A traditional Chinese medicine composition for dispelling wind and moisturizing dryness, a preparation method and application thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for dispelling wind and moistening dryness, a preparation method and application thereof. The traditional Chinese medicine composition comprises, in mass parts, mulberry leaves 5-20 parts, bitter apricot kernels 5-15 parts, Zhejiang fritillary bulbs 5-25 parts, North adenosma 5-25 parts, ophiopogon 5-25 parts, reed roots 10-30 parts, radix peucedani 10-20 parts, peppermint 5-20 parts, and licorice 3-15 parts. The traditional Chinese medicine composition has the effects of dispelling wind, moistening dryness and clearing the lung, and can effectively relieve the symptoms of patients with influenza and dryness, such as cough, itching and dryness of the throat, dryness of the lips and nose, little or little sticky sputum, difficulty in coughing, dry mouth, sore throat, fever, headache, red and dry tongue, thin white or yellowish fur, and floating and uneven pulse, and has a good therapeutic effect on influenza and dryness.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for dispelling wind and moistening dryness, its preparation method, and its application. Background Technology

[0002] Influenza (hereinafter referred to as flu) is an acute respiratory infectious disease caused by the influenza virus. Type A and Type B influenza viruses circulate seasonally each year, with Type A influenza viruses capable of causing global pandemics. National influenza surveillance results show that every October, various parts of my country gradually enter the winter-spring flu season, and the activity intensity of the influenza virus remains at a high level.

[0003] Influenza has a rapid onset, and although most cases are self-limiting, some patients develop severe illness due to complications such as pneumonia or exacerbation of underlying diseases. A small number of cases progress rapidly and can lead to death from complications such as acute respiratory distress syndrome (ARDS), acute necrotizing encephalopathy, or multiple organ failure. Severe influenza mainly occurs in high-risk groups such as the elderly, young children, obese individuals, pregnant women, and those with chronic underlying diseases, but it can also occur in the general population.

[0004] Currently, the main drugs used clinically for the treatment and prevention of influenza 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 being discovered, and potential neurological side effects or hypersensitivity reactions have also been found. Traditional Chinese medicine emphasizes syndrome differentiation and treatment, and it has certain advantages in treating influenza. However, most existing Chinese patent medicines are for wind-heat or wind-cold colds. Some influenza patients suffer from neither wind-heat nor wind-cold colds, but rather present with symptoms such as cough, little or no phlegm, and sticky phlegm that is difficult to expectorate, which manifests as wind-dryness syndrome. There is still an urgent need for a Chinese medicine composition that can specifically treat influenza with wind-dryness syndrome. Summary of the Invention

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

[0006] According to a first aspect of the present invention, a traditional Chinese medicine composition for relieving wind and moisturizing dryness is provided, wherein the raw materials comprising, by weight, are: 5-20 parts of mulberry leaves, 5-15 parts of bitter almonds, 5-25 parts of Fritillaria thunbergii, 5-25 parts of Adenophora stricta, 5-25 parts of Ophiopogon japonicus, 10-30 parts of Phragmites communis rhizome, 10-20 parts of Peucedanum praeruptorum, 5-20 parts of peppermint, and 3-15 parts of licorice.

