阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.712870652868222871582872612867972870210.08
210.742862542860512861520.06
单位质量响应值RSD%判断
26799.3526643.580.42数据可信
供试品溶液-2023101221批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14532-45321.5224.2366.251.524.2366.24
228592-285929.6019.60
311647-116473.9113.91
49877-98773.3173.32
512734-127344.2764.28
68216-82162.7592.76
10min148688-4868816.34921.8417.2816.3621.8717.31
281863-8186327.49027.54
368099-6809922.86822.89
463034-6303421.16721.19
570056-7005623.52523.55
658549-5854919.66119.68
15min193057-9305731.24934.716.7931.3534.856.85
2112488-11248837.77437.98
3105164-10516435.31435.46
4104035-10403534.93535.07
5107773-10777336.19036.34
697622-9762232.78232.91
20min1119370-11937040.08442.645.6840.3642.985.73
2134131-13413145.04145.46
3131121-13112144.03044.38
4128878-12887843.27743.61
5131794-13179444.25644.61
6116667-11666739.17739.48
30min1151807-15180750.97753.323.4551.4753.903.51
2161600-16160054.26554.93
3161489-16148954.22854.82
4162349-16234954.51755.09
5163712-16371254.97555.58
6151799-15179950.97451.50
45min1178016-17801659.77862.243.3760.5663.113.38
2184174-18417461.84662.81
3190504-19050463.97164.86
4192509-19250964.64565.52
5188601-18860163.33264.24
6178247-17824759.85560.66
60min1198713-19871366.72867.542.9567.8468.762.95
2197747-19774766.40467.71
3201825-20182567.77369.02
4210437-21043770.66571.90
5204670-20467068.72869.99
6193446-19344664.95966.10
极限1212877-21287771.48472.042.4172.9773.632.42
2211846-21184671.13872.82
3216979-21697972.86274.48
4220682-22068274.10575.73
5218295-21829573.30474.94
6206445-20644569.32470.83
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.721403621408021409381409871409391408060.19
214.831405861401521403690.22
单位质量响应值RSD%判断
9565.629465.210.75数据可信
供试品溶液-2023101221批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130257-3025720.61619.4829.7220.6219.4829.73
232076-3207621.85621.86
339631-3963127.00427.00
426824-2682418.27718.28
529051-2905119.79519.79
613726-137269.3539.35
10min159016-5901640.21237.9311.7640.3338.0411.81
255578-5557837.87037.99
361092-6109241.62741.78
456958-5695838.81038.91
558465-5846539.83739.95
642864-4286429.20729.26
15min166347-6634745.20743.116.9145.5543.436.97
260976-6097641.54841.88
365580-6558044.68545.07
465826-6582644.85245.17
565572-6557244.67945.01
655301-5530137.68137.90
20min168885-6888546.93744.786.7147.5345.346.78
263995-6399543.60544.17
368268-6826846.51647.15
468141-6814146.43047.00
567602-6760246.06246.64
657454-5745439.14839.57
30min171250-7125048.54846.873.6849.4047.683.75
265782-6578244.82245.63
369327-6932747.23848.13
470875-7087548.29349.12
569997-6999747.69448.53
665513-6551344.63945.28
45min171532-7153248.74047.602.8149.8648.672.83
266380-6638045.23046.28
370325-7032547.91849.07
471708-7170848.86049.95
570158-7015847.80448.90
669082-6908247.07147.96
60min172206-7220649.20047.662.8850.5948.992.78
266560-6656045.35246.66
368890-6889046.94048.36
470460-7046048.01049.37
570114-7011447.77449.14
671450-7145048.68449.83
极限172139-7213949.15447.513.0150.8249.112.94
266412-6641245.25246.81
369190-6919047.14548.82
471425-7142548.66750.30
568614-6861446.75248.38
670575-7057548.08849.51
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.712864162865152867272864342861232864430.08
210.742865602866052865820.02
单位质量响应值RSD%判断
26745.3826683.610.17数据可信
供试品溶液-2023101221批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16216-62162.0883.1852.292.093.1852.30
29621-96213.2323.23
311041-110413.7093.71
418484-184846.2096.21
55678-56781.9071.91
65757-57571.9341.93
10min159914-5991420.12420.5112.2120.1420.5212.24
259283-5928319.91219.93
363230-6323021.23821.26
