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TW202421177A - Composition for ameliorating fatigue, sleep disturbance or eye fatigue and menopausal symptoms - Google Patents

Composition for ameliorating fatigue, sleep disturbance or eye fatigue and menopausal symptoms Download PDF

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TW202421177A
TW202421177A TW111145703A TW111145703A TW202421177A TW 202421177 A TW202421177 A TW 202421177A TW 111145703 A TW111145703 A TW 111145703A TW 111145703 A TW111145703 A TW 111145703A TW 202421177 A TW202421177 A TW 202421177A
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composition
fatigue
symptoms
present
eye fatigue
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TW111145703A
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Chinese (zh)
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小原達矢
中嶋翼
北村幸平
川健吾
廣瀨義
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日商好侍健康食品股份有限公司
日商好侍食品集團本社股份有限公司
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Priority to TW111145703A priority Critical patent/TW202421177A/en
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Abstract

An objective of the present invention is to provide a composition used to ameliorate fatigue, sleep disturbance or eye fatigue and menopausal symptoms. To achieve the objective, a composition containing Lactobacillus plantarum L-137 is proposed.

Description

疲勞感、睡眠障礙或眼睛疲勞及更年期症狀改善用組成物 Composition for improving fatigue, sleep disorders or eye fatigue and menopausal symptoms

本發明係有關疲勞感、睡眠障礙或眼睛疲勞及更年期症狀改善用組成物。 The present invention relates to a composition for improving fatigue, sleep disorders or eye fatigue and menopausal symptoms.

更年期症狀為由於老化所致之卵巢功能降低和荷爾蒙功能降低而於更年期出現之症狀,可列舉例如:熱潮紅(hot flash)等血管運動神經障礙樣症狀、頭痛、肌肉痛等疼痛、精神及睡眠品質降低、全身倦怠感等。大多見於女性,惟於男性亦可看到。又,不論是否為更年期,現代人多數因為心理性或物理性壓力等所造成的疲勞感、睡眠障礙和眼睛疲勞等而感到煩惱。己知發芽發酵豆萃取物可改善此等症狀(專利文獻1)。 Menopausal symptoms are symptoms that occur during menopause due to decreased ovarian and hormonal function caused by aging. Examples include: vasomotor nerve disorder-like symptoms such as hot flashes, headaches, muscle pains, decreased mental and sleep quality, and general fatigue. They are mostly seen in women, but can also be seen in men. In addition, regardless of whether they are menopausal or not, most modern people are troubled by fatigue, sleep disorders, and eye fatigue caused by psychological or physical stress. It is known that germinated fermented bean extract can improve these symptoms (patent document 1).

然而,對於乳酸菌植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)可治療、預防或改善疲勞感、睡眠障礙或眼睛疲勞及更年期症狀一事係屬完全未知。 However, it is completely unknown whether Lactobacillus plantarum L-137 can treat, prevent or improve fatigue, sleep disorders or eye fatigue and menopausal symptoms.

[先前技術文獻] [Prior Art Literature]

[專利文獻] [Patent Literature]

[專利文獻1]日本特表2016-526019號公報 [Patent Document 1] Japanese Patent Publication No. 2016-526019

本發明人等係尋求具有治療、預防或改善疲勞感、睡眠障礙或眼睛疲勞及更年期症狀的作用之素材,並研究了極多之素材,結果出乎意料地發現乳酸菌植物乳酸桿菌L-137株(Lactobacillus plantarum L-137。以下,亦稱為「L-137株」)具有所期望的上述作用。此為本發明人等之驚人發現。本發明人等係再進行更深入的研究而完成本發明。 The inventors of the present invention sought materials that can treat, prevent or improve fatigue, sleep disorders, eye fatigue and menopausal symptoms, and studied a great number of materials. As a result, they unexpectedly found that the lactic acid bacteria Lactobacillus plantarum L-137 strain (Lactobacillus plantarum L-137. Hereinafter, also referred to as "L-137 strain") has the desired above-mentioned effects. This is a surprising discovery of the inventors. The inventors of the present invention completed the present invention after further in-depth research.

亦即,本發明如以下所述。 That is, the present invention is as described below.

[1]一種組成物,其係用於治療、預防或改善選自由疲勞感、睡眠障礙及眼睛疲勞所組成之群組的至少一種症狀者,該組成物中含有植物乳酸桿菌L-137或其處理物,。 [1] A composition for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorders and eye fatigue, comprising Lactobacillus plantarum L-137 or a processed product thereof.

[2]一種組成物,其係用於治療、預防或改善更年期症狀者,該組成物中含有植物乳酸桿菌L-137或其處理物。 [2] A composition for treating, preventing or improving menopausal symptoms, comprising Lactobacillus plantarum L-137 or a processed product thereof.

[3]如[2]所述之組成物,其係用於治療、預防或改善1種以上選自由以下(i)至(xii)所組成之群組之症狀者; [3] The composition as described in [2], which is used to treat, prevent or improve one or more symptoms selected from the group consisting of (i) to (xii) below;

(i)血管運動神經障礙樣症狀;(ii)知覺障礙樣症狀;(iii)失眠;(iv)神經質;(v)憂鬱;(vi)眩暈;(vii)全身倦怠感;(viii)關節痛及/或肌肉痛;(ix)頭痛;(x)心悸(palpitation);(xi)蟻走感(formication);及(xii)眼睛疲勞。 (i) vasomotor neuropathy-like symptoms; (ii) perceptual dysregulation-like symptoms; (iii) insomnia; (iv) neurosis; (v) depression; (vi) dizziness; (vii) general malaise; (viii) joint and/or muscle pain; (ix) headache; (x) palpitations; (xi) formication; and (xii) eye fatigue.

[4]如[1]至[3]中任一項所述之組成物,其為飲食品。 [4] The composition as described in any one of [1] to [3], which is a food product.

[5]如[4]所述之組成物,其中,飲食品為食品添加物或增補劑(supplements)。 [5] The composition as described in [4], wherein the food is a food additive or supplement.

[6]一種植物乳酸桿菌L-137或其處理物之用途,其係用於製造選自由疲勞感、睡眠障礙及眼睛疲勞所組成之群組的至少一種症狀之治療、預防或改善用醫藥。 [6] A use of plant lactobacillus L-137 or a processed product thereof for the manufacture of a medicine for the treatment, prevention or improvement of at least one symptom selected from the group consisting of fatigue, sleep disorders and eye fatigue.

[7]一種植物乳酸桿菌L-137或其處理物之用途,其係用於製造更年期症狀之治療、預防或改善用醫藥。 [7] A use of plant lactobacillus L-137 or its processed product for manufacturing a medicine for treating, preventing or improving menopausal symptoms.

[8]一種治療、預防或改善選自由疲勞感、睡眠障礙及眼睛疲勞所組成之群組的至少一種症狀之方法,其係藉由於對象投予植物乳酸桿菌L-137或其處理物來治療、預防或改善前述症狀。 [8] A method for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorders and eye fatigue, which comprises administering Lactobacillus plantarum L-137 or a processed product thereof to a subject to treat, prevent or improve the aforementioned symptom.

