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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
114.209293089294309297649295399293879294860.02
214.189278299272239275260.05
单位质量响应值RSD%判断
65456.7665410.860.05数据可信
中间条件6月-供试品溶液-2023101921批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1584896-58489664.38472.7214.3464.3872.7114.34
2687304-68730475.65775.66
3808829-80882989.03489.03
4559326-55932661.56961.57
5716983-71698378.92478.92
6606146-60614666.72366.72
10min1947064-947064104.250102.043.33104.44102.263.32
2902460-90246099.34199.57
3892392-89239298.23298.50
4903476-90347699.45299.64
5963294-963294106.037106.27
6953252-953252104.932105.13
15min1955039-955039105.128102.803.61105.63103.323.60
2905998-90599899.730100.25
3891384-89138498.12198.68
4915527-915527100.779101.26
5971413-971413106.931107.49
6963944-963944106.109106.62
20min1950765-950765104.658102.733.59105.48103.563.57
2906214-90621499.754100.58
3890758-89075898.05298.91
4915707-915707100.799101.58
5972219-972219107.019107.90
6963755-963755106.088106.92
30min1949185-949185104.484102.593.64105.62103.743.62
2904867-90486799.606100.73
3888423-88842397.79598.95
4914880-914880100.708101.80
5971164-971164106.903108.10
6963473-963473106.057107.21
45min1945003-945003104.024102.183.57105.47103.633.55
2903042-90304299.405100.83
3883959-88395997.30498.75
4912643-912643100.461101.85
5965325-965325106.261107.78
6959385-959385105.607107.08
60min1944729-944729103.993101.993.77105.75103.743.75
2899349-89934998.998100.72
3880716-88071696.94798.68
4908988-908988100.059101.75
5965590-965590106.290108.13
6959558-959558105.626107.41
极限1941478-941478103.636101.663.79105.71103.723.77
2896075-89607598.638100.66
3878153-87815396.66598.69
4905690-90569099.696101.69
5963326-963326106.041108.20
6956428-956428105.281107.38
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%
19.267769067769217768037768237768137768530.01
29.277755057750047752540.05
单位质量响应值RSD%判断
83893.4183630.420.23数据可信
中间条件6月-供试品溶液-2023101921批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13606-36060.4275.76151.170.435.76151.17
2136651-13665116.18416.18
3150112-15011217.77817.78
4-0.0000.00
51449-14490.1720.17
6-0.0000.00
10min1821244-82124497.26198.791.4697.2698.801.46
2843573-84357399.90599.95
3831653-83165398.49498.55
4839555-83955599.43099.43
5819482-81948297.05297.05
6849173-849173100.569100.57
15min1832779-83277998.627100.081.4698.92100.401.46
2851582-851582100.854101.20
3837478-83747899.18499.53
4853671-853671101.101101.40
5833051-83305198.65998.95
6861969-861969102.084102.39
20min1828510-82851098.12199.781.5098.71100.401.50
2851193-851193100.808101.46
3835229-83522998.91799.56
4850849-850849100.767101.37
5830897-83089798.40498.99
6858667-858667101.693102.30
30min1825321-82532197.74499.431.4998.63100.341.49
2846624-846624100.267101.22
3833014-83301498.65599.60
4848245-848245100.459101.36
5827925-82792598.05298.94
6856155-856155101.395102.31
45min1824040-82404097.59299.151.5198.77100.361.51
2846282-846282100.226101.48
3829778-82977898.27299.51
4845832-845832100.173101.38
5824407-82440797.63698.81
6853010-853010101.023102.24
60min1821604-82160497.30498.891.5398.77100.401.53
2843490-84349099.896101.45
3827840-82784098.04299.58
4842937-84293799.830101.34
5822283-82228397.38498.85
6851687-851687100.866102.39
极限1819265-81926597.02798.501.4798.79100.311.47
2840155-84015599.501101.35
3823368-82336897.51299.34
