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CN101904501B - Functional food for relieving fatigue and preparation method thereof - Google Patents

Functional food for relieving fatigue and preparation method thereof Download PDF

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CN101904501B
CN101904501B CN2010102425741A CN201010242574A CN101904501B CN 101904501 B CN101904501 B CN 101904501B CN 2010102425741 A CN2010102425741 A CN 2010102425741A CN 201010242574 A CN201010242574 A CN 201010242574A CN 101904501 B CN101904501 B CN 101904501B
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fatigue
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american ginseng
relieving fatigue
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邢连喜
赵宏
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Suzhou Kehao Biological Products Co Ltd
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Abstract

本发明涉及一种缓解疲劳的功能食品及其制备方法,该缓解疲劳的功能食品包括重量百分比为10-60%的熟地黄、10-60%的枸杞子、10-60%的制何首乌、15-50%的女贞子以及5-30%的西洋参制备而来。本发明提供了一种能迅速缓解疲劳、无毒副作用以及效果显著的缓解疲劳的功能食品及其制备方法。The invention relates to a functional food for relieving fatigue and a preparation method thereof. The functional food for relieving fatigue comprises 10-60% by weight of rehmannia glutinosa, 10-60% of medlar, 10-60% of Radix Polygoni Multiflori, 15% -50% Ligustrum lucidum and 5-30% American ginseng. The invention provides a fatigue-relieving functional food capable of rapidly relieving fatigue, having no toxic and side effects and remarkable effect and a preparation method thereof.

Description

一种缓解疲劳的功能食品及其制备方法A kind of functional food for alleviating fatigue and its preparation method

技术领域 technical field

本发明属食品领域,尤其涉及一种缓解疲劳的功能食品及其制备方法。The invention belongs to the field of food, and in particular relates to a functional food for relieving fatigue and a preparation method thereof.

背景技术 Background technique

目前,由于各种原因导致的慢性疲劳综合征发病人数众多,而且在全世界范围内正逐年增加,由此引起的生活和工作方面的问题也日益加剧,已经成为了一个社会问题。缓解慢性疲劳一般的做法就是直接按摩、休息或直接服用药品的方式,但这些方式往往效果不佳,而且采用药物治疗时,往往还有毒副作用,久而久之,还容易导致其它病症一起发作。根据国内外文献,能够迅速缓解疲劳的复合食物仍然很少,因此,能够提供一种迅速、有效缓解或解除身心疲劳的功能食品迫在眉睫。At present, the number of chronic fatigue syndromes caused by various reasons is large, and it is increasing year by year all over the world. The problems in life and work caused by it are also increasing, and it has become a social problem. The general way to relieve chronic fatigue is to directly massage, rest or take medicine directly, but these methods are often ineffective, and when using medicine treatment, there are often toxic side effects, and over time, it is easy to cause other diseases to attack together. According to domestic and foreign literature, there are still few compound foods that can quickly relieve fatigue. Therefore, it is imminent to provide a functional food that can quickly and effectively relieve or relieve physical and mental fatigue.

发明内容 Contents of the invention

为了解决背景技术中存在的上述技术问题,本发明提供了一种能迅速缓解疲劳、无毒副作用以及效果显著的缓解疲劳的功能食品及其制备方法。In order to solve the above-mentioned technical problems in the background technology, the present invention provides a fatigue-relieving functional food that can rapidly relieve fatigue, has no toxic and side effects, and has a significant effect and a preparation method thereof.

本发明的技术解决方案是:本发明提供了一种缓解疲劳的功能食品,其特殊之处在于:所述缓解疲劳的功能食品包括重量百分比为10-60%的熟地黄、10-60%的枸杞子、10-60%的制何首乌、15-50%的女贞子以及5-30%的西洋参制备而来。The technical solution of the present invention is: the present invention provides a functional food for relieving fatigue, which is special in that: the functional food for relieving fatigue includes 10-60% rehmannia glutinosa, Lycium barbarum fruit, 10-60% Radix Polygoni Multiflori, 15-50% Ligustrum lucidum and 5-30% American ginseng are prepared.

上述缓解疲劳的功能食品包括重量百分比为15-40%的熟地黄、13-35%的枸杞子、15-30%的制何首乌、16-30%的女贞子以及6-25%的西洋参制备而来。The aforementioned functional food for relieving fatigue comprises 15-40% rehmannia glutinosa, 13-35% medlar, 15-30% Radix Polygoni Multiflori, 16-30% Ligustrum lucidum and 6-25% American ginseng. come.

上述缓解疲劳的功能食品包括重量百分比为20-33%的熟地黄、15-30%的枸杞子、16.5-30%的制何首乌、18-28.5%的女贞子以及7-24%的西洋参制备而来。The above-mentioned functional food for relieving fatigue comprises 20-33% rehmannia glutinosa, 15-30% medlar, 16.5-30% Radix Polygoni Multiflori, 18-28.5% Ligustrum lucidum and 7-24% American ginseng. come.

上述缓解疲劳的功能食品包括重量百分比为22.4-30%的熟地黄、16.7-28.2%的枸杞子、16.8-26%的制何首乌、18.5-27.8%的女贞子以及7.8-22.4%的西洋参制备而来。The aforementioned functional food for relieving fatigue comprises 22.4-30% by weight of Rehmannia glutinosa, 16.7-28.2% of Lycium barbarum, 16.8-26% of Polygonum multiflorum, 18.5-27.8% of Ligustrum lucidum and 7.8-22.4% of American ginseng. come.

