Traditional Chinese medicine composition for clearing away lung-heat as well as preparation method and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for clearing away lung-heat and a preparation method and application thereof. The traditional Chinese medicine composition provided by the invention comprises traditional Chinese medicines such as scutellaria baicalensis, cape jasmine, golden cypress, radix sophorae flavescentis, radices trichosanthis, rhizoma anemarrhenae, platycodon grandiflorum and radix peucedani, effective components are extracted and separated through modern science and technology to obtain an effective extract, the curative effect is exerted through a corresponding proportion, and pharmacodynamic research shows that the traditional Chinese medicine composition has the effect of obviously reducing acute inflammation of mice and has a remarkable curative effect on acute inflammation of mice. The lung tissue inflammatory factor infiltration is improved, so that the effects of clearing lung heat and treating pulmonary nodules are achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for clearing lungs, and a preparation method and application thereof. Background Art

[0002] Pulmonary nodules refer to focal round dense shadows of various sizes, with clear or blurred edges and a diameter of less than or equal to 3 cm on lung images. With the continuous development of medical imaging technology, the detection rate of pulmonary nodules is getting higher and higher.

[0003] The etiology of pulmonary nodules is complex and may be related to infection, genetics, environment, immunity and other factors. For example, acute inflammatory infection may cause pulmonary nodules. At present, the treatment of pulmonary nodules mainly includes follow-up observation, surgical resection, ablation therapy, etc., but these methods have certain limitations. Traditional Chinese medicine has unique advantages in the treatment of pulmonary nodules. According to traditional Chinese medicine, pulmonary nodules belong to the categories of "lung accumulation" and "symptoms". The main causes of the disease are insufficient positive energy, invasion of exogenous evil, stagnation of lung qi, and mutual binding of phlegm and blood stasis. The lung is a delicate organ, likes moisture and hates dryness, and cannot tolerate cold and heat. When exogenous evil invades the lungs, lung qi stagnation, abnormal distribution of body fluids, and phlegm gathers; or when positive energy is insufficient, qi and blood flow poorly, and blood stasis is generated endogenously. Phlegm and blood stasis are mutually bound and knotted in the lung network to form pulmonary nodules.

[0004] Chinese medicines that clear the lungs and suppress fire have shown certain potential in the treatment of lung nodules. This type of Chinese medicine has certain potential in the treatment of lung nodules mainly through the effects of clearing heat and purging fire, moistening the lungs and relieving cough, and resolving phlegm and dispersing nodules. Clearing heat and purging fire can purify the lung environment and create good conditions for subsequent treatment. The effect of moistening the lungs and relieving cough can help relieve the cough symptoms that may occur in patients with lung nodules and reduce the pain of patients. At the same time, by moisturizing the lungs, the physiological function of the lungs can be improved and its own repair ability can be enhanced. Resolving phlegm and dispersing nodules is one of the core functions of lung nodules. It can dissolve the accumulation of phlegm in the lungs, dissipate the nodules, and promote their size reduction.

[0005] Other studies have found that traditional Chinese medicines that clear the lungs and suppress fire combined with other traditional Chinese medicines or Western medicines can play a more significant therapeutic role in the treatment of lung nodules. Combination therapy can combine the advantages of different drugs and treat lung nodules from multiple aspects. For example, combined use with traditional Chinese medicines that have the effect of promoting blood circulation and removing blood stasis can further improve blood circulation in the lungs and promote the absorption of nodules; combined with Western medicines, it may enhance the body's immunity and reduce the risk of malignant transformation of lung nodules. This provides new ideas and methods for the treatment of lung nodules and brings more hope to patients.

[0006] In conclusion, Chinese medicines for clearing the lungs and suppressing fire have important value and potential in the treatment of pulmonary nodules, and are worthy of further in-depth research and promotion and application. However, there are still some shortcomings in the current research on the treatment of pulmonary nodules with Chinese medicines for clearing the lungs and suppressing fire, such as the small sample size of clinical research and the lack of in-depth research on the mechanism of action. An important factor limiting clinical application is that the preparation process of Chinese medicine prescriptions is mostly backward and the dosage of the medicine is large. Therefore, it is of great significance to further develop Chinese medicines for clearing the lungs, improve the efficacy of the treatment of pulmonary nodules, and reduce the dosage. Summary of the invention

[0007] In view of this, the technical problem to be solved by the present invention is to provide a lung-clearing Chinese medicine composition and a preparation method and application thereof.

[0008] The present invention provides a Chinese medicine composition, comprising the following raw materials in parts by weight:

[0009]

[0010] The present invention rationally groups the medicinal materials and adopts a suitable extraction process for each group of drugs, so that the prepared Chinese medicine composition can have a good lung-clearing function. In the composition, the mass fraction of each extract has been screened multiple times, for example, in the embodiment:

[0011] The traditional Chinese medicine composition consists of 3 parts of traditional Chinese medicine extract A, 4 parts of traditional Chinese medicine extract B, 6 parts of traditional Chinese medicine extract C and 2 parts of traditional Chinese medicine extract D.

[0012] Alternatively, the traditional Chinese medicine composition consists of 3 parts of traditional Chinese medicine extract A, 5 parts of traditional Chinese medicine extract B, 8 parts of traditional Chinese medicine extract C and 4 parts of traditional Chinese medicine extract D.

[0013] Alternatively, the traditional Chinese medicine composition consists of 3 parts of traditional Chinese medicine extract A, 6 parts of traditional Chinese medicine extract B, 10 parts of traditional Chinese medicine extract C and 6 parts of traditional Chinese medicine extract D.

[0014] Alternatively, the traditional Chinese medicine composition consists of 5 parts of traditional Chinese medicine extract A, 4 parts of traditional Chinese medicine extract B, 8 parts of traditional Chinese medicine extract C and 6 parts of traditional Chinese medicine extract D.

[0015] Alternatively, the traditional Chinese medicine composition consists of 5 parts of traditional Chinese medicine extract A, 5 parts of traditional Chinese medicine extract B, 10 parts of traditional Chinese medicine extract C and 2 parts of traditional Chinese medicine extract D.

[0016] Alternatively, the traditional Chinese medicine composition consists of 5 parts of traditional Chinese medicine extract A, 6 parts of traditional Chinese medicine extract B, 6 parts of traditional Chinese medicine extract C and 4 parts of traditional Chinese medicine extract D.

[0017] Alternatively, the traditional Chinese medicine composition consists of 7 parts of traditional Chinese medicine extract A, 4 parts of traditional Chinese medicine extract B, 10 parts of traditional Chinese medicine extract C and 4 parts of traditional Chinese medicine extract D.

[0018] Alternatively, the traditional Chinese medicine composition consists of 7 parts of traditional Chinese medicine extract A, 5 parts of traditional Chinese medicine extract B, 6 parts of traditional Chinese medicine extract C and 6 parts of traditional Chinese medicine extract D.

[0019] Alternatively, the traditional Chinese medicine composition consists of 7 parts of traditional Chinese medicine extract A, 6 parts of traditional Chinese medicine extract B, 8 parts of traditional Chinese medicine extract C and 2 parts of traditional Chinese medicine extract D.

