WO2021164344A1

WO2021164344A1 - Traditional chinese medicine composition and use thereof in prevention and treatment of viral pneumonia

Info

Publication number: WO2021164344A1
Application number: PCT/CN2020/129418
Authority: WO
Inventors: 谭行华; 郑星宇
Original assignee: 广州市第八人民医院; 福建省立医院
Priority date: 2020-02-17
Filing date: 2020-11-17
Publication date: 2021-08-26
Also published as: CN111265616B; CN111265616A

Abstract

Disclosed are a traditional Chinese medicine composition for preventing and treating viral pneumonia, and the pharmaceutical use thereof, wherein Forsythiae fructus, Cremastrae pseudobulbus pleiones pseudobulbus, Lonicerae Japonicae flos, Scutellariae radix, and Isatidis folium are used as basic components, and are used in combination with Astragali radix, Pseudostellariae radix, Poria, Bupleuri radix, Artemisiae annuae herba, Periostracum cicadae, Peucedani radix, Fritillariae cirrhosae bulbus, Fritillarie thunbergii bublus, Scrophulariae radix and Mume fructus. The traditional Chinese medicine composition is suitable for treating COVID-19, can relieve symptoms of patients and improve prognosis, and reduces the severe incidence rate and the case fatality rate.

Description

A Chinese medicine composition and its application in the prevention and treatment of viral pneumonia

Technical field

The invention belongs to the technical field of traditional Chinese medicine. More specifically, it relates to a traditional Chinese medicine composition and its application in the preparation of drugs for the prevention and treatment of viral pneumonia, as well as its application in the preparation of drugs for the treatment of novel coronavirus pneumonia (light and common).

Background technique

Viral pneumonia is inflammation of the lungs caused by viral infection of the upper respiratory tract and spreading downward. The disease can occur throughout the year, but most of it is seen in winter and spring, and it can be an outbreak or spread. The main clinical manifestations of viral pneumonia are fever, headache, body aches, dry cough, and lung infiltration. Viral pneumonia is a relatively common disease at present. This disease must be treated in a timely manner, otherwise it will be more harmful to the body. Common viruses that cause viral pneumonia include influenza virus, respiratory syncytial virus, adenovirus, and coronavirus.

[Corrected according to Rule 26 03.12.2020]
Among them, the coronavirus belongs to the nest virus, the coronavirus family, and the coronavirus genus. It is a type of RNA virus with an envelope and a linear single-stranded positive strand genome. It is a large group of viruses that exist in nature and can cause humans and animals. Diseases of the respiratory system, digestive system, and nervous system manifested in different clinical symptoms ranging from the common cold to severe lung infections. The new type of coronavirus (COVID-19) is a new type of coronavirus that has not been found in humans before. The main clinical manifestations are fever, fatigue, dry cough, etc. In severe cases, shock, sepsis, respiratory failure and death can occur. As the source and pathogenesis of the novel coronavirus pneumonia are not yet clear, and the lack of specific antiviral drugs, it has brought great difficulties to clinical diagnosis, treatment and control of the epidemic, causing serious social burdens and crises.

In traditional Chinese medicine, according to the clinical characteristics and onset season, the new type of coronavirus pneumonia can be attributed to the category of "war epidemic". Historical experience tells us that Chinese medicine has made a great contribution to mankind in dealing with the "plague". The "Chinese Epidemic History Book" records that Chinese medicine has resisted 321 large-scale plagues in Chinese history. There has never been a tragedy in China’s history where the Spanish flu, the European Black Death, and the global plague caused tens of millions of deaths in a single plague. Therefore, the development of anti-new coronavirus pneumonia drugs from the perspective of Chinese medicine is very important for the control of the new coronavirus pneumonia epidemic.

Summary of the invention

The present invention aims to provide an effective Chinese medicinal composition capable of treating viral pneumonia, which is mainly aimed at mild or common viral pneumonia caused by coronavirus and new coronavirus, and can specifically alleviate mild and common new coronavirus pneumonia. Symptoms, improve the prognosis, reduce the severe rate and fatality rate, and have a positive effect on the recovery treatment after the severe disease is relieved, protect the people's life safety, and reduce the economic burden of patients and society.

Another object of the present invention is to provide a method for preparing the traditional Chinese medicine composition.

Another object of the present invention is to provide the application of the traditional Chinese medicine composition in the preparation of drugs for the treatment of viral pneumonia.

Another object of the present invention is to provide an application of a Chinese medicine composition combined with a virus-inhibiting western medicine in the preparation of a drug for the treatment of viral pneumonia.

The above objectives of the present invention are achieved through the following technical solutions:

Based on clinical analysis, the inventors concluded that in traditional Chinese medicine, viral pneumonia, especially new coronavirus pneumonia, can be classified as "warm epidemic" based on clinical characteristics and onset season. And the evolution of the disease is similar to SRAS, but the heat toxin is relatively mild; warming evil first infects the lungs, and the initial onset is mostly on the surface. The general trend of pathogenesis is from the surface to the inside, from shallow to deep. Due to different physical factors, disease resistance There are differences in strength and the severity of the sense of evil. Therefore, there are those who warm evil and get better on their own without changing, there are those who gradually deepen the blood with the defense of qi and the blood, and those who have the self-defense invaded and blood are different. Therefore, early, correct and timely treatment is a key link in the treatment of this disease.

