【摘要】：目的:隨著社會的快速發(fā)展,失眠問題愈發(fā)嚴重。為了改善這種狀況,本研究精選刺五加、五味子、茯苓為原料,采用現(xiàn)代制劑工藝開發(fā)研制出雙五茯苓膏,以期諸藥相配,共同發(fā)揮改善睡眠的保健功能�，F(xiàn)已知刺五加、五味子和茯苓均為安全的保健食品原料,改善睡眠功能確切,但以三者為組方研制而成的雙五茯苓膏的安全性及助眠功能尚不明確。因此,本研究將對雙五茯苓膏的安全性予以評價,并在此基礎上,對其睡眠改善功能進行進一步研究,為安全的具有改善睡眠功能的雙五茯苓膏保健食品的開發(fā)提供實驗基礎。方法:根據(jù)《食品安全國家標準》(2014版)食品安全性毒理學評價程序,采用最大耐受劑量法的小鼠經(jīng)口急性毒性試驗,大鼠28天經(jīng)口毒性試驗,常規(guī)的小鼠骨髓細胞微核試驗,小鼠精子畸形試驗以及Ames試驗研究雙五茯苓膏的安全性;并依據(jù)《保健食品檢驗與評價技術規(guī)范》(2003版)改善睡眠功能檢驗方法,采用延長戊巴比妥鈉睡眠時間試驗,戊巴比妥鈉閾下劑量催眠試驗,巴比妥鈉睡眠潛伏期試驗及直接睡眠試驗研究雙五茯苓膏的睡眠改善功能。結(jié)果:雙五茯苓膏的小鼠經(jīng)口急性毒性試驗中,最大耐受劑量MTD大于17.2 g/kg BW,屬于實際無毒級;28天經(jīng)口毒性試驗結(jié)果顯示最大無作用劑量NOAEL大于10g/kg BW;小鼠骨髓細胞微核試驗,小鼠精子畸形試驗,Ames試驗三項遺傳毒性試驗結(jié)果均顯示為陰性,表明雙五茯苓膏不具有致突變作用。在本實驗的劑量條件下,未觀察到急性毒性、短期重復劑量毒性及遺傳毒性作用。改善睡眠功能試驗中,雙五茯苓膏高劑量組與陰性對照組比較,戊巴比妥鈉誘導的小鼠睡眠的時間明顯延長(P0.01),中劑量組小鼠睡眠時間延長(P0.05);與陰性對照組相比,戊巴比妥鈉閾下劑量催眠試驗中,雙五茯苓膏高劑量組小鼠的睡眠發(fā)生率提高(P0.05);巴比妥鈉誘導下的雙五茯苓膏高劑量組小鼠的睡眠潛伏期與陰性對照組相比縮短(P0.05);直接睡眠試驗中,入睡動物數(shù)、睡眠時間各劑量組與陰性對照組比較均無差異。延長戊巴比妥鈉睡眠時間試驗,戊巴比妥鈉閾下劑量催眠試驗和巴比妥鈉睡眠潛伏期試驗三項試驗的結(jié)果均為陽性,并且未發(fā)現(xiàn)直接睡眠作用。結(jié)論:未觀察到雙五茯苓膏的急性毒性、短期重復劑量毒性及遺傳毒性作用,并且具有睡眠改善功能。
[Abstract]:Objective: with the rapid development of society, insomnia is becoming more and more serious. In order to improve this situation, this study selected Acanthopanax senticosus, Schisandra chinensis, Poria cocos as raw materials, using modern preparation technology to develop ShuangwuFuling paste, with a view to matching the drugs to improve sleep health care function. It is now known that Acanthopanax senticosus, Schisandra chinensis and Poria cocos are safe raw materials for health food, and improve sleep function. However, the safety and sleep aid function of ShuangwuFuling ointment developed by them are not clear. Therefore, this study will evaluate the safety of Shuangwu Fuling Ointment, and on this basis, further study on its sleep improvement function, to provide an experimental basis for the safe development of Shuangwuling Ointment health food with improved sleep function. Methods: according to the food safety toxicology evaluation program (2014 edition), the mice were tested by oral acute toxicity test with maximum tolerance dose method, the rats were tested by oral toxicity test for 28 days, and micronucleus test of bone marrow cells of mice was performed. The safety of ShuangwuFuling ointment was studied by sperm malformation test and Ames test, and the test of prolonging the sleep time of pentobarbital sodium was used according to the Technical Specification for Health Food Inspection and Evaluation (version 2003) to improve the sleep function test. Subthreshold dose hypnotic test of pentobarbital sodium, sleep latency test of barbital sodium and direct sleep test were used to study the sleep improvement of Shuangwufuling ointment. Results: in the oral acute toxicity test of mice with Shuangwufuling ointment, the maximum tolerated dose of MTD > 17.2 g/kg BW, belonged to the actual non-toxic grade after 28 days of oral toxicity test. The results showed that the maximum nontoxic dose of NOAEL was greater than that of 10g/kg BW; mice bone marrow cell micronucleus test. The results of three genotoxicity tests of mice sperm malformation test and Ames test showed that Shuangwu Fuling ointment had no mutagenic effect. The acute toxicity, short-term repeated dose toxicity and genotoxicity were not observed in this experiment. In the sleep function improvement test, compared with the negative control group, the sleep time of mice induced by pentobarbital sodium was significantly prolonged (P0.01) in the high dose group of Shuangwufuling ointment (P0.05), and compared with that in the negative control group (P0.05). Pentobarbital sodium subthreshold dose hypnosis test, The sleep latency of mice in the high dose group of Shuangwu Fuling paste was shorter than that in the negative control group (P0.05); in the direct sleep test, the number of sleeping animals was decreased, and the sleep latency of the mice in the high-dose group was shorter than that in the negative control group (P0.05). There was no difference in sleep time between each dose group and negative control group. The results of prolonged pentobarbital sodium sleep time test, pentobarbital sodium subthreshold dose hypnosis test and barbital sodium sleep latency test were all positive, and no direct sleep effect was found. Conclusion: the acute toxicity, short-term repeated dose toxicity and genetic toxicity of ShuangwuFuling ointment were not observed, and the effects of ShuangwuFuling ointment on sleep improvement were not observed.
【學位授予單位】：吉林大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：TS218;R99

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本文編號：2201278