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%
115.341001271010431000951001361001391003080.41
215.399995299910999310.03
单位质量响应值RSD%判断
6538.986493.240.50数据可信
供试品溶液-25080401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%
5min121826-2182621.71416.4125.8421.7116.4125.84
220411-2041120.30620.31
314091-1409114.01914.02
415672-1567215.59115.59
516837-1683716.75016.75
610131-1013110.07910.08
10min146320-4632046.08240.3115.8746.1240.3415.88
246181-4618145.94345.98
341517-4151741.30341.33
441228-4122841.01641.04
539050-3905038.84938.88
628800-2880028.65228.67
15min160692-6069260.38055.2613.4860.4955.3513.48
262113-6211361.79361.90
358324-5832458.02458.12
458827-5882758.52458.62
550767-5076750.50650.60
642547-4254742.32842.39
20min166095-6609565.75562.2411.2765.9762.4211.27
267274-6727466.92867.14
367381-6738167.03467.22
466843-6684366.49966.69
557160-5716056.86657.04
650611-5061150.35150.49
30min166413-6641366.07165.696.7866.3965.986.81
269718-6971869.35969.68
368453-6845368.10168.40
469213-6921368.85769.16
564606-6460664.27464.55
657760-5776057.46357.68
45min167618-6761867.27067.075.2467.7067.475.28
269888-6988869.52869.97
369716-6971669.35769.77
469353-6935368.99669.41
567406-6740667.05967.44
660545-6054560.23460.55
60min167405-6740567.05866.994.6667.6067.504.70
268949-6894968.59469.15
368716-6871668.36268.89
469571-6957169.21369.75
568284-6828467.93368.42
661111-6111160.79761.21
极限167817-6781767.46868.761.8868.1369.381.90
269900-6990069.54070.21
369315-6931568.95869.60
470000-7000069.64070.29
570433-7043370.07170.67
667235-6723566.88967.41
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%
122.581545105154588915476301546193154436515458360.08
222.611550863155099115509270.01
单位质量响应值RSD%判断
68460.4168594.740.14数据可信
供试品溶液-25080401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%
5min1550549-55054916.24512.8824.0616.2412.8824.06
2558356-55835616.47516.48
3371636-37163610.96610.97
4411526-41152612.14312.14
5440007-44000712.98312.98
6286772-2867728.4628.46
10min11185987-118598734.99431.1515.8235.0231.1715.82
21229764-122976436.28636.31
31093535-109353532.26632.28
41064699-106469931.41531.44
5999527-99952729.49229.51
6759975-75997522.42422.44
15min11557186-155718645.94742.3614.1846.0342.4414.19
21633092-163309248.18748.27
31522202-152220244.91544.99
41522142-152214244.91344.99
51283505-128350537.87237.94
61096083-109608332.34232.39
20min11675738-167573849.44547.2311.3449.6147.3711.35
21763898-176389852.04652.21
31710530-171053050.47250.62
41695944-169594450.04150.19
51458191-145819143.02643.16
61299306-129930638.33838.44
30min11674806-167480649.41849.146.4749.6649.366.50
21772857-177285752.31152.57
31723170-172317050.84551.08
41728693-172869351.00851.24
51617847-161784747.73747.94
61473955-147395543.49143.66
45min11670248-167024849.28349.734.8049.6150.044.84
21770342-177034252.23652.58
31722000-172200050.81051.13
41725749-172574950.92151.24
51688146-168814649.81150.10
61536060-153606045.32445.57
60min11670694-167069449.29649.884.3249.7150.264.36
21768809-176880952.19152.62
31719995-171999550.75151.15
41725878-172587850.92551.33
51699874-169987450.15750.53
61556709-155670945.93346.25
极限11669474-166947449.26050.761.9449.7551.241.95
21763687-176368752.04052.56
31715889-171588950.63051.11
41725552-172555250.91551.40
51746623-174662351.53751.99
61701491-170149150.20550.60
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%
