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(%)99.60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%
110.304069260406990240761174072333407185140718930.07
210.244083267408216940827180.02
单位质量响应值RSD%判断
395329.42398702.930.61数据可信
影响因素30天-供试品溶液-24032501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%
5min1546521-54652112.34010.7024.4912.3410.7024.49
2615786-61578613.90413.90
3297787-2977876.7246.72
4543623-54362312.27412.27
5430978-4309789.7319.73
6409101-4091019.2379.24
10min11463916-146391633.05431.0011.3933.0731.0211.39
21526589-152658934.46934.49
31511357-151135734.12534.14
41365838-136583830.83930.86
51199166-119916627.07627.09
61170558-117055826.43026.45
15min12121710-212171047.90646.7711.1947.9846.8411.18
22214434-221443449.99950.08
32404510-240451054.29154.36
42058954-205895446.48946.56
51840986-184098641.56741.63
61786745-178674540.34340.40
20min12672255-267225560.33659.4110.3660.4959.5610.35
22740338-274033861.87462.04
33052523-305252368.92269.08
42622569-262256959.21559.36
52453550-245355055.39855.53
62246050-224605050.71350.84
30min13284076-328407674.15175.387.2774.4175.637.27
23371949-337194976.13576.40
33805890-380589085.93386.21
43243493-324349373.23473.48
53182422-318242271.85572.08
63143423-314342370.97571.19
45min13726656-372665684.14484.237.5984.5284.607.58
23750461-375046184.68185.08
34219106-421910695.26295.68
43580053-358005380.83381.20
53747040-374704084.60484.95
63359142-335914275.84676.18
60min13901347-390134788.08889.428.1588.6189.938.14
23923489-392348988.58889.12
34568261-4568261103.146103.72
43695848-369584883.44883.95
53986103-398610390.00290.49
63687057-368705783.24983.71
极限14106131-410613192.71293.645.8393.3894.305.83
24214809-421480995.16595.85
34497782-4497782101.555102.30
43767829-376782985.07385.72
54246099-424609995.87296.51
64050370-405037091.45392.05
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(%)99.60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%
110.304088419409077440886834089142408919040892420.03
210.244002724399092439968240.21
单位质量响应值RSD%判断
397013.79390314.841.21数据可信
影响因素30天-供试品溶液-24032501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%
5min1674814-67481415.36714.4212.3015.3714.4212.32
2708242-70824216.12816.13
3639980-63998014.57414.57
4690562-69056215.72615.73
5502059-50205911.43311.43
6584041-58404113.30013.30
10min11655341-165534137.69636.737.2537.7236.767.25
21722818-172281839.23339.26
31602031-160203136.48236.51
41739331-173933139.60939.63
51443144-144314432.86432.88
61515902-151590234.52134.54
15min12396549-239654954.57554.165.6254.6654.245.63
22511674-251167457.19757.29
32361184-236118453.77053.85
42534174-253417457.70957.80
52187422-218742249.81349.89
62277801-227780151.87151.95
20min12960376-296037667.41566.815.5367.5966.995.54
23075248-307524870.03170.22
32923782-292378266.58166.76
43139967-313996771.50471.69
52717995-271799561.89562.05
62786839-278683963.46363.63
30min13678381-367838183.76582.134.5284.0682.424.53
23743072-374307285.23885.54
33585612-358561281.65381.94
43797527-379752786.47886.79
53414514-341451477.75678.02
63419569-341956977.87278.14
45min14075264-407526492.80390.203.6793.2390.623.68
24051899-405189992.27192.72
33928993-392899389.47289.89
44119333-411933393.80794.26
53836580-383658087.36887.76
63754215-375421585.49285.89
60min14187423-418742395.35792.993.3395.9493.563.33
24173313-417331395.03695.64
34059774-405977492.45093.02
44205804-420580495.77696.38
54022693-402269391.60692.14
63851514-385151487.70888.25
极限14377172-437717299.67897.293.01100.4298.023.00
24287730-428773097.64298.40
34350882-435088299.08099.80
44283437-428343797.54498.31
54313323-431332398.22498.91
64021232-402123291.57392.26
