【作者】 周珏；

【导师】 王栋；

【作者基本信息】 黑龙江中医药大学 ， 中药学， 2004， 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，进行了北豆根总碱粉针剂的提取制备工艺和指纹图谱的研究。通过采用正交实验设计及T-检验等方法筛选出北豆根总碱制备的最佳工艺。利用Excel及SPSS11.0软件进行统计分析，分别比较了温浸法与渗漉法的优缺点，选取渗漉法为提取方法。以北豆根中酚性总碱含量为指标，对十个不同来源的北豆根药材进行含量测定及聚类分析，将其分为三类，确定了含量较高的三个来源。 本文首次对北豆根总碱粉针剂进行了指纹图谱研究。采用高效液相色谱法确定了其特征指纹图谱，同时进行了方法学考察，确定了相关的技术参数。以蝙蝠葛碱为对照品，对其共有峰的相对保留时间和相对峰面积进行分析，利用夹角余弦法和相关系数法对指纹图谱进行评价，其相似度及各项指标均符合有关要求。 本实验对北豆根总碱及其制剂的提取制备工艺和指纹图潜进行了初步研究。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 dry Rhizoma of Menispermum dauricum is a kind of Traditional Chinese Medicine in common use and the substance extracted from it is clinically used in treating faucitis. It has also been known in recent years 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 fingerprint of powder injection of the whole alkali of Rhizoma Menispermi according to the criterion of the fifth category of new Traditional Chinese Medicines in the management of leechdom enrollment and the technical requirement in the researches on Traditional Chinese Medicine injections, which through orthogonal design test and some other methods , helps us choose the optimum techniques to prepare the whole alkaloid of Rhizoma Menispermi. With the software of Excel and SPSS 11.0 in the statistical analysis , the two methods of warm immersion and infiltration are compared, and the latter is ascertained. With indexes of the contents of the whole alkaloid of hydroxybenzene in Rhizoma Menispermi, assaying and cluster analysis are applied on the ten different resources of Rhizoma Menispermi , which in the end makes certain the three highest ones.The essay is the first fingerprint study on powder infection of the whole alkaloid of Rhizoma Menispermi .Through HPLC and observation on methodology , the pertinent technical parameters are ascertained. With Dauricine as the control material , the relative reservation hours of the mutual peaks and the relative areas are analyzed and in Cosine as well as other ways , the fingerprints are evaluated ,which proved that the similarity and all the indicativesaccord with the pertinent requirements.The study is a primary one on the techniques of extraction , preparation and fingerprint of powder injection of the whole alkaloid in Rhizoma Menispermi , which establishes an important base for the preparation to apply to the fifth category of new Traditional Chinese Medicines.更多还原