Traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis and preparation method thereof

Abstract

The invention belongs to the technical field of Chinese herbal medicines, and particularly relates to a traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis and a preparation method thereof. The traditional Chinese medicine herbal composition comprises lily, dark plum, dried orange peel, perillaseed, platycodon grandiflorum, poria cocos, Chinese date, fried almond, donkey-hide gelatin beads, ophiopogon root, asparagus cochinchinensis, loquat leaf, green olive, semen brassicae, schisandra chinensis, radix glycyrrhizae preparata, fried white mulberry root-bark, fried thunberg fritillary bulb and pear flower honey. The traditional Chinese medicinal materials are combined to achieve the conditioning and maintenance effects of tonifying atmosphere in the chest, nourishing yin, moistening the lung, regulating qi-flowing for eliminating phlegm, clearing away the lung-heat, disinhibiting diaphragm, breaking stagnation, smoothing qi activity, astringing qi, promoting the secretion of saliva or body fluid, clearing metal, dissolving water and relaxing bowel for the pneumoconiosis and the pulmonary fibrosis, and the curative effects of the pneumoconiosis and the pulmonary fibrosis are comprehensively improved. Besides, the traditional Chinese medicine composition is a pure traditional Chinese medicine formula, is high in safety and exact in curative effect, and has a wide application prospect in the field of prevention and treatment of occupational diseases.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and specifically relates to a traditional Chinese herbal composition for treating pneumoconiosis and pulmonary fibrosis and its preparation method. Background Technology

[0002] Pneumoconiosis is a systemic disease primarily characterized by diffuse fibrosis of the lungs, caused by long-term inhalation of large amounts of dust. Its occurrence is closely related to the occupational environment, mainly seen in high-dust industries such as mining, stone processing, and ceramic manufacturing, and it ranks first among occupational diseases in my country. As a chronic and irreversible disease, pneumoconiosis is usually difficult to cure completely once it develops. As the disease progresses, patients often experience symptoms such as difficulty breathing, coughing, and chest pain, along with accompanying symptoms such as fatigue, night sweats, hemoptysis, and limb edema, severely impacting their physical and mental health.

[0003] The epidemiological characteristics of pneumoconiosis reveal the grim reality of this occupational disease and the urgency of its prevention and control. While the etiology of pneumoconiosis is clear, its long-term and insidious nature makes its prevention and control challenging. The pathogenesis of the disease mainly involves diffuse fibrosis of the lung tissue, severely affecting lung function and leading to a decline in patients' quality of life and increased economic burden. Pulmonary fibrosis is the most severe and typical pathological feature of pneumoconiosis. Despite extensive research on pneumoconiosis over the years, the incidence rate remains high, and currently there are still no drugs or measures that can clearly and effectively delay or block the progression of pneumoconiosis and pulmonary fibrosis.

[0004] Currently, conventional treatments for pneumoconiosis typically include: antibiotics for anti-infection intervention, corticosteroids and theophylline for anti-inflammatory effects, bronchodilators to improve airway stress response and enhance pulmonary ventilation, and oxygen support for patients with dyspnea. While these treatments offer some relief, they only alleviate the outward symptoms and cannot completely cure the disease. Patients often experience relapses or recurrences after discontinuing medication, and long-term drug treatment can lead to decreased drug sensitivity and tolerance, limiting further clinical application.

[0005] With the vigorous development of traditional Chinese medicine (TCM) technology, TCM prescriptions have increasingly attracted attention due to their advantages such as fewer side effects and comprehensive effects. Therefore, developing an effective TCM prescription for the prevention and treatment of pulmonary fibrosis and pneumoconiosis has significant theoretical and practical implications in the field of occupational disease prevention and treatment. Summary of the Invention

[0006] To overcome the shortcomings of existing technologies, the present invention aims to provide a traditional Chinese medicine composition for treating pneumoconiosis and pulmonary fibrosis, and its application. The traditional Chinese medicine composition provided by the present invention has good therapeutic effects on pneumoconiosis and pulmonary fibrosis.

[0007] In the analysis of pneumoconiosis, traditional Chinese medicine (TCM) emphasizes the interaction between internal and external factors, believing that the occurrence of pneumoconiosis is not solely caused by external factors, but rather is the result of the combined effects of internal and external factors. From the perspective of TCM, the etiology of pneumoconiosis can be summarized into several aspects, including invasion of external pathogens, physical weakness, qi stagnation and blood stasis, and internal generation of phlegm and dampness.

[0008] Firstly, external pathogens invade: The main external cause of pneumoconiosis refers to industrial dust in the environment. This dust enters the lungs through the respiratory tract, causing damage to lung tissue. Traditional Chinese medicine believes that dust, as an external pathogen, first attacks the lung's defensive qi, leading to damage to lung qi and dysfunction of the lung's defensive qi, thereby affecting the lung's functions of clearing and dispersing, forming "lung accumulation." Dust accumulates in the lungs, eventually forming phlegm and turbidity, obstructing the flow of qi, and becoming the basis for the development of pneumoconiosis.

