WO2023125797A1 - 一种中药组合物及其制备方法与应用 - Google Patents

一种中药组合物及其制备方法与应用 Download PDF

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WO2023125797A1
WO2023125797A1 PCT/CN2022/143363 CN2022143363W WO2023125797A1 WO 2023125797 A1 WO2023125797 A1 WO 2023125797A1 CN 2022143363 W CN2022143363 W CN 2022143363W WO 2023125797 A1 WO2023125797 A1 WO 2023125797A1
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body weight
chinese medicine
medicine composition
traditional chinese
medicinal materials
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English (en)
French (fr)
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刘晓忠
夏文娟
张虎娟
修海楠
靳奇峰
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湖南湘源美东医药科技有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/536—Prunella or Brunella (selfheal)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • the invention relates to a traditional Chinese medicine composition for thyroid nodule, lipoma, mammary gland hyperplasia and oral ulcer, its preparation method and application, and belongs to the technical field of traditional Chinese medicine.
  • Thyroid nodule is a very common endocrine disease. It is a mass in the thyroid gland. It can move up and down with the thyroid gland when swallowing. It is a common clinical disease. There are many clinical thyroid diseases, such as thyroid degeneration, inflammation , autoimmunity, and neoplasms can all manifest as nodules. Thyroid nodules can be single or multiple. The incidence of multiple nodules is higher than that of single nodules, but the incidence of thyroid cancer in single nodules is higher. Patients with thyroid nodules may experience dyspnea, dysphagia, and hoarseness.
  • Enlarged nodules may compress the trachea, recurrent laryngeal nerve, esophagus, and deep jugular veins, which may cause liver disease, renal tubular acidosis, and diabetes. and serious consequences of cardiovascular disease. Its pathogenesis and etiology are still unclear, and it is likely to be caused by comprehensive stimulation from radiation, immunity, inflammation, chemical stimulation and endocrine changes.
  • Representative patents include: CN201410293292 Main components: honeysuckle, raw turtle shell, dandelion, forsythia, triangular, rhubarb, black medicine, Cyperus cyperi, angelica, dragon scale grass, seaweed, white glue incense, conch, wulingzhi, pig Heart, loofah, yam, oyster, cicada, snow lotus, prunella, sea pumice.
  • CN201510273093 Main components: honeysuckle, forsythia, mountain conch, green skin, tangerine peel, dandelion, toad skin, melon, wild chrysanthemum, turmeric, grass river car, fritillary fritillary, Patrinia, Sanzi mushroom, salvia miltiorrhiza, xanthophyll, Tortoise shell, seaweed, wood beetle, puffball, gentian, causean, prunella vulgaris, raw licorice.
  • CN201810994342 Main components: honeysuckle, wild chrysanthemum, dandelion, viola chinensis, geranium, prunella vulgaris, ghost arrow feather, cat's claw, xanthum, panshania, rehmannia glutinosa, red peony root, angelica, chuanxiong, rhubarb, gentian, licorice .
  • Wuhai Yingliu Pills a Chinese patent medicine listed in China for thyroid-related diseases, patent: CN200510105351.X, composition: kelp, seaweed, octopus, clam shell, kelp, Prunella vulgaris, Angelica dahurica, Chuanxiong, woody fragrance, conch (calcined) .
  • Indications For thyroid tumors, thyroid nodules, thyroid cysts, lymphatic tuberculosis, lymphitis, breast lumps, lipomas, myofibromas and other body surface masses.
  • Treatment cycle one course of treatment per month, at least 3 courses of treatment.
  • the composition of Wuhai Yingliu Pills contains non-medicine and food homologous medicinal materials, and the dosage is large and the taking cycle is long.
  • the Chinese medicinal materials in the above patented prescriptions have many flavors, and the dosage is relatively large, and some medicinal materials have certain liver and kidney toxicity.
  • This patent only has 3-7 flavors of medicinal materials, and the main prescription is composed of medicinal and edible medicinal materials.
  • the medicinal materials for the sub-prescription are also composed of medicinal materials with good safety and long-term taking habits.
  • the overall dosage is small, safe and patient compliance Sex is better.
  • the action mechanism of the patent is clear and has no toxic and side effects.
  • the above patents do not constitute an inspiration to this patent.
  • Lipoma is a common benign soft tissue tumor composed of mature fat cells that can occur anywhere in the body with fat. It is more common in the shoulders, back, neck, breasts, and abdomen, followed by the proximal extremities (such as upper arms, thighs, buttocks). Mainly under the skin, it is called superficial lipoma, and it can also be found between the deep part of the limb and the muscle belly, called deep lipoma.
  • the texture of the tumor is soft, round or lobulated, located under the skin, and can be pushed; the size of the tumor varies, the small one is as big as a jujube, and can only be felt by hand, and the large one can bulge the skin surface, but the surface skin is normal.
  • Mammary gland hyperplasia is a breast disease with abnormal proliferation of breast tissue.
  • Mammary gland hyperplasia is usually the hyperplasia of mammary gland epithelium and fibrous tissue.
  • the abnormalities in the number and shape of mammary gland structure caused by hyperplasia of different degrees and incomplete involution are neither tumor nor A pathological state of inflammation; its main pathological manifestations are typical pregnancy-like changes and tumor-like cystic hyperplasia in the main substance and stroma of the breast, clinical manifestations are breast lumps, unilateral or bilateral breast tenderness or tenderness, accompanied There are menstrual disorders, emotional changes, some patients with nipple discharge, etc., and this disease is one of the breast diseases with the highest incidence rate.
  • Oral ulcer commonly known as "oral ulcer” is a common ulcerative injury disease that occurs in the oral mucosa. It is more common in the inner lip, tongue, tongue belly, buccal mucosa, vestibular groove, soft palate and other parts. The mucosa in these parts lacks stratum corneum. or poor keratosis. Tongue ulcers refer to oral ulcers that occur on the tongue and the abdomen of the tongue. When oral ulcers attack, the pain is severe, and the local burning pain is obvious. In severe cases, it will also affect eating and speaking, causing great inconvenience to daily life; Symptoms such as swollen lymph nodes.
  • the inventor of the present invention has accumulated rich experience in the pathological mechanism, diagnosis and treatment of thyroid disease during long-term medical research and practice.
  • the mechanism has been researched, summarized and improved for a long period of time, and a prescription of honeysuckle, dandelion and Prunella vulgaris with the same source of medicine and food is proposed to treat typical thyroid nodules, and the effect is remarkable.
  • a prescription of honeysuckle, dandelion and Prunella vulgaris with the same source of medicine and food is proposed to treat typical thyroid nodules, and the effect is remarkable.
  • Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, and Shixiantao as supplementary side prescriptions.
  • the composition is strengthened to treat the diseases caused by different reasons.
  • the treatment effect of thyroid nodules is significantly shortened compared with the single use of the main prescription three herbs. Such compositions have not been reported prior to the present invention.
  • a traditional Chinese medicine composition which is a mixture of Flos Lonicerae or Flos Lonicerae or Flos Lonicerae and Flos Lonicerae (the mixing ratio of the two is arbitrary, such as 1:100 to 100:1, for example, 100:1, 90:1, 85:1, 80:1, 70:1, 60:1, 50:1, 40:1, 30:1, 20:1, 10:1, 9:1, 8:1, 7:1, 6: 1, 5:1, 4:1, 3:1, 2:1, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, 1:10, 1:20, 1:30, 1:40, 1:50, 1:60, 1:70, 1:80, 1:85, 1:90, 1:100, etc.)
  • the main prescription is the main active ingredients of the three medicinal and edible homologous medicinal materials, dandelion and prunella vulgaris.
  • the prescription of the traditional Chinese medicine composition may be a prescription of raw medicinal materials, or a prescription composed of its extracts, or a composition of partial extracts and raw medicinal materials.
  • A, B, and C respectively represent the raw materials or extracts of honeysuckle or mountain silver flower or a mixture of honeysuckle and mountain silver flower, dandelion, and Prunella vulgaris.
  • the unit is weight ratio.
  • the total amount may be about 0.001 to 20 g/kg body weight, about 0.005 to 10 g/kg body weight, about 0.01 to 5 g/kg body weight, about 0.01 to 2.5 g/kg body weight, about 0.02 to 1 g/kg body weight , about 0.02 to 0.3 g/kg body weight, about 0.02 to 0.2 g/kg body weight, about 0.02 to 0.1 g/kg body weight, or about 0.02 to 0.08 g/kg body weight.
  • the amount is about 0.01 to 0.05 g/kg body weight. In another embodiment, the amount is about 0.05 to 0.10 g/kg body weight.
  • a traditional Chinese medicine composition for the treatment of thyroid nodules, in the mixture of honeysuckle or mountain silver flower or honeysuckle and mountain silver flower (the mixing ratio of the two is arbitrary, such as 1:100 to 100:1, for example, 100:1 , 90:1, 85:1, 80:1, 70:1, 60:1, 50:1, 40:1, 30:1, 20:1, 10:1, 9:1, 8:1, 7 :1, 6:1, 5:1, 4:1, 3:1, 2:1, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7 , 1:8, 1:9, 1:10, 1:20, 1:30, 1:40, 1:50, 1:60, 1:70, 1:80, 1:85, 1:90, 1 : 100, etc.), dandelion, and Prunella vulgaris as the main ingredients, supplemented with Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, and Shixiantao as auxiliary ingredients, prepared into different preparations, suitable
  • D, E, F, and G represent raw materials or extracts of Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, and Shixiantao, respectively.
  • the unit is weight ratio.
  • the total amount may be about 0.001 to 20 g/kg body weight, about 0.005 to 10 g/kg body weight, about 0.01 to 5 g/kg body weight, about 0.01 to 2.5 g/kg body weight, about 0.02 to 1 g/kg body weight , about 0.02 to 0.3 g/kg body weight, about 0.02 to 0.2 g/kg body weight, about 0.02 to 0.1 g/kg body weight, or about 0.02 to 0.08 g/kg body weight.
  • the amount is about 0.01 to 0.05 g/kg body weight. In another embodiment, the amount is about 0.05 to 0.10 g/kg body weight.
  • the preparation of the traditional Chinese medicine composition can be prepared by directly mixing raw materials, or can be prepared by mixing after crushing.
  • the traditional Chinese medicine composition can be prepared by combining the active substance extracts of various single medicinal materials, or it can be a prescription composed of part of the extracts and the original medicinal materials, or a combination of the active substance extracts after the original medicinal materials are mixed.
  • the active ingredient extraction method of any medicinal material, including the active ingredient of a single medicinal material or a mixture of multi-flavored medicinal materials, may include but not limited to the following steps:
  • step (3) decocting the drug in step (2) or extracting it by low-speed percolation
  • the traditional Chinese medicine composition can be prepared from the active substance extract of a single medicinal material or a combination of active substance extracts after mixing the original medicinal materials.
  • the active ingredient is extracted by supercritical extraction or macroporous resin separation of active component groups. .
  • the preparation method of the traditional Chinese medicine composition is characterized in that other nutritional ingredients can be added as auxiliary materials of the preparation to make different dosage forms to enhance the above-mentioned effects.
  • These effective excipients are nutritional supplements composed of amino acids (glycine, arginine, leucine, valine, alanine, serine, proline, isoleucine, phenylalanine, lysine, threonine acid, methionine, tryptophan, histidine, tyrosine, aspartic acid, cysteine, glutamic acid), curcumin or turmeric extract, betaine hydrochloride, chlorogenic acid, reduced glutathione Glycerin, Yeast ⁇ -glucan, Vitamin B6, B2, GABA, Resveratrol, Polyfructose, Galactooligosaccharide, Chitosan, Sodium Alginate, Aloe Vera Gel at least one or two or more of them.
  • amino acids glycine, arginine, le
  • the preparation method of the traditional Chinese medicine composition is characterized in that the dosage forms include: substitute tea, granules, capsules, tablets, powders, oral liquids and other acceptable dosage forms.
  • the traditional Chinese medicine composition can also be used to treat Hashimoto's thyroid inflammation, hypothyroidism, inflammatory hyperthyroidism and the like in patients without surgery or partial thyroidectomy.
  • the traditional Chinese medicine composition can also be used to treat swelling of lymph nodes caused by various inflammations.
  • the traditional Chinese medicine composition can also be used for treating lymphatic tuberculosis (scrofula is also called mouse sore).
  • the traditional Chinese medicine composition can also be used to treat lipoma.
  • the traditional Chinese medicine composition has a good therapeutic effect on mammary gland hyperplasia of nulliparous women, especially the initial effect is more obvious.
  • the traditional Chinese medicine composition has a good therapeutic effect on common oral ulcers, especially recurrent oral ulcers.
  • the above-mentioned traditional Chinese medicine prescriptions for the treatment of thyroid nodules are characterized by utilizing the characteristics of each prescription drug, through the antibacterial, anti-inflammatory, immune-enhancing, and endocrine-improving effects of the following active components of traditional Chinese medicine , Improving cardiovascular function, supplementing vitamins and other essential nutrients for the human body and other mechanisms of action, to achieve overall physical conditioning, to relieve and cure thyroid nodules, hypothyroidism, hyperthyroidism, thyroid inflammation, lymph node enlargement, lymphatic tuberculosis, etc.
  • Honeysuckle mainly contains organic acids, flavonoids, triterpene saponins, and volatile oils, specifically including active ingredients such as chlorogenic acid, isochlorogenic acid, luteolin, hyperin, and oleanolic acid.
  • Honeysuckle is known as "antibiotics in traditional Chinese medicine", which has anti-inflammatory, antibacterial, antiviral, antioxidative, antitumor, and liver protection effects
  • Dandelion The whole herb of dandelion contains dandelion sterol, choline, inulin, pectin, etc. Sterilization, anti-inflammatory, anti-virus, anti-tumor. Liver nourishment, used to "clear blood” and replenish liver blood, enhance human immunity. Dandelion extracts are used to treat liver and gallbladder blockages, improve liver function, stimulate bile secretion and act as a diuretic.
