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
Naltrexone	Injectable Suspension			Phosphate buffered saline with 0.02% Tween 20 and 0.02% Sodium azide, pH 7.4 (final osmolality should be 270 ± 20 mOsm), or any other appropriate medium, at 37°C. 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			2011/09/01
Naltrexone HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Naltrexone HCl / Oxycodone HCl	Capsule (Extended Release)			Develop a dissolution method			2016/12/22
Naltrexone HCl/Bupropion HCl	Tablet (Extended Release)			Develop a dissolution method			2023/09/15
Naproxen	Suspension			Develop a dissolution method			2017/11/16
Naproxen	Tablet (Delayed Release)			Refer to USP			2009/12/15
Naproxen	Tablet			Refer to USP			2007/07/25
Naproxen Sodium	Tablet (Extended Release)	II (Paddle)	50	Phosphate Buffer, pH 7.5	900	0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 14 hours	2010/04/08
Naproxen Sodium	Tablet			Refer to USP			2012/10/04
Naproxen Sodium	Capsule	II (Paddle)	75	Sodium Phosphate Buffer, pH 7.4 ± 0.05	900	10, 15, 20, 30 and 45	2015/05/28
Naproxen Sodium/Diphenhydramine HCl	Tablet	II (Paddle)	75	0.1M Sodium Phosphate buffer, pH 7.4 (deaerated)	900	5, 10, 15, 20 and 30	2015/06/25
Naproxen Sodium/Diphenhydramine HCl	Tablet	II (Paddle)	75	0.1M Sodium Phosphate Buffer, pH 7.4	900	5, 10, 15, 20, 30 and 45	2015/05/28
Naproxen Sodium/Sumatriptan Succinate	Tablet	I (Basket)	75	Phosphate Buffer, pH 6.8	900	10, 15, 20, 30 and 45	2010/07/01
Naproxen/Esomeprazole Magnesium	Tablet (Delayed Release)	II (Paddle) with sinkers	Naproxen::50 rpm Esomeprazole::75 rpm	Naproxen:: Acid Stage: 0.1M HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8. Sampling for Acid stage: Transfer the un-dissolved tablet & sinker to the vessel containing the buffer stage medium. Add, 10 mL of 10 M NaOH to each vessel of the remaining acid stage medium. Continue rotation at 100 rpm for 30 minutes, withdraw aliquot and analyze. Esomeprazole (second set of tablets)(without pre-exposure to acid stage):: 0.05M Phosphate buffer, pH 7.4	Naproxen::Acid Stage: 1000; Buffer Stage: 1000; Esomeprazole::900	Naproxen:: Acid stage: 120; Buffer stage: 10, 20, 30, 45, 60, 75 and 90; Esomeprazole::10, 20, 30, 45, 60, 75 and 90	2013/06/06
Naratriptan HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Nateglinide	Tablet	II (Paddle)	50	0.01 N HCl with 0.5% (w/v) SLS	1000	10, 20, 30 and 45	2007/01/03
Nebivolol HCl	Tablet	II (Paddle)	50	0.01 N HCl	900	10, 20, 30 and 45	2010/01/15
Nebivolol/Valsartan	Tablet	I (Basket)	100	67 mM Phosphate Buffer pH 6.8 with 0.5% SDS	900	5, 10, 15, 20 and 30	2016/10/20
Nefazodone HCl	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30, 45 and 60	2007/01/03
Nelfinavir Mesylate	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20, 30, 45, 60 and 90	2007/01/03