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%
110.053074447307346830755513074230307425130743890.03
210.103065492306866830670800.08
单位质量响应值RSD%判断
305909.35303671.290.52数据可信
供试品溶液-2023010811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%
5min1349756-34975611.43010.778.5511.4310.778.55
2367828-36782812.02012.02
3342234-34223411.18411.18
4309480-30948010.11310.11
5314721-31472110.28510.28
6293346-2933469.5869.59
10min1855672-85567227.96226.466.8827.9826.486.88
2887218-88721828.99329.01
3821119-82111926.83326.85
4771673-77167325.21725.23
5785296-78529625.66225.68
6737658-73765824.10624.12
15min11322325-132232543.21241.116.0143.2741.166.01
21363969-136396944.57344.63
31272151-127215141.57241.63
41204815-120481539.37239.42
51218760-121876039.82739.88
61165398-116539838.08438.13
20min11728700-172870056.49253.605.3056.6253.725.30
21757540-175754057.43457.56
31639577-163957753.57953.70
41579398-157939851.61351.72
51598111-159811152.22452.34
61537352-153735250.23950.35
30min12285901-228590174.70071.853.2074.9172.053.21
22281814-228181474.56774.78
32188258-218825871.50971.71
42147623-214762370.18170.37
52173055-217305571.01271.20
62116058-211605869.15069.33
45min12744386-274438689.68387.681.5390.0087.991.54
22720691-272069188.90889.23
32678873-267887387.54287.85
42663250-266325087.03187.33
52645458-264545886.45086.75
62646271-264627186.47786.76
60min12901703-290170394.82493.930.6195.2894.370.62
22876816-287681694.01094.47
32878758-287875894.07494.51
42874311-287431193.92994.35
52847515-284751593.05393.48
62867790-286779093.71594.13
极限12949714-294971496.39396.210.3996.9996.790.39
22940513-294051396.09296.69
32953374-295337496.51297.09
42945390-294539096.25196.82
52923190-292319095.52696.09
62953310-295331096.51097.07
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%
110.053069304307592730640993065044306489430678540.17
210.103064663306721030659360.06
单位质量响应值RSD%判断
305259.10303558.020.40数据可信
供试品溶液-第1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%
5min1341634-34163411.17811.483.1411.1811.483.14
2367178-36717812.01412.01
3360899-36089911.80811.81
4339062-33906211.09411.09
5349260-34926011.42811.43
6347569-34756911.37211.37
10min1834668-83466827.31027.503.1327.3327.523.14
2879939-87993928.79128.81
3858148-85814828.07828.10
4843342-84334227.59427.61
5820475-82047526.84526.86
6806722-80672226.39526.41
15min11286740-128674042.10142.451.9642.1642.501.96
21338107-133810743.78243.84
31314614-131461443.01343.07
41296539-129653942.42242.48
51278739-127873941.84041.90
61268963-126896341.52041.58
20min11678660-167866054.92555.671.2055.0555.801.21
21733910-173391056.73356.86
31707933-170793355.88356.01
41707430-170743055.86655.99
51680764-168076454.99455.11
61700440-170044055.63755.76
30min12230255-223025572.97374.061.0973.1874.271.09
22265264-226526474.11874.33
32283738-228373874.72374.93
42297874-229787475.18575.39
52257286-225728673.85774.06
62246552-224655273.50673.71
45min12693034-269303488.11588.871.0888.4389.181.08
22705738-270573888.53088.85
32733835-273383589.45089.77
42753524-275352490.09490.41
52733913-273391389.45289.77
62675910-267591087.55487.87
60min12880233-288023394.24094.280.8394.6894.720.83
22866981-286698193.80694.26
32897470-289747094.80495.26
42909622-290962295.20195.65
52890707-289070794.58295.03
62842943-284294393.02093.46
极限12951565-295156596.57496.260.7897.1696.860.78
22928344-292834495.81496.41
32956074-295607496.72197.32
42957639-295763996.77297.37
52957442-295744296.76697.36
62901171-290117194.92595.51
