非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.033242832215324793264932295324130.52
210.053240532759325820.77
单位质量响应值RSD%判断
3231.613241.990.23数据可信
供试品溶液-6010801批-多替诺雷-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17557-755720.94731.4327.6120.9531.4427.60
214616-1461640.51440.51
313863-1386338.42738.43
48148-814822.58622.59
510099-1009927.99427.99
613758-1375838.13638.14
10min116678-1667846.23050.6010.6846.2650.6610.70
220148-2014855.84955.92
319903-1990355.16955.23
415814-1581443.83543.87
517059-1705947.28647.33
619935-1993555.25855.32
15min121039-2103958.31860.446.5658.4360.586.58
222994-2299463.73763.90
322882-2288263.42763.58
419666-1966654.51254.62
521065-2106558.39058.52
623191-2319164.28364.44
20min123295-2329564.57265.984.3264.7866.214.34
224596-2459668.17868.44
324684-2468468.42268.68
422168-2216861.44861.65
523392-2339264.84165.06
624679-2467968.40868.67
30min125794-2579471.49972.362.7471.8272.702.77
226633-2663373.82474.20
326792-2679274.26574.64
425054-2505469.44869.75
525636-2563671.06171.39
626715-2671574.05274.43
45min128178-2817878.10777.832.4378.5478.302.45
228339-2833978.55379.06
328949-2894980.24480.74
426990-2699074.81475.23
527633-2763376.59677.05
628386-2838678.68479.18
60min128513-2851379.03679.791.5379.6080.391.56
228901-2890180.11180.75
329257-2925781.09881.73
428186-2818678.12978.67
528578-2857879.21679.79
629282-2928281.16781.80
极限128968-2896880.29781.131.5480.9981.861.57
229468-2946881.68382.45
329598-2959882.04382.81
428500-2850079.00079.67
529402-2940281.50082.21
629669-2966982.24083.01
非布司他多替诺雷片项目信息
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C025-22401010对照品来源自制对照品使用方法直接使用
对照品含量(%)101.3对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.032535592539682532112550412526822536920.36
29.962541872541802541840.01
单位质量响应值RSD%判断
25293.3225520.480.64数据可信
供试品溶液-6010801批-非布司他-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124690-246908.86016.6326.968.8616.6326.96
254541-5454119.57219.57
347703-4770317.11817.12
461534-6153422.08122.08
546735-4673516.77116.77
642928-4292815.40515.40
10min1101372-10137236.37746.3111.4836.3946.3311.49
2137117-13711749.20449.24
3135889-13588948.76348.79
4143478-14347851.48751.52
5126101-12610145.25145.28
6130303-13030346.75946.78
15min1153944-15394455.24259.714.2855.3259.824.30
2170729-17072961.26661.38
3172266-17226661.81761.93
4171621-17162161.58661.71
5162354-16235458.26058.36
6167448-16744860.08860.19
20min1178810-17881064.16565.801.6564.3366.001.67
2185975-18597566.73766.95
3186357-18635766.87467.09
4185100-18510066.42366.65
5181003-18100364.95265.15
6182928-18292865.64365.85
30min1201126-20112672.17371.950.7472.4572.270.74
2201252-20125272.21972.55
3202776-20277672.76573.09
4199607-19960771.62871.96
5199475-19947571.58171.89
6198830-19883071.34971.66
45min1216610-21661077.73076.881.4078.1277.311.39
2214389-21438976.93377.38
3218844-21884478.53178.98
4212072-21207276.10176.56
5212422-21242276.22776.65
6211122-21112275.76076.19
60min1223913-22391380.35079.151.1080.8779.711.08
2221018-22101879.31279.89
3222712-22271279.91980.50
4218193-21819378.29878.88
5219428-21942878.74179.30
6218072-21807278.25478.81
极限1227454-22745481.62180.560.9882.2881.260.96
2224605-22460580.59981.31
3226785-22678581.38182.09
4222555-22255579.86380.58
5223131-22313180.07080.76
6222435-22243579.82080.51
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