A traditional Chinese medicine composition for clearing the throat, a traditional Chinese medicine preparation, and their preparation methods and applications

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and mainly relates to a traditional Chinese medicine composition for clearing the throat and relieving sore throat, a traditional Chinese medicine preparation, and their preparation methods and applications. The traditional Chinese medicine composition is composed of the following traditional Chinese medicines in parts by weight: 0.9-1.5 parts by weight of Scrophulariae Radix, 1.2-5.0 parts by weight of Polygonati Odorati Rhizoma, 1.0-3.0 parts by weight of Glehniae Radix, 1.0-1.5 parts by weight of Rehmanniae Radix, 1.0-3.0 parts by weight of Ophiopogonis Radix, 1.5-6.0 parts by weight of Gypsum Fibrosum, and 0.5-3.0 parts by weight of Glycyrrhizae Radix. The preparation method of the traditional Chinese medicine preparation includes processes of processing, proportioning, extraction, concentration, soft material preparation, granulation, drying, and sizing. The traditional Chinese medicine composition or preparation for clearing the throat and relieving sore throat can relieve symptoms such as red and swollen pharynx, dry mouth and throat, sore throat, itchy throat, burning sensation, less phlegm, and foreign body sensation in the pharynx caused by pathogenic heat, and shows significant curative effect on the treatment of chronic pharyngitis. Through a unified preparation method, the quality and dosage accuracy of the medicinal materials used are ensured, as well as the stability of the treatment effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations, and mainly relates to a traditional Chinese medicine composition for clearing the throat and relieving sore throat, a traditional Chinese medicine preparation, and its preparation method and application. Background Art

[0002] Chronic pharyngitis is a common pharyngeal disease, and its incidence rate is more significant in cities with serious air pollution and popular means of transportation. In the initial stage, patients usually show discomfort in the pharynx, such as tension and foreign body sensation in the throat. However, as the condition develops, the symptoms will recur repeatedly without clear signs. At present, modern medicine has not found an ideal and highly effective drug to cure chronic pharyngitis. Common treatment methods include oral lozenges, sprays, etc. Although these treatment methods can relieve symptoms temporarily, once stimulated by external factors, the condition is likely to relapse and cannot fundamentally solve the problem. In addition, traditional western medicine treatment often uses non-steroidal anti-inflammatory drugs combined with antibacterial drugs, but the long treatment cycle may cause side effects such as gastrointestinal reactions, liver and kidney damage, dizziness, rash, etc., and the treatment effect is not persistent. In traditional Chinese medicine, traditional Chinese medicine has a good curative effect on chronic pharyngitis caused by heat pathogens, especially when symptoms such as red and swollen pharynx, dry mouth and throat, sore throat, itchy throat, burning sensation, and less phlegm appear. However, there are certain difficulties in the quality control of traditional Chinese medicine decoctions. Measurement errors are prone to occur during the dispensing process, and the decoctions are difficult to store and are prone to deterioration, which also causes certain inconvenience to patients when used. In the present invention, strict management regulations are imposed on the origin, quality, storage, and transportation of the original medicinal materials. Then, for each medicinal material, a unified production process, quality standard, and detection method are formulated according to the nature of its active ingredients, and the dose conversion relationship between the granules and the raw medicinal materials is scientifically formulated to ensure the quality and dose of the medicinal materials, and thus ensure the curative effect. Summary of the Invention

[0003] The purpose of the present invention is to provide a traditional Chinese medicine composition for clearing the throat and relieving sore throat, a traditional Chinese medicine preparation, and its preparation method and application, aiming to solve the problems raised in the above background art.

[0004] The purpose of the present invention is achieved through the following technical solutions:

[0005] A traditional Chinese medicine composition for clearing the throat and relieving sore throat, the traditional Chinese medicine composition is composed of the following traditional Chinese medicines in parts by weight: 0.9 - 1.5 parts by weight of Scrophulariae Radix, 1.2 - 5.0 parts by weight of Polygonati Odorati Rhizoma, 1.0 - 3.0 parts by weight of Glehniae Radix, 1.0 - 1.5 parts by weight of Rehmanniae Radix, 1.0 - 3.0 parts by weight of Ophiopogonis Radix, 1.5 - 6.0 parts by weight of Gypsum Fibrosum, and 0.5 - 3.0 parts by weight of Glycyrrhizae Radix.