474625-7462525.06525.10
555505-5550518.64318.65
653754-5375418.05518.07
15min199403-9940333.38833.504.4933.5133.634.54
296477-9647732.40532.53
3102505-10250534.43034.57
4107317-10731736.04636.22
595494-9549432.07532.19
697265-9726532.67032.78
20min1122355-12235541.09741.773.2341.4142.093.26
2120660-12066040.52840.84
3129361-12936143.45043.78
4129451-12945143.48143.85
5121092-12109240.67340.97
6123304-12330441.41641.71
30min1151581-15158150.91451.852.4851.4552.402.50
2151687-15168750.94951.48
3161532-16153254.25654.83
4155471-15547152.22052.84
5153921-15392151.70052.22
6152066-15206651.07751.60
45min1172863-17286358.06260.753.9958.8861.583.97
2179194-17919460.18961.01
3193320-19332064.93365.81
4182469-18246961.28962.19
5182168-18216861.18861.99
6175124-17512458.82259.63
60min1186732-18673262.72165.346.1963.8666.526.13
2194676-19467665.38966.54
3210321-21032170.64471.88
4200110-20011067.21468.46
5199730-19973067.08668.23
6175700-17570059.01560.15
极限1200528-20052867.35470.283.5868.8571.823.59
2206126-20612669.23570.75
3221107-22110774.26775.89
4213868-21386871.83573.45
5210104-21010470.57172.09
6203665-20366568.40869.87
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.721402681403571408901408511401531405040.25
214.831405311404271404790.06
单位质量响应值RSD%判断
9545.119472.620.54数据可信
供试品溶液-2023101221批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125745-2574517.55415.7415.1717.5515.7415.16
223498-2349816.02216.02
316757-1675711.42611.43
426147-2614717.82817.83
521644-2164414.75814.76
624675-2467516.82416.82
10min153201-5320136.27436.506.6836.3736.596.67
251696-5169635.24835.34
355079-5507937.55537.62
454035-5403536.84336.94
548222-4822232.88032.96
658974-5897440.21140.30
15min160830-6083041.47641.925.5041.7842.215.48
261278-6127841.78242.07
365077-6507744.37244.64
459124-5912440.31340.62
556908-5690838.80239.07
665635-6563544.75245.07
20min163798-6379843.50043.826.1444.0344.356.11
264193-6419343.76944.29
369386-6938647.31047.83
460888-6088841.51642.04
559251-5925140.40040.88
668114-6811446.44347.01
30min166565-6656545.38745.525.8146.1646.285.78
266868-6686845.59346.35
371458-7145848.72349.50
462526-6252642.63343.39
562385-6238542.53643.24
670757-7075748.24549.07
45min167289-6728945.88046.954.9646.9047.974.95
269315-6931547.26248.27
373309-7330949.98551.04
466395-6639545.27146.27
564595-6459544.04344.98
672235-7223549.25350.34
60min167333-6733345.91046.483.9347.1947.763.89
268230-6823046.52247.80
373011-7301149.78251.11
468569-6856946.75348.00
565066-6506644.36445.55
666778-6677845.53246.90
极限166750-6675045.51346.754.0847.0548.304.07
267525-6752546.04147.58
372534-7253449.45651.06
469006-6900647.05148.56
564850-6485044.21745.65
670762-7076248.24849.87
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.712858292861432861132861022860192860410.05
210.742864912867472866190.07
单位质量响应值RSD%判断
26707.8426687.060.06数据可信
供试品溶液-2024010621批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119402-194026.5215.9426.366.525.9426.37
219238-192386.4666.47
324356-243568.1868.19
413632-136324.5824.58
511207-112073.7673.77
618194-181946.1156.11
10min169269-6926923.28123.257.9223.3223.287.95
271866-7186624.15424.19
376263-7626325.63225.68
465146-6514621.89621.92
560823-6082320.44320.46
671734-7173424.11024.14
15min1107099-10709935.99635.754.3036.1635.914.34
2109669-10966936.86037.03
3110173-11017337.02937.22
4102890-10289034.58134.73
598833-9883333.21833.35
6109494-10949436.80136.97
20min1131079-13107944.05644.042.5944.4244.402.63
2133042-13304244.71545.09
3134413-13441345.17645.57
4127215-12721542.75743.10
5126641-12664142.56442.88
6133850-13385044.98745.36
30min1160216-16021653.84954.702.0354.4655.302.06
