Probiotic and traditional Chinese medicine composition for treating insomnia and application

Abstract

The invention discloses a composition for treating insomnia. Comprising probiotic compounds: lactobacillus plantarum, bifidobacterium lactis, lactobacillus crispatus, lactobacillus acidophilus, lactobacillus rhamnosus, bifidobacterium bifidum, lactobacillus reuteri, lactobacillus casei, lactobacillus bulgaricus, lactobacillus fermentum, lactobacillus gasseri, lactococcus lactis, bifidobacterium longum, lactobacillus salivarius, bifidobacterium breve, streptococcus thermophilus and lactobacillus paracasei; lactobacillus helveticus; and traditional Chinese medicine components and prebiotics. Probiotics are matched with traditional Chinese medicines with homology of medicine and food, and corresponding prebiotics are supplemented, so that the balance of intestinal flora can be adjusted and information transmission between intestines and cranial nerves can be promoted through the synergistic effect of the probiotics and the corresponding prebiotics, and then gastrointestinal inflammation, ulcer, helicobacter pylori infection, constipation and insomnia are treated or improved; and treating or improving spleen and stomach disharmony, liver qi stagnation, excessive heart fire, fire excess from yin deficiency, heart-kidney disharmony caused by emotion, pressure, diseases and the like, and insomnia caused by the symptoms.

Description

Technical Field

[0001] The present invention belongs to the field of biomedicine technology, and specifically relates to a composition of a probiotic compound and a traditional Chinese medicine component and its use in treating or improving gastrointestinal inflammation, ulcer, Helicobacter pylori infection, constipation and insomnia. Background Art

[0002] Insomnia, commonly known as "insomnia" or "restless nights", is a common health problem that affects the quality and quantity of an individual's sleep. Insomnia can be divided into many types according to clinical manifestations and causes, such as difficulty falling asleep, difficulty maintaining sleep, early awakening and mixed types. The causes of its onset are complex and diverse, including psychological factors, physiological factors, environmental factors and lifestyle habits. High-risk groups mainly include the elderly, women (especially menopausal women), those with a history or family history of mental illness, and people who are under long-term high-pressure work. Although insomnia itself does not directly lead to death, long-term insomnia can significantly increase the risk of chronic diseases such as cardiovascular disease and diabetes, and indirectly affect the quality of life and life expectancy.

[0003] According to statistics, the number of people suffering from insomnia is increasing every year. Traditional treatment methods, such as taking Western medicine, are highly addictive and have many side effects. They can only work in terms of sedation and inducing sleep, but cannot be taken for a long time. Other methods, such as Chinese medicine and physical therapy, have low effects and are time-consuming and labor-intensive, causing the majority of insomniacs to suffer for a long time.

[0004] Probiotics have a comprehensive and huge effect on human health, and have certain clinical or practical applications in the immune system, digestive system, endocrine metabolic system, neural regulation, reproductive and urinary systems, etc. People expect to treat insomnia by taking probiotics, but in conventional applications, the activity of the strains is poor or the function is unclear (no strain number), the strain compatibility is unscientific or single, the number of live bacteria is low, and the prebiotic compatibility is unscientific. These problems lead to the ineffectiveness of probiotic products and the inability to solve the problem of insomnia caused by various causes.

[0005] In the existing Chinese medicine treatment, most of them are local conditioning, such as starting from the symptoms of liver fire disturbing the heart and stomach qi disharmony, but the causes of insomnia are diverse and complex, and local conditioning cannot fundamentally solve the problem of insomnia. In addition, the human body has problems with the absorption rate of large molecules of Chinese medicine, and the effect is difficult to be stable and not easy to be effective.

[0006] Therefore, it is necessary to find a holistic solution based on the various causes of insomnia in the human body and the need for a holistic solution. Summary of the invention

[0007] In order to solve one of the above technical problems existing in the prior art, the present invention provides a composition of a probiotic compound and a traditional Chinese medicine component and use thereof in improving insomnia.

[0008] In a first aspect, the present invention provides a composition, comprising a probiotic compound and a traditional Chinese medicine component, wherein the probiotic compound comprises the following strains or is composed of the following strains: Lactobacillus plantarum, Bifidobacterium lactis, Lactobacillus crispatus, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Lactobacillus reuteri, Lactobacillus casei, Lactobacillus bulgaricus, Lactobacillus fermentum, Lactobacillus gasseri, Lactococcus lactis, Bifidobacterium longum, Lactobacillus salivarius, Lactobacillus tumefaciens, Lactobacillus salivarius, Lactobacillus salivarius, Lactobacillus tumefaciens ... salivarius), Bifidobacterium breve, Streptococcus thermophilus, Lactobacillus paracasei, Lactobacillus helveticus; the Chinese medicine component includes or consists of the following Chinese medicines: spiny jujube seeds, lily, Poria cocos, lotus seeds, and mulberry.

[0009] In some embodiments, in the composition of the present invention, the probiotic complex includes or consists of the following species: Lactobacillus plantarum, Bifidobacterium lactis, Lactobacillus crispatus, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Lactobacillus reuteri, Lactobacillus casei, Lactobacillus bulgaricus, Lactobacillus fermentum, Lactobacillus gasseri, Lactococcus lactis, Bifidobacterium longum, Lactobacillus salivarius ... salivarius), Bifidobacterium breve, Streptococcus thermophilus, Lactobacillus paracasei, Lactobacillus helveticus.

[0010] In some embodiments, the plant lactobacillus is Lactobacillus plantarum LP9B, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on January 29, 2019, with a deposit number of CGMCC No.17243.

[0011] In some embodiments, the Bifidobacterium lactis is Bifidobacterium lactis Bb108, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on June 30, 2020, with the deposit number CGMCC No.20165.

[0012] In some embodiments, the Lactobacillus crispatus is Lactobacillus crispatus LCP018, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on April 16, 2021, with the deposit number CGMCC No.22190.

[0013] In some embodiments, the Lactobacillus acidophilus is Lactobacillus acidophilus LA5Y, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on January 29, 2019, with a deposit number of CGMCC No.17242.

[0014] In some embodiments, the Lactobacillus rhamnosus is Lactobacillus rhamnosus LR2Y, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on November 4, 2019, with a deposit number of CGMCC No.18800.

[0015] In some embodiments, the Bifidobacterium bifidum is Bifidobacterium bifidum CLME9, which was deposited in the General Microbiological Center of China National Microbiological Culture Collection Administration on September 11, 2023, with a deposit number of CGMCC No. 28421.

[0016] In some embodiments, the Lactobacillus reuteri is Lactobacillus reuteri B1r06, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on June 30, 2020, with the deposit number CGMCC No.20164.

[0017] In some embodiments, the Lactobacillus casei is Lactobacillus casei BLc08, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on November 9, 2020, with the deposit number CGMCC No.21128.

[0018] In some embodiments, the Lactobacillus bulgaricus is Lactobacillus bulgaricus, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on November 9, 2020, with the deposit number CGMCC No.21127.

[0019] In some embodiments, the fermented Lactobacillus is Lactobacillus fermentum CCF33, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on June 7, 2022, with the deposit number CGMCC No.25015.

[0020] In some embodiments, the Lactobacillus gasseri is Lactobacillus gasseri LGD2, which was deposited in the General Microbiology Center of China National Culture Collection Administration on February 1, 2021, with the deposit number CGMCC No.21785.

[0021] In some embodiments, the Lactococcus lactis is Lactococcus lactis AQ001, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on June 7, 2022, with the deposit number CGMCC No.25018.

[0022] In some embodiments, the Bifidobacterium longum is Bifidobacterium longum BL11, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on February 1, 2021, with the deposit number CGMCC No.21783.

[0023] In some embodiments, the salivarius Lactobacillus is Lactobacillus salivarius LS18, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on April 16, 2021, with the deposit number CGMCC No.22192.

[0024] In some embodiments, the Bifidobacterium breve is Bifidobacterium breve BB026, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on April 16, 2021, with the deposit number CGMCC No.22189.

[0025] In some embodiments, the thermophilic Streptococcus is Streptococcus thermophilus BStr06, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on November 9, 2020, with the deposit number CGMCC No.21129.

