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%
110.969204299237199237499222949233129227010.16
210.959233659246149239900.10
单位质量响应值RSD%判断
84188.0584382.650.17数据可信
供试品溶液-2025112721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%
5min1423654-42365445.12535.5724.1045.1235.5724.10
2224848-22484823.94923.95
3363064-36306438.67138.67
4291186-29118631.01531.02
5282596-28259630.10030.10
6418234-41823444.54744.55
10min1860584-86058491.66479.6414.9892.1780.0315.03
2592711-59271163.13263.40
3776033-77603382.65883.09
4701897-70189774.76175.11
5674272-67427271.81972.15
6880520-88052093.78794.28
15min1856135-85613591.19094.476.3692.7195.756.32
2823503-82350387.71488.68
3869981-86998192.66594.01
4984915-984915104.907106.08
5872070-87207092.88794.02
6915242-91524297.48599.02
20min1854962-85496291.06595.092.9793.6097.422.88
2884355-88435594.19696.14
3877646-87764693.48195.86
4931768-93176899.246101.59
5904316-90431696.32298.49
6903681-90368196.25498.87
30min1860038-86003891.60596.463.0395.1599.852.90
2912979-91297997.244100.23
3888577-88857794.64598.06
4910026-91002696.930100.37
5928461-92846198.893102.13
6933862-93386299.469103.16
45min1876719-87671993.38294.571.8097.9599.031.87
2873432-87343293.03297.10
3872036-87203692.88397.35
4898016-89801695.651100.17
5896619-89661995.50299.84
6910328-91032896.962101.76
60min1849065-84906590.43793.131.9396.0498.641.84
2878240-87824093.54498.65
3857707-85770791.35796.86
4887052-88705294.483100.07
5887059-88705994.48499.88
6887060-88706094.484100.36
极限1846074-84607490.11892.592.7696.7299.132.70
2863410-86341091.96598.11
3838186-83818689.27895.79
4889759-88975994.771101.40
5880956-88095693.834100.28
6897061-89706195.549102.47
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%
110.192540952573902558932558152563112559010.47
210.272557152563562560360.18
单位质量响应值RSD%判断
25112.9524930.480.52数据可信
供试品溶液-2025112721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%
5min154454-5445421.70217.6522.7921.7017.6522.79
229813-2981311.88211.88
350712-5071220.21120.21
439189-3918915.61815.62
537861-3786115.08915.09
653648-5364821.38121.38
10min1130968-13096852.19644.7614.9552.4444.9614.99
288444-8844435.24835.38
3121727-12172748.51348.74
4104145-10414541.50641.68
5101485-10148540.44640.61
6127084-12708450.64850.89
15min1150312-15031259.90559.705.9660.7360.395.99
2136105-13610554.24354.77
3153428-15342861.14761.91
4162620-16262064.81065.45
5144419-14441957.55758.17
6151826-15182660.50961.31
20min1165897-16589766.11666.202.0667.6067.562.14
2162026-16202664.57465.70
3169813-16981367.67769.12
4170576-17057667.98169.34
5163722-16372265.25066.51
6164601-16460165.60067.07
30min1185488-18548873.92475.021.1776.1577.111.18
2186933-18693374.50076.34
3191954-19195476.50178.70
4187926-18792674.89677.01
5189097-18909775.36377.34
6187999-18799974.92577.13
45min1202215-20221580.59180.521.4983.6383.451.56
2197963-19796378.89681.57
3206059-20605982.12385.17
4204814-20481481.62684.57
5200677-20067779.97882.80
6200495-20049579.90582.94
60min1210684-21068483.96683.841.2687.9087.661.25
2210306-21030683.81587.36
3213954-21395485.26989.23
4212042-21204284.50788.36
5209126-20912683.34587.05
6206174-20617482.16886.09
极限1222531-22253188.68788.070.8893.5692.820.97
2218845-21884587.21891.70
3221522-22152288.28593.19
4223616-22361689.12093.91
5218977-21897787.27191.90
6220402-22040287.83992.67