[0009] Secondly, weak constitution: Constitutional factors play an important role in the occurrence and development of pneumoconiosis. Traditional Chinese medicine believes that individuals with weak constitutions, especially those with lung qi deficiency, spleen deficiency, and dampness accumulation, have reduced resistance to external pathogens, increasing the risk of developing pneumoconiosis. A weak constitution leads to weakened lung defense mechanisms, making it unable to effectively remove inhaled dust, thus easily causing the disease.

[0010] Thirdly, Qi stagnation and blood stasis: Qi stagnation and blood stasis are important factors in the pathogenesis of pneumoconiosis. Long-term inhalation of dust damages lung Qi, leading to stagnation of Qi and obstruction of blood flow, resulting in blood stasis. Blood stasis in the lungs affects the circulation of Qi and blood in lung tissue, accelerates the process of pulmonary fibrosis, and is one of the important pathogenic mechanisms of pneumoconiosis progression.

[0011] Fourth, the internal generation of phlegm and dampness: The generation of phlegm and dampness is closely related to the dysfunction of the lungs and spleen. The lungs govern qi, and the spleen governs transportation and transformation. Long-term dust inhalation not only damages lung qi but also affects the spleen's transportation and transformation functions, leading to the failure to transform dampness and the internal generation of phlegm and dampness. The accumulation of phlegm and dampness in the lungs obstructs the lung qi's downward flow and aggravates the symptoms of pneumoconiosis.

[0012] Fifth, traditional Chinese medicine also emphasizes the role of emotional factors in the development of pneumoconiosis. Long-term mental stress and emotional depression can damage the heart and lungs, affect the circulation of qi and blood, and make the disease more likely to occur and progress.

[0013] Therefore, in the treatment of pneumoconiosis, traditional Chinese medicine emphasizes syndrome differentiation and treatment. It not only targets the disease itself, but also considers the patient's constitution, emotions and other factors, and adopts comprehensive treatment measures to achieve the goal of treating both the symptoms and the root cause.

[0014] Based on the aforementioned traditional Chinese medicine theories regarding the pathogenesis of pneumoconiosis, the technical solution proposed in this invention is as follows: A traditional Chinese herbal composition for treating pneumoconiosis and pulmonary fibrosis is mainly made from the following raw materials in parts by weight: lily bulb 5-12 parts, dried plum 3-12 parts, dried tangerine peel 1-6 parts, perilla seed 2-8 parts, platycodon root 6-15 parts, poria cocos 3-10 parts, jujube 5-12 parts, roasted apricot kernel 2-8 parts, donkey-hide gelatin beads 3-10 parts, ophiopogon japonicus 5-15 parts, asparagus cochinchinensis 5-15 parts, loquat leaf 3-10 parts, green olive 2-8 parts, white mustard seed 3-12 parts, schisandra chinensis 2-8 parts, roasted licorice root 3-12 parts, roasted mulberry bark 3-10 parts, roasted fritillaria thunbergii 5-15 parts, and pear blossom honey 3-12 parts.

[0015] The medicinal properties and effects of each herbal raw material in the herbal composition of the present invention are described below: Lily: It is sweet and neutral in nature, moistens the lungs and relieves cough, clears the heart and calms the mind. The function of lily is to benefit qi and promote qi circulation, nourish the body and dispel pathogens. It can replenish earth and clear metal, stop cough, promote urination, clear heat in the lungs and stomach and regulate water passages, and drain stagnant heat.

[0016] Ume plum: It is sour and warm in nature, and has the functions of astringing and generating fluids, astringing lung qi, astringing deficiency fire, and guiding qi back to its origin.

[0017] Dried tangerine peel: It is bitter, pungent and warm in nature. It is good at regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It can disperse and drain, warm and nourish. It can eliminate diaphragmatic qi, resolve phlegm and saliva, harmonize the spleen and stop cough. It is essential for qi deficiency and phlegm stagnation, taking advantage of its function of regulating qi and drying dampness.

[0018] Perilla seed: It is pungent and warm in nature, and can lower qi and eliminate phlegm, moisten the lungs and widen the intestines, clear the upper and lower parts of the body, and is effective in treating phlegm stagnation, relieving phlegm and wheezing, and promoting bowel movements. It is suitable to be used with dried tangerine peel.

[0019] Platycodon grandiflorus: It is bitter and pungent in nature. It opens up and disperses lung qi, eliminates phlegm and drains pus. It not only opens up the blockage of lung qi, but also disperses the stagnation of heart qi. It has both ascending and descending properties, and is used as a boat and oars, performing the function of an assistant and guide.

[0020] Poria cocos: It is sweet, bland and neutral in nature. It promotes diuresis and eliminates dampness, benefits the spleen and stomach, calms the mind and soothes the nerves. Its sweetness can nourish and its blandness can promote diuresis. It can not only open the orifices and eliminate dampness, but also open the heart and improve intelligence. It can also guide turbidity and generate fluids. When it eliminates dampness, it expels water and dries the spleen. It nourishes the middle and strengthens the stomach. When the earth element is strong, it generates metal. It treats the root cause of phlegm and is an essential medicine for promoting diuresis and eliminating dampness.