Based on the inventor's understanding that viral pneumonia is a TCM febrile disease, he formulated the therapeutic principles of clearing away heat and detoxifying, dredging the wind, relieving cough and resolving phlegm, replenishing qi and nourishing yin, and developed a compatible mechanism of the monarch and ministers of the present invention. Forsythia suspensa, which is light in quality, is used to moisturize the lungs, to clear the lung heat, Shansi Mushroom clears epidemic toxins, resolves phlegm and dispels knots, both of which are the master medicine; honeysuckle, scutellaria, and Daqingye are used to clear the lungs. Wei Zhire, all medicines are minister medicine. On this basis, the medicines of Qingshangjiaofeiwei, which are compatible with the monarch medicine, are used as minister medicines. At the same time, they follow the principles of traditional Chinese medicine, from "damaging their lungs, benefiting their qi" (see "Difficulty-14 Based on the principle of "Difficult"), the Chinese medicinal materials of Astragalus and Taizishen for nourishing qi and nourishing yin were selected as supplements, together with the components for invigorating the spleen and promoting the movement, and the components for clearing phlegm and heat, and further using Nengzuoshan Mushroom to aid the transformation. The components that dispel phlegm and remove residual heat to prevent the occurrence of pulmonary fibrosis are used as adjuvants; consider medicines that can produce fluids and moisturize the lungs as well as converge the lungs to prevent asthma in order to protect the place free from evil.

Based on this analysis and summary, the present invention provides a Chinese medicinal composition for the treatment of viral pneumonia, which uses Forsythia, Shansi Mushroom, Honeysuckle, Scutellaria baicalensis Georgi, and Daqingye as the basic components of the Chinese medicinal composition, and is formulated in accordance with Chinese medicine Compatible with the contraindicated components for invigorating qi and nourishing yin, invigorating the spleen and assisting transport components, clearing and resolving phlegm heat components, resolving phlegm and dissipating masses, as well as promoting body fluids, moisturizing the lungs, restraining the lungs and preventing asthma.

Preferably, after a large number of clinical trials, the traditional Chinese medicine composition of the present invention, in terms of parts by weight, the basic components are 40 to 130 parts, the qi and yin components are 50 to 110 parts, and the spleen and transport components are 20 parts. ～50 parts, 15-50 parts for clearing phlegm-heat component, 14-50 parts for resolving phlegm and dissipating masses, 20-50 parts for promoting body fluid, moisturizing lung, restraining lung and preventing asthma.

Further preferably, in terms of parts by weight, the basic components are 45 to 95 parts, the qi and yin components are 50 to 80 parts, the spleen and transport aid components are 34 to 70 parts, and the phlegm-removing heat component is 15 parts. ～50 parts, 15-35 parts for resolving phlegm and dissipating masses, 20-40 parts for promoting body fluids, moisturizing lungs, restraining lungs and preventing asthma.

Comprehensively considering the efficacy and cost, especially the significant effect in the treatment of new coronavirus pneumonia, the present invention provides preference for the types of Chinese medicinal materials used in each component on the basis of the above-mentioned combination of monarchs and ministers. It can be divided into astragalus and/or Radix serrata, preferably a mixture of the two; the spleen invigorating and transportation aid component is Poria; the clearing and phlegm-reducing component is Chuanbei, Zhebei and/or Scrophulariaceae, preferably a mixture of the three; The phlegm-resolving and mass-reducing component is Bupleurum, Artemisia annua, Chanyi and/or Qianhu, preferably a mixture of the four; the component for promoting body fluid, moisturizing the lung, constricting the lung and preventing asthma is ebony plum.

That is, preferably, the present invention provides a Chinese medicinal composition for the treatment of viral pneumonia (preferably applied to the treatment of new coronavirus pneumonia), comprising the following components: Forsythia, Shansi Mushroom, Honeysuckle, Scutellaria, Bupleurum, Artemisia annua , Chanyi, Peucedanum, Zhebei, ebony, Scrophulariaceae, Daqingye, Chuanbei, Astragalus, Poria and Taizishen.

In this recipe, Forsythia is the dried fruit of Forsythia suspensa (Forsythia suspensa), which has the functions of clearing heat and detoxifying, reducing swelling and dispelling wind and heat; Shansi mushroom is an orchidaceous plant Cremastra appendiculata Makino Scrophularia ningpoensis Hemsl is the dry root of Scrophularia ningpoensis Hemsl, which has the functions of clearing heat and cooling blood, nourishing yin and reducing fire, detoxifying and dispelling stagnation; Honeysuckle is the first blooming flower of the dry bud of Lonicera japonica Thund, which has the functions of clearing heat and detoxifying, and dispersing wind heat; Daqingye is the dry leaf of the cruciferous plant Isatis indigotica Fort, which has the function of clearing heat and detoxifying. The power of cooling blood to eliminate spots; cicadas are shed as the skin shells of the nymphs of the cicada family insect Black Grasshopper (Cryptotympana pustulata Fabricius) when they emerge. Scutellaria baicalensis (Scutellaria baicalensis Georgi) is the dried root of Scutellaria baicalensis Georgi. It has the functions of clearing heat and dampness, purging fire and detoxification, hemostasis, and antifetal; Fritillaria cirrhosa (Fritillaria cirrhosa D.Don) is the dry bulb of Liliaceae plant Fritillaria cirrhosa D. Cough relieving, dispelling knots and carbuncle; Fritillaria thunbergii is the dry bulb of Liliaceae plant Fritillaria thunbergii Miq, which has the functions of clearing heat, resolving phlegm and relieving cough, detoxification, dispelling knots and carbuncle; P. chinensis is a perennial herb of Caryophyllaceae The dried root tuber of Pseudostellaria heterophylla has the functions of invigorating qi and spleen, nourishing body fluid and nourishing lungs; Astragalus is the dried root of legume Astragalus membranaceus, which has the functions of nourishing qi and promoting yang, replenishing health, strengthening the surface, and promoting water consumption. The power of swelling, nourishing body fluid and nourishing blood; ebony is the dry and nearly mature fruit of Prunus mume (Prunus mume), which has the functions of constricting the lungs, astringent intestines, producing body fluid, and comforting roundworms; Poria cocos is a fungus Poria cocos Wolf (Poria cocos Wolf) The dried sclerotia of sclerotium has the functions of distilling water, invigorating dampness, invigorating the spleen, calming the heart and soothing the nerves; Peucedanum praeruptorum Dum is the dried root of the Umbelliferae plant Peucedanum praeruptorum Dum, which has the functions of lowering qi, dispelling phlegm, dispelling wind and clearing heat. Artemisia annua is the dry aerial part of the Compositae plant Artemisia annua (Artemisia annua L), which has the functions of clearing deficiency and heat, removing bones and steaming, relieving heat, reducing malaria, and retreating yellow.