[9]一種治療、預防或改善更年期症狀之方法,其係藉由於對象投予植物乳酸桿菌L-137或其處理物來治療、預防或改善前述症狀。 [9] A method for treating, preventing or improving menopausal symptoms, which comprises administering Lactobacillus plantarum L-137 or a processed product thereof to a subject to treat, prevent or improve the aforementioned symptoms.

根據本揭示,可提供疲勞感、睡眠障礙或眼睛疲勞及更年期症狀之治療、預防或改善用組成物。又,本發明之組成物係有用於例如治療、預防或改善血管運動神經障礙樣症狀、知覺障礙樣症狀、失眠、神經質、憂鬱、眩暈、全身倦怠感、關節痛及/或肌肉痛、頭痛、心悸、蟻走感及眼睛疲勞等各種更年期症狀之。而且,根據本揭示,亦可提供此等組成物之製造方法。 According to the present disclosure, a composition for treating, preventing or improving fatigue, sleep disorders or eye fatigue and menopausal symptoms can be provided. In addition, the composition of the present invention is useful for treating, preventing or improving various menopausal symptoms such as vasomotor nerve disorder-like symptoms, perceptual disorder-like symptoms, insomnia, nervousness, depression, dizziness, general fatigue, joint pain and/or muscle pain, headache, palpitations, ants and eye fatigue. Moreover, according to the present disclosure, a method for preparing such a composition can also be provided.

[疲勞感、睡眠障礙及/或眼睛疲勞之症狀之治療、預防或改善用組成物] [Composition for treating, preventing or improving symptoms of fatigue, sleep disorders and/or eye fatigue]

本發明較佳為用於疲勞感、睡眠障礙及/或眼睛疲勞之治療、預防或改善。一般而言,疲勞為由於肉體上或精神上的原因出現身心過載而產生之活動能力或效率降低之狀態,疲勞感為自覺到該疲勞的存在之感覺。肉體上之疲勞感可列舉例如在激烈運動和肌力訓練、工作等方面之身體疲倦等,惟不限定於此等。又,精神上的疲勞感可列舉例如人際關係、工作上的煩惱、因搬家或工作調動等所造成之環境變化、因結婚或生產所造成之生活變化等而引起之壓力、衝擊性的事件等為原因者,惟不限定於此等。 The present invention is preferably used for the treatment, prevention or improvement of fatigue, sleep disorders and/or eye fatigue. Generally speaking, fatigue is a state of reduced activity ability or efficiency caused by physical or mental overload, and fatigue is the feeling of being aware of the existence of fatigue. Physical fatigue can be listed, for example, in the physical fatigue caused by intense exercise, muscle training, work, etc., but it is not limited to these. In addition, mental fatigue can be listed, for example, interpersonal relationships, work troubles, environmental changes caused by moving or job transfers, life changes caused by marriage or childbirth, etc., stress, impact events, etc., but it is not limited to these.

睡眠障礙為例如失眠、入睡困難、淺眠、難以維持入睡、過早醒來、惡夢、夢遊症、嗜睡症(somnolence)、睡眠時異常行為、多眠症(hypersomnia)、猝睡症、呼吸相關睡眠障礙、睡眠呼吸中止症、晝夜節律睡眠障礙,惟並不限定於此等。於本發明中,較佳為治療、預防或改善失眠、入睡困難、淺眠,更佳為治療、預防或改善失眠,惟並不限定於此等。 Sleep disorders include, but are not limited to, insomnia, difficulty falling asleep, shallow sleep, difficulty staying asleep, waking up too early, nightmares, sleepwalking, somnolence, abnormal sleep behavior, hypersomnia, narcolepsy, breathing-related sleep disorders, sleep apnea, and circadian rhythm sleep disorders. In the present invention, it is preferred to treat, prevent or improve insomnia, difficulty falling asleep, and shallow sleep, and it is more preferred to treat, prevent or improve insomnia, but is not limited to these.

眼睛(眼)疲勞為例如視覺疲勞、客觀性或自覺性的眼睛疲勞狀態、眼睛乾燥狀態、眼睛發癢狀態,惟並不限定於此等。又,眼睛疲勞較佳為因智慧型手機或個人電腦等OA機器所造成之光(所謂的藍光)刺激而引發者,惟並不限定於此等。於本發明中,較佳係所治療、預防或改善之眼睛疲勞為客觀性或自覺性的眼睛疲勞狀態、視覺疲勞,惟不限定於此等。 Eye fatigue is, for example, visual fatigue, objective or subjective eye fatigue, dry eyes, itchy eyes, but is not limited to these. In addition, eye fatigue is preferably caused by light (so-called blue light) stimulation caused by OA machines such as smart phones or personal computers, but is not limited to these. In the present invention, it is preferred that the eye fatigue to be treated, prevented or improved is objective or subjective eye fatigue, visual fatigue, but is not limited to these.

又,本發明組成物之對象並不限定於後述之更年期及更年期前後之個體或群體,所有年齡層之個體或群體都可作為對象。 Furthermore, the subjects of the composition of the present invention are not limited to the individuals or groups in menopause and before and after menopause described below, but can be subjects of individuals or groups of all ages.

[更年期症狀之治療、預防或改善用組成物] [Composition for treating, preventing or improving menopausal symptoms]

本發明較佳為用於更年期症狀之治療、預防或改善。於本說明書中,所謂的更年期,於女性而言,通常為卵巢功能降低而停經(例如12個月以上無月經)之前後約5年之期間,於經摘除卵巢之女性亦會看到更年期症狀,廣義上係指為女性荷爾蒙之雌激素的分泌量急遽減少之期間,惟會因為個體或群體(例如人種、時代等)之對象而有所差異,故並不只限定於此等期間。又,於男性而言,係與女性不同,並無停經,雖然通常無男性荷爾蒙急速減少之傾向,但為男性荷爾蒙之睪酮之分泌量係有因為老化加上環境變化和壓力等而減少之情況。男性的更年期係指發生如此之與女性之更年期相似的身心失調之期間,惟由於會隨著個體或群體而有所差異,因此並不只限定於此期間。 The present invention is preferably used for the treatment, prevention or improvement of menopausal symptoms. In this specification, the so-called menopause, for women, is usually the period of about 5 years before and after menopause (e.g., no menstruation for more than 12 months) due to decreased ovarian function. Women who have had their ovaries removed will also see menopausal symptoms. In a broad sense, it refers to the period when the secretion of female hormone estrogen decreases rapidly, but it varies depending on the individual or group (e.g., race, era, etc.), so it is not limited to this period. In addition, for men, unlike women, there is no menopause. Although there is usually no tendency for male hormones to decrease rapidly, the secretion of male hormone testosterone decreases due to aging, environmental changes, and stress. Male menopause refers to the period of physical and mental disorders similar to female menopause, but it is not limited to this period because it varies among individuals or groups.