4840577-84057799.551101.36
5819962-81996297.10998.87
6846974-846974100.308102.13
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
114.209249679252049246049242629237899245650.07
214.189428129413349420730.12
单位质量响应值RSD%判断
65110.2166436.741.43数据可信
中间条件6月-供试品溶液-2023102021批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1753011-75301182.47060.8827.5282.4760.8827.52
2558531-55853161.17061.17
3372471-37247140.79340.79
4464847-46484750.91050.91
5722358-72235879.11379.11
6463875-46387550.80450.80
10min1888759-88875997.33794.354.0897.5894.534.11
2895023-89502398.02398.21
3833313-83331391.26591.39
4863144-86314494.53294.68
5882413-88241396.64296.88
6806131-80613188.28888.44
15min1893419-89341997.84793.885.9598.3994.355.97
2906276-90627699.25699.73
3778861-77886185.30185.70
4867750-86775095.03695.47
5886315-88631597.06997.60
6810620-81062088.77989.20
20min1890713-89071397.55194.714.3198.3895.464.34
2906053-90605399.231100.01
3834717-83471791.41892.07
4868123-86812395.07795.80
5882178-88217896.61697.43
6806918-80691888.37489.06
30min1886307-88630797.06894.584.2998.1995.614.32
2904810-90481099.095100.17
3833738-83373891.31192.24
4864848-86484894.71895.72
5885413-88541396.97198.08
6806491-80649188.32789.28
45min1883012-88301296.70894.244.1898.1295.564.21
2900884-90088498.665100.04
3829023-82902390.79592.00
4862056-86205694.41395.70
5881139-88113996.50297.90
6806750-80675088.35589.57
60min1882184-88218496.61794.084.1798.3295.684.20
2899638-89963898.529100.19
3830168-83016890.92092.39
4860219-86021994.21195.79
5877841-87784196.14197.83
6803978-80397888.05289.53
极限1875536-87553695.88993.543.8597.8995.423.88
2887607-88760797.21199.17
3828176-82817690.70292.45
4860449-86044994.23796.09
5871436-87143695.44097.42
6801282-80128287.75789.50
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%
19.267730567732727726147723607719907726580.07
29.277880227869317874760.10
单位质量响应值RSD%判断
83440.3984948.871.27数据可信
中间条件6月-供试品溶液-2023102021批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152906-529066.2345.4994.646.235.4894.69
257729-577296.8026.80
3124168-12416814.63114.63
48274-82740.9750.97
533072-330723.8973.90
63263-32630.3840.38
10min1859743-859743101.30598.651.88101.3298.671.88
2845461-84546199.62299.64
3834418-83441898.32198.36
4811909-81190995.66995.67
5834161-83416198.29198.30
6837770-83777098.71698.72
15min1871235-871235102.65999.152.46102.9899.462.46
2857064-857064100.989101.31
3824683-82468397.17497.51
4814729-81472996.00196.29
5838630-83863098.81799.12
6842487-84248799.27299.57
20min1868324-868324102.31699.022.23102.9599.632.24
2854290-854290100.662101.28
3833577-83357798.22298.85
4814068-81406895.92396.50
5834483-83448398.32998.93
6837570-83757098.69299.29
30min1863521-863521101.75098.752.19102.6999.662.20
2852231-852231100.420101.34
3830671-83067197.87998.80
4810328-81032895.48296.35
5835184-83518498.41199.31
6836425-83642598.55799.45
45min1861469-861469101.50898.462.24102.7599.672.25
2849102-849102100.051101.28
3827149-82714997.46498.68
4807068-80706895.09896.25
5832133-83213398.05299.24
6836929-83692998.61799.80
60min1860599-860599101.40698.302.25102.9599.792.26
2847416-84741699.852101.38
3827167-82716797.46698.98
4805596-80559694.92596.36
5829771-82977197.77399.26
6834674-83467498.35199.83
极限1854975-854975100.74397.802.07102.5999.592.07
2839635-83963598.936100.76
3824130-82413097.10998.91
4803937-80393794.72996.45
5824616-82461697.16698.95
