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%
110.907011270244700197032670337702080.20
210.997052770533705300.01
单位质量响应值RSD%判断
6441.106417.650.26数据可信
供试品溶液-6041601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%
5min113517-1351718.86318.0313.4818.8618.0313.48
214649-1464920.44320.44
312126-1212616.92216.92
49918-991813.84013.84
514392-1439220.08420.08
612910-1291018.01618.02
10min124437-2443734.10232.977.0734.1333.007.07
224800-2480034.60834.64
323505-2350532.80132.83
420453-2045328.54228.57
524980-2498034.85934.89
623594-2359432.92532.96
15min130196-3019642.13841.153.9842.2341.233.99
230304-3030442.28942.38
329710-2971041.46041.54
427263-2726338.04538.12
530269-3026942.24042.33
629165-2916540.69940.78
20min133821-3382147.19746.302.8847.3646.452.89
233949-3394947.37547.54
333517-3351746.77346.92
431472-3147243.91944.05
533659-3365946.97147.13
632651-3265145.56445.72
30min138483-3848353.70353.171.3553.9453.401.36
238427-3842753.62453.87
338354-3835453.52353.75
437407-3740752.20152.41
538460-3846053.67153.91
637480-3748052.30352.53
45min143233-4323360.33159.791.1360.6660.111.13
243111-4311160.16160.49
342987-4298759.98860.31
442780-4278059.69959.99
543052-4305260.07960.41
641916-4191658.49358.81
60min146229-4622964.51264.051.2064.9464.461.20
246115-4611564.35364.78
346144-4614464.39364.81
445984-4598464.17064.56
546116-4611664.35464.78
644788-4478862.50162.91
90min150015-5001569.79569.291.2170.3369.811.21
249270-4927068.75669.29
350072-5007269.87570.40
449884-4988469.61370.11
550072-5007269.87570.41
648594-4859467.81268.33
120min152833-5283373.72873.061.3274.3873.701.31
252412-5241273.14073.79
352721-5272173.57274.21
452589-5258973.38774.00
552583-5258373.37974.03
650975-5097571.13571.77
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153406-5340674.52873.801.3375.3074.561.32
253196-5319674.23475.01
353324-5332474.41375.18
453328-5332874.41975.16
552310-5231072.99873.77
651724-5172472.18072.93
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%
110.865308265307835300475320515309745309360.14
211.105364225353665358940.14
单位质量响应值RSD%判断
48889.1348278.740.89数据可信
供试品溶液-6041601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%
5min161864-6186411.44911.079.6911.4511.079.70
265006-6500612.03112.03
358005-5800510.73510.73
449336-493369.1319.13
564682-6468211.97111.97
660059-6005911.11511.12
10min186934-8693416.08915.773.8416.1115.783.85
287339-8733916.16416.18
385347-8534715.79515.81
478878-7887814.59814.61
587604-8760416.21316.23
685100-8510015.74915.77
15min194205-9420517.43417.331.7317.4817.381.75
294802-9480217.54517.59
393844-9384417.36817.41
490630-9063016.77316.81
595150-9515017.60917.66
693371-9337117.28017.32
20min198297-9829718.19217.961.6018.2718.041.61
298395-9839518.21018.29
395775-9577517.72517.80
495315-9531517.64017.71
598618-9861818.25118.33
695848-9584817.73817.81
30min1101778-10177818.83618.610.9918.9418.721.00
2101691-10169118.82018.93
399663-9966318.44418.55
4100171-10017118.53818.64
5100569-10056918.61218.72
699465-9946518.40818.51
45min1104610-10461019.36019.230.8319.5019.370.84
2105033-10503319.43819.58
3103926-10392619.23319.37
4102826-10282619.03019.16
5104010-10401019.24919.39
6103051-10305119.07119.21
60min1106998-10699819.80219.735.9219.9719.895.87
2107117-10711719.82419.99
3116724-11672421.60221.77
4104514-10451419.34219.50
5107079-10707919.81719.99
697066-9706617.96418.13
90min1108783-10878320.13219.781.1920.3319.981.19
2107596-10759619.91320.12
3106198-10619819.65419.86
4106313-10631319.67519.87
5107347-10734719.86720.07
6105162-10516219.46219.66
120min1110205-11020520.39519.674.1320.6319.904.10
2110000-11000020.35820.59
3103705-10370519.19319.43
498807-9880718.28618.51
5108392-10839220.06020.30
6106525-10652519.71419.94
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1108997-10899720.17219.662.9320.4419.932.91
2109601-10960120.28420.55
3104153-10415319.27519.54
4101373-10137318.76119.02
5107358-10735819.86920.14
6105958-10595819.60919.87
