FDA对于溶出曲线的指导原则？好人做到底，1%以上SDS/SLS只是不提倡，并不代表不可以使用，我检索了FDA溶出数据库，找到以下15个实例产品，希望对你有所帮助。 1.Ziprasidone HCl 介质：Tier I: 0.05 M Na phosphate buffer, pH 7.5 + 2% SDS (w/w) Tier II: 0.05 M Na phosphate buffer, pH 7.5 (700ml) + 1% pancreatin. After 15 min. incubation, add 200 mL of phosphate buffer containg 9% SDS 2.Zileuton 介质：0.1 M SDS (sodium dodecyl sulfate) in water 3.Rufinamide 介质：2.0% SDS (sodium dodecyl sulfate) in water 4.Dutasteride 介质：ier 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. 5.Disulfiram 介质：2% SDS 7.Efavirenz 介质：2% SLS in water 8. Efavirenz 600 mg; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg 介质：2% SLS in water 9.Etravirine (200 mg) 介质：1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 1000 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 800 mL of 2.25% SLS in 0.01 M HCl. 10.Etravirine (25 and 100 mg) 介质：1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 500 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 400 mL of 2.25% SLS in 0.01 M HCl. 11.Lamivudine/Zidovudine + Efavirenz 介质：Lamivudine and Zidovudine: 0.1 N HCl Efavirenz: 2% SLS in water 12.Lamotrigine 介质：Acid Stage: 0.01M HCl; Buffer Stage: Phosphate Buffer, pH 6.8 + 0.5% SLS (Add 200 mL of 0.0205M tribasic sodium phosphate (pH 12) solution containing 2.25% w/v SLS to 700 mL of HCl) 13.Metolazone 介质：2% SLS in 0.05 M Sodium Phosphate Buffer, pH 7.5 14.Orlistat 介质：3% SLS in 0.5% Sodium Chloride, pH 6.0 15.Thalidomide 介质：1.5% (w/v) SLS (pH 3.0, adj w/ HCl)查看更多
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