6832603-83260398.10799.88
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
114.209220569222709220069214839217739219180.04
214.189373729380009376860.05
单位质量响应值RSD%判断
64923.8066127.361.30数据可信
中间条件6月-供试品溶液-2023102121批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1723491-72349179.53568.448.4079.5468.448.40
2599735-59973565.93065.93
3588923-58892364.74264.74
4601814-60181466.15966.16
5587169-58716964.54964.55
6634265-63426569.72669.73
10min1904032-90403299.38394.932.7999.6295.132.80
2839855-83985592.32792.53
3855111-85511194.00594.20
4843473-84347392.72592.92
5860638-86063894.61294.81
6877808-87780896.50096.71
15min1901807-90180799.13895.312.4999.6795.802.50
2844726-84472692.86393.34
3860824-86082494.63395.11
4847287-84728793.14493.62
5866533-86653395.26095.74
6880736-88073696.82297.32
20min1901423-90142399.09695.132.5399.9395.912.54
2842863-84286392.65893.41
3857728-85772894.29295.05
4847022-84702293.11593.87
5864472-86447295.03495.80
6878797-87879796.60897.40
30min1897174-89717498.62994.952.5199.7696.022.52
2838787-83878792.21093.24
3853050-85305093.77894.82
4848195-84819593.24494.28
5865969-86596995.19896.25
6879351-87935196.66997.75
45min1892657-89265798.13294.672.3699.5696.012.37
2836623-83662391.97293.28
3855867-85586794.08895.41
4845416-84541692.93994.25
5861833-86183394.74496.08
6874495-87449596.13697.50
60min1892493-89249398.11494.382.4799.8496.012.49
2832873-83287391.56093.14
3855231-85523194.01895.62
4842021-84202192.56694.16
5857835-85783594.30495.92
6870724-87072495.72197.38
极限1888642-88864297.69194.212.2999.7196.122.31
2834205-83420591.70693.56
3854483-85448393.93695.82
4841527-84152792.51194.38
5854052-85405293.88895.79
6868785-86878595.50897.45
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%
19.267706427705677705437700277702107703980.04
29.277832457836137834290.04
单位质量响应值RSD%判断
83196.3384512.301.11数据可信
中间条件6月-供试品溶液-2023102121批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1795972-79597294.17047.5187.4094.1747.5187.40
22401-24010.2840.28
3427952-42795250.63050.63
4794123-79412393.95193.95
520684-206842.4472.45
6368340-36834043.57743.58
10min1844939-84493999.96399.820.79100.2599.960.85
2831724-83172498.39998.40
3845835-845835100.069100.22
4843697-84369799.816100.10
5844133-84413399.86799.87
6852108-852108100.811100.94
15min1841941-84194199.608100.130.74100.19100.570.73
2839416-83941699.30999.61
3848930-848930100.435100.89
4842136-84213699.631100.21
5849853-849853100.544100.85
6855879-855879101.257101.69
20min1839082-83908299.27099.860.81100.15100.610.80
2836619-83661998.97899.57
3847385-847385100.252101.01
4840296-84029699.413100.29
5846287-846287100.122100.73
6855002-855002101.153101.89
30min1838059-83805999.14999.780.79100.33100.820.77
2836690-83669098.98799.88
3845042-84504299.975101.03
4839029-83902999.264100.44
5847526-847526100.269101.18
6853830-853830101.015102.06
45min1834538-83453898.73299.290.74100.21100.630.72
2832329-83232998.47199.66
3842003-84200399.615100.97
4835048-83504898.793100.27
5843247-84324799.763100.97
6848225-848225100.352101.69
60min1833062-83306298.55898.860.75100.33100.500.75
2827928-82792897.95099.43
3838699-83869999.225100.88
4830976-83097698.311100.08
5837974-83797499.139100.65
6845177-84517799.991101.64
极限1829645-82964598.15398.560.63100.22100.500.64
2828040-82804097.96499.74
3835108-83510898.800100.75
4830999-83099998.314100.38
5832217-83221798.458100.26