[0020] In the present invention, the Chinese medicine extract A is prepared by alcohol extraction of Phellodendron, Sophora flavescens and Peucedanum peucedanum, and purification with macroporous resin. Preliminary experiments show that Phellodendron, Sophora flavescens and Peucedanum peucedanum are more suitable for alcohol extraction. After further purification with macroporous resin, the resulting precipitate contains a large amount of alkaloids, and the impurity content is greatly reduced, thereby improving the anti-inflammatory and lung-clearing effect. In the embodiment of the present invention, the mass ratio of Phellodendron, Sophora flavescens and Peucedanum peucedanum in Chinese medicine extract A is optimized, and excellent effects can be obtained within the range of (4-6): (3-5): (3-5), but preferably, the mass ratio of Phellodendron, Sophora flavescens and Peucedanum peucedanum in Chinese medicine extract A is 5:4:4.

[0021] The present invention screens and optimizes the extraction parameters of Chinese herbal medicine extract A. Compared with other extraction methods and parameters, the conditions described in the embodiment are more conducive to the lung clearing function. Preferably, the preparation of the Chinese herbal medicine extract A comprises: extracting Phellodendron chinense, Sophora flavescens and Peucedanum chinense with an ethanol solution, concentrating and applying to an AB-8 macroporous resin column, washing with water and 10% ethanol solution in sequence, eluting with 50% ethanol solution, adjusting the pH value of the eluent to 0.5-0.7, and collecting the precipitate to obtain the Chinese herbal medicine extract A.

[0022] Preferably, the preparation of the Chinese medicine extract A includes: extracting 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens and 4 parts of Peucedanum peucedanum with 70% ethanol solution, concentrating the extract and applying it to an AB-8 macroporous resin column, washing with 2 column volumes of water and 4 column volumes of 10% ethanol solution in sequence, eluting with 5 column volumes of 50% ethanol solution, adjusting the pH value of the eluent to 0.5-0.7, and collecting the precipitate to obtain the Chinese medicine extract A.

[0023] More preferably, in the extraction step of the 70% ethanol solution, the mass of the ethanol solution is 10 times the mass of the medicinal material. The number of extractions is 2 times, and the extraction conditions include: 2 hours for the first time and 1 hour for the second time. After the extracts are combined, the extracts are concentrated to 1 mL of medicinal solution per 0.05 parts of Phellodendron crude drug. After the eluate is applied to a macroporous resin column, it is concentrated to an extract with a density of 1.05 to 1.10. After adjusting the pH value, the precipitate is collected after standing for 12 hours. Wash with water until neutral, and freeze-dry to obtain Chinese medicine extract A.

[0024] In the present invention, the Chinese medicine extract B is obtained by alcohol extraction of scutellaria baicalensis, gardenia jasminoides and trichosanthes. Preliminary experiments show that scutellaria baicalensis, gardenia jasminoides and trichosanthes are more suitable for extraction with alcohol, and the active ingredients contained in the obtained products are mainly total flavonoids. After optimizing the extraction process and parameters, the obtained extract B can have better anti-inflammatory and lung-clearing effects. In the embodiment of the present invention, the mass ratio of scutellaria baicalensis, gardenia jasminoides and trichosanthes in the Chinese medicine extract B is optimized. Preferably, the mass ratio of scutellaria baicalensis, gardenia jasminoides and trichosanthes is (4-6): (4-6): (2-4). More preferably, the mass ratio of scutellaria baicalensis, gardenia jasminoides and trichosanthes is 5:5:3.

[0025] The present invention screens and optimizes the extraction parameters of the Chinese medicine extract B. Compared with other extraction methods and parameters, the conditions described in the embodiment are more conducive to the lung clearing function of the composition. Preferably, the preparation of the Chinese medicine extract B comprises: extracting 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides and 3 parts of Radix Trichosanthis with 60% ethanol solution, recovering ethanol, and drying to obtain the Chinese medicine extract B.

[0026] More preferably, in the 60% ethanol aqueous solution extraction step, the mass of the ethanol aqueous solution is 20 times the sum of the masses of Scutellaria baicalensis, Gardenia jasminoides and Radix Trichosanthis. The extraction conditions of the ethanol aqueous solution include: extracting twice, each time for 1 hour. After recovering the ethanol, concentrating to a relative density of 1.15 to 1.20, and then freeze-drying to obtain the Chinese medicine extract B.

[0027] In the present invention, the Chinese medicine extract C is obtained by enzymatically hydrolyzing Rhizoma Anemarrhenae and Radix Trichosanthis and then ultrasonically extracting them.

[0028] In the previous experiments, the effect of extracting Anemarrhena and Radix Trichosanthis after enzymatic hydrolysis was significantly better than other processes. In the extracted extract C, the main active ingredient is polysaccharide. In the experiment, the mass ratio of Anemarrhena and Radix Trichosanthis in the traditional Chinese medicine extract C was optimized and improved, and the effect was better in the range of (8-12): (8-12). As a preferred method, the mass ratio of Anemarrhena and Radix Trichosanthis in the traditional Chinese medicine extract C is 10:10.

[0029] The extraction parameters of the Chinese herbal extract C recorded in the present invention have been optimized. Compared with other extraction methods and parameters, the conditions recorded in the embodiment can be more conducive to the lung clearing function. Preferably, in the present invention, the preparation of the Chinese herbal extract C includes: mixing Rhizoma Anemarrhenae, Radix Trichosanthis and water, adding cellulase and pectinase for enzymolysis, ultrasonic extraction, and concentrating and drying the extract to obtain the Chinese herbal extract C.

[0030] Preferably, the preparation of the Chinese medicine extract C comprises: mixing 10 parts of Anemarrhena asphodeloides, 10 parts of Radix Trichosanthis and 10 times the amount of water, adding 0.1 parts of cellulase and 0.15 parts of pectinase, performing enzymatic hydrolysis at pH 5.5 and 50°C for 90 minutes, performing ultrasonic extraction for 30 minutes, concentrating and drying the extract, and obtaining the Chinese medicine extract C.

[0031] More preferably, in the preparation of the Chinese herbal extract C, citric acid is used to adjust the pH value. The conditions of the ultrasonic extraction include room temperature, power 250w, and ultrasonic extraction for 30 minutes. The Chinese herbal extract C is obtained by concentrating to a relative density of 1.15 to 1.20 and freeze-drying.

[0032] In the present invention, the Chinese medicine extract D is prepared by water extraction of Scutellaria baicalensis, Gardenia jasminoides and Platycodon grandiflorum. The main active ingredient in the Chinese medicine extract D is total saponins. Compared with other extraction methods, the water extraction method is simpler, and the obtained extract D shows higher physiological activity in the experiment. In the embodiment of the present invention, the mass ratio of Scutellaria baicalensis, Gardenia jasminoides and Platycodon grandiflorum in the Chinese medicine extract D is optimized, and excellent effects can be obtained within the range of (8-12):(4-6):(4-6), but preferably, the mass ratio of Scutellaria baicalensis, Gardenia jasminoides and Platycodon grandiflorum in the Chinese medicine extract D is 10:5:5.