[0021] Jujube: It is sweet and warm in nature, and can invigorate the spleen and stomach, replenish qi and generate fluids, harmonize yin and yang, regulate the body's defenses, strengthen the spleen and stomach, nourish blood and liver, moisten the heart and lungs, and replenish qi. It is both powerful and detoxifying, and is good at replenishing the essence of the Taiyin and transforming the qi of the Yangming. It can generate fluids, moisten the lungs and eliminate dryness, nourish blood and liver and extinguish wind. It is suitable for all kinds of deficiency and fatigue.

[0022] Roasted almonds: They are bitter and warm in nature, and can stop coughing and eliminate phlegm, relieve asthma and moisten the intestines. Almonds can disperse and descend, so they can relieve muscle tension, dispel wind, lower qi, moisten dryness and eliminate stagnation. They have the ability to disperse wind and cold, and also have the function of lowering qi and relieving asthma. They are pungent to disperse evil, bitter to lower qi, moist to clear constipation, and warm to promote the elimination of stagnation and phlegm, and can relieve stagnation and regulate qi.

[0023] Donkey-hide gelatin beads: They are sweet and neutral in nature, nourish yin and blood, clear the lungs and benefit yin, nourish the spirit and liver, replenish essence and strengthen the kidneys, and strengthen muscles and tendons.

[0024] Ophiopogon japonicus: It is sweet and cold in nature, nourishes yin and moistens the lungs, clears the heart and relieves irritability, benefits the stomach and promotes the production of body fluids. Ophiopogon japonicus drains the latent fire in the lungs, clears the heat evil in the stomach, replenishes the heart qi, benefits the essence and strengthens yin, reduces deficiency heat, relieves thirst, moistens lung dryness, and relieves cough. It is a wonderful product for protecting the lungs and nourishing the stomach.

[0025] Asparagus: It is sweet, bitter, and cold in nature. It nourishes yin and moistens dryness, clears the lungs and reduces fire. Its moistening and cooling properties clear away lung heat and transform water into yin. It is mainly used to treat lung heat. Ophiopogon japonicus enters the heart to clear the heart and reduce fire, while Asparagus enters the kidneys to nourish the kidney essence, allowing the lungs to receive the full qi of the mother organ. Therefore, it has a special effect in eliminating phlegm.

[0026] Loquat leaves: They are bitter and cool in nature, clear the lungs and stomach, lower qi and resolve phlegm. They can be used to protect the lungs and regulate the body, clear the turbid qi and open the middle jiao, and treat all kinds of evils such as wind-heat, damp-heat, summer heat and dryness.

[0027] Green olives: They are sweet, sour, and neutral in nature. They clear the lungs and soothe the throat, promote the production of body fluids and quench thirst, and aid digestion and detoxify.

[0028] White mustard seed: It is pungent and warm in nature. Pungent can enter the lungs, and warm can disperse. Therefore, it has the functions of benefiting qi and resolving phlegm, warming the middle and dispelling cold, unblocking the meridians and relieving pain, reducing swelling and dispelling evil. It is especially good at removing phlegm from under the skin and outside the membrane.

[0029] Schisandra chinensis: It is sour and warm in nature, and astringes the lungs and nourishes the kidneys. It has all five flavors, but sourness is the most prominent. Sour and salty flavors enter the liver and nourish the kidneys, bitter and pungent flavors enter the heart and nourish the lungs, and sweet flavors enter the middle jiao and benefit the spleen and stomach. It enters the lungs to generate fluids and replenish the source, and enters the kidneys to strengthen the essence and nourish the marrow.

[0030] Prepared licorice root: It is warm in nature and sweet in taste. It has the most complete earth energy. All things are born from the earth and return to the earth to transform. Therefore, it can detoxify all poisons and has the function of regulating the spleen and stomach.

[0031] Stir-fried mulberry bark: It is sweet and cold in nature, and can purge the lungs and relieve asthma, promote diuresis and reduce swelling. Its sweetness strengthens the original qi and replenishes deficiency, while its pungentness purges the lung qi and stops coughing. It disperses lung heat and eliminates asthma and fullness, and removes all wind and water qi.

[0032] Fried Fritillaria thunbergii: It is bitter and cold in nature, clears heat and resolves phlegm, disperses nodules and detoxifies. Fritillaria thunbergii is bitter and cold, clears heat and drains downward, and can disperse nodules. It is mainly used for phlegm nodules caused by qi stagnation.

[0033] Pear blossom honey: It is sweet and neutral in nature, nourishes the middle and moistens dryness, relieves pain and detoxifies; honey is made from the essence of hundreds of flowers, nourishes the five internal organs, moistens the three jiaos, and harmonizes the effects of hundreds of medicines, with the same effect as licorice; its aroma is clear and mild, and its taste is pure and sweet. It is suitable for treating various diseases of the spirit, qi and blood, cold and heat, deficiency and excess, yin and yang, internal and external.

[0034] As a preferred embodiment, the herbal composition for treating pneumoconiosis and pulmonary fibrosis is mainly made from the following raw materials in parts by weight: 6 parts lily bulb, 6 parts dried plum, 3 parts dried tangerine peel, 3 parts perilla seed, 8 parts platycodon root, 6 parts poria cocos, 5 parts jujube, 3 parts roasted apricot kernel, 3 parts donkey-hide gelatin beads, 6 parts ophiopogon japonicus, 6 parts asparagus root, 3 parts loquat leaf, 3 parts green olive, 3 parts white mustard seed, 3 parts schisandra fruit, 6 parts roasted licorice root, 8 parts roasted mulberry bark, 8 parts roasted fritillaria thunbergii, and 6 parts pear blossom honey.

