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%
19.711477042147555314755491475775147639314760620.05
29.771488113148765114878820.03
单位质量响应值RSD%判断
152014.62152290.890.13数据可信
供试品溶液-2023010511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%
5min1163004-16300410.6709.4115.6310.679.4115.61
2122331-1223318.0088.01
3170968-17096811.19211.19
4121430-1214307.9497.95
5157274-15727410.29510.30
6127332-1273328.3358.34
10min1410397-41039726.86523.6715.5426.8823.6815.53
2313452-31345220.51920.53
3423197-42319727.70327.72
4307561-30756120.13320.15
5403895-40389526.43926.45
6310938-31093820.35420.37
15min1648724-64872442.46638.1714.3842.5238.2214.38
2506668-50666833.16733.21
3659521-65952143.17343.23
4502494-50249432.89432.94
5669638-66963843.83543.89
6511195-51119533.46333.51
20min1854556-85455655.94051.3712.9456.0651.4812.94
2690353-69035345.19145.28
3870331-87033156.97257.10
4690401-69040145.19445.29
5903679-90367959.15559.28
6699087-69908745.76345.86
30min11172627-117262776.76171.778.9076.9671.968.92
2979689-97968964.13164.29
31170154-117015476.59976.81
41016245-101624566.52466.68
51207137-120713779.02079.23
61032776-103277667.60667.77
45min11402405-140240591.80288.023.8892.1288.323.90
21263986-126398682.74183.00
31383621-138362190.57390.90
41323384-132338486.62986.89
51376920-137692090.13490.46
61317789-131778986.26386.53
60min11441047-144104794.33293.030.8494.7993.450.87
21412762-141276292.48092.86
31422361-142236193.10993.57
41415490-141549092.65993.05
51426977-142697793.41193.87
61408261-140826192.18692.58
极限11455612-145561295.28594.100.7495.8894.670.77
21438139-143813994.14194.66
31440383-144038394.28894.89
41426146-142614693.35693.88
51437625-143762594.10894.71
61427498-142749893.44593.98
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%
19.711486765148886714886521487463149042014884330.10
29.771495195149638914957920.06
单位质量响应值RSD%判断
153288.67153100.510.09数据可信
供试品溶液-第1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%
5min1145279-1452799.44511.5416.399.4511.5416.38
2203791-20379113.25013.25
3165011-16501110.72810.73
4215980-21598014.04214.04
5185407-18540712.05412.05
6149221-1492219.7029.70
10min1401448-40144826.10028.7211.4926.1128.7311.50
2458526-45852629.81129.83
3379828-37982824.69524.71
4512953-51295333.35033.37
5480084-48008431.21331.23
6417397-41739727.13727.15
15min1665069-66506943.24045.359.9543.2945.419.95
2710373-71037346.18546.25
3602664-60266439.18239.24
4781214-78121450.79150.86
5769411-76941150.02450.09
6656484-65648442.68242.74
20min1916464-91646459.58459.789.4059.7059.909.40
2911342-91134259.25159.39
3794433-79443351.65051.76
41001715-100171565.12765.27
51027997-102799766.83666.98
6864436-86443656.20256.32
30min11244780-124478080.93080.665.3181.1480.885.32
21281597-128159783.32483.55
31146358-114635874.53174.72
41307447-130744785.00485.25
51288991-128899183.80484.04
61175032-117503276.39576.60
45min11397284-139728490.84591.241.3791.1791.581.39
21404665-140466591.32591.67
31373056-137305689.27089.57
41432445-143244593.13193.50
51408202-140820291.55591.92
61404422-140442291.30991.63
60min11425599-142559992.68693.420.7393.1593.900.74
21435253-143525393.31493.80
31427073-142707392.78293.22
41450422-145042294.30094.81
51434872-143487293.28993.79
61448429-144842994.17094.63
极限11446158-144615894.02394.570.5194.6395.180.51
21452569-145256994.43995.06
31452578-145257894.44095.01
41459673-145967394.90195.55
51449975-144997594.27194.91
61466685-146668595.35795.95
