Traditional Chinese medicine composition for treating pulmonary nodule as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating pulmonary nodules as well as a preparation method and application thereof, belongs to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for treating pulmonary nodules, which is prepared from the following components in parts by weight: 25-35 parts of cynanchum glaucescens, 12-14 parts of kelp, 10-30 parts of fossil fragments, 25-35 parts of oysters, 6-8 parts of rhizoma sparganii, 10-15 parts of poria cocos, 4-7 parts of curcuma zedoary, 13-17 parts of allium macrostemon, 7-9 parts of ligusticum wallichii and 7-14 parts of bock greenbrier rhizome. According to the traditional Chinese medicine composition provided by the invention, the curative effect of pulmonary nodules is effectively improved, the action mechanism of medicine interaction is defined, and a new formula is provided for pulmonary nodule treatment.

Description

Technical Field

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

[0002] Pulmonary nodules refer to round or quasi-round shadows less than 3 cm found in lung imaging examinations. They can be benign or malignant lesions. With the popularization of chest CT screening, more and more pulmonary nodules are discovered at an early stage. Although most pulmonary nodules are benign, some pulmonary nodules may be manifestations of early lung cancer, so their early diagnosis and treatment are crucial.

[0003] Modern medicine believes that surgical treatment is suitable for large or highly suspected malignant pulmonary nodules, but the surgical risk is high and the postoperative recovery period is long. Current status of treatment in traditional Chinese medicine: Traditional Chinese medicine has a long history and rich experience in the treatment of pulmonary nodules. Traditional Chinese medicine believes that pulmonary nodules are mostly caused by factors such as qi stagnation and blood stasis, phlegm and dampness obstruction, and the treatment method is mainly to promote blood circulation and remove blood stasis, and to resolve phlegm and disperse nodules. Traditional prescriptions such as "Xiao Xianxiong Decoction" in "Treatise on Febrile Diseases" and "Guizhi Fuling Pills" in "Golden Chamber Synopsis" have achieved certain therapeutic effects in clinical applications. However, most of the existing Chinese medicine prescriptions are based on classic ancient prescriptions, lack innovative designs for modern pathological mechanisms, and are difficult to meet the needs of individualized treatment. For example, the efficacy is unstable: the efficacy of existing Chinese medicine prescriptions varies from person to person, with large individual differences, and lack of standardization and normalization. The mechanism of action is unclear: the mechanism of action of most Chinese medicine prescriptions has not been fully elucidated, and it is difficult to explain their specific pharmacological effects. Drug safety issues: Some Chinese medicine ingredients may have potential toxic and side effects, and long-term use requires careful evaluation. Lack of systematic research: Currently, there are relatively few studies on the treatment of lung nodules with traditional Chinese medicine, and there is a lack of large-scale, high-quality clinical trial support.

[0004] In order to overcome the shortcomings of existing technologies and treatment methods, there is an urgent need to develop a new type that can improve efficacy: by optimizing the formulation, enhancing the effectiveness of the drug, and ensuring wide applicability to different types of lung nodules; clarifying the mechanism of action: in-depth research on the compatibility relationship between various medicinal materials and their synergistic effects, revealing their specific pharmacological mechanisms; ensuring safety: strictly screening medicinal materials, controlling quality, and ensuring the safety and low toxicity of the drug. Summary of the invention

[0005] To solve the above technical problems, the present invention proposes a Chinese medicine composition for treating pulmonary nodules, a preparation method and application thereof, which effectively improves the efficacy of pulmonary nodules, clarifies the mechanism of drug interaction, and provides a new formula for the treatment of pulmonary nodules.

[0006] To achieve the above object, the present invention provides a Chinese medicine composition for treating pulmonary nodules, which is prepared by the following components in parts by weight:

[0007] 25-35 parts of Radix Bupleuri, 12-14 parts of Kelp, 10-30 parts of Dragon Bone, 25-35 parts of Oyster, 6-8 parts of Trigonosciadium japonicum, 10-15 parts of Poria, 4-7 parts of Curcuma, 13-17 parts of Allium macrostemon, 7-9 parts of Ligusticum chuanxiong, and 7-14 parts of Radix Angelicae Pubescentis.

