诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.184051224405854040561054059893405865740568840.09
210.144056264405623340562480.01
单位质量响应值RSD%判断
398515.13400024.460.27数据可信
供试品溶液-25010201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%
5min1797520-79752017.90517.367.3517.9117.367.36
2687274-68727415.43015.43
3750235-75023516.84416.84
4779704-77970417.50517.51
5860072-86007219.31019.31
6765834-76583417.19417.19
10min11862253-186225341.81040.833.3741.8440.863.36
21709972-170997238.39138.42
31810582-181058240.64940.68
41857609-185760941.70541.73
51872900-187290042.04942.08
61797739-179773940.36140.39
15min12707157-270715760.77959.432.6860.8859.532.68
22529491-252949156.79056.88
32660228-266022859.72559.82
42725619-272561961.19361.29
52649499-264949959.48459.59
62611493-261149358.63158.73
20min13305467-330546774.21173.001.7574.4173.201.75
23148718-314871870.69270.88
33278851-327885173.61473.81
43289683-328968373.85774.06
53256471-325647173.11173.31
63230523-323052372.52972.72
30min14012011-401201190.07489.211.3690.4089.521.36
23899147-389914787.54087.84
34032944-403294490.54490.86
44013939-401393990.11790.44
53951735-395173588.72189.04
63931236-393123688.26088.57
45min14405244-440524498.90298.562.1599.3899.032.14
24302218-430221896.58997.04
34562251-4562251102.427102.90
44399940-439994098.78399.26
54319598-431959896.98097.45
64351453-435145397.69598.16
60min14469732-4469732100.35099.730.87100.99100.360.87
24382261-438226198.38699.00
34491853-4491853100.847101.49
44451743-445174399.946100.58
54425187-442518799.35099.98
64430995-443099599.481100.11
极限14487202-4487202100.742100.210.89101.55101.010.90
24428203-442820399.418100.19
34530177-4530177101.707102.52
44464144-4464144100.225101.03
54436790-443679099.611100.41
64434022-443402299.549100.34
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.184054674405782740588894058120405464940568320.05
210.144023329402483840240840.03
单位质量响应值RSD%判断
398510.02396852.470.30数据可信
供试品溶液-25010202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%
5min1759998-75999817.13117.634.6317.1317.634.63
2787012-78701217.74017.74
3823260-82326018.55718.56
4824789-82478918.59118.59
5761243-76124317.15917.16
6736510-73651016.60116.60
10min11766303-176630339.81441.602.6739.8441.632.68
21811817-181181740.84040.87
31886283-188628342.51842.55
41896059-189605942.73942.77
51867841-186784142.10342.13
61844521-184452141.57741.60
15min12592106-259210658.42858.398.5458.5258.498.52
22650434-265043459.74359.84
32717011-271701161.24461.35
42730952-273095261.55861.66
52151513-215151348.49748.60
62701131-270113160.88660.98
20min13184421-318442171.77974.221.8171.9774.421.81
23263292-326329273.55773.75
33321124-332112474.86175.06
43341135-334113575.31275.52
53326223-332622374.97675.16
63321295-332129574.86575.06
30min13922990-392299088.42790.771.3488.7491.091.34
24016285-401628590.53090.85
34049824-404982491.28691.61
44046121-404612191.20391.53
54070719-407071991.75792.06
64055018-405501891.40391.73
45min14287529-428752996.64499.651.5797.10100.121.57
24417148-441714899.566100.04
34472559-4472559100.815101.30
44446386-4446386100.225100.71
54473144-4473144100.828101.29
64427573-442757399.801100.28
60min14396507-439650799.101101.221.1299.72101.851.12
24498920-4498920101.409102.05
34531827-4531827102.151102.80
44513067-4513067101.728102.38
54524766-4524766101.992102.62
64476726-4476726100.909101.55
极限14415675-441567599.533101.641.13100.32102.451.13
24510696-4510696101.675102.48
34561036-4561036102.809103.63
44513560-4513560101.739102.56
54548051-4548051102.517103.31
64505998-4505998101.569102.38
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.184062886406313640656244064862406499240643000.03
210.144064373406655440654640.04
单位质量响应值RSD%判断
399243.61400933.330.30数据可信
供试品溶液-25010203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%
5min1670537-67053715.02316.2311.9915.0216.2312.00
2840499-84049918.83218.83
3784251-78425117.57117.57
4766758-76675817.17917.18
5678637-67863715.20515.20
6606673-60667313.59313.59
10min11677501-167750137.58539.767.9837.6139.787.98
21982184-198218444.41144.44
31872666-187266641.95741.99
41822922-182292240.84340.87
51680569-168056937.65337.68
61610564-161056436.08536.11
15min12639476-263947659.13859.554.5359.2359.654.53
22837965-283796563.58563.69
32716148-271614860.85660.95
42665733-266573359.72659.82
52615851-261585158.60958.70
62472795-247279555.40355.49
20min13202721-320272171.75772.903.8671.9473.103.87
23453239-345323977.37077.58
33326403-332640374.52974.73
43246541-324654172.73972.94
53211351-321135171.95172.14
63082703-308270369.06869.24
30min14004167-400416789.71489.892.2790.0290.212.28
24137026-413702692.69193.03
34060581-406058190.97891.30
43966544-396654488.87189.19
54036254-403625490.43390.74
63868660-386866086.67886.97
45min14314026-431402696.65698.051.7697.1198.511.76
24483719-4483719100.458100.95
34433239-443323999.32799.80
44310788-431078896.58497.05
54410800-441080098.82599.28
64303769-430376996.42796.86
60min14428887-442888799.23099.741.3499.85100.371.35
24507443-4507443100.990101.65
34469670-4469670100.144100.79
44366270-436627097.82798.45
54523370-4523370101.347101.97
64414566-441456698.90999.50
极限14439212-443921299.46199.931.12100.24100.721.13
24530919-4530919101.516102.35
34462939-446293999.993100.80
44388503-438850398.32599.11
54498519-4498519100.790101.58
64441149-444114999.505100.26
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