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%
114.074544174545034549704565704554584551840.20
214.074512154525524518840.21
单位质量响应值RSD%判断
32351.3932116.840.52数据可信
中间条件12月-供试品溶液-2023041621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%
5min1331438-33143872.13468.5211.9772.1368.5211.96
2373522-37352281.29381.29
3299571-29957165.19965.20
4261511-26151156.91556.92
5299759-29975965.23965.24
6323088-32308870.31770.32
10min1429570-42957093.49193.501.0393.7193.701.01
2427557-42755793.05393.30
3434562-43456294.57894.77
4428095-42809593.17093.34
5434563-43456394.57894.77
6423247-42324792.11592.33
15min1438954-43895495.53494.711.4996.0395.201.49
2434993-43499394.67295.19
3440127-44012795.78996.27
4434066-43406694.47094.92
5439858-43985895.73196.21
6423028-42302892.06892.55
20min1438790-43879095.49894.851.3596.2895.621.35
2435353-43535394.75095.56
3440835-44083595.94396.71
4435305-43530594.74095.47
5439845-43984595.72896.49
6424789-42478992.45193.21
30min1440897-44089795.95795.461.0397.0396.521.02
2439311-43931195.61296.70
3442934-44293496.40097.45
4437563-43756395.23196.25
5440772-44077295.92996.98
6430231-43023193.63594.68
45min1442768-44276896.36495.621.1197.7296.961.11
2439539-43953995.66197.04
3443768-44376896.58297.93
4434933-43493394.65995.96
5442955-44295596.40597.75
6432039-43203994.02995.35
60min1443608-44360896.54795.611.0098.1997.230.99
2434750-43475094.61996.28
3443130-44313096.44398.08
4438210-43821095.37296.96
5442260-44226096.25397.88
6433735-43373594.39896.00
极限1444021-44402196.63795.441.1398.5797.361.13
2438035-43803595.33497.28
3444382-44438296.71598.64
4433291-43329194.30196.17
5438421-43842195.41897.34
6433083-43308394.25696.14
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%
110.008464208471858492588481778468108475700.14
210.008403538416858410190.12
单位质量响应值RSD%判断
84757.0084101.900.55数据可信
中间条件12月-供试品溶液-2023041621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%
5min133184-331843.89911.5866.543.9011.5866.55
285052-850529.9939.99
310573-105731.2421.24
4150651-15065117.70117.70
5155834-15583418.31018.31
6156079-15607918.33918.34
10min1826417-82641797.10197.530.2597.1197.560.27
2829985-82998597.52097.55
3829266-82926697.43697.44
4832147-83214797.77497.83
5831140-83114097.65697.71
6831249-83124997.66997.72
15min1842128-84212898.94798.940.8499.2599.270.83
2852863-852863100.208100.53
3847179-84717999.54099.84
4838854-83885498.56298.91
5838704-83870498.54598.89
6832829-83282997.85498.20
20min1840551-84055198.76298.550.6499.3699.180.62
2843795-84379599.14399.77
3844793-84479399.26099.85
4837331-83733198.38399.03
5835255-83525598.13998.78
6830835-83083597.62098.26
30min1836178-83617898.24898.080.6199.1499.000.59
2839973-83997398.69499.61
3840448-84044898.75099.64
4832453-83245397.81098.75
5831946-83194697.75198.69
6827370-82737097.21398.15
45min1832309-83230997.79397.690.6198.9898.900.59
2836443-83644398.27999.50
3837596-83759698.41499.60
4828770-82877097.37798.61
5828955-82895597.39998.63
6824445-82444596.86998.10
60min1832921-83292197.86597.460.5499.3598.970.53
2832641-83264197.83299.34
3833663-83366397.95299.44
4826719-82671997.13698.66
5828865-82886597.38998.91
6822224-82222496.60898.12
极限1826164-82616497.07196.980.6298.8598.780.60
2831216-83121697.66599.47
3831013-83101397.64199.42
4822796-82279696.67598.49
5823005-82300596.70098.52
6818271-81827196.14497.95
