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
Estradiol (E2);Progesterone (Pro)	Capsule	III (Reciprocating Cylinder)		E2: USP capsule rupture test Pro: 2.0% sodium lauryl sulfate (SLS) in 0.1 N HCl (3 drops of simethicone to prevent foaming) with 8 mesh basket sinkers	250	Pro: 5, 10, 15, 20, 25 and 30	2026/01/28
Estradiol (Test 1) (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr)	Film, Transdermal (Extended Release)	VI (Cylinder) attach the patch to a disk at the bottom of the cylinder	50	Water at 32 ± 0.5°C	0.025 mg/24 hr and 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL	1, 2, 4, 6, 8, 10 and 12 hours	2010/10/28
Estradiol (Test 2) (0.05 mg/24 hr and 0.1 mg/24 hr)	Film, Transdermal (Extended Release)	V (Paddle over Disk) with a stainless steel disk	50	Water at 32 ± 0.5°C	900	6, 12, 18, 24, 36, 48, 60, 72 and 96 hours	2010/10/28
Estradiol (Test 3) 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr)	Film, Transdermal (Extended Release)	VI (Cylinder) attach the patch to the cylinder with double-sided tape	50	Water at 32 ± 0.5°C	0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL	1, 2, 4, 6, 10, 12, 18, 24 and 36 hours	2013/10/31
Estradiol/Levonorgestrel	Film, Transdermal (Extended Release)	V (Paddle over Disk) attach the patch to the stainless steel plate with double-sided tape	50	30% Ethanol in water at 32±0.5°C	660	30, 60, 120, 180, 240 and 300	2023/03/30
Estradiol/Norethindrone Acetate	Film, Transdermal (Extended Release)	V (Paddle over Disk)	50	0.24% SDS in water at 32±0.5°C	0.05 mg/0.14 mg/24 hr: 500; 0.05mg/0.25 mg/24 hr: 900	1, 2, 4, 8, 12 and 14 hours	2023/03/30
Estradiol/Norethindrone Acetate	Tablet			Develop a dissolution method			2024/01/03
Estradiol/Norgestimate (1mg/0.09mg)	Tablet			Develop a dissolution method			2023/09/15
Estradiol/Progesterone	Capsule	III (Reciprocating Cylinder) [40 mesh for bottom and top of the inner tube]		3% sodium lauryl sulfate (SLS) in 0.1N HCl	250	10, 20, 30, 45 and 60	2020/01/30
Estramustine Phosphate Sodium	Capsule			Develop a dissolution method			2023/09/15
Estrogens Conjugated Synthetic A	Tablet			Develop a dissolution method			2023/09/15
Estrogens, Conjugated (EC)/Medroxyprogesterone Acetate (MPA)	Tablet	II (Paddle) with sinker	50	EC: 0.02 M Na Acetate Buffer (pH 4.5); MPA: Develop a dissolution method	900		2023/09/15
Estrogens, Conjugated Synthetic B	Tablet			Develop a dissolution method			2023/09/15
Eszopiclone	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Ethacrynic Acid	Tablet			Refer to USP			2010/12/23
Ethambutol HCl	Tablet			Develop a dissolution method			2024/01/03
Ethinyl Estradiol	Tablet			Refer to USP			2011/09/22
Ethinyl Estradiol/Ethynodiol Diacetate	Tablet			Develop a dissolution method			2023/09/15
Ethinyl Estradiol/Etonogestrel	Vaginal Ring			Develop a method to characterize in vitro release			2013/01/31
Ethinyl Estradiol/Levonorgestrel	Transdermal System	V (paddle over disk)	75	0.25% Hydroxypropyl-Beta-Cyclodextrin (HPCD) in Water (Deaerated ), 32±0.5˚C	500	1, 2, 4, 6, 12, 24, 36, 48, 72 and 96 hours	2022/05/12