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%
114.069208419201839212879215199200849207830.07
214.059209939213849211880.04
单位质量响应值RSD%判断
65489.5465564.980.09数据可信
中间条件18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%
5min1620670-62067068.22463.8123.6268.2263.8123.62
2617271-61727167.85167.85
3732900-73290080.56180.56
4349853-34985338.45638.46
5666685-66668573.28273.28
6495898-49589854.50954.51
10min1861186-86118694.66294.372.8194.8794.562.84
2880492-88049296.78496.99
3855365-85536594.02294.26
4825792-82579290.77290.89
5889302-88930297.75397.97
6839144-83914492.23992.40
15min1868632-86863295.48195.172.5895.9795.652.61
2888547-88854797.67098.16
3858786-85878694.39894.92
4836288-83628891.92592.31
5893492-89349298.21398.73
6849228-84922893.34893.79
20min1869263-86926395.55095.172.4796.3295.932.50
2886819-88681997.48098.27
3859502-85950294.47795.28
4838313-83831392.14892.81
5892670-89267098.12398.93
6848196-84819693.23493.95
30min1866846-86684695.28494.862.5196.3595.912.54
2884905-88490597.26998.35
3856315-85631594.12795.22
4834465-83446591.72592.66
5889403-88940397.76498.87
6846196-84619693.01494.01
45min1862824-86282494.84294.512.5096.1995.842.52
2882173-88217396.96998.34
3853386-85338693.80595.18
4831261-83126191.37392.59
5885632-88563297.34998.74
6843594-84359492.72894.01
60min1857184-85718494.22294.072.4895.8595.682.51
2877431-87743196.44898.11
3850355-85035593.47195.13
4827445-82744590.95392.44
5882202-88220296.97298.66
6840289-84028992.36593.92
极限1859407-85940794.46694.192.5496.3896.082.56
2879280-87928096.65198.60
3850765-85076593.51795.45
4831490-83149091.39893.16
5884059-88405997.17699.15
6836275-83627591.92493.76
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%
110.038270318267518286818273658269718273600.10
210.108272918274128273520.02
单位质量响应值RSD%判断
82488.5381916.040.50数据可信
中间条件18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%
5min14347-43470.5258.07213.000.528.07213.03
218312-183122.2102.21
312004-120041.4491.45
47374-73740.8900.89
5357540-35754043.14843.15
61829-18290.2210.22
10min1791469-79146995.51497.491.2395.5297.521.25
2805083-80508397.15797.16
3804745-80474597.11697.12
4820393-82039399.00599.01
5813454-81345498.16798.30
6811944-81194497.98597.99
15min1809103-80910397.64298.921.0297.9399.241.01
2816955-81695598.59098.89
3816615-81661598.54998.84
4831162-831162100.304100.60
5816149-81614998.49298.92
6828418-82841899.973100.27
20min1806616-80661697.34299.461.8597.92100.071.82
2814412-81441298.28398.88
3836144-836144100.905101.50
4846628-846628102.171102.77
5814444-81444498.28799.01
6826609-82660999.755100.35
30min1804560-80456097.09498.381.0297.9799.291.01
2812581-81258198.06298.95
3811378-81137897.91798.81
4826430-82643099.733100.64
5812520-81252098.05499.07
6823746-82374699.409100.30
45min1800897-80089796.65298.101.1997.8299.311.18
2809928-80992897.74298.92
3809496-80949697.68998.88
4827624-82762499.877101.08
5808551-80855197.57598.88
6820992-82099299.077100.27
60min1796484-79648496.11997.771.1897.5799.271.17
2808221-80822197.53699.01
3807728-80772897.47698.96
4822245-82224599.228100.73
5806452-80645297.32298.92
6819998-81999898.957100.45
极限1796622-79662296.13697.350.9997.8899.150.99
2804348-80434897.06898.84
3803101-80310196.91898.69
4819313-81931398.874100.68
5804515-80451597.08898.98
6812390-81239098.03999.82
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%