2162876-16287654.74355.37
3167766-16776656.38657.03
4160750-16075054.02854.60
5159365-15936553.56354.12
6165489-16548955.62156.24
45min1185717-18571762.41963.351.3863.3364.261.39
2186241-18624162.59663.52
3192739-19273964.77965.74
4187740-18774063.09963.98
5188437-18843763.33464.19
6190025-19002563.86764.80
60min1200523-20052367.39669.232.2668.6570.492.21
2199932-19993267.19768.47
3210017-21001770.58771.90
4207535-20753569.75270.98
5210485-21048570.74471.95
6207409-20740969.71071.00
极限1213841-21384171.87273.481.5073.5075.131.49
2215472-21547272.42074.07
3222248-22224874.69776.41
4219547-21954773.79075.40
5220954-22095474.26375.86
6219776-21977673.86775.54
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.721407801403731405151405701399801404440.22
214.831404511404721404620.02
单位质量响应值RSD%判断
9541.039471.480.52数据可信
供试品溶液-2024010621批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145641-4564131.12826.4620.4631.1326.4620.46
245755-4575531.20631.21
341437-4143728.26128.26
441933-4193328.59928.60
526614-2661418.15118.15
631420-3142021.42921.43
10min162900-6290042.89942.733.5143.0742.883.56
264002-6400243.65143.82
364472-6447243.97144.13
464541-6454144.01944.18
559156-5915640.34640.45
660874-6087441.51841.64
15min166651-6665145.45846.411.8845.8746.791.89
268223-6822346.53046.95
368237-6823746.53946.94
469853-6985347.64148.04
566519-6651945.36845.69
668772-6877246.90447.25
20min167500-6750046.03747.231.3146.7047.871.27
269572-6957247.45048.12
369132-6913247.15047.81
469925-6992547.69148.36
569542-6954247.42948.01
669839-6983947.63248.24
30min167933-6793346.33247.661.3947.2548.561.36
270440-7044048.04248.98
370287-7028747.93748.86
470270-7027047.92648.86
570390-7039048.00848.85
669923-6992347.68948.56
45min168506-6850646.72347.461.0847.9048.641.02
270124-7012447.82649.03
369129-6912947.14848.34
469657-6965747.50848.71
570643-7064348.18049.29
669506-6950647.40548.54
60min168656-6865646.82547.731.7648.2649.161.66
269821-6982147.62049.09
369132-6913247.15048.60
470285-7028547.93649.40
572192-7219249.23750.61
669814-6981447.61549.02
极限168446-6844646.68247.561.5848.3849.261.49
269630-6963047.48949.22
369241-6924147.22448.94
469859-6985947.64649.38
571739-7173948.92850.58
669507-6950747.40549.07
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.712863612863382859782858752861082861320.08
210.742864532863442863980.03
单位质量响应值RSD%判断
26716.3426666.480.14数据可信
供试品溶液-2024010621批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121849-218497.3455.8920.587.355.8920.59
216224-162245.4545.45
312615-126154.2414.24
420270-202706.8146.81
514599-145994.9084.91
619637-196376.6016.60
10min176917-7691725.85823.478.0825.9023.508.09
271526-7152624.04524.08
362541-6254121.02521.05
473203-7320324.60924.65
563539-6353921.36021.39
671121-7112123.90923.95
15min1111663-11166337.53835.873.4637.7236.033.49
2107579-10757936.16536.33
3103558-10355834.81434.95
4109521-10952136.81836.99
5101755-10175534.20834.35
6106067-10606735.65735.83
20min1136723-13672345.96344.562.9946.3644.923.00
2136520-13652045.89546.26
3131515-13151544.21244.55
4133871-13387145.00445.38
5126574-12657442.55142.89
6130026-13002643.71244.08
30min1166602-16660256.00855.122.1656.6655.722.16
2167329-16732956.25256.87
3166427-16642755.94956.53
4163970-16397055.12355.75
5158874-15887453.41053.98
6160495-16049553.95554.56
45min1191370-19137064.33464.411.9865.2965.321.96
2191511-19151164.38165.31
3198287-19828766.65967.55
4192402-19240264.68165.62
5187617-18761763.07263.94
6188397-18839763.33564.24
60min1210525-21052570.77370.852.4072.0972.132.36
2209599-20959970.46271.75
3219977-21997773.95175.21
4211501-21150171.10272.40