[0008] Baiqian: Spicy and bitter, slightly warm in nature. Enters the lung meridian. It lowers qi, eliminates phlegm, and relieves cough. It is used for lung qi congestion, cough with a lot of phlegm, chest fullness and shortness of breath.

[0009] Kelp: cold in nature, salty in taste. It has the functions of softening and dispersing lumps, reducing swelling and promoting diuresis, moistening and eliminating phlegm. It is clinically used for goiter, cervical lymphadenopathy, bronchitis, tuberculosis, cough and senile cataract, etc. It is also tried to treat cancer. It can eliminate phlegm and soften lumps; promote diuresis and reduce swelling. It is used for scrofula, goiter, choking, hernia, beriberi and edema. It is used for goiter, scrofula, testicular swelling and pain, phlegm and edema.

[0010] Dragon bone: astringent, sweet, neutral in nature. Enters the heart, liver, and kidney meridians. It calms the mind and soothes the nerves, soothes the liver and suppresses yang, consolidates and astringes. It is used for palpitations, insomnia and forgetfulness, epilepsy, dizziness, spontaneous sweating, night sweats, spermatorrhea, enuresis, metrorrhagia, leukorrhea, chronic diarrhea, dysentery, ulcers that do not heal for a long time, and eczema.

[0011] Oyster: salty and moist, cool. Astringes yin, suppresses yang, stops sweating, astringes sperm, resolves phlegm, and softens hard masses. Treats epilepsy, dizziness, spontaneous sweating, night sweats, spermatorrhea, stranguria, metrorrhagia, leucorrhea, scrofula, and goiter. Used for palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm nodules, masses, spontaneous sweating, night sweats, spermatorrhea, metrorrhagia, and stomachache. Calcined oysters are astringent and astringent. Used for spontaneous sweating, night sweats, spermatorrhea, metrorrhagia, and stomachache. Astringes yin and suppresses yang, softens hard masses and resolves lumps.

[0012] Trigonum multiflorum: pungent, bitter, neutral. Enters the liver and spleen meridians. Breaks blood and promotes qi circulation, eliminates stagnation and relieves pain. Used for lumps and masses, dysmenorrhea, amenorrhea due to blood stasis, chest pain, and bloating and pain caused by food stagnation.

[0013] Poria cocos: It tastes sweet, light and neutral in nature. It has the effects of promoting diuresis and reducing swelling, strengthening the spleen, dispelling dampness and calming the mind. It is very effective in treating spleen deficiency diarrhea, palpitations and insomnia, and can also strengthen the spleen and remove dampness.

[0014] Curcuma: Spicy and bitter in taste, warm in nature. Enters the liver and spleen meridians. Promotes qi and resolves blood, eliminates stagnation and relieves pain. Used for heartache caused by blood and qi, stagnation of food, abdominal distension and pain, amenorrhea caused by blood stasis, dysmenorrhea, lumps and masses, and injuries from falls.

[0015] Xiebai: pungent, bitter, warm. Enters the heart, lung, stomach, and large intestine meridians. Promotes yang and dissipates stagnation, promotes qi and relieves stagnation. Used for chest pain, abdominal distension and pain, and heaviness after diarrhea.

[0016] Chuanxiong: pungent and warm in nature. Enters the liver, gallbladder, and pericardium meridians. Goes up to the head and down to the blood sea, promotes blood and qi inside, and dispels wind and cold outside. It has a strong blood-activating effect and treats various pains caused by blood stasis and qi stagnation. It is most suitable for those with cold and is praised by predecessors as "the qi medicine in the blood". It is the best for treating various headaches, especially those caused by wind-cold and blood stasis; it can also be used for those caused by wind-heat, rheumatism, and blood deficiency.

