WO2019114428A1 - 一种具有改善睡眠和/或抗抑郁功效的保健组合物和保健食品 - Google Patents
一种具有改善睡眠和/或抗抑郁功效的保健组合物和保健食品 Download PDFInfo
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Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/17—Amino acids, peptides or proteins
- A23L33/175—Amino acids
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- the present invention relates to the field of health food technology, and in particular to a health care composition and a health food having improved sleep and/or antidepressant effects.
- Depression also known as depressive disorder, is characterized by significant and persistent low mood and is the main type of mood disorder. Clinically, the depression is not commensurate with its situation. The depression of emotions can range from sullen to grief, inferiority and depression, and even pessimistic, may have suicide attempts or behaviors; even stupor; some cases have obvious anxiety and motor agitation; In severe cases, psychotic symptoms such as hallucinations and delusions may occur. Physical symptoms include sleep disorders, fatigue, loss of appetite, weight loss, constipation, pain in any part of the body, loss of libido, impotence, amenorrhea, and so on. Sleep disorders mainly manifest as early awakening, generally wake up 2 to 3 hours earlier than usual, can not fall asleep after waking, which is characteristic of depressive episodes.
- Medication is the main treatment for moderate to moderate depressive episodes.
- the first line of clinical antidepressants mainly include selective serotonin reuptake inhibitors (SSRI, representing the drugs fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram and escitalopram) , serotonin and norepinephrine reuptake inhibitors (SNRI, representing the drugs venlafaxine and duloxetine), norepinephrine and specific serotoninergic antidepressants (NaSSA, representing the drug rice nitrogen equality.
- SSRI selective serotonin reuptake inhibitors
- SNRI serotonin and norepinephrine reuptake inhibitors
- NaSSA norepinephrine and specific serotoninergic antidepressants
- GABA aminobutyric acid ( ⁇ -aminobutyric acid) is a naturally occurring non-protein functional amino acid, a natural active ingredient, which is the main inhibitory neurotransmitter of the central nervous system, mediating the rapid inhibition of the nervous system
- ⁇ -Aminobutyric acid is an important inhibitory neurotransmitter that is deeply involved in research. It is involved in various metabolic activities and has high physiological activity. It can be used for hepatic coma and cerebral metabolic disorders, but also anti-mental anxiety. It is a pure natural substance that fights depression and anxiety, improves mood, relieves stress, promotes sleep, improves brain activity, and detoxifies and sobers.
- L-Theanine is a free amino acid unique to tea.
- Theanine is glutamic acid ⁇ -ethyl amide and has a sweet taste.
- Theanine is similar in chemical structure to the active substances in the brain, such as glutamine and glutamic acid, and is the main component of the sweet and sour taste in tea. Theanine can relieve fatigue, lower blood pressure and improve learning and memory.
- Gastrodia (scientific name: Gastrodia elata Bl.), also known as Red Arrow, Alone Shiba, Separation, Meaning, God Grass, ghost Super, Mokpo, Tomorrow Ma, Dingcao, Bailongpi, etc.
- Gastrodia is a perennial herb. Its roots are used for medicinal treatment to treat dizziness, numbness of the limbs, and convulsions in children. It is a valuable traditional Chinese medicine, and it is combined with Qiongzhen Ganoderma lucidum to treat headache and insomnia.
- the present invention provides a health care composition and a health food having improved sleep and/or antidepressant effects.
- the health care composition when used in combination with GABA-aminobutyric acid, theanine, gastrodia elata extract and Morinda officinalis extract, has a significant synergistic effect in improving sleep and/or antidepressant efficacy.
- the present invention provides the following technical solutions:
- the present invention provides a health care composition
- a health care composition comprising, in parts by weight, from 1 to 20 parts of GABA-aminobutyric acid, from 1 to 30 parts of theanine, from 1 to 50 parts of gastrodia elata extract and from 1 to 80 parts.
- the health care composition is made up of 5 to 10 parts of GABA-aminobutyric acid, 5 to 25 parts of theanine, 10 to 35 parts of gastrodia elata extract, and 30 to 60 parts of Morinda officinalis extract. .
- the health care composition is made up of 5 parts of GABA-aminobutyric acid, 25 parts of theanine, 30 parts of gastrodia elata extract and 40 parts of Morinda officinalis extract in parts by weight. .
- the health care composition is made up of 10 parts of GABA-aminobutyric acid, 25 parts of theanine, 35 parts of gastrodia elata extract and 30 parts of Morinda officinalis extract in parts by weight. to make.
- the health care composition is made up of 10 parts by weight of GABA-aminobutyric acid, 20 parts of theanine, 10 parts of gastrodia elata extract and 60 parts of Morinda officinalis extract. to make.
