Traditional Chinese medicine composition and traditional Chinese medicine preparation for treating chronic pharyngitis and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic pharyngitis, a traditional Chinese medicine preparation and a preparation method thereof, and the traditional Chinese medicine composition comprises the following components in parts by weight: 2-80 parts of physalis alkekengi, 1-70 parts of sugarcane, 1-60 parts of laver, 1-50 parts of lily, 1-50 parts of American ginseng, 1-50 parts of pseudo-ginseng, 1-40 parts of pericarpium citri reticulatae, 1-40 parts of semen coicis and 1-40 parts of lotus seed. The invention further provides a traditional Chinese medicine preparation for treating chronic pharyngitis and a preparation method thereof. The traditional Chinese medicine composition has a remarkable curative effect on chronic pharyngitis, the raw materials of the traditional Chinese medicine composition are all medicinal and edible varieties, are high in safety, free of toxicity and side effects, wide in raw material source, easy to obtain and suitable for being taken for a long time, and the preparation method of the traditional Chinese medicine composition is easy and convenient to operate, can achieve large-scale industrial production and is beneficial to industrial application of the composition.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition and a traditional Chinese medicine preparation for treating chronic pharyngitis and a preparation method thereof. Background Art

[0002] Chronic pharyngitis is a nonspecific inflammation of the pharynx. Symptoms include diffuse disease of the pharyngeal mucosa, submucosa, and lymphoid tissues. Symptoms include dryness, itching, and a foreign body sensation in the throat, sometimes accompanied by hoarseness and mild pain. In Traditional Chinese Medicine, pharyngitis is classified as a "throat numbness," with the pathogenesis primarily due to the ascending of fire toxins, the accumulation of phlegm and blood stasis, or yin and yang qi deficiency. Approximately 300 million people suffer from pharyngitis in my country. The incidence of pharyngitis has increased significantly due to factors such as the continued deterioration of air quality, increased work pressure, and unhealthy lifestyle habits. Currently, the main clinical treatment for chronic pharyngitis is nebulization or even antibiotics, but long-term medication is not beneficial to health.

[0003] At present, functional foods of traditional Chinese medicine that have both oriental medical cultural connotations and traditional dietary characteristics have been widely recognized and welcomed by people. Among them, "medicine and food have the same origin" is not only a concept of traditional Chinese medicine in treating diseases, but also a healthy lifestyle that can regulate its physiological functions while maintaining and improving the health of the body. Therefore, it is of great significance to provide a functional food composition for the treatment of chronic pharyngitis that has the effects of clearing heat and removing phlegm, nourishing yin and moistening the lungs, and replenishing the middle and replenishing qi. Plant extracts have complex ingredients and are thermodynamically unstable systems. In addition to containing active small molecules such as saponins and flavonoids, they also contain macromolecules with no pharmacological activity such as proteins and pectin. These macromolecules with no pharmacological activity will not only form suspended matter that affects the clarity of the extract, but will also cause caking and adhesion problems during subsequent crystallization, drying, etc., reducing the stability, safety and effectiveness of the active ingredients. Therefore, developing efficient separation and purification processes is an important link in obtaining and utilizing active substances in plant extracts. To address these needs, the present invention provides a traditional Chinese medicine composition based on a core ingredient that is both medicinal and edible. This composition achieves precise efficacy through specific weight ratios. Furthermore, a suitable purification process is developed to enhance the quality of the preparation while ensuring efficacy, meeting the requirements of large-scale production. This solution inherits traditional Chinese medicine theory while addressing the safety and process stability issues of existing technologies, possessing significant application value. Summary of the Invention

[0004] In view of the shortcomings of the above-mentioned background technology, the present application aims to provide a Chinese medicine composition, a Chinese medicine preparation and a preparation method thereof for treating chronic pharyngitis.

[0005] The specific technical solutions of the present invention are as follows:

[0006] A traditional Chinese medicine composition for treating chronic pharyngitis is prepared from the following raw materials in parts by weight: 2-80 parts of Physalis berries, 1-70 parts of sugar cane, 1-60 parts of laver, 1-60 parts of lily, 1-50 parts of American ginseng, 1-50 parts of Panax notoginseng, 1-40 parts of tangerine peel, 1-40 parts of coix seeds, and 1-40 parts of lotus seeds.

[0007] Preferably, the traditional Chinese medicine composition for treating chronic pharyngitis is prepared from the following raw materials in parts by weight: 2 to 60 parts of Physalis berries, 1 to 50 parts of sugarcane, 1 to 40 parts of laver, 1 to 40 parts of lily, 1 to 30 parts of American ginseng, 1 to 30 parts of Panax notoginseng, 1 to 20 parts of tangerine peel, 1 to 20 parts of coix seed, and 1 to 20 parts of lotus seeds.

[0008] Preferably, the traditional Chinese medicine composition for treating chronic pharyngitis is prepared from the following raw materials in parts by weight: 10-40 parts of Physalis berries, 10-40 parts of sugarcane, 10-30 parts of laver, 10-30 parts of lily, 5-20 parts of American ginseng, 5-20 parts of Panax notoginseng, 5-10 parts of tangerine peel, 5-10 parts of coix seed, and 5-10 parts of lotus seeds.

[0009] Further preferably, the traditional Chinese medicine composition for treating chronic pharyngitis is prepared from the following raw materials in parts by weight: 70 parts of Physalis berries, 60 parts of sugarcane, 50 parts of seaweed, 50 parts of lily, 40 parts of American ginseng, 40 parts of Panax notoginseng, 30 parts of tangerine peel, 30 parts of coix seed, and 30 parts of lotus seeds.

