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
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	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
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
Bupivacaine; Meloxicam	Solution, Extended Release			Develop a method to characterize in vitro release			2025/09/08
Buprenorphine	Film, Transdermal (Extended Release)	VI (Cylinder) with adapter, if needed	50	0.9% Sodium Chloride at 32°C	600	0.5,1, 2, 4, 6, 8,12, 16 and 24 hours	2013/05/09
Buprenorphine HCl	Implant	II (Paddle)	50	Water	900	1, 4, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours	2016/07/28
Buprenorphine HCl	Film (Buccal)	I (Basket) 100 mL round bottom vessel	100	0.05M NaH2PO4.H2O Phosphate Buffer, pH 4.5	60	10, 15, 20, 30, 45 and 60	2016/10/20
Buprenorphine HCl	Tablet (Sublingual)			Develop a dissolution method			2023/09/15
Buprenorphine HCl/Naloxone HCl	Tablet (Sublingual)			Develop a dissolution method			2023/09/15
Buprenorphine HCl/Naloxone HCl	Film (Sublingual)	V (Paddle over Disk) with 56 mm, 40 mesh stainless steel disk.	100	Acetate Buffer, pH 4.0 (12.5mM Sodium acetate trihydrate and 60mM glacial acetic acid. Adjust the pH with glacial acetic acid or ammonium hydroxide).	900	1, 2, 3, 5, 7 and 10	2013/10/31
Bupropion HCl	Tablet (Extended Release)			Develop a dissolution method			2024/01/03
Bupropion HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Bupropion Hydrobromide	Tablet (Extended Release)	I (Basket)	75	0.1 N HCl	900	1, 2, 4, 6, 8 and 10 hours	2009/06/10
Buspirone Hydrochloride	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Buspirone Hydrochloride	Capsule	II (Paddle)	50	0.01 N HCl	500	10, 20, 30 and 45	2024/11/01
Busulfan	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Busulfan	Tablet			Develop a dissolution method			2023/09/15
Cabergoline	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Cabotegravir	Suspension (Extended Release)	II (Paddle)	20	0.5% w/v cetyltrimethylammonium bromide (CTAB) in 140 mM McIlvaine buffer, pH 7.4	1000	5, 10, 20, 30, 45 and 60	2023/07/07