- the health care composition is made up of 5 parts of GABA-aminobutyric acid, 5 parts of theanine, 30 parts of gastrodia elata extract and 60 parts of Morinda officinalis extract in parts by weight. to make.
- the invention also provides the use of the health care composition for the preparation of a health food for improving sleep and/or antidepressant.
- the present invention also provides a health food comprising the health care composition provided by the present invention.
- the health food is in the form of a capsule, a tablet, a powder or a granule.
- the dosage form of the health food is a capsule
- the raw material comprises: 1 to 10 parts of GABA to aminobutyric acid, 5 to 20 parts of theanine, 10 to 30 parts of gastrodia elata extract, and 10 to 30 parts of Morinda officinalis extract. 10 to 30 parts of pregelatinized starch, 5 to 10 parts of croscarmellose sodium, and 1 to 5 parts of magnesium stearate.
- the dosage form of the health food is a tablet
- the raw materials thereof include: 1 to 10 parts of GABA to aminobutyric acid, 5 to 20 parts of theanine, 10 to 30 parts of gastrodia elata extract, and 10 to 30 parts of Morinda officinalis extract. 10 to 15 parts of microcrystalline cellulose, 5 to 10 parts of anhydrous lactose, 1 to 5 parts of croscarmellose sodium, 1 to 5 parts of silica, 1 to 2 parts of magnesium stearate, 0.5 to 1 part brown film coating powder.
- the present invention provides a health care composition and a health food having improved sleep and/or antidepressant effects.
- the health care composition is prepared in an amount of from 1 to 20 parts by weight of GABA-aminobutyric acid, from 1 to 30 parts of theanine, from 1 to 50 parts of gastrodia extract and from 1 to 80 parts of Morinda officinalis extract.
- the technical effect of the present invention is that the health care composition of the present invention has significant effects in improving sleep and/or antidepressant effects by using GABA-aminobutyric acid, theanine, gastrodia elata extract and Morinda officinalis extract. Synergies.
- the present invention discloses a health care composition and a health food having the effects of improving sleep and/or antidepressant, and those skilled in the art can learn from the contents of the present document and appropriately improve the process parameters. It is to be understood that all such alternatives and modifications are obvious to those skilled in the art and are considered to be included in the present invention.
- the method and the application of the present invention have been described by the preferred embodiments, and it is obvious that the method and application described herein may be modified or appropriately modified and combined without departing from the scope of the present invention. The technique of the present invention is applied.
- the raw materials or excipients used in the health care compositions and health foods having the effects of improving sleep and/or antidepressant provided by the present invention are commercially available.
- Both the Gastrodia elata extract and the Morinda officinalis extract are water extracts, and the extraction method thereof is an extraction method well known to those skilled in the art.
- SPF male Sprague-Dawley rats weighing 180 ⁇ 10 g were used.
- the animals were purchased from Guangdong Medical Laboratory Animal Center and the experimental animals used the license number: SYXK (Guangdong) 2013-0002.
- the SD strain is 110 male rats and weighs about 200 g. Animals were trained to adapt to syrup before the test, and stratified according to the degree of syrup preference, so that the degree of preference for syrup was averaged in each group of rats. The experiment was divided into 11 groups: normal control group, model group, positive control group citalopram group, first control group, second control group, third control group, fourth control group, first test group, The second test group, the third test group, and the fourth test group, 10 in each group.
- CUMS chronic unpredictable mild stimulation
- the specific methods of CUMS are as follows: fasting water for 24h/time, 4° water swimming for 5min/time, litter wet for 8h/time, restraint cage for 2h/time, hemostasis clip for 1min/time, 36V electrical stimulation for 1min interval for 30s 30 cycles/time, 3 stresses were given daily according to a random number table. Starting from 8 weeks of age in rats, the test samples were intervened after 4 weeks of continuous stimulation until the end of the whole experiment.
- Preference level (sugar consumption / total liquid consumption) * 100%.
- the transparent cylindrical swimming tube 45 cm high, 20 cm in diameter, and 25 ° C water temperature, measures the time required for the rat to move from swimming to inactivity. Compare the time required for each group to see if there is a difference.
- the saccharide consumption of the model group was significantly reduced (P ⁇ 0.01), indicating that the model group was successful.
- the positive group and the control group 1 and the control group 2 were sucrose.
- the consumption was also significantly increased. There was a statistically significant difference (P ⁇ 0.01 or P ⁇ 0.05).
- the sucrose consumption of the experimental group was significantly increased (P ⁇ 0.01).
- Explain that the test group has an effect of increasing the consumption of sugar water.