Preferably, the traditional Chinese medicine composition includes the following components in parts by weight: 20-50 parts of Forsythia, 5-30 parts of Shanzi mushroom, 5-20 parts of honeysuckle, 5-15 parts of Scutellaria baicalensis and 5-15 parts of Daqing Ye Parts, 30-60 parts of Astragalus, 20-50 parts of Pseudostellariae, 20-50 parts of Poria, 2-10 parts of Bupleurum, 5-15 parts of Artemisia annua, 5-15 parts of Chanyi, 2-10 parts of Qianhu, Chuan 5-15 parts of shellfish, 5-15 parts of zhebei, 5-20 parts of Scrophulariaceae and 20-50 parts of ebony plum.

Further preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 20-40 parts of Forsythia suspense, 10-20 parts of Shanzi mushroom, 5-15 parts of honeysuckle, 5-10 parts of Scutellaria baicalensis Georgi, 5-10 parts of Daqing Ye 10 parts, 30-40 parts of Astragalus, 20-40 parts of Pseudostellariae, 20-40 parts of Poria, 2-5 parts of Bupleurum, 5-10 parts of Artemisia annua, 5-10 parts of Chanyi, 2-5 parts of Qianhu, 5-10 parts of Chuanbei, 5-10 parts of Zhebei, 5-15 parts of Scrophulariaceae and 20-40 parts of ebony plum.

More preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 30 parts of Forsythia suspense, 15 parts of Shanzi mushroom, 10 parts of honeysuckle, 8 parts of Scutellaria baicalensis Georgi, 8 parts of Daqingye, 35 parts of Radix Astragali, Pseudostellaria chinensis 30 parts, 30 parts of Poria, 3 parts of Bupleurum, 8 parts of Artemisia annua, 8 parts of Chanyi, 3 parts of Qianhu, 8 parts of Chuanbei, 8 parts of Zhebei, 10 parts of Scrophulariaceae and 30 parts of Wumei.

In order to be convenient to use and suitable for use in different scenarios, the traditional Chinese medicine composition may also include a pharmaceutically acceptable carrier to prepare various pharmaceutical preparations. The preparations include, but are not limited to, oral liquids, granules, capsules, tablets, pills, external patches or injections.

In addition, as an optional specific preferred solution, the water extraction preparation method of the traditional Chinese medicine composition includes the following steps:

S1. Mix the components of Chinese medicinal materials except Artemisia annua, add 6-10 times the amount of water, reflux for 1 to 3 hours, and collect the decoction liquid;

S2. Then add the Chinese medicinal material Artemisia annua into the dregs of step S1, add 2 to 5 times the amount of water, reflux for 0.5 to 2 hours, and collect the decoction;

S3. Combine the decoction liquid of steps S1 and S2, filter, concentrate, and dry to obtain.

Among them, preferably, the amount of water in step S1 is 8 times the amount.

Preferably, reflux for 1.5 hours in step S1.

Preferably, the amount of water used in step S2 is 3 times the amount.

Preferably, reflux for 1 hour in step S2.

Further, a certain organic solvent can be added according to research to improve the curative effect, and it is predictable to reduce the dosage. In the above-mentioned preparation method of the present invention, the extraction solvent can be replaced with ethanol or acetone solutions of different concentrations, and the temperature will vary with the concentration. , The pressure changes, but the temperature is definitely lower than the temperature of pure water extraction, which is more conducive to the retention of active ingredients, and the treatment effect of new coronavirus pneumonia will be better.

Therefore, further, the extraction solvent water in the above preparation scheme of the present invention can be replaced with ethanol, acetone, or a mixture of ethanol and acetone.

At the same time, according to research, the extraction rate and concentration of effective ingredients can be improved by changing the acidity and alkalinity of the extraction solvent, thereby improving the efficacy and reducing the dosage.

Therefore, further, in the above-mentioned preparation scheme of the present invention, an acid or a base can be added during the decoction. The acid includes, but is not limited to, hydrochloric acid, sulfuric acid, formic acid, and acetic acid; the base includes, but is not limited to, sodium hydroxide and carbonic acid. Sodium, sodium bicarbonate and ammonia.

