A traditional Chinese medicine composition for invigorating the spleen, resolving phlegm and relieving cough, a preparation method and application thereof, and a corresponding pharmaceutical preparation

Abstract

The application provides a traditional Chinese medicine composition for invigorating the spleen, reducing phlegm and relieving cough, a preparation method and application thereof and corresponding pharmaceutical preparations, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition contains the following components in parts by weight: 10-30 parts of Fructus Aurantii Immaturus, 15-45 parts of Poria cocos, 2-10 parts of Momordica grosvenori, 2-10 parts of leaves of Eriobotrya japonica and 5-15 parts of licorice. The preparation method is to extract the prescription amount of medicinal materials with water, the mass ratio of water added each time to medicinal materials is 6-12:1, boiling is carried out, extraction is carried out for 1-3 times, the extraction liquid is filtered and vacuum concentrated to a volume of 24-30 L, and the concentration is continued until the extractum specific gravity is 24-28 Be and the solid content is 52%-62%. The application also provides the application of the above-mentioned composition in the preparation of medicines for preventing or treating wind-cold cough and pharmaceutical preparations thereof. The traditional Chinese medicine composition prepared by the application can relieve and treat the symptoms related to wind-cold cough.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for strengthening the spleen, resolving phlegm, and relieving cough, its preparation method, its application, and corresponding pharmaceutical preparations. Background Technology

[0002] Infection with a viral infection can trigger a cold and cough. Common symptoms include cough accompanied by fever, irritability, thirst, and sore throat. Studies show that patients with persistent symptoms after viral infection may progress to a subacute or chronic cough stage. International reports indicate an acute cough incidence rate of 44%-72.5%, with an average cough duration of about 2 weeks, although some patients may experience coughs lasting for weeks or months. Most respondents reported that their throats became "more sensitive," frequently experiencing sore throats, and paying more attention to throat / voice health.

[0003] The root cause of chronic cough and asthma is the accumulation of phlegm and dampness. The spleen is the source of phlegm production, and the lungs are the receptacle for phlegm. When the spleen is weak and unable to transform and transport fluids, dampness accumulates, forming phlegm, which then accumulates in the lungs, manifesting as cough with abundant phlegm. Furthermore, external pathogens can easily trigger the condition, exacerbating it and leading to frequent relapses. Therefore, strengthening the spleen and resolving phlegm is the fundamental principle of treatment during the remission phase of chronic cough and asthma.

[0004] Chinese patent CN 104224947 A discloses a traditional Chinese medicine for viral cough. The composition and weight of the medicine are: 20g of Commelina communis, 20g of Ilex chinensis, 20g of Isatis indigotica, 12g of Perilla frutescens, 12g of Schizonepeta tenuifolia, 12g of Forsythia suspensa, 6g of Platycodon grandiflorus, 6g of Mentha haplocalyx, and 6g of Chrysanthemum morifolium. It has the effects of moistening the lungs and relieving cough, antibacterial and anti-inflammatory properties, clearing the head and eyes, and dispelling wind and releasing the exterior, clearing heat and detoxifying. However, it does not have the effect of strengthening the spleen and resolving phlegm.

[0005] Chinese patent CN 111728007 A relates to an edible composition for strengthening the spleen, resolving phlegm, and relieving cough, and its preparation and application. Based on three medicinal and edible ingredients—dried tangerine peel, poria cocos, and sugar palm fruit—and combined with other suitable ingredients, a food product for strengthening the spleen, resolving phlegm, and relieving cough is prepared. However, as a food product, its preparation is complex, and it only provides preventative effects with a slow therapeutic effect.

