盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.944419134426144418554420664419674420830.07
210.014541594536464539020.08
单位质量响应值RSD%判断
44475.1545344.861.37数据可信
供试品溶液-24071801批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1341393-34139375.64477.189.3975.6477.189.39
2322323-32232371.41971.42
3382033-38203384.64984.65
4305173-30517367.61967.62
5388518-38851886.08686.09
6350555-35055577.67477.67
10min1415897-41589792.15290.234.1092.3890.464.11
2386472-38647285.63385.85
3419592-41959292.97193.23
4400682-40068288.78188.98
5428645-42864594.97795.24
6392058-39205886.87087.10
15min1420260-42026093.11992.772.8193.6293.272.80
2420321-42032193.13393.60
3421028-42102893.28993.82
4423169-42316993.76494.23
5431085-43108595.51896.06
6396223-39622387.79388.29
20min1421296-42129693.34992.953.0894.1393.743.07
2429842-42984295.24295.99
3420185-42018593.10293.92
4420022-42002293.06693.82
5430631-43063195.41796.25
6395082-39508287.54088.30
30min1419218-41921892.88892.493.2693.9593.553.25
2427205-42720594.65895.69
3418274-41827492.67993.77
4417212-41721292.44493.47
5430758-43075895.44596.56
6391990-39199086.85587.87
45min1418980-41898092.83592.223.0994.1893.563.08
2427100-42710094.63595.95
3415996-41599692.17493.54
4416609-41660992.31093.62
5426664-42666494.53895.94
6391940-39194086.84488.12
60min1415779-41577992.12692.013.2293.7593.633.21
2425842-42584294.35695.96
3415650-41565092.09893.74
4415756-41575692.12193.71
5428114-42811494.85996.55
6390470-39047086.51888.06
极限1414561-41456191.85692.063.2193.7593.953.20
2425581-42558194.29896.19
3416614-41661492.31194.23
4415587-41558792.08493.94
5429401-42940195.14597.12
6391232-39123286.68788.49
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.944445024448194448754448204445734447180.04
210.014524974444364484661.28
单位质量响应值RSD%判断
44740.2444801.800.10数据可信
供试品溶液-2095120批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1297925-29792566.21169.248.9266.2169.248.92
2318926-31892670.87970.88
3297871-29787166.19966.20
4276730-27673061.50161.50
5357915-35791579.54479.54
6319819-31981971.07771.08
10min1366385-36638581.42683.857.7881.6284.067.79
2384218-38421885.38985.60
3369882-36988282.20382.40
4330118-33011873.36673.55
5415016-41501692.23492.47
6398206-39820688.49888.71
15min1392898-39289887.31889.126.4987.7689.586.50
2402424-40242489.43689.90
3402792-40279289.51789.96
4355917-35591779.10079.50
5422917-42291793.99094.51
6429206-42920695.38895.87
20min1409544-40954491.01891.104.6091.7291.824.61
2412506-41250691.67692.41
3413877-41387791.98192.69
4375427-37542783.43684.08
5415120-41512092.25793.05
6433020-43302096.23597.00
30min1422982-42298294.00493.083.1394.9894.083.15
2416238-41623892.50693.52
3423663-42366394.15695.15
4394911-39491187.76688.66
5421111-42111193.58994.66
6434102-43410296.47697.53
45min1422648-42264893.93093.222.0695.1994.502.08
2415227-41522792.28193.57
3422165-42216593.82395.09
4406610-40661090.36691.52
5417784-41778492.84994.20
6432401-43240196.09897.44
60min1424966-42496694.44593.342.0895.9994.902.09
2415641-41564192.37393.94
3421569-42156993.69095.24
4407940-40794090.66192.09
5416539-41653992.57294.21
6433216-43321696.27997.91
极限1425171-42517194.49193.392.5996.3295.232.60
2412205-41220591.60993.45
3420155-42015593.37695.21
4407858-40785890.64392.34
5417396-41739692.76394.67
6438648-43864897.48699.41
