Traditional Chinese medicine prescription for treating nodules and application thereof

Abstract

The invention discloses a traditional Chinese medicine prescription for treating nodules and application thereof. The traditional Chinese medicine prescription comprises the following raw material medicines: selfheal, bupleurum chinense, rhizoma pinellinae praeparata, thunberg fritillary bulb, radix scrophulariae, oyster, curcuma zedoary, spina gleditsiae, turtle shell and astragalus membranaceus. According to the traditional Chinese medicine prescription disclosed by the invention, the characteristics of the raw material medicines are utilized, the formula is reasonable, the proportioning is scientific, and the synergistic efficacy is achieved. The traditional Chinese medicine prescription disclosed by the invention takes'qi regulating, phlegm reducing, blood circulation promoting, blood stasis removing, hardness softening and stagnation dissipating 'as a treatment principle, and has a good effect on treating various nodules.

Description

Technical Field

[0001] This invention belongs to the field of biomedical technology, specifically relating to a traditional Chinese medicine formula for treating nodules and its application. Background Technology

[0002] Nodules are localized space-occupying lesions on imaging that differ in density from surrounding tissues. Their morphological characteristics typically include round, oval, or irregular shapes. Due to similar pathogenesis, nodular lesions can frequently occur in multiple organs, including the lungs, thyroid, and breast. In recent years, the incidence of nodules has been increasing annually, with a high rate of malignant transformation, making it a significant public health issue in my country.

[0003] Modern medicine's treatment strategies for nodules mainly include regular follow-up, minimally invasive surgery, and surgical resection. The vast majority of patients' nodules lack clear indications for intervention or have risk factors for malignant transformation, and can only undergo regular follow-up observation. This passive management model, with the potential risk of malignant transformation, often places a significant psychological burden on patients and may exacerbate disease progression due to anxiety. Minimally invasive surgery is suitable for suspected malignant nodules, leaving no scars, but it is only applicable to small benign nodules, cannot completely eliminate the lesions, and may require multiple treatments. Surgical resection can completely remove the lesions, but removing the thyroid gland at the neck will leave a scar and may damage nerves or parathyroid glands, leading to lifelong hypothyroidism requiring medication; removing the breast affects the appearance of the breast and carries the risk of bleeding and infection; removing lung tissue may affect respiratory function, causing various uncomfortable symptoms such as cough, fatigue, and insomnia.

[0004] Clinical practice has shown that traditional Chinese medicine (TCM) has positive effects on reducing nodule size, lowering the probability of malignancy, and alleviating anxiety. Thyroid nodules, pulmonary nodules, and breast nodules share similar etiologies and pathogenesis. TCM treatment principles, such as regulating qi and resolving phlegm, promoting blood circulation and removing blood stasis, and softening and dispersing nodules, can not only significantly shrink nodules and reduce the probability of malignancy, but also effectively improve the physical condition of patients prone to nodules. This provides new insights into the prevention and treatment of nodular diseases and has significant clinical implications. Summary of the Invention

[0005] To overcome the shortcomings of the prior art, the present invention aims to provide a traditional Chinese medicine formula that can prevent or treat nodules.

[0006] The first aspect of this invention provides a traditional Chinese medicine formula for treating nodules, the formula mainly containing Prunella vulgaris, Bupleurum chinense, Pinellia ternata, Fritillaria thunbergii, Scrophularia ningpoensis, Ostrea gigas, Curcuma zedoaria, Gleditsia sinensis, Trionyx sinensis, and Astragalus membranaceus.

[0007] Furthermore, the traditional Chinese medicine formula may also include one or more of the following medicinal materials: Sparganium rhizome, white mustard seed, centipede, Scutellaria baicalensis, Cyperus rotundus, Ligusticum chuanxiong rhizome, tangerine peel, white peony root, scabra bark, Codonopsis pilosula root, raw Atractylodes macrocephala rhizome, hemp seed, dandelion, Gynostemma pentaphyllum, Cassia seed, seaweed, kelp, earthworm, Houttuynia cordata, stir-fried Atractylodes macrocephala rhizome, Solanum nigrum, Scutellaria barbata rhizome, Panax notoginseng, licorice root, stir-fried Bombyx mori, turmeric, Vaccaria segetalis rhizome, Anemarrhena asphodeloides rhizome, cinnamon twig, salted tangerine seed, and litchi seed.

[0008] Furthermore, the nodules include thyroid nodules, lung nodules, and breast nodules.

[0009] Furthermore, the traditional Chinese medicine formula contains the following raw materials in the following weight proportions: 15-30 parts of Prunella vulgaris, 9-12 parts of Bupleurum chinense, 9-12 parts of Pinellia ternata, 10-15 parts of Fritillaria thunbergii, 10-15 parts of Scrophularia ningpoensis, 20-30 parts of Ostrea gigas, 10-15 parts of Curcuma zedoaria, 20-30 parts of Gleditsia sinensis thorns, 15-30 parts of Trionyx sinensis, and 15-30 parts of Astragalus membranaceus.

[0010] Furthermore, the traditional Chinese medicine formula contains the following ingredients in the indicated weight proportions: 20 parts of Prunella vulgaris, 9 parts of Bupleurum chinense, 9 parts of Pinellia ternata, 10 parts of Fritillaria thunbergii, 10 parts of Scrophularia ningpoensis, 20 parts of Ostrea gigas, 10 parts of Curcuma zedoaria, 20 parts of Gleditsia sinensis thorns, 20 parts of Trionyx sinensis shell, and 15 parts of Astragalus membranaceus.

[0011] Furthermore, the traditional Chinese medicine formula may also contain one or more raw materials in the following weight proportions: 10 parts of Sparganium rhizome, 20 parts of white mustard seed, 1-2 parts of centipede, 10 parts of Scutellaria baicalensis, 15 parts of Cyperus rotundus, 10 parts of Ligusticum chuanxiong, 10 parts of dried tangerine peel, 10 parts of white peony root, 10 parts of dried tangerine peel, 10 parts of dried tangerine peel, 10-20 parts of Codonopsis pilosula, 30 parts of raw Atractylodes macrocephala, 10 parts of hemp seed, 30 parts of dandelion, 15 parts of Gynostemma pentaphyllum, 15 parts of Cassia tora seed, 20 parts of Sargassum, 20 parts of kelp, 10 parts of earthworm, 30 parts of Houttuynia cordata, 15 parts of stir-fried Atractylodes macrocephala, 20 parts of Solanum nigrum, 20 parts of Scutellaria barbata, 3 parts of Panax notoginseng, 10 parts of licorice root, 10 parts of stir-fried Bombyx mori, 10 parts of turmeric, 90 parts of Vaccaria segetalis, 15 parts of Anemarrhena asphodeloides, 10 parts of cinnamon twig, 60 parts of salted tangerine seed, and 60 parts of litchi seed.

[0012] The traditional Chinese medicine formula provided in this invention is named "Jiejiekang". In the embodiments of this invention, the terms "traditional Chinese medicine formula" and "Jiejiekang" have the same meaning and can be used interchangeably.

