A traditional Chinese medicine composition for treating common cold with wind-cold-dampness syndrome and its preparation method.

Abstract

This invention discloses a traditional Chinese medicine composition and its preparation method for treating common cold with wind-cold-dampness exterior syndrome and stagnation of heat. It belongs to the technical field of acute upper respiratory tract infection treatment. By weight, it comprises the following Chinese medicinal materials: 5-10 parts of Schizonepeta tenuifolia, 8-15 parts of Saposhnikovia divaricata, 8-12 parts of Notopterygium incisum, 8-12 parts of Morus alba leaf, 8-12 parts of Bupleurum chinense, 8-12 parts of stir-fried Scutellaria baicalensis, 8-12 parts of processed Pinellia ternata, 5-10 parts of Sophora tonkinensis, 8-12 parts of Arctium lappa, 5-10 parts of Platycodon grandiflorus, 5-10 parts of Ligusticum chuanxiong, and 3-8 parts of raw Glycyrrhiza uralensis. This invention can treat common cold with wind-cold-dampness exterior syndrome and stagnation of heat, addressing both wind-cold-dampness attacking the exterior and stagnation of heat in the lung meridian.

Description

Technical Field

[0001] This invention relates to the field of acute upper respiratory tract infection treatment technology, specifically to a traditional Chinese medicine composition for treating colds with wind-cold-dampness syndrome and external heat syndrome. Background Technology

[0002] Traditional Chinese medicine (TCM) categorizes acute upper respiratory tract infections under the "common cold" category. Its diagnosis primarily focuses on the nature of the external pathogen's cold or heat pattern and the body's overall condition (deficiency or excess). Textbooks in higher TCM colleges, such as *Internal Medicine of Traditional Chinese Medicine*, and relevant guidelines for treating this disease primarily classify it into wind-cold, wind-heat, and deficiency-type colds. However, in recent years, many patients observed clinically present with a complex mixture of cold and heat patterns rather than purely cold or heat, suggesting stagnation of heat in the lung meridian. These patients still fall under the category of exterior syndromes, and treatment still focuses on relieving exterior symptoms and expelling pathogens. However, prescriptions must consider multiple pathogenesis mechanisms and cannot rely solely on purely cold or heat-based formulas.

[0003] A review of the literature reveals that some classic TCM formulas for relieving exterior syndromes are specifically designed for complex pathogenesis involving cold and heat. For example, the Nine-Ingredient Qianghuo Decoction, used by the renowned physician Zhang Yuansu to treat "the irregular qi of the four seasons," targets the complex pathogenesis of external wind-cold-dampness combined with internal heat. While using Qianghuo and Fangfeng to relieve exterior syndromes, it adds Cangzhu to dispel external dampness, and Huangqin and Shengdi to clear internal heat. Another example is Jingfang Baidu Powder, a modified version of Renshen Baidu Powder from the Taiping Huimin Heji Jufang for treating "epidemic typhoid fever." It also uses Jingjie and Fangfeng to dispel external cold, and Qianghuo and Duhuo to dispel cold and dampness, while using Chaihu and Qianhu to clear heat. Depending on the depth of the heat, Huangqin can also be added, resulting in Baidu Powder plus Huangqin Decoction, used to treat "epidemic diseases." Summary of the Invention

[0004] In order to overcome the shortcomings of the prior art, the purpose of this invention is to provide a traditional Chinese medicine composition for treating colds with wind-cold-dampness exterior syndrome with stagnation of heat. The traditional Chinese medicine composition for treating colds with wind-cold-dampness exterior syndrome with stagnation of heat can treat colds with wind-cold-dampness exterior syndrome with stagnation of heat, and can also treat wind-cold-dampness attacking the exterior and lung meridian stagnation of heat, dispel wind and cold, resolve dampness and release the exterior, and clear and soothe the throat.

[0005] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine composition for treating colds with wind-cold-dampness syndrome and heat stagnation, with low production cost.

