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%
110.073011466301214230109553012054301148630116210.02
210.083010691300652330086070.10
单位质量响应值RSD%判断
299068.62298472.920.15数据可信
供试品溶液-yd1批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1358199-35819911.94112.987.3311.9412.987.33
2400943-40094313.36613.37
3358213-35821311.94211.94
4390019-39001913.00213.00
5433531-43353114.45214.45
6395840-39584013.19613.20
10min1960877-96087732.03233.044.4032.0533.064.40
21005733-100573333.52833.55
3963948-96394832.13532.15
4985556-98555632.85532.87
51072057-107205735.73935.76
6958986-95898631.96931.99
15min11461676-146167648.72750.223.8748.7950.293.87
21495006-149500649.83849.91
31509370-150937050.31750.38
41499006-149900649.97250.04
51617285-161728553.91553.99
61456874-145687448.56748.64
20min11858300-185830061.94963.902.8462.0964.042.84
21894185-189418563.14663.29
31941695-194169564.73064.87
41915751-191575163.86564.01
52010939-201093967.03867.19
61879608-187960862.66062.80
30min12372866-237286679.10381.852.2779.3482.092.26
22409800-240980080.33580.57
32510125-251012583.67983.92
42456886-245688681.90482.14
52512983-251298383.77484.03
62469512-246951282.32582.56
45min12735246-273524691.18492.831.4391.5393.201.44
22740036-274003691.34491.70
32829352-282935294.32194.69
42782010-278201092.74393.11
52803627-280362793.46393.85
62817862-281786293.93894.30
60min12844696-284469694.83395.811.1495.3296.311.14
22827492-282749294.25994.76
32903999-290399996.81097.32
42873119-287311995.78096.28
52884511-288451196.16096.68
62909368-290936896.98997.49
极限12889247-288924796.31897.081.0296.9597.721.02
22866866-286686695.57296.21
32929406-292940697.65798.31
42916460-291646097.22597.87
52920566-292056697.36298.03
62949223-294922398.31798.96
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%
110.073002974300312330025403004492300235530030970.03
210.082999785300180530007950.05
单位质量响应值RSD%判断
298222.14297697.920.13数据可信
供试品溶液-yd2批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1264839-2648398.85310.0710.968.8510.0610.96
2314596-31459610.51610.52
3299390-29939010.00810.01
4316344-31634410.57510.57
5263022-2630228.7928.79
6348623-34862311.65411.65
10min1694722-69472223.22325.978.5123.2425.988.51
2823067-82306727.51327.53
3781578-78157826.12626.14
4824971-82497127.57727.59
5696027-69602723.26623.28
6840815-84081528.10628.12
15min11135746-113574637.96540.615.9538.0140.665.96
21239140-123914041.42141.48
31230821-123082141.14341.20
41279449-127944942.76942.83
51116887-111688737.33537.38
61286997-128699743.02143.08
20min11507792-150779250.40152.894.8650.5153.014.87
21578941-157894152.78052.90
31596788-159678853.37653.49
41668952-166895255.78955.91
51481316-148131649.51649.62
61660099-166009955.49355.62
30min11999494-199949466.83869.454.0267.0269.644.03
22094154-209415470.00270.20
32117892-211789270.79570.99
42106230-210623070.40670.61
51960247-196024765.52665.70
62188075-218807573.14273.35
45min12410574-241057480.57982.892.5780.8683.192.58
22516197-251619784.11084.41
32504201-250420183.70984.01
42485686-248568683.09083.40
52398950-239895080.19080.47
62562863-256286385.67085.99
60min12606935-260693587.14388.671.1287.5489.091.14
22665965-266596589.11689.55
32656890-265689088.81389.24
42660275-266027588.92689.36
52632218-263221887.98888.38
62693030-269303090.02190.47
极限12758505-275850592.20992.850.4292.7493.410.43
22779244-277924492.90393.47
32771205-277120592.63493.19
42791094-279109493.29993.87
52780118-278011892.93293.46
62785957-278595793.12793.71
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%
110.072996742299728229965422996531299539629964990.03
210.082995399299610129957500.02
单位质量响应值RSD%判断
297566.93297197.420.09数据可信
供试品溶液-yd3批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1410014-41001413.73211.5123.0713.7311.5023.07
2290561-2905619.7329.73
3287915-2879159.6439.64
4317187-31718710.62310.62
5282717-2827179.4699.47
6472696-47269615.83215.83
10min11024949-102494934.32829.7816.8834.3529.8016.89
2789099-78909926.42926.44
3801586-80158626.84726.86
4835530-83553027.98428.00
5757646-75764625.37525.39
61126511-112651137.72937.75
15min11529825-152982551.23745.1312.6051.3145.1912.61
21185338-118533839.70039.75
31260862-126086242.22942.28
41312426-131242643.95644.01
51210413-121041340.53940.59
61586102-158610253.12253.20
20min11895699-189569963.49157.3310.1363.6457.4610.14
21515909-151590950.77150.89
31609113-160911353.89354.01
41710380-171038057.28557.41
51595774-159577453.44653.56
61943902-194390265.10665.27
30min12385840-238584079.90774.586.2780.1574.796.29
22070711-207071169.35369.54
32155109-215510972.17972.38
42209919-220991974.01574.22
52130352-213035271.35071.54
62407937-240793780.64780.90
45min12733684-273368491.55788.212.9791.9288.543.00
22547855-254785585.33385.63
32563161-256316185.84686.15
42613902-261390287.54687.87
52622654-262265487.83988.14
62721476-272147691.14891.53
60min12859811-285981195.78292.682.2696.2893.142.28
22727610-272761091.35491.78
32706700-270670090.65491.09
42755400-275540092.28592.74
52725233-272523391.27491.71
62828253-282825394.72595.24
极限12915185-291518597.63695.251.6198.2895.851.64
22819462-281946294.43094.99
32805740-280574093.97194.54
42834510-283451094.93495.52
52804796-280479693.93994.51
62884724-288472496.61697.27
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