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 9867129862039853549853619849869857230.08
211.259852689853189852930.01
单位质量响应值RSD%判断
87697.7887581.600.10数据可信
供试品溶液-1996048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%
5min150565-505655.1804.7410.995.184.7411.01
243776-437764.4844.48
348131-481314.9304.93
437227-372273.8133.81
550512-505125.1745.17
647350-473504.8504.85
10min169510-695107.1206.902.967.186.953.01
265086-650866.6676.72
368506-685067.0187.07
464875-648756.6466.69
568939-689397.0627.12
667065-670656.8706.92
15min171131-711317.2867.072.267.427.192.23
268922-689227.0607.18
370016-700167.1727.30
468081-680816.9747.09
566605-666056.8236.96
669093-690937.0787.21
20min171094-710947.2837.141.667.507.351.67
268393-683937.0067.21
370839-708397.2577.47
469387-693877.1087.30
568499-684997.0177.23
670085-700857.1797.39
30min170258-702587.1977.130.947.507.420.88
269624-696247.1327.41
369404-694047.1107.40
470381-703817.2107.48
568711-687117.0397.33
669117-691177.0807.37
45min169819-698197.1527.132.097.537.501.98
269110-691107.0797.44
370407-704077.2127.58
470648-706487.2377.59
566900-669006.8537.22
670675-706757.2407.61
60min168088-680886.9757.122.047.437.561.90
267436-674366.9087.35
370661-706617.2387.69
470001-700017.1717.60
570970-709707.2707.71
669707-697077.1417.59
极限172082-720827.3847.736.907.928.256.50
269152-691527.0847.60
382213-822138.4228.95
472100-721007.3867.90
576452-764527.8318.36
680585-805858.2558.78
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%
110.122570132578202609562606162605482593910.71
210.162572102571262571680.03
单位质量响应值RSD%判断
25631.5225311.810.89数据可信
供试品溶液-1996048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%
5min174541-7454129.18327.1011.6029.1827.0911.60
264951-6495125.42925.43
373743-7374328.87128.87
454737-5473721.43021.43
575412-7541229.52429.52
671860-7186028.13428.13
10min1128556-12855650.33150.254.7850.6650.564.82
2123225-12322548.24448.53
3134623-13462352.70653.03
4119175-11917546.65846.90
5134197-13419752.53952.87
6130358-13035851.03651.35
15min1158718-15871862.14062.613.2463.0263.473.26
2161186-16118663.10663.92
3166069-16606965.01865.92
4151376-15137659.26560.02
5158154-15815461.91962.83
6164037-16403764.22265.10
20min1176253-17625369.00570.472.6770.5872.022.70
2178733-17873369.97671.50
3185232-18523272.52074.15
4173542-17354267.94369.36
5180738-18073870.76172.36
6185438-18543872.60174.19
30min1198870-19887077.85979.211.7580.2081.551.78
2205843-20584380.58982.89
3203733-20373379.76382.20
4197135-19713577.18079.35
5203041-20304179.49281.88
6205313-20531380.38282.78
45min1218820-21882085.67086.092.4788.8889.302.44
2223718-22371887.58890.78
3222845-22284587.24690.57
4214471-21447183.96786.99
5212917-21291783.35986.63
6226517-22651788.68391.98
60min1218820-21882085.67088.442.6189.8392.612.56
2226036-22603688.49592.66
3224682-22468287.96592.26
4223077-22307787.33791.30
5226152-22615288.54192.74
6236558-23655892.61596.89
极限1235628-23562892.25193.241.3197.3698.401.25
2235960-23596092.38197.53
3236308-23630892.51797.78
4240724-24072494.24699.18
5237116-23711692.83398.01
6243244-24324495.232100.54
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 9811689815879808339804099805119809020.05
211.259839879845359842610.04
单位质量响应值RSD%判断
87268.8687489.870.18数据可信
供试品溶液-1996048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%
5min141450-414504.2594.747.334.264.747.35
243926-439264.5134.51
348052-480524.9374.94
451273-512735.2685.27
546189-461894.7464.75
645792-457924.7054.70
10min162411-624116.4126.662.296.466.722.33
265531-655316.7336.78
365624-656246.7426.80
466280-662806.8106.87
565581-655816.7386.79
663677-636776.5426.59
15min166417-664176.8246.891.776.947.011.78
268468-684687.0357.16
367393-673936.9247.05
467977-679776.9847.12
566745-667456.8586.99
665186-651866.6976.82
20min168072-680726.9947.011.077.197.211.04
269287-692877.1197.32
368242-682427.0117.22
468741-687417.0637.27
567273-672736.9127.12
667668-676686.9527.15
30min167773-677736.9636.981.367.247.261.35
269019-690197.0917.37
368168-681687.0047.29
467847-678476.9717.26
568285-682857.0167.30
666245-662456.8067.08
45min165462-654626.7267.074.297.087.424.13
268617-686177.0507.41
367557-675576.9417.30
474020-740207.6057.97
569827-698277.1747.53
667230-672306.9077.26
60min165908-659086.7727.123.197.207.563.11
