A Chinese medicine preparation for treating pulmonary nodules and its preparation method

Abstract

The invention discloses a Chinese medicine preparation for treating pulmonary nodules and a preparation method thereof, and relates to the technical field of medicines for treating respiratory diseases. Compared with the prior art, the Chinese medicine preparation for treating pulmonary nodules prepared by the invention is treated from five aspects, including tonifying the lung and replenishing qi, resolving phlegm and eliminating phlegm, softening and dispersing nodules, clearing away heat and detoxifying, and eliminating carbuncle and dispersing nodules, by combining selected medicinal materials of Codonopsis pilosula, Astragalus membranaceus, Chinese yam, Schisandra chinensis, Rehmannia glutinosa, Morus alba, Salvia miltiorrhiza, Curcuma zedoaria, Concha oyster, Scrophularia ningpoensis, Rhizoma Anemarrhenae, Scutellaria barbata, and Beehive. It is aimed at treating both the symptoms and the root cause of pulmonary nodules caused by lung deficiency, phlegm, dampness and blood stasis coagulation in the lungs, and is convenient to take, and can effectively control and reduce pulmonary nodules. The preparation of the Chinese medicine preparation of the invention optimizes the heat transfer and mass transfer in the decoction process by physically adding a carrier during the decoction process, changes the osmotic pressure difference at the interface of the medicine liquid, etc., accelerates the dissolution and diffusion of the effective ingredients, is easier to extract and prepare, has a shorter decoction time, and is more efficient.

Description

Technical Field

[0001] The invention relates to the technical field of medicines for treating respiratory diseases, and in particular to a traditional Chinese medicine preparation for treating pulmonary nodules and a preparation method thereof. Background Art

[0002] Pulmonary nodules (PN) are a respiratory disease. They are focal, round, solid or subsolid lung shadows with a diameter of less than 3 cm observed on imaging. They can be isolated or multiple, without atelectasis, hilar lymphadenopathy, and pleural effusion. In recent years, with the widespread use of low-dose CT screening and the continuous improvement of examination methods, more and more pulmonary nodules have been found in physical examinations. Studies have shown that the clinical detection rate of pulmonary nodules can reach 35.5%, of which only 0.5%-3.5% are diagnosed as lung cancer, and 96.4% of positive nodules found by CT screening are benign. According to the recommendations of many domestic and international consensus / guidelines, high-risk pulmonary nodules with high-risk factors and malignant signs require active intervention and surgical resection, while low-risk nodules are managed through long-term follow-up and evaluation. If they are found to have imaging growth or increased solid components, or if they change from low risk to high risk, timely intervention will be performed. At present, there is still a gap in modern medicine regarding drug treatment options for the follow-up observation period of lung nodules.

[0003] As a traditional Chinese medicine with a long history, TCM has the ideas of "preventing disease before it occurs", "holistic concept" and "people-oriented" in the early intervention of some diseases, which are in line with the concept of timely intervention of lung nodules. There is no corresponding disease name for lung nodules in TCM. Modern doctors classify them as "lung accumulation" and "breathing benignity". "Medical Essential Reading" says: "Accumulation is caused by insufficient righteousness, and then evil qi occupies it." Deficiency of righteousness and invasion of evil qi can easily lead to dysfunction of viscera, imbalance of yin and yang, abnormal distribution of qi, blood and body fluids, accumulation of body fluids into phlegm, blood stasis, and phlegm and blood stasis. Phlegm and blood stasis are glued together to form nodules. Therefore, nodules with phlegm and blood stasis are seen in the image. Its transition from phlegm dampness to blood stasis is also in line with the dynamic change process in the imaging of lung nodules. The enlargement of nodules indicates that the qi blockage is deeper, the more dampness, phlegm, blood stasis and evil qi are retained and accumulated, and the longer the course of the disease. In view of this basic pathogenesis, the treatment method of nourishing the lungs, promoting blood circulation, resolving phlegm and dispersing nodules is adopted throughout the process. It can replenish and circulate lung qi, promote blood circulation, resolve phlegm and eliminate tangible evil obstructions, and use nodule-dispersing drugs to disperse the aggregation and slowly dissipate the local nodules.

[0004] CN114699502A discloses a Chinese medicine composition for dispersing nodules, resolving phlegm and promoting blood circulation, a preparation method and application thereof, which is composed of the following raw materials: turtle shell, oyster, bupleurum, scutellaria, belamcanda, bombyx batryticatus, roasted ginger, cinnamon twig, scutellaria baicalensis, pyrrosia, pinellia ternata, ginseng, honeycomb, white mustard seeds, thunbergia thunbergii, cat's claw, sapodilla thorn, zedoaria, golden buckwheat and roasted liquorice; the preparation method of the Chinese medicine composition decoction comprises decocting the above raw materials twice, each decocting time is 20-40 minutes, filtering, and concentrating the filtrate to obtain the decoction of the Chinese medicine composition for dispersing nodules, resolving phlegm and promoting blood circulation; the Chinese medicine composition for dispersing nodules, resolving phlegm and promoting blood circulation is used for preparing medicine for treating pulmonary nodules of phlegm and blood stasis type. The invented Chinese medicinal composition for dispersing nodules, resolving phlegm and promoting blood circulation has the effects of dispersing nodules and resolving phlegm, promoting blood circulation and unblocking meridians, invigorating Qi and strengthening the body. It is mainly used to treat lung nodules of the phlegm and blood stasis type, can be used as a long-term treatment or auxiliary treatment for lung nodules, and is suitable for and relieves patients' symptoms of cough, wheezing, chest tightness and fatigue.

