左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105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2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614226874226244227054239994228164229660.14
213.634193784195124194450.03
单位质量响应值RSD%判断
31077.5930773.660.70数据可信
供试品溶液-2024071721批-左氨氯地平-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%
5min1119266-11926627.05642.2924.5127.0642.2924.50
2205563-20556346.63246.63
3150749-15074934.19834.20
4239494-23949454.32954.33
5179303-17930340.67540.68
6224045-22404550.82550.82
10min1306990-30699069.64171.172.7169.7271.302.73
2303821-30382168.92269.06
3313938-31393871.21771.32
4322384-32238473.13373.30
5310262-31026270.38370.51
6325094-32509473.74873.90
15min1330479-33047974.96976.063.9475.2676.403.95
2316676-31667671.83872.18
3334415-33441575.86276.18
4352866-35286680.04880.43
5329484-32948474.74475.08
6347892-34789278.92079.29
20min1337423-33742376.54577.393.0077.0677.963.01
2329579-32957974.76575.33
3342371-34237177.66778.21
4359076-35907681.45782.08
5334541-33454175.89176.45
6343964-34396478.02878.64
30min1343812-34381277.99479.723.6778.7480.523.68
2340045-34004577.13977.93
3353766-35376680.25281.03
4367849-36784983.44784.31
5337986-33798676.67277.46
6365051-36505182.81283.66
45min1358026-35802681.21882.943.5782.2083.983.58
2349299-34929979.23980.26
3362334-36233482.19683.21
4378718-37871885.91287.03
5361575-36157582.02483.04
6383706-38370687.04488.14
60min1359841-35984181.63083.873.8982.8585.163.90
2353554-35355480.20481.46
3364305-36430582.64383.91
4387036-38703687.79989.17
5365698-36569882.95984.22
6387836-38783687.98189.33
极限1364555-36455582.70087.673.6384.1789.213.64
2378866-37886685.94687.44
3391402-39140288.79090.30
4398139-39813990.31891.96
5382862-38286286.85388.36
6402967-40296791.41393.03
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.068463258460368469408460478474358465570.08
210.078381728411688396700.26
单位质量响应值RSD%判断
84150.8083383.320.65数据可信
供试品溶液-2024071721批-贝那普利-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%
5min181562-815629.65933.85119.699.6633.85119.68
2694206-69420682.21282.21
3-0.0000.00
4159227-15922718.85718.86
5748496-74849688.64188.64
631374-313743.7163.72
10min1844492-844492100.01098.781.03100.0498.881.02
2821317-82131797.26597.51
3832134-83213498.54698.55
4832387-83238798.57698.63
5842894-84289499.821100.09
6831369-83136998.45698.47
15min1849480-849480100.60199.301.23100.9399.701.15
2819551-81955197.05697.59
3843968-84396899.948100.24
4837587-83758799.19299.54
5837666-83766699.20299.77
6842817-84281799.812100.12
20min1846596-846596100.25999.311.19100.89100.001.10
2819230-81923097.01897.85
3845083-845083100.080100.68
4839239-83923999.388100.04
5838948-83894899.353100.22
6842233-84223399.742100.35
30min1842332-84233299.75498.861.14100.6999.851.07
2816280-81628096.66997.79
3839066-83906699.367100.26
4833642-83364298.72599.67
5837841-83784199.222100.38
6839557-83955799.425100.33
45min1843205-84320599.85898.631.36101.0999.921.28
2812513-81251396.22397.63
3836095-83609599.015100.21
4828632-82863298.13299.38
5834648-83464898.844100.30
6841833-84183399.695100.90
60min1840289-84028999.51298.181.35101.0499.771.28
2808362-80836295.73197.43
3833480-83348098.706100.20
4825769-82576997.79399.33
5831891-83189198.518100.27
6834531-83453198.830100.33
极限1837491-83749199.18197.901.31101.0199.781.22
2807717-80771795.65597.64
3834469-83446998.823100.61
4822028-82202897.35099.18
5826980-82698097.93699.99
6831200-83120098.436100.23
