缬沙坦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%
114.032456702459462454402460762459652458190.11
214.232480812479902480360.03
单位质量响应值RSD%判断
17520.9617430.500.37数据可信
供试品溶液-1批-氨氯地平-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148825-4882518.11125.0131.8718.1125.0131.87
247238-4723817.52317.52
347471-4747117.60917.61
485275-8527531.63231.63
587778-8777832.56132.56
688006-8800632.64532.65
10min172215-7221526.78835.7827.6326.8235.8227.64
272597-7259726.93026.96
371588-7158826.55526.58
4119632-11963244.37744.43
5120963-12096344.87144.93
6121690-12169045.14045.19
15min187036-8703632.28642.5425.6632.3642.6425.67
288901-8890132.97733.05
387542-8754232.47332.55
4140517-14051752.12452.25
5141583-14158352.52052.65
6142436-14243652.83652.97
20min197836-9783636.29247.0624.2836.4247.2324.29
2100077-10007737.12337.25
398403-9840336.50236.63
4153721-15372157.02257.24
5155010-15501057.50057.72
6156134-15613457.91758.14
30min1114103-11410342.32653.7221.8642.5253.9721.87
2117611-11761143.62743.82
3116127-11612743.07743.27
4173328-17332864.29564.60
5172561-17256164.01164.32
6175105-17510564.95565.27
45min1131367-13136748.73060.4119.3848.9960.7619.41
2136867-13686750.77051.03
3134105-13410549.74650.01
4190324-19032470.60071.02
5192579-19257971.43671.86
6191931-19193171.19671.62
60min1144461-14446153.58764.8817.4153.9365.3217.45
2149503-14950355.45855.81
3147552-14755254.73455.08
4201720-20172074.82775.36
5203654-20365475.54576.08
6202583-20258375.14775.69
90min1164112-16411260.87770.5814.2861.3171.1214.35
2167143-16714362.00162.44
3165293-16529361.31561.75
4212200-21220078.71579.37
5216169-21616980.18780.85
6216624-21662480.35681.02
120min1177034-17703465.67073.9011.9166.2074.5711.99
2178578-17857866.24366.79
3177258-17725865.75366.29
4218392-21839281.01281.80
5221798-22179882.27583.07
6222341-22234182.47783.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1182742-18274267.78776.3211.2368.4377.1011.32
2187409-18740969.51970.17
3183993-18399368.25268.90
4225189-22518983.53384.46
5226688-22668884.08985.02
6228380-22838084.71785.65
缬沙坦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%
114.032465062466792474222466772470172468600.15
214.232482602485242483920.08
单位质量响应值RSD%判断
17595.1517455.520.57数据可信
供试品溶液-1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%
5min138869-3886914.37819.5134.1114.3819.5134.11
237033-3703313.69813.70
333536-3353612.40512.40
466518-6651824.60524.60
568751-6875125.43125.43
671824-7182426.56826.57
10min177194-7719428.55436.9626.7428.5837.0026.75
277421-7742128.63828.66
372353-7235326.76326.78
4122535-12253545.32645.37
5122450-12245045.29445.34
6127598-12759847.19847.24
15min1107820-10782039.88348.7121.8839.9548.8021.90
2106766-10676639.49339.56
3101936-10193637.70637.77
4156230-15623057.78957.91
5156161-15616157.76457.88
6161226-16122659.63759.76
20min1131215-13121548.53656.7318.0448.6756.9018.07
2129687-12968747.97148.11
3123903-12390345.83245.96
4176298-17629865.21365.43
5177009-17700965.47665.69
6182018-18201867.32867.55
30min1163414-16341460.44768.0013.3660.6768.2813.40
2163515-16351560.48460.70
3157760-15776058.35558.56
4205209-20520975.90776.23
5204038-20403875.47475.80
6209130-20913077.35777.69
45min1198168-19816873.30278.468.0973.6278.848.15
2197968-19796873.22873.55
3193645-19364571.62971.93
4226005-22600583.59984.05
5226321-22632183.71684.17
6230502-23050285.26385.73
60min1220969-22096981.73684.454.4082.1884.964.48
2217708-21770880.53080.97
3219273-21927381.10981.53
