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%
110.334052785406045640635184065335406121940606630.12
210.264084301408161540829580.05
单位质量响应值RSD%判断
393094.19397949.120.87数据可信
影响因素10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%
5min1352051-3520517.9798.288.207.988.288.23
2341870-3418707.7487.75
3347857-3478577.8847.88
4348178-3481787.8917.89
5418943-4189439.4959.50
6382035-3820358.6598.66
10min1995862-99586222.57123.935.7622.5823.945.76
21001042-100104222.68822.70
31042391-104239123.62523.64
41077875-107787524.43024.44
51161606-116160626.32726.34
61056228-105622823.93923.95
15min11557388-155738835.29837.605.6435.3537.665.64
21568721-156872135.55435.61
31655373-165537337.51837.57
41732358-173235839.26339.32
51798645-179864540.76640.83
61640979-164097937.19237.25
20min12073994-207399447.00649.445.5347.1249.555.53
22048997-204899746.44046.55
32203628-220362849.94450.06
42296133-229613352.04152.16
52343519-234351953.11553.24
62120737-212073748.06648.18
30min12764428-276442862.65565.785.3862.8465.985.38
22717947-271794761.60161.79
33008581-300858168.18868.39
43061801-306180169.39469.60
53053402-305340269.20469.42
62807423-280742363.62963.83
45min13360974-336097476.17577.854.7976.4778.164.79
23178228-317822872.03372.32
33574960-357496081.02581.34
43606798-360679881.74782.07
53528667-352866779.97680.31
63358302-335830276.11576.42
60min13635944-363594482.40783.134.8082.8383.574.79
23367292-336729276.31876.73
33843823-384382387.11987.57
43804619-380461986.23086.69
53758810-375881085.19285.66
63596292-359629281.50881.94
极限14259777-425977796.54691.923.7097.1092.503.68
23930182-393018289.07689.61
34129905-412990593.60394.19
44151436-415143694.09194.69
54001157-400115790.68591.29
63862508-386250887.54288.11
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%
110.334065113406325040649574066320406434340647970.03
210.264103445410418841038160.02
单位质量响应值RSD%判断
393494.39399982.071.16数据可信
影响因素10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%
5min1805926-80592618.21116.317.2118.2116.307.21
2696256-69625615.73215.73
3728659-72865916.46516.46
4648865-64886514.66214.66
5738966-73896616.69716.70
6711070-71107016.06716.07
10min11744786-174478639.42534.388.8439.4634.418.84
21477064-147706433.37533.40
31572922-157292235.54135.57
41345268-134526830.39730.42
51534997-153499734.68434.71
61454217-145421732.85932.89
15min12426774-242677454.83547.957.7654.9348.047.76
22053855-205385546.40846.49
32153442-215344248.65948.75
41945568-194556843.96244.04
52107556-210755647.62247.71
62046268-204626846.23746.32
20min12919677-291967765.97258.007.2666.1658.167.26
22498793-249879356.46256.62
32594779-259477958.63158.80
42380000-238000053.77853.93
52522675-252267557.00257.17
62484399-248439956.13756.30
30min13583185-358318580.96572.186.4581.2672.446.45
23147757-314775771.12671.38
33227715-322771572.93373.20
42986001-298600167.47167.71
53108047-310804770.22970.49
63113461-311346170.35170.60
45min13999019-399901990.36182.515.2690.7982.895.27
23637678-363767882.19682.57
33681864-368186483.19483.58
43443081-344308177.79978.15
53515654-351565479.43979.82
63632177-363217782.07282.44
60min14133205-413320593.39386.354.7793.9886.874.78
23839190-383919086.74987.26
33827410-382741086.48387.01
43614003-361400381.66182.14
53664439-366443982.80183.31
63850548-385054887.00687.51
极限14175498-417549894.34987.744.4995.0988.404.50
23907470-390747088.29288.95
33863554-386355487.30087.97
43673867-367386783.01483.63
53744468-374446884.60985.26
63933018-393301888.87089.52
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%
110.334087622408819140913084090403409182840898700.05
210.264075383407474840750660.02
单位质量响应值RSD%判断
395921.59397179.920.23数据可信
影响因素10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%
5min1617602-61760213.96113.4819.1813.9613.4819.19
2601309-60130913.59313.59
3769559-76955917.39617.40
4478276-47827610.81110.81
5650214-65021414.69814.70
6461943-46194310.44210.44
10min11797180-179718040.62536.908.6540.6536.928.66
21648534-164853437.26537.29
31780022-178002240.23740.27
41439580-143958032.54232.56
51609702-160970236.38736.41
61519499-151949934.34834.37
15min12670048-267004860.35654.187.7560.4554.267.76
22417821-241782154.65554.74
32521109-252110956.99057.09
42135142-213514248.26548.34
52340823-234082352.91453.00
62295570-229557051.89151.97
20min13224365-322436572.88766.406.3973.0866.576.40
22968749-296874967.10967.28
33059929-305992969.17069.36
