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%
114.094472774464894474114479284468344471880.13
214.204433664472194452920.62
单位质量响应值RSD%判断
31737.9731358.590.86数据可信
中间条件6月-供试品溶液-2024071721批-左氨氯地平-pH2.0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%
5min1332291-33229173.89470.6610.0773.8970.6610.07
2294403-29440365.46865.47
3363590-36359080.85480.85
4276319-27631961.44761.45
5336304-33630474.78674.79
6303648-30364867.52467.52
10min1432615-43261596.20393.531.6196.4293.741.60
2422035-42203593.85094.05
3419377-41937793.25993.50
4420105-42010593.42193.61
5412529-41252991.73791.96
6416808-41680892.68892.89
15min1437162-43716297.21494.601.8097.7295.091.79
2430936-43093695.83096.31
3422008-42200893.84494.37
4426094-42609494.75395.22
5416973-41697392.72593.22
6419135-41913593.20693.69
20min1439483-43948397.73194.801.8098.5395.581.79
2428947-42894795.38896.15
3421641-42164193.76394.57
4426898-42689894.93295.68
5417119-41711992.75793.54
6423739-42373994.22994.99
30min1438824-43882497.58494.811.6698.6895.871.66
2422096-42209693.86494.92
3427780-42778095.12896.21
4428005-42800595.17896.21
5418785-41878593.12894.18
6422704-42270493.99995.04
45min1432328-43232896.13994.711.3997.5396.061.38
2431846-43184696.03297.37
3422453-42245393.94395.31
4428272-42827295.23796.56
5417504-41750492.84394.18
6422972-42297294.05995.38
60min1436319-43631997.02794.531.6798.7096.161.66
2429677-42967795.55097.17
3420466-42046693.50295.15
4425612-42561294.64696.25
5416622-41662292.64794.26
6421852-42185293.81095.42
极限1434786-43478696.68694.261.7198.6596.181.70
2429696-42969695.55497.46
3419572-41957293.30395.24
4424637-42463794.42996.32
5416119-41611992.53594.43
6418467-41846793.05794.95
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%
110.088444508405688452038430088417058429870.23
210.078348748401558375140.45
单位质量响应值RSD%判断
83629.6683169.220.40数据可信
中间条件6月-供试品溶液-2024071721批-贝那普利-pH2.0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%
5min1181634-18163421.60522.0691.8621.6022.0691.86
257155-571556.7986.80
3399360-39936047.50247.50
421532-215322.5612.56
5388940-38894046.26346.26
664391-643917.6597.66
10min1842691-842691100.23599.910.88100.3099.970.91
2840036-84003699.91999.94
3838714-83871499.76299.90
4827067-82706798.37798.38
5849412-849412101.035101.17
6841579-841579100.103100.13
15min1846461-846461100.684100.700.73101.05101.060.74
2852096-852096101.354101.67
3840652-84065299.993100.43
4838252-83825299.707100.01
5853683-853683101.543101.98
6848335-848335100.907101.23
20min1845226-845226100.537100.340.86101.20101.010.86
2846122-846122100.643101.27
3835486-83548699.378100.12
4834044-83404499.20799.81
5850894-850894101.211101.96
6849799-849799101.081101.71
30min1841342-841342100.075100.160.77101.04101.130.79
2843515-843515100.333101.26
3838954-83895499.791100.83
4831743-83174398.93399.83
5850132-850132101.120102.17
6846654-846654100.707101.64
45min1832864-83286499.06699.710.85100.34100.980.85
2843566-843566100.339101.57
3833373-83337399.127100.47
4829700-82970098.69099.89
5845555-845555100.576101.93
6844603-844603100.463101.69
60min1833195-83319599.10699.220.82100.67100.780.83
2837402-83740299.606101.13
3827129-82712998.384100.02
4825182-82518298.15399.64
5840929-840929100.026101.68
6840938-840938100.027101.56
极限1830930-83093098.83698.910.88100.70100.770.90
2837279-83727999.591101.42
3827288-82728898.403100.33
4819907-81990797.52599.31
