双五茯苓膏的安全性及改善睡眠功能研究
发布时间：2018-08-24 15:44
【摘要】：目的:随着社会的快速发展,失眠问题愈发严重。为了改善这种状况,本研究精选刺五加、五味子、茯苓为原料,采用现代制剂工艺开发研制出双五茯苓膏,以期诸药相配,共同发挥改善睡眠的保健功能。现已知刺五加、五味子和茯苓均为安全的保健食品原料,改善睡眠功能确切,但以三者为组方研制而成的双五茯苓膏的安全性及助眠功能尚不明确。因此,本研究将对双五茯苓膏的安全性予以评价,并在此基础上,对其睡眠改善功能进行进一步研究,为安全的具有改善睡眠功能的双五茯苓膏保健食品的开发提供实验基础。方法:根据《食品安全国家标准》(2014版)食品安全性毒理学评价程序,采用最大耐受剂量法的小鼠经口急性毒性试验,大鼠28天经口毒性试验,常规的小鼠骨髓细胞微核试验,小鼠精子畸形试验以及Ames试验研究双五茯苓膏的安全性;并依据《保健食品检验与评价技术规范》(2003版)改善睡眠功能检验方法,采用延长戊巴比妥钠睡眠时间试验,戊巴比妥钠阈下剂量催眠试验,巴比妥钠睡眠潜伏期试验及直接睡眠试验研究双五茯苓膏的睡眠改善功能。结果:双五茯苓膏的小鼠经口急性毒性试验中,最大耐受剂量MTD大于17.2 g/kg BW,属于实际无毒级;28天经口毒性试验结果显示最大无作用剂量NOAEL大于10g/kg BW;小鼠骨髓细胞微核试验,小鼠精子畸形试验,Ames试验三项遗传毒性试验结果均显示为阴性,表明双五茯苓膏不具有致突变作用。在本实验的剂量条件下,未观察到急性毒性、短期重复剂量毒性及遗传毒性作用。改善睡眠功能试验中,双五茯苓膏高剂量组与阴性对照组比较,戊巴比妥钠诱导的小鼠睡眠的时间明显延长(P0.01),中剂量组小鼠睡眠时间延长(P0.05);与阴性对照组相比,戊巴比妥钠阈下剂量催眠试验中,双五茯苓膏高剂量组小鼠的睡眠发生率提高(P0.05);巴比妥钠诱导下的双五茯苓膏高剂量组小鼠的睡眠潜伏期与阴性对照组相比缩短(P0.05);直接睡眠试验中,入睡动物数、睡眠时间各剂量组与阴性对照组比较均无差异。延长戊巴比妥钠睡眠时间试验,戊巴比妥钠阈下剂量催眠试验和巴比妥钠睡眠潜伏期试验三项试验的结果均为阳性,并且未发现直接睡眠作用。结论:未观察到双五茯苓膏的急性毒性、短期重复剂量毒性及遗传毒性作用,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.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：TS218;R99
本文编号：2201278
[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.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：TS218;R99
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