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%
111.149732179743599741849739809743839740250.05
211.159755949757769756850.02
单位质量响应值RSD%判断
87434.9287505.380.06数据可信
供试品溶液-24091101批-依折麦布-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1390522-39052240.08131.5619.8540.0831.5619.86
2358336-35833636.77836.78
3224312-22431223.02223.02
4265714-26571427.27227.27
5317697-31769732.60732.61
6288157-28815729.57529.58
10min1866045-86604588.88776.8911.8289.3377.2411.85
2793481-79348181.43981.85
3626796-62679664.33164.59
4674695-67469569.24769.55
5801441-80144182.25682.62
6732690-73269075.20075.53
15min1920614-92061494.48794.941.4295.9296.151.46
2919011-91901194.32395.64
3910398-91039893.43994.41
4922233-92223394.65395.73
5948589-94858997.35898.63
6929414-92941495.39096.55
20min1937986-93798696.27095.351.0398.7597.611.00
2922907-92290794.72397.08
3925562-92556294.99597.00
4942373-94237396.72098.84
5917150-91715094.13296.49
6928384-92838495.28597.51
30min1924065-92406594.84195.881.0698.3999.201.09
2938000-93800096.27299.69
3921814-92181494.61097.67
4934242-93424295.88699.08
5948254-94825497.324100.73
6938495-93849596.32299.61
45min1929847-92984795.43595.241.12100.0499.631.13
2915190-91519093.93198.41
3923936-92393694.82898.94
4928892-92889295.33799.60
5946212-94621297.114101.60
6923789-92378994.81399.17
60min1906116-90611692.99994.351.7298.6799.801.64
2910768-91076893.47799.00
3921558-92155894.58499.75
4914669-91466993.87799.20
5949694-94969497.472103.04
6913029-91302993.70999.12
极限1942403-94240396.72495.711.08103.42102.201.07
2914553-91455393.865100.43
3930675-93067595.520101.74
4930432-93043295.495101.86
5939068-93906896.381103.03
6938210-93821096.293102.74
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%
19.832483562483622485002484842489662485340.11
29.902506252501102503680.15
单位质量响应值RSD%判断
25283.2125289.700.02数据可信
供试品溶液-24091101批-贝派度酸-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150032-5003219.73115.8617.5919.7315.8617.58
245428-4542817.91517.92
330975-3097512.21512.22
434685-3468513.67813.68
542345-4234516.69916.70
637783-3778314.90014.90
10min1124849-12484949.23643.2311.2149.4543.4011.23
2117823-11782346.46546.66
392717-9271736.56436.70
497793-9779338.56638.72
5114983-11498345.34545.53
6109484-10948443.17643.34
15min1156886-15688661.87061.002.9362.6461.663.01
2162048-16204863.90564.62
3149396-14939658.91659.46
4151004-15100459.55060.13
5153496-15349660.53361.22
6155314-15531461.25061.90
20min1174174-17417468.68767.582.3670.1468.912.41
2176424-17642469.57571.00
3168038-16803866.26867.46
4170155-17015567.10368.34
5165837-16583765.40066.76
6173576-17357668.45269.78
30min1192946-19294676.09076.292.2578.3178.382.30
2201185-20118579.34081.54
3188289-18828974.25476.19
4190732-19073275.21777.21
5193347-19334776.24978.34
6194176-19417676.57678.66
45min1209899-20989982.77683.401.3185.8486.331.36
2215387-21538784.94088.02
3209629-20962982.67085.43
4208003-20800382.02884.85
5213517-21351784.20387.14
6212394-21239483.76086.70
60min1214956-21495684.77086.361.6388.7590.211.61
2223346-22334688.07992.10
3218894-21889486.32390.00
4215204-21520484.86888.60
5222663-22266387.81091.68
6218796-21879686.28590.15
极限1228043-22804389.93190.021.3394.8694.841.36
2231343-23134391.23396.24
3227795-22779589.83494.47
4223808-22380888.26192.94
5226667-22666789.38994.24
6231955-23195591.47496.30
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%
111.149745429740079740619746199740469742550.04
211.159744019738879741440.04
单位质量响应值RSD%判断
87455.5787367.170.08数据可信
供试品溶液-24091101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%
5min144546-445464.5754.0719.044.584.0719.07
225617-256172.6312.63
340406-404064.1504.15
437719-377193.8743.87
542660-426604.3814.38
646730-467304.7994.80
10min165617-656176.7396.744.256.796.794.33
260953-609536.2606.29
365568-655686.7346.78
465900-659006.7686.81
566186-661866.7986.85
669709-697097.1597.21
