Traditional Chinese medicine composition for treating senile habitual constipation and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating senile habitual constipation. The invention further provides a traditional Chinese medicine extract and a preparation method thereof. The invention further provides a traditional Chinese medicine preparation. The invention further provides application of the traditional Chinese medicine composition, the traditional Chinese medicine extract or the traditional Chinese medicine preparation in preparation of a medicine for treating senile habitual constipation. According to the traditional Chinese medicine composition for treating senile habitual constipation and the preparation method of the traditional Chinese medicine composition, the defecation condition of a patient can be remarkably optimized, relieving of depressive mood of the patient can be promoted, and the living quality of the patient is improved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating habitual constipation in the elderly and a preparation method thereof. Background Art

[0002] Difficulty in defecation is a symptom that many patients will experience. With the improvement of economic level, there are more and more high-oil and high-fat foods on the table; the bad habits of staying up late and prolonging defecation time have gradually formed, making constipation a common disease. In my country, the number of people with constipation has been increasing year by year. At present, there is little in-depth research data on constipation in China. Some patients do not follow the will and take over-the-counter drugs orally on their own. In clinical practice, the treatment of constipation is still a major problem. We often use Western medicine laxatives for treatment, and some patients with poor long-term treatment effects use surgical treatment, but some patients find it difficult to accept. Traditional Chinese medicine has a long history in the treatment of constipation. Chinese medicine attaches importance to the holistic concept and pays more and more attention to syndrome differentiation and treatment in the treatment of constipation. The current severity of constipation is not optimistic. How to effectively prevent, control and treat constipation has become an urgent problem to be solved.

[0003] The term constipation has been recorded and discussed in many ancient Chinese medical books. The symptoms of constipation were first seen in Huangdi Neijing, which called constipation "unfavorable bowel movements" and "difficult bowel movements". Zhang Zhongjing's Treatise on Febrile and Miscellaneous Diseases mentioned "spleen restriction" as constipation. At the same time, Zhang Zhongjing also proposed that "deficiency, excess, cold, and heat" are the four mechanisms of constipation. According to different mechanisms, Zhang Zhongjing summarized and differentiated the treatments and proposed Ma Zi Ren Wan, Hou Pu San Wu Tang, Da Huang Fu Zi Tang, Cheng Qi Tang and honey decoction treatment methods. Jingyue Complete Works·Constipation Chapter divides constipation into Yang knot and Yin knot. The name "constipation" was first seen in Xizhuo of the Origin and Flow of Miscellaneous Diseases written by Shen Jing'ao in the Qing Dynasty and has been used to this day.

[0004] Constipation is caused by abnormal conduction function of the large intestine. However, in addition to the lesions of the large intestine itself, the energy supply of other organs, such as the lungs, liver, spleen, and kidneys, will affect the conduction function of the large intestine, leading to constipation, so it is closely related to the spleen, stomach, lungs, liver, and kidneys. Constipation is mentioned many times in Chinese medicine classics, and how constipation is caused is discussed. "Su Ling Wei Yun·Ye Ge Jie" says: "The power of food digestion is in the spleen; the function of excrement and urine discharge is in the liver." "Chu Bing Yuan Hou Lun·Da Shi Yan Bai Kan" believes that "difficult defecation is caused by the imbalance of the five internal organs, the imbalance of yin and yang, and the disharmony of the three burners, so the cold and heat are combined." "Su Wen·Ju Tong Lun" mentions: "Hot gas flows into the small intestine, the intestine hurts, the heat and thirst are exhausted, and the hard and dry cannot come out, so it hurts and is blocked." Constipation may be caused by the invasion of heat evil. The Suwen Jinkui Zhenlun says: "The north is black, it enters the kidney, opens the orifices of the two yin organs, and stores the essence in the kidney." "The kidney controls the five fluids, so if the kidney is full, the body fluids are sufficient and the stool is moist, and if the kidney is deficient, the body fluids are exhausted and the stool is dry and hard." Therefore, if the patient is affected by external evil invasion, old age, unhealthy diet, emotional damage, or weakness after illness, the qi mechanism is disordered, the viscera are not adjusted, the yin and yang are unbalanced, and the qi and blood are deficient, which can easily lead to dry and hard stools or poor circulation. The pathogenesis, location, and pathological nature of constipation are all explained.