[0010] Further preferably, the traditional Chinese medicine composition for treating chronic pharyngitis is prepared from the following raw materials in parts by weight: 50 parts of Physalis berries, 45 parts of sugarcane, 35 parts of laver, 35 parts of lily, 25 parts of American ginseng, 25 parts of Panax notoginseng, 15 parts of tangerine peel, 15 parts of coix seed, and 15 parts of lotus seeds.

[0011] Further preferably, the traditional Chinese medicine composition for treating chronic pharyngitis is prepared from the following raw materials in parts by weight: 35 parts of Physalis berries, 35 parts of sugarcane, 25 parts of laver, 25 parts of lily, 15 parts of American ginseng, 15 parts of Panax notoginseng, 8 parts of tangerine peel, 8 parts of coix seed, and 8 parts of lotus seeds.

[0012] The present invention also provides a preparation method of the above-mentioned traditional Chinese medicine composition for treating chronic pharyngitis: adding purified water 5 to 30 times the total weight of the medicinal materials of Physalis chinensis, sugar cane, laver, lily, American ginseng, Panax notoginseng, tangerine peel, coix seed, and lotus seed, heating and refluxing extraction 1 to 4 times, each extraction for 0.5 to 4.0 hours, filtering, combining the extracts, and obtaining an extract.

[0013] Preferably, the extract is sequentially transferred through a ceramic membrane and an organic membrane under pressure to obtain a filtrate.

[0014] Preferably, the extract is first filtered through an alumina ceramic membrane.

[0015] Preferably, the ceramic membrane is an alumina ceramic membrane with a pore size of 10-100 nm, a membrane area of ​​0.01-2.0 m2, a membrane tube length of 100-2000 mm, and a pressure of 0.1-0.5 MPa when filtered through the alumina ceramic membrane.

[0016] Further preferably, the ceramic membrane is an alumina ceramic membrane, the membrane pore size is 20-80 nm, the membrane area is 0.05-1.8 m2, the membrane tube length is 200-1500 mm, and the pressure when filtering through the alumina ceramic membrane is 0.1-0.4 MPa.

[0017] Further preferably, the ceramic membrane is an alumina ceramic membrane with a pore size of 30-60 nm, a membrane area of ​​0.8-1.5 m2, a membrane tube length of 400-1000 mm, and a pressure of 0.1-0.3 MPa when filtered through the alumina ceramic membrane.

[0018] Preferably, the organic membrane is a rolled polysulfone organic membrane, a polyarylsulfone organic membrane or a polyethersulfone organic membrane.

[0019] Preferably, the pore size of the rolled polysulfone organic membrane is 20-80KD molecular weight cut-off, the membrane area is 1-3.5m2, the membrane tube length is 500-1500mm, and the pressure during filtration through the organic membrane is 0.5-8.0MPa.

[0020] Further preferably, the pore size of the rolled polysulfone organic membrane is 20-60KD molecular weight cut-off, the membrane area is 1-3.0m2, the membrane tube length is 500-1200mm, and the pressure during filtration through the organic membrane is 0.8-6.5MPa.

[0021] Further preferably, the pore size of the rolled polysulfone organic membrane is 40-60KD molecular weight cut-off, the membrane area is 2-3.0m2, the membrane tube length is 800-1300mm, and the pressure during filtration through the organic membrane is 1.5-3.0MPa.

[0022] In a particularly preferred embodiment of the present invention, the purification process of the extract of the traditional Chinese medicine composition for treating chronic pharyngitis is as follows: first, filtering through an alumina ceramic membrane at a pressure of 0.2-0.5 MPa, a membrane pore size of 80-150 nm, a membrane area of ​​0.8-1.8 m2, and a membrane tube length of 1000-1800 mm; after collecting the membrane filtrate, adding it to a rolled polysulfone organic membrane for filtration at a pressure of 1.0-8.0 MPa, a membrane pore size of 40-80 KD molecular weight cutoff, a membrane area of ​​2-3.5 m2, and a membrane tube length of 800-1500 mm.

[0023] Preferably, the traditional Chinese medicine composition for treating chronic pharyngitis is used in the preparation of medicines or health foods for treating chronic pharyngitis.

[0024] Preferably, the health food is in the form of tablets, capsules or granules.

[0025] Preferably, the medicine is in the form of tablets, capsules or granules.

[0026] The present invention also provides a traditional Chinese medicine preparation for treating chronic pharyngitis, comprising the above-mentioned traditional Chinese medicine composition for treating chronic pharyngitis.

[0027] Preferably, the traditional Chinese medicine preparation for treating chronic pharyngitis further comprises: 5 to 60 parts of filler, 1 to 15 parts of sweetener, 1 to 5 parts of sour agent, and 1 to 5 parts of lubricant.

[0028] Preferably, the traditional Chinese medicine preparation for treating chronic pharyngitis further comprises: 10 to 40 parts of filler, 1 to 8 parts of sweetener, 1 to 4 parts of sour agent, and 1 to 4 parts of lubricant.

[0029] Preferably, the traditional Chinese medicine preparation for treating chronic pharyngitis further comprises: 10 to 35 parts of filler, 1 to 6 parts of sweetener, 1 to 3 parts of sour agent, and 1 to 3 parts of lubricant.

[0030] Further preferably, the traditional Chinese medicine preparation for treating chronic pharyngitis is prepared from the following raw materials in parts by weight: 70 parts of Physalis berries, 60 parts of sugarcane, 50 parts of seaweed, 50 parts of lily, 40 parts of American ginseng, 40 parts of Panax notoginseng, 30 parts of tangerine peel, 30 parts of coix seed, 30 parts of lotus seeds and 45 parts of filler, 9 parts of sweetener, 4 parts of sour agent, and 4 parts of lubricant.

