右佐匹克隆定时释放片的研究

发布时间：2024-02-13 22:31

　　近年来,随着现代化进程的不断推进,生活节奏不断加快,人们的生活压力也不断增加,失眠问题逐渐成为了炙手可热的焦点问题。失眠症是指在良好的睡眠条件下,不存在任何睡眠影响因素时,无法入睡或无法维持睡眠状态,导致日间疲劳、痛苦、日间功能障碍,降低生活质量,并增加精神健康问题、滥用药物和酒精的风险,同时增加医疗保健的占用率。研究显示,失眠与高发的心血管系统疾病如高血压等密切相关。失眠症对于人们的身心健康和生命质量危害极大,是造成意外事故和死亡的高危因素。右佐匹克隆是一种非苯二氮?类镇静催眠药物,相比于苯二氮?类药物,右佐匹克隆具有起效快、作用时间短、安全性高、成瘾潜力低等优势。2004年美国食品药物管理局(FDA)批准该药用于治疗失眠,为目前较为理想的一线助眠药物,2007年由天士力集团首先在国内上市。作为佐匹克隆的右旋异构体,右佐匹克隆对苯二氮?受体的亲和力是左旋体的50倍,具有缩短入睡时间、延长睡眠时间、减少觉醒次数、提高睡眠质量等特点。由于是单一的光学异构体给药,可避免服用消旋佐匹克隆产生的副作用,如:由于唾液分泌药物引起的口干、倦睡、早晨疲劳、头痛、眩晕、神经运动功能损伤等。右佐匹克隆的...

【文章页数】：96 页

【学位级别】：硕士

【文章目录】：
摘要
abstract
Chapter1 Background
    1.1 Introduction
    1.2 Discovery and efficacy of eszopiclone
    1.3 Research progress in oral time controlled released preparations
    1.4 Clinical application and drawbacks of eszopiclone
    1.5 Proposing of the subject
Chapter2 Physical Properties of Eszopiclone
    2.1 Equipment and chemicals
        2.1.1 Equipment
        2.1.2 Chemicals
    2.2 Methods
        2.2.1 Determination of the solubility of eszopiclone
        2.2.2 Melting point
        2.2.3 Specific rotation
    2.3 Results and discussion
        2.3.1 Determination of the solubility of eszopiclone
        2.3.2 Melting point
        2.3.3 Specific rotation
    2.4 Conclusion
Chapter3 Preformulation Studies
    3.1 Equipment and chemicals
        3.1.1 Equipment
        3.1.2 Chemicals
    3.2 Methods
        3.2.1 Pretreatment of eszopiclone API via micronization
        3.2.2 Establishment of method for determination of the dissolution curve
        3.2.3 Establishment of method for determination of the content
        3.2.4 Establishment of method for chiral impurity detection
    3.3 Results and discussion
        3.3.1 Pretreatment of eszopiclone API via micronization
        3.3.2 Establishment of method for determination of the dissolution curve
        3.3.3 Establishment of method for determination of the content
        3.3.4 Establishment of method for chiral impurity detection
    3.4 Conclusion
Chapter4 Preparation of Eszopiclone Tablet Core
    4.1 Equipments and chemicals
        4.1.1 Equipment
        4.1.2 Chemicals
    4.2 Methods
        4.2.1 Evaluation indicators
        4.2.2 Preparation processes for the tablet core
        4.2.3 Screening of the tablet core formulation
        4.2.4 Investigation of preparation processes of the tablet core
    4.3 Results and discussion
        4.3.1 Screening of the tablet core formulation
        4.3.2 Determination of eszopiclone’s tablet core formulation
        4.3.3 Investigation of preparation processes of the tablet core
    4.4 Conclusion
Chapter5 Preparation of Eszopiclone Time-controlled Release Tablets
    5.1 Equipment and chemicals
        5.1.1 Equipment
        5.1.2 Chemicals
    5.2 Methods
        5.2.1 The preparation process of time-controlled release tablets
        5.2.2 The preparation of swelling layer and controlled release layer
        5.2.3 The influence of different conditions on the dissolution rate
    5.3 Results and discussion
        5.3.1 The preparation of swelling layer and controlled release layer
        5.3.2 Experimental verification
        5.3.3 The influence of different conditions on the dissolution rate
    5.4 Conclusion
Chapter6 Pharmacokinetic Study on Eszopiclone Time-controlled Release Tablets
    6.1 Equipment and chemicals
        6.1.1 Equipment
        6.1.2 Chemicals
    6.2 Methods
        6.2.1 Administration to animals and blood collection protocol
        6.2.2 Processing method for plasma samples
        6.2.3 LC-MS/MS chromatographic conditions
    6.3 Results and discussion
    6.4 Conclusion
Chapter7 Conclusions
References
Publications
Acknowledgements



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