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%
111.365613325617285623565621095632045621460.13
211.485661695664415663050.04
单位质量响应值RSD%判断
49484.6849329.700.23数据可信
供试品溶液-24032001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%
5min115824-158242.8733.4127.182.873.4127.13
219200-192003.4863.49
323008-230084.1774.18
422602-226024.1044.10
522054-220544.0044.00
69947-99471.8061.81
10min139739-397397.2157.387.227.257.417.31
241928-419287.6127.65
342835-428357.7777.82
441488-414887.5337.58
542654-426547.7447.79
635078-350786.3696.39
15min142448-424487.7077.781.657.827.901.85
243191-431917.8427.97
343065-430657.8197.95
443177-431777.8397.97
543562-435627.9098.04
641604-416047.5547.64
20min143098-430987.8257.791.378.027.991.38
243722-437227.9388.15
342151-421517.6537.87
442503-425037.7177.93
543310-433107.8638.08
642573-425737.7307.90
30min139970-399707.2577.758.937.548.048.63
250179-501799.1109.41
340162-401627.2927.60
442629-426297.7408.04
541160-411607.4737.78
642086-420867.6417.90
45min140430-404307.3408.7120.447.719.0919.73
263680-6368011.56211.96
341291-412917.4977.88
456893-5689310.32910.72
543152-431527.8358.22
642508-425087.7188.06
60min140529-405297.3589.6124.817.8110.0923.95
274474-7447413.52114.05
344284-442848.0408.51
463169-6316911.46911.97
549347-493478.9599.44
645740-457408.3058.74
极限142395-423957.69711.0427.828.2311.6226.90
285382-8538215.50216.18
345763-457638.3098.87
473996-7399613.43514.06
564752-6475211.75612.33
652402-524029.51410.04
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%
110.011435171436841436131437881439951437190.13
210.041447681447161447420.03
单位质量响应值RSD%判断
14357.5414416.530.29数据可信
供试品溶液-24032001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%
5min121737-2173715.06619.2626.0915.0719.2626.10
230328-3032821.02121.02
335078-3507824.31424.31
433177-3317722.99623.00
530139-3013920.89020.89
616295-1629511.29511.29
10min175086-7508652.04458.1412.9752.2158.3613.02
288820-8882061.56461.80
396162-9616266.65266.92
489010-8901061.69561.95
587623-8762360.73460.97
666595-6659546.15946.28
15min1110435-11043576.54580.143.3677.2981.003.48
2119615-11961582.90883.83
3118481-11848182.12283.13
4118123-11812381.87482.82
5115652-11565280.16281.07
6111398-11139877.21377.85
20min1123904-12390485.88188.642.3687.4890.392.30
2131719-13171991.29893.14
3126815-12681587.89989.82
4126575-12657587.73389.58
5127049-12704988.06189.86
6131232-13123290.96092.46
30min1126483-12648387.66993.205.2090.2295.945.01
2137727-13772795.46298.32
3131108-13110890.87493.77
4132771-13277192.02794.85
5132005-13200591.49694.27
6146697-146697101.680104.19
45min1132355-13235591.73996.255.3295.26100.025.11
2142969-14296999.096103.01
3134704-13470493.36797.28
4136210-13621094.41198.26
5134947-13494793.53597.33
6152025-152025105.373109.01
60min1131678-13167891.27096.645.7495.81101.485.51
2142710-14271098.916103.93
3134912-13491293.51198.46
4137215-13721595.107100.00
5136096-13609694.33299.16
6153988-153988106.733111.54
极限1132707-13270791.98396.525.6097.54102.445.38
2142386-14238698.692104.81
3134592-13459293.28999.28
4136435-13643594.567100.52
5135705-13570594.06199.94
6153707-153707106.538112.53
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%
111.365741215740075741655734175736365738690.06
