【作者】 张艳；

【导师】 王栋；

【作者基本信息】 黑龙江中医药大学 ， 中药学， 2008， 硕士

【摘要】 北豆根为防己科植物蝙蝠葛(Menispermum dauricum DC.)的干燥根茎,为常用中药。其提取物临床上常用于治疗咽喉炎。近年来研究发现北豆根中的蝙蝠葛碱(Dauricine)对高血压和心律失常有较好的治疗作用,因此将蝙蝠葛碱开发为新药蝙蝠葛碱胶囊用于临床具有十分重要的现实意义。本项研究按照国家《中药、天然药物注册分类及申报资料要求》的标准和《中药新药质量标准的技术要求》,运用现代科技手段,对蝙蝠葛碱的提取、分离纯化工艺、制剂成型性工艺及制剂质量等新药药学部分内容做了较为深入的研究。首先以蝙蝠葛酚性总碱含量为指标,采用酸溶碱沉法筛选出酚性总碱的最佳提取工艺,采用此工艺分别对三批不同来源北豆根药材进行提取分离得到酚性总碱,经测定提取物中酚性总碱含量在73.63%～80.72%之间;继以蝙蝠葛碱含量为指标,在酚性总碱的基础上首次应用萃取法分离纯化得到蝙蝠葛碱,经HPLC法测定蝙蝠葛碱的平均含量为93.22%;最后将该蝙蝠葛碱制备为胶囊剂。同时按《中国药典2005版》和《中药新药质量标准研究的技术要求》对制剂的质量进行了研究,采用高效液相色谱法对三批蝙蝠葛碱胶囊中的蝙蝠葛碱进行含量测定,结果表明:三批制剂蝙蝠葛碱的含量在91.61～95.24%之间。本实验对蝙蝠葛碱的提取、分离纯化工艺、剂型成型性工艺、制剂质量等新药药学部分做了较为深入的研究,为蝙蝠葛碱胶囊的研制奠定了重要的药学基础。更多还原

【Abstract】 Rhizoma Menispermi, the Rhizoma of Menispermum dauricum DC is a kind of Traditional Chinese Medicine in common use and Rhizoma Menispermi tablet, the substance extracted from it is clinically used in treating faucitis. Presently, It is found that the Dauricine have eminent curative effect on diseases of hypertension as well as cardiac arrhythmia . For this reason to develop capsules of Dauricine has significant practical importance.The research is a study on extraction, separation , purification, preparation technology and quality control of capsules of Dauricine by modern techniques, according to the technical requirement in the researches on Traditional Chinese Medicine, the criterion of new Traditional Chinese Medicines in the management of leechdom enrollment .First of all with whole alkaloid of hydroxybenzene as the standard substance , method of Acid-dissolve and alkali-precipitate extraction and preparation are applied on the three different resources of Rhizoma Menispermi, it is found that contest of whole alkaloid of hydroxybenzene of the source drug lie in between percent 73.63 and percent 80.72. Secondly, with extraction method to part Dauricine from whole alkaloid of hydroxybenzene for the first time. Through High performance liquid chromatography the average content of Dauricine is percent 93.22. According to Chinese pharmacopoeia, the technical requirement in the researches on Traditional Chinese Medicine, do research on quality control of capsules of Dauricine, through High performance liquid chromatography, it is found that contest of capsules of Dauricine lie in between percent 91.61 and percent 95.24.The study is on the techniques of extraction, separation , purification , preparation technology and quality control of gelatin capsule of Dauricine, which establishes an important base for the preparation of new Traditional Chinese Medicines.更多还原