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%
114.074555054557334559654559254558454557950.05
214.074513684519794516740.10
单位质量响应值RSD%判断
32394.8132101.920.65数据可信
中间条件12月-供试品溶液-2023041621批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100532-10053221.87026.2241.2621.8726.2241.27
2146033-14603331.76931.77
3194328-19432842.27542.28
4138574-13857430.14630.15
591723-9172319.95419.95
651908-5190811.29211.29
10min1409440-40944089.07285.602.7489.1485.682.73
2399135-39913586.83086.93
3378917-37891782.43282.56
4397180-39718086.40586.50
5386134-38613484.00284.06
6390070-39007084.85884.89
15min1427373-42737392.97390.182.8793.3190.512.86
2408365-40836588.83889.19
3407081-40708188.55888.93
4428068-42806893.12493.47
5398572-39857286.70787.02
6417617-41761790.85191.14
20min1416923-41692390.70089.722.4891.3190.332.45
2409511-40951189.08789.71
3394129-39412985.74186.38
4424523-42452392.35392.98
5415242-41524290.33490.91
6414240-41424090.11690.68
30min1410489-41048989.30090.373.0890.1891.243.04
2393292-39329285.55986.45
3415292-41529290.34591.24
4428455-42845593.20894.11
5418445-41844591.03191.87
6426399-42639992.76193.59
45min1424319-42431992.30991.842.5493.4692.982.51
2416547-41654790.61891.76
3408492-40849288.86590.03
4435716-43571694.78895.97
5415016-41501690.28591.40
6432789-43278994.15195.26
60min1426152-42615292.70792.041.8494.1493.461.83
2414140-41414090.09491.51
3418698-41869891.08692.52
4436606-43660694.98296.45
5420065-42006591.38392.77
6422845-42284591.98893.38
极限1437230-43723095.11793.922.4796.8295.622.44
2420539-42053991.48693.17
3417716-41771690.87292.58
4444427-44442796.68398.44
5431350-43135093.83895.50
6439045-43904595.51297.18
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%
110.008474268480408479688481548482618479700.04
210.008358038363758360890.05
单位质量响应值RSD%判断
84797.0083608.901.00数据可信
中间条件12月-供试品溶液-2023041621批-贝那普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.00015.10222.600.0015.10222.60
2-0.0000.00
3708635-70863583.48983.49
4-0.0000.00
560610-606107.1417.14
6-0.0000.00
10min1769915-76991590.70993.913.4090.7193.963.48
2789841-78984193.05693.06
3836514-83651498.55598.81
4767398-76739890.41290.41
5817463-81746396.31196.33
6801513-80151394.43194.43
15min1840253-84025398.99698.560.5999.2798.880.62
2832483-83248398.08098.36
3838373-83837398.77499.32
4828505-82850597.61297.88
5839404-83940498.89699.21
6840105-84010598.97899.26
20min1841949-84194999.19598.630.8799.7699.250.94
2830910-83091097.89598.47
3846979-84697999.788100.63
4827086-82708697.44498.01
5838759-83875998.82099.43
6837191-83719198.63599.22
30min1835640-83564098.45297.920.7399.3298.830.76
2822697-82269796.92797.79
3833177-83317798.16299.30
4824356-82435697.12397.98
5833637-83363798.21699.12
6837009-83700998.61399.49
45min1837825-83782598.71097.660.7899.8798.870.79
2821757-82175796.81797.97
3830166-83016697.80799.24
4821334-82133496.76797.91
5829813-82981397.76698.96
6832723-83272398.10899.28
60min1828944-82894497.66397.150.6599.1298.660.66
2821735-82173596.81498.26
3825097-82509797.21098.94
4815340-81534096.06097.50
5827897-82789797.54099.03
6828525-82852597.61499.08
极限1831043-83104397.91197.150.4899.6698.950.46
2825073-82507397.20798.95
3822208-82220896.87098.89
4819304-81930496.52798.25
5825365-82536597.24299.03
6824691-82469197.16298.92
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%