122.581067340106753010672711065479106481010664860.12
222.611067141106649510668180.05
单位质量响应值RSD%判断
47231.4447183.460.08数据可信
供试品溶液-25080401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%
5min1372917-37291715.10211.8325.1115.1011.8325.09
2376156-37615615.23315.23
3246822-2468229.99610.00
4274423-27442311.11311.11
5294706-29470611.93511.93
6187543-1875437.5957.60
10min1808116-80811632.72729.0616.0732.7529.0816.07
2835872-83587233.85133.88
3744311-74431130.14330.16
4725238-72523829.37029.39
5679626-67962627.52327.54
6512480-51248020.75420.77
15min11063657-106365743.07639.6314.3743.1639.6914.37
21113703-111370345.10245.18
31040199-104019942.12642.19
41035999-103599941.95542.02
5873783-87378335.38635.45
6743503-74350330.11030.16
20min11145686-114568646.39844.2611.5046.5544.3911.51
21203528-120352848.74048.90
31170189-117018947.39047.53
41159153-115915346.94347.08
5994574-99457440.27840.40
6883657-88365735.78635.88
30min11145826-114582646.40346.066.7946.6346.276.82
21214971-121497149.20349.44
31179614-117961447.77247.99
41182299-118229947.88048.10
51100606-110060644.57244.76
61001359-100135940.55340.71
45min11144306-114430646.34246.625.2346.6546.905.27
21212830-121283049.11749.44
31182546-118254647.89048.19
41181179-118117947.83548.13
51146096-114609646.41446.68
61039996-103999642.11742.34
60min11144079-114407946.33246.664.8446.7247.034.88
21209119-120911948.96649.37
31178694-117869447.73448.11
41181636-118163647.85348.23
51151365-115136546.62846.97
61048866-104886642.47742.77
极限11145988-114598846.41047.692.0446.8748.132.06
21211414-121141449.05949.54
31176467-117646747.64448.10
41184657-118465747.97648.43
51191569-119156948.25648.68
61155731-115573146.80447.17
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%
115.341008461008281003061005731003141005730.27
215.391011141011281011210.01
单位质量响应值RSD%判断
6556.266570.570.16数据可信
供试品溶液-25080402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%
5min123105-2310522.82021.854.9522.8221.854.95
221209-2120920.94820.95
322787-2278722.50622.51
420344-2034420.09320.09
522508-2250822.23122.23
622771-2277122.49022.49
10min145605-4560545.04342.445.2945.0842.485.28
241343-4134340.83340.87
343767-4376743.22843.27
439873-3987339.38239.42
545214-4521444.65744.69
642021-4202141.50341.54
15min155057-5505754.37854.626.0254.4954.726.01
254807-5480754.13254.23
358238-5823857.52057.63
452129-5212951.48751.59
560015-6001559.27559.39
651551-5155150.91651.02
20min159604-5960458.86960.146.8459.0760.336.83
260288-6028859.54559.74
366134-6613465.31965.52
457209-5720956.50456.69
565707-6570764.89765.11
656375-5637555.68055.87
30min165326-6532664.52162.376.3764.8262.676.36
262573-6257361.80262.09
367448-6744866.61766.93
458023-5802357.30857.59
566670-6667065.84866.17
658838-5883858.11358.40
45min166927-6692766.10263.526.0066.5163.925.99
263189-6318962.41062.81
367996-6799667.15867.58
458618-5861857.89658.27
567740-6774066.90567.33
661409-6140960.65261.03
60min166966-6696666.14163.845.8466.6664.345.84
263230-6323062.45162.95
368432-6843267.58968.13
458717-5871757.99358.46
567833-6783366.99767.54
662616-6261661.84462.33
极限169419-6941968.56364.226.4369.1964.836.41
263539-6353962.75663.36
367154-6715466.32666.98
457504-5750456.79557.36
567145-6714566.31766.97
665338-6533864.53365.12
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%
122.581565942156561815660561567953156747415666090.07
222.611595753159644615961000.04
