30min11204634-120463481.60879.185.0181.8879.445.02
21120452-112045275.90576.14
31146491-114649177.66977.93
41252060-125206084.82185.12
51193904-119390480.88181.14
61095106-109510674.18874.42
45min11312998-131299888.94988.451.7289.3488.831.74
21270939-127093986.10086.45
31302690-130269088.25188.62
41333893-133389390.36590.79
51321442-132144289.52189.90
61291930-129193087.52287.86
60min11369560-136956092.78191.841.0893.3092.351.09
21338711-133871190.69191.17
31351944-135194491.58892.09
41372438-137243892.97693.54
51339981-133998190.77791.29
61361433-136143392.23092.70
极限11363488-136348892.37093.391.0193.0394.041.01
21362961-136296192.33492.95
31373072-137307293.01993.66
41390076-139007694.17194.87
51393574-139357494.40895.06
61388528-138852894.06694.68
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.681400345142149214167451422552142630214174870.72
29.651437556143779914376780.02
单位质量响应值RSD%判断
146434.61148982.181.22数据可信
中间条件36月-供试品溶液-2023010711批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1346284-34628423.35222.4613.7423.3522.4613.73
2357054-35705424.07824.08
3369713-36971324.93224.93
4353964-35396423.87023.87
5327530-32753022.08722.09
6244178-24417816.46616.47
10min1696528-69652846.97045.8512.4447.0145.8812.44
2725947-72594748.95448.99
3747065-74706550.37850.42
4740154-74015449.91249.95
5644346-64434643.45243.48
6525158-52515835.41435.44
15min1958886-95888664.66362.929.1164.7763.029.12
2967457-96745765.24165.35
3992956-99295666.96067.07
4992894-99289466.95667.07
5916604-91660461.81161.91
6769314-76931451.87951.96
20min11108024-110802474.72073.845.5874.9274.045.59
21119119-111911975.46875.68
31144486-114448677.17977.39
41128605-112860576.10876.32
51094500-109450073.80874.00
6975480-97548065.78265.94
30min11233038-123303883.15084.352.9383.4684.662.95
21258066-125806684.83885.16
31276629-127662986.09086.42
41277374-127737486.14086.47
51275299-127529986.00086.30
61184986-118498679.91080.16
45min11324138-132413889.29389.101.0689.7389.541.06
21298337-129833787.55488.00
31331050-133105089.76090.22
41338571-133857190.26790.72
51314312-131431288.63189.06
61321372-132137289.10789.48
60min11351744-135174491.15591.830.9891.7392.400.98
21346680-134668090.81491.39
31371409-137140992.48193.07
41382536-138253693.23293.82
51356133-135613391.45192.01
61362275-136227591.86592.37
极限11364253-136425391.99992.471.5692.7193.171.58
21384837-138483793.38794.10
31388024-138802493.60294.33
41395448-139544894.10294.83
51351165-135116591.11691.82
61343481-134348190.59891.24
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