[0005] CN116920066A discloses a Chinese medicine composition for treating pulmonary nodules and lung cancer, and its preparation and application, wherein the Chinese medicine composition comprises the following raw materials: Radix Glechomae, Radix Sophorae Fructus, Radix Rhodiolae, Rhizoma Curcumae, Herba Hedyotis Diffusae, Radix Platycodonis, Radix Achyranthis Bidentatae, Fructus Precoci, Rhizoma Cibotii, Bulbus Fritillariae Thunbergii, Rhizoma Pinelliae, Radix Trichosanthis; the preparation method is briefly described as soaking, decocting, filtering, decocting twice, filtering, merging and concentrating, and a decoction is obtained, and the time of the two decoctions is 30-60 minutes. The raw materials used in the Chinese medicine composition of the invention are cheap, the preparation is simple, and the use is convenient. After many years of clinical application and pharmacological research, it has significant curative effects in inhibiting the formation and development of pulmonary nodules, improving lung function, and promoting the dissipation of pulmonary nodules.

[0006] The above invention patents all prepare Chinese medicine compositions by decocting after soaking, and the decocting time and number of times of the Chinese medicine compositions have a significant impact on the overall efficacy. To this end, the present invention proposes a Chinese medicine combination preparation and a technical solution that is easy to extract and prepare, has a shorter decocting time, and has stable quality. On the basis of modern medical laboratory tests, imaging tests, risk prediction models, etc. to distinguish benign and malignant nodules, this formula is used to treat lung nodules in the follow-up period, which can regulate the body's qi, blood, yin and yang, maintain the balance of the body's internal and external environment, effectively control and shrink lung nodules, relieve patients' clinical symptoms, and prevent lung nodules from becoming cancerous, and prevent further progression and deterioration of the disease. Summary of the invention

[0007] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is to provide a Chinese medicine composition for effectively controlling and reducing lung nodules. The composition is a decoction that is easy to extract and prepare and has a shorter decoction time. It mainly targets the basic pathogenesis of lung deficiency, phlegm, dampness and blood stasis condensed in the lungs, and has the effects of nourishing the lungs and replenishing qi, resolving phlegm and dispersing nodules.

[0008] To achieve the above object, the present invention provides a Chinese medicine preparation for treating pulmonary nodules and a preparation method thereof.

[0009] The traditional Chinese medicine preparation for treating pulmonary nodules comprises the following components: codonopsis pilosula, astragalus, yam, cooked rehmannia, schisandra chinensis, mulberry bark, salvia miltiorrhiza, curcuma, scrophularia ningpoensis, raw oyster, anemarrhena, scutellaria barbata, honeycomb, and a carrier; specifically, it comprises the following components in parts by weight: 8-12 parts of codonopsis pilosula, 8-12 parts of astragalus, 8-12 parts of yam, 8-12 parts of cooked rehmannia, 4-8 parts of schisandra chinensis, 8-12 parts of mulberry bark, 8-12 parts of salvia miltiorrhiza, 8-12 parts of curcuma, 8-12 parts of scrophularia ningpoensis, 8-12 parts of raw oyster, 8-12 parts of anemarrhena, 8-12 parts of scutellaria barbata, 8-12 parts of honeycomb, and 40-60 parts of a carrier.

[0010] The preparation method of the Chinese medicine preparation for treating pulmonary nodules comprises the following steps:

[0011] (1) Soaking: put codonopsis pilosula, astragalus, yam, cooked rehmannia, schisandra chinensis, mulberry bark, salvia miltiorrhiza, curcuma, scrophularia ningpoensis, raw oyster, anemarrhena, scutellaria barbata, and honeycomb in a container according to weight, add water to cover the surface of the medicine, and soak;

[0012] (2) First decoction: Add water to cover the medicinal surface, add the carrier, and perform the first decoction. Use high heat before boiling, and use low heat after boiling to obtain the first medicinal juice.

[0013] (3) Secondary decoction: After the juice is taken, the second decoction is performed immediately. During the second decoction, water is added to cover the medicinal surface. The decoction is performed over high heat before boiling, and then over low heat after boiling. The second medicinal juice is obtained by taking the juice and combined with the first medicinal juice to form a decoction, thereby obtaining the Chinese medicinal preparation for treating pulmonary nodules of the present invention.

[0014] The soaking time in step (1) is 15-20 minutes.

[0015] The height of the drug surface in step (1) is 2-4 cm.