114.069204089200719201059200919200489201450.02
214.059103349121639112480.15
单位质量响应值RSD%判断
65444.1764857.510.64数据可信
中间条件18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%
5min1469455-46945551.90251.6425.2451.9051.6425.24
2473675-47367552.36852.37
3569268-56926862.93762.94
4474760-47476052.48852.49
5246680-24668027.27227.27
6568809-56880962.88662.89
10min1854135-85413594.43194.611.3194.5994.761.32
2850784-85078494.06194.22
3873304-87330496.55196.74
4863353-86335395.45095.61
5851745-85174594.16794.25
6840955-84095592.97493.16
15min1869144-86914496.09195.871.0096.5396.311.02
2861856-86185695.28595.72
3881043-88104397.40697.88
4871776-87177696.38296.83
5858036-85803694.86395.23
6860896-86089695.17995.65
20min1867870-86787095.95095.730.8896.6896.450.91
2859186-85918694.99095.71
3879397-87939797.22497.99
4867023-86702395.85696.59
5859015-85901594.97195.62
6862724-86272495.38196.13
30min1866462-86646295.79495.540.9696.8196.550.99
2860370-86037095.12196.13
3877317-87731796.99498.06
4868266-86826695.99497.01
5854165-85416594.43595.37
6858357-85835794.89895.94
45min1862663-86266395.37495.380.9696.6896.680.98
2860060-86006095.08696.38
3876353-87635396.88898.24
4867006-86700695.85497.16
5852979-85297994.30495.52
6857077-85707794.75796.08
60min1863375-86337595.45395.280.8897.0496.860.90
2857000-85700094.74896.33
3874786-87478696.71498.36
4864549-86454995.58397.18
5854300-85430094.45095.95
6856788-85678894.72596.33
极限1863021-86302195.41495.490.9397.2997.370.95
2862670-86267095.37597.24
3876747-87674796.93198.87
4868369-86836996.00597.89
5855383-85538394.56996.35
6856264-85626494.66796.56
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%
110.038261228267598264428245698264258260630.11
210.108176558190578183560.13
单位质量响应值RSD%判断
82359.2281025.351.16数据可信
中间条件18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%
5min125826-258263.13614.43221.683.1414.43221.68
26645-66450.8070.81
322287-222872.7072.71
41017-10170.1240.12
51103-11030.1340.13
6656175-65617579.68579.69
10min1805074-80507497.76899.361.3897.7899.411.39
2830498-830498100.855100.86
3822948-82294899.93899.95
4804385-80438597.68497.68
5828141-828141100.569100.57
6818221-81822199.36499.60
15min1819923-81992399.571100.611.1699.87100.951.19
2841203-841203102.155102.46
3834749-834749101.371101.68
4815292-81529299.00999.30
5827793-827793100.527100.83
6831974-831974101.034101.57
20min1817605-81760599.289100.321.1599.89100.961.17
2837347-837347101.687102.30
3832720-832720101.125101.74
4812306-81230698.64699.24
5827028-827028100.434101.04
6829587-829587100.745101.58
30min1814999-81499998.97399.901.2099.87100.841.21
2835870-835870101.508102.42
3830118-830118100.809101.72
4809020-80902098.24799.13
5821401-82140199.750100.66
6824382-824382100.112101.25
45min1812605-81260598.68299.791.0499.88101.041.05
2834700-834700101.365102.59
3827597-827597100.503101.72
4813073-81307398.73999.92
5820489-82048999.640100.84
6822000-82200099.823101.27
60min1809007-80900798.24599.261.1999.74100.801.21
2830470-830470100.852102.38
3823725-823725100.033101.55
4803746-80374697.60699.08
5817985-81798599.336100.84
6819135-81913599.475101.22
极限1805492-80549297.81899.031.2799.61100.871.27
2829733-829733100.762102.59
3822133-82213399.839101.66
4802087-80208797.40599.18
5816010-81601099.096100.90
6817302-81730299.253101.29
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%
