熊去氧胆酸口服混悬液项目信息
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C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.695201052059524615253652606523340.54
213.615285952964529120.15
单位质量响应值RSD%判断
3822.793887.731.20数据可信
供试品溶液-6087549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%
5min119883-1988337.13646.2219.6937.1446.2219.68
220839-2083938.92138.92
320298-2029837.91137.91
429156-2915654.45554.45
528292-2829252.84152.84
630029-3002956.08556.09
10min123085-2308543.11652.6820.1143.1852.7520.11
223440-2344043.77943.84
322611-2261142.23142.29
434005-3400563.51263.60
533291-3329162.17862.27
632787-3278761.23761.33
15min124834-2483446.38354.2117.7646.5254.3817.76
224469-2446945.70145.84
323749-2374944.35644.49
434514-3451464.46264.66
533275-3327562.14862.34
633314-3331462.22162.42
20min125749-2574948.09255.5217.1448.3055.7717.14
225146-2514646.96547.18
324419-2441945.60845.82
434989-3498965.34965.65
534214-3421463.90264.20
633831-3383163.18763.49
30min127147-2714750.70356.7415.7550.9957.0915.77
225929-2592948.42848.72
325125-2512546.92647.21
435387-3538766.09366.51
534276-3427664.01864.42
634422-3442264.29064.69
45min128244-2824452.75258.0114.7553.1358.4514.77
226867-2686750.18050.55
325809-2580948.20448.57
436226-3622667.66068.18
534560-3456064.54865.06
634644-3464464.70565.22
60min129337-2933754.79358.8113.2355.2659.3513.26
227606-2760651.56052.02
326489-2648949.47449.92
436163-3616367.54268.18
534719-3471964.84565.46
634599-3459964.62165.24
90min130198-3019856.40160.1212.8556.9660.7612.89
228474-2847453.18153.72
327078-2707850.57451.10
437077-3707769.24970.00
535317-3531765.96266.69
635002-3500265.37466.10
120min131256-3125658.37760.9811.8259.0361.7211.87
229126-2912654.39955.03
327712-2771251.75852.37
437371-3737169.79870.66
535579-3557966.45167.29
634853-3485365.09565.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限133565-3356562.69064.517.7563.4465.357.84
233320-3332062.23262.95
330444-3044456.86157.56
438060-3806071.08572.07
536358-3635867.90668.85
635490-3549066.28567.23
熊去氧胆酸口服混悬液项目信息
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C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.695233052491525285256152525524870.18
213.615245652322523890.19
单位质量响应值RSD%判断
3833.973849.300.29数据可信
供试品溶液-6087549批-pH1.2(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122016-2201641.26336.1422.6241.2636.1422.62
224639-2463946.17946.18
322745-2274542.62942.63
414421-1442127.02827.03
515240-1524028.56328.56
616641-1664131.18931.19
10min127728-2772851.96841.0022.3452.0441.0622.34
225780-2578048.31748.39
324992-2499246.84046.91
416326-1632630.59830.64
517075-1707532.00232.05
619365-1936536.29436.35
15min131779-3177959.56146.2023.2859.7246.3223.28
229900-2990056.03956.20
327248-2724851.06851.22
418466-1846634.60934.71
519145-1914535.88235.98
621348-2134840.01140.12
20min133793-3379363.33548.1826.1163.5948.3926.09
231524-3152459.08359.33
328932-2893254.22554.46
417493-1749332.78632.94
519208-1920836.00036.16
623298-2329843.66543.84
30min136728-3672868.83654.1420.5169.2054.4320.53
233973-3397363.67364.02
330987-3098758.07658.40
422009-2200941.24941.46
523522-2352244.08544.31
626118-2611848.95149.20
45min139609-3960974.23659.6018.4974.7159.9718.52
236843-3684369.05269.51
333598-3359862.97063.39
424511-2451145.93946.22
526922-2692250.45750.75
629307-2930754.92755.26
60min141835-4183578.40863.8017.3879.0164.2817.41
239043-3904373.17573.75
335674-3567466.86167.39
426091-2609148.90049.25
529745-2974555.74856.13
631856-3185659.70560.13
90min144720-4472083.81569.3515.1484.5469.9315.18
241650-4165078.06178.75
337717-3771770.69071.33
429255-2925554.83055.27
533711-3371163.18163.65
634956-3495665.51566.04
120min146589-4658987.31873.2013.7788.1973.9013.82
243545-4354581.61282.44
339182-3918273.43574.19
431568-3156859.16559.69
536218-3621867.88068.46
637223-3722369.76470.40
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限149385-4938592.55879.5910.3893.5780.4110.45
245797-4579785.83386.79
340547-4054775.99476.87
437065-3706569.46870.09
540311-4031175.55176.24
641698-4169878.15178.90
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