一种制备缓解疲劳的功能食品的方法,其特殊之处在于:所述方法包括以下步骤:A method for preparing a functional food for relieving fatigue, which is special in that: the method includes the following steps:

1)将熟地黄、枸杞子、制何首乌、女贞子、西洋参分别净制,备用;1) Clean rehmannia glutinosa, medlar, Radix Polygoni Multiflori, Ligustrum lucidum and American ginseng separately, and set aside;

2)取50%重量比的西洋参干燥后粉碎,过100目筛,辐照灭菌,备用;2) take American ginseng with a weight ratio of 50%, dry it, grind it, pass through a 100-mesh sieve, sterilize it by irradiation, and set it aside;

3)取剩余西洋参与制何首乌、女贞子用乙醇回流提取1-4次,每次加7-10倍量溶剂,每次1-3小时,收集所有滤液并浓缩至醇提清膏,备用;3) Take the remaining Radix Polygoni Multiflori and Ligustrum lucidum and extract them with ethanol for 1-4 times, adding 7-10 times the amount of solvent each time for 1-3 hours each time, collecting all the filtrates and concentrating them into an alcohol-extracted clear paste for later use ;

4)取熟地黄、枸杞子和步骤3)所得到的醇提药渣加水煎煮1-3次,每次加7-10倍量水,每次1-3小时,收集所有滤液并浓缩至水提清膏,备用;4) Take Rehmannia glutinosa, Lycium barbarum fruit and the alcohol-extracted medicinal residue obtained in step 3), add water to decoct 1-3 times, add 7-10 times the amount of water each time, and collect all the filtrate and concentrate to Water extraction cream, set aside;

5)将步骤3)以及步骤4)分别得到的醇提清膏和水提清膏干燥,粉碎,过80目筛,得干膏粉;5) drying the alcohol-extracted clear paste and water-extracted clear paste obtained in step 3) and step 4), pulverized, and passed through an 80-mesh sieve to obtain dry paste powder;

6)将步骤2)所得到的西洋参与步骤5)所得到的干膏粉混匀,用85%乙醇制成软材,16目筛制粒,60℃干燥,14目筛整粒,得成品。6) Mix the dry paste powder obtained in step 2) with the western ginseng obtained in step 5), use 85% ethanol to make a soft material, granulate with a 16-mesh sieve, dry at 60°C, and granulate with a 14-mesh sieve to obtain the finished product .

上述步骤2)中辐照灭菌的条件是用60Co辐照灭菌。The condition of irradiation sterilization in the above step 2) is irradiation sterilization with 60 Co.

上述步骤3)得到醇提清膏的条件是将滤液在-0.065~-0.075Mpa,65℃条件下,并浓缩至在60℃下相对密度1.30-1.35的醇提清膏。The above step 3) to obtain the alcohol extraction paste is to concentrate the filtrate to an alcohol extraction paste with a relative density of 1.30-1.35 at 60°C at -0.065 to -0.075Mpa and 65°C.

上述步骤4)得到水提清膏的条件是将滤液在75℃,-0.065~-0.075Mpa的条件下减压浓缩至在60℃时相对密度为1.30-1.35的水提清膏。Above-mentioned step 4) the condition that obtains the water extracting clear cream is that the filtrate is concentrated under reduced pressure under the condition of 75 DEG C,-0.065~-0.075Mpa to the water extracting clear cream that the relative density is 1.30-1.35 at 60 DEG C.

上述步骤5)是将醇提清膏与水提清膏于65℃、-0.085Mpa减压干燥,粉碎,过80目筛,得干膏粉。The above step 5) is to dry the alcohol-extracted paste and the water-extracted paste at 65°C and -0.085Mpa under reduced pressure, pulverize them, and pass through a 80-mesh sieve to obtain dry paste powder.

本发明的优点是:The advantages of the present invention are:

本发明提供了一种能够迅速缓解疲劳的功能食品及其制备方法,利用本发明所提供的制备方法所制备得到的可迅速缓解疲劳的功能食品,其原料采用熟地黄、枸杞子、制何首乌、女贞子和西洋参等纯天然原料,其中熟地黄滋阴补血,益精填髓,枸杞子、女贞子滋补肝肾,制首乌益精强筋骨,西洋参补气养阴、清热生津,达到滋补肝肾、益气养血,调节人体生理状态,起到很好的缓解体力疲劳作用,能够迅速缓解疲劳。同时,由于本发明所采用的纯天然食品原料或国家允许用于功能食品的原料,用量上严格限制在一定范围,所以安全性有保障,长期服用无毒副作用,使用效果非常显著。The present invention provides a functional food capable of rapidly relieving fatigue and a preparation method thereof. The functional food capable of rapidly relieving fatigue prepared by the preparation method provided by the present invention is made of Rehmannia glutinosa, Lycium barbarum, Polygonum multiflorum, Pure natural raw materials such as Ligustrum lucidum and American ginseng, among them, rehmannia glutinosa nourishes yin and blood, nourishes essence and fills marrow, wolfberry fruit and Ligustrum lucidum nourishes liver and kidney, makes Shouwu tonify essence and strengthen bones, American ginseng nourishes qi and nourishes yin, clears heat and promotes body fluid, and achieves Nourishes the liver and kidneys, nourishes qi and blood, regulates the physiological state of the human body, plays a very good role in relieving physical fatigue, and can quickly relieve fatigue. Simultaneously, because the pure natural food raw material that the present invention adopts or the raw material that the country permits to be used in functional food, the usage amount is strictly limited to a certain range, so the safety is guaranteed, the long-term use has no toxic and side effects, and the use effect is very remarkable.

具体实施方式Detailed ways

本发明根据传统中医食疗调养的理论和临床经验选方,提供了一种缓解疲劳的功能食品及其制备方法。The invention provides a functional food for relieving fatigue and a preparation method thereof based on formulas selected according to the theory of traditional Chinese medicine diet therapy and recuperation and clinical experience.

一种缓解疲劳的功能食品,该缓解疲劳的功能食品包括重量百分比为10-60%的熟地黄、10-60%的枸杞子、10-60%的制何首乌、15-50%的女贞子以及5-30%的西洋参制备而来,还可以包括重量百分比为15-40%的熟地黄、13-35%的枸杞子、15-30%的制何首乌、16-30%的女贞子以及6-25%的西洋参制备而来;尤其包括重量百分比为20-33%的熟地黄、15-30%的枸杞子、16.5-30%的制何首乌、18-28.5%的女贞子以及7-24%的西洋参制备而来,最好包括重量百分比为22.4-30%的熟地黄、16.7-28.2%的枸杞子、16.8-26%的制何首乌、18.5-27.8%的女贞子以及7.8-22.4%的西洋参制备而来。A functional food for relieving fatigue, which comprises 10-60% by weight of rehmannia glutinosa, 10-60% of medlar, 10-60% of Polygonum multiflorum, and 15-50% of Ligustrum lucidum and 5-30% American ginseng, and can also include 15-40% rehmannia glutinosa, 13-35% medlar, 15-30% Polygonum multiflorum, 16-30% Ligustrum lucidum and Prepared from 6-25% American ginseng; especially including rehmannia glutinosa 20-33% by weight, 15-30% medlar, 16.5-30% Radix Polygoni Multiflori, 18-28.5% Ligustrum lucidum and 7- 24% American ginseng is prepared, preferably including 22.4-30% rehmannia glutinosa, 16.7-28.2% medlar, 16.8-26% Radix Polygoni Multiflori, 18.5-27.8% Ligustrum lucidum and 7.8-22.4% by weight % American ginseng is prepared.

