Traditional Chinese medicine composition for treating cold as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine research, and particularly relates to a traditional Chinese medicine composition for treating cold and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7-11 parts of cistanche, 10-14 parts of dried ginger, 7-11 parts of pogostemon cablin, 13-17 parts of pericarpium citri reticulatae, 10-14 parts of polygonum cuspidatum, 7-11 parts of bistort rhizome, 8-12 parts of fructus forsythiae, 28-32 parts of honeysuckle, 10-14 parts of radix bupleuri, 10-14 parts of blackberry lily, 8-12 parts of notopterygium root, 7-11 parts of radix angelicae pubescentis, 7-11 parts of divaricate saposhnikovia root, 7-11 parts of schizonepeta, 7-11 parts of radix angelicae, 10-14 parts of fingered citron, 7-11 parts of perilla stem, 13-17 parts of artemisia apiacea and 10-14 parts of folium mori. The traditional Chinese medicine composition has a better curative effect on cold-dampness cold.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine research, and particularly relates to a traditional Chinese medicine composition for treating colds, a preparation method thereof, and an application thereof. Background Art

[0002] A cold is a common clinical disease, which is an exogenous disease caused by six exogenous pathogenic factors or epidemic viruses invading the human body and causing disharmony of the lung and defensive qi functions. It belongs to the category of "warm disease theory". The main symptoms are nasal congestion, runny nose, fever, cough, sneezing, headache, aversion to cold, general discomfort, general soreness or pain, etc. Those with mild conditions are called common cold, wind cold, or cold; those with severe conditions are called severe cold. Modern medicine mainly divides colds into common colds and influenza. Among them, the common cold is the most common acute respiratory infectious disease, which is seasonal and usually occurs frequently during the season change period; influenza (abbreviated as flu) is an infectious acute respiratory disease caused by influenza virus, which causes seasonal epidemics every year globally and can trigger unpredictable pandemics, with a relatively high incidence rate, posing a huge threat to human health. Traditional Chinese medicine has a more refined understanding of colds. Generally, colds mostly occur due to the insecurity of the body's defensive qi and the invasion of exogenous pathogenic factors (wind, cold, summer heat, dampness, dryness, fire). Among them, wind pathogen is the first of the six exogenous pathogenic factors. In different seasons, wind pathogen often combines with the qi of the current season to harm people. For example, in winter, it combines with cold; in spring, it combines with heat; in summer, it combines with summer heat and dampness; in autumn, it combines with dryness qi. Therefore, colds can also be differentiated into those with cold, heat, dampness, summer heat, or dryness. Among them, cold-dampness cold, as the name implies, is the combination of cold pathogen and damp pathogen. The cold-dampness of the six exogenous pathogenic factors is carried by wind to harm people, first attacking the exterior and then spreading from the exterior to the interior, characterized by attacking the exterior, obstructing the lung, and hindering the spleen. The symptoms of cold-dampness attacking the exterior include exterior symptoms such as aversion to cold, fever, and general body aches; the symptoms of cold-dampness obstructing the lung include clinical manifestations of the lung losing its dispersing and descending functions such as chest tightness, shortness of breath, weakness, and dry cough with little sputum; the symptoms of cold-dampness hindering the spleen include clinical manifestations of the spleen losing its transportation and transformation functions such as abdominal distension, nausea, poor appetite, diarrhea, and sticky and unsmooth stools.

[0003] Currently, Western medicine often uses antibacterial or antiviral drugs in the treatment of colds. Their overuse may lead to drug resistance of bacteria and viruses, posing potential safety hazards. Traditional Chinese medicine has unique advantages in the treatment of colds. It differentiates and treats according to clinical symptoms. The traditional Chinese medicines and their preparations used have the characteristics of multiple targets, low drug resistance, and good antipyretic effects, and have certain advantages in relieving flu symptoms, reducing severe cases, and shortening the hospital stay.

[0004] Currently, the marketed traditional Chinese medicine preparations for treating colds include Jiuwei Qianghuo Granules, Biaoshi Ganmao Granules, Guizhi Mixture, Zhengchaihu Yin Granules, etc., which have the effects of inducing sweating to relieve the exterior syndrome and dispelling wind and cold. However, these traditional Chinese medicine preparations cannot achieve good curative effects on cold-dampness type colds. Summary of the Invention

[0005] In view of the above technical problems, the present invention provides a traditional Chinese medicine composition for treating colds, which has a better therapeutic effect on colds of the cold-damp type.

[0006] The specific technical solution provided by the present invention is as follows: In a first aspect of the present invention, there is provided a traditional Chinese medicine composition for treating colds, which is prepared from the following raw materials by weight parts: 7-11 parts of cistanche, 10-14 parts of dried ginger, 7-11 parts of pogostemon cablin, 13-17 parts of dried tangerine peel, 10-14 parts of polygonum cuspidatum, 7-11 parts of bistorta officinalis, 8-12 parts of forsythia suspensa, 28-32 parts of honeysuckle flower, 10-14 parts of bupleurum chinense, 10-14 parts of belamcanda chinensis, 8-12 parts of notopterygium incisum, 7-11 parts of angelica pubescens, 7-11 parts of ledebouriella seseloides, 7-11 parts of schizonepeta tenuifolia, 7-11 parts of dahurian angelica root, 10-14 parts of fingered citron, 7-11 parts of perilla stem, 13-17 parts of artemisia annua, 10-14 parts of mulberry leaf.

[0007] As a preferred embodiment of the present invention, the traditional Chinese medicine composition is prepared from the following raw materials by weight parts: 9 parts of cistanche, 12 parts of dried ginger, 9 parts of pogostemon cablin, 15 parts of dried tangerine peel, 12 parts of polygonum cuspidatum, 9 parts of bistorta officinalis, 10 parts of forsythia suspensa, 30 parts of honeysuckle flower, 12 parts of bupleurum chinense, 12 parts of belamcanda chinensis, 10 parts of notopterygium incisum, 9 parts of angelica pubescens, 9 parts of ledebouriella seseloides, 9 parts of schizonepeta tenuifolia, 9 parts of dahurian angelica root, 12 parts of fingered citron, 9 parts of perilla stem, 15 parts of artemisia annua, 12 parts of mulberry leaf.

[0008] In a second aspect of the present invention, there is provided a preparation method of the traditional Chinese medicine composition, comprising the following steps: Weigh cistanche, dried ginger, pogostemon cablin, dried tangerine peel, polygonum cuspidatum, bistorta officinalis, forsythia suspensa, honeysuckle flower, bupleurum chinense, belamcanda chinensis, notopterygium incisum, angelica pubescens, ledebouriella seseloides, schizonepeta tenuifolia, dahurian angelica root, fingered citron, perilla stem, artemisia annua, mulberry leaf according to weight parts and set aside; Mix the weighed medicinal materials, soak them in water, decoct them, and collect the decoction liquid to obtain the traditional Chinese medicine composition.