[0005] Traditional Chinese medicine has many treatment methods and good curative effects for constipation, including oral administration of Chinese medicine, acupuncture, moxibustion, Chinese medicine application therapy, ear acupuncture and other therapies, but the above therapies are not convenient enough. For example, decoctions are pungent and bitter, and the decoction method is time-consuming and laborious, and it is not convenient to take. Most external treatments are invasive operations that require high technical skills of the implementers, and the patient's compliance is reduced. Most elderly people and children have a certain psychological aversion to drinking and eating Chinese medicine products because of the unique bitter taste and astringent smell of Chinese medicine. Therefore, this type of Chinese medicine treatment products have not been widely popularized and promoted. Summary of the invention

[0006] In view of the shortcomings of the prior art mentioned above, the purpose of the present invention is to provide a Chinese medicine composition for treating habitual constipation in the elderly and a preparation method thereof, and to develop a Chinese medicine composition of both medicine and food for treating the symptoms of habitual constipation in the elderly caused by dryness and heat in the stomach and intestines and insufficient spleen fluid, which can significantly improve the patient's clinical symptoms, significantly optimize the patient's bowel movements, and promote the relief of the patient's depression and improve the patient's quality of life.

[0007] To achieve the above-mentioned object and other related objects, the first aspect of the present invention provides a Chinese medicine composition for treating habitual constipation in the elderly, comprising the following raw material components by weight:

[0008] 5-15 portions of hemp seeds;

[0009] 1-5 servings of almonds;

[0010] 1-5 parts of Citrus aurantium;

[0011] 1-5 parts of Cassia seed;

[0012] 1-5 servings of Chinese yam;

[0013] Poria 0.5-5 parts;

[0014] Imperata root 0.5-5 parts;

[0015] Phragmites australis 0.5-5 parts;

[0016] 0.1-2 parts of honey.

[0017] 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.

[0018] The third aspect of the present invention provides a method for preparing the above-mentioned Chinese medicine extract, comprising: mixing the various raw material components of the Chinese medicine composition described in the first aspect of the present invention according to a ratio, and extracting the obtained mixture using at least one method selected from water decoction, low-temperature grinding or leaching concentration.

[0019] The fourth 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 fifth 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, or the Chinese medicine preparation provided by the fourth aspect of the present invention in the preparation of a medicament for treating habitual constipation in the elderly.

[0021] As described above, the Chinese medicine composition for treating habitual constipation in the elderly and the preparation method thereof provided by the present invention have the following beneficial effects:

[0022] (1) The present invention provides a Chinese medicine composition for treating habitual constipation in the elderly and a preparation method thereof, which can treat constipation caused by dryness and heat in the stomach and intestines and insufficient spleen fluid; it is commonly used for constipation caused by insufficient fluid in the intestines due to febrile diseases, as well as habitual constipation, chronic pharyngitis, recurrent oral ulcers, diabetes, dry skin syndrome, anal fissures, chronic periodontitis and other syndromes due to insufficient yin fluid.

[0023] (2) The present invention provides a Chinese medicine composition for treating habitual constipation in the elderly and a preparation method thereof, which uses natural fruit juice for seasoning to improve the taste of the original medicinal materials; and does not add additional sugar substances such as sucrose that cause blood sugar to rise, but uses low GI materials such as erythritol and isomaltulose to adjust the taste.

[0024] (3) The present invention provides a Chinese medicine composition for treating habitual constipation in the elderly and a preparation method thereof, which, on the one hand, nourishes yin and increases fluid to moisten the intestines and relieve constipation, promotes bowel movement, and promotes the flow of body fluids; on the other hand, it is sweet and moist to slow down the downward force. It has the characteristics of not hurting the body, moistening but not greasy, and combining the attack and moistening, so as to achieve the functions of moistening the intestines, relieving constipation, and relieving downward force, so as to remove dryness and heat, restore yin fluid, and regulate bowel movements.

[0025] (4) The present invention provides a Chinese medicine composition for treating habitual constipation in the elderly and a preparation method thereof, and develops a functional health drink with a suitable taste and the effect of moisturizing the intestines and relieving constipation. It can improve the symptoms of constipation patients' difficulty in defecation, shorten the interval between defecation, improve the nature of stool and the degree of abdominal distension, reduce physical and mental discomfort, is simple and easy to eat, and can better meet the health needs of modern people.

[0026] (5) The present invention provides a Chinese medicine composition for treating habitual constipation in the elderly and a preparation method thereof. The traditional Chinese medicine boiling process is changed, and the Chinese medicine prescription with food-grade high extraction method is used to squeeze out the soup. After a small batch test, it is confirmed that the output rate of the effective ingredients of the Chinese medicine is greatly increased. After a comparative test, the boiling process is used to achieve the expected output. 18 kg of test raw materials are consumed. After the research team's advanced food process improvement, the raw materials consumed for the expected output are reduced to 6 kg. This breakthrough change reduces the use of 2 / 3 of the raw materials and achieves the expected output and efficacy goals. DETAILED DESCRIPTION

[0027] 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.

[0028] 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.

