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%
19.813874087387493038729093874734387310338739530.03
29.823896693389626638964800.01
单位质量响应值RSD%判断
394898.37396790.220.34数据可信
供试品溶液-240821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%
5min1371797-3717978.4197.6415.408.427.6415.39
2385530-3855308.7308.73
3246668-2466685.5865.59
4334130-3341307.5677.57
5313556-3135567.1017.10
6371606-3716068.4158.42
10min11171101-117110126.52023.7812.4226.5323.7912.42
21159581-115958126.25926.27
3867404-86740419.64319.65
4948892-94889221.48821.50
5994685-99468522.52522.54
61158268-115826826.22926.24
15min11949998-194999844.15840.119.7344.2240.169.73
21887624-188762442.74642.80
31557194-155719435.26335.31
41626127-162612736.82436.87
51673305-167330537.89337.94
61933718-193371843.79043.85
20min12641400-264140059.81654.838.7859.9554.958.78
22503297-250329756.68856.82
32193661-219366149.67649.78
42253513-225351351.03251.14
52260019-226001951.17951.29
62675330-267533060.58460.71
30min13586141-358614181.21075.666.8581.4475.876.85
23414646-341464677.32677.55
33157294-315729471.49871.68
43166926-316692671.71671.91
53104295-310429570.29870.50
63615992-361599281.88682.12
45min14234170-423417095.88490.145.8896.2590.485.89
24041883-404188391.53091.88
33875616-387561687.76588.07
43782630-378263085.65985.97
53695777-369577783.69284.01
64252587-425258796.30296.67
60min14413124-441312499.93794.585.07100.4695.075.08
24212148-421214895.38695.89
34135412-413541293.64894.10
43972224-397222489.95390.41
53915957-391595788.67889.13
64410841-441084199.885100.41
极限14516435-4516435102.27696.895.30102.9797.545.31
24330465-433046598.06598.73
34241416-424141696.04996.65
44056119-405611991.85292.46
53993323-399332390.43091.03
64534175-4534175102.678103.37
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%
19.813892387389280538940273891574389224138926070.03
29.823886535388762238870780.02
单位质量响应值RSD%判断
396799.90395832.790.18数据可信
供试品溶液-E001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%
5min1472418-47241810.68511.895.4210.6911.895.40
2522688-52268811.82211.82
3540814-54081412.23212.23
4538919-53891912.18912.19
5553906-55390612.52812.53
6525708-52570811.89111.89
10min11317883-131788329.80830.862.9629.8330.882.96
21356650-135665030.68530.70
31438114-143811432.52832.55
41347764-134776430.48430.50
51372505-137250531.04431.06
61354303-135430330.63230.65
15min12177665-217766549.25550.131.7549.3250.201.75
22221121-222112150.23850.31
32288688-228868851.76651.84
42206170-220617049.90049.97
52211117-221111750.01250.08
62192472-219247249.59049.66
20min12919621-291962166.03766.431.0366.1966.591.03
22923160-292316066.11766.27
32978910-297891067.37867.54
42901151-290115165.61965.77
52931348-293134866.30266.46
62968124-296812467.13467.29
30min13781870-378187085.54086.021.1085.8086.281.10
23786137-378613785.63685.90
33838172-383817286.81387.09
43740341-374034184.60084.86
53819532-381953286.39186.66
63852503-385250387.13787.40
45min14297648-429764897.20696.531.7397.6196.941.72
24253936-425393696.21796.62
34277391-427739196.74797.17
44137283-413728393.57893.98
54280011-428001196.80797.22
64360556-436055698.62899.04
60min14409425-440942599.73498.861.23100.3099.431.23
24343558-434355898.24498.81
34344318-434431898.26198.84
44298804-429880497.23297.79
54378892-437889299.04399.62
64449244-4449244100.634101.21
极限14392672-439267299.35598.651.36100.0999.381.35
24353260-435326098.46399.20
34349586-434958698.38099.12
44259103-425910396.33497.06
54378581-437858199.03699.77
64435588-4435588100.326101.07
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%
19.813869901386782838699083869768387195638698720.04
29.823879154388080338799780.04
单位质量响应值RSD%判断
394482.36395109.780.12数据可信
供试品溶液-E001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%
5min1557701-55770112.66312.142.9512.6612.142.94
2512542-51254211.63711.64
3541659-54165912.29912.30
4536228-53622812.17512.18
5521936-52193611.85111.85
6537294-53729412.19912.20
10min11394423-139442331.66129.913.8331.6829.943.83
21335918-133591830.33330.35
31341034-134103430.44930.47
41254028-125402828.47328.49
51276626-127662628.98629.01
61302997-130299729.58529.61
15min12248215-224821551.04749.082.4851.1249.152.48
22150872-215087248.83648.91
32193450-219345049.80349.87
42154218-215421848.91248.98
52094352-209435247.55347.62
62128816-212881648.33648.41
20min12948266-294826666.94264.742.6767.1064.902.67
22890002-289000265.61965.77
32897688-289768865.79365.95
42763085-276308562.73762.89
52761843-276184362.70962.86
62847260-284726064.64864.80
30min13801579-380157986.31685.081.4086.5985.341.40
23768442-376844285.56485.82
33795360-379536086.17586.44
43745426-374542685.04185.30
53672721-367272183.39183.64
63699024-369902483.98884.25
45min14299139-429913997.61495.920.9398.0396.320.93
24228961-422896196.02096.42
34219986-421998695.81796.22
44201447-420144795.39695.79
54189782-418978295.13195.52
64208041-420804195.54595.94
60min14372869-437286999.28897.741.2299.8698.301.22
24321694-432169498.12698.69
34339211-433921198.52499.09
44304636-430463697.73998.29
54228019-422801995.99996.55
64262801-426280196.78997.35
极限14395549-439554999.80397.661.67100.5598.381.67
24320660-432066098.10298.83
34366357-436635799.14099.87
44263144-426314496.79697.51
54212662-421266295.65096.36
64248616-424861696.46797.19
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