[0017] Jingangteng: warm in nature, slightly pungent in taste. It can dispel wind, promote blood circulation, and detoxify. It can treat rheumatic waist and leg pain, traumatic injuries, and scrofula.

[0018] Preferably, it is prepared by comprising the following components in parts by weight:

[0019] 30 parts of Radix Phellodendri, 13 parts of Kelp, 20 parts of Os Dracaena, 30 parts of Concha Ostreae, 7 parts of Rhizoma Sparganii, 12.5 parts of Poria, 5.5 parts of Rhizoma Curcumae, 15 parts of Radix Allii Macrostemonis, 8 parts of Rhizoma Chuanxiong, and 10.5 parts of Radix Angelicae Dahuricae.

[0020] The present invention also provides a method for preparing the Chinese medicine composition, comprising the following steps:

[0021] (1) Mixing Tripterygium wilfordii with rice vinegar and drying the mixture to obtain vinegar-processed Tripterygium wilfordii;

[0022] (2) The vinegar-processed Trigonum multiflorum obtained in step (1) is mixed with Radix Psoraleae, Kelp, Ossobucus uriculae, Concha oyster, Poria cocos, Rhizoma Curcumae, Radix Allii Macrostemonis, Rhizoma Chuanxiong and Rhizoma Cynomorii Macrostemonis, and the mixture is ground into powder to obtain a Chinese medicine composition.

[0023] Preferably, the mass ratio of the mixture of Tripterygium wilfordii and rice vinegar in step (1) is 1:2-3.

[0024] Preferably, the drying temperature in step (1) is 50-60° C., and the drying is performed until there is no liquid.

[0025] Preferably, the particle size of the crushed product in step (2) is ≤15 mm.

[0026] The present invention also provides application of the traditional Chinese medicine composition in preparing medicine for treating pulmonary nodules.

[0027] The present invention also provides a medicine for preparing a medicine for treating pulmonary nodules, the medicine comprising the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0028] Preferably, the drug is an oral preparation.

[0029] Preferably, the oral preparation includes tablets, capsules, granules, pills or decoctions.

[0030] Compared with the prior art, the present invention has the following advantages and technical effects:

