Traditional Chinese medicine composition for treating insomnia

Abstract

The invention provides a traditional Chinese medicine composition for treating insomnia. The invention further provides a traditional Chinese medicine extract. The invention further provides a traditional Chinese medicine preparation. The invention further provides traditional Chinese medicine jelly and a preparation method thereof. The invention further provides application of the traditional Chinese medicine composition, the traditional Chinese medicine extract, the traditional Chinese medicine preparation or the traditional Chinese medicine jelly in preparation of medicines for treating insomnia. The traditional Chinese medicine composition for treating insomnia provided by the invention is suitable for dysphoria and insomnia caused by deficiency of liver blood, yin deficiency and internal heat, and has a remarkable curative effect on patients with dysphoria and insomnia, palpitation and dreaminess, body deficiency and hidrosis, body fluid impairment and thirst.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating insomnia, and specifically relates to a traditional Chinese medicine composition for treating insomnia, and a preparation method and application thereof. Background Art

[0002] Insomnia is a sleep disorder characterized by frequent and persistent difficulty falling asleep or insufficient sleep time and depth, which leads to decreased sleep satisfaction. The results of an epidemiological study on insomnia involving 10 countries in 2002 showed that about 27% of people in the world have sleep-related problems. Insomnia can lead to a decline in the quality of life of patients, increase the risk of depression, and is also a factor in inducing cardiovascular diseases such as hypertension, coronary heart disease, and heart failure. The treatment of insomnia is a long and complicated process. Modern medicine mainly uses non-drug treatment and drug treatment. Cognitive behavioral therapy for insomnia (CBT-I) is currently the most effective method, but it has not been widely promoted due to the shortage of professional therapists and price reasons; in terms of drug treatment, although new drugs such as zolpidem and doxepin have been introduced, as psychiatric drugs, there are still adverse reactions such as headaches, nausea, drowsiness, and depression.

[0003] Traditional Chinese medicine has a long history of diagnosing and treating insomnia, and has rich experience. The disease is often called "insomnia", "restless sleep", "eyes can't close", "can't sleep", etc. Traditional Chinese medicine believes that the disease is mostly caused by emotional injury, improper diet, imbalance of work and rest, long-term illness and physical weakness, which lead to organ dysfunction, qi and blood disharmony, yin and yang imbalance, and yang not entering yin. The "Golden Chamber" proposes that "deficiency and restlessness can't sleep, and Suanzaoren Decoction is the main treatment". Zhang Zhongjing believed that the "deficiency" of insomnia is often caused by the invasion of exogenous evil, excessive thinking or imbalance of work and rest, which causes liver blood loss and internal heat, and finally leads to restlessness and insomnia. Under the guidance of the basic principle of syndrome differentiation and treatment, traditional Chinese medicine can be added or subtracted according to the course of the disease and symptoms, with the advantages of simplicity, high efficiency and safety. A meta-analysis of traditional Chinese medicine treatment for insomnia showed that the efficacy of traditional Chinese medicine in treating insomnia is better than that of Western medicines such as Zopiclone and Sulazepam, and the difference is statistically significant (P < 0.01), which verifies the effectiveness of traditional Chinese medicine in treating insomnia.

[0004] Patent information of traditional Chinese medicine has exploded in recent years, and patents related to the treatment of insomnia with traditional Chinese medicine compound prescriptions have gradually gained favor. For example, Chinese patent application: CN201911035086.0 discloses a prescription composition of a traditional Chinese medicine foot bath for treating chronic insomnia and a method for its preparation, which relates to a prescription composition of a traditional Chinese medicine foot bath and a method for its preparation. It solves the problems that the existing traditional Chinese medicine foot bath for treating chronic insomnia is not highly effective and unstable, the preparation process is too simple and rough, and the effective ingredients are less dissolved. The prescription of the traditional Chinese medicine foot bath is composed of raw pinellia, prunella vulgaris, ginger, tangerine peel and coix seed. Preparation method 1 of traditional Chinese medicine foot bath: accurately weigh the raw materials; the prescription medicinal materials are suitable for drying; crush and sieve after sufficient mixing. Method 2: accurately weigh the raw materials; the prescription medicinal materials are suitable for drying; ultrafine crushing and sieving after sufficient mixing. However, all the ingredients in this patent are traditional Chinese medicine, which have a long onset time and limited efficacy; and the foot bath is not easy to carry and the operation is relatively complicated.

[0005] For another example, Chinese patent application CN115088796A discloses a solid and liquid beverage of Chinese jujube kernel for improving sleep and a preparation method thereof, which relates to the technical field of traditional Chinese medicine beverages and comprises the following raw materials in percentage by mass: 15%-25% of Chinese jujube kernel, 10%-20% of Poria cocos, 10%-20% of Platycladus chinensis kernel, 5%-10% of Psoralea corylifolia, 5%-10% of Licorice root and food additives, wherein the food additives are composed of the following raw materials in percentage by mass: 5%-10% of aspartame, 3%-8% of whey powder, 5%-8% of edible flavor and 5%-10% of dietary fiber. The patent has better tranquilizing effect with Chinese date seeds, which is convenient for improving sleep. At the same time, aspartame, whey powder, edible flavors and dietary fiber are added. Aspartame has a certain sweetness, but it will not be absorbed by the human body. It is suitable for people with high blood sugar. Whey powder and edible flavors can enhance the aroma and taste of the beverage, increase people's desire to drink, and dietary fiber can facilitate the beverage to be fully absorbed by the human body, moisturize the intestines and relieve constipation, further improving the effect of improving insomnia. However, the aspartame used in the patent is listed as a "substance that may be carcinogenic to humans" (Class 2B) by the International Agency for Research on Cancer (IARC) of the WHO. Studies have shown that aspartame may produce substances that have adverse effects on human health after being decomposed in the body, such as trichloroacetone. The intake of aspartame by the mother during pregnancy or lactation may have adverse effects on the brain development of the offspring, including the reduction of neuronal synapses, neuronal apoptosis, and impairment of learning and memory ability.

[0006] In addition, aspartame has an effect on the reward system of mice, which may affect behavior and emotions. Another example is Suanzaoren Decoction, which is a tranquilizer that nourishes blood and calms the mind, clears the heart and relieves depression. It is mainly used to treat liver blood deficiency and internal disturbance of deficiency heat. The indications are insomnia, palpitations, dizziness, dry throat and mouth, red tongue, and stringy pulse. However, Suanzaoren Decoction is entirely made of traditional Chinese medicine ingredients, which is not well accepted by patients, is not easy to preserve, and is complicated to decoct. Summary of the invention

[0007] In view of the above-mentioned shortcomings of the prior art, the purpose of the present invention is to provide a Chinese medicine composition for treating insomnia and its corresponding products such as jelly, etc., which are used to treat insomnia and achieve the effects of nourishing blood and calming the mind, clearing the heart and relieving depression.

[0008] To achieve the above-mentioned object and other related objects, the first aspect of the present invention provides a Chinese medicine composition for treating insomnia, which comprises the following raw material components by weight:

[0009] 6-11 parts by weight of spinach seed;

[0010] 1-5 parts by weight of Ligusticum chuanxiong;

[0011] 1.8-6 parts by weight of lily;

[0012] 0.5-5 parts by weight of Flos Albizia Julibrissin;

[0013] 0.5-5 parts by weight of wolfberry;

[0014] 0.5-5 parts by weight of Chinese yam;

[0015] Phragmites australis 0-4 parts by weight;

[0016] Poria 0.5-5 parts by weight;

[0017] Licorice 0.1-3 parts by weight.

[0018] The second aspect of the present invention provides a Chinese medicine extract, which is obtained by extracting the Chinese medicine composition described in the first aspect of the present invention as a raw material.

[0019] The third aspect of the present invention provides a Chinese medicine preparation, comprising a therapeutically effective amount of the Chinese medicine composition provided by the first aspect of the present invention, or a therapeutically effective amount of the Chinese medicine extract provided by the second aspect of the present invention, and one or more conventional pharmaceutically acceptable excipients.

[0020] The fourth aspect of the present invention provides a Chinese medicine jelly, comprising the Chinese medicine composition provided in the first aspect of the present invention and auxiliary materials, wherein the auxiliary materials include a first auxiliary material part and a second auxiliary material part by weight.

[0021] The first auxiliary material part includes the following components:

[0022] 0.5-3 parts by weight of blueberry juice;

[0023] Cherry juice 0.5-3 parts by weight;

[0024] 0.5-3 parts by weight of rose juice;

[0025] 0.1-2 parts by weight of tea theanine;

[0026] 0.1-2 parts by weight of γ-aminobutyric acid;

[0027] 0.1-0.8 parts by weight of xylo-oligosaccharide;

[0028] Lactofructooligosaccharide 0.1-0.8 parts by weight;

[0029] Galacto-oligosaccharide 0.1-0.8 parts by weight;

[0030] 0.1-0.8 parts by weight of erythritol;

[0031] 0.1-0.8 parts by weight of xylulose;

[0032] Lactobacillus plantarum 0.01-0.8 parts by weight;

[0033] Lactobacillus acidophilus 0.01-0.8 weight portion;

[0034] Lactococcus lactis 0.01-0.8 parts by weight;

[0035] The second auxiliary material part comprises the following components:

[0036] 30-60 parts by weight of red date concentrated juice;

[0037] 10-40 parts by weight of fruit powder;

[0038] Calcium citrate 0.5-6 parts by weight.

[0039] A fifth aspect of the present invention provides a method for preparing a Chinese medicine jelly, comprising the following steps:

[0040] 1) mixing the components of the first auxiliary material part provided by the fourth aspect of the present invention to obtain a composite jelly colloid;

[0041] 2) The composite jelly colloid obtained in step 1) is mixed with the raw material components of the Chinese medicine composition provided in the first aspect of the present invention and the components of the second auxiliary material part provided in the fourth aspect of the present invention, and then filtered, heated and stirred, and then continued to heat to completely dissolve it and then filtered for a second time to provide the Chinese medicine jelly.