[0035] A method for preparing a traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis as described above includes the following steps: (1) Take the following ingredients in the formula amount: lily bulb, dried plum, dried tangerine peel, perilla seed, platycodon root, poria cocos, jujube, stir-fried apricot kernel, donkey-hide gelatin beads, ophiopogon japonicus, asparagus cochinchinensis, loquat leaf, green olive, white mustard seed, schisandra chinensis, roasted licorice root, stir-fried mulberry bark, and stir-fried fritillaria thunbergii. Mix them and then pulverize them to obtain ultrafine powder of Chinese medicine. (2) Mix the Chinese herbal ultrafine powder with water and stir, then perform a stirring and maturation process, then filter, add pear blossom honey and mix, and perform a second stirring and maturation process to obtain the Chinese herbal liquid; (3) The Chinese medicine liquid is sterilized to obtain the Chinese herbal composition for treating pneumoconiosis and pulmonary fibrosis.

[0036] As a preferred method, the pulverization process is cryogenic pulverization; the mesh size of the ultrafine powder of the traditional Chinese medicine is 800-1200 mesh. Further, the cryogenic pulverization involves soaking the raw materials of the traditional Chinese medicine in liquid nitrogen for 2-10 minutes before pulverization.

[0037] As a preferred method, the temperature of the single-stage stirring and maturation treatment is 70~90℃, and the time is 2~6 hours. In this step, the plant cells of the ultrafine powder are soaked and expanded through a single-stage stirring and maturation treatment.

[0038] As a preferred embodiment, the primary stirring and maturation process is carried out in a maturation tank; a colloid mill is connected in parallel outside the maturation tank for synchronous shearing and cell wall breaking.

[0039] As a preferred method, the filtration is performed using a 200-400 mesh filter.

[0040] As a preferred method, the temperature of the secondary stirring and maturation treatment is 100~120℃, and the time is 2~6h.

[0041] As a preferred method, the sterilization temperature is 105~115℃ and the time is 30~60min.

[0042] The preparation method of the herbal composition of this invention draws on the principle of the "ultra-high pressure micro-explosion process" in the cutting-edge technology of traditional Chinese medicine. Specifically, this invention preferably uses an ultra-low temperature pulverization combined with a colloid mill cell wall breaking process to achieve the same process effect as the ultra-high pressure micro-explosion process in preparing herbal compositions under normal temperature and pressure conditions, with a yield of 100% of the effective components of the raw materials.

[0043] Compared with traditional water extraction and alcohol extraction processes (effective component yield 26-31%), as well as supercritical extraction and ultrasonic extraction processes (effective component yield 50-55%), the preparation process of this invention has the advantages of reducing raw material consumption by 4-5 times, achieving 100% effective component yield, producing highly effective drugs, and being pollution-free (no waste residue, no wastewater, no waste gas). This process not only reduces the raw material cost of the product and improves the utilization rate of social resources, but also greatly enhances the efficacy of the drug in treating diseases.

[0044] The use of a traditional Chinese medicine herbal composition as described above or a traditional Chinese medicine herbal composition prepared by the method described above in the preparation of a drug for treating pneumoconiosis and pulmonary fibrosis, wherein the drug is a traditional Chinese medicine herbal liquid oral preparation.

[0045] The technical solution of the present invention has the following advantages and beneficial effects: The herbal composition of this invention is based on the comprehensive pathogenesis of pneumoconiosis and pulmonary fibrosis, as well as many years of clinical experience. It mainly aims to nourish and protect the internal organs and relieve dysfunction of the five internal organs and six bowels, and eliminate internal pathogenic factors. It starts by regulating the functions of various organs such as the lungs, heart, kidneys, and spleen, providing sufficient nutrition, enhancing physical strength, balancing qi and blood, balancing yin and yang, promoting the metabolism of the five internal organs and six bowels, and restoring the normal function of the internal organs.

[0046] In this formula, lily bulb, donkey-hide gelatin, asparagus root, ophiopogon root, jujube, and licorice root are used as the principal ingredients to greatly replenish qi and blood, nourish yin and moisten the lungs; tangerine peel, apricot kernel, poria cocos, perilla seed, white mustard seed, green olive, and loquat leaf are used as the assistant ingredients to regulate qi and resolve phlegm, promote the smooth flow of qi, clear the lungs and benefit the diaphragm; mulberry bark, dried plum, fritillaria thunbergii, schisandra fruit, and pear blossom honey are used as the adjuvant ingredients to astringe qi and generate fluids, break up stagnation and knots, and moisten the intestines and promote bowel movements; and platycodon root is used to promote the upward and downward movement of qi, acting as a vessel and a facilitator. The combined effects of these herbs target the causes and symptoms of pneumoconiosis and pulmonary fibrosis, fundamentally enhancing physical strength, effectively replenishing lung qi, moistening and clearing the lungs, breaking up stagnation and knots, regulating qi and resolving phlegm, and promoting expectoration, while also moistening the intestines and promoting bowel movements, thus comprehensively improving the treatment efficacy of pneumoconiosis and pulmonary fibrosis.