[0031] Further preferably, the traditional Chinese medicine preparation for treating chronic pharyngitis is prepared from the following raw materials in parts by weight: 50 parts of Physalis berries, 45 parts of sugarcane, 35 parts of seaweed, 35 parts of lily, 25 parts of American ginseng, 25 parts of Panax notoginseng, 15 parts of tangerine peel, 15 parts of coix seed, 15 parts of lotus seeds and 35 parts of filler, 7 parts of sweetener, 3 parts of sour agent, and 3 parts of lubricant.

[0032] Further preferably, the traditional Chinese medicine preparation for treating chronic pharyngitis is prepared from the following raw materials in parts by weight: 35 parts of Physalis berries, 35 parts of sugarcane, 25 parts of seaweed, 25 parts of lily, 15 parts of American ginseng, 15 parts of Panax notoginseng, 8 parts of tangerine peel, 8 parts of coix seed, 8 parts of lotus seeds and 30 parts of filler, 5 parts of sweetener, 2 parts of sour agent, and 2 parts of lubricant.

[0033] Preferably, the filler is one or more of maltodextrin, dextrin, corn starch, modified corn starch, potato starch, pregelatinized starch, lactose, and microcrystalline cellulose;

[0034] The sweetener is one or more of erythritol, xylitol, white sugar, neotame, cyclamate, saccharin sodium, maltitol, alitame, sucralose, thaumatin, sorbitol, steviol glycosides, aspartame, acesulfame potassium, monk fruit sugar, ammonium glycyrrhizate, D-mannitol, and isomaltulose;

[0035] The acidulant is one or more of citric acid, sodium citrate, lactic acid, malic acid, phosphoric acid, tartaric acid, metatartaric acid, oxalic acid, fumaric acid, ascorbic acid, gluconic acid, acetic acid and succinic acid;

[0036] The lubricant is one or more of stearic acid, magnesium stearate, calcium stearate, glyceryl behenate, sodium stearyl fumarate, talc, and silicon dioxide.

[0037] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine preparation for treating chronic pharyngitis, the preparation method comprising the following steps:

[0038] Extraction: Weigh Physalis berries, sugar cane, laver, lily, American ginseng, Panax notoginseng, tangerine peel, coix seed, and lotus seed separately; add 5-30 times the total weight of the medicinal materials in purified water, heat and reflux and extract 1-4 times, each extraction time 0.5-4.0 hours, filter, and combine the extracts;

[0039] Clarification: The compound Chinese medicine extract for treating chronic pharyngitis is first filtered through an alumina ceramic membrane, wherein the ceramic membrane is an alumina ceramic membrane with a pore size of 10-100 nm, a membrane area of ​​0.01-2.0 m2, and a membrane tube length of 100-2000 mm. The pressure during filtration through the alumina ceramic membrane is 0.1-0.5 MPa, and the filtrate is collected;

[0040] Granulation: The filtrate is concentrated to form a concentrated solution with a specific gravity of 1.00 to 1.35. The concentrated solution and the filler are made into granules. A sweetener, an acidulant, and a lubricant are added and mixed with the above granules to form granules.

[0041] Preferably, the prepared granules are further prepared into tablets or capsules.

[0042] Preferably, the particles are sieved through a 10-40 mesh sieve.

[0043] Preferably, the granulation is performed by fluidized bed granulation.

[0044] Further preferably, the fluidized bed granulation is specifically as follows: the filtrate is concentrated to form a concentrated liquid with a specific gravity of 1.00 to 1.35, a filler is added and placed in a fluidized bed, the inlet air is heated to a temperature of 20°C to 80°C, so that the filler in the fluidized bed is in a fluidized state, a peristaltic pump is used to send the concentrated liquid into a spray gun tube, and the concentrated liquid is sprayed into a mist by compressed air and spread on the surface of the fluidized filler powder, so that the powders collide with each other and agglomerate into particles, a sweetener, an acidulant, and a lubricant are added, and mixed with the above particles to form granules.

[0045] Preferably, the batch air volume of the incoming air heating is 50m 3 / h~100m 3 / h.

[0046] Preferably, the temperature of the fluidized filler material in the fluidized bed is 30°C to 55°C.

[0047] Preferably, the pressure of the compressed air used to spray the concentrated liquid into mist is 10 to 500 KPa.

[0048] Preferably, the flow rate of the concentrated liquid is 0.1-2.0 kg / min to avoid the bed collapsing and being unable to dry due to too high or too low flow rate.

[0049] Physalis is sweet and sour in nature, slightly bitter and flat in taste, and has the effects of expectorant, sedation, clearing away heat and detoxification. Physalis is rich in nutrients, with high content of protein, fat, cellulose, etc., especially the carotene content is much higher than many fruits and vegetables. It has a complete range of amino acids, reasonable ratios, and rich mineral elements, and has excellent health care effects. Modern pharmacological research shows that the main chemical components have significant effects in antioxidant, immunity, anti-tumor, anti-inflammatory, diuretic, and hypoglycemic effects. Traditional Chinese medicine believes that Physalis is slightly bitter in nature and belongs to the lung meridian, and it contains a variety of steroid compounds, so it can be widely used clinically to clear away heat and detoxify, relieve sore throat and reduce phlegm, and can treat hepatitis, sore throat, lung heat cough, etc.

