《丹参酮Ⅱa磺酸钠微量杂质的分离与结构鉴定》-毕业论文（设计）.docVIP

丹参酮Ⅱa磺酸钠微量杂质的分离与结构鉴定 摘 要 丹参酮IIa磺酸钠，是从药材丹参中提取的主要脂溶性有效成分丹参酮IIa经磺化反应后形成的一种水溶性钠盐，由于磺酸基的引入，提高了丹参酮IIa的水溶性，在治疗冠心病、心绞痛、心肌梗塞等疾病方面显示出与丹参酮IIa所无法比拟的优越性，成为主要的心血管类中药。 目前从丹参中提取丹参酮IIa的方法和药理活性研究较多，但对于丹参酮IIa磺酸钠杂质的研究很少，原料中的微量杂质成分的研究还是空白。在对丹参酮IIa磺酸钠的药理作用，在药物代谢动力学和相关文献报导的制备工艺等进行综合考察的基础上本课题采用色谱及波谱方法对丹参酮IIa磺酸钠进行微量杂质的分离及结构鉴定。同时，本文建立了高效液相色谱法测定原料药丹参酮ⅡA磺酸钠微量成份含量的方法，可用来对原料药和制剂进行质量控制。 关键词：羟基丹参酮IIa磺酸钠；丹参酮IIa磺酸钠；丹参酮IIa；分离；结构鉴定 Separation of Microimpurity and Identification of Sodium Tanshinone IIa Sulfonate Abstract: Salvia miltiorrhiza is one of the most important tradition Chinese medicinal materials that possess the function of both promoting blood flow and removing blood stasis with anti-coronary artery disease. The consumed quantity only in the aspect of injection has been exceeded 2 billion dosages every year. However, because the undetermined active ingredients and relaxed index of quality control induced the instable effects of clinic traterment, and, moreover, usually adverse functions, which lead salvia miltiorrhiza unable to accommodate requirement of contemporary Chinese medicinal materials melting world. Sulfotanshinone sodium is asodium chloride of water-solubility after sulfonating tanshinone IIa of liposolubility active ingredien tabstraeted in salvia miltiorrhiza.It is an effective medicine of angiocardiopathy to treat coronary artery disease, anginacordis，and myocardial infarction.The amount of clincal utilization continuous. increasing with the high proportion of patients of angiocardiopathy induces raw material resource of salvia miltiorrhiza insufficient in China. So it becomes an extensive focus point in fharmaceutical factory that sufficient utilize and cut down uymost dissipation resource of salvia miltiorrhiza. Keywords:1-Hydroxy-Tanshinone IIa sulfonate ; sodium tanshinoneⅡA sulphonate(STS);tanshinoneIIa;separation;identification 0 前 言 丹参是活血化淤的传统中药，具有良好的抗冠心病等作用。其制剂及复方制剂品种繁多，仅注射剂的年使用量就达20亿支以上，但多数产品有效成分不明确，质量控制指标不严格，由此导致临床疗效不稳定，不良反应时常出现，因此不能适应中药生产现代化和向国际市场挺进的要求。