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(%)99.60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%
110.304057022405410740562964054086405287940548780.05
210.244063934406773240658330.07
单位质量响应值RSD%判断
393677.48397054.000.61数据可信
影响因素30天-供试品溶液-24032501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%
5min1682476-68247615.47415.775.4115.4715.775.42
2752264-75226417.05617.06
3716673-71667316.24916.25
4706202-70620216.01216.01
5645181-64518114.62814.63
6671387-67138715.22215.22
10min11772386-177238640.18538.804.6540.2138.824.65
21773318-177331840.20740.24
31786911-178691140.51540.54
41636029-163602937.09437.12
51599443-159944336.26436.29
61698435-169843538.50938.53
15min12637111-263711159.79157.213.8159.8857.303.81
22555536-255553657.94258.04
32602064-260206458.99759.09
42442814-244281455.38655.47
52383644-238364454.04554.13
62517982-251798257.09057.18
20min13227599-322759973.18070.173.6873.3770.363.68
23112367-311236770.56770.76
33181774-318177472.14172.33
43010613-301061368.26068.44
52917837-291783766.15666.33
63119711-311971170.73370.92
30min13850990-385099087.31485.143.1587.6385.443.15
23751019-375101985.04785.36
33845906-384590687.19987.51
43653374-365337482.83383.13
53575106-357510681.05981.34
63853049-385304987.36187.66
45min14187175-418717594.93692.883.0195.4093.323.01
24098698-409869892.93093.38
34153943-415394394.18394.64
43993445-399344590.54490.98
53910024-391002488.65289.07
64234331-423433196.00596.45
60min14307143-430714397.65695.483.5898.2796.083.58
24207851-420785195.40596.01
34311853-431185397.76398.38
44111264-411126493.21593.80
53965098-396509889.90190.47
64364985-436498598.96899.58
极限14413841-4413841100.07599.463.07100.86100.223.06
24387233-438723399.472100.24
34455784-4455784101.026101.80
44209374-420937495.44096.18
54268065-426806596.77097.49
64585046-4585046103.957104.73
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(%)99.60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%
110.304048966404864240521904050041404961040498900.04
210.244060580405828140594300.05
单位质量响应值RSD%判断
393193.20396428.710.58数据可信
影响因素30天-供试品溶液-24032501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%
5min1365051-3650518.2889.4215.748.299.4215.73
2370828-3708288.4208.42
3343829-3438297.8077.81
4479556-47955610.88810.89
5501196-50119611.38011.38
6428604-4286049.7319.73
10min11068850-106885024.26826.137.7224.2826.147.73
21181735-118173526.83126.85
31023696-102369623.24323.26
41215972-121597227.60927.63
51257268-125726828.54628.57
61156583-115658326.26026.28
15min11778207-177820740.37442.305.0840.4342.365.09
21914487-191448743.46843.53
31721772-172177239.09339.14
41922296-192229643.64643.71
51969172-196917244.71044.78
61873475-187347542.53742.60
20min12299597-229959752.21255.034.5052.3355.164.50
22546947-254694757.82857.96
32279491-227949151.75651.87
42463240-246324055.92856.06
52495613-249561356.66356.80
62457612-245761255.80055.93
30min13021002-302100268.59272.184.4168.8072.404.41
23336633-333663375.75875.99
32994878-299487867.99868.20
43208789-320878972.85573.09
53283187-328318774.54474.78
63229068-322906873.31673.54
45min13398409-339840977.16183.154.9477.4883.504.94
23861000-386100087.66488.02
33491823-349182379.28279.60
43674817-367481783.43683.79
53771774-377177485.63886.00
63776579-377657985.74786.09
60min13697082-369708283.94287.734.4284.3988.214.42
24048100-404810091.91292.41
33654420-365442082.97383.42
43799741-379974186.27386.76
53954176-395417689.77990.28
64030979-403097991.52392.01
极限14038455-403845591.69394.403.6292.2895.033.63
24270874-427087496.97097.62
33952656-395265689.74590.33
44095608-409560892.99093.62
54256879-425687996.65297.30
64332351-433235198.36699.01
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