[0009] As a preferred embodiment of the present invention, the soaking in water is to soak in 8-10 times the total weight of the medicinal materials in water for 30-40 minutes.

[0010] As a preferred embodiment of the present invention, the decocting is to decoct 2-3 times, 60-80 minutes each time.

[0011] As a preferred embodiment of the present invention, the obtained decoction liquid is concentrated to a relative density of 1.26-1.30 at 60 °C to obtain the extract of the traditional Chinese medicine composition.

[0012] In a third aspect of the present invention, there is provided the use of the traditional Chinese medicine composition in the preparation of a product for inhibiting Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus, Moraxella catarrhalis or Haemophilus influenzae.

[0013] As a preferred embodiment of the present invention, the traditional Chinese medicine composition is used for preparing a medicament for treating colds.

[0014] More preferably, the traditional Chinese medicine composition is used for preparing a medicament for treating colds of the cold-damp type.

[0015] In the fourth aspect of the present invention, there is provided a pharmaceutical preparation for treating colds of the cold-damp type, which uses the traditional Chinese medicine composition as the sole active ingredient.

[0016] As a preferred embodiment of the present invention, the pharmaceutical preparation is prepared by compounding the traditional Chinese medicine composition with pharmaceutically acceptable excipients.

[0017] As a preferred embodiment of the present invention, the pharmaceutical preparation is an oral preparation.

[0018] More preferably, the pharmaceutical preparation is a granule, and the granule is prepared according to the following steps: Weigh cistanche deserticola, dried ginger, pogostemon cablin, tangerine peel, polygonum cuspidatum, bistorta officinalis, forsythia suspensa, honeysuckle flower, bupleurum chinense, belamcanda chinensis, notopterygium incisum, angelica pubescens, ledebouriella seseloides, schizonepeta tenuifolia, dahurian angelica root, fingered citron, perilla stem, artemisia annua, and mulberry leaf, and set aside; Mix the weighed medicinal materials, soak them in water, decoct them, collect the decoction, and concentrate it to obtain an extract with a relative density of 1.26 - 1.30 at 60°C. Add corn starch and dextrin to the extract to make soft materials, obtain wet granules, and dry them to obtain the traditional Chinese medicine composition in granule form.

[0019] More preferably, the extract, corn starch, and dextrin are mixed in a mass ratio of 100∶135∶6.

[0020] Xinjiang is located in the northwest region of China. People living on this land are affected by the living environment factors. The common people eat a lot of fatty, sweet, and rich foods. Over time, it damages the spleen and stomach, resulting in disharmony of the spleen and stomach transportation and transformation, and it is easy to present clinical syndromes of spleen deficiency with dampness and stagnation and internal transformation into heat. In addition, the weather in Xinjiang is dry, the temperature difference between day and night in summer is large, and it is cold in winter. It is easy to catch wind-cold externally, and when it enters the interior and combines with dampness, it is easy to transform into heat, resulting in the cold-damp syndrome of respiratory tract infection. The traditional Chinese medicine composition provided by the present invention is formulated based on the situation in Xinjiang region through years of clinical practice and experience summary by experts. This traditional Chinese medicine composition is based on the principle of "dispelling cold and removing dampness, avoiding filth and transforming turbidity, clearing away pestilence and dredging collaterals, warming the kidney and strengthening the spleen", aiming to use rapid and effective traditional Chinese medicine syndrome differentiation and medication to treat colds of the cold-damp type, especially having better curative effects on acute upper respiratory tract infections. Moreover, during the COVID-19 pandemic, in the process of treating COVID-19 virus infections, it has significant curative effects, significantly improves symptoms, shortens the course of disease, and improves traditional Chinese medicine syndromes.

[0021] The traditional Chinese medicine composition provided by the present invention is composed of Cistanche deserticola, dried ginger, Pogostemon cablin, tangerine peel, Polygonum cuspidatum, Bistorta vivipara, Forsythia suspensa, Lonicera japonica, Bupleurum chinense, Belamcanda chinensis, Notopterygium incisum, Angelica pubescens, Saposhnikovia divaricata, Angelica dahurica, Schizonepeta tenuifolia, Citrus medica var. sarcodactylis, Perilla frutescens var. acuta, Artemisia annua, and Morus alba. In this prescription, Cistanche deserticola tonifies the kidney and assists yang, protects the lower energizer, "strengthens the source of fire to dispel yin and turbidity"; dried ginger warms the middle-jiao to dispel cold and strengthens the spleen-yang, warms the middle-jiao, dispels the gloomy cold-dampness qi in the middle-jiao, and activates the spleen and protects yang; the combination of Cistanche deserticola and dried ginger can tonify the kidney-yang, benefit essence and blood, warm the middle-jiao to dispel cold, restore yang and promote blood circulation, warm the lungs to resolve fluid-retention, respectively protect the yang qi of the lower and middle energizers from the invasion of cold qi, and achieve the effect of "strengthening the root and cultivating the yuan", thus relieving the symptoms of cold-dampness directly attacking the spleen and stomach and injuring the transportation and transformation of the kidney-yang, with deficiency-cold in the lower energizer, resulting in gastrointestinal symptoms such as nausea, anorexia, and diarrhea, as well as soreness and weakness in the lower limbs. Pogostemon cablin aromatizes dampness and harmonizes the middle-jiao to stop vomiting; tangerine peel promotes qi circulation to relieve pain, strengthens the spleen and harmonizes the middle-jiao, regulates qi mechanism, and smooths the ascending and descending of qi in the middle-jiao in an orderly manner; the combination of the two together plays the roles of aromatizing dampness, stopping vomiting, regulating qi and strengthening the spleen, and drying dampness and resolving phlegm, synergistically with dried ginger to remove the cold-dampness blockage in the middle-jiao. Dried ginger, Pogostemon cablin, and tangerine peel protect the middle-jiao, combined with Cistanche deserticola, and the combination of these four herbs together exerts the effects of warming the kidney and strengthening the spleen, dispelling cold and dampness, and avoiding filth and turbidity, and they are the monarch drugs. Modern pharmacological studies have shown that Cistanche deserticola, dried ginger, Pogostemon cablin, and tangerine peel all have antiviral, anti-inflammatory, and antibacterial effects; in addition, Cistanche deserticola also has the effects of improving lung injury, anti-fatigue, and immune regulation; dried ginger also has the effects of protecting the spleen and stomach, anti-fatigue, protecting the cardiovascular system, and protecting the liver; Pogostemon cablin also has the effect of protecting the gastrointestinal tract; tangerine peel also has the effects of anti-acute lung injury and promoting digestion.