[0016] The height of the drug surface in step (2) is 5-10 cm.

[0017] The decocting time in step (2) is 15-20 minutes.

[0018] The preparation method of the carrier in step (2) is as follows, in parts by weight:

[0019] M1. Add 40-80 parts of diatomaceous earth to 200-400 parts of 10-30 wt% calcium lactate-water solution, stir at 60-75° C. for 0.5-1 hour, centrifuge and wash with water 2-3 times, dry at 60-70° C., grind through a 5-15 mesh sieve, and obtain modified diatomaceous earth;

[0020] M2. Add 40-80 parts of modified diatomaceous earth to 400-800 parts of 0.2-1.0 wt% cellulose acetate-methanol solution, stir at room temperature for 1-2 hours, filter, wash the filter cake with water 2-3 times, dry at 40-50° C., and grind through a 5-15 mesh sieve to obtain the carrier.

[0021] The height of the drug surface in step (3) is 4-8 cm.

[0022] The decocting time in step (3) is 15-20 minutes.

[0023] During the decoction process, Chinese medicinal materials will absorb water vapor from the air to form a liquid medicine. This is because Chinese medicinal materials themselves contain a certain amount of water and can continuously absorb water vapor from the air. When the water content of the medicinal materials reaches a certain level, the soluble sugars and inorganic salts contained in the medicinal materials will gradually dissolve to form a liquid medicine. After decoction, the effective ingredients of Chinese medicinal materials will dissolve in water. During the decoction process, high temperature can increase the solubility of the medicinal ingredients, promote the release of the medicinal effect, and make the effective ingredients easier to be absorbed by the human body, thereby exerting the therapeutic effect of the medicine. In order to achieve good therapeutic effects, the decoction process requires flexible control of the decoction time, heat, water volume, and the selection of utensils, so as to better exert the therapeutic effect of Chinese medicine and bring greater benefits to patients.

[0024] Codonopsis pilosula, a Chinese medicine name. It is the dried root of Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf.var.modesta (Nannf.) LTShen or Codonopsis tangshen Oliv. of the Campanulaceae family. It has the effects of tonifying the middle, replenishing qi, promoting body fluid, and benefiting the lungs. It is mainly used to treat spleen and stomach weakness, deficiency of qi and blood, fatigue and weakness, poor appetite and loose stools, internal heat and thirst, chronic diarrhea, prolapse of the anus, asthma and cough due to lung deficiency, shortness of breath and spontaneous sweating, and deficiency of qi and blood.

[0025] Astragalus, a Chinese medicine name. It is the root of Astragalus memeranaceus (Fisch.) Bge. Var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the genus Astragalus in the Leguminosae family. It has the effects of strengthening the spleen and replenishing the middle, raising yang and lifting the sunken, strengthening the body's defense system, promoting urination, and expelling toxins and promoting muscle growth. It is mainly used to treat spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency and spontaneous sweating syndrome, qi and blood deficiency, sores that are difficult to heal or ulcers that are difficult to heal, or sores that are difficult to heal after a long time.

[0026] Chinese Yam, a Chinese medicine name. It is the tuber of the plant Chinese Yam of the Dioscoreaceae family. It has the effects of nourishing the spleen and stomach, promoting fluid and benefiting the lungs, nourishing the kidneys and astringing semen. It is mainly used to treat spleen deficiency diarrhea, chronic dysentery, consumptive cough, thirst, spermatorrhea, leucorrhea, frequent urination, etc.

[0027] Rehmannia glutinosa is a Chinese medicine. It is the root of Rehmannia glutinosa, a plant of the Scrophulariaceae family, which is processed, steamed and dried. It has the effects of nourishing yin and blood, replenishing essence and filling marrow. It is mainly used to treat yin deficiency and blood deficiency, weakness of waist and knees, fatigue cough and bone steaming, spermatorrhea, metrorrhagia, irregular menstruation, thirst, frequent urination, deafness and blurred vision.

[0028] Schisandra chinensis, a Chinese medicine name. It is the dried mature fruit of Schisandra chinensis (Turcz.) Baill. or Schisandra sphenanthera Rehd.et Wils. of the Magnoliaceae family. It has the effects of astringing, strengthening qi and promoting body fluid, and nourishing the kidney and calming the mind. It is mainly used to treat chronic cough, weak asthma, nocturnal emission and spermatorrhea, enuresis and frequent urination, chronic diarrhea, spontaneous sweating, night sweats, thirst due to loss of body fluid, shortness of breath and weak pulse, internal heat and thirst, palpitations and insomnia.

[0029] Morus alba bark, a Chinese medicine name. It is the root bark of the mulberry plant of the Moraceae family. It has the effects of purging the lungs and relieving asthma, promoting water circulation and reducing swelling. It is mainly used to treat lung heat, asthma, cough, vomiting blood, edema, beriberi, and difficulty urinating.