[0033] The present invention screens and optimizes the extraction parameters of the Chinese medicine extract D. Compared with other extraction methods and parameters, the conditions described in the embodiment are more conducive to the lung clearing function. In the present invention, the preparation of the Chinese medicine extract D includes: extracting Scutellaria baicalensis, Gardenia jasminoides, and Platycodon grandiflorum with water, concentrating the extract, adjusting the pH value to 2, and drying the precipitate to obtain the Chinese medicine extract D.

[0034] Preferably, the preparation of the Chinese herbal extract D comprises: extracting 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum with 10 times the mass of water, concentrating the extract, adjusting the pH value to 2, and drying the precipitate to obtain the Chinese herbal extract D.

[0035] More preferably, in the step of water extraction, the extraction conditions include reflux extraction twice, each time for 1 hour. The extract is concentrated to a relative density of 1.05 to 1.10, and the pH value condition is hydrochloric acid. After adjusting the hydrochloric acid, it is kept warm at 80°C for 2 hours to obtain a precipitate. After the precipitate is washed with water to neutrality, it is concentrated to an extract with a relative density of 1.15 to 1.20, and then freeze-dried to obtain a Chinese medicine extract D.

[0036] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in preparing a medicine for clearing the lungs and / or treating lung nodules.

[0037] In the present invention, the lung clearing includes: alleviating acute inflammation and / or improving the infiltration of inflammatory factors in lung tissue.

[0038] The present invention also provides a medicine for clearing the lungs and / or treating lung nodules, which comprises a pharmaceutically acceptable adjuvant and the above-mentioned traditional Chinese medicine composition.

[0039] The dosage form of the drug of the present invention includes but is not limited to tablets, granules, soft capsules, hard capsules, oral liquids, pills or syrups.

[0040] The medicine of the present invention further comprises pharmaceutically acceptable excipients, which include at least one of fillers, lubricants, disintegrants, adhesives, suspending agents, emulsifiers, preservatives, flavoring agents, colorants, transdermal enhancers, antioxidants, solubilizers, cosolvents, sustained-release agents, controlled-release agents, enteric materials, coating materials, osmotic pressure regulators, pH regulators, stabilizers, and adsorbents.

[0041] The medicine of the present invention may also include other medicines with lung-clearing, anti-inflammatory or nodule-improving effects. The Chinese medicine composition and other therapeutic agents may exist independently of each other or may be mixed, and the present invention does not limit this.

[0042] The other drugs with lung clearing, anti-inflammatory or nodule improvement effects include: at least one of amoxicillin, azithromycin, cefixime, levofloxacin, moxifloxacin, roxithromycin, clarithromycin, aztreonam, meropenem, imipenem, piperacillin-tazobactam, cefoperazone-sulbactam, dexamethasone, methylprednisolone, prednisone, ibuprofen, acetaminophen, aspirin, ambroxol, and bromhexine.

[0043] In the present invention, the mass fraction of the traditional Chinese medicine composition is 50% to 80%.

[0044] Furthermore, the present invention also provides a method for preparing the drug as described above, which comprises mixing Chinese herbal extract A, Chinese herbal extract B, Chinese herbal extract C, Chinese herbal extract D and pharmaceutically acceptable excipients to prepare the drug.

[0045] The present invention has clearly described the above-mentioned Chinese herbal extract A, Chinese herbal extract B, Chinese herbal extract C and Chinese herbal extract D, which will not be repeated here. The present invention does not limit the specific mixing method, which is well known to those skilled in the art.

[0046] The present invention also provides a method for preventing and treating lung inflammation and improving lung nodules using the above-mentioned drug, which comprises administering the above-mentioned drug to a subject.

[0047] The administration method of the drug includes but is not limited to oral administration.

[0048] In the present invention, the subject of stomach clearing or preventing and treating lung nodules is a human or a mammal, and the mammal includes bovines, equines, ovines, porcines, canines, felines, rodents, and primates.

[0049] The Chinese medicine composition provided by the present invention comprises Chinese medicines such as scutellaria baicalensis, gardenia jasmine, phellodendron chinense, sophora flavescens, root of trichosanthes, rhizoma anemarrhenae, platycodon grandiflorum, and peucedanum peucedanum. The effective ingredients are extracted and separated by modern scientific technology to obtain effective extracts, and the therapeutic effects are exerted through corresponding proportions. Pharmacodynamic studies have shown that the Chinese medicine composition has the effect of significantly reducing acute inflammation in mice and improving the infiltration of inflammatory factors in lung tissue, thereby achieving the effect of clearing lung heat and treating lung nodules. DETAILED DESCRIPTION

[0050] The present invention provides a Chinese medicine composition for clearing the lungs, a preparation method thereof, and an application thereof in the preparation of a medicine for preventing and treating lung nodules. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the method and application of this article without departing from the content, spirit and scope of the present invention to realize and apply the technology of the present invention.

[0051] Unless otherwise defined herein, scientific and technical terms related to the present invention shall have the meanings understood by those of ordinary skill in the art.

[0052] In this application, the term "and / or" describes the association relationship of associated objects, indicating that there may be three relationships. For example, A and / or B may represent: A exists alone, A and B exist at the same time, and B exists alone. A and B may be singular or plural.

[0053] In this application, "at least one" means one or more, "more than one" means two or more. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single or plural items.

[0054] The terms "include", "comprising" and "having" are used interchangeably herein and are intended to indicate the inclusiveness of the solution, meaning that the solution may have other elements in addition to the listed elements. At the same time, it should be understood that the use of "include", "comprising" and "having" descriptions herein also provides a "consisting of..." solution.

[0055] The test materials used in the present invention are all common commercial products and can be purchased on the market. Among them:

[0056] Scutellaria baicalensis is the dried root of Scutellaria baicalensis Georgi, a plant of the Lamiaceae family. It is dug in spring and autumn, the fibrous roots and mud are removed, the rough skin is removed after sun exposure, and then dried. [Nature and flavor] Bitter, cold. [Meridian] Enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. [Functions and indications] Clears heat and dries dampness, purges fire and detoxifies, stops bleeding, and stabilizes the fetus. It is used for damp-heat, summer-heat chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung heat cough, high fever and thirst, blood heat vomiting and bleeding, carbuncle swelling and sore, and fetal movement disorder.

[0057] Gardenia is the dried mature fruit of Gardenia jasminoides Ellis, a plant of the Rubiaceae family. It is harvested from September to November when the fruit is ripe and red and yellow. The fruit stems and impurities are removed, steamed until steaming or slightly scalded in boiling water, taken out, and dried. [Nature and flavor] Bitter, cold. [Meridian] Entries to the heart, lung, and triple burner meridians. [Functions and indications] Fruit: purging fire and relieving restlessness, clearing heat and promoting urination, cooling blood and detoxifying. It is used for restlessness due to fever, jaundice and red urine, bloody stranguria and painful pain, vomiting and bleeding due to blood heat, red and swollen eyes, and fire poison sores; external treatment of sprains and contusions.