[0006] One of the objectives of this invention is achieved through the following technical solution:

[0007] A traditional Chinese medicine composition for treating common cold with wind-cold-dampness syndrome and external heat syndrome, comprising the following Chinese medicinal materials by weight: 5-10 parts of Schizonepeta tenuifolia, 8-15 parts of Saposhnikovia divaricata, 8-12 parts of Notopterygium incisum, 8-12 parts of Morus alba leaf, 8-12 parts of Bupleurum chinense, 8-12 parts of Scutellaria baicalensis (fried), 8-12 parts of Pinellia ternata (processed), 5-10 parts of Sophora tonkinensis, 8-12 parts of Arctium lappa, 5-10 parts of Platycodon grandiflorus, 5-10 parts of Ligusticum chuanxiong, and 3-8 parts of Glycyrrhiza uralensis (raw).

[0008] Furthermore, according to weight, the following herbs are listed: 6g of Schizonepeta tenuifolia, 9g of Saposhnikovia divaricata, 9g of Notopterygium incisum, 9g of Morus alba, 12g of Bupleurum chinense, 12g of Scutellaria baicalensis (fried), 9g of Pinellia ternata (processed), 6g of Sophora tonkinensis, 9g of Arctium lappa, 9g of Platycodon grandiflorus, 9g of Ligusticum chuanxiong, and 6g of Glycyrrhiza uralensis (raw).

[0009] The second objective of this invention is achieved by the following technical solution:

[0010] This invention provides a method for preparing a traditional Chinese medicine composition for treating colds with wind-cold-dampness syndrome and exterior heat syndrome, comprising the following steps:

[0011] Weigh out 12 Chinese medicinal herbs for the Chinese herbal composition for treating colds with wind-cold-dampness exterior syndrome and internal heat. First, add 10 times the total weight of the herbs to water and decoct for 90 minutes. Second, add 10 times the total weight of the herbs to water and decoct for 90 minutes. Third, add 10 times the total weight of the herbs to water and decoct for 90 minutes. Decoction is repeated 3 times. Filter the decoction, combine the three filtrates, concentrate under reduced pressure, let stand and filter, adjust the volume to 50 mL, stir well, and obtain the Chinese herbal composition for treating colds with wind-cold-dampness exterior syndrome and internal heat.

[0012] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0013] (1) The present invention provides a traditional Chinese medicine composition for treating common cold with wind-cold-dampness syndrome and internal heat, which consists of 12 herbs: Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium incisum, Morus alba leaf, Bupleurum chinense, Scutellaria baicalensis (fried), Pinellia ternata (processed), Sophora tonkinensis, Arctium lappa, Platycodon grandiflorus, Ligusticum chuanxiong, and Glycyrrhiza uralensis. In the formula, Schizonepeta tenuifolia, Notopterygium incisum, and Saposhnikovia divaricata dispel wind and cold, and relieve dampness and release the exterior, serving as the principal herbs. Atractylodes lancea is removed to avoid its strong and potential toxicity. Bupleurum chinense and Scutellaria baicalensis assist the principal herbs in relieving the exterior and clearing internal heat, serving as the assistant herbs. Ligusticum chuanxiong relieves the exterior and stops pain, making the exterior-relieving effect more comprehensive and better able to deal with wind-cold-dampness syndrome. The addition of Sophora tonkinensis and stir-fried Arctium lappa enhances the throat-soothing and detoxifying effects of the formula, significantly improving its ability to relieve sore throat and reduce swelling. This provides more effective and rapid relief for common symptoms in patients with wind-cold-dampness exterior syndrome with stagnant heat. Mulberry leaf and Platycodon grandiflorus promote lung function and relieve cough, while Pinellia ternata resolves phlegm and lowers qi. These herbs act as adjuvants, helping to restore the normal function of lung qi, promote phlegm expulsion, and alleviate cough and phlegm symptoms, further enhancing the formula's therapeutic effect. Raw licorice root clears heat and harmonizes the other herbs, serving as both an adjuvant and guiding herb. The formula's effects are to dispel wind and cold, resolve dampness and relieve exterior syndrome, and clear and soothe the throat. Compared with existing technologies, this invention's formula, while dispelling wind and cold and relieving exterior syndrome, also addresses multiple effects such as resolving dampness, soothing the throat, and relieving cough, forming a more comprehensive and balanced formula that better addresses the complex pathogenesis of wind-cold-dampness exterior syndrome with stagnant heat.

