CN113908229A

CN113908229A - Traditional Chinese medicine preparation for eliminating pulmonary nodules and preparation and application thereof

Info

Publication number: CN113908229A
Application number: CN202111202323.5A
Authority: CN
Inventors: 黄常新; 李晓珍; 方厚重; 张伟; 朱影; 熊超婷; 周中华; 王则芳; 李永强
Original assignee: New Antigen Medical Technology Hangzhou Co ltd
Current assignee: New Antigen Medical Technology Hangzhou Co ltd
Priority date: 2021-10-15
Filing date: 2021-10-15
Publication date: 2022-01-11
Anticipated expiration: 2041-10-15
Also published as: CN113908229B

Abstract

The invention discloses a traditional Chinese medicine preparation for eliminating pulmonary nodules and preparation and application thereof. The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 10-30 parts of astragalus membranaceus, 5-25 parts of lily, 5-25 parts of houttuynia cordata, 5-25 parts of salvia miltiorrhiza, 5-20 parts of radix glehniae, 10-45 parts of oyster, 5-15 parts of honey-fried licorice root, 10-30 parts of clam shell, 10-25 parts of oldenlandia diffusa, 5-18 parts of codonopsis pilosula, 5-25 parts of Chinese yam, 5-15 parts of dark plum, 10-20 parts of dried orange peel, 5-18 parts of radix scrophulariae, 5-16 parts of radix paeoniae alba, 5-20 parts of angelica sinensis, 5-16 parts of rhizoma polygonati, 5-40 parts of taxus chinensis, 5-15 parts of rhizoma pinelliae preparata and 5-18 parts of fried gordon euryale seed. The traditional Chinese medicine preparation has the effects of clearing lung, tonifying qi, nourishing yin and promoting blood circulation. The Chinese medicinal preparation can directly act on the lesion part of the pulmonary sarcoidosis, inhibit exudation of capillary inflammatory cells of alveolar wall, and relieve interstitial congestion, hemorrhage, edema and alveolar structure damage of the lung. The traditional Chinese medicine preparation reduces the expression of TLR4 signal conduction path signal molecule protein and local lung tissue related cell cytokine, relieves the inflammatory reaction of lung nodules, and has the effect of inhibiting and killing lung tumors, thereby achieving the purpose of delaying or treating lung nodules.

Description

Traditional Chinese medicine preparation for eliminating pulmonary nodules and preparation and application thereof

Technical Field

The invention relates to the field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine preparation for eliminating pulmonary nodules and preparation and application thereof.

Background

The incidence of breast malignant tumors such as lung cancer and the like is on the rising trend year by year and becomes one of the important factors harming health. With the increasing awareness of people in screening lung nodules, more and more lung cancer nodules are found in clinic. Pulmonary nodules can be classified by number into solitary and multiple pulmonary nodules (two or more coexisting); the nodules are classified into inflammatory and neoplastic nodules according to their nature, and clinically, most pulmonary nodules are inflammatory; according to different densities, the glass can be divided into solid nodules (SD), mixed ground glass nodules (mGGN) and pure ground glass nodules (pGGN); according to the pathological changes, the disease can be divided into inflammatory nodules, atypical adenomatous hyperplasia AAH, in-situ adenocarcinoma AIS, micro-invasive adenocarcinoma MIA and invasive adenocarcinoma IA, and the AAH and AIS are collectively called as pre-invasive lesions. Currently, most scholars believe that Ground Glass Nodules (GGNs) follow a sequential multi-stage progression: imagewise, progress from pGGN to mGGN or SD; pathologically, progress is made from AAH to AIS, MIA, IA. The positive lung nodule screening and prevention and treatment are beneficial to early recognition and treatment of lung cancer, and further improve individual prognosis.

The existing treatment of inflammatory pulmonary nodules mainly uses antibiotics to diminish inflammation, but the long-term use of antibiotics in large quantities for treating the nodular inflammatory lesions has the risk of abuse of the antibiotics and the curative effect is poor. At present, the clinical treatment mode of the pulmonary nodules caused by tumors is mainly regular follow-up, biopsy or surgical excision, but invasive diagnosis and treatment means bring higher wound risk, lung function reserve reduction and larger economic burden to patients, so that the compliance of the patients is not high.

The traditional Chinese medicine considers that lung nodules are tangible pathogens and are mainly formed by mutual fighting of phlegm, stasis and toxin; the early and middle stages are asymptomatic, and the enlargement of nodules is often accompanied by infection, which shows some syndrome type characteristics and can be the syndromes of qi stagnation and phlegm obstruction, cold phlegm stagnation, damp-heat phlegm and blood stasis, phlegm and blood stasis syndrome, yin deficiency and internal heat, and the like in traditional Chinese medicine.

The lung-knot disease is caused by qi deficiency with internal invasion of heat-toxin, phlegm accumulation blocking collaterals, and qi stagnation and blood stasis. In the aspect of prevention and treatment, the pharmacological research progress of anti-tumor, anti-inflammation and detumescence of modern traditional Chinese medicines is combined, the effects of softening hardness and dissipating stagnation, tonifying qi and activating blood, nourishing yin and moistening lung, clearing heat and detoxicating, removing dampness and detumescence and the like are emphasized, and a traditional Chinese medicine optimized combined preparation with unique advantages is found to have better effect on treating pulmonary nodules, no obvious side effect and low cost through long-term exploration; cell molecular biology experiments and clinical application experiments prove that the traditional Chinese medicine composition has stronger anti-tumor, anti-inflammatory and detumescence effects and better clinical application prospect.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine preparation for eliminating pulmonary nodules and preparation and application thereof, aiming at the limitations of the current medical technology.

The technical scheme adopted by the invention is as follows:

the invention provides a traditional Chinese medicine preparation for eliminating pulmonary nodules, which is prepared from the following raw materials in parts by weight: 10-30 parts of astragalus membranaceus, 5-25 parts of lily, 5-25 parts of houttuynia cordata, 5-25 parts of salvia miltiorrhiza, 5-20 parts of radix glehniae, 10-45 parts of oyster, 5-15 parts of honey-fried licorice root, 10-30 parts of clam shell, 10-25 parts of oldenlandia diffusa, 5-18 parts of codonopsis pilosula, 5-25 parts of Chinese yam, 5-15 parts of dark plum, 10-20 parts of dried orange peel, 5-18 parts of radix scrophulariae, 5-16 parts of radix paeoniae alba, 5-20 parts of angelica sinensis, 5-16 parts of rhizoma polygonati, 5-40 parts of taxus chinensis, 5-15 parts of rhizoma pinelliae preparata and 5-18 parts of fried gordon euryale seed.