本发明所采用的中药方解是:The Chinese medicine prescription that the present invention adopts is:

熟地黄:味甘,性微温,入肝、肾经。具有滋阴补血,益精填髓的功效。用于肝肾阴虚,腰膝酸软,盗汗遗精等症。熟地黄含有糖类物质,多种氨基酸,多种微量元素,还含有梓醇,甘露醇,地黄素,维生素A样物质等。很多实验表明,熟地黄提取液对小鼠游泳抗疲劳能力和清除自由基均有明显作用。Rehmannia glutinosa: sweet in taste, slightly warm in nature, enters the liver and kidney channels. It has the effects of nourishing yin and enriching blood, benefiting essence and filling marrow. For liver and kidney yin deficiency, soreness of the waist and knees, night sweats and nocturnal emission embolisms. Rehmannia glutinosa contains carbohydrates, a variety of amino acids, a variety of trace elements, and also contains catalpol, mannitol, rehmanthin, and vitamin A-like substances. Many experiments have shown that Rehmannia glutinosa extract has obvious effects on the anti-fatigue ability of mice in swimming and scavenging free radicals.

枸杞子:性平,味甘,入肝、肾经。具有滋补肝肾,益精明目的功效。枸杞子主要有效成分为枸杞多糖,研究表明枸杞子具有明显的提高抗疲劳及耐缺氧能力。Lycium barbarum: flat in nature, sweet in taste, enters the liver and kidney channels. It has the functions of nourishing liver and kidney, benefiting energy and improving eyesight. The main active ingredient of Lycium barbarum is Lycium barbarum polysaccharides. Research shows that Lycium barbarum can significantly improve the ability to resist fatigue and hypoxia.

制何首乌:苦、甘、涩,温,归肝、心、肾经具有补肝肾、益精血、强筋骨的作用。实验表明,制何首乌除具有很好的抗疲劳和提高免疫力作用之外,还具有降血脂功效。Radix Polygoni Multiflori: Bitter, sweet, astringent, warm, returns to liver, heart, kidney meridian and has the effect of nourishing liver and kidney, benefiting essence and blood, strengthening muscles and bones. Experiments have shown that in addition to anti-fatigue and improving immunity, Radix Polygoni Multiflori also has the effect of lowering blood fat.

女贞子:甘、苦,凉。归肝、肾经,具有滋补肝肾、明目乌发之功效。用于眩晕耳鸣,腰膝酸软,须发早白,目暗不明。实验研究表明其所含有的红景天苷和多糖具有明显的抗疲劳和抗氧化作用。Ligustrum lucidum: sweet, bitter, cool. Return liver, kidney meridian, have the effect of nourishing liver and kidney, improving eyesight and black hair. For dizziness and tinnitus, soreness of the waist and knees, premature graying of the beard and hair, and blindness. Experimental studies have shown that salidroside and polysaccharides contained in it have obvious anti-fatigue and anti-oxidation effects.

西洋参:甘、微苦,凉,归心、肺、肾经。具有补气养阴、清热生津的功能。西洋参含有40余种皂苷、多种微量元素和多糖等成分,具有明显的抗疲劳、增强免疫力和延缓衰老等作用。American ginseng: sweet, slightly bitter, cool, homecoming, lung, kidney meridian. It has the functions of invigorating qi and nourishing yin, clearing away heat and promoting body fluid. American ginseng contains more than 40 kinds of saponins, various trace elements and polysaccharides, which have obvious effects of anti-fatigue, enhancing immunity and delaying aging.

本发明人经过长期实践,得到以下配比实施例(以重量百分比为单位),根据该配比都可实现本发明所提及的有益效果。After long-term practice, the inventors have obtained the following proportioning examples (in weight percent), according to which the beneficial effects mentioned in the present invention can be realized.

Figure BDA0000023966840000041
Figure BDA0000023966840000041

一种制备缓解疲劳的功能食品的方法,该方法包括以下步骤:A method for preparing a functional food for relieving fatigue, the method comprising the following steps:

1)将熟地黄、枸杞子、制何首乌、女贞子、西洋参分别净制,备用;1) Clean rehmannia glutinosa, medlar, Radix Polygoni Multiflori, Ligustrum lucidum and American ginseng separately, and set aside;

2)取50%重量比的西洋参干燥后粉碎,过100目筛,用60Co辐照灭菌,备用;2) take American ginseng with a weight ratio of 50%, dry it, pulverize it, pass through a 100-mesh sieve, sterilize it with 60 Co radiation, and set it aside;

3)取剩余西洋参与制何首乌、女贞子用乙醇回流提取1-4次,每次加7-10倍量溶剂,每次1-3小时,收集所有滤液并浓缩至醇提清膏,备用,醇提清膏的条件是将滤液在-0.065~-0.075Mpa,65℃条件下,并浓缩至在60℃下相对密度1.30-1.35的醇提清膏;3) Take the remaining Radix Polygoni Multiflori and Ligustrum lucidum and extract them with ethanol for 1-4 times, adding 7-10 times the amount of solvent each time for 1-3 hours each time, collecting all the filtrates and concentrating them into an alcohol-extracted clear paste for later use , the condition of the alcohol extraction paste is to concentrate the filtrate at -0.065~-0.075Mpa, 65°C to an alcohol extraction paste with a relative density of 1.30-1.35 at 60°C;

4)取熟地黄、枸杞子和醇提药渣加水煎煮1-3次,每次加7-10倍量水,每次1-3小时,收集所有滤液并浓缩至水提清膏,备用,得到水提清膏的条件是将滤液在75℃,-0.065~-0.075Mpa的条件下减压浓缩至在60℃时相对密度为1.30-1.35的水提清膏;4) Take Rehmannia glutinosa, medlar and alcohol extraction dregs and decoct 1-3 times, add 7-10 times the amount of water each time, 1-3 hours each time, collect all the filtrates and concentrate them into a water-extracted clear paste for later use The condition for obtaining the water extraction paste is to concentrate the filtrate under reduced pressure at 75°C and -0.065~-0.075Mpa to a water extraction paste with a relative density of 1.30-1.35 at 60°C;