  • Prunella vulgaris mainly contains Prunella vulgaris polysaccharides, glycosides such as oleanolic acid, rutin, and hyperoside, and organic acids such as ursolic acid, caffeic acid, and free oleanolic acid; it also contains vitamin B1, Vitamin C, vitamin K, carotene, resin, bitter substance, tannin, volatile oil and other ingredients are suitable for lymphatic tuberculosis and goiter, and have the functions of clearing heat and dissipating stagnation, antibacterial and anti-inflammatory.
  • Hedyotis diffusa the main components are terpenoids, flavonoids, sterols, organic acids, polysaccharides, etc., all of which have good antitumor activity. Flavonoids have strong DNA cleavage activity, can inhibit the growth of various malignant tumors, and regulate the immune function of the body. Polysaccharides can significantly inhibit the growth of liver cancer cells and cervical cancer cells, inhibit the formation of cell colonies, and induce cell apoptosis. Hedyotis diffusa can regulate the immune function of the body, enhance the inhibitory effect of immune cells such as T cells and natural killer cells on tumor cells, reduce the immune suppression of patients, and finally kill tumor cells. It can also inhibit the formation of blood vessels and lymphatic vessels in tumor tissue, and cut off the nutrient source of tumor cells.
  • Seabuckthorn is recognized as the king of Vc in the world's plant groups. It is called “longevity fruit” in Japan, “second ginseng” in Russia, “life energy” in the United States, and “magic fruit” in India. China is known as “Holy Fruit” and “King of Vitamin C”.
  • Fructus aurantium mainly contains volatile oil, orange yellow, mainly contains d-limonene in the oil, and has a small amount of decanal, citric aldehyde, citronellal, methyl anthranilate, linalool. In addition, it contains hesperidin, naringin, neohesperidin, and the bitter ingredient aurinin. It still contains volatile oil and alkaloids. It has the function of regulating gastrointestinal function, cardiovascular system and uterus.
  • Shixiantao which mainly contains adoterene alcohol and adoterene ketone, has the effects of anesthesia, analgesia, anti-fatigue, anti-tumor and hypoxia resistance. By inhibiting the central nervous system, it can exert sedation, hypnosis and Anticonvulsant effect. Shixiantao contains 22 kinds of minerals such as K, Na, P, Mg, Ca, Fe, Al, Mn, B, Zn, Cu, Mo, Ti, As, Tl, Cd, Pb, Se, Co, Ni, Cr, V, etc. material element.
  • the content of constant elements K, Mg, Ca, and P is higher than that of general Chinese medicinal materials; the content of trace elements Fe, Mn, Co, and Se is ten times higher than that of ginseng and astragalus; the content of Cd and Pb is lower than that of heavy metals in the Pharmacopoeia limit standard.
  • Amino acid is the basic substance that constitutes the protein required for animal nutrition. It is mainly involved in the synthesis of tissue proteins, which are converted into acids, hormones, antibodies, creatine and other ammonia-containing substances, converted into carbohydrates and fats, oxidized into carbon dioxide, water and urea, and generate energy. It is an indispensable nutrient for the human body.
  • Curcumin a natural compound, is a rare pigment with a diketone structure in the plant kingdom. It has the effects of lowering blood fat, anti-tumor, anti-inflammatory, choleretic, and anti-oxidation. In addition, some scientists have found that curcumin can help treat drug-resistant tuberculosis.
  • Betaine hydrochloride participates in fat metabolism, promotes protein synthesis, appetizer, has buffering effect, can play a synergistic effect with anti-evil insect drugs, protect vitamins, can be used for gastric acid deficiency, arteriosclerosis and liver diseases, and can increase fat metabolism , Inhibit the deposition of fat in the liver.
  • Chlorogenic acid is an important biologically active substance, which has the functions of antibacterial, antiviral, increasing white blood cells, protecting liver and gallbladder, antitumor, lowering blood pressure, lowering blood fat, scavenging free radicals and stimulating the central nervous system.
  • Reduced glutathione can activate a variety of enzymes and promote the metabolism of carbohydrates, fats and proteins. It can also affect the metabolic process of cells and is an important regulatory metabolic substance in cells.
  • Yeast ⁇ -glucan is the first glucan found to have immune activity. It has antibacterial and immunoregulatory effects, removes toxins, resists radiation, repairs cells, and improves intestinal function. It has unique biological activities on tumors, hepatitis, cardiovascular, diabetes, blood lipid lowering, anti-aging and other aspects.
  • Vitamin B6 participates in the metabolism of neurotransmitters, glycogen, sphingomyelin, heme, steroids and nucleic acids, participates in the metabolism of all amino acids, reduces chronic diseases, treats anemia, treats leukopenia, enhances immunity and fights cancer.
  • Vitamin B2 mainly participates in biological oxidation and energy metabolism in the body, promotes development and cell regeneration, and affects biological oxidation and energy metabolism.
  • ⁇ -aminobutyric acid is a naturally occurring non-protein amino acid that participates in a variety of metabolic activities and has extremely important physiological functions. It can promote the balance of amino acid metabolism in the human body, regulate immune function, delay brain aging, and supplement Inhibitory neurotransmitter in the human body, promotes the improvement and protection of kidney function.
  • Resveratrol a non-flavonoid polyphenolic organic compound
  • Resveratrol is an antitoxin produced by many plants when stimulated. It has anti-inflammatory, anti-aging, anti-tumor, anti-cancer, and cardiovascular disease prevention effects.
  • Polyfructose is an excellent water-soluble dietary fiber and a good "prebiotic”. It has health functions such as regulating intestinal flora, proliferating bifidobacteria, promoting calcium absorption, and promoting immune regulation. It can reduce liver toxins, generate anti-cancer organic acids in the intestines, and has significant anti-cancer functions.
  • Galacto-oligosaccharide is a new functional food, through the highly selective proliferation of bifidobacteria, it can balance the largest micro-ecosystem of the human body - the intestinal micro-ecosystem, thereby affecting the nutrition, immunity and disease prevention of the host. Prevention and treatment play an active role, which can promote the synthesis of B vitamins, improve the absorption and utilization of protein, promote the absorption of minerals, and inhibit endotoxin.
  • Chitosan is a functional food that can nourish cells, activate inactive cells, and repair damaged cells. The ability to age and unleash the natural healing power in the body.
  • Sodium alginate is a natural polysaccharide and an indispensable dietary fiber for the human body. It has unique nutrition, can combine with organic matter, reduce cholesterol in serum and liver, inhibit the increase of total fat and total fatty acid concentration, and improve the absorption of nutrients. Digestion and absorption, long-term consumption will help treat hypertension, coronary heart disease, diabetes and intestinal system diseases.
  • Curacao aloe vera gel is a new resource food, which can improve human immunity, remove free radicals, and relieve inflammation.
  • the composition of this patented formula is not based on the traditional Chinese medicine theory, but based on the modern medical research on the pathological mechanism of the above-mentioned diseases.
  • the formula is formulated on the basis of a large number of active components and their functional studies of the medicinal materials in the formula.
  • the Chinese medicine composition contains active ingredients such as polysaccharides, flavonoids, polyphenols, saponins, sterols, vitamin B, vitamin C, various amino acids, trace elements, minerals and other nutrients that can regulate the body's own Immunity, regulating endocrine level, increasing antibacterial ability, anti-inflammation, improving microcirculation, supplementing nutrition.
  • this patent starts from the treatment mechanism of thyroid nodules, the main active components of the drug and its mechanism of action, nutritional efficacy, etc., to relieve the pain of patients with thyroid nodules, reduce the volume of the tumor until it disappears, and the effect is remarkable.
  • Honeysuckle contains organic acids such as chlorogenic acid, isochlorogenic acid, caffeic acid, and luteolin, which are antibacterial components; flavonoids, polysaccharides, alkaloids, organic acids, and sterols in dandelion have strong Antibacterial effect, the triterpenoid component ursolic acid contained in the fruit ears of Prunella vulgaris has good antibacterial and antiviral effects, and the polyphenolic compounds contained in seabuckthorn include ursolic acid, coumarin, ⁇ -coumarin, phenol Acid and other antibacterial components, the above several medicinal materials synergistically strengthen the therapeutic effect.
  • organic acids such as chlorogenic acid, isochlorogenic acid, caffeic acid, and luteolin, which are antibacterial components
  • flavonoids, polysaccharides, alkaloids, organic acids, and sterols in dandelion have strong Antibacterial effect
  • the triterpenoid component ursolic acid contained in the fruit ears of Prunella vulgaris has good antibacterial and antiviral
  • Honeysuckle, honeysuckle and loganin and other components can inhibit the synthesis and release of inflammatory mediators (prostaglandins, histamine, 5-hydroxytryptamine, malondialdehyde), inhibit the expression of COX-2, and inhibit the expression of COX -1 and COX-2 activity.
  • Flavonoids such as luteolin and quercetin in dandelion mediate the production of tumor necrosis factor TNF- ⁇ by inhibiting the production of interleukin-1, thereby inhibiting the occurrence of inflammation; the triterpenoids in the ears of Prunella vulgaris Ursolic acid, oleanolic acid, betulinic acid, carotene, etc.
  • the polysaccharide (Tof-CFr) extracted from dandelion can strongly stimulate sugar energy, and can significantly reduce the phagocytosis index of T cells with low immunity; dandelion water extract can promote cell growth factors IL-2, FIN- ⁇ , IL The secretion of -4 can significantly increase the immunoglobulin on the surface of B cell membrane, thereby improving the immune function of the body; polysaccharides, ursolic acid, oleanolic acid, etc.
  • Prunella vulgaris can improve the immunity of the body, among which Prunella vulgaris polysaccharides have significant antioxidant properties And immune activity, can significantly scavenge DPPH free radicals, ABTS free radicals and HOO free radicals, and stimulate macrophages to secrete cellular immune factors.
  • the organic acid contained in honeysuckle can improve local blood circulation and vascular permeability.
  • Seabuckthorn stem bark, fruit, and leaves contain a rare ingredient in the plant world - 5-hydroxytryptamine. It exists in free state and compound state.
  • As a neurotransmitter it has an important regulatory effect on human emotional state, blood pressure, body temperature, internal environment of the body, hormones, etc. It also has anti-radiation, anti-infectious disease, anti-cancer It can accelerate the conversion of fibrinogen into fibrin, which is helpful for blood coagulation and so on.
  • Nutritional efficacy the formula is rich in vitamin B, vitamin C and various amino acids, as well as trace amounts of manganese, zinc, potassium, sodium, calcium, magnesium, phosphorus, iron, copper and other elements.
  • Dandelion whole herb contains glucose, glucoside, resin, rubber and so on.
  • the leaves contain lutein, phylloxanthin, phylloquinone, vitamin C (50-70 mg/100 g) and vitamin D (5-9 mg/100 g), and dandelion is also a rare selenium-rich plant in nature.
  • the content of vitamin C in seabuckthorn is extremely high. Per 100 grams of fruit juice, the content of vitamin C can reach 825-1100 mg.
  • active ingredients of vitamin E, vitamin A, flavonoids and SOD which can effectively prevent free radicals and achieve anti-aging effects.
  • Figure 1 is a typical case 9 pre-medication inspection report.
  • Figure 2 is a typical case 9 inspection report after taking the medicine.
  • Honeysuckle is the dry flower bud or the first flower of Lonicera japonica Thunb. (Anhui Jiancheng 170809)
  • Mountain silver flower is the dry flower bud or the first opening of Lonicera macranthoides Hand.-Mazz., Lonicera hypoglauca Miq., Lonicera confusa DC. or Lonicera fulvotomentosa Hsu et S.C.Cheng flowers.
  • Dandelion is the dry whole plant of Taraxacum mongolicum Hand.-Mazz. (Anhui Jiancheng 171002)
  • Prunella vulgaris is the dried fruit ear of Prunella vulgaris L., a plant of Lamiaceae. (Anhui Jiancheng 180201)
  • Hedyotis diffusa is the whole plant of Hedyotis diffusa Willd. [Oldenlandia diffusa (Willd.) Roxb.], a plant of Rubiaceae Auricularia. (Anhui Jiancheng 180102)
  • Seabuckthorn is the dry ripe fruit of Hippophae rhamnoides L. (Anhui Jiancheng 170904)
  • Citrus aurantii is the dry immature fruit of Citrus aurantium L. and its cultivars of the Rutaceae plant. (Anhui Jiancheng 180307)
  • Shixiantao is a plant of the genus Shixiantao in the family Orchidaceae, Pholidota chinensis Lindl. It is used as medicine with pseudobulbs or whole plants. (Anhui Tengxin 180103)
  • A represents honeysuckle or mountain silver flower or a mixture of honeysuckle and mountain silver flower
  • B represents dandelion
  • C represents Prunella vulgaris
  • D represents Hedyotis diffusa
  • E represents seabuckthorn
  • ratios mentioned in the following examples refer to weight ratios.
  • the two extracts obtained above are mixed and further processed to prepare tablets, capsules, granules or oral liquids.
  • Raw or processed medicinal materials of honeysuckle, dandelion, Prunella vulgaris, Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium and Shixiantao that have been fully dried are superfinely pulverized.
  • Example 4 Take the extract dry powder of Example 4 and add or not add the corresponding superfine powder of raw medicinal materials, mix evenly, pack in bags, or make pills, and pack.
  • Weighing add specific microorganisms (including Monascus, yeast) for microbial fermentation treatment or weigh and mix the above medicinal materials in proportion
  • microbial fermentation treatment sterilize the medicinal material after treatment, add water 10 times the total weight of the drug, soak it overnight, decoct it twice, each time for 2 hours, filter, and distill the filtrate to remove water under reduced pressure at 70°C to obtain Concentrated solution with a density of 1.1-1.2, bottled or made into oral solution.
