毛冬青滴丸的药学研究

【作者】 方芳；

【导师】 孙晓波；

【作者基本信息】 成都中医药大学 ， 中药学， 2005， 硕士

【摘要】 毛冬青是中国江南一些省区民间常用药,经药理实验和临床应用证明,是治疗心血管疾病较好的药物,现已应用于临床并载入《中药志》。毛冬青具有活血通脉,清热解毒的作用。本文研制开发了基于毛冬青活血通脉有效部位的现代中药滴丸剂—毛冬青滴丸,完成了其新药临床前的主要药学研究和部分药效学试验。主要研究内容和结果如下: 1.毛冬青的活血通脉有效部位与滴丸处方合理性分析:以药效学为指标,结合指纹图谱,研究毛冬青中作用于心血管系统的有效部位群—大孔吸附树脂有效部位,将毛冬青开发成毛冬青滴丸。 2.有效部位的制备工艺研究:以新毛冬青素及生产可行性为指标,筛选出醇提最佳工艺条件。 醇提液采取大孔吸附树脂精制,筛选出大孔吸附树脂精制最佳工艺条件。 首次研制出毛冬青活血通脉有效部位,含测分析表明,控制性指标物质的转移率均大于60%。 3.滴丸成型工艺研究:确定了毛冬青滴丸的最佳制剂处方。 4.对照品的分离及结构解析:分离、纯化对照物质,并作为控制原药材及成品的对照物质。经核磁共振、质谱解析确定了该物质的化学结构,为木脂素苷类。 5.质量标准的研究:利用高效液相色谱法、薄层色谱法等技术建立了毛冬青药材、原料药、滴丸的内在质量控制标准和方法。 6.指纹图谱的研制:利用高效液相色谱法,首次建立了毛冬青药更多还原

【Abstract】 Maodongqing as a classical herbal drug is used widely in south of China. Being soft bitter, sweet and normal, Maodongqing has the functions of activating the blood and invigorating pulse and dissipating heat and detoxifying.After analyzed the herbal drug, this study exploited a new dripping pills, Maodongqing dripping pills, whose prescription was made up of effective constitutes extracted from medicinal material. At the same time, the preparation, stability, quality and fingerprint were investigated synthetically in this paper.By comparing comprehensively the ethanol extract t with the water extract, the ethanol extract technique was selected and optimized according to the content of effective constitutes and extract yield for its economy and convenience. Macroporous adsorption resin was added into the concentrated ethanol extract to get rid of protein, starch, polysaccharose and so on. Then effective ingredients were enriched by ethyl acetate extraction and the transfer ratio was more than 60%.A marker was extracted and refined. The structure of the molecule was determined by ¹H-NMR, ¹³C-NMR. The quality of medicinal material, stuff drug and Maodongqing dripping pills were controlled successfully.This study built methods and standards for the quality control of medicinal material, stuff drug and Maodongqing dripping pills by HPLC .Speeding up experiment and remaining sample experiment all indicated that Maodongqing dripping pills had perfect stability, which was a key issue for modern Maodongqing dripping pills.For the first time, the fingerprints of the medicinal materials, stuff drug and Maodongqing dripping pills were set up. For sixty minutes, the peaks could be separated on baseline in HPLC chromatogram. A Computer Aided Similarity Evaluation expounded the correlations of更多还原