114.074534064539884541224569124534954543850.32
214.074530904551894541400.33
单位质量响应值RSD%判断
32294.6032277.190.04数据可信
中间条件12月-供试品溶液-2023041621批-左氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228003-22800349.54250.6418.7449.5450.6418.74
2271889-27188959.07859.08
3173399-17339937.67737.68
4242050-24205052.59552.59
5287343-28734362.43662.44
6195525-19552542.48542.49
10min1411943-41194389.51089.361.6089.6689.511.62
2406689-40668988.36988.55
3402774-40277487.51887.63
4417166-41716690.64590.80
5420272-42027291.32091.51
6408657-40865788.79688.92
15min1430496-43049693.54292.411.5493.9692.831.55
2416298-41629890.45690.90
3418669-41866990.97291.35
4430367-43036793.51393.94
5431301-43130193.71694.18
6424669-42466992.27592.67
20min1431649-43164993.79293.221.3094.4993.921.31
2422415-42241591.78692.50
3425746-42574692.50993.16
4432015-43201593.87294.58
5437219-43721995.00295.74
6425008-42500892.34993.02
30min1437281-43728195.01693.881.7995.9994.851.79
2419658-41965891.18792.18
3429549-42954993.33694.26
4437874-43787495.14596.14
5439812-43981295.56696.59
6428037-42803793.00793.95
45min1441988-44198896.03994.991.4797.3096.251.48
2427909-42790992.97994.24
3434303-43430394.36995.57
4439286-43928695.45196.73
5445643-44564396.83398.15
6433828-43382894.26695.49
60min1446275-44627596.97095.441.5498.5296.991.54
2429753-42975393.38094.92
3435943-43594394.72596.21
4438987-43898795.38796.95
5447614-44761497.26198.87
6436927-43692794.93996.45
极限1444704-44470496.62995.371.2798.4797.201.28
2431299-43129993.71695.54
3436350-43635094.81496.59
4442155-44215596.07597.92
5444258-44425896.53298.43
6434776-43477694.47296.27
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%
110.008450488435488432878423648437708436030.12
210.008449508396718423100.45
单位质量响应值RSD%判断
84360.3084231.000.11数据可信
中间条件12月-供试品溶液-2023041621批-贝那普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113630-136301.60417.37173.881.6017.36173.90
2642310-64231075.58875.59
3-0.0000.00
4216639-21663925.49425.49
5-0.0000.00
612841-128411.5111.51
10min1791417-79141793.13596.091.8793.1496.141.93
2836138-83613898.39898.62
3817102-81710296.15796.16
4821780-82178096.70896.78
5808986-80898695.20295.20
6823876-82387696.95596.96
15min1831697-83169797.87599.371.2098.1699.701.18
2840572-84057298.91999.44
3847744-84774499.763100.05
4837347-83734798.54098.91
5848280-84828099.827100.11
6860535-860535101.269101.56
20min1832771-83277198.00199.050.8798.5899.690.85
2840137-84013798.86899.69
3842903-84290399.19499.78
4835311-83531198.30098.96
5846423-84642399.608100.19
6852640-852640100.340100.94
30min1831255-83125597.82398.800.7498.6999.730.71
2836534-83653498.44499.56
3841185-84118598.99299.88
4836053-83605398.38899.34
5843925-84392599.314100.20
6848277-84827799.826100.73
45min1827275-82727597.35598.520.9298.5299.760.88
2832553-83255397.97699.39
3839218-83921898.76099.94
4833555-83355598.09499.35
5842000-84200099.087100.27
6848620-84862099.867101.07
60min1824328-82432897.00898.220.8398.4799.750.82
2834435-83443598.19799.90
3835137-83513798.28099.76
4830716-83071697.76099.31
5838965-83896598.730100.21
6844419-84441999.372100.87
极限1820406-82040696.54697.570.6798.2999.400.68
2829262-82926297.58899.59
3831148-83114897.81099.58
4826123-82612397.21999.06
5831028-83102897.79699.57
6836926-83692698.490100.29
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%