[0042] The sixth aspect of the present invention provides the use of the Chinese medicine composition provided by the first aspect of the present invention, the Chinese medicine extract provided by the second aspect of the present invention, the Chinese medicine preparation provided by the third aspect of the present invention, or the Chinese medicine jelly provided by the fourth aspect of the present invention in the preparation of a medicine for treating insomnia.

[0043] As described above, the Chinese medicine composition for treating insomnia provided by the present invention has the following beneficial effects:

[0044] (1) The present invention provides a Chinese medicine composition for treating insomnia, which is mainly made of medicinal and edible medicinal materials, and is added with nutritious fruits and vegetables, probiotics and other substances, and is suitable for insomnia caused by liver blood deficiency and yin deficiency and internal heat. In the early stage, clinical application was carried out in the outpatient department of the Department of Preventive Medicine of Shanghai Seventh People's Hospital, and it was found that the drink has a significant effect on the treatment of patients with insomnia, palpitations and dreams, physical weakness and sweating, and thirst due to loss of body fluids.

[0045] (2) The Chinese medicine composition for treating insomnia provided by the present invention has improved taste and acceptance, and improves the overall health level. That is, intestinal probiotics are further used to transform the medicinal and edible medicinal materials in the prescription for a long time, which can improve the taste of the original medicinal materials while increasing efficacy and reducing toxicity, and improve absorption rate of the ingredients; natural fruit juice is used for seasoning, and no additional sugar substances such as sucrose that cause blood sugar to rise are added. Erythritol, xylulose and other materials with low blood sugar value increase rate are used to adjust the taste as sugar substitutes with low glycemic index, ensuring a harmonious and healthy taste; the addition of prebiotics such as oligoxylose, oligolactose and oligogalactose can regulate the intestines well, scientifically regulate the intestinal microecology, maintain intestinal health, and keep the intestinal microecology balanced; the entire product strictly follows the principle of no preservatives, no sweeteners, and no artificial colors, and does not contain preservatives, sweeteners, or artificial colors.

[0046] (3) The Chinese medicine composition for treating insomnia provided by the present invention combines nourishing yin and blood with regulating intestinal function. It can nourish yin and blood, regulate the intestines, and is easy to eat and has a good taste. It fully meets the professional needs of modern people for healthy food. Therefore, it can better adapt to the needs of modern people and show excellent economic and social benefits in the market.

[0047] (4) The Chinese medicine composition for treating insomnia provided by the present invention deeply integrates the jelly preparation process with the independently developed Chinese medicine compound extraction process, and carefully creates a functional beverage with a suitable taste and the dual effects of nourishing blood and calming the mind, clearing the heart and relieving depression. The preparation process of the beverage is highly dependent on the advanced modern automated low-temperature extraction system, which accurately simulates the human intestinal environment to ensure that the entire production process is systematized, streamlined and standardized. In the production process, more than 30 fine processes and more than 200 strict control nodes are strictly followed. Through strict process management, the safety, effectiveness, stability and uniformity of the product are ensured, reaching the high standards of modern medical products.

[0048] (5) The Chinese medicine composition for treating insomnia provided by the present invention has overturned the traditional Chinese medicine boiling method and introduced food-grade high-efficiency extraction technology. It can efficiently extract the essence from the Chinese medicine prescription that is both medicine and food, and significantly improve the output rate of the effective ingredients of the Chinese medicine. It not only achieves the established production and efficacy goals, but also achieves a qualitative leap in taste, demonstrating extremely high professional standards and technological innovation.

[0049] (6) The Chinese medicine composition for treating insomnia provided by the present invention has systematically conducted an effect evaluation of the preliminary trial production product and a follow-up visit to the subjects. Among them, 85% of the subjects reported that their insomnia symptoms were significantly improved, 10% of the subjects reported that there was no obvious effect, and 5% of the subjects reported that the product still had a heavy Chinese medicine flavor that interfered with the taste. In the follow-up visit, 60% of the subjects reported that they were willing to purchase the product after it was officially put into production. This data not only demonstrates consumers' recognition of the product's efficacy, but also fully proves the huge potential and broad prospects of the process improvement of the present invention in broadening market applications. DETAILED DESCRIPTION

[0050] Before further describing the specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terms used in the examples of the present invention are intended to describe specific embodiments, rather than to limit the scope of protection of the present invention. The test methods in the following examples without specifying specific conditions are generally carried out under conventional conditions or under conditions recommended by the manufacturers.

[0051] When the embodiments give numerical ranges, it should be understood that, unless otherwise specified in the present invention, both endpoints of each numerical range and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those generally understood by those skilled in the art. In addition to the specific methods, equipment, and materials used in the embodiments, according to the grasp of the prior art by those skilled in the art and the record of the present invention, any methods, equipment, and materials of the prior art similar or equivalent to the methods, equipment, and materials described in the embodiments of the present invention can also be used to realize the present invention.

[0052] Unless otherwise stated, the experimental methods, detection methods, and preparation methods disclosed in the present invention all adopt conventional techniques in the technical field.

[0053] The first aspect of the present invention provides a Chinese medicine composition for treating insomnia, comprising the following raw material components by weight:

[0054] 6-11 parts by weight of Semen Ziziphi Spinosae; specifically 6-7 parts by weight, 7-10 parts by weight, 10-11 parts by weight;

[0055] 1-5 parts by weight of Chuanxiong; specifically 1-2 parts by weight, 2-4 parts by weight, 4-5 parts by weight;

[0056] 1.8-6 parts by weight of lily; specifically 1.8-2 parts by weight, 2-5 parts by weight, 5-6 parts by weight;

[0057] 0.5-5 parts by weight of Albizia Julibrissin; specifically 0.5-2 parts by weight, 2-5 parts by weight;

[0058] 0.5-5 parts by weight of wolfberry; specifically 0.5-2 parts by weight, 2-5 parts by weight;

[0059] 0.5-5 parts by weight of Chinese yam; specifically 0.5-1 parts by weight, 1-4 parts by weight, 4-5 parts by weight;

[0060] Phragmites australis 0-4 parts by weight; specifically 0-2 parts by weight, 2-3 parts by weight, 3-4 parts by weight;

[0061] Poria 0.5-5 parts by weight; specifically 0.5-1 parts by weight, 1-4 parts by weight, 4-5 parts by weight;

[0062] Licorice 0.1-3 parts by weight; specifically 0.1-0.5 parts by weight, 0.5-2 parts by weight, 2-3 parts by weight.

[0063] In the present invention, the Chinese jujube seeds are the dried mature seeds of Chinese jujube of the Rhamnaceae family. The Chinese jujube seeds have the effects of nourishing the heart and liver, calming the mind, astringing sweat and promoting the production of body fluids.

[0064] In the present invention, the chuanxiong is the dried rhizome of the umbelliferae plant chuanxiong, and has the effects of promoting blood circulation and qi, dispelling wind and relieving pain.

[0065] In the present invention, the lily is the dried fleshy scale leaves of Lilium lily, Lilium or Lilium tenuifolium of the Liliaceae family. The lily has the effects of nourishing yin and moistening the lungs, clearing the heart and calming the mind.

[0066] In the present invention, the flower of Albizzia julibrissin is the flower or flower bud of the leguminous plant Albizzia julibrissin. The flower of Albizzia julibrissin has the effects of relieving depression and calming the mind, regulating qi and stimulating appetite, activating blood circulation and relieving pain.

[0067] In the present invention, the wolfberry is the mature fruit of Ningxia wolfberry, a plant of the Solanaceae family. The wolfberry has the effects of nourishing the liver and kidneys and improving vision.

[0068] In the present invention, the Chinese yam is a processed product of the root and rhizome of the Dioscorea plant of the Dioscoreaceae family after germination and drying. The Chinese yam has the effects of nourishing the spleen and stomach, promoting the production of body fluids and benefiting the lungs, and nourishing the kidneys and astringing the essence.

[0069] In the present invention, the reed root is the fresh or dried rhizome of the grass plant reed, and has the effects of clearing away heat and purging fire, promoting body fluid and quenching thirst, relieving restlessness, stopping vomiting and promoting diuresis.

[0070] In the present invention, the Poria cocos is the dried sclerotium of the fungus Poria cocos of the Polyporaceae family. The Poria cocos has the functions of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind.

[0071] In the present invention, the licorice is the dried root and rhizome of the leguminous plants licorice, licorice inflata or licorice glabra. The licorice has the functions of invigorating qi and tonifying the middle, removing phlegm and relieving cough, detoxifying, relieving pain and alleviating the properties of the medicine.

[0072] The above-mentioned raw materials (or medicinal materials) used in the present invention can be purchased from ordinary medical stores or Chinese medicinal material sales companies. Their specifications meet national medical standards or relevant regulations such as the Chinese Pharmacopoeia, and are all included in the catalog of types of medicine and food.

[0073] The Chinese medicine composition for treating insomnia prepared by the present invention fully follows the principle of syndrome differentiation and treatment in traditional Chinese medicine, and uses a variety of authentic medicinal materials of both medicinal and edible origin, such as Chinese jujube seeds, chuanxiong, lily, jujube flower, wolfberry, Chinese yam, Poria cocos, reed root, and liquorice as main raw materials, among which Chinese jujube seeds are used as the main medicine, which is sweet, sour, moist, enters the meridians of the heart and liver, nourishes the liver and blood, and calms the mind. Poria cocos calms the mind and calms the mind, lily and Chinese wolfberry nourish blood, soften the liver, and help the liver restore its smooth nature, and Chinese yam nourishes the heart and liver, and the four are collectively the ministerial medicines. With the pungent and dispersing effect of Chuanxiong, it regulates liver blood and relieves liver qi. It is combined with a large amount of Ziziphus jujuba seeds, which are used together with pungent and dispersing effect, combining blood tonifying and blood circulation, and have the wonderful effect of nourishing blood and regulating liver; Albizzia julibrissin gently ascends, bitter and flat, dispersing and purging, which can relieve depression and regulate qi, and also help Ziziphus jujuba seeds to calm the mind; Phragmites australis can clear away heat and promote body fluid, and can help Poria cocos to clear the orifices and remove dampness to increase the power of purging fire and relieving restlessness. The three are adjuvants. Licorice harmonizes the drugs as a guiding drug. The various medicinal materials are compatible with each other to play their synergistic therapeutic effects. The various components of the Chinese medicinal raw materials used have the effect of interweaving, promoting and coordinating the effects of the medicinal effects, moistening dryness and relieving urgency, and sweet and moistening, and playing the role of nourishing blood and calming the mind, clearing the heart and relieving depression.

