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%
111.471020561101900410208391021636102168310207450.11
211.421034298103403410341660.02
单位质量响应值RSD%判断
88992.5990557.441.24数据可信
供试品溶液-2024092721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%
5min1349622-34962234.96518.8142.8234.9618.8142.81
2164209-16420916.42216.42
3155944-15594415.59615.60
4172514-17251417.25317.25
5157751-15775115.77615.78
6128398-12839812.84112.84
10min1840133-84013384.02052.5730.2984.4152.7830.34
2488875-48887548.89149.07
3458915-45891545.89546.07
4517422-51742251.74651.94
5450021-45002145.00645.18
6398404-39840439.84339.99
15min1920646-92064692.07273.8414.1993.3974.6314.38
2734232-73423273.42974.15
3691956-69195669.20169.88
4788133-78813378.81979.59
5662997-66299766.30566.98
6632126-63212663.21763.80
20min1943122-94312294.31984.069.3696.6685.679.56
2853570-85357085.36386.91
3814342-81434281.44082.89
4915268-91526891.53493.18
5773172-77317277.32378.74
6743461-74346174.35275.64
30min1911385-91138591.14590.313.0794.5492.853.28
2930156-93015693.02395.51
3895490-89549089.55691.91
4933313-93331393.33896.00
5887123-88712388.71990.99
6860522-86052286.05988.17
45min1913976-91397691.40591.371.5295.8194.921.73
2929631-92963192.97096.49
3915331-91533191.54094.89
4927284-92728492.73596.43
5898654-89865489.87293.13
6896712-89671289.67892.75
60min1923442-92344292.35190.881.8597.7795.442.17
2927139-92713992.72197.28
3898089-89808989.81694.18
4920092-92009292.01696.74
5896013-89601389.60893.86
6887624-88762488.76992.84
极限1906962-90696290.70391.661.7097.1597.241.57
2931494-93149493.15698.74
3937591-93759193.76699.13
4908752-90875290.88296.63
5897030-89703089.71094.96
6917535-91753591.76096.81
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%
110.242580142572022577612575232577632576530.12
210.272618392610192614290.23
单位质量响应值RSD%判断
25161.4325455.600.83数据可信
供试品溶液-2024092721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%
5min146625-4662518.37210.2539.6518.3710.2439.66
223371-233719.2099.21
322881-228819.0169.02
423866-238669.4049.40
521048-210488.2948.29
618233-182337.1847.18
10min1127557-12755750.26131.4030.5850.4731.5230.61
274849-7484929.49329.60
371768-7176828.27928.38
478124-7812430.78330.89
566584-6658426.23626.33
659290-5929023.36223.44
15min1158203-15820362.33748.4816.1263.1048.9516.27
2122455-12245548.25148.68
3117695-11769546.37546.79
4129380-12938050.98051.43
5109078-10907842.98043.36
6101478-10147839.98540.32
20min1176778-17677869.65659.4511.1771.1160.4511.35
2151617-15161759.74260.71
3147705-14770558.20059.13
4161455-16145563.61864.63
5138601-13860154.61355.47
6129114-12911450.87551.66
30min1189951-18995174.84770.984.3977.0872.654.66
2181167-18116771.38573.02
3180851-18085171.26172.84
4185323-18532373.02374.74
5176714-17671469.63171.10
6166899-16689965.76367.11
45min1202989-20298979.98478.182.0583.0480.632.35
2196828-19682877.55679.98
3200142-20014278.86281.23
4201690-20169079.47282.00
5197062-19706277.64979.89
6191809-19180975.57977.66
60min1218019-21801985.90683.012.1889.8686.322.49
2209011-20901182.35785.64
3207925-20792581.92985.17
4213673-21367384.19487.61
5210306-21030682.86785.97
6205018-20501880.78383.70
极限1224903-22490388.61987.470.8793.5291.711.06
2219700-21970086.56990.77
3222470-22247087.66091.81
4220533-22053386.89791.25
5221135-22113587.13491.16
6223181-22318187.94091.76