As another alternative specific preferred solution, the water extraction preparation method of the traditional Chinese medicine composition includes the following steps:

Take chuanbei, clean, dry, crush into fine powder, set aside;

Separately take forsythia, decocting with water, extract the volatile oil, and encapsulate the volatile oil with an appropriate amount of beta cyclodextrin; add water to decoct the residue, filter, and concentrate the filtrate into a clear ointment; add the volatile oil inclusion compound to the clear ointment and spray dry, Add an appropriate amount of maltodextrin and mix well to obtain the extract for use;

The remaining fourteen medicines were decocted in water, filtered, and the filtrate was concentrated into a clear ointment, added with an appropriate amount of maltodextrin, spray dried, added with an appropriate amount of maltodextrin, and mixed well to obtain extracts of each component;

After converting according to the equivalent of each component, take the fine powder and extract of the above components, as well as an appropriate amount of povidone K30, microcrystalline cellulose, silicon dioxide and maltodextrin, mix well, dry granulate, and subpackage, that is have to.

In addition, it is possible to further study the development of new viral pneumonia therapeutic drugs on the basis of the present invention. Therefore, the application of the above-mentioned Chinese medicine composition of the present invention in the preparation of viral pneumonia therapeutic drugs should also fall within the protection scope of the present invention.

Furthermore, the present invention further provides that the traditional Chinese medicine composition can be combined with virus-inhibiting western medicine to achieve better therapeutic effects. Therefore, the present invention further provides that the traditional Chinese medicine composition combined with virus-inhibiting western medicine is used in the preparation of viral pneumonia treatment. Application in medicine.

Specifically, preferably, the virus-inhibiting western drug is ribavirin, oseltamivir, vidarabine, amantadine or a-interferon and the like.

The viral pneumonia includes pneumonia caused by influenza virus, cytomegalovirus, adenovirus, rhinovirus, coronavirus or measles virus.

The coronavirus pneumonia includes a new type of coronavirus pneumonia COVID-19.

The present invention has the following beneficial effects:

Based on the inventor's understanding that viral pneumonia is a TCM febrile disease, he formulated the therapeutic principles of clearing away heat and detoxifying, dredging wind, relieving cough and reducing phlegm, replenishing qi and nourishing yin, and developed a compatible mechanism of the monarch and ministers of the present invention. Forsythia suspensa, which is light in quality, is used to moisturize the lungs, to clear the lung heat, Shansi Mushroom clears epidemic toxins, resolves phlegm and dispels knots, both of which are the master medicine; honeysuckle, scutellaria, and Daqingye are used to clear the lungs. Wei Zhire, all medicines are minister medicine. On this basis, the medicines of Qingshangjiaofeiwei, which are compatible with the monarch medicine, are used as minister medicines. At the same time, they follow the principles of traditional Chinese medicine, from "damaging their lungs, benefiting their qi" (see "Difficulty-14 Based on the principle of "Difficult"), the selection is based on astragalus and Chinese medicinal materials for nourishing qi and nourishing yin with Radix Astragali and Radix Pseudostellariae, as well as components for invigorating the spleen and promoting movement, clearing phlegm and heat, and further adopting Nengzuoshan Mushroom to aid transformation The components that dispel phlegm and remove residual heat to prevent the occurrence of pulmonary fibrosis are used as adjuvants; consider medicines that can produce fluids and moisturize the lungs as well as converge the lungs to prevent asthma in order to protect the place free from evil.

It is found through experiments that the traditional Chinese medicine composition provided by the present invention has the effects of clearing away heat and detoxifying, dispelling wind, relieving cough and resolving phlegm, replenishing qi and nourishing yin, and has good effects in the prevention and treatment of viral pneumonia.

Especially for the new type of coronavirus pneumonia, the epidemic situation is developing very fast, and there are not many effective drugs at present. In order to suppress the development of the epidemic, it is urgent to provide traditional Chinese medicine compositions or related Chinese patent medicines with lower cost and better preventive and therapeutic effects. The traditional Chinese medicine composition of the present invention can effectively improve the clinical symptoms of patients with mild and common types of novel coronavirus pneumonia, improve the prognosis, reduce the severe rate and the mortality rate, and have a positive effect on the recovery treatment after severe remission.

In the clinical application of 130 patients, it was found that after clinical observation with the Chinese medicinal composition of the present invention, 68.5% of the patients treated with the Chinese medicinal composition for 6 days or more had their body temperature returned to normal, and 60% had improved cough symptoms. Sore throat symptoms improved in 67.3% of patients, and nausea and vomiting in 68.4% patients improved. The results of the study suggest that the patient's overall clinical symptoms have improved significantly. Therefore, the traditional Chinese medicine composition of the present invention can alleviate the symptoms of mild and common patients with new coronavirus pneumonia, improve the prognosis, reduce the severe rate and fatality rate, and have significant curative effects. It is the clinical diagnosis and treatment of new coronavirus pneumonia, especially for the mild and common new types of coronavirus pneumonia. Coronavirus pneumonia provides effective prescriptions that can effectively control the epidemic, protect people's lives, and reduce the economic burden of patients and society.

The Chinese medicinal composition of the present invention has proposed the idea of compatibility between monarchs and ministers in response to the "plague", which opens up ideas for the development of drugs against viral pneumonia, especially new coronavirus pneumonia, and has the potential to be promoted and applied to the prevention and control of similar coronaviruses and respiratory infectious diseases. The consolidation and development of the medical status of Chinese traditional medicine provides a new kind of strong evidence.

Detailed ways

The present invention will be further described below in conjunction with specific embodiments, but the embodiments do not limit the present invention in any form. Unless otherwise specified, the reagents, methods and equipment used in the present invention are conventional reagents, methods and equipment in the technical field.

Unless otherwise specified, the reagents and materials used in the following examples are all commercially available.