114.069079699083279087679086689085959084650.04
214.059205649174189189910.25
单位质量响应值RSD%判断
64613.4465408.610.87数据可信
中间条件18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%
5min1613891-61389168.01872.9612.2468.0272.9612.23
2620091-62009168.70568.70
3782638-78263886.71486.71
4564513-56451362.54762.55
5725665-72566580.40280.40
6644006-64400671.35471.35
10min1835693-83569392.59394.323.0292.8094.543.00
2832696-83269692.26192.47
3860446-86044695.33595.60
4877937-87793797.27397.46
5819661-81966190.81691.06
6881420-88142097.65997.87
15min1840979-84097993.17895.053.1593.6695.553.13
2838203-83820392.87193.35
3862709-86270995.58696.13
4891145-89114598.73799.22
5826920-82692091.62192.13
6887369-88736998.31898.83
20min1837922-83792292.84095.013.3193.6095.793.29
2837863-83786392.83393.59
3862179-86217995.52796.36
4893240-89324098.96999.74
5825658-82565891.48192.27
6888128-88812898.40299.20
30min1840374-84037493.11194.883.4094.1595.953.38
2832236-83223692.21093.25
3860973-86097395.39496.51
4894698-89469899.130100.20
5824094-82409491.30892.37
6885650-88565098.12899.23
45min1840351-84035193.10994.973.5194.4396.333.49
2836128-83612892.64193.96
3860126-86012695.30096.71
4899559-89955999.669101.04
5822199-82219991.09892.43
6884726-88472698.02599.42
60min1835180-83518092.53694.623.4894.1396.263.46
2833349-83334992.33393.93
3858388-85838895.10796.80
4899793-89979399.695101.36
5821656-82165691.03792.65
6875704-87570497.02698.71
极限1839576-83957693.02394.893.5594.9096.813.52
2834048-83404892.41094.28
3860385-86038595.32997.31
4901808-90180899.918101.89
5822247-82224791.10392.99
6880325-88032597.53899.51
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%
110.038156958160188164278159658150848158380.07
210.108266318255028260660.10
单位质量响应值RSD%判断
81339.7881788.710.39数据可信
中间条件18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%
5min124710-247103.0053.86102.423.013.86102.38
216859-168592.0502.05
385373-8537310.38310.38
42760-27600.3360.34
555594-555946.7626.76
64955-49550.6030.60
10min1799108-79910897.19099.901.5897.2099.911.59
2814959-81495999.11899.12
3835136-835136101.572101.60
4823358-823358100.139100.14
5824472-824472100.275100.29
6831288-831288101.104101.11
15min1811163-81116398.656101.331.4298.96101.641.43
2829000-829000100.825101.13
3840733-840733102.252102.59
4835838-835838101.657101.96
5838575-838575101.990102.31
6843386-843386102.575102.88
20min1808239-80823998.300100.991.4198.90101.601.41
2826932-826932100.574101.18
3838197-838197101.944102.59
4834195-834195101.457102.06
5834723-834723101.521102.15
6839722-839722102.129102.74
30min1806565-80656598.097100.551.3998.99101.471.39
2820599-82059999.804100.71
3835354-835354101.598102.55
4829603-829603100.899101.81
5831066-831066101.077102.01
6837231-837231101.826102.75
45min1803026-80302697.666100.241.3998.85101.461.40
2820865-82086599.836101.04
3831790-831790101.165102.42
4826100-826100100.473101.69
5828107-828107100.717101.95
6834988-834988101.554102.78
60min1800831-80083197.399100.031.4198.88101.551.41
2818765-81876599.581101.09
3831241-831241101.098102.65
4825857-825857100.443101.96
5826829-826829100.561102.10
6831190-831190101.092102.62
极限1799702-79970297.26299.671.3299.03101.481.32
2816241-81624199.274101.08
3828029-828029100.707102.57
4820125-82012599.746101.56
5824050-824050100.223102.06
6828631-828631100.780102.61
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%
