【作者】 刘岩；

【导师】 王栋；

【作者基本信息】 黑龙江中医药大学 ， 中药学， 2005， 硕士

【摘要】 北豆根为防己科植物蝙蝠葛(Menispermum douricum 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)和酚性总碱对脑梗塞和心肌缺血均有较好的治疗作用。 本项研究按照《药品注册管理办法》(试行)中药5类新药的标准和中药注射剂研制的技术要求,并按照《中药新药制备工艺研究的技术要求》及《中药新药质量标准研究的技术要求》,运用现代科技手段和方法,对北豆根及其粉针剂中试规模的提取制备工艺及质量标准进行了深入研究。采用酸溶碱沉法对三批不同来源北豆根药材分别进行提取分离,得到有效部位并采用冻干技术制备成粉针剂。以北豆根中酚性总碱含量为指标,以蝙蝠葛碱为对照品,首次采用紫外分光光度法对三批原料药及制剂分别进行了酚性总碱的含量测定,结果表明:原料药的酚性总碱含量在83.43%～91.24%之间,制剂的酚性总碱含量在82.88%～90.74%之间,符合国家5类新药注射剂的含量标准,同时进行了方法学的考察。采用高效液相色谱法对三批北豆根粉针剂中的蝙蝠葛碱进行了含量测定,结果表明:原料药中蝙蝠葛碱含量在54.18%～65.93%之间,制剂中蝙蝠葛碱含量在54.12%～65.48%之间。对《鉴别》、《检查》、《浸出物测定》等项进行研究,确定了相关的技术参数,结果各项指标均符合中药注射剂的有关要求。 本实验是对北豆根酚性总碱粉针剂中试规模的提取制备工艺和质量标准的研究。为该制剂申报5类新药奠定了重要基础。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 and the whole alkaloid of hydroxybenzene have eminent curative effect on diseases of brain infarct as well as cardial ischemia .The research is a study on extraction, preparation and quality control of powder injection of the whole alkali of Rhizoma Menispermi by modern techniques, according to the criterion of the fifth category of new Traditional Chinese Medicines in the management of leechdom enrollment , the technical requirement in the researches on Traditional Chinese Medicine injections and other techniques, which helps us choose the optimum techniques to prepare the whole alkaloid of Rhizoma Menispermi. Method of Acid-dissolve and alkali-precipitate extraction and preparation are applied on the three different resources of Rhizoma Menispermi, which in the end get the effective position and adopt freezing the technology of doing to prepare into powder injection. The essay is the study on powder infection of the whole alkaloid of Rhizoma Menispermi. According to the technical demamds of quality standard of new drug,with Dauricine as the standard substance,Through Ultraviolet spectrophotometry,High performance liquid chromatography and observation of on methodology , It is found that contest of the whole alkaloid of the resource drug lie in between pecent 83.43 and pecent 91.24, and that of the powder injection lie in between pecent 82.88 and pecent 90.74. It is also found that contest of Dauricine of the resource drug lie in between更多还原