[0006] Chinese Patent CN 117442675 A discloses a traditional Chinese medicine composition for treating cough, comprising, by weight parts: 13-17 parts Aster tataricus, 13-17 parts apricot kernel, 13-17 parts loquat leaf, 13-17 parts Scutellaria baicalensis, 8-12 parts licorice, 13-17 parts Pinellia ternata, 13-17 parts Magnolia officinalis, 13-17 parts Poria cocos, 13-17 parts Perilla frutescens, 8-12 parts Bombyx mori and 8-12 parts Cicadae periostracum.

[0007] Whether acute or chronic, coughs significantly impact patients' quality of life, especially during winter when influenza is prevalent and viruses are rampant, making cross-infection and worsening the condition particularly dangerous for the elderly with underlying health conditions. Therefore, developing readily available and easily digestible traditional Chinese medicine compositions that strengthen the spleen, resolve phlegm, and relieve coughs is a research hotspot in this field. Tangerine peel (Citrus reticulata peel) regulates qi, relieves chest congestion, dries dampness, and resolves phlegm; it is used for coughs with excessive phlegm and indigestion without heat symptoms. Citrus reticulata peel (Citrus medica peel) resolves phlegm, regulates qi, strengthens the spleen, and aids digestion; it is used for phlegm stagnation in the chest, coughs, wheezing, indigestion, vomiting, and hiccups. Although both tangerine peel and Citrus reticulata peel are from the Rutaceae family, they are different species within the same family, and their functions and indications differ.

[0008] Based on this, the researchers of this invention developed a series of cough treatment products with tangerine peel as the main ingredient, based on a combination of five traditional Chinese medicines: tangerine peel, poria cocos, monk fruit, loquat leaf, and licorice. These products are mainly targeted at people with cough and symptoms of spleen deficiency such as indigestion and abdominal distension. Summary of the Invention

[0009] To address the aforementioned problems, this invention provides a traditional Chinese medicine composition for strengthening the spleen, resolving phlegm, and relieving cough. Based on the characteristics of Citrus reticulata peel, it is combined with other traditional Chinese medicinal materials that have the effects of strengthening the spleen and moistening the lungs, providing a reference and technical approach for product development and corresponding preparation methods for relieving and treating symptoms related to wind-cold cough.

[0010] Terminology and Declarations of this Invention:

[0011] 1. As used in this text, the articles “a,” “a kind,” and “the” include plural objects unless otherwise explicitly specified as a single object.

[0012] 2. As used herein, numerical range: Unless otherwise expressly indicated, all ranges or ratios disclosed herein shall be understood to include any and all subranges or subratios contained herein. For example, a stated range or ratio of 1 to 30 shall be considered to be included between a minimum value of 1 and a maximum value of 30, and includes any subranges or subratios, integers, decimals, or subranges or subratios consisting of integers or decimals, including endpoints.

[0013] 3. As used herein, the terms “comprising,” “including,” “having,” “possessing,” “may,” “containing,” and their variations are open-ended conjunctions or terms that do not exclude the possibility of other components or structures.

[0014] Huazhou tangerine peel (or dried immature fruit) is the dried young fruit of the Huazhou pomelo, specifically the fresh fruit with a diameter of 4-8 cm. Besides its well-known cough-relieving and phlegm-reducing effects, many studies have shown that Huazhou tangerine peel also possesses anti-inflammatory, antioxidant, anti-thrombotic, alcohol-detoxifying, blood sugar- and lipid-lowering physiological functions. Huazhou tangerine peel contains many active substances, such as flavonoids, polysaccharides, volatile oils, and inositol, which can thin phlegm and aid in expectoration.

[0015] Poria cocos has the effects of promoting diuresis and removing dampness, anti-inflammation, strengthening the spleen and calming the mind. It is often used for symptoms such as edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations and insomnia.

[0016] Monk fruit is sweet and cool in nature, and enters the lung and large intestine meridians. It has the effects of moistening the lungs and relieving cough, promoting body fluid and quenching thirst. It is suitable for cough due to lung heat or dryness, whooping cough, and thirst due to heatstroke. In addition, it also has the effect of moistening the intestines and relieving constipation.

