贝派度酸依折麦布片项目信息
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%
111.249878849876259876439870719869719874390.05
211.259844549847579846060.03
单位质量响应值RSD%判断
87850.4487520.530.27数据可信
供试品溶液-1993854批-贝派度酸-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%
5min143268-432684.4304.7710.404.434.7610.36
241366-413664.2354.24
347188-471884.8314.83
455308-553085.6635.66
545155-451554.6234.62
646968-469684.8094.81
10min165273-652736.6836.832.216.736.882.23
265030-650306.6586.71
366724-667246.8316.89
468669-686697.0317.09
568088-680886.9717.02
666272-662726.7856.84
15min170128-701287.1807.131.307.307.261.35
268991-689917.0647.18
369010-690107.0657.20
471080-710807.2777.42
568704-687047.0347.16
669836-698367.1507.28
20min170222-702227.1907.231.057.397.441.12
269526-695267.1187.32
370458-704587.2147.42
471235-712357.2937.52
571584-715847.3297.54
670883-708837.2577.47
30min173275-732757.5027.401.197.797.691.16
271802-718027.3517.63
371584-715847.3297.62
472953-729537.4697.77
572988-729887.4737.76
671283-712837.2987.59
45min173344-733447.5097.412.097.887.782.02
272060-720607.3787.74
370321-703217.2007.57
473251-732517.5007.89
574145-741457.5917.96
670880-708807.2577.63
60min171724-717247.3437.351.537.797.801.52
272031-720317.3757.82
370847-708477.2547.70
472832-728327.4577.93
573002-730027.4747.93
670202-702027.1887.64
极限172429-724297.4167.391.237.957.931.23
272508-725087.4247.95
371994-719947.3717.90
472931-729317.4678.02
572889-728897.4638.00
670550-705507.2237.75
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.122549452554952553982554262555202553570.10
210.162552782561552557160.25
单位质量响应值RSD%判断
25232.9125168.900.18数据可信
供试品溶液-1993854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%
5min165127-6512725.77129.9210.8325.7729.9210.84
271972-7197228.47928.48
377924-7792430.83530.83
485967-8596734.01734.02
569323-6932327.43127.43
683344-8334432.97932.98
10min1133065-13306552.65454.203.1452.9454.543.17
2132404-13240452.39252.71
3142950-14295056.56556.91
4140796-14079655.71356.09
5134763-13476353.32653.63
6137892-13789254.56454.93
15min1168553-16855366.69766.731.6767.5767.671.70
2164749-16474965.19166.09
3172575-17257568.28869.26
4170384-17038467.42168.42
5166368-16636865.83266.73
6169233-16923366.96667.94
20min1187122-18712274.04473.971.8075.6675.641.82
2181625-18162571.86973.49
3191617-19161775.82377.55
4187887-18788774.34776.09
5185091-18509173.24174.87
6188243-18824374.48876.20
30min1213552-21355284.50383.241.5086.9485.741.50
2204929-20492981.09183.51
3213050-21305084.30486.88
4211272-21127283.60086.17
5209196-20919682.77985.22
6210144-21014483.15485.70
45min1227414-22741489.98888.271.5593.3691.691.51
2217441-21744186.04289.36
3224073-22407388.66692.17
4222141-22214187.90191.40
5225431-22543189.20392.57
6221938-22193887.82191.29
60min1230187-23018791.08589.821.6495.4694.221.62
2220476-22047687.24391.52
3230682-23068291.28195.78
4226599-22659989.66594.14
5228188-22818890.29494.65
6225806-22580689.35293.80
极限1240135-24013595.02292.881.85100.4198.291.77
2231475-23147591.59596.84
3239237-23923794.666100.17
4229630-22963090.86596.34
5235780-23578093.29898.66
6232154-23215491.86497.30
贝派度酸依折麦布片项目信息
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%
111.249843739843429843899848909844649844920.03
211.259840979838469839720.02
单位质量响应值RSD%判断
87588.2687464.180.11数据可信
供试品溶液-1993854批-贝派度酸-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145733-457334.6915.199.444.695.199.40
254926-549265.6345.63
357551-575515.9035.90
451212-512125.2535.25
547385-473854.8604.86
647051-470514.8264.83
10min166582-665826.8296.817.436.886.877.42
269646-696467.1447.21
372087-720877.3947.46
466968-669686.8696.93
565732-657326.7426.80
657581-575815.9065.96
15min171814-718147.3667.381.877.497.521.94
272413-724137.4277.57
373904-739047.5807.73
471720-717207.3567.49
569744-697447.1547.28
672246-722467.4107.53
20min172903-729037.4787.611.467.697.821.52
275390-753907.7337.96
374874-748747.6807.91
474882-748827.6817.90
572855-728557.4737.68
674185-741857.6097.81
30min176384-763847.8357.761.548.138.061.39
274442-744427.6357.95
375032-750327.6968.01
475706-757067.7658.07
574732-747327.6657.96
677513-775137.9508.24
45min177595-775957.9597.871.288.348.261.18
276162-761627.8128.21
376680-766807.8658.27
475748-757487.7698.16
578196-781968.0218.40
675975-759757.7938.17
60min179612-796128.1668.041.548.638.521.39
276744-767447.8728.35
378391-783918.0418.53
478031-780318.0048.48
577808-778087.9818.45
679990-799908.2058.67
极限180074-800748.2138.022.078.778.591.93
277125-771257.9118.48
379274-792748.1318.71
475937-759377.7898.35
577536-775367.9538.51
679486-794868.1538.71
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.122548632549052550182550642552112550120.06
210.162551692549722550700.06
单位质量响应值RSD%判断
25198.8125105.310.27数据可信
供试品溶液-1993854批-依折麦布-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12922-29221.1581.1353.121.161.1353.07
24492-44921.7811.78
33173-31731.2581.26
42947-29471.1681.17
5-0.0000.00
63590-35901.4231.42
10min13892-38921.5431.6712.131.561.6812.25
25199-51992.0612.08
34283-42831.6981.71
43895-38951.5441.56
53865-38651.5321.53
64153-41531.6471.66
15min14984-49841.9762.125.682.012.155.85
25767-57672.2862.33
35311-53112.1062.14
45389-53892.1372.17
55045-50452.0002.02
65590-55902.2162.25
20min15730-57302.2722.414.402.322.464.63
26488-64882.5722.64
36075-60752.4092.46
46206-62062.4602.51
55851-58512.3202.36
66099-60992.4182.48
30min16945-69452.7532.801.842.832.881.74
26912-69122.7402.84
37087-70872.8102.89
47052-70522.7962.88
57139-71392.8302.90
67265-72652.8802.97
45min18056-80563.1943.103.423.303.213.08
27860-78603.1163.24
37455-74552.9563.07
47803-78033.0943.21
58138-81383.2263.32
67564-75642.9993.12
60min18468-84683.3573.322.083.503.461.98
28351-83513.3113.47
38098-80983.2113.36
48257-82573.2743.42
58404-84043.3323.46
68602-86023.4103.56
极限19079-90793.6003.521.863.783.701.81
29056-90563.5903.79
38748-87483.4683.65
48767-87673.4763.66
58882-88823.5213.69
68694-86943.4473.64
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