[0030] Danshen, a Chinese medicine name. It is the root of the plant Danshen of the Lamiaceae family. It has the effects of removing blood stasis and relieving pain, promoting blood circulation and menstruation, and clearing the heart and eliminating troubles. It is mainly used to treat angina pectoris, irregular menstruation, dysmenorrhea, amenorrhea, metrorrhagia, leukorrhea, masses, accumulation, abdominal pain due to blood stasis, pain in bones and joints, palpitations and insomnia, and malignant sores and swellings.

[0031] Curcuma aerugionosa Roxb. is a Chinese medicine. It is the rhizome of the ginger plant Curcuma aerugionosa Roxb. It has the effects of promoting qi and removing blood, eliminating accumulation and relieving pain. It is mainly used to treat abdominal distension and pain, lumps, accumulation, indigestion, blood stasis and amenorrhea in women, and pain caused by injuries.

[0032] Scrophularia, a Chinese medicine name. It is the root of Scrophularia, a plant of the Scrophulariaceae family. It has the effects of clearing heat and cooling blood, nourishing yin and reducing fire, eliminating restlessness and detoxification. It is mainly used to treat febrile diseases that damage yin, tongue ulcers, thirst, spots, bone steaming and fatigue fever, restless sleep, spontaneous sweating and night sweats, body fluid damage and constipation, vomiting blood and epistaxis, sore throat, carbuncle, scrofula, fever caused by warm poison, red eyes, diphtheria, and sores.

[0033] Raw oyster, a Chinese medicine name. It is the shell of the long oyster Ostrea gigas Thunberg, Dalian Bay oyster Ostrea talienwhanensis Crosse or Ostrea rivularis Gould of the Ostrea family. It has the effects of astringing yin and suppressing yang, stopping sweating and astringing semen, resolving phlegm and softening hard masses. It is mainly used to treat epilepsy, dizziness, spontaneous sweating, night sweats, spermatorrhea, stranguria, metrorrhagia, leucorrhea, scrofula, and goiter.

[0034] Zhimu, a Chinese medicine name. It is the rhizome of the plant Zhimu of the Liliaceae family. It has the effects of nourishing yin and reducing fire, moistening dryness and lubricating the intestines. It is mainly used to treat irritability and thirst, bone steaming and fatigue fever, lung heat cough, dry stool, and difficulty urinating.

[0035] Scutellaria barbata, a Chinese medicine name. It is the dried aerial part of the Scutellaria barbata plant of the Lamiaceae family. It has the effects of clearing away heat, detoxifying, dispersing blood stasis, stopping bleeding and relieving pain. It is mainly used to treat vomiting blood, epistaxis, hematuria, dysentery, jaundice, sore throat, lung abscess, furuncle, scrofula, sore, cancer, traumatic injury, knife wound and snake bite.

[0036] Beehive, a Chinese medicine name. It is the nest of the fruit wasp Polistes olivaceous (DeGeer), the Japanese long-legged wasp Polistes japonicus Saussure or the heterogastric wasp Parapolybia varia Fabricius. It has the effects of dispelling wind, attacking poison and killing insects. It is mainly used to treat epilepsy, rheumatism, itching of urticaria, mastitis, furuncle, scrofula, hemorrhoid fistula, toothache caused by wind and fire, tinea capitis, and swelling and pain caused by bee stings.

[0037] From the perspective of TCM syndrome differentiation, the formation of lung nodules is mainly related to liver depression and qi stagnation, spleen deficiency and phlegm-dampness. The incidence rate of people with liver depression and spleen deficiency and phlegm-dampness type constitution is higher. The Chinese medicine preparation for treating lung nodules of the present invention is treated through five aspects. First, since lung qi deficiency is the internal cause, qi stagnation and dampness obstruction, and phlegm and blood stasis are the basic pathogenesis of this disease, so it is necessary to tonify the lungs and replenish qi; second, since phlegm and blood stasis are difficult to remove, it is necessary to resolve phlegm and eliminate phlegm; third, since lung nodules are caused by evil qi accumulation in the chest, qi stagnation, phlegm obstruction, food stagnation, and blood stasis, it is necessary to soften and disperse the nodules, promote blood circulation and remove blood stasis; fourth, since there is chronic inflammation in the lungs, it is necessary to clear away heat and detoxify; fifth, since drinking water is stagnant and not dispersed, and because of the conflict between food and drink, the nodules are accumulated under the ribs, distension and pain occur, and symptoms such as shortness of breath and wheezing appear, so it is necessary to eliminate carbuncle, disperse the nodules, and fight cancer. The components of the Chinese medicine preparation for treating pulmonary nodules of the present invention include codonopsis pilosula, astragalus, yam, schisandra chinensis, rehmannia glutinosa, and white mulberry bark, which can invigorate the lungs and replenish qi, relieve cough and resolve phlegm; salvia miltiorrhiza, zedoaria, and raw oyster can soften and disperse nodules, promote blood circulation and remove blood stasis; and Scrophularia ningpoensis, rhizoma anemarrhenae, scutellaria barbata, and honeycomb can clear away heat and detoxify, and relieve swelling and relieve pain. The selected medicinal materials of the present invention are suitable for compatibility, in line with the theories of traditional Chinese medicine and pharmacy and modern pharmacy, the present invention has rigorous compatibility, thoughtful medication, and can play the effects of invigorating qi and activating blood circulation, resolving phlegm and resolving nodules, and invigorating the lungs and kidneys, and can treat both the symptoms and the root causes of pulmonary nodules caused by lung deficiency, phlegm, dampness, and blood stasis agglomeration in the lungs, and the medicine is easy to take, can effectively reduce the burden and pain of the patient, has no side effects, and has stable efficacy, and is worthy of clinical wide promotion and application.