  • the concentrated solution of single medicinal material is directly spray-dried to obtain a dry powder, which is mixed evenly with or without the corresponding superfine powder of raw medicinal material, and then packed into a bag, or made into a pill, and packaged.
  • the concentrated solution of single medicinal material is directly spray-dried to obtain a dry powder, which is mixed evenly with or without the corresponding superfine powder of raw medicinal material, and then packed into a bag, or made into a pill, and packaged.
  • Extract dry powder or raw medicinal material superfine powder also can add different adjuvants to make different dosage forms in above embodiment 4,6,7, and added adjuvants and dosage forms are respectively:
  • the superfine powder of raw medicinal materials is added with silicon dioxide, mixed evenly and packed into bags, or prepared into pills by adding water, honey or other binders.
  • fillers are selected from dextrin, starch, sucrose, lactose, microcrystalline cellulose, mannose, xylitol, bifidosaccharide, and trehalose.
  • the binder is selected from sodium carboxymethylcellulose, povidone, sodium alginate and polyethylene glycol.
  • the disintegrating agent is selected from dry starch, sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, and low-substituted hydroxypropyl cellulose.
  • Lubricants are selected from magnesium stearate, micronized silica gel, talcum powder, and polyethylene glycols.
  • the wetting agent is water, different concentrations of ethanol or a mixture thereof.
  • the above raw and auxiliary materials are mixed to make dosage forms such as granules, tablets or capsules.
  • dosage forms described in this patent are not limited to several in the examples, but also include various clinically acceptable dosage forms.
  • honeysuckle, dandelion, Prunella vulgaris, white flower Dry powder of extracts of Hedyotis, seabuckthorn, citrus aurantium and shixiantao, mix add 0.5 part of betaine hydrochloride, 0.1 part of chlorogenic acid, 0.1 part of resveratrol, 0.5 part of polyfructose, 0.1 part of silicon dioxide, add The honey is made into pills, packed in bags and stored in a dry environment.
  • the two mixtures obtained above can be further processed to be prepared into tablets, capsules, granules or oral liquids and the like.
  • the two mixtures obtained above can be further processed to be prepared into tablets, capsules, granules or oral liquids and the like.
  • This patent project uses carrageenan-induced rat inflammation model for anti-inflammatory verification, and uses subacute aging mouse thymus index, in vitro spleen lymphocyte proliferation, mouse spleen lymphocyte proliferation and other experiments to observe the effects of this patent product on the body Effects on immune function.
  • Swelling value the volume of the inflamed rear paw - the volume of the inflamed anterior paw
  • mice body weight (16-20g) were divided into 5 groups at random: normal control group (equal dose of normal saline), subacute mouse model group, low dose of medicine group (embodiment 2 oral gavage 0.1g/kg) , the middle dose group of medicine (Example 2 orally gavaged 0.25g/kg), the high dose group of medicine (Example 2 Orally gavage 0.5g/kg).
  • normal control group equal dose of normal saline
  • subacute mouse model group low dose of medicine group
  • the middle dose group of medicine Example 2 orally gavaged 0.25g/kg
  • the high dose group of medicine Example 2 Orally gavage 0.5g/kg.
  • the same volume of distilled water was given, and at the same time, except for the normal control group with the same volume of sterile saline, the other groups were given 0.1mL/10g of D-galactose per day for 42 consecutive days.
  • decapitation and decapitated Take the thymus, weigh it and calculate the
  • mice thymus index in the low-dose drug group does not increase significantly, and both the middle-dose and high-dose groups of the drug can increase the thymus index in mice, especially the high-dose group. The most obvious.
  • This patented product can directly promote the proliferation index of mouse spleen lymphocytes in vitro, which is equivalent to that of phytohemagglutinin Concanavalin A (4.0 ⁇ g/mL).
  • mice of Kunming kind and be divided into 5 groups at random: blank control group (normal saline), medicine low dosage group (embodiment 5 oral gavage 0.05g/kg), medicine low dosage group (embodiment 5 oral gavage 0.1 g/kg), the low-dose drug group (0.2 g/kg orally administered orally in Example 5), and the positive control group (0.025 g/kg body weight of mannan peptide).
  • the drug was dissolved in normal saline, administered orally by gavage according to body weight, once a day, for 8-10 days in a row.
  • 10 mg/kg of PHA was intramuscularly injected into each mouse every day for the first 3 days of administration. On the 8th day, 2 hours after the administration, the tails of the mice were cut to collect blood, and the percentage of lymphocyte transformation was calculated according to the literature method.
  • the drug group can increase the lymphocyte transformation rate of mice, especially the middle-dose group and high-dose group have more obvious effects, and are better than the positive control group.
  • This patented product can significantly reduce the paw swelling value of rats caused by carrageenan, indicating that it has a good anti-inflammatory effect; it can significantly increase the thymus index of subacute aging mice caused by D-galactose; The proliferation of spleen lymphocytes has a certain promoting effect; it can obviously promote the transformation rate of T lymphocytes in mice, and enhance the cellular immune function of mice.
  • the main points of asking the medical history of patients with thyroid nodules include the patient's age, gender, long-term insufficient or excessive iodine intake, whether there is a head and neck or whole body radiological examination or treatment history or family history, and the size of the thyroid nodule and its changes and growth. Speed and presence or absence of local symptoms, etc. The size, number, activity, texture, tenderness, and cervical lymphadenopathy of nodules.
  • Diagnosis of thyroid nodules Refer to the 2012 "Guidelines for the Diagnosis and Treatment of Thyroid Nodules and Differentiated Thyroid Cancer": 1 Imaging examination: Thyroid color ultrasound shows ⁇ 1 thyroid nodule. 2 Serum TSH is lower than 0.35mIU/L; 3 Palpation of cervical goiter; the diagnosis can be made if the above conditions are met.
  • Imaging examination Ultrasound examination is required for all patients to determine the location, shape, size, number, edge status of nodules, internal structure, echo pattern, blood flow status and lymph node condition.
  • Serological examination mainly to measure serum TSH and thyroid hormone levels. Serum thyroid hormone levels increased, TSH decreased, and most of them were benign nodules.
  • Cytological examination may be considered for thyroid nodules with a diameter ⁇ 1 cm to differentiate benign from malignant nodules.
  • the most commonly used method is thyroid fine needle aspiration.
  • the patient should be in the supine position and the neck should be raised , to fully expose the thyroid gland. 75% alcohol disinfection twice, the operator fixed the thyroid gland or thyroid nodule on the punctured side with the index finger and middle finger of the left hand, held an empty needle in the right hand, left 5-7ml of air in the needle barrel, and quickly pierced the thyroid gland (or nodule) with the puncture needle percutaneously.
  • Cytological diagnosis classification divided into benign, difficult to determine benign and malignant or suspected malignant, malignant and unsatisfactory smear.
  • the criteria for a satisfactory smear are: at least 5-6 follicular epithelial cell clusters on each smear, and at least 10 follicular epithelial cells per cluster.
  • Benign A nodule is benign if cytology includes colloid nodules, hyperplastic nodules, lymphocytic or granulomatous thyroiditis, and benign cysts.
  • Malignant The specimen has the cytological features of a malignant tumor. The most common is PTC, but also includes MTC, anaplastic carcinoma, lymphoma, and other thyroid malignancies and metastatic carcinomas.
  • Exclusion criteria Those who are confirmed as malignant nodules, the volume of nodules has increased by more than 40% in a short period of time; those with hyperthyroidism or hypothyroidism; those who are allergic to the prescription drugs; those with infectious diseases, severe cardiovascular and cerebrovascular diseases, or Patients with severe hepatic and renal insufficiency; pregnant women; patients with incomplete data collection.
  • Treatment method the treatment group took the granule product of Example 13, 3 times a day, 10g once a time (infused with 200mL boiled water), the control group took Wuhaiyingliu Pill, 5g once a day, 2 times a day, and other hormones were prohibited during the test with immunosuppressants.
  • the method of use is: a course of treatment for 7 days.
  • Therapeutic effect 30 cases (75.0%) were cured, 8 cases (20.0%) were effective, 2 cases (5%) were ineffective, and the total effective rate was 95%. The effect was significantly better than that of the control group.
  • Table 2 Comparison of the improvement time (days) of symptoms and signs in the two groups of patients
  • the total improvement rate of common symptoms in the treatment group was 95%, which was significantly higher than 70% in the control group; the time for the patients in the treatment group to become soft and smaller was lower than that in the control group (P ⁇ 0.05); the patients in the treatment group had thyroid nodules after treatment The regression time was significantly lower than that of the control group (P ⁇ 0.05).
  • the medicine of the present invention can effectively improve the postoperative clinical symptoms of patients with thyroid nodules, reduce the diameter of thyroid nodules and even disappear, relieve the pain of patients, improve the quality of life, have high safety, and are suitable for clinical promotion and application.
  • Therapeutic method choose the patient with relevant clinical indication to carry out relevant data collection, take the product of embodiment 6 gained by the present invention, take 3 times every day, once 10g (200mL boiling water brews), using method is: 30 days a course of treatment.
  • Therapeutic method select the patient with relevant clinical indication to carry out relevant data collection, take the product of the gained embodiment 7 of the present invention, take 3 times every day, once 10g (200mL boiled water brewing), using method is: 30 days a course of treatment.
  • Therapeutic method collect 30 20-40 year old unmarried and childless female patients and carry out relevant data collection, the treatment group takes the granule product prepared based on embodiment 4 in the embodiment of the present invention 8, takes 3 times every day, once 10g ( 200mL boiling water), the control group took Xiaoyao Pills, 3 times a day, 8 pills each time.
  • Table 2 Comparison of the improvement time (days) of symptoms and signs in the two groups of patients
  • Therapeutic method choose 20 routine patients who have recurrent oral ulcers all the year round to carry out relevant data collection, the treatment group takes the product of embodiment 10 gained by the present invention, takes 3 times a day, 10g (200mL boiled water for brewing); the control group uses acetic acid Dexamethasone sticky patch, use one patch every day, once a day.
  • Criteria for judging the curative effect cured: the symptoms of discomfort are alleviated, and the ulcer surface disappears; effective: the symptoms of discomfort are alleviated or partially disappeared, the ulcer surface is reduced, and the pain is alleviated; invalid: the symptoms of discomfort are not improved.
  • Therapeutic effect 8 cases (80.0%) were cured, 1 case (10.0%) was effective, 1 case (10.0%) was ineffective, and the total effective rate was 90%. The effect was significantly better than that of the control group.
  • Example 13 of this prescription 3 times a day, 10g each time, after one course of treatment, the patient's breathing was smoother than before, and the discomfort symptoms were alleviated; after continuing to take 5 courses of treatment, the swelling and pain in the patient's thyroid disappeared, and the discomfort symptoms disappeared obviously. get well.
  • Example 13 of this prescription Take the granule product of Example 13 of this prescription, 3 times a day, 10g each time, for 14 days, the patient's neck swelling alleviated, and the lump became smaller; after taking it for 1 month, the patient's neck swelling basically disappeared, and the breathing, eating and drinking It is normal, and the discomfort symptoms basically disappear; continue to take it for 2 weeks, the lump completely disappears, and the patient feels healed.
  • lymphatic tuberculosis 7. Typical case Mr. Liu, 47 years old, began to develop multiple lymphatic tuberculosis in the neck at the age of five. Before taking this prescription, the largest lymphatic tuberculosis was 30*20mm, and multiple lymphatic tuberculosis was 10*20mm. Take this prescription embodiment 6 pills, 3 times a day, each 5g, after two months of the product, most lymphoid tuberculosis disappears, remaining lymphatic tuberculosis is 10*5mm (due to the shrinkage of the largest lymphatic tuberculosis).
  • Example 10 of this patent Take the powder product of Example 10 of this patent, 3 times a day, 10g each time, you can obviously feel that the pain is not as unbearable as before when the recurrence occurs, and the recovery period is obviously shortened, the ulcer surface is very small, does not continue to expand, and 3-4 Ulcerativeness gradually disappeared. There has been no recurrence for nearly half a year.