In some embodiments, the Chinese medicinal preparation is prepared from the following raw materials in parts by weight: 30 parts of astragalus membranaceus, 25 parts of lily, 25 parts of houttuynia cordata, 25 parts of salvia miltiorrhiza, 20 parts of radix glehniae, 45 parts of oyster, 10 parts of honey-fried licorice root, 30 parts of clam shell, 25 parts of oldenlandia diffusa, 10 parts of codonopsis pilosula, 15 parts of Chinese yam, 10 parts of dark plum, 10 parts of dried orange peel, 12 parts of radix scrophulariae, 16 parts of radix paeoniae alba, 18 parts of angelica sinensis, 5 parts of rhizoma polygonati, 6 parts of taxus chinensis, 5 parts of rhizoma pinelliae preparata and 15 parts of fried gorgon fruit. The Chinese medicinal preparation is used for treating low-malignant-risk nodules.

In some embodiments, the Chinese medicinal preparation is prepared from the following raw materials in parts by weight: 20 parts of astragalus membranaceus, 10 parts of lily, 15 parts of houttuynia cordata, 20 parts of salvia miltiorrhiza, 10 parts of radix glehniae, 30 parts of oyster, 12 parts of honey-fried licorice root, 20 parts of clam shell, 12 parts of oldenlandia diffusa, 15 parts of codonopsis pilosula, 25 parts of Chinese yam, 15 parts of dark plum, 15 parts of dried orange peel, 10 parts of radix scrophulariae, 12 parts of radix paeoniae alba, 5 parts of angelica sinensis, 16 parts of rhizoma polygonati, 12 parts of taxus chinensis, 8 parts of rhizoma pinelliae preparata and 12 parts of stir-fried gorgon fruit.

In some embodiments, the Chinese medicinal preparation is prepared from the following raw materials in parts by weight: 15 parts of astragalus membranaceus, 12 parts of lily, 10 parts of houttuynia cordata, 5 parts of salvia miltiorrhiza, 15 parts of radix glehniae, 20 parts of oyster, 5 parts of honey-fried licorice root, 10 parts of clam shell, 15 parts of oldenlandia diffusa, 12 parts of codonopsis pilosula, 10 parts of angelica sinensis, 10 parts of fried gordon euryale seed, 20 parts of Chinese yam, 5 parts of dark plum, 20 parts of dried orange peel, 5 parts of radix scrophulariae, 5 parts of white paeony root, 10 parts of rhizoma polygonati, 15 parts of taxus chinensis and 10 parts of ginger processed pinellia tuber.

In some embodiments, the Chinese medicinal preparation is prepared from the following raw materials in parts by weight: 25 parts of astragalus membranaceus, 22 parts of lily, 23 parts of houttuynia cordata, 23 parts of salvia miltiorrhiza, 18 parts of radix glehniae, 42 parts of oyster, 15 parts of honey-fried licorice root, 28 parts of clam shell, 20 parts of oldenlandia diffusa, 18 parts of codonopsis pilosula, 20 parts of angelica sinensis, 18 parts of fried gordon euryale seed, 25 parts of Chinese yam, 15 parts of dark plum, 18 parts of dried orange peel, 15 parts of radix scrophulariae, 15 parts of white paeony root, 15 parts of rhizoma polygonati, 40 parts of taxus chinensis and 15 parts of ginger processed pinellia tuber. The Chinese medicinal preparation is used for treating high-malignant-risk nodules.

In some embodiments, the Chinese medicinal preparation is prepared from the following raw materials in parts by weight: 10 parts of astragalus membranaceus, 5 parts of lily, 5 parts of houttuynia cordata, 12 parts of salvia miltiorrhiza, 5 parts of radix glehniae, 10 parts of oyster, 8 parts of honey-fried licorice root, 15 parts of clam shell, 10 parts of oldenlandia diffusa, 5 parts of codonopsis pilosula, 15 parts of angelica sinensis, 5 parts of fried gordon euryale seed, 5 parts of Chinese yam, 10 parts of dark plum, 12 parts of dried orange peel, 18 parts of radix scrophulariae, 10 parts of white peony root, 9 parts of taxus chinensis, 8 parts of rhizoma polygonati and 12 parts of ginger processed pinellia.

The invention also provides a preparation method of the traditional Chinese medicine preparation, which comprises the following steps: mixing the components according to the formula amount, adding 3-4 times of water by weight, decocting at 120 ℃ for 30min, adjusting to 80 ℃ and decocting for 20min, filtering to obtain a primary filtrate and a primary filter cake, repeatedly decocting the primary filter cake once, filtering to obtain a secondary filter cake and a secondary filtrate, combining the primary filtrate and the secondary filtrate, and concentrating under reduced pressure to 1.5-2 times of volume to obtain the traditional Chinese medicine preparation. Wherein the vacuum concentration is performed at 0.097MPa and 50-60 deg.C.

In addition, the invention also provides application of the traditional Chinese medicine preparation in preparing a medicine for preventing and treating pulmonary nodules.

The pharmacological actions of the traditional Chinese medicine raw materials of the invention are as follows:

radix astragali has effects of invigorating lung and spleen, strengthening middle warmer and invigorating qi. Astragalus root can promote the hemopoietic function of bone marrow, stimulate the hemopoiesis to increase leukocytes, improve and enhance the phagocytosis and sterilization functions of neutrophils and macrophages to different degrees, also can obviously stimulate the division and proliferation of NK cells, and has the function of resisting infection by inducing lymphocytes to generate interferon. The astragalus polysaccharide contained in the traditional Chinese medicine composition can effectively accelerate the repair of damaged tissues and enhance the immune regulation function of organisms. Thereby improving the anti-infection and anti-tumor effects of the organism and eliminating the pulmonary nodules.

The Bulbus Lilii has effects of nourishing yin, moistening lung, clearing heart fire and tranquilizing mind. It can be used for preventing leukopenia caused by radiotherapy and chemotherapy, and its main ingredient colchicine can increase cAMP level in cancer cell, prevent mitosis, inhibit tumor cell proliferation, and promote lung nodule elimination.

The houttuynia cordata has the effects of clearing away heat and toxic materials, eliminating carbuncle and expelling pus, contains decanoyl acetaldehyde, lauraldehyde, a-pinene and linalool which are antibacterial active ingredients, has an inhibiting effect on various microorganisms (particularly yeasts and molds), and has an obvious inhibiting effect on hemolytic streptococcus, staphylococcus aureus, influenza bacillus, catacoccus catarrhalis and pneumococcus. It also has anti-inflammatory effect on aseptic chronic inflammation. Cell molecular experiments prove that the houttuynia cordata can enhance the phagocytic capacity of white blood cells and improve serum properdin. The inhibitory effect of new houttuynin on ehrlich ascites carcinoma may be related to the increase of cAMP level in cancer cells, the prevention of mitosis thereof, and the inhibition of tumor cell proliferation. Thereby eliminating the pneumonia nodules and tumor nodules.

The salvia miltiorrhiza has the effects of activating blood and dredging channels, removing blood stasis and relieving pain, and cooling blood and reducing swelling, and the modern pharmacology finds that the salvia miltiorrhiza has the anti-fibrosis effect and has good anti-fibrosis curative effect on the pneumonia nodules.

Radix Adenophorae has effects of nourishing yin, clearing lung-heat, moistening lung and eliminating phlegm. The effective components of radix Adenophorae have effects of regulating immune balance, increasing lymphocyte conversion rate, and improving organism immunity, and can be used for eliminating pneumonia nodule and tumor nodule.