[0006] Further, the traditional Chinese medicine composition is composed of the following traditional Chinese medicines by weight: 1.5 parts by weight of Scrophulariae Radix, 2.0 parts by weight of Polygonati Odorati Rhizoma, 2.0 parts by weight of Glehniae Radix, 1.5 parts by weight of Rehmanniae Radix, 1.5 parts by weight of Ophiopogonis Radix, 1.5 parts by weight of Gypsum Fibrosum, and 1.0 part by weight of Glycyrrhizae Radix. The weight ratio of Scrophulariae Radix, Rehmanniae Radix, Ophiopogonis Radix, and Gypsum Fibrosum is 1:1:1:1; the weight ratio of Polygonati Odorati Rhizoma and Glehniae Radix is 1:1; the weight ratio of Polygonati Odorati Rhizoma and Glycyrrhizae Radix is 2:1; the weight ratio of Scrophulariae Radix and Glycyrrhizae Radix is 1.5:1.

[0007] A traditional Chinese medicine preparation for clearing the throat and relieving sore throat is composed of the above-mentioned traditional Chinese medicine composition and medicinal adjuvants.

[0008] A preparation method of the above-mentioned traditional Chinese medicine preparation for clearing the throat and relieving sore throat comprises the following steps:

[0009] (1) Processing step: Processing the traditional Chinese medicines in the traditional Chinese medicine composition to obtain traditional Chinese medicine pieces;

[0010] (2) Weighing step: Weighing the traditional Chinese medicine pieces according to the amount of the traditional Chinese medicine composition;

[0011] (3) Extraction step: Putting the weighed traditional Chinese medicine pieces into an extraction tank, soaking, extracting, and filtering to obtain an extract, and pumping the extract into a storage tank; in the extraction step, extraction is carried out twice. 6 times the amount of water is added for the first time in the extraction tank, and 4 times the amount of water is added for the second time. Each decoction is carried out for 1 hour; soaking is carried out for 40 minutes before the first decoction; filtering through a 100-mesh sieve into the storage tank;

[0012] (4) Concentration step: Pumping the extract in the storage tank into a concentration device for vacuum concentration (vacuum degree is -0.06 to -0.08 Mpa, concentration pressure ≤ 0.2 MP) to obtain an extract with a relative density of 1.25 to 1.30 at 60 °C;

[0013] (5) Soft material preparation step: Mixing the adjuvants, extract, and wetting agent evenly to obtain a soft material; wherein, the ratio of the extract to the adjuvants is 1:2.5. The adjuvants are dextrin and sucrose. The particle size of the sucrose is 100 mesh, and the ratio of dextrin to sucrose is 1:0.4; the wetting agent is 75% ethanol, and the amount of 75% ethanol used is 15 - 20% of the total raw material amount;

[0014] (6) Granulation step: Granulating the soft material and sieving to obtain uniformly sized granules;

[0015] (7) Drying step: Drying the granules at a temperature of 60 - 80 °C for 30 - 50 minutes; preferably, the drying temperature is 60 °C and the drying time is 30 minutes.

[0016] (8) Granulation process: Granulate the dry granules. The top screen of the vibrating sieve is a 10-mesh sieve, and the bottom screen is an 80-mesh sieve. The granulated granules are filled into a clean stainless steel turnover bucket, sealed, weighed, and labeled with material labels.

[0017] Use of the traditional Chinese medicine composition according to the above in the preparation of a medicament for treating chronic pharyngitis, wherein the chronic pharyngitis is a chronic pharyngitis characterized by red and swollen pharynx, dry mouth and throat, sore throat, itchy throat, burning sensation, less phlegm, and a sense of foreign body caused by pathogenic heat.

[0018] Use of the traditional Chinese medicine preparation according to the above in the preparation of a medicament for treating chronic pharyngitis, wherein the chronic pharyngitis is a chronic pharyngitis characterized by red and swollen pharynx, dry mouth and throat, sore throat, itchy throat, burning sensation, less phlegm, and a sense of foreign body caused by pathogenic heat.

[0019] Furthermore, the dosage form of the medicament is a granule, a capsule, a tablet, a pill or a powder.