[0038] Beneficial effects of the present invention:

[0039] 1. Compared with the prior art, the Chinese medicine preparation for treating lung nodules of the present invention is compatible with selected medicinal materials of Codonopsis pilosula, Astragalus membranaceus, Chinese yam, Schisandra chinensis, Rehmannia glutinosa, Morus alba, Salvia miltiorrhiza, Curcuma zedoaria, Raw oyster, Scrophularia ningpoensis, Rhizoma Anemarrhenae, Scutellaria barbata, and Beehives, and treats from five aspects, including tonifying the lung and replenishing qi, resolving phlegm and eliminating phlegm, softening and dispersing nodules, clearing away heat and detoxifying, and eliminating carbuncle and dispersing nodules. It treats both the symptoms and the root cause of lung nodules caused by lung deficiency, phlegm, dampness and blood stasis coagulation in the lungs, and is easy to take, can effectively control and shrink lung nodules, reduce the burden and pain of patients, has no side effects, and has stable efficacy.

[0040] 2. Compared with the prior art, the Chinese medicine preparation for treating pulmonary nodules of the present invention is a decoction that is easy to extract and prepare, and has a shorter decoction time, and the decoction time can be controlled within 40 minutes. The present invention adds a carrier with diatomaceous earth as the main raw material, and then is modified by calcium lactate and cellulose acetate, and finally changes the osmotic pressure difference to improve the exchange and evaporation of water vapor during the decoction process, so that the water-soluble effective ingredients of the medicinal materials quickly diffuse outward with the internal water, that is, decoction to produce juice, thereby improving the decoction efficiency and not affecting the activity of the medicinal ingredients. DETAILED DESCRIPTION

[0041] The parameters of the specific chemical substances used in the examples are from the following sources:

[0042] Calcium lactate: CAS number is 814-80-2.

[0043] Cellulose acetate: CAS number is 9004-35-7.

[0044] Diatomaceous earth: 10 mesh, manufacturer is Zhengzhou Shuoyuan Biotechnology Co., Ltd., model is food grade.

[0045] Example 1

[0046] A method for preparing a traditional Chinese medicine preparation for treating pulmonary nodules comprises the following steps:

[0047] (1) Soaking: Put 10g of Codonopsis pilosula, 10g of Astragalus, 10g of Chinese yam, 10g of Rehmannia glutinosa, 6g of Schisandra chinensis, 10g of Morus alba, 10g of Salvia miltiorrhiza, 10g of Curcuma zedoaria, 10g of Scrophularia ningpoensis, 10g of Oyster shell, 10g of Anemarrhena asphodeloides, 10g of Scutellaria barbata, and 10g of Beehive into a container according to the amount, add 500g of water to cover the surface of the medicine by 3 cm, and soak for 20 minutes.

[0048] (2) First decoction: add 500g of water to cover the medicinal surface by 8cm, and perform the first decoction. The first decoction time is 20 minutes. Use high heat before boiling, and use low heat after boiling to obtain the first medicinal juice.

[0049] (3) Secondary decoction: After the juice is taken, the second decoction is performed immediately. The second decoction time is 18 minutes. During the second decoction, 800 g of water is added to cover the medicine surface by 6 cm. The medicine is decocted with high heat before boiling and with low heat after boiling. The second decoction is obtained by taking the juice and combining it with the first decoction to prepare a decoction, thereby obtaining the Chinese medicine preparation for treating pulmonary nodules of the present invention.

[0050] Example 2

[0051] A method for preparing a traditional Chinese medicine preparation for treating pulmonary nodules comprises the following steps:

[0052] (1) Soaking: Put 10g of Codonopsis pilosula, 10g of Astragalus, 10g of Chinese yam, 10g of Rehmannia glutinosa, 6g of Schisandra chinensis, 10g of Morus alba, 10g of Salvia miltiorrhiza, 10g of Curcuma zedoaria, 10g of Scrophularia ningpoensis, 10g of Oyster shell, 10g of Anemarrhena asphodeloides, 10g of Scutellaria barbata, and 10g of Beehive into a container according to the amount, add 500g of water to cover the surface of the medicine by 3 cm, and soak for 20 minutes.

[0053] (2) First decoction: add 500g of water to cover the medicine surface by 8cm, add 50g of diatomaceous earth carrier, and perform the first decoction. The first decoction time is 20 minutes. Use high heat before boiling, and use low heat after boiling to obtain the first decoction.