[0013] The second aspect of the present invention provides a traditional Chinese medicine composition for treating nodules, the traditional Chinese medicine composition comprising the effective components extracted from Prunella vulgaris, Bupleurum chinense, Pinellia ternata, Fritillaria thunbergii, Scrophularia ningpoensis, Ostrea gigas, Curcuma zedoaria, Gleditsia sinensis, Carapax Trionycis, and Astragalus membranaceus, or medicinal salts of the effective components.

[0014] Furthermore, the traditional Chinese medicine composition may also include one or more of the following medicinal materials: Sparganium rhizome, white mustard seed, centipede, Scutellaria baicalensis, Cyperus rotundus, Ligusticum chuanxiong, tangerine peel, white peony root, scabra bark, Codonopsis pilosula, raw Atractylodes macrocephala, hemp seed, dandelion, Gynostemma pentaphyllum, Cassia seed, seaweed, kelp, earthworm, Houttuynia cordata, stir-fried Atractylodes macrocephala, Solanum nigrum, Scutellaria barbata, Panax notoginseng, licorice, stir-fried Bombyx mori, turmeric, Vaccaria segetalis, Anemarrhena asphodeloides, cinnamon twig, salted tangerine seed, and litchi seed.

[0015] Furthermore, the traditional Chinese medicine composition contains the following raw materials in the indicated weight proportions: 15-30 parts of Prunella vulgaris, 9-12 parts of Bupleurum chinense, 9-12 parts of Pinellia ternata, 10-15 parts of Fritillaria thunbergii, 10-15 parts of Scrophularia ningpoensis, 20-30 parts of Ostrea gigas, 10-15 parts of Curcuma zedoaria, 20-30 parts of Gleditsia sinensis thorns, 15-30 parts of Trionyx sinensis, and 15-30 parts of Astragalus membranaceus.

[0016] Furthermore, the traditional Chinese medicine composition contains the following raw materials in the following weight proportions: 20 parts of Prunella vulgaris, 9 parts of Bupleurum chinense, 9 parts of Pinellia ternata, 10 parts of Fritillaria thunbergii, 10 parts of Scrophularia ningpoensis, 20 parts of Ostrea gigas, 10 parts of Curcuma zedoaria, 20 parts of Gleditsia sinensis thorns, 20 parts of Trionyx sinensis shell, and 15 parts of Astragalus membranaceus.

[0017] Furthermore, the traditional Chinese medicine composition may also contain one or more raw materials in the following weight ratios: 10 parts of Sparganium rhizome, 20 parts of white mustard seed, 1-2 parts of centipede, 10 parts of Scutellaria baicalensis, 15 parts of Cyperus rotundus, 10 parts of Ligusticum chuanxiong, 10 parts of dried tangerine peel, 10 parts of white peony root, 10 parts of Citrus reticulata peel, 10 parts of Citrus aurantium shell, 10-20 parts of Codonopsis pilosula, 30 parts of raw Atractylodes macrocephala, 10 parts of hemp seed, 30 parts of dandelion, 15 parts of Gynostemma pentaphyllum, 15 parts of Cassia tora seed, 20 parts of Sargassum, 20 parts of kelp, 10 parts of earthworm, 30 parts of Houttuynia cordata, 15 parts of stir-fried Atractylodes macrocephala, 20 parts of Solanum nigrum, 20 parts of Scutellaria barbata, 3 parts of Panax notoginseng, 10 parts of licorice root, 10 parts of stir-fried Bombyx mori, 10 parts of turmeric, 90 parts of Vaccaria segetalis, 15 parts of Anemarrhena asphodeloides, 10 parts of Cinnamomum cassia twig, 60 parts of salted Citrus reticulata seed, and 60 parts of Litchi chinensis seed.

[0018] Furthermore, the traditional Chinese medicine composition includes a pharmaceutical composition, a food composition, or a health product composition.

[0019] Furthermore, the types of raw materials include dried medicinal materials, fresh medicinal materials, raw medicinal materials, processed medicinal materials, whole medicinal plants, effective parts of whole medicinal plants, or combinations thereof.

[0020] In some embodiments, the weight proportions of the traditional Chinese medicine composition of the present invention are calculated based on the dry weight of the raw materials. In some embodiments, the raw materials of the traditional Chinese medicine composition should be compared using the same type of raw materials when proportioning by weight.

[0021] In this invention, the term "parts by weight" is synonymous with "parts by weight" and refers to any fixed weight expressed in milligrams, grams, or kilograms (e.g., 1 mg, 1 g, 2 g, or 1 kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b can be a composition consisting of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In the aforementioned composition, the percentage content of a certain component = (the weight of that component / the sum of the weights of all components) × 100%. Therefore, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%.

[0022] Furthermore, the pharmaceutically acceptable salt includes acid addition salts or base addition salts.

[0023] The term "medicinal salt" as used herein includes ammonium phosphates, metal salts, salts formed with amino acids, salts formed with amines, and salts formed with other bases such as piperidine or morpholine. The term "medicinal salt" includes monosalts or disalts. Specifically, it includes ammonium, sodium, calcium, magnesium, cesium, lithium, potassium, barium, zinc, aluminum, lysine, arginine, histidine, methylamine, ethylamine, tert-butylamine, cyclohexylamine, N-methylglucosamine, ethylenediamine, glycine, procaine, benzathine, diethanolamine, triethanolamine, piperidine, and morpholine.

[0024] In some embodiments, the term "medicinal salt" may also include hydrates of the pharmaceutically acceptable salts of the active ingredient of the present invention. Examples of salts include, but are not limited to, sulfates, citrates, acetates, oxalates, chlorides, hydrochlorides, bromides, hydrobromides, iodides, nitrates, bisulfates, phosphates, acid phosphates, isonicotinate, lactate, salicylates, acid citrates, tartrates, oleates, tannates, pantothenates, hydrogen tartrate, ascorbate, gentisinate, gluconate, glucuronate, glycosides, formate, benzoate, glutamate, methanesulfonate, ethanesulfonate, benzenesulfonate, p-toluenesulfonate, camphorsulfonate, naphthalenesulfonate, propionate, succinate, fumarate, maleate, malonate, mandelate, malate, palmitate, aspartate, phthalates, and pyrates. Each of the salts mentioned above may be anhydrous or hydrated. As used herein, the term "medicinal salt" also refers to salts formed by the active ingredients of the medicinal materials of this invention having acidic functional groups, such as carboxylic acid functional groups, and alkalis. Examples of alkalis include, but are not limited to: hydroxides of alkali metals, including sodium, potassium, and lithium; hydroxides of alkaline earth metals, such as calcium and magnesium; hydroxides of other metals, such as aluminum and zinc; ammonia; organic amines, such as unsubstituted or hydroxylated mono-, di-, or trialkylamines, dicyclohexylamine; tributylamine; pyridine; N-methyl, N-ethylamine; diethylamine; triethylamine; mono-, di-, or tri-(2-OH-(C1-C6)-alkylamines), such as N,N-dimethyl-N-(2-hydroxyethyl)amine or tri-(2-hydroxyethyl)amine; N-methyl-D-glucosamine; morpholine; thiomorpholine; piperidine; pyrrolidine; and amino acids such as arginine, lysine, etc.