[0058] Phellodendron chinense Schneid. or Phellodendron amurense Rupr. of the Rutaceae family is a dried bark. The former is commonly known as Sichuan Phellodendron, and the latter is commonly known as Guan Phellodendron. After peeling the bark, remove the rough skin and dry it in the sun. [Nature and flavor] Bitter, cold. [Meridian] Enters the kidney and bladder meridians. [Functions and indications] Clears heat and dries dampness, purges fire and removes steam, detoxifies and treats sores. It is used for damp-heat diarrhea, jaundice, leucorrhea, hot stranguria, beriberi, impotence, bone steaming and fatigue fever, night sweats, spermatorrhea, sores, swelling and poison, eczema and itching. Salted Phellodendron nourishes yin and reduces fire. It is used for yin deficiency and excessive fire, night sweats and bone steaming.

[0059] Sophora flavescens is the dried root of Sophora flavescens Ait. of the Leguminosae family. It is collected in spring and autumn, the root head and small branches are removed, washed and dried, or sliced ​​and dried while fresh. [Nature and flavor] Bitter, cold. [Meridian] Heart, liver, stomach, large intestine, bladder meridian. [Functions and indications] Clearing away heat and dampness, killing insects, diuresis. It is used for heat dysentery, blood in stool, jaundice and urine retention, red and white vaginal discharge, swelling and itching of the genitals, eczema, wet sores, itchy skin, scabies and leprosy; external treatment of trichomonas vaginitis.

[0060] Radix Trichosanthis is the dried root of Trichosanthes kirilowii Maxim. or Trichosanthes rosthornii Herms of the Cucurbitaceae family. [Nature and flavor] Sweet, slightly bitter, slightly cold. [Meridian] Enters the lung and stomach meridians. [Functions and indications] Clears away heat and promotes the production of body fluid, reduces swelling and discharges pus. It is used for fever, thirst, lung heat and dry cough, internal heat and thirst, sores and swelling.

[0061] Zhimu is the dried rhizome of Anemarrhena asphodeloides Bunge., a plant of the Liliaceae family. It is dug up in spring and autumn, the fibrous roots and sand are removed, and it is dried in the sun. It is commonly known as Hairy Zhimu; or the outer skin is removed and dried in the sun. [Nature and flavor] Bitter, sweet, and cold. [Meridian] It enters the lung, stomach, and kidney meridians. [Functions and indications] It clears away heat and purges fire, promotes the production of body fluids and moisturizes dryness. It is used for exogenous febrile diseases, high fever and thirst, dry cough due to lung heat, hot flashes due to bone steaming, internal heat and thirst, and constipation due to dry intestines.

[0062] Platycodon grandiflorum (Jacq.) A.DC. is a plant of the Campanulaceae family. It is harvested in spring and autumn, washed, the fibrous roots are removed, the skin is peeled while fresh or not, and dried. [Nature and flavor] Bitter, pungent, flat. [Meridian] Enters the lung meridian. [Functions and indications] Clear the lungs, relieve sore throat, eliminate phlegm, and discharge pus. It is used for cough with a lot of phlegm, chest tightness, sore throat, hoarseness, lung abscess with spitting pus, and pus-forming sores that do not break.

[0063] Peucedanum praeruptorum Dunn or Peucedanum decursivum Maxim. are dried roots of the plants of the Apiaceae family. They are dug from winter to the next spring when the stems and leaves wither or when the flower stems have not yet emerged. The fibrous roots are removed, washed, and dried in the sun or at low temperature. [Nature and flavor] Bitter, pungent, slightly cold. [Meridian] Enters the lung meridian. [Functions and indications] Disperse wind and clear heat, descend qi and resolve phlegm. It is used for cough with wind-heat and excessive sputum, wheezing due to phlegm-heat, and yellow and thick sputum.

[0064] The numerical ranges and parameters involved in the present invention have been presented in the specific embodiments as accurately as possible. However, any numerical value inherently inevitably contains standard deviations due to individual testing methods. Therefore, unless otherwise explicitly stated, it should be understood that all numerical ranges or specific data used in this disclosure may have certain reasonable deviations within a certain range, for example: within ±10%, ±5%, ±1% or ±0.5%.

[0065] Some cases are recorded in the embodiments and comparative examples of the present invention. The embodiments show some implementations of the present invention. However, this does not mean that the effects of the present invention can only be achieved in these cases. In fact, any concentration of each component between the two endpoint values ​​shown in the embodiments can achieve a good lung clearing effect, and the best case is Example 6. In addition, many attempts were made during the research and development process, such as using different extraction processes, different extraction parameters, and different ratios, but the effects of these attempts were not as good as those of Example 6, which will not be repeated here.

[0066] It should be understood that in the various embodiments of the present application, the size of the serial numbers of the above-mentioned processes does not mean the order of execution, some or all of the steps can be executed in parallel or sequentially, and the execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application.

[0067] The present invention will be further described below in conjunction with embodiments:

[0068] Embodiment 1:

[0069] Lung-clearing effect of Chinese herbal extract A for the treatment of lung nodules:

[0070] Take 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens, and 4 parts of Peucedanum peucedanum, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, and concentrate the medicinal solution (concentrated to 0.05 parts of Phellodendron amurense crude drug / ml) on an AB-8 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, recover the ethanol, and concentrate it to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH to 0.5-0.7, let it stand for 12 hours, centrifuge to obtain the precipitate, wash it with water until it is neutral, and freeze-dry it to obtain a traditional Chinese medicine extract A for the treatment of lung nodules with lung-clearing effect.

[0071] Lung-clearing effect of Chinese herbal extract B for the treatment of lung nodules:

[0072] Take 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 3 parts of Radix Trichosanthis, add 20 times the amount of 60% ethanol, extract twice, each time for 1 hour, combine the extracts, filter, recover the ethanol, concentrate the extract with a relative density of 1.15-1.20, freeze-dry, and obtain the traditional Chinese medicine extract B with lung-clearing effect for treating lung nodules.

[0073] Lung-clearing effect of Chinese herbal extract C for the treatment of lung nodules:

[0074] Take 10 parts of Anemarrhena asphodeloides and 10 parts of Radix Trichosanthis, grind them into fine powder, add 10 times the amount of water, use citric acid to adjust the pH to 5.5, add 0.1 parts of cellulase and 0.15 parts of pectinase, maintain constant temperature enzymolysis at 50°C for 90 minutes, ultrasonically extract for 30 minutes, filter, concentrate the extract with a relative density of 1.15-1.20, and freeze-dry to obtain Chinese medicine extract C with lung-clearing effect for treating lung nodules.

[0075] Lung-clearing effect of Chinese herbal extract for the treatment of lung nodules D:

[0076] Take 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum, add 10 times the amount of water, reflux extraction twice, 1 hour each time, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80°C for 2 hours, let stand, precipitate, filter, wash the precipitate with water until neutral, concentrate to an extract with a relative density of 1.15-1.20, freeze-dry, and use Chinese medicine extract D for the treatment of lung nodules with lung-clearing effect.

