Traditional Chinese medicine composition for dispelling wind and moistening dryness as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for dispelling wind and moistening dryness as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 5 to 20 parts of folium mori, 5 to 15 parts of semen armeniacae amarae, 5 to 25 parts of bulbus fritillariae thunbergii, 5 to 25 parts of radix glehniae, 5 to 25 parts of radix ophiopogonis, 10 to 30 parts of rhizoma phragmitis, 10 to 20 parts of radix peucedani, 5 to 20 parts of herba menthae and 3 to 15 parts of liquorice root. The traditional Chinese medicine composition disclosed by the invention has the effects of dispelling wind, moistening dryness and clearing lung, can effectively relieve cough, throat itching and dry throat, dry lip and nose, no phlegm or less and sticky phlegm and difficulty in cough, or accompanied with dry mouth, pharyngalgia, body fever, headache, red and dry tongue with less saliva, thin white or thin yellow coating and floating pulse of a patient suffering from the flu wind-dryness syndrome, and can be used for treating the flu and wind-dryness syndrome of the flu and wind-dryness syndrome of the flu and wind-dryness syndrome of the flu and wind-dryness syndrome of the flu and wind-dryness syndrome of the flu and wind-dryness syndrome of the flu. The traditional Chinese medicine has a good treatment effect on influenza wind-dryness syndrome.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for dispelling wind and moistening dryness, and a preparation method and application thereof. Background Art

[0002] Influenza (hereinafter referred to as flu) is an acute respiratory infectious disease caused by influenza virus. Influenza A and B viruses are seasonally prevalent every year, and influenza A virus can cause a global pandemic. The results of national influenza monitoring show that in October each year, various parts of my country gradually enter the winter and spring influenza epidemic season, and the intensity of influenza virus activity will be at a high level.

[0003] Influenza has an acute onset and is mostly self-limiting, but some patients develop severe cases due to complications such as pneumonia or worsening of underlying diseases. In a few cases, the disease progresses rapidly and may lead to death due to complications such as acute respiratory distress syndrome (ARDS), acute necrotizing encephalopathy or multiple organ dysfunction. Severe influenza mainly occurs in high-risk groups such as the elderly, young children, obese people, pregnant women and those with chronic underlying diseases, but can also occur in the general population.

[0004] At present, the drugs used in the clinic for the treatment and prevention of influenza mainly include neuraminidase inhibitors (oseltamivir and zanamivir, etc.), influenza virus hemagglutininase (arbidol), and RNA polymerase (mabaloxavir). However, with the widespread use of these drugs, drug-resistant strains are constantly found, and it is also found that they have potential side effects of the nervous system or hypersensitivity reactions. Traditional Chinese medicine pays attention to syndrome differentiation and treatment, and traditional Chinese medicine has certain advantages in the treatment of influenza. However, existing Chinese patent medicines are mostly for wind-heat cold or wind-cold cold. The influenza suffered by some influenza patients is neither wind-heat cold nor wind-cold cold, but with cough, no sputum or less and sticky sputum, difficult to cough up and other symptoms as the main symptoms, manifested as wind-dryness syndrome, and there is still an urgent need for a Chinese medicine composition that can be targeted to treat influenza with wind-dryness syndrome. Summary of the invention

[0005] The first purpose of the present invention is to provide a Chinese medicine composition for dispelling wind and moistening dryness. The second purpose of the present invention is to provide a method for preparing the Chinese medicine composition. The third purpose of the present invention is to provide an application of the Chinese medicine composition.

[0006] According to a first aspect of the present invention, a traditional Chinese medicine composition for dispelling wind and moistening dryness is provided, wherein the raw materials thereof comprise, by weight: 5-20 parts of mulberry leaves, 5-15 parts of bitter almonds, 5-25 parts of Fritillaria thunbergii, 5-25 parts of Adenophora adenophora, 5-25 parts of Ophiopogon japonicus, 10-30 parts of Phragmites australis, 10-20 parts of Peucedanum peucedanum, 5-20 parts of mint, and 3-15 parts of licorice.

