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%
110.969582459579929577119576999571549577600.05
210.959513929514749514330.01
单位质量响应值RSD%判断
87386.8686888.860.41数据可信
供试品溶液-2025112721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%
5min138611-386113.9784.4718.733.984.4718.70
245254-452544.6624.66
348330-483304.9794.98
444844-448444.6204.62
553423-534235.5045.50
630084-300843.0993.10
10min171170-711707.3327.454.667.387.504.77
272924-729247.5137.56
373513-735137.5747.63
473561-735617.5797.63
576264-762647.8577.92
666287-662876.8296.86
15min175216-752167.7497.967.387.878.097.37
274214-742147.6467.78
372641-726417.4847.62
479429-794298.1838.32
587878-878789.0549.20
674064-740647.6317.74
20min176120-761207.8427.971.278.058.191.16
277466-774667.9818.20
378342-783428.0718.29
478120-781208.0488.27
576171-761717.8488.10
677921-779218.0288.22
30min173510-735107.5747.792.107.878.101.98
275874-758747.8178.13
374635-746357.6898.00
476912-769127.9248.24
574700-747007.6968.03
677765-777658.0128.30
45min176484-764847.8807.821.438.268.211.25
277108-771087.9448.34
376253-762537.8568.25
475876-758767.8178.22
573949-739497.6198.04
675534-755347.7828.16
60min170181-701817.2317.622.587.708.102.49
275022-750227.7298.21
373891-738917.6138.10
474688-746887.6958.19
574604-746047.6868.19
675312-753127.7598.22
极限179036-790368.1439.0810.098.699.659.49
299145-9914510.21510.78
396040-960409.89510.46
477208-772087.9558.53
586758-867588.9389.53
690839-908399.3599.90
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%
110.192580852602602595962594182591182592950.31
210.272582362582822582590.02
单位质量响应值RSD%判断
25446.0325146.930.84数据可信
供试品溶液-2025112721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%
5min161562-6156224.26928.4125.6524.2728.4125.64
276779-7677930.26830.27
379367-7936731.28831.29
476696-7669630.23530.24
596184-9618437.91837.92
641767-4176716.46516.47
10min1168294-16829466.34567.7211.8866.6168.0311.94
2177669-17766970.04070.38
3180567-18056771.18371.53
4179840-17984070.89671.23
5191362-19136275.43975.86
6132949-13294952.41152.59
15min1204212-20421280.50481.233.6481.5182.303.80
2208156-20815682.05983.17
3208360-20836082.13983.28
4209550-20955082.60983.73
5213893-21389384.32185.58
6192146-19214675.74876.51
20min1213554-21355484.18786.322.4686.0988.292.62
2219184-21918486.40688.43
3223516-22351688.11490.17
4222475-22247587.70489.75
5223788-22378888.22190.42
6211267-21126783.28584.89
30min1226060-22606089.11790.651.3691.9593.581.51
2232595-23259591.69394.68
3232851-23285191.79494.82
4231242-23124291.16094.18
5230922-23092291.03494.21
6226026-22602689.10491.64
45min1234818-23481892.57093.230.7896.4097.170.96
2235728-23572892.92896.93
3237811-23781193.75097.80
4236902-23690293.39197.42
5239235-23923594.31198.50
6234480-23448092.43695.96
60min1227382-22738289.63891.291.6094.4996.261.57
2229082-22908290.30895.35
3230003-23000390.67295.76
4231241-23124191.16096.23
5237454-23745493.60998.84
6234257-23425792.34996.90
极限1235078-23507892.67293.080.6498.5299.070.65
2236659-23665993.29599.34
3235927-23592793.00799.11
4233830-23383092.18098.26
5237935-23793593.798100.07
6237260-23726093.53299.11
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%
110.969504869502489499129499179493719499870.05
210.959488289485549486910.03
单位质量响应值RSD%判断
86677.6586638.450.04数据可信
供试品溶液-2025112721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%
5min145376-453764.7014.666.734.704.666.75
241353-413534.2844.28
346142-461424.7804.78
445818-458184.7474.75
549347-493475.1125.11
641628-416284.3134.31
10min168678-686787.1157.291.957.177.341.92
271472-714727.4047.45
372346-723467.4957.55
469498-694987.2007.25
569631-696317.2147.27
670590-705907.3137.36
15min169940-699407.2467.543.877.387.673.80
271742-717427.4327.56
371627-716277.4207.56
474383-743837.7067.84
571175-711757.3747.51
677667-776678.0468.18
20min175100-751007.7807.691.947.997.901.92
273174-731747.5817.79
373923-739237.6587.88
476710-767107.9478.17
573417-734177.6067.82
672992-729927.5627.78
30min173686-736867.6347.540.947.937.840.87
272529-725297.5147.81
372457-724577.5067.81
472874-728747.5507.86
573440-734407.6087.91
671848-718487.4437.75
45min173301-733017.5947.521.417.987.911.28
273964-739647.6628.04
372351-723517.4957.88
471006-710067.3567.75
572792-727927.5417.93
672174-721747.4777.86
60min169861-698617.2377.351.307.707.821.22
271963-719637.4557.92
371747-717477.4337.90
471278-712787.3847.86
569850-698507.2367.71
670762-707627.3317.80
极限170698-706987.3247.6412.077.878.1911.29
273000-730007.5638.11
369690-696907.2207.77
491565-915659.48610.04
569195-691957.1687.72
668172-681727.0627.61
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%
110.192572892576482576562576362573162575090.08
210.272571122570272570700.03