[0077] Take each extract according to the following mass fractions:

[0078] 3 servings of Chinese herbal extract A for lung clearing and treatment of lung nodules

[0079] 4 servings of Chinese herbal extract B for lung clearing and treatment of lung nodules

[0080] 6 servings of Chinese herbal extract C for lung clearing and treatment of lung nodules

[0081] 2 servings of Chinese herbal extract D for lung clearing and treatment of lung nodules

[0082] Mix evenly according to the above proportions, add appropriate amount of dextrin, and make 1000 tablets.

[0083] Embodiment 2:

[0084] Lung-clearing effect of Chinese herbal extract A for the treatment of lung nodules:

[0085] Take 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens, and 4 parts of Peucedanum peucedanum, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the medicinal solution (concentrated to 0.05 parts of Phellodendron amurense crude drug / ml), apply it to an AB-8 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, recover the ethanol, concentrate it to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH to 0.5-0.7, let it stand for 12 hours, centrifuge to obtain the precipitate, wash it with water until it is neutral, and freeze-dry it to obtain a traditional Chinese medicine extract A for the treatment of lung nodules with lung clearing effect.

[0086] Lung-clearing effect of Chinese herbal extract B for the treatment of lung nodules:

[0087] Take 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 3 parts of Radix Trichosanthis, add 20 times the amount of 60% ethanol, extract twice, each time for 1 hour, combine the extracts, filter, recover the ethanol, concentrate the extract with a relative density of 1.15-1.20, freeze-dry, and obtain the traditional Chinese medicine extract B with lung-clearing effect for treating lung nodules.

[0088] Lung-clearing effect of Chinese herbal extract C for the treatment of lung nodules:

[0089] Take 10 parts of Anemarrhena asphodeloides and 10 parts of Radix Trichosanthis, grind them into fine powder, add 10 times the amount of water, use citric acid to adjust the pH to 5.5, add 0.1 parts of cellulase and 0.15 parts of pectinase, maintain constant temperature enzymolysis at 50°C for 90 minutes, ultrasonically extract for 30 minutes, filter, concentrate the extract with a relative density of 1.15-1.20, and freeze-dry to obtain Chinese medicine extract C with lung-clearing effect for treating lung nodules.

[0090] Lung-clearing effect of Chinese herbal extract for the treatment of lung nodules D:

[0091] Take 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum, add 10 times the amount of water, extract twice, 1 hour each time, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80℃ for 2 hours, let stand, precipitate, filter, wash the precipitate with water until neutral, concentrate to an extract with a relative density of 1.15-1.20, freeze-dry, and use Chinese medicine extract D for the treatment of lung nodules with lung-clearing effect.

[0092] Take each extract according to the following mass fractions:

[0093] 3 servings of Chinese herbal extract A for lung clearing and treatment of lung nodules

[0094] 5 servings of Chinese herbal extract B for lung clearing and treatment of lung nodules

[0095] 8 servings of Chinese herbal extract C for lung clearing and treatment of lung nodules

[0096] 4 servings of Chinese herbal extract D for lung clearing and treatment of lung nodules

[0097] Mix evenly according to the above proportions, add appropriate amount of dextrin, and make 1000 tablets.

[0098] Embodiment 3:

[0099] Lung-clearing effect of Chinese herbal extract A for the treatment of lung nodules:

[0100] Take 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens, and 4 parts of Peucedanum peucedanum, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the medicinal solution (concentrated to 0.05 parts of Phellodendron amurense crude drug / ml), apply it to an AB-8 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, recover the ethanol, concentrate it to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH to 0.5-0.7, let it stand for 12 hours, centrifuge to obtain the precipitate, wash it with water until it is neutral, and freeze-dry it to obtain a traditional Chinese medicine extract A for the treatment of lung nodules with lung clearing effect.

[0101] Lung-clearing effect of Chinese herbal extract B for the treatment of lung nodules:

[0102] Take 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 3 parts of Radix Trichosanthis, add 20 times the amount of 60% ethanol, extract twice, each time for 1 hour, combine the extracts, filter, recover the ethanol, concentrate the extract with a relative density of 1.15-1.20, freeze-dry, and obtain the traditional Chinese medicine extract B with lung-clearing effect for treating lung nodules.

[0103] Lung-clearing effect of Chinese herbal extract C for the treatment of lung nodules:

[0104] Take 10 parts of Anemarrhena asphodeloides and 10 parts of Radix Trichosanthis, grind them into fine powder, add 10 times the amount of water, use citric acid to adjust the pH to 5.5, add 0.1 parts of cellulase and 0.15 parts of pectinase, maintain constant temperature enzymolysis at 50°C for 90 minutes, ultrasonically extract for 30 minutes, filter, concentrate the extract with a relative density of 1.15-1.20, and freeze-dry to obtain Chinese medicine extract C with lung-clearing effect for treating lung nodules.

[0105] Lung-clearing effect of Chinese herbal extract for the treatment of lung nodules D:

[0106] Take 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum, add 10 times the amount of water, extract twice, 1 hour each time, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80℃ for 2 hours, let stand, precipitate, filter, wash the precipitate with water until neutral, concentrate to an extract with a relative density of 1.15-1.20, freeze-dry, and use Chinese medicine extract D for the treatment of lung nodules with lung-clearing effect.

[0107] Take each extract according to the following mass fractions:

[0108] 3 servings of Chinese herbal extract A for lung clearing and treatment of lung nodules

[0109] 6 servings of Chinese herbal extract B for lung clearing and treatment of lung nodules

[0110] 10 servings of Chinese herbal extract C for lung clearing and treatment of lung nodules

[0111] 6 servings of Chinese herbal extract D for lung clearing and treatment of lung nodules

[0112] Mix evenly according to the above proportions, add appropriate amount of dextrin, and make 1000 tablets.

[0113] Embodiment 4:

[0114] Lung-clearing effect of Chinese herbal extract A for the treatment of lung nodules:

[0115] Take 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens, and 4 parts of Peucedanum peucedanum, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the medicinal solution (concentrated to 0.05 parts of Phellodendron amurense crude drug / ml), apply it to an AB-8 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, recover the ethanol, concentrate it to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH to 0.5-0.7, let it stand for 12 hours, centrifuge to obtain the precipitate, wash it with water until it is neutral, and freeze-dry it to obtain a traditional Chinese medicine extract A for the treatment of lung nodules with lung clearing effect.

[0116] Lung-clearing effect of Chinese herbal extract B for the treatment of lung nodules:

[0117] Take 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 3 parts of Radix Trichosanthis, add 20 times the amount of 60% ethanol, extract twice, each time for 1 hour, combine the extracts, filter, recover the ethanol, concentrate the extract with a relative density of 1.15-1.20, freeze-dry, and obtain the traditional Chinese medicine extract B with lung-clearing effect for treating lung nodules.