[0022] Polygonum bistorta, Polygonum cuspidatum, Lonicera japonica, and Forsythia suspensa mainly clear heat and detoxify, disperse wind-heat, promote diuresis and relieve pain, and resolve phlegm and relieve cough. The combined use of these four herbs can quickly and effectively intercept fever at the initial stage of the disease. When the disease spreads rapidly, it can prevent pathogenic heat from congesting internally, phlegm-heat from congesting and blocking the pericardium, resulting in coma, restlessness, and the development of the syndromes of blockage and collapse. Bupleurum chinense and Belamcanda chinensis mainly relieve exterior syndrome and reduce fever, clear heat and detoxify, and disperse phlegm and soothe the throat. Notopterygium incisum and Heracleum hemsleyanum together relieve exterior syndrome, dispel cold, expel wind and remove dampness. Saposhnikovia divaricata dispels wind and relieves exterior syndrome, eliminates dampness and relieves pain, and stops convulsions. Angelica dahurica relieves exterior syndrome, dispels cold, expels wind and relieves pain, opens the nasal orifice, eliminates dampness and stops leukorrhea, and reduces swelling and drains pus. Schizonepeta tenuifolia dispels wind and relieves exterior syndrome, promotes eruption and resolves carbuncles. Wind-cold-dampness-turbidity invades through the mouth and nose, first attacking the lungs. Coupled with excessive autumn yang, there is latent heat in the lungs, which accumulates and stagnates in the lungs and lodges in the throat, resulting in dry cough, scanty sputum, dry throat, sore throat, and discomfort in the throat. With the interference of the fiery qi of the ministerial fire of Shaoyang, there are accompanying symptoms such as bitter taste in the mouth of Shaoyang. Bupleurum chinense and Belamcanda chinensis mainly relieve exterior syndrome and reduce fever, clear heat and detoxify, resolve phlegm, and soothe the throat. Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium incisum, Heracleum hemsleyanum, and Angelica dahurica mainly dispel wind and relieve exterior syndrome, dispel cold, expel wind and eliminate dampness, eliminate dampness and relieve pain, and open the nasal orifice. They are used to treat exterior syndromes with symptoms such as aversion to cold, fever, and general body aches when cold-dampness attacks the exterior; when cold-dampness blocks the lungs, there are clinical manifestations such as chest tightness, shortness of breath, weakness, dry cough with scanty sputum, etc., indicating the failure of the lungs to disperse and descend. The above-mentioned herbs together achieve the effects of dispelling wind and relieving exterior syndrome, reducing fever, dispelling cold, expelling wind and eliminating dampness, resolving phlegm, and soothe the throat, so they are ministerial herbs. Modern pharmacological research shows that all 11 ministerial herbs have the effects of antiviral, anti-inflammatory, antibacterial, antipyretic, and analgesic. In addition, Polygonum cuspidatum can also improve lung injury and resist pulmonary fibrosis; Lonicera japonica can also enhance the body's immunity; Bupleurum chinense can also regulate immunity and improve lung injury; Belamcanda chinensis can also eliminate the exudate of upper respiratory tract inflammation; Notopterygium incisum can also improve gastrointestinal function; Saposhnikovia divaricata can also enhance immunity.

[0023] The adjuvant herbs, Citrus medica var. sarcodactylis and Perilla frutescens var. acuta, mainly regulate qi and harmonize the middle, dry dampness and resolve phlegm, widen the chest and promote qi movement, and soothe qi. They assist and coordinate with Zingiber officinale, Pogostemon cablin, and Citrus reticulata to regulate the qi of the middle jiao. The adjuvant herbs, Artemisia annua and Morus alba, mainly clear and disperse deficiency heat, cool the blood and relieve hectic fever, disperse wind-heat, and clear the liver and improve eyesight. When combined with Polygonum bistorta, Polygonum cuspidatum, Lonicera japonica, and Forsythia suspensa, they achieve the effect of clearing heat and detoxifying. They are used for cases of heat transformation from cold-dampness, such as the closure of the lung defense, the turbidity lodging in the viscera, and the transformation into heat. After the high fever has subsided, there are still symptoms such as feverishness in the early morning and dry and uncomfortable eyes.

[0024] In summary, the combined use of 19 herbs has the effects of warming the kidney and strengthening the spleen, dispelling cold and removing dampness, avoiding turbidity and resolving turbidity, clearing away pestilence and dredging collaterals. It is used for cold-dampness colds, mainly treating symptoms such as headache, body ache, fever and aversion to cold, nasal congestion, runny nose, sore throat, and cough.

[0025] The traditional Chinese medicine composition provided by the present invention has a bactericidal effect on 5 kinds of cold-causing bacteria, namely Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus, Moraxella catarrhalis, and Haemophilus influenzae. Description of the Drawings

[0026] Figure 1are the test results of the inhibitory and bactericidal effects of the traditional Chinese medicine composition on various pathogenic bacteria; ① - ⑪ are the experimental groups with the addition of traditional Chinese medicine composition solutions at concentrations of 40mg / mL, 20mg / mL, 10mg / mL, 5mg / mL, 2.5mg / mL, 1.25mg / mL, 0.625mg / mL, 0.3125mg / mL, 0.1562mg / mL, 0.0781mg / mL, and 0.0391mg / mL respectively, and ⑫ is the blank control group. Detailed implementation manners

[0027] The technical solutions in the embodiments of the present invention are further clearly described. The described embodiments are only a part of the present invention, used to explain the present invention, but not to limit the present invention. Therefore, other embodiments obtained by those skilled in the art without creative labor fall within the protection scope of the present invention.

[0028] Cold is a common clinical disease, an exogenous disease caused by the invasion of six exogenous pathogenic factors or epidemic viruses into the human body, resulting in the disorder of the lung-defense function. It belongs to the category of "warm disease theory". The main symptoms include nasal congestion, runny nose, fever, cough, sneezing, headache, aversion to cold, general discomfort, general soreness or pain, etc. Those with mild conditions are called common cold, wind cold, or cold; those with severe conditions are called severe cold. Traditional Chinese medicine has a more refined understanding of colds, believing that general colds are mostly caused by the insecurity of the body's defensive qi and the invasion of exogenous pathogenic factors (wind, cold, summer heat, dampness, dryness, and fire).

[0029] At present, Western medicine often uses antibacterial or antiviral drugs in the treatment of colds. Their overuse may lead to drug resistance in bacteria and viruses, posing potential safety hazards. Traditional Chinese medicine has unique advantages in the treatment of colds. It differentiates and treats according to clinical symptoms. The traditional Chinese medicines and their preparations used have the characteristics of multiple targets, low drug resistance, and good antipyretic effects, and have certain advantages in relieving influenza symptoms, reducing severe cases, and shortening hospital stays. However, most of the currently marketed traditional Chinese medicine preparations are drugs for diaphoresis and relieving exterior syndrome, expelling wind and cold, and cannot treat colds of the cold-damp type symptomatically.

