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100
标示量(mg)100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%
110.321511431151100115120281512439151169815117190.04
210.401509913151116315105380.06
单位质量响应值RSD%判断
146484.40145244.040.61数据可信
供试品溶液-23040N1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119959-1199598.1919.9418.478.199.9418.45
2124597-1245978.5088.51
3128402-1284028.7688.77
4177694-17769412.13412.13
5143070-1430709.7699.77
6179993-17999312.29112.29
10min1350273-35027323.91825.7812.1723.9325.7912.17
2354028-35402824.17424.19
3325451-32545122.22322.24
4421976-42197628.81428.83
5368803-36880325.18325.20
6444493-44449330.35230.37
15min1587782-58778240.13641.6010.0040.1841.6510.01
2589843-58984340.27740.33
3523947-52394735.77735.82
4655231-65523144.74244.80
5598430-59843040.86340.92
6699765-69976547.78347.85
20min1920880-92088062.88163.546.4662.9963.666.47
2911839-91183962.26462.37
3836544-83654457.12357.22
4955845-95584565.26965.40
5938195-93819564.06464.18
61020202-102020269.66369.80
30min11149702-114970278.50678.385.6178.7178.595.61
21127234-112723476.97277.17
31042547-104254771.18971.38
41161631-116163179.32179.55
51164830-116483079.53979.75
61240926-124092684.73584.98
45min11363784-136378493.12592.081.8493.4492.411.85
21348789-134878992.10192.42
31311462-131146289.55289.84
41326942-132694290.60990.95
51365810-136581093.26393.59
61374547-137454793.85994.23
60min11399878-139987895.58994.561.3896.0595.031.37
21385986-138598694.64195.10
31379827-137982794.22094.65
41349479-134947992.14892.63
51399054-139905495.53396.00
61394926-139492695.25195.76
极限11437346-143734698.14897.411.1598.7598.021.15
21440282-144028298.34898.95
31412990-141299096.48497.05
41399668-139966895.57596.19
51434660-143466097.96498.58
61434216-143421697.93498.58
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100
标示量(mg)100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%
110.321512743151165815131021512317151048915120620.07
210.401504866150684415058550.10
单位质量响应值RSD%判断
146517.64144793.750.84数据可信
供试品溶液-23040N1批-pH4.5(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1125000-1250008.5489.176.428.559.176.41
2123700-1237008.4598.46
3146239-14623910.00010.00
4139259-1392599.5239.52
5134076-1340769.1689.17
6136321-1363219.3229.32
10min1366934-36693425.09223.287.0125.1023.297.00
2305972-30597220.92320.94
3367064-36706425.10125.12
4343092-34309223.46223.48
5329302-32930222.51922.53
6329842-32984222.55622.57
15min1613307-61330741.94037.717.4041.9937.767.40
2504661-50466134.51034.55
3585441-58544140.03440.09
4550096-55009637.61737.67
5525953-52595335.96636.01
6529351-52935136.19936.25
20min1936312-93631264.02857.546.2064.1457.646.19
2791908-79190854.15354.25
3856203-85620358.55058.66
4840530-84053057.47857.58
5803702-80370254.95955.06
6819705-81970556.05456.16
30min11206983-120698382.53774.195.8582.7574.385.85
21033210-103321070.65470.83
31087548-108754874.37074.57
41077167-107716773.66073.85
51039051-103905171.05371.24
61065203-106520372.84273.03
45min11486881-1486881101.67792.744.78102.0193.044.78
21312978-131297889.78590.07
31336518-133651891.39591.71
41329505-132950590.91591.22
51329485-132948590.91491.20
61341971-134197191.76892.06
60min11544660-1544660105.62896.824.63106.1197.264.63
21374752-137475294.00994.43
31386551-138655194.81695.27
41371144-137114493.76394.20
51419460-141946097.06797.49
61398629-139862995.64296.08
极限11589050-1589050108.66499.824.51109.31100.414.51
21415115-141511596.77097.33
31444729-144472998.79599.39
41411877-141187796.54897.13
51456801-145680199.620100.19
61440851-144085198.52999.11
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100
标示量(mg)100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%
110.321503733150624315061041504709150521015052000.07
210.401503713150860415061580.23
单位质量响应值RSD%判断
145852.71144822.880.51数据可信
供试品溶液-23040N1批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156534-15653410.72711.4415.3910.7311.4415.40
2182967-18296712.53912.54
3133558-1335589.1539.15
4170251-17025111.66711.67
5206707-20670714.16614.17
6151879-15187910.40810.41
10min1422125-42212528.92929.3413.1828.9429.3613.18
2421100-42110028.85828.88
3351697-35169724.10224.12
4445157-44515730.50730.52
5523799-52379935.89635.92
6405053-40505327.75927.77
15min1673871-67387146.18146.6012.3246.2446.6612.32
2651963-65196344.68044.74
3571206-57120639.14539.20
4706135-70613548.39248.46
5824702-82470256.51856.59
6652073-65207344.68744.74
20min1895896-89589661.39761.8810.9261.5362.0210.92
2867565-86756559.45559.58
3778390-77839053.34453.45
4930300-93030063.75463.89
51075821-107582173.72773.89
6870001-87000159.62259.75
30min11211206-121120683.00582.335.7383.2382.555.75
21192624-119262481.73281.95
31091125-109112574.77674.96
41239291-123929184.93085.16
51297533-129753388.92189.19
61176040-117604080.59580.81
45min11396021-139602195.67194.771.4096.0295.121.39
21405675-140567596.33296.67
31361226-136122693.28693.59
41397407-139740795.76696.12
51362876-136287693.39993.80
61374161-137416194.17294.51
60min11424851-142485197.64696.611.2498.1497.101.23
21424471-142447197.62098.11
31407145-140714596.43396.87
41420826-142082697.37097.87
51380229-138022994.58895.13
61400679-140067995.99096.47
极限11467963-1467963100.60199.561.22101.24100.201.19
21469596-1469596100.713101.34
31451287-145128799.458100.04
41453337-145333799.598100.25
51420612-142061297.35698.04
61453971-145397199.642100.26
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