非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.997065870395703637041770507704680.17
211.117156271854717080.29
单位质量响应值RSD%判断
6412.016454.370.47数据可信
供试品溶液-1批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117770-1777024.78320.6723.7924.7820.6723.79
210297-1029714.36114.36
317373-1737324.23024.23
418426-1842625.69825.70
513774-1377419.21019.21
611299-1129915.75815.76
10min137598-3759852.43748.289.2552.4848.319.26
230214-3021442.13942.16
337231-3723151.92551.97
437414-3741452.18052.22
532266-3226645.00145.03
632965-3296545.97546.00
15min146112-4611264.31161.584.4564.4461.694.47
241501-4150157.88057.97
345626-4562663.63363.76
445880-4588063.98864.12
543131-4313160.15460.26
642659-4265959.49559.60
20min150328-5032870.19169.151.9670.4369.371.98
248729-4872967.96168.15
350571-5057170.53070.76
450420-5042070.31970.56
549094-4909468.47068.68
648362-4836267.44967.65
30min154990-5499076.69376.761.4277.0577.101.43
255231-5523177.02977.33
355196-5519676.98077.33
456325-5632578.55578.91
554410-5441075.88476.21
654091-5409175.43975.75
45min158531-5853181.63281.730.9482.1182.190.94
259399-5939982.84283.27
358659-5865981.81082.29
458984-5898482.26382.75
558132-5813281.07581.52
657898-5789880.74981.19
60min161001-6100185.07684.640.9785.6985.230.97
261557-6155785.85286.42
360684-6068484.63485.25
460794-6079484.78885.41
559956-5995683.61984.20
660125-6012583.85584.43
极限161982-6198286.44586.600.6887.2087.340.67
262829-6282987.62688.34
362013-6201386.48887.24
462270-6227086.84687.61
561602-6160285.91586.64
661868-6186886.28687.00
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.055330555334505332895324175333675331160.08
211.215479925482635481280.04
单位质量响应值RSD%判断
48245.7948896.340.95数据可信
供试品溶液-1批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1164117-16411730.38125.4423.4430.3825.4423.45
295133-9513317.61117.61
3161935-16193529.97729.98
4169541-16954131.38531.39
5126959-12695923.50223.50
6106764-10676419.76419.76
10min1307935-30793557.00452.648.3457.0652.688.36
2253186-25318646.86946.90
3304180-30418056.30956.36
4303887-30388756.25556.31
5267611-26761149.54049.58
6269221-26922149.83849.87
15min1359210-35921066.49664.233.7366.6464.363.75
2329095-32909560.92261.03
3356396-35639665.97566.12
4359211-35921166.49766.64
5339387-33938762.82762.95
6338503-33850362.66362.78
20min1384867-38486771.24670.291.5571.5070.531.57
2376092-37609269.62269.83
3383072-38307270.91471.17
4386768-38676871.59871.85
5373885-37388569.21369.44
6373610-37361069.16269.38
30min1412562-41256276.37376.381.0776.7576.731.08
2415542-41554276.92577.25
3414940-41494076.81377.19
4417782-41778277.33977.72
5407258-40725875.39175.73
6407424-40742475.42275.76
45min1439544-43954481.36881.540.9781.8782.020.97
2445636-44563682.49582.95
3440511-44051181.54782.05
4445219-44521982.41882.92
5435728-43572880.66181.13
6436183-43618380.74681.21
60min1456368-45636884.48284.560.9385.1285.180.93
2461411-46141185.41686.01
3456928-45692884.58685.22
4461396-46139685.41386.06
5450499-45049983.39684.00
6454164-45416484.07484.67
极限1465580-46558086.18786.981.1086.9787.741.08
2475072-47507287.94588.68
3467368-46736886.51887.30
4473926-47392687.73288.52
5463045-46304585.71886.46
6474063-47406387.75888.49
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.997101170769709527082970723708570.18
211.117282072731727760.09
单位质量响应值RSD%判断
6447.416550.501.13数据可信
供试品溶液-2批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116947-1694723.39822.6913.6623.4022.6913.67
218063-1806324.93824.94
315867-1586721.90621.91
416111-1611122.24322.24
519046-1904626.29626.30
612560-1256017.34117.34
10min136764-3676450.75849.846.0250.8049.886.03
237744-3774452.11152.15
335741-3574149.34549.38
436305-3630550.12450.16
538024-3802452.49752.54
632033-3203344.22644.25
15min145179-4517962.37661.533.2662.5061.653.27
245769-4576963.19063.32
344109-4410960.89861.02
444770-4477061.81161.93
545691-4569163.08263.21
641884-4188457.82657.93
20min149573-4957368.44267.761.7368.6767.981.75
249826-4982668.79169.03
348804-4880467.38067.60
449271-4927168.02568.25
549484-4948468.31968.56
647497-4749765.57665.77
30min154131-5413174.73574.600.7575.0874.940.76
254330-5433075.01075.36
354102-5410274.69575.03
454256-5425674.90875.24
554145-5414574.75475.10
653229-5322973.49073.80
45min157684-5768479.64079.900.2980.1180.360.29
258082-5808280.19080.66
357956-5795680.01680.47
457950-5795080.00880.47
557875-5787579.90480.38
657676-5767679.62980.06
60min159734-5973482.47182.791.4083.0783.391.40
261543-6154384.96885.58
359656-5965682.36382.95
459775-5977582.52783.12
560030-6003082.87983.49
659067-5906781.55082.11
极限160982-6098284.19484.270.7284.9385.000.72
261788-6178885.30786.06
360691-6069183.79284.52
460703-6070383.80984.54
560750-6075083.87384.62
661312-6131284.64985.35
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.055410135384625403845361675361345384320.43