[0029] Unless otherwise stated, the experimental methods, detection methods, and preparation methods disclosed in the present invention all adopt conventional techniques in the technical field.

[0030] The first aspect of the present invention provides a Chinese medicine composition for treating habitual constipation in the elderly, comprising the following raw material components by weight:

[0031] 5-15 parts of hemp seeds; specifically, 5-8 parts, 8-12 parts, 12-15 parts;

[0032] 1-5 portions of almonds; specifically, 1-2 portions, 2-4 portions, 4-5 portions;

[0033] Fructus Aurantii Immaturus 1-5 parts; specifically, 1-2 parts, 2-4 parts, 4-5 parts;

[0034] 1-5 parts of Cassia seed; specifically, 1-2 parts, 2-4 parts, 4-5 parts;

[0035] 1-5 portions of Chinese yam; specifically, 1-2 portions, 2-4 portions, 4-5 portions;

[0036] Poria 0.5-5 parts; specifically, 0.5-1 parts, 1-3 parts, 3-5 parts;

[0037] 0.5-5 parts of Imperata root; specifically 0.5-1 parts, 1-3 parts, 3-5 parts;

[0038] Phragmites australis 0.5-5 parts; specifically, 0.5-1 parts, 1-3 parts, 3-5 parts;

[0039] 0.1-2 parts of honey; specifically, 0.1-0.5 parts, 0.5-1.5 parts, 1.5-2 parts.

[0040] In the present invention, the hemp seed is the dried mature fruit of the hemp plant of the Moraceae family, and has the effect of moistening the intestines and relieving constipation.

[0041] In the present invention, the almond is the kernel of the deciduous tree apricot or wild apricot of the Rosaceae family, and has the effects of descending qi and removing phlegm, relieving cough, relieving asthma, moistening the intestines and facilitating bowel movements, treating scabies and reducing swelling.

[0042] In the present invention, the fructus trifoliatae is the fleshy and swollen fruit axis, leaves and stems and branches, which has the effects of quenching thirst, relieving restlessness, stopping vomiting, and promoting urination and defecation.

[0043] In the present invention, the cassia seed is the dried mature seed of the leguminous plant cassia or cassia small, which has the effects of clearing away heat, improving eyesight, moistening the intestines and relieving constipation.

[0044] In the present invention, the yam is the dried rhizome of the Dioscorea plant, which has the effects of invigorating qi and nourishing yin, tonifying spleen, lung and kidney, and astringing semen and stopping leukorrhea.

[0045] In the present invention, the Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos, which has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind.

[0046] In the present invention, the Imperata root is the dried rhizome of the Gramineae plant Imperata, which has the effects of cooling blood and stopping bleeding, clearing away heat and promoting body fluid, and promoting diuresis and relieving stranguria.

[0047] In the present invention, the reed root is the fresh or dried rhizome of the grass plant reed, which has the effects of clearing away heat and purging fire, promoting body fluid and quenching thirst, relieving restlessness, stopping vomiting and promoting diuresis.

[0048] In the present invention, the honey is the nectar secreted by bees through the nectar glands of flowers, and has the effects of regulating the spleen and stomach, relieving constipation, and resisting bacteria and inflammation.

[0049] 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 meet relevant regulations such as the Chinese Pharmacopoeia, and are all included in the catalog of medicinal and edible products stipulated by the former Ministry of Health.

[0050] The Chinese medicine composition for treating habitual constipation in the elderly fully follows the principle of syndrome differentiation and treatment in traditional Chinese medicine, wherein hemp seed is sweet and mild in nature, moist and fatty in texture, and has the function of moistening the intestine and relieving constipation, and is the main medicine; apricot kernel can clear the lung qi and moisten the large intestine, cassia seed can clear away heat, moisten the intestine and relieve constipation, and is the ministerial medicine; bitter orange seed is sweet in taste, mild in nature, can quench thirst and relieve restlessness, and can facilitate urination and defecation, white imperata root and reed root can clear away heat and promote body fluid, and remove dryness and heat in the stomach and intestine, and are the adjuvant medicine; yam and poria can strengthen the spleen, tonify the spleen and nourish the stomach, and honey is sweet and slow, and helps hemp seed to moisten the intestine and relieve constipation, and is the guiding medicine. The nine medicines are used together and are compatible with each other to exert their synergistic therapeutic effects.

[0051] In a preferred embodiment of the present invention, the Chinese medicine composition for treating habitual constipation in the elderly comprises the following raw material components by weight:

[0052] 8-12 parts of hemp seeds; preferably 10 parts;

[0053] 2-4 portions of almonds; preferably 3 portions;

[0054] 2-4 parts of Citrus aurantium; preferably 3 parts;

[0055] 2-4 parts of Cassia seed, preferably 3 parts;

[0056] 2-4 portions of Chinese yam, preferably 3 portions;

[0057] 1-3 parts of Poria cocos, preferably 2 parts;

[0058] 1-3 parts of Imperata cylindrica root, preferably 2 parts;

[0059] 1-3 parts of Phragmites australis, preferably 2 parts;

[0060] 0.5-1.5 parts of honey; preferably 1 part.

