A traditional Chinese medicine composition for treating wind-heat cold and a preparation method thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating wind-heat type common cold and its preparation method, relating to the field of traditional Chinese medicine technology. The composition is made from the following raw materials in parts by weight: 15-20 parts of *Ilex asprella*, 10-15 parts of mulberry leaf, 4-10 parts of wild chrysanthemum, 4-10 parts of *Viola yedoensis*, 10-15 parts of *Senecio scandens*, and 4-10 parts of dandelion. The preparation method includes: mixing the raw materials, soaking in 6-10 times the amount of water for 15-60 minutes; decocting twice, maintaining the boil for 1.5-2 hours each time, filtering and combining the filtrates; concentrating to a relative density of 1.14-1.18 at 80°C, cooling, adding 95% ethanol to achieve an alcohol content of 65-70%, stirring and standing for 12-24 hours, collecting the supernatant; recovering the ethanol under reduced pressure to obtain an extract and concentrating to a relative density of 1.25-1.30 at 80°C. This invention solves the problems of existing drugs for treating wind-heat colds having a narrow range of indications, insufficient extraction of effective components or incomplete removal of impurities in the preparation process, and the need to improve product quality stability.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating wind-heat cold and its preparation method. Background Technology

[0002] Upper respiratory tract infections are extremely common exogenous diseases in clinical practice, mostly caused by viral infections such as rhinovirus, coronavirus, and influenza virus, and can be followed by bacterial infections. Modern medical treatment mainly focuses on symptomatic and supportive care, including the use of nonsteroidal anti-inflammatory drugs (NSAIDs) to relieve fever and pain, antihistamines to relieve nasal congestion and runny nose, and antibiotics when bacterial infection is confirmed. For influenza virus, antiviral drugs can be used early. However, current Western medicine has limited means of treating the underlying causes, and symptomatic drugs mainly focus on temporarily relieving symptoms. There is a lack of broad-spectrum, highly effective, and low-toxicity antiviral drugs, and most viral infections still lack specific Western medicines. The overuse of antibiotics carries the risk of adverse reactions such as the development of drug-resistant bacteria and intestinal flora imbalance.

[0003] Against this backdrop, Traditional Chinese Medicine (TCM), with its advantages of multiple components, multiple targets, and holistic regulation, demonstrates unique value in the prevention and treatment of upper respiratory tract infections. It can dispel wind-heat and clear heat toxins to eliminate the cause of the disease, while also regulating immunity, inhibiting inflammation, and protecting the mucosal barrier, potentially achieving a comprehensive therapeutic effect of "preventing disease progression and preventing recurrence after recovery." Currently, there are various TCM preparations available for wind-heat colds, but some formulations suffer from single-component combinations and narrow indications, primarily targeting upper respiratory symptoms and having limited suitability for patients with concurrent skin conditions such as carbuncles, boils, and eczema. Furthermore, the preparation processes of some existing preparations suffer from insufficient extraction of active ingredients or incomplete removal of impurities, leading to room for improvement in product quality stability and efficacy consistency.

[0004] Therefore, developing a traditional Chinese medicine preparation with a reasonable formulation, broader indications, stable preparation process, and controllable quality has positive clinical significance and market value. Summary of the Invention

[0005] The purpose of this invention is to address the problems of existing drugs for treating wind-heat colds having a narrow range of indications, insufficient extraction of effective components or incomplete removal of impurities in the preparation process, and the need to improve product quality stability. This invention provides a traditional Chinese medicine composition for treating wind-heat colds and its preparation method.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: On one hand, the present invention provides a traditional Chinese medicine composition for treating wind-heat cold, which is made from the following raw materials in parts by weight: 15-20 parts of Ilex chinensis, 10-15 parts of mulberry leaves, 4-10 parts of wild chrysanthemum, 4-10 parts of Viola yedoensis, 10-15 parts of Senecio scandens, and 4-10 parts of dandelion.

[0007] A more specific technical solution for the above-mentioned traditional Chinese medicine composition for treating wind-heat colds could be: 16 parts of *Ilex asprella*, 11.2 parts of mulberry leaf, 4.8 parts of wild chrysanthemum, 4.8 parts of *Viola yedoensis*, 12 parts of *Senecio scandens*, and 4.8 parts of dandelion. This preferred ratio of herbs exhibits excellent synergistic effects, high efficacy utilization, and effectively exerts its effects of dispelling wind and heat, clearing heat and detoxifying.

[0008] On the other hand, the present invention provides a method for preparing the aforementioned traditional Chinese medicine composition for treating wind-heat cold, comprising the following steps: (1) Mix the weight parts of Ilex chinensis, mulberry leaves, wild chrysanthemum, Viola yedoensis, Senecio scandens and dandelion, add 6 to 10 times the total weight of the medicinal materials in water, and soak for 15 to 60 minutes; (2) After soaking, heat and boil twice, keeping it boiling for 1.5 to 2 hours after each boiling, filter, and combine the filtrates; (3) Concentrate the filtrate to a concentration with a relative density of 1.14~1.18 at 80℃, and then cool it to room temperature; (4) Slowly add 95% ethanol to the concentrate while stirring, so that the alcohol content in the solution reaches 65-70%; (5) After the medicine solution is stirred evenly, let it stand for 12-24 hours, and then filter the supernatant. (6) The supernatant was heated under reduced pressure to recover ethanol and obtain an extract. The extract was then concentrated to a relative density of 1.25~1.30 at 80°C.