[0007] In the formula, mulberry leaves are sweet, cold and moist, and can clear away heat and expel pathogens; bitter almonds are bitter and warm, and belong to the lung meridian, which can promote lung qi, moisten dryness and relieve cough. The two are cold and warm, and have the effects of dispelling wind and dispersing pathogens, moistening dryness and relieving cough, and are the main medicine. Northern Adenophora is sweet and moist, nourishes lung yin, clears lung heat, and relieves phlegm and cough; Ophiopogon japonicus is sweet and neutral, and can treat deficiency heat in the heart and lungs; Phragmites australis is sweet and cold, and is not greasy, and can promote body fluid without lingering on pathogens. It can clear lung heat and relieve phlegm and cough, and can also clear stomach heat and promote body fluid and quench thirst; the three together have the effects of nourishing yin and clearing heat, moistening dryness and promoting body fluid, and relieving phlegm and cough, and are the assistant medicines. Fritillaria thunbergii is bitter and cold in nature, which can clear away phlegm and heat, and help bitter almonds to relieve cough and resolve phlegm; Peucedanum chinense is bitter and pungent in taste, slightly cold in nature, which can lower qi and resolve phlegm, and dissipate wind-heat; Peppermint is clear in nature and neutral in nature, and its power can penetrate the tendons and bones inside, reach the skin surface outside, dredge the internal organs, and connect the meridians. The three are adjuvants. Licorice harmonizes the various drugs as a guiding drug. This prescription is used for light dispersing, moistening dryness, and clearing heat, and has the effect of dispersing wind and moistening dryness, promoting body fluid and relieving cough.

[0008] The sources of raw materials for this recipe are as follows:

[0009] Mulberry leaves: leaves of the mulberry plant of the Moraceae family.

[0010] Bitter almonds: dried mature seeds of Prunus armeniaca L. var. ansu Maxim., Prunus sibirica L., Prunus mandshurica (Maxim.) Koehne or Prunus armeniaca L., plants of the Rosaceae family.

[0011] Zhejiang Fritillaria: The bulb of Zhejiang Fritillaria Fritillaria thunbergii Miq., a plant of the Liliaceae family.

[0012] Northern Adenophora: The root of Glehnia littoralis Fr.schmidt ex Miq., a plant of the Umbelliferae family.

[0013] Ophiopogon japonicus: the tuberous root of the Liliaceae plant Ophiopogon japonicus.

[0014] Reed root: the rhizome of the grass plant Phragmites communis Trin.

[0015] Peucedanum chinense: the dried roots of the Umbelliferae plants white peucedanum or purple peucedanum.

[0016] Mint: The whole herb or leaves of the dicotyledonous medicinal plant mint or domestic mint, Lamiaceae.

[0017] Licorice: The dried roots of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the Leguminosae family.

[0018] In some embodiments, the raw material composition includes, by mass: 10 parts of mulberry leaves, 10 parts of bitter almonds, 10 parts of Fritillaria thunbergii, 15 parts of Adenophora adenophora, 10 parts of Ophiopogon japonicus, 15 parts of Phragmites australis, 10 parts of Peucedanum peucedanum, 10 parts of mint, and 5 parts of Licorice.

[0019] In some embodiments, the dosage form of the Chinese medicine composition is a Chinese medicine decoction, oral solution, powder or granule.

[0020] In some embodiments, a pharmaceutically acceptable excipient is also included.

[0021] In some embodiments, the auxiliary material is at least one of a sustained-release agent, an excipient, a filler, a binder, a wetting agent, a disintegrant, an absorption enhancer, an adsorption carrier, a surfactant, and a lubricant.

[0022] According to a second aspect of the present invention, a method for preparing the above-mentioned Chinese medicine composition for dispelling wind and moistening dryness is provided. When the dosage form of the Chinese medicine composition is a Chinese medicine decoction, the preparation method comprises the following steps:

[0023] S1, add 8-12 times the weight of the raw materials except mint into water and soak for 20-40 minutes, then heat to boiling, keep slightly boiling for 1-2 hours, filter, repeat the decoction of the filter residue 1-2 times, combine the filtrate, and obtain the treated liquid medicine;

[0024] S2. Add mint to the treated medicinal solution, heat to boiling, and keep it at a slight boil for 3-5 minutes.