211.215569225569785569500.01
单位质量响应值RSD%判断
48726.8849683.321.38数据可信
供试品溶液-2批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159675-15967529.17928.7612.0829.1828.7612.08
2175109-17510932.00032.00
3154711-15471128.27228.27
4154075-15407528.15628.16
5176565-17656532.26632.27
6124231-12423122.70222.70
10min1307025-30702556.10655.794.9256.1655.834.93
2320023-32002358.48258.54
3305500-30550055.82855.87
4305774-30577455.87855.92
5316112-31611257.76757.82
6277201-27720150.65650.69
15min1358835-35883565.57464.743.3865.7264.893.38
2367055-36705567.07667.23
3335889-33588961.38161.52
4358957-35895765.59765.74
5361570-36157066.07466.22
6343469-34346962.76662.89
20min1391629-39162971.56770.661.3471.8270.901.35
2391194-39119471.48871.75
3387165-38716570.75170.99
4386359-38635970.60470.85
5386233-38623370.58170.84
6377282-37728268.94569.17
30min1412869-41286975.44976.101.2275.8276.461.22
2425773-42577377.80778.19
3417816-41781676.35376.71
4416301-41630176.07676.44
5413350-41335075.53775.91
6412390-41239075.36175.70
45min1436244-43624479.72080.751.2880.2281.241.27
2441886-44188680.75181.26
3451794-45179482.56283.05
4444147-44414781.16481.66
5437804-43780480.00580.51
6439446-43944680.30580.77
60min1452457-45245782.68382.800.7283.3183.430.72
2456593-45659383.43984.08
3456476-45647683.41784.04
4453241-45324182.82683.46
5447877-44787781.84682.48
6451984-45198482.59783.20
极限1461943-46194384.41684.630.4285.1885.400.41
2465307-46530785.03185.82
3465072-46507284.98885.75
4461741-46174184.38085.15
5460764-46076484.20184.97
6463958-46395884.78585.52
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.997227172355724517251072488724150.14
211.117208971776719320.31
单位质量响应值RSD%判断
6589.176474.531.25数据可信
供试品溶液-1批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122930-2293031.49927.5718.9931.5027.5718.99
224323-2432333.41233.41
318018-1801824.75124.75
422136-2213630.40830.41
518983-1898326.07726.08
614016-1401619.25419.25
10min142860-4286058.87753.288.1058.9353.328.11
240845-4084556.10956.16
338014-3801452.22052.26
438907-3890753.44653.50
538554-3855452.96253.01
633515-3351546.03946.07
15min147447-4744765.17863.483.2965.3363.613.30
246997-4699764.56064.71
346519-4651963.90364.03
446366-4636663.69363.83
546717-4671764.17564.31
643216-4321659.36659.47
20min152007-5200771.44269.372.7771.7069.612.78
251407-5140770.61870.87
350453-5045369.30769.54
450267-5026769.05269.30
550891-5089169.90970.15
647964-4796465.88866.10
30min155719-5571976.54175.481.2376.9275.831.24
254978-5497875.52375.90
355399-5539976.10276.45
454168-5416874.41074.77
555309-5530975.97876.33
654086-5408674.29874.62
45min159375-5937581.56380.510.8982.0780.990.90
258296-5829680.08180.58
359157-5915781.26481.74
458186-5818679.93080.42
558370-5837080.18380.66
658247-5824780.01480.46
60min161363-6136384.29482.781.2984.9483.401.29
259839-5983982.20182.83
360542-6054283.16683.78
459077-5907781.15481.77
560597-6059783.24283.86
660164-6016482.64783.22
极限161937-6193785.08384.521.2285.8785.281.20
261193-6119384.06184.83
361762-6176284.84285.59
460157-6015782.63883.39
561978-6197885.13985.89
662145-6214585.36886.08
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.055579925565255565165574785563685569760.13
211.215559835546185553000.18
单位质量响应值RSD%判断
50405.0749536.131.23数据可信
供试品溶液-1批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1205519-20551936.98133.0017.0836.9833.0017.09
2218113-21811339.24739.25
3166127-16612729.89329.89
4201065-20106536.18036.18
5176541-17654131.76731.77
6132881-13288123.91123.91
10min1322910-32291058.10456.184.2658.1756.234.28
2328443-32844359.10059.17
3307383-30738355.31055.36
4313278-31327856.37156.43
5310841-31084155.93355.99
6290328-29032852.24152.28
15min1364030-36403065.50364.202.9065.6664.352.91
2365646-36564665.79465.96
3358194-35819464.45364.60
4356998-35699864.23864.39
5358958-35895864.59164.74
6336899-33689960.62160.75
20min1389065-38906570.00868.861.9570.2869.111.97
2389765-38976570.13470.41
3384313-38431369.15369.40
4380926-38092668.54468.80
5382766-38276668.87569.13
6369207-36920766.43566.66
30min1416493-41649374.94474.310.9475.3374.680.95
2417444-41744475.11575.51
3415179-41517974.70775.07
4408641-40864173.53173.91
5410924-41092473.94174.31
6409254-40925473.64173.98
45min1442982-44298279.71079.070.9980.2279.570.98
2441222-44122279.39379.91
3440610-44061079.28379.77
4433255-43325577.96078.46
5434987-43498778.27178.76
6443654-44365479.83180.29
60min1455775-45577582.01281.720.7782.6582.350.76
2456107-45610782.07282.72
3456738-45673882.18582.81
4447692-44769280.55781.19
5452760-45276081.46982.09
6455900-45590082.03482.63
极限1466481-46648183.93883.410.7484.7284.170.73
2463720-46372083.44284.23
3465278-46527883.72284.48
4457488-45748882.32083.08
5461963-46196383.12583.88
6466182-46618283.88584.62
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