[0031] The present invention provides a traditional Chinese medicine composition for treating lung nodules, which can achieve the technical effect of effectively treating lung nodules by softening and dispersing nodules, promoting blood circulation and removing blood stasis, and combining soothing the liver and regulating qi, and dispersing dampness. The expectorant and swelling-removing effects of kelp can complement the expectorant and asthma-relieving effects of white sage, and together they can treat symptoms such as cough and asthma caused by internal obstruction of phlegm and dampness, and resolve phlegm and dissipate stagnation; the combination of the two can enhance the expectorant effect and relieve the discomfort caused by excessive phlegm; the softening and nodule-removing effects of kelp can assist the qi-lowering and cough-relieving effects of white sage, and is suitable for long-term cough and excessive phlegm caused by phlegm and dampness condensation and poor qi movement, softening and dissipating stagnation, and lowering qi to relieve cough, especially for cases where phlegm and dampness are heavy and sticky and difficult to cough up, kelp can help soften phlegm and make it easier to discharge, while white sage can effectively lower qi and relieve cough, and relieve symptoms; the diuretic and swelling-removing effects of kelp can improve the problem of excessive moisture in the body and reduce the formation of phlegm and dampness, while the expectorant and asthma-removing effects of white sage can further relieve airway obstruction. The combined use of the two can effectively improve respiratory diseases caused by phlegm and dampness, and promote diuresis and swelling-removing and resolve phlegm and relieve asthma. The effect of dragon bone in calming the liver and suppressing yang can be superimposed with the same effect of oyster, and it is suitable for symptoms such as headache, dizziness, irritability and anger caused by hyperactivity of liver yang. The combined use of the two can more effectively suppress liver yang, stabilize emotions, and relieve symptoms. The softening and nodule-dispersing effect of oyster can assist the effect of dragon bone in calming the liver and suppressing yang, and it is suitable for symptoms such as scrofula and goiter caused by phlegm and dampness condensation and poor qi movement. Especially for cases with heavy phlegm and dampness and local lumps, oysters can help soften nodules, while dragon bone can calm liver yang and relieve symptoms. Sanleng is good at breaking up blood and promoting qi, eliminating accumulation and resolving symptoms, while Poria has the effect of promoting diuresis and removing dampness. The combination of the two can effectively improve the situation of excessive dampness in the body and blood stasis and qi stagnation, and is particularly suitable for diseases caused by both dampness and blood stasis, promoting blood circulation and removing blood stasis, and promoting diuresis and removing dampness; Sanleng can dredge meridians and relieve pain, and is suitable for pain symptoms such as bruises, rheumatism and arthralgia, while Poria has the effect of strengthening the spleen and calming the mind, and is suitable for symptoms such as weak spleen and stomach, restlessness, etc. Strengthening the spleen and calming the mind and dredge meridians and relieve pain, the combination of the two can simultaneously improve qi and blood circulation and spleen and stomach function, relieve pain and promote overall health; Sanleng's effect of eliminating accumulation and resolving symptoms can assist in the treatment of abdominal lumps, while Poria can help regulate the spleen and stomach, enhance digestive function, and reduce the formation of dampness by strengthening the spleen and removing dampness, thereby more effectively eliminating lumps. Both Curcuma and Ligusticum chuanxiong have significant effects of promoting blood circulation, removing blood stasis, promoting qi and relieving pain. The combination of the two can enhance these effects. They are particularly suitable for various pain symptoms caused by blood stasis and qi stagnation, promoting blood circulation and removing blood stasis, and relieving pain; Xiebai is good at promoting yang and dispersing nodules, regulating qi and relieving chest tightness. It is suitable for symptoms such as chest pain, chest tightness, and abdominal distension and pain; Ligusticum chuanxiong can promote blood circulation and promote qi, and relieve chest and flank pain caused by qi stagnation and blood stasis. The combination of the two can effectively improve symptoms such as chest tightness and chest pain, and promote yang and dispersing nodules, and regulate qi and relieve chest tightness; Vajrapani has the effects of promoting blood circulation and unblocking meridians, detoxifying and reducing swelling. It is suitable for symptoms such as bruises, rheumatic arthralgia, carbuncles, sores and toxins. Curcuma can break up blood and promote qi circulation, eliminate masses. The combination of the two can more effectively improve blood circulation, reduce inflammation and swelling, promote blood circulation and unblock meridians, and detoxify and reduce swelling.Comprehensive regulation of Qi and blood and organ functions: The combination of Curcuma zedoaria, Xiebai, Ligusticum chuanxiong and Vajrapani can comprehensively regulate Qi and blood, improve blood circulation, while taking into account the functions of multiple organs such as the liver, spleen, heart, and lungs. It is suitable for a variety of diseases caused by poor Qi and blood circulation and organ dysfunction. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0033] Figure 1 This is a comparison chart of the therapeutic effects of experimental group 1 and experimental group 2 in treating lung nodules for 3 months. DETAILED DESCRIPTION

[0034] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0035] It should be understood that the terms described in the present invention are only for describing special embodiments and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. Each smaller range between the intermediate value in any stated value or stated range and any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0036] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0037] Without departing from the scope or spirit of the present invention, various modifications and variations may be made to the specific embodiments of the present invention description, which will be apparent to those skilled in the art. Other embodiments obtained from the present invention description will be apparent to those skilled in the art. The present invention description and examples are merely exemplary. Unless otherwise specified, the technical means used in the examples are conventional means well known to those skilled in the art, and the raw materials used are all commercially available commodities.

[0038] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0039] Unless otherwise specified, the "parts" described in the present invention are all based on mass parts.

[0040] Example 1

[0041] 30 parts of Radix Phellodendri, 13 parts of Kelp, 20 parts of Os Dracaena, 30 parts of Concha Ostreae, 7 parts of Rhizoma Sparganii, 12.5 parts of Poria, 5.5 parts of Rhizoma Curcumae, 15 parts of Radix Allii Macrostemonis, 8 parts of Rhizoma Chuanxiong, and 10.5 parts of Radix Angelicae Dahuricae.

