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%
110.903559735583354643548635485355230.18
210.993615636373362640.43
单位质量响应值RSD%判断
3258.993299.730.88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%
5min16925-692518.94719.527.3118.9519.527.30
27034-703419.24519.25
37579-757920.73620.74
47600-760020.79420.79
56239-623917.07017.07
67428-742820.32320.32
10min113535-1353537.03236.592.1337.0636.622.14
213158-1315836.00136.03
313565-1356537.11437.15
413421-1342136.72036.76
512905-1290535.30935.34
613646-1364637.33637.37
15min116734-1673445.78545.371.6745.8845.461.68
216547-1654745.27345.37
316666-1666645.59945.70
416430-1643044.95345.05
516152-1615244.19244.28
616961-1696146.40646.50
20min118663-1866351.06350.842.2451.2351.012.23
218572-1857250.81450.98
318609-1860950.91551.09
418056-1805649.40249.57
518310-1831050.09750.26
619290-1929052.77852.95
30min121316-2131658.32158.272.1958.5858.522.19
221316-2131658.32158.57
321310-2131058.30558.56
420785-2078556.86957.12
520930-2093057.26557.51
622127-2212760.54060.80
45min123827-2382765.19265.301.5265.5465.641.52
223968-2396865.57765.93
323617-2361764.61764.97
423847-2384765.24665.59
523437-2343764.12464.46
624494-2449467.01667.38
60min125509-2550969.79469.501.5470.2569.961.55
225443-2544369.61370.07
325246-2524669.07469.54
424944-2494468.24868.70
525184-2518468.90469.35
626087-2608771.37571.85
90min127734-2773475.88175.241.6576.4675.811.65
227438-2743875.07175.65
327338-2733874.79875.38
426956-2695673.75374.32
527263-2726374.59375.15
628262-2826277.32677.92
120min128823-2882378.86178.471.4779.5679.171.47
228844-2884478.91879.62
328529-2852978.05678.76
428052-2805276.75177.44
528528-2852878.05478.74
629307-2930780.18580.91
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129438-2943880.54379.851.6581.3880.681.65
229311-2931180.19681.03
329203-2920379.90080.73
428342-2834277.54578.37
529041-2904179.45780.27
629775-2977581.46582.32
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%
110.862756162765042759712762072754902759580.16
211.102818282817622817950.02
单位质量响应值RSD%判断
25410.5025386.940.07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%
5min137878-3787813.40913.715.4713.4113.725.46
238379-3837913.58613.59
340162-4016214.21714.22
440590-4059014.36914.37
535077-3507712.41712.42
640365-4036514.28914.29
10min167706-6770623.96823.062.9423.9923.082.93
263208-6320822.37522.40
363914-6391422.62522.65
463960-6396022.64122.67
567350-6735023.84223.86
664704-6470422.90522.93
15min175008-7500826.55226.361.2726.6126.421.26
274652-7465226.42626.49
374548-7454826.39026.45
473922-7392226.16826.23
572973-7297325.83225.89
675711-7571126.80126.86
20min181378-8137828.80728.680.6428.9128.790.64
281256-8125628.76428.87
380821-8082128.61028.72
480592-8059228.52928.63
580376-8037628.45328.56
681745-8174528.93729.04
30min189682-8968231.74731.421.1131.9031.581.10
289516-8951631.68831.84
387673-8767331.03631.19
488489-8848931.32531.48
587594-8759431.00831.16
689617-8961731.72431.88
45min195419-9541933.77833.741.9733.9933.941.95
298810-9881034.97835.18
394871-9487133.58433.79
493948-9394833.25733.46
593519-9351933.10533.31
695268-9526833.72433.93
60min199708-9970835.29634.940.8535.5635.200.84
299694-9969435.29135.55
398716-9871634.94535.21
498256-9825634.78235.04
597934-9793434.66834.93
697889-9788934.65234.92
90min1104188-10418836.88236.671.6637.2036.981.65
2103287-10328736.56336.88
3106676-10667637.76338.08
4103015-10301536.46736.79
5101774-10177436.02736.34
6102551-10255136.30236.62
120min1105389-10538937.30737.170.5937.6937.550.58
2106037-10603737.53637.92
3104572-10457237.01837.40
4104510-10451036.99637.38
5104967-10496737.15837.53
6104536-10453637.00537.39
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1106314-10631437.63537.651.3338.0838.091.31
2106141-10614137.57338.02
3105892-10589237.48537.93
4104940-10494037.14837.59
5109071-10907138.61139.05
6105773-10577337.44337.89