单位质量响应值RSD%判断
69380.3870592.661.23数据可信
供试品溶液-25080402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%
5min1607489-60748917.55216.872.1017.5516.872.10
2582998-58299816.84516.84
3579776-57977616.75216.75
4579067-57906716.73116.73
5571843-57184316.52316.52
6581658-58165816.80616.81
10min11188412-118841234.33733.852.1934.3733.882.19
21177386-117738634.01934.05
31182077-118207734.15434.18
41179946-117994634.09334.12
51181738-118173834.14534.17
61119732-111973232.35332.38
15min11394038-139403840.27943.216.6440.3743.306.63
21577438-157743845.57845.66
31546055-154605544.67144.76
41547049-154704944.70044.78
51563124-156312445.16445.25
61345596-134559638.87938.96
20min11513498-151349843.73046.816.6543.8846.976.64
21675323-167532348.40648.57
31701534-170153449.16349.32
41685725-168572548.70648.87
51690968-169096848.85849.02
61454137-145413742.01542.16
30min11639220-163922047.36348.114.3547.5948.354.35
21714449-171444949.53649.78
31726989-172698949.89950.14
41688571-168857148.78949.03
51691196-169119648.86549.11
61530942-153094244.23444.45
45min11682961-168296148.62748.453.3848.9348.773.39
21715070-171507049.55449.88
31721567-172156749.74250.07
41686498-168649848.72949.05
51689862-168986248.82649.15
61565984-156598445.24745.54
60min11688099-168809948.77548.642.3449.1649.042.34
21710306-171030649.41749.82
31722420-172242049.76750.17
41679212-167921248.51848.92
51690524-169052448.84549.25
61610198-161019846.52446.89
极限11730662-173066250.00549.201.2750.4749.681.25
21714041-171404149.52550.01
31712054-171205449.46749.96
41669449-166944948.23648.72
51688441-168844148.78549.27
61702620-170262049.19549.64
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%
122.581075381107595810752641076464107655510759240.06
222.611086947108800810874780.07
单位质量响应值RSD%判断
47649.4248097.210.67数据可信
供试品溶液-25080402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%
5min1412174-41217416.46015.802.1616.4615.802.17
2393509-39350915.71515.71
3393478-39347815.71415.71
4391828-39182815.64815.65
5387417-38741715.47215.47
6395383-39538315.79015.79
10min1811648-81164832.41331.912.2432.4431.942.24
2802386-80238632.04332.07
3806758-80675832.21832.24
4803989-80398932.10732.13
5806479-80647932.20732.23
6763195-76319530.47830.50
15min1955205-95520538.14640.796.5738.2340.886.56
21078456-107845643.06843.15
31053781-105378142.08342.16
41055621-105562142.15642.24
51067327-106732742.62442.70
6918750-91875036.69036.77
20min11035871-103587141.36844.296.7841.5144.436.77
21146616-114661645.79045.94
31166383-116638346.58046.73
41154147-115414746.09146.24
51158737-115873746.27446.42
6992216-99221639.62439.76
30min11120204-112020444.73645.494.5044.9545.724.49
21173785-117378546.87547.10
31183387-118338747.25947.49
41155901-115590146.16146.39
51157340-115734046.21946.45
61044465-104446541.71141.92
45min11144715-114471545.71445.733.7246.0046.033.72
21174048-117404846.88647.19
31177348-117734847.01847.32
41155236-115523646.13546.44
51157591-115759146.22946.53
61062036-106203642.41342.69
60min11142693-114269345.63445.892.8346.0046.262.84
21171266-117126646.77547.16
31179797-117979747.11547.50
41152411-115241146.02246.40
51160033-116003346.32646.71
61088532-108853243.47143.82
极限11181493-118149347.18346.591.2047.6247.041.19
21177176-117717647.01147.47
31176492-117649246.98347.45
41145379-114537945.74146.20
51160332-116033246.33846.80
61159622-115962246.31046.73
