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
Benzgalantamine Gluconate	Tablet, Delayed Release	I (Basket)	50	Acid Stage: 0.1N HCl; Buffer Stage: 0.05M Sodium Phosphate buffer pH 6.8 with 0.5% SDS	1000	Acid stage: 120; Buffer stage: 15, 20, 30, 45, 60 and 75	2025/06/23
Benzonatate	Capsule			Develop a dissolution method			2024/01/03
Benzoyl Peroxide; Clindamycin Phosphate	Gel			Develop a method to characterize in vitro release			2023/05/18
Benzphetamine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Bepridil HCl	Tablet	I (Basket)	100	0.1 N HCl	900	10, 20, 30, 45 and 60	2004/01/16
Berotralstat HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			2023/02/09
Betamethasone Acetate/Betamethasone Sodium Phosphate	Injectable Suspension	IV (Flow through cell)	Flow @ 8 mL/min	0.05% SLS, pH 3.0 or Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency		5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, and 360	2010/04/08
Bethanechol Chloride	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Bethanechol Chloride	Tablet			Refer to USP			2008/10/06
Betrixaban	Capsule			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Bexagliflozin	Tablet	I (Basket)	50	0.1 N HCl	900	1, 3, 5, 8 and 10 hours	2024/05/31
Bexarotene	Capsule	II (Paddle)	50	Tier 1 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 Tier 2 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 with 0.05 g/L pancreatin enzyme	900	15, 30, 45 and 60	2006/08/17
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