[0017] Loquat leaves possess pharmacological effects such as relieving cough and phlegm, anti-inflammatory and immune-boosting properties, antibacterial and antiseptic effects, antioxidant properties, antitumor properties, and anti-aging properties. They also have the effects of clearing the lungs and stomach, and reducing phlegm. They are used to treat cough with phlegm due to lung heat, hemoptysis, epistaxis, vomiting due to stomach heat, and thirst due to fever.

[0018] Licorice has the effects of tonifying the spleen and replenishing qi, relieving spasms and pain, moistening the lungs and relieving cough, clearing heat and detoxifying, and harmonizing various medicines. When used raw, it can treat sore throat, peptic ulcers, carbuncles and sores, and detoxify drug poisoning and food poisoning.

[0019] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0020] On the one hand, the present invention provides a traditional Chinese medicine composition for strengthening the spleen, resolving phlegm and relieving cough, comprising the following components by weight: 10-30 parts of Citrus reticulata peel, 15-45 parts of Poria cocos, 2-10 parts of Siraitia grosvenorii fruit, 2-10 parts of Eriobotrya japonica leaf and 5-15 parts of Glycyrrhiza uralensis.

[0021] Preferably, the traditional Chinese medicine composition comprises, by weight, the following components: 10-26 parts of Citrus reticulata peel, 15-38 parts of Poria cocos, 2-8 parts of Siraitia grosvenorii, 2-8 parts of Eriobotrya japonica leaf, and 5-12 parts of Glycyrrhiza uralensis; more preferably, the traditional Chinese medicine composition comprises, by weight, the following components: 15-22 parts of Citrus reticulata peel, 26-32 parts of Poria cocos, 3-6 parts of Siraitia grosvenorii, 3-6 parts of Eriobotrya japonica leaf, and 6-11 parts of Glycyrrhiza uralensis; more preferably, the traditional Chinese medicine composition comprises, by weight, the following components: 20 parts of Citrus reticulata peel, 30 parts of Poria cocos, 5 parts of Siraitia grosvenorii, 5 parts of Eriobotrya japonica, and 10 parts of Glycyrrhiza uralensis.

[0022] On the other hand, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0023] Take the prescribed amount of the following medicinal materials: Citrus reticulata peel, Poria cocos, Siraitia grosvenorii, Eriobotrya japonica leaf, and Glycyrrhiza uralensis. Add water for extraction, with the mass ratio of water to medicinal materials being 6-12:1 each time. Boil at 95-100℃ and extract 1-3 times. Filter the extract and concentrate it under vacuum to a volume of 24-30L. Continue to concentrate until the specific gravity of the extract is 24-28Be and the solid content is 52%-62%.

[0024] Preferably, the mass ratio of the added water to the medicinal materials is 8-10:1.

[0025] Preferably, the boiling temperature is 98-100℃ and the boiling time is 0.5-1.5h; more preferably, the boiling temperature is 100℃ and the boiling time is 1h.

[0026] Preferably, the extraction is performed twice.

[0027] Preferably, the extraction operation is as follows: water is added twice for extraction. The mass ratio of water to medicinal material is 10:1 for the first extraction and 8:1 for the second extraction. Each extraction is carried out by boiling at 100°C for 1 hour.

[0028] Preferably, the filter screen is 120-160 mesh, and more preferably, the filter screen is 150 mesh.

[0029] Preferably, the volume of the vacuum concentration is 25-28L.

[0030] Preferably, the specific gravity of the extract is 25-27 Be.

[0031] Preferably, the specific gravity of the extract is measured at a temperature of 75-85°C; more preferably, the specific gravity of the extract is measured at a temperature of 80°C.

[0032] Preferably, the solid content is 55%-60%.

[0033] On the other hand, the present invention provides the application of the above-described traditional Chinese medicine composition in the preparation of a medicine for preventing or treating cough due to wind-cold.