[0050] Sugarcane is sweet and slightly cold in nature. It has the effects of clearing heat and moistening dryness, promoting fluid production and quenching thirst, detoxifying and clearing rashes. In addition to water, sucrose, fiber, organic non-sugars, inorganic non-sugars, and reducing sugars, sugarcane is also rich in amino acids, proteins, organic acids, polyphenols, polysaccharides and other nutritional active substances and trace mineral elements such as potassium, calcium, iron, and zinc required by the human body. It has high nutritional value. Because sugarcane is rich in polyphenols, polysaccharides, flavonoids and other nutritional active substances, it has antioxidant, anti-cancer, blood pressure lowering, cell protection, and immunity enhancement functions; in addition, because sugarcane is rich in iron, it is also known as the "blood-replenishing fruit". Traditional Chinese medicine believes that sugarcane enters the lung and stomach meridians, and has the effects of clearing heat, promoting fluid production, lowering qi, moisturizing dryness, clearing heat and detoxifying, and nourishing the lungs and stomach. It can relieve sore throat caused by excessive heat in the lungs and stomach.

[0051] Nori is sweet, salty and cold in nature. It enters the lung meridian and has the effects of resolving phlegm, softening hard masses, clearing away heat and promoting diuresis, and nourishing the kidneys and the heart. Modern medical research has confirmed that nori contains various nutrients and trace elements. Nori can provide the amino acids needed by the human body, which helps increase muscle growth and repair tissues. Nori also contains vitamin B12, vitamin C, vitamin E and other vitamins, which can enhance the body's immunity, improve resistance, and prevent colds and other diseases. The cellulose in nori helps lower cholesterol, reduce the risk of blood vessel blockage, and protect heart health. Nori is rich in mucus and iodine and other substances, which can lubricate the lungs, relieve symptoms such as dry cough and pharyngitis, and inhibit the inflammatory response of the lungs and reduce the secretion of sputum. Therefore, nori can be used to treat dry cough, bronchitis, asthma and other diseases. Traditional Chinese medicine believes that nori can clear away heat and eliminate phlegm, disperse nodules and relieve sore throat, thereby relieving redness, swelling, burning and pain in the throat caused by wind evil invasion or fire poison.

[0052] Lily is sweet in taste and cold in nature. It has the effects of nourishing yin and moistening the lungs, clearing the heart and calming the mind, and relieving cough. Modern research has confirmed that lily is rich in various active ingredients. Its main effects include relieving cough and expectorant, clearing the heart and calming the mind, tonifying the middle and replenishing qi, etc. It also has good pharmacological effects such as anti-depression, immune regulation, antioxidant, hypoglycemic, anti-inflammatory, and anti-tumor. "New Edition of Materia Medica" records it as: "It can calm the mind and benefit the spirit, eliminate edema and fullness, relieve pain, promote urination, eliminate cough, treat carbuncle, breast swelling, throat paralysis, and typhoid fever, and can also replenish the middle and replenish qi." Modern pharmacological research shows that lily can enhance the excretion function of the respiratory tract, increase lung perfusion volume and antihistamine, thereby having antitussive, expectorant, and antiasthmatic effects.

[0053] American ginseng is sweet, slightly bitter and cool in nature. It has the effects of nourishing yin and replenishing qi, calming the mind and improving intelligence, clearing away heat and promoting fluid production. American ginseng contains a variety of physiologically active ingredients, mainly ginsenosides, polysaccharides, volatile oils, organic acids, sterols, polyacetylenes, amino acids, proteins, vitamins, trace elements, etc. Modern pharmacological research shows that American ginseng has the function of enhancing the central nervous system and protecting the cardiovascular system. Traditional Chinese medicine believes that American ginseng is a preferred health care material for replenishing qi. It has the dual effects of nourishing yin and replenishing qi, calming the mind and improving intelligence, clearing away heat and promoting fluid production, and reducing fire and relieving heat. Because of its characteristics of replenishing without being dry, it can relieve symptoms such as mild sore throat or dry throat caused by spleen and kidney qi deficiency, yang or yin deficiency.

[0054] Panax notoginseng is warm in nature, sweet and slightly bitter in taste, and enters the liver and stomach meridians. It has the effects of dispersing blood stasis, stopping bleeding, reducing swelling and relieving pain. Modern pharmacological research shows that Panax notoginseng contains a variety of saponin active substances, amino acids, trace elements, etc., which have pharmacological effects such as stopping bleeding, dispersing blood stasis, reducing swelling, relieving pain, replenishing deficiency, strengthening, enhancing immune function and inhibiting tumors. It can relieve symptoms such as slight sore throat or dry throat caused by phlegm and blood stasis, and has a good effect both in preventive health care and auxiliary treatment of diseases.

[0055] Tangerine peel is pungent, bitter and warm in nature, and enters the spleen and lung meridians. It has the effects of promoting qi and relieving fullness, drying dampness and resolving phlegm, and strengthening the spleen and stomach. Modern pharmacological research has found that tangerine peel contains volatile oils, hesperidin, vitamins B and C and other ingredients, which have a mild stimulating effect on the gastrointestinal tract, help promote the secretion of digestive juices and increase appetite. Traditional Chinese medicine believes that tangerine peel has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It is suitable for people with symptoms such as stomach bloating, indigestion, lack of appetite, cough and phlegm. It can relieve symptoms such as slight sore throat or dry throat caused by phlegm and blood stasis.