[0061] 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.

[0062] The third aspect of the present invention provides a method for preparing the above-mentioned Chinese medicine extract, comprising: mixing the various raw material components of the Chinese medicine composition described in the first aspect of the present invention according to a ratio, and extracting the obtained mixture using at least one method selected from water decoction, low-temperature grinding or leaching concentration.

[0063] In a preferred embodiment of the present invention, the mixture is extracted by an extraction and concentration method.

[0064] 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 water decoction method, low-temperature grinding method, leaching concentration method, etc.

[0065] In a preferred embodiment of the present invention, the water decoction method comprises: decocting the mixture with water, evaporating the mixture, and filtering the mixture to provide the Chinese herbal medicine extract.

[0066] In a further preferred embodiment of the present invention, the ratio of the mass (g) of the mixture added to the volume (mL) of the water added is 1:2-4, specifically 1:2-3, 1:3-4, preferably 1:3. That is, the water is 2-4 times the amount of the mixture, specifically 2-3 times, 3-4 times, preferably 3 times.

[0067] In a further preferred embodiment of the present invention, the decocting time is 30-60 min, such as 30-45 min, 45-60 min.

[0068] In a further preferred embodiment of the present invention, the evaporation concentrates the volume of water to 0.5-1.5 times the volume of the mixture, such as 0.5-1 times, 1-1.5 times, and preferably 1 times.

[0069] In a further preferred embodiment of the present invention, the filtration is a conventional filtration method, such as filter screen filtration, filter cloth filtration, etc., which is mainly used to remove impurities and requires no drug residue residue.

[0070] In a preferred embodiment of the present invention, the cryogenic grinding method comprises: adding water to the mixture and soaking it at low temperature, and then performing cryogenic grinding to provide the Chinese herbal medicine extract.

[0071] In a further preferred embodiment of the present invention, the ratio of the mass (g) of the mixture added to the volume (mL) of the water added is 1:3.5-4.5, specifically 1:3.5-4.1, 1:4.1-4.5. That is, the water is 3.5-4.5 times the amount of the mixture, specifically 3.5-4.1 times, 4.1-4.5 times.

[0072] In a further preferred embodiment of the present invention, the temperature of the low-temperature soaking is 20-50°C, such as 20-35°C, 35-50°C.

[0073] In a further preferred embodiment of the present invention, the low-temperature soaking time is 30-60 min, specifically 30-45 min, 45-60 min.

[0074] In a further preferred embodiment of the present invention, the cryogenic grinding is performed in a colloid mill.

[0075] In a further preferred embodiment of the present invention, the temperature of the cryogenic grinding is 20-50°C, such as 20-35°C, 35-50°C.

[0076] In a further preferred embodiment of the present invention, the rotation speed of the cryogenic grinding is 800-1200 rpm, such as 800-1000 rpm, 1000-1200 rpm, preferably 1000 rpm.

[0077] In a further preferred embodiment of the present invention, the cryogenic grinding is performed into particles, and the particle size of the particles is not less than 60 mesh.

[0078] The particles are crushed into ultrafine powder with fine and uniform particle size.

[0079] In a preferred embodiment of the present invention, the extraction and concentration method comprises: soaking the mixture in water, boiling, filtering, and concentrating to provide the traditional Chinese medicine extract.

[0080] In a further preferred embodiment of the present invention, the ratio of the mass (g) of the mixture added to the volume (mL) of the water added is 1:7-13, specifically 1:7-11, 1:11-13. That is, the water is 7-13 times the amount of the mixture, specifically 7-11 times, 11-13 times.

[0081] In a further preferred embodiment of the present invention, the soaking is performed at room temperature, which is 20-30°C.

[0082] In a further preferred embodiment of the present invention, the soaking time is 30-60 min, specifically 30-45 min, 45-60 min.

[0083] In a further preferred embodiment of the present invention, the cooking is performed until boiling.

[0084] In a further preferred embodiment of the present invention, the boiling time is 40-90 min, specifically 40-70 min, 70-90 min.

[0085] In a further preferred embodiment of the present invention, the filtration is a conventional filtration method, specifically using a filter machine for filtration.