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%
19.711496780149517814968921496463149731114965250.06
29.771481853148276914823110.05
单位质量响应值RSD%判断
154122.04151720.681.12数据可信
供试品溶液-2023010511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%
5min1167208-16720810.8919.779.1710.899.779.17
2160225-16022510.43610.44
3126765-1267658.2578.26
4148483-1484839.6729.67
5148366-1483669.6649.66
6149074-1490749.7109.71
10min1403896-40389626.30824.496.5926.3224.506.58
2404796-40479626.36726.38
3342284-34228422.29522.31
4364412-36441223.73623.75
5362591-36259123.61823.63
6377623-37762324.59724.61
15min1629838-62983841.02538.655.2141.0838.705.21
2628758-62875840.95441.01
3556151-55615136.22536.27
4585305-58530538.12438.17
5566158-56615836.87736.93
6594020-59402038.69238.74
20min1826370-82637053.82651.954.4053.9452.064.40
2840392-84039254.73954.86
3752060-75206048.98649.09
4800336-80033652.13052.24
5760921-76092149.56349.67
6805444-80544452.46352.57
30min11133242-113324273.81472.942.5074.0173.132.50
21155788-115578875.28375.48
31077501-107750170.18470.36
41132147-113214773.74373.93
51098193-109819371.53171.71
61122079-112207973.08773.28
45min11385289-138528990.23290.020.8990.5490.320.90
21401626-140162691.29691.61
31364193-136419388.85789.14
41377769-137776989.74290.04
51379430-137943089.85090.14
61384339-138433990.17090.47
60min11435907-143590793.52993.220.4193.9793.650.41
21439347-143934793.75394.20
31431317-143131793.23093.64
41423793-142379392.74093.17
51427257-142725792.96593.39
61428953-142895393.07693.51
极限11455955-145595594.83494.590.9695.4295.160.96
21478027-147802796.27296.86
31450727-145072794.49495.05
41444079-144407994.06194.63
51441969-144196993.92394.48
61442180-144218093.93794.51
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%
19.711480769148040714802241479926147915014800950.05
29.771469541146799614687680.08
单位质量响应值RSD%判断
152429.97150334.490.98数据可信
供试品溶液-第1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%
5min1127467-1274678.3879.7310.578.399.7310.55
2146320-1463209.6279.63
3156470-15647010.29510.30
4152775-15277510.05210.05
5170412-17041211.21311.21
6133889-1338898.8098.81
10min1318763-31876320.97424.7210.0720.9924.7310.07
2398265-39826526.20526.22
3388305-38830525.54925.56
4387074-38707425.46825.48
5420048-42004827.63827.65
6341778-34177822.48822.50
15min1515809-51580933.93940.5814.1933.9840.6314.17
2768715-76871550.57950.63
3606465-60646539.90339.96
4612548-61254840.30440.36
5643780-64378042.35942.42
6552739-55273936.36836.42
20min1718510-71851047.27652.586.7847.3752.696.79
2854448-85444856.22056.35
3806242-80624253.04853.16
4824548-82454854.25354.37
5842016-84201655.40255.52
6748549-74854949.25249.35
30min11037091-103709168.23773.234.4368.4073.424.45
21171124-117112477.05677.27
31127905-112790574.21374.41
41129411-112941174.31274.51
51141141-114114175.08475.29
61071429-107142970.49770.67
45min11341365-134136588.25890.421.7488.5390.731.75
21406335-140633592.53292.86
31385375-138537591.15391.46
41378616-137861690.70991.02
51382432-138243290.96091.28
61351666-135166688.93589.22
60min11432144-143214494.23194.250.4994.6394.690.51
21438291-143829194.63595.10
31429140-142914094.03394.47
41440437-144043794.77695.22
51434016-143401694.35494.81
61420836-142083693.48793.90
极限11464651-146465196.36995.270.7296.9195.850.70
21447301-144730195.22895.84
31439787-143978794.73395.32
41454593-145459395.70896.29
51444651-144465195.05495.65
61436480-143648094.51695.07
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