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%
110.969252009258089258299247159256099254320.06
210.959306349290779298560.12
单位质量响应值RSD%判断
84437.2384918.360.41数据可信
供试品溶液-2025112721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%
5min1363805-36380538.57142.2413.3638.5742.2413.37
2368776-36877639.09839.10
3407211-40721143.17343.17
4466309-46630949.43849.44
5452553-45255347.98047.98
6331585-33158535.15535.15
10min1814230-81423086.32589.844.6686.7590.314.70
2821276-82127687.07287.51
3876528-87652892.93093.41
4881682-88168293.47694.03
5889855-88985594.34394.88
6800772-80077284.89885.29
15min1909153-90915396.38996.700.6797.7898.170.61
2912657-91265796.76098.16
3913334-91333496.83298.34
4914802-91480296.98898.58
5902220-90222095.65497.24
6920464-92046497.58898.92
20min1910978-91097896.58295.811.0899.0498.351.03
2917673-91767397.29299.77
3903135-90313595.75198.34
4904087-90408795.85298.52
5892013-89201394.57297.22
6894234-89423494.80797.23
30min1905834-90583496.03795.321.0399.5798.920.96
2900421-90042195.46399.02
3880815-88081593.38497.04
4900635-90063595.48699.22
5901517-90151795.57999.27
6905123-90512395.96199.43
45min1903000-90300095.73694.481.54100.3499.141.42
2909651-90965196.442101.06
3872719-87271992.52697.22
4880632-88063293.36598.16
5888916-88891694.24399.00
6891830-89183094.55299.09
60min1899307-89930795.34593.902.35101.0199.612.25
2889956-88995694.353100.04
3864430-86443091.64797.36
4918405-91840597.370103.20
5870689-87068992.31198.11
6871246-87124692.37097.96
极限1867513-86751391.97492.251.8798.7099.011.68
2896169-89616995.012101.75
3861146-86114691.29998.04
4857159-85715990.87697.79
5855560-85556090.70797.54
6882976-88297693.613100.23
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%
110.192543702578032570152568182563282564670.51
210.272571682580222575950.24
单位质量响应值RSD%判断
25168.5025082.280.25数据可信
供试品溶液-2025112721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%
5min146161-4616118.32120.5913.4018.3220.5913.41
248426-4842619.22019.22
354803-5480321.75121.75
459224-5922423.50523.51
559536-5953623.62923.63
643168-4316817.13317.13
10min1122582-12258248.65250.185.5548.8650.415.58
2121642-12164248.27948.49
3133303-13330352.90753.15
4130278-13027851.70651.97
5133838-13383853.11953.38
6116908-11690846.40046.59
15min1155035-15503561.53262.011.9462.2862.801.96
2158397-15839762.86663.62
3160747-16074763.79964.63
4155044-15504461.53562.37
5156131-15613161.96762.82
6152035-15203560.34161.05
20min1171878-17187868.21767.062.3569.6468.532.35
2170134-17013467.52568.97
3173842-17384268.99670.53
4166773-16677366.19167.71
5168506-16850666.87868.42
6162626-16262664.54565.92
30min1191306-19130675.92874.171.7278.1176.391.72
2185559-18555973.64775.85
3188779-18877974.92577.23
4184050-18405073.04875.30
5188658-18865874.87777.16
6182961-18296172.61574.71
45min1208859-20885982.89480.252.3685.9283.292.30
2204584-20458481.19784.21
3204002-20400280.96684.10
4196137-19613777.84580.91
5202222-20222280.26083.38
6197349-19734978.32681.23
60min1218207-21820786.60484.012.4290.5587.942.37
2210949-21094983.72487.64
3212590-21259084.37588.41
4215690-21569085.60589.54
5208765-20876582.85786.86
6203792-20379280.88384.65
极限1223144-22314488.56487.371.9693.4892.241.88
2224670-22467089.16994.02
3223728-22372888.79693.77
4214474-21447485.12390.01
5216238-21623885.82390.75
6218547-21854786.73991.41
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%