[0025] According to a third aspect of the present invention, a method for preparing the above-mentioned Chinese medicine composition for dispelling wind and moistening dryness is provided. When the dosage form of the Chinese medicine composition is a powder, the preparation method comprises the following steps:

[0026] The raw materials are crushed or chopped separately, and then the crushed or chopped raw materials are passed through 10-mesh and 50-mesh sieves respectively, and the coarse particles that cannot pass through the 10-mesh sieve are further crushed or chopped, and the powder between the 10-mesh sieve and the 50-mesh sieve is taken, and then the raw material powders are mixed according to the proportion, put into the packaging bag, and sealed.

[0027] According to a fourth aspect of the present invention, there is provided use of the above-mentioned wind-dispelling and dryness-removing traditional Chinese medicine composition in the preparation of a medicament for treating influenza.

[0028] In some embodiments, the influenza is wind-dryness syndrome influenza.

[0029] The beneficial effects of the present invention include:

[0030] (1) The Chinese medicine composition of the present invention has the effects of dispelling wind, moistening dryness and clearing the lungs, and can effectively relieve the symptoms of patients with influenza wind-dryness syndrome, such as cough, itchy and dry throat, dry lips and nose, no sputum or little and sticky sputum that is difficult to cough up, or accompanied by dry mouth, sore throat, fever, headache, red and dry tongue with little fluid, thin white or thin yellow tongue coating, and floating and rapid pulse, and has a good therapeutic effect on influenza wind-dryness syndrome.

[0031] (2) The present invention does not use nourishing and greasy tonic products, but uses small doses of refreshing and moistening products, such as Northern Adenophora, Ophiopogon japonicus, and Phragmites australis, through clever combination, matching cold and warm, and lightly dispersing, moistening, and clearing heat, so as to nourish yin without hindering the spleen, and at the same time dispelling wind and dispersing evil, it has the effect of moistening and relieving cough.

[0032] (3) Clinical research results show that the Chinese herbal composition for dispelling wind and moistening dryness of the present invention can significantly improve the symptoms of influenza patients with wind-dryness syndrome and shorten the time it takes for the symptoms to disappear, especially in improving nasal congestion / runny nose and cough symptoms. DETAILED DESCRIPTION

[0033] The present invention is further described in detail below in conjunction with specific embodiments. It is worth noting that the following embodiments are only for better explanation of the present invention and are not intended to limit the scope of protection of the present invention. The undisclosed process steps in the embodiments are prior art. Unless otherwise specified, the following raw materials are commercially available.

[0034] Example 1

[0035] The Chinese medicine decoction for soothing wind and moistening dryness of the present embodiment is composed of the following raw materials: 10g of mulberry leaf, 10g of bitter almond, 10g of Fritillaria thunbergii, 15g of Adenophora australis, 10g of Ophiopogon japonicus, 15g of Phragmites australis, 10g of Peucedanum chinense, 10g of mint and 5g of Licorice.

[0036] The preparation method comprises the following steps:

[0037] (1) adding 10 times the weight of the raw materials except mint to water and soaking for 30 minutes, then heating to boiling, keeping slightly boiling for 1 hour, and separating to obtain a first decoction and a medicinal residue; taking the medicinal residue obtained after the first decoction, adding 8 times the weight of water equivalent to the total mass of the raw material, heating to boiling, keeping slightly boiling for 1 hour, and separating to obtain a second decoction and a medicinal residue; combining the first decoction and the second decoction to obtain a treated medicinal liquid;

[0038] (2) Add mint to the treated liquid medicine, heat to boiling, and keep it at a slight boil for 5 minutes. This ratio is for one dose of medicine, and one dose of medicine is about 400 mL.

[0039] Example 2

[0040] The Shufeng Runzao powder of the present embodiment is composed of the following raw materials: 10g of mulberry leaves, 10g of bitter almonds, 10g of Fritillaria thunbergii, 15g of Adenophora australis, 10g of Ophiopogon japonicus, 15g of Phragmites australis, 10g of Peucedanum chinense, 10g of mint, and 5g of Licorice.

