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
Amoxicillin/Clavulanate Potassium	Tablet (Chewable)			Develop a dissolution method			2023/09/15
Amoxicillin/Omeprazole Mg./Rifabutin	Capsule (Delayed Release)	I (Basket	100	Amoxicillin/Rifabutin: 0.01 N HCl; Omeprazole: 0.1N HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8	Amoxicillin/Rifabutin:900; Omeprazole: Acid Stage: 900; Buffer Stage:900;	Amoxicillin/Rifabutin: 5, 10, 15, 20 and 30; Omeprazole: Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30;	2020/08/27
Amoxicillin; Clarithromycin; Vonoprazan Fumarate	Capsule, Tablet, Tablet	Clarithromycin and Vonoprazan: II (Paddle)	Clarithromycin and Vonoprazan: 50	Amoxicillin: Develop a dissolution method; Clarithromycin: 0.1M Sodium Acetate Buffer (pH 5.0); Vonoprazan: 0.05M Acetate Buffer (pH 4.5)	900	10, 15, 30, 45, 60 and 90	2024/02/05
Amoxicillin; Vonoprazan Fumarate	Capsule, Tablet	Vonoprazan: II (Paddle)	Vonoprazan: 50	Amoxicillin: Develop a dissolution method; Vonoprazan: 0.05M Acetate Buffer (pH 4.5)	900	10, 15, 30, 45, 60 and 90	2024/02/05
Amphetamine	Tablet (Extended Release, Orally Disintegrating)	II (Paddle	75	Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8	Acid Stage: 900 mL; Buffer Stage: 1000 mL	Acid Stage: 10, 15, 30, 45, 60, 90, 120; Buffer Stage: 5, 10, 15, 30 and 45	2016/07/28
Amphetamine	Suspension (Extended Release)			Develop a dissolution method			2016/12/22
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate	Capsule (Extended Release)	II (Paddle)	50	Dilute HCl, pH 1.1 for first 2 hrs, then add 200 mL of 200 mM Phosphate Buffer and adjust to pH 6.0 for the remainder	0-2 hrs: 750 mL. After 2 hrs: 950 mL	0.5, 1, 2, 3, and 4 hours	2007/07/25
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate	Tablet			Develop a dissolution method			2023/09/15
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate [12.5, 25, 37.5, 50 mg]	Capsule (Extended Release)	II (Paddle)	50	Media 1: pH 1.1±0.1, Dilute HCl 2 hours; Media 2: pH 6.0±0.1, Phosphate Buffer 3rd hour, Media 3: pH 7.5±0.1, Phosphate Buffer for the remainder	Media 1: 750 mL; Media 2: 950 mL; Media 3: 1000 mL	0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours	2017/11/16
Amphetamine ER	Capsule	II (Paddle)	50	750 ml of dilute HCl, pH 1.1 for the first 2 hours, then add 200 ml of 200 mM phosphate buffer, and adjust to pH 6 (w/ HCl or NaOH) for the remainder	750 ml of dilute HCl, 200 ml of phosphate buffer	1, 2, 3, 4, and 6 hours	2006/08/17
Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate	Tablet (Extended Release)	II (Paddle)	50	Stage 1: 500 mL of water for 1 hour; Stage 2: 700 mL of 0.001N HCl for next 2 hours (add 200 mL of HCl to Stage 1); Stage 3: 900 mL of Phosphate Buffer, pH 6.8 (add 200 mL of Potassium Phosphate Buffer to Stage 2)	Stage 1: 500; Stage 2: 700; Stage 3: 900	1, 3, 3.17, 3.25, 3.5, 3.75, 4, 6, 8 and 12 hours	2022/05/12
Amphotericin B	Injectable (Liposomal)			Develop a method to characterize in vitro release			2016/07/28
Ampicillin/Ampicillin Trihydrate	for Oral Suspension			Develop a dissolution method			2023/09/15
Ampicillin/Ampicillin Trihydrate	Capsule			Develop a dissolution method			2023/09/15
Amprenavir	Capsule	II (Paddle)	50	0.1 N HCl	900	10, 15, 30, and 45	2008/02/19
Anagrelide HCl	Capsule	I (Basket)	100	0.1 N HCl	900	5, 10, 15, 30 and 45	2004/01/14
Anastrozole	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Apalutamide	Tablet	II (Paddle)	75	0.25% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (60 mg strength); 0.5% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (240 mg strength)	900	5, 10, 15, 20, 30, and 45	2024/02/16
Apixaban	Tablet	II (Paddle)	75	0.05 M Sodium Phosphate Buffer with 0.05% SLS, pH 6.8	900	5, 10, 20, 30 and 45	2013/05/09
Apomorphine HCl	Film (Sublingual)	V (paddle over disk)	75	20mM BIS-TRIS HCl Buffer, pH 6.4	500	2.5, 5, 7.5, 10, 12.5, 15 and 20	2021/08/19