4235494-23549487.10987.70
5236054-23605487.31687.90
6240343-24034388.90389.51
90min1241436-24143689.30789.701.1089.8990.351.14
2243032-24303289.89790.47
3240238-24023888.86489.42
4241463-24146389.31790.05
5241178-24117889.21289.95
6247592-24759291.58492.34
120min1253181-25318193.65291.581.6294.3892.381.55
2248765-24876592.01892.74
3248080-24808091.76592.47
4242655-24265589.75890.64
5243259-24325989.98190.86
6249561-24956192.31393.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1256217-25621794.77592.501.8695.6693.451.79
2253572-25357293.79694.67
3248640-24864091.97292.83
4244256-24425690.35091.38
5245802-24580290.92291.95
6251870-25187093.16794.23
缬沙坦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%
114.032440692441552442602444112439392441670.08
214.232444232451322447780.21
单位质量响应值RSD%判断
17403.2117201.550.83数据可信
供试品溶液-1批-氨氯地平-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154230-5423020.31927.2328.8720.3227.2328.87
255082-5508220.63820.64
351733-5173319.38319.38
496124-9612436.01536.02
588766-8876633.25833.26
690086-9008633.75333.75
10min1109076-10907640.86848.7018.4240.9048.7418.43
2110184-11018441.28341.32
3105937-10593739.69239.72
4157825-15782559.13359.19
5147078-14707855.10655.16
6149755-14975556.10956.17
15min1142983-14298353.57261.8613.0353.6761.9813.05
2148889-14888955.78555.89
3145297-14529754.43954.54
4189753-18975371.09571.25
5182476-18247668.36968.52
6181195-18119567.88968.04
20min1173542-17354265.02170.628.5465.2170.858.57
2174107-17410765.23365.43
3174452-17445265.36265.55
4207973-20797377.92278.20
5200000-20000074.93575.20
6200886-20088675.26775.53
30min1205052-20505276.82780.273.9477.1380.613.98
2208703-20870378.19578.50
3207876-20787677.88578.18
4226397-22639784.82585.23
5216182-21618280.99881.38
6221179-22117982.87083.26
45min1230937-23093786.52686.441.7186.9586.921.70
2231855-23185586.87087.31
3230205-23020586.25286.68
4236291-23629188.53289.08
5224062-22406283.95084.47
6230950-23095086.53187.06
60min1243370-24337091.18489.222.6691.7689.852.60
2241106-24110690.33690.92
3243422-24342291.20491.78
4238246-23824689.26489.96
5226705-22670584.94085.60
6235995-23599588.42189.09
90min1248548-24854893.12490.343.3093.8591.113.23
2245820-24582092.10292.83
3249168-24916893.35694.08
4239189-23918989.61890.46
5230758-23075886.45987.26
6233165-23316587.36188.18
120min1249612-24961293.52390.733.1894.4091.653.11
2247271-24727192.64693.53
3249102-24910293.33294.21
4239585-23958589.76690.76
5230936-23093686.52587.47
6236368-23636888.56189.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1258285-25828596.77294.902.2597.8195.982.19
2256003-25600395.91796.96
3259281-25928197.14698.18
4251612-25161294.27295.42
5244262-24426291.51892.61
6250247-25024793.76194.87
缬沙坦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%
114.032458362466152463942464652461942463010.13
214.232479002481882480440.09
单位质量响应值RSD%判断
17555.3117431.060.51数据可信
供试品溶液批-氨氯地平-pH3.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156546-5654620.95530.1035.3720.9530.1035.38
254871-5487120.33420.33
353817-5381719.94319.94
4104617-10461738.76938.77
5111133-11113341.18341.18
6106307-10630739.39539.40
10min1100474-10047437.23348.0724.9837.2748.1224.99
2100535-10053537.25637.29
399553-9955336.89236.93
4157446-15744658.34658.41
5162687-16268760.28860.36
6157532-15753258.37858.44
15min1129461-12946147.97558.0119.6448.0758.1419.66
2128885-12888547.76247.86
3127412-12741247.21647.31
4182794-18279467.73967.90