268506-685067.0387.48
370553-705537.2497.69
472498-724987.4497.90
569488-694887.1397.58
668656-686567.0547.48
极限166904-669046.8747.489.217.378.008.73
271013-710137.2967.81
368295-682957.0177.54
482796-827968.5079.04
579585-795858.1778.69
668299-682997.0177.52
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%
110.122559942559802560372557702560272559620.05
210.162578472581132579800.08
单位质量响应值RSD%判断
25292.6925391.730.28数据可信
供试品溶液-1996048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%
5min163675-6367525.05628.6010.1725.0628.6010.16
273487-7348728.91728.92
366682-6668226.23926.24
484733-8473333.34233.34
575740-7574029.80329.80
671852-7185228.27328.27
10min1123514-12351448.60251.253.5848.8851.573.62
2131687-13168751.81852.14
3126767-12676749.88250.17
4137034-13703453.92254.29
5131934-13193451.91552.25
6130530-13053051.36351.68
15min1158359-15835962.31463.722.1863.1364.612.22
2165081-16508164.95965.86
3159342-15934262.70063.55
4167334-16733465.84566.81
5161381-16138163.50364.41
6160131-16013163.01163.90
20min1179638-17963870.68771.701.3372.2073.291.36
2183438-18343872.18273.80
3181576-18157671.44972.99
4184701-18470172.67974.38
5179250-17925070.53472.15
6184626-18462672.64974.23
30min1201467-20146779.27680.210.8481.5782.600.86
2204518-20451880.47782.90
3204372-20437280.41982.76
4204393-20439380.42882.94
5202188-20218879.56081.96
6206087-20608781.09483.49
45min1215284-21528484.71386.521.7087.8989.811.65
2220540-22054086.78190.10
3224615-22461588.38591.61
4218874-21887486.12689.53
5216518-21651885.19988.48
6223493-22349387.94391.24
60min1223727-22372788.03689.312.2292.1593.552.12
2227884-22788489.67193.95
3235129-23512992.52296.73
4222973-22297387.73992.10
5222087-22208787.39091.62
6229979-22997990.49694.77
极限1233747-23374791.97891.621.9497.0796.851.84
2228412-22841289.87995.15
3240824-24082494.763100.00
4233308-23330891.80697.14
5228756-22875690.01495.21
6231946-23194691.27096.55
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 9850219835959838469831649830389837330.09
211.259875269878809877030.03
单位质量响应值RSD%判断
87520.7387795.820.23数据可信
供试品溶液-1996048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%
5min1433642-43364244.41154.0411.6144.4154.0411.61
2580372-58037259.43959.44
3528793-52879354.15654.16
4566107-56610757.97857.98
5581641-58164159.56959.57
6475492-47549248.69848.70
10min1859866-85986688.06388.951.6088.5689.551.59
2874679-87467989.58090.24
3869689-86968989.06989.67
4885323-88532390.67091.31
5845988-84598886.64287.30
6875884-87588489.70490.24
15min1918656-91865694.08492.551.5695.5694.141.52
2906021-90602192.79094.45
3890237-89023791.17492.77
4920577-92057794.28195.93
5887177-88717790.86092.48
6899544-89954492.12793.66
20min1909809-90980993.17893.020.5795.7095.640.59
2914389-91438993.64796.33
3903388-90338892.52095.12
4913621-91362193.56896.27
5902341-90234192.41395.05
6906156-90615692.80495.37
30min1903133-90313392.49492.820.7496.0596.470.73
2900939-90093992.27096.00
3912948-91294893.50097.13
4915876-91587693.79997.54
5899572-89957292.13095.79
6905224-90522492.70996.30
45min1897486-89748691.91692.120.6096.5096.810.62
2896384-89638491.80396.56
3899054-89905492.07796.75
4909885-90988593.18697.97
5894626-89462691.62396.31
6899583-89958392.13196.75
60min1899470-89947092.11991.041.0297.7296.740.94
2875019-87501989.61595.39
3891832-89183291.33797.03
4896561-89656191.82197.64
5882755-88275590.40796.11
6887839-88783990.92896.57
极限1911146-91114693.31592.611.0199.9499.320.96
2908473-90847393.04199.81
3900619-90061992.23798.95
4912993-91299393.504100.34
5888267-88826790.97297.68
6903863-90386392.56999.23
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%
110.122577252575662576602575342576342576240.03
210.162597422597352597380.01
单位质量响应值RSD%判断
25456.9225564.760.30数据可信
供试品溶液-1996048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%
5min126903-2690310.51613.3912.2910.5213.4012.28
238518-3851815.05615.06
334814-3481413.60913.61
437161-3716114.52614.53
536015-3601514.07814.08
632151-3215112.56812.57
10min183546-8354632.65834.493.3132.7734.643.34
291364-9136435.71435.88
390584-9058435.40935.56
489146-8914634.84735.01
586141-8614133.67233.83
688584-8858434.62734.77
15min1124282-12428248.58148.891.1949.0649.421.22
2127950-12795050.01550.58
3124278-12427848.58049.12
4125337-12533748.99449.54