[0009] This invention limits the soaking time to 6-10 times the volume of water and 15-60 minutes, which can fully immerse the medicinal materials, soften the plant cell walls, and promote the extraction of effective components such as flavonoids, triterpenoid saponins, and alkaloids. The parameter setting of two decoctions, each boiling for 1.5-2 hours, balances the extraction rate of effective components with production efficiency, avoiding the problems of incomplete extraction of effective components in a single decoction and excessive energy consumption in multiple decoctions. The segmented concentration combined with ethanol precipitation process can effectively remove ineffective components such as starch, pectin, and impurities from the medicinal materials, significantly improving the purity of the decoction, reducing impurities in the finished product, and improving the stability of the preparation. The limitation of the relative density parameter at a specific temperature can precisely control the concentration of the extract, ensuring the uniformity of product quality between batches and avoiding clumping due to excessive concentration or difficulty in molding due to excessively low concentration.

[0010] In the above-mentioned technical solution for preparing the traditional Chinese medicine composition for treating wind-heat cold, a more specific technical solution may also include the step of making the extract into granules: according to the weight ratio of 1 part extract, 5-10 parts sucrose, and 0.02-0.1 parts dextrin, add the sugar powder and dextrin into a trough mixer and mix for 5-10 minutes. Then, while stirring, uniformly add the extract, seal and continue stirring for 4-10 minutes, mixing evenly to obtain a soft material that can be formed into a ball when grasped but crumbles when touched. Make the soft material into wet granules, dry, and granulate to obtain granules. This invention selects sucrose and dextrin as molding excipients. Sucrose has moderate sweetness and good solubility, which can improve the bitter taste of the traditional Chinese medicine extract and improve patient medication compliance. Dextrin, as a commonly used filler and binder excipient, can effectively improve the molding properties of the soft material, avoid granules being loose and broken, and does not react with the effective components in the medicine solution, thus not affecting the efficacy. By limiting the ratio range of extract, sucrose, and dextrin, it is possible to ensure high granule formation rate, uniform particle size, and adequate moisture content, which meets the quality standards of pharmacopoeia granules and is suitable for industrialized and standardized production.

[0011] In some possible implementations, the prepared soft material is placed in a gyratory pellet mill and extruded into wet pellets using a 16-mesh stainless steel sieve or sieve plate.

[0012] In some possible implementations, a hot air circulating oven is turned on, and once the temperature reaches 80°C, the prepared wet granules are pushed into the oven for drying until the moisture content is 2-5%. This reduces the moisture content of the granules while ensuring that the active ingredients are not destroyed by high temperatures, preventing the finished product from becoming damp and moldy, and extending its shelf life.

[0013] In some possible implementations, the dried granules are granulated using a vibrating screen to remove coarse particles and fine powder, with screens of 10 mesh and 80 mesh, respectively.

[0014] In some possible implementations, the sucrose is crushed and then passed through an 80-mesh sieve for later use.

[0015] By adopting the above technical solution, the present invention has the following advantages compared with the prior art: 1. The formula uses Ilex chinensis as the chief ingredient, mulberry leaf and wild chrysanthemum as assistant ingredients, and Viola yedoensis, dandelion and Senecio scandens as adjuvant ingredients. The six ingredients work together, with clear division of labor between the chief, assistant, adjuvant and guide ingredients. It closely addresses the core pathogenesis of wind-heat attack and internal heat toxicity. It can not only dispel wind and heat to treat the symptoms, but also clear away fire toxicity to treat the root cause. It can not only treat symptoms such as fever, sore throat and headache caused by wind-heat cold, but also treat concurrent symptoms such as skin sores and eczema caused by heat toxicity. It reflects the formula concept of treating different diseases with the same method.

[0016] 2. The effective components of each medicinal material complement each other, possessing multiple effects including antibacterial, antiviral, anti-inflammatory, and immunomodulatory properties. Clinical trial results show that the total effective rate of the traditional Chinese medicine composition described in this invention in treating wind-heat colds reaches 93.33%; the disappearance rate of the main symptoms after 3 days of treatment is 43.33%, significantly better than the 23.33% in the control group, indicating that this invention has good potential in promoting rapid symptom resolution and helps shorten the course of the disease.

[0017] 3. Through refined process control such as soaking, segmented decoction, ethanol precipitation, precise concentration, and constant temperature drying, active ingredients such as flavonoids and triterpenoid saponins in medicinal materials can be effectively extracted. At the same time, some impurities are removed through alcohol precipitation. The finished product has uniform particle size, good solubility, and is easy to store and carry.

[0018] 4. This invention is based on a pure traditional Chinese medicine formula, and no obvious toxic side effects were found in clinical trials. All raw materials used are common Chinese medicinal herbs, widely available and inexpensive. The preparation process is simple and stable, and suitable for standardized mass production.