[0020] The present invention has the following beneficial effects:

[0021] The throat-clearing and voice-calming traditional Chinese medicine composition or traditional Chinese medicine preparation provided by the present invention can effectively relieve symptoms such as red and swollen pharynx, dry mouth and throat, sore throat, itchy throat, burning sensation, less phlegm, and a sense of foreign body in the pharynx caused by pathogenic heat, shows significant curative effect on the treatment of chronic pharyngitis, and effectively relieves the pain of patients. At the same time, by unifying the preparation method of the throat-clearing and voice-calming traditional Chinese medicine preparation, the quality of the medicinal materials used and the accuracy of the dosage are ensured, thereby further ensuring the stability and reliability of its therapeutic effect.

[0022] When filtering the extract, a 100-mesh sieve is used for filtration. The filtration speed is moderate, and the clarity of the obtained extract is good, avoiding problems such as when the sieve aperture is large, the filtration speed is fast, but the interception effect on insoluble components is poor, which will affect the solution clarity, and when the sieve aperture is small, although the interception effect is good, it will cause the filtration speed to be too slow, thereby affecting the work efficiency, etc.

[0023] Concentrate the extract to an extract with a relative density of 1.25 - 1.30 at 60 °C. Not only can the concentrated solution be poured out, but also a good foundation is laid for the next drying process, avoiding problems such as when the relative density of the extract is too small, it will affect the normal operation of the next process and prolong the production cycle, and when the relative density is too large, it is not conducive to pouring and transfer, thereby affecting the work efficiency, etc.

[0024] The present invention adopts the wet granulation process, making the granules have the advantages of smooth and beautiful appearance, uniform size, uniform color, good fluidity, strong abrasion resistance, and good compression formability, and also has the advantages of simple equipment, easy operation, low investment, low energy consumption, and high production efficiency.

[0025] The present invention develops it into a granule. The granule has the advantages of accurate metering, rapid dissolution, convenient carrying, stable properties, etc. Moreover, this dosage form of the granule is most in line with the characteristic of the original preparation of the decoction having a rapid effect, and overcomes the disadvantage of inconvenient decoction when the decoction is used. In addition, the granule has a delicious taste and a small volume, and is convenient for taking, storing and transporting, and has the characteristics of rapid absorption, quick onset, convenience, stability and good taste. Specific Embodiments

[0026] The following further elaborates the present invention in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the protection scope of the present invention. In addition, it should be understood that after reading the content disclosed in the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the protection scope defined by the present invention.

[0027] Example 1

[0028] This example provides a traditional Chinese medicine composition for clearing the throat and relieving sore throat. The traditional Chinese medicine composition is composed of the following traditional Chinese medicines:

[0029] Scrophulariae Radix 166.7 g, Polygonati Odorati Rhizoma 222.2 g, Glehniae Radix 222.2 g, Rehmanniae Radix 166.7 g, Ophiopogonis Radix 166.7 g, Gypsum Fibrosum 166.7 g, Glycyrrhizae Radix et Rhizoma 111.1 g.

[0030] The functions of the traditional Chinese medicines in this example are as follows:

[0031] (1) Scrophulariae Radix: The chemical components include alkaloids, saccharides, sterols, amino acids, fatty acids, trace volatile oils, carotenoids, etc. The main chemical components are iridoid compounds. In addition, Scrophulariae Radix also contains phenylpropanoid glycoside angoroside C, trace volatile oils, phytosterols, oleic acid, stearic acid, glucose, asparagine and alkaloids. It has the effects of nourishing yin and reducing fire, removing vexation and detoxifying. It can treat consumptive fever due to yin deficiency, dysphoria with thirst, maculae, steaming bone fever, restlessness at night, spontaneous sweating and night sweating, constipation due to fluid injury, hematemesis and epistaxis, sore throat, carbuncle, scrofula, epidemic febrile disease with maculae, red eyes, diphtheria, etc.