114.074500244501984500804509094520614506540.20
214.074531474529164530320.04
单位质量响应值RSD%判断
32029.4232198.440.38数据可信
中间条件12月-供试品溶液-2023041621批-左氨氯地平-磷酸盐缓冲液(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%
5min1108375-10837523.67528.4235.4523.6728.4235.45
2131370-13137028.69828.70
350397-5039711.00911.01
4158490-15849034.62334.62
5180574-18057439.44739.45
6151343-15134333.06133.06
10min1334100-33410072.98573.102.2573.0673.182.28
2334292-33429273.02773.11
3321520-32152070.23770.27
4336231-33623173.45173.55
5336943-33694373.60673.72
6344715-34471575.30475.40
15min1367360-36736080.25180.151.7880.5480.461.80
2367129-36712980.20080.51
3356848-35684877.95478.20
4364463-36446379.61879.94
5368760-36876080.55780.90
6376941-37694182.34482.67
20min1375800-37580082.09582.312.0882.6382.852.10
2377079-37707982.37482.92
3364686-36468679.66780.14
4376143-37614382.16982.73
5377636-37763682.49683.08
6389276-38927685.03885.61
30min1373368-37336881.56383.523.1982.3484.313.21
2386521-38652184.43785.23
3362214-36221479.12779.84
4386847-38684784.50885.32
5389747-38974785.14185.97
6395154-39515486.32387.15
45min1389595-38959585.10886.342.4886.1387.382.49
2399695-39969587.31488.36
3384786-38478684.05885.01
4388387-38838784.84485.91
5397302-39730286.79287.88
6411503-41150389.89490.98
60min1403312-40331288.10587.251.6189.3888.551.63
2400118-40011887.40788.72
3390120-39012085.22386.43
4395738-39573886.45087.77
5398139-39813986.97588.32
6408872-40887289.31990.68
极限1406767-40676788.85990.031.7790.4091.591.80
2414983-41498390.65492.22
3403376-40337688.11989.58
4408489-40848989.23690.81
5415881-41588190.85092.46
6423286-42328692.46894.09
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%
110.008363328362108365248404868396388378380.25
210.008400288395248397760.05
单位质量响应值RSD%判断
83783.8083977.600.17数据可信
中间条件12月-供试品溶液-2023041621批-贝那普利-磷酸盐缓冲液(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%
5min1-0.0000.80166.970.000.80167.04
2-0.0000.00
313618-136181.6111.61
4-0.0000.00
526935-269353.1853.19
6-0.0000.00
10min1821842-82184297.19496.164.5997.1996.174.59
2836328-83632898.90798.91
3739239-73923987.42587.43
4820709-82070997.06097.06
5841290-84129099.49499.50
6819412-81941296.90696.91
15min1841785-84178599.552100.180.9599.84100.480.95
2852816-852816100.857101.15
3841687-84168799.54199.81
4854350-854350101.038101.33
5855362-855362101.158101.47
6836787-83678798.96199.25
20min1841066-84106699.46799.830.87100.06100.420.87
2851207-851207100.667101.27
3839627-83962799.29799.86
4847943-847943100.281100.87
5851482-851482100.699101.31
6833292-83329298.54899.14
30min1836930-83693098.97899.440.9199.87100.340.92
2846726-846726100.137101.04
3838475-83847599.161100.02
4845629-845629100.007100.90
5848820-848820100.384101.30
6828646-82864697.99898.88
45min1826697-82669797.76898.981.2598.95100.161.25
2844825-84482599.912101.11
3833030-83303098.51799.68
4847060-847060100.176101.37
5846121-846121100.065101.28
6823769-82376997.42298.60
60min1826566-82656697.75298.861.2099.23100.341.20
2845894-845894100.038101.54
3828130-82813097.93799.39
4841472-84147299.515101.01
5847159-847159100.188101.70
6826354-82635497.72799.20
极限1822871-82287197.31598.221.0799.09100.001.07
2840026-84002699.344101.15
3826069-82606997.69499.44
4835416-83541698.799100.59
5839178-83917899.244101.06
6819478-81947896.91498.68
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