坎地沙坦酯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100309-201404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2000
标示量(mg)6.25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%
111.554561274557694556664554734550314556130.09
211.544543784544524544150.02
单位质量响应值RSD%判断
39447.0139377.380.13数据可信
制剂处方摸索--供试品溶液-24032101批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1400834-40083473.00765.9814.0673.0165.9814.06
2271440-27144049.43949.44
3393678-39367871.70371.70
4405302-40530273.82073.82
5359304-35930465.44265.44
6342900-34290062.45562.45
10min1500725-50072591.20086.923.8791.3287.023.88
2444227-44422780.91080.99
3479166-47916687.27487.39
4484385-48438588.22488.35
5476251-47625186.74386.85
6478452-47845287.14487.25
15min1506783-50678392.30489.132.7992.5889.382.80
2465455-46545584.77684.99
3493918-49391889.96190.23
4490114-49011489.26889.54
5486124-48612488.54188.79
6493705-49370589.92290.17
20min1509625-50962592.82190.042.4893.2590.452.49
2473285-47328586.20386.56
3499082-49908290.90191.32
4493679-49367989.91790.34
5490602-49060289.35789.76
6499998-49999891.06891.47
30min1513073-51307393.44991.332.0494.0391.882.05
2484438-48443888.23488.74
3505771-50577192.11992.69
4499580-49958090.99291.56
5496866-49686690.49891.05
6508767-50876792.66593.22
45min1515349-51534993.86492.321.6094.6093.031.62
2495122-49512290.18090.83
3510745-51074593.02593.75
4502050-50205091.44292.16
5503008-50300891.61692.32
6514953-51495393.79294.50
60min1517064-51706494.17692.791.4895.0793.651.49
2500173-50017391.10091.90
3512466-51246693.33994.21
4502688-50268891.55892.43
5506279-50627992.21293.07
6518012-51801294.34995.21
极限1541545-54154598.63597.930.7199.6998.950.73
2533428-53342897.15798.11
3541902-54190298.70099.73
4534276-53427697.31198.34
5535268-53526897.49298.50
6539759-53975998.31099.33
坎地沙坦酯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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.942975022980282978202977292971292976420.12
215.982981892980772981330.03
单位质量响应值RSD%判断
18672.6518656.630.07数据可信
制剂处方摸索--供试品溶液-24032101批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1141689-14168942.61640.0413.1442.6240.0413.14
2100940-10094030.36030.36
3142255-14225542.78642.79
4150219-15021945.18145.18
5136351-13635141.01041.01
6127278-12727838.28138.28
10min1248130-24813074.63072.715.4674.7072.785.46
2215717-21571764.88164.93
3241586-24158672.66272.73
4251644-25164475.68775.76
5247744-24774474.51474.58
6245720-24572073.90573.97
15min1289776-28977687.15685.903.3687.3586.093.37
2267018-26701880.31180.47
3283581-28358185.29285.48
4290505-29050587.37587.58
5290527-29052787.38287.57
6292224-29222487.89288.08
20min1309710-30971093.15191.872.4293.4992.202.43
2291571-29157187.69687.99
3304107-30410791.46691.80
4306145-30614592.07992.43
5308786-30878692.87393.21
6312433-31243393.97094.30
30min1325448-32544897.88596.451.4798.3896.931.49
2312844-31284494.09494.53
3319969-31996996.23796.72
4318812-31881295.88996.39
5321622-32162296.73497.23
6325352-32535297.85698.35
45min1330227-33022799.32297.791.2299.9898.431.22
2320512-32051296.40097.00
3325102-32510297.78198.43
4320842-32084296.49997.16
5325492-32549297.89898.55
6328574-32857498.82599.48
60min1331213-33121399.61998.051.21100.4498.861.22
2321998-32199896.84797.60
3326278-32627898.13498.94
4321239-32123996.61997.44
5325887-32588798.01798.83
6329408-32940899.07699.89
极限1334340-334340100.55999.600.72101.55100.570.73
2328715-32871598.86799.79
3333004-333004100.157101.13
4328486-32848698.79999.78
5330350-33035099.359100.34
6332038-33203899.867100.85
