一种对化学性肝损伤有辅助保护作用的保健食品研发

发布时间：2017-12-31 16:29

本文关键词：一种对化学性肝损伤有辅助保护作用的保健食品研发　出处：《第四军医大学》2015年硕士论文　论文类型：学位论文

【摘要】：背景:化学性肝损伤是由化学性肝毒性物质所造成的肝损伤。随着我国经济的发展和人们生活水平的提高,化学性肝损伤的发病率呈逐年上升趋势,严重影响着国人的身体健康。目前,护肝类保健食品市场尚未形成一个全国性的领导品牌,因此开发以中草药为原料、对化学性肝损伤有辅助保护作用的保健食品市场前景广阔。目的:采用具有辅助保护化学性肝损伤作用的人参、灵芝提取物、绞股蓝提取物、红景天提取物、五味子提取物进行组方,开发成护肝胶囊,拟通过动物实验评估其用量、证实其对化学性肝损伤有辅助保护作用,以期对大量的化学性肝损伤人群提供辅助保护作用。方法:1.在参照大量文献数据的基础上,结合中西医理论,以对肝损伤有辅助保护作用的人参、灵芝提取物、绞股蓝提取物、红景天提取物、五味子提取物为原料进行组方,得到皂苷组分的粉末,对其进行制剂工艺的研究,优化筛选出最优生产工艺,制成胶囊剂,命名为护肝胶囊。2.采用无特定病原体(SPF)级昆明种小鼠、Wistar大鼠进行急性经口毒性试验、遗传毒性试验和30天喂养试验等安全性毒理学试验,观察对小鼠的急性毒性作用、遗传毒性作用以及有害作用等。3.通过建立酒精性肝损伤模型,给予护肝胶囊喂养,并进行肝匀浆中各项指标(丙二醛(MDA)、还原型谷胱甘肽(GSH)、甘油三酯(TG))的检测及肝脏病理组织学检查。结果:1.确定了护肝胶囊的组方,优化了生产工艺流程,并制定了护肝胶囊的质量标准。2.通过安全毒理学试验,得出本品最大耐受剂量(MTD)值为大于20.0 g/kg体重;两项致突变试验(小鼠骨髓细胞微核试验和精子畸形试验)结果均为阴性;30天喂养试验未发现本品有明显的毒性作用。3.通过功能学试验,得出本品对小鼠酒精性肝脏损伤有辅助保护作用。结论:依据《保健食品检验与评价技术规范》中的判定标准,该护肝胶囊无明显的毒性作用,且对小鼠酒精性肝损伤有辅助保护作用。
[Abstract]:Background: chemical liver injury is caused by chemical hepatic toxic substances. With the development of economy and the improvement of people's living standard, the incidence of chemical liver injury is increasing year by year. Seriously affect the health of the people. At present, the liver protection health care food market has not formed a national leading brand, so the development of Chinese herbal medicine as raw materials. Objective: to use ginseng, Ganoderma lucidum extract, gynostemma pentaphyllum extract and Rhodiola rhodiola extract which have auxiliary protective effect on liver injury. Schisandra chinensis extract was used to form the capsule of protecting liver. The dosage of Schisandra chinensis extract was evaluated by animal experiments to prove that it has auxiliary protective effect on chemical liver injury. In order to provide a large number of chemical liver injury to provide auxiliary protection. Methods 1. On the basis of reference to a large number of literature data, combined with the theory of traditional Chinese and Western medicine, in order to protect the liver injury of ginseng. Ganoderma lucidum extract, gynostemma pentaphyllum extract, Rhodiola rhodiola extract and Schisandra chinensis extract were used as raw materials to obtain the powder of saponins. The capsule was made and named as Hugan capsule. The acute oral toxicity test was carried out in Kunming Wistar rats without specific pathogen (SPF). Safety toxicological tests such as genotoxicity test and 30-day feeding test were used to observe the acute toxicity, genotoxicity and harmful effects on mice. 3. A model of alcoholic liver injury was established. The rats were fed with Hugan capsule and the indexes in liver homogenate (malondialdehyde (MDAA), glutathione (GSH)). Detection of triglyceride (TGG) and histopathology of liver. Results: 1. The formulation of Hugan capsule was determined and the production process was optimized. The quality standard of Hugan capsule was established. 2. Through safety toxicology test, the maximum tolerated dose (MTD) of this product was more than 20.0 g / kg body weight. The results of two mutagenic tests (mouse bone marrow micronucleus test and sperm malformation test) were negative. 30 days feeding test did not find that this product has a significant toxic effect. 3. Passed the functional test. Conclusion: according to the criterion of "Health Food Inspection and Evaluation Technical Standard", this capsule has no obvious toxic effect. It also has the auxiliary protective effect on alcoholic liver injury in mice.
【学位授予单位】：第四军医大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R151

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