5840084-84008499.925101.88
6833704-83370499.166101.00
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%
114.094446154432624452734445804433444442150.20
214.204449044418934433980.49
单位质量响应值RSD%判断
31526.9731225.210.69数据可信
中间条件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%
5min1308428-30842868.96377.4110.0368.9677.4210.03
2401160-40116089.69789.70
3351797-35179778.66078.66
4317495-31749570.99070.99
5368032-36803282.29082.29
6330460-33046073.88973.89
10min1431926-43192696.57696.862.1196.7897.102.12
2441996-44199698.82799.10
3424343-42434394.88095.12
4423229-42322994.63194.84
5445682-44568299.65299.90
6432088-43208896.61296.83
15min1437962-43796297.92598.571.5898.4299.091.58
2446741-44674199.888100.45
3431082-43108296.38796.91
4447313-447313100.016100.51
5446541-44654199.844100.39
6435436-43543697.36197.87
20min1439718-43971898.31898.831.7199.1199.651.71
2447159-44715999.982100.85
3429839-42983996.10996.92
4449195-449195100.437101.23
5448134-448134100.200101.05
6437986-43798697.93198.73
30min1442012-44201298.83198.311.2199.9299.431.20
2445992-44599299.721100.89
3432280-43228096.65597.75
4444262-44426299.334100.43
5435854-43585497.45498.60
6437747-43774797.87798.97
45min1439565-43956598.28498.731.6199.67100.141.60
2446372-44637299.806101.27
3428807-42880795.87897.27
4444879-44487999.472100.87
5448540-448540100.291101.73
6441288-44128898.669100.06
60min1437938-43793897.92098.411.5499.60100.121.54
2444193-44419399.319101.08
3429274-42927495.98397.66
4444428-44442899.371101.07
5447905-447905100.149101.89
6437117-43711797.73799.42
极限1439171-43917198.19698.161.46100.17100.161.46
2443922-44392299.258101.32
3429195-42919595.96597.93
4444114-44411499.301101.29
5444248-44424899.331101.37
6433464-43346496.92098.90
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%
110.088389198330808375258379528342688363490.31
210.078347218315618331410.27
单位质量响应值RSD%判断
82971.1382734.960.21数据可信
中间条件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%
5min1-0.00017.06163.610.0017.06163.62
238163-381634.5694.57
3-0.0000.00
4213738-21373825.59125.59
5588334-58833470.44170.44
614640-146401.7531.75
10min1810712-81071297.06797.921.4297.0797.971.45
2812942-81294297.33497.35
3831324-83132499.53599.53
4803465-80346596.19996.28
5832147-83214799.63399.84
6816387-81638797.74697.75
15min1825668-82566898.85799.151.2699.1599.501.24
2828156-82815699.15599.46
3846636-846636101.368101.67
4814654-81465497.53997.90
5828468-82846899.19399.70
6825186-82518698.80099.10
20min1822934-82293498.53098.971.0499.1299.621.05
2824872-82487298.76299.37
3840657-840657100.652101.25
4815661-81566197.65998.32
5831788-83178899.590100.40
6823793-82379398.63399.23
30min1823420-82342098.58898.631.4199.4799.581.40
2819473-81947398.11699.02
3842935-842935100.925101.83
4807270-80727096.65597.61
5827348-82734899.059100.17
6822322-82232298.45799.35
45min1815554-81555497.64798.111.2298.8399.351.22
2818604-81860498.01299.21
3834217-83421799.881101.09
4804083-80408396.27397.51
5824478-82447898.715100.12
6819589-81958998.13099.32
60min1814663-81466397.54097.991.2299.0199.521.22
2816881-81688197.80599.29
3832807-83280799.712101.22
4802730-80273096.11197.64
5823421-82342198.588100.29
6820040-82004098.18499.66
极限1810667-81066797.06197.551.3898.8399.381.37
2812192-81219297.24499.03
3834671-83467199.935101.74
4800933-80093395.89697.71
5817695-81769597.90399.90
6812373-81237397.26699.04
