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
Doxycycline Hyclate ( 150 mg and 75 mg)	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Doxycycline Hyclate ( 200 mg, 150 mg, 100 mg, 80 mg and 75 mg)	Tablet (Delayed Release)			Refer to USP			2015/05/28
Doxycycline Hyclate ( 50 mg)	Tablet (Delayed Release)	I (Basket)	100	Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5	900	Acid stage: 5, 10, 15, 20 and 30; Buffer stage: 5, 10, 15, 20 and 30	2015/05/28
Doxylamine Succinate/Pyridoxine HCl	Tablet (Extended Release)	II (Paddle)	100	Acid stage: 0.1 N HCl: Buffer stage: 0.2M sodium phosphate buffer pH 6.8	Acid stage: 1000 mL; Buffer stage: 1000 mL	Acid stage: 5, 10, 15, 30, 60, 120; Buffer stage: 5, 10, 15, 20 and 30	2017/01/19
Dronabinol	Capsule			Develop a dissolution method; (In addition, the USP capsule rupture test should also be conducted)			2023/09/15
Dronedarone HCl	Tablet	II (Paddle) with sinker	75	pH 4.5 Phosphate buffer	1000	10, 15, 20, 30, 45, 60, 90 and 120	2015/02/25
Drospirenone/Estetrol	Tablet	II (Paddle)	50	Phosphate Buffer pH 6.8	900	5,10, 15, 20 and 30	2023/03/30
Drospirenone/Estradiol	Tablet			Develop a dissolution method			2023/09/15
Drospirenone/Ethinyl Estradiol	Tablet			Develop a dissolution method			2024/01/03
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium	Tablet	II (Paddle)	50	Phosphate buffer pH 6.8, saline with 0.03 % ascorbic acid	900	5, 10, 15, 20 and 30	2016/07/28
Droxidopa	Capsule			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Duetetrabenazine	Tablet, Extended Release	II (Paddle) with sinker	75	50 mM potassium biphthalate buffer, pH 3.0	500	2, 4, 6, 8, 10, 12. 16 and 20 hours	2023/11/30
Duloxetine HCl	Capsule (Delayed Release)			Refer to USP			2016/03/17
Dutasteride	Capsule (Soft-Gelatin)	II (Paddle)	50	Tier I: Dissolution Medium: 0.1 N HCI with 2% (w/v) sodium dodecyl sulfate (SDS) (900 mL) Tier II: Dissolution Medium: 0.1 N HCI with pepsin (as per USP) (450 mL) for the first 25 minutes, followed by addition of 0.1 N HCI with SDS (4% w/v) (450 mL) for the remainder of the dissolution test.	900	15, 30, 45 and 60	2010/08/05
Dutasteride/Tamsulosin HCl	Capsule	Dutasteride: II (Paddle) with sinker. Tamsulosin: II (Paddle)	Dutasteride: 75 Tamsulosin: 50	Dutasteride::Tier I: Dissolution Medium: 1%w/v cetyltrimethylammonium bromide (CTAB) in 0.1 N HCl. Tier II: Dissolution Medium: 1% w/v CTAB in 0.1 N HCl with 0.16% w/v pepsin. Tamsulosin:: Acid Stage (0-2 hrs): 0.1 N HCl. Buffer stage: Add 250 mL of 0.2 M Sodium Phosphate Tribasic, Dodecahydrate pH 6.8	Dutasteride: 900. Tamsulosin: Acid stage: 750; Buffer stage: 1000	Dutasteride: 15, 30, 45 and 60 minutes. Tamsulosin: Acid Stage: 2 hours Buffer stage: 0.5, 1, 2, 3, 5, 7 and 10 hours	2012/01/26
Edaravone	Suspension	II (Paddle)	75	pH 4.0 Acetate Buffer	900	5, 10, 15, 20 and 30	2022/07/28
Efavirenz	Capsule			Develop a dissolution method			2023/09/15
Efavirenz	Tablet			Develop a dissolution method			2023/09/15
Efavirenz 600 mg; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg	Tablet			Develop a dissolution method			2023/09/15
Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate	Tablet			Develop a dissolution method			2023/09/15