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.944455194455424454004446144442424450630.14
210.014541374512944527160.45
单位质量响应值RSD%判断
44774.9545226.370.71数据可信
供试品溶液-24071801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%
5min1252890-25289055.91758.7814.8155.9258.7814.81
2195967-19596743.33143.33
3260643-26064357.63257.63
4300049-30004966.34566.34
5297815-29781565.85165.85
6287553-28755363.58263.58
10min1326847-32684772.27076.037.2872.4476.207.29
2313607-31360769.34369.47
3329623-32962372.88473.06
4360729-36072979.76279.96
5381003-38100384.24584.44
6351205-35120577.65677.85
15min1344621-34462176.20079.475.6476.5879.875.66
2337589-33758974.64574.98
3345390-34539076.37076.76
4376612-37661283.27483.71
5388504-38850485.90386.35
6363724-36372480.42480.85
20min1355943-35594378.70481.304.8079.3281.944.82
2351098-35109877.63278.19
3352978-35297878.04878.67
4386396-38639685.43786.13
5391604-39160486.58987.30
6368129-36812981.39882.06
30min1369754-36975481.75883.563.6982.6184.453.72
2366328-36632881.00081.79
3366067-36606780.94281.80
4396693-39669387.71488.66
5394198-39419887.16288.13
6374435-37443582.79383.70
45min1383401-38340184.77585.923.0985.8787.063.12
2384798-38479885.08486.12
3377200-37720083.40484.50
4406977-40697789.98891.20
5399731-39973188.38689.62
6379277-37927783.86385.02
60min1391029-39102986.46287.312.7787.8188.712.79
2393416-39341686.99088.28
3384460-38446085.00986.36
4411909-41190991.07992.56
5403695-40369589.26290.76
6384785-38478585.08186.49
极限1423454-42345493.63193.451.9795.2495.111.95
2418072-41807292.44194.00
3431501-43150195.41197.01
4432748-43274895.68697.44
5418629-41862992.56494.33
6411420-41142090.97092.63
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.944458554459704459924458664454684458300.05
210.014499484455834477660.69
单位质量响应值RSD%判断
44852.1144731.870.19数据可信
供试品溶液-2095120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%
5min1342155-34215576.00676.404.5476.0176.404.55
2360444-36044480.06880.07
3351699-35169978.12678.13
4323557-32355771.87471.87
5327617-32761772.77672.78
6358102-35810279.54879.55
10min1395746-39574687.91089.664.2488.1489.884.24
2412851-41285191.71091.95
3421264-42126493.57993.81
4384390-38439085.38885.60
5385927-38592785.72985.95
6421464-42146493.62393.86
15min1403188-40318889.56491.864.0690.0692.364.06
2421947-42194793.73194.25
3433557-43355796.31096.82
4398719-39871988.57189.04
5394614-39461487.65988.13
6429235-42923595.35095.87
20min1407420-40742090.50492.653.7391.2693.433.73
2426712-42671294.78995.59
3434504-43450496.52097.32
4404459-40445989.84690.58
5398255-39825588.46889.21
6431269-43126995.80196.61
30min1408834-40883490.81893.563.8491.8594.623.84
2429259-42925995.35596.44
3439366-43936697.60098.69
4410340-41034091.15292.16
5401910-40191089.28090.28
6437476-43747697.18098.27
45min1414463-41446392.06894.043.2093.3795.383.21
2429858-42985895.48896.85
3439101-43910197.54198.93
4416836-41683692.59593.88
5404480-40448089.85191.12
6435363-43536396.71198.10
60min1415050-41505092.19994.363.3793.7895.983.38
2431399-43139995.83097.48
3442428-44242898.28099.96
4414513-41451392.07993.64
5407553-40755390.53392.07
6437807-43780797.25498.93
极限1417179-41717992.67194.513.2594.5396.413.26
2432010-43201095.96697.91
3441141-44114197.99499.97
4414284-41428492.02893.86
5408836-40883690.81892.63
6439368-43936897.60099.57
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