Concha Ostreae has effects of softening and resolving hard mass, astringing, and can be used for eliminating phlegm, relieving cough, eliminating deficiency fire, and removing internal heat. The active ingredients extracted from the oysters and the glycosaminoglycan have the protection effect on the oxidative damage of vascular endothelial cells induced by hydrogen peroxide, and can effectively prevent various cardiovascular diseases such as hypertension, arteriosclerosis, cerebral apoplexy and the like caused by the vascular endothelial damage. The pharmacological and clinical researches on oysters in recent years prove that the oysters have the functions of regulating blood fat, inhibiting platelet aggregation, improving hyperglycemia symptoms, improving human immunity, promoting metabolism and the like, and also have certain effects of resisting cancer and preventing cancer cell diffusion. The oyster-zedoary decoction has satisfactory curative effect on hysteromyoma, and the total effective rate is 86.96%. It also has the effects of treating hyperplasia of mammary glands, resisting gastric cancer, delaying aging, resisting oxidation, protecting liver, resisting inflammation, relieving fatigue, and treating hyperhidrosis and enuresis.

The honey-fried licorice root has the efficacies of nourishing yin and blood, tonifying qi and activating yang, is mainly used for treating the syndrome of deficiency of both heart yin and yang, and has the efficacies of moistening lung and relieving cough and asthma. The formula is mainly used as a 'messenger' drug to coordinate the drugs.

Clam shell has the efficacies of clearing lung and eliminating phlegm, softening hardness and dissipating stagnation, and is used for treating phlegm-fire cough, chest and hypochondrium pain, blood-carrying phlegm, scrofula and galls. Modern pharmacology finds that the clam shells have the functions of resisting inflammation (inhibiting proliferation, vascular permeability, edema and other hormone-like effects), resisting oxidation, tumors, aging, phlegm and acid. The secret recipe of sea clam for treating cancer is distributed among people, and the secret recipe of the sea clam, the golden finger, the diuresis, the thirst, the restlessness, the phlegm reduction, the cough, the hardness softening and the lump disintegrating are adopted; there is a record of removing tumor of clam in Ben Cao Bei Yao of Qing Dynasty Wang. Clam shells have the efficacies of resolving masses, clearing heat and eliminating phlegm, relieving cough and promoting diuresis, and are mainly used for treating diseases such as thirst, dysphoria, cough, asthma, thoracic obstruction, scrofula, subcutaneous nodule and the like. The prescription can not only eliminate acute and chronic inflammatory edema and inflammatory nodules of lung, but also inhibit and kill tumorous pulmonary nodules.

Herba Hedyotidis Diffusae has effects of clearing heat and detoxicating, promoting diuresis and treating stranguria, and is mainly used for treating lung heat cough and asthma, sore throat, and can eliminate intestinal carbuncle, furuncle swelling, sore and ulcer. Modern pharmacological research finds that the anti-infection and anti-inflammation effects of the composition are obvious, and the phagocytic function of white blood cells is increased by stimulating a reticuloendothelial system, so that the congo red phagocytic capability of the white blood cells is improved by 4 times compared with that of a control group. At the same time, the oldenlandia diffusa is a broad-spectrum anticancer drug, contains more than one antitumor component, and has the effects of inhibiting tumor cells, infiltrating lymphocytes and neutrophils in tissues around the tumor, proliferating lymph nodes and spleen reticuloendothelial cells and forming lymph foci in the liver, and obviously proliferating and hypertrophy Kupffer cells. The prescription can not only eliminate acute and chronic inflammatory edema and inflammatory nodules of lung, but also inhibit and kill tumorous pulmonary nodules.

Radix scrophulariae has the effects of clearing heat and cooling blood, and is an important component for nourishing yin, reducing pathogenic fire, detoxifying and resolving masses. It is mainly used for treating warm diseases and heat in nutrient and blood, bone steaming, overstrain cough, toxic gas heat obstruction in upper jiao, sore throat, scrofula, subcutaneous nodule, carbuncle, ulcer, toxic material and body fluid injury. The formula is used as a main drug to eliminate acute and chronic inflammatory edema and inflammatory nodules of the lung.

The taxus chinensis can treat nephritis edema and dysuria and eliminate swelling and pain; yew also has effects of dredging channels, treating menoxenia, puerperal blood stasis, and relieving dysmenorrhea. Modern pharmacology finds that the most important medicinal effect of the taxus chinensis herb is that the taxus chinensis herb has a broad-spectrum anticancer effect: the extracted effective medicinal components are as follows: paclitaxel has effects of inhibiting and killing and promoting apoptosis on breast cancer, lung cancer and esophageal cancer, thereby delaying disease progression and preventing tumor cell diffusion. The Chinese medicinal herb of the yew has a plurality of other effects: the traditional Chinese medicine composition has the effects of reducing blood pressure and blood fat, treating kidney diseases and liver diseases, diminishing inflammation, inhibiting bacteria and the like, but can cause bone marrow suppression after being taken for a long time in a large amount.

The angelica has the effects of enriching and activating blood, regulating menstruation and relieving pain, and relaxing bowel; it is good at tonifying blood for various syndromes of blood deficiency, and is the saint herb for tonifying blood. The combination formula of the patent is matched with astragalus and white paeony root for tonifying qi and generating blood so as to solve the defect of qi and blood inhibition of taxus chinensis and the like.

The white peony root is cool in nature and large in dosage, can cause diarrhea, has 1 very good blood nourishing and blood regulating effects, improves the hematopoietic function, and has good conditioning effects on irregular menstruation, blood deficiency and chlorosis, myocardial ischemia and anemia. 2. Has effects in relieving inflammation, softening and protecting liver, removing toxic materials from liver, astringing yin, and arresting sweating. 3. Relieving spasm, relieving pain, and delaying aging. The combined preparation is matched with qi-tonifying and blood-producing angelica, astragalus, sealwort and the like to solve the defect of qi and blood inhibition of taxus chinensis and the like. And the liver damage side effect possibly existing in other traditional Chinese medicines in the prescription.

Huang Jing is neutral in nature and sweet in flavor, and enters lung, spleen and kidney meridians. Has the effects of invigorating qi, nourishing yin, invigorating spleen, moistening lung and tonifying kidney: 1. treating weakness of spleen and stomach, tiredness, debilitation, xerostomia and anorexia; 2. it is indicated for dry cough due to lung deficiency, deficiency of essence and blood, and polydipsia due to internal heat. Modern pharmacological research finds that rhizoma polygonati can increase coronary flow, regulate blood fat, reduce blood sugar, resist aging and enhance immunity. Has protective effect on chemical hepatic injury and anti-inflammatory effect. The combined formula is matched with angelica, astragalus and white paeony root for tonifying qi and generating blood so as to solve the defect of qi and blood inhibition of taxus chinensis and the like, and has the functions of tonifying lung qi and protecting liver.