The following examples are preferred implementations of the present invention, but the implementations of the present invention are not limited by the following examples, and any other changes, modifications, substitutions, and combinations made without departing from the spirit and essence of the present invention and basic ideas , Simplification, should be regarded as equivalent replacement methods, and should be included in the protection scope of the present invention.

Example 1. A Chinese medicinal composition for the treatment of viral pneumonia

The traditional Chinese medicine composition consists of the following components in parts by weight:

30 parts of Forsythia, 15 parts of Shanzi Mushroom, 10 parts of Honeysuckle, 8 parts of Scutellaria baicalensis Georgi, 8 parts of Daqingye, 35 parts of Radix Astragali, 30 parts of Radix Ginseng, 30 parts of Poria cocos, 3 parts of Bupleurum, 8 parts of Artemisia annua, 8 parts of Chanyi 8 parts, 3 parts of Qianhu, 8 parts of Chuanbei, 8 parts of Zhebei, 10 parts of Scrophulariaceae and 30 parts of Wumei.

The preparation method of the traditional Chinese medicine composition includes the following steps:

S1. Mix the components of Chinese medicinal materials except Artemisia annua L., add 8 times the amount of water, reflux for 1.5 hours, and collect the decoction liquid;

S2. Then add the Chinese herbal medicine Artemisia annua into the dregs of step S1, add 3 times the amount of water, reflux for 1 hour, and collect the decoction;

Example 2. A Chinese medicinal composition for the treatment of viral pneumonia

The traditional Chinese medicine composition is composed of the following components in parts by weight: 40 parts of Forsythia suspense, 20 parts of Shanxi Mushroom, 15 parts of honeysuckle, 10 parts of Scutellaria baicalensis Georgi, 10 parts of Daqingye, 45 parts of Radix Astragali, 40 parts of Radix Ginseng, Poria cocos 40 parts, 5 parts of Bupleurum, 10 parts of Artemisia annua, 10 parts of Chanyi, 5 parts of Qianhu, 10 parts of Chuanbei, 10 parts of Zhebei, 15 parts of Scrophulariaceae, and 40 parts of Wumei.

S1. Mix the components of Chinese medicinal materials except Artemisia annua, add 6 times the amount of water, reflux for 1 hour, and collect the decoction liquid;

S2. Then add the Chinese medicinal material Artemisia annua into the dregs of step S1, add 2 times the amount of water, reflux for 0.5 hours, and collect the decoction liquid;

Example 3. A Chinese medicinal composition for the treatment of viral pneumonia

The traditional Chinese medicine composition is composed of the following components by weight: 50 parts of Forsythia suspense, 30 parts of Shanzi mushroom, 20 parts of honeysuckle, 15 parts of Scutellaria baicalensis Georgi, 15 parts of Daqingye, 60 parts of Astragalus, 50 parts of Radix Ginseng, Poria cocos 50 parts, 10 parts of Bupleurum, 15 parts of Artemisia annua, 15 parts of Chanyi, 10 parts of Qianhu, 15 parts of Chuanbei, 15 parts of Zhebei, 20 parts of Scrophulariaceae, 50 parts of Wumei.

S1. Mix the components of Chinese medicinal materials except Artemisia annua L., add 10 times the amount of water, reflux for 3 hours, and collect the decoction liquid;

S2. Then add the Chinese medicinal material Artemisia annua into the dregs of step S1, add 5 times the amount of water, reflux for 2 hours, and collect the decoction;

Example 4. A Chinese medicinal composition for the treatment of viral pneumonia

The traditional Chinese medicine composition is composed of the following components in parts by weight: 35 parts of Forsythia suspense, 25 parts of Shanxi Mushroom, 15 parts of honeysuckle, 10 parts of Scutellaria baicalensis Georgi, 10 parts of Daqingye, 45 parts of Radix Astragali, 35 parts of Radix Ginseng, Poria cocos 35 parts, 5 parts of Bupleurum, 5 parts of Artemisia annua, 10 parts of Chanyi, 5 parts of Qianhu, 10 parts of Chuanbei, 10 parts of Zhebei, 10 parts of Scrophulariaceae, and 35 parts of Wumei.

The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

Example 5. A Chinese medicinal composition for the treatment of viral pneumonia

The traditional Chinese medicine composition is composed of the following parts by weight: 20 parts of Forsythia suspense, 10 parts of Shanzi Mushroom, 5 parts of honeysuckle, 5 parts of Scutellaria baicalensis Georgi, 5 parts of Daqingye, 30 parts of Astragalus, 20 parts of Pseudostellariae, 20 parts of Poria cocos 20 parts, 2 parts of Bupleurum, 8 parts of Artemisia annua, 5 parts of Chanyi, 2 parts of Qianhu, 5 parts of Chuanbei, 5 parts of Zhebei, 5 parts of Scrophulariaceae, and 20 parts of Wumei.

Example 6. A Chinese medicinal composition for the treatment of viral pneumonia

The traditional Chinese medicine composition is composed of the following components by weight: 20 parts of Forsythia suspense, 5 parts of Shanzi Mushroom, 10 parts of honeysuckle, 10 parts of Scutellaria baicalensis Georgi, 8 parts of Daqingye, 40 parts of Radix Astragali, 30 parts of Radix Ginseng, Poria cocos 30 parts, 5 parts of Bupleurum, 8 parts of Artemisia annua, 8 parts of Chanyi, 3 parts of Qianhu, 8 parts of Chuanbei, 8 parts of Zhebei, 10 parts of Scrophulariaceae, 30 parts of Wumei.