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%
115.341008091007831010471009231009021008930.11
215.391016871017851017360.07
单位质量响应值RSD%判断
6577.126610.530.36数据可信
供试品溶液-25080401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%
5min122809-2280922.42417.3624.9422.4217.3624.94
219909-1990919.57319.57
311817-1181711.61811.62
414826-1482614.57614.58
521641-2164121.27621.28
614943-1494314.69114.69
10min146517-4651745.73235.9618.4245.7735.9918.42
243131-4313142.40342.44
330670-3067030.15230.17
432146-3214631.60431.63
535882-3588235.27635.31
631098-3109830.57330.60
15min161422-6142260.38649.3616.7860.5049.4516.78
260245-6024559.22859.33
341966-4196641.25841.33
444470-4447043.72043.80
547109-4710946.31446.41
646020-4602045.24345.32
20min168819-6881967.65856.5114.8767.8756.6814.87
267755-6775566.61266.81
349912-4991249.07049.21
450641-5064149.78649.94
554512-5451253.59253.76
653243-5324352.34552.50
30min167548-6754866.40860.049.0866.7460.319.12
268570-6857067.41367.73
356572-5657255.61755.84
456113-5611355.16655.40
559331-5933158.33058.59
658309-5830957.32557.56
45min166246-6624665.12862.814.2265.5763.184.26
267654-6765466.51266.94
364459-6445963.37163.68
460999-6099959.97060.29
562563-6256361.50761.87
661434-6143460.39760.73
60min168733-6873367.57364.793.4568.1265.263.50
268769-6876967.60968.14
365305-6530564.20364.62
464521-6452163.43263.86
564446-6444663.35863.82
663640-6364062.56663.00
极限169108-6910867.94267.061.0668.6067.641.12
269019-6901967.85468.50
368170-6817067.02067.55
467635-6763566.49467.02
567353-6735366.21666.78
668008-6800866.86067.40
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%
122.581573690157325615740971574391157436615739600.04
222.611608964160867116088180.02
单位质量响应值RSD%判断
69705.9371155.151.46数据可信
供试品溶液-25080401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%
5min1599391-59939117.21013.5623.2417.2113.5623.24
2545375-54537515.65915.66
3317755-3177559.1239.12
4404246-40424611.60711.61
5554007-55400715.90715.91
6413098-41309811.86111.86
10min11220623-122062335.04727.6318.6035.0827.6518.61
21152598-115259833.09433.12
3799632-79963222.95922.97
4841632-84163224.16524.18
5914363-91436326.25326.28
6844537-84453724.24924.27
15min11613773-161377346.33537.3417.6746.4237.4117.67
21562287-156228744.85744.94
31076821-107682130.91830.97
41127625-112762532.37732.44
51235924-123592435.48635.56
61186321-118632134.06234.12
20min11747552-174755250.17642.0115.1750.3442.1415.18
21742155-174215550.02150.18
31258208-125820836.12636.23
41305866-130586637.49437.61
51379883-137988339.62039.75
61345800-134580038.64138.76
30min11759265-175926550.51244.959.5350.7645.159.56
21749523-174952350.23350.47
31429911-142991141.05641.22
41455251-145525141.78341.96
51517068-151706843.55843.75
61482951-148295142.57942.76
45min11756666-175666650.43847.255.3550.7747.525.40
21746261-174626150.13950.46
31647290-164729047.29747.53
41572469-157246945.14945.39
51599097-159909745.91446.18
61552346-155234644.57144.82
60min11756593-175659350.43648.223.4950.8548.583.55
21745438-174543850.11550.52
31663940-166394047.77548.09
41650821-165082147.39947.72
51650551-165055147.39147.74
61609027-160902746.19946.53
极限11751756-175175650.29749.740.7450.8050.180.83
21744133-174413350.07850.57
31728480-172848049.62850.02
41721036-172103649.41549.81
51728058-172805849.61650.04
61721091-172109149.41649.82
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%
122.581079117108002110785211078723107991310792590.07