坎地沙坦酯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100309-201404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2000
标示量(mg)6.25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%
111.554551044553504551754553424554754552890.04
211.544540044541954541000.03
单位质量响应值RSD%判断
39418.9639350.090.13数据可信
制剂处方摸索--供试品溶液-24032102批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1225627-22562741.12442.5713.5241.1242.5613.52
2221090-22109040.29740.30
3285836-28583652.09852.10
4246339-24633944.89944.90
5190389-19038934.70134.70
6231927-23192742.27242.27
10min1399326-39932672.78371.8210.1672.8571.8910.17
2363533-36353366.25966.33
3459928-45992883.82983.92
4400993-40099373.08773.16
5342587-34258762.44162.50
6397757-39775772.49772.57
15min1484007-48400788.21785.745.5088.4185.935.51
2453433-45343382.64582.82
3502849-50284991.65291.88
4482917-48291788.01988.22
5429769-42976978.33278.49
6469373-46937385.55085.74
20min1510355-51035593.02092.202.8793.3692.542.89
2511954-51195493.31193.63
3519338-51933894.65795.04
4508428-50842892.66893.01
5477491-47749187.03087.32
6507588-50758892.51592.85
30min1524958-52495895.68196.281.6596.1796.771.65
2541155-54115598.63399.10
3529820-52982096.56797.10
4519871-51987194.75495.25
5518975-51897594.59195.03
6534743-53474397.46597.95
45min1531756-53175696.92097.801.4897.5798.441.47
2548095-54809599.898100.53
3535927-53592797.68198.38
4525183-52518395.72296.38
5536463-53646397.77898.37
6541957-54195798.78099.43
60min1533068-53306897.15998.191.6197.9799.001.58
2548482-54848299.969100.77
3537256-53725697.92398.78
4525402-52540295.76296.58
5546170-54617099.547100.31
6541963-54196398.78199.60
极限1547517-54751799.793100.880.97100.77101.860.95
2554108-554108100.994101.96
3557455-557455101.604102.63
4549401-549401100.136101.11
5561648-561648102.369103.29
6550781-550781100.388101.37
坎地沙坦酯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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.942982032985412983842984202982222983540.05
215.982982962981772982360.03
单位质量响应值RSD%判断
18717.3118663.080.21数据可信
制剂处方摸索--供试品溶液-24032102批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189511-8951126.88527.8511.9426.8927.8411.94
285847-8584725.78525.78
3111241-11124133.41233.41
496945-9694529.11829.12
578839-7883923.68023.68
693859-9385928.19128.19
10min1187069-18706956.18856.199.9356.2356.249.93
2169008-16900850.76350.81
3218362-21836265.58765.64
4190064-19006457.08757.14
5167163-16716350.20950.25
6190740-19074057.29057.34
15min1251068-25106875.41074.296.2675.5574.436.27
2229194-22919468.84068.97
3269712-26971281.01081.18
4253486-25348676.13776.28
5229916-22991669.05769.18
6250569-25056975.26175.40
20min1287600-28760086.38385.403.3486.6585.663.36
2274394-27439482.41782.66
3296573-29657389.07889.38
4289441-28944186.93687.21
5271635-27163581.58881.83
6286219-28621985.96886.24
30min1315590-31559094.79095.260.6295.2095.670.63
2317392-31739295.33195.71
3319641-31964196.00796.46
4316689-31668995.12095.54
5314649-31464994.50894.88
6319042-31904295.82796.24
45min1327750-32775098.44399.040.8499.0199.610.82
2332917-33291799.994100.53
3329148-32914898.86299.47
4325665-32566597.81698.39
5332120-33212099.755100.29
6330853-33085399.37599.95
60min1329177-32917798.87199.481.1799.60100.211.15
2335278-335278100.704101.41
3329061-32906198.83699.61
4326122-32612297.95498.69
5336075-336075100.943101.64
6331595-33159599.597100.33
极限1333424-333424100.147101.060.78101.04101.950.77
2337664-337664101.420102.29
3338606-338606101.703102.64
4334075-334075100.342101.24
5339821-339821102.068102.93
6335138-335138100.662101.56
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