[0030] The present invention provides a traditional Chinese medicine composition for treating colds, which is prepared from the following raw materials by weight: 7 - 11 parts of cistanche, 10 - 14 parts of dried ginger, 7 - 11 parts of pogostemon, 13 - 17 parts of tangerine peel, 10 - 14 parts of polygonum cuspidatum, 7 - 11 parts of bistorta, 8 - 12 parts of forsythia, 28 - 32 parts of honeysuckle, 10 - 14 parts of bupleurum, 10 - 14 parts of belamcanda, 8 - 12 parts of notopterygium, 7 - 11 parts of angelica pubescens, 7 - 11 parts of ledebouriella, 7 - 11 parts of schizonepeta, 7 - 11 parts of dahurian angelica root, 10 - 14 parts of fingered citron, 7 - 11 parts of perilla stem, 13 - 17 parts of artemisia annua, 10 - 14 parts of mulberry leaf.

[0031] The following is an illustration with specific embodiments.

[0032] Example 1 A traditional Chinese medicine composition for treating colds, with the formula components being: 9g of Cistanche deserticola, 12g of dried ginger, 9g of Pogostemon cablin, 15g of tangerine peel, 12g of Polygonum cuspidatum, 9g of Bistorta officinalis, 10g of Forsythia suspensa, 30g of Lonicera japonica, 12g of Bupleurum chinense, 12g of Belamcanda chinensis, 10g of Notopterygium incisum, 9g of Heracleum hemsleyanum, 9g of Saposhnikovia divaricata, 9g of Schizonepeta tenuifolia, 9g of Angelica dahurica, 12g of Citrus medica var. sarcodactylis, 9g of Perilla frutescens var. acuta, 15g of Artemisia annua, 12g of Morus alba leaves.

[0033] Example 2 A traditional Chinese medicine composition for treating colds, with the formula components being: 7g of Cistanche deserticola, 10g of dried ginger, 7g of Pogostemon cablin, 13g of tangerine peel, 10g of Polygonum cuspidatum, 7g of Bistorta officinalis, 8g of Forsythia suspensa, 28g of Lonicera japonica, 10g of Bupleurum chinense, 10g of Belamcanda chinensis, 8g of Notopterygium incisum, 7g of Heracleum hemsleyanum, 7g of Saposhnikovia divaricata, 7g of Schizonepeta tenuifolia, 7g of Angelica dahurica, 10g of Citrus medica var. sarcodactylis, 7g of Perilla frutescens var. acuta, 13g of Artemisia annua, 10g of Morus alba leaves.

[0034] Example 3 A traditional Chinese medicine composition for treating colds, with the formula components being: 11g of Cistanche deserticola, 14g of dried ginger, 11g of Pogostemon cablin, 17g of tangerine peel, 14g of Polygonum cuspidatum, 11g of Bistorta officinalis, 12g of Forsythia suspensa, 32g of Lonicera japonica, 14g of Bupleurum chinense, 14g of Belamcanda chinensis, 12g of Notopterygium incisum, 11g of Heracleum hemsleyanum, 11g of Saposhnikovia divaricata, 11g of Schizonepeta tenuifolia, 11g of Angelica dahurica, 14g of Citrus medica var. sarcodactylis, 11g of Perilla frutescens var. acuta, 13 - 17g of Artemisia annua, 14g of Morus alba leaves.

[0035] Example 5 A traditional Chinese medicine composition for treating colds, with the formula components being: 10g of Cistanche deserticola, 12g of dried ginger, 8g of Pogostemon cablin, 15g of tangerine peel, 12g of Polygonum cuspidatum, 10g of Bistorta officinalis, 12g of Forsythia suspensa, 28g of Lonicera japonica, 10g of Bupleurum chinense, 10g of Belamcanda chinensis, 10g of Notopterygium incisum, 10g of Heracleum hemsleyanum, 10g of Saposhnikovia divaricata, 8g of Schizonepeta tenuifolia, 8g of Angelica dahurica, 10g of Citrus medica var. sarcodactylis, 10g of Perilla frutescens var. acuta, 15g of Artemisia annua, 12g of Morus alba leaves.

[0036] Example 6 A traditional Chinese medicine composition for treating colds, with the formula components being: 10g of Cistanche deserticola, 12g of dried ginger, 8g of Pogostemon cablin, 15g of tangerine peel, 10g of Polygonum cuspidatum, 10g of Bistorta officinalis, 8g of Forsythia suspensa, 32g of Lonicera japonica, 10g of Bupleurum chinense, 12g of Belamcanda chinensis, 8g of Notopterygium incisum, 8g of Heracleum hemsleyanum, 8g of Saposhnikovia divaricata, 8g of Schizonepeta tenuifolia, 10g of Angelica dahurica, 12g of Citrus medica var. sarcodactylis, 8g of Perilla frutescens var. acuta, 15g of Artemisia annua, 10g of Morus alba leaves.

[0037] The traditional Chinese medicine compositions provided in the above Examples 1 - 6 are all prepared according to the following steps: Weigh the medicinal materials according to the formula weight, put them into the extraction tank, add 8 times the weight of the total medicinal materials of water, soak for 30 min, heat to boiling and boil for 60 min, then filter. Keep the filtrate, extract twice, and combine the filtrates obtained from the two decoctions; further concentrate to obtain an extract with a relative density of 1.26 (60 °C).

[0038] Example 7 A traditional Chinese medicine composition for treating colds, the difference from Example 1 is only in the preparation process. Specifically: Weigh the medicinal materials according to the formula weight, put them into the extraction tank, add 10 times the weight of the total medicinal materials of water, soak for 40 min, heat to boiling and boil for 80 min, then filter. Keep the filtrate, extract twice, and combine the filtrates obtained from the two decoctions; further concentrate to obtain an extract with a relative density of 1.30 (60 °C).

[0039] The traditional Chinese medicine composition provided by the present invention can be prepared into oral preparations, such as granules, capsules, tablets, syrups, etc., according to pharmaceutically acceptable methods. Taking granules as an example in the embodiments of the present invention, the specific preparation process is described as follows:

[0040] The specific preparation method of the traditional Chinese medicine composition in the form of granules provided by the present invention is: Weigh the medicinal materials according to the formula weight of Example 1, put them into the extraction tank, add 8 times the weight of the total medicinal materials of water, soak for 30 min, heat to boiling and boil for 60 min, then filter. Keep the filtrate, extract twice, and combine the filtrates obtained from the two decoctions; further concentrate to obtain an extract with a relative density of 1.26 (60 °C); add excipients according to the ratio of extract, corn starch and dextrin of 100∶135∶6, make soft materials, pass through a 10-mesh sieve to obtain wet granules, dry at 65 °C for 45 - 60 min, and pass through 10-mesh and 80-mesh sieves to obtain the product.

[0041] It should be noted that the traditional Chinese medicine compositions provided in Examples 1 - 7 can all be prepared into granules according to the above method. Here, only the traditional Chinese medicine composition of Example 1 is taken as an example for description, but it is not a special limitation on the preparation method.