[0086] In a further preferred embodiment of the present invention, the concentration is vacuum concentration, and the vacuum degree of the vacuum concentration is 60-85kPa, such as 60-66kPa, 66-78kPa, 78-85kPa; the temperature of the vacuum concentration is 50-70°C, such as 50-56°C, 56-63°C, 63-70°C; the time of the vacuum concentration is 4-11h, such as 4-5h, 5-9h, 9-11h.

[0087] In a further preferred embodiment of the present invention, the soluble solid content (20° C.) of the traditional Chinese medicine extract is ≤30%.

[0088] In a further preferred embodiment of the present invention, the pH value of the Chinese herbal medicine extract is 4.3±0.2.

[0089] The concentration endpoint is evaluated by taking the soluble solid content and pH as indicators to obtain the concentration endpoint of the Chinese herbal medicine extract as the Chinese herbal medicine concentrated juice.

[0090] After the effective ingredients in the traditional Chinese medicine composition are extracted by the above preparation method, conventional pharmaceutical excipients and additives can be used to prepare the above pharmaceutical composition.

[0091] The fourth 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.

[0092] Pharmaceutically acceptable adjuvants include, but are not limited to, pharmaceutically acceptable carriers, diluents, fillers, binders, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives and other excipients. 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 required.

[0093] In a preferred embodiment of the present invention, the dosage form of the Chinese medicine preparation includes but is not limited to tablets, capsules, pills, syrups, granules, powders, pastes, pellets, suspensions or emulsions.

[0094] The above-mentioned various dosage forms of Chinese medicine preparations can be prepared by conventional methods. The Chinese medicine preparations of the present invention can also be used together with other therapeutic agents.

[0095] The therapeutically effective amount in the present invention is calculated based on the total weight of the raw medicinal materials. The specific dosage should also take into account factors such as the route of administration and the patient's health status, which are all within the skills of skilled physicians.

[0096] The fifth 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, or the Chinese medicine preparation provided by the fourth aspect of the present invention in the preparation of a medicament for treating habitual constipation in the elderly.

[0097] 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.

[0098] 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.

[0099] The production processes, experimental methods or detection methods involved in the embodiments and comparative examples of the present invention are all conventional methods in the prior art unless otherwise specified, and their names and / or abbreviations are all conventional names in the field and are very clear and unambiguous in the relevant application fields. Those skilled in the art can understand the conventional process steps based on the names and apply the corresponding equipment to implement them according to conventional conditions or the conditions recommended by the manufacturer.

[0100] The various instruments, equipment, raw materials or reagents used in the embodiments of the present invention are not particularly limited in terms of their sources, and are all conventional products that can be purchased through regular commercial channels, or can be prepared according to conventional methods well known to those skilled in the art.

[0101] Example 1

[0102] The raw material components of the traditional Chinese medicine composition for treating habitual constipation in the elderly are taken by weight, namely: 10 weight parts of hemp seed, 3 weight parts of apricot kernel, 3 weight parts of bitter orange seed, 3 weight parts of cassia seed, 3 weight parts of yam, 2 weight parts of Poria, 2 weight parts of Imperata root, 2 weight parts of Phragmites australis, and 1 weight part of honey to obtain traditional Chinese medicine composition sample 1#.

[0103] Example 2

[0104] The raw material components of the traditional Chinese medicine composition for treating habitual constipation in the elderly are taken by weight, namely: 8 weight parts of hemp seed, 4 weight parts of apricot kernel, 4 weight parts of bitter orange seed, 4 weight parts of cassia seed, 4 weight parts of yam, 1 weight part of Poria, 1 weight part of Imperata root, 1 weight part of Phragmites australis, and 1.5 weight parts of honey to obtain traditional Chinese medicine composition sample 2#.

[0105] Example 3

[0106] The raw material components of the traditional Chinese medicine composition for treating habitual constipation in the elderly are taken by weight, namely: 12 weight parts of hemp seed, 2 weight parts of apricot kernel, 2 weight parts of bitter orange seed, 2 weight parts of cassia seed, 2 weight parts of yam, 3 weight parts of Poria, 3 weight parts of Imperata root, 3 weight parts of Phragmites australis, and 0.5 weight part of honey to obtain traditional Chinese medicine composition sample 3#.

[0107] Example 4

[0108] The Chinese medicine composition sample 1# of Example 1 was mixed according to the ratio, and the effective components were extracted by leaching and concentration method to obtain Chinese medicine extract sample 1*. The mixture was soaked in 12 times the amount of water at room temperature for 60 minutes, boiled to boiling for 60 minutes, filtered, and concentrated for 9 hours under the conditions of vacuum degree of 79 kPa and temperature of 64°C to obtain.