[0019] The mechanism of action of the formulation in this invention is as follows: This formula has the effects of clearing heat and detoxifying, dispelling wind and heat. It is designed for fever, red eyes, headache, sore throat, upper respiratory tract infections, skin sores and carbuncles, eczema, and other symptoms caused by wind-heat invasion and internal heat toxicity, which are all symptoms of wind-heat or heat toxicity accumulation. The formula adopts the principle of "using both clearing and detoxifying methods, relieving sore throat, and treating both internal and external symptoms." The principal ingredient is *Ilex chinensis*, which is bitter, cold, and descending, clearing heat and generating fluids, and detoxifying and relieving sore throat, directly counteracting the fire toxicity in the lungs and stomach. Mulberry leaves and wild chrysanthemum are the assistant ingredients, assisting the principal ingredient in dispelling wind-heat and clearing the head and eyes. *Viola yedoensis*, dandelion, and *Senecio scandens* are added to clear heat and detoxify, cool the blood and reduce swelling, synergistically enhancing the effects. Together, they achieve the functions of clearing heat and detoxifying, dispelling wind and heat, reducing swelling and relieving pain. The specific mechanism is analyzed as follows: (1) Clears heat and detoxifies, directly counteracts fire toxins - the principal herb plays a key role, with concentrated power and great efficacy. Gangmei (Ilex chinensis): It excels at clearing heat and detoxifying, promoting body fluid production and quenching thirst, and relieving sore throat and swelling. Gangmei is a distinctive ethnic medicine of Guangxi, included in the Guangxi Zhuang and Yao Medicine Standards. It is highly effective in clearing heat and detoxifying, relieving sore throat and pain, and is widely used in the Lingnan region for the prevention and treatment of colds, pharyngitis, and viral infections. This formula uses it as the principal ingredient because it not only clears excess heat in the lungs and stomach, but is also particularly effective in relieving symptoms of excessive heat and toxins such as redness, swelling, heat, pain in the throat, and dry mouth and thirst. Modern pharmacological research shows that Gangmei is rich in triterpenoid saponins and flavonoids, possessing antiviral, antibacterial, and immunomodulatory effects. Its bitter, cold, and descending properties allow it to directly penetrate the affected area, clearing heat and toxins from the upper and middle jiao (upper and middle burners), making it the core and main ingredient for clearing heat and detoxifying in the entire formula.

[0020] (2) Dispel wind and clear heat, clear the head and eyes - the assistant herbs work together to expel pathogens. Mulberry leaves and wild chrysanthemum: Mulberry leaves are sweet, bitter, and cold in nature, entering the lung and liver meridians. They are light, clearing, and dispersing, excelling at dispersing wind-heat, clearing the lungs and moistening dryness, and clearing the liver and improving eyesight. Mulberry leaves are a characteristic ethnic medicine of Guangxi, included in the Guangxi Zhuang and Yao medicine standards, and have a long history of medicinal use. Wild chrysanthemum is bitter and slightly cold, entering the liver and heart meridians, specializing in clearing heat and detoxifying, calming the liver and purging fire, and reducing swelling and relieving pain. The two are combined as assistant herbs, one mainly dispersing pathogens from the exterior, and the other mainly clearing internal heat and detoxifying. They both help the principal herb clear the heat and toxins that have already entered the body and prevent external pathogens from penetrating deeper. Mulberry leaves guide the medicine upwards to the head and face, relieving headaches, red eyes, and coughs; wild chrysanthemum clears liver fire and detoxifies boils, improving sore throat, eye discharge, and facial boils. The combination of the two herbs, pungent and cool, and bitter and cold, embodies the wonder of "clearing within penetrating, and dispersing within clearing," ensuring that heat and toxins neither penetrate deeper nor linger on the surface.

[0021] (3) Clearing heat and detoxifying, cooling blood and eliminating carbuncles - adjuvant medicine penetrates deeply and has a broad spectrum of anti-toxic effects. Viola yedoensis, dandelion, and Senecio scandens are all bitter and cold herbs that clear heat and detoxify, and they are used as adjuvant herbs.

[0022] Viola yedoensis: Clears heat and toxins from the blood, effectively treats carbuncles and boils, especially suitable for skin heat and toxin syndromes; Dandelion: Clears heat and detoxifies, reduces swelling and dissipates nodules, and also promotes urination and relieves strangury, guiding heat and toxins out through urine; Senecio scandens: It has the effects of clearing heat and detoxifying, improving eyesight and killing insects. Modern research has confirmed that it has an inhibitory effect on a variety of bacteria and viruses, and can relieve redness, swelling and itching of eczema and dermatitis.

[0023] The three drugs work synergistically, which not only enhances the overall antiviral, antibacterial and anti-inflammatory capabilities of the formula, but also extends the treatment scope from the upper respiratory tract to skin and mucous membrane heat toxicity syndrome, achieving "internal clearing and external penetration, treating both upper and lower parts of the body". It is especially suitable for complex heat toxicity syndrome accompanied by tonsillitis, boils or eczema exudation.