[0007] In this formula, mulberry leaves are sweet, cold, and moist, clearing away dryness and heat, and expelling pathogens; bitter almonds are bitter and warm, entering the lung meridian, and can promote lung qi, moisten dryness, and stop coughing. The combination of their cold and warm properties achieves the effects of dispelling wind and pathogens, moistening dryness, and stopping coughing, and together they serve as the principal herbs. North American ginseng is sweet and moist, nourishing lung yin, clearing lung heat, and eliminating phlegm and stopping coughing; ophiopogon japonicus is sweet and neutral, and can treat deficiency heat in the heart and lungs; reed rhizome is sweet and cold, not greasy, and generates fluids without retaining pathogens. It can clear lung heat, eliminate phlegm, and stop coughing, as well as clear stomach heat, generate fluids, and quench thirst. Together, these three herbs nourish yin, clear heat, moisten dryness, generate fluids, eliminate phlegm, and stop coughing, and together they serve as the assistant herbs. Fritillaria thunbergii is bitter and cold in nature, and can clear away phlegm and heat, assisting bitter apricot kernel in relieving cough and resolving phlegm; Peucedanum praeruptorum is bitter and pungent, and slightly cold in nature, and can lower qi, resolve phlegm, and disperse wind-heat; Mentha haplocalyx is clear and neutral in nature, and its power can penetrate into the muscles and bones, reach the surface of the skin, clear the internal organs, and connect the meridians. These three herbs serve as adjuvant herbs. Glycyrrhiza uralensis harmonizes the herbs and serves as the guiding herb. This formula, with its mild dispersing, moisturizing, and heat-clearing properties, works together to relieve wind-dryness, generate fluids, and stop cough.

[0008] The raw materials for this formula come from the following sources:

[0009] Mulberry leaves: the leaves of the mulberry tree, a plant in the Moraceae family.

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

[0011] Fritillaria thunbergii Miq., a plant belonging to the Liliaceae family.

[0012] North American ginseng: The root of *Glehnia littoralis* Fr.schmidt ex Miq., a plant belonging to the Apiaceae family.

[0013] Ophiopogon japonicus: the tuberous root of Ophiopogon japonicus, a plant in the Lili

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

[0015] Peucedanum praeruptorum: the dried root of Peucedanum praeruptorum var. praeruptorum or Peucedanum praeruptorum var. ..., both belonging to the Apiaceae family.

[0016] Peppermint: The whole herb or leaves of *Mentha haplocalyx* or *Mentha haplocalyx*, a dicotyledonous plant belonging to the Lamiaceae family.

[0017] Licorice: The dried root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., all belonging to the legume family.

[0018] In some embodiments, the raw material composition by weight includes: 10 parts mulberry leaves, 10 parts bitter almonds, 10 parts Fritillaria thunbergii, 15 parts Adenophora stricta, 10 parts Ophiopogon japonicus, 15 parts Phragmites communis rhizome, 10 parts Peucedanum praeruptorum, 10 parts peppermint, and 5 parts licorice.

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

[0020] In some implementations, pharmaceutically acceptable excipients are also included.

[0021] In some embodiments, the excipient is at least one selected from the following: sustained-release agent, excipient, filler, binder, wetting agent, disintegrant, absorption promoter, adsorbent carrier, surfactant, and lubricant.

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

[0023] S1. Soak the raw materials except for peppermint in 8-12 times their weight of water for 20-40 minutes, then heat to boiling and keep simmering for 1-2 hours. Filter and boil the residue 1-2 times. Combine the filtrates to obtain the processed medicinal liquid.

[0024] S2. Add the peppermint to the treated liquid, heat to a boil, and maintain a gentle boil for 3-5 minutes.

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

[0026] Crush or chop each raw material separately, then pass the crushed or chopped raw materials through 10-mesh and 50-mesh sieves respectively. Continue to crush or chop the coarse particles that cannot pass through the 10-mesh sieve, and take the powder that is between the 10-mesh and 50-mesh sieves. Then mix the powders of each raw material according to the formula, put them into a packaging bag, and seal it.

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

[0028] In some implementations, the influenza is classified as wind-dryness syndrome type influenza.

[0029] The beneficial effects of this invention include:

[0030] (1) The traditional Chinese medicine composition of the present invention has the effect of dispelling wind, moistening dryness and clearing the lungs. It can effectively relieve the symptoms of influenza wind-dryness syndrome, such as cough, itchy and dry throat, dry lips and nose, no phlegm or little sticky phlegm that is not easy to cough up, or accompanied by dry mouth, sore throat, fever, headache, red and dry tongue with little saliva, thin white or thin yellow coating, floating and rapid pulse. It has a very good therapeutic effect on influenza wind-dryness syndrome.