[0026] In some embodiments, the Lactobacillus paracasei is Lactobacillus paracasei, which was deposited in the General Microbiology Center of China National Microbiological Culture Collection Administration on April 16, 2021, with a deposit number of CGMCC No. 22191.

[0027] In some embodiments, the Lactobacillus helveticus is Lactobacillus helveticus (Lactobacillus helveticus), which was deposited in the General Microbiology Center of China National Culture Collection Administration on February 1, 2021, with the deposit number CGMCC No. 21782.

[0028] The present invention uses the above 18 specific strains to form a probiotic complex, the total number of live bacteria can reach more than 200 billion CFU / g, which can effectively regulate intestinal flora, treat and / or regulate intestinal inflammation, ulcers, constipation, inhibit and kill Helicobacter pylori, and improve insomnia by regulating the axis relationship between intestinal nerves and brain nerves. At the same time, it can also improve the detoxification and metabolic capacity of the human intestine and improve the human immunity.

[0029] In some embodiments, in the composition of the present invention, the Chinese medicine components include or consist of the following Chinese medicines: spiny jujube seeds, lily, poria, lotus seeds, and mulberry.

[0030] In some embodiments, the composition of the present invention includes Semen Ziziphi Spinosae.

[0031] Ziziphus jujuba seed has the effects of calming, soothing the nerves, nourishing the heart and tonifying the liver. Its main ingredients include ziziphus jujuba saponins, flavonoids, and trace elements zinc and calcium, which can regulate the central nervous system, calm the nerves, promote sleep, and have a significant improvement effect on insomnia caused by deficiency of heart and gallbladder qi.

[0032] In some embodiments, the compositions of the invention include lily.

[0033] Lily has the effects of calming the mind, beautifying the skin, moisturizing and relieving cough. It can be used for symptoms such as absent-mindedness, insomnia, depression, and can treat insomnia caused by lung deficiency and heat.

[0034] In some embodiments, the composition of the present invention includes Poria cocos.

[0035] Poria cocos can insulate dampness and promote diuresis, benefit the spleen and stomach, and calm the mind and nerves. It has the magical effect of improving sleep quality. The polysaccharides, proteins and trace elements contained in Poria cocos can soothe nerves, calm emotions, and make it easier for people to enter deep sleep, thereby improving sleep quality.

[0036] In some embodiments, the composition of the present invention includes lotus seeds.

[0037] Lotus seeds have the functions of strengthening the spleen and stopping diarrhea, benefiting the kidney and consolidating essence, nourishing the heart and calming the mind. Lotus seeds are rich in various nutrients, such as protein, vitamins, minerals, etc. These ingredients help nourish the body and balance the endocrine system, thus achieving a calming and soothing effect. Some special ingredients in lotus seeds, such as liensinine and nuciferine, have obvious antioxidant and anti-inflammatory effects, help relieve brain fatigue, improve sleep quality, and have a good regulating effect on insomnia caused by excessive heart fire.

[0038] In some embodiments, the compositions of the present invention include mulberries.

[0039] Mulberries have the functions of nourishing yin and blood, promoting the production of body fluids, and moistening the intestines. They are mainly used to treat dizziness, backache, tinnitus, premature graying of hair, insomnia, thirst, thirst, dry intestines and constipation caused by liver and kidney deficiency and blood deficiency. They are used to treat insomnia, dizziness, vertigo and other symptoms. For insomnia patients, mulberries can help adjust the function of the nervous system, relieve anxiety and irritability, thereby improving sleep quality and relieving insomnia symptoms caused by qi deficiency.

[0040] The purpose of the present invention is to provide a Chinese medicine composition of probiotics and medicine and food, which can eliminate the symptoms of insomnia by treating and / or regulating intestinal diseases, constipation, regulating brain nerves, etc. The probiotic complex of the present invention can promote the absorption of Chinese medicine, cooperate with Chinese medicine to take effect, and adjust the human body as a whole in combination with Chinese medicine, so as to achieve the purpose of treating or improving insomnia from multiple angles and multiple causes.

[0041] In some embodiments, the composition of the present invention further comprises prebiotics, and the prebiotics comprise one or more of L-arabinose, β-glucan, inulin, erythritol, lactitol, vitamin C, and γ-aminobutyric acid.

[0042] In some embodiments, the compositions of the invention include L-arabinose.

[0043] L-arabinose is a prebiotic that promotes the proliferation of probiotics, promotes the growth of bifidobacteria, and prevents constipation. L-arabinose selectively affects the sucrase in the small intestine, thereby inhibiting the absorption of sucrose. As a low-calorie sugar, L-arabinose can inhibit the difficulty in falling asleep caused by the increase in blood sugar due to the intake of sucrose.

[0044] In some embodiments, the compositions of the invention include β-glucan.

[0045] β-glucan is an excellent nutrient source and effective proliferation factor for beneficial bacteria such as bifidobacteria in the human intestine, and can improve the digestion and absorption function of the human intestine.

[0046] In some embodiments, the compositions of the invention include inulin.

[0047] Inulin has the functions of controlling blood lipids, promoting the absorption of minerals, preventing and treating constipation. It can regulate intestinal microbial flora and improve intestinal health.

[0048] In some embodiments, the compositions of the present invention include erythritol.

[0049] Erythritol is a prebiotic that has a significant proliferative effect on bifidobacteria in the intestines. The short-chain fatty acids (acetic acid and lactic acid) produced by the metabolism of bifidobacteria can effectively inhibit the growth of pathogens, thereby improving the body's immunity.

[0050] In some embodiments, the compositions of the present invention include lactitol.

[0051] Lactitol can promote intestinal peristalsis, accelerate the elimination of intestinal waste, prevent obesity, and promote the proliferation of probiotics.

[0052] In some embodiments, the compositions of the present invention include vitamin C.

[0053] Vitamin C has antioxidant, immune function maintaining and anti-free radical effects, and can enhance immunity.

[0054] In some embodiments, the compositions of the invention include gamma-aminobutyric acid.

[0055] GABA is an active amino acid that plays an important role in the energy metabolism of the human brain. It has many physiological functions, such as activating glucose metabolism in the brain, promoting acetylcholine synthesis, lowering blood ammonia, anticonvulsant, lowering blood pressure, improving brain function, calming the mind, and promoting the secretion of growth hormone. GABA can resist anxiety, depression, relieve stress, regulate emotions, and promote the brain to fall asleep as soon as possible and enter a deep sleep state as soon as possible.

[0056] In the composition of the present invention, the mutual promotion of multiple probiotics and prebiotics is used to adjust the balance of intestinal flora, promote information transmission between the intestine and the brain, and then adjust the sleep of the human body. Probiotics regulate the brain by regulating hundreds of millions of neurons in the intestine (vagus nerve, enteric nerve, spinal nerve), etc., to build an axis relationship between microorganisms, intestines and brain, which can further improve insomnia caused by diseases or conditions such as gastrointestinal inflammation, ulcers, Helicobacter pylori infection, constipation, heart-kidney disharmony, etc.

[0057] In some embodiments, the composition of the present invention includes the probiotic complex, spinosa jujube seeds, lily, tuckahoe, lotus seeds, mulberry, L-arabinose, β-glucan, inulin, erythritol, lactitol, vitamin C, and γ-aminobutyric acid.

[0058] In some embodiments, the composition of the present invention includes the following components in parts by weight: 2-6 parts of probiotic complex, 2-5 parts of spiny jujube kernel, 2-7 parts of lily, 2-6.5 parts of Poria cocos, 2-8 parts of lotus seeds, 2-8 parts of mulberries, 2-7 parts of L-arabinose, 1-4 parts of β-glucan, 5-10 parts of inulin, 6-10 parts of erythritol, 6-10 parts of lactitol, 0.5-3 parts of vitamin C, and 2-4.5 parts of γ-aminobutyric acid.

[0059] In some embodiments, the composition of the present invention includes the following components in parts by weight: 3-5 parts of probiotic complex, 3-5 parts of spiny jujube kernel, 2-5 parts of lily, 3-5 parts of poria, 2-5 parts of lotus seeds, 3-5 parts of mulberry, 3.3-6.6 parts of L-arabinose, 1-3 parts of β-glucan, 6-8 parts of inulin, 7-9 parts of erythritol, 7-9 parts of lactitol, 0.5-2 parts of vitamin C, and 3-4.5 parts of γ-aminobutyric acid.

