沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
114.053585093579503576383571963572493577080.16
214.293569483562743566110.14
单位质量响应值RSD%判断
25459.6424955.281.42数据可信
供试品溶液-25120201批-氢氯噻嗪-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%
5min1279253-27925379.53280.231.9779.5380.241.97
2275722-27572278.52678.53
3285796-28579681.39581.40
4288229-28822982.08882.09
5275639-27563978.50278.50
6285666-28566681.35881.36
10min1314709-31470989.63088.911.2389.7689.041.23
2305681-30568187.05887.19
3314282-31428289.50889.64
4315822-31582289.94790.08
5312831-31283189.09589.23
6309674-30967488.19688.33
15min1321437-32143791.54690.371.4191.8390.651.41
2309507-30950788.14888.42
3318215-31821590.62890.91
4321040-32104091.43391.72
5318532-31853290.71891.00
6315111-31511189.74490.03
20min1320348-32034891.23690.601.4291.6791.041.42
2310620-31062088.46588.89
3320296-32029691.22191.66
4322333-32233391.80192.24
5320532-32053291.28891.72
6314627-31462789.60690.04
30min1323488-32348892.13091.101.5792.7291.681.57
2311493-31149388.71489.28
3320175-32017591.18691.77
4324778-32477892.49793.09
5322644-32264491.88992.47
6316638-31663890.17990.76
45min1323330-32333092.08591.211.5692.8291.941.55
2311279-31127988.65389.37
3320252-32025291.20891.95
4325831-32583192.79793.54
5321470-32147091.55592.29
6319405-31940590.96791.70
60min1323818-32381892.22491.691.5793.1292.581.57
2312657-31265789.04589.91
3322010-32201091.70992.60
4327511-32751193.27694.18
5324262-32426292.35093.24
6321474-32147491.55692.44
极限1325452-32545292.68991.841.5493.7492.881.54
2313778-31377889.36490.38
3319335-31933590.94791.99
4326006-32600692.84793.90
5326024-32602492.85293.89
6324323-32432392.36893.40
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.886057126046066049986035736056346049050.15
223.236021666008336015000.16
单位质量响应值RSD%判断
26438.1625893.241.48数据可信
供试品溶液-25120201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%
5min182817-828176.40110.6228.906.4010.6228.89
2162133-16213312.53012.53
3183500-18350014.18214.18
4110447-1104478.5368.54
5116406-1164068.9969.00
6168939-16893913.05613.06
10min1358275-35827527.68931.369.5527.7031.389.56
2436057-43605733.70133.72
3463512-46351235.82335.85
4388145-38814529.99830.01
5379899-37989929.36129.38
6409077-40907731.61631.64
15min1576086-57608644.52346.593.8044.5846.663.81
2617736-61773647.74247.82
3639070-63907049.39149.47
4595496-59549646.02346.09
5585096-58509645.21945.28
6603848-60384846.66946.74
20min1654567-65456750.58851.080.5450.7251.220.55
2661281-66128151.10751.26
3663026-66302651.24251.41
4664760-66476051.37651.52
5659777-65977750.99151.13
6661850-66185051.15151.30
30min1669286-66928651.72651.220.5951.9451.460.57
2660153-66015351.02051.26
3659172-65917250.94451.20
4663279-66327951.26251.49
5659788-65978850.99251.22
6664953-66495351.39151.63
45min1662335-66233551.18950.950.9451.4951.270.94
2656259-65625950.71951.05
3655343-65534350.64850.98
4661290-66129051.10851.42
5651598-65159850.35950.67
6668982-66898251.70252.03
60min1662038-66203851.16651.090.7751.5551.500.77
2656555-65655550.74251.15
3656732-65673250.75651.18
4663492-66349251.27851.68
5658153-65815350.86651.26
6669682-66968251.75752.17
极限1660612-66061251.05650.851.5551.5351.341.53
2656919-65691950.77051.27
3639300-63930049.40849.91
4662947-66294751.23651.72
5658668-65866850.90551.38
6669615-66961551.75152.25
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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%