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%
111.471020067102035210202371020879102007310203220.04
211.421025330102517510252520.02
单位质量响应值RSD%判断
88955.7189776.880.65数据可信
供试品溶液-2024092721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%
5min1219967-21996722.09827.2935.4622.1027.2935.46
2220875-22087522.18922.19
3226169-22616922.72122.72
4188762-18876218.96318.96
5334661-33466133.62033.62
6439645-43964544.16644.17
10min1640067-64006764.30166.6722.4064.5566.9822.46
2590433-59043359.31559.56
3551835-55183555.43755.69
4512158-51215851.45151.66
5798079-79807980.17580.55
6889617-88961789.37089.86
15min1894800-89480089.89185.109.8990.8586.1510.05
2815364-81536481.91182.82
3752972-75297275.64376.51
4762801-76280176.63177.41
5892559-89255989.66690.93
6964386-96438696.88298.37
20min1902984-90298490.71389.135.0292.6791.125.26
2899166-89916690.33092.15
3846113-84611385.00086.71
4825127-82512782.89284.53
5901545-90154590.56992.83
6948508-94850895.28797.85
30min1917537-91753792.17591.222.9395.1494.203.16
2916281-91628192.04994.87
3898955-89895590.30992.96
4873459-87345987.74790.30
5891143-89114389.52492.79
6950519-95051995.48999.11
45min1899924-89992490.40690.412.4694.4094.402.65
2898363-89836390.24994.09
3904721-90472190.88894.54
4880716-88071688.47692.01
5876871-87687188.09092.35
6938936-93893694.32599.00
60min1897435-89743590.15689.952.4695.1594.952.66
2896965-89696590.10994.95
3904314-90431490.84795.51
4865513-86551386.94991.46
5878846-87884688.28893.53
6929428-92942893.37099.10
极限1914142-91414291.83491.072.1197.8397.072.00
2884263-88426388.83394.68
3928221-92822193.24998.92
4912528-91252891.67297.15
5881752-88175288.58094.80
6918434-91843492.26599.03
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%
110.242582592579492578052579262580482579970.07
210.272594862592202593530.08
单位质量响应值RSD%判断
25195.0225253.460.17数据可信
供试品溶液-2024092721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%
5min128430-2843011.23914.3636.6511.2414.3636.65
230735-3073512.15112.15
328703-2870311.34711.35
424985-249859.8779.88
546146-4614618.24318.24
658877-5887723.27623.28
10min193789-9378937.07839.4123.4237.2039.5723.47
290076-9007635.61035.75
380286-8028631.74031.87
477362-7736230.58430.69
5121973-12197348.22048.42
6134696-13469653.25053.51
15min1147267-14726758.22056.3111.4658.7656.9011.61
2137308-13730854.28354.81
3124030-12403049.03349.51
4125879-12587949.76450.21
5155122-15512261.32562.06
6164986-16498665.22566.07
20min1165243-16524365.32664.516.6166.5165.746.80
2166208-16620865.70866.84
3150854-15085459.63860.66
4149439-14943959.07860.08
5171922-17192267.96769.39
6175438-17543869.35770.93
30min1190668-19066875.37873.833.3377.2975.773.55
2189485-18948574.91076.77
3180341-18034171.29572.98
4177741-17774170.26771.93
5188977-18897774.70976.88
6193324-19332476.42878.77
45min1205411-20541181.20680.041.9683.9582.802.18
2204213-20421380.73283.43
3200264-20026479.17181.65
4195700-19570077.36779.81
5202759-20275980.15883.16
6206440-20644081.61384.81
60min1215991-21599185.38983.952.2389.0487.602.36
2215134-21513485.05088.64
3212233-21223383.90387.26
4203073-20307380.28283.58
5213442-21344284.38188.28
6214229-21422984.69288.79
极限1228637-22863790.38888.061.8394.9992.651.63
2220272-22027287.08191.62
3227079-22707989.77294.06
4220925-22092587.33991.53
5221017-22101787.37692.21
6218627-21862786.43191.47
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%
