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%
111.149810179808449805459785499784629798830.13
211.159777439761579769500.12
单位质量响应值RSD%判断
87960.7787618.830.28数据可信
供试品溶液-24091202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%
5min1193180-19318019.75534.5735.3619.7534.5735.36
2357717-35771736.58136.58
3396125-39612540.50840.51
4448599-44859945.87445.87
5445802-44580245.58845.59
6186939-18693919.11719.12
10min1531939-53193954.39779.9620.8454.6280.3420.90
2889891-88989191.00291.41
3879919-87991989.98290.43
4872623-87262389.23689.75
5899328-89932891.96792.47
6617835-61783563.18163.39
15min1745965-74596576.28491.139.3777.1192.409.55
2960719-96071998.24599.66
3950607-95060797.21198.66
4904502-90450292.49694.00
5943256-94325696.45997.99
6841571-84157186.06086.97
20min1823859-82385984.24993.665.6985.9295.955.91
2968419-96841999.032101.54
3949599-94959997.10899.64
4906315-90631592.68195.21
5945618-94561896.70099.30
6901697-90169792.20994.08
30min1833158-83315885.20093.134.9387.8196.465.16
2953744-95374497.531101.14
3947382-94738296.881100.49
4893422-89342291.36394.92
5932968-93296895.40799.08
6903715-90371592.41595.31
45min1866442-86644288.60492.903.7692.1697.263.92
2954387-95438797.597102.29
3927882-92788294.88799.57
4870772-87077289.04793.62
5920930-92093094.17698.91
6910347-91034793.09497.02
60min1857006-85700687.63992.743.5592.1898.143.84
2947737-94773796.917102.69
3928823-92882394.983100.72
4894175-89417591.44097.00
5920467-92046794.12999.91
6893342-89334291.35596.31
极限1886082-88608290.61294.152.5496.12100.572.86
2942956-94295696.428103.28
3946787-94678796.820103.62
4904362-90436292.48299.06
5928545-92854594.955101.78
6915101-91510193.58099.55
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%
19.832472872485512481022473822483502479340.24
29.902498302503152500720.14
单位质量响应值RSD%判断
25222.1825259.800.11数据可信
供试品溶液-24091202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%
5min118625-186257.35816.9939.317.3617.0039.32
237997-3799715.01215.01
352031-5203120.55620.56
460002-6000223.70523.71
559449-5944923.48723.49
629994-2999411.85011.85
10min173571-7357129.06640.9620.9229.1541.1420.98
2120807-12080747.72747.89
3112355-11235544.38844.62
4119040-11904047.02947.29
5117824-11782446.54946.81
678393-7839330.97131.10
15min1107387-10738742.42653.4112.1142.8354.0512.26
2144994-14499457.28357.98
3142856-14285656.43857.16
4147557-14755758.29659.08
5145504-14550457.48558.26
6122845-12284548.53349.01
20min1137414-13741454.28862.467.7955.1663.708.00
2165857-16585765.52566.86
3160858-16085863.55064.90
4170378-17037867.31268.75
5164411-16441164.95466.37
6149693-14969359.14060.15
30min1164473-16447364.97971.494.8966.4673.425.14
2186890-18689073.83575.90
3184185-18418572.76674.82
4187592-18759274.11276.29
5185150-18515073.14875.29
6177412-17741270.09171.76
45min1198522-19852278.43080.591.9180.6383.322.13
2209593-20959382.80485.69
3201045-20104579.42782.29
4205461-20546181.17284.18
5205735-20573581.28084.23
6203609-20360980.44082.89
60min1212491-21249183.94986.082.2687.0289.702.47
2223675-22367588.36892.17
3213684-21368484.42188.17
4222656-22265687.96591.87
5220355-22035587.05690.91
6214408-21440884.70788.05
极限1231659-23165991.52290.871.3595.5395.451.38
2232818-23281891.98096.76
3226507-22650789.48794.17
4233755-23375592.35097.23
5227863-22786390.02294.84
6227488-22748889.87494.16
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%
111.149785029782099776129768469759949774330.11
211.159740549742259741400.02
单位质量响应值RSD%判断
87740.8487366.820.31数据可信
供试品溶液-24091202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%
5min143227-432274.4324.503.744.434.503.72
242191-421914.3264.33
342099-420994.3174.32
445027-450274.6174.62
546214-462144.7394.74
644307-443074.5434.54
10min168764-687647.0517.030.587.107.080.57
268672-686727.0417.09
367992-679926.9727.02
469065-690657.0827.13
568173-681736.9907.04
668599-685997.0347.08