[0047] Experiments have confirmed that the herbal composition of traditional Chinese medicine provided by this invention for treating pneumoconiosis and pulmonary fibrosis has the following clear therapeutic effects in treating and improving the condition of patients with pneumoconiosis: ① Expectorant and expectorant effect: After use, patients experience increased coughing, expectorating smooth, round phlegm pellets and thick, brownish-black phlegm. ② Lung-moistening and lung-clearing effect: After use, patients experience deeper inhalation, expanded lung capacity, and smoother breathing. ③ Enhanced physical strength effect: After use, patients experience improved breathing, increased blood oxygen saturation, and enhanced physical strength. ④ Enhanced immunity effect: After use, patients experience fewer colds or are less prone to catching colds. ⑤ No side effects: After consumption, patients experience no adverse reactions, feel stronger, and gain weight.

[0048] Therefore, this invention uses traditional Chinese herbal raw materials, which have a significant effect on improving pneumoconiosis and its complications. It is also safe to consume and has no adverse reactions. At the same time, the raw materials of the composition are common and widely available, and the processing technology is stable, which can be used for large-scale industrial processing and production. It has broad application prospects in the field of occupational disease prevention and treatment. Attached Figure Description

[0049] Figure 1 The results of weight tests on mice in the model group and drug intervention group in this invention; Figure 2 The images show the immunohistochemical (IHC) staining results of lung tissue from mice in the model group and drug intervention group in this invention. Figure 3 The results of Masson staining are shown in the lung tissue of mice in the blank control group, model group, and drug intervention group in this invention. Figure 4 The results of hematoxylin-eosin (HE) staining of lung tissue from mice in the blank control group, model group, and drug intervention group in this invention are shown. Detailed Implementation

[0050] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0051] Example 1 This embodiment provides a traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis, made from the following parts by weight of traditional Chinese medicine raw materials: 6 parts lily bulb, 6 parts dried plum, 3 parts dried tangerine peel, 3 parts perilla seed, 8 parts platycodon root, 6 parts poria cocos, 5 parts jujube, 3 parts stir-fried apricot kernel, 3 parts donkey-hide gelatin beads, 6 parts ophiopogon japonicus, 6 parts asparagus root, 3 parts loquat leaf, 3 parts green olive, 3 parts white mustard seed, 3 parts schisandra fruit, 6 parts roasted licorice root, 8 parts stir-fried mulberry bark, 8 parts stir-fried fritillaria thunbergii, and 6 parts pear blossom honey.

[0052] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis, including the following steps: (1) Take the prescribed amount of Chinese herbal raw materials (including lily bulb, dried plum, dried tangerine peel, perilla seed, platycodon root, poria cocos, jujube, stir-fried apricot kernel, donkey-hide gelatin beads, ophiopogon japonicus, asparagus cochinchinensis, loquat leaf, green olive, white mustard seed, schisandra chinensis, roasted licorice root, stir-fried mulberry bark, and stir-fried fritillaria thunbergii) and mix them. Then soak them in liquid nitrogen for 3 minutes and then pulverize them to obtain Chinese herbal ultrafine powder of 800 mesh to 1000 mesh.

[0053] (2) Add the ultrafine powder of Chinese medicine to the maturation kettle, add 10 times the mass of the ultrafine powder of Chinese medicine with room temperature purified water, mix and stir for 2 hours to allow the ultrafine powder particles of Chinese medicine to swell upon soaking in water, then stir and heat to 80°C, start the double parallel colloid mill outside the kettle, and maintain the temperature at 80°C for 4 hours to stir and mature, so as to break the plant cell walls of the ultrafine powder particles of Chinese medicine and obtain flocculent liquid. Then filter the flocculent liquid in the maturation kettle through a 300-mesh filter to remove the microparticles in the flocculent liquid. Then add the prescribed amount of pear blossom honey to the maturation kettle, heat the maturation kettle to 105°C, maintain the temperature at 105°C for 4 hours to stir and mature, thus completing the liquid maturation process and obtaining the matured Chinese medicine liquid.

[0054] (3) The matured Chinese herbal medicine liquid is filled into 50mL glass bottles, then sterilized by high-temperature steam at 108℃ for 45min. Finally, the sterilized product is labeled and packaged to obtain the Chinese herbal medicine composition for the treatment of pneumoconiosis and pulmonary fibrosis. According to the calculation, each 50mL of the Chinese herbal medicine composition contains 6g of medicine.

[0055] Experimental Example 1: Animal Experiment 1. Test materials Main experimental equipment: Biosafety cabinet, IVC independently ventilated isolation cage, tissue homogenizer (VCX130, USA), TGuide S96 fully automated nucleic acid extractor (model: OSE-S96). Experimental samples: The herbal composition of traditional Chinese medicine in Example 1 of this invention (6g / 50mL). Experimental animals: BALB / c mice, 8-9 weeks old, female, purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. Main reagents and consumables: DMEM culture medium (Gibco), fetal bovine serum (Gibco), 4% paraformaldehyde (Sigma), magnetic bead-based viral DNA / RNA extraction kit (catalog number: DP-438-02, Tiangen Biotech Co., Ltd.), 96-well deep-well plates, magnetic rod sleeves, PCR tubes. Related experiments were conducted in a biosafety level 3 laboratory.