[0024] (4) The formula is well-matched, treating both the symptoms and the root cause. The entire formula uses *Ilex chinensis* as the chief herb to directly clear heat and toxins from the lungs and stomach to treat the root cause; mulberry leaves and wild chrysanthemum are the assistant herbs to dispel wind and clear heat to treat the symptoms; and *Viola yedoensis*, dandelion, and *Senecio scandens* are the adjuvant herbs to detoxify and prevent further complications. The six herbs work together to address the pathogenesis of "excessive heat and toxins combined with external wind-heat attack," clearing heat from the qi level, dispersing pathogens from the skin surface, and detoxifying the blood level. Although the herbs are predominantly cold in nature, the combination is well-balanced: the chief herb descends without stagnation, the assistant herbs are light and dispersing without dispersion, and the adjuvant herbs are bitter and cold but have a way to dissipate. Therefore, it clears heat without harming the body's vital energy and detoxifies without suppressing pathogens. The entire formula conforms to the principle of "releasing stagnant fire and treating heat with cold," and is suitable for those with a high fever at the onset of wind-heat colds. It can also be used for acute pharyngitis, tonsillitis, mumps, and heat-toxin type skin diseases, fully demonstrating the advantages of traditional Chinese medicine in "treating different diseases with the same method and multi-target intervention." Detailed Implementation

[0025] The present invention will be further described in detail below with reference to embodiments: Example 1 The traditional Chinese medicine composition for treating wind-heat cold in this embodiment is made from the following raw materials in parts by weight: 16 kg of Ilex chinensis, 11.2 kg of mulberry leaves, 4.8 kg of wild chrysanthemum, 4.8 kg of Viola yedoensis, 12 kg of Senecio scandens, and 4.8 kg of dandelion.

[0026] The preparation method of this embodiment includes the following steps: (1) Mix the above weight of Ilex chinensis, mulberry leaves, wild chrysanthemum, Viola yedoensis, Senecio scandens and dandelion, add water with a total weight of 8 times the weight of the medicinal materials, and soak for 30 minutes; (2) After soaking, heat and boil twice. After boiling for 2 hours, add 6 times the amount of water and boil for 1.5 hours. Filter with an 80-mesh sieve and combine the filtrates. (3) Concentrate the filtrate to a concentration with a relative density of 1.16 at 80°C, and then cool it to room temperature; (4) Slowly add 95% ethanol to the concentrate while stirring, so that the alcohol content in the solution reaches 68%; (5) After the medicine solution is stirred evenly, let it stand for 18 hours and filter out the supernatant; (6) The supernatant was heated under reduced pressure to recover ethanol, yielding an extract. The extract was then concentrated to a relative density of 1.28 at 80°C. The extract yield was 18.6% based on the total weight of the raw materials. The extract was a dark brown to blackish-brown viscous liquid with a fragrant odor, bitter taste, and a uniform and fine texture, free of visible impurities. It exhibited good fluidity at 80°C; upon cooling, it thickened and flowed down in continuous flakes.

[0027] Example 2 Take the extract obtained in Example 1 and prepare granules according to the following steps: Crush the sucrose and pass it through an 80-mesh sieve. Mix the sugar powder and dextrin in a trough mixer at a ratio of 1 part extract, 7 parts sucrose, and 0.35 parts dextrin for 8 minutes. Then, while stirring, evenly add the extract, seal the container, and continue stirring for another 7 minutes until a soft mass that can be formed into a ball but crumbles easily when touched is obtained. Place the prepared soft mass in a vibrating pellet mill and extrude it into wet pellets using a 16-mesh stainless steel sieve. Turn on a hot air circulating oven and, once the temperature reaches 80℃, push the prepared wet pellets into the oven for drying until the moisture content is 3.5%. Use a vibrating screen with 10-mesh and 80-mesh screens to granulate the dried pellets, removing coarse particles and fine powder. Store the qualified pellets in a clean container. After inspection and approval, repackage and export the finished product.

[0028] Example 3 The traditional Chinese medicine composition for treating wind-heat cold in this embodiment is made from the following raw materials in parts by weight: 15kg of Ilex chinensis, 10kg of mulberry leaves, 4kg of wild chrysanthemum, 4kg of Viola yedoensis, 10kg of Senecio scandens, and 4kg of dandelion.

[0029] The preparation method of this embodiment includes the following steps: (1) Mix the above weight of Ilex chinensis, mulberry leaves, wild chrysanthemum, Viola yedoensis, Senecio scandens and dandelion, add water with a total weight of 6 times the weight of the medicinal materials, and soak for 15 minutes; (2) After soaking, heat and boil twice, keeping it boiling for 1.5 hours after each boiling, filter through an 80-mesh sieve, and combine the filtrates; (3) Concentrate the filtrate to a concentration with a relative density of 1.14 at 80°C, and then cool it to room temperature; (4) Slowly add 95% ethanol to the concentrate while stirring, so that the alcohol content in the solution reaches 65%; (5) After the medicine solution is stirred evenly, let it stand for 12 hours and filter out the supernatant; (6) The supernatant was heated under reduced pressure to recover ethanol, and the extract was concentrated to a relative density of 1.25 at 80°C. (7) Grind the sucrose and pass it through an 80-mesh sieve for later use; (8) Mix 1 part extract, 5 parts sucrose and 0.02 parts dextrin. Mix the sugar powder and dextrin for 5 minutes, add the extract and stir in a sealed container for 4 minutes to obtain a qualified soft material. (9) Wet granulation by extrusion through a 16-mesh sieve; (10) Dry at 80℃ until the moisture content of the particles is 2%; (11) Granulate using 10-mesh and 80-mesh sieves, and then package the finished product.