[0025] In this invention, the treatment refers to the act of preventing and reducing the occurrence or development of a disease, thereby inhibiting, suppressing, alleviating, improving, slowing down, stopping, delaying, or reversing the progression or aggravation of the disease. The various indicators of maintaining and / or using the medication include alleviating or reducing symptoms or complications, or curing or eliminating the disease, disorder, or condition. In a specific embodiment of this invention, the disease is preferably a thyroid nodule, a lung nodule, or a breast nodule.

[0026] In this invention, prevention refers to various means or measures, including medical, physical or chemical methods, used to prevent the occurrence or development of a disease before it is recognized by clinical standards, in order to stop and reduce the occurrence or development of various symptoms of the disease. In a specific embodiment of this invention, the disease is preferably thyroid nodules, pulmonary nodules or breast nodules.

[0027] A third aspect of the present invention provides a traditional Chinese medicine preparation for treating nodules, the traditional Chinese medicine preparation comprising the traditional Chinese medicine composition described in the second aspect of the present invention.

[0028] Furthermore, the traditional Chinese medicine preparation includes pharmaceutically acceptable excipients.

[0029] When preparing the traditional Chinese medicine preparations described in this invention, the effective components extracted by this invention are added to pharmaceutically acceptable excipients, and conventional formulation techniques known to those skilled in the art are used to prepare the drug dosage forms commonly required in clinical practice.

[0030] In this invention, the excipients are those required to prepare various dosage forms. They can be fillers, such as lactose, dextrin, microcrystalline fiber, starch, sorbitol, mannitol, pregelatinized starch, etc.; disintegrants, such as crospovidone, crospovidone sodium carboxymethyl cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, etc.; binders, such as starch paste, sodium starch paste, hydroxypropyl methyl cellulose, povidone, etc.; surfactants, such as sodium dodecyl sulfate, sodium hexadecyl sulfate, stearic acid, oleic acid, lauric acid, etc.; and lubricants, such as magnesium stearate, talc, polyethylene glycol, etc.

[0031] Furthermore, pharmaceutically acceptable suspending agents, solubilizers, flavoring agents, preservatives, antioxidants, and stabilizers may also be added to the traditional Chinese medicine preparation.

[0032] Furthermore, the suspending agent may be gum arabic, tragacanth gum, peach gum, methylcellulose, sodium carboxymethylcellulose, hydroxypropylcellulose, bentonite, etc.

[0033] Furthermore, the co-solvent can be hydrochloric acid, phosphoric acid, propionic acid, acetic acid, lactic acid, citric acid, tartaric acid, boric acid, glucuronic acid, gluconic acid, lactobionic acid, malic acid, threonic acid, glucoheponic acid, 2,5-dihydroxybenzoic acid, acidic amino acids, etc.

[0034] Furthermore, the flavoring agent may be sodium saccharin, cyclamate, aspartame, acetylsupan-K, glycerin, sorbitol, mannitol, sucrose, simple syrup, aromatic syrup, etc.

[0035] Furthermore, the preservative may be phenol, cresol, chlorocresol, thymol, benzoic acid and its salts, sorbic acid and its salts, boric acid and its salts, propionic acid, formaldehyde, glutaraldehyde, benzyl alcohol, phenethyl alcohol, chlorobutanol, chloroform, chlorhexidine, etc.

[0036] Furthermore, the antioxidants and stabilizers may be sulfurous acid, sulfites, bisulfites, metabisulfites, dithionite, thiosulfates, thiourea, glutathione, dimercaprol, mercaptoacetic acid and its salts, thiolactic acid and its salts, thiodipropionic acid and its salts, gallic acid and its salts, caffeic acid or its pharmaceutical salts, ferulic acid or its pharmaceutical salts, di-tert-butyl-p-phenol, 2,5-dihydroxybenzoic acid or its salts, salicylic acid or its salts, ascorbic acid and its salts, isoascorbic acid and its salts, nicotinamide, tartaric acid, phosphates, pharmaceutical salts of acetate, citrates, EDTA and its salts, etc.

[0037] In specific implementation schemes, the choice of which pharmaceutical excipients to combine with the traditional Chinese medicine composition depends on the formulation to be prepared. When preparing ordinary formulations, the choice of which pharmaceutical excipients to use is well known to those skilled in the art.

[0038] Furthermore, the dosage form of the traditional Chinese medicine preparation is an oral dosage form.

[0039] Furthermore, the oral dosage forms include granules, tablets, capsules, oral liquids, pills, and drop pills.

[0040] As a non-limiting example, the preparation of the dosage form of the traditional Chinese medicine preparation is as follows:

[0041] Granules: Using the traditional Chinese medicine composition for treating nodules as the active ingredient described in the second aspect of the present invention, pharmaceutical excipients are added, mixed, granulated, dried, and packaged to obtain traditional Chinese medicine granules containing the traditional Chinese medicine composition for treating nodules.

[0042] Tablets: Using the traditional Chinese medicine composition for treating nodules as described in the second aspect of this invention as the active ingredient, the ingredients are dried, then pharmaceutical excipients are added, mixed, granulated, dried, compressed, and coated to obtain traditional Chinese medicine tablets containing the traditional Chinese medicine composition for treating nodules. The tablets can be plain tablets or coated tablets, such as sugar-coated, gastric-coated, or enteric-coated tablets.

[0043] Capsules: Using the traditional Chinese medicine composition for treating nodules as described in the second aspect of this invention as the active ingredient, the ingredients are dried, then pharmaceutical excipients are added, mixed, granulated, dried, and encapsulated to obtain a traditional Chinese medicine capsule containing the traditional Chinese medicine composition for treating nodules. The capsule can be a hard capsule or a soft capsule.

[0044] Oral liquid: Using the traditional Chinese medicine composition for treating nodules as the active ingredient, water is added and stirred until homogeneous. Then, pharmaceutical excipients are added, stirred until homogeneous, filtered, filled, sterilized, and packaged to obtain a traditional Chinese medicine oral liquid containing the traditional Chinese medicine composition for treating nodules.

[0045] Pills: Using the traditional Chinese medicine composition for treating nodules as described in the second aspect of this invention as the active ingredient, after drying and pulverizing, pharmaceutical excipients are added, the mixture is placed in a sugar coating pan, a polar solvent is added while rotating the sugar coating machine, the mixture is stirred, formed into pills, dried, coated, and packaged to obtain traditional Chinese medicine pills containing the traditional Chinese medicine composition for treating nodules.

[0046] Droplets: Using the traditional Chinese medicine composition for treating nodules as described in the second aspect of this invention as the active ingredient, after drying and pulverizing, pharmaceutical excipients are added, mixed, heated and melted, stirred evenly, made into pills, washed, dried, and packaged to obtain traditional Chinese medicine droplets containing the traditional Chinese medicine composition for treating nodules.

[0047] A fourth aspect of the present invention provides a method for preparing the traditional Chinese medicine composition described in the second aspect of the present invention, the method comprising the following steps:

[0048] Step 1: Weigh the raw materials according to the above-mentioned proportions of Chinese herbal medicine ingredients.

