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(%)99.70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%
110.32 4105216410702041088994109250410903641078840.05
210.344086719408616740864430.01
单位质量响应值RSD%判断
398050.78395207.250.51数据可信
影响因素10天-供试品溶液-24041601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%
5min187683-876831.9842.7320.631.982.7320.66
298939-989392.2382.24
3112320-1123202.5412.54
4149872-1498723.3913.39
5142410-1424103.2223.22
6132420-1324202.9963.00
10min1269894-2698946.1067.8321.736.117.8321.71
2330960-3309607.4877.49
3249892-2498925.6535.66
4380321-3803218.6048.61
5429473-4294739.7169.72
6415708-4157089.4059.41
15min1443148-44314810.02612.4219.9310.0412.4419.93
2533998-53399812.08112.10
3403359-4033599.1259.14
4589633-58963313.34013.36
5670291-67029115.16415.19
6652801-65280114.76914.79
20min1588791-58879113.32016.4220.0113.3516.4619.99
2686902-68690215.54015.58
3552394-55239412.49712.53
4756854-75685417.12317.16
5924875-92487520.92420.97
6846003-84600319.14019.18
30min1827983-82798318.73223.2719.0918.7823.3419.10
2938367-93836721.22921.29
3827836-82783618.72918.78
41081946-108194624.47724.55
51298021-129802129.36629.45
61197473-119747327.09127.17
45min11091353-109135324.69029.6617.8624.7729.7717.86
21203021-120302127.21627.31
31068343-106834324.17024.25
41341812-134181230.35630.47
51644900-164490037.21337.34
61517995-151799534.34234.46
60min11281212-128121228.98534.2316.5629.1134.3816.56
21381497-138149731.25431.40
31266080-126608028.64328.76
41535146-153514634.73034.89
51872022-187202242.35242.54
61741185-174118539.39239.57
极限12428790-242879054.94856.957.1555.1257.167.18
22363657-236365753.47453.67
32321285-232128552.51552.68
42570585-257058558.15558.38
52796272-279627263.26163.52
62622688-262268859.33459.58
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(%)99.70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%
110.32 4100487410060541001984099785411286141027870.14
210.344081006408779340844000.12
单位质量响应值RSD%判断
397556.88395009.670.46数据可信
影响因素10天-供试品溶液-24041601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%
5min1518849-51884911.74811.878.5711.7511.878.57
2579760-57976013.12813.13
3557453-55745312.62212.62
4465163-46516310.53310.53
5479950-47995010.86810.87
6544749-54474912.33512.33
10min11293406-129340629.28729.596.7429.3129.626.75
21428425-142842532.34432.37
31401063-140106331.72431.75
41250729-125072928.32028.34
51210364-121036427.40627.42
61257828-125782828.48128.50
15min11959820-195982044.37644.626.1644.4444.686.17
22132225-213222548.28048.36
32102271-210227147.60247.68
41903661-190366143.10543.17
51830878-183087841.45741.52
61893335-189333542.87142.94
20min12494381-249438156.48156.115.2756.6256.265.27
22651960-265196060.04960.20
32602465-260246558.92859.08
42422926-242292654.86355.00
52313083-231308352.37552.51
62383809-238380953.97754.12
30min13209431-320943172.67272.663.9172.9172.903.92
23355736-335573675.98476.24
33356113-335611375.99376.24
43175921-317592171.91372.14
53081240-308124069.76969.99
63074548-307454869.61769.85
45min13720079-372007984.23484.473.5584.5984.833.55
23844116-384411687.04387.43
33928837-392883788.96189.34
43654268-365426882.74483.09
53662339-366233982.92783.26
63573809-357380980.92281.27
60min13931327-393132789.01889.343.6689.5289.843.66
24064248-406424892.02792.56
34141262-414126293.77194.30
43849337-384933787.16187.65
53946547-394654789.36289.84
63740241-374024184.69185.17
极限14131582-413158293.55294.231.8594.2094.881.86
24219999-421999995.55496.24
34253120-425312096.30496.99
44166088-416608894.33394.96
54166979-416697994.35394.98
64031967-403196791.29691.92
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(%)99.70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%
110.32 4069867407017040743774069835407008540708670.05
210.344041193403687540390340.08
单位质量响应值RSD%判断
394463.86390622.240.70数据可信
影响因素10天-供试品溶液-24041601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%
5min1532453-53245312.17111.5417.3412.1711.5417.32
2504387-50438711.53011.53
3650101-65010114.86114.86
4391795-3917958.9568.96
5506691-50669111.58311.58
6444360-44436010.15810.16
10min11318708-131870830.14528.6311.1530.1628.6511.15
21280436-128043629.27029.29
31439193-143919332.89932.92
41042938-104293823.84123.86
51291595-129159529.52529.54
61142904-114290426.12626.14
15min12003179-200317945.79143.888.4645.8643.948.46
21925910-192591044.02544.09
32113925-211392548.32348.40
41642495-164249537.54637.60
51985853-198585345.39545.46
61845037-184503742.17642.24
20min12566728-256672858.67356.418.4958.8256.568.49
22437798-243779855.72655.87
32719123-271912362.15762.32
42101802-210180248.04548.16
52562504-256250458.57758.72
62419600-241960055.31055.44
30min13274490-327449074.85273.136.9975.1073.367.00
23176610-317661072.61572.85
33486687-348668779.70379.97
42808935-280893564.21064.41
53283753-328375375.06475.31
63163756-316375672.32172.54
45min13891947-389194788.96786.156.3689.3486.506.37
23739875-373987585.49185.85
34102224-410222493.77494.17
43370162-337016277.03977.34
53770357-377035786.18786.55
63736955-373695585.42485.77
60min14095457-409545793.61990.826.1094.1491.326.11
23924350-392435089.70790.21
34317576-431757698.69699.25
43580410-358041081.84582.28
53998513-399851391.40391.91
63920730-392073089.62590.11
极限14184672-418467295.65894.846.9096.3395.496.90
24064636-406463692.91493.56
34458204-4458204101.911102.63
43634586-363458683.08483.65
54339228-433922899.19199.85
64212604-421260496.29796.93
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