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Abstract

一种用于治疗甲状腺结节、脂防瘤、乳腺增生以及口腔溃疡的中药组合物，该组合物是以金银花或山银花或金银花和山银花的混合、蒲公英、夏枯草三味药食同源药材为主要有效成分的主方。在此主方的基础上，补充药材白花蛇舌草、沙棘、枳壳、石仙桃作为副方，制备成不同的制剂，适合不同类型的甲状腺结节。该中药组合物组方可以是原药材的组方，也可以是由其提取物组成的组方，也可以是原药材与提取物组成的组方。该中药组合物对炎症、自身免疫以及新生物引起的甲状腺内肿大的症状具有显著的治疗效果。

Description

一种中药组合物及其制备方法与应用 技术领域
本发明涉及用于甲状腺结节、脂肪瘤、乳腺增生以及口腔溃疡的中药组合物及其制备方法和应用，属于中药技术领域。
背景技术
甲状腺结节是一种非常常见的内分泌领域疾病，是甲状腺内的肿块，可随吞咽动作随甲状腺而上下移动，是临床常见的病症，临床上有多种甲状腺疾病，如甲状腺退行性变、炎症、自身免疫以及新生物等都可以表现为结节。甲状腺结节可以单发，也可以多发，多发结节比单发结节的发病率高，但单发结节甲状腺癌的发生率较高。甲状腺结节患者可出现呼吸困难、吞咽困难和声音嘶哑，结节肿大者可压迫气管、压迫喉返神经、压迫食管、压迫颈深部大静脉等，可能引起肝病、肾小管性酸中毒、糖尿病和心血管病严重后果。其发病机制与病因目前仍不明了，很可能系放射、免疫、炎症、化学物质刺激及内分泌变化等多方面综合刺激所致。
目前，医学上治疗甲状腺结节的技术和方法众多，西医在治疗良性甲状腺结节的方法上主要有随访观察、甲状腺激素抑制治疗、手术治疗等。其中手术治疗在临床上应用广泛，但是存在治疗过度或术后复发的缺点。且可能导致甲状腺正常功能减退或丧失，术后需激素替代，亦会加剧患者焦虑恐惧而影响其生活质量。西药大多疗效一般且副作用大，不能达到好的治疗效果。本发明提供一种纯中药组合物，且组成组合物的主方药材为药食同源食材，无毒副作用，让患者在食疗过程中除去病患，提高生活质量。
目前研究论文、专利文献报道治疗甲状腺结节的方法除了手术之外多以中药为主，但是相关研究及专利均是由很多种传统中药材组方，包含非药食同源的中药材多种，甚至是有毒药材，药物之间的安全相容性不明确，质量标准不易建立，药物作用机理不明确，多数单天服用剂量较大(超过50克)，服用久了容易会产生肝肾毒性。代表性专利包括：CN201410293292主要组成：金银花、生鳖甲、蒲公英、连翘、三棱、大黄、乌药、香附、当归、龙鳞草、海藻、白胶香、海螺、五灵脂、猪心、丝瓜络、山药、牡蛎、金蝉、雪莲、夏枯草、海浮石。CN201510273093主要组成：金银花、连翘、山海螺、青皮、陈皮、蒲公英、蟾皮、瓜蒌、野菊花、郁金、草河车、浙贝母、败酱草、山慈菇、丹参、黄药子、龟板、海藻、土鳖虫、马勃、龙胆草、胆南星、夏枯草、生甘草。CN201810994342主要组成：金银花、野菊花、蒲公英、紫花地丁、天葵子、夏枯草、鬼箭羽，猫爪草、黄药子、穿山龙、生地黄、赤芍、当归、川芎、大黄、龙胆、甘草。针对甲状腺相关疾病的中国上市中成药五海瘿瘤丸，专利：CN200510105351.X，构成：海带、海藻、海螵蛸、蛤壳、昆布、夏枯草、白芷、川芎、木香、海螺(煅)。适应症：用于甲状腺瘤、甲状腺结节、甲状腺囊肿、***核、淋巴炎、***肿块、脂肪瘤、肌纤维瘤等体表肿块。治疗周期：一个月一疗程，至少服用3个疗程。五海瘿瘤丸的组成含非药食同源药材，服用剂量大，服用周期长。
以上专利组方中药材味数比较多，服用剂量比较大，部分药材有一定的肝肾毒性。本专利仅3-7味药材，以药食同源药材组方作为主方，副方组成药材也是选择安全性好、有长期服用习惯的药材组成，整体服用剂量少，安全性好，患者顺应性比较好。本专利作用机理明确，无毒副作用。以上专利并不会对本专利构成启示。
脂肪瘤是一种常见的软组织良性肿瘤，由成熟脂肪细胞构成，可发生于身体任何有脂肪的部位。好发于肩、背、颈、***和腹部，其次为四肢近端(如上臂、大腿、臀部)。主 要在皮下，称为浅表脂肪瘤，也可见于肢体深部和肌腹之间，称为深部脂肪瘤。瘤体质地柔软，圆形或分叶状，位于皮下，可以推动；瘤体大小不等，小的如枣大，用手摸方能触知，大的可***皮面，但表面皮肤正常。患者年龄多较大，多见于40～60岁中年人，儿童较少见。深部脂肪瘤多沿肌肉生长，可深达骨膜，但很少侵犯邻近骨骼。脂肪瘤很少恶变，手术易切除。现有的治疗脂肪瘤的中药种类繁多，但治疗效果有待提高，因此还需要开发疗效更好的治疗脂肪瘤的药物。
乳腺增生是一种乳腺组织异常增生性乳腺疾病，乳腺增生通常为乳腺上皮、纤维组织的增生，不同程度增生及复旧不全所致的乳腺结构在数量和形态上的异常，既非肿瘤，也非炎症的一种病理状态；其主要病理表现为乳腺主质与间质的典型妊娠样变化和瘤样囊性增生，临床表现为***包块，单侧或双侧***胀痛或触痛，伴有***，情志改变，部分病人合并***溢液等，该病为发病率最高的乳腺疾病之一。
口腔溃疡俗称“口疮”，是一种常见的发生于口腔黏膜的溃疡性损伤病症，多见于唇内侧、舌头、舌腹、颊黏膜、前庭沟、软腭等部位，这些部位的黏膜缺乏角质化层或角化较差。舌头溃疡指发生于舌头、舌腹部位的口腔溃疡。口腔溃疡发作时疼痛剧烈，局部灼痛明显，严重者还会影响饮食、说话，对日常生活造成极大不便；可并发口臭、慢性咽炎、便秘、头痛、头晕、恶心、乏力、烦躁、发热、***肿大等全身症状。
发明内容
1.本发明的发明人在长期的医学研究和实践过程中，对该甲状腺疾病的病理机制、诊断、治疗等方面积累了丰富的经验，通过对传统中药材的活性组分群及其相关药理作用机制进行了长期的深入的调研、总结、完善，提出了以金银花、蒲公英、夏枯草三味药食同源药材组方，治疗典型的甲状腺结节，效果显著。结合现代医药技术，在通过不断实验和总结的基础上，提出以白花蛇舌草、沙棘、枳壳、石仙桃作为补充副方，通过配比的差异化，强化该组合物治疗不同原因引起的甲状腺结节的治疗效果，且相对于单用主方三味药材治疗周期明显缩短。上述组合物在本发明之前未曾被报道。
2.一种中药组合物，是以金银花或山银花或金银花和山银花的混合(二者的混合比例任意，例如1:100至100:1，例如，100:1、90:1、85:1、80:1、70:1、60:1、50:1、40:1、30:1、20:1、10:1、9:1、8:1、7:1、6:1、5:1、4:1、3:1、2:1、1:1、1:2、1:3、1:4、1:5、1:6、1:7、1:8、1:9、1:10、1:20、1:30、1:40、1:50、1:60、1:70、1:80、1:85、1:90、1:100等等)、蒲公英、夏枯草三味药食同源药材为主要有效成分的主方。在此主方的基础上，补充药材白花蛇舌草、沙棘、枳壳、石仙桃作为副方，制备成不同的制剂，适合炎症、自身免疫以及新生物引起的甲状腺结节。该中药组合物组方可以是原药材的组方，也可以是由其提取物组成的组方，也可以是部分提取物与原药材组成的组方。
Figure PCTCN2022143363-appb-000001
其中A、B、C分别代表以金银花或山银花或金银花和山银花的混合、蒲公英、夏枯草原料药材或提取物。单位为重量比。
主组方活性组分的总含量范围：
10.0％≤总黄酮≤25.0％    5.0％≤总多糖≤15.0％
2.0％≤总皂苷≤10.0％    2.0％≤总多酚≤10.0％
主方药材或提取物相当于主药药材的用量的选择，受到使用者体重及疾病进展程度的影响。在一些实施方案中，总量可能约为0.001至20g/kg体重，大约0.005至10g/kg体重，大约0.01至5g/kg体重，大约0.01至2.5g/kg体重，大约0.02至1g/kg体重，大约 0.02至0.3g/kg体重，大约0.02至0.2g/kg体重，大约0.02至0.1g/kg体重，或约0.02至0.08g/kg体重。在一些实施方案中，用量约为0.01至0.05g/kg体重。在另一实施方案中，用量约为0.05至0.10g/kg体重。
3.一种治疗甲状腺结节的中药组合物，在以金银花或山银花或金银花和山银花的混合(二者的混合比例任意，例如1:100至100:1，例如，100:1、90:1、85:1、80:1、70:1、60:1、50:1、40:1、30:1、20:1、10:1、9:1、8:1、7:1、6:1、5:1、4:1、3:1、2:1、1:1、1:2、1:3、1:4、1:5、1:6、1:7、1:8、1:9、1:10、1:20、1:30、1:40、1:50、1:60、1:70、1:80、1:85、1:90、1:100等等)、蒲公英、夏枯草三味药食同源药材为主要成分的基础上补充药材白花蛇舌草、沙棘、枳壳、石仙桃作为副方，制备成不同的制剂，适合不同的甲状腺结节，以上组方可以是原药材的组方，也可以是由其提取物组成的组方，也可以是部分提取物与原药材组成的组方。
其中配比分别为：
Figure PCTCN2022143363-appb-000002
Figure PCTCN2022143363-appb-000003
其中D、E、F、G分别代表白花蛇舌草、沙棘、枳壳、石仙桃原料药材或提取物。单位为重量比。
全组方活性组分的总含量范围：
5.0％≤总黄酮≤20.0％    5.0％≤总多糖≤20.0％
2.0％≤总皂苷≤10.0％    2.0％≤总多酚≤15.0％
上述副方药材或提取物相当于副药药材的用量的选择，受到使用者体重及疾病进展程度的影响。在一些实施方案中，总量可能约为0.001至20g/kg体重，大约0.005至10g/kg体重，大约0.01至5g/kg体重，大约0.01至2.5g/kg体重，大约0.02至1g/kg体重，大约0.02至0.3g/kg体重，大约0.02至0.2g/kg体重，大约0.02至0.1g/kg体重，或约0.02至0.08g/kg体重。在一些实施方案中，用量约为0.01至0.05g/kg体重。在另一实施方案中，用量约为0.05至0.10g/kg体重。
4.该中药组合物的制备可以直接以原材料混合制备而成，也可以经过粉碎之后混合而成。
5.该中药组合物可以以各种单味药材的活性物质提取物组合而成，也可以是部分提取物与原药材组成的组方，或者原药材混合后的活性物质提取物组合制备而成。任一药材的活性成分提取方法，包括单味药材或者多味药材混合的活性物质，可以包括但不限于以下步骤：
(1)中药植物药材粉碎；
(2)将中药植物粉料用提取剂过夜浸泡；提取剂为水或乙醇；提取剂为乙醇时，乙醇浓度为30％-95％；
(3)将步骤(2)药物水煎煮或低速渗漉提取；
(4)将提取物浓缩，包括提取后的溶液通过旋转蒸发、喷雾干燥或真空干燥得到干膏粉末
6.该中药组合物可以以单味药材的活性物质提取物或者原药材混合后的活性物质提取物组合制备而成，活性成分提取通过超临界提取或者大孔树脂分离活性组分群的方法制得。
7.该中药组合物的制备方法，其特征在于，可以添加其他营养成分作为制剂的辅料， 制成不同剂型，增强上述功效。这些有效辅料为营养补充剂由氨基酸(甘氨酸、精氨酸、亮氨、缬氨酸、丙氨酸、丝氨酸酸、脯氨酸、异亮氨酸、苯丙氨酸、赖氨酸、苏氨酸、蛋氨酸、色氨酸、组氨酸、酪氨酸、天门冬氨酸、半胱氨酸、谷氨酸)、姜黄素或姜黄提取物、盐酸甜菜碱、绿原酸、还原型谷胱甘肽、酵母β-葡聚糖、维生素B6、B2、γ-氨基丁酸、白藜芦醇、多聚果糖、低聚半乳糖、壳聚糖、海藻酸钠、库拉索芦荟凝胶中的至少一种或两种以上组成。
8.该中药组合物的制备方法，其特征在于，制成剂型包括：代用茶、颗粒剂、胶囊剂、片剂、散剂、口服液及其他可接受的剂型。
9.该中药组合物还可用于治疗桥本氏甲状腺炎症、未手术或者部分甲状腺切除患者的甲减疾病、炎性甲亢等。
10.该中药组合物还可用于治疗各种炎症引起的***节肿大。
11.该中药组合物还可用于治疗***节核(瘰疬又称老鼠疮)。
12.该中药组合物还可用于治疗脂肪瘤。
13.该中药组合物对于未生育女性的乳腺增生有很好的治疗效果，尤其是初期效果更明显。
14.该中药组合物对于常见口腔溃疡，尤其是复发性口腔溃疡有很好的治疗效果。
15.上述的用于治疗甲状腺结节的中药组方，其组方的特点在于利用了每一组方药物的特性，通过下述中药活性组分群的抗菌、抗炎、提高免疫力、改善内分泌、改善心血管功能、补充维生素及其他人体必须营养素等作用机制，达到整体体质的调理，达到缓解、治愈甲状腺结节、甲减、甲亢、甲状腺炎症、***肿大、***核等。
(1)金银花主要含有有机酸类、黄酮类、三萜皂苷、挥发油类的成分，具体包括绿原酸、异绿原酸、木犀草素、金丝桃苷、齐墩果酸等活性成分。金银花有“中药中的抗生素”之称，具有抗炎、抗菌、抗病毒、抗氧化、抗肿瘤、保肝等作用