单位质量响应值RSD%判断
25270.7625031.160.68数据可信
供试品溶液-2025112721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%
5min173173-7317329.01329.8414.5129.0129.8414.50
263473-6347325.16725.17
370053-7005327.77627.78
483342-8334233.04533.04
593018-9301836.88136.88
668554-6855427.18127.18
10min1169562-16956267.23068.713.8067.5569.043.85
2165476-16547665.61065.89
3172154-17215468.25868.57
4178416-17841670.74171.11
5183617-18361772.80373.21
6170556-17055667.62567.93
15min1199873-19987379.24980.501.8180.3281.601.87
2200635-20063579.55180.56
3200280-20028079.41080.48
4206278-20627881.78882.94
5208781-20878182.78184.00
6202322-20232280.22081.27
20min1212167-21216784.12385.101.1086.0787.081.16
2214047-21404784.86986.76
3212435-21243584.22986.18
4217237-21723786.13388.20
5217671-21767186.30588.44
6214157-21415784.91286.86
30min1225893-22589389.56589.241.1292.4592.181.18
2222876-22287688.36991.20
3222386-22238688.17591.06
4226194-22619489.68592.70
5229091-22909190.83393.93
6224020-22402088.82391.71
45min1230300-23030091.31390.990.6095.1994.920.54
2228386-22838690.55494.37
3230410-23041091.35695.22
4227499-22749990.20294.22
5229234-22923490.89095.00
6231053-23105391.61195.49
60min1225242-22524289.30789.870.8294.2094.810.72
2230217-23021791.28096.10
3226101-22610189.64894.53
4226834-22683489.93994.96
5225307-22530789.33394.45
6226312-22631289.73294.62
极限1227343-22734390.14089.790.7296.0395.730.63
2228426-22842690.57096.41
3226497-22649789.80595.68
4223669-22366988.68494.70
5226941-22694189.98196.09
6225943-22594389.58595.48
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%
110.969486849486319483639478449478959482830.05
210.959500989492549496760.07
单位质量响应值RSD%判断
86522.1786728.400.17数据可信
供试品溶液-2025112821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%
5min150842-508425.2695.4610.765.275.4610.71
262572-625726.4856.48
346092-460924.7774.78
452158-521585.4055.41
554989-549895.6995.70
649461-494615.1265.13
10min171855-718557.4477.521.387.517.581.37
272737-727377.5387.61
372707-727077.5357.59
473590-735907.6277.69
573536-735367.6217.68
671009-710097.3597.42
15min174052-740527.6747.745.167.827.895.05
276707-767077.9508.11
381084-810848.4038.54
474318-743187.7027.85
570264-702647.2827.43
671706-717067.4317.57
20min179862-798628.2778.122.108.508.352.02
277171-771717.9988.24
376126-761267.8898.12
478116-781168.0968.33
580535-805358.3468.58
678196-781968.1048.33
30min174073-740737.6777.583.538.007.903.42
273479-734797.6157.95
377291-772918.0108.33
471912-719127.4537.77
572467-724677.5107.83
669535-695357.2067.52
45min172957-729577.5617.751.897.968.161.81
274554-745547.7268.14
376887-768877.9688.38
474743-747437.7468.15
573827-738277.6518.06
675877-758777.8648.26
60min176119-761197.8897.821.198.388.311.13
275642-756427.8398.34
374632-746327.7358.23
476731-767317.9528.44
575266-752667.8008.29
674363-743637.7078.19
极限182542-825428.5548.1210.659.138.699.90
276318-763187.9098.50
373459-734597.6138.19
472291-722917.4928.07
571958-719587.4578.03
693316-933169.67110.24
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%
110.192578932573162571522570052568972572530.16
210.272576992575342576160.05
单位质量响应值RSD%判断
25245.6325084.320.46数据可信
供试品溶液-2025112821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%
5min1101824-10182440.35039.9120.5440.3539.9120.54
2138072-13807254.71454.71
381131-8113132.15032.15
496904-9690438.40038.40
5103916-10391641.17941.18
682448-8244832.67232.67
10min1183860-18386072.85872.446.0373.3172.886.10
2194502-19450277.07577.68
3168172-16817266.64167.00
4188206-18820674.58075.01
5191462-19146275.87076.33
6170567-17056767.59067.95
15min1211555-21155583.83383.901.9885.0985.142.10
2216567-21656785.81987.28
3207156-20715682.09083.19
4213670-21367084.67185.93
5214973-21497385.18786.49
6206371-20637181.77882.89
20min1219968-21996887.16788.040.9489.3690.221.04
2223874-22387488.71491.13
3220905-22090587.53889.55
4223673-22367388.63590.83
5224523-22452388.97291.22
6220080-22008087.21189.23
30min1228212-22821290.43391.911.1293.5995.071.10
2231700-23170091.81695.22
3234061-23406192.75195.73
4231761-23176191.84095.02
5235462-23546293.30696.54
6230409-23040991.30494.30
45min1230938-23093891.51493.771.3695.6897.951.25
2236353-23635393.65998.08
3240508-24050895.30699.32
4236248-23624893.61897.82
5237278-23727894.02698.30
6238428-23842894.48298.49
60min1233177-23317792.40194.361.1397.5899.581.06
2236922-23692293.88599.35
3239732-23973294.998100.07
4240385-24038595.257100.50
5239171-23917194.776100.09
6239341-23934194.84399.90
极限1234211-23421192.81194.341.2199.02100.611.10
2236617-23661793.764100.27
3242599-24259996.134102.26
4237134-23713493.969100.27
5239775-23977595.015101.39
6238117-23811794.358100.47
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