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%
117159272080715087144571299715850.42
217199771890719440.11
单位质量响应值RSD%判断
71585.0071944.000.36数据可信
供试品溶液-1批-多替诺雷-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19408-94081.1761.205.061.181.205.00
210183-101831.2731.27
39412-94121.1771.18
49865-98651.2331.23
510051-100511.2571.26
68889-88891.1111.11
10min118342-183422.2932.281.842.302.281.83
218155-181552.2702.27
318220-182202.2782.28
418495-184952.3122.31
518479-184792.3102.31
617590-175902.1992.20
15min123270-232702.9092.901.752.922.901.81
223017-230172.8782.88
322844-228442.8562.86
423870-238702.9842.99
523399-233992.9252.93
622790-227902.8492.85
20min126263-262633.2833.311.473.293.321.44
226294-262943.2873.30
326444-264443.3063.32
427213-272133.4023.41
526339-263393.2933.30
626131-261313.2673.28
30min130779-307793.8483.850.933.863.860.91
230476-304763.8103.83
330564-305643.8213.84
431222-312223.9033.92
530984-309843.8743.89
630608-306083.8273.84
45min135127-351274.3924.410.794.414.430.81
235515-355154.4404.46
334884-348844.3614.38
435639-356394.4564.48
535164-351644.3964.42
635235-352354.4054.43
60min137878-378784.7364.740.614.774.770.60
237626-376264.7044.73
338025-380254.7544.78
438247-382474.7824.81
538100-381004.7634.79
637767-377674.7224.75
90min141812-418125.2275.230.985.275.270.94
241111-411115.1405.18
341888-418885.2375.27
442347-423475.2945.33
541884-418845.2365.27
642047-420475.2575.29
120min144401-444015.5515.551.025.605.591.05
244151-441515.5205.57
343574-435745.4485.49
444854-448545.6085.66
544589-445895.5755.62
644583-445835.5745.62
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144586-445865.5745.620.705.635.670.69
244959-449595.6215.68
344471-444715.5605.62
445157-451575.6465.70
545121-451215.6415.70
645200-452005.6515.71
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%
115495465508245510395474735465135490790.37
215529115533195531150.06
单位质量响应值RSD%判断
549079.00553115.000.52数据可信
供试品溶液-1批-非布司他-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13359-33590.0550.069.890.050.0612.91
24156-41560.0680.07
33337-33370.0540.05
43845-38450.0630.06
53378-33780.0550.06
63908-39080.0640.06
10min14407-44070.0720.085.490.070.077.05
24448-44480.0730.07
35115-51150.0830.08
44522-45220.0740.07
54476-44760.0730.07
64709-47090.0770.08
15min14662-46620.0760.084.540.080.080.00
24667-46670.0760.08
34826-48260.0790.08
44742-47420.0770.08
55185-51850.0850.08
64657-46570.0760.08
20min15574-55740.0910.0811.140.090.0811.19
24312-43120.0700.07
35209-52090.0850.09
44756-47560.0780.08
54880-48800.0800.08
64139-41390.0680.07
30min14471-44710.0730.0814.120.070.0814.32
26280-62800.1020.10
35012-50120.0820.08
45440-54400.0890.09
54738-47380.0770.08
64326-43260.0710.07
45min14033-40330.0660.0811.950.070.0812.34
24843-48430.0790.08
35260-52600.0860.09
45867-58670.0960.10
55077-50770.0830.08
65235-52350.0850.09
60min14240-42400.0690.0810.720.070.089.61
24610-46100.0750.08
35140-51400.0840.08
45641-56410.0920.09
54660-46600.0760.08
64472-44720.0730.07
90min15006-50060.0820.0810.950.080.0810.65
24395-43950.0720.07
35573-55730.0910.09
44114-41140.0670.07
54928-49280.0800.08
64508-45080.0740.07
120min14466-44660.0730.087.850.070.089.61
24133-41330.0670.07
35189-51890.0850.09
44583-45830.0750.08
54754-47540.0780.08
64738-47380.0770.08
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14697-46970.0770.085.740.080.085.22
24094-40940.0670.07
34670-46700.0760.08
44854-48540.0790.08
54603-46030.0750.08
64794-47940.0780.08
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%