- Test 3 10 42.68 ⁇ 5.89** Test 4 10 45.32 ⁇ 3.76**
- the forced swimming time in the model group was significantly prolonged, which was statistically significant (P ⁇ 0.05), indicating successful modeling.
- the forced swimming time in the positive group was significantly shortened, which was statistically significant (P ⁇ 0.05).
- the forced swimming in the control group 1 and the control group 2 showed a shortening trend, but there was no statistical difference (P >0.05), the time of forced swimming in the experimental group was significantly shortened, which was statistically significant (P ⁇ 0.05), indicating that the experimental group can improve the forced time of forced swimming test caused by chronic moderate unforeseen stress.
- SPF-grade pungent ICR mice weighing 20 ⁇ 2g were used. The animals were purchased from the Guangdong Medical Laboratory Animal Center and the experimental animals used the license number: SYXK (Guangdong) 2013-0002.
- Healthy female ICR mice weighing 18g ⁇ 22g, 120, were used in 3 batches for trial, the first batch of animals were used for direct sleep experiments and extended pentobarbital sodium sleep time experiments, and the second batch of animals were used for pentabar The third batch of animals was used for the barbital sodium sleep latency test.
- the experiment was divided into 9 groups, 20 animals in each group, namely: blank group, control group 1, control group 2, control group 3, control group 4, trial group 1, trial group 2, trial group 3, trial group 4,
- the rats were orally administered with 0.2 mL/10 g ⁇ BW, and the negative control group was given the same amount of solvent, and the stomach was intragastrically administered once a day.
- Pentobarbital sodium subthreshold dose hypnosis test Before the formal experiment, the pre-experiment was carried out to determine the sub-hypnotic dose of pentobarbital sodium, that is, 80% to 90% of the mice did not disappear. The maximum subthreshold dose of sodium. After the last administration of the solvent and the test samples of different concentrations, the animals were given intraperitoneal injection of pentobarbital sodium for the maximum threshold hypnotic dose (the dose of this experiment: 29 mg/kg ⁇ BW) 10 min to 15 min before the peak effect. Record the number of sleeping animals within 30 minutes (the correction of the righting reflex disappeared for more than 1 min).
- Pentobarbital sodium sleep latency test Before the formal experiment, the pre-experiment was carried out to determine the dose of barbital sodium which made the animal 100% fall asleep, but did not make the sleep time too long. After the last administration of the solvent and the test samples of different concentrations for 10 min to 20 min, the rats in each group were intraperitoneally injected with barbital sodium (the dose of this experiment: 240 mg/kg ⁇ BW), and the disappearance of the righting reflex was used as an indicator to observe the test. The effect of the sample on the sleep latency of barbital sodium.
- the data was statistically analyzed using SPSS 17.0.
- the sleep time is the measurement data, the data is statistically analyzed by analysis of variance, and the appropriate variable conversion is performed on the non-normal or variance data. After the normal or variance requirements are met, the converted data is used for statistics; After the purpose of normal or variance is still not reached, the rank sum test is used for statistics. The number of sleeping animals was counted and the ⁇ 2 test was used.
- test samples were given to the test groups, and the negative control group was given the same volume of solvent. After 30 minutes of observation, the righting reflex was present, and no sleep phenomenon occurred.
- the average sleep time of the mice in the control group 1, 2 and the test group was slightly prolonged, and the sleep time of the mice in the test group was significantly increased compared with the control group (P ⁇ 0.05), and was statistically significant. That is, the experimental group has a prolonged effect on the mean sleep time of mice induced by pentobarbital.
- the sleep incidence rate of the control group 1, the control group 2 and the test group did not change significantly, and there was no statistical significance (P>0.05), so the product was induced by the subthreshold dose of pentobarbital. There was no significant effect on the incidence of sleep in rats.
- the average sleep time of the mice in the control group 1, 2 and the test group was slightly prolonged, and the average sleep latency of the mice in the test group was significantly shorter than that in the control group (P ⁇ 0.05), and was statistically significant.
- Bottling Adjust the equipment as required, and pack the capsules in 150ml brown, 60 capsules/bottle, and 1 pack of desiccant.
- the amount of food and how to eat 2 times a day, 2 bags each time, 150ml warm water.
- Weighing and preparation weigh the prescribed amount of GABA-aminobutyric acid, theanine, gastrodia elata extract, Morinda officinalis extract, microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, Silica, magnesium stearate and brown film coating powder (water soluble), ready for use.
- Tableting using a long strip mold, 800mg/tablet, hardness 22-27kg/cm 2 , to ensure that the difference in tablet weight is within ⁇ 4.5%, the disintegration time limit is less than 30 minutes, and the appearance of the film is checked at any time.
