【作者】 王晓丽；

【导师】 王建明；

【作者基本信息】 黑龙江中医药大学 ， 药剂学， 2007， 硕士

【摘要】 脑得生片（丸）为药典方，由三七、川芎、红花、葛根、山楂（去核）组成，具有活血化瘀，疏通经络，醒脑开窍的功效，用于脑动脉硬化，缺血性脑中风及脑出血后遗症。本课题系统地研究了复方脑得生有效成分的提取、精制以及复方脑得生口服液成型工艺、稳定性的评价，研制出了疗效确切、作用迅速、质量稳定、口感好的脑得生口服液剂型。在制备工艺的研究中：在方中各味药的提取实验中，采用正交实验的方法，运用分光光度计为检测手段，以三七总皂苷为定量指标，优选了三七的醇提取工艺；运用高效液相法，以葛根素为定量指标，拟定葛根、川芎、山楂、红花及三七醇提后残渣的水提条件；用沉淀法分别对三七醇提液和五味药材的水提液进行了精制；将精制液合并，加入PH调节剂，并用高速离心的方法对药材的精制液进行进一步纯化后，加入矫味剂，灌封、灭菌制得脑得生口服液。在质量标准的研究中：对川芎、红花、葛根等药进行了薄层定性鉴别，斑点分离效果好、阴性对照无干扰，证明所选方法专属性强；含量测定采用HPLC梯度洗脱法测定方中君药三七主要有效成分三七皂苷R₁、人参皂苷Rg₁、人参皂苷Rb₁的含量，测得加样回收率分别为100.35％（RSD=1.69％），99.95％（RSD=1.26％），100.32％（RSD=1.38％），含量分别不低于0.234mg／ml，0.957mg／ml，0.477mg／ml；通过初步稳定性试验证明工艺合理可行，质量稳定、可控。本研究以中医药理论为指导，采用现代技术为实验手段，为脑得生开发新剂型提供质量评价方法，为脑得生口服液工业大生产提供了科学依据，为新药开发研究奠定了良好的基础。更多还原

【Abstract】 The formula of Naodesheng tablet（pill） comes from Chinese Pharmacopoeia, which is made of several Chinese herbs, including Radix Notoginseng, Rhizoma Ligustici Chuanxiong, Flos Carthami, Radix Puerariae and Fructus Crataegi. The major effects of this medicine include reducing stasis and improving blood circulation, mediating main and collateral channels, and regaining consciousness. It is a remedy for cerebral arteriosclerosis, stroke and sequelae of cerebral hemorrhage. The topic systematically reseach on extraction, purifying the effective component of Naodesheng, on the molding process, and on the appraisal of stability, which has achieved the topic design goal.In this research, orthogonal method was designed to screen the extraction procedure of all drug components to get the best one. Quantitative analysis was carried out on total notoginseng saponin, puerarin by spectrophotometer method, HPLC to ensure quality control of NDS oral liquid.When we studied the quality standard, we used the TLC to identify the Rhizona Ligustici Chuanxiong, Flos Carthami, radix puerariae respectively, the separation of the stains was apparent and the negative contrast was not disturbed. All of these proved that the method we used is specific. We used HPLC gradient elution method to determination the amount of Notoginsenoside R₁, Ginsenoside Rg₁ and Rb₁ in Naodesheng Oral Liquid. Their average recoveries: Notoginsenoside R₁ was 100.35% （RSD=1.69%） , Ginsenoside Rg₁ was99.95%（RSD=1.26%） and Ginsenoside Rb₁ was 100.32% （RSD=1.38%） , respectively. Through the tentative stability of Naodesheng, all of the results showed that the preparing technology is rational and the quality of this medicine is stable.In this research, under the guidance of the Chinese medicinal theory and practice, new technology was used as experimental method. The experiment will provide the drug efficacy and quality control evaluation standards for NDS new drug form, provide the scientific foundation for the big industry’s production, set a good foundation for the research and exploration of new medicine.更多还原