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%
114.094426844416744437384446304433444432140.26
214.204406824416044411430.15
单位质量响应值RSD%判断
31455.9331066.410.89数据可信
中间条件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%
5min1290632-29063265.22369.6816.5565.2269.6816.55
2347748-34774878.04178.04
3384261-38426186.23586.24
4259511-25951158.23958.24
5254573-25457357.13157.13
6326248-32624873.21673.22
10min1429682-42968296.42994.891.3296.6295.101.29
2419371-41937194.11594.35
3418947-41894794.02094.28
4426581-42658195.73395.91
5426650-42665095.74895.92
6415656-41565693.28193.50
15min1428482-42848296.16095.751.4996.6496.251.47
2420183-42018394.29794.81
3427524-42752495.94596.49
4431275-43127596.78697.25
5434481-43448197.50697.96
6418091-41809193.82894.33
20min1431262-43126296.78395.591.9397.5696.381.91
2421156-42115694.51595.31
3426374-42637495.68696.52
4426851-42685195.79496.55
5436945-43694598.05998.81
6413141-41314192.71793.50
30min1430863-43086396.69492.585.5897.7693.655.51
2372859-37285983.67784.76
3424782-42478295.32996.44
4399159-39915989.57990.62
5432454-43245497.05198.10
6415011-41501193.13694.20
45min1427103-42710395.85095.141.4397.2096.481.41
2418851-41885193.99895.33
3423601-42360195.06496.47
4428140-42814096.08397.39
5430901-43090196.70298.04
6414919-41491993.11694.45
60min1427340-42734095.90395.001.8897.5496.621.84
2416377-41637793.44395.06
3420841-42084194.44596.13
4427891-42789196.02797.62
5434221-43422197.44799.07
6413106-41310692.70994.33
极限1425381-42538195.46494.771.5297.3996.691.50
2415683-41568393.28795.18
3423608-42360895.06697.04
4426047-42604795.61397.50
5429745-42974596.44398.36
6413358-41335892.76594.66
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%
110.088314168350958343238357628361888345570.23
210.078304948332118318520.24
单位质量响应值RSD%判断
82793.3582606.950.16数据可信
中间条件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%
5min1283424-28342433.99723.73125.1134.0023.73125.10
2133623-13362316.02816.03
329185-291853.5013.50
480746-807469.6869.69
5-0.0000.00
6659785-65978579.14279.14
10min1833854-833854100.02298.841.62100.1298.911.60
2834894-834894100.147100.19
3802039-80203996.20696.22
4825327-82532798.99999.03
5833494-83349499.97999.98
6814210-81421097.66697.90
15min1836018-836018100.28299.581.64100.6899.941.58
2837750-837750100.489100.84
3816961-81696197.99698.29
4837071-837071100.408100.73
5843509-843509101.180101.48
6809525-80952597.10497.63
20min1840087-840087100.77099.172.06101.4799.842.01
2837104-837104100.412101.06
3810797-81079797.25697.85
4828465-82846599.376100.00
5842835-842835101.099101.70
6801395-80139596.12996.95
30min1834478-834478100.09798.441.77101.1099.411.73
2828715-82871599.406100.36
3807116-80711696.81597.70
4820913-82091398.47099.40
5833488-83348899.978100.88
6799445-79944595.89597.00
45min1826605-82660599.15398.261.71100.4699.521.66
2830132-83013299.576100.83
3802600-80260096.27397.45
4826917-82691799.190100.41
5828974-82897499.437100.64
6799907-79990795.95097.35
60min1828729-82872999.40798.032.00101.0199.581.95
2822260-82226098.631100.18
3798339-79833995.76297.23
4824482-82448298.898100.42
5834242-834242100.069101.57
6795398-79539895.40997.09
极限1824624-82462498.91597.721.59100.8299.571.54
2819584-81958498.310100.15
3803045-80304596.32798.08
4821326-82132698.519100.33
5825418-82541899.010100.82
6794169-79416995.26297.23
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