[0054] (3) Secondary decoction: After the juice is taken, the second decoction is performed immediately. The second decoction time is 18 minutes. During the second decoction, 800 g of water is added to cover the medicine surface by 6 cm. The medicine is decocted with high heat before boiling and with low heat after boiling. The second decoction is obtained by taking the juice and combining it with the first decoction to prepare a decoction, thereby obtaining the Chinese medicine preparation for treating pulmonary nodules of the present invention.

[0055] Example 3

[0056] A method for preparing a traditional Chinese medicine preparation for treating pulmonary nodules comprises the following steps:

[0057] (1) Soaking: Put 10g of Codonopsis pilosula, 10g of Astragalus, 10g of Chinese yam, 10g of Rehmannia glutinosa, 6g of Schisandra chinensis, 10g of Morus alba, 10g of Salvia miltiorrhiza, 10g of Curcuma zedoaria, 10g of Scrophularia ningpoensis, 10g of Oyster shell, 10g of Anemarrhena asphodeloides, 10g of Scutellaria barbata, and 10g of Beehive into a container according to the amount, add 500g of water to cover the surface of the medicine by 3 cm, and soak for 20 minutes.

[0058] (2) First decoction: add 500g of water to cover the medicinal surface by 8cm, add 50g of carrier, and perform the first decoction. The first decoction time is 20 minutes. Use high heat before boiling, and use low heat after boiling to obtain the first medicinal juice.

[0059] (3) Secondary decoction: After the juice is taken, the second decoction is performed immediately. The second decoction time is 18 minutes. During the second decoction, 800 g of water is added to cover the medicine surface by 6 cm. The medicine is decocted with high heat before boiling and with low heat after boiling. The second decoction is obtained by taking the juice and combining it with the first decoction to prepare a decoction, thereby obtaining the Chinese medicine preparation for treating pulmonary nodules of the present invention.

[0060] The preparation method of the carrier in step (2) is as follows:

[0061] 60 g of diatomaceous earth was added to 300 g of a 25 wt % calcium lactate-water solution, and the mixture was stirred at 60° C. for 1 hour, centrifuged and washed with water twice, dried at 70° C., and ground through a 10-mesh sieve to obtain the carrier.

[0062] Example 4

[0063] A method for preparing a traditional Chinese medicine preparation for treating pulmonary nodules comprises the following steps:

[0064] (1) Soaking: Put 10g of Codonopsis pilosula, 10g of Astragalus, 10g of Chinese yam, 10g of Rehmannia glutinosa, 6g of Schisandra chinensis, 10g of Morus alba, 10g of Salvia miltiorrhiza, 10g of Curcuma zedoaria, 10g of Scrophularia ningpoensis, 10g of Oyster shell, 10g of Anemarrhena asphodeloides, 10g of Scutellaria barbata, and 10g of Beehive into a container according to the amount, add 500g of water to cover the surface of the medicine by 3 cm, and soak for 20 minutes.

[0065] (2) First decoction: add 500g of water to cover the medicinal surface by 8cm, add 50g of carrier, and perform the first decoction. The first decoction time is 20 minutes. Use high heat before boiling, and use low heat after boiling to obtain the first medicinal juice.

[0066] (3) Secondary decoction: After the juice is taken, the second decoction is performed immediately. The second decoction time is 18 minutes. During the second decoction, 800 g of water is added to cover the medicine surface by 6 cm. The medicine is decocted with high heat before boiling and with low heat after boiling. The second decoction is obtained by taking the juice and combining it with the first decoction to prepare a decoction, thereby obtaining the Chinese medicine preparation for treating pulmonary nodules of the present invention.

[0067] The preparation method of the carrier in step (2) is as follows:

[0068] M1, add 60g of diatomaceous earth to 300g of 25wt% calcium lactate-water solution, stir at 60°C for 1 hour, centrifuge and wash twice with water, dry at 70°C, grind through a 10-mesh sieve to obtain modified diatomaceous earth;

[0069] M2. Add 50 g of modified diatomaceous earth to 600 g of 0.6 wt% cellulose acetate-methanol solution, stir at room temperature for 1.5 hours, filter, wash the filter cake twice, dry at 45° C., and grind through a 10-mesh sieve to obtain the carrier.

[0070] Test Example 1

[0071] 40 patients who were confirmed by thin-layer chest CT to have low-risk pulmonary nodules and required regular follow-up were screened, and the long-axis diameters of all nodules were 5-8 mm. The patients were randomly divided into 4 groups; a clinical trial was carried out using the Chinese medicine preparation for treating pulmonary nodules obtained by the preparation method of Examples 1-4. One dose was decocted every day and drunk three times in the morning, noon and evening, 120 mL each time, and a course of treatment was 6 weeks. The nodule size was recorded at the 2nd, 4th and 6th weeks, respectively. The average value of the initial nodule long diameter minus the average value of the nodule long diameter at the same level after treatment was the average value of the nodule reduction, which is summarized in Table 1.