(2)蒲公英：蒲公英全草含蒲公英甾醇、胆碱、菊糖、果胶等。杀菌、消炎、抗病毒、抗肿瘤。肝脏滋养，用于“清血”和补充肝血，增强人体免疫力。蒲公英提取物被用于治疗肝脏和胆囊阻塞，改善肝功能，促进胆汁分泌和作为利尿剂使用。
(3)夏枯草主要含有夏枯草多糖、含齐敦果酸、芸香苷、金丝桃苷等苷类物质及熊果酸、咖啡酸、游离齐敦果酸等有机酸；尚含维生素B1、维生素C、维生素K、胡萝卜素、树脂、苦味质、鞣质、挥发油等成分，适用于***核、甲状腺肿，具有清热散结、抗菌、消炎等作用。
(4)白花蛇舌草，主要成分为萜类、黄酮类、甾醇类、有机酸类、多糖类等，这些成分都具有较好的抗肿瘤活性。黄酮类具有较强的DNA裂解活性，可以抑制多种恶性肿瘤的生长，调节机体免疫功能。多糖类可以显著抑制肝癌细胞和***细胞生长，抑制其细胞集落的形成，诱导细胞凋亡。白花蛇舌草可以调节机体免疫功能，增强T细胞、自然杀伤细胞等免疫细胞对肿瘤细胞的抑制作用，减轻患者免疫抑制，最终杀死肿瘤细胞。还可以抑制肿瘤组织血管、***生成，切断肿瘤细胞的营养来源。
(5)沙棘，是世界植物群体中公认的Vc之王，被日本称为“长寿果”、俄罗斯称为“第二人参”、美国称为“生命能源”、印度称为“神果”、中国称为“圣果”、“维C之王”。主要含有异鼠李素、芸香甙、紫云英甙、槲皮素、山柰酚、还含维生素A、B1、B2、C、E，去氢抗坏血酸、叶酸、胡萝卜素、类胡萝卜素、儿茶精、花色素、棕榈酸、硬脂酸、油酸、亚油酸、亚麻酸等成分，具有清除人体内的自由基，提高免疫功能，对于提高人体的抗病能力，延缓人体衰老，抗菌、消炎、防癌、抗癌等作用。
(6)枳壳，主要含挥发油、橙黄色，油中主含d-苎烯,并有少量癸醛、柑醛、香茅醛、邻氨基苯甲酸甲酯、芳樟醇。此外含橙皮甙、柚皮苷、新橙皮甙以及苦味成分苦橙甙等。尚含挥发油、生物碱类。具有调节胃肠功能及心血管***与子宫的作用。
(7)石仙桃，主要含环石仙桃萜醇，环石仙桃萜酮，具有麻醉、镇痛、抗疲劳、抗肿瘤和耐缺氧的作用，通过抑制中枢神经***，从而发挥镇静、催眠和抗惊厥作用。石仙桃含有K、Na、P、Mg、Ca、Fe、Al、Mn、B、Zn、Cu、Mo、Ti、As、Tl、Cd、Pb、Se、Co、Ni、Cr、V等22种矿物质元素。其中恒量元素K、Mg、Ca、P含量高于一般中药材含量；微量元素Fe、Mn、Co、Se高于人参、黄芪含量的十倍之多；Cd和Pb的含量均低于药典中重金属的限量标准。
(8)氨基酸，是构成动物营养所需蛋白质的基本物质。主要参与合成组织蛋白质，变成酸、激素、抗体、肌酸等含氨物质，转变为碳水化合物和脂肪，氧化成二氧化碳和水及尿素，产生能量，是人体不可缺少的营养物质。
姜黄素，是一种天然化合物，是植物界很稀少的具有二酮结构的色素。具有降血脂、抗肿瘤、抗炎、利胆、抗氧化等作用，另外，也有科学家发现姜黄素有助治疗耐药结核病。
盐酸甜菜碱，参与脂肪代谢、促进蛋白质的合成，开胃，具有缓冲作用，可以跟抗邪虫药物起到协同作用，保护维生素，可以用于胃酸缺乏、动脉硬化以及肝脏疾病，可以增加脂肪的代谢，抑制脂肪在肝脏的沉积。
绿原酸，是一种重要的生物活性物质，具有抗菌、抗病毒、增高白血球、保肝利胆、抗肿瘤、降血压、降血脂、清除自由基和兴奋中枢神经***等作用。
还原型谷胱甘肽，能激活多种酶，促进糖类、脂肪及蛋白质代谢。并能影响细胞的代谢过程，是一种细胞内重要的调节代谢物质。
酵母β-葡聚糖，是第一个被发现具有免疫活性的葡聚糖，具有抗菌及免疫调节作用，清除毒素、抗辐射、修复细胞、改善肠道功能。对肿瘤、肝炎、心血管、糖尿病、降血脂、抗衰老等方面均有独特的生物活性。
维生素B6，参与神经递质、糖原、神经鞘磷脂、血红素、类固醇和核酸的代谢，参与所有氨基酸代谢，降低慢性病、治疗贫血、治疗白细胞减少症、增强免疫力和抗癌。
维生素B2，主要参与体内生物氧化与能量代谢、促进发育和细胞的再生，影响生物氧化和能量代谢。
γ-氨基丁酸，是一种天然存在的非蛋白组成氨基酸，参与多种代谢活动，具有极其重要的生理功能，能促进人体内氨基酸代谢的平衡，调节免疫功能，延缓脑衰老机能，能补充人体抑制性神经递质，促进肾机能改善和保护作用。
白藜芦醇，是一种非黄酮类多酚有机化合物，是许多植物受到刺激时产生的一种抗毒素，具有抗炎，抗衰老，抗肿瘤、抗癌，防治心血管疾病等作用。
多聚果糖，是一种优良的水溶性膳食纤维，同时还是一种很好的“益生元”，具有调节肠道菌群、增殖双歧杆菌、促进钙的吸收、促进免疫调节等保健功能，可减少肝脏毒素，能在肠中生成抗癌的有机酸，有显著的防癌功能。
低聚半乳糖，是一种新的功能性食品，通过高选择性地增殖双歧杆菌而使人体最大微生态***——肠道微生态***得以平衡，从而对宿主的营养、免疫和疾病的预防与治疗发挥着积极的作用，可以促进合成B族维生素、提高蛋白质的吸收利用率、促进矿物质吸收、抑制内毒素。
壳聚糖，是一种机能性食品，能够营养细胞、活化失去活性的细胞、修复受损的细胞，通过提高机体的生理调节机能，强化人体免疫机能，大大增强人体抗疾病、抗疲劳、抗衰老的能力，发挥体内自然治愈力。
海藻酸钠，是一种天然多糖，人体不可缺少的一种饮食纤维，具有独特营养，可结合有机物，降低血清和肝脏中的胆固醇，抑制总脂肪和总脂肪酸浓度上升，还可以改善营养物质的消化与吸收，长期食用将有助于治疗高血压、冠心病、糖尿病以及肠道***的疾病。
库拉索芦荟凝胶，是一种新资源食品，提高人体免疫力，清除自由基，缓解发炎等作用。
16.相比较于由22味药材组成的专利CN201410293292一种用于治疗甲状腺肿瘤的中药，本专利仅由3-7味药材组成，用于甲状腺结节有明显的治疗效果，且该中药组合物还可用于治疗各种炎症引起的***节肿大、***节核(瘰疬又称老鼠疮)，以及在脂肪瘤、未生育女性的乳腺增生尤其是初期有很好的治疗效果，对复发性口腔溃疡也有很好的疗效。
本专利配方的组成，不是基于传统中医理论，而是基于上述疾病病理机制的现代医学研究，对前人针对组方中的药材进行大量的活性组分及其功效学的研究基础上进行组方，该中药组合物中含有的多糖类、黄酮类、多酚类、皂苷类、甾醇类等活性成分以及维生素B、维生素C及各种氨基酸、微量元素、矿物质等营养成分可以调节机体自身免疫力、调控内分泌水平、增加抑菌能力、抗炎症、改善微循环、补充营养。基于此本专利从甲状腺结节治病机理、药物的主要活性组分及其作用机理、营养功效学等方面出发，缓解甲状腺结节患者的病痛，减小肿块的体积至消失，效果显著。
抗菌作用：金银花中含有抑菌成分绿原酸、异绿原酸、咖啡酸、木犀草素等有机酸类成分，蒲公英中的黄酮、多糖、生物碱、有机酸和甾醇类物质具有较强的抗菌作用，夏枯草果穗中含有的三萜类成分熊果酸具有很好的抗菌、抗病毒作用，沙棘中含有的多酚类化合物包括乌索酸、香豆素、β-香豆素、酚酸等抑菌成分，以上几味药材协同强化治疗效果。
消炎作用：金银花的忍冬苦苷、忍冬苷和马钱子苷等成分，可以抑制炎性介质(***素、组胺、5-羟色胺、丙二醛)合成释放可以抑制COX-2表达，抑制COX-1和COX-2的活性。蒲公英中成分木犀草素、槲皮素等黄酮类成分通过抑制白介素-1的产生来介导抑制肿瘤坏死因子TNF-α的产生，从而抑制炎症反应的发生；夏枯草果穗中的三萜类成分熊果酸、齐墩果酸、白桦脂酸、胡萝卜苷等。
调节机体免疫力：蒲公英中提取的多糖(Tof-CFr)强大的能够激化糖能，能够显著免疫力低下T细胞吞噬指数；蒲公英水提物能促进细胞生长因子IL-2、FIN-γ、IL-4的分泌，显著提高B细胞膜表面免疫球蛋白，从而提高机体免疫功能；夏枯草中的多糖、熊果酸、齐墩果酸等具有提高机体免疫力、其中夏枯草多糖具有显著的抗氧化和免疫活性，能够显著地清除DPPH自由基、ABTS自由基和HOO自由基，并且刺激巨噬细胞分泌细胞免疫因子。
改善微循环：金银花含有的有机酸成分能够改善局部的血液循环和血管通透性。沙棘的茎皮、果实、叶片中含有一种植物界罕见的成分-5-羟色胺。它以游离态和化合态存在,作为一种神经递质,对人的感情状态、血压、体温、机体的内环境、激素等有重要的调节作用,还具有抗强烈辐射、抗传染病、抗癌的作用,并能加速纤维蛋白原转化为纤维蛋白,有助于血液凝固等作用。
营养功效学：该组方中含丰富的维生素B、维生素C及各种氨基酸，以及微量的锰、锌、钾、钠、钙、镁、磷、铁、铜等元素。蒲公英全草含有葡萄糖、葡萄糖甙以及树脂、橡胶等。叶含叶黄素、蝴蝶梅黄素、叶绿醌、维生素C(50～70毫克/100克)和维生素D(5～9毫克/100克)，而且蒲公英还是自然界罕见的富硒植物。沙棘中维生素C含量极高，每100克果汁中，维生素C含量可达到825—1100毫克，还有维生素E、维生素A、黄酮和SOD活性成分能够有效防止自由基以达到抗衰老的作用。
附图说明
图1为典型病例9服药前检查报告单。
图2为典型病例9服药后检查报告单。
具体实施方式
金银花为忍冬科忍冬属植物忍冬Lonicera japonica Thunb.的干燥花蕾或带初开的花。(安徽健诚170809)
山银花为忍冬科植物灰毡毛忍冬Lonicera macranthoides Hand.-Mazz.、红腺忍冬Lonicera hypoglauca Miq.、华南忍冬Lonicera confusa DC.或黄褐毛忍冬Lonicera fulvotomentosa Hsu et S.C.Cheng的干燥花蕾或带初开的花。
蒲公英为菊科植物蒲公英Taraxacum mongolicum Hand.-Mazz.植物的干燥全草。(安徽健诚171002)
夏枯草为唇形科植物夏枯草Prunella vulgaris L.的干燥果穗。(安徽健诚180201)
白花蛇舌草为茜草科耳草属植物白花蛇舌草Hedyotis diffusa Willd.[Oldenlandia diffusa(Willd.)Roxb.]的全草。(安徽健诚180102)
沙棘为胡颓子科植物沙棘Hippophae rhamnoides L.的干燥成熟果实。(安徽健诚170904)
枳壳为芸香科植物酸橙Citrus aurantium L.及其栽培变种的干燥未成熟果实。(安徽健诚180307)
石仙桃为兰科石仙桃属植物石仙桃Pholidota chinensis Lindl.以假鳞茎或全草入药。(安徽腾信180103)
以下实施例中A代表金银花或山银花或者金银花和山银花的混合物；B代表蒲公英；C代表夏枯草；D代表白花蛇舌草；E代表沙棘；F代表枳壳；G代表石仙桃。
以下实施例中所提到比例是指重量比。
实施例1
将充分干燥后的金银花、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃生药材或炮制药材，按照配方比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)称取，超微粉碎，混合，制成袋装，或加入蜂蜜制成丸剂，装袋后干燥环境中保存。
实施例2
将充分干燥后的山银花、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃生药材或炮制药材，按照配方比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)称取，加入药物总重量10倍的水浸泡放置过夜，水煎煮两次，每次2小时，过滤，滤液70℃减压下蒸除水分，得到密度为1.1-1.2的浓缩液，装瓶或制成口服液。
实施例3
将充分干燥后的金银花和山银花的1:1混合物、蒲公英、夏枯草按照配方比例(A/B/C＝1:1:1)称取，超微粉碎，加入药物总重量10倍的水浸泡放置过夜，水煎煮两次，每次2小时，过滤，滤液70℃减压下蒸除水分，得到密度为1.1-1.2的浓缩液，装瓶或制成口服液，或者进行充分浓缩、干燥成粉末。
将充分干燥后的白花蛇舌草、沙棘、枳壳、石仙桃生药材或炮制药材，按照配方比例(D/E/F/G＝1:1:1:1)称取，超微粉碎，加入药物总重量10倍的水浸泡放置过夜，水煎煮两次，每次2小时，过滤，滤液70℃减压下蒸除水分，得到密度为1.1-1.2的浓缩液，装瓶或制成口服液，或者进行充分浓缩、干燥成粉末。
上述得到的两种提取物混合，进行进一步处理，制备成片剂、胶囊、颗粒剂或口服液等。
实施例4
将充分干燥后的金银花、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃生药材或炮制药材分别超微粉碎。
取粉碎后的金银花药材，加入20倍水进行加热提取两次，每次1.5小时，提取温度为95℃，提取液加入乙醇，使其醇浓度达到75％，醇沉液浓缩到一定密度后进行喷雾干 燥得干粉。
取粉碎后的蒲公英药材，加入3％的生物酶，PH值调为8.7，酶解120min，温度为48℃，酶解结束后加入药物总重量10倍的水进行加热提取两次，每次2小时，提取温度为90℃，合并滤液，滤液70℃减压下蒸除水分，喷雾干燥得干粉。
