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%
114.094471744470644470034465694464714468560.08
214.204449984444434447200.09
单位质量响应值RSD%判断
31714.4131318.310.89数据可信
长期6月-供试品溶液-2024071721批-左氨氯地平-pH2.0的盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1321407-32140771.54672.533.4571.5572.533.45
2308151-30815168.59568.60
3320725-32072571.39471.39
4332405-33240573.99473.99
5338911-33891175.44275.44
6333431-33343174.22274.22
10min1420776-42077693.66695.051.3093.8895.261.29
2433819-43381996.56996.77
3432292-43229296.22996.44
4422591-42259194.07094.29
5423204-42320494.20694.43
6429286-42928695.56095.78
15min1444263-44426398.89496.311.5999.3996.811.58
2437124-43712497.30597.80
3427247-42724795.10695.61
4426668-42666894.97795.48
5428755-42875595.44295.95
6431791-43179196.11896.63
20min1449510-449510100.06296.861.94100.8597.651.93
2439004-43900497.72398.51
3435639-43563996.97497.76
4425844-42584494.79495.58
5429577-42957795.62596.42
6431104-43110495.96596.76
30min1450174-450174100.21097.041.97101.3098.121.95
2440120-44012097.97299.05
3437135-43713597.30798.39
4426164-42616494.86595.94
5430050-43005095.73096.81
6431940-43194096.15197.24
45min1450707-450707100.32896.792.10101.7298.172.08
2439089-43908997.74299.12
3434796-43479696.78698.16
4425613-42561394.74296.10
5429129-42912995.52596.89
6429608-42960895.63297.01
60min1437877-43787797.47296.021.2599.1797.681.25
2435912-43591297.03598.70
3433284-43328496.45098.11
4423361-42336194.24195.88
5428135-42813595.30496.96
6429578-42957895.62597.29
极限1451457-451457100.49595.683.03102.4897.632.99
2434716-43471696.76998.73
3412231-41223191.76393.71
4423337-42333794.23696.16
5428394-42839495.36197.30
6428781-42878195.44897.40
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%
1 10.088417308400418401708383208395018399520.15
2 10.078374448356668365550.16
单位质量响应值RSD%判断
83328.5783073.980.22数据可信
长期6月-供试品溶液-2024071721批-贝那普利-pH2.0的盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185428-18542822.10832.1486.4222.1132.1486.42
2115815-11581513.80913.81
3222352-22235226.51126.51
4693811-69381182.72382.72
543898-438985.2345.23
6356147-35614742.46342.46
10min1837684-83768499.876101.491.0199.94101.591.06
2846145-846145100.885100.93
3848977-848977101.223101.30
4860432-860432102.589102.84
5857192-857192102.202102.22
6857045-857045102.185102.31
15min1846704-846704100.952101.770.70101.32102.180.75
2848787-848787101.200101.54
3849692-849692101.308101.69
4861032-861032102.660103.22
5858798-858798102.394102.72
6856608-856608102.133102.57
20min1849790-849790101.320101.560.50101.99102.270.54
2846514-846514100.929101.58
3849245-849245101.255101.94
4857292-857292102.214103.08
5856293-856293102.095102.72
6851687-851687101.546102.29
30min1850266-850266101.377101.310.42102.35102.320.47
2844620-844620100.703101.65
3846864-846864100.971101.96
4854315-854315101.859103.03
5852017-852017101.585102.52
6850291-850291101.380102.42
45min1848838-848838101.206100.890.51102.48102.210.55
2840372-840372100.197101.45
3842057-842057100.398101.69
4851019-851019101.466102.94
5849105-849105101.238102.48
6845834-845834100.848102.20
60min1849313-849313101.263100.540.57102.84102.150.59
2837203-83720399.819101.37
3838211-83821199.939101.53
4846449-846449100.921102.70
5845098-845098100.760102.30
6843120-843120100.525102.18
极限1849791-849791101.320100.031.01103.20101.951.01
2832312-83231299.236101.09
3826314-82631498.521100.42
4842752-842752100.481102.56
5843768-843768100.602102.45