15min172918-729187.4897.282.297.617.402.30
268823-688237.0687.17
370127-701277.2027.32
472752-727527.4727.59
570154-701547.2057.33
670619-706197.2537.39
20min172019-720197.3977.491.577.617.691.54
272067-720677.4027.58
374102-741027.6117.81
474387-743877.6407.84
571792-717927.3737.58
673320-733207.5307.74
30min170769-707697.2687.612.497.567.892.33
275255-752557.7297.99
375218-752187.7258.01
475797-757977.7858.07
573606-736067.5607.85
673678-736787.5677.86
45min172906-729067.4887.661.887.868.031.89
272715-727157.4687.81
375956-759567.8018.17
475352-753527.7398.11
575481-754817.7528.12
675021-750217.7058.09
60min171859-718597.3807.602.387.848.062.24
274267-742677.6288.06
375158-751587.7198.18
476725-767257.8808.34
572652-726527.4627.92
673533-735337.5528.02
极限172496-724967.4467.582.307.988.122.09
275669-756697.7728.28
375250-752507.7288.27
474584-745847.6608.21
571249-712497.3187.86
673710-737107.5708.12
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%
19.832483572495312500302499342499622495630.29
29.902496582484752490660.34
单位质量响应值RSD%判断
25387.8925158.180.65数据可信
供试品溶液-24091101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%
5min15470-54702.1581.5551.642.161.5551.64
2-0.0000.00
33932-39321.5511.55
44821-48211.9021.90
53993-39931.5761.58
65287-52872.0862.09
10min17103-71032.8032.954.492.832.974.33
27850-78503.0973.10
37311-73112.8852.90
47258-72582.8642.88
57426-74262.9302.95
67932-79323.1303.15
15min19353-93533.6903.278.623.753.328.71
27367-73672.9072.94
37860-78603.1013.15
48162-81623.2213.27
58872-88723.5013.55
68116-81163.2023.26
20min18985-89853.5453.557.953.643.647.87
28461-84613.3393.41
38919-89193.5193.60
48943-89433.5293.62
58325-83253.2853.37
610343-103434.0814.17
30min19450-94503.7293.764.403.863.894.26
29203-92033.6313.74
39413-94133.7143.84
49479-94793.7403.87
510360-103604.0884.21
69288-92883.6653.80
45min110915-109154.3074.046.814.484.216.64
29691-96913.8243.97
310132-101323.9984.16
49713-97133.8334.00
511297-112974.4584.63
69725-97253.8374.02
60min19989-99893.9413.833.134.174.052.99
210034-100343.9594.15
39234-92343.6443.85
49867-98673.8934.11
59589-95893.7844.00
69585-95853.7824.00
极限110354-103544.0853.864.014.354.113.80
29768-97683.8544.08
310124-101243.9954.24
49375-93753.6993.95
59557-95573.7714.03
69453-94533.7303.99
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%
111.149738289733609737089736639737739736660.02
211.159694129700049697080.05
单位质量响应值RSD%判断
87402.6986969.330.36数据可信
供试品溶液-24091101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%
5min154645-546455.6275.0116.075.635.0116.07
238248-382483.9383.94
347109-471094.8514.85
453283-532835.4875.49
540995-409954.2214.22
657509-575095.9225.92
10min172103-721037.4247.283.737.497.343.76
268011-680117.0037.05
373910-739107.6117.66
471755-717557.3897.45
567006-670066.9006.95
671409-714097.3537.42
15min171839-718397.3977.562.107.547.702.09
274188-741887.6397.76
374989-749897.7227.86
473142-731427.5317.67
571531-715317.3667.49
675043-750437.7277.87
20min173834-738347.6037.502.887.837.722.89
271274-712747.3397.55
375062-750627.7297.95
474200-742007.6407.87
569435-694357.1507.36
673204-732047.5387.77
30min171846-718467.3987.521.997.717.821.86
273970-739707.6177.90
375469-754697.7718.08
471639-716397.3777.69
572867-728677.5037.79
672508-725087.4667.78
45min173233-732337.5417.491.497.937.881.35
274125-741257.6338.01
373683-736837.5877.98
471710-717107.3847.78
572433-724337.4587.83
671474-714747.3607.76
60min171511-715117.3637.481.767.847.961.64
274517-745177.6738.13
374002-740027.6208.10
472069-720697.4217.90
571614-716147.3747.83
672332-723327.4487.93
极限173679-736797.5877.513.368.158.063.11
273966-739667.6168.16
376011-760117.8278.39
471627-716277.3757.93
573268-732687.5448.08
668813-688137.0867.65
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%
19.832498932483542485512479572483272486160.30
29.902482462482202482330.01
