WO2023125797A1 - Composition de médecine chinoise traditionnelle et sa méthode de préparation et son utilisation - Google Patents

Composition de médecine chinoise traditionnelle et sa méthode de préparation et son utilisation 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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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

L'invention concerne une composition de médecine chinoise traditionnelle pour le traitement de nodules thyroïdiens, de lipomes, d'hyperplasie des glandes mammaires et d'ulcères de la bouche, la composition comprenant, en tant que formule primaire des principaux ingrédients actifs, trois matières premières médicinales/comestibles constituées de : Lonicera japonica ou Lonicera hypoglauca ou un mélange de Lonicera japonica et de Lonicera hypoglauca, et de Taxacum et de Prunella vulgaris. La base de la formule primaire est complétée par une formule secondaire consistant en Scleromitrion diffusa, Hippophae rhamnoides, Poncirus trifoliata et Pholidota, et différentes préparations sont préparées, appropriées pour différents types de nodules thyroïdiens. La formule combinée de médecine chinoise traditionnelle peut être une formule combinée d'herbes source, et peut également être une formule combinée d'extraits de celles-ci, et peut également être une formule combinée d'herbes source et d'extraits. La composition de médecine chinoise traditionnelle a un effet thérapeutique significatif sur les symptômes d'une hypertrophie de la glande thyroïde provoquée par une inflammation, une auto-immunité et de nouveaux organismes.
PCT/CN2022/143363 2021-12-29 2022-12-29 Composition de médecine chinoise traditionnelle et sa méthode de préparation et son utilisation WO2023125797A1 (fr)

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