- Bottling Adjust the equipment as required, and pack the coated tablets in 150ml brown, 60 pieces / bottle, 1 pack of desiccant.
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Abstract
一种具有改善睡眠和/或抗抑郁功效的保健组合物，以重量份计，该保健组合物由1～20份GABA‑氨基丁酸、1～30份茶氨酸、1～50份天麻提取物和1～80份巴戟天提取物制成。一种保健食品，含有上述保健组合物。
Description
本申请要求于2017年12月14日提交中国专利局、申请号为201711336886.7、发明名称为“一种具有改善睡眠和/或抗抑郁功效的保健组合物和保健食品”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
本发明涉及保健食品技术领域，特别涉及一种具有改善睡眠和/或抗抑郁功效的保健组合物和保健食品。
抑郁症又称抑郁障碍，以显著而持久的心境低落为主要临床特征，是心境障碍的主要类型。临床可见心境低落与其处境不相称，情绪的消沉可以从闷闷不乐到悲痛欲绝，自卑抑郁，甚至悲观厌世，可有自杀企图或行为；甚至发生木僵；部分病例有明显的焦虑和运动性激越；严重者可出现幻觉、妄想等精神病性症状。躯体症状主要有睡眠障碍、乏力、食欲减退、体重下降、便秘、身体任何部位的疼痛、性欲减退、阳痿、闭经等。睡眠障碍主要表现为早醒，一般比平时早醒2～3小时，醒后不能再入睡，这对抑郁发作具有特征性意义。
药物治疗是中度以上抑郁发作的主要治疗措施。目前临床上一线的抗抑郁药主要包括选择性5-羟色胺再摄取抑制剂(SSRI，代表药物氟西汀、帕罗西汀、舍曲林、氟伏沙明、西酞普兰和艾司西酞普兰)、5-羟色胺和去甲肾上腺素再摄取抑制剂(SNRI，代表药物文拉法辛和度洛西汀)、去甲肾上腺素和特异性5-羟色胺能抗抑郁药(NaSSA，代表药物米氮平)等。传统的三环类、四环类抗抑郁药和单胺氧化酶抑制剂由于不良反应较大，应用明显减少。
GABA氨基丁酸(γ-氨基丁酸)是一种天然存在的非蛋白质功能性氨基酸，一种天然活性成分，是中枢神经系统主要的抑制性神经递质，介导神经系统快速抑制作用，γ-氨基丁酸是研究较为深入的一种重要的抑制性 神经递质，它参与多种代谢活动，具有很高的生理活性。可用于肝昏迷及脑代谢障碍，还可抗精神不安，是对抗抑郁焦虑、改善情绪、缓解压力、促进睡眠、提高脑活动、解毒醒酒的一种纯天然物质。
茶氨酸(L-Theanine)是茶叶中特有的游离氨基酸，茶氨酸是谷氨酸γ-乙基酰胺，有甜味。茶氨酸在化学构造上与脑内活性物质谷酰胺、谷氨酸相似，是茶叶中生津润甜的主要成份。茶氨酸可以解消疲劳、降低血压和提高学习记忆能力。
天麻(学名：Gastrodia elata Bl.)，又名赤箭、独摇芝、离母、合离草、神草、鬼督邮、木浦、明天麻、定风草、白龙皮等，是兰科天麻属多年生草本植物。其根茎入药用以治疗头晕目眩、肢体麻木、小儿惊风等症，是名贵中药，与琼珍灵芝合用治疗头痛失眠。
巴戟天(学名：Morinda officinalis How)，为双子叶植物茜草科，主产于广东、广西等地。药用植物，主治阳痿遗精、宫冷不孕、月经不调、少腹冷痛、风湿痹痛、筋骨痿软。
目前还未见将GABA-氨基丁酸、茶氨酸、天麻提取物和巴戟天提取物配合使用的报道。
发明内容
有鉴于此，本发明提供了一种具有改善睡眠和/或抗抑郁功效的保健组合物和保健食品。该保健组合物将GABA-氨基丁酸、茶氨酸、天麻提取物和巴戟天提取物配合使用后，在改善睡眠和/或抗抑郁功效方面具有显著的协同增效作用。
为了实现上述发明目的，本发明提供以下技术方案：
本发明提供了一种保健组合物，以重量份计，该保健组合物由1～20份GABA-氨基丁酸、1～30份茶氨酸、1～50份天麻提取物和1～80份巴戟天提取物制成。
作为优选，以重量份计，该保健组合物由5～10份GABA-氨基丁酸、5～25份茶氨酸、10～35份天麻提取物和30～60份巴戟天提取物制成。
