非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103769439376441337760043778854375912137695660.22
2103809716382198038158480.23
单位质量响应值RSD%判断
376956.60381584.800.87数据可信
供试品溶液-4226B批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12220876-222087652.65057.4720.2052.6557.4720.20
22693622-269362263.85763.86
32386481-238648156.57656.58
41588058-158805837.64837.65
52998979-299897971.09771.10
62656556-265655662.97962.98
10min13571966-357196684.68086.904.7084.8087.034.72
23769922-376992289.37389.52
33568987-356898784.61084.74
43421617-342161781.11681.20
53882942-388294292.05392.21
63777249-377724989.54789.69
15min13995613-399561394.72495.671.5095.0395.991.53
24096144-409614497.10797.45
33987289-398728994.52694.84
43972642-397264294.17994.44
54117009-411700997.60297.96
64044673-404467395.88796.23
20min14172981-417298198.92898.630.5099.4499.160.52
24177560-417756099.03799.59
34145934-414593498.28798.81
44141475-414147598.18298.65
54184877-418487799.21099.79
64138410-413841098.10998.66
30min14293348-4293348101.782100.000.99102.52100.750.96
24207332-420733299.743100.52
34223696-4223696100.131100.87
44221890-4221890100.088100.78
54187079-418707999.263100.06
64175655-417565598.99299.76
45min14315626-4315626102.310100.011.29103.27100.981.27
24188600-418860099.299100.30
34250099-4250099100.757101.72
44180188-418018899.099100.01
54178353-417835399.056100.08
64198662-419866299.537100.53
60min14149324-414932498.36897.241.2999.5698.441.27
24150587-415058798.39899.62
34086114-408611496.86998.06
44104100-410410097.29698.43
54112248-411224897.48998.73
64007780-400778095.01296.22
极限14251087-4251087100.78098.531.38102.1999.941.36
24137135-413713598.07999.52
34192786-419278699.398100.80
44124335-412433597.77599.13
54141351-414135198.17999.64
64089600-408960096.95298.37
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103795373380937538128883812621380293938066390.20
2103848612384516238468870.07
单位质量响应值RSD%判断
380663.90384688.700.75数据可信
供试品溶液-4226B批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12290336-229033653.81359.6814.0153.8159.6814.02
22903405-290340568.21868.22
32168694-216869450.95550.95
42854595-285459567.07167.07
52195038-219503851.57451.57
62827524-282752466.43566.43
10min13562381-356238183.70187.013.0683.8287.153.08
23800054-380005489.28589.44
33599578-359957884.57584.69
43804830-380483089.39789.55
53647288-364728885.69685.81
63805876-380587689.42289.57
15min14007747-400774794.16595.130.7894.4795.460.79
24060858-406085895.41395.76
34081956-408195695.90896.21
44067610-406761095.57195.92
54010864-401086494.23894.54
64063722-406372295.48095.83
20min14159807-415980797.73897.510.3898.2598.050.36
24132688-413268897.10097.66
34162006-416200697.78998.30
44128234-412823496.99697.56
54155534-415553497.63798.15
64163139-416313997.81698.37
30min14195990-419599098.58898.450.2899.3299.200.28
24180303-418030398.21999.00
34182522-418252298.27199.00
44209758-420975898.91199.69
54190150-419015098.45199.18
64181354-418135498.24499.02
45min14200214-420021498.68798.340.3599.6499.310.36
24177842-417784298.16199.16
34165101-416510197.86298.81
44199175-419917598.66399.66
54175906-417590698.11699.07
64193679-419367998.53399.53
60min14195119-419511998.56796.311.5799.7497.501.52
24044626-404462695.03196.25
34133284-413328497.11498.28
44054039-405403995.25296.47
54130988-413098897.06098.23
64035302-403530294.81296.03
