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%
110.051527185152631015270551527906152781615272540.05
210.101533928153531815346230.07
单位质量响应值RSD%判断
151965.57151942.870.02数据可信
供试品溶液-2023010711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%
5min1145780-1457809.55511.0613.859.5611.0613.84
2202268-20226813.25813.26
3187618-18761812.29812.30
4175030-17503011.47311.47
5147338-1473389.6579.66
6153940-15394010.09010.09
10min1389392-38939225.52328.6411.2325.5428.6611.22
2523327-52332734.30234.32
3449704-44970429.47629.49
4445298-44529829.18829.20
5394922-39492225.88625.90
6419455-41945527.49427.51
15min1630383-63038341.31945.7510.3841.3745.8110.39
2831234-83123454.48454.56
3698557-69855745.78845.85
4710701-71070146.58446.64
5640963-64096342.01342.07
6675953-67595344.30644.36
20min1847028-84702855.51960.779.9655.6360.899.97
21101919-110191972.22672.38
3915501-91550160.00760.14
4937379-93737961.44161.57
5857507-85750756.20656.32
6903179-90317959.20059.32
30min11172458-117245876.85081.155.4277.0581.375.43
21357052-135705288.94989.21
31238198-123819881.15981.38
41255655-125565582.30382.53
51178675-117867577.25777.46
61226114-122611480.36780.58
45min11408998-140899892.35493.731.1992.6794.071.20
21439824-143982494.37594.77
31444452-144445294.67895.02
41443836-144383694.63894.98
51408314-140831492.30992.63
61434327-143432794.01494.35
60min11450809-145080995.09595.770.9295.5596.260.92
21456279-145627995.45395.99
31473750-147375096.59997.08
41475662-147566296.72497.21
51442650-144265094.56095.02
61467846-146784696.21296.68
极限11480285-148028597.02797.691.1597.6298.321.15
21486422-148642297.42998.11
31515518-151551899.33699.97
41502445-150244598.47999.11
51466879-146687996.14896.74
61490957-149095797.72698.34
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%
110.051545339154707415468861546766154639015464910.05
210.101528900152986315293820.05
单位质量响应值RSD%判断
153879.70151423.961.14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%
5min1162615-16261510.61110.7115.0510.6110.7115.05
2188135-18813512.27612.28
3158516-15851610.34310.34
4184825-18482512.06012.06
5171112-17111211.16511.17
6119828-1198287.8197.82
10min1413815-41381527.00227.7913.7027.0227.8113.70
2499817-49981732.61332.63
3449737-44973729.34629.36
4445200-44520029.05029.07
5423386-42338627.62627.64
6323609-32360921.11621.13
15min1652041-65204142.54644.8013.5142.6044.8513.51
2793998-79399851.80951.88
3752039-75203949.07149.13
4699517-69951745.64445.71
5695256-69525645.36645.42
6526189-52618934.33434.38
20min1869596-86959656.74259.7213.0856.8659.8413.08
21055914-105591468.89969.04
31023579-102357966.78966.92
4926320-92632060.44360.57
5894212-89421258.34858.47
6721816-72181647.09947.19
30min11195229-119522977.99080.389.2078.1980.599.20
21341807-134180787.55487.80
31339766-133976687.42187.65
41262119-126211982.35482.57
51214640-121464079.25679.47
61037421-103742167.69267.86
45min11428925-142892593.23892.893.1893.5693.233.20
21433440-143344093.53393.91
31450271-145027194.63195.00
41461115-146111595.33995.68
51433140-143314093.51393.85
61334853-133485387.10087.37
60min11458997-145899795.20195.491.3995.6695.961.41
21451137-145113794.68895.21
31470763-147076395.96896.47
41495393-149539397.57598.06
51468571-146857195.82596.30
61435291-143529193.65494.05
极限11474301-147430196.19996.731.4796.8097.351.48
21460546-146054695.30295.96
31483379-148337996.79297.44
41515762-151576298.90599.54
51498981-149898197.81098.43
61461546-146154695.36795.91
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