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
Nicotine Polacrilex	Lozenge	I (Basket)	100	Phosphate Buffer, pH 7.4	900	0.5, 1, 2, 3, 6 and 8 hours	2010/12/23
Nicotine Polacrilex	Chewing Gum	Chewing Machine as desribed in European Pharmacopoeia (2.9.25)	60 cycles (chews) per minute	Phosphate Buffer, pH 7.4 or or any other appropriate buffer and conditions	20	5, 10, 20 and 30	2012/01/05
Nifedipine	Capsule			Refer to USP			2011/03/03
Nifedipine	Tablet (Extended Release)			Develop a dissolution method			2024/01/03
Nifurtimox	Tablet	II (Paddle)	100	Acetate Buffer, pH 4.5 with 1.0 % Sodium Dodecyl Sulfate (SDS) (for 30 mg strength) and 1.5 % SDS (for 120 mg strength)	900	10, 20, 30, 60 and 75	2022/07/07
Nifurtimox	Tablet	II (Paddle)	100	Acetate buffer pH 4.5 with 1% sodium dodecyl sulfate (SDS) for 30 mg strength and 1.5 % SDS for 120 mg strength	900	15, 30, 45, 60, 90 and 120	2023/02/09
Nilotinib HCl	Capsule	I (Basket)	100	0.1 N HCl	1000	10, 15, 20, 30 and 45	2024/02/05
Nilotinib Hydrochloride Monohydrate	Capsule	I (Basket)	100	0.1 N HCl	1000	10, 15, 30 and 45	2009/10/30
Nilotinib Tartrate	Tablet	II (Paddle)	75	pH 6.8 Buffer with 1.25% CTAB	1000	5, 10, 15, 20, 30, 45 and 60	2026/01/28
Nilutamide	Tablet			Develop a dissolution method			2009/05/20
Nimodipine	Capsule			Develop a dissolution method			2023/09/15
Nintedanib Esylate	Capsule	II (Paddle) with sinker	100	0.1 N HCl	900	10, 15, 20, 30, 45 and 60	2015/09/03
Niraparib	Capsule	II (Paddle) with sinker	50	Tier 1: 0.08M Sodium Acetate Buffer, pH 4.0; Tier 2: 0.08M Sodium Acetate Buffer, pH 4.0 containing pepsin (750,000 units/L)	900	10, 15, 20, 30, 45 and 60	2017/11/02
Niraparib Tosylate	Tablet	II (Paddle)	60	0.1 M Citrate buffer, pH 4.6	900	5, 10, 15, 20, 25, 30 and 45	2024/02/05
Nirmatrelvir (NIR); Ritonavir (RIT)	Tablet (copackage)	II (Paddle)	75	NIR: 0.05 M Sodium Phosphate, pH 6.8 with 0.2% Sodium Dodecyl Sulfate; RIT: Refer to USP	900	15, 20, 30, 45 and 60	2024/08/05
Nirogacestat Hydrobromide	Tablet	II (Paddle)	75	pH 1.2 HCl buffer	500	5, 10, 15, 20, 30, 45 and 60	2025/09/08
Nisoldipine	Tablet (Extended Release)	II (Paddle) with option to use a sinker	50	HCl with SLS (32.5 ± 0.1 g Sodium Lauryl Sulfate in 6489 mL of purified water containing 17.0 mL HCl, pH adjusted to 1.20 ± 0.05 with HCl)	900	1, 4, 8, 12, 15, 18 and 24 hours	2009/04/02
Nitazoxanide	Tablet	II (Paddle)	75	Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC	900	10, 20, 30, 45, 60	2007/01/03
Nitazoxanide	Oral Suspension	II (Paddle	100	Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC	900	10, 20, 30, 45 and 60	2010/10/21
Nitisinone	Capsule	II (Paddle) with sinker	50	Phosphate Buffer, pH 6.8	1000	5, 10, 15, 20, 30 and 45	2017/11/02