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  本文關(guān)鍵詞：一種對化學(xué)性肝損傷有輔助保護作用的保健食品研發(fā)　出處：《第四軍醫(yī)大學(xué)》2015年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 化學(xué)性肝損傷 輔助保護 保健食品 皂苷 護肝膠囊

【摘要】：背景:化學(xué)性肝損傷是由化學(xué)性肝毒性物質(zhì)所造成的肝損傷。隨著我國經(jīng)濟的發(fā)展和人們生活水平的提高,化學(xué)性肝損傷的發(fā)病率呈逐年上升趨勢,嚴(yán)重影響著國人的身體健康。目前,護肝類保健食品市場尚未形成一個全國性的領(lǐng)導(dǎo)品牌,因此開發(fā)以中草藥為原料、對化學(xué)性肝損傷有輔助保護作用的保健食品市場前景廣闊。目的:采用具有輔助保護化學(xué)性肝損傷作用的人參、靈芝提取物、絞股藍提取物、紅景天提取物、五味子提取物進行組方,開發(fā)成護肝膠囊,擬通過動物實驗評估其用量、證實其對化學(xué)性肝損傷有輔助保護作用,以期對大量的化學(xué)性肝損傷人群提供輔助保護作用。方法:1.在參照大量文獻數(shù)據(jù)的基礎(chǔ)上,結(jié)合中西醫(yī)理論,以對肝損傷有輔助保護作用的人參、靈芝提取物、絞股藍提取物、紅景天提取物、五味子提取物為原料進行組方,得到皂苷組分的粉末,對其進行制劑工藝的研究,優(yōu)化篩選出最優(yōu)生產(chǎn)工藝,制成膠囊劑,命名為護肝膠囊。2.采用無特定病原體(SPF)級昆明種小鼠、Wistar大鼠進行急性經(jīng)口毒性試驗、遺傳毒性試驗和30天喂養(yǎng)試驗等安全性毒理學(xué)試驗,觀察對小鼠的急性毒性作用、遺傳毒性作用以及有害作用等。3.通過建立酒精性肝損傷模型,給予護肝膠囊喂養(yǎng),并進行肝勻漿中各項指標(biāo)(丙二醛(MDA)、還原型谷胱甘肽(GSH)、甘油三酯(TG))的檢測及肝臟病理組織學(xué)檢查。結(jié)果:1.確定了護肝膠囊的組方,優(yōu)化了生產(chǎn)工藝流程,并制定了護肝膠囊的質(zhì)量標(biāo)準(zhǔn)。2.通過安全毒理學(xué)試驗,得出本品最大耐受劑量(MTD)值為大于20.0 g/kg體重;兩項致突變試驗(小鼠骨髓細胞微核試驗和精子畸形試驗)結(jié)果均為陰性;30天喂養(yǎng)試驗未發(fā)現(xiàn)本品有明顯的毒性作用。3.通過功能學(xué)試驗,得出本品對小鼠酒精性肝臟損傷有輔助保護作用。結(jié)論:依據(jù)《保健食品檢驗與評價技術(shù)規(guī)范》中的判定標(biāo)準(zhǔn),該護肝膠囊無明顯的毒性作用,且對小鼠酒精性肝損傷有輔助保護作用。
[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.
【學(xué)位授予單位】：第四軍醫(yī)大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R151

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本文編號：1360565