[0074] In a preferred embodiment of the present invention, the Chinese medicine composition comprises the following raw material components by weight:

[0075] 7-10 parts by weight of spinosa jujube seeds; 2-4 parts by weight of chuanxiong; 2-5 parts by weight of lily; 2-5 parts by weight of julibrissin; 2-5 parts by weight of wolfberry; 1-4 parts by weight of yam; 0-2 parts by weight of reed root; 1-4 parts by weight of poria; and 0.5-2 parts by weight of liquorice.

[0076] In a further preferred embodiment of the present invention, the Chinese medicine composition comprises the following raw material components by weight:

[0077] 10 parts by weight of Semen Ziziphi Spinosae; 4 parts by weight of Rhizoma Chuanxiong; 4 parts by weight of Bulbus Lilii; 4 parts by weight of Flos Albiziae; 4 parts by weight of Lycium Barbarum; 4 parts by weight of Rhizoma Dioscoreae; 0 parts by weight of Rhizoma Phragmites; 4 parts by weight of Poria; and 2 parts by weight of Radix Glycyrrhizae.

[0078] The second aspect of the present invention provides a Chinese medicine extract, which is obtained by extracting the Chinese medicine composition described in the first aspect of the present invention as a raw material.

[0079] In a preferred embodiment of the present invention, the method for extracting the raw material is selected from at least one of a cryogenic grinding method or an extraction and concentration method.

[0080] In a further preferred embodiment of the present invention, the method for extracting the raw material is a low-temperature grinding method or an extraction and concentration method, preferably an extraction and concentration method.

[0081] In the present invention, each raw material component in the formula of the Chinese medicine composition is the most critical. After knowing the formula of the Chinese medicine composition, technicians in this technical field can use various extraction methods of effective ingredients of Chinese medicine to extract its effective ingredients according to the characteristics of different raw material components in the Chinese medicine composition, such as low-temperature grinding method, leaching concentration method, etc.

[0082] In a further preferred embodiment of the present invention, the cryogenic grinding method comprises: mixing the raw material components, soaking them in water at low temperature, and then performing cryogenic grinding to provide the Chinese herbal medicine extract.

[0083] In a further preferred embodiment of the present invention, the ratio of the mass (g) of the raw material components added to the volume (mL) of the water added is 1:8-12, specifically 1:8-10, 1:10-12, preferably 1:10. That is, the water is 8-12 times the amount of the raw material components, specifically 8-10 times, 10-12 times, preferably 10 times.

[0084] In a further preferred embodiment of the present invention, the temperature of the low-temperature soaking is 20-50°C, such as 20-30°C, 30-40°C, 40-50°C.

[0085] In a further preferred embodiment of the present invention, the low-temperature soaking time is 2-3 hours.

[0086] In a further preferred embodiment of the present invention, the cryogenic grinding is performed in a colloid mill.

[0087] In a further preferred embodiment of the present invention, the temperature of the cryogenic grinding is not higher than 50°C, such as 1-10°C, 10-20°C, 20-30°C, 30-40°C, 40-50°C.

[0088] In a further preferred embodiment of the present invention, the rotation speed of the cryogenic grinding is 1000-10000 rpm, preferably 3000-5000 rpm.

[0089] In a further preferred embodiment of the present invention, the cryogenic grinding forms particles, and the particle size of the particles is 0.25-0.45 mm, preferably 0.297-0.425 mm.

[0090] In a further preferred embodiment of the present invention, the extraction and concentration method comprises: mixing the raw material components, soaking in water, boiling, filtering and concentrating to provide the traditional Chinese medicine extract.

[0091] In a further preferred embodiment of the present invention, the ratio of the mass (g) of the raw material components added to the volume (mL) of the water added is 1:8-12, specifically 1:8-10, 1:10-12, preferably 1:10. That is, the water is 8-12 times the amount of the raw material components, specifically 8-10 times, 10-12 times, preferably 10 times.

[0092] In a further preferred embodiment of the present invention, the soaking is performed at room temperature, which is 20-30°C.

[0093] In a further preferred embodiment of the present invention, the soaking time is 2-3 hours.

[0094] In a further preferred embodiment of the present invention, the cooking is performed until boiling.

[0095] In a further preferred embodiment of the present invention, the boiling time is 50-90 min, preferably 60-80 min.

[0096] In a further preferred embodiment of the present invention, the filtration is a conventional filtration method, such as screen filtration, filter cloth filtration, etc.

[0097] In a further preferred embodiment of the present invention, the concentration is vacuum concentration, the vacuum degree of the vacuum concentration is 60-80kPa, specifically 60-65kPa, 65-75kPa, 75-80kPa, preferably 65-75kPa; the temperature of the vacuum concentration is 50-65°C, specifically 50-55°C, 55-60°C, 60-65°C, preferably 55-60°C; the time of the vacuum concentration is 4-9h, specifically 4-5h, 5-8h, 8-9h, preferably 5-8h.

[0098] The third aspect of the present invention provides a Chinese medicine preparation, comprising a therapeutically effective amount of the Chinese medicine composition provided by the first aspect of the present invention, or a therapeutically effective amount of the Chinese medicine extract provided by the second aspect of the present invention, and one or more conventional pharmaceutically acceptable excipients.

[0099] Pharmaceutically acceptable excipients include (but are not limited to): pharmaceutically acceptable carriers, diluents, fillers, binders, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives and other excipients. Therapeutically inert inorganic or organic carriers known to those skilled in the art include (but are not limited to) lactose, corn starch or its derivatives, talc, vegetable oils, waxes, fats, polyol compounds such as polyethylene glycol, water, sucrose, ethanol, glycerol, and the like, various preservatives, lubricants, dispersants, flavoring agents. Moisturizers, antioxidants, sweeteners, colorants, stabilizers, salts, buffers and the like may also be added thereto, and these substances are used to help the stability of the formulation or to help improve the activity or its biological effectiveness as needed.

[0100] Traditional Chinese medicine preparations such as granules and ointments can be prepared by conventional methods. The pharmaceutical composition of the present invention can also be used together with other therapeutic agents.

[0101] After the effective ingredients in the traditional Chinese medicine composition are extracted, conventional pharmaceutical excipients and additives can be used to prepare the aforementioned pharmaceutical composition.

[0102] The effective therapeutic dose of the pharmaceutical composition of the present invention is based on the total weight of the raw medicinal materials. The specific dose should also take into account factors such as the route of administration and the patient's health condition, which are all within the skills of skilled physicians.

[0103] The fourth aspect of the present invention provides a Chinese medicine jelly, comprising the Chinese medicine composition provided in the first aspect of the present invention and auxiliary materials, wherein the auxiliary materials include a first auxiliary material part and a second auxiliary material part by weight.

[0104] The first auxiliary material part includes the following components:

[0105] 0.5-3 parts by weight of blueberry juice; specifically 0.5-1 parts, 1-2 parts, 2-3 parts;

[0106] Cherry juice 0.5-3 parts by weight; specifically 0.5-1 parts, 1-2 parts, 2-3 parts;

[0107] Rose juice 0.5-3 parts by weight; specifically 0.5-1 parts, 1-2 parts, 2-3 parts;

[0108] 0.1-2 parts by weight of tea theanine; specifically 0.1-0.5 parts, 0.5-1 parts, 1-2 parts;

[0109] γ-aminobutyric acid 0.1-2 parts by weight; specifically 0.1-0.5 parts, 0.5-1 parts, 1-2 parts;

[0110] 0.1-0.8 parts by weight of xylo-oligosaccharide; specifically 0.1-0.4 parts, 0.4-0.5 parts, 0.5-0.8 parts;

[0111] Lactofructooligosaccharide 0.1-0.8 parts by weight; specifically 0.1-0.4 parts, 0.4-0.5 parts, 0.5-0.8 parts;

[0112] Galacto-oligosaccharide 0.1-0.8 parts by weight; specifically 0.1-0.4 parts, 0.4-0.5 parts, 0.5-0.8 parts;

[0113] Erythritol 0.1-0.8 parts by weight; specifically 0.1-0.4 parts, 0.4-0.5 parts, 0.5-0.8 parts;

[0114] 0.1-0.8 parts by weight of xylulose; specifically 0.1-0.4 parts, 0.4-0.5 parts, 0.5-0.8 parts;

[0115] Lactobacillus plantarum 0.01-0.8 parts by weight; specifically 0.01-0.2 parts, 0.2-0.5 parts, 0.5-0.8 parts;

[0116] Lactobacillus acidophilus 0.01-0.8 parts by weight; specifically 0.01-0.2 parts, 0.2-0.5 parts, 0.5-0.8 parts;

[0117] Lactococcus lactis 0.01-0.8 parts by weight; specifically 0.01-0.2 parts, 0.2-0.5 parts, 0.5-0.8 parts;

[0118] The second auxiliary material part comprises the following components:

[0119] 30-60 parts by weight of red date concentrated juice; specifically 30-40 parts by weight, 40-50 parts by weight, 50-60 parts by weight;

[0120] 10-40 parts by weight of fruit powder; specifically 10-20 parts by weight, 20-30 parts by weight, 30-40 parts by weight;

[0121] Calcium citrate 0.5-6 parts by weight; specifically 0.5-1 parts by weight, 1-5 parts by weight, 5-6 parts by weight.

[0122] The auxiliary materials are calculated in the same weight ratio as the traditional Chinese medicine composition provided in the first aspect of the present invention.