114.069268319267809192239197529233269231820.40
214.059199499178429188960.17
单位质量响应值RSD%判断
65660.1765401.850.28数据可信
长期18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%
5min1631903-63190369.45573.949.1369.4673.949.12
2765355-76535584.12484.12
3623895-62389568.57568.58
4613437-61343767.42667.43
5724262-72426279.60779.61
6677315-67731574.44774.45
10min1863411-86341194.90295.931.0195.1196.151.02
2883530-88353097.11397.37
3863069-86306994.86495.07
4871103-87110395.74795.95
5873673-87367396.02996.27
6881878-88187896.93197.15
15min1873679-87367996.03096.620.8396.5297.130.84
2886994-88699497.49498.04
3870311-87031195.66096.15
4876402-87640296.32996.82
5878721-87872196.58497.11
6888416-88841697.65098.16
20min1867251-86725195.32496.260.9396.1097.060.94
2881023-88102396.83797.67
3866946-86694695.29096.07
4874473-87447396.11796.90
5876909-87690996.38597.20
6887914-88791497.59598.40
30min1871156-87115695.75396.160.8796.8297.250.88
2882717-88271797.02498.15
3866176-86617695.20596.27
4870606-87060695.69296.76
5872986-87298695.95497.06
6885573-88557397.33798.44
45min1863928-86392894.95895.800.9196.3197.180.92
2882628-88262897.01498.43
3862868-86286894.84296.19
4869915-86991595.61696.97
5871552-87155295.79697.19
6878671-87867196.57997.97
60min1865889-86588995.17495.640.9296.8197.310.93
2880745-88074596.80798.52
3860982-86098294.63596.27
4865084-86508495.08596.73
5869385-86938595.55897.24
6878768-87876896.58998.27
极限1867398-86739895.34095.630.6197.2697.580.63
2877840-87784096.48798.49
3863140-86314094.87296.79
4867383-86738395.33897.26
5870538-87053895.68597.65
6873835-87383596.04798.02
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%
110.038336468336498286918311018344628323100.29
210.108276008260558268280.14
单位质量响应值RSD%判断
82982.0581864.160.96数据可信
长期18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%
5min1793926-79392695.55755.9575.9495.5655.9475.94
2144910-14491017.44117.44
3830948-830948100.013100.01
4693021-69302183.41283.41
514618-146181.7591.76
6311501-31150137.49237.49
10min1828989-82898999.77799.091.72100.0699.261.76
2813337-81333797.89397.95
3842907-842907101.452101.75
4814036-81403697.97798.23
5833873-833873100.365100.37
6806619-80661997.08597.20
15min1826521-82652199.48099.561.74100.07100.031.73
2817804-81780498.43198.78
3843049-843049101.469102.07
4813530-81353097.91798.46
5846419-846419101.875102.18
6815818-81581898.19298.60
20min1824483-82448399.23599.271.67100.12100.031.67
2813774-81377497.94698.59
3840736-840736101.191102.10
4812555-81255597.79998.64
5842481-842481101.401102.01
6814456-81445698.02898.73
30min1820686-82068698.77899.021.6699.96100.081.64
2814647-81464798.05198.99
3837609-837609100.815102.03
4807605-80760597.20398.33
5841001-841001101.223102.14
6814396-81439698.02199.01
45min1817201-81720198.35898.601.6799.8499.961.65
2813499-81349997.91399.14
3832680-832680100.221101.74
4805461-80546196.94598.37
5838891-838891100.969102.19
6807697-80769797.21598.50
60min1817276-81727698.36798.701.52100.14100.351.48
2821431-82143198.868100.39
3830911-830911100.009101.82
4803686-80368696.73298.45
5836826-836826100.720102.24
6810107-81010797.50599.08
极限1813994-81399497.97298.141.63100.04100.101.61
2807731-80773197.21999.04
3828653-82865399.737101.85
4801961-80196196.52498.53
5834500-834500100.441102.27
6805637-80563796.96798.84
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%