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%
110.903637836354363603639636389363750.05
210.993623036550363900.63
单位质量响应值RSD%判断
3337.163311.190.56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%
5min15533-553314.93414.0914.9614.9314.0914.95
25101-510113.76813.77
35935-593516.01916.02
45829-582915.73315.73
55131-513113.84913.85
63790-379010.23010.23
10min112457-1245733.62332.674.9133.6532.704.91
212289-1228933.16933.19
312293-1229333.18033.21
412486-1248633.70133.73
512192-1219232.90732.93
610915-1091529.46129.48
15min116188-1618843.69341.973.3343.7742.053.33
215417-1541741.61241.69
315713-1571342.41142.49
415885-1588542.87542.96
515419-1541941.61741.70
614679-1467939.62039.69
20min118341-1834149.50448.132.6449.6648.282.65
218055-1805548.73248.88
318126-1812648.92449.08
417695-1769547.76047.91
517778-1777847.98448.13
617005-1700545.89846.03
30min121224-2122457.28555.981.6757.5256.211.68
220813-2081356.17656.40
320745-2074555.99356.23
420730-2073055.95256.19
520790-2079056.11456.34
620145-2014554.37354.58
45min123720-2372064.02263.041.9864.3563.361.98
224039-2403964.88365.21
323319-2331962.94063.27
423129-2312962.42762.75
523184-2318462.57662.90
622739-2273961.37561.67
60min125313-2531368.32267.341.3668.7667.761.37
225300-2530068.28768.72
324870-2487067.12667.56
424898-2489867.20267.63
524914-2491467.24567.67
624394-2439465.84266.24
90min127729-2772974.84373.181.3875.4073.721.39
227240-2724073.52374.07
327035-2703572.97073.51
427129-2712973.22473.77
526935-2693572.70073.24
626605-2660571.80972.32
120min129000-2900078.27477.011.5478.9577.681.55
228835-2883577.82878.50
328436-2843676.75177.42
428692-2869277.44278.11
528483-2848376.87877.54
627748-2774874.89475.53
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129255-2925578.96277.851.1779.7778.641.18
229097-2909778.53579.33
328848-2884877.86378.66
428827-2882777.80778.60
528763-2876377.63478.42
628271-2827176.30677.06
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%
110.862819802819292819662829812826822823080.18
211.102871472874452872960.08
单位质量响应值RSD%判断
25995.2125882.520.31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%
5min134414-3441411.92911.3611.6211.9311.3611.65
232316-3231611.20211.20
336057-3605712.49812.50
435417-3541712.27612.28
532890-3289011.40011.40
625572-255728.8648.86
10min161953-6195321.47420.984.6221.4921.004.63
261445-6144521.29821.32
361885-6188521.45121.47
460661-6066121.02721.05
562221-6222121.56721.59
654923-5492319.03819.05
15min173520-7352025.48425.022.7425.5425.072.74
269908-6990824.23224.29
373387-7338725.43825.49
472396-7239625.09425.15
574281-7428125.74825.80
669608-6960824.12824.17
20min180062-8006227.75127.541.2927.8527.641.30
279563-7956327.57827.67
380046-8004627.74627.84
479157-7915727.43827.54
580348-8034827.85127.95
677553-7755326.88226.97
30min189888-8988831.15730.541.2031.3030.681.21
287734-8773430.41130.55
387754-8775430.41830.56
487900-8790030.46830.61
588595-8859530.70930.85
686758-8675830.07230.20
45min194779-9477932.85332.741.2333.0532.931.23
295804-9580433.20833.40
394942-9494232.90933.11
492624-9262432.10632.30
595025-9502532.93833.13
693538-9353832.42332.60
60min198906-9890634.28333.930.9934.5334.170.99
298678-9867834.20434.45
398145-9814534.01934.27
496627-9662733.49333.74
598131-9813134.01534.26
696762-9676233.54033.78
90min197488-9748833.79235.282.2234.1035.592.20
2103557-10355735.89536.20
3103279-10327935.79936.11
4101403-10140335.14935.45
5102098-10209835.39035.70
6102940-10294035.68235.97
120min1105737-10573736.65136.540.5737.0236.900.58
2106172-10617236.80237.17
3105538-10553836.58236.95
4105375-10537536.52636.89
5105254-10525436.48436.85
6104397-10439736.18736.54
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1103999-10399936.04936.560.8936.4736.980.89
2105023-10502336.40436.83
3106599-10659936.95037.38
4106055-10605536.76137.18
5106004-10600436.74437.17
6105156-10515636.45036.86
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%
