氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661469064147136914706361471837147216514710140.09
210.611462745146751214651280.24
单位质量响应值RSD%判断
137993.81138089.350.05数据可信
供试品溶液-X0794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%
60min197999-979996.5576.7410.276.566.7410.27
2101843-1018436.8156.81
3116634-1166347.8047.80
484332-843325.6435.64
5102755-1027556.8766.88
6100733-1007336.7406.74
120min1191088-19108812.78613.2112.9012.8013.2212.90
2192663-19266312.89212.90
3237669-23766915.90315.91
4158938-15893810.63510.64
5206286-20628613.80313.81
6197812-19781213.23613.25
240min1380453-38045325.45725.7612.1225.4925.7912.13
2386753-38675325.87925.91
3447639-44763929.95329.99
4305882-30588220.46720.49
5410205-41020527.44827.48
6378716-37871625.34125.37
360min1578199-57819938.68938.1511.5138.7638.2211.51
2577532-57753238.64438.71
3638768-63876842.74142.82
4450891-45089130.17030.23
5618191-61819141.36541.44
6557138-55713837.27937.35
480min1763690-76369051.10050.1311.5051.2350.2611.50
2763370-76337051.07951.21
3828465-82846555.43555.58
4587969-58796939.34239.44
5814366-81436654.49154.63
6737137-73713749.32449.45
600min1949013-94901363.50162.3710.6763.7062.5710.67
2944839-94483963.22163.42
31013185-101318567.79568.02
4745481-74548149.88250.04
51018307-101830768.13768.35
6921839-92183961.68261.88
720min11127382-112738275.43674.789.5875.7375.079.58
21141013-114101376.34876.65
31195209-119520979.97480.30
4909239-90923960.83961.07
51200875-120087580.35380.67
61131426-113142675.70676.00
840min11310630-131063087.69785.508.8988.1185.908.90
21306626-130662687.42987.84
31344197-134419789.94390.39
41048246-104824670.14170.47
51341661-134166189.77490.21
61315042-131504287.99388.40
960min11489031-148903199.63596.177.11100.1896.717.12
21490530-149053099.735100.28
31489370-148937099.657100.24
41230659-123065982.34682.78
51465222-146522298.04198.61
61458987-145898797.62498.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11465787-146578798.07998.391.6298.7799.071.66
21489573-148957399.671100.36
31491976-149197699.832100.57
41427184-142718495.49696.05
51469055-146905598.29899.02
61479318-147931898.98599.67
1200min11485927-148592799.42798.470.59100.2799.300.62
21474576-147457698.66799.51
31471409-147140998.45599.34
41459950-145995097.68998.39
51467736-146773698.21099.08
61470530-147053098.39799.23
1320min11474842-147484298.68598.000.6399.6798.970.64
21468678-146867898.27399.26
31468836-146883698.28399.31
41458182-145818297.57098.41
51449621-144962196.99898.01
61467674-146767498.20699.18
1440min11473772-147377298.61497.780.6699.7598.900.68
21461135-146113597.76898.91
31465985-146598598.09399.27
41452174-145217497.16898.16
51448279-144827996.90898.07
61466076-146607698.09999.22
极限11472419-147241998.52397.620.6999.8198.890.71
21456308-145630897.44598.73
31464120-146412097.96899.29
41449378-144937896.98198.12
51446507-144650796.78998.10
61464873-146487398.01899.29
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661463195145667714680311457077145629114602540.36
210.611457113145832914577210.06
单位质量响应值RSD%判断
136984.43137391.230.21数据可信
供试品溶液-X0794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%
60min1102546-1025466.9047.058.356.907.058.33
297682-976826.5776.58
3121229-1212298.1628.16
4100382-1003826.7596.76
5107149-1071497.2147.21
699207-992076.6806.68
120min1199627-19962713.44113.626.5213.4513.626.52
2187157-18715712.60112.61
3225442-22544215.17915.19
4200639-20063913.50913.52
5206760-20676013.92113.93
6193742-19374213.04413.05
240min1401623-40162327.04127.446.3827.0727.476.39
2371339-37133925.00225.03
3451579-45157930.40430.44
4400619-40061926.97327.00
5414219-41421927.88927.92
6405946-40594627.33227.36
360min1596655-59665540.17241.043.6340.2441.113.64
2581450-58145039.14839.21
3644778-64477843.41243.49
4603180-60318040.61140.68
5607513-60751340.90340.98
6623875-62387542.00542.08
480min1801206-80120653.94454.664.3754.0854.804.37
2767469-76746951.67351.80
3841246-84124656.64056.79
4796130-79613053.60353.73
5799132-79913253.80553.94
6865946-86594658.30358.44
600min1992233-99223366.80667.414.1467.0267.634.13
2938337-93833763.17763.38
31031081-103108169.42269.65
4976941-97694165.77665.99
51014131-101413168.28068.50
61054831-105483171.02171.24
720min11187302-118730279.94079.633.5180.2579.943.51
21106757-110675774.51774.81
31198214-119821480.67481.01
41172538-117253878.94679.26
51203617-120361781.03881.36
61227535-122753582.64982.98