[0118] Lung-clearing effect of Chinese herbal extract C for the treatment of lung nodules:

[0119] Take 10 parts of Anemarrhena asphodeloides and 10 parts of Radix Trichosanthis, grind them into fine powder, add 10 times the amount of water, use citric acid to adjust the pH to 5.5, add 0.1 parts of cellulase and 0.15 parts of pectinase, maintain constant temperature enzymolysis at 50°C for 90 minutes, ultrasonically extract for 30 minutes, filter, concentrate the extract with a relative density of 1.15-1.20, and freeze-dry to obtain Chinese medicine extract C with lung-clearing effect for treating lung nodules.

[0120] Lung-clearing effect of Chinese herbal extract for the treatment of lung nodules D:

[0121] Take 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum, add 10 times the amount of water, extract twice, 1 hour each time, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80℃ for 2 hours, let stand, precipitate, filter, wash the precipitate with water until neutral, concentrate to an extract with a relative density of 1.15-1.20, freeze-dry, and use Chinese medicine extract D for the treatment of lung nodules with lung-clearing effect.

[0122] Take each extract according to the following mass fractions:

[0123] 5 servings of Chinese herbal extract A for lung clearing and treatment of lung nodules

[0124] 4 servings of Chinese herbal extract B for lung clearing and treatment of lung nodules

[0125] 8 servings of Chinese herbal extract C for lung clearing and treatment of lung nodules

[0126] 6 servings of Chinese herbal extract D for lung clearing and treatment of lung nodules

[0127] Mix evenly according to the above proportions, add appropriate amount of dextrin, and make 1000 tablets.

[0128] Embodiment 5:

[0129] Lung-clearing effect of Chinese herbal extract A for the treatment of lung nodules:

[0130] Take 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens, and 4 parts of Peucedanum peucedanum, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the medicinal solution (concentrated to 0.05 parts of Phellodendron amurense crude drug / ml), apply it to an AB-8 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, recover the ethanol, concentrate it to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH to 0.5-0.7, let it stand for 12 hours, centrifuge to obtain the precipitate, wash it with water until it is neutral, and freeze-dry it to obtain a traditional Chinese medicine extract A for the treatment of lung nodules with lung clearing effect.

[0131] Lung-clearing effect of Chinese herbal extract B for the treatment of lung nodules:

[0132] Take 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 3 parts of Radix Trichosanthis, add 20 times the amount of 60% ethanol, extract twice, each time for 1 hour, combine the extracts, filter, recover the ethanol, concentrate the extract with a relative density of 1.15-1.20, freeze-dry, and obtain the traditional Chinese medicine extract B with lung-clearing effect for treating lung nodules.

[0133] Lung-clearing effect of Chinese herbal extract C for the treatment of lung nodules:

[0134] Take 10 parts of Anemarrhena asphodeloides and 10 parts of Radix Trichosanthis, grind them into fine powder, add 10 times the amount of water, use citric acid to adjust the pH to 5.5, add 0.1 parts of cellulase and 0.15 parts of pectinase, maintain constant temperature enzymolysis at 50°C for 90 minutes, ultrasonically extract for 30 minutes, filter, concentrate the extract with a relative density of 1.15-1.20, and freeze-dry to obtain Chinese medicine extract C with lung-clearing effect for treating lung nodules.

[0135] Lung-clearing effect of Chinese herbal extract for the treatment of lung nodules D:

[0136] Take 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum, add 10 times the amount of water, extract twice, 1 hour each time, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80℃ for 2 hours, let stand, precipitate, filter, wash the precipitate with water until neutral, concentrate to an extract with a relative density of 1.15-1.20, freeze-dry, and use Chinese medicine extract D for the treatment of lung nodules with lung-clearing effect.

[0137] Take each extract according to the following mass fractions:

[0138] 5 servings of Chinese herbal extract A for lung clearing and treatment of lung nodules

[0139] 5 servings of Chinese herbal extract B for lung clearing and treatment of lung nodules

[0140] 10 servings of Chinese herbal extract C for lung clearing and treatment of lung nodules

[0141] 2 servings of Chinese herbal extract D for lung clearing and treatment of lung nodules

[0142] Mix evenly according to the above proportions, add appropriate amount of dextrin, and make 1000 tablets.

[0143] Embodiment 6:

[0144] Lung-clearing effect of Chinese herbal extract A for the treatment of lung nodules:

[0145] Take 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens, and 4 parts of Peucedanum peucedanum, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the medicinal solution (concentrated to 0.05 parts of Phellodendron amurense crude drug / ml), apply it to an AB-8 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, recover the ethanol, concentrate it to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH to 0.5-0.7, let it stand for 12 hours, centrifuge to obtain the precipitate, wash it with water until it is neutral, and freeze-dry it to obtain a traditional Chinese medicine extract A for the treatment of lung nodules with lung clearing effect.

[0146] Lung-clearing effect of Chinese herbal extract B for the treatment of lung nodules:

[0147] Take 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 3 parts of Radix Trichosanthis, add 20 times the amount of 60% ethanol, extract twice, each time for 1 hour, combine the extracts, filter, recover the ethanol, concentrate the extract with a relative density of 1.15-1.20, freeze-dry, and obtain the traditional Chinese medicine extract B with lung-clearing effect for treating lung nodules.

[0148] Lung-clearing effect of Chinese herbal extract C for the treatment of lung nodules:

[0149] Take 10 parts of Anemarrhena asphodeloides and 10 parts of Radix Trichosanthis, grind them into fine powder, add 10 times the amount of water, use citric acid to adjust the pH to 5.5, add 0.1 parts of cellulase and 0.15 parts of pectinase, maintain constant temperature enzymolysis at 50°C for 90 minutes, ultrasonically extract for 30 minutes, filter, concentrate the extract with a relative density of 1.15-1.20, and freeze-dry to obtain Chinese medicine extract C with lung-clearing effect for treating lung nodules.

[0150] Lung-clearing effect of Chinese herbal extract for the treatment of lung nodules D:

[0151] Take 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum, add 10 times the amount of water, extract twice, 1 hour each time, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80℃ for 2 hours, let stand, precipitate, filter, wash the precipitate with water until neutral, concentrate to an extract with a relative density of 1.15-1.20, freeze-dry, and use Chinese medicine extract D for the treatment of lung nodules with lung-clearing effect.

[0152] Take each extract according to the following mass fractions:

[0153] 5 servings of Chinese herbal extract A for lung clearing and treatment of lung nodules

[0154] 6 servings of Chinese herbal extract B for lung clearing and treatment of lung nodules

[0155] 6 servings of Chinese herbal extract C for lung clearing and treatment of lung nodules

[0156] 4 servings of Chinese herbal extract D for lung clearing and treatment of lung nodules

[0157] Mix evenly according to the above proportions, add appropriate amount of dextrin, and make 1000 tablets.

[0158] Embodiment 7:

[0159] Lung-clearing effect of Chinese herbal extract A for the treatment of lung nodules:

[0160] Take 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens, and 4 parts of Peucedanum peucedanum, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the medicinal solution (concentrated to 0.05 parts of Phellodendron amurense crude drug / ml), apply it to an AB-8 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, recover the ethanol, concentrate it to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH to 0.5-0.7, let it stand for 12 hours, centrifuge to obtain the precipitate, wash it with water until it is neutral, and freeze-dry it to obtain a traditional Chinese medicine extract A for the treatment of lung nodules with lung clearing effect.