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105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2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614222874225374232174225024237454228580.15
213.634215844213424214630.05
单位质量响应值RSD%判断
31069.6530921.720.34数据可信
供试品溶液-2024071721批-左氨氯地平-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%
5min1133337-13333730.17940.4736.6030.1840.4736.60
267143-6714315.19715.20
3200265-20026545.32745.33
4222266-22226650.30650.31
5236744-23674453.58353.58
6212956-21295648.19948.20
10min1294219-29421966.59271.406.2466.6871.526.28
2295589-29558966.90266.95
3312857-31285770.81070.95
4313241-31324170.89771.05
5341571-34157177.30977.47
6335336-33533675.89876.04
15min1308360-30836069.79276.066.5170.0876.406.55
2319888-31988872.40172.65
3329757-32975774.63574.98
4334955-33495575.81276.18
5363296-36329682.22682.62
6360151-36015181.51481.89
20min1316191-31619171.56577.976.9072.0678.546.94
2322122-32212272.90773.37
3339774-33977476.90277.47
4345253-34525378.14278.73
5371163-37116384.00784.65
6372555-37255584.32284.94
30min1322533-32253373.00078.806.8673.7179.606.89
2327465-32746574.11674.80
3340404-34040477.04577.85
4344449-34444977.96078.79
5373425-37342584.51985.41
6380593-38059386.14187.01
45min1318934-31893472.18680.227.8273.1281.267.83
2339727-33972776.89277.80
3343695-34369577.79078.82
4348999-34899978.99080.05
5385866-38586687.33588.48
6389411-38941188.13789.27
60min1342509-34250977.52182.406.0678.6783.686.10
2345766-34576678.25979.39
3356391-35639180.66381.93
4356782-35678280.75282.05
5389142-38914288.07689.48
6393878-39387889.14890.54
极限1352912-35291279.87685.326.0381.2686.846.07
2357664-35766480.95182.32
3371534-37153484.09185.60
4370640-37064083.88885.43
5400129-40012990.56392.23
6408936-40893692.55694.22
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.068452988455438448698473488483918462900.18
210.078450558438868444700.10
单位质量响应值RSD%判断
84124.2583859.980.23数据可信
供试品溶液-2024071721批-贝那普利-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%
5min141440-414404.89428.73127.234.8928.74127.23
2-0.0000.00
377322-773229.1329.13
483020-830209.8059.81
5748045-74804588.34988.35
6509939-50993960.22760.23
10min1833927-83392798.49299.221.1098.5199.301.16
2844262-84426299.71399.71
3825356-82535697.48097.51
4840710-84071099.29399.32
5844756-84475699.771100.04
6851307-851307100.545100.73
15min1845016-84501699.802100.171.27100.11100.551.25
2862165-862165101.827102.13
3831738-83173898.23498.55
4857318-857318101.255101.58
5843700-84370099.647100.21
6848675-848675100.234100.72
20min1843996-84399699.68299.901.31100.29100.581.28
2858927-858927101.445102.05
3829762-82976298.00098.61
4856465-856465101.154101.79
5837991-83799198.97299.84
6847918-847918100.145100.93
30min1842901-84290199.55299.741.25100.46100.721.23
2859030-859030101.457102.37
3827700-82770097.75798.67
4851070-851070100.517101.45
5840993-84099399.327100.49
6845109-84510999.813100.90
45min1837471-83747198.91199.211.45100.12100.491.42
2856587-856587101.169102.38
3822058-82205897.09098.29
4849349-849349100.314101.55
5833601-83360198.45499.91
6840984-84098499.326100.71
60min1837364-83736498.89899.081.46100.40100.661.42
2857010-857010101.219102.74
3823051-82305197.20898.70
4848445-848445100.207101.74
5830444-83044498.08199.83
6837172-83717298.876100.56
极限1832471-83247198.32098.621.17100.12100.491.14
2849093-849093100.283102.10
3821371-82137197.00998.79
4841497-84149799.386101.22
5828870-82887097.89599.94
6836676-83667698.817100.79
