非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.373857993855433847013854673850093853040.12
211.353869353859293864320.19
单位质量响应值RSD%判断
33887.7734046.870.34数据可信
供试品溶液-BXK3152批-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%
5min182628-8262821.87621.536.7721.8821.536.76
281894-8189421.68121.68
371939-7193919.04619.05
478458-7845820.77220.77
586325-8632522.85522.85
686613-8661322.93122.93
10min1208174-20817455.11452.555.2055.1552.595.20
2209251-20925155.39955.44
3186706-18670649.43049.46
4185437-18543749.09449.13
5199542-19954252.82952.87
6201871-20187153.44553.48
15min1269784-26978471.42568.073.7871.5568.193.78
2265719-26571970.34970.48
3251154-25115466.49366.61
4243440-24344064.45164.57
5253829-25382967.20167.33
6258721-25872168.49668.62
20min1299898-29989879.39875.973.1679.6576.213.17
2293768-29376877.77578.02
3283525-28352575.06375.29
4273807-27380772.49072.71
5283554-28355475.07175.31
6287147-28714776.02276.26
30min1326818-32681886.52583.892.2686.9084.252.26
2322159-32215985.29285.67
3316330-31633083.74884.10
4305966-30596681.00581.35
5314462-31446283.25483.62
6315344-31534483.48783.86
45min1342560-34256090.69388.491.8791.2289.001.87
2337896-33789689.45889.98
3334966-33496688.68289.17
4323998-32399885.77886.26
5334296-33429688.50589.01
6331834-33183487.85388.36
60min1348110-34811092.16290.341.8192.8490.991.81
2343890-34389091.04591.71
3343083-34308390.83191.47
4330440-33044087.48488.11
5343670-34367090.98791.64
6338188-33818889.53590.19
90min1353235-35323593.51991.671.6394.3592.481.63
2347763-34776392.07092.89
3348146-34814692.17292.96
4337096-33709689.24690.01
5348730-34873092.32693.13
6342609-34260990.70691.51
120min1353383-35338393.55891.831.6994.5492.791.69
2348196-34819692.18593.16
3349135-34913592.43393.38
4337491-33749189.35190.27
5350583-35058392.81793.77
6342370-34237090.64291.60
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1365998-36599896.89896.021.1398.0497.121.13
2359508-35950895.18096.31
3365593-36559396.79197.89
4356775-35677594.45695.52
5366838-36683897.12098.23
6361305-36130595.65696.76
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.373869483865133863043866593866133866070.07
211.353918713924893921800.12
单位质量响应值RSD%判断
34002.3734553.301.14数据可信
供试品溶液-BXK3152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%
5min172990-7299019.15016.2825.6519.1516.2825.65
262406-6240616.37316.37
376141-7614119.97719.98
457760-5776015.15415.15
532700-327008.5798.58
670258-7025818.43318.43
10min1148087-14808738.85335.1013.5738.8935.1313.58
2138331-13833136.29436.32
3147769-14776938.77038.80
4124433-12443332.64732.67
5101278-10127826.57226.59
6142835-14283537.47537.51
15min1186887-18688749.03345.3210.0349.1345.4110.04
2176482-17648246.30346.39
3184694-18469448.45848.56
4166458-16645843.67343.75
5140632-14063236.89736.96
6181261-18126147.55747.65
20min1213031-21303155.89251.958.3556.0752.118.36
2201580-20158052.88853.05
3207391-20739154.41354.59
4190128-19012849.88350.04
5168267-16826744.14844.27
6207534-20753454.45054.62
30min1244865-24486564.24560.406.0664.5260.646.09
2232993-23299361.13061.38
3235983-23598361.91462.18
4223760-22376058.70758.94
5205474-20547453.91054.10
6238119-23811962.47562.74
45min1270561-27056170.98667.474.1671.3667.824.19
2258385-25838567.79268.15
3259199-25919968.00568.38
4252566-25256666.26566.60
5239047-23904762.71863.00
6263219-26321969.06069.43
60min1285103-28510374.80271.663.2475.3072.123.27
2273610-27361071.78672.25
3272871-27287171.59272.08
4269659-26965970.75071.19
5258864-25886467.91768.31
6278620-27862073.10173.58
90min1301252-30125279.03976.232.5279.6676.812.55
2291758-29175876.54877.14
3288304-28830475.64276.25
4287274-28727475.37175.93
5279784-27978473.40673.91
6294944-29494477.38477.99
120min1310566-31056681.48278.922.1382.2479.622.16
2301396-30139679.07679.79
3297840-29784078.14378.87
4298222-29822278.24478.93
5291975-29197576.60577.23
6304764-30476479.96080.69
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1315800-31580082.85680.421.8383.7481.261.85
2307605-30760580.70581.55
3303785-30378579.70380.56
4302566-30256679.38380.20
5300287-30028778.78579.54
6309030-30903081.07981.95
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