贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.969758269753499748309758079740139751650.08
210.959835959813729824840.16
单位质量响应值RSD%判断
88974.9189724.570.60数据可信
供试品溶液-2025112821批-依折麦布-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%
5min149422-494224.9665.3312.154.975.3412.12
260318-603186.0616.06
343959-439594.4174.42
449577-495774.9814.98
559204-592045.9495.95
656061-560615.6335.63
10min173291-732917.3647.312.137.427.372.15
273442-734427.3797.45
370540-705407.0887.14
472725-727257.3077.36
571477-714777.1827.25
674912-749127.5277.59
15min173201-732017.3557.301.647.497.441.65
271682-716827.2027.35
371219-712197.1567.28
474167-741677.4527.59
571832-718327.2187.36
673560-735607.3917.54
20min177199-771997.7577.692.627.987.912.62
276131-761317.6497.88
372669-726697.3027.51
477896-778967.8278.05
577618-776187.7998.02
677780-777807.8158.04
30min173127-731277.3487.453.717.657.763.52
277462-774627.7838.10
377738-777387.8118.10
471391-713917.1737.48
572885-728857.3237.64
672243-722437.2597.57
45min171999-719997.2347.502.667.627.892.46
272847-728477.3207.72
376312-763127.6688.04
476672-766727.7048.09
576136-761367.6508.04
674142-741427.4507.85
60min172174-721747.2527.462.367.727.932.23
272555-725557.2907.77
375619-756197.5988.06
473460-734607.3817.85
576369-763697.6738.15
675313-753137.5678.05
极限165376-653766.5697.7713.487.128.3312.56
269855-698557.0197.58
395164-951649.56210.11
476090-760907.6458.20
581945-819458.2348.80
675553-755537.5918.15
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.192561452567442568522570712567602567140.14
210.272566072558522562300.21
单位质量响应值RSD%判断
25192.7424949.370.69数据可信
供试品溶液-2025112821批-贝派度酸-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%
5min188465-8846535.18838.3521.5335.1938.3521.53
2122133-12213348.57948.58
368296-6829627.16527.17
480628-8062832.07132.07
5114362-11436245.48945.49
6104596-10459641.60441.60
10min1178995-17899571.19771.3810.4071.5971.8110.46
2196106-19610678.00378.54
3145903-14590358.03458.34
4172720-17272068.70169.06
5191214-19121476.05776.56
6191860-19186076.31476.78
15min1209394-20939483.28882.794.7284.4784.014.85
2216491-21649186.11187.52
3189976-18997675.56576.51
4204921-20492181.50982.63
5214693-21469385.39686.75
6213430-21343084.89486.20
20min1218388-21838886.86687.182.9388.9789.323.10
2224130-22413089.15091.51
3207902-20790282.69584.48
4216574-21657486.14488.17
5224178-22417889.16991.47
6223840-22384089.03491.29
30min1227196-22719690.36991.421.6793.4494.531.85
2232415-23241592.44595.80
3224333-22433389.23091.94
4228438-22843890.86393.85
5231999-23199992.28095.57
6234597-23459793.31396.56
45min1233804-23380492.99893.671.8297.0797.801.94
2234882-23488293.42697.81
3231862-23186292.22595.92
4231059-23105991.90695.90
5239882-23988295.41599.73
6241507-24150796.062100.34
60min1234786-23478693.38893.391.3498.5098.561.51
2234419-23441993.24298.66
3229475-22947591.27696.00
4234187-23418793.15098.16
5237536-23753694.48299.86
6238406-23840694.828100.18
极限1231796-23179692.19993.721.1998.3599.921.19
2233713-23371392.96199.42
3234360-23436093.21998.95
4238960-23896095.048101.10
5238162-23816294.731101.16
6236718-23671894.157100.56
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.969813629841179817909834899828539827220.12
210.959853499832679843080.15
单位质量响应值RSD%判断
89664.4289891.140.18数据可信
供试品溶液-2025112921批-依折麦布-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%
5min147999-479994.8004.937.894.804.937.92
251499-514995.1505.15
350858-508585.0865.09
450925-509255.0925.09
552363-523635.2365.24
641919-419194.1924.19
10min168943-689436.8947.071.716.957.121.76
271381-713817.1387.20
371094-710947.1097.17
471836-718367.1837.24
571383-713837.1387.20
669351-693516.9356.98
15min171334-713347.1337.170.677.267.300.69
271075-710757.1077.24
372377-723777.2377.37
471894-718947.1897.33
572068-720687.2077.34
671701-717017.1707.29
20min175473-754737.5477.671.487.767.891.43
275925-759257.5927.81
376597-765977.6597.88
478759-787597.8768.09
576812-768127.6817.90
676894-768947.6897.89
30min175124-751247.5127.582.137.817.882.07
277322-773227.7328.03
373943-739437.3947.70
477928-779287.7938.10
576303-763037.6307.93
674383-743837.4387.73
45min174859-748597.4867.581.647.867.961.63
275871-758717.5877.97
376608-766087.6618.04
477816-778167.7818.17
575478-754787.5487.94
674396-743967.4397.81
60min176616-766167.6617.611.648.128.081.50
274169-741697.4177.89
376122-761227.6128.08
477120-771207.7128.19
575239-752397.5248.00
677514-775147.7518.21
极限174604-746047.4607.634.658.008.184.40
274290-742907.4297.98
382856-828568.2858.84
475212-752127.5218.08
577884-778847.7888.34
673219-732197.3227.86
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.192559972553132558742567262566052561030.23
210.272562362559832561100.07