又,於本發明中,所治療、預防或改善之更年期症狀較佳為例如:1種以上的選自由以下之(i)至(xii)所組成之群組者,惟不限定於此等症狀。 Furthermore, in the present invention, the menopausal symptoms to be treated, prevented or improved are preferably, for example, one or more selected from the group consisting of (i) to (xii) below, but are not limited to these symptoms.

(i)血管運動神經障礙樣症狀[例如熱潮紅(顏面潮紅、潮熱、出汗等)、畏寒、心搏過速、心搏過慢等,惟並不限定於此等]、(ii)知覺障礙樣症狀[例如發麻感、知覺過敏、知覺麻痺等,胳膊、手或下肢(腿根、大腿、膝蓋、小腿肚、脛、腳踝、腳等)發麻、感覺變遲鈍之狀態,惟並不限定於此等]、(iii)失眠、(iv)神經質、(v)憂鬱、(vi)眩暈、(vii)全身倦怠感、(viii)關節痛及/或肌肉痛(例如脖子、肩膀、背、腰、臀、腳、胳膊、手等之一者以上呈疼痛狀態,惟並不限定於此等)、(ix)頭痛(可列舉例如緊張型頭痛、偏頭痛等,惟並不限定於此等)、(x)心悸、(xi)蟻走感及(xii)眼睛疲勞。 (i) Vasomotor neurological disorder-like symptoms [such as hot flashes (facial flushing, hot flashes, sweating, etc.), chills, tachycardia, bradycardia, etc., but not limited to these], (ii) sensory disorder-like symptoms [such as numbness, hypersensitivity, numbness, etc., numbness and dullness of sensation in the arms, hands or lower limbs (leg roots, thighs, knees, calves, shins, ankles, feet, etc.), but not limited to these], (iii) insomnia, ( iv) neurosis, (v) depression, (vi) dizziness, (vii) general malaise, (viii) joint pain and/or muscle pain (e.g. pain in one or more of the neck, shoulders, back, waist, hips, feet, arms, hands, etc., but not limited to these), (ix) headache (e.g. tension headache, migraine, etc., but not limited to these), (x) palpitations, (xi) ants' feeling and (xii) eye fatigue.

上述之症狀中,於本發明,治療、預防或改善之症狀較佳為失眠及/或全身倦怠感,惟並不限定於此等。 Among the above symptoms, the present invention preferably treats, prevents or improves insomnia and/or general fatigue, but is not limited to these.

又,本發明較佳為用於女性及男性的更年期症狀之治療、預防或改善,更佳為用於女性的更年期症狀之治療、預防或改善。 Furthermore, the present invention is preferably used for the treatment, prevention or improvement of menopausal symptoms in women and men, and more preferably for the treatment, prevention or improvement of menopausal symptoms in women.

[植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)] [Lactobacillus plantarum L-137]

本發明之組成物係含有為乳酸菌之植物乳酸桿菌L-137株(Lactobacillus plantarum L-137、受託編號:FERM BP-08607號)或其處理物。 The composition of the present invention contains the lactic acid bacteria Lactobacillus plantarum L-137 strain (Lactobacillus plantarum L-137, entrusted number: FERM BP-08607) or its processed product.

於本發明所使用之乳酸菌植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)係於獨立行政法人產業技術綜合研究所專利生物寄託中心(現為:獨立行政法人製品評價技術基盤機構特許微生物寄託中心;地址:郵遞區號292-0818日本千葉縣木更津市上總鎌足2-5-8 120號室),以受託編號:FERM BP-08607號(從於平成7年11月30日寄託之FERM P-15317號移管)寄託。又,即使為植物乳酸桿菌L-137之突變株,若為具備植物乳酸桿菌L-137之特徵者即屬於植物乳酸桿菌L-137之範疇。又,植物乳酸桿菌L-137株可與其他乳酸菌一起包含於本發明之組成物中。 The lactic acid bacteria Lactobacillus plantarum L-137 strain used in the present invention is deposited at the Patent Organism Deposit Center of the National Institute of Advanced Industrial Technology (currently: Patent Organism Deposit Center of the Institute of Technology Evaluation; address: Room 120, 2-5-8, Kazusa Kamata, Kisarazu-shi, Chiba Prefecture, 292-0818, Japan) under the trust number: FERM BP-08607 (transferred from FERM P-15317 deposited on November 30, 1998). Furthermore, even if it is a mutant strain of Lactobacillus plantarum L-137, if it has the characteristics of Lactobacillus plantarum L-137, it belongs to the category of Lactobacillus plantarum L-137. Furthermore, Lactobacillus plantarum L-137 strain can be included in the composition of the present invention together with other lactic acid bacteria.

於本發明之組成物中,相對於組成物之全部量,所包含的植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)或其處理物較佳係約0.0001至10重量%,更佳係約0.001至8重量%,又更佳係含有約0.002至4重量%。惟並不限定於此等範圍。 In the composition of the present invention, relative to the total amount of the composition, the amount of Lactobacillus plantarum L-137 or its processed material contained is preferably about 0.0001 to 10% by weight, more preferably about 0.001 to 8% by weight, and even more preferably about 0.002 to 4% by weight. However, it is not limited to these ranges.

又,本發明之植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)或其處理物之攝取量為經口或注射投予時,可依照攝取者之年齡及體重、症狀、投予時間、劑型、投予方法、藥劑之組合等而決定。例如,就成人1人(約60kg)每1日而言,將植物乳酸桿菌L-137株作成乾燥死菌體時,以設定成攝取較佳的約0.5至200mg,更佳的約1至 100mg,又更佳的約2至50mg為宜,惟並不限定於此等範圍。又,就成人1人(約60kg)每1日而言,若將植物乳酸桿菌L-137以活菌換算,則以設定成攝取較佳的約5×108至2×1011cfu(colony-forming unit;菌落形成單位),更佳的約1×109至1×1011cfu為宜。惟並不限定於此範圍。攝取次數可以是分為1日1次或複數次來進行。前述之投予用量可以是分為每1日1次至數次來投予或應用。 In addition, when the Lactobacillus plantarum L-137 strain or its processed product of the present invention is administered orally or by injection, the intake amount can be determined according to the age and weight of the person taking the Lactobacillus plantarum L-137 strain, symptoms, administration time, dosage form, administration method, combination of drugs, etc. For example, for an adult (about 60 kg) per day, when the Lactobacillus plantarum L-137 strain is made into a dried dead cell body, the intake amount is preferably about 0.5 to 200 mg, more preferably about 1 to 100 mg, and more preferably about 2 to 50 mg, but it is not limited to these ranges. Furthermore, for an adult (about 60 kg) per day, if Lactobacillus plantarum L-137 is converted to live bacteria, the optimal intake is about 5×10 8 to 2×10 11 cfu (colony-forming unit), and more preferably about 1×10 9 to 1×10 11 cfu. However, it is not limited to this range. The intake frequency can be divided into once a day or multiple times. The aforementioned dosage can be divided into once a day to several times for administration or application.

