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%
110.083054861305466030539923052456305099030533920.06
210.133046878304475330458160.05
单位质量响应值RSD%判断
302915.87300672.850.53数据可信
供试品溶液-2023010811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%
5min1352504-35250411.63411.198.3311.6311.198.32
2371077-37107712.24712.25
3292250-2922509.6459.65
4337363-33736311.13411.13
5323838-32383810.68810.69
6357935-35793511.81311.81
10min1843428-84342827.83626.696.0927.8526.716.09
2857485-85748528.30028.32
3716754-71675423.65523.67
4814837-81483726.89226.91
5807623-80762326.65426.67
6812267-81226726.80726.83
15min11285227-128522742.41641.354.5642.4841.414.56
21312569-131256943.31943.38
31145651-114565137.81037.86
41251489-125148941.30341.36
51259988-125998841.58341.64
61262599-126259941.67041.73
20min11671019-167101955.14954.123.7455.2754.243.74
21705528-170552856.28856.41
31525761-152576150.35550.46
41631510-163151053.84553.96
51655882-165588254.64954.77
61649096-164909654.42554.55
30min12222655-222265573.35472.402.6873.5672.602.69
22235036-223503673.76373.97
32080288-208028868.65668.84
42184696-218469672.10272.30
52234263-223426373.73873.94
62205473-220547372.78772.99
45min12675757-267575788.30887.761.2688.6288.071.26
22661115-266111587.82588.15
32601709-260170985.86486.15
42668376-266837688.06588.37
52700849-270084989.13689.45
62647359-264735987.37187.68
60min12845879-284587993.92393.650.8294.3794.090.82
22813053-281305392.83993.29
32815886-281588692.93393.35
42852797-285279794.15194.59
52872164-287216494.79095.23
62826490-282649093.28393.73
极限12912835-291283596.13296.070.6796.7296.660.67
22882637-288263795.13695.73
32904768-290476895.86696.42
42923255-292325596.47697.06
52939410-293941097.01097.60
62903407-290340795.82196.40
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%
110.083042117304827830434303043694304171530438470.09
210.133114325311731831158220.07
单位质量响应值RSD%判断
301968.95307583.611.31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%
5min1318051-31805110.39510.726.6410.3910.726.64
2324555-32455510.60710.61
3316645-31664510.34910.35
4341556-34155611.16311.16
5303459-3034599.9189.92
6364620-36462011.91711.92
10min1789488-78948825.80226.334.1625.8226.344.16
2779493-77949325.47625.49
3808097-80809726.41126.43
4851509-85150927.82927.85
5766758-76675825.06025.07
6837649-83764927.37627.39
15min11253158-125315840.95641.714.5341.0141.764.54
21225739-122573940.06040.11
31334785-133478543.62443.68
41341966-134196643.85943.92
51202837-120283739.31239.36
61298339-129833942.43342.49
20min11645852-164585253.79154.403.9053.9154.523.90
21612900-161290052.71452.83
31734450-173445056.68656.81
41738496-173849656.81856.94
51578242-157824251.58151.69
61676683-167668354.79854.92
30min12206573-220657372.11672.872.6672.3173.082.67
22172432-217243271.00071.19
32290248-229024874.85175.06
42299631-229963175.15875.37
52160454-216045470.60970.80
62249249-224924973.51173.72
45min12687448-268744887.83287.751.1688.1488.061.17
22649519-264951986.59386.89
32723212-272321289.00189.32
42715613-271561388.75389.08
52650672-265067286.63186.93
62683873-268387387.71688.03
60min12852888-285288893.23993.460.7993.6893.900.80
22827769-282776992.41992.85
32877299-287729994.03794.49
42872767-287276793.88994.34
52841978-284197892.88393.31
62885672-288567294.31194.76
极限12916175-291617595.30895.590.6295.8896.170.63
22904731-290473194.93495.50
32936892-293689295.98596.58
42926237-292623795.63796.23
52910802-291080295.13295.70
62953411-295341196.52597.11
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%
110.083063774306231430664143065156304785130611020.25
210.133065188306353730643620.04
单位质量响应值RSD%判断
303680.75302503.650.28数据可信
供试品溶液-2023010811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%
5min1419971-41997113.80112.498.0713.8012.498.05
2374032-37403212.29112.29
3401786-40178613.20313.20
4330959-33095910.87610.88
5385366-38536612.66412.66
6367758-36775812.08512.09
10min1873784-87378428.71427.455.5728.7327.475.56
2841016-84101627.63727.66
3893869-89386929.37429.39
4779949-77994925.63025.65
5840821-84082127.63127.65
6782849-78284925.72625.74
15min11322088-132208843.44641.983.1943.5142.043.19
21286775-128677542.28542.35
31318724-131872443.33543.40
41235228-123522840.59140.65
51276503-127650341.94842.01
61225583-122558340.27440.33
20min11686958-168695855.43654.302.0555.5654.422.05
21676294-167629455.08555.21
31676483-167648355.09255.22
