塞来昔布胶囊项目信息
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%
110.152984929298525329828842984654297789529831230.11
210.192971429297638229739060.12
单位质量响应值RSD%判断
293903.74291845.530.50数据可信
供试品溶液-20211229批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11376880-137688046.82540.9216.1146.8340.9216.12
2851107-85110728.94528.94
31331143-133114345.27045.27
41243702-124370242.29642.30
51296202-129620244.08144.08
61120121-112012138.09338.09
10min11834224-183422462.37965.3910.0762.4565.4610.06
21730422-173042258.84858.89
31918071-191807165.23065.30
42129776-212977672.43072.49
51742842-174284259.27159.34
62181825-218182574.20074.26
15min12479505-247950584.32382.357.4084.4982.517.40
22141294-214129472.82172.95
32355316-235531680.10080.27
42584629-258462987.89888.07
52343493-234349379.69879.85
62624380-262438089.25089.42
20min12834892-283489296.40995.123.9696.7095.413.96
22576931-257693187.63787.88
32823679-282367996.02896.31
42859017-285901797.23097.53
52877295-287729597.85198.13
62810606-281060695.58395.89
30min12971926-2971926101.070100.142.45101.50100.572.44
22893740-289374098.41198.78
33022691-3022691102.796103.23
42903242-290324298.73499.18
53023752-3023752102.832103.25
62852812-285281297.01997.46
45min12967346-2967346100.914100.042.46101.50100.622.45
22899225-289922598.59799.12
33017712-3017712102.627103.21
42900338-290033898.63599.23
53022408-3022408102.786103.36
62843700-284370096.70997.30
60min12972233-2972233101.08099.962.42101.82100.682.41
22887245-288724598.19098.86
33018643-3018643102.658103.40
42898889-289888998.58699.33
53010620-3010620102.386103.12
62847662-284766296.84497.58
极限12974362-2974362101.15399.852.48102.04100.722.46
22888914-288891498.24799.06
33009568-3009568102.350103.24
42892351-289235198.36399.26
53012439-3012439102.447103.33
62838586-283858696.53597.42
塞来昔布胶囊项目信息
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%
110.152976176297555929752612973869297135229744430.07
210.192966902297149929692000.11
单位质量响应值RSD%判断
293048.57291383.710.41数据可信
供试品溶液-20211229批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11621043-162104355.25345.7816.5055.2545.7816.49
21408380-140838048.00448.00
3979845-97984533.39833.40
41364431-136443146.50646.51
51467500-146750050.01950.02
61217122-121712241.48541.49
10min12528762-252876286.19273.0811.1686.2773.1511.15
21921510-192151065.49465.57
32038216-203821669.47269.52
42101901-210190171.64371.71
51943109-194310966.23066.31
62331735-233173579.47679.54
15min12988247-2988247101.85388.019.10102.0788.199.10
22491493-249149384.92285.09
32521492-252149285.94486.10
42470078-247007884.19284.37
52315799-231579978.93379.11
62705196-270519692.20692.39
20min13134533-3134533106.83999.613.98107.2099.923.99
22883356-288335698.27898.58
32895848-289584898.70498.99
42781329-278132994.80195.10
52909553-290955399.17199.46
62929716-292971699.858100.18
30min13164438-3164438107.859103.905.04108.38104.365.02
22976088-2976088101.439101.88
33118262-3118262106.285106.72
42820033-282003396.12096.57
53238224-3238224110.374110.82
62971881-2971881101.295101.77
45min13152611-3152611107.456103.765.09108.14104.385.07
22981509-2981509101.624102.22
33118080-3118080106.279106.87
42812837-281283795.87596.46
53239462-3239462110.416111.02
62960713-2960713100.915101.54
60min13143971-3143971107.161103.545.00108.01104.324.99
22974539-2974539101.386102.14
33112707-3112707106.095106.85
42812458-281245895.86296.60
53229357-3229357110.071110.84
62954245-2954245100.694101.47
极限13141156-3141156107.065103.345.02108.07104.265.01
22961481-2961481100.941101.84
33102854-3102854105.760106.67
42810646-281064695.80096.68
53226540-3226540109.975110.91
62948185-2948185100.488101.41
塞来昔布胶囊项目信息