[0123] In a preferred embodiment of the present invention, the first auxiliary material part comprises the following components by weight:

[0124] 1-2 parts by weight of blueberry juice; 1-2 parts by weight of cherry juice; 1-2 parts by weight of rose juice; 0.5-1 parts by weight of tea theanine; 0.5-1 parts by weight of gamma-aminobutyric acid; 0.1-0.4 parts by weight of xylo-oligosaccharide; 0.1-0.4 parts by weight of lactofructo-oligosaccharide; 0.1-0.4 parts by weight of galacto-oligosaccharide; 0.1-0.4 parts by weight of erythritol; 0.1-0.4 parts by weight of xylulose; 0.2-0.5 parts by weight of Lactobacillus plantarum; 0.2-0.5 parts by weight of Lactobacillus acidophilus; 0.2-0.5 parts by weight of Lactococcus lactis.

[0125] In a further preferred embodiment of the present invention, the first auxiliary material part comprises the following components by weight:

[0126] 2 parts by weight of blueberry juice; 2 parts by weight of cherry juice; 2 parts by weight of rose juice; 1 part by weight of tea theanine; 1 part by weight of gamma-aminobutyric acid; 0.4 parts by weight of xylo-oligosaccharide; 0.4 parts by weight of lactofructo-oligosaccharide; 0.4 parts by weight of galacto-oligosaccharide; 0.4 parts by weight of erythritol; 0.4 parts by weight of xylulose; 0.5 parts by weight of Lactobacillus plantarum; 0.5 parts by weight of Lactobacillus acidophilus; and 0.5 parts by weight of Lactococcus lactis.

[0127] In a preferred embodiment of the present invention, the second auxiliary material part comprises the following components by weight:

[0128] 40-50 parts by weight of red date concentrated juice; 20-30 parts by weight of fruit powder; and 1-5 parts by weight of calcium citrate.

[0129] In a further preferred embodiment of the present invention, the second auxiliary material part comprises the following components by weight:

[0130] 40 parts by weight of red date concentrated juice; 20 parts by weight of fruit powder; and 1 part by weight of calcium citrate.

[0131] In the first auxiliary material part, the blueberry juice is an aqueous solution of 55-65% by mass of blueberries, preferably an aqueous solution of 60% by mass of blueberries, that is, concentrated blueberry juice.

[0132] In the first auxiliary material part, the cherry juice is an aqueous solution of 55-65% by mass of cherry, preferably an aqueous solution of 60% by mass of cherry, that is, cherry concentrated juice.

[0133] In the first auxiliary material part, the cherry juice is a rose water solution with a mass percentage of 55-65%, preferably a rose water solution with a mass percentage of 60%, that is, rose concentrated juice.

[0134] In the first auxiliary material part, the tea theanine is theanine contained in tea leaves (CAS No. 3081-61-6).

[0135] In the first auxiliary material part, the CAS number of the gamma-aminobutyric acid is 56-12-2.

[0136] In the first auxiliary material part, the xylooligosaccharide is xylooligosaccharide, and the CAS number of the xylooligosaccharide is 87-99-0.

[0137] In the first auxiliary material part, the lactofructo-oligosaccharide is a kind of starch sugar, and the CAS number of the lactofructo-oligosaccharide is 87419-56-5.

[0138] In the first auxiliary material part, the CAS number of the galacto-oligosaccharide is 6587-31-1.

[0139] In the first auxiliary material part, the CAS number of the erythritol is 149-32-6.

[0140] In the first auxiliary material part, the CAS number of the xylulose is 551-84-8.

[0141] In the first auxiliary material part, the Lactobacillus plantarum is a conventionally used Lactobacillus plantarum, which can be purchased from the market, specifically NSL0101 Lactobacillus plantarum powder.

[0142] In the first auxiliary material part, the Lactobacillus acidophilus is a commonly used Lactobacillus acidophilus, which can be purchased from the market, specifically NCFM Lactobacillus acidophilus powder.

[0143] In the first auxiliary material part, the Lactococcus lactis is a conventionally used Lactococcus lactis, which can be purchased from the market, such as NSS0302 Lactococcus lactis powder.

[0144] In the second auxiliary material part, the red date concentrated juice is a commonly used red date concentrated juice, which can be purchased from the market.

[0145] In the second auxiliary material part, the fruit powder is a commonly used fruit powder that can be purchased from the market. Specifically, the fruit powder is a food prepared by pre-processing, mixing, tableting, testing and packaging apple powder, citric acid, malic acid, white sugar powder, glucose powder, vitamin C, DHA powder, arachidonic acid powder, etc. according to a certain proportion, and has health care and therapeutic effects such as promoting digestion, preventing and treating diseases, increasing immunity and anti-aging, and retains the effective ingredients in vinegar powder, DHA powder and arachidonic acid powder intact, so as to better promote human metabolism and reduce the occurrence of cardiovascular diseases.

[0146] In the second auxiliary material part, the calcium citrate is the commonly used calcium citrate that complies with GB 17203-1998 and can be purchased from the market.

[0147] A fifth aspect of the present invention provides a method for preparing a Chinese medicine jelly, comprising the following steps:

[0148] 1) mixing the components of the first auxiliary material part provided by the fourth aspect of the present invention to obtain a composite jelly colloid;

[0149] 2) mixing the composite jelly colloid obtained in step 1) with the raw material components of the Chinese medicine composition provided in the first aspect of the present invention and the components of the second auxiliary material part provided in the fourth aspect of the present invention, filtering, heating and stirring to mix,

[0150] Continue heating to completely dissolve it and then filter it for the second time to provide the Chinese medicine jelly.

[0151] In step 2), the filtration is sieve filtration.

[0152] In a preferred embodiment of the present invention, the mesh size of the sieve is 40-60 meshes, specifically 40-50 meshes, 50-60 meshes, preferably 50 meshes.

[0153] In step 2), the heating is performed by adding the mixture into hot water for heating.

[0154] In step 2), the heating temperature is 35-55°C, specifically 35-40°C, 40-50°C, 50-55°C, preferably 40-50°C.

[0155] In step 2), the heating time is 10-20 minutes, specifically 10-15 minutes, 15-20 minutes, preferably 15 minutes.

[0156] In step 2), the stirring and mixing is used to fully swell the components.

[0157] In step 2), the continued heating temperature is 75-95°C, specifically 75-80°C, 80-90°C, 90-95°C, preferably 80-90°C.

[0158] In step 2), the continued heating time is 40-55 minutes, specifically 40-45 minutes, 45-50 minutes, 50-55 minutes, preferably 45-50 minutes.

[0159] In step 2), the second filtration is filtering through filter cloth.

[0160] In a preferred embodiment of the present invention, the filter cloth has a filter mesh number of 90-110 meshes, specifically 90-100 meshes, 100-110 meshes, and preferably 100 meshes.

[0161] In step 2), the Chinese medicine jelly is further subjected to cooling and heat preservation, pH adjustment, flavoring, filling, sterilization, cold water cooling, air drying, and sealing.

[0162] In a preferred embodiment of the present invention, in the cooling and heat preservation, the temperature is cooled to 65-75°C and kept warm, preferably 70°C.

[0163] In a preferred embodiment of the present invention, the pH is adjusted to 4.3±0.2.

[0164] In a preferred embodiment of the present invention, the flavoring is a process step of adding spices to adjust the flavor during conventional food production.

[0165] In a preferred embodiment of the present invention, the sterilization temperature is 80-90°C, specifically 80-85°C, 85-90°C, preferably 85°C.

[0166] In a preferred embodiment of the present invention, the sterilization time is 15-25 minutes, such as 15-20 minutes, 20-25 minutes, and preferably 20 minutes.

[0167] In a preferred embodiment of the present invention, the filling, sterilization, cold water cooling, air shower drying and sealing are all conventional filling, sterilization, cold water cooling, air shower drying and sealing processing processes, which are used to maintain the quality and safety of traditional Chinese medicine jelly.

[0168] The sixth aspect of the present invention provides the use of the Chinese medicine composition provided by the first aspect of the present invention, the Chinese medicine extract provided by the second aspect of the present invention, the Chinese medicine preparation provided by the third aspect of the present invention, or the Chinese medicine jelly provided by the fourth aspect of the present invention in the preparation of a medicine for treating insomnia.

[0169] The present invention aims at insomnia, tends to nourish the heart and regulate the liver, clear the heart and help sleep, achieves nourishing blood and calming the mind, clearing the heart and relieving depression, and is suitable for insomnia caused by liver blood deficiency and yin deficiency and internal heat.

[0170] The present invention uses various authentic edible and medicinal materials such as Chinese jujube seeds, Chuanxiong, lily, julibrissin, wolfberry, yam, Poria, reed root, licorice, etc. as main raw materials, and further adds nutritious fruits and vegetables such as blueberry concentrated juice, cherry concentrated juice, rose juice, etc., and compound tea theanine, γ-aminobutyric acid and other sedative and sleep-inducing nutritional enhancers, and adds various probiotics such as oligoxylose and oligolactose to regulate the intestines, to develop a product that nourishes blood, soothes the nerves, clears the heart and relieves depression.

[0171] The present invention is further described below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not used to limit the scope of protection of the present invention.

[0172] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0173] Example 1

[0174] The raw material components of the traditional Chinese medicine composition for treating insomnia are taken by weight, namely: 10 parts by weight of Ziziphus jujuba seeds, 4 parts by weight of Chuanxiong; 4 parts by weight of lily; 4 parts by weight of Albizzia julibrissin; 4 parts by weight of wolfberry, 4 parts by weight of yam, 0 parts by weight of Phragmites australis, 4 parts by weight of Poria cocos, and 2 parts by weight of Licorice, to obtain a traditional Chinese medicine composition 1.

[0175] Example 2

[0176] The raw material components of the traditional Chinese medicine composition for treating insomnia are taken by weight, namely: 7 weight parts of Ziziphus jujuba seeds, 2 weight parts of Chuanxiong, 3 weight parts of lily, 1 weight part of Albizzia julibrissin; 1 weight part of wolfberry, 1 weight part of yam, 1 weight part of reed root, 2 weight parts of Poria cocos, and 0.5 weight part of licorice, to obtain traditional Chinese medicine composition 2.