[0041] The preparation method comprises the following steps:

[0042] (1) Take mulberry leaves, crush them, and pass them through 10-mesh and 50-mesh sieves at the same time. Continue to crush the coarse particles that cannot pass through the 10-mesh sieve, and take the powder between the 10-mesh sieve and the 50-mesh sieve;

[0043] (2) crushing bitter almond, Fritillaria thunbergii, Glehnia littoralis, Radix Ophiopogonis, Rhizoma Phragmites, Peucedanum peucedanum, Mentha arvense, and Radix Glycyrrhizae into powder according to the method of step (1);

[0044] (3) Mix all the raw material powders evenly, put them into a packaging bag, and seal it. When taking it, take it with about 150 mL of warm water.

[0045] Example 3

[0046] The Chinese medicine decoction for soothing wind and moistening dryness of the present embodiment is composed of the following raw materials: 5g of mulberry leaf, 5g of bitter almond, 5g of Fritillaria thunbergii, 5g of Adenophora australis, 5g of Ophiopogon japonicus, 10g of Phragmites australis, 10g of Peucedanum peucedanum, 5g of Mint, and 3g of Licorice.

[0047] The preparation method is the same as that of Example 1.

[0048] Example 4

[0049] The wind-clearing and dryness-removing powder of the present embodiment is composed of the following raw materials: 20g of mulberry leaves, 15g of bitter almonds, 25g of Fritillaria thunbergii, 25g of Adenophora australis, 25g of Ophiopogon japonicus, 30g of Phragmites australis, 20g of Peucedanum chinense, 20g of mint, and 15g of Licorice.

[0050] The preparation method is the same as that of Example 2.

[0051] Next, to illustrate the efficacy of the Chinese herbal composition for dispelling wind and moistening dryness of the present invention, a comparative study was conducted using the Chinese herbal composition for dispelling wind and moistening dryness of the present invention and existing antiviral drugs in Western medicine. This study is a prospective real-world study. The research process and results are as follows:

[0052] 1. Inclusion criteria

[0053] (1) The patient must meet the influenza diagnosis requirements in the Influenza Diagnosis and Treatment Program (2020 Edition).

[0054] (2) Meet the diagnostic criteria for influenza wind-dryness syndrome. Main symptoms: fever, sore throat, cough, no sputum or little and sticky sputum that is difficult to cough up, etc. Secondary symptoms: nasal congestion, headache, dry mouth, thirst, fatigue, etc.

[0055] (3) Age: 18-85 years old (inclusive of the boundary values).

[0056] (4) The subject or his / her legal representative signs the informed consent form.

[0057] Those who meet (1)(3)(4) can be included as subjects of this study. Then, some subjects who meet (2) will be randomly selected from the included subjects and assigned to the wind-clearing and dryness-replenishing group, and the remaining subjects will be assigned to the antiviral group.

[0058] 2. Exclusion criteria

[0059] (1) Patients who need to be hospitalized;

[0060] (2) Pregnant or lactating women;

[0061] (3) Subjects who are judged by the researchers to be unsuitable for participating in the study, such as those with poor compliance, lack of enthusiasm for treatment, etc., which may lead to loss to follow-up.

[0062] 3. General Information

[0063] The Shufeng Runzao group included 48 patients with influenza of wind-dryness syndrome. The Shufeng Runzao group took the Shufeng Runzao Chinese medicine decoction prepared in Example 1 of the present invention, with a dosage of about 400 mL, one dose per day, taken warm twice, and taken continuously for 5 days.

[0064] The antiviral group included 145 influenza patients who took Western medicine antiviral drugs, including 72 patients (49.7%) who used oseltamivir, 69 patients (47.6%) who used mabaloxavir, and 4 patients (2.8%) who used arbidol. All patients took the drugs for 5 consecutive days.

[0065] 4. Baseline analysis

[0066] (1) Baseline data analysis

[0067] The baseline data of the two groups of patients are shown in Table 1:

[0068] Table 1 Comparison of baseline characteristics between the wind-clearing and moistening group and the antiviral group

[0069]

[0070]

[0071] As can be seen from Table 1, the patients in the Shufeng Runzao group were older, with a median age of 40 years. The baseline symptoms of the antiviral group were more severe than those in the Shufeng Runzao group, and the baseline total score was significantly higher than that in the Shufeng Runzao group (9 points vs 7 points, P<0.001). The highest body temperature before the visit was also higher than that in the Shufeng Runzao group (39℃ vs 37.8℃, P<0.001). In addition, there were no significant differences between the two groups in terms of gender, time from onset to visit, BMI, underlying diseases, concomitant medications, and baseline laboratory test results.