[0049] Step 2: Extract the raw materials from Step 1 with a polar solvent 1-5 times, filter, and combine the extracts to obtain the traditional Chinese medicine composition.

[0050] Furthermore, the preparation method can also concentrate and dry the extract in step two under reduced pressure to obtain the traditional Chinese medicine composition.

[0051] Furthermore, the polar solvent is any one or a mixture of any of water, methanol, ethanol, and acetone; when mixed, it is preferably a mixture of water with ethanol, methanol, or acetone.

[0052] Furthermore, the extraction is any one of soaking extraction, water decoction extraction, percolation extraction, reflux extraction, or supercritical extraction.

[0053] Furthermore, the drying process includes, but is not limited to, vacuum drying or spray drying.

[0054] The fifth aspect of the present invention provides the use of the traditional Chinese medicine composition described in the second aspect of the present invention in the preparation of a medicament for treating nodules.

[0055] Furthermore, the nodules include thyroid nodules, lung nodules, and breast nodules.

[0056] Furthermore, the nodules exhibit a TCM syndrome: phlegm and blood stasis syndrome.

[0057] The sixth aspect of the present invention provides the application of the traditional Chinese medicine preparation described in the third aspect of the present invention in the preparation of a drug for treating nodules.

[0058] Furthermore, the nodules include thyroid nodules, lung nodules, and breast nodules.

[0059] Furthermore, the nodules exhibit a TCM syndrome: phlegm and blood stasis syndrome.

[0060] The properties, flavors, meridian tropisms, and efficacy of the Chinese medicinal materials used in this invention are as follows:

[0061] Prunella vulgaris, also known as Niu Di Dai Tou, Deng Long Cao, Gu Niu Cao, and Yang Ti Jian, has a pungent and bitter taste, is cold in nature, and enters the liver and gallbladder meridians. It has the effects of clearing liver fire, improving eyesight, and dispersing nodules and reducing swelling.

[0062] Bupleurum chinense, also known as hard Bupleurum chinense, is bitter and cool in nature. It enters the liver and gallbladder meridians and has the effects of relieving exterior symptoms and reducing fever, soothing the liver and relieving depression, and raising yang qi.

[0063] Pinellia ternata, also known as Pinellia ternata or Pinellia tataricus, is pungent and warm in nature. It enters the spleen, stomach, and lung meridians and has the effects of drying dampness and resolving phlegm, relieving nausea and vomiting, and eliminating masses and nodules.

[0064] Fritillaria thunbergii, also known as Zhejiang fritillary bulb, large fritillary bulb, elephant fritillary bulb, Yuanbaobei fritillary bulb, and pearl fritillary bulb, is bitter and cold in nature. It enters the lung and heart meridians and has the effects of clearing heat and resolving phlegm, lowering qi and relieving cough, and dispersing nodules and reducing swelling.

[0065] Scrophularia, also known as Yuan Shen, Zhe Xuan Shen, Hei Shen, Chong Tai, Gui Zang, Zheng Ma, Lu Chang, Duan, and Xuan Tai, has a sweet, bitter, and salty taste and is slightly cold in nature. It has the effects of clearing heat and cooling blood, nourishing yin and reducing fire, and detoxifying and dispersing nodules.

[0066] Oyster, also known as oyster clam, is salty and cool in nature. It enters the liver and kidney meridians and has astringent, sedative, detoxifying, and analgesic effects.

[0067] Curcuma zedoaria, also known as peng zedoaria, jujube, peng zedoaria, guang zedoaria, peng zhu, qing jiang, qiang qi, guang zhu, hei xin jiang, and wen zhu, is pungent and bitter in taste, warm in nature, and enters the liver and spleen meridians. It has the effects of promoting qi circulation, breaking up blood stasis, eliminating stagnation, and relieving pain.

[0068] Soapberry thorn, also known as soapberry thorn, soap thorn, or heavenly thorn, is pungent and warm in nature. It enters the liver and stomach meridians and has the effects of reducing swelling and promoting detoxification, draining pus, and killing parasites.

[0069] Turtle shell, also known as upper shell or turtle shell, is salty in taste and slightly cold in nature. It enters the liver and kidney meridians and has the effects of nourishing yin and suppressing yang, reducing fever and eliminating steaming, and softening hard masses and dispersing nodules.

[0070] Astragalus, also known as cotton astragalus, is sweet in taste and slightly warm in nature. It enters the spleen and lung meridians and has the effects of strengthening the spleen and replenishing the middle jiao, raising yang and lifting prolapse, benefiting wei qi and consolidating the exterior, promoting diuresis, and promoting tissue regeneration and detoxification.

[0071] Advantages and beneficial effects of the present invention: Based on classic prescriptions, the present invention targets the key pathogenesis of "phlegm and blood stasis" and gradually explores a core Chinese herbal medicine formula for treating nodules using traditional Chinese medicine. This formula utilizes the inherent characteristics of each component drug, rationally combines them, and scientifically proportions them to achieve synergistic efficacy. It has the advantage of directly reducing the volume of nodules and has no obvious side effects, filling the gap in modern medicine for the treatment of nodules in patients without surgical indications. The dosage form meets the characteristics of clinical needs and is suitable for large-scale clinical application. Detailed Implementation

[0072] The present invention will be further illustrated below with reference to specific embodiments. These specific embodiments are for illustrative purposes only and should not be construed as limiting the invention. Those skilled in the art will understand that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the invention. The scope of the invention is defined by the claims and their equivalents.

[0073] The drugs, reagents and raw materials used in this invention are readily available to those skilled in the art and can be obtained commercially unless otherwise specified. Experimental methods not specified in this invention are generally performed under conventional conditions or according to the manufacturer's recommendations. In particular, the following examples are for illustrative purposes only and should not be construed as limiting the scope of the invention in any way.

[0074] The following evaluation of the therapeutic effect of the traditional Chinese medicine formula of the present invention on nodules is based on clinical efficacy. The specific composition ratios used should not be construed as limiting the weight composition ratios of the drugs in the present invention. In conjunction with the claims, the specification, and common knowledge in the art, those skilled in the art can make any modifications or changes based on the following embodiments without departing from the spirit and scope of the present invention, and such modifications are also included within the scope of the present invention.

[0075] Example 1: Clinical observation trial on the efficacy of the traditional Chinese medicine formula of the present invention in treating patients with nodules.

[0076] I. Experimental Methods

[0077] 1. Study Subjects: From November 2023 to May 2025, 21 patients diagnosed with nodules were enrolled at the Third Affiliated Hospital of Beijing University of Chinese Medicine, including 25 nodules from different locations. Among them, there were 11 males and 10 females.

[0078] 1) Inclusion criteria: ① Meets the Western medicine diagnostic criteria for nodules; ② Meets the TCM diagnostic criteria for nodules with phlegm and blood stasis syndrome; ③ Age 18–70 years; ④ Voluntarily participate in this study and sign informed consent form.