[0014] (2) The present invention provides a Chinese medicine composition for treating colds with wind-cold-dampness syndrome. Considering the loose skin of the southern population, the "Jiawei Jingfang Heji" regards Jingjie, Qianghuo, and Fangfeng as "Ma Gui" for inducing sweating, which is more in line with the physical characteristics and disease patterns of the southern population. This makes it more adaptable and effective in treating colds with wind-cold-dampness syndrome in the southern region, reflecting the close combination of regional population characteristics and formula application.

[0015] (3) The traditional Chinese medicine composition for treating colds with wind-cold-dampness syndrome provided by this invention has a certain scientific basis. Modern pharmacology shows that Schizonepeta tenuifolia has weak antipyretic, analgesic, and anti-inflammatory effects, inhibits pathogens such as Staphylococcus aureus and Corynebacterium diphtheriae, has a significant protective effect against H1N1 influenza virus infection in mice, and can inhibit respiratory syncytial virus; Notopterygium incisum has anti-inflammatory, analgesic, antipyretic, and anti-allergic effects, inhibits skin fungi and Brucella, and has antiviral effects; Saposhnikovia divaricata has antipyretic, anti-inflammatory, sedative, analgesic, anticonvulsant, and anti-allergic effects, and inhibits Pseudomonas aeruginosa, It has a certain inhibitory effect on Staphylococcus aureus, Shigella dysenteriae, and hemolytic streptococci; Bupleurum has significant antipyretic and anti-inflammatory effects, as well as sedative, tranquilizing, analgesic, antitussive, antimicrobial, and immune-boosting effects, and can inhibit respiratory syncytial virus; Scutellaria baicalensis has inhibitory effects on a variety of pathogens such as Staphylococcus aureus, hemolytic streptococci, Streptococcus pneumoniae, Escherichia coli, influenza A, and influenza B, and also has anti-inflammatory, anti-allergic, antipyretic, and sedative effects; Pinellia ternata has antitussive, expectorant, anti-inflammatory, and analgesic effects; Ligusticum chuanxiong has myocardial protection, anticoagulation, antithrombotic, analgesic, and hypotensive effects.

[0016] (4) The present invention provides a method for preparing a traditional Chinese medicine composition for treating colds with wind-cold-dampness syndrome. First, add 10 times the total weight of the medicinal materials to water and decoct for 90 minutes. Second, add 10 times the total weight of the medicinal materials to water and decoct for 90 minutes. Third, add 10 times the total weight of the medicinal materials to water and decoct for 90 minutes. Using the calcium preparation method, the extract yield, cimicifugain glycoside content, and O-methylvisamidol glycoside content are the highest, so the comprehensive score is the highest, which is 100 points. Detailed Implementation

[0017] The present invention will now be further described in conjunction with specific embodiments. It should be noted that, without conflict, the embodiments or technical features described below can be arbitrarily combined to form new embodiments.

[0018] Example 1

[0019] This embodiment provides a traditional Chinese medicine composition for treating common cold with wind-cold-dampness syndrome and external heat syndrome, which, by weight, consists of: 6g of Schizonepeta tenuifolia, 9g of Saposhnikovia divaricata, 9g of Notopterygium incisum, 9g of Morus alba, 12g of Bupleurum chinense, 12g of Scutellaria baicalensis (fried), 9g of Pinellia ternata (processed), 6g of Sophora tonkinensis, 9g of Arctium lappa, 9g of Platycodon grandiflorus, 9g of Ligusticum chuanxiong, and 6g of Glycyrrhiza uralensis (raw).