[0034] In another aspect, the present invention provides a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition.

[0035] Preferably, the dosage form of the pharmaceutical preparation includes at least one of ointment, syrup, pill, capsule, granule, oral liquid, powder, tablet, lozenge, and sugar lozenge; more preferably, the dosage form of the pharmaceutical preparation is an ointment.

[0036] Preferably, the method for preparing the ointment, using the extract obtained by the above preparation method as raw material, includes the following steps:

[0037] S1: Add water, boil, add sucrose, and stir to dissolve; the mass ratio of water to sucrose is 1:2.8-3.2;

[0038] S2: Add glucose syrup, boil to 128-132℃, maintain for 1-2 hours, add water to a fixed mass to obtain refined sugar syrup; the mass ratio of glucose syrup to sucrose in S1 is 1:0.9-1.1; the mass ratio of fixed mass to glucose syrup is 2-2.4:1.

[0039] S3: Dissolve citric acid in water to obtain a citric acid solution; the mass ratio of citric acid to water is 1:9-12;

[0040] S4: Take the extract, honey, and citric acid solution, heat and stir for 5-10 minutes, add refined sugar syrup, boil at 105-110℃ for 5-10 minutes, add water to a fixed mass, stir well, and the product is obtained; the mass ratio of the extract, honey, and refined sugar syrup is 1:3-4:25-32; the mass ratio of the extract to a fixed mass is 1:30-35;

[0041] Preferably, the mass ratio of water to sucrose in S1 is 1:3.04;

[0042] Preferably, the mass ratio of the glucose syrup in S2 to the sucrose in S1 is 1:1;

[0043] Preferably, the mass ratio of the fixed mass to the glucose syrup in S2 is 2.29:1;

[0044] Preferably, the mass ratio of citric acid to water in S3 is 1:10;

[0045] Preferably, the mass ratio of the extract, honey, and refined syrup in S4 is 1:3.33:29;

[0046] Preferably, the mass ratio of the extract to the fixed mass in S4 is 1:33.3.

[0047] Compared with the prior art, the present invention has the following beneficial effects:

[0048] 1. This invention utilizes a specific ratio of five traditional Chinese medicinal herbs—Citrus reticulata peel, Poria cocos, Siraitia grosvenorii, Eriobotrya japonica leaf, and Glycyrrhiza uralensis—to synergistically produce a herbal extract with spleen-strengthening, phlegm-reducing, and cough-relieving effects. This extract can be further processed through dilution, flavoring, and other techniques to create various products such as ointments, hard candies, soft candies, and herbal jellies, suitable for different consumer needs.

[0049] 2. The traditional Chinese medicine composition of this invention, *Citrus reticulata* 'Huajuhongtai', has unique effects of strengthening the stomach, regulating qi, resolving phlegm, and relieving cough, and is the principal ingredient in the formula; *Poria cocos* benefits the spleen and stomach, calms the mind and soothes the nerves, and is the assistant ingredient in the formula; *Siraitia grosvenorii* clears the lungs and soothes the throat, resolves phlegm and relieves cough, and moistens the intestines and promotes bowel movements. *Eriobotrya japonica* clears the lungs and soothes the stomach, lowers qi and resolves phlegm. Both are adjuvant ingredients; licorice root harmonizes the middle jiao, relieves spasms, moistens the lungs, detoxifies, and can harmonize the effects of the other ingredients. The five medicinal materials are properly combined, with comprehensive effects, and the principal, assistant, adjuvant, and guide ingredients complement each other. The formula is simple and easy to apply in practice. Attached Figure Description

[0050] Figure 1 This is a flowchart of the preparation process in Example 1 of the present invention. Detailed Implementation

[0051] To make the technical means, creative features, achieved objectives, and effects of this invention readily understandable, the invention is further illustrated below with specific embodiments. However, these embodiments are merely preferred embodiments and not all embodiments. Other embodiments obtained by those skilled in the art based on the embodiments described herein without creative effort are all within the scope of protection of this invention. It is worth noting that the raw materials used in this invention are all common commercially available products, and their sources are not specifically limited. The technical and scientific terms used in the embodiments have the meanings commonly understood by those skilled in the art to which this invention pertains.