单位质量响应值RSD%判断
25291.5625074.040.62数据可信
供试品溶液-24091101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%
5min19405-94053.7243.0726.613.723.0726.59
25246-52462.0772.08
36729-67292.6652.66
49452-94523.7433.74
55826-58262.3072.31
69912-99123.9253.93
10min115171-151716.0086.2014.836.056.2314.78
213298-132985.2665.29
319598-195987.7617.79
416715-167156.6196.66
513544-135445.3635.39
615601-156016.1786.22
15min116212-162126.4206.512.226.536.612.41
216093-160936.3736.45
316952-169526.7136.83
416727-167276.6246.74
516079-160796.3676.45
616569-165696.5616.67
20min116751-167516.6336.764.486.816.934.57
216158-161586.3986.55
317888-178887.0847.27
417756-177567.0317.22
516288-162886.4506.61
617550-175506.9507.13
30min117851-178517.0696.921.917.327.171.90
217349-173496.8707.09
317408-174086.8937.16
417826-178267.0597.33
517422-174226.8997.13
616960-169606.7166.98
45min118166-181667.1947.262.047.537.591.95
218570-185707.3547.65
318245-182457.2257.57
417997-179977.1277.47
518100-181007.1677.47
618995-189957.5227.86
60min117970-179707.1167.233.357.537.643.04
219142-191427.5807.96
317373-173736.8807.31
418426-184267.2977.72
517989-179897.1237.51
618604-186047.3677.79
极限118284-182847.2407.352.507.737.832.31
218846-188467.4637.93
318840-188407.4607.96
418984-189847.5188.02
518596-185967.3647.83
617752-177527.0307.53
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%
111.149701719698799705599697999705089701830.04
211.159725309725649725470.01
单位质量响应值RSD%判断
87090.0487223.950.11数据可信
供试品溶液-24091101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%
5min144821-448214.6175.179.024.625.179.01
256064-560645.7755.77
355325-553255.6995.70
447023-470234.8444.84
548945-489455.0425.04
649074-490745.0555.05
10min170187-701877.2307.111.497.287.171.43
267614-676146.9657.03
368832-688327.0907.15
468805-688057.0877.14
570323-703237.2447.30
668610-686107.0677.12
15min172206-722067.4377.242.797.577.382.71
269795-697957.1897.33
368614-686147.0687.21
470607-706077.2737.41
572687-726877.4877.62
667724-677246.9767.11
20min170720-707207.2847.9722.297.508.1921.71
270687-706877.2817.50
369234-692347.1317.35
471180-711807.3327.55
5112538-11253811.59211.81
669911-699117.2017.41
30min1106131-10613110.9328.9925.1011.239.3024.46
270660-706607.2787.58
371759-717597.3917.69
479356-793568.1748.47
5122788-12278812.64813.00
673061-730617.5267.82
45min1125220-12522012.89810.4029.8413.3110.8029.06
272419-724197.4597.84
378485-784858.0848.47
4108903-10890311.21711.60
5144834-14483414.91815.41
675721-757217.8008.18
60min1134895-13489513.89514.9235.8814.4515.4435.01
299388-9938810.23710.70
3119003-11900312.25812.73
4215634-21563422.21122.72
5202886-20288620.89821.55
697075-970759.99910.46
极限1164710-16471016.96622.0130.9117.6822.7030.42
2150146-15014615.46616.05
3198056-19805620.40121.01
4293031-29303130.18330.94
5299814-29981430.88231.77
6176132-17613218.14218.72
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%
19.832484892478312474832476942474972477990.17
29.902489352486892488120.07
单位质量响应值RSD%判断
25208.4425132.530.22数据可信
供试品溶液-24091101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%
5min179602-7960231.53739.0914.9731.5439.0914.97
2115906-11590645.92045.92
3116943-11694346.33046.33
491588-9158836.28536.29
593268-9326836.95136.95
694631-9463137.49137.49
10min1180484-18048471.50474.133.8171.8574.563.78
2176186-17618669.80170.31
3192712-19271276.34876.86
4191804-19180475.98976.39
5193000-19300076.46376.87
6188464-18846474.66675.08
15min1214975-21497585.16985.684.0386.3186.933.96
2203314-20331480.54981.83
3215799-21579985.49586.86
4221835-22183587.88689.13
5229072-22907290.75492.01
6212545-21254584.20685.45
20min1225210-22521089.22489.822.5991.3192.032.57
2218671-21867186.63388.81
3225575-22557589.36891.68
4230585-23058591.35393.58
5235849-23584993.43895.71
6224443-22444388.92091.10
30min1234401-23440192.86593.182.9195.9596.392.87
2225026-22502689.15192.29