[0060] In some embodiments, the composition of the present invention includes the following components in parts by weight: 3 parts of probiotic complex, 3 parts of spiny jujube kernel, 3 parts of lily, 3 parts of poria, 2 parts of lotus seeds, 3 parts of mulberry, 3.5 parts of L-arabinose, 1.5 parts of β-glucan, 7 parts of inulin, 8 parts of erythritol, 8 parts of lactitol, 0.5 parts of vitamin C, and 4.5 parts of γ-aminobutyric acid.

[0061] In some embodiments, in the probiotic complex of the present invention, the number of viable bacteria of the strains is: Lactobacillus plantarum 85-95 billion CFU / g, Bifidobacterium lactis 5-15 billion CFU / g, Lactobacillus crispatus 8-12 billion CFU / g, Lactobacillus acidophilus 10-18 billion CFU / g, Lactobacillus rhamnosus 5-15 billion CFU / g, Bifidobacterium bifidum 10-8 billion CFU / g, Lactobacillus reuteri 6-15 billion CFU / g, Lactobacillus casei 6-15 billion CFU / g, Lactobacillus bulgaricus 10-6 billion CFU / g, Lactobacillus fermentum 60-10 billion CFU / g, Lactobacillus gasseri 10-6 billion CFU / g, Lactococcus lactis 10-6 billion CFU / g, Bifidobacterium longum 20-8 billion CFU / g, Lactobacillus salivarius 100-150 billion CFU / g, Bifidobacterium breve 10-80 billion CFU / g, Streptococcus thermophilus 50-100 billion CFU / g, Lactobacillus paracasei 120-160 billion CFU / g, Lactobacillus helveticus 50-100 billion CFU / g.

[0062] In some embodiments, in the probiotic complex of the present invention, the number of viable bacteria of the strains is: Lactobacillus plantarum 90-93 billion CFU / g, Bifidobacterium lactis 10-13 billion CFU / g, Lactobacillus crispatus 8-11 billion CFU / g, Lactobacillus acidophilus 13-16 billion CFU / g, Lactobacillus rhamnosus 10-13 billion CFU / g, Bifidobacterium bifidum 2-5 billion CFU / g, Lactobacillus reuteri 10-13 billion CFU / g, Lactobacillus casei 10-13 billion CFU / g. U / g, Lactobacillus bulgaricus 10-40 billion CFU / g, Lactobacillus fermentum 60-90 billion CFU / g, Lactobacillus gasseri 10-40 billion CFU / g, Lactococcus lactis 10-40 billion CFU / g, Bifidobacterium longum 30-60 billion CFU / g, Lactobacillus salivarius 100-130 billion CFU / g, Bifidobacterium breve 30-60 billion CFU / g, Streptococcus thermophilus 50-80 billion CFU / g, Lactobacillus paracasei 120-150 billion CFU / g, Lactobacillus helveticus 50-80 billion CFU / g.

[0063] In some embodiments, in the probiotic complex of the present invention, the live bacterial counts of the strains are: 90 billion CFU / g of Lactobacillus plantarum, 10 billion CFU / g of Bifidobacterium lactis, 8 billion CFU / g of Lactobacillus crispatus, 13 billion CFU / g of Lactobacillus acidophilus, 10 billion CFU / g of Lactobacillus rhamnosus, 2 billion CFU / g of Bifidobacterium bifidum, 10 billion CFU / g of Lactobacillus reuteri, 10 billion CFU / g of Lactobacillus casei, 1 billion CFU / g of Lactobacillus bulgaricus, 6 billion CFU / g of Lactobacillus fermentum, 1 billion CFU / g of Lactobacillus gasseri, 1 billion CFU / g of Lactococcus lactis, 3 billion CFU / g of Bifidobacterium longum, 10 billion CFU / g of Lactobacillus salivarius, 3 billion CFU / g of Bifidobacterium breve, 5 billion CFU / g of Streptococcus thermophilus, 12 billion CFU / g of Lactobacillus paracasei, and 5 billion CFU / g of Lactobacillus helveticus.

[0064] In some embodiments, the total number of viable bacteria in the probiotic complex of the present invention is greater than 200 billion CFU / g, greater than 210 billion CFU / g, or greater than 220 billion CFU / g.

[0065] In a second aspect, the present invention provides a preparation, wherein the preparation is made from the composition according to the first aspect of the present invention.

[0066] The preparation of the present invention can be prepared by the following method: according to the composition of the first aspect, the probiotic complex is taken by weight, and the probiotic powder is prepared by embedding technology; each Chinese medicine component is taken by weight, and the Chinese medicine water extract is obtained by water extraction method, and the powder is prepared; each prebiotic is taken by weight and prepared into powder; the probiotic powder, the Chinese medicine water extract powder, and the prebiotic powder are dried, and the dried powders of each component are mixed, and prepared into solid beverages, chewable tablets or oral lozenges according to conventional preparation methods.

[0067] The embedding technology can be implemented by conventional techniques in the art.

[0068] In some embodiments, the embedding can be performed as follows: the protective agent is evenly sprayed on the bacterial mud in an emulsification tank, stirred, and embedded. The protective agent can be, for example, lactic acid bacteria extracellular polysaccharide, extracted from strains such as Bifidobacterium longum, Bifidobacterium lactis, Streptococcus thermophilus, and Lactobacillus casei that have high extracellular polysaccharide production.

[0069] The Chinese herbal medicine water extract can be prepared by conventional techniques in the art or purchased commercially.

[0070] In some embodiments, the Chinese medicine water extract can be prepared in the following manner: take Semen Ziziphi Spinosae, Lily, Poria, Lotus Seed, and Mulberry by weight, crush them, soak them in 6-8 times water for 30-60 minutes, add them to an extraction tank and extract them 2-3 times, boil them for 60-80 minutes for the first time, and boil them for 30-50 minutes for the second time with 4-5 times water. Combine the two filtrates, concentrate them to 1 times the amount of the medicinal materials, sieve them, and dry them into fine powder.

[0071] In some embodiments, the Chinese herbal medicine water extract can be obtained by mixing commercially available powders of water extracts of various Chinese herbal medicine components.

[0072] The preparation of the present invention can be taken by mixing with warm water or directly orally.

[0073] In a third aspect, the present invention also provides use of the composition or preparation of the present invention in preparing medicines and / or foods for treating or improving gastrointestinal inflammation, ulcers, Helicobacter pylori infection, constipation, and insomnia.

[0074] In some embodiments, the composition or preparation of the present invention is used in the preparation of a drug for treating gastrointestinal inflammation, ulcer, Helicobacter pylori infection, constipation, and insomnia.

[0075] In some embodiments, the composition or the preparation of the present invention is used in preparing food for improving gastrointestinal inflammation, ulcer, Helicobacter pylori infection, constipation, and insomnia.

[0076] In some embodiments, the composition of the present invention or the preparation of the present invention is used in the preparation of a medicament for treating insomnia.

[0077] In some embodiments, the composition or the preparation of the present invention is used in preparing a food for improving insomnia.

[0078] In some embodiments, the insomnia includes insomnia caused by gastrointestinal inflammation, ulcer, Helicobacter pylori infection, constipation, heart-kidney disharmony, etc.

[0079] The composition of the present invention comprises a probiotic complex and a Chinese medicinal component that is both a medicine and food, and prebiotics that have a proliferation effect on probiotics and serve as a nutrient source for probiotics, wherein the probiotic complex contains more than 200 billion CFU / g of active probiotics, and the probiotics are combined with the Chinese medicinal component that is both a medicine and food, supplemented with corresponding prebiotics, so as to treat or improve insomnia caused by spleen and stomach disharmony, liver qi stagnation, heart fire, yin deficiency and fire, heart-kidney disharmony and the like caused by emotions, stress, diseases and the like.