[0032] (2) Polygonati Odorati Rhizoma: It contains various compounds such as flavonoids, polysaccharides, saponins, volatile oils, etc. The flavonoid compounds in Polygonati Odorati Rhizoma are mostly homo-isoflavonoids; the polysaccharides are mainly neutral polysaccharides, mainly composed of glucose and mannose, and at the same time contain a small amount of galactose; the main active components in the saponins of Polygonati Odorati Rhizoma are steroidal saponin compounds, namely spirostanol steroidal saponins and furostanol steroidal saponins. It has the effects of nourishing yin and moistening dryness, promoting the production of body fluid and quenching thirst, and is mainly used to treat dry cough, consumptive cough, dryness and thirst due to consumption of body fluid by febrile diseases, internal heat and polydipsia, yin deficiency and exogenous contraction, dizziness, and spasmodic pain of tendons and vessels.

[0033] (3)Glehnia littoralis: It contains components such as xanthotoxin, isoimperatorin, scopoletin, aucubin, bergapten, secoisolariciresinol, caffeic acid, syringin, and coumarin compounds. It has the effects of nourishing yin and moistening the lung, benefiting the stomach and promoting the production of body fluid, resolving phlegm and replenishing qi, and is used for dry cough due to lung heat, consumptive cough due to yin deficiency, dry cough with sticky phlegm, insufficient stomach yin, anorexia and vomiting, insufficient qi and yin, restlessness and dry mouth, etc.

[0034] (4)Rehmannia glutinosa: It contains chemical substances such as amino acid components, trace elements, glycosides, and iridoids. Iridoid glycosides are the characteristic components in Rehmannia glutinosa. The chemical structure of iridoids has the characteristics of hemiacetal and cyclopentane; now 8 kinds of sugars such as stachyose, raffinose, glucose, sucrose, fructose, mannotriose, verbascose, and galactose have been isolated and identified from Rehmannia glutinosa, among which stachyose accounts for the highest proportion. It has the effects of anti-inflammatory and antipyretic, anti-aging, clearing heat and cooling blood, and nourishing yin and promoting the production of body fluid, and can be used for epidemic toxin maculae, hematemesis, epistaxis caused by heat entering nutrient blood, and polydipsia, constipation, sore throat caused by febrile disease injuring yin fluid.

[0035] (5)Ophiopogon japonicus: It contains various amino acids and sugar components, which can increase the secretion of body moisture and lubricating fluid, thus playing a role in nourishing yin and moistening dryness; the polysaccharide substances and flavonoid compounds it contains have strong heat-clearing and detoxifying effects and can be used to treat symptoms such as fever and oral ulcers; the polysaccharide substances and flavonoid compounds in Ophiopogon japonicus have certain antioxidant effects, can scavenge free radicals in the body, and prevent oxidative damage; the polysaccharide substances and flavonoid compounds in Ophiopogon japonicus have certain anti-inflammatory and analgesic effects.

[0036] (6)Gypsum: The main chemical component is the hydrate of calcium sulfate (CaSO4), which is a monoclinic mineral. It has the effects of clearing heat and purging fire, removing vexation and quenching thirst; the calcium contained has an inhibitory effect on nerve and muscle, which is more suitable for patients with restlessness. And as an adjuvant therapeutic drug, it also has a certain antispasmodic effect on convulsions caused by high fever and can be used for quenching thirst and treating stomach heat and polydipsia; it can also inhibit the body temperature regulation center, reduce the excitability of skeletal muscle, and reduce vascular permeability. Therefore, it has an anti-inflammatory effect.

[0037] (7)Glycyrrhiza uralensis: It contains a variety of active components, mainly including triterpenoid saponins (such as glycyrrhizic acid, glycyrrhetinic acid), flavonoids (such as liquiritin, isoliquiritin), polysaccharides, amino acids, and trace elements, etc. Among them, glycyrrhizic acid and liquiritin are its main active components and have significant pharmacological effects. Glycyrrhiza uralensis has the effects of invigorating the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasm and pain, and coordinating various medicinal herbs, and is widely used in traditional Chinese medicine clinical practice.

[0038] The legal standard sources of each traditional Chinese medicine are as follows:

[0039] (1)Scrophulariae Radix: This product is the dried root of Scrophularia ningpoensis Hemsl. of the family Scrophulariaceae. Remove the remaining rhizomes and impurities, wash, moisten until soft, and cut into thin slices. Origin: Hubei.

[0040] This product shall comply with the relevant provisions under Scrophulariae Radix in Part I of the Chinese Pharmacopoeia 2020 Edition, page 121.