[0030] Example 4 The traditional Chinese medicine composition for treating wind-heat cold in this embodiment is made from the following raw materials in parts by weight: 20 kg of Ilex chinensis, 15 kg of mulberry leaves, 10 kg of wild chrysanthemum, 10 kg of Viola yedoensis, 15 kg of Senecio scandens, and 10 kg of dandelion.

[0031] The preparation method of this embodiment includes the following steps: (1) Mix all the medicinal materials and soak them in 10 times their weight of water for 60 minutes; (2) Boil twice, each time for 2 hours, then filter through an 80-mesh sieve and combine the filtrates; (3) Concentrate to a relative density of 1.18 at 80℃, then cool to room temperature; (4) Add 95% ethanol and stir to make the alcohol content of the solution 70%; (5) Let stand for 24 hours, then filter the supernatant; (6) The ethanol was recovered under reduced pressure, and the extract was concentrated to a relative density of 1.30 at 80°C; (7) Grind the sucrose and pass it through an 80-mesh sieve for later use; (8) Mix the excipients in the ratio of 1 part extract, 10 parts sucrose and 0.1 parts dextrin for 10 minutes, add the extract and stir in a sealed container for 10 minutes to obtain a soft material; (9) Wet granules are sieved through a 16-mesh screen; (10) Dry at 80℃ until the particle moisture content is 5%; (11) Granulate the grains using 10-mesh and 80-mesh sieves, inspect and repackage them to obtain the finished product.

[0032] The herbal extract obtained by this invention has stable physicochemical properties and controllable quality control indicators, and can be used as a general intermediate for the preparation of various dosage forms. The herbal extract obtained by this invention has stable quality and uniform physicochemical indicators. In addition to preparing granules, the extract can also be combined with pharmaceutically acceptable conventional excipients and processed into various oral dosage forms such as oral liquids, capsules, tablets, powders, or pills according to conventional pharmaceutical processes, with a wide range of applications.

[0033] In the above embodiments, the formulation of Example 1 exhibits superior synergistic properties, excellent product quality, and superior efficacy, making it the preferred formulation for this invention. Meanwhile, the granules prepared according to the standardized preparation process of Example 2 of this invention are named Sangju Qingre Granules. These granules are stable in appearance and possess significant advantages such as rapid dissolution, quick absorption by the human body, convenient administration, and easy storage and portability. They are suitable for patients with wind-heat colds of all ages. Therefore, the granules prepared using this process were selected as the test drug for subsequent clinical trials. The formulation of this invention has the effects of clearing heat and detoxifying, and dispelling wind and heat. Clinically, it is suitable for wind-heat colds and can improve symptoms such as fever, red eyes, headache, sore throat, and upper respiratory tract infections. It can also be used to treat skin sores, carbuncles, boils, and eczema caused by heat toxins. The dosage and administration are as follows: dissolve in boiling water and take 10-20g each time, 3 times a day. Clinically, the dosage can be flexibly adjusted according to the patient's age and the severity of the condition. For mild cases, the usual dosage is 10g per dose; for severe cases and elderly patients, it is 20g per dose.

[0034] Clinical trial data 1. Source of cases All cases observed in this study were collected from the emergency department outpatient clinic of our hospital. The collection period was continuous and uninterrupted, and a total of 60 patients with acute upper respiratory tract infection of wind-heat syndrome were included. All cases were randomly assigned to a treatment group and a control group using a random number table, with 30 cases in each group. There were no dropouts or exclusions during the study, and all subjects successfully completed the clinical trial observation. There were no statistically significant differences in baseline data such as age, gender, course of disease, TCM syndrome scores, and basic clinical characteristics between the two groups before treatment (P>0.05), indicating that the baselines between the groups were comparable and met the requirements for a controlled clinical trial.

[0035] 2. Clinical case data Five typical cases of different ages, disease severity, and recurrence were randomly selected for individualized efficacy demonstration, visually showcasing the drug's suitability for various conditions, dosage adjustability, and treatment advantages in recurring cases. The remaining cases were included in a standardized randomized controlled statistical analysis. The typical case data and the batch trial data complemented and corroborated each other, jointly confirming the definite efficacy, broad applicability, and safety of the drug's formulation. To more intuitively illustrate the efficacy of the invention, the treatment cases of five representative patients are listed below. All patients were from the aforementioned 60 cases. It should be noted that this section only presents individual cases; the overall efficacy is subject to subsequent statistical analysis results. Specific cases are as follows: Case 1. Patient: Zuo Moumou, male, age: 56, outpatient number: ******182 Chief complaint: Sore throat Present illness: Two days ago, the patient developed a sore throat, accompanied by runny nose, cough with sputum, red throat, enlarged tonsils (Type I), and coarse breath sounds in both lungs. The tongue is red with a thin yellow coating, and the pulse is floating and rapid.

[0036] Western medicine diagnosis: Acute pharyngitis Traditional Chinese Medicine Diagnosis: Common Cold with Wind-Heat Syndrome Treatment principle: Dispel wind and clear heat Treatment: Take 10g of Sangju Qingre Granules dissolved in boiling water, three times a day.

[0037] Clinical efficacy: After 3 days of medication, the patient's condition improved and healed. He no longer had symptoms such as sore throat, runny nose, or cough. He did not need to return for a follow-up visit.