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105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2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614193494216984197004199114200754201470.22
213.634138764139354139060.02
单位质量响应值RSD%判断
30870.4630367.281.17数据可信
供试品溶液-2024071921批-左氨氯地平-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%
5min1145542-14554233.34938.8925.8133.3538.8925.82
2200227-20022745.87945.88
3185747-18574742.56142.56
4182720-18272041.86741.87
5211422-21142248.44448.44
692801-9280121.26421.26
10min1314454-31445472.05271.482.9172.1571.602.93
2317272-31727272.69872.84
3313699-31369971.87972.01
4321319-32131973.62573.75
5309863-30986371.00071.15
6295212-29521267.64367.71
15min1341126-34112678.16376.762.0678.4877.092.07
2339187-33918777.71978.07
3332435-33243576.17276.52
4342108-34210878.38878.73
5330403-33040375.70676.06
6324856-32485674.43574.70
20min1349007-34900779.96978.452.3380.5279.012.35
2347919-34791979.72080.31
3349874-34987480.16880.74
4340358-34035877.98778.57
5337150-33715077.25277.84
6329904-32990475.59276.08
30min1354359-35435981.19579.202.7481.9980.002.72
2349073-34907379.98480.81
3347486-34748679.62180.43
4352992-35299280.88281.70
5328930-32893075.36976.19
6340973-34097378.12878.85
45min1360325-36032582.56281.632.7683.6082.672.76
2364160-36416083.44184.51
3362705-36270583.10884.16
4362754-36275483.11984.18
5341395-34139578.22579.27
6346319-34631979.35380.30
60min1371556-37155685.13682.473.5486.4283.753.50
2370874-37087484.98086.30
3343478-34347878.70280.00
4370895-37089584.98486.29
5348367-34836779.82281.10
6354476-35447681.22282.41
极限1375730-37573086.09285.212.5587.6386.742.54
2380295-38029587.13888.71
3374210-37421085.74487.28
4379330-37933086.91788.48
5355494-35549481.45682.97
6366284-36628483.92885.36
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.068448728458318447018483688461028459750.18
210.078287758293178290460.05
单位质量响应值RSD%判断
84092.9482328.301.50数据可信
供试品溶液-2024071921批-贝那普利-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%
5min1523114-52311462.37026.6688.0062.3726.6688.00
211321-113211.3501.35
3292777-29277734.90734.91
4286440-28644034.15234.15
5227835-22783527.16527.16
6-0.0000.00
10min1829432-82943298.89297.482.5799.0897.562.62
2808494-80849496.39696.40
3833984-83398499.43599.54
4840676-840676100.233100.34
5808390-80839096.38396.46
6784616-78461693.54993.55
15min1831173-83117399.10098.251.8099.5898.621.85
2815660-81566097.25097.54
3836996-83699699.794100.20
4842452-842452100.445100.85
5811308-81130896.73197.10
6806667-80666796.17896.46
20min1828029-82802998.72597.881.8199.5198.551.86
2813665-81366597.01297.60
3832833-83283399.298100.00
4840276-840276100.185100.89
5807780-80778096.31196.97
6803286-80328695.77596.34
30min1824097-82409798.25697.561.7399.3398.521.77
2811599-81159996.76697.64
3830518-83051899.022100.02
4836457-83645799.730100.73
5804294-80429495.89596.84
6802775-80277595.71496.57
45min1822422-82242298.05797.471.7299.4398.721.76
2817646-81764697.48798.65
3828537-82853798.786100.08
4834579-83457999.506100.81
5801280-80128095.53696.77
6800660-80066095.46296.61
60min1819544-81954497.71396.951.8299.3898.501.86
2805449-80544996.03397.49
3825827-82582798.462100.06
4832044-83204499.204100.81
5796597-79659794.97796.50
6799313-79931395.30196.73
极限1816482-81648297.34896.591.7699.3198.431.80
2803323-80332395.77997.53
3822055-82205598.01399.90
4828342-82834298.762100.66
5797032-79703295.02996.84
6793519-79351994.61096.33