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%
110.053065563306727830694003072554307623430702060.14
210.103068079307111730695980.07
单位质量响应值RSD%判断
305493.13303920.590.37数据可信
供试品溶液-2023010811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%
5min1365038-36503811.93211.157.9511.9311.157.96
2338306-33830611.05811.06
3338229-33822911.05611.06
4296227-2962279.6839.68
5373243-37324312.20012.20
6334977-33497710.95010.95
10min1870243-87024328.44627.634.5028.4627.654.50
2850100-85010027.78827.80
3830097-83009727.13427.15
4788710-78871025.78125.80
5900011-90001129.41929.44
6832846-83284627.22427.24
15min11331390-133139043.52042.453.3443.5842.513.34
21310806-131080642.84742.91
31270562-127056241.53141.59
41241958-124195840.59640.65
51359699-135969944.44544.51
61277883-127788341.77141.83
20min11702271-170227155.64354.942.4955.7755.072.49
21721261-172126156.26356.39
31648387-164838753.88154.00
41640481-164048153.62353.74
51730406-173040656.56256.69
61642554-164255453.69153.81
30min12248383-224838373.49472.702.1273.7072.902.12
22302052-230205275.24875.45
32195122-219512271.75371.95
42184194-218419471.39671.59
52233882-223388273.02073.23
62180560-218056071.27771.48
45min12686378-268637887.81187.560.9088.1387.870.90
22721892-272189288.97189.29
32659085-265908586.91887.23
42678516-267851687.55487.86
52669339-266933987.25487.58
62656416-265641686.83187.14
60min12834297-283429792.64692.830.7893.1093.280.77
22869754-286975493.80594.26
32843336-284333692.94193.38
42857370-285737093.40093.83
52807746-280774691.77892.23
62827974-282797492.43992.88
极限12882991-288299194.23794.840.6694.8395.420.65
22923399-292339995.55896.15
32908421-290842195.06995.65
42921358-292135895.49296.06
52879592-287959294.12694.72
62892981-289298194.56495.14
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%
110.053066014306782230687243066362306859030675020.05
210.103088542308998230892620.04
单位质量响应值RSD%判断
305224.08305867.520.15数据可信
供试品溶液-第1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%
5min1351211-35121111.44910.884.1811.4510.884.17
2346295-34629511.28811.29
3339519-33951911.06711.07
4326113-32611310.63010.63
5324476-32447610.57710.58
6315589-31558910.28710.29
10min1873298-87329828.46727.843.1828.4827.853.18
2886887-88688728.91028.93
3873114-87311428.46128.48
4839002-83900227.34927.37
5821329-82132926.77326.79
6830089-83008927.05927.07
15min11353309-135330944.11443.152.8144.1743.212.81
21370942-137094244.68944.75
31332954-133295443.45143.51
41310968-131096842.73442.79
51265791-126579141.26241.32
61309236-130923642.67842.73
20min11756895-175689557.27055.972.5957.4056.102.60
21761738-176173857.42857.56
31706169-170616955.61755.74
41721465-172146556.11556.24
51638639-163863953.41553.53
61717884-171788455.99956.12
30min12275926-227592674.18973.991.6774.4074.201.67
22276910-227691074.22174.43
32281403-228140374.36874.58
42291442-229144274.69574.90
52194708-219470871.54271.74
62298123-229812374.91375.12
45min12701538-270153888.06388.260.6688.3988.580.66
22696933-269693387.91388.24
32717100-271710088.57188.89
42720307-272030788.67588.99
52680615-268061587.38187.69
62729154-272915488.96389.28
60min12858141-285814193.16893.220.6393.6293.670.62
22837479-283747992.49592.95
32859729-285972993.22093.67
42890225-289022594.21494.66
52848317-284831792.84893.28
62864872-286487293.38793.84
极限12911103-291110394.89595.020.2395.4995.610.23
22904260-290426094.67195.27
32922910-292291095.27995.87
42919355-291935595.16495.76
52915541-291554195.03995.61
62916505-291650595.07195.66
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