42698932-269893261.00961.16
52825905-282590563.88064.05
62846144-284614464.33764.50
30min13863525-386352587.33580.854.9987.6581.145.00
23624972-362497281.94282.23
33659759-365975982.72983.04
43359862-335986275.95076.20
53466367-346636778.35778.64
63485115-348511578.78179.05
45min14160031-416003194.03789.343.5594.5089.763.56
24048135-404813591.50891.93
33983376-398337690.04490.49
43787169-378716985.60985.99
53829265-382926586.56086.97
63904099-390409988.25288.65
60min14271221-427122196.55192.832.9197.1793.402.92
24192332-419233294.76895.34
34116282-411628293.04893.64
44009761-400976190.64191.16
53941834-394183489.10589.66
64108636-410863692.87693.42
极限14529523-4529523102.39097.722.55103.1798.452.57
24327248-432724897.81798.55
34322987-432298797.72198.47
44213764-421376495.25295.93
54250789-425078996.08996.79
64293948-429394897.06597.77
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%
110.334100982410546441032554104744410374741036380.05
210.264062138406239340622660.01
单位质量响应值RSD%判断
397254.40395932.360.24数据可信
影响因素10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%
5min1593970-59397013.42515.338.9513.4315.338.94
2669001-66900115.12115.12
3723224-72322416.34716.35
4685236-68523615.48815.49
5634182-63418214.33414.33
6762917-76291717.24417.24
10min11489375-148937533.66436.745.0933.6936.765.09
21722001-172200138.92238.95
31654849-165484937.40437.43
41609231-160923136.37336.40
51588505-158850535.90435.93
61687583-168758338.14438.17
15min12207221-220722149.88953.324.8449.9753.414.84
22532473-253247357.24057.33
32392195-239219554.07054.16
42315856-231585652.34452.43
52286954-228695451.69151.77
62419648-241964854.69054.78
20min12748854-274885462.13165.334.4062.2965.504.40
23125854-312585470.65270.84
32887429-288742965.26365.44
42847954-284795464.37164.54
52833728-283372864.05064.22
62897717-289771765.49665.68
30min13369646-336964676.16379.174.1676.4379.464.16
23782816-378281685.50185.80
33524980-352498079.67479.96
43446122-344612277.89178.17
53442111-344211177.80178.08
63451675-345167578.01778.31
45min13869711-386971187.46586.913.4787.8687.323.47
24098564-409856492.63893.08
33764115-376411585.07985.50
43833126-383312686.63887.05
53744888-374488884.64485.05
63759454-375945484.97385.40
60min14046257-404625791.45689.543.8291.9990.103.81
24220548-422054895.39596.00
33918211-391821188.56289.12
43929889-392988988.82689.38
53847835-384783586.97187.52
63806846-380684686.04486.61
极限14158691-415869193.99794.642.7694.6995.352.77
24406570-440657099.600100.36
34113445-411344592.97493.69
44219918-421991895.38196.08
54109725-410972592.89093.58
64114556-411455692.99993.71
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%
110.334104711410769641059464107429410661041064780.03
210.264030315403015540302350.01
单位质量响应值RSD%判断
397529.33392810.430.85数据可信
影响因素10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%
5min1633879-63387914.37914.029.4414.3814.029.44
2710494-71049416.11716.12
3586246-58624613.29913.30
4544816-54481612.35912.36
5586222-58622213.29813.30
6646506-64650614.66614.67
10min11567325-156732535.55435.896.6335.5835.926.62
21767439-176743940.09440.12
31508712-150871234.22534.25
41628966-162896636.95336.97
51474745-147474533.45433.48
61546661-154666135.08635.11
15min12275761-227576151.62552.545.6351.7152.635.63
22524994-252499457.27957.37
32259286-225928651.25151.33
42424905-242490555.00855.09
52189742-218974249.67449.75
62223085-222308550.43050.51
20min12773425-277342562.91464.185.8763.0864.355.87
23066024-306602469.55269.74
32706649-270664961.40061.56
43011359-301135968.31268.49
52685347-268534760.91661.08
62731802-273180261.97062.14
30min13421265-342126577.61079.046.1877.8879.326.18
23767963-376796385.47585.78
33437343-343734377.97578.24
43724538-372453884.49084.78
53249462-324946273.71373.98
63305725-330572574.98975.26
45min13764706-376470685.40187.486.4285.8087.896.41
24194951-419495195.16195.61
33806778-380677886.35686.75
44123758-412375893.54693.97
53645099-364509982.68883.07
63603155-360315581.73782.13
60min13868661-386866187.76090.406.4188.3190.966.41
24355665-435566598.80799.41
33939406-393940689.36489.91
44238608-423860896.15296.74
53780930-378093085.76986.29
63726534-372653484.53585.07
极限14242908-424290896.24996.504.0596.9497.204.05
24490384-4490384101.863102.63
34291624-429162497.35498.04
44358630-435863098.87499.62
53993428-399342890.59091.26
64146534-414653494.06394.74
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