[0042] (1) Mixing Tripterygium wilfordii and rice vinegar in a mass ratio of 1:3, and drying at 55° C. until no liquid is left, to obtain vinegar-processed Tripterygium wilfordii;

[0043] (2) Mix the vinegar-processed Trigonum multiflorum with Radix Psoraleae, Kelp, Ossobuci, Concha Ostreae, Poria, Rhizoma Curcumae, Radix Allii Macrostemonis, Rhizoma Chuanxiong and Rhizoma Cynomorii, grind them into particles with a size of ≤15 mm, with no limitation on the minimum particle size, to obtain a Chinese medicine composition.

[0044] Example 2

[0045] 25 parts of Radix Phellodendri, 12 parts of Kelp, 30 parts of Os Dracaena, 35 parts of Concha Ostreae, 6 parts of Rhizoma Sparganii, 10 parts of Poria, 7 parts of Rhizoma Curcumae, 17 parts of Radix Allii Macrostemonis, 9 parts of Rhizoma Chuanxiong, and 14 parts of Radix Angelicae Dahuricae.

[0046] (1) Mixing Tripterygium wilfordii and rice vinegar in a mass ratio of 1:2, and drying at 50° C. until no liquid is left, to obtain vinegar-processed Tripterygium wilfordii;

[0047] (2) Mix the vinegar-processed Trigonum multiflorum with Radix Psoraleae, Kelp, Ossobuci, Concha Ostreae, Poria, Rhizoma Curcumae, Radix Allii Macrostemonis, Rhizoma Chuanxiong and Rhizoma Cynomorii, grind them into particles with a size of ≤15 mm, with no limitation on the minimum particle size, to obtain a Chinese medicine composition.

[0048] Example 3

[0049] 35 parts of Radix Phellodendri, 14 parts of Kelp, 10 parts of Os Dracaena, 25 parts of Concha Ostreae, 8 parts of Rhizoma Sparganii, 15 parts of Poria, 4 parts of Rhizoma Curcumae, 13 parts of Radix Allii Macrostemonis, 7 parts of Rhizoma Chuanxiong, and 7 parts of Radix Angelicae Dahuricae.

[0050] (1) Mixing Tripterygium wilfordii with rice vinegar in a mass ratio of 1:3, and drying at 60° C. until no liquid is left, to obtain vinegar-processed Tripterygium wilfordii;

[0051] (2) Mix the vinegar-processed Trigonum multiflorum with Radix Psoraleae, Kelp, Ossobuci, Concha Ostreae, Poria, Rhizoma Curcumae, Radix Allii Macrostemonis, Rhizoma Chuanxiong and Rhizoma Cynomorii, grind them into particles with a size of ≤15 mm, with no limitation on the minimum particle size, to obtain a Chinese medicine composition.

[0052] Example 4

[0053] 28 parts of Radix Phellodendri, 13 parts of Kelp, 25 parts of Os Dracaenae, 28 parts of Concha Ostreae, 7 parts of Rhizoma Sparganii, 14 parts of Poria, 5 parts of Rhizoma Curcumae, 14 parts of Radix Allii Macrostemonis, 8 parts of Rhizoma Chuanxiong, and 9 parts of Radix Angelicae Dahuricae.

[0054] (1) Mixing Tripterygium wilfordii and rice vinegar in a mass ratio of 1:3, and drying at 55° C. until no liquid is left, to obtain vinegar-processed Tripterygium wilfordii;

[0055] (2) Mix the vinegar-processed Trigonum multiflorum with Radix Psoraleae, Kelp, Ossobuci, Concha Ostreae, Poria, Rhizoma Curcumae, Radix Allii Macrostemonis, Rhizoma Chuanxiong and Rhizoma Cynomorii, grind them into particles with a size of ≤15 mm, with no limitation on the minimum particle size, to obtain a Chinese medicine composition.

