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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.069535749504829525279517169491749514950.19
211.009499689478949489310.16
单位质量响应值RSD%判断
86030.2986266.450.20数据可信
供试品溶液-24090601批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1251576-25157626.19627.3136.7026.2027.3136.70
2184215-18421519.18219.18
3423818-42381844.13144.13
4289036-28903630.09630.10
5147893-14789315.40015.40
6277024-27702428.84628.85
10min1611501-61150163.67370.7819.5863.9671.0819.64
2634057-63405766.02266.24
3885532-88553292.20792.70
4754969-75496978.61278.95
5496751-49675151.72551.90
6695438-69543872.41372.73
15min1783735-78373581.60786.279.2182.6187.369.37
2841553-84155387.62888.57
3938602-93860297.73399.25
4859246-85924689.47090.68
5711151-71115174.05074.80
6836810-83681087.13488.26
20min1814585-81458584.82089.576.3586.7391.626.56
2875319-87531991.14493.06
3942084-94208498.096100.70
4880505-88050591.68493.89
5786301-78630181.87583.44
6862257-86225789.78491.88
30min1830225-83022586.44890.734.9289.3093.785.15
2873290-87329090.93393.87
3951443-95144399.070102.76
4868981-86898190.48493.70
5839358-83935887.39989.88
6864762-86476290.04593.14
45min1831142-83114286.54490.164.4590.3594.214.70
2874232-87423291.03194.97
3931856-93185697.031101.82
4878284-87828491.45395.68
5828591-82859186.27889.73
6851174-85117488.63092.72
60min1817773-81777385.15289.853.6989.9294.903.91
2866327-86632790.20795.16
3916394-91639495.421101.29
4866898-86689890.26795.51
5858035-85803589.34493.75
6851960-85196088.71193.79
极限1853731-85373188.89692.024.2094.6198.074.35
2873782-87378290.98496.94
3956625-95662599.610106.54
4869537-86953790.54296.79
5883807-88380792.02897.43
6864656-86465690.03396.10
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%
110.15 2539362539152541392535682536812538480.09
210.122538892539482539180.02
单位质量响应值RSD%判断
25009.6625090.710.23数据可信
供试品溶液-24090601批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125038-250389.96711.0928.679.9711.0928.66
222179-221798.8298.83
341166-4116616.38716.39
430443-3044312.11912.12
518354-183547.3067.31
629940-2994011.91911.92
10min182588-8258832.87735.0317.4532.9935.1517.48
281117-8111732.29132.39
3105593-10559342.03542.22
499424-9942439.57939.71
563467-6346725.26525.35
695728-9572838.10838.24
15min1121302-12130248.28850.229.0748.7650.739.16
2125255-12525549.86250.32
3135329-13532953.87254.52
4134661-13466153.60654.18
5105991-10599142.19342.56
6134331-13433153.47554.03
20min1143681-14368157.19759.316.4758.2160.386.58
2149821-14982159.64160.65
3153600-15360061.14562.39
4157459-15745962.68263.85
5132309-13230952.67053.50
6156992-15699262.49663.65
30min1169730-16973067.56669.613.8369.2171.343.98
2174510-17451069.46971.14
3176985-17698570.45572.38
4180939-18093972.02973.90
5164802-16480265.60567.02
6182278-18227872.56274.41
45min1193181-19318176.90277.953.6279.3080.463.73
2195390-19539077.78180.23
3193379-19337976.98179.69
4205532-20553281.81984.49
5185500-18550073.84475.99
6201915-20191580.37983.03
60min1199271-19927179.32682.603.1282.5885.973.15
2205748-20574881.90585.21
3203395-20339580.96884.53
4214528-21452885.40088.98
5206181-20618182.07785.04
6215898-21589885.94589.49
极限1209962-20996283.58287.512.7087.7291.802.67
2222885-22288588.72692.95
3216717-21671786.27190.74
4221489-22148988.17192.70
5220636-22063687.83191.71
6227258-22725890.46794.97
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.069474379482619485479476869478949479650.05
211.009502479513669508060.09
单位质量响应值RSD%判断
85711.1286436.910.60数据可信
供试品溶液-24090601批-依折麦布-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%
5min139076-390764.0724.0012.124.074.0012.16
237416-374163.8993.90
344311-443114.6184.62
441977-419774.3754.37
530943-309433.2253.22
636557-365573.8103.81
10min164998-649986.7746.912.206.826.962.24