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105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2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614226934228304227194227424229934227950.03
213.634228424229534228980.02
单位质量响应值RSD%判断
31065.0331027.000.09数据可信
供试品溶液-2024071921批-左氨氯地平-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%
5min1214303-21430348.42532.2128.0148.4332.2228.01
2129971-12997129.36929.37
3135700-13570030.66430.66
4116220-11622026.26226.26
5101418-10141822.91722.92
6157768-15776835.65035.65
10min1304714-30471468.85566.946.0269.0067.046.01
2302673-30267368.39468.48
3308875-30887569.79569.89
4288491-28849165.18965.27
5309364-30936469.90669.97
6263311-26331159.49959.61
15min1334078-33407875.49074.623.0075.8474.923.00
2333292-33329275.31375.61
3333479-33347975.35575.66
4314970-31497071.17271.45
5342923-34292377.48977.77
6322556-32255672.88773.17
20min1350143-35014379.12076.633.5279.7077.163.53
2341900-34190077.25877.78
3343395-34339577.59578.12
4320295-32029572.37672.86
5349756-34975679.03379.54
6329365-32936574.42574.93
30min1359544-35954481.24578.802.2582.0679.552.27
2347182-34718278.45179.20
3349362-34936278.94479.70
4335986-33598675.92176.63
5353279-35327979.82980.58
6346877-34687778.38279.11
45min1366463-36646382.80880.912.4083.8781.902.41
2358067-35806780.91181.90
3356387-35638780.53181.53
4343217-34321777.55578.49
5366615-36661582.84283.83
6357694-35769480.82781.79
60min1373755-37375584.45682.452.0685.7683.682.08
2367786-36778683.10784.34
3362367-36236781.88283.12
4351822-35182279.50080.67
5368955-36895583.37184.61
6364486-36448682.36183.57
极限1380744-38074486.03585.461.3287.6086.941.34
2377278-37727885.25286.73
3379328-37932885.71587.20
4368855-36885583.34984.75
5383280-38328086.60888.09
6379805-37980585.82387.27
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.068461198452028456308454458453698455530.05
210.078439028439418439220.01
单位质量响应值RSD%判断
84050.9983805.560.21数据可信
供试品溶液-2024071921批-贝那普利-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%
5min1147506-14750617.43514.6492.8017.4314.6492.81
224967-249672.9512.95
3-0.0000.00
4236478-23647827.95127.95
557630-576306.8126.81
6276405-27640532.67032.67
10min1802824-80282494.89194.940.7394.9494.980.72
2811603-81160395.92995.94
3794804-79480493.94393.94
4800670-80067094.63694.72
5807589-80758995.45495.47
6801834-80183494.77494.87
15min1817179-81717996.58896.190.7796.9296.520.75
2818322-81832296.72397.02
3806666-80666695.34595.63
4808059-80805995.51095.88
5822008-82200897.15897.47
6810721-81072195.82496.21
20min1815146-81514696.34795.890.8096.9796.510.78
2816279-81627996.48197.07
3803618-80361894.98595.55
4806330-80633095.30595.96
5819358-81935896.84597.44
6806938-80693895.37796.05
30min1813892-81389296.19995.830.8197.1196.740.81
2814589-81458996.28197.16
3799820-79982094.53695.39
4809715-80971595.70596.65
5818540-81854096.74897.64
6808169-80816995.52396.48
45min1812946-81294696.08795.650.8497.2996.840.84
2812583-81258396.04497.21
3797168-79716894.22295.36
4807277-80727795.41796.64
5816461-81646196.50397.68
6809142-80914295.63896.88
60min1808585-80858595.57295.260.7997.0696.730.79
2808630-80863095.57797.03
3794805-79480593.94395.36
4804976-80497695.14596.66
5813515-81351596.15597.62
6804920-80492095.13996.67
极限1806330-80633095.30595.030.7897.0896.790.78
2806302-80630295.30297.04
3793652-79365293.80795.51
4805720-80572095.23397.03
5811643-81164395.93397.69
6800258-80025894.58896.40
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