单位质量响应值RSD%判断
25132.7824937.680.56数据可信
供试品溶液-2025112921批-贝派度酸-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%
5min174999-7499929.87431.8013.6129.8731.8013.61
291574-9157436.47636.48
384945-8494533.83633.84
482653-8265332.92332.92
584318-8431833.58633.59
660491-6049124.09524.10
10min1162023-16202364.53866.262.4564.8766.622.51
2170300-17030067.83568.24
3168605-16860567.16067.54
4166842-16684266.45766.82
5169672-16967267.58567.96
6160689-16068964.00664.27
15min1195679-19567977.94478.160.9878.9979.250.99
2193543-19354377.09378.25
3198121-19812178.91680.04
4196235-19623578.16579.27
5198666-19866679.13480.26
6195049-19504977.69378.67
20min1206853-20685382.39584.641.4084.3186.601.39
2211848-21184884.38486.40
3214259-21425985.34587.34
4213294-21329484.96086.93
5215072-21507285.66887.67
6213669-21366985.11086.95
30min1226011-22601190.02691.030.9892.8693.930.92
2228369-22836990.96593.92
3227388-22738890.57493.52
4228579-22857991.04993.97
5228216-22821690.90493.86
6232689-23268992.68695.47
45min1233411-23341192.97393.951.3896.8097.861.30
2231300-23130092.13396.10
3236273-23627394.11398.07
4236581-23658194.23698.16
5236874-23687494.35398.32
6240785-24078595.91199.73
60min1235228-23522893.69794.331.9698.5699.281.84
2229867-22986791.56296.55
3235401-23540193.76698.77
4239514-23951495.404100.38
5237162-23716294.46799.48
6243681-24368197.064101.95
极限1233620-23362093.05794.911.9898.96100.911.88
2236900-23690094.363100.37
3244240-24424097.287103.33
4232892-23289292.76798.80
5238912-23891295.165101.23
6243009-24300996.796102.76
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.969856559857799854659853849865179857600.05
210.959849649851049850340.02
单位质量响应值RSD%判断
89941.6189957.440.02数据可信
供试品溶液-2025112921批-依折麦布-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%
5min136371-363713.6304.5914.223.634.5914.20
252031-520315.1935.19
349958-499584.9864.99
449813-498134.9724.97
539149-391493.9073.91
648787-487874.8694.87
10min169930-699306.9796.991.627.027.041.60
270817-708177.0687.13
368817-688176.8686.92
468633-686336.8506.91
570281-702817.0147.06
671535-715357.1407.19
15min171077-710777.0947.091.027.217.220.95
271019-710197.0887.22
370080-700806.9947.13
471226-712267.1097.24
572208-722087.2077.33
670535-705357.0407.17
20min173716-737167.3577.501.687.557.701.70
276609-766097.6467.86
374159-741597.4027.61
476629-766297.6487.86
575155-751557.5017.70
674415-744157.4277.64
30min174130-741307.3997.491.687.687.781.62
274230-742307.4097.71
377286-772867.7148.01
474281-742817.4147.71
575698-756987.5557.84
674466-744667.4327.73
45min171343-713437.1207.261.247.487.641.24
272950-729507.2817.66
372335-723357.2197.60
473780-737807.3647.74
573614-736147.3477.72
672606-726067.2477.62
60min174536-745367.4397.421.057.887.880.95
273571-735717.3437.81
373642-736427.3507.81
475671-756717.5528.01
574756-747567.4617.91
674190-741907.4057.86
极限171747-717477.1617.203.397.687.743.17
271367-713677.1237.67
368713-687136.8587.40
475689-756897.5548.10
571220-712207.1087.64
674097-740977.3957.93
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.192561692566112571632574232572992569330.21
210.272568752572452570600.11
单位质量响应值RSD%判断
25214.2325030.190.52数据可信
供试品溶液-2025112921批-贝派度酸-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%
5min155128-5512821.88330.5719.8221.8830.5719.82
287940-8794034.90734.91
390367-9036735.87135.87
486325-8632534.26634.27
560378-6037823.96723.97
681925-8192532.52032.52
10min1154988-15498861.52263.852.6461.7664.182.72
2164066-16406665.12565.51
3161290-16129064.02364.42
4162080-16208064.33764.72
5156686-15668662.19662.46
6165938-16593865.86866.23
15min1192134-19213476.26777.191.1477.1978.241.18
2194505-19450577.20878.32
3192393-19239376.36977.48
4197139-19713978.25379.35
5193607-19360776.85177.81
6197043-19704378.21579.31
20min1208700-20870082.84283.481.4084.6285.391.38
2211227-21122783.84585.81
3205108-20510881.41783.38
4213004-21300484.55186.52
5211562-21156283.97885.79
6212212-21221284.23686.20
30min1224684-22468489.18789.480.9891.8892.310.95
2224670-22467089.18292.08
3222699-22269988.39991.26
4228807-22880790.82493.73
5227179-22717990.17892.92
6224456-22445689.09791.99
45min1229395-22939591.05791.371.5794.7495.201.50
2223706-22370688.79992.69
3229571-22957191.12794.97
4233452-23345292.66896.58
5232693-23269392.36696.11
6232330-23233092.22296.11
60min1234909-23490993.24692.401.7297.9497.241.59
2225558-22555889.53494.41
3233902-23390292.84697.70
4231860-23186092.03696.98
5237381-23738194.22799.00
6233065-23306592.51497.43
极限1233804-23380492.80792.872.0298.5498.741.92
2228400-22840090.66296.54
3231660-23166091.95697.85
4233307-23330792.61098.58
5233982-23398292.87898.70
6242596-24259696.297102.24
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