41626533-162653353.45053.57
51647053-164705354.12454.25
61600787-160078752.60452.72
30min12215127-221512772.79272.691.0673.0072.891.06
22239182-223918273.58373.79
32234916-223491673.44273.65
42204045-220404572.42872.62
52202249-220224972.36972.57
62176288-217628871.51671.71
45min12640607-264060786.77487.011.0187.1087.321.01
22668495-266849587.69188.01
32685819-268581988.26088.58
42645483-264548386.93487.24
52635881-263588186.61986.93
62609660-260966085.75786.06
60min12785150-278515091.52492.301.0591.9892.741.04
22795315-279531591.85892.31
32805830-280583092.20492.66
42801485-280148592.06192.50
52866745-286674594.20594.65
62797186-279718691.91992.35
极限12855543-285554393.83794.560.8394.4395.140.82
22869024-286902494.28094.87
32890616-289061694.99095.58
42912920-291292095.72396.30
52849724-284972493.64694.23
62886681-288668194.86095.43
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%
110.083063424305088630513313067593306588830598240.27
210.133041465303887130401680.07
单位质量响应值RSD%判断
303553.97300115.300.81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%
5min1324514-32451410.70910.8310.7310.7110.8310.73
2317034-31703410.46210.46
3349397-34939711.53011.53
4272747-2727479.0009.00
5378482-37848212.49012.49
6327427-32742710.80510.80
10min1779113-77911325.71025.592.4225.7325.612.43
2760942-76094225.11125.13
3773815-77381525.53525.55
4771994-77199425.47525.49
5809939-80993926.72726.75
6757521-75752124.99825.01
15min11254719-125471941.40540.872.0841.4640.922.09
21209648-120964839.91839.97
31276130-127613042.11142.17
41224324-122432440.40240.45
51249337-124933741.22741.29
61216542-121654240.14540.20
20min11658695-165869554.73654.012.1854.8554.132.18
21620592-162059253.47853.59
31694949-169494955.93256.05
41627692-162769253.71353.82
51626888-162688853.68653.81
61591767-159176752.52752.64
30min12208314-220831472.87372.311.9373.0772.501.93
22177774-217777471.86572.06
32260618-226061874.59974.80
42177658-217765871.86172.05
52190280-219028072.27872.48
62132426-213242670.36970.56
45min12649432-264943287.42986.990.6487.7487.300.64
22626524-262652486.67386.97
32646651-264665187.33887.65
42653454-265345487.56287.86
52631515-263151586.83887.15
62610003-261000386.12886.43
60min12828877-282887793.35192.730.6693.7993.160.65
22820683-282068393.08093.51
32787858-278785891.99792.44
42823357-282335793.16993.60
52812603-281260392.81493.25
62786680-278668091.95892.39
极限12882738-288273895.12894.800.6295.7195.380.61
22900497-290049795.71496.29
32858613-285861394.33294.92
42879581-287958195.02495.60
52858211-285821194.31994.90
62857668-285766894.30194.87
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%
110.083043628304842230458263043813304448830452350.07
210.133068386307234230703640.10
单位质量响应值RSD%判断
302106.65303096.150.24数据可信
供试品溶液-2023011011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%
5min1340370-34037011.20311.352.2711.2011.352.25
2349166-34916611.49311.49
3354924-35492411.68211.68
4351325-35132511.56411.56
5336820-33682011.08611.09
6337172-33717211.09811.10
10min1768006-76800625.27925.923.5025.3025.943.50
2833494-83349427.43427.45
3793230-79323026.10926.13
4779457-77945725.65625.67
5754323-75432324.82824.84
6797314-79731426.24326.26
15min11202309-120230939.57440.543.7139.6340.603.71
21304578-130457842.94043.00
31240613-124061340.83440.89
41220166-122016640.16140.22
51171338-117133838.55438.61
61251024-125102441.17741.23
20min11546346-154634650.89752.693.5051.0152.813.50
21683683-168368355.41855.54
31633278-163327853.75953.88
41575394-157539451.85451.97
51541335-154133550.73350.84
61625482-162548253.50253.62
30min12093648-209364868.91270.933.0569.1071.123.05
22235605-223560573.58473.79
32233676-223367673.52173.72
42126031-212603169.97870.17
52089813-208981368.78668.97
62150746-215074670.79170.99
45min12599275-259927585.55485.991.5085.8586.291.50
22665779-266577987.74388.06
32632361-263236186.64386.95
42567790-256779084.51884.82
52572286-257228684.66684.96
62637280-263728086.80587.11
60min12813934-281393492.62092.210.9993.0492.640.99
22833593-283359393.26793.71
32823993-282399392.95193.39
42774907-277490791.33591.76
52764564-276456490.99591.41
62798710-279871092.11992.55
极限12912066-291206695.85095.450.5796.4196.020.57
22906551-290655195.66896.26
32912196-291219695.85496.43
42909139-290913995.75396.32
52872574-287257494.55095.10
62887119-288711995.02995.60
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