114.069205259189269164399214949211389197040.23
214.059272119252869262480.15
单位质量响应值RSD%判断
65412.8065925.120.56数据可信
长期18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%
5min1538874-53887459.10663.6118.3159.1163.6118.31
2629164-62916469.01069.01
3771372-77137284.60884.61
4521551-52155157.20657.21
5476168-47616852.22852.23
6542230-54223059.47459.47
10min1885781-88578197.15795.972.7897.3396.162.76
2861004-86100494.43994.65
3857321-85732194.03594.29
4920027-920027100.913101.08
5862580-86258094.61294.77
6863074-86307494.66694.84
15min1891504-89150497.78596.802.9998.2597.272.96
2870053-87005395.43295.92
3855514-85551493.83794.37
4930665-930665102.080102.55
5876788-87678896.17096.61
6870441-87044195.47495.94
20min1891019-89101997.73196.643.0698.4997.413.03
2869226-86922695.34196.12
3853640-85364093.63194.45
4930044-930044102.012102.79
5875786-87578696.06196.79
6866879-86687995.08495.83
30min1886561-88656197.24296.492.8098.3097.542.78
2870440-87044095.47496.54
3856574-85657493.95395.05
4925765-925765101.543102.63
5873019-87301995.75796.77
6865646-86564694.94895.98
45min1883276-88327696.88296.402.9098.2397.752.87
2870766-87076695.51096.86
3854882-85488293.76895.15
4927139-927139101.693103.08
5873302-87330295.78897.09
6864155-86415594.78596.10
60min1887222-88722297.31596.133.1198.9597.773.08
2863851-86385194.75196.39
3848784-84878493.09994.76
4926001-926001101.568103.26
5867790-86779095.18496.78
6865116-86511694.89096.49
极限1889999-88999997.62096.443.0999.5598.363.07
2868110-86811095.21997.14
3855688-85568893.85695.80
4929624-929624101.966103.97
5866938-86693895.09096.97
6864971-86497194.87496.76
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%
110.038279608262018280268285338280528277540.11
210.108335798317458326620.16
单位质量响应值RSD%判断
82527.8282441.780.08数据可信
长期18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%
5min169326-693268.33736.19110.078.3436.19110.07
2801683-80168396.41496.41
3566149-56614968.08868.09
412895-128951.5511.55
54029-40290.4850.48
6351341-35134142.25442.25
10min1833836-833836100.281100.581.54100.31100.691.48
2825594-82559499.29099.58
3832366-832366100.104100.31
4861166-861166103.568103.57
5828222-82822299.60699.61
6836930-836930100.653100.78
15min1843203-843203101.407101.311.73101.73101.721.63
2824336-82433699.13899.73
3833407-833407100.229100.73
4867810-867810104.367104.68
5843412-843412101.433101.73
6842039-842039101.267101.70
20min1842497-842497101.323101.051.83101.95101.771.73
2821670-82167098.81899.70
3830765-83076599.912100.72
4867216-867216104.295104.92
5842128-842128101.278101.88
6837330-837330100.701101.43
30min1836220-836220100.568100.471.65101.50101.491.56
2819661-81966198.57699.76
3828638-82863899.656100.76
4860455-860455103.482104.42
5837090-837090100.672101.58
6830586-83058699.890100.92
45min1831800-831800100.036100.261.70101.27101.581.61
2819322-81932298.535100.01
3824778-82477899.192100.60
4859857-859857103.410104.66
5836456-836456100.596101.81
6829905-82990599.808101.14
60min1834529-834529100.36499.961.67101.90101.581.58
2814932-81493298.00799.78
3820847-82084798.719100.42
4855207-855207102.851104.41
5830214-83021499.845101.36
6831208-83120899.965101.60
极限1832201-832201100.08499.521.89101.92101.441.79
2808438-80843897.22699.29
3820092-82009298.628100.63
4854685-854685102.788104.66
5827975-82797599.576101.39
6821846-82184698.839100.77