[0042] The identification method of the traditional Chinese medicine composition or its preparation provided by the present invention is: Take 2 g of the powder of this product, add 10 ml of methanol, ultrasonically treat for 30 minutes, filter, take 5 ml of the filtrate, concentrate to 1 ml, and use it as the test solution. Separately take hesperidin reference substance, and make a saturated solution with methanol as the reference substance solution. According to the thin-layer chromatography method (General Rule 0502), respectively draw 5 μl of the above-mentioned test solution and 2 μl of the reference substance solution, spot them on a silica gel G thin-layer plate respectively, use ethyl acetate-methanol-water (11:2:0.5) as the developing solvent, develop to about 3 cm, take out, dry in air, then use the upper layer solution of toluene-ethyl acetate-formic acid-water (20:10:1:1) as the developing solvent, develop to about 8 cm, take out, dry in air, spray with aluminum trichloride test solution, and examine under an ultraviolet lamp (365 nm). In the chromatogram of the test solution, at the position corresponding to the chromatogram of the reference substance, there are the same yellow-green fluorescent spots.

[0043] Take 2 g of the powder of this product, add 10 ml of absolute ethanol, ultrasonically treat for 20 minutes, filter, concentrate the filtrate to dryness, dissolve the residue in 0.5 ml of absolute ethanol to make a solution, and use it as the test solution. Separately take 1 g of the control crude drug of fingered citron, and prepare the control crude drug solution in the same way. According to the thin-layer chromatography method (General Rule 0502), respectively draw 5 μl of the above two solutions, spot them on the same silica gel G thin-layer plate respectively, use cyclohexane-ethyl acetate (2:1) as the developing solvent, develop, take out, dry in air, and examine under an ultraviolet lamp (365 nm). In the chromatogram of the test solution, at the position corresponding to the chromatogram of the control crude drug, there are fluorescent spots of the same color.

[0044] Take 5 g of the powder of this product, add 30 ml of petroleum ether (60-90 °C), heat under reflux for 30 minutes, discard the petroleum ether solution, dry the medicinal residue by evaporation, add 30 ml of ethanol, ultrasonically treat for 20 minutes, filter, evaporate the filtrate to dryness, heat 10 ml of hot water to the residue, stir to dissolve it in a water bath at 60 °C, filter, evaporate the filtrate to dryness, dissolve the residue in 2 ml of methanol to make a solution, and use it as the test solution. Separately take 2 g of the control crude drug of mulberry leaf, and prepare the control crude drug solution in the same way. According to the thin-layer chromatography method (General Rule 0502), respectively draw 5 μl of the above two solutions, spot them on the same silica gel G thin-layer plate respectively, use the upper layer solution of xylene-ethyl acetate-formic acid (5∶2∶1) as the developing solvent, place it in a developing tank pre-saturated with the developing solvent for 25 minutes, develop to about 8 cm, take out, dry in air, and examine under an ultraviolet lamp (365 nm). In the chromatogram of the test solution, at the position corresponding to the chromatogram of the control crude drug, there are fluorescent spots of the same color.

[0045] Take 2 g of the powder of this product, add 10 ml of methanol, ultrasonically treat for 30 minutes, filter, concentrate the filtrate to 2 ml, and use it as the test solution. Separately take chlorogenic acid reference substance, add methanol to prepare a solution containing 1 mg per 1 ml, and use it as the reference solution. According to the thin-layer chromatography method (General Rule 0502), respectively draw 5 μl of the test solution and 2 μl of the reference solution, and spot them on the same silica gel H thin-layer plate. Use the upper layer solution of butyl acetate-formic acid-water (7:2.5:2.5) as the developing solvent, develop, take out, dry in air, and examine under an ultraviolet lamp (365 nm). In the chromatogram of the test solution, at the position corresponding to the chromatogram of the reference substance, there appears the same green fluorescent spot.

[0046] Take 2 g of the powder of this product, add 5 ml of methanol, ultrasonically treat for 30 minutes, let stand, and take the supernatant as the test solution. Separately take nodakenin reference substance, add methanol to prepare a solution containing 0.5 mg per 1 ml, and use it as the reference solution. According to the thin-layer chromatography method (General Rule 0502), respectively draw 5 μl of the above two solutions, and spot them on the same silica gel G thin-layer plate prepared with 3% sodium acetate solution. Use chloroform-methanol (7:3) as the developing solvent, develop, take out, dry in air, and examine under an ultraviolet lamp (365 nm). In the chromatogram of the test solution, at the position corresponding to the chromatogram of the reference substance, there appears the same blue fluorescent spot.

[0047] 1 Clinical data and test methods 1.1 Clinical data Select 100 patients with cold-dampness cold (acute upper respiratory tract infection) diagnosed from May 2022 to October 2024 and admitted to the Department of Respiratory Medicine of the Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region for clinical observation. Among them, there are 48 males and 52 females, aged 18 - 65 years.

[0048] 1.2 Diagnostic criteria 1.2.1 Key points for the diagnosis and differential diagnosis of common cold Refer to the "Clinical Practice Guidelines for the Diagnosis and Treatment of Adult Common Cold" (2023 edition) and the "Expert Consensus on the Standard Diagnosis and Treatment of Common Cold" (2012 edition). With the addition of 1 digestive tract symptom (diarrhea or nausea and vomiting), other digestive or respiratory symptoms may also be present. Exclude other gastrointestinal diseases such as bacterial infections, food poisoning, and infectious enteritis, and then the diagnosis can be made. The diagnosis of common cold and gastrointestinal diseases is mainly based on typical clinical symptoms and is confirmed on the premise of excluding other diseases.

[0049] Clinical symptoms: Acute onset with symptoms such as aversion to cold, fever, fatigue, cough with expectoration, diarrhea or nausea and vomiting, headache, and muscle soreness, and the symptoms of aversion to cold, fever, and fatigue are prominent.

[0050] Physical examination: Nasal mucosa is congested, edematous, with secretions, pharynx is slightly congested, and there are mostly no abnormalities in the chest physical examination.

[0051] Peripheral blood picture: The total white blood cell count is normal or low, and the proportion of lymphocytes increases relatively. In severe cases, the total white blood cell count and the number of lymphocytes may decrease.

[0052] Differential diagnosis: Influenza (including influenza A, influenza B, etc.), acute bacterial sinusitis, allergic rhinitis, acute bronchitis, streptococcal pharyngitis, herpangina, 2019 novel coronavirus infection (COVID-19).

[0053] 1.2.2 TCM syndrome differentiation criteria for cold with dampness-cold syndrome: Refer to the "Diagnosis and Treatment Guidelines for Common Diseases in TCM Internal Medicine" (China Association of Chinese Medicine, 2008).

[0054] Dampness-cold syndrome: Main symptoms: Aversion to cold is severe, fever is mild, and there is fatigue and weakness.

[0055] Secondary symptoms: Nausea and vomiting, profuse and clear phlegm, abdominal pain, loss of appetite, loose stools, and clear and long urination. The tongue coating is white and greasy, and the pulse is soggy and slow.

[0056] If 2 main symptoms are present and 2 or more secondary symptoms are present, combined with the tongue and pulse conditions, the diagnosis can be made.