122.881095130109972610959951104779110721211005680.49
223.231099299109620010977500.20
单位质量响应值RSD%判断
48101.7547255.701.26数据可信
供试品溶液-25120201批-缬沙坦钠-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%
5min1143023-1430235.7359.8130.245.749.8130.22
2293100-29310011.75311.75
3329728-32972813.22213.22
4191278-1912787.6707.67
5208808-2088088.3738.37
6302267-30226712.12112.12
10min1649698-64969826.05329.559.8526.0629.579.86
2792872-79287231.79531.81
3845133-84513333.89033.91
4702082-70208228.15428.17
5685935-68593527.50627.52
6746046-74604629.91729.94
15min11045006-104500641.90544.104.1741.9644.164.19
21129738-112973845.30345.38
31170929-117092946.95547.03
41086975-108697543.58843.65
51062697-106269742.61542.67
61103095-110309544.23544.30
20min11214063-121406348.68548.610.5948.8148.750.59
21211526-121152648.58348.73
31212110-121211048.60648.76
41214892-121489248.71848.85
51199676-119967648.10848.24
61221439-122143948.98049.12
30min11222679-122267949.03048.930.6949.2349.150.68
21216571-121657148.78549.01
31214321-121432148.69548.93
41224918-122491849.12049.33
51210057-121005748.52448.73
61233067-123306749.44749.67
45min11225575-122557549.14648.901.1649.4349.201.15
21212171-121217148.60948.92
31205584-120558448.34448.66
41223584-122358449.06649.36
51206819-120681948.39448.69
61242715-124271549.83350.14
60min11225966-122596649.16248.981.0649.5349.361.04
21206126-120612648.36648.76
31211757-121175748.59248.99
41227031-122703149.20549.58
51216046-121604648.76449.14
61241944-124194449.80350.19
极限11225954-122595449.16147.876.3649.6148.346.28
21210524-121052448.54349.01
31040254-104025441.71542.20
41229441-122944149.30149.76
51217104-121710448.80649.26
61239312-123931249.69750.17
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
114.053614033617063613603617203624453617270.13
214.293607863614873611360.14
单位质量响应值RSD%判断
25745.6925271.941.32数据可信
供试品溶液-25120202批-氢氯噻嗪-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%
5min1271612-27161276.44174.693.6376.4474.693.63
2259388-25938873.00073.00
3259715-25971573.09273.09
4274990-27499077.39177.39
5274573-27457377.27477.27
6252030-25203070.93070.93
10min1316649-31664989.11588.121.8989.2488.251.89
2303999-30399985.55585.68
3312032-31203287.81687.94
4313594-31359488.25688.38
5321594-32159490.50790.64
6310842-31084287.48187.60
15min1330830-33083093.10692.081.7393.3892.351.73
2316722-31672289.13689.40
3327224-32722492.09292.36
4327312-32731292.11692.39
5333253-33325393.78894.07
6327691-32769192.22392.49
20min1337638-33763895.02293.731.7495.4594.161.74
2322854-32285490.86291.27
3332784-33278493.65694.08
4332242-33224293.50493.93
5339474-33947495.53995.98
6333364-33336493.82094.24
30min1342648-34264896.43295.151.6897.0295.731.68
2327905-32790592.28392.85
3339020-33902095.41195.99
4336462-33646294.69195.28
5343801-34380196.75797.35
6338634-33863495.30395.88
45min1341289-34128996.05095.581.8696.8096.321.86
2327488-32748892.16692.88
3341598-34159896.13796.87
4339482-33948295.54196.28
5345843-34584397.33298.09
6341955-34195596.23796.97
60min1347395-34739597.76896.791.6698.6897.681.66
2333283-33328393.79794.67
3344978-34497897.08897.99
4342184-34218496.30297.20
5349045-34904598.23399.15
6346526-34652697.52498.42
极限1347975-34797597.93296.891.2899.0097.951.29
2337316-33731694.93295.96
3345066-34506697.11398.17
4341695-34169596.16497.23
5349531-34953198.37099.45
6344117-34411796.84697.90
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.886145326137166131386142346147816140800.11
