沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900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2000
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%
115.471015981015651014541015251012671014820.13
215.511009021008991009000.01
单位质量响应值RSD%判断
6559.926505.480.59数据可信
供试品溶液-8196156批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min198379-9837997.62595.861.4297.6295.861.42
297320-9732096.57496.57
394525-9452593.80093.80
495749-9574995.01595.02
597368-9736896.62296.62
696280-9628095.54295.54
10min197883-9788397.13396.131.4897.3096.291.48
297928-9792897.17797.34
395192-9519294.46294.62
496082-9608295.34595.50
598577-9857797.82197.98
695563-9556394.83094.99
15min197081-9708196.33795.061.4796.6695.381.47
293973-9397393.25393.58
394521-9452193.79694.11
495520-9552094.78895.11
597565-9756596.81797.14
696087-9608795.35095.67
20min194344-9434493.62194.351.0894.1194.831.08
295483-9548394.75195.23
393766-9376693.04793.52
494757-9475794.03194.51
596699-9669995.95896.44
695410-9541094.67995.15
30min194792-9479294.06593.201.2094.7193.841.20
294309-9430993.58694.22
392224-9222491.51792.14
493037-9303792.32492.96
595234-9523494.50495.15
693929-9392993.20993.84
45min194131-9413193.40992.601.2994.2193.391.29
293526-9352692.80993.60
391499-9149990.79891.58
492386-9238691.67892.46
594819-9481994.09294.90
693521-9352192.80493.59
60min194122-9412293.40092.391.3294.3593.341.31
293708-9370892.99093.94
391371-9137190.67191.60
491946-9194691.24192.18
594419-9441993.69594.65
693082-9308292.36893.31
极限194141-9414193.41989.368.3094.5390.468.20
293369-9336992.65393.76
391060-9106090.36291.44
474975-7497574.40075.49
593974-9397493.25494.37
692760-9276092.04993.15
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.631560147155930615603941560957156145115604510.06
2 22.591558405156057715594910.10
单位质量响应值RSD%判断
68954.9769034.570.09数据可信
供试品溶液-8196156批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.19154.960.000.19154.96
219468-194680.5710.57
3-0.0000.00
420175-201750.5910.59
5-0.0000.00
6-0.0000.00
10min184116-841162.4653.4029.722.473.4029.72
2164002-1640024.8064.81
3117274-1172743.4373.44
4144086-1440864.2234.22
573104-731042.1422.14
6114296-1142963.3503.35
15min1180508-1805085.2906.2121.085.296.2221.10
2257430-2574307.5447.55
3215368-2153686.3126.32
4245713-2457137.2017.21
5139133-1391334.0784.08
6233565-2335656.8456.85
20min1278432-2784328.1608.7510.948.178.7710.95
2320284-3202849.3869.41
3281296-2812968.2448.26
4339899-3398999.9619.98
5253406-2534067.4267.44
6318808-3188089.3439.36
30min1405471-40547111.88312.599.9711.9112.6210.00
2462109-46210913.54313.58
3420358-42035812.31912.35
4483170-48317014.16014.20
5363436-36343610.65110.67
6443380-44338012.99413.03
45min1488044-48804414.30315.325.0214.3515.385.04
2536665-53666515.72815.79
3498460-49846014.60814.66
4559795-55979516.40616.47
5531858-53185815.58715.63
6522616-52261615.31615.37
60min1524266-52426615.36416.605.8015.4316.685.80
2596173-59617317.47217.56
3530115-53011515.53615.61
4600797-60079717.60717.69
5581353-58135317.03717.10
6566263-56626316.59516.68
极限1614750-61475018.01618.464.8018.1118.564.81
2639148-63914818.73118.85
3584142-58414217.11917.22
4673210-67321019.73019.85
5644862-64486218.89918.99
6622402-62240218.24018.35
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.631082737108262510822191082223108205310823710.03
2 22.591075306107675210760290.10
单位质量响应值RSD%判断
47829.0347632.980.30数据可信
供试品溶液-8196156批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.20154.930.000.20154.92
214839-148390.5940.59
3-0.0000.00
414661-146610.5870.59
5-0.0000.00
6-0.0000.00
10min167434-674342.7013.6929.362.703.6929.39
2129604-1296045.1915.19
393722-937223.7543.75
4113751-1137514.5564.56
557983-579832.3222.32
690120-901203.6103.61
15min1144686-1446865.7956.7920.755.806.8020.77
2205737-2057378.2418.25