[0041] (2)Polygonati Rhizoma: This product is the dried rhizome of Polygonatum odoratum (Mill.) Druce of the family Liliaceae. Remove impurities, wash, moisten until soft, cut into thick slices, and dry. Origin: Hunan.

[0042] This product shall comply with the relevant provisions under Polygonati Rhizoma in Part I of the Chinese Pharmacopoeia 2020 Edition, page 86.

[0043] (3)Glehniae Radix: This product is the dried root of Glehnia littoralis Fr. Schmidt ex Miq. of the family Umbelliferae. Remove the remaining stems and impurities, slightly moisten, cut into sections, and dry. Origin: Hebei.

[0044] This product shall comply with the relevant provisions under Glehniae Radix in Part I of the Chinese Pharmacopoeia 2020 Edition, page 103.

[0045] (4)Rehmanniae Radix: This product is the dried tuberous root of Rehmannia glutinosa Libosch. of the family Scrophulariaceae. Slowly bake Rehmanniae Radix until it is about 80% dry, commonly known as "Raw Rehmanniae Radix". Origin: Henan.

[0046] This product shall comply with the relevant provisions under Rehmanniae Radix in Part I of the Chinese Pharmacopoeia 2020 Edition, page 129.

[0047] (5)Ophiopogonis Radix: This product is the dried tuberous root of Ophiopogon japonicus (L. f.) Ker-Gawl. of the family Liliaceae. Remove impurities, wash, moisten until soft, roll flat, and dry. Origin: Sichuan.

[0048] This product shall comply with the relevant provisions under Ophiopogonis Radix in Part I of the Chinese Pharmacopoeia 2020 Edition, page 162.

[0049] (6)Gypsum Fibrosum: This product is gypsum of the gypsum group of sulfate minerals, mainly containing calcium sulfate dihydrate (CaSO4·2H2O). After mining, remove miscellaneous stones and sediment, break, and crush into coarse powder. Origin: Shandong.

[0050] This product shall comply with the relevant provisions under Gypsum Fibrosum in Part I of the Chinese Pharmacopoeia 2020 Edition, page 98.

[0051] (7) Licorice: This product is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. of the Leguminosae family. After excavation, impurities are removed, it is washed, moistened thoroughly, cut into thick slices, and dried. Origin: Mainly produced in Inner Mongolia, Gansu, Xinjiang and other places.

[0052] This product complies with the relevant regulations under Licorice on page 88 of Volume I of the Chinese Pharmacopoeia (2020 Edition).

[0053] Scrophularia is sweet and cold, nourishing yin, bitter and cold, clearing heat, and has the functions of nourishing yin and clearing heat, detoxifying and dissipating nodules, and clearing and moistening the throat. Aiming at the main pathogenesis of excessive heat injuring body fluid, internal heat of toxin, and unfavorable throat, it is the monarch drug; Polygonatum odoratum, Ophiopogon japonicus, and Rehmannia glutinosa are sweet and juicy, nourishing yin and clearing heat, promoting the production of body fluid and moistening the throat. Glehnia littoralis is sweet and slightly bitter, being good at nourishing yin and moistening the lung, and also clearing the heat of the lung. The above four herbs are used together to enhance the function of the monarch drug in nourishing yin and promoting the production of body fluid, and clearing and benefiting the throat, and are the ministerial drugs; The Stomach Meridian of Foot-Yangming passes through the throat, Gypsum is attributed to the Lung and Stomach Meridians, being good at clearing the heat of the Lung and Stomach, detoxifying and detumescence, and is the adjuvant drug. Licorice has the effects of invigorating the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasm and pain, and harmonizing various drugs, and is the guiding drug. All the herbs are used together to achieve the effects of clearing and moistening the throat, nourishing yin and promoting the production of body fluid, and detumescence and pain relief.

[0054] Each traditional Chinese medicine was purchased from Anhui Yuankang Traditional Chinese Medicine Decoction Pieces Co., Ltd. and Hebei Hu's Yubo Pharmaceutical Co., Ltd. The company has complete licenses and certificates. The quality of the traditional Chinese medicines it operates is stable, and the quality standards meet the requirements of the Chinese Pharmacopoeia, meeting the basic requirements of supplier audits.