[0109] Example 5

[0110] The Chinese medicine composition sample 2# of Example 2 was mixed according to the ratio, and the effective components were extracted by leaching and concentration method to obtain Chinese medicine extract sample 2*. The mixture was soaked in 10 times the amount of water at room temperature for 45 minutes, boiled to a boil for 70 minutes, filtered, and concentrated for 7 hours under the conditions of a vacuum degree of 72 kPa and a temperature of 55°C to obtain.

[0111] Example 6

[0112] The Chinese medicine composition sample 2# of Example 2 was mixed according to the ratio, and the effective components were extracted by decoction to obtain Chinese medicine extract sample 3*. The mixture was decocted with 3 times the amount of water for 60 minutes, evaporated until the volume of water was concentrated to 1 times the volume of the mixture, filtered, and obtained.

[0113] Example 7

[0114] The Chinese medicine composition sample 3# of Example 3 was mixed according to the ratio, and the effective components were extracted by decoction to obtain Chinese medicine extract sample 4*. The mixture was decocted with 4 times the amount of water for 40 minutes, evaporated until the volume of water was concentrated to 1.5 times the volume of the mixture, filtered, and obtained.

[0115] Example 8

[0116] The Chinese medicine composition sample 1# of Example 1 was mixed according to the proportions, and the effective components were extracted by cryogenic grinding to obtain Chinese medicine extract sample 5*. The mixture was added with 4 times the amount of water and soaked at 28°C for 60 minutes, and then added to a colloid mill and ground at 28°C at a speed of 1000 rpm into particles with a particle size of 60 mesh to obtain.

[0117] Example 9

[0118] The Chinese medicine composition sample 3# of Example 3 was mixed according to the proportions, and the effective components were extracted by cryogenic grinding to obtain Chinese medicine extract sample 6*. The mixture was added with 4.5 times the amount of water and soaked at 30°C for 40 minutes, and then added to a colloid mill and ground at 30°C at a speed of 1100 rpm into particles with a particle size of 70 mesh to obtain.

[0119] Example 10

[0120] The quality of the Chinese herbal medicine extract sample 1* of Example 4 was evaluated, and the specific situation was as follows:

[0121] 1. Sensory requirements: Chinese herbal medicine extract sample 1* has a brown-black color, uniform and translucent color; the sour and bitter taste of Chinese herbal medicine is pure; there is no foreign matter visible to normal vision.

[0122] 2. Physical and chemical index requirements: soluble solid content (20℃) ≤ 30%; pH = 4.3 ± 0.2.

[0123] 3. The requirements for microbial limit indicators are shown in Table 1.

[0124] Table 1

[0125]

[0126] Embodiment 11

[0127] The Chinese medicine extract sample 1* of Example 4 was subjected to a self-test laboratory accelerated shelf life test. That is, 9 groups of conditions were set at 37°C for 0, 15, 30, 45, and 90 days, at 54°C for 6, 9, 12, and 15 days, and at room temperature for 90, 180, and 270 days, and the bulging of the product, color, smell, taste, water separation, and microbial conditions were observed and recorded.

[0128] (1) Purpose of the test

[0129] In order to understand the shelf life of the corresponding products and ensure that they can be better applied after being put on the market.

[0130] (2) Analyze food ingredients and determine factors affecting food quality

[0131] The test analysis found that the oil content in this product is relatively high. From this aspect, temperature fluctuations are likely to pose a threat to the product and cause it to deteriorate.

[0132] (3) Choose appropriate packaging to protect products during shelf life

[0133] This product is sold in small packages, each weighing approximately 20ml.

[0134] (4) Determine the optimum temperature

[0135] Carry out detailed tests on suitable temperatures to understand the product storage time at different temperatures, so as to guarantee the shelf life of the product and ensure that the product sales are more efficient.

[0136] Tests have shown that the product is best stored at 37°C, and the humidity of the surrounding environment should be maintained at around 60%.

[0137] (5) Test the changing state of food

[0138] Considering the characteristics of the product, it is decided to test the food stored at 47°C once every 2 days. Q10 is temporarily set to 2. The formula shows that f2(30°C)=1x22 / 2 is approximately 2, that is, the test is conducted once every 2 days at 30°C.

[0139] (6) Detection of kinetic parameters

[0140] The test results show that if the product is always kept at 37°C, it can be stably stored for 5 to 6 days, after which it will deteriorate. If it is kept at 47°C, it can only be stored for 2 days.

[0141] (7) Speculation and analysis of storage conditions

[0142] The life of products with different shelf life at 37℃ and 47℃ was calculated and analyzed, and the corresponding Q10 data results were obtained. Specific calculations were made from the humidity aspect, and the following results were obtained:

[0143] θs(T1)=θs(T2)xQ10△T / 10=5x2.51.7=24d;

[0144] θs(T1)=θs(T2)xQ10ΔT / 10=6x31.7=39d.