5124077-12407748.50149.03
6124439-12443948.64349.17
20min1159294-15929462.26759.682.3863.2960.762.31
2154113-15411360.24261.36
3150715-15071558.91460.00
4149933-14993358.60859.70
5152290-15229059.52960.60
6149769-14976958.54459.61
30min1181809-18180971.06870.442.5172.7872.182.47
2183610-18361071.77273.56
3183756-18375671.82973.57
4182899-18289971.49473.24
5173005-17300567.62769.36
6176190-17619068.87270.59
45min1207687-20768781.18481.270.6783.6883.790.64
2208015-20801581.31283.90
3205594-20559480.36682.90
4208181-20818181.37783.92
5208011-20801181.31083.79
6209943-20994382.06684.55
60min1222472-22247286.96385.361.0390.3788.780.96
2215859-21585984.37887.87
3217174-21717484.89288.32
4218604-21860485.45188.89
5218104-21810485.25688.64
6217969-21796985.20388.60
极限1238993-23899393.42191.891.1997.7996.271.16
2237446-23744692.81697.24
3232557-23255790.90595.28
4235609-23560992.09896.49
5231894-23189490.64694.98
6234035-23403591.48395.82
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 9857939865649857419864259851919859430.06
211.259871099872779871930.02
单位质量响应值RSD%判断
87717.3587750.490.03数据可信
供试品溶液-1996048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%
5min1420548-42054843.03352.9915.5043.0352.9915.50
2447552-44755245.79645.80
3570128-57012858.33958.34
4595075-59507560.89260.89
5601581-60158161.55861.56
6472447-47244748.34448.34
10min1843875-84387586.35188.592.2386.8389.182.30
2870354-87035489.06089.57
3869404-86940488.96389.61
4883266-88326690.38191.06
5886654-88665490.72891.41
6841269-84126986.08486.62
15min1911111-91111193.23192.711.2394.6794.281.27
2901249-90124992.22293.72
3904103-90410392.51494.15
4907997-90799792.91294.59
5922422-92242294.38896.08
6888999-88899990.96892.46
20min1909737-90973793.09092.011.0695.5694.620.98
2905044-90504492.61095.13
3895429-89542991.62694.29
4883862-88386290.44293.16
5905786-90578692.68695.43
6895306-89530691.61394.12
30min1908291-90829192.94293.281.9296.4596.901.88
2934221-93422195.59699.15
3898025-89802591.89295.57
4904691-90469192.57496.29
5931705-93170595.33899.11
6892455-89245591.32294.84
45min1892356-89235691.31291.400.7695.8596.060.83
2885816-88581690.64295.26
3895855-89585591.67096.37
4895523-89552391.63696.38
5903675-90367592.47097.30
6886176-88617690.67995.22
60min1890336-89033691.10591.521.3996.6697.201.38
2908345-90834592.94898.57
3893930-89393091.47397.19
4896880-89688091.77597.54
5903897-90389792.49398.35
6873046-87304689.33694.88
极限1918028-91802893.93991.883.35100.5198.573.17
2923204-92320494.468101.12
3892627-89262791.33998.08
4908749-90874992.98999.77
5904103-90410392.51499.40
6840718-84071886.02892.56
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%
110.122582902587592585852587562584142585610.09
210.162600242596822598530.10
单位质量响应值RSD%判断
25549.5125576.080.08数据可信
供试品溶液-1996048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%
5min126262-2626210.24513.2716.0110.2413.2716.01
229473-2947311.49711.50
339102-3910215.25415.25
439349-3934915.35015.35
537324-3732414.56014.56
632574-3257412.70712.71
10min182418-8241832.15134.554.6032.2634.694.66
286084-8608433.58133.71
392065-9206535.91436.08
493401-9340136.43636.61
589978-8997835.10035.26
687394-8739434.09234.23
15min1123701-12370148.25649.032.3748.7349.562.42
2121189-12118947.27647.78
3129293-12929350.43751.01
4128112-12811249.97650.55
5126661-12666149.41049.96
6125199-12519948.84049.36
20min1150198-15019858.59258.611.6559.6059.681.64
2146886-14688657.30058.33
3152797-15279759.60660.73
4148702-14870258.00859.14
5149509-14950958.32359.42
6153360-15336059.82560.89
30min1184348-18434871.91471.970.5473.5773.700.53
2184984-18498472.16273.82
3185173-18517372.23674.03
4183403-18340371.54573.32
5185735-18573572.45574.20
6183285-18328571.49973.23
45min1208609-20860981.37880.681.5383.8483.211.52
2200775-20077578.32280.79
3209773-20977381.83284.43
4206571-20657180.58383.15
5207633-20763380.99783.55
6207629-20762980.99683.52
60min1221803-22180386.52585.940.8389.8989.360.81
2220400-22040085.97889.31
3221784-22178486.51890.02
4219677-21967785.69689.16
5221176-22117686.28089.73
6216976-21697684.64288.06
极限1241983-24198394.39791.423.2798.7295.803.10
2240632-24063293.87098.16
3234786-23478691.59096.05
4235079-23507991.70496.12
5233175-23317590.96195.37
6220443-22044385.99490.36
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