Gorgon fruit has the effects of reinforcing kidney, arresting seminal emission, tonifying spleen, checking diarrhea, inducing diuresis and excreting dampness. The prescription is matched with codonopsis pilosula, rhizoma polygonati, Chinese yam and dried orange peel to be used for treating the diarrhea caused by spleen deficiency and cold due to cold and cool medicines such as salvia miltiorrhiza, houttuynia cordata, oldenlandia diffusa, white paeony root and the like and has the effects of astringing essence and reinforcing kidney

Codonopsis pilosula is sweet in flavor and neutral in nature. Tonify middle-jiao and Qi, invigorate spleen and benefit lung, nourish blood and promote the production of body fluid. Can be used for treating weakness of spleen and stomach, deficiency of both qi and blood, asthenia, anorexia, thirst, and chronic diarrhea. Can be used for treating cough, asthma, deficiency of qi and blood, palpitation, short breath, and polydipsia due to internal heat. The formula is matched with gordon euryale seed, dried orange peel, rhizoma polygonati and Chinese yam to treat spleen deficiency and cold deficiency caused by cold and cool medicaments such as salvia miltiorrhiza, houttuynia cordata, oldenlandia diffusa and the like, and has the effects of tonifying lung, qi and blood deficiency and the like.

The Chinese yam has the most obvious effect of tonifying spleen and stomach, and is used for treating weakness of the spleen and the stomach, tiredness, anorexia and diarrhea. The second is promoting the production of body fluid and tonifying the lung, and is used for treating lung deficiency cough and dyspnea, consumptive disease cough and diabetes. And the third is to tonify kidney and astringe essence. It should be used with cautions for patients with excessive dampness or accumulation and stagnation, and prohibited for those with excessive heat and pathogenic excess. The formula is matched with gordon euryale seed, rhizoma polygonati, codonopsis pilosula and dried orange peel to treat spleen deficiency cold caused by cold and cool medicines such as salvia miltiorrhiza, radix scrophulariae, houttuynia cordata, oldenlandia diffusa and the like.

Dried orange peel has the effects of regulating qi, regulating the middle warmer, eliminating dampness and phlegm, inducing diuresis and relaxing bowels: 1. has good effect on incoordination between the spleen and the stomach, abdominal pain and swelling, chronic diarrhea, dysentery, and polydipsia; 2. stimulating appetite, promoting digestion, stimulating gastrointestinal tract, accelerating secretion of digestive juice, eliminating intestinal tract pneumatosis, improving emesis and stimulating appetite; 3. the dried orange peel also has the effects of reducing phlegm, relieving cough and reducing blood fat, treating chronic cough due to lung deficiency or eliminating pulmonary inflammation, reducing phlegm and discharging phlegm, and is beneficial to dissipating nodules. Chen Pi is easy to cause excessive internal heat, dry cough, qi deficiency, yin deficiency and internal heat. It should be used with cautions for pregnant women especially for qi deficiency and body dryness or yin deficiency and dry cough accompanied by excessive heat bleeding. The formula is matched with gordon euryale seed, rhizoma polygonati and Chinese yam to treat deficiency-cold in spleen and stomach caused by cold and cool medicaments such as salvia miltiorrhiza, figwort root, houttuynia cordata, oldenlandia diffusa and the like; but also can relieve chronic gastroenteritis caused by long-term administration of other medicines.

Pinellia tuber, rhizoma Pinelliae with pungent and warm natured properties, enters spleen, stomach and lung meridians; descending the adverse flow of stomach-qi, arresting vomiting and resolving cold-phlegm, mainly indicated for phlegm accumulation due to spleen failing to resolve dampness, are the essential dampness-drying herbs for damp-phlegm, and indicated for phlegm-damp stagnation, cough and adverse flow of qi, and often combined with Chen Pi, etc. also indicated for heat-phlegm and wind-phlegm. 2. Can be used for treating chest and gastric cavity stuffiness, thoracic obstruction, and thoracic obstruction pain. Has the effects of relieving pain, dispersing pathogen accumulation and relieving oppression. The prescription of the medicine is matched with clam shells, oysters and the like to treat nodules caused by inflammation and phlegm-dampness accumulation. But also can relieve chronic gastroenteritis caused by long-term administration of other medicines.

Compared with the prior art for treating pulmonary nodules, the invention has the following beneficial effects: the invention takes the principle of clearing away the lung-heat, tonifying qi, nourishing yin and activating blood circulation, and various medicaments mutually form a synergistic effect. The astragalus and the adenophora stricta in the combined preparation are monarch drugs for tonifying qi, nourishing lung and moistening lung; herba Dendrobii and Bulbus Lilii as ministerial drugs for clearing lung heat; and the angelica sinensis is used as a messenger for supplementing blood and regulating blood circulation, and promoting blood circulation to remove blood stasis, and all the medicines supplement each other. Has effects of clearing lung-heat, invigorating qi, nourishing yin and promoting blood circulation.

In addition, the traditional Chinese medicinal materials in the proportion are matched for use, the traditional Chinese medicinal materials have obvious treatment effect on pulmonary nodules (the number, the size, the pathological results, the imaging evidence and other specific limited ranges), after the traditional Chinese medicinal materials are taken, the traditional Chinese medicinal materials can directly act on the pathological change parts of the pulmonary nodules through the medicines, the exudation of alveolar mural capillary inflammatory cells, the pulmonary interstitial congestion, the hemorrhage, the edema and the damage of alveolar structures are inhibited, and the expression of TLR4 signal channel signal molecule protein and cytokines of local lung tissue related cells is reduced, so that the inflammatory response of the pulmonary nodules is relieved, and meanwhile, the traditional Chinese medicinal materials have an anti-tumor effect, and the purpose of delaying or treating the pulmonary nodules is achieved. According to RISIST standard, different combinations of the traditional Chinese medicine preparation have certain curative effect on lung nodules with different tumor risks, the effective rate is 37.1% -45.0%, and the difference is obvious compared with a control group. And has definite clinical curative effect, safety and no toxic or side effect. Meanwhile, the invention has the advantages of convenient manufacture, low treatment cost and the like.

Drawings

Fig. 1 shows rat lung tissue sections viewed under HE stained microscopy (HE × 400).

Fig. 2 shows a view of the expression of the conduction pathway molecular protein MyD88 in west blotting, wherein lane 1 (model mouse + dexamethasone), lane 2 (model mouse + TCM 1), lane 3 (model mouse + TCM 2), lane 4 (model mouse + TCM 3), lane 5 (model mouse + TCM 4), lane 6 (model mouse + TCM 5), lane 7 (model mouse + distilled water), and lane 8 (healthy mouse + distilled water).

FIG. 3 shows the effect of the Chinese medicinal preparation on tumors in tumor-bearing mice.

FIG. 4 shows the survival curves of tumor-bearing mice.

Detailed Description

The following examples are presented to enable those skilled in the art to more fully understand the present invention and are not intended to limit the invention in any way.

