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%
110.751335089133430913343951333563133345813341630.06
210.671324028132456213242950.03
单位质量响应值RSD%判断
124108.19124113.870.01数据可信
供试品溶液-X0734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%
60min170326-703265.2345.345.075.235.345.09
271260-712605.3035.30
376478-764785.6925.69
476011-760115.6575.66
567715-677155.0405.04
669090-690905.1425.14
120min1122355-1223559.1069.895.619.119.905.62
2140533-14053310.45910.47
3133273-1332739.9199.93
4142088-14208810.57510.58
5130644-1306449.7239.73
6128637-1286379.5749.58
240min1230246-23024617.13617.671.7817.1617.701.78
2240400-24040017.89117.91
3236974-23697417.63617.66
4241820-24182017.99718.02
5239895-23989517.85417.88
6235602-23560217.53417.56
360min1325689-32568924.23924.774.3724.2924.824.37
2333377-33337724.81124.86
3324296-32429624.13524.18
4325167-32516724.20024.25
5361679-36167926.91726.97
6326391-32639124.29124.34
480min1423704-42370431.53331.213.9231.6231.303.90
2417181-41718131.04831.14
3397045-39704529.54929.64
4411428-41142830.62030.71
5446927-44692733.26233.35
6419599-41959931.22831.31
600min1481360-48136035.82436.244.1635.9636.384.15
2501339-50133937.31137.45
3453198-45319833.72833.86
4484095-48409536.02836.16
5512553-51255338.14638.28
6489461-48946136.42736.56
720min1560194-56019441.69141.793.9541.8841.983.95
2573953-57395342.71542.91
3525938-52593839.14239.32
4550742-55074240.98841.18
5591252-59125244.00344.20
6567331-56733142.22242.41
840min1620686-62068646.19347.066.7146.4447.316.69
2628430-62843046.77047.02
3591837-59183744.04644.29
4618794-61879446.05246.30
5715056-71505653.21653.48
6619032-61903246.07046.32
960min1688369-68836951.23052.987.4951.5553.307.47
2708379-70837952.72053.04
3681363-68136350.70951.01
4685574-68557451.02251.34
5819057-81905760.95761.30
6688693-68869351.25451.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1776855-77685557.81658.697.9658.2159.097.94
2766892-76689257.07457.48
3760937-76093756.63157.01
4770250-77025057.32457.72
5914403-91440368.05268.49
6742319-74231955.24555.64
1200min1875273-87527365.14063.995.5365.6264.485.52
2848245-84824563.12963.62
3832278-83227861.94062.41
4802691-80269159.73960.22
5942881-94288170.17270.71
6857274-85727463.80164.28
1320min1935537-93553769.62569.665.8470.2070.245.84
2921626-92162668.59069.17
3897493-89749366.79467.35
4889850-88985066.22566.80
51041273-104127377.49478.14
6930037-93003769.21669.79
1440min1975553-97555372.60373.604.7973.2974.294.80
2988339-98833973.55574.24
3965468-96546871.85372.51
4937776-93777669.79270.46
51077627-107762780.20080.96
6988704-98870473.58274.26
1560min11009257-100925775.11276.103.2375.9076.903.25
21041597-104159777.51978.32
3983600-98360073.20273.97
41009978-100997875.16575.94
51078450-107845080.26181.14
61011936-101193675.31176.10
1680min11013401-101340175.42078.213.2276.3279.123.23
21063946-106394679.18280.10
31036780-103678077.16078.04
41035591-103559177.07277.96
51111403-111140382.71483.71
61044189-104418977.71178.61
1800min11049259-104925978.08978.462.4679.1179.492.49
21063300-106330079.13480.17
31032083-103208376.81077.80
41031549-103154976.77177.77
51101192-110119281.95483.08
61047950-104795077.99179.01
1920min11059836-105983678.87678.682.7180.0179.842.72
21080528-108052880.41681.57
31037810-103781077.23778.35
41021040-102104075.98977.11
51098618-109861881.76283.01
61045667-104566777.82178.96
2040min11050863-105086378.20877.753.6879.4679.013.66
21082670-108267080.57581.85
31014798-101479875.52476.75
41046715-104671577.89979.13
51085785-108578580.80782.17
6987178-98717873.46974.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min11061298-106129878.98578.991.7980.3580.381.82
21075866-107586680.06981.46
31041599-104159977.51978.86
41048393-104839378.02479.37
51091286-109128681.21782.71
61050064-105006478.14979.51
极限11051293-105129378.24078.751.6379.7380.251.66
21073813-107381379.91681.43
31042086-104208677.55579.01
41048106-104810678.00379.47
51085159-108515980.76182.37
61048454-104845478.02979.51