[0145] Through calculation, it is found that if the temperature of the product is controlled at 37℃ and the humidity is kept at around 60%, the shelf life of the product can be maintained for 24 to 39 days.

[0146] Example 12

[0147] 1. Case source: 80 elderly patients diagnosed with habitual constipation in the geriatric department of a hospital in Shanghai were selected and randomly divided into a control group and a treatment group according to the digital table method, with 40 patients in each group. The general data of the included cases were analyzed at the baseline. Among the 40 patients in the control group, there were 17 females and 23 males, with an average age of (68.24±5.29) years old; among the 40 patients in the treatment group, there were 19 females and 21 males, with an average age of (67.36±6.18) years old. Through statistical analysis, there was no statistically significant difference (P>0.05), which was comparable.

[0148] 2. Inclusion criteria:

[0149] ① Agree to be included in the study and meet the diagnostic criteria for dry bowel type constipation in the book "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes";

[0150] ② Aged between 60 and 85 years old;

[0151] ③ All patients had symptoms such as dry and hard stools, decreased frequency of defecation, and difficulty in defecation;

[0152] ④Agree to sign the informed consent form;

[0153] ⑤ Those without mental, cognitive or consciousness disorders;

[0154] ⑥ The clinical data were not lost and were complete during the study.

[0155] Exclusion criteria:

[0156] ② Due to drug allergy, the drugs in this study cannot be used;

[0157] ② Patients with gastrointestinal malignancies or those with rectal or colonic lesions;

[0158] ③ Patients with heart, liver, kidney and other organ dysfunction or abnormalities, or with blood, mental, endocrine, or immune system diseases;

[0159] ④Secondary constipation caused by other reasons;

[0160] ④ Those with skin infection and ulceration at the acupoint selection site.

[0161] ⑤ Actively request to withdraw from the study;

[0162] ⑥Poor treatment compliance;

[0163] ⑧Unable to collect complete clinical data;

[0164] ⑨Discontinuation of treatment due to severe adverse reactions after medication;

[0165] ⑩Receive other treatments during the study.

[0166] 3. Methods

[0167] Both groups of patients were given dietary guidance, the control group was given conventional treatment, and the observation group was given the Chinese medicine composition sample 1# prepared in Example 1. Chinese medicine composition sample 1# is composed of 10g of hemp seed, 3g of apricot kernel, 3g of bitter orange, 3g of cassia seed, 3g of yam, 2g of Poria, 2g of Imperata root, 2g of Phragmites australis, and 1g of honey.

[0168] The medicine was decocted by the automatic decoction machine in our hospital's Chinese medicine pharmacy, with a specification of 200 mL per bag, and one bag was taken orally each time, twice a day. Both groups of patients were treated for 14 days.

[0169] 4. Observation indicators

[0170] (1) Comparison of weekly bowel movement frequency, abdominal distension relief time and first bowel movement time between the two groups of patients.

[0171] (2) Patients with Constipation Quality of Life Scale (PAC-QOL) score: There are 28 options in four dimensions, including whether the patient has physical discomfort, worry and anxiety about constipation, psychosocial discomfort, and satisfaction. As the score increases, the quality of life becomes worse.

[0172] (3) Patient Assessment of Constipation Symptoms (PAC-SYM) score: includes abdominal symptoms, rectal symptoms, stool characteristics, etc. As the score increases, the symptoms of constipation become more severe.

[0173] 5. Statistical methods

[0174] SPSS 22.0 statistical software was used for data processing. Normally distributed measurement data with equal variance were used The t test was performed between groups, and the count data were expressed as frequency and percentage (%). The χ2 test was performed between groups. P<0.05 was considered statistically significant.

[0175] 6. Results

[0176] 6.1 Clinical efficacy

[0177] After 2 weeks, the total effective rate of clinical efficacy in the treatment group was 92.5%, while that in the control group was 75%, P=0.0001, and the difference was statistically significant (P<0.05), see Table 2.

[0178] Table 2 Comparison of the therapeutic efficacy of constipation between the two groups of patients [n (%)]

[0179]

[0180] Note: Inter-group comparison, *P<0.05

[0181] 6.2 Effects of the patient's first bowel movement time, weekly bowel movement frequency, and abdominal distension relief time

[0182] After 2 weeks, the first bowel movement time of the patients in the treatment group was shortened, the number of bowel movements per week increased, and the time of abdominal distension relief was reduced, which were all better than those in the control group, and the differences were statistically significant (P < 0.05), as shown in Table 3.

