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%
110.903543835472354083544035483354480.09
210.993648536437364610.10
单位质量响应值RSD%判断
3252.113317.651.42数据可信
供试品溶液-6042701批-多替诺雷-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%
5min17425-742520.28217.8910.0820.2817.8810.08
26554-655417.90317.90
36379-637917.42517.42
45429-542914.83014.83
56902-690218.85418.85
66602-660218.03418.03
10min113645-1364537.27335.913.1937.3135.943.20
213010-1301035.53835.57
313076-1307635.71835.75
412537-1253734.24634.27
512996-1299635.50035.53
613606-1360637.16637.20
15min116755-1675545.76844.832.3245.8644.922.32
216249-1624944.38644.47
316380-1638044.74444.83
415824-1582443.22543.31
516363-1636344.69744.79
616891-1689146.14046.23
20min119129-1912952.25350.732.8552.4350.892.85
218347-1834750.11750.28
318374-1837450.19050.35
418005-1800549.18349.34
518242-1824249.83049.99
619324-1932452.78652.95
30min121471-2147158.65057.912.1258.9158.162.13
220983-2098357.31757.56
321165-2116557.81458.06
420670-2067056.46256.70
520967-2096757.27457.52
621943-2194359.94060.20
45min123999-2399965.55664.901.9965.9165.251.99
223399-2339963.91764.26
323764-2376464.91465.26
423318-2331863.69664.03
523507-2350764.21264.56
624573-2457367.12467.48
60min125581-2558169.87769.461.8070.3469.921.80
225220-2522068.89169.34
325493-2549369.63770.09
424991-2499168.26668.70
525059-2505968.45168.90
626231-2623171.65372.12
90min127706-2770675.68275.122.0476.2675.692.04
227259-2725974.46175.02
327453-2745374.99175.56
427221-2722174.35774.91
526870-2687073.39873.96
628494-2849477.83478.42
120min129134-2913479.58378.922.1280.2979.622.12
228512-2851277.88378.57
329256-2925679.91680.61
428463-2846377.75078.42
528180-2818076.97777.66
629809-2980981.42682.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限129429-2942980.38879.721.9381.2380.551.93
228922-2892279.00379.82
329344-2934480.15680.98
428819-2881978.72279.53
528501-2850177.85378.67
630096-3009682.21083.06
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%
110.862657482658122658502667582663802661100.17
211.102758392759362758880.03
单位质量响应值RSD%判断
24503.6824854.771.01数据可信
供试品溶液-6042701批-非布司他-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%
5min138971-3897114.19812.828.8814.2012.828.86
235393-3539312.89512.89
334656-3465612.62612.63
429548-2954810.76510.77
536178-3617813.18113.18
636316-3631613.23113.23
10min162382-6238222.72822.212.8522.7522.232.85
260957-6095722.20922.23
361233-6123322.30922.33
458484-5848421.30821.33
559539-5953921.69221.71
663142-6314223.00523.03
15min172607-7260726.45326.855.7726.5126.915.76
281775-8177529.79329.85
372597-7259726.44926.51
470526-7052625.69525.75
570239-7023925.59025.65
674427-7442727.11627.18
20min178444-7844428.58028.521.6828.6928.621.69
278138-7813828.46828.58
377943-7794328.39728.50
477336-7733628.17628.27
577079-7707928.08228.18
680752-8075229.42129.53
30min185418-8541831.12131.331.3731.2731.481.37
285862-8586231.28231.44
386607-8660731.55431.70
484973-8497330.95831.10
585040-8504030.98331.13
688038-8803832.07532.23
45min191623-9162333.38133.751.7633.5933.951.75
291385-9138533.29533.50
392491-9249133.69833.90
491074-9107433.18133.38
594131-9413134.29534.49
695078-9507834.64034.85
60min194566-9456634.45434.981.2934.7135.241.29
296120-9612035.02035.28
396770-9677035.25635.51
495078-9507834.64034.89
595525-9552534.80335.06
697962-9796235.69135.96
90min198786-9878635.99136.371.4236.3136.681.42
298961-9896136.05536.38
3100563-10056336.63836.96
499815-9981536.36636.67
598509-9850935.89036.20
6102248-10224837.25237.58
120min1102060-10206037.18437.250.8237.5637.620.83
2102431-10243137.31937.70
3102301-10230137.27237.65
4101504-10150436.98137.35
5101399-10139936.94337.32
6103710-10371037.78538.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1102232-10223237.24637.450.6037.6937.890.60
2103239-10323937.61338.06
3103525-10352537.71838.16
4102447-10244737.32537.75
5102052-10205237.18137.62
6103178-10317837.59138.04