[0056] Coix seed is sweet, light and cool in nature. It has the effects of promoting water and eliminating dampness, strengthening the spleen and stopping diarrhea, removing dampness, detoxifying and dispersing stagnation. Coix seed is rich in proteins, minerals and vitamins, fatty acids and their esters, sterols, triterpenes, polysaccharides, alkaloids, lignans, polyphenols, flavonoids, lactams, adenosine and other active ingredients. Modern pharmacological studies have shown that coix seed has the effects of anti-tumor, improving the body's immunity, antibacterial, antiviral, lowering blood sugar, calcium and blood pressure, regulating blood lipids, inhibiting pancreatic protein, inducing It has many functions such as ovulation promotion, anti-inflammatory, analgesic, and antioxidant. It is used in modern clinical practice to treat various malignant tumors such as lung cancer, gastric cancer, and liver cancer; gynecological diseases such as anovulation and dysmenorrhea in women; inflammation such as acute pharyngitis, enteritis, rheumatoid arthritis, periostitis, and gout; symptoms of low immunity such as primary hyperhidrosis and intractable insomnia. Traditional Chinese medicine believes that coix seed can clear away heat by clearing away lung heat and dampness in the stomach and intestines, thereby relieving symptoms such as sticky and uncomfortable throat, foreign body sensation, and dry cough caused by phlegm and dampness.

[0057] Lotus seeds are sweet, mild and flat in nature. They enter the heart, lung and spleen meridians and have the effects of dispelling dampness and promoting diuresis, strengthening the spleen and stomach, and calming the mind. Lotus seeds are rich in various nutrients, including protein, fat, carbohydrates, vitamin B1, vitamin B2, vitamin C, etc. Lotus seeds have a high carbohydrate content and are an ideal source of energy; vitamin B1 and vitamin B2 play an important role in maintaining the normal functioning of the nervous system and metabolism; vitamin C is a powerful antioxidant that helps improve immunity. In addition, lotus seeds are also rich in minerals. Lotus seeds contain a lot of nutrients, such as calcium, phosphorus, and iron, which play an important role in bone health and blood circulation. Modern pharmacology shows that lotus seeds have an inhibitory effect on hemodynamics, can inhibit myocardial contractility, slow down heart rate, dilate coronary arteries, relax blood vessels, lower blood pressure, and have anti-arrhythmia and anti-myocardial ischemia effects; lotus seeds have anti-free radical effects; lotus seeds have anti-aging and life-extending effects. Traditional Chinese medicine believes that lotus seeds can strengthen the spleen and resolve phlegm, expel water from the middle burner, and calm the upward rushing qi, thereby relieving symptoms such as sticky and uncomfortable throat, foreign body sensation, and dry cough caused by phlegm and dampness.

[0058] Compared with the prior art, the present invention has the following beneficial effects:

[0059] The composition of the present invention is composed of Physalis berry, sugar cane, American ginseng, Panax notoginseng, tangerine peel, coix seed, lotus seed and laver with high safety. Among them, Physalis berry, sugar cane, lily, tangerine peel, coix seed, lotus seed and laver are all medicinal and edible products. American ginseng and Panax notoginseng have high nutritional value and no toxic side effects, and are widely eaten by the public. The formula of the composition is safe and healthy, and the safety of the product is guaranteed from the perspective of raw materials, and the composition has the effect of diet therapy and health care.

[0060] The present invention utilizes the heat-clearing and detoxifying, heat-clearing and moistening, heat-clearing and expectorant effects of Physalis berries, sugarcane and laver, thereby clearing away heat and relieving sore throat and removing phlegm; supplemented with lily and American ginseng to nourish yin and moisten the lungs, relieve cough and remove phlegm, and invigorate the middle and replenish qi, thereby promoting qi and resolving phlegm, moistening dryness and relieving sore throat; supplemented with Panax notoginseng and tangerine peel to disperse blood stasis and stop bleeding, regulate qi and invigorate the spleen, dry dampness and resolve phlegm, thereby promoting blood circulation and removing blood stasis, dispersing stagnation and relieving sore throat; matched with coix seed and lotus seed to promote diuresis and eliminate dampness, invigorate the spleen and eliminate turbidity, thereby invigorating qi and invigorating the spleen, eliminating dampness and stopping diarrhea, and simultaneously invigorating lung qi. The present invention targets phlegm and blood stasis and lung and kidney yin deficiency, slight pain in the throat, dry itchy cough, burning or sore throat The symptoms include choking and discomfort; a feeling of foreign body obstruction in the pharynx, a feeling of sticky phlegm, uncomfortable coughing up phlegm, dark red pharyngeal mucosa or dilated and tortuous blood vessels, hyperplasia of lymphoid follicles on the posterior pharyngeal wall, dark red color, or hot palms and soles, red cheeks in the afternoon, insomnia and dreaminess. The present invention is a Chinese medicine composition for treating chronic pharyngitis with the functions of clearing away heat and removing phlegm as the main function, nourishing yin and moistening the lungs, and invigorating the middle and replenishing qi, while dispersing blood stasis and resolving phlegm. While using lung-tonifying and spleen-tonifying drugs, the addition of qi-tonifying and spleen-strengthening, dampness-removing and diarrhea-stopping, and lung-qi-tonifying products can more effectively solve the TCM pathological mechanism of phlegm and blood stasis and long-term lung qi deficiency in patients with chronic pharyngitis of lung and kidney yin deficiency type.

[0061] The present invention purifies a compound Chinese medicine extract for treating chronic pharyngitis under pressure conditions. The entire membrane filtration process is highly efficient and time-saving, and can retain the effective ingredients to the greatest extent. The purified product obtained by the method has the characteristics of high effective ingredient content and avoids the introduction of harmful residues.

[0062] The present invention adopts a continuous operation mode, and its production capacity is higher than that of macroporous resin purification; and the membrane filtration process is fully closed, avoiding cross contamination between people and materials, and meeting GMP requirements.