[0080] While the various components of the composition of the present invention work synergistically to treat or improve insomnia, the probiotics can also promote the absorption of various Chinese medicines and other ingredients that are both medicinal and edible, and maximize their effects. At the same time, the various components can play an overall coordination role, achieving the purpose of overall treatment or improvement of insomnia from multiple angles and multiple causes. DETAILED DESCRIPTION

[0081] In order to make the purpose, technical scheme and advantages of the present invention clearer, the present invention is further described in detail below in conjunction with embodiments. The specific embodiments described herein are only used to explain the present invention and are not intended to constitute any limitation of the present invention. In addition, in the following description, the description of known structures and technologies is omitted to avoid unnecessary confusion of the concepts of the present disclosure. Such structures and technologies are also described in many publications.

[0082] definition

[0083] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly used in the field to which the present invention belongs. For the purpose of interpreting this specification, the following definitions will apply, and where appropriate, terms used in the singular will also include the plural form, and vice versa.

[0084] Unless otherwise specified, references herein that do not explicitly state a quantity include the plural form.

[0085] As used herein, the term "about" refers to a range of ±20% of the value that follows. In some embodiments, the term "about" refers to a range of ±10% of the value that follows. In some embodiments, the term "about" refers to a range of ±5% of the value that follows.

[0086] The numerical ranges involved in this article include end values ​​and any values ​​therebetween. For example, the weight range is 5-10 parts, including 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts and any values ​​therebetween; the viable count of the strain is 85-95 billion CFU / g, including 85 billion CFU / g, 86 billion CFU / g, 87 billion CFU / g, 88 billion CFU / g, 89 billion CFU / g, 90 billion CFU / g, 91 billion CFU / g, 92 billion CFU / g, 93 billion CFU / g, 94 billion CFU / g, 95 billion CFU / g and any values ​​therebetween; and so on.

[0087] Examples are provided below to help understand the present invention. However, it should be understood that these examples are only used to illustrate the present invention, but do not constitute any limitation. The actual protection scope of the present invention is set forth in the claims. It should be understood that any modifications and changes can be made without departing from the spirit of the present invention.

[0088] The components such as Chinese medicine and prebiotics involved in the following examples can also be purchased commercially unless otherwise specified.

[0089] Example 1.

[0090] This embodiment provides a probiotic composition, comprising the following components in parts by weight:

[0091] 3 servings of probiotic complex (Lactobacillus plantarum 90 billion CFU / g, Bifidobacterium lactis 10 billion CFU / g, Lactobacillus crispatus 8 billion CFU / g, Lactobacillus acidophilus 13 billion CFU / g, Lactobacillus rhamnosus 10 billion CFU / g, Bifidobacterium bifidum 2 billion CFU / g, Lactobacillus reuteri 10 billion CFU / g, Lactobacillus casei 10 billion CFU / g, Lactobacillus bulgaricus 1 billion CFU / g, Lactobacillus fermentum 6 billion CFU / g, Lactobacillus gasseri 1 billion CFU / g, Lactococcus lactis 1 billion CFU / g, Bifidobacterium longum 3 billion CFU / g, Lactobacillus salivarius 10 billion CFU / g, Bifidobacterium breve 3 billion CFU / g, Streptococcus thermophilus 5 billion CFU / g, Lactobacillus paracasei 12 billion CFU / g, Lactobacillus helveticus 5 billion CFU / g); total effective viable count 200 billion CFU / g;

[0092] 3 parts of sour jujube seeds, 3 parts of lilies, 3 parts of poria cocos, 2 parts of lotus seeds, 3 parts of mulberries, 3.5 parts of L-arabinose, 1.5 parts of beta-glucan, 7 parts of inulin, 8 parts of erythritol, 8 parts of lactitol, 0.5 parts of vitamin C, and 4.5 parts of gamma-aminobutyric acid.

[0093] The above 18 kinds of bacterial powders were processed by using the embedding technology: the extracellular polysaccharide of lactic acid bacteria was evenly sprayed on the bacterial mud in an emulsifying tank, stirred, embedded and protected, and dried to prepare probiotic bacterial powder.

[0094] The above five Chinese medicinal components are processed by water boiling extraction: Semen jujuba, lily, Poria, lotus seed and mulberry are weighed by weight, soaked in 6 times water for 40 minutes, added to the extraction tank for extraction twice, boiled for 70 minutes for the first time, and boiled for 40 minutes for the second time with 5 times water. The two filtrates are combined, concentrated to 1 times the amount of the medicinal materials, filtered, and dried into fine powder.

[0095] The probiotic powder, the Chinese herbal medicine water extract powder and the prebiotic component powder are mixed, dried and made into a solid beverage preparation, 5g / dose.

[0096] Example 2.

[0097] This embodiment provides a probiotic composition, comprising the following components in parts by weight:

[0098] 4 servings of probiotic complex (Lactobacillus plantarum 91 billion CFU / g, Bifidobacterium lactis 11 billion CFU / g, Lactobacillus crispatus 10 billion CFU / g, Lactobacillus acidophilus 10 billion CFU / g, Lactobacillus rhamnosus 11 billion CFU / g, Bifidobacterium bifidum 3 billion CFU / g, Lactobacillus reuteri 11 billion CFU / g, Lactobacillus casei 8 billion CFU / g, Lactobacillus bulgaricus 2 billion CFU / g, Lactobacillus fermentum 6 billion CFU / g, Lactobacillus gasseri 1 billion CFU / g, Lactococcus lactis 1 billion CFU / g, Bifidobacterium longum 2 billion CFU / g, Lactobacillus salivarius 10 billion CFU / g, Bifidobacterium breve 1 billion CFU / g, Streptococcus thermophilus 5 billion CFU / g, Lactobacillus paracasei 12 billion CFU / g, Lactobacillus helveticus 5 billion CFU / g); total effective viable count 200 billion CFU / g;

[0099] 3 parts of sour jujube seeds, 5 parts of lilies, 4 parts of poria cocos, 4 parts of lotus seeds, 5 parts of mulberries, 4 parts of L-arabinose, 2 parts of beta-glucan, 6 parts of inulin, 7 parts of erythritol, 9 parts of lactitol, 1 part of vitamin C, and 4 parts of gamma-aminobutyric acid.

[0100] The same embedding, water extraction and other treatment methods as in Example 1 were used to mix the obtained powders of the components, dry them, and prepare a solid beverage preparation, 5 g / dose.

[0101] Example 3.

[0102] This embodiment provides a probiotic composition, comprising the following components in parts by weight:

[0103] 3 servings of probiotic complex (Lactobacillus plantarum 93 billion CFU / g, Bifidobacterium lactis 10 billion CFU / g, Lactobacillus crispatus 8 billion CFU / g, Lactobacillus acidophilus 12 billion CFU / g, Lactobacillus rhamnosus 10 billion CFU / g, Bifidobacterium bifidum 3 billion CFU / g, Lactobacillus reuteri 10 billion CFU / g, Lactobacillus casei 10 billion CFU / g, Lactobacillus bulgaricus 2 billion CFU / g, Lactobacillus fermentum 6 billion CFU / g, Lactobacillus gasseri 1 billion CFU / g, Lactococcus lactis 1 billion CFU / g, Bifidobacterium longum 6 billion CFU / g, Lactobacillus salivarius 10 billion CFU / g, Bifidobacterium breve 6 billion CFU / g, Streptococcus thermophilus 5 billion CFU / g, Lactobacillus paracasei 11 billion CFU / g, Lactobacillus helveticus 6 billion CFU / g); total effective viable count 210 billion CFU / g;

[0104] 4 parts of sour jujube seeds, 3 parts of lilies, 5 parts of poria cocos, 2 parts of lotus seeds, 4 parts of mulberries, 6.6 parts of L-arabinose, 2 parts of beta-glucan, 6 parts of inulin, 9 parts of erythritol, 8 parts of lactitol, 0.5 parts of vitamin C, and 3 parts of gamma-aminobutyric acid.

[0105] The same embedding, water extraction and other treatment methods as in Example 1 were used to mix the obtained powders of the components, dry them, and prepare chewable tablets, 5 g / dose.

[0106] Example 4.

