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%
111.631022485102293510226321022979102298310228030.03
211.641022729102208210224060.05
单位质量响应值RSD%判断
87945.2387835.570.09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%
5min143899-438994.4844.0526.354.484.0526.33
248664-486644.9714.97
352812-528125.3945.39
426720-267202.7292.73
529970-299703.0613.06
636046-360463.6823.68
10min164730-647306.6126.744.256.666.794.37
269432-694327.0927.15
369631-696317.1127.17
463497-634976.4866.52
563613-636136.4986.53
665153-651536.6556.70
15min169781-697817.1287.202.017.257.322.12
272627-726277.4187.55
371016-710167.2547.39
468515-685156.9987.10
569939-699397.1447.25
671168-711687.2697.38
20min174195-741957.5797.580.487.787.780.51
274689-746897.6297.85
373703-737037.5287.75
474155-741557.5757.75
574449-744497.6057.79
673956-739567.5547.75
30min170950-709507.2477.381.747.537.671.71
272652-726527.4217.72
372630-726307.4197.72
470625-706257.2147.48
573840-738407.5427.81
673085-730857.4657.74
45min173772-737727.5357.451.127.907.811.13
272623-726237.4187.80
372658-726587.4227.81
471734-717347.3277.67
572696-726967.4257.78
673918-739187.5507.91
60min171693-716937.3237.501.367.777.941.33
274069-740697.5668.03
373658-736587.5247.99
472972-729727.4547.88
574562-745627.6168.05
673300-733007.4877.93
极限171124-711247.2657.473.627.808.003.39
272979-729797.4548.00
373513-735137.5098.06
471334-713347.2867.80
578168-781687.9848.51
671659-716597.3207.85
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%
110.312576322581642578102576002576812577770.09
210.262573792572752573270.03
单位质量响应值RSD%判断
25002.6225080.600.23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%
5min187982-8798235.03629.3637.3735.0429.3637.37
291262-9126236.34236.34
3112361-11236144.74444.74
442844-4284417.06117.06
548742-4874219.41019.41
659131-5913123.54723.55
10min1175829-17582970.01864.4815.9770.4164.8016.07
2183490-18349073.06973.47
3191209-19120976.14376.64
4129754-12975451.67051.86
5134268-13426853.46853.68
6156959-15695962.50462.77
15min1212159-21215984.48680.928.9985.6581.969.14
2223566-22356689.02890.24
3214202-21420285.29986.64
4175682-17568269.96070.72
5186477-18647774.25975.07
6207067-20706782.45883.41
20min1224334-22433489.33487.064.3691.4489.004.58
2224619-22461989.44791.65
3226178-22617890.06892.36
4203870-20387081.18582.73
5209318-20931883.35484.99
6223353-22335388.94390.82
30min1226944-22694490.37389.962.1593.4792.872.37
2230269-23026991.69794.90
3228530-22853091.00594.30
4216615-21661586.26088.70
5227801-22780190.71493.28
6225333-22533389.73292.59
45min1233534-23353492.99792.741.8497.1096.642.10
2236612-23661294.22398.44
3235618-23561893.82798.13
4224953-22495389.58092.98
5231487-23148792.18295.75
6235049-23504993.60197.46
60min1232872-23287292.73492.631.4097.8797.571.64
2235633-23563393.83399.10
3233268-23326892.89298.24
4226373-22637390.14694.54
5232942-23294292.76297.35
6234617-23461793.42998.33
极限1233808-23380893.10793.240.5499.2799.210.79
2236130-23613094.031100.34
3234551-23455193.40299.78
4233102-23310292.82598.22
5234601-23460193.42299.05
6232647-23264792.64498.58
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%
111.631023420102299110230391023115102213510229400.05
211.641020706102095210208290.02
单位质量响应值RSD%判断
87957.0187700.090.21数据可信
供试品溶液-24091201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%
5min127078-270782.7683.8533.772.773.8533.77
242838-428384.3794.38
351713-517135.2865.29
451422-514225.2565.26
522767-227672.3272.33
629937-299373.0603.06
10min160231-602316.1576.544.626.196.584.79
265503-655036.6956.74
367211-672116.8706.93
466840-668406.8326.89
561450-614506.2816.31
662462-624626.3856.42
15min166715-667156.8196.992.136.927.102.24
268088-680886.9607.08
371108-711087.2687.40
467948-679486.9457.08
568135-681356.9657.06
668155-681556.9677.07
20min169343-693437.0887.191.187.267.381.40
271046-710467.2627.46
371101-711017.2687.48
470963-709637.2547.47
569355-693557.0897.26
670339-703397.1907.37
30min171064-710647.2647.351.187.527.621.23
271754-717547.3347.62
373196-731967.4827.78
470925-709257.2507.54
572092-720927.3697.62
672340-723407.3947.66
45min170502-705027.2067.251.057.547.611.23
271136-711367.2717.63