[0072] Table 1 Mean values ​​of lung nodule reduction in clinical trials

[0073]

[0074] The raw materials of the Chinese medicine preparation for treating lung nodules in the embodiment of the present invention are selected from Codonopsis pilosula, Astragalus membranaceus, Chinese yam, Rehmannia glutinosa, Schisandra chinensis, Morus alba bark, Salvia miltiorrhiza, Curcuma zedoaria, Scrophularia ningpoensis, Raw oyster, Anemarrhena asphodeloides, Scutellaria barbata, and Beehive. The results of clinical trials show that patients with low-risk lung nodules who are treated with the Chinese medicine preparation for treating lung nodules in Examples 1-4 during the follow-up period begin to show good therapeutic effects in the second week, and the lung nodules can be significantly reduced after 6 weeks of treatment, which can effectively control and reduce the lung nodules.

[0075] Test Example 2

[0076] 500mL of the Chinese medicine preparation for treating pulmonary nodules obtained by the preparation method of Examples 1-4 was concentrated and dried at 80°C until the moisture content of the concentrated paste was 5.0%, and the weight of the effective ingredient was judged by weighing the paste weight; that is, under the same decoction time, decoction temperature and decoction scheme, the greater the weight of the concentrated paste, the easier it is to extract and prepare the Chinese medicine preparation for treating pulmonary nodules in this embodiment, the shorter the decoction time, and the higher the efficiency. Five parallel test groups were set for each embodiment, and the test data were averaged, summarized as shown in Table 2.

[0077] Table 2 Concentrated active ingredients

[0078]

[0079] The decoction schemes of Examples 1 to 4 are all two decoctions after soaking, the first water myrrh height is 8 cm, the decoction time is 20 minutes, the second water myrrh height is 6 cm, and the decoction time is 18 minutes. In Test Example 2, the weight of the concentrated paste is compared to determine which group of examples of Chinese medicine preparations for treating pulmonary nodules are easier to extract and prepare, have a shorter decoction time, and are more efficient under the same decoction time, decoction temperature, and decoction scheme. By comparison, it can be seen that with the different carriers added during decoction and the improvement of the carrier preparation method, it is reflected in the weight of the concentrated effective ingredients, and the addition of the carrier for decoction gradually improves the extraction efficiency of the effective ingredients.

[0080] In Example 1, no carrier is used, and its concentrated effective ingredients are low; in Example 2, diatomaceous earth is introduced as a carrier to improve the decoction efficiency, increase the extraction amount of effective ingredients, and the weight of effective ingredients is increased to 39.06g. Diatomaceous earth has a unique porous structure and high specific surface area, which enables it to provide more contact points during the decoction process, thereby increasing the contact area between the medicinal material and water, and helping to more effectively dissolve and extract the effective ingredients from the medicinal material faster. The pore structure of diatomaceous earth may also help to improve the fluidity of the decoction liquid and promote the dissolution and diffusion of effective ingredients. In Example 3, diatomaceous earth is modified to obtain a carrier, which can further improve the decoction efficiency. The addition of calcium lactate increases the contact area between the bubbles and the decoction medicinal material and water, promotes the effective transfer of heat energy and mass, accelerates the dissolution and diffusion of effective ingredients in the medicinal material, and makes it more effective to extract and concentrate effective ingredients from the medicinal material during the decoction process, thereby increasing the weight of the final concentrated effective ingredients. The carrier of Example 4 is modified by calcium lactate and cellulose acetate, so that the weight of the concentrated effective ingredients is the highest. The carrier added in Example 4 is mainly made of hydrophobic diatomaceous earth. The porous structure and large specific surface area of ​​diatomaceous earth provide more channels and contact points for water molecules and effective ingredients, which helps to accelerate the penetration and diffusion rate of water molecules during the decoction process; and then through the modification of calcium lactate, the macropores are reduced to dense small pores, and the bubbles are refined by physical action, which increases the contact area between the bubbles and the decoction medicinal materials and water, promotes the effective transfer of heat energy and mass, and accelerates the dissolution and diffusion of effective ingredients in the medicinal materials. Cellulose acetate is a derivative of cellulose with high safety, biocompatibility, biodegradability and film-forming properties. The addition of cellulose acetate provides hydrophobic groups for calcium lactate-diatomaceous earth carriers to prevent the dissolution of hydrophilic calcium lactate from affecting the overall efficacy of the Chinese medicine composition. After modification by calcium lactate and cellulose acetate, the diatomaceous earth carrier is finally obtained. During the decoction process, the bubbles generated by boiling usually carry heat and steam to the surface and are released. The role of the diatomaceous earth carrier in Example 4 is to convert large bubbles into a larger number of small bubbles. With the rapid formation and rise of small bubbles, the convection inside the liquid is accelerated, and the diffusion of effective ingredients in the medicinal materials into the liquid is promoted. Because small bubbles are more likely to adhere to the surface of the medicinal materials, the tiny pressure difference they generate when they rupture can have a mild mechanical effect on the medicinal material tissue, which helps to break the cell wall and release the active ingredients inside. As the number of small bubbles increases, the surface area of ​​the bubbles in contact with the liquid and the medicinal materials is increased, thereby improving the efficiency of heat energy and mass transfer.