[0056] Example 5

[0057] 32 parts of Radix Phellodendri, 13 parts of Kelp, 15 parts of Os Dracaenae, 32 parts of Concha Ostreae, 7 parts of Rhizoma Sparganii, 11 parts of Poria, 6 parts of Rhizoma Curcumae, 15 parts of Radix Allii Macrostemonis, 8 parts of Rhizoma Chuanxiong, and 11 parts of Radix Angelicae Dahuricae.

[0058] (1) Mixing Tripterygium wilfordii with rice vinegar in a mass ratio of 1:3, and drying at 50° C. until no liquid is left, to obtain vinegar-processed Tripterygium wilfordii;

[0059] (2) Mix the vinegar-processed Trigonum multiflorum with Radix Psoraleae, Kelp, Ossobuci, Concha Ostreae, Poria, Rhizoma Curcumae, Radix Allii Macrostemonis, Rhizoma Chuanxiong and Rhizoma Cynomorii, grind them into particles with a size of ≤15 mm, with no limitation on the minimum particle size, to obtain a Chinese medicine composition.

[0060] Comparative Example 1

[0061] 30 parts of Platycodon grandiflorum, 13 parts of Kelp, 20 parts of Dragon Bone, 30 parts of Oyster, 7 parts of Trigonosciadium japonicum, 12.5 parts of Poria, 5.5 parts of Curcuma zedoaria, 15 parts of Allium macrostemon, 8 parts of Salvia miltiorrhiza, and 10.5 parts of Radix Angelicae Dahuricae.

[0062] Platycodon grandiflorum: bitter, pungent, neutral in nature. Enters the lung meridian. Clears the lungs, relieves sore throat, removes phlegm, and discharges pus.

[0063] Poria: sweet, mild and flat in nature. It has the functions of dispelling dampness, strengthening the spleen and calming the mind. It is used for phlegm, edema, urinary incontinence, diarrhea, palpitations and dizziness.

[0064] Danshen: bitter, slightly cold. Enters the heart and liver meridians. Promotes blood circulation and removes blood stasis, relieves pain, clears the heart and relieves vexation, cools blood and eliminates carbuncle. Used for chest pain, abdominal pain, flank pain, accumulation of masses, pain caused by heat, restlessness and insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0065] (1) Mixing Tripterygium wilfordii and rice vinegar in a mass ratio of 1:3, and drying at 55° C. until no liquid is left, to obtain vinegar-processed Tripterygium wilfordii;

[0066] (2) Mix the vinegar-processed Trigonum multiflorum with Radix Psoraleae, Kelp, Ossobuci, Concha Ostreae, Poria, Rhizoma Curcumae, Radix Allii Macrostemonis, Rhizoma Chuanxiong and Rhizoma Cynomorii, grind them into particles with a size of ≤15 mm, with no limitation on the minimum particle size, to obtain a Chinese medicine composition.

[0067] Experimental example

[0068] 1. General Information

[0069] The patients who participated in the treatment were those who visited the Guizhou Panjiang Coal and Electricity Group Co., Ltd. Hospital from January 31, 2022 to September 30, 2023. There were 50 males and 71 females, a total of 121 cases, with an average age of 55 years.

[0070] 2. Diagnostic Criteria

[0071] The diagnostic criteria include both Western medicine and traditional Chinese medicine.

[0072] Among them, the diagnostic standard of Western medicine refers to the definition, diagnosis and classification of pulmonary nodules in the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition)" and the "Guidelines for the Classification, Diagnosis and Treatment of Pulmonary Nodules in China (2016 Edition)". The classification is based on the following three dimensions: ① Quantity: A single lesion is isolated, and two or more lesions are defined as multiple. ② Density: According to the density and degree of mixing, it is divided into three categories: solid nodules, pure ground glass nodules, and partially solid nodules. ③ Danger level: solid nodules are divided into <5% (low risk), 5% to 65% (medium risk), and >65% (high risk) according to the results of the Mayo malignancy probability prediction formula and lung cancer risk factors; partially solid nodules are divided into 8mm, >8mm (high risk), ≤8mm (medium risk); pure ground glass nodules are divided into 5mm, >5mm (medium risk), ≤5mm (low risk). Multiple nodules are graded according to the nodules with the highest risk level.