Example 1

The traditional Chinese medicine composition and the dosage thereof in the embodiment are as follows: 10-30 parts of astragalus membranaceus, 5-25 parts of lily, 5-25 parts of houttuynia cordata, 5-25 parts of salvia miltiorrhiza, 5-20 parts of radix glehniae, 10-45 parts of oyster, 5-15 parts of honey-fried licorice root, 10-30 parts of clam shell and 10-25 parts of oldenlandia diffusa. 5-18 parts of codonopsis pilosula and 5-25 parts of Chinese yam; 5-15 parts of dark plum fruit and 10-20 parts of dried orange peel; 5-18 parts of radix scrophulariae; 5-16 parts of white peony root; 5-20 parts of angelica sinensis and 5-16 parts of rhizoma polygonati; 5-40 parts of Chinese yew; 5-15 parts of ginger processed pinellia tuber; 5-18 parts of fried gorgon fruit.

The Chinese medicine preparation No. 1 is prepared from the following raw materials in parts by weight: 10 parts of astragalus mongholicus, 5 parts of lily, 5 parts of houttuynia cordata, 12 parts of salvia miltiorrhiza, 5 parts of radix glehniae, 10 parts of oyster, 8 parts of honey-fried licorice root, 15 parts of clam shell and 9 parts of oldenlandia diffusa. 5 parts of codonopsis pilosula, 15 parts of angelica sinensis, 5 parts of fried gordon euryale seed and 5 parts of Chinese yam; dark plum 10, dried orange peel 12; 18 parts of radix scrophulariae; white peony root 10, yew 9; 8 parts of rhizoma polygonati; 12 parts of ginger processed pinellia tuber;

the Chinese medicine preparation No. 2 is prepared from the following raw materials in parts by weight: 20 parts of astragalus membranaceus, 10 parts of lily, 15 parts of houttuynia cordata, 20 parts of salvia miltiorrhiza, 10 parts of radix glehniae, 30 parts of oyster, 12 parts of honey-fried licorice root, 20 parts of clam shell and 12 parts of oldenlandia diffusa. 15 parts of codonopsis pilosula and 25 parts of Chinese yam; dark plum 15, dried orange peel 15; 10 parts of radix scrophulariae; 12 parts of white peony root; 5 parts of angelica sinensis and 16 parts of rhizoma polygonati; 12 parts of Chinese yew; 8 parts of ginger processed pinellia tuber; stir-fried gorgon fruit 12 parts.

The Chinese medicine preparation No. 3 is prepared from the following raw materials in parts by weight: 25 parts of astragalus, 22 parts of lily, 23 parts of houttuynia cordata, 23 parts of salvia miltiorrhiza, 18 parts of radix glehniae, 42 parts of oyster, 15 parts of honey-fried licorice root, 28 parts of clam shell and 20 parts of oldenlandia diffusa. 18 parts of codonopsis pilosula, 20 parts of angelica sinensis, 18 parts of fried gordon euryale seed and 25 parts of Chinese yam; dark plum 15, dried orange peel 18; 15 parts of radix scrophulariae; 15 parts of white peony root; 15 parts of rhizoma polygonati; 40 parts of Chinese yew; 15 parts of ginger processed pinellia.

The Chinese medicine preparation No. 4 is prepared from the following raw materials in parts by weight: 15 parts of astragalus, 12 parts of lily, 10 parts of houttuynia cordata, 5 parts of salvia miltiorrhiza, 15 parts of radix glehniae, 20 parts of oyster, 5 parts of honey-fried licorice root, 10 parts of clam shell and 15 parts of oldenlandia diffusa. 12 parts of codonopsis pilosula, 10 parts of angelica sinensis, 10 parts of fried gordon euryale seed and 20 parts of Chinese yam; 5 parts of dark plum fruit and 20 parts of dried orange peel; 5 parts of radix scrophulariae; 5 parts of white peony root; 10 parts of rhizoma polygonati; 15 parts of Chinese yew; 10 parts of ginger processed pinellia.

The Chinese medicine preparation No. 5 is prepared from the following raw materials in parts by weight: 30 parts of astragalus, 25 parts of lily, 25 parts of houttuynia cordata, 25 parts of salvia miltiorrhiza, 20 parts of radix glehniae, 45 parts of oyster, 10 parts of honey-fried licorice root, 30 parts of clam shell and 25 parts of oldenlandia diffusa. 10 parts of codonopsis pilosula and 15 parts of Chinese yam; dark plum 10, dried orange peel 10; 12 parts of radix scrophulariae; 16 parts of white peony root; 18 parts of angelica sinensis and 5 parts of rhizoma polygonati; 6 parts of Chinese yew; 5 parts of rhizoma pinelliae; 15 parts of stir-fried gorgon fruit.

EXAMPLE 2 pharmacological animal experiments

1. Anti-inflammatory assay (swelling of the foot of the rat)

The rats are administrated by gastric lavage, the decoction and the positive control drug dexamethasone are respectively taken by the drug groups, and the normal saline with the same volume is given by the control group. After half an hour after administration, egg white was injected from the hindpaw of the rat to induce inflammation, and the hindpaw volume at different time periods was measured to compare the change in the solvent value before and after administration. The medicine of the invention has obvious effect of inhibiting the swelling of the rat foot , and the action time can be prolonged to more than 6 hours.

2. Anti-lung tissue inflammation assay

2.1 the experimental animals were grouped into SD rats of healthy males, weighing (200. + -. 20) g, 56, provided by the Shanghai laboratory animal center of the Chinese academy of sciences, and randomly divided into: a (model mouse + dexamethasone), B (model mouse + traditional Chinese medicine No. 1), C (model mouse + traditional Chinese medicine No. 2), D (model mouse + traditional Chinese medicine No. 3), E (model mouse + traditional Chinese medicine No. 4), F (model mouse + traditional Chinese medicine No. 5), G (model mouse + distilled water), H (healthy mouse + distilled water), 8 groups in total, and 8 mice in each group.

2.2 Experimental animal model and preparation of drugs No. 1-5 is a decoction of crude drug concentration 2g/ml prepared in example 1. Dexamethasone 5mg was dissolved in distilled water 25ml to prepare an aqueous solution of 0.2 mg/ml. 3. The experimental animals are molded into 8 groups, the experimental animals are adaptively fed for 1 week, 1mL of bleomycin diluent (containing Bleo2.5 u) is dripped into the trachea of the model group mice under isoflurane anesthesia for molding, and the blank group is dripped with 0.9% sodium chloride injection with the same amount by the same method. The mice in the blank group and the model group are subjected to intragastric administration according to the weight of (0.01mL/g) every day after the model is built, 0.9% sodium chloride injection is administered to the mice in each treatment group according to the weight of (100mg/kg) every day, the change of the weight is measured, the administration dosage is adjusted at any time, the mental and activity states of the mice in each group are observed, the mice are killed by dislocation of cervical vertebrae after 14 days, three mice in each group are randomly extracted, the left lung of each mouse is taken to prepare paraffin white slices, and the paraffin white slices are used for subsequent pathological observation of lung tissues.