5207746-20774669.83971.06
6205201-20520168.98470.25
极限1224505-22450575.47374.861.8077.1876.531.79
2223119-22311975.00776.69
3229176-22917677.04378.71
4222228-22222874.70876.40
5218923-21892373.59775.20
6218206-21820673.35675.00
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.721406641404321399831403131397581402300.26
214.831405051405341405200.02
单位质量响应值RSD%判断
9526.499475.390.39数据可信
供试品溶液-2024010621批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130361-3036120.71824.4822.0420.7224.4822.03
239424-3942426.90326.90
344077-4407730.07830.08
444110-4411030.10130.10
524792-2479216.91816.92
632497-3249722.17622.18
10min165337-6533744.58642.2810.1844.7042.4210.20
262527-6252742.66942.82
369573-6957347.47747.64
465027-6502744.37544.54
552124-5212435.56935.66
657195-5719539.03039.15
15min170945-7094548.41346.325.6748.7846.695.72
267604-6760446.13346.52
372608-7260849.54849.98
469211-6921147.23047.64
562643-6264342.74843.04
664268-6426843.85744.20
20min172501-7250149.47547.454.1850.1148.084.23
269655-6965547.53348.18
372908-7290849.75350.46
469631-6963147.51648.19
566386-6638645.30245.83
666081-6608145.09445.68
30min172954-7295449.78447.674.0450.6948.564.02
269883-6988347.68848.60
373194-7319449.94850.93
465887-6588744.96145.90
568906-6890647.02247.80
668344-6834446.63847.47
45min172098-7209849.20047.872.5150.3849.022.56
268568-6856846.79147.96
372623-7262349.55850.82
469495-6949547.42348.61
569257-6925747.26148.30
668827-6882746.96848.06
60min173087-7308749.87548.123.0251.3349.543.04
268041-6804146.43147.86
373184-7318449.94151.48
470005-7000547.77249.22
569392-6939247.35348.66
669410-6941047.36548.72
极限172732-7273249.63247.902.5351.3749.592.56
268245-6824546.57048.26
372045-7204549.16450.98
469347-6934747.32349.04
569332-6933247.31248.88
669432-6943247.38149.00
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.712885102886432885802882752881762884370.07
210.742880782878962879870.05
单位质量响应值RSD%判断
26931.5626814.430.31数据可信
供试品溶液-2024010721批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18816-88162.9445.7037.422.945.7037.45
211433-114333.8183.82
318502-185026.1786.18
426764-267648.9378.94
519884-198846.6396.64
616987-169875.6725.67
10min161145-6114520.41724.4210.7420.4324.4610.78
268730-6873022.94922.97
377912-7791226.01526.05
484005-8400528.05028.10
574940-7494025.02325.06
672151-7215124.09224.12
15min1101081-10108133.75236.625.7633.8836.785.80
2106195-10619535.45935.61
3115560-11556038.58638.76
4118277-11827739.49339.70
5109313-10931336.50036.68
6107549-10754935.91136.08
20min1128833-12883343.01844.853.8043.3445.233.85
2131452-13145243.89344.24
3139928-13992846.72347.12
4141451-14145147.23147.66
5132148-13214844.12544.50
6132172-13217244.13344.50
30min1160240-16024053.50555.473.0554.0656.083.08
2165056-16505655.11355.70
3172163-17216357.48658.14
4171079-17107957.12457.81
5160699-16069953.65854.28
6167449-16744955.91256.52
45min1187806-18780662.70964.642.3563.5665.562.38
2193045-19304564.45965.35
3200331-20033166.89267.86
4196691-19669165.67666.68
5189852-18985263.39364.31
6193800-19380064.71165.63
60min1206685-20668569.01369.842.4270.2271.122.42
2208222-20822269.52670.78
3217922-21792272.76574.11
4208493-20849369.61770.99
5202807-20280767.71868.99
6210751-21075170.37171.65
极限1217089-21708972.48773.093.8374.0774.763.80
2219393-21939373.25774.90
3229231-22923176.54278.29
4222597-22259774.32676.08
5203986-20398668.11269.76
6220995-22099573.79175.46
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.721426441427791426711424351426341426330.09
214.831421821423881422850.11
单位质量响应值RSD%判断
9689.749594.400.70数据可信
供试品溶液-2024010721批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128306-2830619.03425.8118.6419.0325.8118.64
