美国FDA药品溶出方法数据库

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
Bicalutamide	Tablet			Develop a dissolution method			2023/09/15
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate	Tablet	II (Paddle)	75	50 mM Citrate buffer, pH 5.5	900	5, 10, 15, 20, 30, 45 and 60	2024/11/01
Bimatoprost	Implant			Develop a method to characterize in vitro release			2023/07/07
Bisacodyl/Polyethylene glycol 3350/ Potassium Chloride/Sodium Bicarbonate/ Sodium Chloride	Tablet (Delayed Release), For Solution,	II (Paddle)	100	Acid stage: 0.1 N HCl: Buffer stage: 0.05 M Phosphate buffer, pH 6.8, with 0.15% sodium lauryl sulfate (SLS) [only for Bisacodyl Tablets]	Acid stage: 900 mL; Buffer stage: 900 mL	Acid stage: 60; Buffer stage: 10, 20, 30, 45 and 60	2017/03/02
Bismuth Subcitrate Potassium/Metronidazole/Tetracycline HCl	Capsule			Develop a dissolution method			2023/09/15
Bismuth Subsalicylate (BiSub)/Metronidazole (Met)/Tetracycline HCl (Tet)	BiSub: Tablet (Chewable) /Met:Tablet /Tet: Capsule	II (Paddle)	50	BiSub: 0.1 N HCl /Met: Refer to USP /Tet: Refer to FDA's Dissolution Guidance, 2018	900	5, 10, 15, 20 and 30	2022/07/07
Bisoprolol Fumarate	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Bisoprolol Fumarate/Hydrochlorothiazide	Tablet	II (Paddle)	75	0.1 N HCl	900	5, 10, 20, 30 and 45	2004/01/20
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	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 15, 20, 30 and 45	2015/06/25
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	Tablet			Refer to USP			2007/07/25