[0056] 2. Test methods BALB / c mice were divided into three groups: a blank control group, a model group, and a drug intervention group. The blank control group consisted of healthy mice without modeling, while the model and drug intervention groups consisted of mice undergoing modeling treatment. Before the experiment, mice in the model and drug intervention groups underwent tracheal puncture and bleomycin infusion to establish animal models of severe pneumonia and simulated pneumoconiosis and pulmonary fibrosis. After successful model establishment, mice in the drug intervention group were treated with the herbal composition from Example 1 via gavage, twice daily (morning and evening), 300 μL per mouse each time, for 15 days. The model and blank control groups were treated with 300 μL of physiological saline per mouse via gavage. The gavage time and frequency were consistent for all groups. Body weight was measured at 9:00 AM and 3:00 PM daily. On day 16 of the intervention, mice in the blank control, model, and drug intervention groups were euthanized, and lungs were harvested for examination. Simultaneously, mouse tissue was fixed in 4% paraformaldehyde solution for later pathological examination.

[0057] 3. Weight test At the same time on days 1, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 of the drug administration cycle, the body weight of mice in the drug intervention group and the model group was measured, and changes in body weight and mortality were recorded. Results are as follows: Figure 1 As shown.

[0058] Depend on Figure 1 It was observed that mice that were not administered the herbal composition of Example 1 of this invention by gavage experienced a continuous decrease in average weight, from 22g to 12g, and 40% of the mice died during the acute exacerbation of pulmonary fibrosis. The remaining mice barely maintained a very low weight and barely survived. Mice administered the drug of Example 1 of this invention by gavage showed good survival. The mice's weight decreased from an initial 22g to 15g. After gavage administration of the drug of Example 1, the average weight of the mice steadily recovered to the normal value of 19-20g, and no mouse deaths were observed. They successfully passed through the acute and dangerous period of severe pneumonia and pulmonary fibrosis.

[0059] 4. Staining test After the drug administration cycle, lung tissues from mice in the blank control group, model group, and drug intervention group were subjected to immunohistochemical (IHC) staining, Massom staining, and hematoxylin-eosin (HE) staining, respectively. The results of IHC staining, Massom staining, and HE staining are shown below. Figure 2 , Figure 3 , Figure 4 As shown. Figure 3 In the middle, the indigo-stained part is fibrous tissue.

[0060] Depend on Figure 2 It can be seen that, 15 days after drug intervention, anatomical examination showed that the drug of this invention can inhibit the fibroproliferative lesions of pneumonia. From Figure 3 It can be seen that, 15 days after drug intervention, anatomical resection examination showed that the drug of this invention can inhibit pulmonary fibrosis-like lesions. Figure 4 It can be seen that, 15 days after drug intervention, anatomical examination showed that the drug of the present invention can inhibit the exudative lesions of pneumonia.

[0061] In summary, the inflammatory response and degree of pulmonary fibrosis in the drug intervention group mice were significantly reduced compared with the model group, indicating that the drug provided by this invention can effectively inhibit the process of pulmonary fibrosis.

[0062] Experimental Example 2: Clinical Validation 1. Test Methods The Emergency General Hospital organized a clinical trial involving 180 patients with pneumoconiosis from coal mines in Jixi, Heilongjiang and Huaibei, Anhui. Two drugs were used in the clinical trial: tetrandrine (a Western medicine) and the herbal composition (traditional Chinese medicine) described in Example 1 of this invention.

[0063] 2. Treatment Plan Patients with pneumoconiosis were divided into two groups, A and B. Group A: Patients took the herbal composition of Example 1 of this invention orally, 16.67 mL (1 / 3 bottle) three times daily; patient condition was observed at the end of each month, for a total of 4 observation points (4 months). Group B: Patients took Hanfang Hexamethylenetetramine tablets orally, 100 mg three times daily after meals; treatment lasted 6 days, followed by a 1-day break; patient condition was observed at the end of each month, for a total of 4 observation points (4 months). Changes in cough, chest pain, shortness of breath (dyspnea), and cold symptoms were assessed and analyzed after 4 months of treatment.

[0064] 3. Results of clinical trials The clinical observation results of the two groups of patients with pneumoconiosis were shown in Table 1.

[0065] Table 1. Treatment efficacy in patients with pneumoconiosis

[0066] As shown in Table 1, after taking tetrandrine, the respiratory distress symptoms of 90 patients with pneumoconiosis were only initially relieved; other symptoms such as coughing and susceptibility to colds did not improve. After taking the herbal composition of this invention, the 90 patients showed significant improvement in respiratory status, coughing, chest pain, and cold resistance, indicating that the herbal composition of this invention has a good therapeutic effect on pneumoconiosis.

[0067] Experimental Example 3: Typical Case The treatment for typical cases is as follows: twice a day, 50 mL (containing 6 g of medicine) of the herbal composition of Example 1, orally, for a period of 45-90 days.