[0031] (2) This invention does not use greasy and strong tonics, but uses small doses of mild and moisturizing ingredients, such as North American ginseng, Ophiopogon japonicus and Phragmites communis. Through clever combination, cold and warm ingredients are matched. By combining mild dispersing, moisturizing and clearing heat, the yin is nourished without hindering the spleen. While dispelling wind and evil, it also has the effect of moisturizing dryness and relieving cough.

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

[0033] The present invention will be further described in detail below with reference to specific embodiments. It is worth noting that the following embodiments are only for better explaining the content of the present invention and do not limit the scope of protection of the present invention. Process steps not disclosed in the embodiments are prior art. Unless otherwise specified, all raw materials are commercially available.

[0034] Example 1

[0035] The herbal decoction for relieving wind and dryness in this embodiment consists of the following ingredients: 10g mulberry leaves, 10g bitter almonds, 10g Zhejiang fritillary bulbs, 15g North American ginseng, 10g Ophiopogon japonicus, 15g reed rhizome, 10g Peucedanum praeruptorum, 10g peppermint, and 5g licorice.

[0036] Its preparation method includes the following steps:

[0037] (1) Soak the raw materials except peppermint in 10 times their weight of water for 30 minutes, then heat to boiling and keep simmering for 1 hour. After separation, obtain the first decoction and the dregs. Take the dregs obtained after the first decoction, add water equivalent to 8 times the total weight of the raw materials, heat to boiling and keep simmering for 1 hour. After separation, obtain the second decoction and the dregs. Combine the first decoction and the second decoction to obtain the processed medicinal liquid.

[0038] (2) Add the peppermint to the treated liquid, heat to boiling, and keep simmering for 5 minutes. This is the dosage for one dose, which is approximately 400 mL.

[0039] Example 2

[0040] The ingredients of the wind-dispelling and dryness-moistening powder in this embodiment are: 10g mulberry leaf, 10g bitter almond, 10g Zhejiang fritillary bulb, 15g North American ginseng, 10g Ophiopogon japonicus, 15g reed rhizome, 10g Peucedanum praeruptorum, 10g peppermint, and 5g licorice.

[0041] Its preparation method includes 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 that is between the 10-mesh and 50-mesh sieves.

[0043] (2) Following the method in step (1), pulverize bitter almond, fritillaria thunbergii, glehnia littoralis, ophiopogon japonicus, reed rhizome, angelica dahurica, mint, and licorice into powder respectively;

[0044] (3) Mix all the raw material powders evenly, pack them into a sealed bag, and seal it. When taking it, dissolve it in about 150mL of warm water.

[0045] Example 3

[0046] The herbal decoction for relieving wind and dryness in this embodiment consists of the following ingredients: 5g mulberry leaves, 5g bitter almonds, 5g Zhejiang fritillary bulbs, 5g North American ginseng, 5g Ophiopogon japonicus, 10g reed rhizome, 10g Peucedanum praeruptorum, 5g peppermint, and 3g licorice.

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

[0048] Example 4

[0049] The ingredients of the wind-dispelling and dryness-moistening powder in this embodiment are: 20g mulberry leaves, 15g bitter almonds, 25g Fritillaria thunbergii, 25g Adenophora stricta, 25g Ophiopogon japonicus, 30g reed rhizome, 20g Peucedanum praeruptorum, 20g peppermint, and 15g licorice.

[0050] Its preparation method is the same as that in Example 2.

[0051] To illustrate the efficacy of the wind-dispelling and dryness-moistening traditional Chinese medicine composition of the present invention, a comparative study was conducted between the wind-dispelling and dryness-moistening traditional Chinese medicine composition 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) Meets the criteria for influenza diagnosis in the "Influenza Diagnosis and Treatment Protocol (2020 Edition)".