[0020] This embodiment provides a method for preparing a traditional Chinese medicine composition for treating common cold with wind-cold-dampness syndrome and external heat stagnation, including the following steps:

[0021] Weigh out 12 Chinese medicinal herbs for a traditional Chinese medicine composition used to treat colds with wind-cold-dampness exterior syndrome and internal heat. First, add 10 times the total weight of the herbs to water and decoct for 90 minutes. Second, add 10 times the total weight of the herbs to water and decoct for 90 minutes. Third, add 10 times the total weight of the herbs to water and decoct for 90 minutes. Decoction is repeated 3 times. Filter the decoction, combine the three filtrates, concentrate under reduced pressure, let stand and filter, adjust the volume to 50 mL, stir well, and obtain the traditional Chinese medicine composition for treating colds with wind-cold-dampness exterior syndrome and internal heat.

[0022] Example 2

[0023] This embodiment provides a traditional Chinese medicine composition for treating common cold with wind-cold-dampness syndrome and external heat syndrome, which, by weight, consists of: 5g of Schizonepeta tenuifolia, 15g of Saposhnikovia divaricata, 8g of Notopterygium incisum, 12g of Morus alba leaf, 8g of Bupleurum chinense, 8g of Scutellaria baicalensis (fried), 8g of Pinellia ternata (processed), 5g of Sophora tonkinensis, 8g of Arctium lappa, 5g of Platycodon grandiflorus, 5g of Ligusticum chuanxiong, and 3g of Glycyrrhiza uralensis (raw).

[0024] Example 3

[0025] This embodiment provides a traditional Chinese medicine composition for treating common cold with wind-cold-dampness syndrome and external heat syndrome, which, by weight, consists of: 10g of Schizonepeta tenuifolia, 8g of Saposhnikovia divaricata, 12g of Notopterygium incisum, 8g of Morus alba, 12g of Bupleurum chinense, 12g of Scutellaria baicalensis (fried), 12g of Pinellia ternata (processed), 10g of Sophora tonkinensis, 12g of Arctium lappa, 10g of Platycodon grandiflorus, 10g of Ligusticum chuanxiong, and 8g of Glycyrrhiza uralensis (raw).

[0026] Experimental Example 1

[0027] Inclusion criteria: Patients aged 18-65 years who met the TCM diagnostic criteria for wind-cold-dampness exterior syndrome with stagnation and heat (referring to relevant TCM diagnostic criteria and syndrome classification), accompanied by fever (body temperature ≥38℃), chills and fever, headache and body aches, dry and sore throat, cough, little or no sputum, etc., with a course of illness within 48 hours, and who voluntarily participated in this study and signed an informed consent form. Thirty patients were included and divided into three groups: Jingfang Baidu San group, Jiuwei Qianghuo Tang group, and Example 1 group.

[0028] Exclusion criteria: Individuals with severe dysfunction of organs such as the heart, liver, and kidneys; pregnant or lactating women; individuals allergic to the relevant drug components; and individuals who have used drugs that may affect the immune or respiratory system within the past week.

[0029] Dosage instructions:

[0030] Example 1 group: The traditional Chinese medicine composition of Example 1 for treating colds with wind-cold-dampness syndrome was administered orally twice a day, 25 mL each time, for 5 days.

[0031] Nine-Ingredient Qianghuo Decoction Group: The patient was given Nine-Ingredient Qianghuo Decoction prepared according to traditional methods and commonly used dosages, decocted in water and taken orally once a day, divided into two oral doses, for at least 5 consecutive days.

[0032] Jingfang Baidu Powder Group: Jingfang Baidu Powder was prepared according to traditional methods and commonly used dosages, decocted in water and taken orally, 1 dose per day, divided into 2 oral doses, for at least 5 consecutive days.