[0068] Typical Case 1: Male, 45 years old, coal miner. Diagnosed with early stage of coal worker's pneumoconiosis, presenting with cough, sputum production, and mild dyspnea. Diagnosis: Lung qi stagnation and phlegm-dampness obstruction. Treatment plan: The herbal composition of this invention. Efficacy: After two months of treatment, the patient's cough and sputum production symptoms were significantly reduced, dyspnea was relieved, and pulmonary function tests showed an improvement in vital capacity. Analysis: By clearing the lungs and resolving phlegm, the treatment improved pulmonary blood circulation, promoted sputum expectoration, and reduced pulmonary inflammation, thereby alleviating the symptoms of pneumoconiosis.

[0069] Typical Case 2: Female, 50 years old, cement factory worker. Diagnosed with mid-stage cement pneumoconiosis, presenting with shortness of breath, fatigue, and pale complexion. Diagnosis: Lung and spleen qi deficiency, qi stagnation and blood stasis. Treatment plan: The herbal composition of this invention. Efficacy: After three months of treatment, the patient's shortness of breath and fatigue significantly improved, her complexion became rosy, and pulmonary function tests showed some recovery in lung tissue elasticity. Analysis: By replenishing qi and blood, the microcirculation of lung tissue was improved, promoting the absorption of fibrotic tissue, thereby achieving the effect of alleviating the symptoms of pneumoconiosis.

[0070] Typical Case 3: Male, 60 years old, foundry worker. Diagnosed with late-stage foundry worker's pneumoconiosis, presenting with severe dyspnea, cough, and yellow sputum. Diagnosis: Lung Yin deficiency, dryness and heat damaging the lungs. Treatment: Herbal composition of this invention. Efficacy: After four months of treatment, the patient's dyspnea was relieved, cough and sputum symptoms lessened, quality of life significantly improved, and pulmonary function tests showed reduced lung inflammation. Analysis: By nourishing Yin and moistening dryness, the dryness and heat in the lungs were cleared, the inflammatory response in the lungs was reduced, the patient's respiratory function was improved, and the quality of life was enhanced.

[0071] Typical Case 4: Male, 45 years old, asbestos factory worker. Diagnosed with asbestosis, presenting with chest pain and dyspnea. Diagnosis: Lung cold and dampness, blood stasis. Treatment: Herbal composition of this invention. Efficacy: After two months of treatment, the patient's chest pain was significantly reduced, dyspnea symptoms improved, and pulmonary function tests showed improved pulmonary blood circulation. Analysis: By warming the Yang and dispelling cold, pulmonary blood circulation was improved, promoting the absorption of blood stasis, thereby alleviating the chest pain symptoms of pneumoconiosis.

[0072] Case 5: Male, 52 years old, coal miner. The patient was diagnosed with early-stage coal miner's pneumoconiosis 10 years ago, presenting with chronic cough, sputum production, and occasional dyspnea. Traditional Chinese medicine diagnosis was impaired lung qi circulation and internal obstruction of phlegm and dampness. Treatment: Herbal composition of this invention. Efficacy evaluation: After 12 weeks of treatment, pulmonary function tests showed an improvement in FEV1, and blood oxygen saturation increased from 92% to 96%. Symptom improvement: Cough and sputum production were significantly reduced, and dyspnea was significantly improved compared to before treatment. Quality of life assessment: According to the pneumoconiosis-specific quality of life questionnaire, the patient's quality of life score improved by 20 points. Safety evaluation: No significant adverse reactions; liver and kidney function and blood routine examination results were normal. Imaging evaluation: Chest CT showed slight improvement in pulmonary fibrosis, and high-resolution CT (HRCT) of the lungs showed slight signs of repair in the lung microstructure.

[0073] Case Study 6: A 48-year-old female cement factory worker. The patient was diagnosed with mid-stage cement pneumoconiosis, presenting with shortness of breath, fatigue, and pale complexion. Traditional Chinese medicine diagnosis indicated lung and spleen qi deficiency, qi stagnation, and blood stasis. Treatment regimen: The herbal composition of this invention. Efficacy evaluation: After 16 weeks of treatment, pulmonary function parameters FVC and FEV1 significantly improved, and blood oxygen saturation stabilized at 94%. Symptom improvement: Shortness of breath and fatigue were significantly reduced, and complexion became rosy. Quality of life assessment: The quality of life score improved by 18 points, and sleep quality improved. Safety evaluation: No adverse reactions were reported, and liver and kidney function were normal. Imaging evaluation: Chest CT showed a slight reversal in the degree of pulmonary fibrosis, and high-resolution CT (HRCT) of the lungs showed some recovery of lung tissue elasticity.