[0081] Example 4 In the process of decoction of the traditional Chinese medicine preparation for treating pulmonary nodules, a carrier is added by physical means to optimize the heat transfer and mass transfer during the decoction process, and improve the decoction efficiency; and by changing the osmotic pressure difference of the drug liquid interface, the water inside the medicinal material and the dissolved effective ingredients can be promoted to migrate to the outside faster. This change in osmotic pressure is due to the carrier increasing the contact frequency and area between the liquid and the medicinal material, resulting in an increase in the difference in solute concentration inside and outside the medicinal material, thereby accelerating the dissolution and diffusion of the effective ingredients. Ultimately, the traditional Chinese medicine composition can release juice faster, and ultimately increase the weight of the concentrated effective ingredients, making it easier to extract and prepare, with a shorter decoction time and higher efficiency under the same decoction time, decoction temperature and decoction scheme.

[0082] The preferred specific embodiments of the present invention are described in detail above. It should be understood that a person skilled in the art can make many modifications and changes based on the concept of the present invention without creative work. Therefore, any technical solution that can be obtained by a person skilled in the art through logical analysis, reasoning or limited experiments based on the concept of the present invention on the basis of the prior art should be within the scope of protection determined by the claims.

Claims

1. A Chinese medicine preparation for treating pulmonary nodules, characterized in that: The invention is composed of the following components in parts by weight: 8-12 parts of Codonopsis pilosula, 8-12 parts of Astragalus, 8-12 parts of Dioscorea opposita, 8-12 parts of Rehmannia glutinosa, 4-8 parts of Schisandra chinensis, 8-12 parts of Morus alba, 8-12 parts of Salvia miltiorrhiza, 8-12 parts of Curcuma zedoaria, 8-12 parts of Scrophularia ningpoensis, 8-12 parts of Raw Oyster, 8-12 parts of Anemarrhena asphodeloides, 8-12 parts of Scutellaria barbata, 8-12 parts of Honeycomb, and 40-60 parts of a carrier; The preparation method of the carrier is as follows, in parts by weight: M1. Add 40-80 parts of diatomaceous earth to 200-400 parts of 10-30 wt% calcium lactate-water solution, stir at 60-75° C. for 0.5-1 hour, centrifuge and wash with water 2-3 times, dry at 60-70° C., grind through a 5-15 mesh sieve, and obtain modified diatomaceous earth; M2. Add 40-80 parts of modified diatomaceous earth to 400-800 parts of 0.2-1.0 wt% cellulose acetate-methanol solution, stir at room temperature for 1-2 hours, filter, wash the filter cake with water 2-3 times, dry at 40-50° C., and grind through a 5-15 mesh sieve to obtain the carrier.

2. A method for preparing the Chinese medicine preparation for treating pulmonary nodules according to claim 1, characterized in that: The preparation method comprises the following steps: (1) Soaking: put codonopsis pilosula, astragalus, yam, cooked rehmannia, schisandra chinensis, mulberry bark, salvia miltiorrhiza, curcuma, scrophularia ningpoensis, raw oyster, anemarrhena, scutellaria barbata, and honeycomb in a container according to weight, add water to cover the surface of the medicine, and soak; (2) First decoction: Add water to cover the medicinal surface, add the carrier, and perform the first decoction. Use high heat before boiling, and use low heat after boiling to obtain the first medicinal juice. (3) Secondary decoction: After the juice is taken, the second decoction is performed immediately. During the second decoction, water is added to cover the medicinal surface. The decoction is performed over high heat before boiling, and then over low heat after boiling. The second medicinal juice is obtained by taking the juice and combined with the first medicinal juice to form a decoction, thereby obtaining the Chinese medicinal preparation for treating pulmonary nodules of the present invention.

3. The method for preparing the Chinese medicine preparation for treating pulmonary nodules according to claim 2, characterized in that: The soaking time in step (1) is 15-20 minutes.

4. The method for preparing the Chinese medicine preparation for treating pulmonary nodules according to claim 2, characterized in that: The height of the drug surface in step (1) is 2-4 cm.

5. The method for preparing the Chinese medicine preparation for treating pulmonary nodules according to claim 2, characterized in that: The height of the drug surface in step (2) is 5-10 cm.

6. The method for preparing the Chinese medicine preparation for treating pulmonary nodules according to claim 2, characterized in that: The decocting time in step (2) is 15-20 minutes.

7. The method for preparing the Chinese medicine preparation for treating pulmonary nodules according to claim 2, characterized in that: The height of the drug surface in step (3) is 4-8 cm.

8. The method for preparing the Chinese medicine preparation for treating pulmonary nodules according to claim 2, characterized in that: The decocting time in step (3) is 15-20 minutes.

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