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100
标示量(mg)100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%
19.661423011142293714218061422622142092014222590.07
29.601421563142374214226520.11
单位质量响应值RSD%判断
147231.78148192.920.47数据可信
供试品溶液-2023010711批-pH6.8(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%
5min1179944-17994412.13312.5220.2812.1312.5220.28
2230519-23051915.54415.54
3177233-17723311.95111.95
4130533-1305338.8028.80
5169434-16943411.42511.42
6226495-22649515.27215.27
10min1451915-45191530.47231.2916.4430.4931.3016.44
2548713-54871336.99937.02
3419885-41988528.31228.33
4351940-35194023.73123.74
5462536-46253631.18831.21
6549048-54904837.02237.04
15min1706980-70698047.67148.8013.6547.7348.8613.65
2827795-82779555.81755.90
3658646-65864644.41244.47
4576195-57619538.85238.90
5742818-74281850.08850.15
6829833-82983355.95556.03
20min1925111-92511162.37963.6811.4062.5163.8211.41
21057809-105780971.32771.49
3873443-87344358.89559.02
4780472-78047252.62652.73
5977383-97738365.90466.04
61052643-105264370.97971.14
30min11239732-123973283.59484.428.2183.8284.658.22
21347547-134754790.86491.13
31181574-118157479.67279.89
41088458-108845873.39473.58
51311830-131183088.45588.69
61342640-134264090.53390.80
45min11423438-142343895.98195.822.5196.3496.182.54
21438520-143852096.99897.40
31427657-142765796.26696.60
41350712-135071291.07791.37
51438070-143807096.96897.34
61448124-144812497.64698.05
60min11456242-145624298.19398.040.7198.6998.540.74
21453082-145308297.98098.53
31455900-145590098.17098.65
41434349-143434996.71797.15
51463492-146349298.68299.20
61460637-146063798.48999.04
极限11477371-147737199.61899.320.46100.2699.970.46
21464843-146484398.77399.47
31481160-148116099.873100.50
41465564-146556498.82299.40
51476960-147696099.590100.25
61471581-147158199.22799.93
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100
标示量(mg)100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%
19.661420782142264814228481420776141906014212230.11
29.601421346142446514229060.16
单位质量响应值RSD%判断
147124.53148219.380.53数据可信
供试品溶液-第1批-pH6.8(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%
5min1176542-17654211.90714.7515.6011.9114.7515.59
2219218-21921814.78614.79
3212876-21287614.35814.36
4221631-22163114.94914.95
5201869-20186913.61613.62
6279620-27962018.86018.86
10min1439153-43915329.62036.6813.6729.6436.7013.66
2580038-58003839.12239.14
3507455-50745534.22734.25
4557163-55716337.57937.60
5520450-52045035.10335.12
6659107-65910744.45544.48
15min1691602-69160246.64756.7013.0746.7156.7813.07
2913599-91359961.62061.70
3775030-77503052.27452.35
4851374-85137457.42357.50
5806611-80661154.40454.48
61005602-100560267.82667.92
20min1917837-91783761.90672.2610.3562.0472.4210.35
21167105-116710578.71978.89
3992460-99246066.93967.09
41082147-108214772.98873.15
51049520-104952070.78870.94
61219062-121906282.22382.42
30min11257169-125716984.79390.764.7085.0291.034.72
21378305-137830592.96493.25
31286032-128603286.74086.99
41365142-136514292.07692.35
51357886-135788691.58691.85
61429185-142918596.39596.72
45min11444865-144486597.45398.741.5397.8199.151.52
21446044-144604497.53297.96
31505082-1505082101.514101.90
41455113-145511398.14498.56
51470796-147079699.20299.60
61461651-146165198.58599.05
60min11472207-147220799.29799.260.2299.8099.820.22
21469428-146942899.11099.69
31467889-146788999.00699.54
41470918-147091899.21099.77
51477033-147703399.623100.17
61472464-147246499.31499.93
极限11490954-1490954100.56199.880.44101.21100.580.41
21471182-147118299.22899.95
31480065-148006599.827100.51
41479092-147909299.761100.47
51483097-1483097100.032100.73