222.611095745109188810938160.25
单位质量响应值RSD%判断
47797.1248377.530.86数据可信
供试品溶液-25080401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%
5min1410295-41029516.31312.7524.0116.3112.7524.00
2372439-37243914.80714.81
3211912-2119128.4258.43
4272762-27276210.84410.84
5376784-37678414.98014.98
6280087-28008711.13611.14
10min1837148-83714833.28326.1718.9533.3126.1918.95
2792594-79259431.51231.54
3545259-54525921.67821.69
4574497-57449722.84122.86
5624101-62410124.81324.84
6575973-57597322.90022.92
15min11109963-110996344.13035.4617.9644.2135.5217.96
21075073-107507342.74342.82
3735623-73562329.24729.30
4772880-77288030.72830.78
5846344-84634433.64933.72
6811302-81130232.25632.31
20min11200326-120032647.72339.9115.3747.8840.0315.37
21198116-119811647.63547.78
3860799-86079934.22434.32
4892883-89288335.49935.61
5946879-94687937.64637.77
6923296-92329636.70836.82
30min11210334-121033448.12142.699.8448.3642.889.87
21205129-120512947.91448.14
3978494-97849438.90339.06
4996723-99672339.62839.79
51037075-103707541.23241.42
61014742-101474240.34440.52
45min11208539-120853948.04944.915.5948.3745.175.64
21204113-120411347.87348.18
31126809-112680944.80045.02
41076801-107680142.81243.04
51096178-109617843.58243.84
61064805-106480542.33542.57
60min11207811-120781148.02045.853.6748.4246.183.74
21201970-120197047.78848.18
31141030-114103045.36545.66
41133244-113324445.05645.36
51132817-113281745.03945.37
61102054-110205443.81644.12
极限11206098-120609847.95247.410.7948.4347.820.87
21201056-120105647.75248.22
31190668-119066847.33947.71
41184197-118419747.08147.46
51189272-118927247.28347.68
61182756-118275647.02447.41
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%
115.341010991009161011591011491010791010800.10
215.391005591005281005440.03
单位质量响应值RSD%判断
6589.316533.070.61数据可信
供试品溶液-25080402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%
5min113064-1306412.90817.9121.5512.9117.9121.55
222993-2299322.71822.72
318728-1872818.50418.50
413887-1388713.72113.72
519223-1922318.99318.99
620851-2085120.60120.60
10min133312-3331232.91338.9414.2532.9338.9714.25
246976-4697646.41446.45
338037-3803737.58237.61
433355-3335532.95632.98
540593-4059340.10740.14
644227-4422743.69743.73
15min147349-4734946.78252.3712.0946.8652.4712.10
261220-6122060.48760.60
351321-5132150.70750.80
444838-4483844.30144.38
554479-5447953.82753.93
658835-5883558.13158.24
20min161249-6124960.51660.0310.8660.6760.2110.86
267522-6752266.71466.93
353191-5319152.55452.73
453339-5333952.70052.85
560795-6079560.06760.26
668442-6844267.62367.83
30min166658-6665865.86061.488.3366.1261.768.32
264161-6416163.39363.72
354591-5459153.93754.20
458420-5842057.72157.96
561234-6123460.50160.79
668302-6830267.48467.80
45min167364-6736466.55762.145.9266.9262.535.92
263501-6350162.74163.17
358165-5816557.46957.82
459899-5989959.18259.52
561563-6156360.82661.22
666877-6687766.07666.51
60min164603-6460363.82963.024.8164.3163.514.81
265612-6561264.82665.36
359623-5962358.90959.36
465046-6504664.26764.70
560449-6044959.72560.22
667390-6739066.58367.12
极限168127-6812767.31164.825.1767.8965.415.15
267437-6743766.63067.28
361047-6104760.31660.87
467290-6729066.48467.03
561473-6147360.73761.33
668243-6824367.42668.08
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%
122.581566044156824815687231566568156818915675540.08
222.611570403157071815705600.02
单位质量响应值RSD%判断