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

[0055] (3) Age 18-85 years old (including boundary values).

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

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

[0058] 2. Exclusion criteria

[0059] (1) Patients who require hospitalization;

[0060] (2) Pregnant or lactating women;

[0061] (3) Subjects who are deemed unsuitable for the study by the researchers, such as those with poor compliance or lack of willingness to receive treatment, are likely to be lost to follow-up.

[0062] 3. General Information

[0063] The group that relieves wind and moistens dryness included 48 patients with influenza of the wind-dryness type. The group took the traditional Chinese medicine decoction for relieving wind and moistening dryness prepared in Example 1 of this invention. One dose was about 400 mL, one dose per day, taken twice a day, and continued for 5 days.

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

[0065] 4. Baseline Analysis

[0066] (1) Baseline data analysis

[0067] Baseline data for the two groups of patients are shown in Table 1:

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

[0069]

[0070]

[0071] Table 1 shows that patients in the "Wind-Clearing and Moisturizing Group" were older, with a median age of 40 years. Patients in the antiviral group had more severe baseline symptoms than those in the "Wind-Clearing and Moisturizing Group," with significantly higher baseline total scores (9 vs. 7, P<0.001). Their highest pre-visit temperature was also higher in the antiviral group (39℃ vs. 37.8℃, P<0.001). Furthermore, 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) Baseline influenza symptom analysis

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

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

[0075]

[0076]

[0077]

[0078] As shown in Table 2, in terms of the presence or absence of symptoms, the proportion of patients in the antiviral group who experienced nausea, fever, cough, and muscle pain was significantly higher than that in the wind-dispelling and dryness-moistening group, while no significant differences were found in other symptoms.

[0079] (3) Baseline symptom severity analysis

[0080] The severity of patients' baseline symptoms is shown in Table 3:

[0081] Table 3 Comparison of baseline symptom severity between the wind-dispelling and dryness-moistening group and the antiviral group.

[0082]

[0083]

[0084] As shown in Table 3, the proportion of patients with severe fever in the antiviral group was significantly higher than that in the wind-dispelling and dryness-moistening group (93.7% vs 72.2%, P<0.001), while the proportion of patients with severe cough in the wind-dispelling and dryness-moistening 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. Therapeutic effect analysis

[0086] This study evaluated and followed up patients on 12 major influenza symptoms (nasal congestion / runny nose, fever, cough, muscle pain, chills, fatigue, headache, shortness of breath / dyspnea, sore throat, nausea, vomiting, and diarrhea). The primary outcome measure was the time to symptom resolution after treatment, defined as a decrease in the score of all 12 major influenza symptoms to 0. The comparison results of the primary outcome measures are shown in Table 4.

[0087] Table 4 Comparison of symptom disappearance time between the wind-dispelling and dryness-moistening group and the antiviral group.

[0088]

[0089]

[0090] Note: ① Since none of the patients in the wind-dispelling and dryness-moistening 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 these three symptoms is not shown in Table 4.

[0091] ② The sample size listed in Table 4 is the actual sample size that can be used for the calculation and comparison of disappearance time. Patients are required to have symptoms and follow-up data at at least two time points. Patients with only baseline data and 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 seroconversion rate in the wind-dispelling and dryness-moistening group was higher than that in the antiviral group (88.6% vs 49.2%). Kaplan-Meier test showed that the median symptom disappearance time in the wind-dispelling and dryness-moistening group was 6 days, which was 2 days shorter than that in the antiviral group (6 days vs 8 days, P<0.001). Analysis of individual symptom disappearance time 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) was significantly shorter in the wind-dispelling and dryness-moistening group.

[0093] Considering the baseline analysis showed differences between the two groups in age, baseline total score, and highest body temperature before consultation, this study further conducted a 1:1 propensity score matching analysis. Matching factors included age, sex, time from onset to consultation, BMI, underlying diseases, concomitant medications, and baseline total score. A total of 39 pairs were successfully matched. Among these, 36 patients in the "dispelling wind and moistening dryness" group and 34 patients in the "antiviral" group had data at at least two time points, allowing for disappearance time calculation analysis.