[0057] 1.2.3 Inclusion criteria 1 Those who meet the criteria of acute upper respiratory tract infection - common cold in Western medicine; 2 Those who meet the TCM cold with dampness-cold syndrome criteria; 3 Aged ≥ 18 years old and ≤ 65 years old, regardless of gender; 4 Those who are newly diagnosed with a disease course within 48 hours before randomization; 5 At the time of enrollment, fever (axillary body temperature ≥ 37.5°C and ≤ 39°C within 24 hours before randomization), aversion to cold are necessary, and at least one of nausea and vomiting, fatigue is required; 1.2.4 Exclusion criteria 6 Those with complications such as influenza, 2019 novel coronavirus infection, pneumonia, suppurative tonsillitis, acute tracheo-bronchitis, pulmonary tuberculosis, acute exacerbation of asthma, primary ciliary dyskinesia syndrome, other acute nasal diseases (such as allergic rhinitis, acute and chronic rhinitis, acute and chronic sinusitis, etc.), abnormal nasal mucosa function in those who have undergone nasal surgery or radiotherapy in the nasopharynx; 7 White blood cells > 1.2 times the upper limit of the normal value or neutrophil percentage > the upper limit of the normal value, and those considered by the researcher to be infected with bacteria; 8 Those with severe malnutrition or a tendency to hypotension and a history of convulsions; 9 Those who have used antibiotics or antiviral drugs after the onset of this illness; those who have used traditional Chinese or Western medicines that can relieve the symptoms of common cold within 6 hours before randomization, including but not limited to antihistamines, steroids, decongestants, antipyretics, antitussives, and expectorants. 10 Those with ALT or AST ≥ 1.5 times the upper limit of normal value or SCr > the upper limit of normal value during screening. 11 Those with primary diseases in severe respiratory, cardiovascular, cerebrovascular, endocrine, digestive, and hematopoietic systems or those with severe mental illnesses during screening. 12 Those suspected of having or with a confirmed history of alcohol or drug abuse. 13 Pregnant women, lactating women, or women of childbearing age planning to conceive; or female subjects of childbearing age and male subjects (whose partners are female subjects of childbearing age) who do not agree to take effective contraceptive measures voluntarily from the screening period to 1 month after the last dose. 14 Those with allergic constitution or those allergic to the test drug. 15 Those who have participated in other clinical trials and taken investigational drugs within the past 3 months. 16 Other patients considered by clinicians to be unsuitable for the trial.

[0058] 2 Treatment and Observation 2.1 Treatment Method Take the granule of the present invention orally three times a day, in the morning, at noon, and in the evening, and take it continuously for 5 days (15 times). Each time, take 30 g (2 packs) of the granule. If a dose is missed on the same day, record it on the diary card according to the actual medication situation and do not make up the missed dose. During the medication period, stop taking other drugs and avoid eating raw, cold, spicy, and stimulating foods.

[0059] (1) Regulations on concomitant medications During the trial, ① if the body temperature of the subject ≥ 39.0 °C or the body temperature after taking the medicine ≥ 38.5 °C and lasts for more than 4 hours, antipyretic analgesics (paracetamol tablets) can be given for treatment, and the dosage and time point of taking the medicine should be recorded; ② the use of drugs for the treatment of underlying diseases is allowed; ③ according to the needs of the condition, fluid replacement treatment can be given appropriately.

[0060] (2) Prohibited concomitant medications or treatments During the trial, except for the test drug and drugs for the treatment of underlying diseases, other drugs that affect the evaluation of the efficacy and safety of wind-cold syndrome of common cold should be avoided, mainly including: ① drugs of the same kind for the treatment of common cold (including traditional Chinese medicines) other than those specified in the protocol; ② glucocorticoids; ③ antibiotics or Western antiviral drugs, etc.

[0061] 2.2 Observation Indicators 2.2.1 Efficacy Observation Indicators and Observation Time Points Take body temperature, clinical symptoms of the disease, and TCM syndrome score as efficacy observation indicators.

[0062] (1) Body temperature: The body temperature of the subject was recorded once before the first dose, and then once every 6 hours until the body temperature returned to ≤ 37.2°C (axillary temperature) and remained so for 24 hours, after which recording could cease.

[0063] (2) Traditional Chinese medicine (TCM) syndrome scores: Main symptoms: severe aversion to cold, mild fever, fatigue; secondary symptoms: headache, muscle soreness, nausea and vomiting, profuse and clear phlegm, abdominal pain, loss of appetite, loose stools, clear and profuse urine. Records were taken before the first dose (baseline) and on the fifth day of medication.

[0064] (3) Laboratory test indicators: ① Blood routine: including white blood cells (WBC), neutrophil ratio (NEUT%), lymphocyte percentage (LY%).

[0065] 2.2.2 Safety observation indicators and observation time points (1) Vital signs (respiratory rate, pulse, body temperature, blood pressure): Observed and recorded at the first visit and on the 5 + 1 day of medication (treatment endpoint).

[0066] (2) Physical examination: Head and neck; chest; abdomen; limb joints; mental / neurological; lymph nodes; others. Observed and recorded at the first visit and on the 5 + 1 day of medication (treatment endpoint).

[0067] (3) Adverse reactions: The whole process of the subject receiving the study drug was monitored, and any adverse reactions such as dizziness, nausea, diarrhea, dry mouth, loss of appetite, and rash during the medication process were recorded in detail at any time.

[0068] 2.3 Evaluation indicators 2.3.1 Efficacy evaluation indicators The disease effective rate and the TCM syndrome score / efficacy rate were used as efficacy evaluation indicators. The above evaluations were statistically analyzed 5 days after medication.

[0069] 1) Disease effective rate: After medication, fever disappeared, and symptoms such as aversion to cold and fever, fatigue, cough and expectoration, diarrhea or nausea and vomiting, headache, and muscle soreness all disappeared and remained so for 24 hours or more.

[0070] Total treatment effective rate = cure rate + marked effective rate + effective rate.

[0071] 2) TCM syndrome score / efficacy rate: After medication, the reduction of the TCM syndrome score was ≥ 50%.

[0072] TCM syndrome effective rate (%) = (number of effective cases of TCM syndrome / total number of patients) × 100%.

[0073] Table 1 Quantitative evaluation criteria for main symptoms Table 2 Secondary Symptom Classification and Quantification Evaluation Criteria 2.3.2 Treatment Criteria Clinical cure: Symptoms and signs disappear, the observed indicators return to normal, and the total score decreases by ≥95%; Marked effect: Symptoms and signs disappear, the observed indicators return close to normal, and the total score decreases by ≥70%; Effective: Some symptoms and signs disappear, the observed indicators do not return to normal, and the total score decreases by ≥30% and <70%; Ineffective: Those with no obvious improvement or aggravation of symptoms, or those who add western medicine, and the total score decreases by <30%.

[0074] Total treatment effective rate = cure rate + marked effect rate + effective rate.

