抗抑郁药盐酸度洛西汀的合成及其质量标准的制定-药物分析学专业毕业论文.docxVIP

郑州人学硕i堵。位论文Abstract 郑州人学硕i堵。位论文 Abstract Duloxetine Hydrochloride is selective serotunin and norepinephrine reuptake inhibitor (SSNRI)for oral administration and has better pharmacological profile for antidepressant drug．Duloxetine is not only highly efficient antidepressant agent for treating psychiatric disorders，but also be used for treating other symptums such urinary incontinence，diabetic peripheral neuropathic pain and fibromyalgia．Duloxetine has some features such as improved efficacy,tolerability,safety,faster reCOVery,fewer side effects than other antidepressant in the clinical investigations． On the basis ofthe investigation about the synthetic methods ofdaloxetine which is promising ehiral medicine，an economical and reasonable synthetic roul[e was studied．The target compound Was obtained through resolution by S-(+)-mandelic acid and six steps．The starting materials include 2-aeetylthiophene，paraformaldehyda and concentrated and low cost process for the synthesis ofduloxetine hydrochloride is attained． The structural establishment is made for the compound with the methods ofMS、UV、IR、NMR and its structure is conformed． In the article．Duloxetine’s quality standard is basically determined after careful research an the relative material limit，organic volatile impurities and effective ingredient Contents．The stability research has also been performed under high temperature cirettmstanees，high wet circumstances and highlight circumstances respectively．Conclusions have been drawn out that at cool circumstances，the quality is stable，SO duloxetine preserve in well-closed containers，protected from light．Store at room temperature． Duloxetine enteric-coated tablets’quality standard is basically determined after careful research the realease as the UC This article has established HPLC method for determination Of duloxetine hydrochloride tablets and its related substances． The brief synthesis route is low-contamiuation and feasible．A comparatively rounded study whose