[0107] This embodiment provides a probiotic composition, comprising the following components in parts by weight:

[0108] 5 servings of probiotic complex (Lactobacillus plantarum 85 billion CFU / g, Bifidobacterium lactis 6 billion CFU / g, Lactobacillus crispatus 8 billion CFU / g, Lactobacillus acidophilus 10 billion CFU / g, Lactobacillus rhamnosus 6 billion CFU / g, Bifidobacterium bifidum 2 billion CFU / g, Lactobacillus reuteri 6 billion CFU / g, Lactobacillus casei 6 billion CFU / g, Lactobacillus bulgaricus 2 billion CFU / g, fermented lactobacillus Bacteria 10 billion CFU / g, Lactobacillus gasseri 6 billion CFU / g, Lactococcus lactis 6 billion CFU / g, Bifidobacterium longum 8 billion CFU / g, Lactobacillus salivarius 15 billion CFU / g, Bifidobacterium breve 8 billion CFU / g, Streptococcus thermophilus 10 billion CFU / g, Lactobacillus paracasei 16 billion CFU / g, Lactobacillus helveticus 10 billion CFU / g); total effective viable count 220 billion CFU / g;

[0109] 3 parts of sour jujube seeds, 2 parts of lily, 3 parts of poria, 3 parts of lotus seeds, 3 parts of mulberries, 5 parts of L-arabinose, 2 parts of beta-glucan, 8 parts of inulin, 7 parts of erythritol, 8 parts of lactitol, 0.5 parts of vitamin C, and 3 parts of gamma-aminobutyric acid.

[0110] The same embedding, water extraction and other treatment methods as in Example 1 were used to mix the obtained powders of the components, dry them, and prepare oral lozenges, 5 g / dose.

[0111] Comparative Example 1.

[0112] This comparative example provides a probiotic composition, comprising the following components in parts by weight:

[0113] Lactobacillus plantarum 40 billion CFU / g, Bifidobacterium lactis 5 billion CFU / g, Lactobacillus crispatus 8 billion CFU / g, Lactobacillus acidophilus 5 billion CFU / g, Lactobacillus rhamnosus 5 billion CFU / g, Bifidobacterium bifidum 1 billion CFU / g, Lactobacillus reuteri 6 billion CFU / g, Lactobacillus casei 6 billion CFU / g, Lactobacillus fermentum 6 billion CFU / g, Lactobacillus gasseri 1 billion CFU / g, Lactococcus lactis 1 billion CFU / g, Bifidobacterium longum 2 billion CFU / g, Lactobacillus salivarius 6 billion CFU / g, Bifidobacterium breve 3 billion CFU / g, Streptococcus thermophilus 5 billion CFU / g; total effective viable count 100 billion CFU / g;

[0114] 10 parts of sour jujube seeds, 3 parts of lilies, 3 parts of poria cocos, 2 parts of lotus seeds, 3 parts of mulberries, 2 parts of longan pulp, 2 parts of L-arabinose, 2 parts of galacto-oligosaccharides, 7 parts of inulin, 8 parts of erythritol, and 6 parts of gamma-aminobutyric acid.

[0115] The same embedding, water extraction and other treatment methods as in Example 1 were used to mix the obtained powders of the components, dry them, and prepare a solid beverage preparation, 5 g / dose.

[0116] Comparative Example 2.

[0117] This comparative example provides a probiotic composition, comprising the following components in parts by weight:

[0118] Lactobacillus plantarum 42 billion CFU / g, Bifidobacterium lactis 6 billion CFU / g, Lactobacillus crispatus 9 billion CFU / g, Lactobacillus acidophilus 8 billion CFU / g, Lactobacillus rhamnosus 8 billion CFU / g, Bifidobacterium bifidum 2 billion CFU / g, Lactobacillus reuteri 10 billion CFU / g, Lactobacillus casei 10 billion CFU / g, Lactobacillus bulgaricus 2 billion CFU / g, Lactobacillus fermentum 8 billion CFU / g, Lactobacillus gasseri 2 billion CFU / g, Lactococcus lactis 2 billion CFU / g, Bifidobacterium longum 3 billion CFU / g, Lactobacillus salivarius 10 billion CFU / g, Bifidobacterium breve 3 billion CFU / g, Streptococcus thermophilus 5 billion CFU / g; total effective viable count 130 billion CFU / g;

[0119] 7 parts of sour jujube seeds, 3 parts of lilies, 3 parts of poria cocos, 2 parts of lotus seeds, 3 parts of mulberries, 3 parts of L-arabinose, 3 parts of galacto-oligosaccharides, 3 parts of mogroside, 6 parts of inulin, and 5 parts of gamma-aminobutyric acid.

[0120] The same embedding, water extraction and other treatment methods as in Example 1 were used to mix the obtained powders of the components, dry them, and prepare a solid beverage preparation, 5 g / dose.

[0121] Comparative Example 3.

[0122] This comparative example provides a probiotic composition, comprising the following components in parts by weight:

[0123] Lactobacillus plantarum 52 billion CFU / g, Bifidobacterium lactis 10 billion CFU / g, Lactobacillus crispatus 8 billion CFU / g, Lactobacillus acidophilus 13 billion CFU / g, Lactobacillus rhamnosus 10 billion CFU / g, Bifidobacterium bifidum 2 billion CFU / g, Lactobacillus reuteri 11 billion CFU / g, Lactobacillus casei 11 billion CFU / g, Lactobacillus bulgaricus 2 billion CFU / g, Lactobacillus fermentum 6 billion CFU / g, Lactobacillus gasseri 1 billion CFU / g, Lactococcus lactis 1 billion CFU / g, Bifidobacterium longum 3 billion CFU / g, Lactobacillus salivarius 12 billion CFU / g, Bifidobacterium breve 3 billion CFU / g, Streptococcus thermophilus 5 billion CFU / g; total effective viable count 150 billion CFU / g;

[0124] 6 parts of sour jujube seeds, 3 parts of lilies, 3 parts of poria cocos, 2 parts of lotus seeds, 3 parts of mulberries, 3 parts of L-arabinose, 2 parts of galacto-oligosaccharides, 8 parts of erythritol, 7 parts of inulin, 7 parts of lactitol, and 3 parts of gamma-aminobutyric acid.

[0125] The same embedding, water extraction and other treatment methods as in Example 1 were used to mix the obtained powders of the components, dry them, and prepare a solid beverage preparation, 5 g / dose.

[0126] Comparative Example 4.

[0127] Zhusha Anshen Pills (Jilin Xinhui Pharmaceutical Co., Ltd.), 9g / pill.

[0128] Experimental Example 1. Isolation and screening of strains

[0129] 1. Isolation and screening methods

[0130] Samples: yogurt, kimchi, human intestinal isolate, human saliva.

[0131] Method: Weigh an appropriate amount of sample into sterile saline (add appropriate amount of glass beads) as the mother solution, shake for 10 minutes to mix thoroughly, and then -2 ~10 -7 Gradient dilution. Spread on Lactobacillus MRS medium and Bifidobacterium BL selective medium, and make 2 parallels for each dilution. Culture anaerobicly at 37℃ for 48h, observe, number and record the colony morphology. Through catalase test and gas production and capsule spore test, Gram-positive, catalase-negative non-spore-bacillus is refrigerated. At the same time, it is preserved in the General Microbiology Center of China Microbiological Culture Collection Administration.

[0132] 2. Microbiological characteristics

[0133] Lactobacillus plantarum (CGMCC No.17243):

[0134] On the MRS plate, the colonies are 0.5mm-2mm in diameter, white, round, smooth and moist, with neat edges and raised. They are Gram-positive, catalase-negative, and the bacteria are short rod-shaped under the microscope.

[0135] Bifidobacterium lactis (CGMCC No.20165):

[0136] Anaerobic culture on bifidobacteria medium produces white, round, moist, opaque, neatly edged colonies, Gram-positive, catalase-negative, and rod-shaped with swollen ends under a microscope.

[0137] Lactobacillus crispatus (CGMCC No.22190):

[0138] The colonies are white, with irregular edges, flake-like, and convex in the center. They can utilize mannose, galactose, glucose, maltose, melibiose, raffinose, ribose, sucrose, trehalose, and fructose. They are Gram-positive and appear as slender rods under a microscope, slightly bent into chains.