6838866-838866100.017101.97
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%
114.094442064438864445084445514439094442120.08
214.204444224439754441980.08
单位质量响应值RSD%判断
31526.7631281.550.56数据可信
长期6月-供试品溶液-2024071921批-左氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1321815-32181571.89177.1617.4271.8977.1617.42
2401800-40180089.75989.76
3268578-26857859.99860.00
4418168-41816893.41593.42
5368088-36808882.22882.23
6294054-29405465.68965.69
10min1442170-44217098.77797.691.0298.9997.921.04
2434614-43461497.08997.36
3429974-42997496.05396.23
4439337-43933798.14498.42
5440528-44052898.41098.66
6437112-43711297.64797.84
15min1448544-448544100.20198.710.99100.7199.240.99
2437701-43770197.77998.34
3436794-43679497.57698.04
4443762-44376299.13399.71
5443349-44334999.04199.58
6441132-44113298.54599.04
20min1449656-449656100.45098.840.99101.2699.661.00
2440281-44028198.35599.21
3437017-43701797.62698.39
4444376-44437699.270100.14
5443127-44312798.99199.83
6440211-44021198.34099.13
30min1448993-448993100.30198.331.32101.4299.441.29
2439507-43950798.18299.33
3438258-43825897.90398.96
4431264-43126496.34197.51
5440138-44013898.32399.46
6442738-44273898.90499.98
45min1448423-448423100.17498.891.02101.59100.301.03
2439502-43950298.18199.62
3437487-43748797.73199.08
4445820-44582099.593101.05
5445593-44559399.542100.97
6439234-43923498.12199.50
60min1447957-447957100.07098.721.00101.79100.431.01
2438825-43882598.03099.77
3437458-43745897.72599.37
4446634-44663499.774101.53
5441467-44146798.620100.35
6439174-43917498.10899.78
极限1446168-44616899.67098.491.20101.69100.501.20
2434859-43485997.14499.18
3435292-43529297.24199.17
4447159-44715999.892101.95
5442251-44225198.795100.82
6439560-43956098.194100.16
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%
1 10.088350928346938348328362718350718351920.08
2 10.078353038357648355340.04
单位质量响应值RSD%判断
82856.3582972.590.10数据可信
长期6月-供试品溶液-2024071921批-贝那普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1402201-40220148.12049.2856.9348.1249.2856.93
2297313-29731335.57135.57
3544480-54448065.14265.14
4689050-68905082.43982.44
517604-176042.1062.11
6520569-52056962.28262.28
10min1820478-82047898.16398.530.6998.3198.680.73
2815390-81539097.55497.66
3830042-83004299.30799.50
4822874-82287498.45098.70
5822531-82253198.40998.42
6829861-82986199.28699.47
15min1828832-82883299.16399.220.5799.6099.670.56
2821483-82148398.28398.68
3831682-83168299.504100.00
4827630-82763099.01999.56
5835442-83544299.953100.26
6831042-83104299.42799.91
20min1828983-82898399.18199.050.4699.9299.800.43
2822453-82245398.39999.09
3827865-82786599.04799.84
4827603-82760399.01699.86
5834087-83408799.791100.39
6826499-82649998.88499.67
30min1824418-82441898.63598.700.6499.6799.740.60
2817905-81790597.85598.84
3825704-82570498.78899.88
4821671-82167198.30699.44
5833504-83350499.722100.62
6826764-82676498.91599.99
45min1820911-82091198.21598.470.6899.5499.810.65
2816967-81696797.74399.03
3820982-82098298.22399.61
4827035-82703598.948100.38
5832337-83233799.582100.78
6820123-82012398.12199.50
60min1821031-82103198.22998.320.5799.8599.950.58
2815329-81532997.54799.12
3819878-81987898.09199.77
4828144-82814499.080100.81
5826147-82614798.841100.34
6820331-82033198.14699.82
极限1817081-81708197.75797.950.7999.6899.880.80
2809463-80946396.84598.71
3816051-81605197.63399.61
4827594-82759499.015101.04
5824499-82449998.644100.44
6817697-81769797.83099.80