[0079] 2) Diagnostic criteria: Thyroid nodules refer to localized masses in the thyroid tissue resulting from abnormal proliferation of thyroid cells, which move up and down with the thyroid gland during swallowing; pulmonary nodules refer to focal, round or oval, solid or subsolid lung shadows with increased density ≤3 cm in diameter; breast nodules are a general term for breast masses in ultrasound diagnosis. Subjects included in this study included individuals with single or multiple nodules, and those with nodules in a single organ or multiple organs.

[0080] 3) Exclusion criteria: ① Pregnant or lactating women; ② Those with other serious brain, heart, lung, kidney, or blood system diseases and malignant tumors other than hypertension, diabetes, and hyperlipidemia, requiring drug treatment; ③ Those with infectious diseases, such as viral hepatitis, tuberculosis, and AIDS.

[0081] 2. Experimental protocol: Patients used "Jiejiekang" for 3 months.

[0082] It should be noted that, through repeated experiments, this invention has confirmed that the dosage range of the traditional Chinese medicine formula "Jiejiekang" is as follows: Prunella vulgaris 15-30 g, Bupleurum chinense 9-12 g, Pinellia ternata 9-12 g, Fritillaria thunbergii 10-15 g, Scrophularia ningpoensis 10-15 g, Ostrea gigas 20-30 g, Curcuma zedoaria 10-15 g, Gleditsia sinensis thorns 20-30 g, Trionyx sinensis 15-30 g, and Astragalus membranaceus 15-30 g. Within the above dosage range, "Jiejiekang" can effectively improve the nodule symptoms of patients. This embodiment only presents the therapeutic effect of the optimal dosage of "Jiejiekang".

[0083] The ingredients of "Jiejiekang" are: Prunella vulgaris 20 g, Bupleurum chinense 9 g, Pinellia ternata 9 g, Fritillaria thunbergii 10 g, Scrophularia ningpoensis 10 g, Ostrea gigas 20 g, Curcuma zedoaria 10 g, Gleditsia sinensis thorns 20 g, Trionyx sinensis 20 g, Astragalus membranaceus 15 g.

[0084] Formula: The principal ingredient is Prunella vulgaris, used to clear heat and dissipate nodules. The assistant ingredients are Bupleurum chinense, used to soothe the liver, regulate qi, and relieve depression; Pinellia ternata, used to dry dampness and resolve phlegm; and Fritillaria thunbergii, used to clear heat, resolve phlegm, dissipate nodules, and eliminate carbuncles. Astragalus membranaceus is used as an adjuvant to tonify qi and strengthen the spleen, replenish qi and expel toxins, and support the body's resistance to dissipate nodules, while also preventing aggressive herbs from depleting the body's vital energy. The guiding ingredients are Curcuma zedoaria and Gleditsia sinensis, used to invigorate blood, remove blood stasis, and dissipate nodules; and Ostrea gigas, Scrophularia ningpoensis, and Carapax Trionycis, used to clear heat, resolve phlegm, soften hardness, and dissipate nodules.

[0085] Effects: Regulates Qi and resolves phlegm, invigorates blood circulation and removes blood stasis, softens and disperses nodules.

[0086] Preparation method: concentrated decoction, 2 bags per dose, 100 ml per bag. Specific preparation method: prepare 40 doses, use a 30 L decoction pot, add 14.5 L of water, soak for 30 minutes, decoct for 70 minutes, package 100 ml / bag, yielding a total of 80 bags of finished product, with approximately 200 ml of liquid remaining.

[0087] 3. Statistical Analysis

[0088] 1) In the imaging report, the maximum diameter is the longest single diameter on the largest cross-sectional area (unit: cm).

[0089] 2) The two diameters perpendicular to each other on the maximum cross-sectional area are A and B, and the sum of the maximum diameters = A + B (unit: cm).

[0090] 3) Rate of change of cross-sectional area:

[0091] The rate of change of cross-sectional area was calculated using the Nimodipine method. The rate of change of cross-sectional area (S, unit: cm²) was compared with the change in diameter. 2 The changes are more intuitive in describing changes in nodule size.

[0092] The formula for calculating the rate of change of cross-sectional area (ΔS) is as follows:

[0093] S = A × B;

[0094] ΔS (%) = (S after treatment - S before treatment) / S before treatment × 100%.

[0095] 4) Clinical efficacy evaluation criteria:

[0096] Cure: Nodules disappear, cross-sectional area reduced by 100%.

[0097] Significant effect: Nodules are reduced in size, and the cross-sectional area is reduced by 50% to 100%.

[0098] Effective: Nodules are reduced in size, and the cross-sectional area is reduced by less than 50%.

[0099] Stable: No significant changes were observed in the nodules and the cross-sectional area remained unchanged.

[0100] Progression: Nodules enlarge, cross-sectional area increases, or malignant signs increase.

[0101] Overall effective rate (%) = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0102] II. Experimental Results

[0103] This study included 21 patients with nodules, encompassing 25 nodules from different locations. No deaths were observed during the treatment process. Three months after treatment, the maximum diameter, total maximum diameter, and cross-sectional area of ​​the nodules were significantly reduced compared to before treatment (P < 0.001) (Table 1), indicating that the present invention can effectively shrink nodules.

[0104] Table 1. Changes in nodule diameter and area

[0105]

[0106] Clinical efficacy evaluation criteria were used to evaluate nodules in 25 different locations. The results showed a cure rate of 20%, a significant efficacy rate of 36%, an effective rate of 40%, and a total effective rate as high as 96%, indicating that the present invention has good clinical efficacy in treating nodules (Table 2). Furthermore, no cases of disease progression were observed in the study, and the small vacuolar shadows within the pulmonary nodules and the surrounding spiculation shadows disappeared. The TI-RADS classification of thyroid nodules decreased from category 3 to category 2, indicating that the present invention can effectively reduce the risk of malignant transformation.

[0107] Table 2 Clinical efficacy evaluation

[0108]

[0109] Example 2: Typical Cases and the Therapeutic Effects of Treating Patients with the Traditional Chinese Medicine Formula "Jiejiekang" Described in this Invention

[0110] In this embodiment, the "Jiejiekang" prescription was modified to some extent according to the differences in the patients' own conditions, including but not limited to: for cough, loquat leaf and mulberry bark were added; for insomnia, jujube seed, Polygonum multiflorum, and Albizia bark were added; for malignant signs (lobes, spiculation, pleural indentation, vascular convergence, etc.), black nightshade, Scutellaria barbata, Hedyotis diffusa, and centipede were added; for positive thyroid antibody, Dioscorea nipponica and Cynanchum paniculatum were added.

[0111] (1) Mr. Chen, male, 60 years old. Date of consultation: June 15, 2024.

[0112] Six months ago, a thyroid nodule was discovered, accompanied by discomfort in the right liver area and hypochondrium. The patient experiences dry mouth but a normal appetite. Bowel movements are sometimes dry, occurring once a day. Sleep is normal, but the patient wakes up early, experiencing excessive sweating and a feeling of heat upon waking. Blood lipids and blood pressure are slightly elevated. The tongue is dark red with a thick, greasy coating and cracks in the center; the pulse is wiry.