371777-717777.3377.72
471355-713557.2947.67
569699-696997.1247.46
671223-712237.2807.62
60min174267-742677.5917.501.568.017.941.55
273520-735207.5157.96
374449-744497.6108.07
473155-731557.4787.93
573667-736677.5307.94
671285-712857.2867.71
极限175026-750267.6697.586.368.178.105.94
283096-830968.4949.02
372833-728337.4457.99
469836-698367.1387.68
572983-729837.4607.96
671219-712197.2807.79
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%
110.312574642570602572392573522571342572500.07
210.262562612564592563600.06
单位质量响应值RSD%判断
24951.5024986.350.10数据可信
供试品溶液-24091201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%
5min143662-4366217.43826.9037.9217.4426.9037.92
277226-7722630.84230.84
391942-9194236.71936.72
499329-9932939.67039.67
540548-4054816.19416.19
651372-5137220.51720.52
10min1129641-12964151.77662.6815.2551.9762.9815.36
2173500-17350069.29269.63
3176044-17604470.30870.72
4185207-18520773.96774.41
5136424-13642454.48554.66
6140827-14082756.24356.47
15min1184299-18429973.60579.935.9074.3780.926.09
2210360-21036084.01385.13
3211761-21176184.57285.76
4209326-20932683.60084.86
5190942-19094276.25877.04
6194093-19409377.51678.37
20min1205241-20524181.96887.083.6083.5688.963.78
2226438-22643890.43492.48
3222663-22266388.92691.06
4223245-22324589.15991.35
5217451-21745186.84588.48
6213170-21317085.13586.85
30min1232219-23221992.74393.611.2695.2496.461.32
2237591-23759194.88897.94
3236796-23679694.57197.69
4231120-23112092.30495.49
5236779-23677994.56497.16
6231875-23187592.60595.27
45min1243994-24399497.44597.141.51100.97101.031.29
2245640-24564098.103102.21
3240429-24042996.022100.19
4238014-23801495.05799.26
5248266-24826699.152102.80
6243023-24302397.058100.75
60min1251103-251103100.28598.142.23104.90103.111.91
2246336-24633698.381103.58
3240948-24094896.229101.46
4238858-23885895.394100.66
5252697-252697100.921105.67
6244394-24439497.605102.37
极限1250989-250989100.23998.072.78105.96104.132.43
2249153-24915399.506105.79
3238387-23838795.206101.51
4235825-23582594.183100.51
5252074-252074100.672106.54
6246939-24693998.622104.47
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%
111.631022079102312710242251021674102298510228180.10
211.641022365102170910220370.05
单位质量响应值RSD%判断
87946.5287803.870.12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%
5min132962-329623.3674.0425.853.374.0425.83
232174-321743.2873.29
337632-376323.8453.84
452754-527545.3895.39
551885-518855.3015.30
629840-298403.0493.05
10min165717-657176.7146.852.626.756.902.78
265995-659956.7426.78
365784-657846.7216.76
469584-695847.1097.17
569001-690017.0497.11
666238-662386.7676.80
15min171189-711897.2737.211.067.387.330.88
270255-702557.1777.29
371081-710817.2627.38
469927-699277.1447.28
569616-696167.1127.25
671392-713927.2947.40
20min172535-725357.4107.551.827.607.751.84
273254-732547.4847.67
374087-740877.5697.77
472601-726017.4177.64
575969-759697.7617.98
674766-747667.6387.83
30min171762-717627.3317.411.327.617.701.35
271817-718177.3377.61
372625-726257.4207.70
472057-720577.3617.66
574317-743177.5927.89
672745-727457.4327.71
45min172248-722487.3817.380.767.747.750.66
271650-716507.3207.68
372632-726327.4207.78
472042-720427.3607.74
571858-718587.3417.73
673146-731467.4737.83
60min171869-718697.3427.421.937.787.871.88
273289-732897.4877.92
372947-729477.4527.90
471059-710597.2607.72
574928-749287.6558.12
671670-716707.3227.76
极限175661-756617.7307.382.658.257.922.45
272386-723867.3957.92
370439-704397.1967.73
471339-713397.2887.83
573024-730247.4608.01
670866-708667.2407.76
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%
110.312567352569252566902565042570472567800.09
210.262563902563752563820.01
单位质量响应值RSD%判断
24905.9224988.500.24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%
5min158868-5886823.53128.9439.0323.5328.9439.03
255344-5534422.12222.12
362231-6223124.87524.88
4100045-10004539.99139.99
5114763-11476345.87445.87
643151-4315117.24917.25
10min1164333-16433365.68865.2312.8865.9565.5613.00
2156050-15605062.37762.62
3148429-14842959.33159.61
4185362-18536274.09474.54
5189382-18938275.70176.21
6135615-13561554.20954.40
15min1203764-20376481.45080.176.2882.4481.226.46
2193854-19385477.48878.43
3192858-19285877.09078.03