[0139] Lactobacillus acidophilus (CGMCC No.17242):

[0140] Small, reticular, raised, rough-surfaced, curled-edge colonies are formed on the plate. Gram-positive, bacilli appear under the microscope.

[0141] Lactobacillus rhamnosus (CGMCC No.18800):

[0142] The colonies on the plate are white, round, smooth and moist, with neat edges and raised. They cannot utilize lactose, but can metabolize monosaccharides: Gram-positive, appearing as rods under a microscope.

[0143] Bifidobacterium bifidum (CGMCC No.28421):

[0144] Gram-positive, rod-shaped cells, solitary, paired, V-shaped or pile-shaped. Usually stained irregularly. Not motile, not spore-forming, acid-fast staining negative, fermentation products are mainly acetic acid and lactic acid, no CO2 is produced. No butyric acid and propionic acid are produced. Catalase negative, strictly anaerobic, fermentation of glucose to produce lactic acid.

[0145] Lactobacillus reuteri (CGMCC NO.20164):

[0146] The colonies grown on the MRS plates were round, milky white, and had a smooth surface. Gram-positive bacteria were slightly curved rods under microscope.

[0147] Lactobacillus casei (CGMCC No.21128):

[0148] It forms white, sometimes slightly yellowish, round, moist colonies with a diameter of 0.5-2 mm. It is a Gram-positive bacterium that does not produce spores, has no flagella, and is non-motile. The bacteria vary in length and often form chains.

[0149] Lactobacillus bulgaricus (CGMCC No.21127):

[0150] Gram-positive, thick and long rods, slightly curved in chains, no flagella, no spores, grayish white colonies, irregular edges, sticky, convex in the center, chemoheterotrophic, facultative anaerobic, does not liquefy gelatin, can utilize fructose, glucose, lactose. Catalase negative, oxidase negative, acid-resistant, thermophilic, growth temperature 15-40℃.

[0151] Lactobacillus fermentum (CGMCC No.25015):

[0152] Colony morphology is round. Edges are neat and milky white. Cells are rod-shaped. Non-spore-forming, Gram-positive. Non-motile, no capsule. Facultative anaerobic. Optimum temperature is 36℃.

[0153] Lactobacillus gasseri (CGMCC No.21785):

[0154] The colony morphology of the strain on MRS solid culture medium is round colonies with a diameter of 0.5-0.75 mm and a rough surface, and it appears as Gram-positive short rods under a microscope.

[0155] Lactococcus lactis (CGMCC No.25018):

[0156] The cells are spherical or oval, Gram-positive, facultative anaerobic, do not produce capsules and spores, have complex nutritional requirements, and the most suitable growth temperature is 30°C.

[0157] Bifidobacterium longum (CGMCC No.21783):

[0158] Gram-positive, with one end swollen and tadpole-shaped, appearing in piles, short cells, often rod-shaped, without flagella, without spores, white and shiny colonies, neat edges, round, with a convex center, chemoheterotrophic, and anaerobic.

[0159] Lactobacillus salivarius (CGMCC No.22192):

[0160] Gram-positive, short rods, appearing in piles, without flagella, without spores, round colonies, milky white, raised, with neat edges, chemoheterotrophic, facultative anaerobic, and does not liquefy gelatin.

[0161] Bifidobacterium breve (CGMCC No.22189):

[0162] The cells are short, often rod-shaped, Gram-positive, anaerobic, glucose-acidogenic, catalase-negative, and produce α-galactosidase.

[0163] Streptococcus thermophilus (CGMCC No.21129):

[0164] The colonies are small, round and convex, shiny, with spherical or oval cells, in pairs or chains. Gram-positive, catalase-negative. No spores, no capsule, no movement.

[0165] Lactobacillus paracasei (CGMCC No.22191):

[0166] Gram-positive, catalase-negative. Grows readily on simple nutrient media, colonies may be smooth (S), low convex, moist, shiny, entire, gray, or rough (R).

[0167] Lactobacillus helveticus (CGMCC No.21782):

[0168] Gram-positive bacteria are probiotics. They are long rods, without flagella and spores. The colonies are round, milky white, with neat edges. They are chemoheterotrophic and facultative anaerobic.

[0169] 3. Proliferation characteristics

[0170] Lactobacillus plantarum (CGMCC No.17243):

[0171] The optimal growth temperature of aerobic or facultative anaerobic, facultative heterotrophic fermentative lactic acid bacteria is 30-37°C, and the optimal pH is about 6.5. The best nitrogen source combination is 10g / L yeast extract, 10g / L peptone, and 2g / L triammonium citrate.

[0172] Bifidobacterium lactis (CGMCC No.20165):

[0173] Anaerobic bacteria, the optimum growth temperature is 37-41℃; the optimum fermentation temperature is 35-40℃; the minimum growth temperature is 25-28℃; the maximum growth temperature is 43-45℃; the initial growth pH is 6.7-7.0, and it will not grow in an environment below pH 4.5-5.0 or above pH 8.0-8.5.

[0174] Lactobacillus crispatus (CGMCC No.22190):

[0175] It is facultatively anaerobic, acidogenic, thermophilic, and grows at 15-40°C, with an optimum growth temperature of 37°C and pH 6.5. It has a strong tolerance to acids and bile salts and can still grow slowly in an acidic environment of pH 3.5. It has complex nutritional requirements and can degrade various carbohydrates to produce L- and D-lactic acid isomers.

[0176] Lactobacillus acidophilus (CGMCC No.17242):

[0177] Anaerobic or facultative anaerobic. Strong acid resistance, grows well in slightly acidic environment, and the optimal pH value for growth is around 5.5-6.0. It is sensitive to temperature and will not grow below 20°C. It has poor heat resistance and generally grows best at around 37°C. It can use glucose, fructose, lactose, and sucrose for homotypic fermentation.

[0178] Lactobacillus rhamnosus (CGMCC No.18800):

[0179] Facultative anaerobic bacteria can grow in a wide pH range of 4.5-5.5, with an optimum pH of 5.5-6.2 and an optimum growth temperature of around 37°C. The fermentation temperature range is 30°C-40°C, with an optimum fermentation temperature of around 35°C.

[0180] Bifidobacterium bifidum (CGMCC No.28421):

[0181] Obligate anaerobe, suitable growth temperature 37-38℃, suitable pH 6.0-7.0. Requires carbon dioxide for growth. Strict nutritional requirements, needs to ferment sugars. Casein hydrolysate, multiple amino acids, vitamins. Can ferment glucose, fructose, lactose and galactose.

[0182] Lactobacillus reuteri (CGMCC NO.20164):

[0183] The optimum growth temperature is 36-40℃, the optimum fermentation temperature is 35-40℃, the minimum growth temperature is 25-28℃, the maximum growth temperature is 43-45℃, the initial growth pH is 6.7-7.0, and it generally does not grow in an environment with a pH value below 4.5-5.0 or above 8.0-8.5.

[0184] Lactobacillus casei (CGMCC No.21128):

[0185] Microaerophilic bacteria do not have a high demand for oxygen and can survive and reproduce in a relatively low-oxygen environment. The suitable growth temperature is 30-37°C, and the optimum temperature is 37°C. They can grow in an environment with a pH value of 4.5-9.0, and the optimum pH range is 6.2-6.6. They have good acid resistance and bile resistance.

[0186] Lactobacillus bulgaricus (CGMCC No.21127):

[0187] Microaerobic or anaerobic bacteria grow best in an anaerobic environment. The optimum growth temperature is around 40°C. It will not grow above 50°C or below 20°C. In the temperature range of 37°C-45°C, Lactobacillus bulgaricus can grow and reproduce well, but has poor tolerance to heat. It is suitable for growth in an acidic environment, and its optimum pH value is 4.6-5.4. In this pH range, the bacteria can maintain the best physiological activity.

[0188] Lactobacillus fermentum (CGMCC No.25015):

[0189] Facultative anaerobes have a wide range of suitable growth temperatures, generally between 25°C and 40°C. Specifically, Lactobacillus fermentum grows best in the temperature range of 30°C to 37°C, and the suitable pH range is 5.0 to 6.5. Within this pH range, Lactobacillus fermentum grows and reproduces most actively.