[0072] (2) Analysis of baseline influenza symptoms

[0073] The patients' baseline symptoms are shown in Table 2:

[0074] Table 2 Comparison of baseline influenza symptoms between the wind-clearing and moistening group and the antiviral group

[0075]

[0076]

[0077]

[0078] As can be seen from Table 2, in terms of the presence or absence of symptoms, the proportion of patients in the antiviral group experiencing nausea, fever, cough, and muscle pain was significantly higher than that in the wind-clearing and dryness-replenishing group, and no significant differences were found in other symptoms.

[0079] (3) Analysis of baseline symptom severity

[0080] The baseline symptom severity of the patients is shown in Table 3:

[0081] Table 3 Comparison of baseline symptom severity between the wind-clearing and dryness-replenishing group and the antiviral group

[0082]

[0083]

[0084] As can be seen from Table 3, the proportion of patients with moderate to severe fever in the antiviral group was significantly higher than that in the soothing wind and moistening dryness group (93.7% vs 72.2%, P<0.001), while the proportion of patients with moderate to severe cough in the soothing wind and moistening dryness group was significantly higher than that in the antiviral group (59.4% vs 39.2%, P=0.047). There was no significant difference in the severity of other symptoms between the two groups.

[0085] 5. Efficacy analysis

[0086] This study evaluated and followed up the 12 main symptoms of influenza in patients (nasal congestion / runny nose, fever, cough, muscle pain, chills / chills, fatigue, headache, shortness of breath / dyspnea, sore throat, nausea, vomiting, diarrhea), and used the time of symptom disappearance after treatment as the main outcome indicator, where symptom disappearance was defined as: the scores of the 12 main symptoms of influenza were all reduced to 0 points. The comparison results of the main outcome indicators are shown in Table 4.

[0087] Table 4 Comparison of symptom disappearance time between the wind-clearing and dryness-replenishing group and the antiviral group

[0088]

[0089]

[0090] Note: ① As none of the patients in the Shufeng Runzao group experienced nausea, vomiting, and diarrhea, the disappearance time could not be calculated, and the P value could not be calculated. Therefore, the disappearance time of the three symptoms of nausea, vomiting, and diarrhea was not shown in Table 4.

[0091] ②The sample size listed in Table 4 is the sample size that can actually be used for disappearance time calculation and comparison. It requires that the patient has symptoms and has follow-up data at at least two time points. Patients with only baseline data but no subsequent follow-up data are not included in this analysis. Therefore, the sample size here is smaller than the sample size in the aforementioned baseline table.

[0092] Before propensity score matching, the overall symptom negative conversion rate of patients in the Shufeng Runzao group was higher than that in the antiviral group (88.6% vs 49.2%). The Kaplan-Meier test showed that the median symptom disappearance time of patients in the Shufeng Runzao group was 6 days, which was 2 days shorter than that in the antiviral group (6 days vs 8 days, P<0.001). The analysis of the disappearance time of single symptom showed that compared with the antiviral group, the disappearance time of nasal congestion / runny nose (3 days vs 6 days, P=0.001) and cough (6 days vs 8 days, P<0.001) in the Shufeng Runzao group was significantly shortened.

[0093] Considering that the baseline analysis showed that the two groups of patients had differences in age, baseline total score, and highest body temperature before consultation, this study further conducted a 1:1 propensity score matching analysis, and the matching factors included: age, gender, time from onset to consultation, BMI, underlying disease, concomitant medication, baseline total score, etc. Finally, 39 pairs were successfully matched, of which 36 patients in the wind-clearing and moisturizing group and 34 patients in the antiviral group had data at at least two time points, which could be used for disappearance time calculation analysis.