[乳酸菌之培養] [Cultivation of lactic acid bacteria]

於本發明中,植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)及其他之乳酸菌可以是用天然培養基、合成培養基及半合成培養基等培養基所培養出之任意者。於本發明中,乳酸菌之培養係可依照公知方法、本身為公知之方法或以此等為基準之方法來進行。 In the present invention, Lactobacillus plantarum L-137 and other lactic acid bacteria can be cultured in any medium such as natural medium, synthetic medium and semi-synthetic medium. In the present invention, the culture of lactic acid bacteria can be carried out according to a known method, a method that is known per se or a method based on the above.

前述培養基無並特別限定,較佳係使用例如含有氮源及/或碳源者。前述氮源無並特別限定,可列舉例如肉萃取物、蛋白腖、麩質、酪蛋白、酵母萃取物或胺基酸等。前述碳源並無特別限定,可列舉例如:葡萄糖、木糖、果糖、肌醇、麥芽糖、水飴、麴汁、澱粉、蔗渣、麩皮、糖蜜或甘油等。此等可係使用1種或將2種以上組合使用。前述培養基除了添加前述氮源及/或碳源之外,亦可再添加無機物。前述無機物無特別限定,可列舉例如硫酸銨、磷酸鉀、氯化鎂、食鹽、鐵、錳、鉬或各種維生素類等,此等可使用1種或將2種以上組合使用。 The aforementioned culture medium is not particularly limited, and preferably contains a nitrogen source and/or a carbon source. The aforementioned nitrogen source is not particularly limited, and examples thereof include meat extract, peptone, gluten, casein, yeast extract, or amino acids. The aforementioned carbon source is not particularly limited, and examples thereof include glucose, xylose, fructose, inositol, maltose, syrup, koji juice, starch, bagasse, bran, molasses, or glycerol. These may be used alone or in combination of two or more. In addition to the aforementioned nitrogen source and/or carbon source, inorganic substances may also be added to the aforementioned culture medium. The aforementioned inorganic substances are not particularly limited, and examples thereof include ammonium sulfate, potassium phosphate, magnesium chloride, salt, iron, manganese, molybdenum, or various vitamins, etc. These can be used alone or in combination of two or more.

植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)及其他乳酸菌之培養溫度及培養時間,若為可有效率地實施培養即無特別限定,於本發明之一態樣中,培養溫度例如通常為約25至40度(℃),較佳可為約27至35度,培養時間例如可為約12至48小時。而且,於本發明之一 態樣中,乳酸菌之培養可藉由通氣振盪來實施。又,培養基之pH並無特別限定,而於本發明之一態樣中,通常為約pH3至6,較佳可為約pH4至6。 The culture temperature and culture time of Lactobacillus plantarum L-137 and other lactic acid bacteria are not particularly limited as long as the culture can be carried out efficiently. In one aspect of the present invention, the culture temperature is, for example, usually about 25 to 40 degrees (℃), preferably about 27 to 35 degrees, and the culture time is, for example, about 12 to 48 hours. Moreover, in one aspect of the present invention, the culture of lactic acid bacteria can be carried out by ventilation and shaking. In addition, the pH of the culture medium is not particularly limited, but in one aspect of the present invention, it is usually about pH 3 to 6, preferably about pH 4 to 6.

[乳酸菌之處理物] [Processed products of lactic acid bacteria]

就乳酸菌的植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)之「處理物」而言,較佳為將L-137株加工所成者,可列舉其培養液或培養上清液、將該等過濾或離心分離出之殘渣、菌體之超音波破碎液等,惟並不限定於此等。而且,本發明之處理物亦包括以酵素或物理性處理而將細胞壁去除後之處理液、以藥品或鹽析處理而獲得之蛋白質或肽之複合體、此等之濃縮物、乾燥物或稀釋物等,惟並不限定於此等。 As for the "processed material" of the lactic acid bacteria Lactobacillus plantarum L-137, it is preferably the product obtained by processing the L-137 strain, which may include its culture solution or culture supernatant, the residue separated by filtration or centrifugation, the ultrasonic disruption solution of the bacteria, etc., but it is not limited to these. In addition, the processed material of the present invention also includes the processed liquid after the cell wall is removed by enzyme or physical treatment, the protein or peptide complex obtained by drug or salinization treatment, the concentrate, dried or diluted products of these, but it is not limited to these.

又,L-137株可為活菌體、乾燥菌體、離心菌體、經破碎之菌體等,亦可為死菌體,惟從穩定性及操作容易性等之觀點來看,較佳為死菌體。 In addition, the L-137 strain can be live bacteria, dried bacteria, centrifuged bacteria, broken bacteria, etc., or dead bacteria. However, from the perspective of stability and ease of operation, dead bacteria are preferred.

於本發明中,將上述處理物可係以原狀使用,亦可以冷凍乾燥、低溫乾燥、噴霧乾燥或L-乾燥等或者將此等予以組合而作成粉末狀來使用。又,此等處理物可以適當之溶劑(水、乙醇、有機溶劑等)稀釋而使用,亦可加入適當之添加劑,作成凝膠或固體劑而使用。 In the present invention, the above-mentioned processed materials can be used in their original state, or can be freeze-dried, low-temperature dried, spray-dried or L-dried, or a combination of these to make them into powders for use. In addition, these processed materials can be diluted with appropriate solvents (water, ethanol, organic solvents, etc.) and used, or can be added with appropriate additives to make them into gels or solids for use.

以下,係就調製植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)及其他乳酸菌之死菌體之方法進行具體的說明。 The following is a detailed description of the method for preparing dead cells of Lactobacillus plantarum L-137 and other lactic acid bacteria.

於本發明中,前述死菌體之調製方法只要不會失去本發明之效果,則無特別限定,而例如可藉由「(I)於培養完成後,將乳酸菌之活菌體從培養液分離之後,將前述活菌體進行殺菌或滅菌處理而作成死菌體之狀態之方法」、「(II)於培養液中將乳酸菌之活菌體進行殺菌處理,作成死菌體之狀態,之後從培養液分離出前述死菌體之方法」等任意方法來進行調製。滅菌係例如可藉由過濾器過濾來進行,此外亦可藉由公知之方法,例如藉由 環氧乙烷(ethylene oxide)、過氧化氫進行之氣體滅菌(gaseous sterilization),藉由γ射線、電子射線照射、高頻等進行之加熱滅菌等來進行。 In the present invention, the method for preparing the dead cells is not particularly limited as long as the effects of the present invention are not lost, and for example, the dead cells may be prepared by any method such as "(I) after the culture is completed, the live cells of lactic acid bacteria are separated from the culture solution and then the live cells are sterilized or sterilized to be in a dead cell state", "(II) the live cells of lactic acid bacteria are sterilized in the culture solution to be in a dead cell state and then the dead cells are separated from the culture solution". Sterilization can be performed, for example, by filtering with a filter, or by known methods such as gas sterilization using ethylene oxide or hydrogen peroxide, or heat sterilization using gamma rays, electron beams, or high frequency.