[0052] Example 1

[0053] A traditional Chinese medicine composition for strengthening the spleen, resolving phlegm, and relieving cough, comprising the following components by weight:

[0054] 20 parts of Citrus reticulata peel, 30 parts of Poria cocos, 5 parts of Siraitia grosvenorii, 5 parts of Eriobotrya japonica leaf, and 10 parts of Glycyrrhiza uralensis.

[0055] The efficacy of this traditional Chinese medicine composition was tested by preparing it into an ointment, including the following steps:

[0056] Step 1: Take the dried tangerine peel, Poria cocos, monk fruit, loquat leaf, and licorice root and put them into a 500L multi-functional extraction tank. Add water and extract twice. Add 10 times the amount of water for the first extraction and 8 times the amount of water for the second extraction. Boil at 100℃ for 1 hour each time.

[0057] Step 2: After filtering the extract through a 150-mesh filter, concentrate it in a vacuum concentrator to 25-28L.

[0058] Step 3: Transfer the concentrate to an open pan and continue concentrating until the specific gravity of the extract is 25-27Be (measured by heat) and the solid content is 55%-60%. Set aside for later use.

[0059] Step 4: Take 50 kg of purified water, boil it at 100°C, then add 152 kg of sucrose and stir until dissolved.

[0060] Step 5: Add 152 kg of glucose syrup, boil to 128-132℃, add purified water and maintain this temperature for 1.5 h.

[0061] Step 6: Add purified water to 348 kg to obtain refined sugar syrup.

[0062] Step 7: Take 2 kg of citric acid and add 10 times the amount of water, stir to dissolve, and obtain citric acid solution.

[0063] Step 8: Place the mixture in a 500L open pot, add 12kg of extract, 40kg of honey, and the citric acid solution from Step 7, and heat while stirring.

[0064] Step 9: Boil at 98±2℃ for about 5 minutes until the extract is fully dispersed, then add the 348kg refined sugar syrup obtained in Step 6.

[0065] Step 10: Boil for 5 minutes, add purified water to 400 kg, stir well, and the product is ready.

[0066] Example 2

[0067] The ingredients are: 16 parts of Citrus reticulata peel, 24 parts of Poria cocos, 10 parts of Siraitia grosvenorii, 10 parts of Eriobotrya japonica leaf, and 12 parts of Glycyrrhiza uralensis.

[0068] Example 3

[0069] 10 parts of Citrus reticulata peel, 33 parts of Poria cocos, 5 parts of Siraitia grosvenorii, 15 parts of Eriobotrya japonica leaf, and 12 parts of Glycyrrhiza uralensis.

[0070] Example 4

[0071] 12 parts of Citrus reticulata peel, 25 parts of Poria cocos, 8 parts of Siraitia grosvenorii, 8 parts of Eriobotrya japonica leaf, and 16 parts of Glycyrrhiza uralensis.

[0072] Example 5

[0073] 10 parts of Citrus reticulata peel, 30 parts of Poria cocos, 10 parts of Siraitia grosvenorii fruit, 10 parts of Eriobotrya japonica leaf, and 15 parts of Glycyrrhiza uralensis.

[0074] Example 6

[0075] 24 parts of Citrus reticulata peel, 20 parts of Poria cocos, 15 parts of Siraitia grosvenorii, 5 parts of Eriobotrya japonica leaf, and 8 parts of Glycyrrhiza uralensis.

[0076] Example 7

[0077] 15 parts of Citrus reticulata peel, 15 parts of Poria cocos, 10 parts of Siraitia grosvenorii, 15 parts of Eriobotrya japonica leaf, and 10 parts of Glycyrrhiza uralensis.