5)将步骤3)以及步骤4)分别得到的醇提清膏和水提清膏干燥,于65℃、-0.085Mpa减压干燥,粉碎,过80目筛,得干膏粉;5) Dry the alcohol-extracted clear paste and water-extracted clear paste obtained in step 3) and step 4), dry at 65°C and -0.085Mpa under reduced pressure, pulverize, and pass through a 80-mesh sieve to obtain a dry paste powder;

6)将步骤2)所得到的西洋参与步骤5)所得到的干膏粉混匀,用85%乙醇制成软材,16目筛制粒,60℃干燥,14目筛整粒,得成品。6) Mix the dry paste powder obtained in step 2) with the western ginseng obtained in step 5), use 85% ethanol to make a soft material, granulate with a 16-mesh sieve, dry at 60°C, and granulate with a 14-mesh sieve to obtain the finished product .

本发明的一些试验数据:Some experimental data of the present invention:

根据以上配比,选取多组药材配比方式,进行安全性毒理、动物喂养、功效等试验,其结果如下:According to the above ratios, multiple groups of medicinal material ratios were selected to conduct safety and toxicology, animal feeding, efficacy and other tests. The results are as follows:

1安全性毒理试验资料1 safety and toxicology test data

1.1小鼠急性经口毒性试验1.1 Acute oral toxicity test in mice

表1对小鼠的急性毒性试验结果Table 1 Acute toxicity test results on mice

Figure BDA0000023966840000051
Figure BDA0000023966840000051

从表1可见,以最大给药量(剂量为30000mg/kg BW)的样品给予小鼠灌胃后,动物生长良好,未见体重受到影响。受试小鼠均未见有中毒症状,观察14天无动物死亡。试验结束解剖动物、大体观察,肝、肾、脾、心、肺、胃、肠等主要脏器均未见明显异常改变,按急性毒性分级标准,该样品的急性经口毒性属无毒级。As can be seen from Table 1, after the sample of the maximum dosage (dose is 30000mg/kg BW) was given to mice for gavage, the animals grew well, and no body weight was affected. None of the tested mice had symptoms of poisoning, and no animal died after 14 days of observation. At the end of the test, the animal was dissected and observed in general. There were no obvious abnormal changes in major organs such as liver, kidney, spleen, heart, lung, stomach, and intestine. According to the acute toxicity classification standard, the acute oral toxicity of the sample was non-toxic.

1.2遗传毒性试验1.2 Genetic toxicity test

三项遗传毒性试验(Ames、小鼠骨髓细胞微核试验、小鼠精子畸形试验)结果均为阴性。The results of three genetic toxicity tests (Ames, mouse bone marrow cell micronucleus test, and mouse sperm abnormality test) were all negative.

表2Ames试验结果(第一次)Table 2 Ames test results (first time)

Figure BDA0000023966840000052
Figure BDA0000023966840000052

表3Ames试验结果(第二次)Table 3 Ames test results (second time)

Figure BDA0000023966840000061
Figure BDA0000023966840000061

从表2、表3可见,对TA97a、TA98、TA100、TA102四种试验菌株,无论是否加入S-9,样品各剂量组的回变菌落数均未超过自发回变菌落数的两倍,亦无剂量-反应关系,表明该受试物诱变试验结果为阴性。As can be seen from Table 2 and Table 3, to TA97a, TA98, TA100, TA102 four kinds of test bacterial strains, no matter whether add S -9 , the number of back-changing colonies of each dosage group of the sample is not more than twice of the number of spontaneous back-changing colonies, also There is no dose-response relationship, indicating that the mutagenesis test result of the test substance is negative.

1.3小鼠骨髓微核试验1.3 Mouse bone marrow micronucleus test

表4对小鼠骨髓微核发生率的影响Table 4 Effects on the incidence of bone marrow micronuclei in mice

从表4可见,样品各剂量组的微核率与阴性对照组比较,差异均无显著性(P>0.05),而环磷酰胺阳性对照组与阴性对照组比较差异有极显著性(P<0.01)。未见该样品对小鼠的骨髓细胞有损伤作用。As can be seen from Table 4, the micronucleus rate of each dose group of the sample is compared with the negative control group, and the difference is all insignificant (P>0.05), while the cyclophosphamide positive control group and the negative control group have a very significant difference (P<0.05). 0.01). The sample was not found to have any damage to the bone marrow cells of the mice.

1.4小鼠精子畸形试验1.4 Mouse sperm abnormality test

表5对小鼠精子畸形发生率的影响Table 5 Effects on the Incidence Rate of Sperm Deformity in Mice

Figure BDA0000023966840000071
Figure BDA0000023966840000071

从表5可见,样品对小鼠精子畸形发生率未产生明显改变,样品各剂量组的精子畸形率与阴性对照组比较,差异均无显著性(P>0.05),而环磷酰胺阳性对照组与阴性对照组比较差异有极显著性(P<0.01)。未见该样品对小鼠精子产生畸变作用。As can be seen from Table 5, the sample does not produce significant changes to the incidence of sperm deformity in mice. Compared with the negative control group, the sperm deformity rate of each dose group of the sample has no significant difference (P>0.05), while the cyclophosphamide positive control group Compared with the negative control group, the difference was extremely significant (P<0.01). The sample was not found to have a distortion effect on mouse sperm.

2大鼠30天喂养试验2 Rat 30-day feeding test

2.1动物一般表现:实验期间,各组动物生长发育良好,未见动物有异常行为和中毒表现,各组动物均无死亡。2.1 General performance of animals: During the experiment, the animals in each group grew and developed well, no abnormal behavior and poisoning performance were found in the animals, and no animals in each group died.

2.2样品对大鼠体重及食物利用率的影响:结果见表6~表7,以4000、3000、2000mg/kg BW剂量的塑珊牌乐力胶囊给大鼠灌胃30天,实验期间,样品各剂量组雌雄鼠每周的体重、增重量、每周进食量及总进食量、每周食物利用率及总食物利用率与对照组比较,差异均无显著性(P>0.05),表明该样品对大鼠的体重增长和食物利用率无明显影响。2.2 The influence of the sample on the body weight and food utilization rate of rats: the results are shown in Table 6~Table 7. Sushan Leli Capsules of 4000, 3000, and 2000 mg/kg BW were given to rats by gavage for 30 days. During the experiment, the samples The weekly body weight, weight gain, weekly food intake and total food intake, weekly food utilization rate and total food utilization rate of male and female mice in each dosage group were compared with those of the control group, and there was no significant difference (P>0.05), indicating that the The samples had no significant effect on body weight gain and food utilization in rats.