223.236207936204466206200.04
单位质量响应值RSD%判断
26839.1626716.320.33数据可信
供试品溶液-25120202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%
5min1111407-1114078.41210.2510.948.4110.2410.95
2138599-13859910.46610.47
3141701-14170110.70010.70
4156825-15682511.84211.84
5131548-1315489.9339.93
6134023-13402310.12010.12
10min1367858-36785827.77728.443.5127.7928.463.51
2366808-36680827.69827.72
3396059-39605929.90729.92
4364119-36411927.49527.51
5389341-38934129.40029.42
6375432-37543228.34928.37
15min1568111-56811142.89942.573.2542.9642.643.25
2543865-54386541.06841.13
3568915-56891542.95943.03
4538997-53899740.70040.77
5579288-57928843.74343.81
6583243-58324344.04144.11
20min1652857-65285749.29849.071.0949.4349.201.09
2638798-63879848.23648.37
3651762-65176249.21549.35
4644935-64493548.70048.83
5651730-65173049.21349.35
6659029-65902949.76449.90
30min1655720-65572049.51449.660.6649.7349.880.66
2652455-65245549.26849.48
3660951-66095149.90950.13
4660750-66075049.89450.11
5653675-65367549.36049.58
6662748-66274850.04550.27
45min1643651-64365148.60349.361.2948.9049.661.29
2643389-64338948.58348.88
3655908-65590849.52849.83
4663172-66317250.07750.37
5655032-65503249.46249.76
6660738-66073849.89350.20
60min1656853-65685349.60049.980.8449.9850.360.84
2658533-65853349.72650.10
3661252-66125249.93250.32
4667488-66748850.40350.78
5657478-65747849.64750.03
6669980-66998050.59150.98
极限1658528-65852849.72650.080.8250.1950.540.83
2656365-65636549.56350.02
3671228-67122850.68551.16
4666291-66629150.31250.78
5661776-66177649.97150.44
6664750-66475050.19650.67
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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%
122.881119049111767811161321116345112004611178500.16
223.231117446111874411180950.09
单位质量响应值RSD%判断
48857.0848131.511.06数据可信
供试品溶液-25120202批-缬沙坦钠-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%
5min1195127-1951277.6939.4510.937.699.4510.94
2243505-2435059.6009.60
3249260-2492609.8279.83
4275915-27591510.87810.88
5235064-2350649.2679.27
6239166-2391669.4299.43
10min1668866-66886626.37026.963.5826.3826.983.57
2665297-66529726.22926.25
3716869-71686928.26328.28
4659005-65900525.98126.00
5710445-71044528.00928.02
6682718-68271826.91626.93
15min11037995-103799540.92340.583.7940.9840.643.78
2990520-99052039.05139.11
31040754-104075441.03241.10
4973776-97377638.39138.45
51065600-106560042.01142.07
61067496-106749642.08642.15
20min11198231-119823147.24047.121.2647.3747.261.26
21177183-117718346.41146.54
31201218-120121847.35847.49
41177561-117756146.42646.55
51202878-120287847.42447.56
61214695-121469547.89048.02
30min11210460-121046047.72347.830.7347.9348.040.73
21201166-120116647.35647.56
31223293-122329348.22948.44
41213309-121330947.83548.04
51207370-120737047.60147.81
61223085-122308548.22048.43
45min11201347-120134747.36347.790.7447.6548.080.74
21201673-120167347.37647.66
31215663-121566347.92848.22
41221047-122104748.14048.42
51212055-121205547.78548.08
61221087-122108748.14248.43
60min11216213-121621347.94948.220.8248.3148.580.82
21215784-121578447.93248.29
31225206-122520648.30448.68
41230076-123007648.49648.86
51212300-121230047.79548.17
61238315-123831548.82149.19
极限11213984-121398447.86248.291.1248.3048.741.12
21208403-120840347.64148.08
31246825-124682549.15649.61
41230124-123012448.49848.94
51221366-122136648.15348.60
61228602-122860248.43848.89
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