15min173390-733907.5257.461.937.657.591.90
273893-738937.5777.70
373594-735947.5467.67
472548-725487.4397.57
570068-700687.1857.31
673216-732167.5077.64
20min173168-731687.5027.504.857.717.714.75
276019-760197.7958.01
374796-747967.6697.88
474131-741317.6017.81
566151-661516.7836.99
674570-745707.6467.86
30min173007-730077.4867.500.997.787.800.99
272968-729687.4827.78
374144-741447.6037.90
473590-735907.5467.84
572007-720077.3837.67
673374-733747.5247.82
45min169874-698747.1657.563.077.547.942.91
274933-749337.6838.06
375225-752257.7138.09
475261-752617.7178.10
575062-750627.6978.06
672046-720467.3877.77
60min173841-738417.5717.641.388.038.101.35
275623-756237.7548.22
374933-749337.6838.15
475478-754787.7398.21
574361-743617.6258.08
672955-729557.4817.94
极限174541-745417.6437.701.338.188.241.24
275992-759927.7928.34
374034-740347.5918.14
475752-757527.7678.32
576093-760937.8028.34
673946-739467.5828.13
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%
19.832468032468892476162478332478212473920.21
29.902477872485132481500.21
单位质量响应值RSD%判断
25167.0425065.660.29数据可信
供试品溶液-24091202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%
5min12761-27611.0960.9855.191.100.9855.13
23120-31201.2391.24
3-0.0000.00
42318-23180.9200.92
54110-41101.6321.63
62541-25411.0091.01
10min17901-79013.1373.134.383.153.144.39
27263-72632.8842.90
37917-79173.1433.14
47970-79703.1643.17
58333-83333.3083.33
67923-79233.1463.16
15min18965-89653.5593.452.483.613.502.44
28565-85653.4013.45
38830-88303.5063.54
48743-87433.4713.52
58643-86433.4323.49
68349-83493.3153.36
20min19103-91033.6143.7711.323.703.8511.05
211611-116114.6104.69
39112-91123.6183.69
48713-87133.4593.54
58886-88863.5283.62
69475-94753.7623.84
30min19100-91003.6133.722.413.743.842.30
29476-94763.7623.90
39600-96003.8123.93
49191-91913.6493.77
59210-92103.6573.79
69612-96123.8163.94
45min19810-98103.8953.903.864.064.073.63
210060-100603.9944.17
310343-103434.1074.26
49612-96123.8163.98
59912-99123.9354.11
69241-92413.6693.84
60min19857-98573.9144.021.884.124.231.89
210437-104374.1444.36
310057-100573.9934.20
410063-100633.9954.20
510178-101784.0414.26
610154-101544.0314.24
极限19821-98213.8994.064.214.154.323.97
29782-97823.8844.15
310172-101724.0394.29
410202-102024.0514.30
510515-105154.1754.44
610918-109184.3354.59
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%
111.149759019724169698779669369694179709090.36
211.159729289735109732190.05
单位质量响应值RSD%判断
87155.2187284.220.11数据可信
供试品溶液-24091202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%
5min126075-260752.6844.5323.362.684.5323.39
250786-507865.2275.23
352516-525165.4055.41
437272-372723.8363.84
548504-485044.9934.99
648673-486735.0105.01
10min161909-619096.3727.155.566.407.205.68
272441-724417.4567.51
371591-715917.3697.43
469344-693447.1387.18
570963-709637.3047.36
670811-708117.2897.34
15min172677-726777.4817.591.097.587.721.19
273097-730977.5247.66
374902-749027.7107.85
474246-742467.6427.76
573792-737927.5957.73
673572-735727.5737.71
20min173482-734827.5637.640.707.757.850.82
274637-746377.6827.91
374675-746757.6867.91
474616-746167.6807.89
573740-737407.5907.81
674122-741227.6297.85
30min173935-739357.6107.640.837.887.940.91
274670-746707.6868.00
374816-748167.7018.01
473613-736137.5777.87
574693-746937.6887.99
673413-734137.5567.86
45min173762-737627.5927.541.737.947.921.59
274193-741937.6378.03
373633-736337.5797.98
474289-742897.6478.02
571091-710917.3177.71
672270-722707.4397.83
60min174510-745107.6697.560.968.118.030.82
273718-737187.5888.07
373504-735047.5668.05
473550-735507.5708.03
572582-725827.4717.94
672726-727267.4867.96
极限173209-732097.5357.510.968.068.060.87
273161-731617.5308.09
373287-732877.5438.11
473850-738507.6018.15
572619-726197.4758.03
671820-718207.3927.95
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%
19.832450572464552450752448312457212454280.28
29.902479872476882478380.09
