普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.991743917340174571756517514174630.49
217.081747317352174120.50
单位质量响应值RSD%判断
1027.841019.440.59数据可信
供试品溶液-LW0489批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min116312-1631295.04092.761.9995.0492.761.99
215407-1540789.76789.77
315935-1593592.84392.84
415735-1573591.67891.68
516115-1611593.89293.89
616019-1601993.33393.33
5min118373-18373107.048108.061.16107.05108.061.16
218370-18370107.030107.03
318801-18801109.542109.54
418593-18593108.330108.33
518792-18792109.489109.49
618347-18347106.896106.90
10min118521-18521107.910108.550.83107.91108.540.83
218456-18456107.532107.53
318849-18849109.821109.82
418544-18544108.044108.04
518771-18771109.367109.37
618639-18639108.598108.60
15min118213-18213106.116108.071.32106.12108.081.32
218549-18549108.073108.07
318731-18731109.134109.13
418615-18615108.458108.46
518862-18862109.897109.90
618325-18325106.768106.77
30min118414-18414107.287108.361.34107.29108.361.34
218495-18495107.759107.76
318887-18887110.043110.04
418754-18754109.268109.27
518787-18787109.460109.46
618250-18250106.331106.33
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.991738117507174381733517287173900.50
217.081725117388173200.56
单位质量响应值RSD%判断
1023.541014.050.66数据可信
供试品溶液-LW0489批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min115447-1544790.42892.911.7990.4392.911.79
215844-1584492.75292.75
315822-1582292.62392.62
415876-1587692.93992.94
516335-1633595.62795.63
615905-1590593.10993.11
5min118436-18436107.926108.261.03107.93108.261.03
218725-18725109.618109.62
318608-18608108.933108.93
418618-18618108.991108.99
518221-18221106.667106.67
618354-18354107.446107.45
10min118481-18481108.189109.040.80108.19109.040.80
218408-18408107.762107.76
318748-18748109.752109.75
418739-18739109.700109.70
518650-18650109.179109.18
618735-18735109.676109.68
15min118719-18719109.583108.740.69109.58108.740.69
218424-18424107.856107.86
318650-18650109.179109.18
418461-18461108.072108.07
518506-18506108.336108.34
618691-18691109.419109.42
30min118618-18618108.991109.211.22108.99109.211.22
218345-18345107.393107.39
318610-18610108.945108.94
419042-19042111.474111.47
518599-18599108.880108.88
618721-18721109.594109.59
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.995572555618560445580156011558400.33
217.085584155780558100.08
单位质量响应值RSD%判断
3286.643267.560.42数据可信
供试品溶液-LR6707批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min147017-4701785.56774.5023.5685.5774.5023.56
244666-4466681.28881.29
343598-4359879.34579.34
442013-4201376.46076.46
521635-2163539.37439.37
646692-4669284.97684.98
5min156957-56957103.657101.161.45103.66101.161.45
254678-5467899.50999.51
355001-55001100.097100.10
455651-55651101.280101.28
555313-55313100.665100.67
655897-55897101.728101.73
10min157283-57283104.250102.081.28104.25102.081.28
255528-55528101.056101.06
355243-55243100.538100.54
456305-56305102.470102.47
556232-56232102.338102.34
655946-55946101.817101.82
15min157062-57062103.848102.121.26103.85102.121.26
255293-55293100.629100.63
355277-55277100.600100.60
456161-56161102.208102.21
556419-56419102.678102.68
656468-56468102.767102.77
30min156945-56945103.635102.000.97103.64102.000.97
255481-55481100.971100.97
355609-55609101.204101.20
456346-56346102.545102.54
556067-56067102.037102.04
655839-55839101.622101.62
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.995550055523556305552155569555490.10
217.085536855465554160.13
单位质量响应值RSD%判断
3269.513244.500.55数据可信
供试品溶液-LR6707批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min130010-3001054.95368.8825.2154.9568.8825.21
243389-4338979.45279.45
344634-4463481.73281.73
443432-4343279.53179.53
542465-4246577.76077.76
621756-2175639.83939.84
5min154901-54901100.532101.550.79100.53101.560.79
256084-56084102.699102.70
355222-55222101.120101.12
455170-55170101.025101.02
555700-55700101.995102.00
655679-55679101.957101.96
10min155468-55468101.571102.550.99101.57102.550.99
256142-56142102.805102.80
356728-56728103.878103.88
455291-55291101.247101.25
555980-55980102.508102.51
656416-56416103.307103.31
15min155507-55507101.642102.411.35101.64102.411.35
256092-56092102.713102.71
356894-56894104.182104.18
456132-56132102.787102.79
554685-54685100.137100.14
656258-56258103.017103.02
30min155312-55312101.285102.691.37101.28102.691.38
255824-55824102.223102.22
357162-57162104.673104.67
456348-56348103.182103.18
555208-55208101.095101.09
656619-56619103.678103.68
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.991052621052171055951053951054661053870.15
217.081054041056201055120.15
单位质量响应值RSD%判断
6202.886177.520.29数据可信
供试品溶液-LW0477批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min168427-6842765.92764.392.7765.9364.392.78
266002-6600263.59063.59
365012-6501262.63762.64
466289-6628963.86763.87
569758-6975867.20967.21
665517-6551763.12363.12
5min1101040-10104097.34896.770.4997.3596.770.49
2100355-10035596.68896.69
399679-9967996.03796.04
4100738-10073897.05797.06
5100127-10012796.46996.47
6100685-10068597.00697.01
10min1102117-10211798.38698.690.4798.3998.690.47
2103117-10311799.34999.35
3102303-10230398.56598.57
4102861-10286199.10399.10
5102379-10237998.63898.64
6101818-10181898.09898.10
15min1102752-10275298.99898.840.2099.0098.830.20
2102695-10269598.94398.94
3102271-10227198.53498.53
4102777-10277799.02299.02
5102592-10259298.84498.84
6102412-10241298.67098.67
30min1102785-10278599.02998.620.7999.0398.620.79
2103355-10335599.57999.58
3102324-10232498.58598.59
4102603-10260398.85498.85
5100978-10097897.28897.29
6102129-10212998.39798.40
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.991053551051681052301049771056011052660.23
217.081049591049001049300.04
单位质量响应值RSD%判断
6195.766143.440.60数据可信
供试品溶液-LW0477批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min168666-6866666.37965.042.3166.3865.042.31
266719-6671964.49764.50
365100-6510062.93262.93
468211-6821165.93965.94
566056-6605663.85663.86
668911-6891166.61666.62
5min1100865-10086597.50596.920.5097.5196.920.50
2100351-10035197.00997.01
3100699-10069997.34597.34
4100211-10021196.87396.87
599857-9985796.53196.53
699556-9955696.24096.24
10min1102788-10278899.36498.550.7999.3698.550.79
2101719-10171998.33198.33
3101083-10108397.71697.72
4102303-10230398.89698.90
5102793-10279399.36999.37
6101004-10100497.64097.64
15min1102849-10284999.42398.820.8199.4298.820.81
2102226-10222698.82198.82
3103257-10325799.81899.82
4101980-10198098.58398.58
5102198-10219898.79498.79
6100868-10086897.50897.51
30min1102794-10279499.37098.960.7999.3798.960.79
2102227-10222798.82298.82
3103687-103687100.233100.23
4102198-10219898.79498.79
5101312-10131297.93897.94
6101975-10197598.57898.58
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