取粉碎后的夏枯草药材，加入15倍水进行加热提取两次，每次2小时，提取温度为90℃，提取液加入2倍量95％乙醇，醇沉液浓缩到1.07-1.12(30℃)后进行喷雾干燥得干粉。
取粉碎后的白花蛇舌草药材，加入2.4％的生物酶，PH值调为7.9，温度为58℃，提取时间为2小时，提取两次，合并滤液，滤液70℃减压下浓缩至一定浓度，喷雾干燥得干粉。
取粉碎后的沙棘药材，加入5％的生物酶，PH值调为5.2，酶解温度为52℃，酶解时间为2小时，后加入药材量20倍的70％乙醇加热提取，提取温度为55℃，提取时间2小时，提取次数为2次，提取液浓缩至一定浓度后喷雾干燥得干粉。
取粉碎后的枳壳药材，加入10倍量50％乙醇，加热回流提取3次，每次2小时，提取液合并后浓缩至一定浓度后喷雾干燥得干粉。
取粉碎后的石仙桃药材，加入30倍水进行加热提取两次，每次3小时，提取温度为80℃，提取液加入乙醇，使其醇浓度达到80％，醇沉液浓缩到一定密度后进行喷雾干燥得干粉。
以上药材干膏粉按照配方比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)混合后进行包装，或者加入辅料制备成不同剂型进行包装。
实施例5
取实施例4的提取物干粉加入或者不加入相应的生药材超微粉混合均匀后袋装，或者制成丸剂，包装。
实施例6
将充分干燥后的山银花、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃生药材或炮制药材，按照配方比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)称取，分别加入特定微生物(包红曲霉、酵母菌)进行微生物发酵处理或者将以上药材按比例称取混合后加入微生物发酵处理，处理后将药材进行灭菌，加入药物总重量10倍的水浸泡放置过夜，水煎煮两次，每次2小时，过滤，滤液70℃减压下蒸除水分，得到密度为1.1-1.2的浓缩液，装瓶或制成口服液。或者单味药材浓缩液直接喷雾干燥得干粉，加入或者不加入相应的生药材超微粉混合均匀后装袋，或者制成丸剂，包装。又或者单味药材浓缩液直接喷雾干燥得干粉，按配方比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)称取，加入辅料制备成不同剂型进行包装。
实施例7
将充分干燥后的金银花和山银花的1:1混合物、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃生药材或炮制药材，按照配方比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)称取，分别加入特定生物酶(纤维素酶、果胶酶)进行酶处理或者将以上药材按比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)称取混合后加入生物酶处理，处理后将药材进行灭菌，加入药物总重量10倍的水浸泡放置过夜，水煎煮两次，每次2小时，过滤，滤液70℃减压下蒸除水分，得到密度为1.1-1.2的浓缩液，装瓶或制成口服液。或者单味药材浓缩液直接喷雾干燥得干粉，加入或者不加入相应的生药材超微粉混合均匀后装袋，或者制成丸剂，包装。又或者单味药材浓缩液直接喷雾干燥得干粉，按配方比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)称取，加入辅料制备成不同剂型进行包装。
实施例8
以上实施例4、6、7中提取物干粉或者生药材超微粉也可以加入不同辅料制成不同的 剂型，所添加的辅料及剂型分别为：
生药材超微粉加入二氧化硅后混合均匀装袋，或者加入水、蜂蜜或其他粘合剂制备成丸剂。
混合药材提取物干粉，加入营养补充剂盐酸甜菜碱、绿原酸、酵母β-葡聚糖、γ-氨基丁酸、白藜芦醇、多聚果糖、低聚半乳糖、壳聚糖、海藻酸钠中，加入蜂蜜、低聚异麦芽糖粉、糖粉制成口服液或者膏滋。
混合药材提取物干粉，加入营养补充剂姜黄素或姜黄提取物、氨基酸、盐酸甜菜碱、绿原酸、还原型谷胱甘肽、维生素B6、B2、γ-氨基丁酸、白藜芦醇、壳聚糖、海藻酸钠、库拉索芦荟凝胶中；
添加制剂用辅料：填充剂选择糊精、淀粉、蔗糖、乳糖、微晶纤维素、甘露糖、木糖醇、双歧糖、海藻糖。
粘合剂选择羧甲基纤维素钠、聚维酮、海藻酸钠、聚乙二醇中。
崩解剂选择干淀粉、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、交联羧甲基纤维素钠、低取代羟丙基纤维素中。
润滑剂选择硬脂酸镁、微粉硅胶、滑石粉、聚乙二醇类中。
润湿剂选择水、不同浓度乙醇或其混合物。
以上原辅料混合后制成颗粒剂、片剂或者胶囊剂等剂型。
本专利所述的剂型不限于实施例中的几种，还包括临床上可接受的各种剂型。
实施例9
按照配方比例(A/B/C＝1:1:1；A/E＝1:2；D/E/F/G＝1:1:1:1)称取金银花、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃提取物干粉，混合，加入盐酸甜菜碱0.5份、绿原酸0.1份、白藜芦醇0.1份、多聚果糖0.5份、二氧化硅0.1份，加入蜂蜜制成丸剂，装袋后干燥环境中保存。
实施例10
按照配方比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)称取山银花、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃提取物干粉，混合，再按照上述配方比例加入各自药材重量的三分之一量的山银花、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃生药材超微粉，盐酸甜菜碱0.3份、绿原酸0.1份、白藜芦醇0.1份、多聚果糖0.3份，制成散剂装袋，或加入蜂蜜制成丸剂，装袋后干燥环境中保存。
实施例11
按照配方比例(A/B/C＝1:1:1:1)称取金银花和山银花的1:1混合物、蒲公英、夏枯草提取物干粉，混合，再按照上述配方比例加入各自药材重量的三分之一量的金银花和山银花的1:1混合物、蒲公英、夏枯草生药材超微粉，盐酸甜菜碱0.5份、绿原酸0.1份、白藜芦醇0.1份、低聚半乳糖0.5份，海藻酸钠0.2份，制成袋装，或加入蜂蜜制成丸剂，装袋后干燥环境中保存。
按照配方比例(D/E/F/G＝1:1:1:1)称取白花蛇舌草、沙棘、枳壳、石仙桃提取物干粉，混合，再按照上述配方比例加入各自药材重量的三分之一量的白花蛇舌草、沙棘、枳壳、石仙桃生药材超微粉，盐酸甜菜碱0.5份、绿原酸0.1份、白藜芦醇0.1份、多聚果糖0.5份，制成袋装，或加入蜂蜜制成丸剂，装袋后干燥环境中保存。
上述得到的两种混合物，可以进行进一步处理，制备成片剂、胶囊、颗粒剂或口服液等。
实施例12
按照配方比例(A/B/C＝1:1:1；A/E＝1:2；D/E/F/G＝1:1:1:1)称取金银花、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃提取物干粉，混合，加入L-酪氨酸0.1份、姜黄素0.1份、绿原酸0.1份、白藜芦醇0.1份、低聚半乳糖0.1份，加入聚维酮K30、羧甲基纤维素钠、羧甲基淀粉钠，混合均匀后用90％乙醇制备颗粒，干燥，压片，装袋或装瓶保 存。
实施例13
将充分干燥后的山银花、蒲公英、夏枯草、白花蛇舌草、沙棘、枳壳、石仙桃生药材或炮制药材，按照配方比例(A/B/C＝1:1:1；A/E＝2:1；D/E/F/G＝1:1:1:1)称取，超微粉碎，加入药物总重量10倍的水浸泡放置过夜，水煎煮两次，每次2小时，过滤，滤液70℃减压下蒸除水分，得到密度为1.1-1.2的浓缩液，干燥后得干膏粉。干膏粉加入L-酪氨酸0.1份、姜黄素0.1份、绿原酸0.1份、白藜芦醇0.1份、γ-氨基丁酸0.1份、低聚半乳糖0.1份，加入聚维酮K30、羧甲基纤维素钠、羧甲基淀粉钠，混合均匀后用90％乙醇制备颗粒，干燥，灌装胶囊或者压片，装袋或装瓶保存。
实施例14
将充分干燥后的金银花和山银花的1:1混合物、蒲公英、夏枯草药材或炮制药材，按照配方比例(A/B/C＝1:1:1)称取，超微粉碎，加入药物总重量10倍的水浸泡放置过夜，水煎煮两次，每次2小时，过滤，滤液70℃减压下蒸除水分，得到密度为1.1-1.2的浓缩液，干燥后得干膏粉。干膏粉加入赖氨酸0.1份、姜黄素提取物0.5份、绿原酸0.1份、维生素B2 0.01份、还原型谷胱甘肽0.1份、多聚果糖0.1份，加入聚维酮K30、羧甲基纤维素钠、羧甲基淀粉钠，混合均匀后用90％乙醇制备颗粒，干燥，压片，装袋或装瓶保存。
将充分干燥后的白花蛇舌草、沙棘、枳壳、石仙桃生药材或炮制药材，按照配方比例(D/E＝1:1；D/F＝2:1；F/G＝1:1)称取，超微粉碎，加入药物总重量10倍的水浸泡放置过夜，水煎煮两次，每次2小时，过滤，滤液70℃减压下蒸除水分，得到密度为1.1-1.2的浓缩液，干燥后得干膏粉。干膏粉加入组氨酸0.1份、姜黄素提取物0.1份、绿原酸0.1份、白藜芦醇0.1份、维生素B6 0.01份、多聚果糖0.1份、海藻酸钠0.1份，加入聚维酮K30、羧甲基纤维素钠、羧甲基淀粉钠、交联聚维酮，混合均匀后干法制粒机制备颗粒，干燥，压片，装袋或装瓶保存。
上述得到的两种混合物，可以进行进一步处理，制备成片剂、胶囊、颗粒剂或口服液等。
按照本专利配方组合的方剂或产品，用于某些免疫机制影响的炎症疾病领域的预防或治疗进行了观察性临床研究，或体内体外实验。结果表明，该专利产品具有很强的抗炎作用，并且可以提高机体免疫力。
本专利项目采用角叉菜胶致大鼠炎症模型进行抗炎验证，采用亚急性衰老小鼠胸腺指数、体外脾淋巴细胞增殖、小鼠脾淋巴细胞增殖反应的影响等实验观察本专利产品对机体免疫功能的影响。
1.角叉菜胶致大鼠炎症模型抗炎实验
选取180-220g的雄性大鼠60只，环境适应喂养3天后，随机分成4组，每组15只，分别为空白对照组(给予等量的生理盐水)、阿司匹林组(口服阿司匹林0.5g/kg)、药物低剂量组(口服实施例13组药物10g/kg)、药物高剂量组(口服实施例13组药物20g/kg)。实验室温度控制在18-26℃，外购标准饲料喂养，自由摄食、摄水。按体重连续灌胃给药7天，每天给药1次，末次给药2小时后，于大鼠右后足跖皮下注入1％角叉菜胶0.1mL/只，致炎后的1.0h、2.0h、3.0h、6.0h分别测定大鼠足跖体积，计算肿胀度值。
肿胀度值＝致炎后足跖体积-致炎前足跖体积
角叉菜胶致大鼠炎症后不同肿胀值的影响
Figure PCTCN2022143363-appb-000004
注：与生理盐水组比较，*表示P＜0.05
从表中可以看出，与空白对照组比较，药物低剂量组使致炎后肿胀度值有轻微降低，但效果不太明显，而高剂量组降低程度明显，且明显优于阿司匹林组。说明本专利产品有较好的抗炎作用。
2.机体免疫功能影响实验
(1)D-半乳糖所致亚急性衰老小鼠胸腺指数的影响试验
雄性小鼠40只，体重(16-20g)随机分成5组：正常对照组(等剂量生理盐水)，亚急性小鼠模型组，药物低剂量组(实施例2口服灌胃0.1g/kg)，药物中剂量组(实施例2口服灌胃0.25g/kg)，药物高剂量组(实施例2口服灌胃0.5g/kg)。分别给予等容量蒸馏水，同时除正常对照组等容量无菌生理盐水外，其余各组分别D-半乳糖每只每天0.1mL/10g，连续42天，末次给药1小时后，断头处死摘取胸腺，称重并计算胸腺指数。
对亚急性衰老小鼠胸腺指数影响
组别 剂量(g/Kg) 胸腺指数(mg/Kg)
对照组   19.1±4.7
模型组   13.2±3.8
药物低剂量组 0.1 18.5±4.5
药物中剂量组 0.25 21.2±3.7
药物高剂量组 0.5 23.1±3.8
从表中可以看出，相对于对照组，药物低剂量组的小鼠胸腺指数增长不明显，药物中剂量组和高剂量组均可以使小鼠胸腺指数有所增长，尤其是高剂量组效果最明显。
(2)小鼠脾淋巴细胞增殖反应的影响试验
取24只ICR雌性小鼠，断头处死无菌取脾，按文献制备脾细胞悬液，调整细胞浓度为4*106/mL，接种于96孔平底细胞培养板。每孔100μL，再分别加入植物血凝素Concanavalin A、药物I-IV组(实施例3产品分别配置成25，50，100，125μg/mL浓度)药液100μL，每组做三个重复，培养箱中培养72小时。结束前每孔吸去上清，加入100μL 1mg/mL MTT，结束时，离心吸取清夜，每孔加入100μL二甲亚砜，酶标仪测定A570，计算细胞增殖指数。
对小鼠淋巴细胞增殖反应的影响
组别 剂量(μg/mL) A570 增殖指数
空白对照组   0.14±0.01  
Concanavalin A组 4.0 0.24±0.02 1.71