[0177] Example 3

[0178] The raw material components of the traditional Chinese medicine composition for treating insomnia are taken by weight, namely: 7 weight parts of Ziziphus jujuba seeds, 2 weight parts of Chuanxiong, 2 weight parts of lily, 1 weight part of Albizzia julibrissin; 3 weight parts of wolfberry, 1.5 weight parts of yam, 0 weight part of Phragmites australis, 2 weight parts of Poria cocos, and 2 weight parts of Licorice, to obtain traditional Chinese medicine composition 3.

[0179] Example 4

[0180] The raw material components of the traditional Chinese medicine composition for treating insomnia are taken by weight, namely: 10 weight parts of Ziziphus jujuba seeds, 4 weight parts of Chuanxiong, 5 weight parts of lily, 1 weight part of Albizzia julibrissin; 1 weight part of wolfberry, 1 weight part of yam, 1 weight part of reed root, 1.5 weight parts of Poria cocos, and 0.5 weight part of licorice, to obtain traditional Chinese medicine composition 4.

[0181] Example 5

[0182] The raw material components of the traditional Chinese medicine composition for treating insomnia are taken by weight, namely: 9 weight parts of Ziziphus jujuba seeds, 3 weight parts of Chuanxiong, 4 weight parts of lily, 2 weight parts of Albizzia julibrissin; 2 weight parts of wolfberry, 2 weight parts of yam, 2 weight parts of reed root, 1.5 weight parts of Poria cocos, and 1 weight part of licorice, to obtain traditional Chinese medicine composition 5.

[0183] Example 6

[0184] In terms of weight, the raw material components of the traditional Chinese medicine composition for treating insomnia are: 9 weight parts of Chinese jujube seeds, 2.5 weight parts of Chuanxiong, 3.5 weight parts of lily, 1.5 weight parts of Albizzia julibrissin; 3 weight parts of wolfberry, 1.5 weight parts of yam, 0 weight parts of reed root, 1.5 weight parts of Poria cocos, and 1.5 weight parts of licorice, to obtain traditional Chinese medicine composition 6.

[0185] Example 7

[0186] The raw material components of the traditional Chinese medicine composition for treating insomnia are taken by weight, namely: 10 weight parts of Ziziphus jujuba seeds, 3.5 weight parts of Ligusticum chuanxiong, 3.5 weight parts of Lilium bulgur, 2.5 weight parts of Albizzia julibrissin; 2 weight parts of Lycium barbarum, 2 weight parts of Dioscorea opposita, 0 weight parts of Phragmites australis, 1.5 weight parts of Poria cocos, and 1 weight part of Licorice, to obtain traditional Chinese medicine composition 7.

[0187] Example 8

[0188] The above-mentioned Chinese medicine composition 1 is mixed according to the ratio and then the effective components are extracted to obtain the Chinese medicine extract sample 1*. The effective components are extracted by low temperature grinding method, that is, the raw material components are mixed according to the ratio and 10 times the amount of water is added and soaked at 20°C for 2 hours, and then added to the colloid mill at 40°C and 3000 rpm to grind into particles with a particle size of 0.297-0.425 mm.

[0189] Example 9

[0190] The above-mentioned Chinese medicine composition 1 was mixed according to the ratio and then the effective components were extracted to obtain the Chinese medicine extract sample 2*. The effective components were extracted by an leaching and concentration method, that is, the raw material components were mixed according to the ratio and 10 times the amount of water was added and soaked at room temperature for 2 hours, boiled to a boil for 60 minutes, filtered and concentrated for 6 hours under the conditions of a vacuum degree of 70 kPa and a temperature of 57°C to obtain.

[0191] Example 10

[0192] The above-mentioned Chinese medicine composition 2 was mixed according to the ratio and then the effective components were extracted to obtain the Chinese medicine extract sample 3*. The effective components were extracted by low temperature grinding method, that is, the raw material components were mixed according to the ratio and 9 times the amount of water was added and soaked at 30°C for 2 hours, and then added to the colloid mill at 30°C and 4000 rpm to grind into particles with a particle size of 0.297-0.425 mm.

[0193] Embodiment 11

[0194] The above-mentioned Chinese medicine composition 3 was mixed according to the ratio and then the effective components were extracted to obtain the Chinese medicine extract sample 4*. The effective components were extracted by low temperature grinding method, that is, the raw material components were mixed according to the ratio, 11 times the amount of water was added, and soaked at 20°C for 3 hours, and then added to the colloid mill at 20°C and 3500 rpm to grind into particles with a particle size of 0.297-0.425 mm.

[0195] Example 12

[0196] The above-mentioned Chinese medicine composition 2 was mixed according to the ratio and then the effective components were extracted to obtain the Chinese medicine extract sample 5*. The effective components were extracted by an leaching and concentration method, that is, the raw material components were mixed according to the ratio and 9 times the amount of water was added and soaked at room temperature for 3 hours, boiled to a boil for 70 minutes, filtered and concentrated for 8 hours under the conditions of a vacuum degree of 65kPa and a temperature of 60°C to obtain.

[0197] Embodiment 13

[0198] The above-mentioned Chinese medicine composition 3 was mixed according to the ratio and then the effective components were extracted to obtain the Chinese medicine extract sample 6*. The effective components were extracted by an leaching and concentration method, that is, the raw material components were mixed according to the ratio and 11 times the amount of water was added and soaked at room temperature for 2 hours, boiled to a boil for 80 minutes, filtered and concentrated for 5 hours under the conditions of a vacuum degree of 75kPa and a temperature of 55°C to obtain.

[0199] Embodiment 14

[0200] Take 2 parts by weight of 60% blueberry juice, 2 parts by weight of 60% cherry juice, 2 parts by weight of 60% rose juice, 1 part by weight of tea theanine, 1 part by weight of γ-aminobutyric acid, 0.4 parts by weight of xylo-oligosaccharides, 0.4 parts by weight of lactulose, 0.4 parts by weight of fructo-oligosaccharides, 0.4 parts by weight of erythritol, 0.4 parts by weight of xylulose, 0.5 parts by weight of Lactobacillus plantarum, 0.5 parts by weight of Lactobacillus acidophilus, and 0.5 parts by weight of Lactococcus lactis to obtain the first auxiliary material part 1.

[0201] Take 40 parts by weight of red date concentrated juice, 20 parts by weight of fruit powder and 1 part by weight of calcium citrate to obtain the second auxiliary material part 1.

[0202] Embodiment 15

[0203] Take 0.5 weight part of 60% blueberry juice, 0.5 weight part of 60% cherry juice, 0.5 weight part of 60% rose juice, 0.1 weight part of tea theanine, 0.1 weight part of γ-aminobutyric acid, 0.1 weight part of xylo-oligosaccharide, 0.1 weight part of lactofructo-oligosaccharide, 0.1 weight part of galacto-oligosaccharide, 0.1 weight part of erythritol, 0.1 weight part of xylulose, 0.01 weight part of Lactobacillus plantarum, 0.01 weight part of Lactobacillus acidophilus, and 0.01 weight part of Lactococcus lactis to obtain the first auxiliary material part 2.

[0204] Take 40 parts by weight of red date concentrated juice, 20 parts by weight of fruit powder and 1 part by weight of calcium citrate to obtain the second auxiliary material part 2.

[0205] Example 16

[0206] Take 2 parts by weight of 60% blueberry juice, 2 parts by weight of 60% cherry juice, 2 parts by weight of 60% rose juice, 1 part by weight of tea theanine, 1 part by weight of γ-aminobutyric acid, 0.5 parts by weight of xylo-oligosaccharides, 0.5 parts by weight of lactofructo-oligosaccharides, 0.5 parts by weight of galacto-oligosaccharides, 0.5 parts by weight of erythritol, 0.5 parts by weight of xylulose, 0.5 parts by weight of Lactobacillus plantarum, 0.5 parts by weight of Lactobacillus acidophilus, and 0.5 parts by weight of Lactococcus lactis to obtain the first auxiliary material part 3.

[0207] Take 40 parts by weight of red date concentrated juice, 20 parts by weight of fruit powder and 1 part by weight of calcium citrate to obtain the second auxiliary material part 3.

[0208] Embodiment 17

[0209] Take 0.5 weight part of 60% blueberry juice, 2 weight parts of 60% cherry juice, 0.5 weight part of 60% rose juice, 1 weight part of tea theanine, 0.1 weight part of γ-aminobutyric acid, 0.5 weight part of xylo-oligosaccharide, 0.1 weight part of lactofructo-oligosaccharide, 0.5 weight part of galacto-oligosaccharide, 0.1 weight part of erythritol, 0.5 weight part of xylulose, 0.01 weight part of Lactobacillus plantarum, 0.5 weight part of Lactobacillus acidophilus, and 0.01 weight part of Lactococcus lactis to obtain the first auxiliary material part 4.

[0210] Take 47 parts by weight of red date concentrated juice, 23 parts by weight of fruit powder, and 2 parts by weight of calcium citrate to obtain the second auxiliary material part 4.

[0211] Embodiment 18

[0212] Take 2 weight parts of 60% blueberry juice, 0.5 weight parts of 60% cherry juice, 2 weight parts of 60% rose juice, 0.1 weight parts of tea theanine, 1 weight part of γ-aminobutyric acid, 0.1 weight parts of xylo-oligosaccharides, 0.5 weight parts of lactofructo-oligosaccharides, 0.1 weight parts of galacto-oligosaccharides, 0.5 weight parts of erythritol, 0.1 weight parts of xylulose, 0.5 weight parts of plant lactobacillus, 0.01 weight parts of Lactobacillus acidophilus, and 0.5 weight parts of Lactococcus lactis to obtain the first auxiliary material part 5.

[0213] Take 43 parts by weight of red date concentrated juice, 27 parts by weight of fruit powder, and 4 parts by weight of calcium citrate to obtain the second auxiliary material part 5.