110.969224429218129218999224779219239221110.04
210.959257529275899266700.15
单位质量响应值RSD%判断
84134.2284627.400.42数据可信
供试品溶液-2025112821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%
5min1272879-27287929.03334.3925.9829.0334.3925.98
2278902-27890229.67329.67
3387141-38714141.18941.19
4210489-21048922.39522.39
5437638-43763846.56246.56
6352553-35255337.50937.51
10min1699203-69920374.39179.9315.1674.7180.3215.22
2688794-68879473.28373.61
3844801-84480189.88190.34
4581007-58100761.81562.06
5879908-87990893.61794.13
6814143-81414386.62087.04
15min1890819-89081994.77793.716.7495.9394.986.86
2881379-88137993.77394.92
3922228-92222898.11999.58
4764955-76495581.38682.32
5924856-92485698.39999.96
6900637-90063795.82297.20
20min1897265-89726595.46395.234.4997.6797.544.59
2920308-92030897.915100.10
3946835-946835100.737103.28
4826674-82667487.95389.79
5887080-88708094.38097.03
6892237-89223794.92897.37
30min1907825-90782596.58796.042.6299.8599.412.73
2925566-92556698.474101.75
3925869-92586998.507102.17
4863366-86336691.85794.67
5890280-89028094.72098.42
6903381-90338196.11499.61
45min1897687-89768795.50894.891.5199.8499.331.64
2903785-90378596.157100.52
3907931-90793196.598101.36
4872985-87298592.88096.72
5883016-88301693.94798.70
6885883-88588394.25298.82
60min1889698-88969894.65894.521.88100.06100.011.81
2887209-88720994.39399.83
3915565-91556597.410103.24
4890687-89068794.76399.63
5863369-86336991.85797.65
6883964-88396494.04899.66
极限1871114-87111492.68194.662.9899.13101.202.88
2883205-88320593.967100.45
3939986-939986100.008106.92
4896824-89682495.416101.34
5876851-87685193.291100.11
6870559-87055992.62299.28
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%
110.192534472566592558802553582556852554060.47
210.272568832568762568800.01
单位质量响应值RSD%判断
25064.3825012.660.15数据可信
供试品溶液-2025112821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%
5min134184-3418413.61416.4427.4713.6116.4427.48
234580-3458013.77213.77
348663-4866319.38119.38
426944-2694410.73110.73
557655-5765522.96222.96
645717-4571718.20818.21
10min1102298-10229840.74243.9216.1840.8944.1116.23
299732-9973239.72039.87
3121093-12109348.22748.44
484566-8456633.68033.80
5133228-13322853.06053.32
6120823-12082348.12048.32
15min1147806-14780658.86658.828.2559.4759.498.36
2144577-14457757.58058.17
3150146-15014659.79860.55
4126730-12673050.47250.97
5163700-16370065.19666.04
6153134-15313460.98861.73
20min1164740-16474065.61065.944.7266.8767.264.86
2167871-16787166.85768.09
3171289-17128968.21969.63
4150617-15061759.98661.04
5171942-17194268.47970.05
6166925-16692566.48167.90
30min1188923-18892375.24274.703.0177.2376.753.14
2191204-19120476.15078.13
3185982-18598274.07076.24
4176830-17683070.42672.15
5191432-19143276.24178.57
6190947-19094776.04878.20
45min1203984-20398481.24080.871.8984.0683.762.02
2206099-20609982.08284.91
3199701-19970179.53482.53
4197631-19763178.71081.21
5207833-20783382.77385.95
6203064-20306480.87483.87
60min1213336-21333684.96584.910.4688.6988.690.66
2213598-21359885.06988.80
3212255-21225584.53488.41
4212048-21204884.45287.83
5214719-21471985.51589.61
6213217-21321784.91788.81
极限1216713-21671386.31087.691.6190.9892.421.68
2218447-21844787.00091.68
3223780-22378089.12493.94
4219241-21924187.31691.63
5225316-22531689.73694.78
6217561-21756186.64791.49
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%