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%
110.751488069148901314883211489689148907714888340.05
210.671467679146699814673380.04
单位质量响应值RSD%判断
138496.19137519.960.51数据可信
供试品溶液-X0734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%
60min162399-623994.1764.404.504.184.404.43
263580-635804.2554.26
363648-636484.2604.26
469077-690774.6234.62
566762-667624.4684.47
669088-690884.6244.62
120min1117973-1179737.8968.725.417.908.735.40
2132295-1322958.8548.86
3132561-1325618.8728.88
4137721-1377219.2189.22
5126703-1267038.4808.49
6134603-1346039.0099.02
240min1232516-23251615.56215.360.9815.5815.380.97
2228097-22809715.26615.29
3226407-22640715.15315.17
4230075-23007515.39915.42
5231369-23136915.48515.50
6228842-22884215.31615.34
360min1317689-31768921.26321.634.3521.3021.674.34
2324751-32475121.73521.78
3315099-31509921.08921.13
4304379-30437920.37220.42
5332401-33240122.24722.29
6344405-34440523.05123.09
480min1405396-40539627.13327.354.2927.2127.434.28
2413958-41395827.70627.78
3379437-37943725.39625.47
4406542-40654227.21027.28
5433433-43343329.00929.09
6413355-41335527.66627.74
600min1478730-47873032.04131.923.5032.1632.043.50
2462732-46273230.97031.09
3457975-45797530.65230.76
4472052-47205231.59431.71
5503492-50349233.69833.82
6486728-48672832.57632.70
720min1538848-53884836.06536.772.7236.2336.942.72
2555208-55520837.16037.32
3527846-52784635.32835.49
4545075-54507536.48236.64
5567579-56757937.98838.16
6561940-56194037.61037.78
840min1609335-60933540.78241.386.5041.0041.606.47
2609019-60901940.76140.98
3563505-56350537.71537.93
4608624-60862440.73540.95
5686063-68606345.91846.14
6632841-63284142.35642.58
960min1683318-68331845.73446.546.6846.0146.836.66
2680559-68055945.54945.83
3675479-67547945.20945.48
4644275-64427543.12143.40
5780449-78044952.23552.53
6708501-70850147.42047.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1757656-75765650.70951.157.0851.0651.517.06
2740212-74021249.54249.89
3714622-71462247.82948.16
4739997-73999749.52849.87
5868843-86884358.15158.53
6764536-76453651.17051.53
1200min1843646-84364656.46556.765.0356.8957.195.03
2827417-82741755.37955.80
3820467-82046754.91355.32
4807706-80770654.05954.48
5925619-92561961.95162.41
6863670-86367057.80558.24
1320min1927102-92710262.05061.664.8062.5662.184.80
2883264-88326459.11659.62
3886883-88688359.35959.85
4895615-89561559.94360.44
51000321-100032166.95167.51
6934878-93487862.57163.09
1440min1935969-93596962.64463.624.0663.2464.224.05
2961711-96171164.36764.96
3923251-92325161.79362.37
4929185-92918562.19062.78
51024063-102406368.54069.19
6928751-92875162.16162.78
1560min1961298-96129864.33965.922.9465.0366.622.94
21008550-100855067.50268.19
3964768-96476864.57165.24
4976769-97676965.37566.06
51031935-103193569.06769.82
6965745-96574564.63765.35
1680min11017306-101730668.08868.693.0268.8869.493.03
21036147-103614769.34970.14
3993592-99359266.50167.27
41009086-100908667.53868.32
51082897-108289772.47873.34
61019040-101904068.20469.01
1800min1902083-90208360.37667.185.2261.2768.085.17
21018168-101816868.14569.04
31032231-103223169.08769.95
41020179-102017968.28069.16
51049449-104944970.23971.21
61000235-100023566.94567.85
1920min11046140-104614070.01870.032.3971.0071.032.39
21061901-106190171.07272.07
31033414-103341469.16670.14
41019663-101966368.24569.23
51087373-108737372.77773.85
61029035-102903568.87369.88
2040min11030478-103047868.96969.651.9570.0670.761.96
21063541-106354171.18272.29
31013913-101391367.86168.94
41039204-103920469.55370.64
51065435-106543571.30972.49
61031093-103109369.01070.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min11045403-104540369.96870.292.3771.1671.502.37
21073462-107346271.84673.06
31014844-101484467.92369.10
41045939-104593970.00471.19
51083421-108342172.51373.80
61038226-103822669.48870.70
极限11050056-105005670.28070.272.1571.5871.602.16
21074274-107427471.90173.22
31019975-101997568.26669.55
41028997-102899768.87070.17
51074671-107467171.92773.33
61051855-105185570.40071.72
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