FDA药品溶出方法数据库
(FDA-Recommended Dissolution Methods Database)
药品通用名称 剂型 USP溶出装置 速度 溶出介质 介质体积 建议取样时间(分钟) 更新日期
Boceprevir Capsule II (Paddle) with sinker 50 50 mM phosphate buffer, pH 6.8 with 0.1% sodium dodecyl sulfate 900 10, 20, 30, 45, 60 and 75 2013/01/31
Bosentan Tablet Develop a dissolution method 2023/09/15
Bosentan Tablet (For Suspension) II (Paddle) 75 0.1 N HCl with 0.5% sodium dodecyl sulfate (SDS), pH 1.1 900 5, 10, 15, 20 and 30 2017/11/16
Bosutinib Monohydrate Capsule II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20, 30, 45 and 60 2026/05/22
Bosutinib Monohydrate Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45 2015/06/25
Brensocatib Tablet Refer to FDA's Dissolution Guidance, 2018 2026/05/22
Brexpiprazole Tablet II (Paddle) 50 0.05 M Acetate buffer, pH 4.3 900 10, 15, 20, 30 and 45 2016/10/20
Brigatinib Tablet II (Paddle) 70 50 mM Potassium Phosphate Buffer, pH 7.2 900 5, 10, 15, 20, 30 and 45 2017/11/02
Brimonidine Tartrate/Brinzolamide Ophthalmic Suspension Develop a method to characterize in vitro release 2015/01/15
Brincidofovir Tablet I (Basket) 50 50 mM sodium phosphate buffer, pH 6.4 + 0.3% SDS 900 5, 10, 15, 20, 30, 45, 60, 75 and 90 2023/07/07
Brincidofovir Suspension II (Paddle) 50 0.05 M Sodium Phosphate Monobasic, Monohydrate Buffer, pH 6.4 + 0.05% Tween 80 900 5, 10, 15, 20, 30, 45, 60, 75 and 90 2023/07/07
Brinzolamide Ophthalmic Suspension Develop a method to characterize in vitro release 2011/09/01
Brivaracetam Tablet II (Paddle 50 Phosphate Buffer, pH 6.4 2.5 and 5 mg tablets: 500 mL; 10, 25, 50, 75 and 100 mg tablets: 900 mL 5, 10, 15, 20 and 30 2016/07/28
Bromocriptine Mesylate Capsule I (Basket) 75 0.1 N HCl 500 5, 10, 15, 20, 30, 45 and 60 2026/05/22
Bromocriptine Mesylate Tablet Refer to USP 2007/07/25
Budesonide Tablet (Extended Release) II (Paddle) 100 Acid Stage: 0.1 M HCl containing 0.5% Macrogol Cetostearyl Ether; Buffer Stage: pH 7.2 phosphate buffer containing 0.5% Macrogol Cetostearyl Ether. Acid Stage: 500 mL ; Buffer Stage: 1000 mL Acid Stage: 2 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours 2015/04/02
Budesonide Capsule II (Paddle) with sinker 75 Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 7.5 Acid stage: 1000; Buffer stage: 1000 Acid stage: 2 hours; Buffer stage: 0.25, 0.5, 1, 2, 4, 6 and 8 hours 2015/02/25
Budesonide Suspension II (Paddle) 50 0.25% SDS in 0.009 N HCl 500 5, 10, 15, 20, 30, 45 and 60 2026/01/28
Bumetanide Tablet Develop a dissolution method 2024/01/03
Bupivacaine Solution (Extended Release), Infiltration II (Paddle) 50 0.025 M Sodium Phosphate Buffer with 0.03% Sodium Dodecyl Sulfate (SDS), pH 7.4 900 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours 2022/07/07

数据库说明:

当前数据更新日期:2026年06月06日。
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