將菌體從培養液分離之方法係可採用於此領域通常使用之各種方法,而無特別限定。於本發明之一態樣中,具體而言,可採用例如從培養液藉由離心分離等手段將上清液去除,並將培養液及菌體分離之方法等。又,於此態樣中,可在將蒸餾水加入至培養液中並進行離心分離後去除上清液之後,視期望而將「於經去除上清液之殘留物再加入蒸餾水,並進行離心分離」之操作重覆進行數次。於本發明之一態樣中,分離操作可包含過濾步驟。就上述之菌體而言,係可藉由付諸以噴霧乾燥裝置來進行的乾燥操作,而獲得乾燥菌。裝置較佳可列舉例如具備可形成約1至10μm左右之噴霧液滴之微粒化裝置的噴霧乾燥裝置,惟不限定於此等。 The method for separating the bacterial cells from the culture solution can be various methods commonly used in this field, and is not particularly limited. In one aspect of the present invention, specifically, a method can be adopted in which the supernatant is removed from the culture solution by means of centrifugation, etc., and the culture solution and the bacterial cells are separated. In addition, in this aspect, after adding distilled water to the culture solution and performing centrifugation to remove the supernatant, the operation of "adding distilled water to the residue after the supernatant is removed and performing centrifugation" can be repeated several times as desired. In one aspect of the present invention, the separation operation can include a filtering step. As for the above-mentioned bacteria, dried bacteria can be obtained by subjecting them to a drying operation using a spray drying device. A preferred device is, for example, a spray drying device equipped with a micronizing device that can form spray droplets of about 1 to 10 μm, but it is not limited to this.

前述殺菌處理方法並無特別限定,可列舉例如:加熱、紫外線照射、福馬林處理等處理。又,前述殺菌處理可以是對所採取之活菌體進行,亦可是對包含活菌體之培養液來進行。 The aforementioned sterilization treatment method is not particularly limited, and examples thereof include: heating, ultraviolet irradiation, formalin treatment, etc. In addition, the aforementioned sterilization treatment can be performed on the collected live bacteria, or on the culture medium containing the live bacteria.

進行前述加熱處理時,加熱溫度並無特別限定,例如通常為約60至100度(℃),較佳可為約70至90度。加熱手段可以使用公知之方法,無特別限定,可為例如加熱器等手段。加熱時間若可充分地完成殺菌處理即無特別限定,例如,當加熱時間達到所期望之溫度後,通常為約5至40分鐘,較佳為約10至30分鐘。 When performing the aforementioned heat treatment, the heating temperature is not particularly limited, for example, it is usually about 60 to 100 degrees (℃), preferably about 70 to 90 degrees. The heating means can use a known method, without particular limitation, such as a heater. The heating time is not particularly limited as long as it can fully complete the sterilization treatment. For example, when the heating time reaches the desired temperature, it is usually about 5 to 40 minutes, preferably about 10 to 30 minutes.

作為死菌體之處理物,可以是將如上所述之操作所獲得之前述死菌體進一步進行磨碎、破碎、噴霧乾燥、低溫乾燥或冷凍乾燥處理或是與其他之原料素材(例如維生素、胺基酸、寡肽(oligopeptide)等)進行混合等而得者。於本發明中,死菌體之處理物適合作為死菌體適當使用。 The dead bacteria treated material can be obtained by further grinding, crushing, spray drying, low temperature drying or freeze drying the dead bacteria obtained by the above-mentioned operation, or mixing with other raw materials (such as vitamins, amino acids, oligopeptides, etc.). In the present invention, the dead bacteria treated material is suitable for use as the dead bacteria.

本發明組成物之較佳例為飲食品用及/或醫藥品用(亦包含動物藥)。就他之較佳例而言,本發明之組成物可作為飲食品用之添加劑使用。為飲食品用、飲食品用添加劑用或醫藥品用之組成物係可將上述之本發明之培養上清液或其處理物、L-137株或其處理物進一步與藥學上容許之載體、添加劑等適當調配而製劑化等。由於用於該製劑化之製劑化方法或製劑化技術在過去便已充分確立,故根據過去所確立者進行即可。例如,為醫藥品用時,具體而言係可作成錠劑、包覆錠劑、丸劑、散劑、顆粒劑、膠囊劑、液劑、懸浮劑、乳劑等經口劑,注射劑、輸液、栓劑、軟膏、貼片(patch)劑等非經口劑。載體或添加劑之調配比例以於飲食品、醫藥品或獸醫學領域所通常採用之範圍為基礎進行適當設定即可。 The preferred examples of the composition of the present invention are for food and/or medicine (including animal medicine). As for other preferred examples, the composition of the present invention can be used as an additive for food. The composition for food, food additive or medicine can be prepared by further mixing the culture supernatant or its processed product, L-137 strain or its processed product with pharmaceutically acceptable carriers, additives, etc. as appropriate. Since the formulation method or formulation technology used for the formulation has been fully established in the past, it can be carried out according to what has been established in the past. For example, when used as medicine, it can be made into oral preparations such as tablets, coated tablets, pills, powders, granules, capsules, liquids, suspensions, emulsions, and non-oral preparations such as injections, infusions, suppositories, ointments, and patches. The proportion of carriers or additives can be appropriately set based on the range commonly used in the fields of food, medicine, or veterinary medicine.

藥學上容許之載體或添加劑並無特別限制,載體之例子可列舉水性或油性基劑等各種載體,水性載體可列舉例如:水、生理食鹽水、乙醇、甘油、聚乙二醇、丙二醇、甲基纖維素、羥丙基甲基纖維素、羥丙基纖維素、聚乙烯吡咯啶酮、聚丙烯酸、多醣膠(polysaccharide gums)系天然高分子類等,油性載體可列舉例如:凡士林、角鯊烯、石蠟等適當之油類或蠟類等,惟並不限定於此等。 There is no particular limitation on pharmaceutically acceptable carriers or additives. Examples of carriers include various carriers such as aqueous or oily bases. Aqueous carriers include, for example, water, physiological saline, ethanol, glycerol, polyethylene glycol, propylene glycol, methylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, polyvinylpyrrolidone, polyacrylic acid, polysaccharide gums (natural polymers), etc. Oily carriers include, for example, petrolatum, squalene, wax, and other appropriate oils or waxes, but are not limited thereto.

添加劑之例子可列舉:酵素、pH調整劑、保存料、殺菌料、抗氧化劑、防黴劑、保質期延長劑、漂白劑、光澤劑、香料、甜味料、酸味料、調味料、苦味料、乳化劑、增黏劑、穩定劑、膠化劑、糊料、賦形劑、結合劑、崩解劑、潤滑劑、著色劑、矯味劑等,惟不限定於此等。由於此等相關之技術在過去便已充分確立,故於本發明可根據過去所確立者進行。 Examples of additives include: enzymes, pH adjusters, preservatives, bactericides, antioxidants, mold inhibitors, shelf life extenders, bleaching agents, glossing agents, spices, sweeteners, acidulants, seasonings, bittering agents, emulsifiers, thickeners, stabilizers, gelling agents, pastes, shaping agents, binders, disintegrants, lubricants, colorants, flavoring agents, etc., but are not limited to these. Since these related technologies have been fully established in the past, the present invention can be carried out according to those established in the past.