Example 7 Test Example 1: Clinical treatment of mild and common type of novel coronavirus infection

1. Test materials

The traditional Chinese medicine composition prepared in Example 1.

Western medicine: symptomatic treatment, ambroxol to eliminate phlegm, 30 mg once a day for adults; levofloxacin tablets anti-bacterial infection, 0.5 g (1 tablet) once a day for adults.

2. Test method

The clinical trial originated from the Eighth People's Hospital of Guangzhou.

The study included 83 confirmed cases of new coronavirus infection (new coronavirus infection mild and common), 50 cases in the experimental group (Chinese medicine + western medicine group), and 33 cases in the control group (western medicine group). Among the 83 patients, 35 were males and 48 were females. The male-to-female ratio was 1:137; the age ranged from 14 to 79 years, with a median age of 47 years. There were no statistically significant differences in gender composition (χ2=0.24, P=0.622) and age (t=0.24, P=0.721) between the two groups.

3. Treatment results

(1) Result 1: Influence on fever:

The body temperature of 83 patients at admission was 36℃～38.8℃, and the average body temperature was 37.4℃. After treatment, the average body temperature of the experimental group was 37.4℃, 37.0℃ and 36.9℃ respectively when they were admitted to the hospital, on the 3rd day of treatment, and on the 6th day of treatment. ; The control group was 37.5℃, 37.4℃ and 37.0℃ respectively. Both groups showed a downward trend, and the experimental group declined faster.

(2) Result 2: Fever, sore throat, fatigue, cough, expectoration, chills, nausea, vomiting, diarrhea and other 9 clinical symptoms:

On day 3, the average score of 9 symptoms in the experimental group was 0.51, and the average score after 3 days of treatment was 0.26. The paired t-test showed that the overall symptoms of the treatment group were significantly reduced after 3 days of treatment (t=6.15, P< 0.01). The proportions of the four main symptoms of fever, sore throat, fatigue, and cough were 52.8%, 52.4%, 69.6% and 40.5%, respectively.

The average score of 9 symptoms in the control group was 0.42, and the average score after 3 days of treatment was 0.29. The paired t-test results showed that the overall symptoms of the treatment group were significantly reduced after 3 days of treatment (t=4.09, P<0.01). The proportions of the four main symptoms of fever, sore throat, fatigue, and coughing were 57.5%, 35.3%, 33.3%, and 33.3%, respectively.

After 3 days of treatment, the total symptom score of the experimental group was reduced by an average of 0.25 points, and the control group was reduced by an average of 0.12 points. The results of two independent samples t-test showed that the experimental group had better efficacy than the control group (t = 2.49, p = 0.015)

On the 6th day, the average score of the 9 symptoms in the experimental group before treatment was 0.56 (because only 23 cases continued to be treated for 6 days, it is not consistent with the 0.51 written on the third day above), and the average score after 6 days of treatment was 0.14. The t-test results showed that the overall symptoms of the treatment group were significantly reduced after 3 days of treatment (t=5.47, P<0.01). The proportions of the four main symptoms of fever, sore throat, fatigue and coughing were 88.2%, 54.5%, 84.6% and 68.4%, respectively.

The average score of the 9 symptoms in the control group before treatment was 0.35 (because only 9 cases continued to be treated for 6 days, it is not consistent with the 0.42 written on the third day above), and the average score after 3 days of treatment was 0.20. The paired t-test result showed The overall symptoms of the treatment group were significantly reduced after 3 days of treatment (t=3.02, P=0.016). The four main symptoms of fever, sore throat, fatigue, and cough accounted for 42.9%, 33.3%, 40%, and 50% of cases with significant improvement.

After 6 days of treatment, the total symptom score of the experimental group decreased by 0.42 points on average, and the control group decreased by 0.15 points on average. The results of two independent sample t-tests showed that the therapeutic effect of the experimental group was better than that of the control group (t=2.96, p=0.006).

The above results show that the traditional Chinese medicine composition for treating the mild and common type of novel coronavirus infection provided by the present invention has obvious curative effect on shortening the fever time and reducing the clinical symptoms.

Example 8 Test Example 2: Clinical treatment of mild and common type of novel coronavirus infection

With reference to the test method in Example 7, 154 confirmed cases of novel coronavirus infection (new coronavirus infection mild and common) were divided into 3 groups:

43 patients in the traditional Chinese medicine group (the traditional Chinese medicine composition of Example 1, no antiviral drugs were used),

78 cases in the integrated traditional Chinese and Western medicine group (Chinese medicine plus antiviral drugs Abidol and Kelizhi are used alternately),

There were 33 cases in the western medicine group (not treated with traditional Chinese medicine).

Treatment time: 6 days. The clinical trial originated from the Eighth People's Hospital of Guangzhou.

3. Treatment results

Treatment result 1: The effect on symptoms, see Table 2

Table 2: Statistics of symptom improvement rate

Among the 43 patients in the TCM group: 33 had fever, 29 had improved symptoms, and the improvement rate was 87.88%; 23 had sore throat, 18 had improved symptoms, and had an improvement rate of 78.26%; 37 had cough, 29 had improved symptoms, and had an improvement rate of 78.38 %; 24 cases of expectoration, 19 cases improved, the rate of improvement was 79.17%; 20 cases of fatigue, 15 cases of symptom improvement, the rate of improvement was 75%; 14 cases of anorexia, 12 cases of improvement, the rate of improvement: 85.71%.