[0033] Observation indicators and time points:

[0034] Symptom scoring: Before treatment and on days 1, 2, 3, and 5 after treatment, the patients' symptoms such as fever, headache, sore throat, sputum, and cough were quantitatively scored. Each symptom was graded as none (0 points), mild (1 point), moderate (2 points), and severe (3 points), and the total symptom score of each group of patients was calculated.

[0035] Recovery time: The time from the start of treatment until all symptoms of the patient have completely disappeared and the body temperature has returned to normal for more than 24 hours, recorded in days.

[0036] Recurrence rate: Follow-up was conducted on the 14th and 30th days after the patients were cured. The number of patients with symptom recurrence was counted and the recurrence rate was calculated (the patient had one of the main symptoms such as sore throat, no sputum, or persistent cough again, and the symptoms were consistent with the syndrome of wind-cold-dampness exterior syndrome with stagnation of heat).

[0037] Experimental results

[0038] 1. Speed ​​of symptom relief:

[0039] Before treatment, the total symptom score was 136 in the Example 1 group, 121 in the Jiuwei Qianghuo Decoction group, and 132 in the Jingfang Baidu Powder group. On the first day after treatment, the total symptom score decreased by 85 in the Example 1 group, by 18 in the Jiuwei Qianghuo Decoction group, and by 52 in the Jingfang Baidu Powder group. The differences between the groups were statistically significant (P<0.05), and the symptom relief was more obvious in the Example 1 group.

[0040] On the third day of treatment, the total symptom score of the Example 1 group dropped to 25 points, the Jiuwei Qianghuo Decoction group was 82 points, and the Jingfang Baidu Powder group was 60 points (P<0.05). The symptoms of the Example 1 group were significantly improved and were better than the other two groups.

[0041] By the 5th day of treatment, the total symptom score of the Example 1 group was close to 5 points, and the patients had basically recovered to normal. In contrast, some patients in the Jiuwei Qianghuo Decoction group and the Jingfang Baidu Powder group still had mild symptoms, with scores of 60 points and 45 points respectively. The difference was significant compared with the Example 1 group (P<0.05).

[0042] 2. Healing time:

[0043] The average cure time in Example 1 group was (3.5±0.8) days, in the Jiuwei Qianghuo Decoction group it was (8.2±1.2) days, and in the Jingfang Baidu Powder group it was (5.0±1.1) days. The differences between the groups were highly statistically significant (P<0.01). The cure time in Example 1 group was significantly shorter than that in the Jiuwei Qianghuo Decoction group and the Jingfang Baidu Powder group.

[0044] 3. Recurrence rate:

[0045] On the 14th day after recovery, the recurrence rate was 10% in the Example 1 group, 50% in the Jiuwei Qianghuo Decoction group, and 30% in the Jingfang Baidu Powder group. The difference between the groups was statistically significant (P<0.05), and the recurrence rate was the lowest in the Example 1 group.

[0046] At the 30th day after treatment, the recurrence rate was 20% in the Example 1 group, 80% in the Jiuwei Qianghuo Decoction group, and 40% in the Jingfang Baidu Powder group. The recurrence rate in Example 1 was significantly lower than that in the other two groups (P<0.05), demonstrating its advantage in maintaining long-term efficacy.