药物I组 25 0.15±0.02 1.06
药物II组 50 0.16±0.02 1.14
药物III组 100 0.20±0.02 1.42
药物IV组 125 0.22±0.03 1.56
结论：本专利产品体外能直接促进小鼠脾淋巴细胞增殖指数与植物血凝素 Concanavalin A(4.0μg/mL)作用相当。
(3)对小鼠淋巴细胞转化的影响试验
选取昆明种50只小鼠被随机分为5组:空白对照组(生理盐水)、药物低剂量组(实施例5口服灌胃0.05g/kg)、药物低剂量组(实施例5口服灌胃0.1g/kg)、药物低剂量组(实施例5口服灌胃0.2g/kg)，阳性对照组(甘露聚糖肽0.025g/kg体重)。药物用生理盐水溶解，按体重口服灌胃给药，1次/d，连续8-10d。各组于给药的前3d，每鼠每天均肌注PHA 10mg/kg，于第8天给药后2h，小鼠剪尾取血，按文献方法计算淋巴细胞转化百分率。
组别 剂量(g/Kg) 淋巴细胞转化率(％)
对照组 - 40.15±1.43
甘露聚糖肽阳性组 0.025 53.1±7.61
药物低剂量组 0.05 47.3±2.31
药物中剂量组 0.1 57.1±3.21
药物高剂量组 0.2 67.8±2.54
结论：与对照组比较药物组均可以提高小鼠淋巴细胞转化率，尤其中剂量组和高剂量组效果更明显，且优于阳性对照组。
动物实验结论：
本专利产品能够明显减少角叉菜胶致大鼠足肿胀值，说明有较好的抗炎作用；可明显升高D-半乳糖所致亚急性衰老小鼠降低的胸腺指数；体外对小鼠脾淋巴细胞增殖有一定促进作用；能明显促进小鼠T淋巴细胞的转化率，增强小鼠的细胞免疫功能。
临床试验数据
询问甲状腺结节患者病史的要点包括患者的年龄、性别、长期碘摄入不足或过多、有无头颈部或全身放射性检查或治疗史或家族史以及甲状腺结节的大小及其变化、增长速度和有无局部症状等。结节的大小、数目、活动度、质地、有无压痛和有无颈部***肿大等。
(一)甲状腺结节临床应用：
1.资料与方法
1.1一般资料：2018年10月-2019年10月，在3家正规医疗机构筛选80例患者。试验之前2周，对该人群进行连续观察，记录症状及变化，随机分为两组，治疗组和对照组，两组患者在性别、年龄、发病时间、疼痛程度、结节大小等方面的差异均无统计学意义(P＞0.05)，具有可比性。
1.2诊断标准：甲状腺结节诊断：参照2012年《甲状腺结节和分化型甲状腺癌诊治指南》：①影像学检查：甲状腺彩超显示≥1个甲状腺结节。②血清TSH低于0.35mIU/L；③触诊颈部甲状腺肿大；符合上述即可诊断。
影像学检查：患者均需进行超声检查，以此来确定结节的位置、形态、大小、数目、结节边缘状态、内部结构、回声形式、血流状况和***情况。
血清学检查：主要进行血清TSH和甲状腺激素水平测定。血清甲状腺激素水平增高，TSH降低，大多数为良性结节。
细胞学检查：对于直径≥1cm的甲状腺结节可考虑进行细胞学检查，以鉴别结节的良恶性，最常用的方法是甲状腺细针穿刺法，穿刺时患者取平卧位，垫高颈部，充分暴露甲状腺。75％酒精消毒二次，术者用左手食指和中指固定穿刺侧甲状腺或甲状腺结节，右手持空针，针筒内留5-7ml空气，穿刺针经皮快速刺人甲状腺内(或结节内)，空针抽2～ 5ml负压，然后在不同方向来回穿刺2-3次，迅速消除负压，拔出针头，穿刺局部棉球压迫10min。将吸出物注于载玻片上，均匀推开，涂片待干后用95％酒精固定后送检。送检活检标本至少有6组完好的甲状腺上皮细胞、且每组至少有10个细胞时，才具诊断价值。
细胞学诊断分类：分为良性、难以确定良恶性或可疑恶性、恶性及涂片不满意。被视为涂片满意的标准是：至少每张涂片上大于5～6个滤泡上皮细胞团，每个细胞团至少10个滤泡上皮细胞以上。
检测结果：
良性：如果细胞学结果包括胶样结节、增生性结节、淋巴细胞性或肉芽肿性甲状腺炎和良性囊肿，说明结节为良性。
可疑恶性：标本中细胞学特征提示恶性，但又不完全符合恶性肿瘤确诊标准；细胞结构不完整和(或)标本固定、保存不好，但又有提示恶性肿瘤的明确征象。
恶性：标本具有恶性肿瘤的细胞学特征。最常见的是PTC，还包括MTC、未分化癌、淋巴瘤及其他甲状腺恶性肿瘤和转移性癌。
1.3排除标准：证实为恶性结节者，短期内结节体积增长超过40％；甲状腺功能亢进或甲状腺功能减退者；对治疗配方药物过敏者；患有感染性疾病，严重心脑血管疾病，或严重肝肾功能不全患者；孕妇；资料收集不全患者。
1.4治疗方法：治疗组服用实施例13颗粒产品，每天服用3次，一次10g(200mL开水冲泡)，对照组服用五海瘿瘤丸，每天服用2次，一次5g，试验期间禁止使用其它激素与免疫抑制剂。使用方法为:7天一个疗程。
1.5观察指标：不适症状减轻、肿块***变小、肿块消失、复发率。
1.6疗效情况判定标准:治愈:服用本品四个疗程，不适症状消失，呼吸顺畅，结节肿块消失；有效：服用本品四个疗程，不适症状减轻或部分消失，精力状态改善；无效：服用本品四个疗程，不适症状无变化。
2.结果
表1:两组患者临床综合疗效比较
Figure PCTCN2022143363-appb-000005
治疗效果：治愈30例(75.0％)，有效8例(20.0％)，无效2例(5％)，总有效率95％。效果明显优于对照组。
表2：两组患者症状体征改善时间(天)的比较
Figure PCTCN2022143363-appb-000006
结论：治疗组和对照组服用药物后不适症状最终均有改善，但是治疗组明显低于对照组，两组数据具有统计学意义(P＜0.05)；肿块***变小时间治疗组与对照组比较具有统计学意义(P＜0.05)，治疗组明显低于对照组；甲状腺结节消退时间治疗组与对照组比较具有统计学意义(P＜0.05)，治疗组明显低于对照组。
表3.两组患者停药后的复发率的比较
Figure PCTCN2022143363-appb-000007
结论：治疗组与对照组复发率比较具有统计学意义(*P＜0.01)，治疗组明显低于对照组。
结果显示：治疗组患者的症状改善情况与甲状腺结节变小及消退水平显著优于甲亢灵对照组。治疗组患者常见症状的总好转率为95％，显著高于对照组的70％；治疗组患者肿块***变小时间均低于对照组(P＜0.05)；治疗组患者治疗后甲状腺结节消退时间显著低于对照组(P＜0.05)。
可见，本发明药物可以有效地改善甲状腺结节患者术后的临床症状，缩小甲状腺结节直径以至消失，减轻患者的痛苦，提高生活质量，安全性高，适于临床推广、应用。
(二)淋巴肿大临床应用
治疗方法：选取具有相关临床指征的患者进行相关数据收集，服用本发明所得实施例6产品，每天服用3次，一次10g(200mL开水冲泡)，使用方法为:30天一个疗程。
***肿大数据收集结果
Figure PCTCN2022143363-appb-000008
以上表中数据说明本专利产品对单发或多发***肿大均有较好的治疗效果。
(三)脂肪瘤的临床应用
治疗方法：选取具有相关临床指征的患者进行相关数据收集，服用本发明所得实施例7产品，每天服用3次，一次10g(200mL开水冲泡)，使用方法为:30天一个疗程。
脂肪瘤数据收集结果
Figure PCTCN2022143363-appb-000009
以上表中数据说明本专利产品对单发或多发脂肪瘤均有较好的治疗效果。
(四)乳腺增生的临床应用
1.治疗方法：收集30名20-40岁未婚未育的女性患者进行相关数据收集，治疗组服用本发明实施例8中基于实施例4所制备的颗粒产品，每天服用3次，一次10g(200mL开 水冲泡)，对照组服用逍遥丸，每天服用3次，一次8丸。
2.观察指标：不适症状减轻、肿块***变小、肿块消失。
3.疗效情况判定标准:治愈:服用本品四个疗程，不适症状消失，呼吸顺畅，增生肿块消失；有效：服用本品四个疗程，不适症状减轻或部分消失，精力状态改善；无效：服用本品四个疗程，不适症状无变化。
4.结果
表1:两组患者临床综合疗效比较
Figure PCTCN2022143363-appb-000010
治疗效果：治愈10例(66.7％)，有效3例(20.0％)，无效2例(13.3％)，总有效率86.7％。效果明显优于对照组。
表2：两组患者症状体征改善时间(天)的比较
Figure PCTCN2022143363-appb-000011
结论：治疗组和对照组服用药物后不适症状最终均有改善，但是治疗组明显低于对照组。
结果显示：治疗组患者的症状改善情况与乳腺肿块变小及消退水平显著优于逍遥丸对照组。治疗组患者肿块***变小时间均低于对照组(P＜0.05)；治疗组患者治疗后肿块消退时间显著低于对照组(P＜0.05)。
(五)口腔溃疡的临床应用
1.治疗方法：选取常年有复发性口腔溃疡的20例患者进行相关数据收集，治疗组服用本发明所得实施例10产品，每天服用3次，一次10g(200mL开水冲泡)；对照组使用醋酸***粘贴片，每天使用一贴，一天一次。
2.观察指标：不适症状减轻、溃疡面减小、疼痛减轻。
3.疗效情况判定标准:治愈:不适症状减轻，溃疡面消失；有效：不适症状减轻或部分消失，溃疡面减小，疼痛减轻；无效：不适症状未改善。
4..结果
表1:两组患者临床综合疗效比较
Figure PCTCN2022143363-appb-000012
治疗效果：治愈8例(80.0％)，有效1例(10.0％)，无效1例(10.0％)，总有效率90％。效果明显优于对照组。
表2：两组患者停药后的复发率的比较
Figure PCTCN2022143363-appb-000013
结论：治疗组与对照组复发率比较具有统计学意义(*P＜0.01)，治疗组明显低于对照组。
典型案例报告：
1.典型病例一易先生，年龄：52岁。患者自述咽喉底部近锁骨处存在小粒状甲状腺结节5年以上，突然出现肿大，发展成球状硬块，每天很久才入眠。两周后感到吞咽困难，工作和生活受到严重影响，去医院做B超检查，发现甲状腺处有12*7mm大小的甲状腺结节。服用实施例13颗粒产品，每天3次，每次10g，服用7天，患者不适症状减轻，结节体积变小；服用14天，甲状腺结节彻底消失。继续服用一周后，进行检查，甲状腺结节完全消失。连续三年进行影像学复查，没有复发。
2.典型病例二陈女士，女29岁，2015年患者公司体检时检查出患有甲状腺结节，并未太在意，后逐渐出现咽喉肿痛、吞咽困难等症状，并伴随出现多个结节，经过B超检查，右侧甲状腺较大的一个为29×15mm的结节，经细胞学甲状腺细针穿刺法检查，确诊为良性甲状腺结节，多次治疗效果不佳。服用本组方实施例13颗粒产品，每天3次，每次10g，一个疗程后患者呼吸较之前顺畅，不适症状减轻；继续服用5个疗程，患者甲状腺处肿痛消失，不适症状明显消失，患者痊愈。
3.典型病例三张女士，年龄：36岁。患者自述2年前体检查出右颈部无痛性包块，没有甲亢症状。彩超提示：甲状腺左侧叶见0.1cm×0.2cm，大小分别为2.7cm×1.6cm、0.3cm×0.5cm。右侧甲状腺下有一大小为2.0cm×3.0cm左右暗红色块，经细胞学甲状腺细针穿刺法检查，确诊为良性甲状腺结节。患者不想手术治疗，后经人介绍用本组方实施例13颗粒产品，每天3次，每次10g，一个疗程后包块即见缩小，继续治疗四个疗程后B超检查肿块消失，后继续服用两个疗程巩固，随访1年未复发。
4.典型病例四杨女士，年龄：50岁。患者自述1年前右颈部无痛性包块，表面光滑无结节，可随吞咽上下移动，B超检查20*30mm的肿块，经细胞学甲状腺细针穿刺法检查后确诊为良性甲状腺结节。常感咽喉部异物感，呼吸困难，声音沙哑，患者拒绝手术治疗，经人介绍服用本实施例13所得甲状腺结节颗粒剂，每天3次，每次10g，服用7天，患者包块有变小，不适症状有所改善；服用1个月，患者肿块消失，不适症状消失。
5.典型病例五徐先生，年龄：33岁。患者前段时间感觉自己嗓子不舒服，以为上火所致并没有在意，直到一次重感冒后，咽喉部位出现两个拇指肚大小的肿块，不用手按压也能感觉到肿块部位有胀痛感，嗓子很不舒服，好像有东西堵着，吃东西喝水也明显感觉有异物感，咽不下去，B超检查分别是15*10mm和12*8mm的甲状腺结节。服用本本组方实施例13颗粒产品，每天3次，每次10g，服用14天，患者颈部肿大减轻，肿块变小；服用1个月，患者颈部肿大基本消失，呼吸、饮食正常，不适症状基本消失；继续服用2周，肿块彻底消失，患者自感痊愈。
6、典型病例姜女士，年龄：34岁，5年前因多发性甲状腺结节进行部分手术切除后，坚持服用优甲乐，不能停用，停用优甲乐出现甲减。服用本组方后一星期开始停用优甲乐，坚持服用本组方实施例13颗粒三个月，每天3次，每次10g，不再服用，半年内持续监测甲状腺特异性指标，保持正常。