[0094] After propensity score matching, the overall symptom seroconversion rate in the wind-dispelling and dryness-moistening group was still higher than that in the antiviral group (88.9% vs 58.8%). Kaplan-Meier test showed that the median symptom disappearance time in the wind-dispelling and dryness-moistening group was 6 days, which was 1 day shorter than that in the antiviral group (6 days vs 7 days, P = 0.017). Analysis of individual symptom disappearance time 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) was significantly shorter in the wind-dispelling and dryness-moistening group, but the disappearance time of chills or shivering was longer (3 days vs 2 days, P = 0.026).

[0095] Therefore, the results of this study suggest that the wind-dispelling and dryness-moistening traditional Chinese medicine composition of the present invention can significantly improve the symptoms of patients with wind-dryness syndrome influenza and shorten the time for the symptoms to disappear, especially in improving nasal congestion / runny nose and cough symptoms.

[0096] The above descriptions are merely some specific embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for dispelling wind and moistening dryness, characterized in that, The raw material composition by weight is as follows: 5-20 parts mulberry leaves, 5-15 parts bitter almonds, 5-25 parts Zhejiang fritillary bulb, 5-25 parts North American ginseng, 5-25 parts Ophiopogon japonicus, 10-30 parts reed rhizome, 10-20 parts Peucedanum praeruptorum, 5-20 parts peppermint, and 3-15 parts licorice.

2. The traditional Chinese medicine composition for dispelling wind and moistening dryness according to claim 1, characterized in that, The raw materials are composed of the following parts by weight: 10 parts mulberry leaves, 10 parts bitter almonds, 10 parts Zhejiang fritillary bulb, 15 parts North American ginseng, 10 parts Ophiopogon japonicus, 15 parts reed rhizome, 10 parts Peucedanum praeruptorum, 10 parts peppermint, and 5 parts licorice.

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

4. The traditional Chinese medicine composition for dispelling wind and moistening dryness according to claim 1 or 2, characterized in that, It also includes pharmaceutically acceptable excipients.

5. The traditional Chinese medicine composition for dispelling wind and moistening dryness according to claim 4, characterized in that, The excipients are at least one of the following: slow-release agent, filler, binder, wetting agent, disintegrant, absorption promoter, adsorbent carrier, surfactant, and lubricant.

6. The method for preparing the traditional Chinese medicine composition for dispelling wind and moistening dryness according to any one of claims 1-5, characterized in that, When the dosage form of the traditional Chinese medicine composition is a decoction, its preparation method includes the following steps: S1. Soak the raw materials except for peppermint in 8-12 times their weight of water for 20-40 minutes, then heat to boiling and keep simmering for 1-2 hours. Filter and boil the residue 1-2 times. Combine the filtrates to obtain the processed medicinal liquid. S2. Add the peppermint to the treated liquid, heat to a boil, and maintain a gentle boil for 3-5 minutes.

7. The method for preparing the traditional Chinese medicine composition for dispelling wind and moistening dryness according to any one of claims 1-5, characterized in that, When the dosage form of the traditional Chinese medicine composition is a powder, its preparation method includes the following steps: Crush or chop each raw material separately, then pass the crushed or chopped raw materials through 10-mesh and 50-mesh sieves respectively. Continue to crush or chop the coarse particles that cannot pass through the 10-mesh sieve, and take the powder that is between the 10-mesh and 50-mesh sieves. Then mix the powders of each raw material according to the formula, put them into a packaging bag, and seal it.

8. The use of the traditional Chinese medicine composition for dispelling wind and moistening dryness according to any one of claims 1-5 in the preparation of a medicament for treating influenza.

9. The application according to claim 8, characterized in that, The influenza mentioned is the wind-dryness syndrome type of influenza.

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