单位质量响应值RSD%判断
24967.2425034.140.19数据可信
供试品溶液-24091202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%
5min13963-39631.5813.2729.641.583.2729.68
29397-93973.7483.75
39822-98223.9183.92
46527-65272.6032.60
59558-95583.8123.81
69874-98743.9383.94
10min112101-121014.8275.868.834.845.898.96
214932-149325.9566.00
315007-150075.9866.03
414960-149605.9676.00
515497-154976.1816.22
615597-155976.2216.26
15min115887-158876.3376.643.126.416.743.24
216187-161876.4576.56
316855-168556.7236.83
416849-168496.7216.82
517299-172996.9007.01
616869-168696.7296.84
20min116657-166576.6446.911.946.797.082.07
217451-174516.9617.14
317413-174136.9467.13
417512-175126.9857.15
517282-172826.8937.08
617555-175557.0027.19
30min117539-175396.9967.111.587.217.361.64
217966-179667.1667.42
317665-176657.0467.31
417931-179317.1527.40
518269-182697.2877.55
617586-175867.0157.28
45min117859-178597.1237.271.347.427.611.42
218428-184287.3507.69
318316-183167.3067.65
418528-185287.3907.72
518101-181017.2207.57
618160-181607.2437.59
60min118580-185807.4117.331.817.787.741.68
218145-181457.2377.66
318431-184317.3527.77
418124-181247.2297.64
518067-180677.2067.63
618913-189137.5447.97
极限118548-185487.3987.281.257.857.781.06
217957-179577.1637.66
318432-184327.3527.86
418247-182477.2787.77
518327-183277.3107.82
618037-180377.1947.70
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%
111.149778999736959736569754149709159743160.27
211.159756109720949738520.26
单位质量响应值RSD%判断
87461.0487340.990.10数据可信
供试品溶液-24091202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%
5min146535-465354.7804.3816.424.784.3816.47
233146-331463.4053.40
338517-385173.9563.96
447100-471004.8384.84
538504-385043.9553.95
651885-518855.3295.33
10min166324-663246.8136.762.426.876.812.48
263721-637216.5456.58
363923-639236.5666.61
467479-674796.9316.98
566928-669286.8756.92
666443-664436.8256.88
15min170788-707887.2717.182.227.407.302.11
271345-713457.3287.44
371254-712547.3197.44
469255-692557.1147.24
569389-693897.1277.25
667324-673246.9157.05
20min181847-818478.4077.387.088.627.586.91
270930-709307.2867.48
370856-708567.2787.48
468501-685017.0367.25
570929-709297.2867.49
667913-679136.9767.19
30min1106334-10633410.9228.7316.2111.239.0215.75
289800-898009.2249.50
381638-816388.3868.66
470400-704007.2317.52
591246-912469.3729.65
670598-705987.2527.54
45min1114520-11452011.76310.7015.5612.1911.0815.10
2127323-12732313.07813.45
3108901-10890111.18611.56
481353-813538.3568.72
598125-9812510.07910.46
694709-947099.72810.10
60min1163351-16335116.77914.9823.7817.3315.4823.05
2159609-15960916.39416.92
3123238-12323812.65913.16
4123356-12335612.67113.13
5105746-10574610.86211.36
6199593-19959320.50120.98
极限1229886-22988623.61321.7325.5324.3522.4024.89
2190400-19040019.55720.26
3179723-17972318.46019.10
4224915-22491523.10223.70
5143529-14352914.74315.36
6300856-30085630.90331.61
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%
19.832459352483032474992469752472932472010.35
29.902503912483752493830.58
单位质量响应值RSD%判断
25147.6125190.200.12数据可信
供试品溶液-24091202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%
5min193735-9373537.13832.7332.1237.1432.7232.13
250183-5018319.88319.88
360582-6058224.00324.00
498747-9874739.12439.12
571382-7138228.28228.28
6120968-12096847.92847.93
10min1187185-18718574.16368.3611.7474.5868.7211.83
2144646-14464657.30957.53
3150368-15036859.57659.84
4185799-18579973.61474.05
5175120-17512069.38369.70
6192076-19207676.10176.63
15min1221960-22196087.94182.455.1089.1883.585.25
2193934-19393476.83777.70
3197569-19756978.27879.21
4212553-21255384.21485.47
5208237-20823782.50483.59
6214387-21438784.94186.32
20min1235707-23570793.38888.723.5395.6090.763.64
2212008-21200883.99885.71
3220200-22020087.24489.04
4224041-22404188.76690.95
5228053-22805390.35592.36
6223550-22355088.57190.89
30min1248129-24812998.31093.833.07101.5696.863.16
2228408-22840890.49693.14
