【作者】 李元波；

【导师】 殷辉安； 唐明林；

【作者基本信息】 成都理工大学 ， 分析化学， 2005， 硕士

【摘要】 舒心降压颗粒是基于临床经验方开发研制成的现代中药复方制剂,主要由三七、郁金、丹参、当归等中药组成。 本研究根据《药品注册管理办法》,按中药第六类新药的研制要求,以处方药物的化学成分、性质和药理作用为依据,确定了舒心降压颗粒的制备工艺路线和主要工艺指标成分:三七总皂苷、姜黄素、原儿茶醛、挥发油,以各有效成分含量及干膏率为指标,采用正交实验法和单因素法全面系统的优化了三七皂苷的复合酶解法提取、姜黄素的乙醇回流法提取、水煎煮提取、当归挥发油的水蒸气蒸馏和超声包合、浓缩、除杂、制粒等工艺条件。采用薄层色谱法对各有效成分进行了鉴别,采用HPLC法对主要有效成分人参皂苷Rg₁和姜黄素的含量进行测定,从而建立了该复方制剂的质量控制内容。 各提取方法中有效成分含量稳定,三批制剂样品中人参皂苷Rg₁和姜黄素的平均含量分别为1.495mg/g_颗粒、1.033mg/g_颗粒,说明制备工艺稳定可行。 在各药材的薄层色谱鉴别中,各有效成分斑点清晰,阴性无干扰,分离效果较好;采用HPLC法测定颗粒中人参皂苷Rg₁和姜黄素含量时,均能与其他组分分离,回收率分别为98.1%、98.2%。结果表明建立的质量控制体系专属性强、准确稳定,为制剂的内在质量控制提供了可靠的保证。更多还原

【Abstract】 Shuxinjiangya granule is a new modem compound preparation of Chinese medicine based on a clinically experienced prescription of Traditional Chinese Medicine, which contains the tuber of Panax notoginseng,Curcuma Louga L, Radix salviae miltiorrhizae, Radix Angelica Sinensis.According to "regulator regime of new medicine register" and requirement of the No.6 class of new Chinese medicines,and under the function and indication of the formula and the properties of its chemical components, as well as their pharmacology function, the route of preparative procedure and index components were ascertained. Guided by the contents of index components, which were curcumine, saponins and volatile oil, the extract rate and so on, the research used orthogonal experiment design or signal factor method to optimum conditions of preparation, which included Conbined enzymolysis extraction, refluxing extraction, water decocting extraction, purification, steam distillation, packing procedure, condensing and drying process, granulation.The reduplicate experiments and feasible analysis were conducted.under optimum operating condition. Moreover, the formula were identified by TLC, at the same time, curcumin and Panax saponin Rg₁ were determined, so that the research establish the main quality control of patent medicine.The content of effective component kept stable in all kinds of extraction means. The Panax saponin Rg₁ and curcumin content in the granule is 1.495mg/g_granule, 1.033mg/g_granule which showed that the preparation technology was stable, reasonable and practical.In the identifying materials of all kinds of medicinal materials by TLC, materials and sample had many same, clearly colorific speckles at the corresponding place without interferes of negative contrasts, and the separation effect was fine; HPLC methods being used to determine the Panax saponins Rg₁ and curcumin content, negative contrasts also were not interferential, the recovery of the components arrived at 98.1%, 98.2%. The results showed that these methods controlling quality were selectively, accurate and stable.更多还原