840min11385980-138598093.31791.253.8093.7591.683.79
21263029-126302985.03885.45
31351779-135177991.01491.47
41415795-141579595.32495.75
51349816-134981690.88291.32
61365029-136502991.90692.36
960min11515237-1515237102.01999.901.55102.59100.481.54
21477659-147765999.489100.03
31487773-1487773100.170100.76
41502002-1502002101.128101.70
51467809-146780998.82699.40
61452292-145229297.78198.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11504145-1504145101.27299.741.37102.00100.461.36
21487323-1487323100.140100.83
31483573-148357399.887100.63
41497362-1497362100.816101.54
51466634-146663498.74799.47
61449394-144939497.58698.32
1200min11504556-1504556101.30099.431.59102.18100.301.57
21480022-148002299.648100.48
31485218-148521899.998100.89
41491102-1491102100.394101.27
51459959-145995998.29799.17
61439545-143954596.92397.81
1320min11494203-1494203100.60399.011.46101.63100.031.44
21474120-147412099.251100.24
31474856-147485699.300100.34
41489071-1489071100.258101.28
51452226-145222697.77798.80
61438613-143861396.86097.89
1440min11488934-1488934100.24899.071.69101.43100.241.67
21483420-148342099.877101.01
31469322-146932298.928100.12
41500512-1500512101.028102.20
51452353-145235397.78598.95
61433785-143378596.53597.71
极限11486079-1486079100.05698.341.49101.3999.661.47
21464983-146498398.63699.92
31461209-146120998.38299.72
41478946-147894699.576100.90
51444698-144469897.27098.58
61427619-142761996.12097.44
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661459038146164514606511460006145771714598110.11
210.611452910145045914516840.12
单位质量响应值RSD%判断
136942.87136822.240.07数据可信
供试品溶液-X0801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%
60min1122131-1221318.2417.406.908.247.396.89
2110131-1101317.4327.43
3111367-1113677.5157.51
4108096-1080967.2947.29
5107037-1070377.2237.22
698794-987946.6676.67
120min1231107-23110715.59513.936.8715.6113.946.86
2212907-21290714.36714.38
3205320-20532013.85513.87
4198990-19899013.42813.44
5199537-19953713.46513.48
6190666-19066612.86612.88
240min1431062-43106229.08826.256.6529.1226.286.65
2397445-39744526.81926.85
3384704-38470425.95925.99
4374566-37456625.27525.31
5392765-39276526.50326.53
6353453-35345323.85123.88
360min1606266-60626640.91038.275.0740.9938.345.08
2587100-58710039.61739.69
3564303-56430338.07938.15
4545545-54554536.81336.88
5573603-57360338.70638.78
6526048-52604835.49735.56
480min1780563-78056352.67249.843.7052.8149.973.71
2759497-75949751.25051.38
3735716-73571649.64549.77
4710781-71078147.96348.09
5733314-73331449.48349.61
6711662-71166248.02248.14
600min1973437-97343765.68761.874.7165.9162.084.71
2968746-96874665.37065.58
3897922-89792260.59160.79
4871824-87182458.83059.03
5890637-89063760.09960.30
6898783-89878360.64960.84
720min11147777-114777777.45173.454.8577.7773.744.84
21151033-115103377.67077.98
31053950-105395071.11971.41
41039403-103940370.13870.42
51036724-103672469.95770.25
61102002-110200274.36274.64
840min11289247-128924786.99783.604.0487.4384.004.04
21297487-129748787.55387.98
31204697-120469781.29281.69
41198119-119811980.84881.24
51182159-118215979.77180.17
61261288-126128885.11085.50
960min11411462-141146295.24493.512.4295.8194.042.43
21421823-142182395.94396.50
31374651-137465192.76093.28
41389472-138947293.76094.27
51326721-132672189.52690.04
61390269-139026993.81494.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11492990-1492990100.745101.030.56101.45101.700.56
21504785-1504785101.541102.24
31509695-1509695101.873102.53
41494696-1494696100.861101.51
51487356-1487356100.365101.02
61493430-1493430100.775101.44
1200min11495188-1495188100.894101.200.51101.75102.030.51
21503937-1503937101.484102.34
31509572-1509572101.864102.68
41493762-1493762100.797101.60
51490655-1490655100.588101.39
61505449-1505449101.586102.40
1320min11488244-1488244100.425100.750.54101.44101.720.53
21493085-1493085100.752101.76
31508771-1508771101.810102.78
41487941-1487941100.405101.36
51488698-1488698100.456101.41
61491379-1491379100.637101.60
1440min11486862-1486862100.332100.420.42101.49101.540.42
21490072-1490072100.548101.70
31499562-1499562101.189102.31
41484999-1484999100.206101.31
51485352-1485352100.230101.33
61481993-1481993100.003101.12
极限11485883-1485883100.266100.240.47101.58101.520.47
21487211-1487211100.355101.66
31497571-1497571101.055102.33
41479626-147962699.844101.10
51478418-147841899.762101.02
61483937-1483937100.135101.40
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