[0161] Lung-clearing effect of Chinese herbal extract B for the treatment of lung nodules:

[0162] Take 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 3 parts of Radix Trichosanthis, add 20 times the amount of 60% ethanol, extract twice, each time for 1 hour, combine the extracts, filter, recover the ethanol, concentrate the extract with a relative density of 1.15-1.20, freeze-dry, and obtain the traditional Chinese medicine extract B with lung-clearing effect for treating lung nodules.

[0163] Lung-clearing effect of Chinese herbal extract C for the treatment of lung nodules:

[0164] Take 10 parts of Anemarrhena asphodeloides and 10 parts of Radix Trichosanthis, grind them into fine powder, add 10 times the amount of water, use citric acid to adjust the pH to 5.5, add 0.1 parts of cellulase and 0.15 parts of pectinase, maintain constant temperature enzymolysis at 50°C for 90 minutes, ultrasonically extract for 30 minutes, filter, concentrate the extract with a relative density of 1.15-1.20, and freeze-dry to obtain Chinese medicine extract C with lung-clearing effect for treating lung nodules.

[0165] Lung-clearing effect of Chinese herbal extract for the treatment of lung nodules D:

[0166] Take 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum, add 10 times the amount of water, extract twice, 1 hour each time, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80℃ for 2 hours, let stand, precipitate, filter, wash the precipitate with water until neutral, concentrate to an extract with a relative density of 1.15-1.20, freeze-dry, and use Chinese medicine extract D for the treatment of lung nodules with lung-clearing effect.

[0167] Take each extract according to the following mass fractions:

[0168] 7 servings of Chinese herbal extract A for lung clearing and treatment of lung nodules

[0169] 4 servings of Chinese herbal extract B for lung clearing and treatment of lung nodules

[0170] 10 servings of Chinese herbal extract C for lung clearing and treatment of lung nodules

[0171] 4 servings of Chinese herbal extract D for lung clearing and treatment of lung nodules

[0172] Mix evenly according to the above proportions, add appropriate amount of dextrin, and make 1000 tablets.

[0173] Embodiment 8:

[0174] Lung-clearing effect of Chinese herbal extract A for the treatment of lung nodules:

[0175] Take 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens, and 4 parts of Peucedanum peucedanum, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the medicinal solution (concentrated to 0.05 parts of Phellodendron amurense crude drug / ml), apply it to an AB-8 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, recover the ethanol, concentrate it to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH to 0.5-0.7, let it stand for 12 hours, centrifuge to obtain the precipitate, wash it with water until it is neutral, and freeze-dry it to obtain a traditional Chinese medicine extract A for the treatment of lung nodules with lung clearing effect.

[0176] Lung-clearing effect of Chinese herbal extract B for the treatment of lung nodules:

[0177] Take 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 3 parts of Radix Trichosanthis, add 20 times the amount of 60% ethanol, extract twice, each time for 1 hour, combine the extracts, filter, recover the ethanol, concentrate the extract with a relative density of 1.15-1.20, freeze-dry, and obtain the traditional Chinese medicine extract B with lung-clearing effect for treating lung nodules.

[0178] Lung-clearing effect of Chinese herbal extract C for the treatment of lung nodules:

[0179] Take 10 parts of Anemarrhena asphodeloides and 10 parts of Radix Trichosanthis, grind them into fine powder, add 10 times the amount of water, use citric acid to adjust the pH to 5.5, add 0.1 parts of cellulase and 0.15 parts of pectinase, maintain constant temperature enzymolysis at 50°C for 90 minutes, ultrasonically extract for 30 minutes, filter, concentrate the extract with a relative density of 1.15-1.20, and freeze-dry to obtain Chinese medicine extract C with lung-clearing effect for treating lung nodules.

[0180] Lung-clearing effect of Chinese herbal extract for the treatment of lung nodules D:

[0181] Take 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum, add 10 times the amount of water, extract twice, 1 hour each time, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80℃ for 2 hours, let stand, precipitate, filter, wash the precipitate with water until neutral, concentrate to an extract with a relative density of 1.15-1.20, freeze-dry, and use Chinese medicine extract D for the treatment of lung nodules with lung-clearing effect.

[0182] Take each extract according to the following mass fractions:

[0183] 7 servings of Chinese herbal extract A for lung clearing and treatment of lung nodules

[0184] 5 servings of Chinese herbal extract B for lung clearing and treatment of lung nodules

[0185] 6 servings of Chinese herbal extract C for lung clearing and treatment of lung nodules

[0186] 6 servings of Chinese herbal extract D for lung clearing and treatment of lung nodules

[0187] Mix evenly according to the above proportions, add appropriate amount of dextrin, and make 1000 tablets.

[0188] Embodiment 9:

[0189] Lung-clearing effect of Chinese herbal extract A for the treatment of lung nodules:

[0190] Take 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens, and 4 parts of Peucedanum peucedanum, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the medicinal solution (concentrated to 0.05 parts of Phellodendron amurense crude drug / ml), apply it to an AB-8 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, recover the ethanol, concentrate it to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH to 0.5-0.7, let it stand for 12 hours, centrifuge to obtain the precipitate, wash it with water until it is neutral, and freeze-dry it to obtain a traditional Chinese medicine extract A for the treatment of lung nodules with lung clearing effect.

[0191] Lung-clearing effect of Chinese herbal extract B for the treatment of lung nodules:

[0192] Take 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 3 parts of Radix Trichosanthis, add 20 times the amount of 60% ethanol, extract twice, each time for 1 hour, combine the extracts, filter, recover the ethanol, concentrate the extract with a relative density of 1.15-1.20, freeze-dry, and obtain the traditional Chinese medicine extract B with lung-clearing effect for treating lung nodules.

[0193] Lung-clearing effect of Chinese herbal extract C for the treatment of lung nodules:

[0194] Take 10 parts of Anemarrhena asphodeloides and 10 parts of Radix Trichosanthis, grind them into fine powder, add 10 times the amount of water, use citric acid to adjust the pH to 5.5, add 0.1 parts of cellulase and 0.15 parts of pectinase, maintain constant temperature enzymolysis at 50°C for 90 minutes, ultrasonically extract for 30 minutes, filter, concentrate the extract with a relative density of 1.15-1.20, and freeze-dry to obtain Chinese medicine extract C with lung-clearing effect for treating lung nodules.

[0195] Lung-clearing effect of Chinese herbal extract for the treatment of lung nodules D:

[0196] Take 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides, and 5 parts of Platycodon grandiflorum, add 10 times the amount of water, extract twice, 1 hour each time, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80℃ for 2 hours, let stand, precipitate, filter, wash the precipitate with water until neutral, concentrate to an extract with a relative density of 1.15-1.20, freeze-dry, and use Chinese medicine extract D for the treatment of lung nodules with lung-clearing effect.