[0113] (Imaging examination 2024-12-24): The thyroid gland is of normal size and regular shape, with a relatively smooth capsule and heterogeneous internal echoes. Multiple medium and low echoes are visible bilaterally. The larger one on the right is about 0.9×0.6 cm, with relatively clear borders and regular shape. The internal echoes are moderately heterogeneous and low. CDFI: Blood flow signals are visible in the periphery and inside. The larger one on the left is about 2.8×2.2 cm, with unclear borders and relatively regular shape. The internal echoes are heterogeneous and moderately high. CDFI: Blood flow signals are visible in the periphery and inside.

[0114] Western medicine diagnosis: Thyroid nodule. Traditional Chinese medicine diagnosis: Goiter; Traditional Chinese medicine syndrome: Phlegm and blood stasis.

[0115] Prescription: Prunella vulgaris 30 g; Bupleurum chinense 12 g; Pinellia ternata 12 g; Gleditsia sinensis thorns 30 g; Fritillaria thunbergii 10 g; Scrophularia ningpoensis 10 g; Ostrea gigas 30 g; Carapax Trionycis 30 g; Sparganium stoloniferum 10 g; Curcuma zedoaria 10 g; Astragalus membranaceus 30 g; Sinapis alba 20 g; Scolopendra subspinipes 1 piece; Scutellaria baicalensis 10 g; Cyperus rotundus 15 g; Ligusticum chuanxiong 10 g; Citrus reticulata peel 10 g; Paeonia lactiflora 10 g; Citrus aurantium 10 g; Codonopsis pilosula 20 g; Atractylodes macrocephala 30 g; Cannabis sativa 10 g.

[0116] Decoct in water and take orally, 7 doses, 1 dose per day.

[0117] This case focuses on the 10-ingredient formula "Jiejiekang" to treat thyroid nodules. Due to the large size of the nodules, Sparganium rhizome, centipede, and white mustard seed were added to enhance their nodule-dispersing effect. Based on the patient's right-sided chest and rib discomfort and other signs of liver and spleen imbalance, a modified Chaihu Shugan San formula was prescribed. Furthermore, considering the symptoms of constipation and a cracked tongue, raw Atractylodes macrocephala and hemp seed were added to nourish yin, moisten the intestines, and promote bowel movements.

[0118] Second visit (June 22, 2025): Stools were sticky for the first two days after taking the medication, but are now normal. Increased flatulence with a foul odor. The feeling of heat has significantly decreased, and sweating has reduced. The dry mouth that was previously upon waking has significantly improved. Discomfort in the liver area and hypochondrium has improved. The cracks in the tongue coating have significantly decreased.

[0119] Prescription: Prunella vulgaris 30 g; Bupleurum chinense 12 g; Pinellia ternata 12 g; Gleditsia sinensis thorns 30 g; Fritillaria thunbergii 10 g; Scrophularia ningpoensis 10 g; Ostrea gigas 30 g; Carapax Trionycis 30 g; Sparganium stoloniferum 10 g; Curcuma zedoaria 10 g; Astragalus membranaceus 30 g; Sinapis alba 20 g; Codonopsis pilosula 20 g; Atractylodes macrocephala 30 g; Citrus aurantium 10 g; Cannabis sativa 10 g; Scutellaria baicalensis 10 g; Taraxacum mongolicum 30 g; Gynostemma pentaphyllum 15 g; Cassia tora 15 g; Sargassum fusiforme 20 g; Laminaria japonica 20 g; Pheretima aspergillum 10 g.

[0120] Decoct in water and take orally, 14 doses, one dose per day.

[0121] (Imaging examination 2025-07-07): The thyroid gland is of normal size in cross section, with slightly thickened internal echogenicity and uneven distribution. Multiple hypoechoic nodules of varying sizes are visible in both lobes, with uneven internal echoes and linear and patchy hyperechoic areas. The largest nodule in the right lobe is approximately 1.0 × 0.6 cm, and the largest nodule in the left lobe is approximately 1.7 × 1.4 cm. The borders are relatively clear and the shape is relatively regular. CDFI showed no obvious blood flow signal within the nodules.

[0122] (2) Song XX, male, 63 years old, date of initial consultation: 2024-12-6.

[0123] The patient has had pulmonary nodules for over a year, and an examination three months ago revealed that the nodules had worsened. Symptoms include anxiety, cold feet, hot palms and soles, and one formed bowel movement per day. Sleep is normal. The tongue is dark red with a thin, greasy coating, and the pulse is wiry.

[0124] Imaging examination (2024-10-21): The chest is symmetrical, the trachea is in the middle, and ground-glass opacities are seen in the right middle lobe (M153) and left lower lobe (IM160), the largest of which is about 10×12 mm in size, with pleural traction. Multiple nodular opacities are also seen in the left lower lobe (IM218), right upper lobe (IM115), and right middle lobe (IM140), with a long diameter range of about 3-5 mm. Strip-like areas of increased density are seen in the medial segment of the right middle lobe and the lower lingular segment of the left upper lobe. The bronchial openings in each segment are patent. Multiple small lymph nodes are seen in the mediastinum. No obvious abnormal density shadows are seen in the heart and great vessels.

[0125] Western medicine diagnosis: pulmonary nodules. Traditional Chinese medicine diagnosis: pulmonary effusion; Traditional Chinese medicine syndrome: phlegm and blood stasis.

[0126] Prescription: Prunella vulgaris 30 g; Bupleurum chinense 12 g; Scutellaria baicalensis 10 g; Houttuynia cordata 30 g; Astragalus membranaceus 30 g; Fritillaria thunbergii 12 g; Scrophularia ningpoensis 15 g; Gleditsia sinensis thorns 30 g; Turtle shell (decocted first) 30 g; Atractylodes macrocephala (stir-fried with wheat bran) 15 g; Ostrea gigas (decocted first) 30 g; Solanum nigrum 20 g; Scutellaria barbata 20 g; Scolopendra subspinipes 2 pieces; Panax notoginseng powder (taken with water) 3 g; Codonopsis pilosula 10 g; Curcuma zedoaria (stir-fried with vinegar) 10 g; Glycyrrhiza uralensis 10 g; Bombyx mori (stir-fried) 10 g; Curcuma longa 10 g; Pheretima aspergillum 10 g.

[0127] Decoct in water and take orally, 30 doses, one dose per day.

[0128] In this case, Pinellia ternata was not used. Pinellia ternata is warm in nature and is mostly used for phlegm due to cold. The patient was anxious and had hot palms and soles, which are manifestations of internal heat. It is not appropriate to use warming medicines. Scutellaria baicalensis tablets were added to clear the internal heat.

[0129] Follow-up examination on February 10, 2025: The chest is symmetrical, the trachea is midline, and ground-glass opacities are seen in the right middle lobe (IM155) and left lower lobe (IM152), the largest of which is approximately 5 mm × 4 mm; multiple nodules are also seen in the left lower lobe (IM210), right upper lobe (IM118), and right middle lobe (IM141), with a long diameter ranging from approximately 3-5 mm; the bronchial openings in each lobe segment are patent; multiple small lymph nodes are visible in the mediastinum; nodular dense shadows are visible in the aortic wall; no obvious abnormal density shadows are seen in the heart and great vessels. The ground-glass nodules in the right middle lobe and left lower lobe have significantly decreased in size compared to the previous film (October 21, 2024).