在本发明提供的一具体实施例中，以重量份计，该保健组合物由5 份GABA-氨基丁酸、25份茶氨酸、30份天麻提取物和40份巴戟天提取物制成。
在本发明提供的另一具体实施例中，以重量份计，该保健组合物由10份GABA-氨基丁酸、25份茶氨酸、35份天麻提取物和30份巴戟天提取物制成。
在本发明提供的另一具体实施例中，以重量份计，该保健组合物由10份GABA-氨基丁酸、20份茶氨酸、10份天麻提取物和60份巴戟天提取物制成。
在本发明提供的另一具体实施例中，以重量份计，该保健组合物由5份GABA-氨基丁酸、5份茶氨酸、30份天麻提取物和60份巴戟天提取物制成。
本发明还提供了该保健组合物在制备改善睡眠和/或抗抑郁保健食品中的应用。
本发明还提供了一种保健食品，包括本发明提供的保健组合物。
作为优选，该保健食品的剂型为胶囊剂、片剂、粉剂或颗粒剂。
作为优选，保健食品的剂型为胶囊剂，其原料包括：1～10份GABA～氨基丁酸、5～20份茶氨酸、10～30份天麻提取物、10～30份巴戟天提取物、10～30份预胶化淀粉、5～10份交联羧甲基纤维素钠、1～5份硬脂酸镁。
作为优选，保健食品的剂型为片剂，其原料包括：1～10份GABA～氨基丁酸、5～20份茶氨酸、10～30份天麻提取物、10～30份巴戟天提取物、10～15份微晶纤维素、5～10份无水乳糖、1～5份交联羧甲基纤维素钠、1～5份二氧化硅、1～2份硬脂酸镁、0.5～1份棕色薄膜包衣粉。
本发明提供了一种具有改善睡眠和/或抗抑郁功效的保健组合物和保健食品。以重量份计，该保健组合物由1～20份GABA-氨基丁酸、1～30份茶氨酸、1～50份天麻提取物和1～80份巴戟天提取物制成。本发明具有的技术效果为：本发明保健组合物将GABA-氨基丁酸、茶氨酸、天麻提取物和巴戟天提取物配合使用后，在改善睡眠和/或抗抑郁功效方面具有显著的协同增效作用。
本发明公开了一种具有改善睡眠和/或抗抑郁功效的保健组合物和保健食品，本领域技术人员可以借鉴本文内容，适当改进工艺参数实现。特别需要指出的是，所有类似的替换和改动对本领域技术人员来说是显而易见的，它们都被视为包括在本发明。本发明的方法及应用已经通过较佳实施例进行了描述，相关人员明显能在不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合，来实现和应用本发明技术。
本发明提供的具有改善睡眠和/或抗抑郁功效的保健组合物和保健食品中所用原料或辅料均可由市场购得。天麻提取物和巴戟天提取物均为水提取物，其提取方法为本领域技术人员熟知的提取方法。
下面结合实施例，进一步阐述本发明：
试验例1
(一)改善抑郁动物试验
1.1实验动物
选用SPF级雄性SD大鼠，体重180±10g，动物购自广东省医学实验动物中心，实验动物使用许可证号：SYXK(粤)2013-0002。
1.2实验分组
SD品系雄性大鼠110只，体重200g左右。试验前训练动物适应糖水，根据糖水偏好程度分层，使得每组大鼠偏好糖水的程度分布平均。试验分为11个组，分别为：正常对照组、模型组、阳性对照组西酞普兰组、第一对照组、第二对照组、第三对照组、第四对照组、第一试验组、第二试验组、第三试验组、第四试验组，每组10只。
表1 试验各组给药成分
表2 对照组及试验组给药成分配比
1.3试验方法
各组均单笼饲养，正常对照组大鼠置于另外的房间，5只/笼，在相同的室温、光照条件下正常喂养，除糖水偏爱实验和强迫游泳实验前禁食、禁水外，不接受刺激。除正常对照组外，其余各组均采用慢性不可预知温和刺激(CUMS)+孤养方式制备抑郁症模型。CUMS具体方法如下：禁食禁水24h/次，4度水游泳5min/次，垫料潮湿8h/次，束缚笼束缚2h/次，止血钳夹尾1min/次，36V电刺激1min间隔30s共30循环/次，根据随机数字表每天给予3种应激。从大鼠8周龄开始，连续刺激4周后予以受试样品干预，一直持续至整个实验结束。
1.4检测指标
1)糖水偏好实验(干预前，干预15d，干预30d)：
禁食禁水24h后，称量体重，同时给予每只动物1瓶2％的蔗糖水100mL和1瓶100mL纯水，观察1h内动物饮用蔗糖溶液量，计算糖水偏好程度，比较各组糖水偏好程度是否存在差异：