[0214] Embodiment 19

[0215] Take 1 weight part of 60% blueberry juice, 1 weight part of 60% cherry juice, 1 weight part of 60% rose juice, 0.5 weight part of tea theanine, 0.5 weight part of γ-aminobutyric acid, 0.1 weight part of xylo-oligosaccharide, 0.1 weight part of lactofructo-oligosaccharide, 0.1 weight part of galacto-oligosaccharide, 0.1 weight part of erythritol, 0.1 weight part of xylulose, 0.2 weight part of Lactobacillus plantarum, 0.2 weight part of Lactobacillus acidophilus, and 0.2 weight part of Lactococcus lactis to obtain the first auxiliary material part 6.

[0216] Take 42 parts by weight of red date concentrated juice, 28 parts by weight of fruit powder, and 3 parts by weight of calcium citrate to obtain the second auxiliary material part 6.

[0217] Embodiment 20

[0218] Take 1 weight part of 60% blueberry juice, 2 weight parts of 60% cherry juice, 1 weight part of 60% rose juice, 1 weight part of tea theanine, 0.5 weight part of γ-aminobutyric acid, 0.4 weight part of xylo-oligosaccharide, 0.1 weight part of lactofructo-oligosaccharide, 0.4 weight part of galacto-oligosaccharide, 0.1 weight part of erythritol, 0.4 weight part of xylulose, 0.2 weight part of Lactobacillus plantarum, 0.5 weight part of Lactobacillus acidophilus, and 0.2 weight part of Lactococcus lactis to obtain the first auxiliary material part 7.

[0219] Take 50 parts by weight of red date concentrated juice, 30 parts by weight of fruit powder, and 5 parts by weight of calcium citrate to obtain the second auxiliary material part 7.

[0220] Embodiment 21

[0221] Take 2 parts by weight of 60% blueberry juice, 1 part by weight of 60% cherry juice, 2 parts by weight of 60% rose juice, 0.5 parts by weight of tea theanine, 1 part by weight of γ-aminobutyric acid, 0.1 parts by weight of xylo-oligosaccharides, 0.4 parts by weight of lactofructo-oligosaccharides, 0.1 parts by weight of galacto-oligosaccharides, 0.4 parts by weight of erythritol, 0.1 parts by weight of xylulose, 0.5 parts by weight of Lactobacillus plantarum, 0.2 parts by weight of Lactobacillus acidophilus, and 0.5 parts by weight of Lactococcus lactis to obtain the first auxiliary material part 8.

[0222] Take 45 parts by weight of red date concentrated juice, 25 parts by weight of fruit powder, and 3 parts by weight of calcium citrate to obtain the second auxiliary material part 8.

[0223] Embodiment 22

[0224] The first auxiliary material part 1 is mixed to obtain a compound jelly colloid 1. The compound jelly colloid 1 is then mixed with the Chinese medicine extract sample 2* and the second auxiliary material part 1, and then passed through a 50-mesh sieve, added to 45°C hot water and heated for 15 minutes, and stirred to mix evenly and fully swell. Then continue to heat in 85°C hot water for 48 minutes to completely dissolve it, then pass through a 100-mesh filter cloth, cool to 70°C in the mixing tank for insulation, adjust the pH to 4.3, adjust the flavor, fill, sterilize at 85°C for 20 minutes, cool with cold water, air-dry, and seal to obtain the Chinese medicine jelly 1.

[0225] Embodiment 23

[0226] The first auxiliary material part 2 is mixed to obtain a compound jelly colloid 2. The compound jelly colloid 2 is then mixed with the Chinese medicine extract sample 1* and the second auxiliary material part 2, and then passed through a 45-mesh sieve, added to 50°C hot water and heated for 12 minutes, stirred to mix evenly and fully swell. Then continue to heat in 90°C hot water for 45 minutes to completely dissolve it, then pass through a 95-mesh filter cloth, cool to 65°C in the mixing tank for insulation, adjust the pH to 4.1, adjust the flavor, fill, sterilize at 80°C for 25 minutes, cool with cold water, air-dry, and seal to obtain the Chinese medicine jelly 2.

[0227] Embodiment 24

[0228] The first auxiliary material part 3 is mixed to obtain the compound jelly colloid 3. The compound jelly colloid 3 is then mixed with the Chinese medicine extract sample 3* and the second auxiliary material part 3, and then passed through a 55-mesh sieve, added to 40°C hot water and heated for 18 minutes, stirred to mix evenly and fully swell. Then continue to heat in 80°C hot water for 50 minutes to completely dissolve it, then pass through a 105-mesh filter cloth, cool to 75°C in the mixing tank for insulation, adjust the pH to 4.5, adjust the fragrance, fill, sterilize at 90°C for 15 minutes, cool with cold water, air-dry, and seal to obtain the Chinese medicine jelly 3.

[0229] Embodiment 25

[0230] The quality of the Chinese herbal extract sample 2* obtained in Example 9 and the Chinese herbal jelly 1 obtained in Example 22 was evaluated, and the specific results are as follows:

[0231] 1. Quality evaluation indicators

[0232] 1.1 Quality indicators of Chinese herbal medicine extracts

[0233] (1) Sensory requirements: The Chinese medicine juice should be brown-black in color, uniform and translucent; the sour and bitter taste of the Chinese medicine should be pure; and there should be no foreign matter visible to normal vision.

[0234] (2) Physical and chemical index requirements: soluble solid content (20°C) ≥ 30%; pH = 4.3 ± 0.2.

[0235] (3) Microbiological index requirements are shown in Table 1.

[0236] Table 1 Microbial Limits

[0237]

[0238] 1.2 Quality indicators of Chinese herbal jelly

[0239] (1) Sensory requirements: Chinese herbal jelly should be brown-black in color, with a uniform and translucent color; it should taste sweet and sour, with a slightly bitter taste of Chinese herbal medicine and a fruity aroma; and there should be no foreign matter visible to normal vision.

[0240] (2) Physical and chemical index requirements: soluble solid content (20°C) = 22% ± 1%; pH = 4.0 ± 0.2.

[0241] (3) Microbiological index requirements are shown in Table 2.

[0242] Table 2 Microbial Limits

[0243]

[0244]

[0245] 2. Evaluation results

[0246] As shown in Tables 1 and 2, after evaluation, it was found that the quality of Chinese medicine extract sample 2* and Chinese medicine jelly 1 met the requirements. It can be seen that the Chinese medicine extract and Chinese medicine jelly prepared by the present invention selected authentic medicinal materials and adopted advanced extraction technology to ensure that the effective ingredients of the raw materials are fully retained, while removing impurities and improving the purity of the product. After strict safety evaluation, no obvious toxic reactions were found in the Chinese medicine extract sample, which meets national standards and is safe and reliable.

[0247] Embodiment 26

[0248] The Chinese medicine jelly 1 obtained in Example 22 was subjected to a self-test laboratory accelerated shelf life test, i.e., 9 groups of conditions were set at 37°C for 0, 15, 30, 45, 90d, 54°C for 6, 9, 12, 15d, and 90, 180, 270d at room temperature, and the jelly product was observed and recorded for swelling, color, smell, taste, water separation, gel strength, and microbial conditions. It was found that Chinese medicine jelly 1 met the quality requirements. It can be seen that the Chinese medicine jelly prepared by the present invention selected authentic medicinal materials and adopted advanced extraction technology to ensure that the effective ingredients of the raw materials were fully retained, while removing impurities and improving the purity of the product. After strict safety evaluation, no obvious toxic reactions were found in the Chinese medicine extract sample, which met national standards and was safe and reliable.

[0249] Embodiment 27

[0250] In order to verify the effect of the present invention in treating insomnia, the present invention carried out the following clinical experiments.

[0251] 1. Patient selection

[0252] 1.1 Case collection

[0253] A total of 62 patients with insomnia of liver depression and blood deficiency type who were treated in the outpatient department and ward of the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were selected. The observation period was from October 1, 2021 to September 30, 2022. The patients were randomly divided into an observation group and a control group by random number table method, with 30 cases in each group. There were 15 males and 16 females in the observation group, with an average age of (49.51±11.03) years old, and 17 males and 14 females in the control group, with an average age of (50.10±12.75) years old. There was no statistically significant difference between the two groups in age, gender, and Pittsburgh Sleep Quality Index (PSQI) at admission. This study was approved by the Ethics Committee of the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Registration No. 2023-7th-HIRB-049). All selected cases voluntarily accepted observation and treatment and signed informed consent.

[0254] 1.2 Western medicine diagnostic criteria

[0255] The diagnostic criteria of Western medicine refer to the diagnostic criteria for chronic insomnia or short-term insomnia in adults in the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults (2017 Edition)" (Zhang Peng, Li Yanpeng, Wu Huijuan, et al. [J]. Chinese Journal of Neurology, 2018.51(5):324-335). The diagnostic criteria for chronic insomnia: ① one or more abnormal sleep symptoms; ② one or more daytime symptoms related to insomnia; ③ abnormal sleep symptoms and related daytime symptoms cannot be simply explained by the lack of appropriate sleep time or inappropriate sleep environment; ④ abnormal sleep symptoms and related daytime symptoms occur at least 3 times a week; ⑤ abnormal sleep symptoms and related daytime symptoms last for at least 3 months; ⑥ difficulty sleeping and waking up cannot be better explained by other types of sleep disorders. The diagnostic criteria for short-term insomnia: meet the criteria of ①, ②, ③, and ⑥ of chronic insomnia at the same time, but the course of the disease is less than 3 months and / or the frequency of related symptoms does not reach 3 times a week.

[0256] 1.3 TCM diagnostic criteria

[0257] The diagnostic criteria of traditional Chinese medicine refer to the diagnostic criteria of insomnia in the Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes (State Administration of Traditional Chinese Medicine. Traditional Chinese Medicine Industry Standards of the People's Republic of China, ZY / T001.1~001.9-94[S]. Nanjing: Nanjing University Press, 1994:19.): ① In mild cases, it is difficult to fall asleep or wake up easily during sleep and cannot fall asleep after waking up; in severe cases, it is difficult to sleep all night; ② It is often accompanied by headache, dizziness, palpitations, forgetfulness, and dreaminess; ③ No abnormalities were found after various system and laboratory tests.