[0063] The food / medicine of the present invention can clear the throat and moisten the throat. The raw materials used are all plant varieties that can be used as both medicine and food. They are safe to eat, have no toxic side effects, are widely available, and have no adverse effects on the human body even if taken for a long time. The drawbacks of existing Chinese and Western medicines for treating pharyngitis can be overcome. The preparation method of the present invention is simple, easy to operate, and suitable for large-scale industrial production. DETAILED DESCRIPTION

[0064] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0065] Example 1:

[0066] Take the following raw materials in parts by weight:

[0067] 70 parts of Physalis berries, 60 parts of sugar cane, 50 parts of laver, 50 parts of lily, 40 parts of American ginseng, 40 parts of Panax notoginseng, 30 parts of dried tangerine peel, 30 parts of coix seed, 30 parts of lotus seeds, 45 parts of filler (maltodextrin: microcrystalline cellulose: lactose in a ratio of 1:2:1 by weight), 9 parts of sweetener (xylitol), 4 parts of acidulant (lactic acid), and 4 parts of lubricant (magnesium stearate). A traditional Chinese medicine composition is prepared according to the following preparation method:

[0068] Step (1), extraction: take Physalis berries, sugar cane, laver, lily, American ginseng, Panax notoginseng, tangerine peel, coix seed, and lotus seed, add purified water 30 times the total weight of the medicinal materials, heat and reflux extraction for 3.0 hours, extract three times, filter, and obtain an extract;

[0069] Step (2), clarification: The extract was first filtered through an alumina ceramic membrane with a pressure of 0.5 MPa, a membrane pore size of 80 nm, and a membrane area of ​​2.0 m 2 The membrane tube length is 2000mm; the membrane filtrate is collected and then added to the polysulfone spiral organic membrane for filtration, the pressure is 0.8MPa, the membrane pore size is 80KD molecular weight cut-off, and the membrane area is 3.5m 2 , the membrane tube length is 1500 mm, and the membrane filtrate is collected;

[0070] Step (3), granulation: The membrane filtrate is concentrated to a concentrate with a specific gravity of 1.2, and the batch air volume is set to 90m 3 / h, heating the inlet air to 70°C to fluidize the filler in the bed, with the filler material temperature at 50°C. A peristaltic pump was used to deliver the concentrate into the spray gun at a rate of 0.8 kg / min. Compressed air was then sprayed into a mist at a pressure of 80 kPa. The concentrate was spread over the surface of the fluidized powder, causing the powder to collide and agglomerate into particles. These particles were then mixed with xylitol, lactic acid, and magnesium stearate to produce composite particles. Analysis of the prepared dried material revealed active ingredient contents of 7.81 mg / g total saponins and 22.15 mg / g total polysaccharides, respectively.

[0071] Example 2:

[0072] Take the following raw materials in parts by weight:

[0073] 50 parts of Physalis berries, 45 parts of sugar cane, 35 parts of seaweed, 35 parts of lily, 25 parts of American ginseng, 25 parts of Panax notoginseng, 15 parts of dried tangerine peel, 15 parts of coix seed, 15 parts of lotus seeds, 35 parts of filler (maltodextrin: corn starch: dextrin by weight = 1:1:1), 7 parts of sweetener (erythritol), 3 parts of acidulant (malic acid), and 3 parts of lubricant (silicon dioxide). A traditional Chinese medicine composition is prepared according to the following preparation method:

[0074] Step (1), extraction: take Physalis berries, sugar cane, seaweed, lily, American ginseng, Panax notoginseng, tangerine peel, coix seed, and lotus seed, add purified water 25 times the total weight of the medicinal materials, heat and reflux extraction for 2.5 hours, extract twice, filter, and obtain the extract.

[0075] Step (2), clarification: the extract was first filtered through an alumina ceramic membrane with a pressure of 0.1 MPa, a membrane pore size of 60 nm, and a membrane area of ​​0.8 m 2 The membrane tube length is 400 mm; the membrane filtrate is collected and then added to the polysulfone spiral organic membrane for filtration, the pressure is 1.0 MPa, the membrane pore size is 20KD molecular weight cut-off, and the membrane area is 1.0 m 2 , the membrane tube length is 500 mm, and the membrane filtrate is collected;

[0076] Step (3), granulation: The membrane filtrate is concentrated to a concentrate with a specific gravity of 1.15, and the batch air volume is set to 70m 3 / h. The inlet air is heated to 50°C, causing the hot air to fluidize the filler in the bed, with the filler material temperature reaching 45°C. A peristaltic pump is used to deliver the concentrate into the spray gun at a rate of 0.5 kg / min. Compressed air is then sprayed into a mist at a pressure of 60 kPa. The concentrate is then spread over the surface of the fluidized powder, causing the powder to collide and agglomerate into particles. These particles are then mixed with erythritol, malic acid, and silicon dioxide to produce composite particles. Analysis of the prepared dried material revealed active ingredient contents of 7.75 mg / g total saponins and 21.80 mg / g total polysaccharides, respectively.