偏好程度＝(糖水消耗/总液体消耗)*100％。
2)强迫游泳试验(干预前，干预15d，干预30d)
透明圆柱形游泳筒，高45cm，直径20cm，水温25摄氏度，检测大鼠从游泳开始到进入不动状态所需的时间。比较各组所需时间是否存在差异。
1.5数据统计方法
数据采用
表示，应用SPSS21.0软件进行统计分析。计量资料数据若方差齐或经转换后方差齐，则采用单因素方差分析，组间比较用LSD法，若方差不齐，数据经转换后方差仍不齐，采用秩和检验进行统计分析。检验水平α＝0.05。
1.6结果及分析
1.6.1慢性中度不可预见应激对大鼠糖水消耗量的影响：
与空白组比较，模型组大鼠糖水消耗量明显减少，有统计学差异(P<0.01)，说明模型组造模成功，与模型组比较，阳性组和对照1组、对照2组大鼠糖水消耗量也显著增多，具有统计学差异(P<0.01或P<0.05)试验组大鼠糖水消耗量明显增多，具有统计学差异(P<0.01)。说明试验组具有增多糖水消耗量的作用。
表3 慢性中度不可预见应激对大鼠糖水消耗量的影响
| 组别 | 动物数 | 糖水消耗量(％) |
| 空白组 | 10 | 75.50±9.35 |
| 模型组 | 10 | 27.63±5.71 ▲▲ |
| 阳性组 | 10 | 47.50±9.35** |
| 对照1组 | 10 | 30.10±3.87 |
| 对照2组 | 10 | 28.27±4.56 |
| 对照3组 | 10 | 26.79±4.93 |
| 对照4组 | 10 | 30.12±5.78 |
| 试验1组 | 10 | 35.00±7.29* |
| 试验2组 | 10 | 38.13±6.64* |
| 试验3组 | 10 | 42.68±5.89** |
| 试验4组 | 10 | 45.32±3.76** |
注：与空白对照组比较，
▲P<0.05，
▲▲P<0.01；与模型组比较，*P<0.05，**P<0.01。
1.6.2慢性中度不可预见应激对强迫游泳试验不动时间的影响
与空白组比较，模型组大鼠强迫游泳不动时间明显延长，具有统计学差异(P<0.05)，说明造模成功。与模型组比较，阳性组大鼠强迫游泳不动时间明显缩短，具有统计学差异(P<0.05)；对照1组、对照2组大鼠强迫游泳有缩短的趋势，但无统计学差异(P＞0.05)，试验组大鼠强迫游泳不动时间明显缩短，具有统计学差异(P<0.05)，说明试验组能改善大鼠由慢性中度不可预见应激造成的强迫游泳试验不动时间。
表4 慢性中度不可预见应激对强迫游泳试验不动时间的影响
| 组别 | 动物数 | 不动时间(秒) |
| 空白组 | 10 | 85.13±12.79 |
| 模型组 | 10 | 123.50±18.54 ▲▲ |
| 阳性对照组 | 10 | 98.63±11.49* |
| 对照1组 | 10 | 109.13±11.95 |
| 对照2组 | 10 | 108.25±10.82 |
| 对照3组 | 10 | 114.13±15.44 |
| 对照4组 | 10 | 112.88±13.30 |
| 试验1组 | 10 | 102.75±17.29* |
| 试验2组 | 10 | 104.00±16.59* |
| 试验3组 | 10 | 102.75±12.50* |
| 试验4组 | 10 | 100.75±12.17* |
注：与空白对照组比较，
▲P<0.05，
▲▲P<0.01；与模型组比较，*P<0.05，**P<0.01。
(二)改善睡眠动物试验
1.1实验动物
选用SPF级刺性ICR小鼠，体重20±2g，动物购自广东省医学实验 动物中心，实验动物使用许可证号：SYXK(粤)2013-0002。
1.2实验分组
参照《保健食品检验与评价技术规范》(2003版)中方法。将健康雌性ICR小鼠，体重18g～22g，120只，分3批用于试验，第1批动物用于直接睡眠实验和延长戊巴比妥钠睡眠时间实验，第2批动物用于戊巴比妥钠阈下剂量催眠实验，第3批动物用于巴比妥钠睡眠潜伏期实验。