表6对大鼠体重的影响

Figure BDA0000023966840000081
Table 6 Effects on Rat Body Weight
Figure BDA0000023966840000081

Figure BDA0000023966840000082
Figure BDA0000023966840000082

注:表中各剂量组与阴性对照组比较,差异均无显著性(P>0.05)。Note: There is no significant difference between each dosage group in the table and the negative control group (P>0.05).

表7对大鼠总食物利用率的影响

Figure BDA0000023966840000083
Table 7 on the impact of total food utilization in rats
Figure BDA0000023966840000083

Figure BDA0000023966840000084
Figure BDA0000023966840000084

注:表中各剂量组与阴性对照组比较,差异均无显著性(P>0.05)。Note: There is no significant difference between each dosage group in the table and the negative control group (P>0.05).

2.3样品对大鼠血常规指标的影响2.3 Effect of samples on blood routine indicators in rats

表8  30天喂养试验结束大鼠血常规指标检查结果

Figure BDA0000023966840000091
Table 8 30-day feeding test results of blood routine index inspection of rats
Figure BDA0000023966840000091

注:表中各剂量组与阴性对照组比较,差异均无显著性(P>0.05)。Note: There is no significant difference between each dosage group in the table and the negative control group (P>0.05).

表9  30天喂养试验结束大鼠血常规指标检查结果

Figure BDA0000023966840000093
Table 9 Result of blood routine index inspection of rats at the end of 30-day feeding test
Figure BDA0000023966840000093

注:表中各剂量组与阴性对照组比较,差异均无显著性(P>0.05)。Note: There is no significant difference between each dosage group in the table and the negative control group (P>0.05).

从表8、表9可见,以4000、3000、2000mg/kg BW剂量给大鼠灌胃30天,样品各剂量组雌、雄性大鼠的血红蛋白、红细胞总数、白细胞总数及其分类、血小板数的数值均处于正常值范围内,且与对照组比较,差异均无显著性(P>0.05),表明该样品对大鼠的血常规指标无明显影响。As can be seen from Table 8 and Table 9, with 4000, 3000, 2000mg/kg BW dosage, rats were given intragastric administration for 30 days, the hemoglobin, total number of red blood cells, total number of white blood cells and their classification, platelet count of each dosage group of samples The numerical values were all within the normal range, and compared with the control group, there was no significant difference (P>0.05), indicating that the sample had no obvious influence on the blood routine indexes of the rats.

2.4样品对大鼠血液生化指标的影响2.4 Effect of samples on blood biochemical indicators of rats

结果见表10、表11,以4000、3000、2000mg/kg BW剂量的塑珊牌乐力胶囊给大鼠灌胃30天,样品各剂量组雌、雄性大鼠的血清谷草转氨酶、谷丙转氨酶、尿素氮、肌酐、胆固醇、甘油三脂、总蛋白、白蛋白、血糖的数值均处于正常值范围内,且与对照组比较,差异均无显著性(P>0.05),表明该样品对大鼠的血液生化指标无明显影响。The results are shown in Table 10 and Table 11. The Sushan brand Leli Capsules of 4000, 3000, and 2000 mg/kg BW doses were administered to rats for 30 days, and the serum aspartate aminotransferase and alanine aminotransferase of female and male rats in each dosage group were sampled. , blood urea nitrogen, creatinine, cholesterol, triglycerides, total protein, albumin, and blood sugar were all within the normal range, and compared with the control group, there was no significant difference (P>0.05), indicating that the sample had no significant effect on large There was no obvious effect on the blood biochemical indexes of the mice.

表10  30天喂养试验结束大鼠血液生化指标检查结果

Figure BDA0000023966840000101
Table 10 30-day feeding test ended rat blood biochemical index inspection results
Figure BDA0000023966840000101

Figure BDA0000023966840000102
Figure BDA0000023966840000102

注:表中各剂量组与阴性对照组比较,差异均无显著性(P>0.05)。Note: There is no significant difference between each dosage group in the table and the negative control group (P>0.05).

表11  30天喂养试验结束大鼠血液生化指标检查结果

Figure BDA0000023966840000103
Table 11 30-day feeding test results of blood biochemical indicators in rats
Figure BDA0000023966840000103

注:表中各剂量组与阴性对照组比较,差异均无显著性(P>0.05)。Note: There is no significant difference between each dosage group in the table and the negative control group (P>0.05).

结论:以最大给药量(剂量为30000mg/kg BW)的样品给予小鼠灌胃后,未见动物有中毒症状和死亡,急性经口毒性属无毒级。三项遗传毒性试验(Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验)结果均为阴性。30天喂养试验,以4000、3000、2000mg/kg BW 3个剂量(分别相当于人体推荐用量100、75、50倍)的样品连续给大鼠灌胃30天,实验期间动物生长发育良好,各剂量组大鼠的体重、增重量、进食量、食物利用率、血常规指标、血液生化指标、脏器重量及脏器/体重比值等均未受明显影响;大体解剖观察和组织病理学检查未见与样品有关的异常改变。提示该样品30天喂养对大鼠各项观察指标未产生毒副作用。Conclusion: After administration of the sample with the maximum dose (30000mg/kg BW) to the mice, no symptoms of poisoning and death were observed in the animals, and the acute oral toxicity was non-toxic. The results of three genetic toxicity tests (Ames test, mouse bone marrow cell micronucleus test, and mouse sperm abnormality test) were all negative. In the 30-day feeding test, 3 doses of 4000, 3000, and 2000 mg/kg BW (respectively equivalent to 100, 75, and 50 times the recommended dosage for the human body) were continuously administered to rats for 30 days. During the experiment, the animals grew and developed well. The body weight, weight gain, food intake, food utilization rate, blood routine index, blood biochemical index, organ weight and organ/body weight ratio of rats in the dose group were not significantly affected; gross anatomical observation and histopathological examination were not significantly affected. See Unusual Changes Related to Samples. It is suggested that feeding the sample for 30 days has no toxic and side effects on the observed indicators of rats.