极限14124404-412440496.90696.870.3498.3098.270.33
24099814-409981496.32897.75
34128219-412821996.99598.38
44141895-414189597.31798.74
54119111-411911196.78198.17
64123189-412318996.87798.30
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103815549384497038351173839733385008738370910.35
2103893346390037638968610.13
单位质量响应值RSD%判断
383709.10389686.101.10数据可信
供试品溶液-4226B批-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%
5min1323194-3231947.5157.4311.397.517.4311.41
2269206-2692066.2606.26
3364190-3641908.4688.47
4346043-3460438.0468.05
5284033-2840336.6046.60
6329892-3298927.6717.67
10min1618721-61872114.38714.043.4714.4014.063.48
2579330-57933013.47113.48
3623550-62355014.49914.52
4624621-62462114.52414.54
5594504-59450413.82313.84
6582549-58254913.54513.56
15min1704406-70440616.37915.862.8816.4315.902.89
2664883-66488315.46015.50
3688582-68858216.01116.06
4696524-69652416.19616.25
5684674-68467415.92015.97
6652595-65259515.17415.22
20min1717308-71730816.67916.472.9316.7616.552.93
2696208-69620816.18816.27
3727394-72739416.91317.00
4723549-72354916.82416.91
5713533-71353316.59116.67
6672290-67229015.63215.71
30min1733000-73300017.04417.002.3917.1717.122.37
2723499-72349916.82316.94
3755925-75592517.57717.70
4703484-70348416.35716.48
5739980-73998017.20617.32
6730019-73001916.97417.09
45min1705439-70543916.40317.403.8816.5617.563.87
2726292-72629216.88817.04
3783663-78366318.22218.39
4771418-77141817.93718.10
5758100-75810017.62717.78
6745249-74524917.32917.48
60min1710161-71016116.51316.447.1616.7116.647.06
2740828-74082817.22617.41
3684344-68434415.91216.12
4710797-71079716.52816.73
5771659-77165917.94318.14
6623865-62386514.50614.70
极限1767240-76724017.84017.631.9418.0717.861.92
2745785-74578517.34117.57
3752006-75200617.48617.72
4740909-74090917.22817.46
5780454-78045418.14718.38
6761912-76191217.71617.94
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103829709383695638401133829988382779038329110.14
2103777668376142537695460.31
单位质量响应值RSD%判断
383291.10376954.601.18数据可信
供试品溶液-4226B批-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%
5min1338569-3385698.0097.887.038.017.887.03
2370116-3701168.7558.75
3344749-3447498.1558.15
4305357-3053577.2237.22
5326528-3265287.7247.72
6313287-3132877.4117.41
10min1579271-57927113.70213.982.5013.7214.002.49
2614449-61444914.53414.55
3602186-60218614.24414.26
4575107-57510713.60413.62
5587218-58721813.89013.91
6587995-58799513.90913.93
15min1663773-66377315.70115.841.5415.7515.881.54
2681178-68117816.11316.16
3675972-67597215.99016.04
4656866-65686615.53815.58
5678339-67833916.04616.09
6660657-66065715.62815.67
20min1687188-68718816.25516.033.4516.3416.123.44
2636543-63654315.05715.14
3677352-67735216.02216.11
4676343-67634315.99916.08
5708234-70823416.75316.84
6681497-68149716.12016.20
30min1708082-70808216.74916.412.4516.8716.532.43
2662748-66274815.67715.80
3690001-69000116.32216.44
4698068-69806816.51216.63
5709410-70941016.78116.90
6694289-69428916.42316.54
45min1664532-66453215.71917.2913.1715.8817.4513.06
2913535-91353521.60921.77
3728070-72807017.22217.38
4705569-70556916.69016.84
5732361-73236117.32417.48
6642139-64213915.18915.34
60min1673111-67311115.92216.708.5116.1116.908.43
2701829-70182916.60116.81
3816410-81641019.31219.51
4717623-71762316.97517.17
5641142-64114215.16615.36
6685910-68591016.22516.41
极限1728683-72868317.23716.932.9917.4617.162.95