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%
114.069265539268329272059251859262189263990.09
214.059327749305899316820.17
单位质量响应值RSD%判断
65888.9866311.890.46数据可信
长期18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%
5min1419694-41969445.73364.2716.0245.7364.2716.03
2664770-66477072.43972.44
3676244-67624473.68973.69
4560287-56028761.05461.05
5631249-63124968.78668.79
6586505-58650563.91163.91
10min1830501-83050190.49891.081.8490.6491.271.85
2835054-83505490.99591.21
3865127-86512794.27294.49
4836472-83647291.14991.33
5825214-82521489.92290.13
6822408-82240889.61789.81
15min1838349-83834991.35491.641.7091.7692.101.71
2837335-83733591.24391.73
3867293-86729394.50895.01
4844724-84472492.04892.50
5827878-82787890.21390.69
6830010-83001090.44590.91
20min1836708-83670891.17591.471.8091.8692.211.81
2833868-83386890.86591.63
3866373-86637394.40795.19
4846142-84614292.20392.94
5825945-82594590.00290.75
6827224-82722490.14190.87
30min1837216-83721691.23091.311.7392.1992.321.74
2833435-83343590.81891.85
3862831-86283194.02195.09
4844596-84459692.03493.04
5821872-82187289.55890.57
6827589-82758990.18191.18
45min1836416-83641691.14391.221.8192.3792.511.82
2833813-83381390.85992.17
3862709-86270994.00895.36
4844814-84481492.05893.34
5823581-82358189.74491.03
6821680-82168089.53790.81
60min1827592-82759290.18190.611.8891.6892.181.89
2823984-82398489.78891.37
3858615-85861593.56295.20
4839583-83958391.48893.05
5813657-81365788.66390.22
6825940-82594090.00191.54
极限1832047-83204790.66791.011.7692.4492.851.76
2826216-82621690.03291.88
3857869-85786993.48195.40
4848466-84846692.45694.29
5820778-82077889.43991.26
6825941-82594190.00291.81
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%
110.038333268337258337088331328310658329910.14
210.108389258363098376170.23
单位质量响应值RSD%判断
83049.9582932.380.11数据可信
长期18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%
5min11470-14700.17641.4273.850.1841.4273.85
283950-8395010.03510.03
3663451-66345179.30379.30
4484707-48470757.93757.94
5358619-35861942.86642.87
6487113-48711358.22558.23
10min1818366-81836697.82098.651.5797.8298.781.63
2802433-80243395.91695.95
3827550-82755098.91899.16
4834187-83418799.71199.88
5834477-83447799.74699.87
6835069-83506999.81799.99
15min1829916-82991699.20199.231.4099.4999.651.45
2808581-80858196.65096.97
3827424-82742498.90399.44
4837659-837659100.126100.60
5837927-837927100.158100.59
6839308-839308100.323100.80
20min1826836-82683698.83298.831.4299.4299.541.47
2804856-80485696.20596.81
3824619-82461998.56799.40
4836740-836740100.016100.79
5832957-83295799.564100.29
6834802-83480299.785100.56
30min1825584-82558498.68398.491.4099.5799.501.44
2802813-80281395.96196.86
3819967-81996798.01199.14
4833537-83353799.633100.71
5829399-82939999.139100.17
6832405-83240599.498100.57
45min1823603-82360398.44698.131.2799.6399.441.31
2801296-80129695.78096.96
3818383-81838397.82299.24
4829668-82966899.171100.54
5827414-82741498.902100.23
6825426-82542698.664100.04
60min1815390-81539097.46497.641.4598.9499.241.50
2796079-79607995.15696.63
3813514-81351497.24098.95
4826444-82644498.786100.46
5820648-82064898.09399.71
6828993-82899399.090100.76
极限1817563-81756397.72497.511.5199.5099.411.55
2792784-79278494.76296.52
3812453-81245397.11399.12
4825892-82589298.720100.69
5821124-82112498.150100.07
6824752-82475298.583100.55
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