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CN-121987744-A - Traditional Chinese medicine composition, preparation, pharmaceutical composition and application thereof

CN121987744ACN 121987744 ACN121987744 ACN 121987744ACN-121987744-A

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, a preparation thereof, a pharmaceutical composition and application thereof. The Chinese medicinal composition comprises Bulbus Fritillariae Cirrhosae, thallus laminariae, bulbus Fritillariae Thunbergii, curcuma rhizome, endothelium corneum Gigeriae Galli, fructus crataegi, and Prunellae Spica. The application adopts the compatibility of the fritillary bulb and the fritillary bulb, and cooperatively plays the effects of resolving phlegm and resolving masses, the kelp is used for softening hardness and resolving masses, the turmeric is used for activating blood and dissolving stasis, the chicken's gizzard-skin and the raw hawthorn are used for removing food retention and resolving stagnation, and the selfheal is used for clearing liver and resolving masses, and the medicines are combined to play roles of resolving phlegm and resolving stasis, and softening hardness and resolving masses. Experiments show that the traditional Chinese medicine composition can remarkably improve liver function of Wilson disease model mice, reduce collagen deposition of liver tissues, down regulate fibrosis markers and inhibit hepatic stellate cell activation.

Inventors

  • DONG JIANJIAN
  • WU SICHEN
  • XIA XIAOXUE
  • SHAO XIAOHAN
  • XU CHENCHEN
  • CHENG NAN
  • HAN YONGZHU

Assignees

  • 安徽中医药大学

Dates

Publication Date
20260508
Application Date
20260211

Claims (10)

  1. 1. A Chinese medicinal composition is characterized by comprising, by weight, 8-12 parts of fritillaria cirrhosa, 15-25 parts of kelp, 25-35 parts of fritillaria thunbergii, 8-12 parts of turmeric, 15-25 parts of chicken's gizzard-skin, 25-35 parts of raw hawthorn and 12-18 parts of selfheal.
  2. 2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following raw materials, by weight, 10 parts of fritillaria cirrhosa, 20 parts of kelp, 30 parts of fritillaria thunbergii, 10 parts of turmeric, 20 parts of chicken's gizzard-skin, 30 parts of raw hawthorn and 15 parts of selfheal.
  3. 3. A pharmaceutical formulation comprising the traditional Chinese medicine composition of claim 1 or 2 and pharmaceutically acceptable excipients.
  4. 4. A pharmaceutical formulation according to claim 3, wherein the dosage form of the pharmaceutical formulation comprises a pill, powder, granule, capsule, tablet or oral liquid.
  5. 5. A pharmaceutical composition characterized in that the Chinese medicinal composition as claimed in claim 1 or 2 is used as one of the active pharmaceutical ingredients.
  6. 6. The use of the traditional Chinese medicine composition according to claim 1 or 2, the preparation according to claim 3 or 4 and the pharmaceutical composition according to claim 5 in the preparation of medicines for treating Wilson disease liver fibrosis.
  7. 7. Use of the traditional Chinese medicine composition according to claim 1 or 2, the preparation according to claim 3 or 4 and the pharmaceutical composition according to claim 5 in the preparation of a medicament for improving Wilson's liver injury.
  8. 8. Use of the traditional Chinese medicine composition according to claim 1 or 2, the preparation according to claim 3 or 4, and the pharmaceutical composition according to claim 5 for preparing a medicament for down-regulating the expression of genes related to liver fibrosis of Wilson disease, wherein the genes related to liver fibrosis comprise Col1a1, acta2, tgfb1, pdgfrb.
  9. 9. The use of the traditional Chinese medicine composition according to claim 1 or 2, the preparation according to claim 3 or 4 and the pharmaceutical composition according to claim 5 in preparing medicines for regulating and controlling Wilson's liver lipid metabolism.
  10. 10. Use of the traditional Chinese medicine composition according to claim 1 or 2, the preparation according to claim 3 or4, and the pharmaceutical composition according to claim 5 for preparing a medicament for up-regulating phosphoenolpyruvate carboxykinase 1 expression in Wilson's liver.