2729147-72914717.24817.49
3703719-70371916.64616.88
4744280-74428017.60617.83
5700683-70068316.57416.80
6688527-68852716.28716.51
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103808744380594137972813803596379596838023060.15
2103846860384577738463180.02
单位质量响应值RSD%判断
380230.60384631.800.82数据可信
供试品溶液-4226B批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11522769-152276935.80242.5820.1635.8042.5820.16
21922423-192242345.19845.20
31589741-158974137.37637.38
41388621-138862132.64832.65
52166744-216674450.94250.94
62277000-227700053.53453.53
10min13396447-339644779.85378.737.4179.9378.837.42
23350476-335047678.77378.87
33047224-304722471.64371.73
43074905-307490572.29472.37
53628233-362823385.30385.42
63595474-359547484.53384.65
15min13807128-380712889.50988.884.5489.7789.144.56
23800957-380095789.36489.64
33591496-359149684.43984.68
43566186-356618683.84484.08
53984444-398444493.67893.98
63930828-393082892.41792.72
20min14008059-400805994.23393.523.7794.6993.983.79
24000093-400009394.04694.52
33822129-382212989.86290.29
43777119-377711988.80389.22
54112570-411257096.69097.20
64145633-414563397.46897.98
30min14156219-415621997.71697.062.9098.3897.732.93
24156179-415617997.71598.40
34009229-400922994.26194.89
43961915-396191593.14893.77
54274555-4274555100.499101.22
64210710-421071098.99899.73
45min14181961-418196198.32297.812.8199.2098.702.84
24176762-417676298.19999.10
34043644-404364495.07095.91
44003521-400352194.12694.95
54307979-4307979101.284102.23
64246561-424656199.840100.79
60min14165542-416554297.93697.702.5499.0498.812.57
24173728-417372898.12899.25
34038229-403822994.94295.99
44026528-402652894.66795.70
54286735-4286735100.785101.96
64241796-424179699.728100.90
极限14154101-415410197.66797.392.9498.9998.722.97
24160393-416039397.81599.15
34005914-400591494.18395.44
43998742-399874294.01495.26
54306738-4306738101.255102.65
64228558-422855899.417100.81
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103802809380971738058193807738379987838051920.11
2103798177382016438091700.41
单位质量响应值RSD%判断
380519.20380917.000.08数据可信
供试品溶液-4226B批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11669328-166932839.42346.6014.3939.4246.5914.39
22260010-226001053.37253.37
31729938-172993840.85440.85
42217332-221733252.36452.36
51747154-174715441.26141.26
62214667-221466752.30152.30
10min13490758-349075882.43782.863.4182.5382.963.42
23617054-361705485.42085.54
33369879-336987979.58379.67
43613268-361326885.33185.45
53363371-336337179.42979.52
63597822-359782284.96685.08
15min13798306-379830689.70091.512.0789.9791.802.09
23936213-393621392.95793.27
33802892-380289289.80990.08
43954118-395411893.38093.69
53805365-380536589.86790.14
63953781-395378193.37293.68
20min13999556-399955694.45395.891.5794.9296.381.59
24117286-411728697.23397.75
34015332-401533294.82695.29
44131003-413100397.55798.07
53995084-399508494.34894.82
64104330-410433096.92797.44
30min14135884-413588497.67399.201.1098.3599.911.12
24236883-4236883100.058100.79
34180122-418012298.71799.40
44247177-4247177100.301101.03
54166245-416624598.39099.07
64237563-4237563100.074100.80
45min14179413-417941398.701100.121.2499.60101.051.26
24289693-4289693101.305102.26
34220299-422029999.666100.56
44291110-4291110101.338102.29
54182000-418200098.76299.66
64275515-4275515100.970101.92
60min14168826-416882698.45199.611.2099.57100.761.22