3232074-23207491.94994.72
4233799-23379992.63295.81
5242569-24256996.10799.11
6235951-23595193.48596.79
45min1250042-25004299.06895.641.90103.4199.711.95
2239071-23907194.72198.37
3240039-24003995.10498.89
4241689-24168995.75899.96
5240874-24087495.43599.51
6236682-23668293.77498.12
60min1248053-24805398.27995.811.85103.72100.941.74
2242456-24245696.062100.76
3244605-24460596.913101.76
4241160-24116095.548100.82
5239691-23969194.966100.10
6234911-23491193.07398.46
极限1251008-25100899.45096.791.85105.99102.991.79
2242094-24209495.918101.69
3248465-24846598.443104.37
4240088-24008895.124101.45
5243974-24397496.663102.85
6240182-24018295.161101.58
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%
111.149769799776689778409750669763139767730.12
211.159772069816089794070.32
单位质量响应值RSD%判断
87681.6087839.190.13数据可信
供试品溶液-24091202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%
5min147206-472064.8295.568.224.835.568.19
250812-508125.1985.20
354912-549125.6175.62
457202-572025.8525.85
556793-567935.8105.81
658994-589946.0356.03
10min169196-691967.0787.071.227.137.131.21
267954-679546.9517.01
368406-684066.9987.06
470376-703767.1997.26
569389-693897.0987.16
669106-691067.0697.14
15min171603-716037.3257.191.107.467.331.04
270577-705777.2207.35
369410-694107.1007.24
470526-705267.2157.36
569969-699697.1587.30
669846-698467.1457.29
20min169966-699667.1577.253.297.377.483.24
269321-693217.0917.31
370278-702787.1897.41
475282-752827.7017.93
571620-716207.3267.55
668976-689767.0567.28
30min171105-711057.2747.7112.237.578.0111.82
269661-696617.1267.42
369853-698537.1467.44
490051-900519.2129.52
583848-838488.5778.88
667868-678686.9437.25
45min198181-9818110.0438.4414.8310.428.8314.25
272383-723837.4047.78
370963-709637.2597.64
492462-924629.4589.87
589521-895219.1589.56
671622-716227.3277.71
60min1107519-10751910.9998.8216.5911.489.3015.93
274376-743767.6088.06
372372-723727.4037.86
493774-937749.59310.11
594066-940669.62310.12
675332-753327.7068.17
极限1117718-11771812.04210.1322.6612.6510.7021.82
276775-767757.8548.39
379189-791898.1018.64
4116642-11664211.93212.56
5123642-12364212.64813.26
680008-800088.1848.73
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%
19.832469502468162462212477722475212470560.25
29.902494242491892493060.07
单位质量响应值RSD%判断
25132.8625182.420.14数据可信
供试品溶液-24091202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%
5min181105-8110532.14843.8517.9332.1543.8517.93
294680-9468037.52937.53
3110250-11025043.70143.70
4119319-11931947.29647.30
5123054-12305448.77648.78
6135329-13532953.64253.64
10min1200849-20084979.61385.183.7879.9785.663.86
2210311-21031183.36383.78
3216745-21674585.91486.40
4218801-21880186.72987.25
5219104-21910486.84987.39
6223503-22350388.59289.19
15min1236418-23641893.71294.750.8894.9596.180.95
2240640-24064095.38596.73
3237718-23771894.22795.67
4238996-23899694.73396.22
5238220-23822094.42695.93
6242182-24218295.99697.58
20min1240635-24063595.38397.221.0597.6799.711.13
2245769-24576997.41899.82
3247222-24722297.994100.48
4246587-24658797.742100.28
5244087-24408796.75199.31
6247388-24738898.060100.71
30min1245251-24525197.21397.631.37100.56101.201.28
2248454-24845498.482101.97
3248453-24845398.482102.06
4246780-24678097.819101.45
5248902-24890298.660102.29
6240045-24004595.14998.89
45min1247195-24719597.98398.060.71102.41102.720.63
2250258-25025899.198103.78
3246776-24677697.817102.49
4247368-24736898.052102.77
5247928-24792898.274103.00
6244873-24487397.063101.86
60min1241490-24149095.72296.890.72101.23102.630.75
2246618-24661897.755103.44
3244827-24482797.045102.80
4245588-24558897.346103.15
5244361-24436196.860102.68
6243703-24370396.599102.47
极限1239349-23934994.87396.501.30101.45103.321.28
2244740-24474097.010103.78
3243092-24309296.357103.19
4245422-24542297.281104.17
5247701-24770198.184105.08
6240433-24043395.303102.25
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