又,本發明之組成物為飲食品用時,飲食品係包含健康食品、功能標示食品、特定保健用食品、病患用食品。飲食品之形態並無特別限定,具體例子可列舉例如:作為所謂之營養輔助食品或增補劑(supplement)之錠劑、顆粒劑、散劑、飲料劑等。除此之外,可列舉例如茶飲料、清涼飲料、碳酸飲料、營養飲料、果實飲料、乳酸飲料等飲料,蕎麥麵、烏龍麵、中式麵、速食麵等麵類,飴糖、糖果(candy)、口香糖、巧克力、零食點心、餅乾、果凍、果醬、鮮奶油、烘焙點心、麵包等點心及麵包類,火腿、香腸、半片、竹輪等水產/畜產加工食品,加工乳、發酵乳等乳製品,沙拉油、天婦羅油、人造奶油(margarine)、美乃滋、酥油(shortening)、打發鮮奶油(whipped cream)、調味醬(dressing)等油脂及油脂加工食品,醬汁、高湯等調味料,咖哩、燉菜、丼、粥、雜煮等調理包食品,冰淇淋、雪酪、刨冰等冷凍甜點等,惟並不限定於此等。由於此等相關之技術在過去便已充分確立,故於本發明可根據過去所確立者進行。 Furthermore, when the composition of the present invention is used as a food, the food includes health food, food with functional labeling, food for specific health care, and food for patients. The form of the food is not particularly limited, and specific examples include: tablets, granules, powders, drinks, etc. as so-called nutritional supplements or supplements. In addition, beverages such as tea, soft drinks, carbonated drinks, nutritional drinks, fruit drinks, lactic acid drinks, etc., noodles such as buckwheat noodles, udon noodles, Chinese noodles, instant noodles, etc., candy, gum, chocolate, snacks, biscuits, jelly, jam, fresh cream, baked snacks, bread, etc., snacks and breads, ham, sausage, half slice, bamboo rolls, etc., seafood/livestock processed foods, processed milk, fermented milk, etc., dairy products, salad oil, tempura oil, margarine, mayonnaise, shortening, whipped cream, etc. Cream), dressings and other fats and fat processed foods, sauces, soups and other condiments, curry, stews, donburi, porridge, mixed dishes and other prepared foods, ice cream, sorbet, shaved ice and other frozen desserts, but not limited to these. Since these related technologies have been fully established in the past, the present invention can be carried out based on those established in the past.

再者,本發明之組成物只要不失去本發明之效果,可含有例如於醫學、藥學、獸醫學、畜產或食品等領域所知之任意成分。 Furthermore, the composition of the present invention may contain any ingredients known in the fields of medicine, pharmacy, veterinary medicine, livestock or food, as long as the effects of the present invention are not lost.

[疲勞感、睡眠障礙或眼睛疲勞及更年期症狀改善作用與其確認方法] [Improvement effects on fatigue, sleep disorders, eye fatigue, and menopausal symptoms and how to confirm them]

確認本發明組成物之效果之方法係可列舉例如:將含有植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)或其處理物之組成物與未含L-137株或其處理物之組成物進行比較,以確認於疲勞感、睡眠障礙或眼睛疲勞及更年期症狀之改善為優越之方法。 The method for confirming the effect of the composition of the present invention is, for example, to compare a composition containing Lactobacillus plantarum L-137 or its processed product with a composition not containing L-137 or its processed product to confirm the superiority in improving fatigue, sleep disorders or eye fatigue and menopausal symptoms.

具體而言,疲勞感、睡眠障礙或眼睛疲勞及更年期症狀改善效果之確認方法,係可列舉例如為自覺性疲勞度的測定方法之VAS(視覺類比量表(Visual Analogue Scale));測定血中氧化應激標記(oxidative-stress marker)、入眠所需之時間(睡眠潛伏期)及總睡眠維持時間(總睡眠時間)之方法、除了使用大鼠或小鼠之強迫游泳實驗(forced swim test:FST);除此之外,可列舉以後述之問診單及庫珀曼指數(Kupperman index)為基礎,評估效果之方法等,惟不限定於此等。 Specifically, the methods for confirming the improvement effect of fatigue, sleep disorders, eye fatigue and menopausal symptoms include, for example, VAS (Visual Analogue Scale) for measuring perceived fatigue; methods for measuring oxidative-stress markers in the blood, the time required to fall asleep (sleep latency) and the total sleep duration (total sleep time); forced swim tests (FST) using rats or mice; in addition, methods for evaluating the effect based on the questionnaire and Kupperman index described later can be listed, but are not limited to these.

本發明組成物之效果不只限於更年期症狀之治療、預防或改善,關於更年期症狀之評估方面,亦可使用例如己知之作為更年期模型包含卵巢摘除動物(較佳為大鼠、小鼠等)。又,進行關於眼睛疲勞之評估時,可使用例如測定於人類或動物(例如兔子等)之視網膜色素上皮細胞等照射藍光時的細胞生存度之方法等。 The effects of the composition of the present invention are not limited to the treatment, prevention or improvement of menopausal symptoms. For the evaluation of menopausal symptoms, known menopausal models including ovariectomized animals (preferably rats, mice, etc.) can also be used. In addition, when evaluating eye fatigue, methods such as measuring the cell survival rate of retinal pigment epithelial cells in humans or animals (such as rabbits, etc.) when irradiated with blue light can be used.

例如,使對象攝取(投予)本發明之組成物時,與未攝取(或投予)本發明之組成物之對照組比較,於VAS或血中氧化應激標記之測定值特別降低或顯著降低之情況、入眠潛潛伏期及/或總睡眠時間特別延長或顯著延長之情況等,可判斷本發明之組成物具有所期望之效果。 For example, when a subject ingests (administers) the composition of the present invention, compared with a control group that does not ingest (or administer) the composition of the present invention, if the measured values of VAS or blood oxidative stress markers are particularly or significantly reduced, or the sleep latency and/or total sleep time are particularly or significantly prolonged, etc., it can be judged that the composition of the present invention has the desired effect.

除此之外,亦可依照上述以外之公知方法等、於該領域己充分確定之方法來進行評估。此等方法之一例係可參照後述之實施例。 In addition, the evaluation can also be performed according to the known methods other than those mentioned above, or methods that have been fully established in the field. An example of such methods can be found in the following embodiments.

本發明之組成物經調製為飲食品、醫藥品(亦包含動物用醫藥)或準藥品之形態時,係可有鑑於本發明組成物之作用而於該飲食品、醫藥品或準藥品、其所附之說明書或其包裝盒等標示「具有疲勞感、睡眠障礙或眼睛疲勞及更年期症狀改善作用」。 When the composition of the present invention is formulated into a food, medicine (including animal medicine) or quasi-drug, it can be labeled "having the effect of improving fatigue, sleep disorders or eye fatigue and menopausal symptoms" on the food, medicine or quasi-drug, its attached instructions or its packaging box in view of the effect of the composition of the present invention.