[0077] Example 3:

[0078] Take the following raw materials in parts by weight:

[0079] 35 parts of Physalis berries, 35 parts of sugar cane, 25 parts of laver, 25 parts of lily, 15 parts of American ginseng, 15 parts of Panax notoginseng, 8 parts of dried tangerine peel, 8 parts of coix seed, 8 parts of lotus seeds, 30 parts of filler (maltodextrin: dextrin by weight = 1:2), 5 parts of sweetener (sucralose), 2 parts of acidulant (malic acid), and 2 parts of lubricant (sodium stearyl fumarate) were prepared according to the following preparation method:

[0080] Step (1) extraction: take Physalis berries, sugar cane, laver, lily, American ginseng, Panax notoginseng, tangerine peel, coix seed, and lotus seed, add purified water 20 times the total weight of the medicinal materials, heat and reflux extraction for 2.0 hours, extract three times, filter, and obtain an extract;

[0081] Step (2), clarification: the extract was first filtered through an alumina ceramic membrane with a pressure of 0.3 MPa, a membrane pore size of 20 nm, and a membrane area of ​​0.8 m 2 The membrane tube length is 400 mm; the membrane filtrate is collected and then added to the polysulfone spiral organic membrane for filtration at a pressure of 1.5 MPa, a membrane pore size of 40 KD molecular weight cut-off, and a membrane area of ​​2.0 m 2 , the membrane tube length is 900 mm, and the membrane filtrate is collected;

[0082] Step (3), granulation: The membrane filtrate is concentrated to a concentrate with a specific gravity of 1.15, and the batch air volume is set to 50m 3 / h. The inlet air is heated to 50°C, causing the hot air to fluidize the filler in the bed, with the filler material temperature at 35°C. A peristaltic pump is used to deliver the concentrate into the spray gun at a rate of 0.3 kg / min. Compressed air is then sprayed into a mist at a pressure of 40 kPa. The concentrate is spread over the surface of the fluidized powder, causing the powder to collide and agglomerate into particles. These particles are then mixed with sucralose, malic acid, and sodium stearyl fumarate to produce composite particles. Analysis of the prepared dried material revealed active ingredient contents of 7.95 mg / g total saponins and 23.10 mg / g total polysaccharides, respectively.

[0083] Example 4:

[0084] Protective effect of the Chinese medicinal composition for treating chronic pharyngitis of the present invention on ear swelling in mice:

[0085] Sixty mice were randomly divided into blank group, model group, positive drug group and clarithromycin (0.36 g·kg -1 ), Example 1 low-dose group (2.46 g·kg -1 ), Example 1 low and medium dose group (5.92g·kg -1 ), Example 1 low and high dose group (11.84g·kg -1) and 6 other groups, 10 mice in each group. 50 μL of the drug solution was applied to the right ear of the mice except the blank group. An appropriate amount of the drug solution was applied to the right ear of the mice in the positive control group and the sample group of Example 1. The same volume of distilled water was applied to the normal control group and the model control group. 30 minutes after administration, the right ear was gently wiped with a cotton swab dipped in water to remove residual drug. Then, 20 μL of xylene was applied to the front and back of the right ear of the mouse. 30 minutes after the application of the inflammatory agent, the mice were killed, both ears were cut off, and round ear pieces were punched in the same position with a 9 mm diameter puncher, and weighed on a balance. The swelling degree of the mouse ear (the difference in mass of the left and right ear pieces) and the inhibition rate were calculated.

[0086] Swelling degree = right ear piece weight - left ear piece weight;

[0087] Inhibition rate = (swelling degree of model group - swelling degree of drug-treated group) / swelling degree of model group × 100%.

[0088] The results are shown in Table 1. Compared with the normal group, the right ear mass of the model mice increased significantly (P < 0.01). Compared with the model group, the low-, medium-, and high-dose groups of the Chinese herbal composition of the present invention all significantly reduced the right ear mass of the mice (P < 0.01), and the difference in mass between the two ears (swelling) was significantly reduced (P < 0.01). The inhibition rate increased with increasing dose. The positive drug clarithromycin group also reduced the right ear mass and swelling of the mice, with an inhibition rate of 69.78% ± 6.58%. These results indicate that the Chinese herbal composition of the present invention for treating chronic pharyngitis has a significant inhibitory effect on xylene-induced auricular swelling.

[0089] Table 1 Effect of the Chinese medicine composition of the present invention on xylene-induced ear swelling in mice ( n=10)

[0090]

[0091] Note: Compared with the normal group: 1) P<0.01, compared with the model group and control group: 2) P<0.01.

[0092] Example 5:

[0093] The protective effect of the Chinese medicinal composition for treating chronic pharyngitis of the present invention on ether-induced chronic pharyngitis in rats:

[0094] 60 Wistar rats, half male and half female, were randomly divided into 6 groups, namely blank group, model group, positive drug group, low-dose group, medium-dose group and high-dose group, with 10 rats in each group. Except the blank group (sprayed with equal amount of normal saline), the other groups were sprayed with 15% ammonia solution on the rat pharynx twice a day (once in the morning and once in the afternoon), sprayed 3 times each time, for 3 consecutive days. On the 4th day after modeling, the rats were gavaged once a day for 5 consecutive days, with a dosage of 10 mL kg-1 body weight. The gavage dosage of the low, medium and high dose groups of Example 1 sample was 2.46 g kg-1, 5.92 g kg-1 and 11.84 g kg-1 respectively, and the clarithromycin (positive drug) dosage was 0.36 g kg-1. The blank group and model group were given normal saline. Observe and record the latency period from the start of spraying to the occurrence of cough (with the rat abdominal muscle contraction and opening the mouth and sticking out the tongue as the cough index) and the number of coughs within 3 minutes.

[0095] The results are shown in Table 2. Compared with the model group, the cough latency of rats in the low, medium and high dose groups of the Chinese medicine composition of the present invention was significantly prolonged (P<0.01), and the number of coughs within 3 minutes was significantly reduced (P<0.05); the cough latency of rats in the positive drug clarithromycin group was prolonged (P<0.01), and the number of coughs within 3 minutes was reduced (P<0.01). The results show that the Chinese medicine composition of the present invention has a significant inhibitory effect on cough induced by concentrated ammonia water.