[0074] Case Study 7: A 65-year-old male foundry worker. The patient was diagnosed with late-stage foundry worker's pneumoconiosis, presenting with severe dyspnea, cough, and yellow sputum. Traditional Chinese medicine diagnosis indicated lung yin deficiency and lung dryness-heat. Treatment regimen: The herbal composition of this invention. Efficacy evaluation: After 20 weeks of treatment, vital capacity (VC) slightly improved, and blood oxygen saturation stabilized at 93%. Symptom improvement: Dyspnea lessened, and cough and sputum production were alleviated. Quality of life assessment: Quality of life score improved by 15 points, and emotional state improved. Safety evaluation: Mild gastrointestinal reactions occurred during treatment; liver and kidney function remained normal. Imaging evaluation: Chest CT showed significant reduction in lung inflammation, and high-resolution CT (HRCT) showed that lung microstructural changes were stabilizing.

[0075] The above-described typical case analyses demonstrate that the herbal composition of this invention, in the treatment of pneumoconiosis, not only improves patients' physiological function indicators and alleviates their clinical symptoms, but also enhances their quality of life, with good safety. Simultaneously, imaging assessments show varying degrees of improvement in pulmonary fibrosis, bringing new hope to pneumoconiosis patients. These case efficacy evaluations provide strong evidence supporting the application of the herbal composition of this invention in the treatment of pneumoconiosis.

[0076] In summary, the herbal composition provided by this invention can effectively improve the efficacy of pneumoconiosis and pulmonary fibrosis, and has broad application potential in the prevention and treatment of occupational diseases.

[0077] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese herbal composition for treating pneumoconiosis and pulmonary fibrosis, characterized in that, It is mainly made from the following ingredients in parts by weight: lily bulb 5-12 parts, dried plum 3-12 parts, dried tangerine peel 1-6 parts, perilla seed 2-8 parts, platycodon root 6-15 parts, poria cocos 3-10 parts, jujube 5-12 parts, roasted almond 2-8 parts, donkey-hide gelatin beads 3-10 parts, ophiopogon japonicus 5-15 parts, asparagus cochinchinensis 5-15 parts, loquat leaf 3-10 parts, green olive 2-8 parts, white mustard seed 3-12 parts, schisandra chinensis 2-8 parts, roasted licorice root 3-12 parts, roasted mulberry bark 3-10 parts, roasted fritillaria thunbergii 5-15 parts, and pear blossom honey 3-12 parts.

2. The traditional Chinese herbal composition for treating pneumoconiosis and pulmonary fibrosis according to claim 1, characterized in that, It is mainly made from the following ingredients in parts by weight: 6 parts lily bulb, 6 parts dried plum, 3 parts dried tangerine peel, 3 parts perilla seed, 8 parts platycodon root, 6 parts poria cocos, 5 parts jujube, 3 parts roasted almond, 3 parts donkey-hide gelatin beads, 6 parts ophiopogon japonicus, 6 parts asparagus root, 3 parts loquat leaf, 3 parts green olive, 3 parts white mustard seed, 3 parts schisandra fruit, 6 parts roasted licorice root, 8 parts roasted mulberry bark, 8 parts roasted fritillaria thunbergii, and 6 parts pear blossom honey.

3. A method for preparing a traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis as described in claim 1, characterized in that, Includes the following steps: (1) Take the following ingredients in the formula amount: lily bulb, dried plum, dried tangerine peel, perilla seed, platycodon root, poria cocos, jujube, stir-fried apricot kernel, donkey-hide gelatin beads, ophiopogon japonicus, asparagus cochinchinensis, loquat leaf, green olive, white mustard seed, schisandra chinensis, roasted licorice root, stir-fried mulberry bark, and stir-fried fritillaria thunbergii. Mix them and then pulverize them to obtain ultrafine powder of Chinese medicine. (2) Mix the Chinese herbal ultrafine powder with water and stir, then perform a stirring and maturation process, then filter, add pear blossom honey and mix, and perform a second stirring and maturation process to obtain the Chinese herbal liquid; (3) The Chinese medicine liquid is sterilized to obtain the Chinese herbal composition for treating pneumoconiosis and pulmonary fibrosis.

4. The method for preparing the traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis according to claim 3, characterized in that, The pulverization process is ultra-low temperature pulverization; the mesh size of the ultrafine powder of the traditional Chinese medicine is 800~1200 mesh.

5. The method for preparing the traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis according to claim 3, characterized in that, The temperature for the first stirring and maturation treatment is 70~90℃, and the time is 2~6h.

6. The method for preparing the traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis according to claim 3, characterized in that, The primary stirring and maturation process is carried out in a maturation tank; a colloid mill is connected in parallel outside the maturation tank for synchronous shearing and cell wall breaking.

7. A method for preparing a traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis according to any one of claims 3 to 6, characterized in that, The filtration is performed using a 200-400 mesh filter.

8. A method for preparing a traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis according to any one of claims 3 to 6, characterized in that, The secondary stirring and maturation treatment is carried out at a temperature of 100~120℃ for 2~6 hours.

9. A method for preparing a traditional Chinese medicine herbal composition for treating pneumoconiosis and pulmonary fibrosis according to any one of claims 3 to 6, characterized in that, The sterilization temperature is 105~115℃ and the time is 30~60min.

10. The use of the herbal composition of claim 1 or the herbal composition of claim 3 to 9 prepared by any one of the preparation methods in the preparation of a medicament for treating pneumoconiosis and pulmonary fibrosis, characterized in that, The drug is a traditional Chinese herbal liquid oral preparation.

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