[0190] Lactobacillus gasseri (CGMCC No.21785):

[0191] The facultative heterogeneous acidogenic strain can grow in aerobic and anaerobic environments, with an optimal growth pH of 5-7, an optimal growth temperature of 30-37°C, an optimal inoculum size of 0.5%-2% (v / v), and can grow in 0.1% bile salts and 5% NaCl.

[0192] Lactococcus lactis (CGMCC No.25018):

[0193] Facultative anaerobe, the most suitable growth temperature is 30℃, it is a facultative anaerobe and can survive in the range of 20-45℃, but the specific temperature range may vary depending on the strain. The optimal growth pH value is 5.5-6.0. It has strong acid resistance and can reproduce in acidic environments where other lactic acid bacteria cannot grow.

[0194] Bifidobacterium longum (CGMCC No.21783):

[0195] Obligate anaerobe. It grows well in MRS culture concentrate anaerobic culture, with a suitable growth temperature of 37-38°C and a suitable growth pH of 6.0-7.0. It can ferment glucose, fructose, sucrose, etc. to produce lactic acid and acetic acid. Some strains have weak fermentation performance on milk, but strong ability to hydrolyze casein.

[0196] Lactobacillus salivarius (CGMCC No.22192):

[0197] Facultative heterogeneous acidogenic strain, suitable for growth in facultative anaerobic or absolute anaerobic conditions, with optimum growth temperature of 30-43°C, optimum pH of 5.0-5.5 or lower, and most suitable growth temperature of around 37°C. It grows better in anaerobic environment, produces lactic acid, is acid-resistant, can withstand acid to pH 2.5 and bile salts to 0.4% for 4 hours.

[0198] Bifidobacterium breve (CGMCC No.22189):

[0199] For obligate anaerobic bacteria, the key to culture and live bacteria count is to provide an anaerobic and low redox potential culture environment. The optimum growth temperature is 37℃-41℃, the minimum growth temperature is 25℃-28℃, and the maximum is 43℃-45℃. The initial optimum pH is 6.5-7.0, and it does not grow at pH 4.5-5.0 or pH 8.0-8.5.

[0200] Streptococcus thermophilus (CGMCC No.21129):

[0201] Facultative anaerobe, the optimal growth temperature is about 40℃, but it can also grow at 45℃ under laboratory conditions. In addition, studies have shown that thermophilic Streptococcus can also grow at 37℃. It grows best in a medium with a pH value of 7.0. It can grow on sugars such as galactose, glucose, fructose, lactose and sucrose.

[0202] Lactobacillus paracasei (CGMCC No.22191):

[0203] It is facultatively anaerobic, with a growth temperature range of 15-45°C, an optimum temperature of 37°C, and is acid-resistant to pH 2.5, with an optimum pH of 5.3. It ferments glucose to produce mainly L-lactic acid.

[0204] Lactobacillus helveticus (CGMCC No.21782):

[0205] Aerobic or microaerophilic bacteria, suitable for growth in the temperature range of 30-45°C, the optimum temperature is 37°C. It can use sugars such as glucose, fructose, maltose and lactose as carbon sources in a 1:1 ratio, and produce DL-lactic acid by homofermentation. It cannot use disaccharides such as linseed and rhamnose, or polysaccharides such as cottonseed and inulin.

[0206] Experimental Example 2. Effect of the composition of the present invention on improving insomnia

[0207] A total of 56 clinical insomnia patients aged between 25 and 60 were selected. The clinical symptoms of insomnia patients mainly include difficulty falling asleep, frequent awakenings at night, early awakenings and difficulty falling asleep again, and feeling tired and inattentive after waking up. Patients with long-term insomnia also have complications such as memory loss, mood swings, and decreased immunity.

[0208] With the informed consent of the subjects, they were randomly divided into 8 groups, with 7 people in each group, including 28 cases in the treatment group and 28 cases in the control group.

[0209] The treatment group was administered with the probiotic composition preparations of Examples 1-4 of the present invention, and the control group was administered with the preparations of Comparative Examples 1-4. The oral preparations of Examples 1-4 and Comparative Examples 1-3 were taken once a day, 5 g each time; Comparative Example 4 was taken 1 pill each time. The dosage was 1-10 days (D1-D10).

[0210] The overall effects of the probiotic composition preparations of Examples 1-4 of the present invention and the preparations of Comparative Examples 1-4 on improving the symptoms of insomnia are shown in Table 1.

[0211] Table 1.

[0212]

[0213]

[0214]

[0215] As shown in Table 1, after taking the probiotic composition preparation of Examples 1-4 of the present invention for 2-3 days, the difficulty in falling asleep is improved, the number of waking up at night is reduced, the sleep time is extended by 2-3 hours, the head is not drowsy after waking up, and the mental state is good, indicating that the improvement effect on insomnia is very good and the effect is fast; after taking it for 5-7 days, normal sleep can be basically restored. Comparative Examples 1-3 have a slow onset of the improvement effect of insomnia after taking the probiotic preparation due to the reduction of the number of viable bacteria in the preparation or the lack of appropriate Chinese medicine components or prebiotics. The Chinese medicine preparation of Comparative Example 4 has a slow onset of the improvement effect on insomnia. From the perspective of the taste and compliance of the preparation, the bitterness in Comparative Examples 1-3 is mainly caused by Ziziphus jujuba seeds, and the numbness is mainly caused by γ-aminobutyric acid. The patient's compliance is not good, the preparation takes a slow onset, and the effect is not obvious. Comparative Example 2 attempts to use mogroside to improve the taste, but the effect of improving insomnia is not obvious. The probiotic complex of the present application improves the taste by adding or subtracting the formula and dosage of traditional Chinese medicine components and prebiotics, and masks the bitterness and numbness by adjusting the functional sugars. The preparation has no bitterness or strange taste, and has good compliance. By combining the adjustment of the number of live bacteria, the preparation takes effect quickly and has a significant effect in improving insomnia.

[0216] Experimental Example 3. Effect of the composition of the present invention on improving insomnia caused by Helicobacter pylori

[0217] Clinical insomnia patient A has suffered from insomnia for more than 10 years, and the insomnia is recurrent and severe. The DPM value of Helicobacter pylori detected by C14 breath test is 1452 (reference value 0-100), and the serum total bilirubin value in the five liver function tests is 28.6 (reference value 1.7-17.1μmol / L).

[0218] The clinical diagnosis of Helicobacter pylori infection is relatively serious. The results of gastroscopy show chronic gastritis and gastric ulcer. The patient has clinical manifestations such as abdominal pain, abdominal distension, nausea, and acid reflux, which affect the sleep quality and cause insomnia.

[0219] Patient A took the probiotic composition solid beverage preparation prepared in Example 1, once a day, 5 g each time. The improvement of clinical symptoms is shown in Table 2.

[0220] Table 2.

[0221]

[0222] It can be seen from the results in Table 2 that the patient was seriously infected with Helicobacter pylori and suffered from insomnia. After taking the probiotic composition of the present invention for 10 days, abdominal pain and bloating were alleviated, nausea and acid reflux were reduced, the number of insomnia was reduced, and the sleep time was increased; after taking it for 1 month, the above symptoms disappeared, and the sleep time was 6-7 hours; after taking it for 6 months, the gastric ulcer surface healed, and the sleep time was 7-8 hours; after taking it for 8 months, the DPM value of Helicobacter pylori detected by C14 breath test was 0, and Helicobacter pylori infection and insomnia caused by it were completely cured.

[0223] Experimental Example 4. Effect of the composition of the present invention on improving insomnia

[0224] Clinical patient B, who had been under stress for several months and suffered from mental stimulation, suffered from insomnia. After taking the preparation of Example 2 of the present application for 1-2 days, 5 g per day, sleep improved significantly. After waking up on the second day of taking the preparation, he was clear-headed, in a good mental state, with less stress and a happy mood.

[0225] Clinical patient C, who had insomnia for 3-5 years, had poor sleep quality, shallow sleep, and was easily awakened in the middle. After taking the preparation of Example 3 of the present application for 2-3 days, 5g per day, sleep improved significantly, sleep time was prolonged, and deep sleep effect was good. After waking up the next day after taking it, he was clear-headed, energetic, and in a good mood.

