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%
110.304102408410413141045894096058409870441011780.09
210.244092469410671740995930.25
单位质量响应值RSD%判断
398172.62400350.880.39数据可信
中间条件18月-供试品溶液-22101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%
5min1518904-51890411.65012.356.6111.6512.346.60
2558809-55880912.54612.55
3516217-51621711.59011.59
4549232-54923212.33112.33
5540377-54037712.13212.13
6615753-61575313.82513.82
10min11610573-161057336.16037.323.0936.1837.343.10
21654716-165471637.15137.17
31628747-162874736.56836.59
41686272-168627237.86037.88
51639148-163914836.80236.82
61752793-175279339.35339.38
15min12510718-251071856.37057.762.7956.4557.852.79
22530960-253096056.82456.91
32611764-261176458.63858.72
42544744-254474457.13457.22
52537630-253763056.97457.06
62701369-270136960.65060.74
20min13126686-312668670.19972.362.6770.3772.542.67
23208558-320855872.03772.21
33247622-324762272.91473.09
43255446-325544673.09073.27
53139920-313992070.49670.67
63359966-335996675.43775.63
30min13816106-381610685.67888.782.5885.9789.082.58
23931582-393158288.27088.57
33990184-399018489.58689.89
43986926-398692689.51389.81
53886697-388669787.26387.56
64112929-411292992.34292.66
45min14178534-417853493.81596.312.1094.2596.762.10
24260589-426058995.65796.10
34309019-430901996.74497.19
44321583-432158397.02697.48
54230294-423029494.97795.42
64438383-443838399.649100.12
60min14193503-419350394.15197.252.0894.7497.862.08
24330750-433075097.23297.84
34375066-437506698.22798.84
44369854-436985498.11098.72
54269876-426987695.86696.46
64450139-445013999.913100.55
极限14230261-423026194.97698.351.8495.7299.121.84
24417970-441797099.19199.96
34387396-438739698.50499.28
44364829-436482997.99798.77
54425509-442550999.360100.12
64458228-4458228100.094100.90
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%
110.304114918411150041108364101383411468941106650.14
210.244063984406293340634580.02
单位质量响应值RSD%判断
399093.69396822.070.41数据可信
中间条件18月-供试品溶液-22102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%
5min1694797-69479715.65014.475.8215.6514.475.83
2640737-64073714.43314.43
3622888-62288814.03114.03
4678451-67845115.28215.28
5595800-59580013.42113.42
6622602-62260214.02414.02
10min11884738-188473842.45440.934.5342.4840.954.53
21810178-181017840.77540.80
31827240-182724041.15941.18
41921658-192165843.28643.31
51692702-169270238.12838.15
61765141-176514139.76039.78
15min12813324-281332463.37161.953.2263.4762.043.22
22729411-272941161.48061.57
32770766-277076662.41262.50
42867256-286725664.58564.68
52613218-261321858.86358.95
62707965-270796560.99761.09
20min13459610-345961077.92876.302.5778.1376.492.57
23345704-334570475.36375.56
33373051-337305175.97976.17
43517144-351714479.22479.43
53275837-327583773.78973.97
63352038-335203875.50575.70
30min14128709-412870993.00092.072.2293.3392.392.22
24140119-414011993.25793.58
34075191-407519191.79492.12
44210650-421065094.84695.18
53978312-397831289.61289.92
63991517-399151789.91090.23
45min14392858-439285898.95099.251.2999.4499.731.30
24459169-4459169100.444100.92
34360256-436025698.21698.69
44490647-4490647101.153101.65
54388572-438857298.85399.31
64346168-434616897.89898.37
60min14409897-440989799.334100.091.0899.99100.731.08
24485198-4485198101.030101.67
34384364-438436498.75999.40
44512813-4512813101.652102.32
54429461-442946199.774100.40
64437845-443784599.963100.59
极限14395690-439569099.014100.061.2999.83100.871.29
24496909-4496909101.294102.10
34365934-436593498.34399.15
44508834-4508834101.562102.40
54422629-442262999.621100.41
64463923-4463923100.551101.35
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%
110.304057439405827840643754068645405937440616220.12
210.244079494408185740806760.05
单位质量响应值RSD%判断
394332.23398503.520.75数据可信
中间条件18月-供试品溶液-22103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%
5min1540696-54069612.22710.7215.0912.2310.7215.10
2389572-3895728.8098.81
3412861-4128619.3369.34
4435359-4353599.8459.84
5501996-50199611.35211.35
6563179-56317912.73512.74
10min11456444-145644432.93532.034.9932.9632.054.98
21479519-147951933.45733.47
31301381-130138129.42829.44
41479307-147930733.45233.47
51410177-141017731.88931.91
61371083-137108331.00431.03
15min12435626-243562655.07751.716.0855.1551.786.07
22454931-245493155.51455.58
32142156-214215648.44148.51
42326988-232698852.62052.69
52202699-220269949.81049.88
62158148-215814848.80248.88
20min13090996-309099669.89766.006.1170.0666.166.11
23163052-316305271.52671.69
32764044-276404462.50462.65
42945051-294505166.59766.76
52817689-281768963.71763.87
62732159-273215961.78361.94
30min13961176-396117689.57583.566.3889.8683.836.37
23960781-396078189.56689.85
33628234-362823482.04682.30
43725109-372510984.23684.51
53512020-351202079.41879.68
63383650-338365076.51576.77
45min14400746-440074699.51593.695.8999.9594.105.89
24384443-438444399.14699.58
34190856-419085694.76895.15
44158999-415899994.04894.46
53941136-394113689.12189.52
63782914-378291485.54485.93
60min14443607-4443607100.48496.724.81101.0897.284.81
24493940-4493940101.622102.22
34348427-434842798.33298.88
44306118-430611897.37597.94
54117648-411764893.11393.66
63952494-395249489.37889.91
极限14456484-4456484100.77599.082.10101.5499.812.11
24506370-4506370101.903102.67
34420237-442023799.955100.66
44296720-429672097.16297.89
54290032-429003297.01197.71
64320263-432026397.69598.37
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