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%
1 15.691031991027091029071028901027101028830.20
2 15.761046811047511047160.05
单位质量响应值RSD%判断
6557.236644.420.94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%
5min116100-1610015.81217.205.6615.8117.205.65
218564-1856418.23218.23
317248-1724816.94016.94
417050-1705016.74516.75
517376-1737617.06517.07
618740-1874018.40518.40
10min142087-4208741.33442.294.1041.3642.314.10
245175-4517544.36744.40
340201-4020139.48239.51
443135-4313542.36442.39
543290-4329042.51642.54
644447-4444743.65243.68
15min160968-6096859.87860.821.3159.9760.921.31
261010-6101059.91960.02
363073-6307361.94562.04
462057-6205760.94761.05
562289-6228961.17561.27
662152-6215261.04161.14
20min168778-6877867.54867.971.3667.7468.171.35
267500-6750066.29366.50
369781-6978168.53368.73
470057-7005768.80469.00
569505-6950568.26268.46
669608-6960868.36368.57
30min171800-7180070.51669.601.2770.8269.911.26
269252-6925268.01468.33
370672-7067269.40869.72
471560-7156070.28070.60
571068-7106869.79770.11
670839-7083969.57269.89
45min171984-7198470.69770.280.4571.1270.700.44
271172-7117269.89970.33
371624-7162470.34370.77
471818-7181870.53470.97
571252-7125269.97870.41
671478-7147870.20070.63
60min171675-7167570.39369.821.5670.9470.371.55
269070-6907067.83568.38
372144-7214470.85471.40
471789-7178970.50571.05
570759-7075969.49470.04
671105-7110569.83470.39
极限172147-7214770.85769.452.3771.5270.122.35
268958-6895867.72568.38
371085-7108569.81470.48
472149-7214970.85971.53
568303-6830367.08267.75
671641-7164170.36071.03
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%
122.801581625157881215787471580554157914615797770.09
222.821610771161160516111880.04
单位质量响应值RSD%判断
69288.4670604.211.34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%
5min1456862-45686213.20814.306.8013.2114.306.81
2527424-52742415.24815.25
3485410-48541014.03314.03
4467712-46771213.52213.52
5488626-48862614.12614.13
6542619-54261915.68715.69
10min11146767-114676733.15434.282.1133.1834.302.10
21195001-119500134.54834.57
31185378-118537834.27034.29
41170630-117063033.84333.87
51196257-119625734.58434.61
61219838-121983835.26635.29
15min11621351-162135146.87447.370.9446.9547.450.95
21637368-163736847.33747.42
31643374-164337447.51147.59
41625132-162513246.98347.06
51639636-163963647.40347.48
61664656-166465648.12648.21
20min11794159-179415951.87051.880.3352.0352.040.33
21789515-178951551.73651.90
31795068-179506851.89652.06
41796664-179666451.94252.10
51788041-178804151.69351.85
61804383-180438352.16652.33
30min11802899-180289952.12351.950.4252.3652.200.42
21788490-178849051.70651.95
31797045-179704551.95352.20
41798352-179835251.99152.24
51788009-178800951.69251.94
61806658-180665852.23152.48
45min11796990-179699051.95251.820.3252.2852.160.32
21788733-178873351.71352.05
31794631-179463151.88452.22
41792562-179256251.82452.15
51783346-178334651.55751.89
61798726-179872652.00252.34
60min11786672-178667251.65451.620.3552.0752.040.35
21773343-177334351.26851.69
31787201-178720151.66952.09
41787606-178760651.68152.10
51786862-178686251.65952.08
61791195-179119551.78452.21
极限11791081-179108151.78151.520.5152.2852.020.50
21776542-177654251.36151.87
31784879-178487951.60252.11
41781739-178173951.51152.01
51767272-176727251.09351.60
61790064-179006451.75252.26
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%
122.801077407107579410749291076460107554810760280.09
222.821094147109551110948290.09
单位质量响应值RSD%判断
47194.2147976.731.17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%
5min1304083-30408312.21813.256.8812.2213.256.87
2351043-35104314.10414.10
3323328-32332812.99112.99
4311813-31181312.52812.53
5325912-32591213.09513.09
6362603-36260314.56914.57
10min1769666-76966630.92432.002.2030.9432.022.20
2804161-80416132.31032.33
3794556-79455631.92431.95
4785624-78562431.56531.59
5805092-80509232.34732.37
6819892-81989232.94232.97
15min11094044-109404443.95744.410.9444.0344.480.94
21103455-110345544.33544.41
31109644-110964444.58444.66
41096429-109642944.05344.13
51105320-110532044.41044.49
61122869-112286945.11545.19
20min11212033-121203348.69848.790.4348.8448.940.43
21210700-121070048.64448.80
31213014-121301448.73748.89
41215728-121572848.84648.99
51210349-121034948.63048.78
61223966-122396649.17749.33
30min11219749-121974949.00848.920.4049.2349.150.40
21212018-121201848.69748.93
31217688-121768848.92549.16
41218336-121833648.95149.18
51212444-121244448.71448.95
61224960-122496049.21749.45
45min11219963-121996349.01648.840.3749.3249.150.36
21213126-121312648.74249.06
31213313-121331348.74949.06
41215195-121519548.82549.13
51210118-121011848.62148.93
61221682-122168249.08549.40
60min11212136-121213648.70248.670.4049.0949.060.40
21202017-120201748.29548.69
31212808-121280848.72949.12
41212492-121249248.71649.11
51211996-121199648.69649.09
61215963-121596348.85649.26
极限11215550-121555048.83948.560.6049.3149.030.60
21203612-120361248.35948.83
31210606-121060648.64049.11
41208209-120820948.54449.02
51197403-119740348.11048.58
61215961-121596148.85649.34
