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%
111.24 9909739910569909879903519905069907750.04
211.259885509887619886560.02
单位质量响应值RSD%判断
88147.2487880.530.22数据可信
供试品溶液-1993854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%
5min142641-426414.3494.9812.684.354.9812.67
257351-573515.8505.85
348083-480834.9054.90
449928-499285.0935.09
541367-413674.2194.22
653619-536195.4695.47
10min168746-687467.0126.797.537.066.857.50
270254-702547.1667.23
356917-569175.8065.86
469813-698137.1217.18
565591-655916.6906.74
668246-682466.9617.02
15min173967-739677.5457.372.537.677.502.53
273300-733007.4777.62
372231-722317.3687.49
473774-737747.5257.66
569305-693057.0697.19
671020-710207.2447.38
20min172258-722587.3707.451.587.587.661.59
273882-738827.5367.76
373947-739477.5437.74
474148-741487.5637.78
571270-712707.2707.47
672736-727367.4197.64
30min174880-748807.6387.482.337.937.772.29
273585-735857.5067.82
374084-740847.5577.84
474681-746817.6187.92
570473-704737.1887.47
672113-721137.3567.66
45min174241-742417.5737.491.607.957.871.59
274600-746007.6098.00
373629-736297.5107.88
473798-737987.5277.92
573078-730787.4547.81
671290-712907.2727.65
60min175094-750947.6607.521.788.127.981.75
274682-746827.6188.10
373278-732787.4747.93
474307-743077.5798.05
573430-734307.4907.93
671469-714697.2907.75
极限174553-745537.6047.531.428.158.071.40
275115-751157.6628.23
374337-743377.5828.12
473249-732497.4718.03
573106-731067.4577.98
672360-723607.3817.93
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%
110.12 2547942548082547332546962547252547510.02
210.162550002550602550300.02
单位质量响应值RSD%判断
25173.0225101.380.21数据可信
供试品溶液-1993854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%
5min12803-28031.1121.3716.431.111.3716.56
24208-42081.6691.67
33036-30361.2041.20
43499-34991.3881.39
53118-31181.2371.24
64021-40211.5951.60
10min16417-64172.5462.559.682.562.569.70
26776-67762.6882.71
35187-51872.0582.07
46654-66542.6402.66
56729-67292.6692.68
66791-67912.6942.71
15min18489-84893.3683.463.183.413.503.12
28563-85633.3973.45
38684-86843.4453.48
49265-92653.6753.72
58676-86763.4423.49
68643-86433.4293.48
20min19575-95753.7983.881.943.883.971.88
29680-96803.8403.93
310035-100353.9814.06
49617-96173.8153.90
59919-99193.9354.02
69906-99063.9304.02
30min111643-116434.6194.550.964.744.670.85
211407-114074.5254.65
311554-115544.5844.70
411373-113734.5124.64
511411-114114.5274.65
611391-113914.5194.65
45min112971-129715.1465.091.495.325.271.40
212672-126725.0275.21
312997-129975.1565.33
412791-127915.0745.25
513010-130105.1615.34
612557-125574.9815.16
60min114162-141625.6185.442.015.855.681.91
213570-135705.3835.62
313639-136395.4115.64
413773-137735.4645.70
513836-138365.4895.72
613347-133475.2955.53
极限114698-146985.8315.731.476.126.021.36
214371-143715.7016.00
314567-145675.7796.07
414449-144495.7326.03
514520-145205.7606.05
614082-140825.5865.88
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%
111.24 9893629895689890559883869880999888940.07
211.259891359887499889420.03
单位质量响应值RSD%判断
87979.8987905.960.06数据可信
供试品溶液-1993854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%
5min152697-526975.3795.0111.225.385.0011.24
240772-407724.1624.16
344705-447054.5644.56
455751-557515.6915.69
548842-488424.9864.99
651453-514535.2525.25
10min169054-690547.0497.061.977.117.122.02
267274-672746.8686.91
369363-693637.0817.13
471323-713237.2817.34
569674-696747.1137.17
668318-683186.9747.03
15min170878-708787.2357.251.477.377.381.48
271428-714287.2927.41
370123-701237.1587.29
471734-717347.3237.47
572417-724177.3937.53
669636-696367.1097.24
20min173179-731797.4707.431.117.697.641.16
272203-722037.3717.57
372862-728627.4387.65
473586-735867.5127.74
573410-734107.4947.71
671479-714797.2977.51
30min173406-734067.4947.541.017.807.831.04
273291-732917.4827.77
373878-738787.5427.83
474552-745527.6117.92
574810-748107.6377.94
672937-729377.4467.74
45min173415-734157.4947.601.707.887.981.59
275604-756047.7188.09
375398-753987.6978.07
474897-748977.6468.04
574858-748587.6428.03
672396-723967.3907.77
60min173819-738197.5367.591.488.008.061.39
275372-753727.6948.15
375630-756307.7218.18
474752-747527.6318.11
573983-739837.5528.02
672682-726827.4207.88
极限172188-721887.3697.472.427.928.022.32
272315-723157.3827.92
375337-753377.6918.24
474946-749467.6518.21
573472-734727.5008.05
670731-707317.2207.76
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%
110.12 2551372550992550032548842549812550210.04
210.162555712555012555360.02
单位质量响应值RSD%判断
25199.7025151.180.14数据可信
供试品溶液-1993854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%