[組成物之製造方法] [Manufacturing method of the composition]

本發明較佳係包含疲勞感、睡眠障礙或眼睛疲勞及更年期症狀之治療、預防或改善用組成物之製造方法,該製造方法包括將植物乳酸桿菌L-137或其處理物與載體及/或賦形劑進行混合之步驟。 The present invention preferably includes a method for preparing a composition for treating, preventing or improving fatigue, sleep disorders or eye fatigue and menopausal symptoms, the method comprising the step of mixing plant lactobacillus L-137 or its processed product with a carrier and/or a formulator.

由於過去在食品或醫藥領域便已充分確立於上述步驟所使用之較佳之載體,故本發明亦可依照過去所確立者,而可列舉例如水性或油性基劑等各種載體,水性載體可列舉例如水、生理食鹽水、乙醇、甘油、聚乙二醇、丙二醇、甲基纖維素、羥丙基甲基纖維素、羥丙基纖維素、聚乙烯吡咯啶酮、聚丙烯酸、多醣膠系天然高分子類等;油性載體可列舉例如凡士林、角鯊烯、石蠟等適當之油類或蠟類等,惟並不限定於此等。 Since the preferred carriers used in the above steps have been fully established in the food or pharmaceutical fields in the past, the present invention can also be based on those established in the past, and various carriers such as aqueous or oily bases can be listed. Aqueous carriers can be listed, for example, water, physiological saline, ethanol, glycerol, polyethylene glycol, propylene glycol, methylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, polyvinylpyrrolidone, polyacrylic acid, polysaccharide gum-based natural polymers, etc.; oily carriers can be listed, for example, vaseline, squalene, wax, etc. Appropriate oils or waxes, etc., but are not limited to these.

又,由於過去在食品或醫藥領域便已充分確立於上述步驟使用之較佳之賦形劑,故本發明亦可依照過去所確立者,較佳可使用乳糖、白糖、甘露醇、玉米澱粉、粉末纖維素、磷酸氫鈣、碳酸鈣等,惟並不限定於此等。 Furthermore, since the preferred formulations used in the above steps have been fully established in the food or pharmaceutical fields in the past, the present invention can also be based on those established in the past, preferably using lactose, white sugar, mannitol, corn starch, powdered cellulose, calcium hydrogen phosphate, calcium carbonate, etc., but is not limited to these.

本發明之組成物,除了於組成物中添加植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)或其處理物以外,亦可根據一般之組成物之製造方法而適當進行加工及製造。亦即,本發明係包含組成物之製造方法,該組成物之製造方法係含有將植物乳酸桿菌L-137株(Lactobacillus plantarum L-137)或其處理物視期望而與其他成分混合之步驟。 The composition of the present invention can be appropriately processed and manufactured according to a general method for manufacturing a composition, in addition to adding Lactobacillus plantarum L-137 or its processed product to the composition. That is, the present invention includes a method for manufacturing a composition, and the method for manufacturing the composition includes the step of mixing Lactobacillus plantarum L-137 or its processed product with other ingredients as desired.

本發明只要能發揮本發明之效果,便於本發明之技術範圍內包括上述構成之各種組合的態樣。又,若為屬於本發明之技術範圍者,即能夠進行適當變更。 As long as the effects of the present invention can be exerted, the various combinations of the above-mentioned structures are included within the technical scope of the present invention. In addition, if it is within the technical scope of the present invention, it can be appropriately modified.

[實施例] [Implementation example]

以下,列舉實施例及試驗例以更具體的說明本發明,惟,本發明不限定於此等。 The following lists embodiments and test examples to more specifically illustrate the present invention, but the present invention is not limited to these.

[試驗例]使用含有乳酸菌L-137株之組成物之人類臨床試驗(更年期症狀及眼睛疲勞之評估) [Test example] Human clinical trial using a composition containing lactic acid bacteria L-137 strain (evaluation of menopausal symptoms and eye fatigue)

<1.使用之組成物> <1. Ingredients used>

作為本發明之組成物,係使用每1錠(300mg)包含經加熱處理之植物乳酸桿菌死菌體L-137株10mg之市售的錠劑(日文商品名:

Figure 111145703-A0202-12-0014-4
Figure 111145703-A0202-12-0014-5
乳酸菌L-137
Figure 111145703-A0202-12-0014-6
)。於錠劑中亦包含L-137株以外之成分(乳糖、澱粉、蔗糖脂肪酸酯等),惟此等成分對於以下之實驗並無特別之影響。 As the composition of the present invention, a commercially available tablet (Japanese trade name:
Figure 111145703-A0202-12-0014-4
high
Figure 111145703-A0202-12-0014-5
Lactic acid bacteria L-137
Figure 111145703-A0202-12-0014-6
The tablets also contain ingredients other than L-137 (lactose, starch, sucrose fatty acid esters, etc.), but these ingredients have no special effect on the following experiments.

<2.根據組成物之攝取及更年期症狀問診單來實施評估> <2. Conduct assessment based on the intake of ingredients and the menopausal symptom questionnaire>

將41至73歲之22名男女分為2群[非攝取群6名(男性1名、女性5名)、死菌體L-137株攝取群16名(男性5名、女性11名)]。使死菌體L-137株攝取群以1日1錠持續攝取上述之組成物12個月。 22 males and females aged 41 to 73 were divided into 2 groups [6 non-ingesting group (1 male, 5 females) and 16 dead bacteria L-137 strain ingesting group (5 males, 11 females)]. The dead bacteria L-137 strain ingesting group was made to ingest the above composition at a dosage of 1 tablet per day for 12 months.

於試驗開始前及攝取組成物3、6、12個月時,根據庫珀曼更年期症狀問診單實施評估。再者,就從試驗開始前算起之問診單分數之變化量進行評估。於更年期症狀問診單之症狀為以下11個項目:(1)血管運動神經障礙樣症狀、(2)知覺障礙樣症狀、(3)失眠、(4)神經質、(5)憂鬱、(6)眩暈、(7)全身倦怠感、(8)關節痛/肌肉痛、(9)頭痛、(10)心悸及(11)蟻走感。 The subjects were evaluated using the Cooperman Menopausal Symptom Questionnaire before the start of the study and at 3, 6, and 12 months after taking the composition. In addition, the change in the questionnaire score from before the start of the study was evaluated. The symptoms in the menopausal symptom questionnaire were the following 11 items: (1) vasomotor neuropathy-like symptoms, (2) perceptual disorder-like symptoms, (3) insomnia, (4) nervousness, (5) depression, (6) dizziness, (7) general fatigue, (8) joint/muscle pain, (9) headache, (10) palpitations, and (11) feeling of ants.

結果係如下述表1所示。 The results are shown in Table 1 below.

[表1]

Figure 111145703-A0202-12-0015-1
[Table 1]
Figure 111145703-A0202-12-0015-1

考察:在關於「11項目總分」(亦即,於上述之項目(1)至(11))與「失眠」及「全身倦怠感」之項目中,於L-137非攝取群,顯示更年期症狀之指數係經時性地上昇,相對於此,於L-137攝取群則顯示出特別地抑制該上昇或有抑制上昇之傾向[雙因子變異數分析(2way ANOVA分析)]。 Investigation: Regarding the "total score of 11 items" (i.e., in the above items (1) to (11)) and the items of "insomnia" and "general fatigue", the index of menopausal symptoms in the L-137 non-consuming group showed a gradual increase over time, while in contrast, the L-137 consuming group showed a particularly suppressed increase or a tendency to suppress the increase [two-way ANOVA analysis].