[0078] Comparative Example 1

[0079] The difference from Example 1 is that the tangerine peel in the formula is removed.

[0080] Comparative Example 2

[0081] The difference from Example 1 is that Poria cocos in the formula is removed.

[0082] Comparative Example 3

[0083] The difference from Example 1 is that an equal amount of Alisma plantago-aquatica was used to replace Poria cocos in the formula.

[0084] Comparative Example 4

[0085] The difference from Example 1 is that an equal amount of Atractylodes lancea is used to replace Poria cocos in the formula.

[0086] Comparative Example 5

[0087] 20 parts of Citrus reticulata peel, 15 parts of Alisma plantago-aquatica, 15 parts of Atractylodes lancea, 5 parts of Siraitia grosvenorii, 5 parts of Eriobotrya japonica leaf, and 10 parts of Glycyrrhiza uralensis.

[0088] Test case

[0089] One hundred and twenty office workers, regardless of gender, aged 20-60, were randomly selected from those who had persistent coughs and symptoms of spleen deficiency such as indigestion and loss of appetite after the pandemic.

[0090] The volunteers were divided into 9 groups. Each group used the same tangerine peel ointment prepared in Examples 1-8 or Comparative Examples 1-4 twice a day after meals for 7 consecutive days.

[0091] Experiment 1: Cough Suppression Test

[0092] Improvement in cough frequency was assessed on days 1, 3, and 7 of the trial. Perceived cough scores were used as the evaluation criteria: a significant reduction in cough frequency was scored as 8-9 points; a slight reduction as 5-7 points; a minor reduction as 1-4 points; and no significant change as 0 points. The scores from each group of volunteers were tallied, and the average scores for each group were calculated and recorded. The results are shown in the table below.

[0093] Experimental Example 2: Expectorant Test

[0094] Improvement in sputum volume was assessed on days 1, 3, and 7 of the trial. Perceived sputum volume was evaluated using a subjective score: 8-9 points for a significant reduction; 5-7 points for a slight reduction; 1-4 points for a minor reduction; and 0 points for no significant change. The scores from each group of volunteers were tallied, and the average scores for each group were calculated and recorded. The results are shown in the table below.

[0095] Experiment Example 3: Spleen-Strengthening Experiment

[0096] On days 1, 3, and 7 of the trial, the improvement in indigestion and loss of appetite was assessed using a subjective evaluation score. Significant improvement in indigestion and loss of appetite was scored as 8-9 points; some relief as 5-7 points; slight improvement as 1-4 points; and no change as 0 points. The scores from each group were tallied, and the average scores for each group were calculated and recorded. The results are shown in Table 1 below.

[0097] Table 1. Average scores of volunteers in each group

[0098]

[0099]

[0100] Based on the data comparison between Example 1 and Comparative Example 1 in Table 1, it can be seen from the comparison of the average score data of the improvement in the number of coughs that the decrease in the content of Citrus reticulata peel will significantly weaken the effect of the traditional Chinese medicine composition in treating cough. The number of coughs in Comparative Example 1 is significantly higher than that in Example 1.

[0101] Based on the data comparison of Example 1 and Comparative Examples 2-5 in Table 1, it can be seen from the comparison of the average score data of the improvement of indigestion and loss of appetite that the content of Poria cocos affects the improvement of indigestion and loss of appetite by this traditional Chinese medicine composition, and Poria cocos has a synergistic effect with other drugs in improving indigestion and loss of appetite.

[0102] Based on the data comparison between Example 1 and Examples 1-7 in Table 1, and the comparison of the average score data on the improvement of sputum volume, it can be seen that the four throat-clearing and phlegm-reducing herbs in this traditional Chinese medicine formula, namely, Citrus reticulata peel, Luo Han Guo, loquat leaf, and licorice, need to be properly proportioned to achieve the best throat-clearing and phlegm-reducing effects.