3172650-1726506.9156.92
4194537-1945377.7927.80
5112083-1120834.4894.49
6187231-1872317.4997.51
20min1222909-2229098.9289.5310.138.949.5510.16
2252465-25246510.11210.14
3223981-2239818.9718.99
4268191-26819110.74210.76
5205225-2052258.2208.23
6254895-25489510.20910.23
30min1323679-32367912.96413.639.4112.9913.669.42
2363311-36331114.55214.59
3332005-33200513.29813.33
4380368-38036815.23515.27
5290254-29025411.62611.65
6351748-35174814.08914.12
45min1384858-38485815.41516.464.9515.4716.524.94
2419337-41933716.79616.86
3390598-39059815.64515.70
4438635-43863517.56917.63
5422385-42238516.91816.96
6409875-40987516.41716.48
60min1409844-40984416.41617.695.7216.4917.775.74
2461225-46122518.47418.57
3412445-41244516.52016.60
4467406-46740618.72118.82
5458221-45822118.35318.43
6440590-44059017.64717.73
极限1474775-47477519.01619.374.9019.1219.484.89
2488596-48859619.57019.69
3445737-44573717.85317.96
4515704-51570420.65620.78
5497856-49785619.94120.04
6478364-47836419.16019.28
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900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2000
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%
115.471015361017501017941017561016431016960.11
215.511021311026821024060.39
单位质量响应值RSD%判断
6573.766602.580.31数据可信
供试品溶液-8196156批-沙库巴曲-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%
5min196544-9654494.99695.011.6495.0095.011.64
298995-9899597.40897.41
397354-9735495.79395.79
494555-9455593.03993.04
596691-9669195.14195.14
695211-9521193.68593.68
10min1105473-105473103.782102.621.35103.94102.781.35
2103639-103639101.977102.14
3103854-103854102.189102.35
4104870-104870103.189103.34
5105861-105861104.164104.32
6102053-102053100.417100.57
15min1102196-102196100.55899.251.00100.8999.581.00
2101061-10106199.44199.77
3100627-10062799.01499.34
4101660-101660100.030100.36
5100265-10026598.65798.99
699382-9938297.78998.11
20min199901-9990198.29998.060.4098.8098.550.39
299064-9906497.47697.97
399318-9931897.72698.22
499979-9997998.37698.87
599650-9965098.05298.55
6100019-10001998.41598.90
30min199167-9916797.57797.070.6798.2497.730.67
299069-9906997.48198.14
398197-9819796.62397.28
499465-9946597.87098.53
597880-9788096.31196.97
698135-9813596.56297.21
45min198811-9881197.22797.181.0298.0598.001.01
299911-9991198.30999.13
398435-9843596.85797.68
499772-9977298.17298.99
597185-9718595.62796.45
698470-9847096.89197.70
60min197401-9740195.83996.940.7696.8397.920.75
298830-9883097.24698.23
398783-9878397.19998.18
498791-9879197.20798.19
597868-9786896.29997.28
699450-9945097.85698.83
极限199547-9954797.95197.741.0899.1098.881.06
299381-9938197.78898.94
399210-9921097.61998.76
499969-9996998.36699.51
597372-9737295.81196.95
6100497-10049798.886100.02
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.631565582156721315675801567847156668015669800.06
2 22.591590657159921215949340.38
单位质量响应值RSD%判断
69243.4870603.541.38数据可信
供试品溶液-8196156批-缬沙坦-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%
5min1392611-39261111.35411.104.2811.3511.104.27
2394734-39473411.41611.42
3394093-39409311.39711.40
4393091-39309111.36811.37
5354971-35497110.26610.27
6372717-37271710.77910.78
10min1972333-97233328.12026.594.3128.1426.614.31
2954977-95497727.61827.64
3927637-92763726.82726.85
4897445-89744525.95425.97
5867549-86754925.09025.11
6896360-89636025.92325.94
15min11401121-140112140.52137.905.2340.5937.975.22
21365448-136544839.48939.55
31331706-133170638.51338.58
41278626-127862636.97837.04
51213910-121391035.10635.17
61273068-127306836.81736.88
20min11701364-170136449.20446.004.9349.3446.134.93
21639038-163903847.40147.53
31601200-160120046.30746.43
41554137-155413744.94645.07
51470401-147040142.52442.64
61577969-157796945.63545.76
30min11819547-181954752.62151.672.0452.8451.882.04
21811139-181113952.37852.59
31744496-174449650.45150.66