6842480-84248099.672101.62
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
114.209265349292999272489267599271879274050.12
214.189093579088929091240.04
单位质量响应值RSD%判断
65310.2164113.121.31数据可信
中间条件6月-供试品溶液-MU5570批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1861926-86192695.94679.9212.7195.9579.9212.71
2730298-73029881.29381.29
3602198-60219867.03467.03
4685867-68586776.34876.35
5769835-76983585.69585.69
6657783-65778373.22173.22
10min1891749-89174999.26593.493.3099.5593.733.32
2836487-83648793.11493.36
3810823-81082390.25790.46
4839161-83916193.41293.64
5837627-83762793.24193.50
6823147-82314791.62991.85
15min1888109-88810998.86094.252.7899.4594.772.81
2842473-84247393.78094.30
3817744-81774491.02891.50
4852499-85249994.89695.41
5845335-84533594.09994.64
6834054-83405492.84393.34
20min1886863-88686398.72293.902.8499.6094.702.86
2832461-83246192.66693.47
3816327-81632790.87091.61
4849433-84943394.55595.35
5841806-84180693.70694.53
6834320-83432092.87393.65
30min1882595-88259598.24693.332.8499.4294.422.86
2832638-83263892.68593.77
3811656-81165690.35091.37
4841614-84161493.68594.76
5833593-83359392.79293.89
6828576-82857692.23393.28
45min1879114-87911497.85993.272.8099.3394.632.82
2833927-83392792.82994.19
3808904-80890490.04391.33
4843587-84358793.90495.26
5836237-83623793.08694.46
6825551-82555191.89793.22
60min1871993-87199397.06692.822.6598.8394.472.68
2832195-83219592.63694.28
3804679-80467989.57391.13
4838675-83867593.35795.00
5832019-83201992.61794.27
6823759-82375991.69793.30
极限1872735-87273597.14992.452.8599.2194.372.87
2828225-82822592.19494.11
3801229-80122989.18991.02
4832771-83277192.70094.62
5829361-82936192.32194.26
6818734-81873491.13893.02
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%
19.267740897763087748407742607746127748220.12
29.277602607594427598510.08
单位质量响应值RSD%判断
83674.0881968.821.46数据可信
中间条件6月-供试品溶液-MU5570批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1629677-62967775.42824.98109.4575.4324.98109.45
237200-372004.4564.46
33304-33040.3960.40
4108974-10897413.05413.05
5246138-24613829.48429.48
6225964-22596427.06827.07
10min1810844-81084497.13096.440.8997.3696.510.94
2800696-80069695.91495.93
3800364-80036495.87495.88
4798173-79817395.61295.65
5816396-81639697.79597.88
6803812-80381296.28796.37
15min1809998-80999897.02898.010.9697.5598.370.94
2812796-81279697.36497.66
3813979-81397997.50597.79
4827204-82720499.08999.42
5828423-82842399.23599.62
6816524-81652497.81098.18
20min1809685-80968596.99197.751.0597.8098.411.04
2805071-80507196.43897.03
3813611-81361197.46198.04
4826886-82688699.05199.67
5824843-82484398.80799.49
6816220-81622097.77498.44
30min1808384-80838496.83597.620.7397.9398.570.71
2809371-80937196.95397.84
3813310-81331097.42598.30
4824235-82423598.73499.65
5818444-81844498.04099.02
6815927-81592797.73998.70
45min1805091-80509196.44197.460.9797.8398.710.94
2808439-80843996.84298.02
3809751-80975196.99998.16
4824659-82465998.785100.00
5821792-82179298.44199.71
6812108-81210897.28198.53
60min1799486-79948695.76996.980.9897.4598.520.96
2805693-80569396.51397.98
3805138-80513896.44697.90
4816735-81673597.83599.35
5820778-82077898.32099.89
6809722-80972296.99598.54
极限1800119-80011995.84596.660.8397.8198.490.81
2802376-80237696.11597.87
3802155-80215596.08997.84
4815181-81518197.64999.46
5814860-81486097.61199.47
6806773-80677396.64298.47
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