[0055] Example 2

[0056] This example provides a preparation method for a traditional Chinese medicine preparation for clearing and benefiting the throat, including the following steps:

[0057] (1) Processing step: Process the traditional Chinese medicines in the traditional Chinese medicine composition to obtain traditional Chinese medicine decoction pieces;

[0058] (2) Weighing step: After the operator checks and verifies the name, quantity and other items of the traditional Chinese medicine decoction pieces to be fed according to the production instruction, weigh and set aside.

[0059] (3) Extraction step: Put the ingredients that have been weighed correctly into the extraction tank. Soak for 40 minutes before extraction, extract twice, add 6 times and 4 times the amount of water respectively, decoct for 1 hour each time, and combine the decoction; Filter through a 100-mesh sieve and put it into the storage tank.

[0060] (4) Concentration process: Pump the extract in the storage tank into the concentration equipment for vacuum concentration. Control the vacuum degree at -0.06 to -0.08 Mpa, the concentration pressure ≤ 0.2 MPa, and the concentration temperature at 60 °C. Concentrate the medicinal liquid to a relative density of 1.25 to 1.30 to form an extract paste. Put it into a clean stainless steel turnover barrel, weigh it, affix a material label, and transfer it to the next process.

[0061] (5) Soft material preparation process: Select dextrin and sucrose as excipients. According to the operating procedures, obtain dextrin and sucrose, and after verifying the weights are correct, put them into a wet granulation mixer and stir for 15 minutes to mix evenly. Then add the extract paste to be granulated and an appropriate amount of 75% ethanol, and stir to make a soft material that "forms a ball when held and disperses when touched".

[0062] (6) Granulation process: Place the prepared soft material into a swing granulator for granulation. Use a 14-mesh nylon sieve, and make uniformly sized granules according to the operating procedures. Connect to a material tray. During granulation, check the granule shape at any time, tighten or loosen the sieve mesh in a timely manner. When large pieces of soft material fall off, stop the machine immediately to replace the sieve mesh.

[0063] (7) Drying process: Put the wet granules into a baking tray and place them in a drying oven for drying at a drying temperature of 60 °C for 30 minutes.

[0064] (8) Screening process: According to the screening operating procedures, screen the dry granules. Pass them through an oscillating sieve. The top mesh of the oscillating sieve is 10 meshes, and the bottom mesh is 80 meshes. Put the screened granules into a clean turnover barrel, seal it, weigh it, and affix a material label.

[0065] In one embodiment of the present invention, weigh various traditional Chinese medicine decoction pieces in proportion, and add 6 times the weight of the traditional Chinese medicine decoction pieces of water for soaking. The water absorption of the medicinal materials continuously increases with time. After soaking for 40 minutes, the water absorption reaches saturation.

[0066] In one embodiment of the present invention, the soaking time of the medicinal materials is 40 minutes, and the water absorption rate is 176%.

[0067] In one embodiment of the present invention, the average extract paste rate of three batches of verification tests is 31.33%. The results are almost the same as those of the orthogonal test (in the orthogonal test, the process of extracting twice, adding 6 times the amount of water for the first time, adding 4 times the amount of water for the second time, and decocting for 1 hour each time, the extract paste rate is 31.30%), indicating that the process is stable and feasible.

[0068] In one embodiment of the present invention, the traditional Chinese medicine decoction pieces are extracted twice. Add 6 times the amount of water for the first time and 4 times the amount of water for the second time. Soak for 40 minutes before the first decoction, and decoct for 1 hour each time.

[0069] In one embodiment of the present invention, when filtering the extract, a 100-mesh sieve is used for filtration. The filtration speed is moderate, and the clarity of the obtained extract is good.

[0070] In one embodiment of the present invention, if the relative density of the decoction concentrate is too large, due to poor fluidity, it is difficult to pour out completely, resulting in waste. If the relative density is too small, it is not conducive to drying. Concentrating the extract to a relative density of 1.25 - 1.30 (60 °C) not only enables the concentrate to be poured out, but also lays a good foundation for the next drying process.

[0071] In one embodiment of the present invention, when the concentration temperature is 60 °C, the liquid medicine has good fluidity and is easy to pour out. When the concentration temperature is 70 °C, the fluidity of the liquid medicine is still good and it is still relatively easy to pour out. Considering production efficiency and production cost, the concentration temperature of 60 °C is selected.