3功能试验资料3 Function test data

分别经口给予小鼠215、420、840mg/kg BW(分别相当于人体推荐量5、10、20倍)剂量的参元胶囊给小鼠连续灌胃30天,能延长小鼠的负重游泳时间,增加小鼠的肝糖原的储备量,降低小鼠运动后的血清尿素氮含量,对小鼠体重增长和疲劳小鼠的血乳酸含量无明显影响,提示该样品具有缓解体力疲劳的功能。Oral administration of 215, 420, and 840 mg/kg BW (respectively equivalent to 5, 10, and 20 times the recommended human dose) of Shenyuan Capsules to mice for 30 consecutive days can prolong the weight-bearing swimming time of mice , increase the reserve of liver glycogen in mice, reduce the serum urea nitrogen content of mice after exercise, and have no significant effect on the weight gain of mice and the blood lactic acid content of fatigued mice, suggesting that this sample has the function of alleviating physical fatigue.

3.1样品对小鼠负重游泳时间的影响3.1 Effects of samples on weight-bearing swimming time of mice

表12各组小鼠的负重游泳时间

Figure BDA0000023966840000111
Table 12 Weight-bearing swimming time of mice in each group
Figure BDA0000023966840000111

Figure BDA0000023966840000112
Figure BDA0000023966840000112

从表12可见,样品各剂量组小鼠的负重(5%)游泳时间均比阴性对照组的延长,其中高、中剂量组与阴性对照组的差异均具有显著性(P<0.05),表明该样品具有延长小鼠的负重游泳时间的作用。As can be seen from Table 12, the weight-bearing (5%) swimming time of the mice in each dose group of the sample is all longer than that of the negative control group, and the differences between the high and middle dose groups and the negative control group are all significant (P<0.05), indicating that This sample has the effect of prolonging the weight-bearing swimming time of mice.

3.2样品对小鼠运动后的血清尿素水平的影响3.2 Effect of samples on serum urea levels in mice after exercise

从表13可见,样品高、中剂量组小鼠的血清尿素含量均低于对照组,与阴性对照组比较差异均有显著性(P<0.05),表明该样品能显著减少疲劳小鼠血清尿素的产生。As can be seen from Table 13, the serum urea content of the mice in the high and middle dose groups of the sample is all lower than that of the control group, and there is significant difference compared with the negative control group (P < 0.05), indicating that the sample can significantly reduce the serum urea of the fatigued mice. generation.

表13各组小鼠运动后的血清尿素测定结果 Table 13 The results of serum urea determination after exercise in each group of mice

Figure BDA0000023966840000122
Figure BDA0000023966840000122

3.3样品对小鼠的肝糖原含量的影响3.3 Effects of samples on liver glycogen content of mice

表14各组小鼠肝糖原含量测定结果

Figure BDA0000023966840000123
Table 14 Determination results of liver glycogen content in each group of mice
Figure BDA0000023966840000123

从表14可见,样品各剂量组小鼠的肝糖原含量均高于阴性对照组,其中的高、中剂量组与阴性对照组的差异具有显著性(分别P<0.01和P<0.05),表明该样品具有促进小鼠的肝糖原储备的作用。As can be seen from Table 14, the liver glycogen content of the mice in each dose group of the sample was higher than that of the negative control group, and the difference between the high and middle dose groups and the negative control group was significant (P<0.01 and P<0.05 respectively), It shows that the sample has the effect of promoting liver glycogen storage in mice.

3.4样品对小鼠运动后的血乳酸值的影响3.4 Effect of samples on blood lactic acid value of mice after exercise

表15各组小鼠运动后的血乳酸(mg/L)曲线下面积

Figure BDA0000023966840000125
Table 15 Area under the curve of blood lactic acid (mg/L) after exercise in each group of mice
Figure BDA0000023966840000125

Figure BDA0000023966840000126
Figure BDA0000023966840000126

从表15可见,样品各剂量的3个时间点血乳酸曲线下面积与阴性对照组接近,各剂量组与阴性对照组的差异无显著性(P>0.05),表明该样品对小鼠运动后的血乳酸曲线下面积无明显影响。As can be seen from Table 15, the area under the blood lactic acid curve at 3 time points of each dose of the sample is close to that of the negative control group, and there is no significant difference between each dose group and the negative control group (P>0.05), indicating that the sample has no effect on the mice after exercise. The area under the curve of blood lactate had no significant effect.

3.5临床试验3.5 Clinical trials

按照最佳配比将本发明制成的缓解疲劳的功能食品进行以下临床试验:The functional food for relieving fatigue made by the present invention is carried out following clinical trials according to the optimal proportioning:

观察病人均为门诊病人。服食时间:2009年3月2009年10月,服食者主要症状为:精神紧张,烦躁失眠,气短神疲,腰酸腿软,食欲不振,记忆力减退,性功能减退等。凡具备其中四项主要症状者,均纳入试验病例。The observed patients were all outpatients. Time of taking: March 2009 to October 2009. The main symptoms of the users are: nervousness, irritability, insomnia, shortness of breath, fatigue, sore waist and legs, loss of appetite, memory loss, sexual dysfunction, etc. Anyone with four of the main symptoms was included in the test cases.

试食者共计100例,随机分为治疗组和对照组。治疗组和对照组人数各50例。病程均在4-15周之间,年龄在38~65岁之间。两组人员性别、年龄等分布大致均衡,具有可比性。治疗组食用缓解体力疲劳产品,对照组食用安慰剂,观察时间4周。A total of 100 food testers were randomly divided into a treatment group and a control group. There were 50 cases in each treatment group and control group. The course of disease was between 4-15 weeks, and the age ranged from 38 to 65 years. The distribution of gender and age of the two groups was roughly balanced and comparable. The treatment group took products for relieving physical fatigue, and the control group took placebo, and the observation time was 4 weeks.

观察项目与指标Observation items and indicators

3.5.1安全性观测3.5.1 Safety observation

1)血、尿、便常规化验;2)肝、肾功能检查;3)胸部X线检查;1) Blood, urine, and stool routine tests; 2) Liver and kidney function tests; 3) Chest X-ray examination;

4)B超、心电图检查。4) B-ultrasound and electrocardiogram examination.