[0103] Based on the data comparison between Example 1 and Comparative Examples 3-5 in Table 1, the average scores for improvement in indigestion and loss of appetite show that the effects of Alisma plantago-aquatica and Atractylodes lancea combined with other herbs in this formula are not as effective as those achieved when combined with Poria cocos. In this formula, Citrus reticulata peel is the principal herb, Poria cocos is the assistant herb, Siraitia grosvenorii and Eriobotrya japonica are the adjuvant herbs, and Glycyrrhiza uralensis harmonizes the other herbs. The combination of these five herbs achieves the best therapeutic effect.

[0104] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for strengthening the spleen, resolving phlegm, and relieving cough, characterized in that, The product is composed of the following components by weight: 20 parts of Citrus reticulata peel, 30 parts of Poria cocos, 5 parts of Siraitia grosvenorii, 5 parts of Eriobotrya japonica, and 10 parts of Glycyrrhiza uralensis.

2. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, Includes the following steps: Take the prescribed amount of medicinal materials including Citrus reticulata peel, Poria cocos, Siraitia grosvenorii, Eriobotrya japonica leaf, and Glycyrrhiza uralensis. Add water for extraction, with the mass ratio of water to medicinal materials being 6-12:1 each time. Boil at 95-100℃ and extract 1-3 times. Filter the extract and concentrate it under vacuum to a volume of 24-30L. Continue to concentrate until the specific gravity of the extract is 24-28Be and the solid content is 52%-62%.

3. The preparation method according to claim 2, characterized in that, The mass ratio of water to medicinal materials is 8-10:

1.

4. The preparation method according to claim 2, characterized in that, The boiling temperature is 95-100℃, and the time is 0.5-1.5h.

5. The preparation method according to claim 2, characterized in that, The extraction process is as follows: water is added twice for extraction. The mass ratio of water to medicinal material is 10:1 for the first extraction and 8:1 for the second extraction. Each extraction is carried out by boiling at 100°C for 1 hour.

6. The preparation method according to claim 2, characterized in that, The vacuum concentration volume is 25-28L; the specific gravity of the extract is 25-27Be; the specific gravity of the extract is measured at a temperature of 75-85℃; and the solid content is 55%-60%.

7. A pharmaceutical preparation, characterized in that, The traditional Chinese medicine composition as described in claim 1 is included.

8. The pharmaceutical preparation according to claim 7, characterized in that, The dosage form of the pharmaceutical preparation is at least one of the following: ointment, syrup, pill, capsule, granule, oral liquid, powder, tablet, and lozenge.

9. The pharmaceutical preparation according to claim 8, characterized in that, The dosage form of the pharmaceutical preparation is an ointment.

10. The pharmaceutical preparation according to claim 9, characterized in that, The method for preparing the ointment, using the extract obtained by any one of the preparation methods of claims 2-6 as raw material, includes the following steps: S1: Add water, boil, add sucrose, and stir to dissolve; the mass ratio of water to sucrose is 1:2.8-3.2; S2: Add glucose syrup, boil to 128-132℃, maintain for 1-2 hours, add water to a fixed mass to obtain refined sugar syrup; the mass ratio of glucose syrup to sucrose in S1 is 1:0.9-1.1; the mass ratio of fixed mass to glucose syrup is 2-2.4:

1. S3: Dissolve citric acid in water to obtain a citric acid solution; the mass ratio of citric acid to water is 1:9-12; S4: Take the extract, honey, and citric acid solution, heat and stir for 5-10 minutes, add refined sugar syrup, boil at 105-110℃ for 5-10 minutes, add water to a fixed mass, stir well, and the product is obtained; the mass ratio of the extract, honey, and refined sugar syrup is 1:3-4:25-32; the mass ratio of the extract to a fixed mass is 1:30-35.

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