[0038] Case 2. Patient: Zou, female, age 41, outpatient number: ******211 Chief complaint: Nasal congestion, runny nose, sore throat Present illness: Nasal congestion and runny nose for 3 days, accompanied by sore throat, low-grade fever, occasional cough with little sputum. Red throat, red tongue with thick coating, and rapid pulse.

[0039] Western medicine diagnosis: Upper respiratory tract infection Traditional Chinese Medicine Diagnosis: Common Cold with Wind-Heat Syndrome Treatment principle: Clear heat and detoxify Treatment: Take 10g of Sangju Qingre Granules dissolved in boiling water, three times a day.

[0040] Clinical efficacy: After 6 days of treatment, the patient's condition improved, with no more nasal congestion, runny nose, sore throat, fever, cough, or phlegm. Three months later, the patient returned for a common cold due to wind-heat, with sore throat, a slight cough, and phlegm. The patient was again given Sangju Qingre Granules (20g each time, 3 times a day) dissolved in hot water. After 5 days of treatment, the patient recovered completely, with no more sore throat, cough, or phlegm, and did not require a follow-up visit.

[0041] Case 3. Patient: Zhuge Moumou, female, age: 16, outpatient number: ******017 Chief complaint: Sore throat Present illness: Two days ago, the patient developed a sore throat after eating hot and dry food. There was no nasal congestion or runny nose, no fever or cough, and the throat was slightly congested. The tongue was red with a thin, slightly yellow coating, and the pulse was floating and rapid.

[0042] Western medicine diagnosis: pharyngitis Traditional Chinese Medicine Diagnosis: Wind-Heat Syndrome, Throat Syndrome Treatment principle: Clear heat and detoxify Treatment: Take 10g of Sangju Qingre Granules dissolved in boiling water, three times a day.

[0043] Clinical efficacy: After 3 days of treatment, the patient's condition improved and healed, with no more sore throat. 7 weeks later, the patient returned for a sore throat and was again prescribed Sangju Qingre Granules, 20g each time, 3 times a day, dissolved in hot water. After 3 days of treatment, the patient improved and healed completely, and did not require a follow-up visit.

[0044] Case 4. Patient: Zhu Moumou, male, age: 92, outpatient number: ******995 Chief complaint: Nasal congestion, sore throat Present illness: Nasal congestion, sore throat, no fever, occasional cough with small amount of sputum that is difficult to expectorate, and sometimes loose stools. Dark red tongue with a thin yellow coating, and slightly floating pulse.

[0045] Western medicine diagnosis: Acute pharyngitis Traditional Chinese Medicine Diagnosis: Common Cold with Wind-Heat Syndrome Treatment principle: dispel wind and clear heat, soothe the throat Treatment: Take 20g of Sangju Qingre Granules dissolved in boiling water, three times a day.

[0046] Clinical efficacy: The patient's condition improved after 6 days of medication. There was no nasal congestion, sore throat, cough, or sputum. No follow-up visit was required.

[0047] Case 5. Patient: Zhou Moumou, Male, Age: 42, Outpatient Number: ******014 Chief complaint: Dry throat, sore throat, cough Present illness: One day ago, the patient developed dry throat, sore throat, cough, dry cough, thin yellow tongue coating, and a floating, wiry, and slippery pulse at the cun position without any obvious cause.

[0048] Western medicine diagnosis: Acute upper respiratory tract infection Traditional Chinese Medicine Diagnosis: Common Cold with Wind-Heat Syndrome Treatment principle: Dispel wind and clear heat Treatment: Take 20g of Sangju Qingre Granules dissolved in boiling water, three times a day.

[0049] Clinical efficacy: After 7 days of treatment, the patient's condition improved, with no more dry throat, sore throat, or cough, and no further follow-up visit was required.

[0050] 3. Diagnostic criteria 3.1 Western Medicine Diagnostic Criteria According to the "Guidelines for the Diagnosis and Treatment of Acute Upper Respiratory Tract Infections in Primary Care (2018)," the following criteria should be met: (1) Symptoms of the nose and throat, such as nasal congestion, runny nose, sneezing, dry throat, sore throat, cough, etc., may be accompanied by systemic symptoms, such as chills and fever, headache, body aches, etc.; (2) Physical examination may reveal pharyngeal congestion and tonsil enlargement, and no obvious abnormalities on lung auscultation, such as dry and wet rales, wheezing, etc.; (3) Blood routine examination: white blood cell count is normal or low, lymphocyte ratio is increased, which is consistent with the characteristics of viral infection; (4) Exclude other respiratory diseases such as allergic rhinitis, influenza, and pneumonia. Among them, the differentiation of influenza needs to be combined with the epidemiological history and etiological test results for comprehensive judgment.

[0051] 3.2 Traditional Chinese Medicine Diagnostic Criteria The diagnostic criteria for acute upper respiratory tract infection of wind-heat type are formulated with reference to the "Technical Guidelines for Clinical Trial Design and Evaluation of Traditional Chinese Medicine for Acute Upper Respiratory Tract Infection": (1) Primary symptoms: fever or aversion to wind, sore throat, headache, nasal congestion, runny nose; (2) Secondary symptoms: cough, expectoration, dry throat, systemic symptoms such as body aches, fatigue, sweating, etc. A diagnosis can be made if two primary symptoms or one primary symptom accompanied by two secondary symptoms are present, combined with the tongue and pulse characteristics of red tongue, thin yellow coating, and floating and rapid pulse.