61480367-148036799.847100.61
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100
标示量(mg)100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%
19.661425612143013014262401425128142586014265940.15
29.601419816142073614202760.05
单位质量响应值RSD%判断
147680.54147945.420.13数据可信
供试品溶液-2023010711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%
5min1130181-1301818.7728.788.408.778.788.39
2151805-15180510.22910.23
3122414-1224148.2498.25
4126136-1261368.4998.50
5127728-1277288.6078.61
6123284-1232848.3078.31
10min1337349-33734922.73122.867.7222.7422.877.71
2378945-37894525.53425.55
3330665-33066522.28122.29
4345037-34503723.24923.26
5345421-34542123.27523.29
6298063-29806320.08420.10
15min1545073-54507336.72837.347.4336.7837.387.43
2614843-61484341.43041.48
3543741-54374136.63936.68
4567207-56720738.22038.27
5565336-56533638.09438.14
6488569-48856932.92132.96
20min1742354-74235450.02250.986.5450.1251.086.54
2825657-82565755.63555.75
3749291-74929150.48950.59
4774740-77474052.20452.31
5772172-77217252.03152.14
6675163-67516345.49445.59
30min11068622-106862272.00672.804.6372.1872.984.64
21155191-115519177.84078.04
31055293-105529371.10871.28
41098600-109860074.02674.21
51098310-109831074.00774.19
61006430-100643067.81667.98
45min11356307-135630791.39191.351.8791.6891.641.88
21381021-138102193.05793.37
31337188-133718890.10390.39
41368299-136829992.19992.49
51375872-137587292.71093.00
61315226-131522688.62388.89
60min11446774-144677497.48796.670.7597.9197.100.74
21431126-143112696.43396.89
31417742-141774295.53195.95
41429193-142919396.30396.74
51440146-144014697.04197.47
61442818-144281897.22197.62
极限11471547-147154799.15798.680.7599.7399.250.74
21457068-145706898.18198.78
31449811-144981197.69298.25
41459271-145927198.32998.91
51479408-147940899.686100.26
61469808-146980899.03999.58
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100
标示量(mg)100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%
19.661426068142732314252961427660142638514265460.07
29.601445582144416114448720.07
单位质量响应值RSD%判断
147675.57150507.501.35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%
5min1122606-1226068.1918.251.528.198.251.50
2122049-1220498.1548.15
3123509-1235098.2528.25
4127128-1271288.4948.49
5122365-1223658.1758.18
6123354-1233548.2418.24
10min1349271-34927123.33522.077.5023.3522.097.50
2304102-30410220.31720.33
3356478-35647823.81723.83
4315003-31500321.04621.06
5352083-35208323.52323.54
6305341-30534120.40020.41
15min1552079-55207936.88536.117.8736.9336.167.87
2496954-49695433.20233.24
3592366-59236639.57639.62
4515632-51563234.45034.49
5586009-58600939.15239.20
6500189-50018933.41833.46
20min1757296-75729650.59549.756.5450.7049.856.54
2691872-69187246.22446.32
3805463-80546353.81353.92
4711669-71166947.54747.64
5795768-79576853.16653.27
6705864-70586447.15947.25
30min11093365-109336573.04871.734.6473.2371.904.64
21024363-102436368.43868.60
31137940-113794076.02676.21
41036551-103655169.25369.42
51119765-111976574.81275.00
61029927-102992768.81068.97
45min11387481-138748192.69891.382.3692.9991.662.38
21330586-133058688.89789.16
31411023-141102394.27194.57
41348612-134861290.10290.37
51388521-138852192.76893.07
61340170-134017089.53889.80
60min11464829-146482997.86697.201.0198.2997.611.02
21457290-145729097.36297.76
31474885-147488598.53898.98
41453146-145314697.08697.49
51445543-144554396.57897.02
61433024-143302495.74196.14
极限11488461-148846199.44598.691.22100.0299.251.22
21490376-149037699.573100.12
31493726-149372699.797100.39
41478689-147868998.79299.34
51462598-146259897.71798.30
61448688-144868896.78897.33
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