111.471022166102598710261661026164102522610251420.17
211.421022375102178410220800.05
单位质量响应值RSD%判断
89375.9489499.120.10数据可信
供试品溶液-2024092721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%
5min1161688-16168816.23022.0130.7816.2322.0030.77
2142772-14277214.33114.33
3222218-22221822.30622.31
4207922-20792220.87120.87
5331196-33119633.24533.24
6249606-24960625.05525.05
10min1476792-47679247.85955.7519.9548.0455.9919.99
2419114-41911442.07042.23
3561734-56173456.38556.63
4541528-54152854.35754.59
5742850-74285074.56574.93
6590425-59042559.26559.54
15min1670015-67001567.25477.5515.1967.9778.4115.27
2611842-61184261.41562.04
3791153-79115379.41480.29
4786230-78623078.92079.76
5939435-93943594.29895.50
6836559-83655983.97284.91
20min1758621-75862176.14886.2311.0477.6187.9611.18
2726950-72695072.96974.28
3889482-88948289.28491.04
4891188-89118889.45591.17
5966484-96648497.01399.26
6921530-92153092.50194.37
30min1813692-81369281.67688.387.4683.9891.067.69
2783202-78320278.61680.74
3910915-91091591.43594.18
4908209-90820991.16493.87
5945961-94596194.95398.28
6920931-92093192.44195.34
45min1856159-85615985.93989.944.0689.1593.604.42
2847285-84728585.04888.04
3901106-90110690.45194.22
4914535-91453591.79995.52
5937515-93751594.10598.48
6919360-91936092.28396.21
60min1833219-83321983.63689.203.6187.8093.873.93
2868233-86823387.15191.09
3903142-90314290.65595.42
4898313-89831390.17094.91
5915172-91517291.86397.29
6913906-91390691.73596.69
极限1897456-89745690.08491.961.5195.1897.611.73
2928153-92815393.16698.07
3905689-90568990.91196.69
4913931-91393191.73897.48
5934546-93454693.807100.25
6916922-91692292.03898.01
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%
110.242591022592022588392589012587462589580.08
210.272595872584822590340.31
单位质量响应值RSD%判断
25288.8725222.400.19数据可信
供试品溶液-2024092721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%
5min121985-219858.68111.5529.258.6811.5529.25
220208-202087.9797.98
328676-2867611.32311.32
427357-2735710.80210.80
543693-4369317.25217.25
633600-3360013.26713.27
10min174933-7493329.58733.0519.2429.6833.1819.28
263399-6339925.03325.12
382559-8255932.59832.72
480239-8023931.68231.80
5111176-11117643.89744.09
689907-8990735.49935.65
15min1115990-11599045.79850.9514.7446.2251.4414.80
2102271-10227140.38140.75
3129846-12984651.26951.76
4128325-12832550.66851.14
5157009-15700961.99462.67
6140727-14072755.56556.11
20min1142990-14299056.45961.6710.6457.3962.7310.76
2130986-13098651.71952.53
3159313-15931362.90463.96
4159496-15949662.97664.01
5176657-17665769.75271.12
6167649-16764966.19567.35
30min1171689-17168967.79071.426.6269.3573.176.79
2161119-16111963.61765.01
3185615-18561573.28975.05
4185886-18588673.39675.13
5192484-19248476.00178.14
6188525-18852574.43876.33
45min1199835-19983578.90480.123.5881.2282.663.81
2189762-18976274.92677.02
3203861-20386180.49383.06
4207084-20708481.76684.32
5208317-20831782.25385.24
6208707-20870782.40785.13
60min1205987-20598781.33384.042.7984.5287.473.00
2204973-20497380.93283.86
3216307-21630785.40788.87
4215718-21571885.17588.63
5214662-21466284.75888.66
6219378-21937886.62090.26
极限1228498-22849890.22189.910.5894.3294.270.63
2228071-22807190.05293.88
3225099-22509988.87993.29
4228509-22850990.22594.63
5227764-22776489.93194.77
6228298-22829890.14294.74
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%