3233862-23386292.65195.96
4239451-23945194.86698.10
5245408-24540897.226100.53
6233043-23304392.32795.50
45min1237446-23744694.07193.432.3398.1997.672.30
2226756-22675689.83693.97
3234941-23494193.07997.41
4236575-23657593.72698.02
5243783-24378396.582100.97
6235396-23539693.25997.45
60min1235346-23534693.23993.342.1498.4098.622.14
2229843-22984391.05996.19
3236083-23608393.53198.90
4238434-23843494.46399.80
5243324-24332496.400101.86
6230565-23056591.34596.58
极限1229094-22909490.76292.382.8396.9698.702.80
2224097-22409788.78394.93
3235657-23565793.36299.77
4235969-23596993.48699.87
5243175-24317596.341102.87
6231086-23108691.55197.80
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%
111.149754969744269743869744269744209746310.05
211.159789639793879791750.04
单位质量响应值RSD%判断
87489.3287818.390.27数据可信
供试品溶液-24091101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%
5min133441-334413.4254.8416.123.434.8416.06
244892-448924.5984.60
353356-533565.4655.46
448570-485704.9754.97
554471-544715.5795.58
648770-487704.9955.00
10min163309-633096.4846.944.286.527.004.36
268171-681716.9827.03
370907-709077.2627.32
467977-679776.9627.02
570653-706537.2367.30
665806-658066.7406.80
15min167736-677366.9387.132.127.057.262.21
270128-701287.1837.31
370095-700957.1797.32
469927-699277.1627.29
571624-716247.3367.48
667986-679866.9637.09
20min169248-692487.0927.132.677.287.342.66
271476-714767.3217.53
371564-715647.3307.55
466878-668786.8507.06
570354-703547.2067.43
668295-682956.9957.20
30min170878-708787.2598.0513.137.538.3412.80
290184-901849.2379.53
380414-804148.2368.54
468600-686007.0267.31
591304-913049.3519.66
670055-700557.1757.46
45min176639-766397.8498.968.278.209.348.17
291376-913769.3599.75
392987-929879.5249.92
484356-843568.6409.01
596095-960959.84210.25
683651-836518.5688.93
60min1124467-12446712.74812.099.3713.1812.578.95
2111539-11153911.42411.92
3132801-13280113.60214.10
4106447-10644710.90211.36
5107290-10729010.98911.51
6125795-12579512.88413.34
极限1175972-17597218.02316.6213.6118.6017.2413.06
2174244-17424417.84618.47
3172666-17266617.68418.34
4166626-16662617.06617.65
5117961-11796112.08212.72
6166297-16629717.03217.64
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%
19.832487622497022499352492662494122494150.18
29.902509112506332507720.08
单位质量响应值RSD%判断
25372.8425330.510.12数据可信
供试品溶液-24091101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%
5min172992-7299228.71145.5620.3728.7145.5620.37
2107732-10773242.37642.38
3136130-13613053.54653.55
4117111-11711146.06546.07
5134794-13479453.02153.02
6126169-12616949.62849.63
10min1171988-17198867.65183.379.5567.9783.889.61
2213484-21348483.97384.44
3227396-22739689.44690.04
4215899-21589984.92385.44
5223838-22383888.04688.64
6219056-21905686.16586.72
15min1221258-22125887.03192.954.2588.1094.384.36
2234837-23483792.37293.78
3239187-23918794.08495.67
4235738-23573892.72794.18
5252503-25250399.321100.89
6234355-23435592.18393.69
20min1237950-23795093.59794.420.9195.6396.881.04
2241692-24169295.06997.50
3242848-24284895.52498.16
4237700-23770093.49995.98
5241219-24121994.88397.55
6238782-23878293.92496.46
30min1241039-24103994.81295.700.8697.8999.220.94
2246846-24684697.096100.58
3244093-24409396.01399.71
4243498-24349895.77999.30
5242787-24278795.50099.22
6241546-24154695.01198.59
45min1240856-24085694.74094.981.0398.8799.551.05
2242263-24226395.29399.86
3245099-24509996.409101.17
4242839-24283995.520100.11
5239530-23953094.21899.00
6238138-23813893.67198.30
60min1235538-23553892.64894.131.5797.8399.761.63
2243136-24313695.637101.26
3242346-24234695.326101.16
4233885-23388591.99897.65
5240108-24010894.446100.28
6240851-24085194.738100.41
极限1237040-23704093.23993.460.9099.45100.140.94
2235743-23574392.72999.42
3241453-24145394.975101.87
4238570-23857093.841100.51
5236030-23603092.84299.72
6236819-23681993.15299.88
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