Description

Traditional Chinese medicine composition, preparation, pharmaceutical composition and application thereof Technical Field The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, a preparation thereof, a pharmaceutical composition and application thereof. Background Wilson's Disease (WD) is an autosomal recessive inherited copper metabolic disorder caused by mutation of the ATP7B gene. Copper ions accumulate abnormally in the liver, resulting in progressive liver injury, from steatosis, inflammation, fibrosis, and eventually can progress to cirrhosis or even liver failure. Liver fibrosis is a key pathological link in the course of WD disease and a major factor affecting prognosis. Currently, standard treatments for WD mainly include copper chelators (e.g., penicillamine, trientine) and zinc agents. However, these therapies have significant limitations in that copper chelators have large side effects, are intolerable to some patients, zinc agents have slow onset of action, and have limited reversal of established liver fibrosis. Current western medicine mainly focuses on copper driving, lacks specific intervention means for the downstream pathological process of already initiated and sustained "liver fibrosis", and is difficult to completely prevent the progress of the disease to cirrhosis. In the theory of traditional Chinese medicine, WD liver fibrosis can be categorized into "accumulation", "hypochondriac pain", "mass" and the like. The pattern of phlegm-blood stasis is a pattern of clinically common and critical aspects. Its core pathogenesis is that copper toxin is accumulated in the liver, spleen is not healthy and transported, which leads to body fluids not being recovered and transformed into phlegm, qi movement is unsmooth, blood circulation is unfavorable, and stagnation is caused by blood stasis. Turbid phlegm and stagnant blood mutually pulsation and accumulation, and adhere to liver collaterals to form "mass" (i.e. liver fibrosis/early cirrhosis). Clinically, there are symptoms of distension and fullness in the hypochondrium (hepatosplenomegaly), stabbing pain or distending pain in the hypochondrium, dark complexion, purple tongue with ecchymosis, greasy coating, wiry and unsmooth pulse. For this syndrome, the Chinese medicine treatment emphasizes "resolving phlegm, resolving masses, activating blood and eliminating mass". However, the existing traditional Chinese medicine prescription for treating WD liver fibrosis is mainly prepared from liver soothing, dampness removing and deficiency tonifying, and is specially aimed at the nuclear heart disease machine of 'phlegm and blood stasis internetworking', and the compound prescription with precise and appropriate compatibility and relatively clear mechanism is still blank. Therefore, a traditional Chinese medicine compound capable of accurately intervening in liver fibrosis with the syndrome of phlegm and blood stasis based on a treatment method of resolving phlegm, resolving masses and eliminating mass is developed, and the traditional Chinese medicine compound has important clinical significance and application prospect. Disclosure of Invention In order to solve the problems, the application provides a traditional Chinese medicine composition, which comprises, by weight, 8-12 parts of fritillaria cirrhosa, 15-25 parts of kelp, 25-35 parts of fritillaria thunbergii, 8-12 parts of turmeric, 15-25 parts of chicken's gizzard-skin, 25-35 parts of raw hawthorn and 12-18 parts of selfheal. Further, the traditional Chinese medicine composition comprises the following raw materials, by weight, 10 parts of fritillaria cirrhosa, 20 parts of kelp, 30 parts of fritillaria thunbergii, 10 parts of turmeric, 20 parts of chicken's gizzard-skin, 30 parts of raw hawthorn and 15 parts of selfheal. In a second aspect, the application provides a pharmaceutical preparation, which comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials, and the preparation method of the pharmaceutical preparation comprises the following steps: Decocting the rest materials (thallus laminariae, bulbus Fritillariae Thunbergii, curcuma rhizome, endothelium corneum Gigeriae Galli, fructus crataegi and Prunellae Spica) with water twice for 0.5-2 hr, adding water 6-10 times of the rest materials, decocting for 30-60 min, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract with relative density of 1.25-1.30; Grinding Bulbus Fritillariae Cirrhosae into fine powder, mixing with the soft extract, drying at 60-70deg.C, drying, and pulverizing into fine powder; adding adjuvants into the fine powder, and making into desired dosage forms by conventional preparation process. Further, the dosage forms of the pharmaceutical preparation comprise pills, powder, granules, capsules, tablets or oral liquid. In a third aspect, the pre