41749314-174931450.59050.79
51770914-177091451.21551.40
61825486-182548652.79352.99
45min11811917-181191752.40151.671.7752.7051.961.77
21811310-181131052.38352.68
31750354-175035450.62050.91
41754810-175481050.74951.03
51771311-177131151.22651.50
61820490-182049052.64952.94
60min11812405-181240552.41551.531.8152.8151.901.81
21801911-180191152.11152.50
31744879-174487950.46250.84
41743493-174349350.42250.79
51775414-177541451.34551.70
61812396-181239652.41552.79
极限11814905-181490552.48751.501.8552.9651.971.85
21799740-179974052.04952.52
31745567-174556750.48250.94
41744244-174424450.44450.90
51767076-176707651.10451.55
61814093-181409352.46452.93
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.631081873108292410831751083291108243710827400.06
2 22.591093044109849110957680.36
单位质量响应值RSD%判断
47845.3448506.770.98数据可信
供试品溶液-8196156批-氨氯地平-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%
5min1260926-26092610.35510.054.5210.3510.054.52
2260808-26080810.35010.35
3260261-26026110.32910.33
4259642-25964210.30410.30
5233884-2338849.2829.28
6244624-2446249.7089.71
10min1656402-65640226.04924.564.4426.0724.584.45
2644096-64409625.56125.58
3623997-62399724.76324.78
4599765-59976523.80223.82
5586284-58628423.26723.28
6602213-60221323.89923.92
15min1952851-95285137.81435.235.3437.8735.295.34
2925446-92544636.72736.79
3900885-90088535.75235.81
4863380-86338034.26334.32
5824811-82481132.73332.79
6858811-85881134.08234.14
20min11156327-115632745.88942.854.8946.0142.974.89
21112847-111284744.16444.28
31086689-108668943.12643.24
41053189-105318941.79641.91
51001869-100186939.75939.87
61068040-106804042.38542.50
30min11243684-124368449.35648.412.0149.5648.602.01
21238185-123818549.13849.33
31190720-119072047.25447.44
41194459-119445947.40247.59
51209801-120980148.01148.19
61241823-124182349.28249.47
45min11243392-124339249.34448.641.8049.6348.911.81
21244363-124436349.38349.66
31200655-120065547.64847.92
41202249-120224947.71247.97
51215321-121532148.23048.49
61247744-124774449.51749.78
60min11246331-124633149.46148.581.8849.8348.931.88
21239145-123914549.17649.53
31198016-119801647.54447.89
41196011-119601147.46447.81
51219988-121998848.41648.75
61244967-124496749.40749.75
极限11247311-124731149.50048.561.9049.9548.991.90
21237619-123761949.11549.56
31197959-119795947.54147.97
41197797-119779747.53547.96
51214386-121438648.19348.61
61246504-124650449.46849.90
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900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2000
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%
115.471023831021941025321027241020781023820.26
215.511016531012261014400.30
单位质量响应值RSD%判断
6618.106540.300.84数据可信
供试品溶液-8196156批-沙库巴曲-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%
5min162852-6285261.93160.073.2861.9360.073.27
259423-5942358.55258.55
362863-6286361.94161.94
458829-5882957.96657.97
559221-5922158.35358.35
662621-6262161.70361.70
10min179301-7930178.13879.752.4978.2479.852.49
283549-8354982.32482.42
382414-8241481.20681.31
478270-7827077.12277.22
581912-8191280.71180.81
680191-8019179.01579.12
15min180033-8003378.86081.741.8679.0981.971.86
283453-8345382.22982.46
383532-8353282.30782.55
483968-8396882.73782.96
584214-8421482.97983.21
682550-8255081.34081.57
20min181086-8108679.89782.362.2980.2682.732.28
282723-8272381.51081.88
385310-8531084.05984.43
482205-8220581.00081.36
586044-8604484.78285.15
684149-8414982.91583.29
30min183875-8387582.64585.442.0883.1485.942.07
286410-8641085.14385.65
388774-8877487.47287.99
487716-8771686.43086.93
587904-8790486.61587.13
685561-8556184.30784.81
45min188161-8816186.86887.661.6987.5088.301.68
287796-8779686.50987.16
391215-9121589.87890.54
489769-8976988.45389.09
589613-8961388.29988.95
687205-8720585.92686.58
60min191004-9100489.67089.021.1890.4589.811.17
290459-9045989.13389.93