Among 78 patients in the integrated traditional Chinese and Western medicine group: 39 cases had fever, 33 cases had improved symptoms, and the improvement rate was 84.62%; 33 cases had sore throat, 20 cases had improved symptoms, and the improvement rate was 60.61%; 71 cases had cough, 43 cases had improved symptoms, and the improvement rate had been improved. It was 60.56%; 37 cases of expectoration, 32 cases of improvement, the improvement rate was 86.49%; 48 cases of fatigue, 38 cases of improvement, the improvement rate was 79.17%; 25 cases of anorexia, 12 cases of symptom improvement, and the improvement rate was 48%.

Among the 33 patients in the western medicine group: 26 had fever, 15 had improved symptoms, and the improvement rate was 57.69%; 17 had sore throat, 9 had improved symptoms, and the improvement rate was 52.94%; 21 had cough, 12 had improved symptoms, and the improvement rate was 57.14 %; 7 cases of expectoration, 6 cases of improvement, improvement rate of 85.71%; 18 cases of fatigue, 15 cases of improvement, improvement rate of 83.33%; 4 cases of anorexia, improvement of 1 case, improvement rate: 25%.

Studies have shown that the traditional Chinese medicine group and the Chinese and Western medicine group are significantly better than the Western medicine group in improving fever, sore throat, cough, and anorexia. The three groups have better effects in improving expectoration and fatigue, and there is no significant difference between the groups.

Treatment Outcome 2: Impact on the cure rate

The cure rate within 14 days (the number of people discharged/the number of groups): 25.58% (10/43) in the traditional Chinese medicine group, 19.23% (15/78) in the integrated traditional Chinese and western medicine group, and 15.15% (5/33) in the western medicine group.

Treatment result 3: Conversion to weight ratio

4.65% (2/43) in the traditional Chinese medicine group, 6.41% (5/78) in the integrated traditional Chinese and western medicine group, and 9.09% (3/33) in the western medicine group, including 2 severe cases and 1 critical case). Two severe cases in the traditional Chinese medicine group have not been transferred to ICU treatment, and have been converted to the common type; of the 5 severe cases in the integrated traditional Chinese and Western medicine group, 4 cases have been converted to the common type, and 1 case has been converted to critical (ICU rescue); the western medicine group has neither severe nor critical Number of cases of improvement.

The results of the study showed that the overall clinical symptoms of the Chinese medicine group and the Chinese and Western medicine group were significantly improved, which can reduce the incidence of severe pneumonia, with a total effective rate of 94% (7/121).

Moreover, compared with the simple western medicine group, the overall clinical symptom improvement rate and cure rate of the traditional Chinese medicine group and the western medicine group are significantly higher than the western medicine group, and the traditional Chinese medicine group is significantly higher than the traditional Chinese and western medicine group, indicating that the traditional Chinese medicine composition of the present invention is effective against new coronavirus infections. The confirmed clinical cases do have a better therapeutic effect.

In addition, according to practical statistical data, the traditional Chinese medicine composition of Examples 2-6 also has a good therapeutic effect on confirmed clinical cases of new coronavirus infection, and can significantly shorten the fever time and reduce the clinical symptoms.

After exploring the mechanism of Chinese medicine compatibility and a large amount of experimental data, based on the optimization of the treatment effect, the present invention is used in the formulation of the light and common Chinese medicine composition for the treatment of novel coronavirus infection, and the ratio of each component can preferably be expanded to:

In parts by weight, 20-50 parts of Forsythia, 5-30 parts of Shanzi Mushroom, 5-20 parts of Honeysuckle, 5-15 parts of Scutellaria baicalensis Georgi, 5-15 parts of Daqingye, 30-60 parts of Radix Astragali, 20 parts of Radix Pseudostellariae ～50 parts, 20～50 parts of Poria, 2～10 parts of Bupleurum, 5～15 parts of Artemisia annua, 5～15 parts of Chanyi, 2～10 parts of Qianhu, 5～15 parts of Chuanbei, 5～15 parts of Zhebei Parts, 5-20 parts of Scrophulariaceae and 20-50 parts of ebony plum.

More preferably, 20-40 parts of Forsythia suspensa, 10-20 parts of Shanzi Mushroom, 5-15 parts of honeysuckle, 5-10 parts of Scutellaria baicalensis Georgi, 5-10 parts of Daqingye, 30-40 parts of Radix Astragali, 20-40 parts of Pseudostellariae Servings, 20-40 servings of Poria, 2-5 servings of Bupleurum, 5-10 servings of Artemisia annua, 5-10 servings of Chanyi, 2-5 servings of Peucedanum, 5-10 servings of Chuanbei, 5-10 servings of Zhebei, 5-15 parts of Scrophulariaceae and 20-40 parts of ebony plum.

Example 9. Traditional Chinese medicine composition for treating viral pneumonia

In addition, the research team conducted a large number of experimental investigations on the optimization of the components of the traditional Chinese medicine composition based on the aforementioned compatibility principle. According to the preparation method of traditional Chinese medicine similar to Example 1, a series of traditional Chinese medicine compositions were prepared with the formula shown in Table 1:

Table 1

Practice statistics show that the above 38 groups of traditional Chinese medicine compositions also have a good therapeutic effect on confirmed clinical cases of new coronavirus infection, which can significantly shorten the fever time and reduce the clinical symptoms.

Example 10: Therapeutic effect of traditional Chinese medicine composition on influenza virus pneumonia

Taking the traditional Chinese medicine composition of Example 1 as an example, 30 confirmed cases of influenza virus pneumonia were divided into 3 groups: the traditional Chinese medicine group used the traditional Chinese medicine composition of example 1, and the integrated traditional Chinese and western medicine group used traditional Chinese medicine plus antiviral drug Abidol Er, the western medicine group uses Arbidol. The treatment time is 5 days.