2.3 pathological changes in Lung tissue

The tissue sample is embedded by normal paraffin, then the tissue section is placed on a glass slide and soaked by warm water at 40 ℃, then the section is placed in dimethylbenzene and absolute ethyl alcohol in sequence and soaked for 10 minutes, then the section is placed in 85% ethyl alcohol and soaked for 5 minutes, after the section is fully hydrated, the tissue sample section is soaked and cleaned by PBS solution, hematoxylin staining solution is absorbed by a liquid transfer method, 100 mu L of each tissue section is dripped, and the tissue section is fully stained for 10 minutes. Tissue sections were differentiated with 1% ethanol hydrochloride and then washed clean with double distilled water. Adding the blue promoting liquid into the tissue slices, and cleaning with clear water after the anti-blue reaction is finished. And adding eosin dye solution into the tissue sample slice for 3 minutes, and after dyeing, performing gradient dehydration on the tissue slice by using 80% and 95% of absolute ethyl alcohol respectively. The dehydrated tissue specimen sections were soaked in xylene for 8 minutes, mounted with neutral gum, and observed under a microscope as in fig. 1. The method for grading alveolar inflammation and marking standard refers to Szapiel and other methods, wherein 0 grade is 0 grade without alveolitis and is marked with 0 grade; mild alveolitis at level 1, the alveolar septal infiltration is observed under a microscope to thicken, but the lesion range does not exceed 20 percent of the whole lung, the alveolar structure is not obviously changed, and the score is 1; grade 2, moderate alveolitis, the lesion area of alveolus inflammation accounts for 20-50% of the whole lung, the structure of the alveolus changes, and the score is 2; grade 3, severe alveolitis, with lesion range over 50% of the total lung area, inflammatory cells and erythrocytes in alveolar space, score 3. Lung pathology was altered as follows: the rats in each model group have different degrees of inflammatory manifestations, and the pathological changes are mainly exudation. The main pathological manifestations are: thickening of lung space, widening of alveolar wall, congestion of capillary vessels in alveolar wall, congestion and edema of pulmonary interstitium, and infiltration of neutrophils in the alveolar space and partial alveolar cavities. A. H, the lung tissue sections of two groups of rats have clear alveolar structures under an electron microscope and have no obvious inflammatory exudation; obvious alveolar wall thickening, pulmonary interstitial capillary congestion, edema, alveolar structural disorder and even transparent film formation can be observed under the optical microscope of the pathological sections of the groups B and G; while a small amount of congestion, edema and inflammatory exudation of pulmonary interstitial tissues can be observed under a light microscope of C, D, E, F groups of rats, but the phenomenon is not obvious; the alveolar structure is clearer, the alveolar wall is thinner, and the inflammatory response is lighter than that of B, G groups. See fig. 1. Table 1 shows the alveolar inflammatory scores (x. + -.s) of the groups of mice.

TABLE 1

Note: compared with group A, # is p<0.01; in comparison with the group H,^△p<0.01; in comparison with the group G,^□p<0.01

2.4 Western blotting detection of Signal transduction pathway molecular protein expression

The method comprises the following main experimental steps: (1) extraction of total protein from lung tissue: taking 20mg of the right lung middle lobe sample of each sample and placing the sample in an EP tube; adding RIPA cell lysate and phenylmethylsulfonyl fluoride (PMSF) into each EP tube, and adding steel balls; grinding with a grinder, centrifuging at 4 deg.C, collecting supernatant, and storing at-80 deg.C. (2) SDS-PAGE gel preparation: the 10% ammonium persulfate solution is divided into small tubes and stored at-20 ℃, separation gel of 10% SDS-PAGE is prepared according to the molecular weight (33-35kD) of MyD88 of rats, the separation gel is injected into a gap between two glass plates by a pipette, and the liquid surface is sealed by water. Standing for gelation, and pouring out the upper water layer after layering. Preparing 5% SDS-PAGE concentrated gel (i.e. upper layer gel), adding into glass plate, removing bubbles, rapidly inserting into comb, and standing for 15 min. (3) And (3) sealing: after electrophoresis and semi-dry conversion, the polyvinylidene fluoride (PVDF) membrane is placed into a TBST washing solution (containing Tris-HCl, NaCl and tween20) prepared in advance, and the membrane conversion solution on the membrane is washed away. Adding 5% skimmed milk powder TBST blocking solution, slowly shaking, blocking at room temperature for 40min, and washing for 3 times. (4) Antibody incubation: the dilutions were made in the appropriate ratio (1:500) with reference to the instructions for MyD88 primary antibody (R & D). After incubation at 4 ℃ overnight, washing was carried out. The secondary antibody was diluted at a 1:5000 ratio, incubated at room temperature for 1 hour and washed 3 times, according to the instructions for the secondary antibody. (5) Exposure and analysis: adding a developer for 3-4min for color development, and processing the Image collected by a bioluminescent imaging system by using Image J software. And (3) taking the gray value of the beta-actin as 1, and representing the quantitative value by the ratio of the gray value measured by each sample to the gray value of the beta-actin to analyze.

The results of protein expression of the transduction pathway molecules are shown in FIG. 2 and Table 2.

TABLE 2 groups of MyD88 Gray values (x + -s)

and (3) displaying a result after gray value analysis: compared with a healthy normal group, each model mouse shows high MyD88 expression (p is less than 0.01) except for dexamethasone treatment; compared with the model mouse without treatment, the healthy control group and each model mouse group show high MyD88 expression (p < 0.01); compared with dexamethasone-treated model mice, the other model mice have MyD88 high expression (p < 0.01); but no significant difference was observed in the healthy control group (p > 0.05).

2.5 detection of cytokines TNF-alpha, IL-17, TGF-beta

The cell factors TNF-alpha, IL-17 and TGF-beta are signal molecules of a main inflammatory response signaling pathway TLR4 signaling pathway, the expression level of the signal molecules is detected by an Elisa method, the detection steps are basically the same, and the main steps are as follows:

(1) adding 100ul of standard substance and sample into each well, sealing, and incubating at room temperature for 2.5 h;

(2) discarding liquid in each hole, sucking to dry, adding WashBuffer, standing, sucking to dry, and repeating for 4 times;

(3) adding a detection antibody; sealing and incubating for 1h at room temperature; repeating the process of (2);

(4) adding HRP-Streptavidin Solution (Kingsry) for incubation at room temperature; repeating the process of (2);

(5) adding TMB One-Step Substrate Reagent (Thermo), and incubating at room temperature;

(6) adding the stop solution into each hole, namely placing the hole into an enzyme labeling instrument to measure the optical density (OD value) of each hole, wherein the wavelength is 450 nm. Drawing a standard curve (y ═ 116.71 e)^3.1608xY is the standard concentration and x is the OD value), the sample concentration is calculated from the curve.

The results of measuring the expression levels of TNF-. alpha.IL-17 and TGF-. beta.in each group are shown in Table 3. The expression level of the cell factors TNF-alpha, IL-17 and TGF-beta of rats in the dexamethasone treatment group (group G) is obviously lower than that of the normal group; compared with the normal group, the expression levels of TNF-alpha, IL-17 and TGF-beta are obviously increased in the other model groups (p is less than 0.01); and the expression conditions of TNF-alpha, IL-17 and TGF-beta of A, B, C, D, E groups are obviously reduced (p is less than 0.01) compared with that of F group (contrast), which indicates that the Chinese medicinal preparation 1-5 formulas have anti-inflammatory effects of different degrees, and reduce the inflammatory reaction of pulmonary nodules, thereby treating the pulmonary nodules. The Chinese medicine No. 3 and 5 has the strongest effect, but is weaker than the hormone dexamethasone. Table 3 shows the results (x ± s) of Elisa assay for each cytokine.