[0052] 3.3 Syndrome Quantification Scoring Standard (for efficacy assessment) Main symptoms: (1) No fever (0 points); body temperature 37.3-38.0℃ (2 points); 38.1-39.0℃ (4 points); >39.0℃ (6 points). (2) Sore throat, headache, nasal congestion, runny nose: rated as 0, 2, 4, and 6 points respectively according to the degree of absence, mildness, obviousness, and severity.

[0053] Secondary symptoms: None (0 points); Mild (1 point); Obvious (2 points); Severe (3 points).

[0054] 4. Inclusion criteria (1) Meets the above diagnostic criteria for acute upper respiratory tract infection and wind-heat syndrome in both traditional Chinese and Western medicine; (2) Age 15-75 years, gender not limited; (3) Onset time within 72 hours, body temperature not high or between 37.5℃ and 39.0℃; (4) Good compliance, able to follow the doctor's treatment well, and can cooperate well with the doctor in observation and assessment; (5) Has not used any drug treatment since onset; (6) The patient understands the clinical research and signs the consent form.

[0055] 5. Exclusion criteria (1) Those who have taken other traditional Chinese medicines or Western medicines such as antibiotics, antivirals, and glucocorticoids within 24 hours before the experiment; (2) Those who have acute exacerbations of respiratory diseases such as rhinitis, chronic bronchitis, asthma, and emphysema; (3) Those who have serious diseases of the heart, liver, kidneys, or hematopoietic system; (4) Patients who are allergic to this preparation; (5) Those who do not agree to sign the consent form; (6) Those who experience serious side effects during the experiment, have poor compliance, or voluntarily give up the experiment will be excluded or dropped out.

[0056] 6. Research Methods 6.1 Case Grouping The software generates random numbers and seals them. The subjects are randomly selected in the order in which they participated in the experiment. They are then grouped by number, with odd-numbered numbers assigned to the treatment group and even-numbered numbers assigned to the control group. Each group consists of 30 people.

[0057] 6.2 Treatment Plan (1) Control group: The control group received Lanqin oral liquid, 20ml each time, 3 times a day; combined with lifestyle interventions such as drinking plenty of water, eating a light diet, getting enough rest, and quitting smoking and alcohol. (2) Treatment group: The lifestyle interventions were the same as the control group, and the treatment group received Sangju Qingre granules dissolved in hot water, 10g~20g each time, 3 times a day. The course of treatment for both groups was 3~7 days.

[0058] During treatment, neither group of patients received additional antipyretics, analgesics, antihistamines, or antibacterial or antiviral drugs. If the body temperature remained above 38.5°C, temporary physical cooling or a single dose of 0.5g acetaminophen tablets after a meal could be administered to reduce the fever.

[0059] 7. Observation indicators and judgment criteria 7.1 Clinical efficacy observation indicators (1) Changes in main symptom scores: Record the TCM syndrome and symptom scores before and after treatment regularly.

[0060] (2) Changes in body temperature: Record body temperature at different time points after administration, and calculate the onset time and the time to complete de-icterification.

[0061] (3) Changes in physical signs: Observe the pharyngeal congestion and the reduction of tonsil swelling.

[0062] 7.2 Efficacy evaluation criteria (refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines") Cure: Body temperature returns to normal within 3 days of medication, main symptoms disappear, and syndrome score decreases by ≥95%; Significant effect: Body temperature returns to normal within 3 days of medication, main symptoms improve significantly, and syndrome score decreases by ≥70%; Effective: Body temperature decreased within 3 days of medication, main symptoms improved, and syndrome score decreased by ≥30%; Ineffective: If the body temperature does not decrease or increases after 3 days of medication, the symptoms do not improve or worsen, and the syndrome score decreases by less than 30%.

[0063] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of effective cases) / total number of cases × 100%.

[0064] 7.3 Security Assessment (1) General vital signs (monitor body temperature, blood pressure, heart rate, and respiration); (2) Observe whether adverse reactions such as rash, nausea, vomiting, and diarrhea occur during medication.

[0065] 7.4 Data Analysis Data in ( Mean ± standard deviation (S) is expressed as mean ± standard deviation. Statistical analysis was performed using SPSS 25.0. t-tests were used for continuous data and categorical data were analyzed using... 2. For ordinal data, the rank-sum test was used. Statistical tests were two-tailed, and a p-value ≤ 0.05 was considered statistically significant.

[0066] 8. Research Results 8.1 General Information of the Research Subjects A total of 60 eligible subjects were included, with 30 in the treatment group and 30 in the control group. Before treatment, the data of the two groups were analyzed. There were no statistically significant differences in age, disease duration and symptom scores, and the baselines were comparable (P>0.05, see Tables 1 and 2).

[0067] Table 1 Comparison of basic data of the two groups of patients before treatment Table 2 Comparison of symptom scores between the two groups before treatment 8.2 Disappearance of main symptoms Table 3. Comparison of the disappearance rate of main symptoms between the two groups of patients after 3 days of treatment (P>0.05) After 3 days of treatment, the disappearance rate of main symptoms in the treatment group was 43.33%, which was higher than that in the control group (23.33%). The treatment group showed a higher trend of relief of main symptoms, suggesting that Sangju Qingre Granules have a significant advantage in promoting the recovery of main symptoms.

