依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.553247913259373249843251613250463251840.14
29.583247183259583253380.27
单位质量响应值RSD%判断
34050.6833960.130.19数据可信
供试品溶液-23110902批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1160204-16020446.99446.3717.1146.9946.3717.11
2152630-15263044.77244.77
3174021-17402151.04751.05
4200543-20054358.82758.83
5125724-12572436.87936.88
6135374-13537439.71039.71
10min1290074-29007485.08984.779.0785.2384.919.07
2262372-26237276.96377.10
3322907-32290794.72094.87
4309544-30954490.80090.98
5293612-29361286.12786.24
6255456-25545674.93575.05
15min1316686-31668692.89592.564.9993.2992.955.01
2301526-30152688.44988.81
3332664-33266497.58298.02
4322075-32207594.47694.93
5328092-32809296.24196.61
6292126-29212685.69186.04
20min1322103-32210394.48494.812.1395.1695.482.15
2317907-31790793.25493.88
3330863-33086397.05497.78
4322750-32275094.67495.41
5331452-33145297.22797.88
6314302-31430292.19692.80
30min1324175-32417595.09295.710.9996.0596.661.00
2325007-32500795.33696.25
3330650-33065096.99298.01
4323545-32354594.90795.92
5330060-33006096.81997.77
6324204-32420495.10195.98
45min1325195-32519595.39196.100.7896.6497.340.76
2327505-32750596.06997.27
3329363-32936396.61497.93
4324473-32447395.18096.48
5331271-33127197.17498.41
6327805-32780596.15797.32
60min1324195-32419595.09896.060.8596.6397.590.83
2327247-32724795.99397.48
3329075-32907596.53098.13
4324408-32440895.16196.75
5331269-33126997.17398.70
6328649-32864996.40597.86
极限1339691-33969199.64499.720.92101.46101.540.94
2342542-342542100.480102.25
3340251-34025199.808101.70
4343803-343803100.850102.72
5338442-33844299.277101.10
6334963-33496398.257100.00
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.553246413241473255713244933245083246720.17
29.583249323252193250760.07
单位质量响应值RSD%判断
33997.0733932.780.14数据可信
供试品溶液-23120101批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1208087-20808761.11255.5013.5561.1155.5013.54
2210305-21030561.76461.76
3146233-14623342.94742.95
4205080-20508060.22960.23
5170389-17038950.04150.04
6193726-19372656.89556.89
10min1299949-29994988.09186.793.6588.2786.963.66
2308191-30819190.51190.70
3289487-28948785.01885.15
4306500-30650090.01590.20
5284882-28488283.66683.82
6284167-28416783.45683.63
15min1317834-31783493.34392.841.1093.7993.261.10
2315634-31563492.69793.15
3316330-31633092.90293.29
4318630-31863093.57794.03
5318714-31871493.60294.00
6309518-30951890.90191.32
20min1318420-31842093.51593.971.0694.2494.681.03
2317688-31768893.30094.04
3319691-31969193.88994.55
4317880-31788093.35794.09
5326627-32662795.92696.61
6319548-31954893.84794.54
30min1318846-31884693.64094.721.5594.6595.711.51
2320290-32029094.06595.08
3325779-32577995.67796.62
4316704-31670493.01194.02
5330326-33032697.01297.98
6323189-32318994.91695.89
45min1320625-32062594.16394.771.5895.4596.041.54
2319675-31967593.88495.18
3325627-32562795.63296.86
4316054-31605492.82194.11
5330607-33060797.09598.36
6323550-32355095.02296.28
60min1323061-32306194.87895.001.4996.4596.561.45
2320765-32076594.20495.78
3326968-32696896.02697.54
4316299-31629992.89294.46
5330140-33014096.95798.51
6323695-32369595.06596.61
极限1331075-33107597.23297.020.6999.0998.860.68
2331315-33131597.30299.16
3332344-33234497.60599.41
4328546-32854696.48998.34
5332159-33215997.55099.39
6326632-32663295.92797.76
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.553238223251523263683273723265023258430.43
29.583251173251163251160.01
单位质量响应值RSD%判断
34119.6933936.950.38数据可信
供试品溶液-23120102批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1177051-17705151.90153.9910.6151.9053.9910.61
2209449-20944961.39861.40
3174093-17409351.03451.03
4154583-15458345.31545.31
5196884-19688457.71557.71
6193098-19309856.60556.60
10min1309251-30925190.65487.514.8590.8187.674.86
2315797-31579792.57392.76
3298634-29863487.54287.69
4276786-27678681.13781.27
5303776-30377689.04989.22
6286961-28696184.12084.29
15min1323298-32329894.77293.352.1295.2093.782.13
2325684-32568495.47195.93
3322789-32278994.62295.04
4308175-30817590.33990.72
5317277-31727793.00793.45
6313500-31350091.89992.32
20min1321539-32153994.25693.611.5794.9794.311.59
2324866-32486695.23195.98
3323114-32311494.71895.42
4311000-31100091.16791.82
5317318-31731893.01993.74
6318119-31811993.25493.95
30min1321612-32161294.27793.681.4495.2794.661.46
2323606-32360694.86295.90
3323249-32324994.75795.74
4311232-31123291.23592.16
5318428-31842893.34494.34
6319279-31927993.59494.57
45min1319949-31994993.79093.621.3995.0794.891.41
2324043-32404394.99096.31
3322159-32215994.43895.71
4311339-31133991.26692.46
5318000-31800093.21994.50
6320716-32071694.01595.27
60min1319780-31978093.74093.391.2795.3094.941.29
2322402-32240294.50996.11
3321340-32134094.19895.75
4311015-31101591.17192.64
5318070-31807093.23994.80
6318851-31885193.46895.01
极限1336517-33651798.64798.530.63100.49100.360.64
2337237-33723798.858100.74
3336409-33640998.615100.45
4333580-33358097.78699.53
5333842-33384297.86399.70
6339126-33912699.412101.23
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