[0072] In one embodiment of the present invention, dextrin and sucrose are selected as excipients. The ratio of the extract paste to the excipients is 1:2.5, and the granulation formability is good, and it is easy to granulate.

[0073] In one embodiment of the present invention, when the ratio of the extract paste to the excipients is fixed at 1:2.5, and the ratio of dextrin to sucrose in the excipients is 1:0.4, the granulation rate is high. The granulation effect is better when the soft material is combined for 15 minutes according to this ratio. Therefore, the mixing time of the extract paste and the excipients is determined to be 15 minutes.

[0074] In one embodiment of the present invention, 75% ethanol is selected as the wetting agent. Its wetting property and dispersibility are good. The soft material prepared has moderate viscosity, and the granules are easy to form and loose.

[0075] In one embodiment of the present invention, the granules made by a 14-mesh sieve are selected. The filling amount of the granules for packaging is stable, the particle size is uniform, and the forming is good.

[0076] In one embodiment of the present invention, the granules are dried at a temperature of 60 °C for 30 minutes. The state of the granules is good, easy to size, and the moisture content is low.

[0077] Clinical cases:

[0078] The cases of 100 patients were randomly selected from the China-Japan Union Hospital of Jilin University from 2020 to 2024.

[0079] Target population: For those with red and swollen pharynx, dry mouth and throat, sore throat, itchy throat, burning sensation, less phlegm, and a feeling of foreign body caused by pathogenic heat; those with chronic pharyngitis showing the above syndromes.

[0080] The distribution of patients is as follows:

[0081] Patient gender / age distribution Number of outpatient medical records of patients aged 20 - 30 Number of outpatient medical records of patients aged 31 - 40 Number of outpatient medical records of patients aged 41 - 50 Number of outpatient medical records of patients aged 51 - 60 Number of outpatient medical records of patients aged 61 - 70 Whether it is a special population Number of outpatient medical records of female patients 9 10 11 8 9 No Number of outpatient medical records of male patients 11 11 11 12 8 No

[0082] Through the retrospective analysis of clinical cases, it can be obtained that the traditional Chinese medicine preparation for clearing the throat and relieving sore throat provided by the present invention effectively alleviates symptoms such as red and swollen pharynx, dry mouth and throat, sore throat, itchy throat, burning sensation, less phlegm, and a sense of foreign body in the pharynx caused by pathogenic heat, shows significant curative effect on the treatment of chronic pharyngitis, and effectively relieves the pain of patients.

[0083] Typical cases are listed as follows:

[0084] Typical case 1:

[0085] Name: Han Moumou;

[0086] Chief complaint: Repeated sore throat and hoarseness;

[0087] Physical examination: Red tongue, yellow coating, slippery and rapid pulse, normal body temperature;

[0088] Auxiliary examination: Oral pharyngeal examination was performed, and the pharynx was slightly edematous;

[0089] Diagnosis: Laryngeal obstruction caused by pathogenic heat (chronic pharyngitis);

[0090] Follow-up visit: The symptoms of hoarseness, sore throat, dry mouth and throat have improved.

[0091] Typical case 2:

[0092] Name: Yang Mou;

[0093] Chief complaint: Intermittent a sense of foreign body in the throat, occasionally with a small amount of phlegm;

[0094] Physical examination: Red tongue, yellow coating, slippery and rapid pulse, follicular hyperplasia in the posterior pharyngeal wall, normal body temperature;

[0095] Auxiliary examination: Oral pharyngeal examination was performed, and the pharynx was red and swollen;

[0096] Diagnosis: Laryngeal obstruction caused by pathogenic heat (chronic pharyngitis);

[0097] Follow-up visit: The symptoms of a sense of foreign body in the throat have improved after repeated throat clearing, and the amount of phlegm has decreased.

[0098] Typical case 3:

[0099] Name: Gong Moumou;

[0100] Chief complaint: Intermittent hoarseness and sore throat;

[0101] Physical examination: Red tongue, yellow coating, slippery and rapid pulse, follicular hyperplasia in the posterior pharyngeal wall, normal body temperature;

[0102] Auxiliary examination: Oral pharyngeal examination was performed, and the blood vessels in the pharynx were dilated;

[0103] Diagnosis: Laryngeal obstruction caused by pathogenic heat (chronic pharyngitis);

[0104] Follow - up visit: The symptoms of hoarseness, sore throat, dry mouth and throat have improved.