243513-4351329.25929.26
348428-4842832.56432.56
439676-3967626.67926.68
536759-3675924.71824.72
633607-3360722.59822.60
10min160273-6027340.52942.697.8840.6342.837.92
269664-6966446.84447.01
369889-6988946.99547.18
462370-6237041.93942.09
559510-5951040.01640.15
659182-5918239.79539.92
15min168239-6823945.88646.434.3446.2246.814.38
271545-7154548.10948.53
373573-7357349.47249.91
468754-6875446.23246.61
565981-6598144.36744.73
666231-6623144.53544.88
20min170887-7088747.66647.493.2748.2548.133.33
271879-7187948.33349.02
373988-7398849.75150.47
470953-7095347.71148.35
567810-6781045.59746.20
668246-6824645.89046.48
30min170979-7097947.72848.062.3848.5848.962.43
272081-7208148.46949.43
373923-7392349.70850.70
471647-7164748.17749.08
568696-6869646.19347.05
671538-7153848.10448.95
45min170574-7057447.45647.971.7148.5749.141.79
272129-7212948.50149.73
373235-7323549.24550.51
471401-7140148.01249.18
569781-6978146.92248.04
670957-7095747.71348.83
60min170893-7089347.67047.691.9449.0549.121.98
270827-7082747.62649.12
373145-7314549.18550.73
470062-7006247.11148.55
569090-6909046.45847.83
671517-7151748.09049.47
极限170063-7006347.11246.903.5148.7648.603.49
270269-7026947.25149.01
372430-7243048.70450.52
470572-7057247.45449.15
565108-6510843.78045.42
670061-7006147.11148.76
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.712884952882622883642882882885322883880.05
210.742885432884762885100.02
单位质量响应值RSD%判断
26926.9826863.130.17数据可信
供试品溶液-2024010721批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118521-185216.1795.2731.856.185.2731.81
220861-208616.9606.96
312672-126724.2284.23
419047-190476.3556.35
516374-163745.4635.46
67272-72722.4262.43
10min172909-7290924.32524.158.7824.3624.188.82
277683-7768325.91725.96
367354-6735422.47122.49
478773-7877326.28126.32
575249-7524925.10525.14
662419-6241920.82520.84
15min1110134-11013436.74436.874.2236.9137.034.26
2113978-11397838.02738.21
3105460-10546035.18535.33
4114447-11444738.18338.36
5114676-11467638.25938.43
6104338-10433834.81034.94
20min1134608-13460844.90945.032.8445.2845.402.88
2138353-13835346.15946.55
3131544-13154443.88744.23
4137590-13759045.90446.30
5138381-13838146.16846.55
6129348-12934843.15443.48
30min1165356-16535655.16855.851.4155.7956.471.41
2167469-16746955.87356.52
3164260-16426054.80255.39
4167802-16780255.98456.63
5170790-17079056.98157.62
6168811-16881156.32156.88
45min1198575-19857566.25166.041.3667.1866.961.38
2200632-20063266.93767.90
3192740-19274064.30465.20
4198888-19888866.35567.31
5198608-19860866.26267.22
6198146-19814666.10866.98
60min1213884-21388471.35871.931.8172.6673.231.81
2220666-22066673.62174.95
3209101-20910169.76271.01
4216640-21664072.27873.61
5217433-21743372.54273.87
6215906-21590672.03373.28
极限1225489-22548975.23075.741.7776.9277.441.78
2233488-23348877.89979.64
3221506-22150673.90175.54
4228509-22850976.23877.97
5227794-22779475.99977.73
6225303-22530375.16876.81
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.721425581426831425201427071426161426170.06
214.831425191427631426410.13
单位质量响应值RSD%判断
9688.659618.410.52数据可信
供试品溶液-2024010721批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133287-3328722.35624.5139.2322.3624.5139.23
251042-5104234.28134.28
319344-1934412.99212.99
445071-4507130.27130.27
549796-4979633.44433.44
620432-2043213.72313.72
10min160436-6043640.59042.008.4640.7142.138.55
267039-6703945.02545.22
354875-5487536.85536.93
466591-6659144.72444.89
567546-6754645.36545.55
658695-5869539.42139.50
15min167407-6740745.27246.413.4045.6246.783.52
270403-7040347.28447.72
366228-6622844.48044.76
470246-7024647.17947.60
572523-7252348.70849.15