[0073] Among them, there is currently no standard for TCM disease diagnosis and syndrome differentiation for lung nodules. Patients may have no obvious symptoms or signs, and no syndrome can be identified. All patients who have lung nodules on lung imaging, excluding tuberculosis and wind-heat lung heat disease, can be included in the category of "lung nodules" in TCM.

[0074] III. Inclusion Criteria

[0075] (1) Patients with pulmonary nodules who meet the above diagnostic criteria; (2) Patients who only require CT follow-up, or patients who require surgery but refuse or are unable to undergo surgery; (3) Patients aged 20 to 90 years.

[0076] IV. Exclusion criteria

[0077] (1) Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and blood system diseases; (2) Patients with active tuberculosis and other infectious diseases; (3) Patients who are unable to cooperate with the observation and research.

[0078] 5. Treatment Methods

[0079] The Chinese medicine composition prepared by Example 1 and the Chinese medicine composition prepared by Comparative Example 1 were prepared into a group of experimental medicine decoctions and a group of experimental medicine decoctions in 1000mL of water, respectively, and oral treatment was given. 1 dose per day, taken twice, once in the morning and evening, for 3 months of treatment, during which a follow-up visit was made once every 4 weeks, and a chest CT was reviewed 1 time after 3 months of treatment, and the results of the most recent chest CT before the initial visit were compared to evaluate the efficacy. The patients were randomly divided into an experimental group and an experimental group 2. When grouping, it was ensured that the pulmonary nodules of the patients in the two groups were evenly distributed from low risk to high risk, and the patients with pulmonary nodules from short to long time were evenly distributed in the two groups, and the consistency of the types of the two groups of patients was ensured as much as possible. A group of 60 cases were treated with a group of experimental medicine decoctions, and a group of 61 cases were treated with a group of experimental medicine decoctions in the two groups.

[0080] VI. Efficacy Standards

[0081] The size of the nodules on chest CT is used as the main basis for efficacy, and combined with the density and number of nodules, a comparison is made before and after treatment. The area of ​​the nodule with the largest diameter on chest CT: the area of ​​the nodule with the largest diameter is calculated as S = π × A × B / 4 (ellipse area formula, A and B are the long and short diameters reported in the chest CT report, respectively. If the chest CT report only has the diameter D, then A = B = D, which is the circular area formula), and the area reduction rate before and after treatment is compared.

[0082] According to the chest CT report and film reading, the number and density of nodules were compared. The efficacy was divided into the following levels: ① Cured: chest CT showed that the nodules disappeared; ② Significantly effective: chest CT showed that the nodules became smaller, lighter, and fewer, and the area (area sum) of the largest diameter decreased by ≥50%; ③ Effective: chest CT showed that the nodules became smaller, lighter, and fewer, and the area (area sum) of the largest diameter decreased by <50%; ④ Ineffective: chest CT showed that the size, density, and number of nodules were stable without obvious changes or progression.

[0083] Total effective rate (%) = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0084] VII. Statistics

[0085] SPSS 20.0 software was used, and the two-sided nonparametric rank sum test was used to compare the ordered count data between groups. P < 0.05 was considered statistically significant.

[0086] 8. Results

[0087] (1) Pulmonary nodules in 121 cases

[0088] Table 1121 Pulmonary nodules in patients

[0089]

[0090] As shown in Table 1, the 121 cases were classified from three aspects: number, density, and risk level, covering patients with different degrees of pulmonary tuberculosis. Most of them were medium-risk nodules, and low- and medium-risk nodules accounted for the majority of multiple nodules.

[0091] (2) Time of discovery of pulmonary nodules in 121 cases at the time of initial diagnosis

[0092] Table 2 Time of discovery of pulmonary nodules at the first visit

[0093]

[0094]

[0095] As shown in Table 2 , the length of the patients' history of pulmonary nodules at the time of initial diagnosis varied, with most having developed the disease within 3 months.