[0096] Table 2 Effects of the Chinese medicine composition of the present invention on the cough latency and cough frequency of rats induced by concentrated ammonia water ( n=10)

[0097]

[0098] Note: Compared with the model group and the control group: 2) P<0.01,3 ) P<0.05.

[0099] The embodiments of the present application are described in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the present application. The description of the above embodiments is only intended to help understand the method and core ideas of the present application. At the same time, changes or modifications made by those skilled in the art based on the ideas of the present application, the specific implementation methods, and the scope of application of the present application, all fall within the scope of protection of the present application. In summary, the contents of this specification should not be construed as limiting the present application.

Claims

1. A Chinese medicine composition for treating chronic pharyngitis, characterized in that: In parts by weight, it includes the following raw materials: 2-80 parts of Physalis berries, 1-70 parts of sugarcane, 1-60 parts of laver, 1-50 parts of lily bulbs, 1-50 parts of American ginseng, 1-50 parts of Panax notoginseng, 1-40 parts of tangerine peel, 1-40 parts of coix seed, and 1-40 parts of lotus seeds.

2. A Chinese medicine composition for treating chronic pharyngitis according to claim 1, characterized in that, The invention comprises the following raw materials in parts by weight: 2-60 parts of Physalis berries, 1-50 parts of sugarcane, 1-40 parts of laver, 1-40 parts of lily, 1-30 parts of American ginseng, 1-30 parts of Panax notoginseng, 1-20 parts of tangerine peel, 1-20 parts of coix seed and 1-20 parts of lotus seed.

3. A Chinese medicine composition for treating chronic pharyngitis according to any one of claims 1-2, characterized in that The traditional Chinese medicine composition is used in preparing medicine or health food for treating chronic pharyngitis.

4. A Chinese medicine preparation for treating chronic pharyngitis, characterized in that: A Chinese medicine composition for treating chronic pharyngitis comprising the Chinese medicine composition according to any one of claims 1 to 2.

5. A Chinese medicine preparation for treating chronic pharyngitis according to claim 4, characterized in that, The invention also comprises 5 to 60 parts of fillers, 1 to 15 parts of sweeteners, 1 to 5 parts of sour agents and 1 to 5 parts of lubricants.

6. A Chinese medicine preparation for treating chronic pharyngitis according to claim 4, characterized in that, The invention also comprises 10 to 40 parts of fillers, 1 to 8 parts of sweeteners, 1 to 4 parts of sour agents and 1 to 4 parts of lubricants.

7. A Chinese medicine preparation for treating chronic pharyngitis according to claim 5, characterized in that: The filler is one or more of maltodextrin, dextrin, corn starch, modified corn starch, potato starch, pregelatinized starch, lactose, and microcrystalline cellulose; The sweetener is one or more of erythritol, xylitol, white sugar, neotame, cyclamate, saccharin sodium, maltitol, alitame, sucralose, thaumatin, sorbitol, steviol glycosides, aspartame, acesulfame potassium, monk fruit sugar, ammonium glycyrrhizate, D-mannitol, and isomaltulose; The acidulant is one or more of citric acid, sodium citrate, lactic acid, malic acid, phosphoric acid, tartaric acid, metatartaric acid, oxalic acid, fumaric acid, ascorbic acid, gluconic acid, acetic acid and succinic acid; The lubricant is one or more of stearic acid, magnesium stearate, calcium stearate, glyceryl behenate, sodium stearyl fumarate, talc, and silicon dioxide.

8. A method for preparing the traditional Chinese medicine preparation for treating chronic pharyngitis according to claim 5, characterized in that: The following steps are involved: Extraction: Weigh Physalis berries, sugar cane, laver, lily, American ginseng, Panax notoginseng, tangerine peel, coix seed, and lotus seed separately; add 5-30 times the total weight of the medicinal materials in purified water, heat and reflux and extract 1-4 times, each extraction time 0.5-4.0 hours, filter, and combine the extracts; Clarification: The extract is first filtered through an alumina ceramic membrane with a pressure of 0.2-0.5 MPa, a membrane pore size of 80-150 nm, and a membrane area of ​​0.8-1.8 m 2 The membrane tube length is 1000-1800mm; after collecting the membrane filtrate, it is added to the polysulfone spiral organic membrane for filtration, the pressure is 1.0-8.0MPa, the membrane pore size is 40-80KD molecular weight cut-off, and the membrane area is 2-3.5m 2 , the membrane tube length is 800~1500mm, and the filtrate is collected; Granulation: The filtrate is concentrated to form a concentrate with a specific gravity of 1.00 to 1.35, and the concentrate and filler are made into granules; Mixing: Add sweetener, acidulant and lubricant, mix well with the above particles to form granules.

9. The method for preparing the Chinese medicine preparation for treating chronic pharyngitis according to claim 8, wherein: The granulation is a fluidized bed granulation, specifically: the inlet air is heated to a temperature of 20°C to 80°C to fluidize the filler in the fluidized bed, a concentrated liquid is fed into a spray gun tube using a peristaltic pump, and the concentrated liquid is sprayed into a mist by compressed air and spread on the surface of the fluidized filler powder, so that the powder collides with each other and agglomerates into granules.

10. The method for preparing the Chinese medicine preparation for treating chronic pharyngitis according to claim 9, characterized in that: The batch air volume of the incoming air heating is 50m 3 / h~100m 3 / h, the temperature of the fluidized filler material in the fluidized bed is 30℃~55℃, the flow rate of the concentrated liquid is 0.1~2.0kg / min; the pressure of the compressed air to spray the concentrated liquid into a mist is 10~500kPa.

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