[0075] 2.3.3 Safety Evaluation Indicators It includes the analysis of vital signs, physical examination, and the incidence of adverse reactions. Mainly focus on the subjects who were normal before treatment but abnormal after treatment, and those who were abnormal before treatment but worsened after treatment; for vital signs, descriptive analysis and self-comparison before and after treatment are carried out.

[0076] 3 Statistical Analysis SPSS 20.0 statistical software is used. Count data are expressed as rate (%), and the X 2 test is performed for comparison between groups; measurement data are expressed as mean ± standard deviation (x ± s), the independent samples t-test is performed for comparison between groups, and the paired samples t-test is performed for comparison within groups. P <0.05 is considered statistically significant for the difference.

[0077] 4 Treatment Results 4.1 Summary of Patients' Clinical Efficacy After drug treatment, the total effective rate of the patients is 96%, among which the clinical cure rate is 41%, the marked effect rate is 38%, and the effective rate is 15%, as shown in Table 3.

[0078] Table 3 Summary Table of Clinical Efficacy of Patients with Cold due to Cold-Dampness 4.2 Comparison of Symptom Efficacy before and after Treatment After drug treatment, the TCM syndrome scores of the three main symptom indicators of fever, aversion to cold / wind, and fatigue decreased significantly compared with before administration, and the number of cases decreased significantly, with statistically significant differences (P<0.05, P<0.01), as shown in Table 4.

[0079] After drug treatment, the TCM syndrome scores of headache, muscle soreness, nausea and vomiting, abdominal pain, cough with expectoration, anorexia, and loose stools, five secondary symptom indicators, decreased significantly compared with those before drug administration, and the number of cases decreased significantly, with statistically significant differences (P<0.05, P<0.01), as shown in Table 5.

[0080] Table 4 Comparison of TCM syndrome scores of main symptoms before and after treatment Compared with before treatment, # indicates P <0.05, ## indicates P <0.01.

[0081] Table 5 Comparison of TCM syndrome scores of secondary symptoms before and after treatment Compared with before treatment, # indicates P <0.05, ## indicates P <0.01.

[0082] 4.3 Comparison of physical sign curative effects After drug treatment, the onset time of fever reduction was 15.23±10.51 (h), and the fever reduction time was 35.61±12.42 (h), as shown in Table 6.

[0083] Table 6 Statistical table of onset time of fever reduction and fever reduction time (x±s, h) After drug treatment, four indicators such as respiratory rate, blood pressure, body temperature, and heart rate showed no significant changes compared with before drug administration, as shown in Table 7.

[0084] Table 7 Comparison of physical sign curative effects before and after treatment Compared with before treatment, # indicates P <0.05, ## indicates P <0.01.

[0085] 4.4 Comparison of changes in blood routine before and after treatment Before drug treatment, the white blood cell count (x10 9 / L) and neutrophil percentage (%) were slightly higher than the normal values, and decreased to the normal level after drug administration, with no statistically significant difference between before and after drug administration; before drug treatment, the lymphocyte percentage (%) was higher than the normal value, and decreased significantly after drug administration, with a statistically significant difference (P<0.01), as shown in Table 8.

[0086] Table 8 Comparison of changes in blood routine before and after treatment After treatment compared with before treatment, # indicates P <0.05, ## indicates P <0.01.

[0087] 4.5 Adverse Reactions After drug treatment, 1 case of dry mouth, 1 case of loss of appetite, and 1 case of rash occurred in the patients; there were no other adverse reactions such as diarrhea, nausea, and vomiting. See Table 9.

[0088] Table 9 Summary Table of Adverse Reactions in the Treatment Group In summary, the traditional Chinese medicine composition provided by the present invention has significant clinical efficacy in the treatment of cold-dampness cold (acute upper respiratory tract infection), with a total effective rate of 94%; it can promote the remission of 3 main symptoms including fever, aversion to cold / wind, and fatigue, and 5 secondary symptoms such as headache, muscle soreness, nausea and vomiting, abdominal pain, cough with phlegm, loss of appetite, and loose stools, and can significantly improve the traditional Chinese medicine syndromes; there is a statistically significant difference compared with before treatment, and there are no obvious adverse reactions. It is indicated that the traditional Chinese medicine composition provided by the present invention has the effects of dispersing cold and removing dampness, avoiding filth and resolving turbidity, clearing away pestilence and dredging collaterals, warming the kidney and strengthening the spleen, and has good clinical application value for the treatment of cold-dampness cold (acute upper respiratory tract infection).

[0089] II. In Vitro Bacteriostatic and Bactericidal Studies 1 Materials and Instruments 1.1 Test Drugs and Bacterial Strains Staphylococcus aureus CMCC(B)26003 was provided by the China National Center for Medical Culture Collection; Streptococcus pneumoniae ATCC49619, Haemophilus influenzae ATCC49274, Streptococcus pyogenes ATCC19615, and Moraxella catarrhalis ATCC25238 were purchased from the American Type Culture Collection.

[0090] 1.2 Materials M-H broth (batch number 20241011), MH agar plate (batch number MHP-241103D-1), Haemophilus chocolate agar selective medium (HIN-241213D-1), drug sensitivity test kits for Haemophilus and Moraxella catarrhalis (bioMérieux, France), 6mm sterile test paper, shaking tubes, disposable culture dishes, 96-well plates, sterile needle filters, pipettes (0.1 - 2.5 μL, 5 - 10 μL, 10 - 100 μL, 20 - 200 μL, 100 - 1000 μL), tips, EP tubes (2mL, 5mL).

[0091] 1.3 Instruments SW-CJ-2FD double-sided purification workbench for two persons; MJX—160BZ biochemical incubator (Shanghai Boxun Industry Co., Ltd.); HFsafe—1800LC biological safety cabinet (Likon Biomedical Technology Holdings Co., Ltd.); Haier ultra-low temperature refrigerator.

[0092] 2 Microbroth dilution method 2.1 Preparation of sample medicinal solution Take 12 sterilized 5 mL EP tubes. Add 1 mL of the corresponding nutrient solution to each of the 1st to 11th EP tubes. Add 1 mL of the sample solution of the traditional Chinese medicine composition in Example 1 with a concentration of 80 mg / mL to the 1st tube of each group. After pipetting and mixing evenly with a pipette gun, take 1 mL from the 1st tube and add it to the 2nd tube, and dilute successively to the 11th tube. The corresponding concentrations are 40, 20, 10, 5, 2.5, 1.25, 0.625, 0.3125, 0.1562, 0.0781, 0.0391 mg / mL; however, only add 2 mL of injection physiological saline to the 12th EP tube as the experimental blank control group; the experiment is in parallel for 3 replicates.

[0093] 2.2 Strain resuscitation and culture Take out the strains stored in the -78°C refrigerator, operate in a sterile workbench, add injection physiological saline to dissolve the strains, dip the bacterial liquid with a disposable inoculation loop and streak it on an agar plate for resuscitation for 24 h. Inoculate the remaining dissolved strains into a shaking flask containing liquid medium (sterilized), and culture it in a biochemical incubator until the logarithmic phase (the temperature of the constant temperature incubator is 37 ± 0.2°C).