TABLE 3

Note: compared with group F, # is p<0.05, # # is p<0.01; in comparison with the group H,^△p<0.05,^△△p<0.01; in comparison with the group G,^□p<0.05,^□□p<0.01。

3. tumor inhibition test

Establishment of a human lung cancer animal tumor model 24 male SCID mice of 4-6 weeks old were selected, and the average body weight was 20-25 g. Mice were randomized into 2 groups: experimental group (traditional Chinese medicine group) and control group (PBS group). To establish a human lung cancer tumor model, human lung cancer cell line A549 was resuspended in PBS, the left axilla of each mouse was selected and injected subcutaneously with a solution containing 2X 10⁶200. mu.l PBS of individual A549 cells. Observing the tumor formation condition of the mice every day, measuring the tumor size of each mouse every 2 days for 1 time after tumor formation,

meanwhile, 5ml of the decoction and 5ml of PBS are respectively infused into the mice of the experimental group and the control group. This was repeated every 24 hours over a period of 4 weeks. The tumor size of the mice was measured every 2 days, and the tumor volume V ═ 2 (major diameter + minor diameter)/2 was calculated from the longest diameter of the tumor and the transverse diameter perpendicular thereto. The tumor volume progression was observed in 2 groups of SCID mice. Once tumors ulcerate or mice suffer great distress, they are euthanized. Studies involving animal experiments have passed ethical review by the ethical committee on laboratory animals. The growth curve of the mouse tumor is drawn and is shown in figure 3; survival of 2 groups of SCID mice was observed, starting on the first day of subcutaneous neoplasia of a549 cells and ending on 50 days as survival, and the survival curves of the mice were plotted as shown in fig. 4. Table 4 shows the growth inhibition effect of the traditional Chinese medicine on tumor bodies of tumor-bearing mice. Fig. 3, table 4 results show: after the tumor is inoculated for 14 days, the tumor body of the traditional Chinese medicine experimental group is obviously smaller than that of the control group, and the size difference between the two groups is gradually increased; the Chinese medicine can continuously inhibit the tumor development. This is confirmed by the results of the growth graph (figure 4) of the mice: the traditional Chinese medicine can inhibit the growth of tumor, and the survival time of the mouse is prolonged.

TABLE 4

Note: compared with the control group, # is p <0.01

Example 3 toxicological test

The LD50 test result shows that the mice are continuously gavaged for three days according to 80 times, 60 times and 50 times of human dose, and the mice are all healthy and survive without toxic reaction after being observed for seven days.

EXAMPLE 4 clinical trial for treatment of pulmonary nodules

Case selection criteria

1. Inclusion criteria were:

1.1 according to 2018 version of Chinese Lung nodule diagnosis and treatment expert consensus, the Lung nodule refers to a quasi-circular or irregular focus with lung inner diameter less than or equal to 2 cm, and the imaging shows that the density is increased, the focus can be singly or multiply, and the boundary is clear or unclear. According to the density, the pulmonary nodules can be divided into 3 types of solid pulmonary nodules, pure ground glass nodules and partial solid nodules. Such nodules are present in the patient's lungs. For non-isolated multiple lung nodules, 1 dominant nodule and/or multiple small nodules were found in the evaluation, and each nodule incorporation group was evaluated individually. The solitary subvertical lung nodule is pGGN or mGGN.

High risk group: 1. those aged 40 or older and having any risk factor. 2. The solid nodule > 8mm has malignant signs of leaf division, burr and pleural depression; or pGGN > 10mm or pGGN >5mm with increased substantial components or mGGN > 8mm with enlarged nodules or increased substantial components (thin-layer flat scan). pGGN or mGGN are of inferior substantivity. Solid nodules > -10 mm (follow-up 3 months).

Middle risk group: 1. those aged more than or equal to 40 years and having any risk factor; 2. pGGN >5mm, ≦ 10mm or mGGN ≦ 8mm but with enlarged nodules or increased solid content (thin-layer flat scan); 3. or solid nodules >4, ≦ 8mm (follow-up >6, — 12 months).

Low risk group: 1. age <40 years without risk factors. 2. pGGN is less than or equal to 5mm or mGGN is less than or equal to 8mm, no nodule growth or increase of solid components (thin-layer flat scan) occurs. Or the solid nodule is less than or equal to 4mm (selected by follow-up).

1.2 determine the test age range 20-70 years.

2. Exclusion criteria (including maladaptive symptoms or kicking criteria)

2.1 those who do not meet the differentiation and diagnosis criteria of the traditional Chinese medicine, such as qi and blood deficiency syndrome, heat-stasis and qi collapse syndrome

2.2 cases not within the scope of action of the drug

2.3 with obvious intercurrent syndrome or complications.

2.4 women who are nursing or preparing for pregnancy;

2.5 allergic constitution and people allergic to various drugs;

2.6 the patients with serious primary diseases and mental diseases such as liver and kidney hematopoietic system and endocrine system are combined.

2.7 critical illness, it is difficult to make exact appraisers of the effectiveness and safety of new drugs.

3. Safety and efficacy assessment

3.1 safety assessment

The method includes the steps of firstly, checking up a physical examination item; (2) hematuria and stool are routinely assayed. (3) And (5) performing heart, liver and kidney function examination.

3.2. Evaluation of therapeutic effects

The therapeutic effect judgment standard is as follows: the following 1 and more evidences were met and evaluated as therapeutically effective: the visual disappearance of isolated or multiple nodules; the number of pulmonary nodules is reduced by ≧ 1; density index: the imaging evidence shows that the reduction of the density of the pulmonary nodule is greater than or equal to 1 magnitude; the nodule area index: the major diameter is multiplied by the minor diameter, the single diameter is reduced by 2 MM, or the diameters are reduced by more than 1MM, and the size is judged to be reduced; the tumor marker inspection shows that the lung cancer related markers are reduced by more than 15 percent; the X-ray shows that the original persistent increase in nodule size was stable and unchanged.

Treatment was assessed as ineffective, meeting the following evidence: the number of pulmonary nodules is increased by ≧ 1; the imaging evidence shows that the solid component of the lung nodule is increased by more than or equal to 1 magnitude; the nodule area index: the long diameter is multiplied by the short diameter, the single diameter is increased by 2 MM, or the single diameter is increased by more than 1MM, and the nodule is judged to be increased; lung cancer related markers are increased by more than 15%;

fourth, the therapeutic method

The treatment groups were administered samples of the Chinese medicinal preparation of the present invention. It is administered orally with water. 1 bag at a time, 2 times a day. Is administered after meal.

The control group did not take traditional Chinese medicine, and 2 groups all took 2 weeks as 1 course of treatment with 5 days interval. The curative effect is judged after 5 treatment courses.