7、典型病例刘先生，47岁，五岁开始颈部出现多处***核，服用本组方之前，***核最大30*20mm，多个***核10*20mm。服用本组方实施例6丸剂，每天3次，每次5g，产品两个月后，多数***核消失，剩下***核为10*5mm(为最大***核缩小所致)。
8、典型病例唐女士，40岁，17年单位体检发现有多发甲状腺结节，甲状腺左侧叶下段可见一大小约3*5mm的低回声结节，纵横比＞1，边界尚清，内部回声欠均匀，内可见丰富血彩，超声提示为TI-RADS:4a类。甲状腺右侧叶可见多个低-无回声结节，边界清，结节内未见明显血彩，较大者约5*3mm，超声提示TI-RADS:3类。医生建议手术切除，患者不想手术，也不想进行细胞学检查，想保守治疗，因此不定期的服用消结节的中药， 效果均不理想，后经人介绍服用该专利实施例13颗粒剂，每天3次，每次10g，，连续服用一个月后结节***且缩小，右侧叶较大者变为2*3mm，且结节数量变少，继续服用三个月后结节全部消失，随后一年没有复发。
9、典型病例黄先生，38岁，20年8月体检发现左侧颈部较大***，大小为25mm*5mm，右侧颈部较大***，大小为27mm*10mm，超声诊断：甲状腺右侧叶近气管低回声结节(TI-RADS 4类)；双侧颈部***。服用本项目实施例6丸剂产品，每天3次，每次5g，一个月后，双侧颈部***消除，甲状腺右侧叶混合回声、低回声结节(TI-RADS 3类)。继续服用产品两个月，结节***变小。
10、典型病例罗先生，38岁，20年5月体检发现左侧颈部较大***，大小为16mm*7mm，右侧颈部较大***，大小为17mm*6mm，超声诊断：双侧颈部多发***。服用本项目实施例6丸剂产品，每天3次，每次5g，一个月后，双侧颈部多发***消失。
11、典型病例章先生，50岁，19年12月因吞咽颈部不舒服就医，检查发现双侧甲状腺结节，超声提示：甲状腺右侧叶结节大小1.37cm*0.61cm，TI-RADS分级：4a级；甲状腺左侧叶结节大小1.07cm*0.58cm，TI-RADS分级：3a级，双侧颈部多发***，颈部右侧最大***大小1.63cm*0.50cm，颈部左侧最大***大小1.90cm*0.54cm。服用本项目实施例13颗粒产品，每天3次，每次10g，1个月后：双侧甲状腺结节明显缩小，双侧均变为0.5cm*0.3cm，颈部右侧***明显缩小，变为0.6cm*0.7cm，颈部左侧***消失。服药2个月：颈部双侧***全部消除。服药3个月：右侧甲状腺结节由4a级转为甲状腺炎症，左侧甲状腺结节保持3a级，颈部双侧***全部消除。
12、典型病例十二朱先生，48岁，20年10月因颈部硬结体检，检查发现双侧腋窝***节，双侧颈部多个***，超声提示：左侧颈部结节大小7mm*3mm，左侧腋窝结节大小12mm*6mm，右侧腋窝结节大小9*8mm。服用本项目实施例6丸剂产品，每天3次，每次5g，2个月：各种结节均明显缩小，继续服药3个月：除出左侧腋窝较大结节还在，其他颈部双侧***全部消除。
13、典型病例十三彭女士，54岁，21年11月体检，报告显示：甲状腺左侧单发结节，大小3.4*3.2.*4.1mm，形态规则，边界清楚，分类为TI-RADS:4a类；右侧多发结节，大小3.0*3.0*2.7mm-8.5*6.0*5.5mm不等，形态规则，边界清楚，分类为TI-RADS:4a类；左侧乳腺结节4.0*2.0mm，形态规则，边界清楚，分类为TI-RADS:3类；右侧囊性暗区4.4*2.5mm，边界清，分类为TI-RADS:2类，左侧腋窝***21*6.0mm，形态规则，边界清；右侧腋窝***18*5.0mm，形态规则，边界清，服用本项目实施例13颗粒产品，每天3次，每次10g，3个月后，所有以上指标均有不同程度的减少，左侧单发结节变成TI-RADS:4b类，右侧结节级别分类均降低，乳腺结节和囊肿均消失，左侧和右侧颈部***大小分别降为12*6mm，12*4mm；继续服用产品3个月，左侧单发结节还存在，右侧多发结节小者已没有了，大者半软变小，颈部***节已全部消失。
14、典型病例十四王先生，42岁，一年前发现右前臂有多个小凸起，大的3*4，小的1*2，经医院诊断为脂肪瘤，采取手术切除后，没过一年又复发了，且其他部位出现相同硬块，不愿再做手术，因此寻求中药治疗，经人介绍后服用本项目实施例7片剂产品，每天3次，每次3片，服用45天后大的硬块开始***变小，小的硬块***且有的已消失，继续服用该产品3个月，硬块全部消失，且后期没有再复发。
15、典型病例十五冯先生，36岁，多年前发现后颈部长有一个拇指肚大小的硬块，边界清楚，经医院诊断为脂肪瘤，2*3cm，因惧怕手术，且医生说不继续长可不用管。一年后硬块有长大的趋势，因不想手术，吃了很多中药产品，均不见效果，后经人介绍服用本项目实施例7片剂产品1个月，每天3次，每次3片，硬块开始***，继续服用1个月，硬块开始变小，又继续服用两个月，硬块消失，目前没有复发。
16、典型病例十六黄女士，25岁，未婚未育，刚毕业进入社会不久，工作压力比较 大，加之家里父母催相亲，一度心情比较压抑，几个月前偶尔碰触***有痛感，摸之有硬块，经期更甚。去医院检查诊断为乳腺增生，医生给开了西药口服，服用一段时间没有效果。改为服用中药，经人介绍服用本专利实施例8中基于实施例6所制备的颗粒产品，每天3次，每次10g，，服用初期没有不适症状，服用1个月后硬块有***的趋势，继续服用1个月后硬块消失，且之前的***的症状也改善。硬块消失后，调整了心态，暂时没再复发。
17、典型病例十七魏女士，28岁，未婚未育，工作两年，2年前体检时查出右侧***有硬结，触之无痛感，诊断为乳腺增生，医生告知不需要特别处理，定期复查即可，近期因工作压力比较大，硬结有增大的趋势，触之有痛感，且经期疼痛加剧。经人介绍服用本专利实施例8中基于实施例7所制备的颗粒产品，每天3次，每次10g，，服用1个月后症状有所缓解，疼痛感减弱，硬结依然在，继续服用2个月硬结***，又继续服用两个月后硬块消失，后期回访没有复发。
18、典型病例十八郑女士，34岁，常年易发口腔溃疡，前期基本上未经治疗可自愈。近来发作教之前频繁，每次都是疼痛难忍，且周期较长，严重影响到他的工作和生活，也有尝试去医院的口腔科治疗，医生建议盐水漱口，多补充VC，要不就是给开些激素类药物，并没有特别好的其他治疗方法。服用本专利实施例10散剂产品，每天3次，每次10g，复发时能够明显的感觉到疼痛没有之前那么难忍，且恢复周期明显缩短，溃疡面很小，没有继续扩大，且3-4天溃疡性就慢慢消失了。已经有将近半年的时间没有再复发。
19、典型病例十九杨显示，36岁，从事销售工作，是复发性口腔溃疡受害者，基本上有些着急上火的事就会复发口腔溃疡，因工作需要常要与客户面对面交流，此时口腔溃疡导致的口腔异味让她苦不堪言，给她的工作带来了极大的影响。找过各种方式来治疗，也吃过中药，效果均不理想，经人推荐后服用本专利实施例10散剂产品，每天3次，每次10g，服用3个月后口腔溃疡复发的次数减少，且每次的溃疡面在没有延展到很大的时候就已经慢慢愈合了，继续服用一个月后停药，停药到现在有4个多月的时间没有再复发。

Claims (13)

  1. 一种中药组合物，其特征在于，该组合物是以金银花或山银花或金银花和山银花的混合、蒲公英、夏枯草三味药食同源药材为主要有效成分的主方；
    任选地，在此主方的基础上，补充药材白花蛇舌草、沙棘、枳壳、石仙桃作为副方；
    任选地，该中药组合物组方是原药材的组方，或者是由其提取物组成的组方，或者是原药材与提取物组成的组方；
    原药材或组方提取物的主方配比：
    Figure PCTCN2022143363-appb-100001
    其中A、B、C分别代表以金银花或山银花或金银花和山银花的混合、蒲公英、夏枯草原料药材或提取物，单位为重量比；
    主方中活性组分的总含量范围：
    10.0％≤总黄酮≤25.0％    5.0％≤总多糖≤15.0％
    2.0％≤总皂苷≤10.0％    2.0％≤总多酚≤10.0％；
    主方药材或提取物相当于主药药材的用量的选择；优选地，总量可能约为0.001至20g/kg体重，大约0.005至10g/kg体重，大约0.01至5g/kg体重，大约0.01至2.5g/kg体重，大约0.02至1g/kg体重，大约0.02至0.3g/kg体重，大约0.02至0.2g/kg体重，大约0.02至0.1g/kg体重，或约0.02至0.08g/kg体重；或者，优选地，用量约为0.01至0.05g/kg体重；或者，优选地，用量约为0.05至0.10g/kg体重。
  2. 根据权利要求1所述的中药组合物，其特征在于，主方补充药材白花蛇舌草、沙棘、枳壳、石仙桃作为副方，制备成不同的制剂，以上组方是原药材的组方，或者是由其提取物组成的组方，
    其中配比分别为：
    Figure PCTCN2022143363-appb-100002
    Figure PCTCN2022143363-appb-100003
    其中D、E、F、G分别代表白花蛇舌草、沙棘、枳壳、石仙桃原料药材或提取物，单位为重量比；
    全组方活性组分的总含量范围：
    5.0％≤总黄酮≤20.0％    5.0％≤总多糖≤20.0％
    2.0％≤总皂苷≤10.0％    2.0％≤总多酚≤15.0％
    上述副方药材或提取物相当于副药药材的用量的选择；优选地，总量可能约为0.001至20g/k使用者g体重，大约0.005至10g/kg使用者体重，大约0.01至5g/kg使用者体重，大约0.01至2.5g/kg使用者体重，大约0.02至1g/kg使用者体重，大约0.02至0.3g/kg使用者体重，大约0.02至0.2g/kg使用者体重，大约0.02至0.1g/kg使用者体重，或约0.02至0.08g/kg使用者体重；或者，优选地，用量约为0.01至0.05g/kg使用者体重；或者，优选地，用量约为0.05至0.10g/kg使用者体重。
  3. 根据权利要求1或2所述的中药组合物，其特征在于，所述中药组合物的制备可 以直接以原材料混合制备而成，也可以经过粉碎之后混合而成。
  4. 根据权利要求1-3中任一项所述的中药组合物，其特征在于，所述中药组合物为剂型，所述制剂包括：代用茶、颗粒剂、胶囊剂、片剂、散剂、口服液及其他可接受的剂型。
  5. 用于制备权利要求1-3中任一项所述的中药组合物的方法，其特征在于，所述中药组合物可以以各种单味药材的活性物质提取物组合而成，或者原药材混合后的活性物质提取物组合制备而成；任一药材的活性成分提取方法，包括单味药材或者多味药材混合的活性物质，可以包括但不限于以下步骤：
    (1)中药植物药材粉碎；
    (2)将中药植物粉料用提取剂过夜浸泡；提取剂为水或乙醇；提取剂为乙醇时，乙醇浓度为30％-95％；
    (3)将步骤(2)药物水煎煮或低速渗漉提取；
    (4)将提取物浓缩，包括提取后的溶液通过旋转蒸发、喷雾干燥或真空干燥得到干膏粉末。
  6. 根据权利要求5所述的方法，其特征在于，所述中药组合物可以以单味药材的活性物质提取物或者原药材混合后的活性物质提取物组合制备而成，活性成分提取通过超临界提取或者大孔树脂分离活性组分群的方法制得。
  7. 根据权利要求5或6所述的方法，其特征在于，可以添加其他营养成分作为制剂的辅料，制成不同剂型，增强上述功效。这些有效辅料为营养补充剂由氨基酸(甘氨酸、精氨酸、亮氨、缬氨酸、丙氨酸、丝氨酸酸、脯氨酸、异亮氨酸、苯丙氨酸、赖氨酸、苏氨酸、蛋氨酸、色氨酸、组氨酸、酪氨酸、天门冬氨酸、半胱氨酸、谷氨酸)、姜黄素或姜黄提取物、盐酸甜菜碱、绿原酸、还原型谷胱甘肽、酵母β-葡聚糖、维生素B6、B2、γ-氨基丁酸、白藜芦醇、多聚果糖、低聚半乳糖、壳聚糖、海藻酸钠、库拉索芦荟凝胶中的至少一种或两种以上组成。
  8. 权利要求1-4中任一项所述的中药组合物在制备药物中的用途，所述药物用于治疗桥本氏甲状腺炎症、未手术或者部分甲状腺切除患者的甲减疾病、炎性甲亢甲状腺疾病。
  9. 权利要求1-4中任一项所述的中药组合物在制备药物中的用途，所述药物用于治疗各种炎症引起的***节肿大。
  10. 权利要求1-4中任一项所述的中药组合物在制备药物中的用途，所述药物用于治疗***节核。
  11. 权利要求1-4中任一项所述的中药组合物在制备药物中的用途，所述药物用于治疗脂肪瘤。
  12. 权利要求1-4中任一项所述的中药组合物在制备药物中的用途，所述药物用于治疗未生育女性的乳腺增生。
  13. 权利要求1-4中任一项所述的中药组合物在制备药物中的用途，所述药物用于治疗常见口腔溃疡，尤其是复发性口腔溃疡。
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