667812-6781245.54445.84
20min169741-6974146.83947.531.7447.4448.151.83
270541-7054147.37748.08
370184-7018447.13747.66
470675-7067547.46748.15
573184-7318449.15249.86
670247-7024747.17947.73
30min171173-7117347.80148.532.2548.6649.422.17
270212-7021247.15648.12
372595-7259548.75649.54
471368-7136847.93248.87
574017-7401749.71150.69
674218-7421849.84650.66
45min171961-7196148.33049.111.5249.4650.271.47
271744-7174448.18549.41
373365-7336549.27350.33
473020-7302049.04250.25
574182-7418249.82251.08
674435-7443549.99251.08
60min171186-7118647.81048.841.8449.2150.271.79
271274-7127447.86949.37
373074-7307449.07850.41
472387-7238748.61650.10
574236-7423649.85851.39
674123-7412349.78251.15
极限171272-7127247.86848.681.2549.5350.381.23
271787-7178748.21449.98
372672-7267248.80850.41
472165-7216548.46750.22
573426-7342649.31451.13
673536-7353649.38851.03
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.712878342877672876752879862876692877860.05
210.742881152880892881020.01
单位质量响应值RSD%判断
26870.7726825.140.13数据可信
供试品溶液-2024010921批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134400-3440011.4979.2617.4411.509.2617.46
220235-202356.7636.76
327950-279509.3419.34
429237-292379.7719.77
524642-246428.2368.24
629789-297899.9569.96
10min188864-8886429.70028.794.8829.7628.844.89
279485-7948526.56526.60
389795-8979530.01130.06
489102-8910229.77929.83
582511-8251127.57627.62
687146-8714629.12629.18
15min1123245-12324541.19041.322.9141.4241.532.93
2119793-11979340.03740.22
3128384-12838442.90843.13
4127487-12748742.60842.83
5120288-12028840.20240.40
6122627-12262740.98441.20
20min1147128-14712849.17249.792.9449.6350.232.94
2145776-14577648.72149.13
3152458-15245850.95451.41
4155838-15583852.08352.54
5144262-14426248.21548.64
6148312-14831249.56850.01
30min1178568-17856859.68059.644.2060.4160.364.17
2179627-17962760.03460.71
3186169-18616962.22162.96
4185336-18533661.94262.69
5175354-17535458.60659.30
6165692-16569255.37756.10
45min1207680-20768069.41069.472.2870.4770.522.29
2204402-20440268.31469.33
3214596-21459671.72172.81
4212672-21267271.07872.17
5204063-20406368.20169.22
6203795-20379568.11169.14
60min1222783-22278374.45875.061.9375.9176.501.93
2225932-22593275.51076.90
3230179-23017976.92978.41
4228416-22841676.34077.82
5221148-22114873.91175.31
6219059-21905973.21374.62
极限1235704-23570478.77679.181.7180.6481.041.70
2241506-24150680.71582.53
3241790-24179080.81082.72
4237005-23700579.21181.12
5233268-23326877.96279.77
6232254-23225477.62379.44
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.721424951424231422361423341421091423190.11
214.831426161424231425200.10
单位质量响应值RSD%判断
9668.419610.250.43数据可信
供试品溶液-2024010921批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131194-3119420.98125.7315.5220.9825.7415.51
242405-4240528.52228.52
335841-3584124.10724.11
445032-4503230.28930.29
532241-3224121.68521.69
642846-4284628.81828.82
10min160097-6009740.42241.323.1340.5441.463.16
264954-6495443.68843.85
360257-6025740.52940.66
462349-6234941.93642.10
560142-6014240.45240.57
660823-6082340.91041.07
15min165116-6511643.79744.711.9644.1445.081.96
268249-6824945.90546.31
366730-6673044.88345.24
466787-6678744.92145.32
567144-6714445.16145.51
664802-6480243.58643.97
20min166917-6691745.00945.831.5845.5946.441.59
269055-6905546.44747.10
368336-6833645.96346.57
469048-6904846.44247.09
568760-6876046.24846.84
666672-6667244.84445.47
30min168088-6808845.79645.774.0546.6346.643.98
269847-6984746.97947.89
369391-6939146.67347.54
469260-6926046.58547.49
569128-6912846.49647.35
662549-6254942.07142.95
45min169171-6917146.52546.441.7047.6147.571.67
268511-6851146.08147.26
370199-7019947.21648.34