[0094] After propensity score matching, the overall symptom negative conversion rate of patients in the Shufeng Runzao group was still higher than that in the antiviral group (88.9% vs 58.8%). The Kaplan-Meier test showed that the median symptom disappearance time of patients in the Shufeng Runzao group was 6 days, which was 1 day shorter than that in the antiviral group (6 days vs 7 days, P=0.017). The analysis of the disappearance time of single symptom showed that compared with the antiviral group, the disappearance time of nasal congestion / runny nose (3 days vs 6 days, P=0.005) and cough (5 days vs 7 days, P=0.035) in the Shufeng Runzao group was significantly shortened, but the disappearance time of chills or chills was longer (3 days vs 2 days, P=0.026).

[0095] Therefore, the results of this study suggest that the wind-dispersing and dryness-replenishing Chinese medicine composition of the present invention can significantly improve the symptoms of patients with wind-dryness syndrome influenza, shorten the time it takes for the symptoms to disappear, and is particularly effective in improving nasal congestion / runny nose and cough symptoms.

[0096] The above are only some specific embodiments of the present invention. For those skilled in the art, several modifications and improvements can be made without departing from the creative concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. A Chinese medicine composition for dispelling wind and moistening dryness, characterized in that: The raw materials include, by weight: 5-20 parts of mulberry leaves, 5-15 parts of bitter almonds, 5-25 parts of thunbergia thunbergii, 5-25 parts of northern adenophora, 5-25 parts of ophiopogon, 10-30 parts of reed roots, 10-20 parts of peucedanum, 5-20 parts of mint and 3-15 parts of liquorice.

2. The Chinese medicine composition for dispelling wind and moistening dryness according to claim 1, characterized in that: The raw material composition includes, by weight: 10 parts of mulberry leaves, 10 parts of bitter almonds, 10 parts of Fritillaria thunbergii, 15 parts of Adenophora adenophora, 10 parts of Ophiopogon japonicus, 15 parts of Phragmites australis, 10 parts of Peucedanum peucedanum, 10 parts of mint and 5 parts of Licorice.

3. The Chinese medicine composition for dispelling wind and moistening dryness according to claim 1 or 2, characterized in that: The dosage form of the Chinese medicine composition is Chinese medicine decoction, oral solution, powder or granule.

4. The Chinese medicinal composition for dispelling wind and moistening dryness according to claim 1 or 2, characterized in that: Pharmaceutically acceptable excipients are also included.

5. The Chinese medicinal composition for dispelling wind and moistening dryness according to claim 4, characterized in that: The auxiliary material is at least one of a sustained-release agent, an excipient, a filler, a binder, a wetting agent, a disintegrant, an absorption promoter, an adsorption carrier, a surfactant, and a lubricant.

6. The method for preparing the wind-dispelling and dryness-removing Chinese medicinal composition according to any one of claims 1 to 5, characterized in that: When the dosage form of the Chinese medicine composition is a Chinese medicine decoction, the preparation method thereof comprises the following steps: S1, add 8-12 times the weight of the raw materials except mint into water and soak for 20-40 minutes, then heat to boiling, keep slightly boiling for 1-2 hours, filter, repeat the decoction of the filter residue 1-2 times, combine the filtrate, and obtain the treated liquid medicine; S2. Add mint to the treated medicinal solution, heat to boiling, and keep it at a slight boil for 3-5 minutes.

7. The method for preparing the wind-dispelling and dryness-removing Chinese medicinal composition according to any one of claims 1 to 5, characterized in that: When the dosage form of the Chinese medicine composition is a powder, the preparation method thereof comprises the following steps: The raw materials are crushed or chopped separately, and then the crushed or chopped raw materials are passed through 10-mesh and 50-mesh sieves respectively, and the coarse particles that cannot pass through the 10-mesh sieve are further crushed or chopped, and the powder between the 10-mesh sieve and the 50-mesh sieve is taken, and then the raw material powders are mixed according to the proportion, put into the packaging bag, and sealed.

8. Use of the wind-dispelling and dryness-removing Chinese medicinal composition according to any one of claims 1 to 5 in the preparation of a medicament for treating influenza.

9. The use according to claim 8, characterized in that: The influenza is wind-dryness syndrome type influenza.

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