八味丹参胶囊工艺及质量标准研究

【作者】 李昊宣；

【导师】 张元桐；

【作者基本信息】 辽宁中医药大学 ， 生药学， 2008， 硕士

【摘要】 本文以临床治疗冠心病药物为研究对象,以临床有效经验方剂为基础,完成临床经验方剂(主要由丹参、黄芪等中药组成)的部分新药开发工作。首先,对最佳组方进行工艺考察,在原有基础上进行合理、有效的改造,制定先进可行的工艺路线以提高产品疗效,研制成一种疗效确切、质量可控、服用剂量小、毒副作用小的新制剂。其次,确定合理可行的多指标质量控制方法,加强药物质量管理,建立该药成品及其各单味药材的指纹峰归属,并且采用电感耦合等离子体色谱仪对该药中的无机离子进行测定,分析该药中重金属元素、常量元素、有害元素,从而达到对该制剂质量的全面控制,为创新型药物研究打下良好基础。更多还原

【Abstract】 This thesis takes the clinical treatment of coronary artery as the object of study. Basing on the clinical effective empirical formula, it complete the new drug development of the empirical formula, consisted by salvia miltiorrhiza , salvia miltiorrhiza etc, and get an exactly effective new drug.First, it determines a rational high quality control method to enforce the quality of the drugs and accomplishes the fingerprints of the original herbs to control the preparing quality from the sources.Secondly,thorough the comparison of finished products, each flavor’s HPLC and the ultraviolet spectrums, it primarily discusses the sources and ascriptions of the liyan spray-film dosage’s fingerprints;moreover,develop the determination of inorganic with ICP-MS,analyze the elements of heavy metals、macroelements、harmful elements in the preparation.In order to set a good base for the research of drug’s second development and the innovate drugs.更多还原