熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.051001331004241000931004391002001002580.17
2 10.071004791004021004400.06
单位质量响应值RSD%判断
9975.929974.180.02数据可信
中间条件24月-供试品溶液-2023111721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%
5min167789-6778960.97955.9313.2260.9855.9413.22
270442-7044263.36663.37
348429-4842943.56443.56
467802-6780260.99160.99
558740-5874052.83952.84
659884-5988453.86853.87
10min188752-8875279.83681.026.4580.1881.336.45
295235-9523585.66886.02
385000-8500076.46176.70
493090-9309083.73984.08
596352-9635286.67386.97
681973-8197373.73874.04
15min196536-9653686.83888.324.4587.6289.084.46
2100334-10033490.25591.08
396712-9671286.99787.66
4103373-10337392.98993.79
5101052-10105290.90191.68
691063-9106381.91582.62
20min198055-9805588.20590.183.6489.4791.433.65
2100678-10067890.56491.89
399701-9970189.68590.84
4104147-10414793.68595.01
5104191-10419193.72495.00
694725-9472585.20986.37
30min1100399-10039990.31392.392.9292.0794.142.91
2101688-10168891.47393.31
3104708-10470894.18995.84
4107484-10748496.68798.53
5102687-10268792.37294.17
699285-9928589.31190.95
45min1101960-10196091.71892.562.3893.9794.832.37
2102291-10229192.01594.36
3105157-10515794.59396.77
4105679-10567995.06397.44
5103335-10333592.95495.27
698965-9896589.02391.16
60min1102394-10239492.10892.252.1394.8795.042.12
2101613-10161391.40594.26
3104575-10457594.07096.77
4105522-10552294.92297.83
5101705-10170591.48894.32
699525-9952589.52792.16
极限1109940-10994098.896100.041.08102.17103.331.05
2111555-111555100.349103.71
3113247-113247101.871105.09
4110741-11074199.616103.05
5111502-111502100.301103.64
6110261-11026199.185102.31
熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.051001881001741001611000551002251001610.07
2 10.0799917100008999620.07
单位质量响应值RSD%判断
9966.279926.710.29数据可信
中间条件24月-供试品溶液-2023111821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%
5min174847-7484767.52256.0713.1267.5256.0713.12
251624-5162446.57246.57
367487-6748760.88260.88
460657-6065754.72154.72
556724-5672451.17251.17
661598-6159855.56955.57
10min192760-9276083.68278.819.9384.0679.139.91
281186-8118673.24073.50
385838-8583877.43777.78
499387-9938789.66089.96
574944-7494467.60967.89
690077-9007781.26181.57
15min198632-9863288.97986.117.8889.8286.867.87
290769-9076981.88682.55
390040-9004081.22882.00
4105986-10598695.61396.42
586450-8645077.98978.65
6100822-10082290.95591.71
20min199894-9989490.11787.966.5291.4589.186.52
296430-9643086.99288.11
390862-9086281.96983.19
4105243-10524394.94396.28
589650-8965080.87681.97
6102913-10291392.84194.11
30min1102357-10235792.33990.345.2194.1792.065.22
2100558-10055890.71692.32
393541-9354184.38686.06
4106145-10614595.75797.62
594180-9418084.96386.51
6104089-10408993.90295.68
45min1107922-10792297.36091.475.0299.7193.695.05
299239-9923989.52791.63
395553-9555386.20188.35
4105718-10571895.37197.76
596422-9642286.98589.00
6103526-10352693.39495.70
60min1106811-10681196.35791.844.0099.2594.574.05
2101980-10198091.99994.60
397368-9736887.83990.46
4104567-10456794.33397.26
596587-9658787.13489.63
6103534-10353493.40196.22
极限1107819-10781997.26799.851.73100.69103.091.64
2111472-111472100.562103.68
3109996-10999699.231102.34
4113132-113132102.060105.51
5112044-112044101.078104.06
6109629-10962998.900102.24
熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.0510013599821100256998711000041000170.19
2 10.079954499794996690.18
单位质量响应值RSD%判断
9951.949897.620.39数据可信
中间条件24月-供试品溶液-2023111921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%
5min155262-5526249.96344.7220.5649.9644.7220.56
247533-4753342.97542.97
366702-6670260.30660.31
442884-4288438.77238.77
538132-3813234.47534.48
646238-4623841.80441.80
10min193100-9310084.17271.3711.7184.4571.6211.73
276974-7697469.59369.83
384993-8499376.84377.18
475578-7557868.33168.55
565838-6583859.52559.72
677173-7717369.77370.00
15min1100188-10018890.58183.037.0591.3383.687.07
287495-8749579.10579.73
393175-9317584.24085.00
496861-9686187.57388.17
582178-8217874.29874.82
691146-9114682.40683.03
20min1104519-10451994.49690.034.9595.7491.144.98
296828-9682887.54388.61
3101169-10116991.46892.70
4105162-10516295.07896.16
592482-9248283.61484.55
697343-9734388.00989.09
30min1108770-10877098.34096.032.32100.1197.642.36
2102052-10205292.26693.82
3107731-10773197.40099.14
4107605-10760597.28698.90
5106398-10639896.19597.59
6104741-10474194.69796.26
45min1109605-10960599.09597.651.34101.4199.791.31
2106504-10650496.29198.35
3106537-10653796.32198.60
4108779-10877998.348100.50
5109470-10947098.973100.91
6107159-10715996.88398.98
60min1112090-112090101.34198.941.44104.21101.621.48
2109185-10918598.715101.31
3108614-10861498.199101.01
4110106-11010699.548102.24
5109160-10916098.692101.18
6107442-10744297.13999.77
极限1107511-10751197.20297.450.88100.63100.680.88
2107908-10790897.560100.71
3107483-10748397.176100.54
4109604-10960499.094102.34
5107346-10734697.052100.08
6106884-10688496.63599.81
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