111.47101220310076511015726100666499410710072700.82
211.421024795102162310232090.22
单位质量响应值RSD%判断
87817.7989597.991.42数据可信
供试品溶液-2024092721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%
5min1258154-25815426.12936.9626.8326.1336.9626.82
2369081-36908137.35637.36
3236894-23689423.97723.98
4434321-43432143.95943.96
5478700-47870048.45148.45
6413813-41381341.88341.88
10min1653065-65306566.09979.4717.9366.3979.8817.97
2818056-81805682.79883.21
3570656-57065657.75858.02
4915416-91541692.65293.14
5895257-89525790.61291.15
6858594-85859486.90187.37
15min1885343-88534389.60891.945.9690.6393.246.15
2924054-92405493.52694.86
3812129-81212982.19883.11
4962473-96247397.41598.93
5948214-94821495.97297.52
6918253-91825392.93994.37
20min1939635-93963595.10394.162.1897.1296.482.32
2919874-91987493.10395.48
3908508-90850891.95393.77
4959526-95952697.11799.72
5943068-94306895.45198.06
6911375-91137592.24394.71
30min1908772-90877291.98093.891.3795.0697.261.50
2930942-93094294.22497.63
3932776-93277694.40997.25
4941511-94151195.29398.97
5936397-93639794.77698.45
6915746-91574692.68696.17
45min1930894-93089494.21993.990.8998.3298.401.00
2930012-93001294.12998.59
3926027-92602793.72697.62
4938566-93856694.99599.73
5932429-93242994.37499.10
6914052-91405292.51497.03
60min1901124-90112491.20692.691.5996.3598.141.65
2911731-91173192.27997.78
3923227-92322793.44398.38
4935568-93556894.692100.49
5924522-92452293.57499.35
6898612-89861290.95196.50
极限1907791-90779191.88092.011.0898.0498.481.34
2905131-90513191.61198.14
3892561-89256190.33996.31
4920045-92004593.12199.97
5917113-91711392.82499.64
6911521-91152192.25898.81
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%
110.242554442544612526582511302473732522131.26
210.272591192582142586660.25
单位质量响应值RSD%判断
24630.1825186.561.58数据可信
供试品溶液-2024092721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%
5min129355-2935511.75417.5931.8611.7517.5931.87
243151-4315117.27817.28
325631-2563110.26310.26
452718-5271821.10821.11
561119-6111924.47224.47
651580-5158020.65220.65
10min195316-9531638.16446.7619.8538.2946.9619.90
2119307-11930747.77047.96
382027-8202732.84332.96
4136283-13628354.56754.80
5138673-13867355.52455.80
6129096-12909651.69051.92
15min1143259-14325957.36161.708.6757.9262.418.83
2156534-15653462.67663.40
3133226-13322653.34353.82
4165417-16541766.23367.07
5167694-16769467.14468.03
6158398-15839863.42264.23
20min1168841-16884167.60369.084.2868.8070.484.49
2171192-17119268.54569.96
3161666-16166664.73165.80
4179798-17979871.99173.57
5181733-18173372.76574.40
6171885-17188568.82270.33
30min1183334-18333473.40676.823.0575.3578.983.24
2191794-19179476.79478.97
3188461-18846175.45977.25
4196822-19682278.80781.18
5199646-19964679.93882.38
6191044-19104476.49478.77
45min1205416-20541682.24883.821.8585.0186.842.06
2208688-20868883.55886.59
3206622-20662282.73185.36
4212717-21271785.17188.42
5215358-21535886.22989.56
6207308-20730883.00686.13
60min1209362-20936283.82886.912.4387.5090.862.52
2216298-21629886.60590.57
3218666-21866687.55391.10
4221912-22191288.85393.05
5223067-22306789.31593.61
6213046-21304685.30389.35
极限1218847-21884787.62689.341.9092.2394.262.13
2222501-22250189.08994.01
3218483-21848387.48092.00
4226412-22641290.65595.84
5229355-22935591.83397.12
6223211-22321189.37394.37
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