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
Simvastatin	Tablet (Orally Disintegrating)	II (Paddle)	75	0.15% SDS Buffer, pH 6.8	900	5, 10, 15 and 30	2008/09/03
Siponimod Fumaric Acid	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8 with 0.1% (m/v) Polysorbate 80	900 mL [for 2 mg strength] 500 mL [for 0.25 mg strength]	5, 10, 15, 20 and 30	2021/08/19
Sirolimus	Gel			Develop a method to characterize in vitro release			2023/05/18
Sirolimus	Tablet			Develop a dissolution method			2023/09/15
Sitagliptin Phosphate	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Sitagliptin Phosphate/Simvastatin	Tablet	II (Paddle) with stainless steel stationary quadrangular hanging basket	100	10 mM Sodium phosphate buffer containing 1% Tween 80 with 50 μg/mL Butylated hydroxyanisole	900	5, 10, 15, 20, 30, and 45	2013/10/31
Sodium Iodide I-123	Capsule			Develop a dissolution method			2023/09/15
Sodium Iodide I-131	Capsule			Develop a dissolution method			2022/07/07
Sodium Oxybate	For Suspension (Extended Release)	II (Paddle)	100	Stage 1: 0.1N HCl for 2h; Stage 2: pH 6.0 Phosphate Buffer for 6h	900	0.25, 1, 2, 2.5, 3, 3.5, 4 and 5 hours	2024/05/31
Sodium Phenylbutyrate	Pellets	II (Paddle)	75	Simulated Intestinal Fluid without pancreatin	900	5, 10, 15, 30 and 45	2024/02/05
Sodium Phenylbutyrate	Powder for Oral	II (Paddle)	75	Simulated Intestinal Fluid	900	15, 30, 45, 60 and 90	2009/04/02
Sodium Phenylbutyrate; Taurursodiol	Powder	II (Paddle)	75	5 mM phosphate w/ 0.1% SDS, pH 6.8	900	5, 10, 15, 30 and 45	2024/02/05
Sodium Phosphate Dibasic Anhydrous/Sodium Phosphate Monobasic Monohydrate	Tablet			Develop a dissolution method			2023/09/15
Sofosbuvir	Pellets	II (Paddle)	75	25 mM Potassium Phosphate Buffer, pH 5.5	900	5, 10, 15, 20, 30 and 45	2021/08/19
Sofosbuvir	Tablet	II (Paddle)	75	0.05 M Phosphate Buffer, pH 6.8	900	5, 10, 15, 20 and 30	2021/08/19
Sofosbuvir/Velpatasvir	Tablet	II (Paddle)	75	50 mM sodium acetate buffer,pH 5.0, with 0.5% w/v Cetyltrimethyl ammonium bromide (CTAB)	900	5, 10, 15, 20 and 30	2016/10/20
Solifenacin Succinate	Suspension	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	2022/07/07
Solifenacin Succinate	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Solriamfetol HCl	Tablet	I (Basket)	100	0.1 N HCl	900	5, 10, 15, 20 and 30	2021/08/19
Sonidegib Phosphate	Capsule	II (Paddle) with sinker	75	Tier 1: 0.1 M HCl with 1.0% SDS; Tier II: Stage 1: 850 mL of 0.1 N HCl solution with pepsin [250’000 units/L]. Stage 2: After 10 minutes add 50 mL of 18% SDS in 0.1 N HCl	Tier 1: 900; Tier 2: Stage 1: 850 mL, Stage 2: 900 mL	15, 30, 45, 60, and 90	2016/03/17