117259372538723607245572914725720.30
217266972357725130.31
单位质量响应值RSD%判断
72572.0072513.000.06数据可信
供试品溶液-1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%
5min113748-137481.7001.5011.131.701.5011.28
210304-103041.2741.27
312907-129071.5961.60
411192-111921.3841.38
513277-132771.6421.64
611506-115061.4231.42
10min125964-259643.2113.073.063.213.083.02
224169-241692.9892.99
325078-250783.1023.10
424249-242492.9993.00
525439-254393.1463.15
624197-241972.9933.00
15min131629-316293.9123.862.413.923.862.43
230704-307043.7973.80
332055-320553.9653.97
431043-310433.8393.85
531682-316823.9183.93
630023-300233.7133.72
20min136594-365944.5264.422.364.544.432.33
235221-352214.3564.37
336014-360144.4544.47
435525-355254.3944.41
536540-365404.5194.53
634407-344074.2554.27
30min140782-407825.0445.031.465.075.061.47
240384-403844.9955.02
341428-414285.1245.15
440981-409815.0695.09
540798-407985.0465.07
639679-396794.9084.93
45min145946-459465.6835.671.065.715.701.07
245850-458505.6715.70
346477-464775.7485.78
445853-458535.6715.70
545735-457355.6575.69
644981-449815.5635.59
60min148420-484205.9896.021.196.036.061.16
248806-488066.0366.07
349508-495086.1236.16
448858-488586.0436.08
548897-488976.0486.09
647769-477695.9085.95
90min152419-524196.4836.460.846.536.520.86
252043-520436.4376.49
352920-529206.5456.60
452254-522546.4636.51
552378-523786.4786.53
651610-516106.3836.43
120min155063-550636.8106.760.586.876.820.61
254522-545226.7436.80
354720-547206.7686.83
454817-548176.7806.84
554497-544976.7406.80
654141-541416.6966.75
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155899-558996.9146.860.696.996.940.67
255272-552726.8366.91
355862-558626.9096.98
455713-557136.8916.96
555031-550316.8066.88
655185-551856.8256.90
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%
115574875582475561475569485570955571850.14
215611235605385608300.08
单位质量响应值RSD%判断
557185.00560830.000.47数据可信
供试品溶液-1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%
5min162741-627411.0090.937.691.010.927.70
251613-516130.8300.83
360244-602440.9690.97
454941-549410.8840.88
561098-610980.9830.98
654584-545840.8780.88
10min186917-869171.3981.392.561.401.392.68
286952-869521.3991.40
385959-859591.3831.38
482164-821641.3221.32
587079-870791.4011.40
688716-887161.4271.43
15min196330-963301.5491.512.251.551.512.20
295603-956031.5381.54
391991-919911.4801.48
494221-942211.5151.52
592540-925401.4881.49
691008-910081.4641.47
20min199421-994211.5991.572.991.611.582.90
298443-984431.5831.59
396267-962671.5481.55
498230-982301.5801.59
5101762-1017621.6371.64
693229-932291.4991.51
30min190366-903661.4531.596.181.461.606.23
2103786-1037861.6691.68
3102215-1022151.6441.65
4104637-1046371.6831.69
5100826-1008261.6221.63
692389-923891.4861.49
45min199839-998391.6061.644.121.621.664.04
2102705-1027051.6521.66
3105902-1059021.7031.72
4105786-1057861.7011.71
5103899-1038991.6711.68
694848-948481.5261.54
60min187929-879291.4141.598.151.431.608.01
2107204-1072041.7241.74
3106106-1061061.7071.72
490361-903611.4531.47
5101797-1017971.6371.65
699817-998171.6051.62
90min1111288-1112881.7901.722.991.811.743.05
2107725-1077251.7331.75
3106810-1068101.7181.74
4109421-1094211.7601.78
5104210-1042101.6761.69
6102727-1027271.6521.67
120min196811-968111.5571.674.641.581.694.60
2108540-1085401.7461.77
3107492-1074921.7291.75
498919-989191.5911.61
5103799-1037991.6701.69
6106295-1062951.7101.73
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196355-963551.5501.704.851.571.724.78
2110061-1100611.7701.79
3109474-1094741.7611.78
4107327-1073271.7261.75
5106214-1062141.7081.73