[0183] Table 3 Comparison of first defecation time, abdominal distension relief time, and weekly defecation frequency between the two groups

[0184]

[0185] Note: Inter-group comparison, *P<0.05

[0186] 6.3 Outcomes of Quality of Life Scales and Self-Assessment Scales

[0187] After 2 weeks, the scores of the quality of life scale and self-assessment scale decreased, and the difference was statistically significant (P < 0.05); the scores of the quality of life scale and self-assessment scale in the treatment group were lower than those in the control group, and the difference was statistically significant (P < 0.05), see Table 4.

[0188] Table 4 Comparison of PAC-SYM and PAC-QOL scores between the two groups before and after treatment

[0189]

[0190] Note: After treatment, intra-group comparison, ▲P<0.05; After treatment, inter-group comparison, *P<0.05

[0191] Embodiment 13

[0192] The Chinese herbal extract sample 1* of Example 4 was tested and followed up, and 86% of the subjects reported that their insomnia symptoms were significantly improved, 8% reported that there was no significant effect, and 6% reported that the product still had a strong Chinese herbal flavor that interfered with the taste. The specific test results are shown in Table 5.

[0193] Table 5

[0194]

[0195] 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: 5-15 portions of hemp seeds; 1-5 servings of almonds; 1-5 parts of Citrus aurantium; 1-5 parts of Cassia seed; 1-5 servings of Chinese yam; Poria 0.5-5 parts; Imperata root 0.5-5 parts; Phragmites australis 0.5-5 parts; 0.1-2 parts of honey.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw material components by weight: 8-12 portions of hemp seeds; 2-4 almonds; 2-4 portions of Citrus aurantium; 2-4 parts of Cassia seed; 2-4 servings of yam; 1-3 parts of Poria cocos; 1-3 parts of Imperata root; 1-3 parts of Phragmites australis; 0.5-1.5 parts of honey.

3. A Chinese medicine extract obtained by extracting the Chinese medicine composition according to any one of claims 1-2 as raw material.

4. A method for preparing a Chinese medicine extract, comprising: The raw material components of the Chinese medicine composition according to any one of claims 1-2 are mixed according to the ratio, and the obtained mixture is extracted by at least one method selected from the group consisting of water decoction, low-temperature grinding or leaching concentration.

5. The method for preparing the Chinese medicine extract according to claim 4, characterized in that: Includes any one or more of the following conditions: 1) The decoction method comprises: decoct the mixture with water, evaporate it, and filter it to provide the Chinese medicine extract; 2) The cryogenic grinding method comprises: soaking the mixture in water at low temperature, and then performing cryogenic grinding to provide the Chinese herbal medicine extract; 3) The extraction and concentration method comprises: soaking the mixture in water, boiling, filtering and concentrating to provide the Chinese medicine extract.

6. The method for preparing the Chinese medicine extract according to claim 5, characterized in that: The decoction method includes any one or more of the following conditions: 11) The ratio of the mass of the mixture added to the volume of water added is 1:2-4, g / mL; 12) The boiling time is 30-60 minutes; 13) The evaporation concentrates the volume of water to 0.5-1.5 times the volume of the mixture.

7. The method for preparing the Chinese medicine extract according to claim 5, characterized in that: The cryogenic grinding method includes any one or more of the following conditions: 21) The ratio of the mass of the mixture added to the volume of water added is 1:3.5-4.5, g / mL; 22) The low-temperature soaking temperature is 20-50°C; 23) The low temperature soaking time is 30-60min; 24) The temperature of the cryogenic grinding is 20-50°C; 25) The rotation speed of the cryogenic grinding is 800-1200 rpm; 26) The low temperature grinding is into particles, and the particle size of the particles is not less than 60 mesh.

8. The method for preparing the Chinese medicine extract according to claim 5, characterized in that: The extraction and concentration method includes any one or more of the following conditions: 31) The ratio of the mass of the mixture added to the volume of water added is 1:7-13, g / mL; 32) the immersion is carried out at room temperature; 33) The soaking time is 30-60min; 34) boiling; 35) the boiling time is 40-90min; 36) The concentration is vacuum concentration, the vacuum degree of the vacuum concentration is 60-85 kPa; the temperature of the vacuum concentration is 50-70° C.; the time of the vacuum concentration is 4-11 h; 37) The soluble solid content of the Chinese herbal medicine extract is ≤30% at 20°C; 38) The pH value of the Chinese herbal medicine extract is 4.3±0.

2.

9. A Chinese medicine preparation comprising a therapeutically effective amount of the Chinese medicine composition according to any one of claims 1-2, or a therapeutically effective amount of the Chinese medicine extract according to claim 3, and one or more conventional pharmaceutically acceptable excipients.

10. Use of the Chinese medicine composition according to any one of claims 1-2, the Chinese medicine extract according to claim 3, or the Chinese medicine preparation according to claim 9 in the preparation of a medicament for treating habitual constipation in the elderly.

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