除胸透、B超、心电图用药前检查一次外,其余指标用药前后各检查一次,结果证实治疗组治疗前后各项指标统计结果无显著性差异(P>0.05),说明该缓解疲劳产品安全无毒副作用。In addition to the chest X-ray, B-ultrasound, and electrocardiogram, the other indicators were checked before and after the treatment. The results confirmed that there was no significant difference in the statistical results of the indicators before and after treatment in the treatment group (P>0.05), indicating that the product for relieving fatigue is safe. toxic side effect.

3.5.2疗效性观察3.5.2 Curative effect observation

疗效评定标准:Efficacy evaluation criteria:

1)治愈:精力充沛,思维敏捷,神安眠佳,食欲旺盛,腰酸腿软症状消失;1) Healing: full of energy, quick thinking, good sleep, strong appetite, and the symptoms of sore waist and legs disappear;

2)显效:上述症状中有三项改善者;2) Significant effect: three of the above symptoms have improved;

3)有效:上述症状中有两项改善者:4)无效:上述症状无一改善者。3) Effective: two of the above symptoms improved: 4) Ineffective: none of the above symptoms improved.

3.5.3疗效观察结果表3.5.3 Curative Effect Observation Result Table

16治疗组与对照组疗效比较表16 Table of curative effect comparison between the treatment group and the control group

  组别 group   治愈 cure   显效 Significantly effective   有效 efficient   无效 invalid   总有效率% Total effective rate%   治疗组 therapy group   18 18   23 twenty three   8 8   1 1   98.0**△△ 98.0 **△△   对照组 control group   1 1   2 2   3 3   44 44   12 12

注:**,与对照组比较,P>0.01,△△自身症状积分前后比较,P>0.01。Note: **, compared with the control group, P>0.01, compared with before and after △△ self-symptom scores, P>0.01.

两组比较治疗组疗效明显高于对照组,自身症状积分前后比较,治疗组明显改善。Compared with the two groups, the curative effect of the treatment group was significantly higher than that of the control group, and the self-symptom scores were compared before and after, and the treatment group was significantly improved.

按照不同比例制作的产品临床资料如下:The clinical data of the products prepared according to different ratios are as follows:

实施例一:Embodiment one:

取熟地黄10%(重量比)、枸杞子57.5%、制何首乌11%、女贞子15%以及西洋参6.5%制备成缓解疲劳的功能食品,对临床200例经过3-6小时运动后,直接口服,其结果参见下表:Take Rehmannia glutinosa 10% (weight ratio), wolfberry fruit 57.5%, Polygonum multiflorum 11%, Ligustrum lucidum 15% and American ginseng 6.5% to prepare functional food for relieving fatigue. After 3-6 hours of exercise in 200 clinical cases, directly Orally, the results are shown in the table below:

表17实施例一治疗组与对照组疗效比较表Table 17 embodiment one treatment group and control group curative effect comparative table

 组别 group   治愈 cure   显效 Significantly effective   有效 efficient   无效 invalid   总有效率% Total effective rate%  治疗组100人 Treatment group 100 people   65 65   24 twenty four   7 7   4 4   96.0**△△ 96.0 **△△  对照组100人 100 people in the control group   3 3   5 5   5 5   87 87   13 13

注:**,与对照组比较,P>0.01,△△自身症状积分前后比较,P>0.01。Note: **, compared with the control group, P>0.01, compared with before and after △△ self-symptom scores, P>0.01.

实施例二:Embodiment two:

取熟地黄16%(重量比)、枸杞子10%、制何首乌27%、女贞子30%以及西洋参5.5%制备成缓解疲劳的功能食品,对临床153例长期熬夜工作者进行临床试验,直接口服,其结果参见下表:Take Rehmannia glutinosa 16% (by weight), medlar 10%, Polygonum multiflorum 27%, Ligustrum lucidum 30% and American ginseng 5.5% to prepare a functional food for relieving fatigue. Clinical trials were carried out on 153 long-term workers who stayed up late for a long time. Orally, the results are shown in the table below:

表18实施例二治疗组与对照组疗效比较表Table 18 embodiment two treatment group and control group curative effect comparative table

  组别 group   治愈 cure   显效 Significantly effective   有效 efficient   无效 invalid   总有效率% Total effective rate%   治疗组81人 81 people in the treatment group   51 51   21 twenty one   6 6   3 3   96.3**△△ 96.3 **△△   对照组72人 72 people in the control group   1 1   3 3   3 3   65 65   9.6 9.6

注:**,与对照组比较,P>0.01,△△自身症状积分前后比较,P>0.01。Note: **, compared with the control group, P>0.01, compared with before and after △△ self-symptom scores, P>0.01.

实施例三:Embodiment three:

取熟地黄18%(重量比)、枸杞子13.6%、制何首乌11.4%、女贞子50%以及西洋参7%制备成缓解疲劳的功能食品,对临床78例长期进行建筑工作的建筑工地工人进行临床试验,直接口服,其结果参见下表:Take Rehmannia glutinosa 18% (by weight), Lycium barbarum 13.6%, Radix Polygoni Multiflori 11.4%, Ligustrum lucidum 50% and American ginseng 7% to prepare functional food for relieving fatigue. 78 clinical cases of construction site workers who have been doing construction work for a long time were tested. Clinical trials, direct oral administration, the results are shown in the table below:

表18实施例三治疗组与对照组疗效比较表Table 18 embodiment three treatment groups and control group curative effect comparative table

  组别 group   治愈 cure   显效 Significantly effective   有效 efficient   无效 invalid   总有效率% Total effective rate%   治疗组39人 39 people in the treatment group   24 twenty four   10 10   4 4   1 1   97.4**△△ 97.4 **△△   对照组39人 39 people in the control group   1 1   1 1   2 2   35 35   10.2 10.2

注:**,与对照组比较,P>0.01,△△自身症状积分前后比较,P>0.01。Note: **, compared with the control group, P>0.01, compared with before and after △△ self-symptom scores, P>0.01.