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%
110.907116271310712967143771540713490.21
210.997178772019719030.23
单位质量响应值RSD%判断
6545.786542.580.04数据可信
供试品溶液-6042201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%
5min113752-1375218.85418.108.1218.8518.108.11
214254-1425419.54219.54
311143-1114315.27715.28
413300-1330018.23418.23
513464-1346418.45918.46
613290-1329018.22118.22
10min124447-2444733.51733.212.7733.5533.242.78
224904-2490434.14334.18
322968-2296831.48931.51
424577-2457733.69533.73
524115-2411533.06233.09
624329-2432933.35533.39
15min129974-2997441.09441.180.9041.1841.260.91
230285-3028541.52141.61
329666-2966640.67240.75
430400-3040041.67941.77
529885-2988540.97241.06
629991-2999141.11841.20
20min133461-3346145.87546.170.8246.0346.320.82
233894-3389446.46946.63
333622-3362246.09646.24
434105-3410546.75846.91
533377-3337745.76045.91
633590-3359046.05246.21
30min138376-3837652.61452.780.9252.8553.020.92
238332-3833252.55352.79
338624-3862452.95453.18
439144-3914453.66753.90
538404-3840452.65252.88
638121-3812152.26452.50
45min142745-4274558.60459.070.6758.9259.390.67
243258-4325859.30759.63
343257-4325759.30659.62
443490-4349059.62559.95
542900-4290058.81659.13
642879-4287958.78759.11
60min145751-4575162.72563.160.5863.1463.580.58
246077-4607763.17263.59
346103-4610363.20763.62
446524-4652463.78564.21
545875-4587562.89563.31
646077-4607763.17263.59
90min149446-4944667.79168.230.3968.3168.750.39
249688-4968868.12268.65
349803-4980368.28068.80
450033-5003368.59569.12
549845-4984568.33868.86
649779-4977968.24768.77
120min152073-5207371.39271.660.2872.0372.300.27
252098-5209871.42772.07
352384-5238471.81972.45
452363-5236371.79072.43
552347-5234771.76872.40
652343-5234371.76272.40
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152690-5269072.23872.610.4972.9973.370.49
252834-5283472.43673.20
352923-5292372.55873.31
453438-5343873.26474.03
552859-5285972.47073.22
653027-5302772.70073.46
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%
110.865435405434755417495435835432015431100.15
211.105526815526305526560.01
单位质量响应值RSD%判断
50010.1349788.830.32数据可信
供试品溶液-6042201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%
5min163352-6335211.41511.085.4311.4111.085.43
265302-6530211.76611.77
355385-553859.9799.98
461561-6156111.09211.09
561993-6199311.17011.17
661315-6131511.04811.05
10min185815-8581515.46215.282.0015.4815.292.00
287601-8760115.78415.80
382981-8298114.95214.97
484760-8476015.27215.29
583813-8381315.10215.12
683722-8372215.08515.10
15min190337-9033716.27716.581.5916.3216.621.58
294548-9454817.03617.08
392167-9216716.60716.65
491679-9167916.51916.56
592301-9230116.63116.67
690947-9094716.38716.43
20min197023-9702317.48217.181.4717.5517.251.47
292959-9295916.75016.82
395278-9527817.16717.24
495892-9589217.27817.35
596176-9617617.32917.40
694770-9477017.07617.15
30min1100747-10074718.15318.142.7518.2518.242.74
2105842-10584219.07119.17
399463-9946317.92218.02
4100083-10008318.03318.13
5100462-10046218.10218.20
697549-9754917.57717.68
45min1104164-10416418.76922.1137.7018.9022.2437.47
2105328-10532818.97819.11
3217089-21708939.11639.24
4104719-10471918.86919.00
5103971-10397118.73418.86
6101027-10102718.20318.33
60min1105862-10586219.07518.921.2419.2419.081.24
2107028-10702819.28519.45
3105192-10519218.95419.15
4103857-10385718.71318.88
5104043-10404318.74718.91
6103885-10388518.71818.88
90min1106347-10634719.16219.072.4119.3619.272.45
2106803-10680319.24419.44
3110199-11019919.85620.08
4103066-10306618.57118.76
5104194-10419418.77418.97
6104447-10444718.82019.01
120min1109769-10976919.77919.442.0720.0019.662.06
2109957-10995719.81220.04
3108474-10847419.54519.80
4104046-10404618.74718.97
5108330-10833019.51919.74
6106608-10660819.20919.43
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1107596-10759619.38719.320.7419.6519.580.77
2108020-10802019.46319.73
3107843-10784319.43119.72
4105843-10584319.07119.33
5107008-10700819.28119.54
6107031-10703119.28519.54