[0094] MH broth and MH agar plates are used to culture Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes and Moraxella catarrhalis; Haemophilus influenzae chocolate agar selective medium and Haemophilus influenzae and Moraxella catarrhalis drug susceptibility test kits are used to culture Haemophilus influenzae.

[0095] 2.3 Sample addition and incubation Operate in a sterile workbench, and add the above drug solutions diluted in multiples to a sterile 96-well cell culture plate in sequence. Take the sample medicinal solutions from the 1st to 11th EP tubes and add 100 μL to the corresponding 1st to 11th wells respectively. Use a sterile cotton swab to pick the corresponding bacteria, dissolve them in sterile physiological saline, prepare a 0.5 McFarland unit, and then dilute it 1000 times to obtain a bacterial suspension solution. Take 100 μL of the bacterial suspension solution into the 96-well plate and mix evenly; add 100 μL of injection physiological saline and 100 μL of the bacterial suspension to the 12th well as a blank control, and place it in a biochemical incubator (37 ± 0.2°C) for culture for 18 - 24 h.

[0096] 2.4 Judgment of test results After culturing for 18 to 24 hours, take it out and observe with the naked eye. If there is no bacterial growth in the well with the lowest drug concentration, the minimum inhibitory concentration (MIC value) of the test drug against the bacterium is obtained. Then, use a pipette to take 10 μL from the mixed solution in each well and streak it on a sterile agar medium without drugs. Let it stand for five minutes until the solution completely penetrates into the agar plate, and then transfer it to a biochemical incubator at 37°C for 18 to 24 hours. Then observe whether there is colony growth on the medium. If there is no colony growth, it indicates that the drug concentration at that place can be regarded as the minimum bactericidal concentration (MBC) value of the drug. The test is carried out with 3 parallel detections.

[0097] 3 Results By observing with the naked eye, there was no growth of Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus, Moraxella catarrhalis, and Haemophilus influenzae in the traditional Chinese medicine composition solution, indicating its antibacterial effect.

[0098] Observe the growth of the suspension liquid of the transferred bacterial liquid in the corresponding medium. The results show that the traditional Chinese medicine composition solution has a killing effect on 5 cold-causing bacteria, namely Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus, Moraxella catarrhalis, and Haemophilus influenzae. The specific results are shown in Table 10 and Figure 1 .

[0099] The microbroth dilution method can very intuitively read out the antibacterial and bactericidal concentrations of the traditional Chinese medicine composition solution against bacteria, indicating that this method can be used to preliminarily evaluate the basic efficacy of the traditional Chinese medicine composition.

[0100] Table 10 Antibacterial and bactericidal test results The above is only the preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the method of the present invention, several improvements and supplements can be made, and these improvements and supplements should also be regarded as the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating colds, characterized in that: The invention is prepared from the following raw materials by weight: 7-11 parts of cistanche deserticola, 10-14 parts of dried ginger, 7-11 parts of patchouli, 13-17 parts of tangerine peel, 10-14 parts of polygonum cuspidatum, 7-11 parts of polygonum bistorta, 8-12 parts of forsythia, 28-32 parts of honeysuckle, 10-14 parts of bupleurum, 10-14 parts of belamcanda chinensis, 8-12 parts of notopterygium wilfordii, 7-11 parts of angelica dahurica, 7-11 parts of angelica sinensis, 7-11 parts of schizonepeta tenuifolia, 7-11 parts of angelica dahurica, 10-14 parts of citron, 7-11 parts of perilla stem, 13-17 parts of artemisia annua and 10-14 parts of mulberry leaf.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials by weight: 9 parts of Cistanche deserticola, 12 parts of dried ginger, 9 parts of patchouli, 15 parts of dried tangerine peel, 12 parts of Polygonum cuspidatum, 9 parts of Polygonum multiflorum, 10 parts of Forsythia suspensa, 30 parts of honeysuckle, 12 parts of bupleurum, 12 parts of Belamcanda chinensis, 10 parts of Notopterygium wilfordii, 9 parts of Angelica dahurica, 9 parts of Schizonepeta tenuifolia, 9 parts of Angelica dahurica, 12 parts of bergamot, 9 parts of Perilla stem, 15 parts of Artemisia annua, and 12 parts of mulberry leaf.

3. A method for preparing the Chinese medicine composition according to claim 1, characterized in that: The following steps are involved: Weigh Cistanche deserticola, dried ginger, patchouli, tangerine peel, Polygonum cuspidatum, Bistorta, Forsythia suspensa, Honeysuckle, Bupleurum, Belamcanda chinensis, Notopterygium wilfordii, Angelica dahurica, Saposhnikovia divaricata, Nepeta tenuifolia, Angelica dahurica, Citron, Perilla stem, Artemisia annua, and mulberry leaf according to weight and set aside; The weighed medicinal materials are mixed, soaked in water, boiled, and the boiled liquid is collected to obtain the traditional Chinese medicine composition.

4. The Chinese medicine composition according to claim 3, characterized in that: The soaking in water is to add water equivalent to 8 to 10 times the total weight of the medicinal materials and soak for 30 to 40 minutes; The decoction is performed 2 to 3 times, each time for 60 to 80 minutes; The obtained decoction is concentrated to a relative density of 1.26-1.30 at 60° C. to obtain an extract of the traditional Chinese medicine composition.

5. Use of the Chinese medicine composition according to claim 1 in preparing a product for inhibiting Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus, Moraxella catarrhalis or Haemophilus influenzae.

6. The use according to claim 5, characterized in that: The traditional Chinese medicine composition is used for preparing medicine for treating colds.

7. The use according to claim 6, characterized in that: The traditional Chinese medicine composition is used for preparing medicine for treating cold and dampness type cold.

8. A pharmaceutical preparation for treating cold-dampness type colds, characterized in that: The Chinese medicine composition according to claim 1 is used as the only effective ingredient.

9. The pharmaceutical preparation according to claim 8, characterized in that The pharmaceutical preparation is prepared by compounding the traditional Chinese medicine composition with pharmaceutically acceptable excipients.

10. The pharmaceutical preparation according to claim 9, characterized in that The pharmaceutical preparation is a granule, and the granule is prepared according to the following steps: Weigh Cistanche deserticola, dried ginger, patchouli, tangerine peel, Polygonum cuspidatum, Bistorta, Forsythia suspensa, Honeysuckle, Bupleurum, Belamcanda chinensis, Notopterygium wilfordii, Angelica dahurica, Saposhnikovia divaricata, Nepeta tenuifolia, Angelica dahurica, Citron, Perilla stem, Artemisia annua, and mulberry leaf, and set aside; The weighed medicinal materials are mixed, soaked in water, boiled, the decoction is collected, and concentrated to obtain an extract with a relative density of 1.26-1.30 at 60°C; Corn starch and dextrin are added to the extract to prepare a soft material, obtain wet granules, and dry to obtain a granular dosage form of the traditional Chinese medicine composition.

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