替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1114.45628745631325625885637375616505627960.14
2114.85675255699485687360.31
单位质量响应值RSD%判断
4919.554954.150.50数据可信
供试品溶液-1批-含1%吐温80的磷酸盐缓冲液（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%
5min111052-110521.9831.7812.091.981.7811.85
210101-101011.8121.81
38669-86691.5551.56
10min19969-99691.7881.796.071.791.795.86
210589-105891.9001.90
39384-93841.6831.69
15min128116-281165.0444.949.555.054.949.50
229815-298155.3485.35
324656-246564.4234.43
20min133365-333655.9856.055.426.006.065.44
232092-320925.7575.77
335691-356916.4036.42
30min142219-422197.5747.528.607.607.558.57
245412-454128.1468.17
338211-382116.8556.88
45min154301-543019.7419.294.499.789.334.46
249714-497148.9188.96
351363-513639.2149.25
60min157432-5743210.3039.6411.5010.369.6911.47
257188-5718810.25910.31
346614-466148.3628.41
90min168993-6899312.37711.873.7412.4511.943.75
264467-6446711.56511.63
365004-6500411.66111.73
120min173854-7385413.24912.808.4413.3412.898.44
275754-7575413.58913.68
364501-6450111.57111.65
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181249-8124914.57514.371.9414.6914.481.91
278368-7836814.05814.17
380780-8078014.49114.59
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1114.45656905637615647385640625627875642080.20
2114.85640755672835656790.41
单位质量响应值RSD%判断
4931.894927.520.07数据可信
供试品溶液-1批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min111900-119002.1382.4310.392.142.4310.39
214179-141792.5472.55
314463-144632.5982.60
10min115399-153992.7662.3540.092.772.3639.92
27087-70871.2731.28
316795-167953.0173.02
15min139365-393657.0727.335.517.087.345.45
243406-434067.7987.80
339682-396827.1297.14
20min154117-541179.7228.5817.919.748.6117.84
238055-380556.8366.86
351188-511889.1969.22
30min153837-538379.6729.882.359.719.922.30
256399-5639910.13210.16
354812-548129.8479.88
45min164708-6470811.62511.2213.0111.6811.2712.98
253458-534589.6049.65
369230-6923012.43712.49
60min164811-6481111.64312.012.8211.7112.082.82
267218-6721812.07512.14
368519-6851912.30912.38
90min185176-8517615.30213.6713.5215.3913.7613.45
264932-6493211.66511.75
378232-7823214.05414.15
120min182962-8296214.90415.312.4815.0215.422.43
287152-8715215.65615.76
385503-8550315.36015.48
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1104783-10478318.82417.399.5018.9717.539.49
286756-8675615.58515.71
398847-9884717.75717.90
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