试验分为9组，每组20只动物，分别为：空白组、对照1组、对照2组、对照3组、对照4组、试验1组、试验2组、试验3组、试验4组，按0.2mL/10g·BW经口灌胃，阴性对照组给予等量溶剂，每日灌胃1次。
表5 试验各组给药成分
表6 对照组及试验组给药成分配比
1.3试验方法
按照卫生部《保健食品检验与评价技术规范》(2003年版)方法进行。实验设3个部分：延长戊巴比妥钠睡眠时间实验、戊巴比妥钠阈下剂量催眠实验和巴比妥钠睡眠潜伏期实验。
1.3.1直接睡眠实验：观察受试组动物给予受试样品后，阴性对照组给予同体积溶剂后，是否出现睡眠现象。睡眠以翻正反射消失为指标。如超过30s～60s不能翻正者，既认为翻正反射消失，进入睡眠。翻正反射恢复即为觉醒，翻正反射消失至恢复这段时间为动物睡眠时间。记录对照组与受试样品组入睡动物数及睡眠时间。
1.3.2延长戊巴比妥钠睡眠时间实验：:在直接睡眠实验的基础上进行，如直接睡眠实验为阴性，则进行延长戊巴比妥钠睡眠时间实验。做正式实验前先进行预实验，确定使动物100％入睡，但又不使睡眠时间过长的戊巴比妥钠剂量，用此剂量做正式实验(本实验剂量为：47mg/kg·BW)。动物末次给予溶剂及不同浓度受试样品后，出现峰作用前10min～15min，给各组动物腹腔注射戊巴比妥钠，以翻正反射消失为指标，观察受试样品能否延长戊巴比妥钠睡眠时间。
1.3.3戊巴比妥钠阈下剂量催眠实验：做正式实验前先进行预实验，确定戊巴比妥钠阈下催眠剂量，即80％～90％小鼠翻正反射不消失的戊巴比妥钠最大阈下剂量。动物末次给予溶剂及不同浓度受试样品后，出现峰作用前10min～15min，给各组动物腹腔注射戊巴比妥钠最大阈下催眠剂量(本实验剂量为：29mg/kg·BW)，记录30min内入睡动物数(翻正反射消失达1min以上者)。
1.3.4戊巴比妥钠睡眠潜伏期实验：做正式实验前先进行预实验，确定使动物100％入睡，但又不使睡眠时间过长的巴比妥钠的剂量，用此剂量正式实验。动物末次给予溶剂及不同浓度受试样品10min～20min后，给各组动物腹腔注射巴比妥钠(本实验剂量为：240mg/kg·BW)，以翻正反射消失为指标，观察受试样品对巴比妥钠睡眠潜伏期的影响。
1.4结果判定：
延长戊巴比妥钠睡眠时间实验、戊巴比妥钠(或巴比妥钠)阈下剂量催眠实验、巴比妥钠睡眠潜伏期实验三项实验中有两项阳性，且无明显直接睡眠作用，可判定该受试物样品具有改善睡眠功能作用。
1.5统计学方法
数据采用SPSS 17.0进行统计分析。睡眠时间为计量资料，数据采用方差分析进行统计，对非正态或方差不齐的数据进行适当的变量转换，待满足正态或方差齐要求后，用转换后的数据进行统计；若变量转换后仍未达到正态或方差齐的目的，改用秩和检验进行统计。入睡动物数为计数资料，采用χ2检验。
1.6结果及分析
1.6.1直接睡眠实验
各试验组给予受试样品，阴性对照组给予同体积溶剂后，经观察30min，翻正反射存在，未出现睡眠现象。
表7 样品对直接睡眠试验的影响
| 组别 | 动物数 | 睡眠动物数 | 睡眠率(％) |
| 空白组 | 20 | 0 | 0 |
| 对照1组 | 20 | 0 | 0 |
| 对照2组 | 20 | 0 | 0 |
| 对照3组 | 20 | 0 | 0 |
| 对照4组 | 20 | 0 | 0 |
| 试验1组 | 20 | 0 | 0 |
| 试验2组 | 20 | 0 | 0 |
| 试验3组 | 20 | 0 | 0 |
| 试验4组 | 20 | 0 | 0 |
注：空白对照组比较，
▲P<0.05，
▲▲P<0.01。
1.6.2延长戊巴比妥钠睡眠时间的试验
与空白对照组比较，对照1、2组和试验组小鼠的平均睡眠时间稍有延长，其中试验组小鼠的睡眠时间与对照组比较有显著增加(P﹤0.05)，且具有统计学意义，即试验组对戊巴比妥纳诱导的小鼠平均睡眠时间有延长作用。
表8 样品对延长戊巴比妥钠睡眠时间的影响
注：空白对照组比较，
▲P<0.05，
▲▲P<0.01。
1.6.3戊巴比妥钠阈下剂量催眠实验
与空白组比较，对照组1、对照组2、试验组小鼠的睡眠发生率无明显改变，无统计学意义(P﹥0.05)，故本产品对阈下剂量戊巴比妥纳诱导的小鼠睡眠发生率无明显作用。