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%
110.152978411297559729734402975372297721429760070.07
210.192975480297062329730520.12
单位质量响应值RSD%判断
293202.66291761.730.35数据可信
供试品溶液-8149402批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11775201-177520160.45251.1822.0660.4551.1822.06
21720897-172089758.60358.60
31198468-119846840.81240.81
41061996-106199636.16536.16
51863046-186304663.44363.44
61398623-139862347.62847.63
10min12443456-244345683.20881.337.5683.3081.417.55
22180964-218096474.27074.36
32185246-218524674.41574.48
42463378-246337883.88783.94
52404970-240497081.89881.99
62652076-265207690.31390.38
15min12752643-275264393.73790.738.0293.9590.938.01
22401394-240139481.77681.98
32398003-239800381.66181.83
42739649-273964993.29593.47
52786091-278609194.87695.09
62908449-290844999.04399.25
20min12958834-2958834100.75998.584.15101.1198.924.15
22763750-276375094.11694.44
32722211-272221192.70193.00
42944370-2944370100.266100.59
52977341-2977341101.389101.75
63002580-3002580102.249102.60
30min12999419-2999419102.141101.860.81102.65102.340.83
22975993-2975993101.343101.81
32951818-2951818100.520100.95
42996952-2996952102.057102.53
53001278-3001278102.204102.72
63020884-3020884102.872103.38
45min12989142-2989142101.791101.690.91102.45102.330.93
22976785-2976785101.370101.99
32939173-2939173100.089100.67
42998191-2998191102.099102.72
52993794-2993794101.949102.62
63020292-3020292102.852103.51
60min13001811-3001811102.222101.670.91103.04102.460.93
22976817-2976817101.371102.14
32937150-2937150100.020100.76
42991180-2991180101.860102.64
52992267-2992267101.897102.72
63014772-3014772102.664103.48
极限12984679-2984679101.639101.480.79102.61102.420.81
22970510-2970510101.156102.08
32940010-2940010100.118101.00
42990059-2990059101.822102.75
52985438-2985438101.665102.64
63009393-3009393102.481103.45
塞来昔布胶囊项目信息
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%
110.152969879297122529702852974616297571729723440.09
210.192977081297727029771760.01
单位质量响应值RSD%判断
292841.77292166.440.17数据可信
供试品溶液-8149402批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11761083-176108359.96642.1436.8959.9742.1436.89
21485737-148573750.59150.59
3771753-77175326.27926.28
41655499-165549956.37156.37
5713571-71357124.29824.30
61037968-103796835.34435.34
10min12606002-260600288.73776.3715.1488.8376.4415.15
22330470-233047079.35479.43
31603431-160343154.59854.64
42401579-240157981.77681.86
52290695-229069578.00078.04
62225305-222530575.77475.83
15min12919389-291938999.40892.1310.0699.6392.3010.07
22730097-273009792.96293.16
32169086-216908673.85973.98
42802468-280246895.42695.63
52750113-275011393.64493.80
62862373-286237397.46697.63
20min12996580-2996580102.03698.893.16102.4199.213.20
22962982-2962982100.892101.23
32734359-273435993.10793.34
42934883-293488399.935100.29
52904221-290422198.89199.19
62892936-289293698.50798.82
30min12993999-2993999101.948100.501.48102.47100.961.51
22991615-2991615101.867102.35
32907568-290756899.00599.38
42964084-2964084100.930101.43
52962531-2962531100.877101.32
62889225-288922598.38198.84
45min12983851-2983851101.603100.431.59102.28101.041.61
23009310-3009310102.470103.11
32902571-290257198.83599.36
42948874-2948874100.412101.06
52963377-2963377100.906101.50
62888097-288809798.34298.95
60min12990305-2990305101.822100.321.50102.65101.091.53
22988560-2988560101.763102.56
32900835-290083598.77699.44
42948840-2948840100.411101.21
52962877-2962877100.888101.63
62886533-288653398.28999.04
极限12978031-2978031101.404100.011.42102.39100.921.45
22976000-2976000101.335102.28
32896466-289646698.62799.44
42940055-2940055100.111101.06
52953986-2953986100.586101.48
62878003-287800397.99898.90
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