[0105] Typical case 4:

[0106] Name: Jiang XX;

[0107] Chief complaint: There is a persistent foreign - body sensation in the throat, and occasionally a small amount of phlegm.

[0108] Physical examination: The tongue is red, the tongue coating is yellow, the pulse is slippery and rapid, there is follicular hyperplasia on the posterior pharyngeal wall, and the body temperature is normal.

[0109] Auxiliary examination: Oral pharyngeal examination was performed, and a small amount of secretions were produced.

[0110] Diagnosis: Laryngeal obstruction caused by heat pathogen (chronic pharyngitis);

[0111] Follow - up visit: The foreign - body sensation in the throat has improved, and the amount of phlegm has decreased.

[0112] Typical case 5:

[0113] Name: He XX;

[0114] Chief complaint: Repeated hoarseness, sometimes coughing.

[0115] Physical examination: The tongue is red, the tongue coating is yellow, the pulse is slippery and rapid, and the body temperature is normal.

[0116] Auxiliary examination: Oral pharyngeal examination was performed, and a small amount of secretions were produced.

[0117] Diagnosis: Laryngeal obstruction caused by heat pathogen (chronic pharyngitis);

[0118] Follow - up visit: Hoarseness, sometimes coughing, sore throat, and itchy throat have improved.

[0119] The above are only the preferred embodiments of the present invention. It should be noted that for those skilled in the art, without departing from the concept of the present invention, several deformations and improvements can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the implementation effect of the present invention and the practicality of the patent.

Claims

1. A Chinese medicine preparation for clearing the throat, characterized in that: The throat-clearing and throat-removing Chinese medicine preparation is composed of a Chinese medicine composition and pharmaceutical excipients; the Chinese medicine composition is composed of the following Chinese medicines in parts by weight: 0.9-1.5 parts by weight of Scrophularia ningpoensis, 1.2-5.0 parts by weight of Polygonatum odoratum, 1.0-3.0 parts by weight of Glehnia littoralis, 1.0-1.5 parts by weight of Rehmannia glutinosa, 1.0-3.0 parts by weight of Ophiopogon japonicus, 1.5-6.0 parts by weight of Gypsum Fibrosum and 0.5-3.0 parts by weight of Licorice; The preparation method of the throat-clearing and throat-relief Chinese medicine preparation comprises the following steps: (1) Processing step: processing the Chinese medicine in the Chinese medicine composition to obtain Chinese medicine pieces; (2) batching process: weighing the Chinese herbal medicine pieces according to the amount of the Chinese herbal medicine composition; (3) Extraction process: putting the weighed Chinese herbal medicine pieces into an extraction tank, soaking, extracting, filtering to obtain an extract, and pumping the extract into a storage tank; in the extraction process, extracting twice in total, adding 6 times the amount of water to the extraction tank for the first time, and adding 4 times the amount of water for the second time, and decocting for 1 hour each time; soaking for 40 minutes before the first decoction; filtering with a 100-mesh sieve into the storage tank; (4) Concentration step: pump the extract in the storage tank into the concentration equipment for concentration to obtain an extract with a relative density of 1.25 to 1.30 at 60°C; (5) Soft material preparation process: the auxiliary material, the extract and the wetting agent are uniformly mixed to obtain the soft material; wherein the ratio of the extract to the auxiliary material is 1:2.5, the auxiliary material is dextrin and sucrose, the particle size of the sucrose is 100 mesh, the ratio of dextrin to sucrose is 1:0.4; the wetting agent is 75% ethanol; (6) Granulation process: granulate the soft material and sieve it to obtain particles of uniform size; (7) Drying process; (8) Granulation process.

2. Use of the Chinese medicine preparation according to claim 1 in preparing a drug for treating chronic pharyngitis, characterized in that: Chronic pharyngitis is a chronic pharyngitis caused by heat evil, which is characterized by redness and swelling of the throat, dry mouth and throat, sore throat, itchy throat, burning sensation, little sputum, and a foreign body sensation.

3. The use according to claim 2, characterized in that: The dosage form of the medicine is granules, capsules, tablets or pills.