<3.藉由組成物之攝取與關於眼睛疲勞之問診單所實施的評估> <3. Evaluation by composition intake and questionnaire on eye fatigue>

將41至73歲之男女22名分為2群[非攝取群6名(男性1名、女性5名)、死菌體L-137株攝取群16名(男性5名、女性11名)]。使死菌體L-137株攝取群以1日1錠持續攝取上述之組成物12個月。 22 males and females aged 41 to 73 were divided into 2 groups [6 non-ingesting group (1 male, 5 females) and 16 dead bacteria L-137 strain ingesting group (5 males, 11 females)]. The dead bacteria L-137 strain ingesting group was made to ingest the above composition at a dosage of 1 tablet per day for 12 months.

於試驗開始前及攝取組成物3、6、12個月時,藉由關於眼睛疲勞之問診單實施評估。再者,就從試驗開始前算起之問診單分數之變化量進行評估。關於眼睛疲勞之問診單,除了記載「眼睛之疲勞」以外,亦記載關於「眼睛乾澀」、「眼睛癢」之內容。 The evaluation was conducted using a questionnaire on eye fatigue before the start of the trial and at 3, 6, and 12 months after taking the composition. In addition, the change in the questionnaire score from before the start of the trial was evaluated. In addition to recording "eye fatigue", the questionnaire on eye fatigue also recorded content related to "dry eyes" and "itchy eyes".

結果如下述表2所述。 The results are shown in Table 2 below.

[表2]

Figure 111145703-A0202-12-0016-3
[Table 2]
Figure 111145703-A0202-12-0016-3

考察:相對於L-137非攝取群之關於眼睛疲勞之指數係經時性地上昇,L-137攝取群則特別地抑制該上昇(2way ANOVA分析)。 Investigation: Compared with the L-137 non-intake group, the index of eye fatigue increased over time, while the L-137 intake group specifically suppressed the increase (2-way ANOVA analysis).

從上述試驗例之結果明瞭到:含有本發明之乳酸菌L-137株之組成物係顯示出改善更年期症狀及改善眼睛疲勞之作用。 The results of the above test examples show that the composition containing the lactic acid bacteria L-137 strain of the present invention shows the effect of improving menopausal symptoms and eye fatigue.

[產業上之可利用性] [Industrial availability]

如上所述,本發明之組成物係具有各種有用之效果。因此,例如有用於(i)血管運動神經障礙樣症狀;(ii)知覺障礙樣症狀;(iii)失眠;(iv)神經質;(v)憂鬱;(vi)眩暈;(vii)全身倦怠感;(viii)關節痛及/或肌肉痛;(ix)頭痛;(x)心悸;(xi)蟻走感;及(xii)眼睛疲勞之治療、預防或改善,而該組成物係有用於作為飲食品、醫藥品或準藥品等。 As described above, the composition of the present invention has various useful effects. Therefore, for example, it is useful for the treatment, prevention or improvement of (i) vasomotor nerve disorder-like symptoms; (ii) perceptual disorder-like symptoms; (iii) insomnia; (iv) neurosis; (v) depression; (vi) dizziness; (vii) general fatigue; (viii) joint pain and/or muscle pain; (ix) headache; (x) palpitations; (xi) ants walking sensation; and (xii) eye fatigue, and the composition is useful as a food, medicine or quasi-drug, etc.

Claims (9)

一種組成物,其係用於治療、預防或改善選自由疲勞感、睡眠障礙及眼睛疲勞所組成之群組的至少一種症狀者,該組成物中含有植物乳酸桿菌L-137或其處理物。 A composition for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorders and eye fatigue, wherein the composition contains plant lactobacillus L-137 or a processed product thereof. 一種組成物,其係用於治療、預防或改善更年期症狀者,該組成物中含有植物乳酸桿菌L-137或其處理物。 A composition for treating, preventing or improving menopausal symptoms, which contains plant lactobacillus L-137 or a processed product thereof. 如請求項2所述之組成物,其係用於治療、預防或改善1種以上選自由以下(i)至(xii)所組成之群組之症狀者; The composition as described in claim 2 is used to treat, prevent or improve one or more symptoms selected from the group consisting of (i) to (xii) below; (i)血管運動神經障礙樣症狀;(ii)知覺障礙樣症狀;(iii)失眠;(iv)神經質;(v)憂鬱;(vi)眩暈;(vii)全身倦怠感;(viii)關節痛及/或肌肉痛;(ix)頭痛;(x)心悸;(xi)蟻走感;及(xii)眼睛疲勞。 (i) vasomotor neuropathy-like symptoms; (ii) perceptual dysregulation-like symptoms; (iii) insomnia; (iv) nervousness; (v) depression; (vi) dizziness; (vii) general malaise; (viii) joint and/or muscle pain; (ix) headache; (x) palpitations; (xi) antsy feeling; and (xii) eye fatigue. 如請求項1至3中任一項所述之組成物,其中,組成物為飲食品。 A composition as described in any one of claims 1 to 3, wherein the composition is a food. 如請求項4所述之組成物,其中,飲食品為食品添加物或增補劑。 The composition as described in claim 4, wherein the food is a food additive or supplement. 一種植物乳酸桿菌L-137或其處理物之用途,其係用於製造選自由疲勞感、睡眠障礙及眼睛疲勞所組成之群組的至少一種症狀之治療、預防或改善用醫藥。 A use of plant lactobacillus L-137 or its processed product, which is used to manufacture a medicine for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorders and eye fatigue. 一種植物乳酸桿菌L-137或其處理物之用途,其係用於製造更年期症狀之治療、預防或改善用醫藥。 A use of plant lactobacillus L-137 or its processed product, which is used to manufacture medicines for treating, preventing or improving menopausal symptoms. 一種治療、預防或改善選自由疲勞感、睡眠障礙及眼睛疲勞所組成之群組的至少一種症狀之方法,其係藉由於對象投予植物乳酸桿菌L-137或其處理物來治療、預防或改善前述症狀。 A method for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorders and eye fatigue, wherein the method treats, prevents or improves the aforementioned symptom by administering plant lactobacillus L-137 or a processed product thereof to a subject. 一種治療、預防或改善更年期症狀之方法,其係藉由於對象投予植物乳酸桿菌L-137或其處理物來治療、預防或改善前述症狀。 A method for treating, preventing or improving menopausal symptoms, which is to treat, prevent or improve the aforementioned symptoms by administering plant lactobacillus L-137 or its processed product to a subject.
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119286718A (en) * 2024-11-18 2025-01-10 山东环亿生物科技有限公司 Lactobacillus plantarum 9A-2 and its application in preparing intestinal regulation and eye protection products

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