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%
114.094419514419974419244421434418024419630.03
214.204441184442984442080.03
单位质量响应值RSD%判断
31367.1431282.250.20数据可信
长期6月-供试品溶液-2024072121批-左氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338798-33879875.87677.1112.6875.8877.1112.68
2379799-37979985.05885.06
3364395-36439581.60881.61
4295494-29549466.17866.18
5395788-39578888.63988.64
6291478-29147865.27865.28
10min1424081-42408194.97596.161.2195.2096.391.18
2426965-42696595.62195.88
3424312-42431295.02795.27
4436416-43641697.73897.94
5430222-43022296.35196.62
6434182-43418297.23897.43
15min1429243-42924396.13196.611.3396.6497.131.31
2427944-42794495.84096.38
3423283-42328394.79795.33
4438901-43890198.29498.79
5432665-43266596.89897.45
6436249-43624997.70098.19
20min1427411-42741195.72196.571.5396.5297.381.50
2424443-42444395.05695.89
3424796-42479695.13595.95
4440008-44000898.54299.33
5434071-43407197.21398.06
6436543-43654397.76698.55
30min1423822-42382294.91796.401.4796.0197.501.45
2425640-42564095.32496.44
3425076-42507695.19896.30
4438175-43817598.13299.21
5435830-43583097.60798.74
6434086-43408697.21698.29
45min1424472-42447295.06396.231.2696.4497.621.25
2427295-42729595.69597.10
3423570-42357094.86196.25
4437251-43725197.92599.30
5432803-43280396.92998.36
6432719-43271996.91098.28
60min1423800-42380094.91295.851.9896.5797.521.95
2422057-42205794.52296.21
3416330-41633093.23994.91
4438004-43800498.09399.76
5432996-43299696.97298.69
6434683-43468397.35099.01
极限1422678-42267894.66194.392.1896.6096.362.15
2420542-42054294.18396.15
3419426-41942693.93395.88
4405465-40546590.80692.77
5429891-42989196.27798.29
6430861-43086196.49498.44
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%
1 10.088306528308038300798300408308688304880.05
2 10.078348488344778346620.04
单位质量响应值RSD%判断
82389.6882886.000.43数据可信
长期6月-供试品溶液-2024072121批-贝那普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1330782-33078239.70834.03106.4639.7134.03106.46
2716365-71636585.99585.99
3551750-55175066.23466.23
4-0.0000.00
5101866-10186612.22812.23
6-0.0000.00
10min1820331-82033198.47599.370.9998.5999.471.08
2841863-841863101.060101.32
3832126-83212699.891100.09
4825523-82552399.09899.10
5820353-82035398.47898.51
6826413-82641399.20599.21
15min1830236-83023699.664100.270.59100.08100.670.62
2840195-840195100.859101.42
3834995-834995100.235100.73
4829554-82955499.58299.88
5835317-835317100.274100.61
6841412-841412101.006101.30
20min1826027-82602799.15999.860.6399.87100.560.59
2832882-83288299.982100.85
3827037-82703799.280100.08
4829739-82973999.604100.20
5836419-836419100.406101.04
6839084-839084100.726101.33
30min1817739-81773998.16499.490.7999.17100.490.78
2831013-83101399.757100.92
3827396-82739699.323100.42
4826547-82654799.221100.12
5836314-836314100.394101.33
6833630-833630100.071100.97
45min1820048-82004898.44199.220.6299.75100.520.66
2833397-833397100.043101.51
3825095-82509599.047100.44
4821833-82183398.65599.85
5829535-82953599.580100.82
6829470-82947099.572100.78
60min1816732-81673298.04399.070.7799.64100.670.72
2824241-82424198.944100.71
3822202-82220298.700100.39
4823253-82325398.826100.31
5832247-83224799.905101.44
6833186-833186100.018101.52
极限1813532-81353297.65998.460.6399.55100.360.59
2821258-82125898.586100.65
3815502-81550297.89599.88
4820046-82004698.441100.23
5823657-82365798.874100.71
6827491-82749199.334101.14
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