[0130] (3) Chen X, male, 38 years old, date of initial consultation: 2024-7-16.

[0131] The patient was diagnosed with thyroid nodules more than six months ago. They experience irritability, shortness of breath, and anger; dry mouth and bitter taste; and since the beginning of this year, they have experienced general cold intolerance, acid reflux, and loose stools once a day. Sleep is normal. The sides of their tongue are red with a yellow coating, and their pulse is deep and wiry.

[0132] Imaging examination (2024-07-02): A solid hypoechoic nodule measuring approximately 5.6 mm × 5.1 mm × 4.5 mm was detected in the ventral part of the lower right lobe of the thyroid gland, closely adhering to the capsule. The nodule had blurred margins, an irregular shape, and an aspect ratio >1 on some sections. The internal echoes were relatively homogeneous, with the anterior margin slightly protruding outwards. Color Doppler flow imaging (CDFI) showed linear blood flow signals within and around the nodule, class 4b in C-TIRADS. A hypoechoic nodule measuring approximately 3.5 mm × 2.4 mm × 3.1 mm was detected in the dorsal part of the lower left lobe of the thyroid gland. The nodule had relatively clear margins, was horizontal, and had homogeneous internal echoes. CDFI showed linear blood flow signals within the nodule, class 3 in C-TIRADS. Several hypoechoic nodules were detected in bilateral cervical regions II and III, the largest measuring 15 mm × 6 mm. These nodules had clear and regular borders, with thin cortex and clear corticomedullary boundaries. Color Doppler flow imaging (CDFP) showed punctate blood flow signals within the nodule.

[0133] Western medicine diagnosis: Thyroid nodule. Traditional Chinese medicine diagnosis: Goiter; Traditional Chinese medicine syndrome: Phlegm and blood stasis syndrome.

[0134] Prescription: Prunella vulgaris 20 g; Bupleurum chinense 9 g; Pinellia ternata 9 g; Fritillaria thunbergii 10 g; Scrophularia ningpoensis 15 g; Ostrea gigas (decocted first) 30 g; Gleditsia sinensis thorns 30 g; Scutellaria baicalensis slices 10 g; Curcuma zedoaria (processed with vinegar) 10 g; Stir-fried mustard seed 20 g; Stir-fried Vaccaria segetalis 90 g; Stir-fried turtle shell (decocted first) 30 g; Stir-fried Atractylodes macrocephala (processed with wheat bran) 15 g; Anemarrhena asphodeloides 15 g; Scutellaria barbata 20 g; Solanum nigrum 20 g; Sargassum fusiforme 20 g; Laminaria japonica 20 g; Cinnamomum cassia twig 10 g; Scolopendra subspinipes 2 pieces; Citrus reticulata seed 60 g; Litchi chinensis seed 60 g; Sparganium stoloniferum (processed with vinegar) 10 g; Codonopsis pilosula slices 15 g; Glycyrrhiza uralensis slices 10 g.

[0135] 120 doses, decocted in water and taken orally twice daily, 1 dose per day.

[0136] The patient, in the prime of life, exhibited symptoms of excessive liver fire, including irritability, dry mouth, bitter taste, and redness on both sides of the tongue. Astragalus membranaceus, being a qi-tonifying herb, would likely exacerbate these symptoms; therefore, it was not used. Instead, tangerine seed and lychee seed were added to soothe the liver and regulate qi, while Scutellaria baicalensis was used to clear liver fire. For the patient's general cold intolerance, Codonopsis pilosula, being neutral in nature, was used to tonify the middle jiao and replenish qi, regulating the spleen and stomach to ensure their normal digestive function.

[0137] Second visit (2024-12-05): Regular diet, no hiccups, belching, acid reflux or bloating, occasional bitter taste in mouth, good sleep, bowel movements once a day, occasionally formed, good mood, no fatigue or shortness of breath.

[0138] Imaging examination (2024-11-29): The bilateral lobes of the thyroid gland have clear outlines, normal shape and size, and the bilateral thyroid parenchyma is isoechoic with uniform echo distribution and fine echogenicity. A 4.2 × 4.1 mm isoechoic nodule was detected in the right lobe of the thyroid gland, adjacent to the capsule, with clear borders and a regular shape. Color Doppler flow imaging (CDFI) showed a ring-shaped blood flow signal around the nodule, C-TI-RADS: 4a. Adjacent to this nodule was a 3.8 × 2.4 mm hypoechoic nodule with clear borders and a relatively regular shape. CDFI showed no obvious abnormal blood flow signal in the left lobe of the thyroid gland. Bilateral cervical scans in regions III, IV, and V showed no significantly enlarged lymph nodes.

Claims

1. A traditional Chinese medicine formula for treating nodules, characterized in that, The herbal formula mainly contains Prunella vulgaris, Bupleurum chinense, Pinellia ternata, Fritillaria thunbergii, Scrophularia ningpoensis, Ostrea gigas, Curcuma zedoaria, Gleditsia sinensis, Trionyx sinensis, and Astragalus membranaceus.

2. The traditional Chinese medicine formula according to claim 1, characterized in that, The traditional Chinese medicine formula may also include one or more of the following medicinal materials: Sparganium rhizome, white mustard seed, centipede, Scutellaria baicalensis, Cyperus rotundus, Ligusticum chuanxiong rhizome, tangerine peel, white peony root, scabra bark, Codonopsis pilosula root, raw Atractylodes macrocephala rhizome, hemp seed, dandelion, Gynostemma pentaphyllum, Cassia seed, seaweed, kelp, earthworm, Houttuynia cordata, stir-fried Atractylodes macrocephala rhizome, Solanum nigrum, Scutellaria barbata rhizome, Panax notoginseng, licorice root, stir-fried Bombyx mori, turmeric, Vaccaria segetalis rhizome, Anemarrhena asphodeloides rhizome, cinnamon twig, salted tangerine seed, and litchi seed.

3. The traditional Chinese medicine formula according to claim 1, characterized in that, The nodules include thyroid nodules, lung nodules, and breast nodules.