[0096] (3) Efficacy

[0097] Table 3 The efficacy of the experimental group of pulmonary nodules treated for 3 months

[0098] Efficacy Number of cases Proportion (%) cure 10 16.67％ Significant effect 17 28.33％ efficient 25 41.67％ invalid 8 13.33％ Total effective rate (%) 86.67％ -

[0099] Table 4 The efficacy of pulmonary nodules in experimental group 2 for 3 months

[0100] Efficacy Number of cases Proportion (%) cure 5 8.33％ Significant effect 7 11.67％ efficient 22 36.67％ invalid 26 43.33％ Total effective rate (%) 56.67％ -

[0101] As shown in Tables 3 and 4, and Figure 1 From the comparison information in Table 4, it can be seen that the treatment of patients with pulmonary nodules by using a prescription composed of Chinese medicines with similar efficacy is recorded in Table 4. It can be seen that the Chinese medicine composition decoction prepared by the present invention recorded in Table 3 has an effective rate of 86.67%, a cure rate of 16.67% within 3 months, and an ineffective rate of only 13.33%. Compared with the Chinese medicine composition decoction prepared in Comparative Example 1, it has a faster and better therapeutic effect, and can effectively treat pulmonary nodules faster.

[0102] The embodiments described above are only descriptions of the preferred embodiments of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should all fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating pulmonary nodules, characterized in that: The composition comprises the following components in parts by weight: 25-35 parts of Radix Bupleuri, 12-14 parts of Kelp, 10-30 parts of Dragon Bone, 25-35 parts of Oyster, 6-8 parts of Trigonosciadium japonicum, 10-15 parts of Poria, 4-7 parts of Curcuma, 13-17 parts of Allium macrostemon, 7-9 parts of Ligusticum chuanxiong, and 7-14 parts of Radix Angelicae Pubescentis.

2. The Chinese medicine composition according to claim 1, characterized in that: The composition comprises the following components in parts by weight: 30 parts of Radix Phellodendri, 13 parts of Kelp, 20 parts of Os Dracaena, 30 parts of Concha Ostreae, 7 parts of Rhizoma Sparganii, 12.5 parts of Poria, 5.5 parts of Rhizoma Curcumae, 15 parts of Radix Allii Macrostemonis, 8 parts of Rhizoma Chuanxiong, and 10.5 parts of Radix Angelicae Dahuricae.

3. The method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The following steps are involved: (1) Mixing Tripterygium wilfordii with rice vinegar and drying the mixture to obtain vinegar-processed Tripterygium wilfordii; (2) The vinegar-processed Tripterygium wilfordii obtained in step (1) is mixed with Radix Psoraleae, Kelp, Ossobuci, Concha Ostreae, Poria, Rhizoma Curcumae, Radix Allii Macrostemonis, Rhizoma Chuanxiong and Rhizoma Cynomorii Herba, and the mixture is ground into powder to obtain a Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that: The mass ratio of the mixture of the three-edged swordfish and the rice vinegar in step (1) is 1:2-3.

5. The preparation method according to claim 3, characterized in that: The drying temperature in step (1) is 50-60° C., and the drying is performed until there is no liquid.

6. The preparation method according to claim 3, characterized in that: The particle size of the crushed product in step (2) is ≤15 mm.

7. Use of the Chinese medicine composition according to claim 1 or 2 or the Chinese medicine composition prepared by the preparation method according to any one of claims 3 to 6 in preparing drugs for treating pulmonary nodules.

8. A drug for treating pulmonary nodules, characterized in that: The medicine comprises the Chinese medicine composition according to claim 1 or 2 and pharmaceutically acceptable excipients.

9. The drug according to claim 8, characterized in that: The medicine is an oral preparation.

10. The drug according to claim 9, characterized in that: The oral preparations include tablets, capsules, granules, pills or decoctions.

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