5min14698-46981.8611.8529.931.861.8530.00
23238-32381.2831.28
33892-38921.5421.54
44414-44141.7481.75
57320-73202.8992.90
64469-44691.7701.77
10min17444-74442.9492.883.872.972.904.03
26737-67372.6692.68
37241-72412.8682.89
47476-74762.9612.98
57462-74622.9562.99
67249-72492.8712.89
15min19212-92123.6493.623.163.703.673.32
29012-90123.5703.61
38948-89483.5443.59
49161-91613.6293.68
59660-96603.8263.89
68843-88433.5033.55
20min110380-103804.1124.184.104.214.274.09
210330-103304.0924.18
310333-103334.0934.18
411367-113674.5024.60
510651-106514.2194.33
610186-101864.0354.13
30min111903-119034.7154.762.084.854.902.20
211830-118304.6864.81
311760-117604.6584.79
412211-122114.8374.98
512417-124174.9185.07
612019-120194.7614.90
45min113379-133795.2995.321.875.495.521.85
213627-136275.3985.58
313499-134995.3475.53
413114-131145.1945.39
513794-137945.4645.67
613243-132435.2465.43
60min114039-140395.5615.691.985.815.941.90
214816-148165.8696.11
314342-143425.6815.93
414434-144345.7175.97
514484-144845.7376.01
614093-140935.5825.83
极限114519-145195.7515.881.986.066.191.97
214725-147255.8336.14
315051-150515.9626.27
415247-152476.0396.36
514954-149545.9236.26
614537-145375.7586.07
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%
111.24 9881639886169885149884049882129883820.02
211.259842599848099845340.04
单位质量响应值RSD%判断
87934.3487514.130.34数据可信
供试品溶液-1993854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%
5min1399834-39983440.91832.8820.8040.9232.8820.81
2387256-38725639.63139.63
3329559-32955933.72733.73
4273939-27393928.03428.03
5224160-22416022.94022.94
6313166-31316632.04932.05
10min1678318-67831869.41877.876.6269.8778.246.59
2824598-82459884.38884.83
3789798-78979880.82781.20
4771098-77109878.91379.22
5732922-73292275.00675.26
6768909-76890978.68979.04
15min1765871-76587178.37889.186.0679.6090.416.00
2909828-90982893.11094.49
3896336-89633691.73093.00
4891954-89195491.28192.47
5886419-88641990.71591.80
6878349-87834989.88991.12
20min1824001-82400184.32792.024.1986.4294.244.15
2910976-91097693.22895.64
3906664-90666492.78695.08
4929358-92935895.10997.31
5913679-91367993.50495.60
6910203-91020393.14995.38
30min1839335-83933585.89693.974.2888.9397.214.24
2928341-92834195.00598.45
3941564-94156496.35899.68
4942603-94260396.46499.72
5932731-93273195.45498.59
6924546-92454694.61697.88
45min1842852-84285286.25693.834.2790.2498.114.21
2912764-91276493.41197.91
3942519-94251996.456100.85
4953154-95315497.544101.88
5929020-92902095.07499.27
6920624-92062494.21598.53
60min1844693-84469386.44493.493.8191.3998.823.77
2915751-91575193.71699.26
3929873-92987395.162100.63
4926413-92641394.808100.22
5940828-94082896.283101.53
6923677-92367794.52899.89
极限1889855-88985591.06693.811.8796.97100.181.91
2908028-90802892.92699.51
3928142-92814294.984101.51
4929067-92906795.079101.55
5935076-93507695.694102.02
6909805-90980593.10899.52
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%
110.12 2550872553492552352552252551332552060.04
210.162546602551902549250.15
单位质量响应值RSD%判断
25217.9825091.040.36数据可信
供试品溶液-1993854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%
5min130706-3070612.1738.2728.5312.178.2628.53
223783-237839.4289.43
320787-207878.2418.24
416629-166296.5926.59
513670-136705.4195.42
619530-195307.7427.74
10min174900-7490029.69327.608.5929.8327.708.64
276261-7626130.23230.34
371246-7124628.24428.34
464941-6494125.74525.82
560563-6056324.00924.07
669875-6987527.70127.79
15min1105841-10584141.95942.644.3542.4243.044.39
2114344-11434445.33045.77
3111393-11139344.16044.57
4104211-10421141.31341.67
5101699-10169940.31740.64
6107911-10791142.77943.17
20min1132067-13206752.35653.262.2753.2954.142.31
2137630-13763054.56155.51
3137680-13768054.58155.48
4134349-13434953.26054.08
5129984-12998451.53052.30
6134422-13442253.28954.16
30min1161366-16136663.97167.583.4465.4869.053.33
2171599-17159968.02769.58
3175699-17569969.65371.16
4170142-17014267.45068.86
5177287-17728770.28271.63
6166756-16675666.10767.57
45min1187203-18720374.21379.173.8476.4481.383.73
2197401-19740178.25680.56
3205827-20582781.59683.87
4203977-20397780.86383.02
5196124-19612477.75079.88
6207650-20765082.31984.51
60min1203124-20312480.52584.922.8283.5788.012.75
2215173-21517385.30288.48
3220240-22024087.31090.49
4216542-21654285.84488.90
5217801-21780186.34389.34
6212333-21233384.17687.29
极限1225989-22598989.58992.463.2193.5396.503.08
2230252-23025291.27995.40
3235103-23510393.20297.36
4246033-24603397.535101.55
5235483-23548393.35397.30
6226484-22648489.78693.83
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