[0258] 1.4 Inclusion and Exclusion Criteria

[0259] Inclusion criteria: ① Meet the above-mentioned Chinese and Western medicine diagnostic criteria at the same time; ② Age 18 to 80 years old; ③ Pittsburgh Sleep Quality Index (PSQI) score > 5 points; ④ Understand the corresponding trial plan and sign the informed consent.

[0260] Exclusion criteria: ① Patients with insomnia caused by systemic diseases such as pain, fever, cough, surgery, etc., as well as external environmental interference factors; ② Patients with mental illnesses that seriously affect sleep, such as schizophrenia, bipolar disorder, paranoid disorder, schizoaffective disorder, mental disorders caused by epilepsy, and severe mental retardation; ③ Patients who are pregnant, breastfeeding, and those who plan to become pregnant; ④ Patients with other serious circulatory system, hematopoietic system, digestive system, endocrine system and other diseases; ⑤ Patients who have taken other Western medicines for insomnia or sedative effects one month before enrollment; ⑥ Patients who are participating in other clinical studies.

[0261] 1.5 Shedding Standard

[0262] ① Patients lost to follow-up during the study; ② Patients decide to withdraw from the study due to adverse reactions or personal reasons; ③ During the study, the patient's insomnia symptoms continue to worsen, seriously affecting their life and work, and the researcher judges that the clinical study of this case should be stopped; ④ The patient's health condition changes after enrollment, and the researcher believes that he is not suitable for continuing to receive research treatment.

[0263] 1.6 Elimination criteria

[0264] ① Patients who use other insomnia-related treatment methods on their own during the study; ② Patients who have poor compliance with the study protocol, which affects the judgment of efficacy and / or safety; ③ Patients who have completely failed to complete the efficacy and safety indicators required by the study protocol.

[0265] 2. Methods

[0266] 2.1 Conventional Western medicine treatment (control group)

[0267] Instruct the patient to take diazepam (Yantai Rongchang Pharmaceutical Co., Ltd., National Medicine Standard Z37021412) orally before bedtime. 2.5 mg / tablet, 1 tablet / time, 30 minutes before bedtime, for 1 month.

[0268] 2.2 Oral administration of Chinese herbal jelly (observation group)

[0269] The observation group was treated with the Chinese medicine jelly 1 obtained in Example 22 on the basis of conventional western medicine treatment of the control group. The patients were instructed to take 2 bags of Chinese medicine jelly 1 every day, warm at noon and before bedtime. During the medication period, it was necessary to correct bad living habits, maintain appropriate exercise, pay attention to diet, and take medication for 1 course of treatment (after 1 month) to observe the effect.

[0270] 2.3 Efficacy indicators

[0271] The PSQI scale is suitable for sleep quality assessment. The PSQI consists of 18 self-assessment items, which are divided into 7 components. Each dimension is scored on a scale of 0 to 3, and the sum of the scores of each component is the total PSQI score, which ranges from 0 to 18 points. The lower the score, the better the sleep quality, and vice versa. The dimension of hypnotic drugs is not included in this study plan.

[0272] 2.4 Efficacy criteria

[0273] According to the efficacy criteria of "insomnia" in the "Guidelines for Clinical Research of New Chinese Medicines" (Zheng Xiaoyu. [M]. Beijing: China Medical Science and Technology Press, 2002: 186-188), cured: all sleep indicators return to normal, or the nighttime sleep time exceeds 6.5 hours; markedly effective: all sleep indicators are significantly improved, the sleep depth is deepened, and the sleep time increases by 3 hours or more compared with the previous time, but the total sleep time is less than 6.5 hours. Effective: all sleep indicators are improved, and the sleep time does not increase by more than 3 hours; Ineffective: sleep disorders have no significant improvement or even worsen.

[0274] Total effective rate (%) = ((number of cured cases + markedly effective cases + effective cases) / total number of cases] × 100%.

[0275] 2.5 Safety and adverse reactions

[0276] Before enrollment, all patients underwent routine blood tests, four liver function tests (alanine aminotransferase, aspartate aminotransferase, glutamyl transferase, serum alkaline phosphatase), renal function tests (creatinine, urea nitrogen, uric acid, glucose), electrocardiogram, and routine urine tests to rule out heart, liver, and kidney function damage and circulatory blood system diseases. During the treatment, the patients were observed for allergic reactions such as skin rash, chest tightness and shortness of breath caused by taking Chinese medicine granules. When leaving the group, all patients underwent routine blood tests, four liver function tests, four renal function tests, electrocardiogram, and routine urine tests to determine whether the intervention method caused heart, liver, and kidney function damage and circulatory blood system diseases to the patients, so as to ensure the safety of the study.

[0277] 2.6 Statistical methods

[0278] SPSS 26.0 software was used for data analysis. Chi-square test was used for count data; non-parametric test was used for rank data; measurement data did not conform to normal distribution, so median (interquartile range) was used for description and non-parametric test was used for comparison. P < 0.05 indicated statistical significance.

[0279] 3 Results

[0280] 3.1 General Information

[0281] One case dropped out of the observation group, and 30 cases were actually observed, including 14 males and 16 females, with an average age of (49.51±11.03) years. One case dropped out of the control group due to personal reasons (automatically withdrawn), and 30 cases were actually observed, including 17 males and 14 females, with an average age of (50.10±12.75) years. There was no statistically significant difference in the general data of the two groups before treatment.

[0282] 3.2 Post-treatment results (comparison of PSQI items and total score)

[0283] There was no significant difference in the PSQI items and total scores between the two groups before treatment (P>0.05). After treatment, the sleep quality, sleep time and total score of the observation group were reduced compared with those before treatment (P<0.05); after treatment, the sleep time, sleep efficiency score and total score of the control group were reduced compared with those before treatment (P<0.05). After treatment, the sleep quality and total score of the observation group were reduced compared with those of the control group (P<0.05). The results are shown in Table 3.

[0284] Table 3 Comparison of PSQI between the two groups of patients before and after treatment (x±s, points)

[0285]

[0286] Note: Intra-group comparison before and after treatment, *P<0.05; Inter-group comparison after treatment, #P<0.05.

[0287] The PSQI total score was compared with that before treatment in the same group, *P<0.05; compared with that in the control group after treatment, △P<0.05, which was statistically significant.

[0288] 3.3 Comparison of efficacy

[0289] After 4 weeks of treatment, 21 cases in the observation group showed marked effect, 7 cases were effective, 2 cases were ineffective, and the total effective rate was 90%; 29 cases in the control group showed marked effect, 2 cases were effective, 1 case was ineffective, and the total effective rate was 96.67%. The Mann-Whitney U rank sum test showed that the difference was statistically significant (P<0.05), as shown in Table 4.

[0290] Table 4 Comparison of treatment effects between the two groups of patients (cases, %)

[0291]

[0292] 3.4 Comparison of ALT and creatinine before and after

[0293] The results of the safety check at the end of the study showed that this study did not cause adverse events such as heart, liver, and kidney function damage to patients and related adverse reactions.

[0294] 4 Conclusion

[0295] Chinese herbal jelly is indeed effective in treating primary insomnia without causing liver or kidney damage. It can effectively improve patients' sleep quality and sleep time. This may be related to the regulatory effect of Chinese herbal jelly on nerves and is worthy of clinical promotion.

[0296] Embodiment 28

[0297] The effect of the Chinese medicine jelly 1 obtained in Example 22 was tested and followed up, where 85% of the subjects reported that their insomnia symptoms were significantly improved, 10% reported that there was no significant effect, and 5% reported that the product still had a strong Chinese medicine flavor that interfered with the taste. In the follow-up, 60% of the subjects reported that they were willing to purchase the product after it was officially put into production, proving that this process improvement can greatly expand the market breadth.

[0298] Example 29 Animal Experiment

[0299] 1. Animals

[0300] Thirty-five healthy male Wistar rats, weighing 220-240 g.

[0301] 2. Methods

[0302] 2.1 Modeling

[0303] The animals were randomly divided into 7 groups, namely normal group, model group, experimental group, control group 1, control group 2, control group 3, and control group 4, with 5 animals in each group. Before the experiment, the animals were housed in cages and adapted to the environment for 7 days, during which they had normal food and water, and were given 12h light / 12h dark (8 am-8 pm).

[0304] Except for the normal group, rats in other groups were modeled according to the water environment intermittent sleep deprivation method: a 50cm*40cm*20cm box with a built-in platform with a diameter of 6.5cm, surrounded by a water environment with a water depth of 3cm and a platform 1cm above the water. A rat was placed on the platform of each box. The rat could eat normally, turn around, raise its head, and do other activities on the platform. However, if it entered rapid eye movement sleep, it would fall into the water below and wake up due to the decrease in systemic muscle tension, muscle relaxation, and rhythmic drooping of the head. Because the rat was afraid of water, it would climb back onto the platform and continue to stand awake in the original posture. Each sleep deprivation lasted for 24h, once every other day, and repeated sleep deprivation for 7 times. Normal cleaning was performed during the period. The only difference between the normal group and the normal group was that the rats were placed on a large platform with a diameter of 15cm. The rats would not fall into the water when sleeping on the large platform, and could maintain a complete sleep cycle.

[0305] 2.2 Method of administration

[0306] The model group and the normal group ate and drank normally.

[0307] The experimental group was given the powder of the Chinese medicine jelly 1 prepared by the method described in Example 22. The raw material composition of the experimental group is shown in Examples 1 and 14.

[0308] The difference between the control group and the experimental group is only the different weight ratio of raw materials: 5 parts of spinach seed, 0.5 parts of chuanxiong, 1.5 parts of lily, 2.5 parts of julibrissin, 4 parts of wolfberry, 3.5 parts of yam, 0.5 parts of reed root, 1 part of poria, 1.5 parts of licorice, 2.5 parts of 60% blueberry juice, 2.5 parts of 60% cherry juice, 2.5 parts of 60% rose juice, 1.5 parts of tea theanine, 1.5 parts of γ-aminobutyric acid, 0.1 parts of xylo-oligosaccharide, 1.5 parts of lactofructo-oligosaccharide, 1.5 parts of galacto-oligosaccharide, 1.5 parts of erythritol, 1.5 parts of xylulose, 1 part of Lactobacillus plantarum, 1 part of Lactobacillus acidophilus, 1 part of Lactococcus lactis, 20 parts of red date concentrated juice, 45 parts of fruit powder, and 7 parts of calcium citrate.