266162-661626.8956.94
367976-679767.0847.14
468004-680047.0877.14
566415-664156.9226.96
664521-645216.7246.77
15min166285-662856.9087.052.017.037.172.04
269077-690777.1997.32
368433-684337.1327.26
468619-686197.1517.28
567585-675857.0447.16
665704-657046.8486.96
20min163610-636106.6296.902.886.837.102.85
266494-664946.9307.13
365681-656816.8457.05
469369-693697.2297.44
566848-668486.9677.16
665390-653906.8157.01
30min164722-647226.7457.6214.027.027.9013.60
265902-659026.8687.15
383261-832618.6778.96
488219-882199.1949.48
571964-719647.5007.77
664727-647276.7467.01
45min163489-634896.6178.0822.356.968.4421.59
265678-656786.8457.20
378791-787918.2118.59
4107943-10794311.25011.64
585121-851218.8719.22
664154-641546.6867.03
60min164739-647396.7478.5027.117.178.9626.15
266773-667736.9597.39
383363-833638.6889.16
4120554-12055412.56413.08
590827-908279.4669.92
663281-632816.5957.01
极限163410-634106.6088.5325.377.109.0824.53
272977-729777.6068.11
384035-840358.7589.33
4118650-11865012.36513.02
588535-885359.2279.78
663573-635736.6257.12
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%
110.15 2537262529042536082535712535462534710.13
210.122545152547372546260.07
单位质量响应值RSD%判断
24972.5125160.670.54数据可信
供试品溶液-24090601批-贝派度酸-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%
5min190536-9053636.01833.5813.6236.0233.5813.62
278380-7838031.18231.18
396074-9607438.22138.22
494415-9441537.56137.56
566008-6600826.26026.26
681018-8101832.23132.23
10min1205455-20545581.73578.763.4482.1479.133.47
2192506-19250676.58476.93
3197144-19714478.42978.85
4205360-20536081.69882.11
5188551-18855175.01075.30
6198826-19882679.09879.46
15min1234557-23455793.31390.212.7694.6291.462.75
2229785-22978591.41492.61
3218762-21876287.02988.33
4232079-23207992.32793.65
5222755-22275588.61889.74
6222645-22264588.57489.81
20min1241945-24194596.25292.483.3498.6094.743.31
2238049-23804994.70296.92
3221023-22102387.92990.19
4235527-23552793.69996.05
5226227-22622789.99992.11
6232048-23204892.31594.54
30min1246484-24648498.05894.762.98101.4798.042.96
2241685-24168596.14999.41
3227093-22709390.34393.58
4243578-24357896.902100.29
5235220-23522093.57796.69
6235080-23508093.52196.77
45min1245708-24570897.74993.453.36102.2597.783.31
2238590-23859094.91799.25
3222316-22231688.44392.69
4237821-23782194.61199.08
5231801-23180192.21696.37
6233157-23315792.75697.04
60min1243456-24345696.85393.273.11102.4498.643.06
2238362-23836294.827100.21
3222482-22248288.50993.74
4237420-23742094.45299.97
5234589-23458993.32698.50
6230353-23035391.64096.96
极限1239946-23994695.45792.423.23102.1298.833.16
2237124-23712494.334100.78
3218368-21836886.87293.08
4233005-23300592.69599.26
5234254-23425493.19299.40
6231224-23122491.98798.32
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.069502279497989498519505919486519498240.08
211.009493729494109493910.01
单位质量响应值RSD%判断
85879.2086308.270.36数据可信
供试品溶液-24090601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%
5min132952-329523.4334.4020.013.434.4020.03
230523-305233.1803.18
351057-510575.3205.32
447572-475724.9574.96
546933-469334.8904.89
644595-445954.6464.65
10min162406-624066.5026.347.356.546.397.23
264746-647466.7466.78
352552-525525.4765.53
463962-639626.6646.72
559384-593846.1876.24
662133-621336.4746.53
15min165734-657346.8496.913.716.967.033.60
270820-708207.3797.49
364111-641116.6806.80
466500-665006.9297.06
566614-666146.9417.06
664167-641676.6866.81
20min169074-690747.1977.032.507.387.222.37
269718-697187.2647.46
367398-673987.0227.22
466037-660376.8817.09
567019-670196.9837.18
665389-653896.8137.01
30min169006-690067.1907.003.547.467.283.39
269983-699837.2927.56
366472-664726.9267.20
468626-686267.1507.43
565098-650986.7837.06
663995-639956.6686.94
45min199781-9978110.3967.8716.7510.748.2215.99
270756-707567.3727.73