Fifth, statistical method

The measurement data adopts t test and the counting data adopts x²And (5) checking and analyzing, and checking the grade data by using radius.

Table 5 shows the comparison of the therapeutic effects of each group of one of the Chinese medicinal composition formulas, and the results show that the Chinese medicinal preparation 5 is significantly effective for patients in high, medium and low risk groups, and the effective rate for the low risk group is significantly higher than that for the high risk group; table 6 shows the comparison of the effective rates of the two Chinese medicinal composition groups, and the results show that the Chinese medicinal preparation 3 is obviously effective for patients with high, medium and low risk groups, and the effective rates of the groups have no significant difference.

TABLE 5

Note: in comparison with the control group, # # is p<0.01; compared with the high-risk group, the method has the advantages that,^△p<0.05

TABLE 6

Note: compared with the control group, # is p <0.05, # is p <0.01

Those skilled in the art will appreciate that the above embodiments are merely exemplary embodiments and that various changes, substitutions, and alterations can be made without departing from the spirit and scope of the application.

Claims

1. A traditional Chinese medicine preparation for eliminating pulmonary nodules is characterized in that: the traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 10-30 parts of astragalus membranaceus, 5-25 parts of lily, 5-25 parts of houttuynia cordata, 5-25 parts of salvia miltiorrhiza, 5-20 parts of radix glehniae, 10-45 parts of oyster, 5-15 parts of honey-fried licorice root, 10-30 parts of clam shell, 10-25 parts of oldenlandia diffusa, 5-18 parts of codonopsis pilosula, 5-25 parts of Chinese yam, 5-15 parts of dark plum, 10-20 parts of dried orange peel, 5-18 parts of radix scrophulariae, 5-16 parts of radix paeoniae alba, 5-20 parts of angelica sinensis, 5-16 parts of rhizoma polygonati, 5-40 parts of taxus chinensis, 5-15 parts of rhizoma pinelliae preparata and 5-18 parts of fried gordon euryale seed.

2. The traditional Chinese medicine preparation of claim 1, which is prepared from the following raw materials in parts by weight: 30 parts of astragalus membranaceus, 25 parts of lily, 25 parts of houttuynia cordata, 25 parts of salvia miltiorrhiza, 20 parts of radix glehniae, 45 parts of oyster, 10 parts of honey-fried licorice root, 30 parts of clam shell, 25 parts of oldenlandia diffusa, 10 parts of codonopsis pilosula, 15 parts of Chinese yam, 10 parts of dark plum, 10 parts of dried orange peel, 12 parts of radix scrophulariae, 16 parts of radix paeoniae alba, 18 parts of angelica sinensis, 5 parts of rhizoma polygonati, 6 parts of taxus chinensis, 5 parts of rhizoma pinelliae preparata and 15 parts of fried gorgon fruit.

3. The traditional Chinese medicine preparation of claim 1, which is prepared from the following raw materials in parts by weight: 20 parts of astragalus membranaceus, 10 parts of lily, 15 parts of houttuynia cordata, 20 parts of salvia miltiorrhiza, 10 parts of radix glehniae, 30 parts of oyster, 12 parts of honey-fried licorice root, 20 parts of clam shell, 12 parts of oldenlandia diffusa, 15 parts of codonopsis pilosula, 25 parts of Chinese yam, 15 parts of dark plum, 15 parts of dried orange peel, 10 parts of radix scrophulariae, 12 parts of radix paeoniae alba, 5 parts of angelica sinensis, 16 parts of rhizoma polygonati, 12 parts of taxus chinensis, 8 parts of rhizoma pinelliae preparata and 12 parts of stir-fried gorgon fruit.

4. The traditional Chinese medicine preparation of claim 1, which is prepared from the following raw materials in parts by weight: 15 parts of astragalus membranaceus, 12 parts of lily, 10 parts of houttuynia cordata, 5 parts of salvia miltiorrhiza, 15 parts of radix glehniae, 20 parts of oyster, 5 parts of honey-fried licorice root, 10 parts of clam shell, 15 parts of oldenlandia diffusa, 12 parts of codonopsis pilosula, 10 parts of angelica sinensis, 10 parts of fried gordon euryale seed, 20 parts of Chinese yam, 5 parts of dark plum, 20 parts of dried orange peel, 5 parts of radix scrophulariae, 5 parts of white paeony root, 10 parts of rhizoma polygonati, 15 parts of taxus chinensis and 10 parts of ginger processed pinellia tuber.

5. The traditional Chinese medicine preparation of claim 1, which is prepared from the following raw materials in parts by weight: 25 parts of astragalus membranaceus, 22 parts of lily, 23 parts of houttuynia cordata, 23 parts of salvia miltiorrhiza, 18 parts of radix glehniae, 42 parts of oyster, 15 parts of honey-fried licorice root, 28 parts of clam shell, 20 parts of oldenlandia diffusa, 18 parts of codonopsis pilosula, 20 parts of angelica sinensis, 18 parts of fried gordon euryale seed, 25 parts of Chinese yam, 15 parts of dark plum, 18 parts of dried orange peel, 15 parts of radix scrophulariae, 15 parts of white paeony root, 15 parts of rhizoma polygonati, 40 parts of taxus chinensis and 15 parts of ginger processed pinellia tuber.

6. The traditional Chinese medicine preparation of claim 1, which is prepared from the following raw materials in parts by weight: 10 parts of astragalus membranaceus, 5 parts of lily, 5 parts of houttuynia cordata, 12 parts of salvia miltiorrhiza, 5 parts of radix glehniae, 10 parts of oyster, 8 parts of honey-fried licorice root, 15 parts of clam shell, 10 parts of oldenlandia diffusa, 5 parts of codonopsis pilosula, 15 parts of angelica sinensis, 5 parts of fried gordon euryale seed, 5 parts of Chinese yam, 10 parts of dark plum, 12 parts of dried orange peel, 18 parts of radix scrophulariae, 10 parts of white peony root, 9 parts of taxus chinensis, 8 parts of rhizoma polygonati and 12 parts of ginger processed pinellia.

7. A method for preparing the traditional Chinese medicine preparation of claim 1, which is characterized by comprising the following steps: mixing the components according to the formula amount, adding water, slowly decocting with slow fire, and concentrating the water decoction to obtain the traditional Chinese medicine.

8. The method for preparing a Chinese medicinal preparation according to claim 7, wherein the method comprises the following steps: mixing the components according to the formula amount, adding 3-4 times of water by weight, decocting at 120 ℃ for 30min, adjusting to 80 ℃ and decocting for 20min, filtering to obtain a primary filtrate and a primary filter cake, repeatedly decocting the primary filter cake once, filtering to obtain a secondary filter cake and a secondary filtrate, combining the primary filtrate and the secondary filtrate, and concentrating under reduced pressure to 1.5-2 times of volume to obtain the traditional Chinese medicine preparation.

9. The method for preparing a Chinese medicinal preparation according to claim 8, wherein the concentration under reduced pressure is carried out at 0.097Mpa and 50-60 ℃.