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%
110.903626136355364673644436439363930.24
210.993733437315373240.04
单位质量响应值RSD%判断
3338.813396.181.21数据可信
供试品溶液-6042702批-多替诺雷-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%
5min15630-563015.00115.676.9815.0015.676.99
25432-543214.47414.47
35580-558014.86814.87
46469-646917.23717.24
55913-591315.75515.76
66253-625316.66116.66
10min112366-1236632.94933.011.0632.9733.041.07
212235-1223532.60032.62
312276-1227632.71032.73
412603-1260333.58133.61
512429-1242933.11733.14
612431-1243133.12333.15
15min115687-1568741.79841.880.4941.8841.960.49
215649-1564941.69741.78
315675-1567541.76641.85
415664-1566441.73741.82
515832-1583242.18542.27
615790-1579042.07342.16
20min117783-1778347.38347.560.6547.5347.710.64
217844-1784447.54647.69
317869-1786947.61247.76
417765-1776547.33547.49
518067-1806748.14048.29
617769-1776947.34647.50
30min120600-2060054.88955.081.4455.1255.311.44
220782-2078255.37455.60
320644-2064455.00655.23
420418-2041854.40454.64
521196-2119656.47756.71
620382-2038254.30854.54
45min123209-2320961.84161.871.4362.1662.191.43
223496-2349662.60662.93
323198-2319861.81262.13
422875-2287560.95161.27
523690-2369063.12263.45
622855-2285560.89861.22
60min124852-2485266.21966.241.0866.6466.671.07
224998-2499866.60867.03
324945-2494566.46666.89
424534-2453465.37165.80
525245-2524567.26667.70
624587-2458765.51365.94
90min127048-2704872.07072.051.3372.6072.581.33
227339-2733972.84573.38
327093-2709372.19072.72
426608-2660870.89871.43
527500-2750073.27473.82
626648-2664871.00471.54
120min128351-2835175.54275.451.0476.2076.111.03
228520-2852075.99276.65
328429-2842975.75076.40
427885-2788574.30074.95
528658-2865876.36077.03
628057-2805774.75875.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限128678-2867876.41376.261.1477.1977.041.14
228897-2889776.99777.78
328798-2879876.73377.51
428210-2821075.16675.94
528925-2892577.07177.86
628225-2822575.20675.98
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%
110.862734092733842740552738182739982737330.12
211.102831132827092829110.11
单位质量响应值RSD%判断
25205.6225487.480.79数据可信
供试品溶液-6042702批-非布司他-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%
5min133370-3337011.83712.364.2011.8412.364.20
234042-3404212.07612.08
333488-3348811.87911.88
436192-3619212.83912.84
535021-3502112.42312.42
636891-3689113.08613.09
10min158773-5877320.84920.971.0220.8720.991.03
258660-5866020.80920.83
358576-5857620.77920.80
458971-5897120.91920.94
559726-5972621.18721.21
660014-6001421.28921.31
15min169990-6999024.82824.880.5024.8824.940.51
270280-7028024.93124.99
369859-6985924.78124.84
469870-6987024.78524.84
570109-7010924.87024.93
670785-7078525.11025.17
20min176091-7609126.99227.170.6627.0927.270.66
276264-7626427.05327.15
376339-7633927.08027.18
476531-7653127.14827.25
576885-7688527.27427.37
677461-7746127.47827.58
30min184396-8439629.93830.030.3330.0830.180.32
284991-8499130.14930.29
384503-8450329.97630.12
484365-8436529.92730.07
584863-8486330.10430.25
684847-8484730.09830.24
45min189755-8975531.83932.050.7032.0332.240.70
289933-8993331.90232.09
391158-9115832.33732.53
491049-9104932.29832.49
590417-9041732.07432.27
689799-8979931.85532.05
60min193670-9367033.22833.630.7333.4733.880.73
294709-9470933.59633.84
395823-9582333.99234.24
494984-9498433.69433.94
594903-9490333.66533.91
694730-9473033.60433.85
90min194248-9424833.43334.872.0933.7335.182.08
299216-9921635.19535.50
399188-9918835.18535.49
498935-9893535.09635.40
599929-9992935.44835.75
698325-9832534.87935.18
120min197097-9709734.44435.052.4034.8035.412.38
295886-9588634.01434.37
397052-9705234.42834.79
4101159-10115935.88536.25
5100915-10091535.79836.16
6100673-10067335.71236.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限193824-9382433.28335.303.4833.6935.723.46
2100484-10048435.64536.06
3101964-10196436.17036.59
4102794-10279436.46536.89
5101191-10119135.89636.32
696857-9685734.35834.78
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%