[0197] Take each extract according to the following mass fractions:

[0198] 7 servings of Chinese herbal extract A for lung clearing and treatment of lung nodules

[0199] 6 servings of Chinese herbal extract B for lung clearing and treatment of lung nodules

[0200] 8 servings of Chinese herbal extract C for lung clearing and treatment of lung nodules

[0201] 2 servings of Chinese herbal extract D for lung clearing and treatment of lung nodules

[0202] Mix evenly according to the above proportions, add appropriate amount of dextrin, and make 1000 tablets.

[0203] Comparative experimental study on the pharmacodynamics of nine groups of extracts

[0204] By using a lipopolysaccharide-induced mouse inflammation model, it was found that the extract exerts its lung-clearing effect in treating lung nodules, possibly by improving damaged lung tissue and thereby alleviating inflammatory lung nodules.

[0205] 1. Grouping Modeling and Drug Administration

[0206] ICR mice, half male and half female, with a body weight of 18-22g, were randomly divided into a blank group, a model group, a Chinese medicine positive group (Qingfei Yihuo Tablets, a dose of 15g / kg), a Western medicine positive group (dexamethasone, a dose of 0.20g / kg), a drug group 1, a drug group 2, a drug group 3, a drug group 4, a drug group 5, a drug group 6, a drug group 7, a drug group 8, and a drug group 9, with 10 mice in each group. After grouping, the mice were given oral administration once a day for 15 consecutive days. The normal control group and the model group were given an equal amount of normal saline. On the 16th day, except for the normal control group, the other groups were modeled by LPS (10mg / kg body weight) nasal drops. Six hours after modeling, blood samples were collected for routine blood tests of whole blood and ELISA kits were used to determine the levels of TNF-α, IL-1β, and IL-6 in the serum of each group of mice.

[0207] 2. Mouse whole blood serum test

[0208] Blood was collected from the abdominal aorta of mice and placed in a blood analyzer to measure the results of the whole serum of mice. Compared with the normal control group, the total white blood cell count and the total neutrophil count in the model group were significantly increased, and the total red blood cell count and the total platelet count were significantly decreased (P<0.01), indicating that the model was successful; compared with the model group, the total white blood cell count and the total neutrophil count in the drug 6 group were significantly decreased (P<0.01), and the total cell count and the total platelet count were significantly decreased (P<0.01). The results were better than those in the Chinese medicine positive group and consistent with those in the western medicine positive group dexamethasone group, indicating that the drug 6 group had a significant alleviating effect on LPS-induced acute pneumonia in mice.

[0209] Table 1 Results of whole blood serum of mice in each group ( n=10)

[0210]

[0211]

[0212] Note: Compared with the blank group, ###P<0.001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001.

[0213] 3. Contents of IL-1β, IL-6 and TNF-α in serum of mice in each group

[0214] Compared with the normal control group, the IL-1β, IL-6 and TNF-α in the model group were significantly increased (P<0.01), indicating that the model was successful; compared with the model group, the expression levels of IL-1β, IL-6 and TNF-α in the drug 6 group were significantly reduced (P<0.01), indicating that the drug 6 group had a significant alleviating effect on LPS-induced acute inflammatory pneumonia in mice.

[0215] Table 2 Expression levels of IL-1β, IL-6 and TNF-α in the serum of mice in each group ( n=10)

[0216]

[0217]

[0218] Note: Compared with the blank group, ###P<0.001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001.

[0219] According to the above data results, it was found that the formulation of group 6 of the present invention has a significant effect on improving lipopolysaccharide-induced acute inflammation in mice, improving the infiltration of inflammatory factors in lung tissue, and has obvious advantages in clearing lung heat and thus treating lung nodules.

[0220] The above are only preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The invention comprises the following raw materials in parts by weight: The Chinese medicine extract A is prepared by extracting Phellodendron amurense, Sophora flavescens and Peucedanum chinense through alcohol and then purifying it with macroporous resin; The Chinese medicine extract B is prepared by alcohol extraction of Scutellaria baicalensis, Gardenia jasminoides and Radix Trichosanthis; The Chinese medicine extract C is obtained by enzymatic hydrolysis of Anemarrhena asphodeloides and Radix Trichosanthis and then ultrasonic extraction; The Chinese medicine extract D is prepared by water extraction of scutellaria baicalensis, gardenia jasmine and platycodon grandiflorum.

2. The Chinese medicine composition according to claim 1, characterized in that: The preparation of the Chinese medicine extract A comprises: 5 parts of Phellodendron amurense, 4 parts of Sophora flavescens and 4 parts of Peucedanum peucedanum were extracted with 70% ethanol solution. After the extract was concentrated, it was loaded on an AB-8 macroporous resin column, washed with 2 column volumes of water and 4 column volumes of 10% ethanol solution in sequence, and eluted with 5 column volumes of 50% ethanol solution. The pH value of the eluent was adjusted to 0.5-0.7, and the precipitate was collected to obtain Chinese medicine extract A.

3. The Chinese medicine composition according to claim 1, characterized in that The preparation of the Chinese medicine extract B comprises: 5 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides and 3 parts of Radix Trichosanthis were extracted with 60% ethanol solution, and after recovering the ethanol, the extract was dried to obtain a Chinese medicine extract B.

4. The Chinese medicine composition according to claim 1, characterized in that: The preparation of the Chinese medicine extract C comprises: Mix 10 parts of Anemarrhena asphodeloides, 10 parts of Radix Trichosanthis and 10 times the amount of water, add 0.1 parts of cellulase and 0.15 parts of pectinase, and perform enzymolysis at pH 5.5 and 50°C for 90 minutes, then perform ultrasonic extraction for 30 minutes. The extract is concentrated and dried to obtain Chinese medicine extract C.

5. The Chinese medicine composition according to claim 1, characterized in that: The preparation of the Chinese medicine extract D comprises: 10 parts of Scutellaria baicalensis, 5 parts of Gardenia jasminoides and 5 parts of Platycodon grandiflorum were extracted with 10 times the weight of water, the extract was concentrated, the pH value was adjusted to 2, and the precipitate was dried to obtain the Chinese medicine extract D.

6. Use of the Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a medicine for clearing the lungs and / or treating lung nodules.

7. The use according to claim 6, characterized in that: The lung clearing and / or lung nodule treatment includes: alleviating acute inflammation and / or improving the infiltration of inflammatory factors in lung tissue.

8. A medicine for clearing the lungs and / or treating lung nodules, characterized in that: The invention comprises pharmaceutically acceptable excipients and the traditional Chinese medicine composition according to any one of claims 1 to 5.

9. The drug according to claim 8, characterized in that The mass fraction of the traditional Chinese medicine composition is 50% to 80%.

10. The method for preparing the drug according to claim 8 or 9, characterized in that: The method comprises mixing a traditional Chinese medicine extract A, a traditional Chinese medicine extract B, a traditional Chinese medicine extract C, a traditional Chinese medicine extract D and pharmaceutically acceptable excipients to prepare the medicine.

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