[0309] The difference between the control group 2 and the experimental group was only the raw material composition: 10 parts of Chinese jujube seeds, 3 parts of wolfberries, 2 parts of Poria cocos, 3 parts of reed roots, 2.5 parts of malt, and 1 part of licorice.

[0310] The only difference between the three control groups and the experimental groups was the raw material composition: 5 parts of Ziziphus jujuba seeds, 3.5 parts of Chuanxiong, 0.5 parts of Anemarrhena asphodeloides, 1 part of Poria cocos, 2.5 parts of Licorice, 2 parts of 60% blueberry juice, 2 parts of 60% cherry juice, 2 parts of 60% rose juice, 1 part of tea theanine, 1 part of γ-aminobutyric acid, 0.4 parts of xylo-oligosaccharides, 0.4 parts of lactofructo-oligosaccharides, 0.4 parts of galacto-oligosaccharides, 0.4 parts of erythritol, 0.4 parts of xylulose, 0.5 parts of Lactobacillus plantarum, 0.5 parts of Lactobacillus acidophilus, and 0.5 parts of Lactococcus lactis.

[0311] The only difference between the four control groups and the experimental groups was the raw material composition: 5 parts of Ziziphus jujuba seeds, 0.5 parts of Anemarrhena asphodeloides, 0.5 parts of Chrysanthemum morifolium, 1 part of Poria cocos, 2.5 parts of Licorice, 2 parts of 60% blueberry juice, 2 parts of 60% cherry juice, 2 parts of 60% rose juice, 1 part of tea theanine, 1 part of γ-aminobutyric acid, 0.4 parts of xylo-oligosaccharides, 0.4 parts of lactofructo-oligosaccharides, 0.4 parts of galacto-oligosaccharides, 0.4 parts of erythritol, 0.4 parts of xylulose, 0.5 parts of Lactobacillus plantarum, 0.5 parts of Lactobacillus acidophilus, and 0.5 parts of Lactococcus lactis.

[0312] 2.3 Observation indicators

[0313] After the rats were adapted to the box for 5 minutes, the number of spontaneous activities of the rats was recorded within 10 minutes using the open field method.

[0314] 2.4 Results

[0315] The results of the activity times of the rats in each group in the open field test were as follows:

[0316] Normal group / times: 323, 324, 324, 325, 325;

[0317] Model group / times: 418, 420, 421, 422, 423;

[0318] Experimental groups / times: 323, 324, 323, 323, 324;

[0319] Control group / time: 340, 341, 341, 340, 342;

[0320] Control group II / times: 348, 349, 349, 349, 351;

[0321] Control three groups / times: 346, 346, 347, 347, 348;

[0322] Four control groups / times: 343, 345, 346, 347, 347.

[0323] The statistical results are shown in Table 5.

[0324] Table 5 Comparison of the results of the mine field experiment in rats of each group (x±s)

[0325] Group Number of cases Number of rat activities / times Normal group 5 324.2±0.75 Model Group 5 420.8±1.33 Experimental Group 5 323.4±0.49 A control group 5 340.8±0.75 Control group 2 5 349.2±1.48 Control group 5 346.8±0.75 Control group 5 345.6±1.50

[0326] 3. Conclusion

[0327] From the above results, it can be seen that the number of activities of the model group rats increased significantly compared with the normal group (P < 0.01), indicating that the model was successfully established. The number of activities of the experimental group rats was significantly reduced compared with the number of activities of the control group one to four groups of rats (P < 0.01), and the number of activities of the experimental group rats was slightly lower than that of the normal group (P > 0.05), indicating that there is a synergistic effect between the components of the experimental group, and the components of the experimental group have unexpected technical effects compared with the therapeutic effects of the components of the other groups. It represents that the synergistic effect of the components of the present invention can be used to treat insomnia.

[0328] The above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any technician familiar with this profession, without departing from the spirit and scope of the present invention, can make some changes, modifications and evolutions of the technical content disclosed above, which are equivalent embodiments of the present invention; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition, comprising the following raw material components by weight: 6-11 parts by weight of spiny jujube seeds; 1-5 parts by weight of Ligusticum chuanxiong; 1.8-6 parts by weight of lily; 0.5-5 parts by weight of Flos Albizia Julibrissin; 0.5-5 parts by weight of wolfberry; 0.5-5 parts by weight of Chinese yam; Phragmites australis 0-4 parts by weight; Poria 0.5-5 parts by weight; Licorice 0.1-3 parts by weight.

2. A Chinese medicine extract obtained by extracting the Chinese medicine composition according to claim 1 as raw material.

3. The Chinese medicine extract according to claim 2, characterized in that The method of extracting the raw material is selected from at least one of a cryogenic grinding method or an extraction and concentration method; Preferably, the cryogenic grinding method comprises: mixing the raw material components, soaking them in water at low temperature, and then performing cryogenic grinding to provide the Chinese herbal medicine extract; And / or, the extraction and concentration method comprises: mixing the raw material components, soaking in water, boiling, filtering and concentrating to provide the traditional Chinese medicine extract.

4. The Chinese herbal medicine extract according to claim 3, characterized in that: Includes any one or more of the following conditions: A1) In the cryogenic grinding method, the ratio of the mass of the raw material components added to the volume of water added is 1:8-12, g / mL; A2) In the cryogenic grinding method, the low-temperature immersion temperature is 20-50°C; A3) In the cryogenic grinding method, the low-temperature soaking time is 2-3 hours; A4) in the cryogenic grinding method, wherein the cryogenic grinding is performed in a colloid mill; A5) In the cryogenic grinding method, the cryogenic grinding temperature is not higher than 50°C; A6) In the cryogenic grinding method, the rotation speed of the cryogenic grinding is 1000-10000 rpm; A7) In the cryogenic grinding method, the cryogenic grinding forms particles, and the particle size of the particles is 0.25-0.45 mm; A8) In the extraction and concentration method, the ratio of the mass of the raw material component added to the volume of the water added is 1:8-12, g / mL; A9) In the extraction and concentration method, the immersion is carried out at room temperature; A10) In the extraction and concentration method, the soaking time is 2-3 hours; A11) In the extraction and concentration method, the boiling is performed; A12) In the extraction and concentration method, the boiling time is 50-90 min; A13) In the extraction and concentration method, the concentration is vacuum concentration, the vacuum degree of the vacuum concentration is 60-80 kPa; the temperature of the vacuum concentration is 50-65° C.; and the time of the vacuum concentration is 4-9 h.

5. A Chinese medicine preparation comprising a therapeutically effective amount of the Chinese medicine composition according to claim 1, or a therapeutically effective amount of the Chinese medicine extract according to any one of claims 2-4, and one or more conventional pharmaceutically acceptable excipients.

6. A Chinese medicine jelly, comprising the Chinese medicine composition according to claim 1 and auxiliary materials, wherein the auxiliary materials include a first auxiliary material part and a second auxiliary material part by weight, The first auxiliary material part includes the following components: 0.5-3 parts by weight of blueberry juice; Cherry juice 0.5-3 parts by weight; 0.5-3 parts by weight of rose juice; 0.1-2 parts by weight of tea theanine; 0.1-2 parts by weight of γ-aminobutyric acid; 0.1-0.8 parts by weight of xylo-oligosaccharide; Lactofructooligosaccharide 0.1-0.8 parts by weight; Galacto-oligosaccharide 0.1-0.8 parts by weight; 0.1-0.8 parts by weight of erythritol; 0.1-0.8 parts by weight of xylulose; Lactobacillus plantarum 0.01-0.8 parts by weight; Lactobacillus acidophilus 0.01-0.8 weight portion; Lactococcus lactis 0.01-0.8 parts by weight; The second auxiliary material part comprises the following components: 30-60 parts by weight of red date concentrated juice; 10-40 parts by weight of fruit powder; Calcium citrate 0.5-6 parts by weight.

7. A method for preparing Chinese medicinal jelly, comprising the following steps: 1) mixing the components of the first auxiliary material part according to claim 6 to obtain a composite jelly colloid; 2) The composite jelly colloid obtained in step 1) is mixed with the raw material components of the Chinese medicine composition according to claim 1 and the components of the second auxiliary material part according to claim 6, filtered, heated, stirred and mixed, and then continued to heat to completely dissolve it and then filtered for a second time to provide the Chinese medicine jelly.

8. The method for preparing the Chinese medicinal jelly according to claim 7, characterized in that: Includes any one or more of the following conditions: B1) the filtration is screen filtration; B2) the heating is adding into hot water for heating; B3) the heating temperature is 35-55°C; B4) the heating time is 10-20 minutes; B5) the continued heating temperature is 75-95°C; B6) the continued heating time is 40-55 minutes; B7) The second filtration is performed by filtering with filter cloth; B8) The Chinese medicinal jelly is also subjected to cooling and heat preservation, pH adjustment, flavoring, filling, sterilization, cold water cooling, air shower drying and sealing.

9. The method for preparing the Chinese medicinal jelly according to claim 8, characterized in that: Includes any one or more of the following conditions: B11) The mesh size of the sieve is 40-60 mesh; B71) The filter cloth has a mesh size of 90-110 meshes; B81) During the cooling and heat preservation, the temperature is lowered to 65-75° C. and kept warm; B82) adjusting the pH to 4.3±0.2; B83) The sterilization temperature is 80-90°C; B84) The sterilization time is 15-25 minutes.

10. Use of the Chinese medicine composition according to claim 1, the Chinese medicine extract according to any one of claims 2-4, the Chinese medicine preparation according to claim 5, or the Chinese medicine jelly according to claim 6 in the preparation of a medicine for treating insomnia.

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