[0068] 8.3 Comparison of TCM syndrome differentiation and treatment efficacy Table 4. Comparison of treatment efficacy between the two groups after treatment (P>0.05) The effective rate of both groups of patients after treatment was ≥90%, and there was no statistically significant difference in the total effective rate between the groups (P>0.05). In terms of eliminating symptoms, shortening the course of the disease, and reducing the severity of symptoms, Sangju Qingre Granules showed clinical effects comparable to Lanqin Oral Liquid, especially in relieving sore throat, which is closely related to its scientific and reasonable formulation.

[0069] 8.4 Security No serious adverse events or reactions occurred in either group of patients during this study.

[0070] 9. Research Conclusions and Discussion The results of this study indicate that Sangju Qingre Granules can significantly alleviate the main symptoms of acute upper respiratory tract infection with wind-heat syndrome, such as fever, sore throat, nasal congestion, runny nose, cough, and sputum production. The efficacy is definite and the safety is high, with a total effective rate of 93.33%, comparable to that of the marketable traditional Chinese medicine Lanqin Oral Liquid (P>0.05). In particular, Sangju Qingre Granules are more rapid and effective than Lanqin Oral Liquid in eliminating symptoms, shortening the course of the disease, and reducing the severity of symptoms, especially in relieving sore throat. This is closely related to its scientific and rational formulation, suggesting its potential in symptomatic treatment. No significant adverse reactions were observed in the study, and patient compliance and tolerance were good. Furthermore, Sangju Qingre Granules are made from high-quality traditional Chinese medicine slices, with a mature and stable production process, and the price is more affordable for primary healthcare institutions and patients, making it suitable for clinical promotion.

Claims

1. A traditional Chinese medicine composition for treating wind-heat type common cold, characterized in that, It is made from the following raw materials in parts by weight: 15-20 parts of Ilex chinensis, 10-15 parts of mulberry leaves, 4-10 parts of wild chrysanthemum, 4-10 parts of Viola yedoensis, 10-15 parts of Senecio scandens, and 4-10 parts of dandelion.

2. The traditional Chinese medicine composition for treating wind-heat type common cold according to claim 1, characterized in that: 16 portions of *Ilex chinensis*, 11.2 portions of mulberry leaves, 4.8 portions of wild chrysanthemum, 4.8 portions of *Viola yedoensis*, 12 portions of *Senecio scandens*, and 4.8 portions of dandelion.

3. A method for preparing a traditional Chinese medicine composition for treating wind-heat type common cold as described in claim 1 or 2, characterized in that, Includes the following steps: (1) Mix the weight parts of Ilex chinensis, mulberry leaves, wild chrysanthemum, Viola yedoensis, Senecio scandens and dandelion, add 6 to 10 times the total weight of the medicinal materials in water, and soak for 15 to 60 minutes; (2) After soaking, heat and boil twice, keeping it boiling for 1.5 to 2 hours after each boiling, filter, and combine the filtrates; (3) Concentrate the filtrate to a concentration with a relative density of 1.14~1.18 at 80℃, and then cool it to room temperature; (4) Slowly add 95% ethanol to the concentrate while stirring, so that the alcohol content in the solution reaches 65-70%; (5) After the medicine solution is stirred evenly, let it stand for 12-24 hours, and then filter the supernatant. (6) The supernatant was heated under reduced pressure to recover ethanol and obtain an extract. The extract was then concentrated to a relative density of 1.25~1.30 at 80°C.

4. The method for preparing a traditional Chinese medicine composition for treating wind-heat cold according to claim 3, characterized in that: It also includes the step of making the extract into granules: according to the weight ratio of 1 part extract, 5-10 parts sucrose, and 0.02-0.1 parts dextrin, put the sugar powder and dextrin into a trough mixer and mix for 5-10 minutes. Then, while stirring, add the extract evenly, seal and continue stirring for 4-10 minutes. Mix evenly to obtain a soft material that can be formed into a ball when squeezed and crumbles when touched. Make the soft material into wet granules, dry and granulate to obtain granules.

5. The method for preparing a traditional Chinese medicine composition for treating wind-heat cold according to claim 4, characterized in that: The prepared soft material is placed in a gyratory pellet mill and extruded into wet pellets using a 16-mesh stainless steel sieve or sieve plate.

6. The method for preparing a traditional Chinese medicine composition for treating wind-heat cold according to claim 5, characterized in that: Turn on the hot air circulating oven and wait until the temperature reaches 80℃. Then put the prepared wet granules into the oven for drying until the moisture content of the granules is 2~5%.

7. A method for preparing a traditional Chinese medicine composition for treating wind-heat type common cold according to claim 6, characterized in that: The dried granules are granulated using a vibrating screen to remove coarse particles and fine powder. The screens are 10 mesh and 80 mesh, respectively.

8. The method for preparing a traditional Chinese medicine composition for treating wind-heat cold according to claim 4, characterized in that: After crushing the sucrose, pass it through an 80-mesh sieve for later use.

Images