实施例四:Embodiment four:

取熟地黄22%(重量比)、枸杞子15%、制何首乌12%、女贞子21%以及西洋参20%制备成缓解疲劳的功能食品,对临床164例大学生进行临床试验,直接口服,其结果参见下表:Take Rehmannia glutinosa 22% (by weight), Lycium barbarum 15%, Polygonum multiflorum 12%, Ligustrum lucidum 21% and American ginseng 20% to prepare a functional food for relieving fatigue. Clinical trials were conducted on 164 cases of college students, and they were directly orally administered. See the table below for the results:

表19实施例四治疗组与对照组疗效比较表Table 19 embodiment four treatment group and control group curative effect comparative table

  组别 group   治愈 cure   显效 Significantly effective   有效 efficient   无效 invalid   总有效率% Total effective rate%   治疗组82人 82 people in the treatment group   48 48   14 14   15 15   5 5   94.5**△△ 94.5 **△△   对照组82人 82 people in the control group   2 2   4 4   3 3   73 73   11 11

注:**,与对照组比较,P>0.01,△△自身症状积分前后比较,P>0.01。Note: **, compared with the control group, P>0.01, compared with before and after △△ self-symptom scores, P>0.01.

Claims (7)

1.一种缓解疲劳的功能食品,其特征在于:所述缓解疲劳的功能食品由重量百分比为10-60%的熟地黄、10-60%的枸杞子、10-60%的制何首乌、15-50%的女贞子以及5-30%的西洋参制备而来。 1. A functional food for relieving fatigue, characterized in that: the functional food for relieving fatigue is composed of 10-60% rehmannia glutinosa, 10-60% medlar, 10-60% Polygonum multiflorum, 15% by weight. -50% Ligustrum lucidum and 5-30% American ginseng. 2.根据权利要求1所述的缓解疲劳的功能食品,其特征在于:所述缓解疲劳的功能食品由重量百分比为15-40%的熟地黄、13-35%的枸杞子、15-30%的制何首乌、16-30%的女贞子以及6-25%的西洋参制备而来。 2. The functional food for relieving fatigue according to claim 1, characterized in that: the functional food for relieving fatigue consists of 15-40% rehmannia glutinosa, 13-35% medlar, 15-30% Prepared from Polygonum multiflorum, 16-30% Ligustrum lucidum and 6-25% American ginseng. 3.根据权利要求2所述的缓解疲劳的功能食品,其特征在于:所述缓解疲劳的功能食品由重量百分比为20-33%的熟地黄、15-30%的枸杞子、16. 5-30%的制何首乌、18-28. 5%的女贞子以及7-24%的西洋参制备而来。 3. The functional food for relieving fatigue according to claim 2, characterized in that: the functional food for relieving fatigue consists of 20-33% rehmannia glutinosa, 15-30% medlar, 16.5- 30% Radix Polygoni Multiflori, 18-28.5% Ligustrum lucidum and 7-24% American Ginseng are prepared. 4.根据权利要求3所述的缓解疲劳的功能食品,其特征在于:所述缓解疲劳的功能食品由重量百分比为22. 4-30%的熟地黄、16. 7-28. 2%的枸杞子、16. 8-26%的制何首乌、18. 5-27. 8%的女贞子以及7. 8-22. 4%的西洋参制备而来。 4. The functional food for relieving fatigue according to claim 3, characterized in that: the functional food for relieving fatigue consists of rehmannia glutinosa of 22.4-30% by weight, wolfberry of 16.7-28.2% 4% American ginseng prepared. 5.一种制备权利要求1-4任一权利要求所述的缓解疲劳的功能食品的方法,其特征在于:所述方法包括以下步骤: 5. A method for preparing the fatigue-relieving functional food according to any one of claims 1-4, characterized in that: the method comprises the following steps: 1)将熟地黄、枸杞子、制何首乌、女贞子、西洋参分别净制,备用;1) Clean rehmannia glutinosa, medlar, Radix Polygoni Multiflori, Ligustrum lucidum, and American ginseng separately, and set aside; 2)取50%重量比的西洋参干燥后粉碎,过100目筛,辐照灭菌,备用;2) Take American ginseng with 50% by weight, dry it, crush it, pass through a 100-mesh sieve, sterilize it by irradiation, and set it aside; 3)取剩余西洋参与制何首乌、女贞子用乙醇回流提取1-4次,每次加7-10倍量溶剂,每次1-3小时,收集所有滤液并浓缩至醇提清膏,备用;3) Take the remaining Radix Polygoni Multiflori and Ligustrum lucidum, extract with ethanol for 1-4 times under reflux, add 7-10 times the amount of solvent each time, and collect all the filtrates and concentrate them into alcohol-extracted clear paste for later use ; 4)取熟地黄、枸杞子和步骤3)所得到的醇提药渣加水煎煮1-2次,每次加7-10倍量水,每次1-3小时,收集所有滤液并浓缩至水提清膏,备用;4) Take Rehmannia glutinosa, Lycium barbarum fruit and the alcohol-extracted medicinal residue obtained in step 3), add water to decoct 1-2 times, add 7-10 times the amount of water each time, 1-3 hours each time, collect all the filtrate and concentrate to Water extraction cream, for later use; 5)将步骤3)以及步骤4)分别得到的醇提清膏和水提清膏干燥,粉碎,过80目筛,得干膏粉;5) Drying the alcohol-extracted clear paste and water-extracted clear paste obtained in step 3) and step 4), crushed, and passed through a 80-mesh sieve to obtain dry paste powder; 6)将步骤2)所得到的西洋参与步骤5)所得到的干膏粉混匀,用85%乙醇制成软材,16目筛制粒,60℃干燥,14目筛整粒,得成品。6) Mix the dry cream powder obtained in step 2) with Xiyangginseng obtained in step 5), use 85% ethanol to make a soft material, granulate with a 16-mesh sieve, dry at 60°C, and granulate with a 14-mesh sieve to obtain the finished product . 6.根据权利要求5所述的制备缓解疲劳的功能食品的方法,其特征在于:所述步骤2)中辐照灭菌的条件是用辐照灭菌。 6. The method for preparing a fatigue-relieving functional food according to claim 5, characterized in that: the condition of irradiation sterilization in the step 2) is irradiation sterilization. 7.根据权利要求6所述的制备缓解疲劳的功能食品的方法,其特征在于:所述步骤3)得到醇提清膏的条件是将滤液在-0.065~-0.075Mpa, 65℃条件下,并浓缩至在60℃下相对密度1. 30-1.35的醇提清膏。 7. The method for preparing a fatigue-relieving functional food according to claim 6, characterized in that: the condition for obtaining the alcohol extraction cream in the step 3) is to put the filtrate at -0.065~-0.075Mpa, 65°C, 30-1.35的粉量液油。 And concentrated to the relative density of 1.30-1.35 alcohol extraction paste at 60 ° C.
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