24264268-4264268100.705101.88
34182775-418277598.78099.90
44274156-4274156100.938102.12
54166677-416667798.40099.52
64251465-4251465100.402101.58
极限14163418-416341898.32399.431.3999.66100.801.41
24269046-4269046100.817102.22
34156001-415600198.14899.49
44258617-4258617100.571101.97
54151575-415157598.04399.38
64262001-4262001100.651102.05
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103811621381252238110353808090380406038094660.10
2103801677380095838013180.02
单位质量响应值RSD%判断
380946.60380131.800.16数据可信
供试品溶液-4226B批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117743-177430.4190.4914.060.420.4914.24
223851-238510.5640.56
317101-171010.4040.40
423492-234920.5550.56
522604-226040.5340.53
620499-204990.4840.48
10min134279-342790.8100.826.350.810.826.44
234606-346060.8180.82
331306-313060.7400.74
436469-364690.8620.86
537525-375250.8870.89
633567-335670.7930.79
15min137593-375930.8880.892.320.890.902.31
238340-383400.9060.91
337946-379460.8970.90
438901-389010.9190.92
538116-381160.9010.90
636304-363040.8580.86
20min138408-384080.9070.913.730.910.913.71
236234-362340.8560.86
340074-400740.9470.95
439357-393570.9300.94
539325-393250.9290.93
637431-374310.8840.89
30min138770-387700.9160.922.150.920.922.02
238088-380880.9000.91
338818-388180.9170.92
440057-400570.9460.95
539353-393530.9300.94
637766-377660.8920.90
45min138552-385520.9110.932.530.920.942.41
238516-385160.9100.92
340892-408920.9660.97
440080-400800.9470.96
538702-387020.9140.92
638823-388230.9170.93
60min139070-390700.9230.921.380.930.931.59
238761-387610.9160.93
338841-388410.9180.93
439092-390920.9240.94
539187-391870.9260.94
637766-377660.8920.90
极限136855-368550.8710.924.060.880.934.11
239777-397770.9400.95
341270-412700.9750.99
439682-396820.9380.95
537985-379850.8970.91
638233-382330.9030.92
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院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%
1103758244376033637594163761271376088237600300.04
2103706109370583237059700.01
单位质量响应值RSD%判断
376003.00370597.001.03数据可信
供试品溶液-4226B批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119040-190400.4590.496.290.460.496.11
219815-198150.4770.48
320238-202380.4870.49
422845-228450.5500.55
520204-202040.4870.49
620190-201900.4860.49
10min132460-324600.7820.803.840.780.803.84
232571-325710.7850.79
332024-320240.7710.77
435378-353780.8520.85
532404-324040.7800.78
633821-338210.8150.82
15min137149-371490.8950.872.710.900.883.01
237056-370560.8930.90
334509-345090.8310.83
436346-363460.8750.88
536636-366360.8820.89
635897-358970.8650.87
20min136014-360140.8670.892.080.870.902.08
238063-380630.9170.92
337035-370350.8920.90
436314-363140.8750.88
537571-375710.9050.91
637123-371230.8940.90
30min137753-377530.9090.912.840.920.922.70
238004-380040.9150.92
336521-365210.8800.89
438949-389490.9380.95
539363-393630.9480.95
637075-370750.8930.90
45min136933-369330.8900.901.170.900.911.09
237763-377630.9100.92
337357-373570.9000.91
436900-369000.8890.90
537837-378370.9110.92
636895-368950.8890.90
60min137430-374300.9020.903.380.910.913.62
238521-385210.9280.94
337515-375150.9040.91
435446-354460.8540.86
538939-389390.9380.95
636644-366440.8830.89
极限136895-368950.8890.903.530.900.913.68
239194-391940.9440.96
337931-379310.9140.93
435689-356890.8600.87
537646-376460.9070.92
635944-359440.8660.88
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