4212115-21211584.78886.06
5216901-21690186.70188.05
6183909-18390973.51374.31
20min1219827-21982787.87086.114.4989.7788.044.69
2209601-20960183.78385.58
3209599-20959983.78285.57
4224595-22459589.77691.99
5226571-22657190.56692.88
6202318-20231880.87282.48
30min1230564-23056492.16290.573.3195.0393.463.52
2225617-22561790.18592.92
3222365-22236588.88591.61
4231445-23144592.51495.72
5235142-23514293.99297.31
6214349-21434985.68188.19
45min1236038-23603894.35093.241.7298.2597.141.97
2230168-23016892.00495.74
3233085-23308593.17096.88
4235416-23541694.10298.34
5237761-23776195.03999.40
6227125-22712590.78894.25
60min1233144-23314493.19493.241.9798.1498.182.15
2230333-23033392.07096.83
3235667-23566794.20298.95
4232392-23239292.89398.17
5240664-24066496.199101.62
6227368-22736890.88595.35
极限1237770-23777095.04393.931.12101.0299.901.28
2230737-23073792.23198.01
3233194-23319493.21499.01
4235710-23571094.219100.53
5237172-23717294.804101.29
6235341-23534194.07299.55
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%
111.631020051102101810214731021382102199510211840.08
211.641028472102647010274710.14
单位质量响应值RSD%判断
87806.0288270.700.38数据可信
供试品溶液-2024092721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%
5min147730-477304.8674.0819.154.874.0819.13
246956-469564.7884.79
332738-327383.3383.34
445986-459864.6894.69
535694-356943.6403.64
631139-311393.1753.18
10min176422-764227.7937.364.827.857.404.90
275004-750047.6487.70
372376-723767.3807.42
472331-723317.3767.43
566707-667076.8026.84
670089-700897.1477.18
15min178581-785818.0137.933.038.158.063.08
278237-782377.9788.12
379806-798068.1388.26
480273-802738.1868.32
574401-744017.5877.70
675522-755227.7017.82
20min183076-830768.4728.212.908.708.432.87
282999-829998.4648.69
380399-803998.1998.41
476830-768307.8358.06
579655-796558.1238.32
680300-803008.1888.39
30min177252-772527.8788.122.398.208.422.17
277583-775837.9118.23
381842-818428.3468.65
479679-796798.1258.44
581435-814358.3048.59
679888-798888.1468.44
45min179146-791468.0718.091.518.488.491.54
280880-808808.2488.66
379989-799898.1578.55
479920-799208.1508.55
577426-774267.8958.28
678797-787978.0358.42
60min179788-797888.1368.152.488.648.632.47
281240-812408.2848.78
382020-820208.3648.85
481041-810418.2648.76
576714-767147.8238.29
678533-785338.0088.48
极限181421-814218.3038.073.238.898.653.13
277820-778207.9368.53
382766-827668.4409.02
479456-794568.1028.69
576267-762677.7778.33
677105-771057.8638.42
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%
110.312560882565612561362564162563382563080.08
210.262581532576612579070.14
单位质量响应值RSD%判断
24860.1425137.130.79数据可信
供试品溶液-2024092721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%
5min191036-9103636.31628.5623.5336.3228.5623.53
289436-8943635.67735.68
356057-5605722.36222.36
478360-7836031.25931.26
560956-6095624.31624.32
653662-5366221.40721.41
10min1180450-18045071.98465.0411.0572.3965.3611.11
2183670-18367073.26973.66
3148628-14862859.29059.54
4172243-17224368.71069.06
5140944-14094456.22556.49
6152386-15238660.78961.03
15min1208713-20871383.25981.524.0384.4682.564.15
2214753-21475385.66886.88
3200700-20070080.06280.97
4210582-21058284.00485.11
5193616-19361677.23678.13
6197691-19769178.86279.78
20min1221250-22125088.26087.592.7190.3989.542.81
2225127-22512789.80691.97
3222230-22223088.65190.45
4224513-22451389.56191.61
5211855-21185584.51286.27
6212424-21242484.73986.53
30min1225551-22555189.97592.572.3193.0895.482.28
2234471-23447193.53496.69
3238205-23820595.02397.81
4237376-23737694.69397.73
5229192-22919291.42894.12
6227496-22749690.75193.48
45min1233499-23349993.14694.812.4297.2598.762.43
2240503-24050395.940100.14
3243120-24312096.984100.82
4244610-24461097.578101.67
5231705-23170592.43096.14
6232571-23257192.77696.52
60min1234098-23409893.38594.691.4898.5399.691.54
2241038-24103896.153101.42
3240632-24063295.991100.91
4239186-23918695.415100.59
5232569-23256992.77597.51
6236639-23663994.39999.17
极限1233761-23376193.25195.231.3199.43101.281.28
2239210-23921095.424101.76
3241299-24129996.258102.24
4242448-24244896.716102.95
5238522-23852295.150100.92
6237037-23703794.557100.38
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