110.969221439221929228929224589224259224220.04
210.959271059271389271220.01
单位质量响应值RSD%判断
84162.5984668.680.43数据可信
供试品溶液-2025112821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%
5min1208624-20862422.18733.7522.2422.1933.7522.23
2281747-28174729.96429.96
3295810-29581031.45931.46
4338459-33845935.99536.00
5375836-37583639.97039.97
6403792-40379242.94342.94
10min1548015-54801558.28180.4116.2458.5380.7916.26
2688819-68881973.25673.59
3756800-75680080.48580.84
4811090-81109086.25986.66
5853289-85328990.74791.19
6878709-87870993.45093.93
15min1746840-74684079.42694.217.9280.3295.488.03
2884087-88408794.02295.17
3911448-91144896.93298.18
4915222-91522297.33498.69
5933906-93390699.321100.77
6923402-92340298.20499.72
20min1915513-91551397.36597.920.9299.14100.241.04
2924175-92417598.286100.48
3908358-90835896.60498.92
4933349-93334999.261101.70
5920654-92065497.911100.47
6922391-92239198.096100.70
30min1848601-84860190.24897.153.6693.11100.553.82
2918259-91825997.657100.94
3914193-91419397.224100.62
4935464-93546499.486103.03
5940764-940764100.050103.69
6923559-92355998.220101.92
45min1870278-87027892.55495.561.6496.42100.041.90
2898701-89870195.57799.95
3898313-89831395.535100.01
4909667-90966796.743101.39
5905300-90530096.278101.03
6908788-90878896.649101.44
60min1861975-86197591.67195.023.1096.56100.563.20
2892247-89224794.890100.32
3859815-85981591.44196.98
4927279-92727998.616104.34
5906734-90673496.431102.26
6912701-91270197.066102.93
极限1895196-89519695.20495.941.11101.11102.541.30
2904769-90476996.222102.71
3885142-88514294.135100.69
4908662-90866296.636103.45
5908376-90837696.606103.50
6910802-91080296.864103.80
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%
110.192534752565482558622558762556222554770.46
210.272569382573722571550.12
单位质量响应值RSD%判断
25071.3425039.440.10数据可信
供试品溶液-2025112821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%
5min125488-2548810.14415.8422.3910.1415.8422.41
234868-3486813.87713.88
339786-3978615.83515.83
441217-4121716.40416.40
546973-4697318.69518.70
650499-5049920.09920.10
10min178877-7887731.39343.2315.8931.5143.4015.91
298797-9879739.32139.48
3112195-11219544.65344.83
4114122-11412245.42045.60
5123240-12324049.04949.26
6124417-12441749.51849.74
15min1120296-12029647.87857.868.8548.3458.528.93
2144090-14409057.34857.94
3153128-15312860.94561.62
4148593-14859359.14059.83
5154953-15495361.67162.42
6151246-15124660.19660.97
20min1168436-16843667.03766.940.5668.0368.240.56
2167853-16785366.80568.03
3169093-16909367.29968.65
4168307-16830766.98668.33
5168987-16898767.25768.69
6166547-16654766.28567.73
30min1169713-16971367.54574.314.6069.2876.364.67
2189489-18948975.41677.39
3191648-19164876.27678.37
4189346-18934675.35977.45
5193033-19303376.82779.01
6187067-18706774.45276.63
45min1190730-19073075.91080.252.7978.4083.122.89
2205378-20537881.74084.55
3205967-20596781.97584.92
4202724-20272480.68483.61
5203715-20371581.07884.12
6201264-20126480.10383.11
60min1199728-19972879.49184.333.2682.8288.093.33
2215377-21537785.72089.44
3208065-20806582.81086.66
4218502-21850286.96390.79
5215920-21592085.93689.88
6213739-21373985.06888.96
极限1214114-21411485.21788.131.9389.4392.832.03
2226542-22654290.16394.83
3221517-22151788.16392.94
4222318-22231888.48293.27
5224229-22422989.24394.14
6219907-21990787.52392.36
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