替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1 110.85515195516645514185510415514905514260.05
2 112.65557175556925557040.01
单位质量响应值RSD%判断
4976.774935.200.60数据可信
供试品溶液-JS2M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1273645-27364548.89951.008.7948.9051.008.79
2291101-29110152.01952.02
3315456-31545656.37156.37
4246860-24686044.11344.11
5308121-30812155.06055.06
6277164-27716449.52849.53
10min1369195-36919565.97467.422.1366.0667.502.14
2383703-38370368.56668.65
3377177-37717767.40067.49
4366247-36624765.44765.52
5386141-38614169.00269.09
6381265-38126568.13168.21
15min1409538-40953873.18375.081.6273.3775.281.61
2419824-41982475.02175.22
3426103-42610376.14376.35
4424002-42400275.76875.95
5415022-41502274.16374.37
6426446-42644676.20476.40
20min1440122-44012278.64880.311.8178.9680.631.80
2440681-44068178.74879.07
3457093-45709381.68182.01
4454494-45449481.21681.53
5446248-44624879.74380.07
6457850-45785081.81682.14
30min1482654-48265486.24887.281.3586.6987.741.34
2481182-48118285.98586.44
3491599-49159987.84788.32
4494314-49431488.33288.78
5484200-48420086.52586.99
6496573-49657388.73689.20
45min1521589-52158993.20693.761.3893.7994.361.37
2519859-51985992.89793.50
3527416-52741694.24794.86
4532678-53267895.18795.78
5514601-51460191.95792.56
6532084-53208495.08195.69
60min1543207-54320797.06997.571.3797.8198.321.37
2540961-54096196.66897.42
3547868-54786897.90298.67
4554461-55446199.08099.83
5535556-53555695.70296.46
6553873-55387398.97599.74
90min1562826-562826100.575101.271.42101.48102.191.41
2566476-566476101.227102.14
3568265-568265101.547102.48
4575715-575715102.878103.79
5553500-55350098.90899.83
6573596-573596102.499103.43
极限1563870-563870100.761102.111.34101.83103.201.33
2574825-574825102.719103.80
3573157-573157102.421103.53
4579469-579469103.549104.64
5560225-560225100.110101.20
6576824-576824103.076104.18
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1 110.85674515678305669505686685640975669990.31
2 112.65551055543395547220.10
单位质量响应值RSD%判断
5117.324926.482.69数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-JS2M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1304118-30411853.65047.9811.6253.6547.9811.62
2296560-29656052.31752.32
3252988-25298844.63044.63
4274781-27478148.47448.47
5218824-21882438.60338.60
6284517-28451750.19250.19
10min1401519-40151970.83264.258.2670.9264.328.27
2371436-37143665.52565.61
3383790-38379067.70567.78
4368840-36884065.06865.15
5317492-31749256.00956.07
6342020-34202060.33660.42
15min1430342-43034275.91770.626.2276.1270.806.22
2409714-40971472.27872.47
3410538-41053872.42472.61
4409271-40927172.20072.39
5361078-36107863.69863.86
6380803-38080367.17867.36
20min1458447-45844780.87576.495.9581.2176.805.96
2440333-44033377.68078.00
3452141-45214179.76380.07
4447156-44715678.88379.19
5394555-39455569.60469.87
6408878-40887872.13172.43
30min1500445-50044588.28483.414.2888.7583.844.29
2474340-47434083.67984.13
3482740-48274085.16185.60
4479799-47979984.64285.08
5443908-44390878.31078.69
6455670-45567080.38580.80
45min1537353-53735394.79590.563.6995.4191.133.70
2515986-51598691.02691.61
3522413-52241392.16092.74
4523017-52301792.26692.85
5491178-49117886.64987.16
6490139-49013986.46687.02
60min1560080-56008098.80495.092.9399.5895.812.95
2540603-54060395.36896.11
3543339-54333995.85196.59
4547810-54781096.64097.38
5515913-51591391.01391.67
6526261-52626192.83893.53
90min1579172-579172102.17299.532.11103.11100.412.14
2567158-567158100.053100.95
3565376-56537699.739100.63
4570971-570971100.726101.62
5544534-54453496.06296.87
6557842-55784298.41099.26
极限1581483-581483102.580101.521.46103.69102.561.48
2583136-583136102.872103.93
3570728-570728100.683101.75
4581239-581239102.537103.60
5561338-56133899.02699.99
6574881-574881101.415102.43
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1 110.85733265730705723055703345724405722950.21
2 112.65598245594825596530.05
单位质量响应值RSD%判断
5165.124970.282.72数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-JS2M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1375827-37582765.70246.2726.2465.7046.2726.24
2238308-23830841.66141.66
3220930-22093038.62338.62
4197896-19789634.59634.60
5324174-32417456.67256.67
6230841-23084140.35540.36
10min1384011-38401167.13267.932.8967.2468.012.90
2399912-39991269.91269.98
3394497-39449768.96569.03
4370197-37019764.71764.77
5398212-39821269.61569.71
6384652-38465267.24467.31
15min1420620-42062073.53273.742.5073.7573.932.50
2434227-43422775.91176.10
3429056-42905675.00775.19
4403332-40333270.51070.68
5423013-42301373.95174.16
6420467-42046773.50573.68
20min1435636-43563676.15777.672.8476.5077.992.83
2460017-46001780.42080.73
3451564-45156478.94279.25
4425147-42514774.32474.61
5451054-45105478.85379.19
6442369-44236977.33477.64
30min1468193-46819381.84983.702.0082.3284.142.00
2491168-49116885.86586.31
3482921-48292184.42484.86
4466520-46652081.55681.96
5483159-48315984.46584.93
6480743-48074384.04384.47
45min1506817-50681788.60190.041.4089.2190.621.40
2525448-52544891.85892.45
3518465-51846590.63791.21
4506831-50683188.60389.15
5516910-51691090.36590.97
6515710-51571090.15690.73
60min1528198-52819892.33993.481.2593.0994.211.24
2543538-54353895.02195.76
3539475-53947594.31095.04
4526270-52627092.00292.69
5533912-53391293.33894.09
6536951-53695193.86994.59
90min1548918-54891895.96196.941.1996.8797.831.19
2559879-55987997.87798.78
3557631-55763197.48498.37
4545656-54565695.39196.23
5552475-55247596.58397.49
6562539-56253998.34299.22
极限1553664-55366496.79197.270.7997.8698.320.79
2562712-56271298.37399.44
3560316-56031697.95499.00
4551868-55186896.47797.48
5552983-55298396.67297.74
6556936-55693697.36398.40
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