368113-681137.0977.45
467745-677457.0597.42
579081-790818.2408.59
667722-677227.0567.40
60min1103466-10346610.78010.0620.2811.2410.5019.50
274709-747097.7848.22
373638-736387.6738.10
4109893-10989311.45011.89
5122686-12268612.78313.23
694647-946479.86210.29
极限1154222-15422216.06915.6118.0216.6516.1617.56
2114856-11485611.96712.49
3128611-12861113.40013.91
4184617-18461719.23619.80
5175616-17561618.29818.88
6141173-14117314.70915.24
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%
110.15 2548382549722550552546792550302549150.07
210.122544772549082546920.12
单位质量响应值RSD%判断
25114.7825167.190.15数据可信
供试品溶液-24090601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%
5min145875-4587518.19625.2129.1618.2025.2129.15
238390-3839015.22715.23
384860-8486033.65933.66
479277-7927731.44531.44
561298-6129824.31324.31
671601-7160128.40028.40
10min1139076-13907655.16460.979.1455.3761.259.16
2147479-14747958.49758.67
3142223-14222356.41256.79
4175817-17581769.73770.09
5153362-15336260.83061.10
6164279-16427965.16065.48
15min1181371-18137171.94078.914.5372.7579.874.57
2202666-20266680.38681.21
3201174-20117479.79480.80
4206536-20653681.92183.05
5203447-20344780.69681.64
6198538-19853878.74979.79
20min1209277-20927783.00886.612.3984.6288.442.46
2216655-21665585.93587.65
3223798-22379888.76890.66
4218683-21868386.73988.77
5222821-22282188.38190.22
6218855-21885586.80788.72
30min1232797-23279792.33791.450.5094.8794.250.41
2230019-23001991.23693.90
3229991-22999191.22494.10
4230815-23081591.55194.55
5229803-22980391.15093.97
6230000-23000091.22894.11
45min1233845-23384592.75392.752.9396.3296.562.76
2234372-23437292.96296.64
3234058-23405892.83896.72
4221116-22111687.70491.72
5239764-23976495.10198.94
6239893-23989395.15299.04
60min1234507-23450793.01694.451.4897.6199.291.48
2237744-23774494.30099.01
3237266-23726694.11099.03
4234561-23456193.03798.03
5241978-24197895.979100.87
6242642-24264296.242101.19
极限1236085-23608593.64293.191.9899.2799.081.85
2235301-23530193.33199.09
3227872-22787290.38496.35
4231725-23172591.91297.94
5241280-24128095.702101.66
6237413-23741394.168100.19
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.069513689527779508169500789512959512670.11
211.009491549483019487280.07
单位质量响应值RSD%判断
86009.6786248.000.20数据可信
供试品溶液-24090601批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147990-479904.9984.1921.515.004.1921.53
243306-433064.5104.51
333470-334703.4863.49
450028-500285.2105.21
527486-274862.8632.86
639204-392044.0834.08
10min169162-691627.2037.182.577.267.222.65
270858-708587.3807.43
369141-691417.2017.24
469921-699217.2827.34
565639-656396.8366.87
668788-687887.1647.21
15min172250-722507.5257.451.237.667.571.19
272120-721207.5117.64
372450-724507.5467.66
470309-703097.3237.46
571200-712007.4157.52
670795-707957.3737.50
20min172028-720287.5027.492.207.727.702.02
271952-719527.4947.71
372774-727747.5797.78
469321-693217.2207.44
574017-740177.7097.90
671173-711737.4137.62
30min170129-701297.3047.442.167.617.732.02
273088-730887.6127.91
372484-724847.5497.84
469795-697957.2697.57
572832-728327.5857.86
670134-701347.3047.59
45min168795-687957.1657.363.017.557.742.75
271369-713697.4337.82
371318-713187.4287.80
468513-685137.1367.52
574260-742607.7348.09
669858-698587.2767.65
60min169023-690237.1897.333.377.657.793.13
271154-711547.4117.88
370203-702037.3127.76
468060-680607.0887.55
574738-747387.7848.23
669256-692567.2137.66
极限169298-692987.2177.302.137.767.841.97
270756-707567.3697.92
370138-701387.3057.84
468192-681927.1027.64
572587-725877.5608.09
669631-696317.2527.78
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%
110.15 2554942549702542102549092552492549660.19
210.122554212550042552120.12
单位质量响应值RSD%判断
25119.8025218.580.28数据可信
供试品溶液-24090601批-贝派度酸-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min114933-149335.9164.8449.135.924.8449.13
