阿齐沙坦左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DJ301-191212对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
110.983749643746873749933744213746553747440.07
211.113748973736773742870.24
单位质量响应值RSD%判断
34129.6933689.200.92数据可信
制剂处方摸索--供试品溶液-24011701SP批-pH1.2(内含1.5%吐温80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min115711-157114.1604.3029.064.164.3029.02
214980-149803.9663.97
322942-229426.0746.07
417182-171824.5494.55
58491-84912.2482.25
618150-181504.8054.81
10min153058-5305814.04815.9026.0514.0715.9226.05
263154-6315416.72116.74
381132-8113221.48121.51
465873-6587317.44117.47
534032-340329.0109.02
662993-6299316.67816.70
15min1101644-10164426.91130.6221.9527.0130.7321.97
2119726-11972631.69931.81
3147376-14737639.01939.17
4129834-12983434.37534.50
573658-7365819.50219.56
6121721-12172132.22732.35
20min1148933-14893339.43242.5715.8139.6842.8515.86
2165069-16506943.70443.99
3189668-18966850.21750.59
4176219-17621946.65646.97
5116695-11669530.89631.07
6168104-16810444.50744.81
30min1201104-20110453.24456.949.6753.7157.469.76
2212509-21250956.26456.80
3240290-24029063.61964.27
4230382-23038260.99661.57
5183088-18308848.47448.82
6223033-22303359.05059.60
45min1249975-24997566.18368.955.6066.9569.785.72
2257821-25782168.26169.11
3277860-27786073.56674.57
4271975-27197572.00872.92
5238608-23860863.17463.79
6266202-26620270.48071.35
60min1273875-27387572.51175.263.8473.6476.483.97
2280961-28096174.38775.61
3297146-29714678.67280.08
4294882-29488278.07379.38
5270712-27071271.67472.64
6288070-28807076.27077.53
极限1305069-30506980.77080.752.3982.3182.382.53
2299916-29991679.40681.04
3315079-31507983.42085.27
4310154-31015482.11783.86
5294536-29453677.98179.34
6305192-30519280.80382.49
阿齐沙坦左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DJ301-191212对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
110.983728313725393724023725523723953725440.05
211.113732843731283732060.03
单位质量响应值RSD%判断
33929.3333591.900.71数据可信
制剂处方摸索--供试品溶液-24011701SP批-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%
5min179939-7993921.25819.3113.4421.2619.3113.44
269482-6948218.47718.48
372924-7292419.39219.39
479878-7987821.24121.24
578731-7873120.93620.94
654663-5466314.53614.54
10min1207900-20790055.28548.8513.4755.4048.9513.47
2165967-16596744.13444.24
3174438-17443846.38746.49
4208852-20885255.53955.66
5196849-19684952.34752.46
6148101-14810139.38339.46
15min1301078-30107880.06475.4310.9180.4975.8110.92
2257123-25712368.37568.72
3277405-27740573.76874.13
4318591-31859184.72185.15
5307913-30791381.88182.29
6239776-23977663.76264.06
20min1319609-31960984.99183.407.6585.8684.207.67
2279196-27919674.24574.97
3310700-31070082.62283.40
4340323-34032390.50091.40
5337402-33740289.72390.58
6294513-29451378.31878.97
30min1331602-33160288.18186.586.2289.5287.846.27
2297125-29712579.01280.15
3322169-32216985.67286.91
4347503-34750392.40993.81
5346293-34629392.08793.45
6308788-30878882.11483.20
45min1330281-33028187.82986.545.3389.6688.285.37
2295848-29584878.67380.25
3322626-32262685.79487.50
4339602-33960290.30892.22
5344393-34439391.58293.45
6319750-31975085.02986.57
60min1327608-32760887.11987.055.7689.4489.275.77
2292826-29282677.86979.89
3327232-32723287.01989.21
4347010-34701092.27894.69
5341355-34135590.77493.16
6328044-32804487.23489.25
极限1337723-33772389.80890.722.1092.6193.422.13
2334325-33432588.90591.35
3332553-33255388.43391.10
4345569-34556991.89594.82
5348134-34813492.57795.46
6348617-34861792.70595.21
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