110.903749637415373223736837242373690.26
210.993730237339373200.08
单位质量响应值RSD%判断
3428.353395.810.68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%
5min15986-598615.74114.3116.4115.7414.3116.40
26172-617216.23016.23
36204-620416.31416.31
44468-446811.74911.75
54182-418210.99711.00
65639-563914.82814.83
10min112817-1281733.70332.564.8733.7332.584.88
212904-1290433.93233.96
312787-1278733.62433.65
411840-1184031.13431.15
511444-1144430.09330.11
612507-1250732.88832.91
15min116112-1611242.36841.861.7442.4541.941.74
216325-1632542.92843.01
315792-1579241.52641.61
415989-1598942.04442.12
515568-1556840.93741.01
615737-1573741.38241.46
20min118333-1833348.20847.811.5748.3647.961.58
218605-1860548.92349.08
317974-1797447.26447.42
418324-1832448.18448.33
517844-1784446.92247.06
618017-1801747.37747.53
30min120919-2091955.00854.950.8055.2455.170.81
221188-2118855.71555.95
320851-2085154.82955.06
420938-2093855.05855.28
520753-2075354.57154.79
620724-2072454.49554.72
45min123412-2341261.56362.061.3761.8962.381.36
224052-2405263.24663.58
323252-2325261.14361.47
423951-2395162.98163.29
523469-2346961.71362.02
623479-2347961.74062.06
60min125211-2521166.29466.450.8166.7266.880.80
225536-2553667.14967.58
324948-2494865.60266.03
425431-2543166.87367.29
525282-2528266.48166.89
625222-2522266.32366.74
90min127096-2709671.25171.980.7471.7972.510.73
227500-2750072.31372.86
327209-2720971.54872.08
427611-2761172.60573.14
527513-2751372.34772.87
627304-2730471.79872.33
120min128525-2852575.00875.500.6775.6776.150.67
228912-2891276.02676.69
328472-2847274.86975.52
428935-2893576.08776.74
528686-2868675.43276.07
628743-2874375.58276.23
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128878-2887875.93776.280.4676.7277.060.46
229225-2922576.84977.64
328890-2889075.96876.75
429079-2907976.46577.24
528950-2895076.12676.89
629026-2902676.32677.10
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%
110.862900562902752898742887672883822894710.30
211.102895972901742898860.15
单位质量响应值RSD%判断
26654.7926115.861.45数据可信
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%
5min132578-3257811.10210.1216.3611.1010.1216.34
233575-3357511.44211.44
333421-3342111.39011.39
424414-244148.3208.32
522675-226757.7277.73
631565-3156510.75710.76
10min161188-6118820.85220.243.4220.8720.263.42
260900-6090020.75420.77
361004-6100420.79020.81
457649-5764919.64619.66
556318-5631819.19319.21
659334-5933420.22120.24
15min173708-7370825.11924.422.1025.1724.482.11
272763-7276324.79724.85
372402-7240224.67424.73
470892-7089224.16024.21
570276-7027623.95023.99
669969-6996923.84523.90
20min179913-7991327.23426.781.1827.3326.871.19
279183-7918326.98527.08
378940-7894026.90227.00
478037-7803726.59426.68
577487-7748726.40726.49
677862-7786226.53526.63
30min186952-8695229.63329.450.9129.7729.590.91
287294-8729429.74929.89
387121-8712129.69029.83
485665-8566529.19429.33
585704-8570429.20729.34
685781-8578129.23429.37
45min188762-8876230.24931.622.2130.4431.812.19
293643-9364331.91332.10
394303-9430332.13832.33
493533-9353331.87532.06
593821-9382131.97432.15
692708-9270831.59431.78
60min197430-9743033.20332.871.2733.4433.111.26
297670-9767033.28533.53
394917-9491732.34732.59
497446-9744633.20933.44
595274-9527432.46932.70
695953-9595332.70032.94
90min1101402-10140234.55733.842.4034.8534.142.39
298237-9823733.47833.78
3101447-10144734.57234.87
499643-9964333.95834.25
595121-9512132.41732.70
6100021-10002134.08634.38
120min1104504-10450435.61434.734.0335.9735.084.01
2102585-10258534.96035.31
3104647-10464735.66336.02
4103614-10361435.31135.66
593756-9375631.95132.29
6102330-10233034.87335.22
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1105699-10569936.02134.852.6636.4335.262.64
2100983-10098334.41434.83
3104153-10415335.49535.91
4102821-10282135.04135.44
597853-9785333.34833.74
6102089-10208934.79135.20
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