214639-146395.8005.80
314014-140145.5525.55
415304-153046.0636.06
5-0.0000.00
614367-143675.6925.69
15min117127-171276.7866.928.636.856.978.64
216545-165456.5556.62
316900-169006.6966.76
420496-204968.1218.19
517080-170806.7676.77
616619-166196.5846.65
20min118065-180657.1577.063.247.307.193.35
217366-173666.8807.02
318731-187317.4217.56
418112-181127.1767.33
517403-174036.8956.97
617263-172636.8406.98
30min118182-181827.2047.383.867.427.584.08
218574-185747.3597.57
319276-192767.6377.86
419638-196387.7818.02
517712-177127.0177.17
618327-183277.2617.47
45min118501-185017.3307.543.537.637.833.06
218869-188697.4767.77
318964-189647.5147.82
418837-188377.4637.79
520362-203628.0678.30
618662-186627.3947.69
60min119151-191517.5887.721.847.978.101.66
219491-194917.7228.10
319902-199027.8858.27
418995-189957.5267.93
519580-195807.7588.08
619806-198067.8478.22
极限118954-189547.5107.693.757.988.153.82
219449-194497.7068.17
319569-195697.7538.23
420649-206498.1818.67
518474-184747.3197.73
619375-193757.6768.14
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.069521759514169508849520299504499513910.08
211.009497439502319499870.04
单位质量响应值RSD%判断
86020.8986362.450.29数据可信
供试品溶液-24090601批-依折麦布-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%
5min119330-193302.0123.3527.002.013.3427.00
223254-232542.4202.42
336290-362903.7773.78
440971-409714.2644.26
536512-365123.8003.80
636500-365003.7993.80
10min158947-589476.1356.765.326.166.805.41
263594-635946.6186.65
364423-644236.7056.75
468314-683147.1107.16
567350-673507.0097.05
667043-670436.9777.02
15min170257-702577.3127.341.567.407.451.49
272166-721667.5117.61
368884-688847.1697.29
471149-711497.4057.53
570415-704157.3287.45
670181-701817.3047.42
20min171690-716907.4617.440.927.637.640.83
272347-723477.5297.71
371070-710707.3977.59
471490-714907.4407.65
570501-705017.3377.54
671967-719677.4907.69
30min174738-747387.7787.541.618.037.821.42
271713-717137.4637.73
372526-725267.5487.83
471724-717247.4657.76
571770-717707.4697.75
672378-723787.5337.82
45min173648-736487.6657.610.988.017.970.80
274283-742837.7318.08
373096-730967.6077.97
472478-724787.5437.92
572558-725587.5517.92
672693-726937.5657.93
60min174530-745307.7577.631.458.188.071.24
274022-740227.7048.14
374061-740617.7088.15
471814-718147.4747.93
572588-725887.5558.00
672769-727697.5738.03
极限175456-754567.8537.651.858.378.181.64
274433-744337.7478.27
373878-738787.6898.22
472130-721307.5078.05
571958-719587.4898.02
673160-731607.6148.15
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%
110.15 2554422556642555492559972547272554760.19
210.122539842547782543810.23
单位质量响应值RSD%判断
25170.0525136.460.10数据可信
供试品溶液-24090601批-贝派度酸-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0001.4877.840.001.4877.82
25160-51602.0462.05
3-0.0000.00
46039-60392.3942.39
55494-54942.1782.18
65658-56582.2432.24
15min16157-61572.4412.7912.902.442.8113.21
28589-85893.4053.43
36185-61852.4522.45
47423-74232.9432.97
56787-67872.6912.71
67136-71362.8292.85
20min17056-70562.7972.967.392.823.007.68
28170-81703.2393.30
37018-70182.7822.81
48114-81143.2173.28
57396-73962.9322.99
66992-69922.7722.83
30min18259-82593.2743.232.833.333.302.53
27742-77423.0693.17
38265-82653.2773.33
48380-83803.3223.42
58006-80063.1743.26
68160-81603.2353.32
45min110252-102524.0643.607.214.163.726.84
29462-94623.7513.88
38574-85743.3993.49
48638-86383.4253.56
58741-87413.4653.59
68841-88413.5053.63
60min18840-88403.5053.563.043.643.723.25
29271-92713.6753.85
38715-87153.4553.59
49207-92073.6503.82
59195-91953.6453.81
68663-86633.4343.60
极限18446-84463.3483.464.063.533.663.97
29068-90683.5953.81
38990-89903.5643.73
49057-90573.5913.80
58557-85573.3923.59
68255-82553.2733.47
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