469820-6982046.96148.13
569630-6963046.83447.94
666973-6697345.04646.16
60min168760-6876046.24846.331.5647.6047.721.55
269092-6909246.47247.90
369297-6929746.61047.99
469377-6937746.66348.09
569913-6991347.02448.40
666828-6682844.94946.31
极限168616-6861646.15246.381.3647.7648.031.36
269849-6984946.98148.67
369296-6929646.60948.25
469273-6927346.59348.28
569480-6948046.73348.37
667236-6723645.22346.84
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.712887412884682885332887892888312886720.06
210.742881232885592883410.11
单位质量响应值RSD%判断
26953.5026847.390.28数据可信
供试品溶液-2024010921批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115506-155065.1727.7618.765.177.7618.77
227916-279169.3129.31
322040-220407.3527.35
425477-254778.4988.50
525861-258618.6268.63
622800-228007.6057.61
10min175529-7552925.19427.825.1525.2227.875.17
286146-8614628.73528.79
381320-8132027.12527.17
486217-8621728.75928.81
585421-8542128.49328.54
685868-8586828.64328.68
15min1117444-11744439.17540.612.1739.3440.802.20
2122504-12250440.86341.07
3119773-11977339.95240.14
4124447-12444741.51141.72
5123693-12369341.26041.47
6122570-12257040.88541.09
20min1141969-14196947.35648.802.0547.7449.222.07
2147420-14742049.17449.61
3143940-14394048.01348.43
4148678-14867849.59450.03
5149945-14994550.01650.45
6145875-14587548.65949.09
30min1176122-17612258.74859.421.9959.4060.121.99
2176264-17626458.79559.51
3173868-17386857.99658.68
4181724-18172460.61761.33
5182984-18298461.03761.75
6177904-17790459.34260.04
45min1206836-20683668.99369.111.8569.9770.131.84
2202997-20299767.71368.75
3203830-20383067.99068.99
4212487-21248770.87871.93
5210964-21096470.37071.42
6206004-20600468.71669.74
60min1222981-22298174.37974.902.7175.7476.312.69
2219156-21915673.10374.52
3220048-22004873.40074.78
4235581-23558178.58180.03
5227061-22706175.73977.18
6222436-22243674.19775.61
极限1235070-23507078.41178.891.5780.1880.711.58
2232405-23240577.52279.34
3233184-23318477.78279.57
4242010-24201080.72682.61
5239408-23940879.85881.72
6236945-23694579.03680.86
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.721425251426361426651424531426831425920.07
214.831425241428591426920.17
单位质量响应值RSD%判断
9686.969621.850.48数据可信
供试品溶液-2024010921批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136779-3677924.69928.0414.3224.7028.0414.32
239899-3989926.79426.79
338929-3892926.14326.14
437299-3729925.04825.05
552194-5219435.05135.05
645435-4543530.51230.51
10min160836-6083640.85542.135.2140.9942.285.24
261287-6128741.15841.31
359222-5922239.77139.92
461636-6163641.39241.53
567837-6783745.55645.75
665566-6556644.03144.20
15min167315-6731545.20645.213.2345.5745.603.25
265780-6578044.17544.55
363917-6391742.92443.29
468021-6802145.68046.05
569633-6963346.76347.21
669248-6924846.50446.92
20min167540-6754045.35745.882.7445.9746.522.77
267529-6752945.35045.97
365454-6545443.95644.56
469410-6941046.61347.24
570758-7075847.51848.23
669226-6922646.48947.16
30min168528-6852846.02046.152.8246.8947.042.85
267540-6754045.35746.23
365579-6557944.04044.89
470172-7017247.12548.01
570828-7082847.56548.54
669651-6965146.77547.71
45min169483-6948346.66246.612.7447.7847.772.77
267920-6792045.61246.74
366516-6651644.66945.76
471136-7113647.77248.92
571451-7145147.98349.22
669973-6997346.99148.18
60min168359-6835945.90746.522.8447.2947.932.84
268579-6857946.05547.43
366331-6633144.54545.89
471863-7186348.26049.67
570819-7081947.55949.06
669671-6967146.78848.24
极限168680-6868046.12346.522.4647.7648.182.49
269025-6902546.35447.99
366268-6626844.50346.09
470664-7066447.45549.13
570810-7081047.55349.32
670146-7014647.10748.82
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