依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.459638419631409616369612949612589622340.13
211.419794029777529785770.12
单位质量响应值RSD%判断
84037.9085764.861.44数据可信
供试品溶液-24053101批-依折麦布-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148536-485365.1294.2124.475.134.2124.44
244687-446874.7224.72
327877-278772.9462.95
431074-310743.2833.28
551488-514885.4415.44
635357-353573.7363.74
10min168248-682487.2127.132.697.277.182.82
268562-685627.2457.30
366534-665347.0307.06
464497-644976.8156.85
569666-696667.3617.42
667353-673537.1177.16
15min170759-707597.4777.561.957.617.691.90
272392-723927.6497.78
373387-733877.7557.87
471849-718497.5927.70
571787-717877.5857.73
669343-693437.3277.45
20min169130-691307.3057.503.687.527.713.46
269471-694717.3417.56
372416-724167.6527.85
475737-757378.0038.20
569337-693377.3277.55
670020-700207.3997.60
30min170043-700437.4017.9812.037.708.2711.55
270001-700017.3977.70
383473-834738.8209.10
490281-902819.5409.83
569900-699007.3867.69
669280-692807.3217.60
45min171788-717887.5868.6913.807.979.0713.25
287245-872459.2199.60
397293-9729310.28110.66
491609-916099.68010.07
574924-749247.9178.31
670375-703757.4367.80
60min174049-740497.8249.2813.728.299.7613.15
276283-762838.0618.54
398112-9811210.36710.86
494490-944909.98410.48
5102445-10244510.82511.30
681625-816258.6259.07
极限192103-921039.73213.4115.3810.2914.0014.82
2115510-11551012.20612.78
3135702-13570214.33914.95
4136722-13672214.44715.06
5140041-14004114.79815.40
6141634-14163414.96615.51
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.459791259784169771519757109719029764610.30
211.419892409874399883400.13
单位质量响应值RSD%判断
85280.4486620.511.11数据可信
供试品溶液-24053101批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1416489-41648943.47053.2816.5043.4753.2816.50
2427769-42776944.64744.65
3634329-63432966.20666.21
4492251-49225151.37751.38
5517982-51798254.06354.06
6573983-57398359.90859.91
10min1705778-70577873.66475.0816.6474.1575.6716.61
2566346-56634659.11159.61
3877237-87723791.55992.29
4601145-60114562.74363.31
5760354-76035479.36079.96
6805309-80530984.05284.72
15min1883669-88366992.23188.3112.0193.5389.7412.02
2697005-69700572.74873.90
3907768-90776894.74696.50
4742957-74295777.54478.81
5893433-89343393.25094.73
6952054-95205499.368100.97
20min1888588-88858892.74491.348.6495.0793.758.73
2780538-78053881.46783.43
3903147-90314794.26397.07
4785002-78500281.93284.06
5935906-93590697.683100.20
6957812-95781299.969102.67
30min1920407-92040796.06593.945.1299.4297.375.28
2861712-86171289.93992.81
3906208-90620894.58398.44
4835097-83509787.16190.20
5911323-91132395.11798.72
6965782-965782100.801104.62
45min1895828-89582893.50093.703.1297.9298.173.30
2895765-89576593.49397.36
3896970-89697093.61998.52
4854770-85477089.21493.22
5900487-90048793.98698.65
6942879-94287998.410103.34
60min1898918-89891893.82293.343.4399.2998.853.47
2905694-90569494.52999.43
3875581-87558191.38697.33
4851853-85185388.91093.91
5890742-89074292.96998.67
6943024-94302498.426104.45
极限1931122-93112297.18396.932.94103.69103.473.00
2943051-94305198.428104.38
3913984-91398495.395102.35
4889084-88908492.79698.78
5925047-92504796.549103.29
6969926-969926101.233108.35
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.459853609838479809819761839695609791860.66
211.419936589922919929740.10
单位质量响应值RSD%判断
85518.4387026.641.24数据可信
供试品溶液-24052301批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1688735-68873571.61871.907.7671.6271.907.76
2697137-69713772.49172.49
3744967-74496777.46577.46
4590004-59000461.35161.35
5723127-72312775.19475.19
6705009-70500973.31073.31
10min1908431-90843194.46391.018.7495.2691.808.70
2931515-93151596.86397.67
3958834-95883499.704100.56
4777064-77706480.80281.48
5785300-78530081.65982.49
6889984-88998492.54493.36
15min1909406-90940694.56496.282.5696.4198.092.63
2938019-93801997.53999.42
3956458-95645899.457101.43
4888764-88876492.41794.00
5932769-93276996.99398.74
6930077-93007796.71398.56
20min1898744-89874493.45595.272.7096.3598.152.76
2943914-94391498.152101.12
3948805-94880598.661101.73
4887775-88777592.31594.92
5909277-90927794.55097.37
6908691-90869194.49097.41
30min1935829-93582997.31195.762.27101.2599.702.35
2935586-93558697.286101.34
3939838-93983897.728101.90
4885086-88508692.03595.67
5911669-91166994.79998.67
6917631-91763195.41999.39
45min1869417-86941790.40693.692.7595.4298.692.77
2920922-92092295.761100.90
3930471-93047196.754102.01
4874640-87464090.94995.60
5899761-89976193.56198.49
6910679-91067994.69699.72
60min1879518-87951891.45693.822.0997.4899.862.13
2904701-90470194.075100.28
3925556-92555696.243102.57
4885405-88540592.06897.73
5896136-89613693.18499.15
6922012-92201295.875101.95
极限1884359-88435991.95993.642.9899.00100.732.82
2926170-92617096.307103.55
3875207-87520791.00898.41
4884171-88417191.94098.63
5891811-89181192.73499.73
6941434-94143497.894105.04
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