4. The traditional Chinese medicine formula according to claim 1, characterized in that, The traditional Chinese medicine formula contains the following ingredients in the indicated weight proportions: 15-30 parts of Prunella vulgaris, 9-12 parts of Bupleurum chinense, 9-12 parts of Pinellia ternata, 10-15 parts of Fritillaria thunbergii, 10-15 parts of Scrophularia ningpoensis, 20-30 parts of Ostrea gigas, 10-15 parts of Curcuma zedoaria, 20-30 parts of Gleditsia sinensis, 15-30 parts of Carapax Trionycis, and 15-30 parts of Astragalus membranaceus. Preferably, the traditional Chinese medicine formula contains the following ingredients in the indicated weight proportions: 20 parts of Prunella vulgaris, 9 parts of Bupleurum chinense, 9 parts of Pinellia ternata, 10 parts of Fritillaria thunbergii, 10 parts of Scrophularia ningpoensis, 20 parts of Ostrea gigas, 10 parts of Curcuma zedoaria, 20 parts of Gleditsia sinensis thorns, 20 parts of Trionyx sinensis shell, and 15 parts of Astragalus membranaceus. Preferably, the traditional Chinese medicine formula may also contain one or more raw materials in the following weight ratios: 10 parts of Sparganium rhizome, 20 parts of white mustard seed, 1-2 parts of centipede, 10 parts of Scutellaria baicalensis, 15 parts of Cyperus rotundus, 10 parts of Ligusticum chuanxiong, 10 parts of dried tangerine peel, 10 parts of white peony root, 10 parts of dried tangerine peel, 10 parts of dried tangerine peel, 10-20 parts of Codonopsis pilosula, 30 parts of raw Atractylodes macrocephala, 10 parts of hemp seed, 30 parts of dandelion, 15 parts of Gynostemma pentaphyllum, 15 parts of Cassia tora seed, 20 parts of Sargassum, 20 parts of kelp, 10 parts of earthworm, 30 parts of Houttuynia cordata, 15 parts of stir-fried Atractylodes macrocephala, 20 parts of Solanum nigrum, 20 parts of Scutellaria barbata, 3 parts of Panax notoginseng, 10 parts of licorice root, 10 parts of stir-fried Bombyx mori, 10 parts of turmeric, 90 parts of Vaccaria segetalis, 15 parts of Anemarrhena asphodeloides, 10 parts of cinnamon twig, 60 parts of salted tangerine seed, and 60 parts of litchi seed.

5. A traditional Chinese medicine composition for treating nodules, characterized in that, The traditional Chinese medicine composition includes the effective components extracted from Prunella vulgaris, Bupleurum chinense, Pinellia ternata, Fritillaria thunbergii, Scrophularia ningpoensis, Ostrea gigas, Curcuma zedoaria, Gleditsia sinensis, Trionyx sinensis, and Astragalus membranaceus, or medicinal salts of the effective components. Preferably, the traditional Chinese medicine composition may further include one or more of the following medicinal materials: Sparganium rhizome, white mustard seed, centipede, Scutellaria baicalensis, Cyperus rotundus, Ligusticum chuanxiong rhizome, tangerine peel, white peony root, scabra bark, Codonopsis pilosula root, raw Atractylodes macrocephala rhizome, hemp seed, dandelion, Gynostemma pentaphyllum, Cassia seed, seaweed, kelp, earthworm, Houttuynia cordata, stir-fried Atractylodes macrocephala rhizome, Solanum nigrum, Scutellaria barbata rhizome, Panax notoginseng, licorice root, stir-fried Bombyx mori, turmeric, Vaccaria segetalis rhizome, Anemarrhena asphodeloides rhizome, cinnamon twig, salted tangerine seed, litchi seed; Preferably, the traditional Chinese medicine composition may be a pharmaceutical composition, a food composition, or a health product composition; Preferably, the pharmaceutically usable salt includes acid addition salts and alkali addition salts.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, The traditional Chinese medicine composition contains the following raw materials in the following weight proportions: 15-30 parts of Prunella vulgaris, 9-12 parts of Bupleurum chinense, 9-12 parts of Pinellia ternata, 10-15 parts of Fritillaria thunbergii, 10-15 parts of Scrophularia ningpoensis, 20-30 parts of Ostrea gigas, 10-15 parts of Curcuma zedoaria, 20-30 parts of Gleditsia sinensis, 15-30 parts of Carapax Trionycis, and 15-30 parts of Astragalus membranaceus. Preferably, the traditional Chinese medicine composition contains the following raw materials in the following weight ratios: 20 parts of Prunella vulgaris, 9 parts of Bupleurum chinense, 9 parts of Pinellia ternata, 10 parts of Fritillaria thunbergii, 10 parts of Scrophularia ningpoensis, 20 parts of Ostrea gigas, 10 parts of Curcuma zedoaria, 20 parts of Gleditsia sinensis thorns, 20 parts of Trionyx sinensis shell, and 15 parts of Astragalus membranaceus. Preferably, the traditional Chinese medicine composition may also contain one or more raw materials in the following weight ratios: 10 parts of Sparganium rhizome, 20 parts of white mustard seed, 1-2 parts of centipede, 10 parts of Scutellaria baicalensis, 15 parts of Cyperus rotundus, 10 parts of Ligusticum chuanxiong, 10 parts of dried tangerine peel, 10 parts of white peony root, 10 parts of Citrus reticulata peel, 10 parts of Citrus aurantium shell, 10-20 parts of Codonopsis pilosula, 30 parts of raw Atractylodes macrocephala, 10 parts of hemp seed, 30 parts of dandelion, 15 parts of Gynostemma pentaphyllum, 15 parts of Cassia tora seed, 20 parts of Sargassum, 20 parts of kelp, 10 parts of earthworm, 30 parts of Houttuynia cordata, 15 parts of stir-fried Atractylodes macrocephala, 20 parts of Solanum nigrum, 20 parts of Scutellaria barbata, 3 parts of Panax notoginseng, 10 parts of licorice root, 10 parts of stir-fried Bombyx mori, 10 parts of turmeric, 90 parts of Vaccaria segetalis, 15 parts of Anemarrhena asphodeloides, 10 parts of Cinnamomum cassia twig, 60 parts of salted Citrus reticulata seed, and 60 parts of Litchi chinensis seed.

7. A traditional Chinese medicine preparation for treating nodules, characterized in that, The traditional Chinese medicine preparation comprises the traditional Chinese medicine composition as any one of claims 5 or 6 as the active ingredient, plus pharmaceutically acceptable excipients; Preferably, the excipients include fillers, disintegrants, binders, surfactants, lubricants, suspending agents, solubilizers, flavoring agents, preservatives, antioxidants, and stabilizers.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The traditional Chinese medicine preparation is an oral dosage form; Preferably, the oral dosage form is granules, tablets, capsules, oral liquid, pills, or drop pills.

9. A method for preparing the traditional Chinese medicine composition according to any one of claims 5 or 6, comprising the following steps: Step 1: Weigh the raw materials according to the above-mentioned proportions of Chinese herbal medicine ingredients; Step 2: Extract the raw materials from Step 1 using a polar solvent 1-5 times, filter, combine the extracts, and obtain the traditional Chinese medicine composition. Preferably, the preparation method may further involve concentrating and drying the extract in step two under reduced pressure to obtain the traditional Chinese medicine composition; Preferably, the polar solvent includes any one or a mixture of any of water, methanol, ethanol, and acetone; when mixed, it is preferably a mixture of water with ethanol, methanol, or acetone. Preferably, the extraction is any one of soaking extraction, water decoction extraction, percolation extraction, reflux extraction or supercritical extraction; Preferably, the drying is vacuum drying or spray drying.

10. The use of the traditional Chinese medicine composition or preparation according to any one of claims 5-8 in the preparation of a drug for treating nodules; Preferably, the nodules are thyroid nodules, lung nodules, or breast nodules; Preferably, the nodules exhibit the TCM syndrome of phlegm and blood stasis.

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