贝派度酸片项目信息
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BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.852948622951092948912945592951942949230.09
29.862944032944952944490.03
单位质量响应值RSD%判断
29941.4229862.980.19数据可信
制剂处方摸索--供试品溶液-24022301批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min197452-9745232.49931.174.7132.5031.174.72
295224-9522431.75631.76
391017-9101730.35330.35
499048-9904833.03133.03
589757-8975729.93329.93
688293-8829329.44529.44
10min1184225-18422561.43760.871.0661.4960.931.06
2183389-18338961.15861.21
3181302-18130260.46260.51
4184911-18491161.66661.72
5181442-18144260.50960.56
6179966-17996660.01660.07
15min1216590-21659072.23071.760.8672.3971.920.86
2214984-21498471.69571.85
3213583-21358371.22771.38
4218069-21806972.72372.88
5214628-21462871.57671.73
6213294-21329471.13171.28
20min1239753-23975379.95579.610.7880.2379.880.78
2238271-23827179.46079.73
3236728-23672878.94679.22
4241757-24175780.62380.90
5238716-23871679.60979.88
6237092-23709279.06779.33
30min1274539-27453991.55591.030.7891.9791.440.79
2272648-27264890.92591.33
3270679-27067990.26890.67
4276357-27635792.16292.58
5272331-27233190.81991.22
6271307-27130790.47890.88
45min1300444-300444100.19499.930.80100.76100.490.80
2298844-29884499.661100.22
3297238-29723899.12599.68
4304064-304064101.402101.97
5298702-29870299.613100.17
6298670-29867099.603100.15
60min1307359-307359102.500102.410.80103.23103.130.80
2305764-305764101.969102.69
3304734-304734101.625102.34
4311701-311701103.948104.68
5306265-306265102.136102.86
6306635-306635102.259102.98
极限1307909-307909102.684102.580.85103.58103.470.85
2306935-306935102.359103.25
3304572-304572101.571102.46
4312380-312380104.175105.08
5306748-306748102.297103.19
6306954-306954102.365103.25
贝派度酸片项目信息
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BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.852946792944992946402945602945752945910.03
29.862943662946622945140.08
单位质量响应值RSD%判断
29907.7229869.570.10数据可信
制剂处方摸索--供试品溶液-24022301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%
5min1112124-11212437.40938.504.3537.4138.504.35
2123086-12308641.06641.07
3120201-12020140.10440.10
4113318-11331837.80737.81
5110691-11069136.93136.93
6112937-11293737.68037.68
10min1215122-21512271.77372.590.9771.8472.660.97
2217696-21769672.63272.70
3219985-21998573.39573.46
4215323-21532371.84071.90
5219855-21985573.35273.41
6217480-21748072.56072.62
15min1258266-25826686.16786.730.5886.3586.910.58
2260263-26026386.83487.02
3261903-26190387.38187.57
4258166-25816686.13486.32
5261082-26108287.10787.29
6259949-25994986.72986.91
20min1285846-28584695.36995.540.3095.6995.870.30
2286505-28650595.58995.92
3287969-28796996.07896.41
4285799-28579995.35495.68
5285696-28569695.31995.65
6286367-28636795.54395.87
30min1308679-308679102.987102.500.54103.47103.000.54
2308183-308183102.822103.32
3308393-308393102.892103.39
4307403-307403102.561103.05
5304348-304348101.542102.03
6306391-306391102.224102.71
45min1311974-311974104.087103.310.58104.74103.970.58
2310400-310400103.561104.23
3310175-310175103.486104.15
4309943-309943103.409104.07
5306704-306704102.328102.99
6308666-308666102.983103.64
60min1311115-311115103.800103.010.59104.63103.850.59
2309651-309651103.312104.15
3309308-309308103.197104.04
4308741-308741103.008103.84
5305749-305749102.010102.84
6308005-308005102.762103.59
极限1310786-310786103.690102.790.63104.69103.790.63
2308954-308954103.079104.09
3308411-308411102.898103.91
4308043-308043102.775103.78
5304891-304891101.723102.72
6307422-307422102.568103.57
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