5189042-18904270.05570.22
6181669-18166967.32367.49
20min1149942-14994255.56564.8415.0455.7465.0615.08
2151865-15186556.27856.45
3151386-15138656.10056.27
4197477-19747773.18173.46
5203311-20331175.34375.63
6195809-19580972.56372.84
30min1179962-17996266.69073.239.0166.9673.579.07
2182923-18292367.78768.06
3181697-18169767.33367.60
4212349-21234978.69279.09
5217785-21778580.70681.12
6211024-21102478.20178.60
45min1208171-20817177.14480.103.8177.5280.563.89
2211488-21148878.37378.76
3207542-20754276.91177.29
4222188-22218882.33882.87
5227426-22742684.27984.83
6220004-22000481.52982.06
60min1224501-22450183.19583.951.2183.7084.541.28
2225539-22553983.58084.09
3225321-22532183.49984.01
4226682-22668284.00384.67
5231939-23193985.95286.64
6225228-22522883.46584.13
90min1239966-23996688.92687.642.7389.5788.372.61
2245834-24583491.10191.75
3240170-24017089.00289.65
4232689-23268986.22987.03
5230475-23047585.40986.24
6229899-22989985.19686.00
120min1246356-24635691.29489.463.2692.0990.343.15
2252221-25222193.46894.27
3245238-24523890.88091.67
4233570-23357086.55687.50
5238983-23898388.56289.53
6232130-23213086.02286.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1254176-25417694.19292.623.0695.1493.642.96
2260808-26080896.65097.61
3252498-25249893.57094.52
4243095-24309590.08691.18
5249149-24914992.32993.45
6239827-23982788.87589.96
缬沙坦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%
114.032461982460302460782468602467922463920.17
214.232449922454782452350.15
单位质量响应值RSD%判断
17561.8017233.661.34数据可信
供试品溶液批-氨氯地平-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165644-6564424.46231.5826.9624.4631.5826.97
263182-6318223.54423.54
363408-6340823.62823.63
4104704-10470439.01739.02
5101243-10124337.72737.73
6110326-11032641.11241.11
10min1128305-12830547.81254.9616.3247.8555.0116.33
2124281-12428146.31246.35
3124536-12453646.40746.45
4166375-16637561.99862.06
5166955-16695562.21462.28
6174432-17443265.00065.07
15min1170452-17045263.51768.259.1463.6468.409.16
2166405-16640562.00962.13
3167970-16797062.59262.71
4194399-19439972.44172.61
5195300-19530072.77772.94
6204438-20443876.18276.36
20min1197139-19713973.46275.745.1873.6975.995.22
2192713-19271371.81372.03
3193029-19302971.93072.15
4208094-20809477.54477.83
5209969-20996978.24378.53
6218494-21849481.42081.72
30min1222919-22291983.06982.761.6783.4283.151.69
2220292-22029282.09082.43
3220132-22013282.03082.37
4218506-21850681.42481.84
5221745-22174582.63183.05
6229010-22901085.33885.78
45min1233035-23303586.83886.031.6787.3386.561.65
2231799-23179986.37886.85
3232451-23245186.62187.10
4223847-22384783.41483.97
5229421-22942185.49186.05
6234695-23469587.45788.04
60min1235174-23517487.63586.631.6488.2787.301.62
2231825-23182586.38787.01
3234750-23475087.47788.10
4225459-22545984.01584.71
5232007-23200786.45587.15
6235642-23564287.81088.54
90min1236542-23654288.14587.231.6388.9288.041.60
2235429-23542987.73088.49
3236043-23604387.95988.73
4226938-22693884.56685.40
5232686-23268686.70887.55
6236904-23690488.28089.15
120min1236035-23603587.95687.361.7388.8888.311.70
2235524-23552487.76688.68
3237703-23770388.57889.49
4226653-22665384.46085.43
5233796-23379687.12288.11
6236881-23688188.27189.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1252095-25209593.94192.532.0495.0193.631.99
2252218-25221893.98695.04
3253155-25315594.33695.40
4240319-24031989.55290.67
5245309-24530991.41292.54
6246783-24678391.96193.13
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