110.903701137095371643717837129371150.18
210.993644536384364140.12
单位质量响应值RSD%判断
3405.053313.381.93数据可信
供试品溶液-6042703批-多替诺雷-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%
5min15814-581415.53113.3120.0815.5313.3120.07
25189-518913.86213.86
34506-450612.03712.04
43605-36059.6309.63
54439-443911.85811.86
66341-634116.93916.94
10min112634-1263433.75031.955.0533.7831.975.06
212045-1204532.17732.20
311930-1193031.87031.89
411238-1123830.02130.04
511308-1130830.20830.23
612599-1259933.65733.69
15min116050-1605042.87641.452.6742.9641.532.68
215687-1568741.90641.98
315530-1553041.48741.56
415210-1521040.63240.70
514888-1488839.77239.84
615742-1574242.05342.14
20min118102-1810248.35847.211.9748.5147.351.98
217764-1776447.45547.60
317635-1763547.11047.25
417638-1763847.11847.25
517054-1705445.55845.69
617833-1783347.63947.79
30min120968-2096856.01455.151.3556.2555.371.35
220700-2070055.29855.52
320516-2051654.80655.03
420847-2084755.69155.90
520176-2017653.89854.11
620658-2065855.18655.42
45min123710-2371063.33962.381.1763.6762.701.17
223358-2335862.39862.72
323187-2318761.94262.25
423639-2363963.14963.45
523026-2302661.51161.81
623191-2319161.95262.28
60min125603-2560368.39666.921.4368.8367.341.43
225160-2516067.21267.63
324852-2485266.38966.80
425235-2523567.41367.82
524593-2459365.69866.10
624865-2486566.42466.85
90min127503-2750373.47172.601.0774.0273.121.07
227403-2740373.20473.74
327021-2702172.18472.71
427372-2737273.12173.64
526783-2678371.54872.06
626969-2696972.04572.58
120min129070-2907077.65776.191.4578.3376.841.45
228639-2863976.50677.16
328246-2824675.45676.10
428915-2891577.24377.89
528156-2815675.21675.85
628102-2810275.07175.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限129119-2911977.78876.751.0578.5977.521.05
228828-2882877.01177.79
328504-2850476.14576.92
429015-2901577.51078.28
528402-2840275.87376.63
628507-2850776.15376.94
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%
110.862814432815862815502816152806302813650.15
211.102782812782032782420.02
单位质量响应值RSD%判断
25908.3825066.852.34数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-6042703批-非布司他-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%
5min131070-3107010.9639.6119.5610.969.6119.55
230479-3047910.75510.75
324580-245808.6738.67
419692-196926.9486.95
523887-238878.4298.43
633667-3366711.88011.88
10min157931-5793120.44119.674.3920.4619.694.41
256573-5657319.96219.98
355494-5549419.58119.60
452437-5243718.50318.51
553481-5348118.87118.89
658636-5863620.69020.71
15min169342-6934224.46823.971.8824.5224.021.89
268868-6886824.30024.35
367569-6756923.84223.89
466677-6667723.52723.57
566268-6626823.38323.43
668812-6881224.28124.33
20min176255-7625526.90726.522.9227.0026.602.93
275663-7566326.69826.79
375019-7501926.47126.56
474133-7413326.15826.24
571636-7163625.27725.36
678171-7817127.58327.68
30min184192-8419229.70829.450.8029.8529.580.82
284229-8422929.72129.86
383308-8330829.39629.53
482802-8280229.21729.34
582688-8268829.17729.30
683542-8354229.47829.62
45min190952-9095232.09331.831.1132.2832.021.09
291179-9117932.17332.36
390750-9075032.02232.20
490017-9001731.76331.94
589919-8991931.72831.90
688465-8846531.21531.41
60min194497-9449733.34432.990.7433.5833.220.75
294109-9410933.20733.45
393503-9350332.99333.23
492806-9280632.74732.97
592990-9299032.81233.04
692987-9298732.81133.05
90min198138-9813834.62934.360.6934.9334.650.70
298260-9826034.67234.97
396825-9682534.16534.45
497066-9706634.25034.53
597138-9713834.27634.56
696750-9675034.13934.44
120min1101374-10137435.77035.031.4336.1235.381.44
2100563-10056335.48435.84
398354-9835434.70535.05
498503-9850334.75735.10
597671-9767134.46434.80
699220-9922035.01035.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限198920-9892034.90435.180.6635.3235.590.64
2100658-10065835.51835.93
3100056-10005635.30535.71
499191-9919135.00035.40
5100003-10000335.28735.68
699390-9939035.07035.48
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