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Study on the Synthesis and Quality of Duloxetine Hydrochloride

Author: YangXiangYang
Tutor: LiJianJunï¼›QuLingBo
School: Zhengzhou University
Course: Pharmaceutical Analysis
Keywords: Duloxetine hydrochloride Quality standards Tablet
CLC: R927
Type: Master's thesis
Year: 2007
Downloads: 382
Quote: 1
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Abstract


Duloxetine hydrochloride is a 5 - serotonin / norepinephrine reuptake inhibitor , is an effective antidepressant . Duloxetine hydrochloride can effectively inhibit 5 - serotonin and norepinephrine reuptake , improve concentration within the cell gap . This product can effectively treat female urinary incontinence , diabetic peripheral neuropathic pain . The clinical application has to play a fast, effective and well tolerated , safe , with few side effects . Synthesis of duloxetine hydrochloride , a comprehensive study to determine an economically viable synthetic route . 2 - acetyl - thiophene, N - methylbenzylamine hydrochloride , paraformaldehyde as a starting material , the S- ( ) - mandelic acid split by the six-step reaction , the target compound duloxetine . The high yield of the synthesis process , the production is easy to control, low cost , and is suitable for industrial production . The synthesis of refined products through methods such as mass spectrometry , ultraviolet , infrared and nuclear magnetic resonance structure of conclusive evidence that the structure of the compound . Quality studies of duloxetine hydrochloride , residual solvent , the substance and content of key research , detection of residual solvent , the substance and content of basic the duloxetine quality standards for the development of the hydrochloric acid degree provide the basis . Stability of duloxetine hydrochloride . Observation of the high temperature , high humidity, glare and other influencing factors in the acceleration , the duloxetine hydrochloride stability under long-term conditions , in order to determine the storage conditions of duloxetine hydrochloride sealed and stored in a cool dark place . Duloxetine hydrochloride tablets are enteric-coated tablets , tablet quality research focused on the release by UV spectrophotometer ; tablet Determination follows the HPLC method of bulk drugs . Process routes identified simple and environmentally friendly , practical, quality bulk drugs and formulations , mature methods , quality control and evaluation of duloxetine hydrochloride tablets .

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CLC: > Medicine, health > Pharmacy > Pharmacopoeia Codex ( formulary ),drug identification > Drug identification
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