表9 样品对戊巴比妥钠阈下剂量催眠试验的影响
注：空白对照组比较，
▲P<0.05，
▲▲P<0.01。
1.6.4戊巴比妥钠睡眠潜伏期实验
与空白组比较，对照1、2组和试验组小鼠的平均睡眠时间稍有延长， 其中试验组小鼠平均睡眠潜伏时间与对照组有显著缩短(P﹤0.05)，且具有统计学意义。
表10 对戊巴比妥钠睡眠潜伏期时间的影响
注：空白对照组比较，
▲P<0.05，
▲▲P<0.01。
实施例1 胶囊产品配方及工艺
一、配方(按重量份计)：
二、生产工艺：
1.称量、备料：称取处方量的GABA-氨基丁酸、茶氨酸、天麻提取物、巴戟天提取物、预胶化淀粉、交联羧甲基纤维素钠和硬脂酸镁，备用。
2.总混：将上述备好的物料加入混合机中，混合30分钟至混合均匀后出料。
3.填充：将混合均匀的物料加入胶囊填充机中，用0#空心胶囊填充，400mg/粒，装量控制在±4.5％以内，崩解时间小于60分钟。
4.装瓶：按要求调整好设备，将胶囊装于150ml棕色中，60粒/瓶，干燥剂1包。
三、食用量及食用方法：每日2次，每次2袋，150ml温水冲服。
实施例2片剂产品配方及工艺
一、配方(按重量份计)：
二、生产工艺：
1.称量、备料：称取处方量的GABA-氨基丁酸、茶氨酸、天麻提取物、巴戟天提取物、微晶纤维素、无水乳糖、交联羧甲基纤维素钠、二氧化硅、硬脂酸镁和棕色薄膜包衣粉(水溶性)，备用。
2.总混：将上述备好的物料(除硬脂酸镁和棕色薄膜包衣粉)加入混合机中，混合25分钟后加入配方量的硬脂酸镁混合5分钟，至混合物均匀后出料。
3.压片：使用长条形模具压片，800mg/片，硬度22-27kg/cm
2，确保片重差异在±4.5％之内，崩解时限小于30分钟，并随时检查片子外观。
4.包衣：使用棕色薄膜包衣粉(水溶性)包衣，增重3.63％，固含量为16％。
5.装瓶：按要求调整好设备，将包衣片装于150ml棕色中，60片/ 瓶，干燥剂1包。
三、食用量及食用方法：每日2次，每次2片，吞服。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (10)
- 一种保健组合物，其特征在于，以重量份计，由1～20份GABA-氨基丁酸、1～30份茶氨酸、1～50份天麻提取物和1～80份巴戟天提取物制成。
- 根据权利要求1所述的保健组合物，其特征在于，以重量份计，由5～10份GABA-氨基丁酸、5～25份茶氨酸、10～35份天麻提取物和30～60份巴戟天提取物制成。
- 根据权利要求1或2所述的保健组合物，其特征在于，以重量份计，由5份GABA-氨基丁酸、25份茶氨酸、30份天麻提取物和40份巴戟天提取物制成。
- 根据权利要求1或2所述的保健组合物，其特征在于，以重量份计，由10份GABA-氨基丁酸、25份茶氨酸、35份天麻提取物和30份巴戟天提取物制成。
- 根据权利要求1或2所述的保健组合物，其特征在于，以重量份计，由10份GABA-氨基丁酸、20份茶氨酸、10份天麻提取物和60份巴戟天提取物制成。
- 权利要求1至5中任一项保健组合物在制备改善睡眠和/或抗抑郁保健食品中的应用。
- 一种保健食品，其特征在于，包括权利要求1至5中任一项保健组合物。
- 根据权利要求7所述的保健食品，其特征在于，所述保健食品的剂型为胶囊剂、片剂、粉剂或颗粒剂。
- 根据权利要求8所述的保健食品，其特征在于，所述保健食品的剂型为胶囊剂，其原料包括：1～10份GABA～氨基丁酸、5～20份茶氨酸、10～30份天麻提取物、10～30份巴戟天提取物、10～30份预胶化淀粉、5～10份交联羧甲基纤维素钠、1～5份硬脂酸镁。
- 根据权利要求8所述的保健食品，其特征在于，所述保健食品的剂型为片剂，其原料包括：1～10份GABA～氨基丁酸、5～20份茶氨酸、 10～30份天麻提取物、10～30份巴戟天提取物、10～15份微晶纤维素、5～10份无水乳糖、1～5份交联羧甲基纤维素钠、1～5份二氧化硅、1～2份硬脂酸镁、0.5～1份棕色薄膜包衣粉。
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