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%
1 15.691043891042291045941044721042911043950.14
2 15.761056361052461054410.27
单位质量响应值RSD%判断
6653.606690.420.40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%
5min116832-1683216.35418.777.8216.3518.777.82
219436-1943618.88418.88
319542-1954218.98718.99
421564-2156420.95220.95
519058-1905818.51718.52
619463-1946318.91018.91
10min137412-3741236.35041.537.5836.3841.567.57
242838-4283841.62241.65
344348-4434843.08943.12
446756-4675645.42845.46
540956-4095639.79339.82
644180-4418042.92642.96
15min153765-5376552.23856.716.3552.3356.816.35
258183-5818356.53156.63
361879-6187960.12260.23
462546-6254660.77060.88
554329-5432952.78652.88
659521-5952157.83157.93
20min159959-5995958.25663.235.4458.4363.435.44
263057-6305761.26761.46
368701-6870166.75066.95
468906-6890666.94967.16
563440-6344061.63961.82
666432-6643264.54664.75
30min162670-6267060.89165.495.0961.1665.795.10
266343-6634364.45964.76
369954-6995467.96868.28
470719-7071968.71169.03
564394-6439462.56662.85
670352-7035268.35468.66
45min163112-6311261.32065.654.7461.6966.064.75
266680-6668064.78765.19
369574-6957467.59868.03
470584-7058468.58069.02
564779-6477962.94063.33
670687-7068768.68069.10
60min163539-6353961.73566.204.9562.2166.724.95
266561-6656164.67165.18
371533-7153369.50270.04
470640-7064068.63469.19
565517-6551763.65764.15
671037-7103769.02069.56
极限160909-6090959.18065.586.1359.7666.216.12
267010-6701065.10765.73
371097-7109769.07869.73
470784-7078468.77469.44
564572-6457262.73863.34
670598-7059868.59369.24
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%
122.801607226160642116086411605373160549016066300.09
222.821639094163591516375040.14
单位质量响应值RSD%判断
70466.2371757.411.29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%
5min1505522-50552214.37515.505.0614.3815.505.06
2556655-55665515.82915.83
3532863-53286315.15315.15
4577775-57777516.43016.43
5569266-56926616.18816.19
6527861-52786115.01115.01
10min11132641-113264132.20834.023.3732.2334.043.37
21216249-121624934.58634.61
31196646-119664634.02834.05
41235903-123590335.14535.17
51230635-123063534.99535.02
61165939-116593933.15533.18
15min11586067-158606745.10246.431.6845.1846.511.68
21653569-165356947.02247.11
31644998-164499846.77846.86
41655092-165509247.06547.15
51642618-164261846.71046.80
61613432-161343245.88045.96
20min11769787-176978750.32750.910.7150.4851.070.72
21804223-180422351.30651.47
31795220-179522051.05051.21
41792240-179224050.96551.13
51799259-179925951.16551.33
61781424-178142450.65750.81
30min11768292-176829250.28450.840.7250.5251.090.73
21804205-180420551.30551.55
31792064-179206450.96051.21
41795745-179574551.06551.31
51788919-178891950.87151.12
61778392-177839250.57150.81
45min11766630-176663050.23750.700.7250.5651.020.72
21805091-180509151.33051.66
31783770-178377050.72451.05
41781980-178198050.67351.01
51783482-178348250.71651.05
61775782-177578250.49750.82
60min11761870-176187050.10150.630.7250.5151.050.72
21797618-179761851.11851.54
31780995-178099550.64551.06
41778935-177893550.58751.01
51790712-179071250.92251.34
61773029-177302950.41950.83
极限11763469-176346950.14750.600.7550.6351.100.76
21800563-180056351.20251.71
31781133-178113350.64951.15
41775208-177520850.48150.98
51787000-178700050.81651.32
61769779-176977950.32650.82
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%
122.801092153109281410942681092840109225510928660.08
222.821109546110697311082600.17
单位质量响应值RSD%判断
47932.7248565.290.93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%
5min1335725-33572513.30314.405.2313.3014.405.24
2371734-37173414.73014.73
3355602-35560214.09114.09
4385560-38556015.27815.28
5379906-37990615.05415.05
6351363-35136313.92313.92
10min1760448-76044830.13331.903.4730.1531.923.48
2818992-81899232.45332.48
3803532-80353231.84031.86
4833646-83364633.03333.06
5827834-82783432.80332.83
6785744-78574431.13531.16
15min11069210-106921042.36843.661.7242.4443.731.72
21116347-111634744.23544.31
31111050-111105044.02544.10
41117565-111756544.28444.36
51106931-110693143.86243.94
61089227-108922743.16143.24
20min11196911-119691147.42848.050.7947.5748.200.79
21222189-122218948.42948.58
31217367-121736748.23848.39
41213021-121302148.06648.22
51219435-121943548.32048.47
61206069-120606947.79147.94
30min11199254-119925447.52148.070.7247.7448.300.73
21224022-122402248.50248.74
31217172-121717248.23148.46
41216993-121699348.22348.46
51214320-121432048.11848.35
61207137-120713747.83348.06
45min11199155-119915547.51747.930.6847.8248.240.69
21224070-122407048.50448.82
31209236-120923647.91648.23
41208810-120881047.89948.21
51210703-121070347.97448.29
61205536-120553647.76948.08
60min11195571-119557147.37547.900.7347.7648.290.73
21219658-121965848.32948.72
31209552-120955247.92948.32
41207177-120717747.83448.23
51216739-121673948.21348.61
61204216-120421647.71748.10
极限11195135-119513547.35747.840.7647.8248.310.76
21221112-122111248.38748.86
31208249-120824947.87748.35
41204882-120488247.74448.22
51213095-121309548.06948.54
61201083-120108347.59348.06
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