[0226] Clinical patient D, who had insomnia for 2-3 years, slept for 2-3 hours, and needed to take diazepam to help him sleep. After taking the preparation of Example 4 of the present application for 3 days, 5g per day, his sleep improved significantly, and his sleep time was 5-6 hours. The dosage of diazepam was halved, and after taking it for one week, diazepam was discontinued. The sleep time was 6-7 hours.

[0227] The above clinical results show that the composition of the present invention includes a probiotic complex and a Chinese medicinal component that is both edible and medicinal, as well as prebiotics that have a proliferative effect on probiotics and serve as a nutrient source for probiotics. The probiotic complex contains more than 200 billion CFU / g of active probiotics. The probiotics are combined with Chinese medicinal components that are both edible and medicinal, and supplemented with corresponding prebiotics. It can treat or improve insomnia caused by spleen and stomach disharmony, liver qi stagnation, heart fire, yin deficiency and fire, heart-kidney disharmony caused by emotions, stress, diseases, etc., and the effect is fast and the effect of improving insomnia is obvious.

[0228] The technical solution of the present invention is not limited to the above-mentioned specific embodiments. All technical variations made according to the technical solution of the present invention fall within the protection scope of the present invention.

Claims

1. A composition, characterized in that The composition comprises a probiotic compound and a traditional Chinese medicine component, wherein the probiotic compound comprises or consists of the following bacterial species: Lactobacillus plantarum, Bifidobacterium lactis, Lactobacillus crispatus, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Lactobacillus reuteri, Lactobacillus casei, Lactobacillus bulgaricus, Lactobacillus fermentum, Lactobacillus gasseri, Lactococcus lactis, Bifidobacterium longum, Lactobacillus salivarius ... salivarius), Bifidobacterium breve, Streptococcus thermophilus, Lactobacillus paracasei, Lactobacillus helveticus; the Chinese medicine component includes or consists of the following Chinese medicines: spiny jujube seeds, lily, Poria cocos, lotus seeds, and mulberry.

2. The composition according to claim 1, characterized in that The composition further comprises prebiotics, which are selected from one or more of L-arabinose, β-glucan, inulin, erythritol, lactitol, vitamin C, and γ-aminobutyric acid.

3. The composition according to claim 2, characterized in that The composition comprises the probiotic complex, spinosa jujube seeds, lily, tuckahoe, lotus seeds, mulberry, L-arabinose, beta-glucan, inulin, erythritol, lactitol, vitamin C and gamma-aminobutyric acid.

4. The composition according to any one of claims 1 to 3, characterized in that The composition comprises the following components in parts by weight: 2-6 parts of probiotic complex, 2-5 parts of spinach seeds, 2-7 parts of lilies, 2-6.5 parts of poria cocos, 2-8 parts of lotus seeds, 2-8 parts of mulberries, 2-7 parts of L-arabinose, 1-4 parts of β-glucan, 5-10 parts of inulin, 6-10 parts of erythritol, 6-10 parts of lactitol, 0.5-3 parts of vitamin C, and 2-4.5 parts of γ-aminobutyric acid.

5. The composition according to claim 4, characterized in that The composition comprises the following components in parts by weight: 3-5 parts of probiotic complex, 3-5 parts of spiny jujube seeds, 2-5 parts of lilies, 3-5 parts of tuckahoe, 2-5 parts of lotus seeds, 3-5 parts of mulberries, 3.3-6.6 parts of L-arabinose, 1-3 parts of β-glucan, 6-8 parts of inulin, 7-9 parts of erythritol, 7-9 parts of lactitol, 0.5-2 parts of vitamin C, and 3-4.5 parts of γ-aminobutyric acid; Preferably, the composition comprises the following components in parts by weight: 3 parts of probiotic complex, 3 parts of spiny jujube kernel, 3 parts of lily, 3 parts of poria, 2 parts of lotus seeds, 3 parts of mulberry, 3.5 parts of L-arabinose, 1.5 parts of β-glucan, 7 parts of inulin, 8 parts of erythritol, 8 parts of lactitol, 0.5 parts of vitamin C, and 4.5 parts of γ-aminobutyric acid.

6. The composition according to any one of claims 1 to 3, characterized in that The viable counts of the strains in the probiotic complex are: 85-95 billion CFU / g of Lactobacillus plantarum, 5-15 billion CFU / g of Bifidobacterium lactis, 8-12 billion CFU / g of Lactobacillus crispatus, 10-18 billion CFU / g of Lactobacillus acidophilus, 5-15 billion CFU / g of Lactobacillus rhamnosus, 10-8 billion CFU / g of Bifidobacterium bifidum, 6-15 billion CFU / g of Lactobacillus reuteri, 6-15 billion CFU / g of Lactobacillus casei, and 6-15 billion CFU / g of Lactobacillus bulgaricus. Bacteria 10-6 billion CFU / g, Lactobacillus fermentum 60-10 billion CFU / g, Lactobacillus gasseri 10-6 billion CFU / g, Lactococcus lactis 10-6 billion CFU / g, Bifidobacterium longum 20-8 billion CFU / g, Lactobacillus salivarius 10-15 billion CFU / g, Bifidobacterium breve 10-8 billion CFU / g, Streptococcus thermophilus 50-10 billion CFU / g, Lactobacillus paracasei 120-160 billion CFU / g, Lactobacillus helveticus 50-10 billion CFU / g.

7. The composition according to claim 6, characterized in that The viable bacterial counts of the strains in the probiotic complex are: 90-93 billion CFU / g of Lactobacillus plantarum, 10-13 billion CFU / g of Bifidobacterium lactis, 8-11 billion CFU / g of Lactobacillus crispatus, 13-16 billion CFU / g of Lactobacillus acidophilus, 10-13 billion CFU / g of Lactobacillus rhamnosus, 2-5 billion CFU / g of Bifidobacterium bifidum, 10-13 billion CFU / g of Lactobacillus reuteri, 10-13 billion CFU / g of Lactobacillus casei, and 10-13 billion CFU / g of Lactobacillus thuringiensis. Lactobacillus leucoderma 1-4 billion CFU / g, Lactobacillus fermentum 6-9 billion CFU / g, Lactobacillus gasseri 1-4 billion CFU / g, Lactococcus lactis 1-4 billion CFU / g, Bifidobacterium longum 3-6 billion CFU / g, Lactobacillus salivarius 10-13 billion CFU / g, Bifidobacterium breve 3-6 billion CFU / g, Streptococcus thermophilus 5-8 billion CFU / g, Lactobacillus paracasei 12-15 billion CFU / g, Lactobacillus helveticus 5-8 billion CFU / g; Preferably, in the probiotic complex, the live bacteria counts of the strains are: 90 billion CFU / g of Lactobacillus plantarum, 10 billion CFU / g of Bifidobacterium lactis, 8 billion CFU / g of Lactobacillus crispatus, 13 billion CFU / g of Lactobacillus acidophilus, 10 billion CFU / g of Lactobacillus rhamnosus, 2 billion CFU / g of Bifidobacterium bifidum, 10 billion CFU / g of Lactobacillus reuteri, 10 billion CFU / g of Lactobacillus casei, 1 billion CFU / g of Lactobacillus bulgaricus, 6 billion CFU / g of Lactobacillus fermentum, 1 billion CFU / g of Lactobacillus gasseri, 1 billion CFU / g of Lactococcus lactis, 3 billion CFU / g of Bifidobacterium longum, 10 billion CFU / g of Lactobacillus salivarius, 3 billion CFU / g of Bifidobacterium breve, 5 billion CFU / g of Streptococcus thermophilus, 12 billion CFU / g of Lactobacillus paracasei, and 5 billion CFU / g of Lactobacillus helveticus.

8. A preparation, characterized in that The preparation is made from the composition according to any one of claims 1 to 7.

9. The preparation according to claim 8, characterized in that The dosage form of the preparation is solid beverage, chewable tablet or oral lozenge.

10. Use of the composition according to any one of claims 1 to 7 or the preparation according to any one of claims 8 to 9 in the preparation of medicines and / or foods for treating or improving gastrointestinal inflammation, ulcers, Helicobacter pylori infection, constipation, and insomnia.

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