The clinical trial originated from the Eighth People's Hospital of Guangzhou.

The treatment results showed that, compared with the western medicine group alone, the overall clinical symptom improvement rate and cure rate of the traditional Chinese medicine group and the western medicine group were significantly higher than those of the western medicine group, and the traditional Chinese medicine group was significantly higher than the traditional Chinese and western medicine group. It shows that the traditional Chinese medicine composition of the present invention has a good therapeutic effect on influenza virus pneumonia.

In addition, clinical data proves that the traditional Chinese medicine composition of the present invention has good curative effect on cytomegalovirus pneumonia, adenovirus pneumonia, rhinovirus pneumonia, and measles virus pneumonia.

Claims

A Chinese medicinal composition for treating viral pneumonia, which uses Forsythia suspensa, Shanzi mushroom, honeysuckle, scutellaria baicalensis Georgi, and Daqingye as the basic components of the Chinese medicinal composition; it is characterized in that the Chinese medicinal composition also includes compatibility with Chinese medicines. The contraindicated components for replenishing qi and nourishing yin, invigorating the spleen and assisting transportation, clearing phlegm and heat, resolving phlegm and dispelling stagnation, as well as promoting body fluid, moisturizing the lung, converging the lung and preventing asthma; in parts by weight, the basic group It can be divided into 40-130 parts, 50-110 parts for nourishing qi and nourishing yin, 20-50 parts for invigorating the spleen, 15-50 parts for clearing phlegm heat, 14-50 parts for resolving phlegm and dissipating stagnation, 20-50 parts of body fluid moisturizing lung, astringent lung and anti-asthmatic components.
The traditional Chinese medicine composition according to claim 1, characterized in that, in parts by weight, the basic components are 45 to 95 parts, the qi and yin components are 50 to 80 parts, and the spleen and transport aid components are 34 to 70 parts, 15-50 parts for clearing phlegm-heat component, 15-35 parts for resolving phlegm and relieving stagnation, 20-40 parts for promoting body fluid, moisturizing the lung, restraining lung and preventing asthma.
The traditional Chinese medicine composition according to claim 1 or 2, wherein the component for replenishing qi and nourishing yin is Astragalus and/or Radix Pseudostellariae, preferably a mixture of the two; the component for invigorating the spleen and assisting transportation is Poria; The components for clearing phlegm heat are Chuanbei, Zhebei and/or Scrophulariaceae, preferably a mixture of the three; the phlegm-resolving components are Bupleurum, Artemisia annua, Chanyi and/or Peucedanum, preferably a mixture of the four The component for promoting body fluid, moisturizing the lungs, restraining the lungs and preventing asthma is ebony plum.
The traditional Chinese medicine composition according to claim 3, characterized in that it comprises the following components in parts by weight: 20-50 parts of Forsythia, 5-30 parts of Shanzi mushroom, 5-20 parts of honeysuckle, 5-15 parts of scutellaria, 5-15 parts of Daqingye, 30-60 parts of Astragalus, 20-50 parts of Radix Pseudostellariae, 20-50 parts of Poria cocos, 2-10 parts of Bupleurum, 5-15 parts of Artemisia annua, 5-15 parts of Chanyi, Qianhu 2-10 servings, 5-15 servings of Chuanbei, 5-15 servings of Zhebei, 5-20 servings of Scrophulariaceae, and 20-50 servings of ebony.
The traditional Chinese medicine composition according to claim 4, characterized in that it comprises the following components in parts by weight: 20-40 parts of Forsythia suspense, 10-20 parts of Shanzi mushroom, 5-15 parts of honeysuckle, 5-10 parts of scutellaria, 5-10 parts of Daqingye, 30-40 parts of Astragalus, 20-40 parts of Radix Pseudostellariae, 20-40 parts of Poria cocos, 2-5 parts of Bupleurum, 5-10 parts of Artemisia annua, 5-10 parts of Chanyi, Qianhu 2 to 5 portions, 5 to 10 portions of Chuanbei, 5 to 10 portions of Zhebei, 5 to 15 portions of Scrophulariaceae, and 20 to 40 portions of ebony.
The traditional Chinese medicine composition according to claim 5, characterized in that it comprises the following components in parts by weight: 30 parts by weight of Forsythia, 15 parts of Shanzi mushroom, 10 parts of honeysuckle, 8 parts of Scutellaria baicalensis Georgi, 8 parts of Daqingye, 35 parts of Astragalus membranaceus Parts, 30 parts of Taizishen, 30 parts of Poria, 3 parts of Bupleurum, 8 parts of Artemisia annua, 8 parts of Chanyi, 3 parts of Qianhu, 8 parts of Chuanbei, 8 parts of Zhebei, 10 parts of Scrophulariaceae and 30 parts of Wumei.
The use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a drug for the treatment of viral pneumonia.
The use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in combination with a virus-inhibiting western medicine in the preparation of a drug for the treatment of viral pneumonia.
The use according to claim 8, wherein the virus-inhibiting western drug is ribavirin, oseltamivir, vidarabine, amantadine or a-interferon.
The application according to claim 7 or 8, wherein the viral pneumonia includes pneumonia caused by influenza virus, cytomegalovirus, adenovirus, rhinovirus, coronavirus or measles virus; preferably, the coronavirus pneumonia Including the new coronavirus pneumonia COVID-19.