391384-9138490.04490.86
490145-9014588.82389.61
590698-9069889.36890.17
688360-8836087.06587.86
极限196897-9689795.47693.701.8696.4194.641.84
292532-9253291.17592.12
393763-9376392.38893.35
495392-9539293.99394.93
597061-9706195.63896.59
694893-9489393.50294.44
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.631601052159819116000691602811159703515998320.15
2 22.591573986156980515718960.19
单位质量响应值RSD%判断
70695.1869583.711.13数据可信
供试品溶液-8196156批-缬沙坦-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%
5min1442381-44238112.75412.223.8312.7512.223.84
2435442-43544212.55412.55
3426830-42683012.30612.31
4398683-39868311.49411.49
5411124-41112411.85311.85
6429691-42969112.38812.39
10min1985752-98575228.41928.563.7528.4428.583.75
21033793-103379329.80429.83
31028252-102825229.64529.67
4958924-95892427.64627.67
5940202-94020227.10627.13
6996710-99671028.73528.76
15min11378438-137843839.74140.223.0739.8140.293.06
21442302-144230241.58241.65
31441695-144169541.56441.63
41382236-138223639.85039.92
51329719-132971938.33638.40
61396653-139665340.26640.33
20min11649041-164904147.54247.891.7947.6848.031.80
21698728-169872848.97549.11
31694035-169403548.83948.98
41653880-165388047.68247.81
51621040-162104046.73546.86
61650456-165045647.58347.72
30min11772826-177282651.11150.631.6451.3250.841.63
21768246-176824650.97951.20
31757209-175720950.66150.88
41722070-172207049.64849.86
51793589-179358951.70951.92
61722257-172225749.65349.87
45min11774258-177425851.15250.601.6651.4550.901.66
21765993-176599350.91451.22
31758921-175892150.71051.01
41717622-171762249.51949.81
51790911-179091151.63251.93
61722834-172283449.67049.97
60min11769639-176963951.01950.501.6451.4050.881.63
21763406-176340650.83951.23
31755232-175523250.60450.99
41713684-171368449.40649.78
51786653-178665351.50951.89
61720744-172074449.60949.99
极限11768167-176816750.97650.401.7651.4550.871.75
21760515-176051550.75651.23
31745065-174506550.31050.78
41711274-171127449.33649.80
51789214-178921451.58352.05
61715077-171507749.44649.91
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.631097244109613010976061100208109643710975250.15
2 22.591084057108188910829730.15
单位质量响应值RSD%判断
48498.6747940.370.82数据可信
供试品溶液-8196156批-氨氯地平-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%
5min1301155-30115511.94011.414.1311.9411.414.14
2296261-29626111.74611.75
3290194-29019411.50611.51
4269723-26972310.69410.69
5277614-27761411.00711.01
6292057-29205711.58011.58
10min1675985-67598526.80226.943.9426.8226.953.94
2709781-70978128.14228.16
3706762-70676228.02228.04
4657425-65742526.06626.08
5642259-64225925.46525.48
6684038-68403827.12127.14
15min1947159-94715937.55438.023.1537.6238.083.15
2991808-99180839.32439.39
3991479-99147939.31139.38
4950066-95006637.66937.73
5912256-91225636.17036.23
6960620-96062038.08838.15
20min11133293-113329344.93445.281.7945.0645.411.80
21168266-116826646.32146.45
31163853-116385346.14646.28
41138256-113825645.13145.25
51114109-111410944.17344.29
61135098-113509845.00545.13
30min11219887-121988748.36747.931.6248.5748.131.61
21215490-121549048.19348.40
31210375-121037547.99048.20
41186631-118663147.04947.25
51235242-123524248.97649.17
61185635-118563547.00947.21
45min11222453-122245348.46947.941.6848.7548.231.67
21217021-121702148.25448.54
31211546-121154648.03748.32
41184121-118412146.94947.23
51234330-123433048.94049.22
61185915-118591547.02047.30
60min11218028-121802848.29447.841.6348.6648.201.63
21215188-121518848.18148.55
31208853-120885347.93048.30
41180696-118069646.81347.17
51231066-123106648.81049.17
61185342-118534246.99847.36
极限11218428-121842848.30947.761.7348.7548.211.72
21212401-121240148.07048.52
31202339-120233947.67148.12
41179570-117957046.76947.20
51232714-123271448.87649.32
61182678-118267846.89247.33
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