69422.2369463.070.05数据可信
供试品溶液-25080402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%
5min1347862-34786210.12914.2522.7310.1314.2522.72
2599328-59932817.45117.45
3529286-52928615.41215.41
4349801-34980110.18510.19
5562367-56236716.37516.37
6546924-54692415.92515.93
10min1902066-90206626.26630.9715.3126.2830.9915.32
21207127-120712735.14935.18
31098685-109868531.99132.02
4820821-82082123.90023.92
51185788-118578834.52734.55
61167094-116709433.98334.01
15min11236424-123642436.00241.5713.1736.0641.6513.18
21592510-159251046.37046.46
31424847-142484741.48841.57
41163729-116372933.88533.94
51583358-158335846.10446.19
61565778-156577845.59245.67
20min11587961-158796146.23847.029.6346.3647.169.64
21740677-174067750.68450.85
31497197-149719743.59543.74
41375625-137562540.05540.17
51742573-174257350.74050.90
61744278-174427850.78950.95
30min11758849-175884951.21349.096.3051.4149.316.31
21743280-174328050.76051.01
31573737-157373745.82346.04
41526814-152681444.45744.64
51755809-175580951.12551.37
61756590-175659051.14851.39
45min11761879-176187951.30250.003.2251.5850.303.25
21741119-174111950.69751.03
31660541-166054148.35148.65
41633891-163389147.57547.83
51751820-175182051.00951.34
61753852-175385251.06851.40
60min11758996-175899651.21850.302.0151.5950.692.05
21737024-173702450.57851.00
31699853-169985349.49649.87
41670770-167077048.64948.98
51746871-174687150.86551.28
61750980-175098050.98451.40
极限11760642-176064251.26650.640.8551.7251.110.87
21733310-173331050.47050.97
31727213-172721350.29250.75
41720995-172099550.11150.53
51745641-174564150.82951.33
61747438-174743850.88151.38
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%
122.581077258107680410772421077982107835910775290.06
222.611075646107673010761880.08
单位质量响应值RSD%判断
47720.5047597.880.19数据可信
供试品溶液-25080402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%
5min1232603-2326039.33113.3223.469.3313.3223.47
2408513-40851316.38716.39
3359723-35972314.43014.43
4234691-2346919.4149.41
5383755-38375515.39415.39
6372928-37292814.96014.96
10min1617494-61749424.77029.2515.5824.7929.2715.57
2829704-82970433.28333.31
3754805-75480530.27830.30
4558944-55894422.42122.44
5813868-81386832.64732.67
6800326-80032632.10432.13
15min1848151-84815134.02339.3113.3634.0839.3813.37
21093891-109389143.88043.96
3977016-97701639.19239.27
4795510-79551031.91131.96
51089712-108971243.71343.79
61075896-107589643.15843.24
20min11089327-108932743.69744.469.8943.8144.609.90
21196035-119603547.97848.13
31025383-102538341.13241.27
4939972-93997237.70637.81
51199961-119996148.13548.29
61199526-119952648.11848.27
30min11208501-120850148.47846.476.4448.6646.686.44
21199776-119977648.12848.36
31080375-108037543.33843.55
41046210-104621041.96742.14
51208294-120829448.46948.70
61207076-120707648.42048.65
45min11211522-121152248.59947.333.4848.8747.613.51
21198203-119820348.06448.38
31138038-113803845.65145.93
41117529-111752944.82845.07
51205229-120522948.34648.66
61208136-120813648.46348.77
60min11208958-120895848.49647.602.2048.8447.972.23
21194025-119402547.89748.29
31166883-116688346.80847.16
41143331-114333145.86346.18
51201637-120163748.20248.60
61205352-120535248.35148.74
极限11212166-121216648.62548.030.8449.0548.470.86
21194989-119498947.93648.41
31187957-118795747.65348.09
41185050-118505047.53747.93
51200370-120037048.15148.63
61202859-120285948.25148.72
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