211.485903525896415899960.09
单位质量响应值RSD%判断
50516.6451393.381.22数据可信
供试品溶液-24032001批-依折麦布-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1198832-19883235.00639.4823.5535.0139.4823.55
2195750-19575034.46334.46
3217552-21755238.30138.30
4257869-25786945.40045.40
5311745-31174554.88554.88
6163781-16378128.83528.83
10min1230562-23056240.59254.4824.9540.9854.9224.93
2269405-26940547.43147.81
3330831-33083158.24558.67
4366989-36698964.61165.12
5422779-42277974.43375.04
6236265-23626541.59641.92
15min1343161-34316160.41679.7620.5161.2680.8120.54
2403303-40330371.00471.91
3507716-50771689.38790.46
4518041-51804191.20592.43
5574576-574576101.158102.59
6371572-37157265.41866.20
20min1436439-43643976.83893.7815.3478.3595.7115.47
2482372-48237284.92586.62
3583848-583848102.790104.86
4594197-594197104.612106.85
5635004-635004111.797114.36
6464103-46410381.70883.22
30min1449306-44930679.10397.1913.3481.47100.1613.52
2524433-52443392.33094.97
3595805-595805104.895108.10
4607968-607968107.037110.43
5639011-639011112.502116.31
6495573-49557387.24989.67
45min1461217-46121781.20097.3112.9784.44101.3613.16
2520123-52012391.57195.24
3593097-593097104.419108.79
4620894-620894109.312113.90
5630557-630557111.014116.07
6490337-49033786.32789.71
60min1461444-46144481.24097.5212.6885.39102.6512.87
2520355-52035591.61296.30
3584219-584219102.856108.39
4622404-622404109.578115.38
5634468-634468111.702117.99
6500418-50041888.10292.45
极限1450700-45070079.34996.4112.8184.40102.6212.99
2516179-51617990.87796.58
3578729-578729101.889108.57
4619368-619368109.044116.06
5622545-622545109.603117.13
6498065-49806587.68893.01
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%
110.011468471468041467291465471466141467080.09
210.041509581506311507940.16
单位质量响应值RSD%判断
14656.1415019.321.74数据可信
供试品溶液-24032001批-贝派度酸-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15346-53463.5935.0833.053.595.0833.07
26649-66494.4694.47
37057-70574.7444.74
49042-90426.0786.08
511831-118317.9527.95
65388-53883.6223.62
10min123422-2342215.74418.3920.5015.7818.4420.52
225945-2594517.43917.49
330583-3058320.55720.61
431030-3103020.85720.92
534144-3414422.95123.04
619006-1900612.77512.82
15min146319-4631931.13434.0415.2131.3534.3015.25
248984-4898432.92633.17
357572-5757238.69838.98
454014-5401436.30736.61
558643-5864339.41839.76
638336-3833625.76825.95
20min169349-6934946.61446.7311.1847.1847.3611.24
267959-6795945.68046.29
377270-7727051.93952.65
471497-7149748.05848.76
575576-7557650.80051.58
655433-5543337.26037.73
30min192769-9276962.35760.958.9563.4462.119.01
292508-9250862.18163.30
398942-9894266.50667.79
490328-9032860.71661.95
594325-9432563.40364.75
675210-7521050.55451.44
45min1114220-11422076.77572.538.2678.5574.368.30
2109630-10963073.69075.50
3115663-11566377.74579.77
4107485-10748572.24874.16
5109572-10957273.65175.70
690847-9084761.06562.51
60min1126332-12633284.91779.646.8387.5482.286.89
2120550-12055081.03083.66
3124193-12419383.47986.37
4116357-11635778.21280.93
5119845-11984580.55683.42
6103580-10358069.62371.75
极限1132572-13257289.11184.045.9192.6887.565.98
2128385-12838586.29789.82
3130328-13032887.60391.42
4122813-12281382.55186.13
5124086-12408683.40787.17
6111971-11197175.26478.16
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