[0047] Experimental Example 2

[0048] Using cimicifugain glycoside and 5-O-methylvisamidol glycoside as evaluation indicators, the factors investigated were the water addition ratio (A), decoction time (B), and number of decoctions (C), with three levels for each factor. The experimental factors are shown in Table 1. Nine samples were weighed according to the prescription provided in Example 1, and three parallel decoctions were performed according to L9(3 4Extraction was performed under the experimental conditions of the orthogonal array. The test samples were injected into a high-performance liquid chromatograph (HPLC) to determine the content. The results of the orthogonal experiment are shown in Table 2. The chromatographic conditions were as follows: Column: SVEA C18 GOLD (4.6×250mm, 5μm); Mobile phase: acetonitrile-phosphoric acid water as the mobile phase, injection volume 5μL; Flow rate 1.0mL / min; Column temperature 35℃; UV detection wavelength 310nm. 50mL of each of the nine orthogonal experimental sample solutions was accurately measured, transferred to an evaporating dish dried to constant weight, weighed, evaporated to dryness in a water bath, dried at 105℃ for 3h, removed and cooled in a desiccator for 30min, weighed quickly, and the extract yield was calculated. Extract yield (%) = (W×V) / (20×Wt)×100%; W is the weight of the extract, V is the final volume, and Wt is the weight of the processed medicinal pieces. The extract yield, cimicifugain glycoside, and 5-O-methylvisamidol glycoside content were comprehensively scored and assigned weights of 0.4, 0.3, and 0.3, respectively. The calculation formula is as follows: Comprehensive score (%) = (Extract yield / highest value in the group × 0.4 + Cimicifugain glycoside content / highest value in the group × 0.3 + 5-O-methylvisamidol glycoside content / highest value in the group × 0.3) × 100%.

[0049] Table 1 Experimental Factors Table

[0050]

[0051] Table 2. Results of the Orthogonal Experiment

[0052]

[0053]

[0054] As can be seen from the experimental results in Table 2, the highest comprehensive score of 100 points was achieved when the water volume was 10 times, the decocting time was 90 minutes, and the decocting was performed 3 times.

[0055] The above embodiments are merely preferred embodiments of the present invention and should not be construed as limiting the scope of protection of the present invention. Any non-substantial changes and substitutions made by those skilled in the art based on the present invention shall fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for treating common cold with wind-cold-dampness exterior syndrome and internal heat, characterized in that, The herbal ingredients are composed of the following Chinese medicinal materials by weight: 5-10 parts of Schizonepeta tenuifolia, 8-15 parts of Saposhnikovia divaricata, 8-12 parts of Notopterygium incisum, 8-12 parts of Morus alba leaf, 8-12 parts of Bupleurum chinense, 8-12 parts of stir-fried Scutellaria baicalensis, 8-12 parts of processed Pinellia ternata, 5-10 parts of Sophora tonkinensis, 8-12 parts of Arctium lappa, 5-10 parts of Platycodon grandiflorus, 5-10 parts of Ligusticum chuanxiong, and 3-8 parts of raw Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating common cold with wind-cold-dampness syndrome as described in claim 1, characterized in that, Based on weight, the ingredients are: 6g of Schizonepeta tenuifolia, 9g of Saposhnikovia divaricata, 9g of Notopterygium incisum, 9g of Morus alba leaves, 12g of Bupleurum chinense, 12g of Scutellaria baicalensis (fried), 9g of Pinellia ternata (processed), 6g of Sophora tonkinensis, 9g of Arctium lappa, 9g of Platycodon grandiflorus, 9g of Ligusticum chuanxiong, and 6g of Glycyrrhiza uralensis (raw).

3. A method for preparing a traditional Chinese medicine composition for treating common cold with wind-cold-dampness exterior syndrome and internal heat, characterized in that, Includes the following steps: Weigh out 12 Chinese medicinal herbs for the Chinese herbal composition for treating colds with wind-cold-dampness exterior syndrome and internal heat. First, add 10 times the total weight of the herbs to water and decoct for 90 minutes. Second, add 10 times the total weight of the herbs to water and decoct for 90 minutes. Third, add 10 times the total weight of the herbs to water and decoct for 90 minutes. Decoction is repeated 3 times. Filter the decoction, combine the three filtrates, concentrate under reduced pressure, let stand and filter, adjust the volume to 50 mL, stir well, and obtain the Chinese herbal composition for treating colds with wind-cold-dampness exterior syndrome and internal heat.

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