6102898-1028981.6551.68
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%
113664336658365323676836428366060.36
213614036528363340.76
单位质量响应值RSD%判断
36606.0036334.000.53数据可信
供试品溶液-2批-多替诺雷-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15928-59281.4581.1519.071.461.1619.11
24716-47161.1601.16
34825-48251.1871.19
44815-48151.1851.18
53129-31290.7700.77
64744-47441.1671.17
10min19944-99442.4462.307.902.452.307.99
29702-97022.3872.39
39714-97142.3902.39
49345-93452.2992.30
57896-78961.9431.94
69383-93832.3082.31
15min112463-124633.0663.005.133.073.015.12
212662-126623.1153.12
312413-124133.0543.06
412404-124043.0523.06
510949-109492.6942.70
612376-123763.0453.05
20min114471-144713.5603.533.693.573.543.75
214900-149003.6663.68
314623-146233.5983.61
414358-143583.5323.54
513348-133483.2843.29
614307-143073.5203.53
30min116805-168054.1344.141.474.154.151.47
217122-171224.2124.23
316927-169274.1644.18
416916-169164.1624.18
516395-163954.0334.05
616732-167324.1164.13
45min119571-195714.8154.771.504.844.801.47
219666-196664.8384.86
319674-196744.8404.86
419339-193394.7584.78
519187-191874.7204.74
618952-189524.6634.69
60min120992-209925.1645.181.795.205.211.80
221670-216705.3315.36
321062-210625.1825.21
421251-212515.2285.26
520749-207495.1055.13
620611-206115.0715.10
90min123315-233155.7365.771.935.785.811.93
224208-242085.9566.00
323518-235185.7865.83
423501-235015.7825.82
522834-228345.6185.66
623259-232595.7225.76
120min124925-249256.1326.181.626.186.231.65
225434-254346.2576.31
325075-250756.1696.22
425765-257656.3396.39
524890-248906.1236.17
624653-246536.0656.11
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125397-253976.2486.240.976.316.300.98
225709-257096.3256.39
325200-252006.2006.26
425542-255426.2846.34
525238-252386.2096.27
625037-250376.1606.22
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%
112783382800402797092790852782702790880.29
212792652768102780380.63
单位质量响应值RSD%判断
279088.00278038.000.27数据可信
供试品溶液-2批-非布司他-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15131-51310.1660.1140.930.170.1139.35
23077-30770.0990.10
32654-26540.0860.09
44789-47890.1550.15
51709-17090.0550.06
62554-25540.0820.08
10min13453-34530.1110.1211.060.110.1210.65
23188-31880.1030.10
33409-34090.1100.11
44141-41410.1340.13
53384-33840.1090.11
64045-40450.1310.13
15min14291-42910.1380.147.540.140.149.04
24505-45050.1450.15
34718-47180.1520.15
44486-44860.1450.15
53841-38410.1240.12
64037-40370.1300.13
20min13717-37170.1200.1512.380.120.1513.09
25223-52230.1690.17
34766-47660.1540.15
44954-49540.1600.16
54831-48310.1560.16
64111-41110.1330.13
30min14769-47690.1540.155.140.150.165.22
24892-48920.1580.16
35116-51160.1650.17
44503-45030.1450.15
54522-45220.1460.15
64945-49450.1600.16
45min14370-43700.1410.154.950.140.155.33
24574-45740.1480.15
34944-49440.1600.16
44797-47970.1550.16
54748-47480.1530.15
65001-50010.1610.16
60min14800-48000.1550.147.700.160.159.32
24511-45110.1460.15
34036-40360.1300.13
44079-40790.1320.13
54553-45530.1470.15
64839-48390.1560.16
90min14059-40590.1310.158.130.130.157.05
25035-50350.1630.16
34564-45640.1470.15
44153-41530.1340.14
54722-47220.1520.15
64614-46140.1490.15
120min14147-41470.1340.136.910.140.147.56
23996-39960.1290.13
33688-36880.1190.12
44529-45290.1460.15
54256-42560.1370.14
64293-42930.1390.14
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14135-41350.1330.143.970.140.142.89
24272-42720.1380.14
34599-45990.1480.15
44385-43850.1420.14
54319-43190.1390.14
64152-41520.1340.14
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