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%
110.906995170116700647013470108700750.11
210.997106470956710100.11
单位质量响应值RSD%判断
6428.906461.330.36数据可信
供试品溶液-6042401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%
5min112447-1244717.32718.0421.0517.3318.0421.06
211202-1120215.59415.59
38586-858611.95211.95
415100-1510021.02121.02
515211-1521121.17521.18
615207-1520721.16921.17
10min124005-2400533.41733.298.8933.4533.328.90
222561-2256131.40731.43
320352-2035228.33228.35
425327-2532735.25735.29
525922-2592236.08636.12
625332-2533235.26435.30
15min130184-3018442.01941.275.7042.1041.365.71
228372-2837239.49639.57
326876-2687637.41437.48
430472-3047242.42042.51
531411-3141143.72743.82
630567-3056742.55242.65
20min134097-3409747.46646.653.8647.6246.803.88
232639-3263945.43645.58
331338-3133843.62543.75
434043-3404347.39147.56
534909-3490948.59648.76
634046-3404647.39547.56
30min139206-3920654.57853.652.4154.8153.882.43
237855-3785552.69752.92
337159-3715951.72951.93
438569-3856953.69153.93
539749-3974955.33455.58
638704-3870453.87954.12
45min143430-4343060.45859.991.7060.7860.311.71
242679-4267959.41359.72
342065-4206558.55858.85
442932-4293259.76560.10
544222-4422261.56161.90
643224-4322460.17260.51
60min145945-4594563.95964.061.3364.3864.481.35
245652-4565263.55263.96
345280-4528063.03463.42
445958-4595863.97864.41
547093-4709365.55866.00
646157-4615764.25564.69
90min150015-5001569.62569.491.2470.1670.021.25
249577-4957769.01569.53
349203-4920368.49568.99
449921-4992169.49470.03
551027-5102771.03471.59
649779-4977969.29769.84
120min152155-5215572.60472.771.0973.2573.411.11
252102-5210272.53073.16
351690-5169071.95772.56
452341-5234172.86373.52
553345-5334574.26174.93
651996-5199672.38373.04
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152723-5272373.39573.501.3574.1674.271.36
252772-5277273.46374.21
351826-5182672.14672.87
452637-5263773.27574.05
554035-5403575.22176.02
652811-5281173.51774.29
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%
110.865280225279745273335280685286555280100.09
211.105355015348375351690.09
单位质量响应值RSD%判断
48619.7148213.420.60数据可信
供试品溶液-6042401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%
5min157106-5710610.60510.7714.8510.6010.7714.88
252467-524679.7439.74
343902-439028.1538.15
465302-6530212.12712.13
564726-6472612.02012.02
664491-6449111.97611.98
10min181282-8128215.09415.225.5415.1115.245.55
278751-7875114.62414.64
374934-7493413.91613.93
486486-8648616.06116.08
584318-8431815.65815.68
686046-8604615.97916.00
15min189621-8962116.64316.664.3516.6916.704.35
283311-8331115.47115.51
387122-8712216.17916.22
492741-9274117.22217.27
593360-9336017.33717.38
692110-9211017.10517.15
20min198666-9866618.32317.543.7118.3917.613.69
293149-9314917.29817.36
392021-9202117.08917.15
489389-8938916.60016.68
596928-9692818.00018.07
696467-9646717.91417.99
30min1103536-10353619.22718.243.7619.3318.343.74
299008-9900818.38618.48
397413-9741318.09018.18
496980-9698018.01018.11
592378-9237817.15517.26
699940-9994018.55918.66
45min1102359-10235919.00818.672.4019.1418.802.39
297180-9718018.04718.17
3102118-10211818.96419.09
499275-9927518.43618.57
598866-9886618.36018.49
6103260-10326019.17619.31
60min1100420-10042018.64818.374.6718.8118.534.61
2102673-10267319.06719.22
3100861-10086118.73018.88
491451-9145116.98317.15
5102941-10294119.11719.28
695127-9512717.66517.83
90min1257104-25710447.74524.0448.3647.9424.2347.98
2104302-10430219.36919.56
3100507-10050718.66518.85
4102332-10233219.00319.20
5105312-10531219.55719.75
6107026-10702619.87520.07
120min1102988-10298819.12520.2914.9919.4020.5214.81
2103034-10303419.13419.35
3106019-10601919.68819.90
4102857-10285719.10119.33
5142280-14228026.42226.65
698319-9831918.25818.49
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190364-9036416.78118.496.5817.0918.756.44
2104596-10459619.42419.68
395496-9549617.73417.98
495642-9564217.76118.02
5105887-10588719.66419.94
6105265-10526519.54819.81
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