CN118286376A - Compound traditional Chinese medicine preparation for treating liver fibrosis and early liver cirrhosis and preparation method thereof - Google Patents

Compound traditional Chinese medicine preparation for treating liver fibrosis and early liver cirrhosis and preparation method thereof Download PDF

Info

Publication number
CN118286376A
CN118286376A CN202410441423.0A CN202410441423A CN118286376A CN 118286376 A CN118286376 A CN 118286376A CN 202410441423 A CN202410441423 A CN 202410441423A CN 118286376 A CN118286376 A CN 118286376A
Authority
CN
China
Prior art keywords
parts
root
liver
extraction
traditional chinese
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202410441423.0A
Other languages
Chinese (zh)
Inventor
高凯
黄源毅
刘相军
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guangzhou Yuehua Pharmaceutical Co ltd
Original Assignee
Guangzhou Yuehua Pharmaceutical Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Guangzhou Yuehua Pharmaceutical Co ltd filed Critical Guangzhou Yuehua Pharmaceutical Co ltd
Publication of CN118286376A publication Critical patent/CN118286376A/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K36/537—Salvia (sage)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/02—Medicinal preparations containing materials or reaction products thereof with undetermined constitution from inanimate materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/58—Reptiles
    • A61K35/586—Turtles; Tortoises, e.g. terrapins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A61K35/64—Insects, e.g. bees, wasps or fleas
    • 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
    • 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)
    • A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • 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
    • 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)
    • A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
    • 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)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734—Crataegus (hawthorn)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8998—Hordeum (barley)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Zoology (AREA)
  • Insects & Arthropods (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Husbandry (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention provides a compound traditional Chinese medicine preparation for treating hepatic fibrosis and early cirrhosis and a preparation method thereof, wherein the active ingredients of the compound traditional Chinese medicine preparation comprise the following raw materials in parts by weight: the invention relates to a Chinese medicinal composition which is prepared from 5-12 parts of red sage root, 2-8 parts of dragon bone, 3-7 parts of turtle shell, 5-10 parts of achyranthes root, 4-8 parts of stiff silkworm, 2-5 parts of white paeony root, 1-6 parts of herba lycopi, 2-8 parts of charred triplet, 1-6 parts of radix curcumae, 2-8 parts of liquorice, 1-5 parts of moutan bark and 1-5 parts of concha arcae, and is prepared into active components of medicaments respectively according to monarch and minister, the active components of the active components are fully exerted, the active components of the active components are scientifically compatible and jointly acted, liver disease symptoms can be relieved, liver fibrosis is inhibited, early liver cirrhosis is prevented, the injury degree of CCl 4 induced liver injury mouse hepatocytes is effectively reduced, intrahepatic inflammation is effectively inhibited, immunity is regulated, liver fibrosis induction is removed, tissue cirrhosis is formed, clinical tests are carried out on 2 groups of examples, the treatment efficiency is 82.1% and 85.7%, and the total effective efficiency is 96.4% and 95.2%.

Description

Compound traditional Chinese medicine preparation for treating liver fibrosis and early liver cirrhosis and preparation method thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a compound traditional Chinese medicine preparation for treating hepatic fibrosis and early cirrhosis and a preparation method thereof.
Background
Liver fibrosis is a pathophysiological process that refers to abnormal proliferation of connective tissue in the liver caused by various pathogenic factors. Any liver injury has liver fibrosis in the course of liver repair and healing, and if injury factors cannot be removed for a long period of time, the fibrosis process continues for a long period of time to develop cirrhosis. Liver fibrosis and early cirrhosis are a chronic liver disease characterized by alterations in liver structure and function. Traditional Chinese medicine and western medicine have different views and schemes in treating liver fibrosis and early cirrhosis.
Western medicine considers that liver fibrosis and early liver cirrhosis are liver injury and fibrosis caused by chronic liver diseases such as chronic hepatitis, fatty liver and the like. The therapeutic principle is to treat the etiology and simultaneously to treat liver protection, anti-inflammatory, anti-fibrosis and the like. Commonly used drugs include antiviral drugs, liver protecting drugs, anti-fibrosis drugs, etc.
The traditional Chinese medicine considers that liver fibrosis and early liver cirrhosis belong to the categories of accumulation, hypochondriac pain and the like, and etiology and pathogenesis mainly comprise deficiency of vital energy and evil, long-term evil, liver meridian damage, qi stagnation and blood stasis and the like, and liver cirrhosis patients often show qi stagnation and phlegm coagulation symptoms at the early stage, and are particularly shown as irritability, inappetence or easy awakening from midnight to early morning. The patients with deficiency of both qi and yin consume qi to hurt yin, and have symptoms of emaciation, sallow complexion, hypodynamia and the like;
Both modes have effects of treating liver fibrosis and liver cirrhosis, but although Western medicine can effectively inhibit virus replication and reduce further damage to liver, viruses cannot be thoroughly removed, and liver fibrosis and liver cirrhosis cannot be reversed. In addition, antiviral treatment requires long-term administration, and certain adverse reactions exist, and although western medicines can inhibit the progress of liver fibrosis, the medicines are not necessarily capable of reversing liver fibrosis and cirrhosis. The traditional Chinese medicine treatment overcomes the defects of western medicine treatment to a certain extent by the characteristics of the whole concept and the dialectical treatment, but the main defects of the traditional Chinese medicine treatment of hepatic fibrosis and early liver cirrhosis are the lack of large-scale clinical tests and scientific verification. The urgent need is that the traditional Chinese medicine has the characteristics of overall concept and diagnosis and treatment of liver fibrosis and early cirrhosis, and is focused on adopting personalized treatment schemes aiming at different etiologies and different diseases from the overall condition of the patient.
Disclosure of Invention
In view of the above, the invention provides a compound Chinese medicinal preparation for treating hepatic fibrosis and early cirrhosis and a preparation method thereof, which solve the problems.
The technical scheme of the invention is realized as follows: a compound Chinese medicinal preparation for treating liver fibrosis and early stage liver cirrhosis: the active ingredients of the composition comprise the following raw materials in parts by weight: 5-12 parts of red sage root, 2-8 parts of dragon bone, 3-7 parts of turtle shell, 5-10 parts of achyranthes root, 4-8 parts of stiff silkworm, 2-5 parts of white peony root, 1-6 parts of herba lycopi, 2-8 parts of charred triplet, 1-6 parts of radix curcumae, 2-8 parts of liquorice, 1-5 parts of moutan bark and 1-5 parts of concha arcae.
Further, a compound traditional Chinese medicine preparation for treating liver fibrosis and early cirrhosis: the active ingredients of the composition comprise the following raw materials in parts by weight: 8-10 parts of red sage root, 3-5 parts of dragon bone, 4-6 parts of turtle shell, 6-8 parts of achyranthes root, 5-7 parts of stiff silkworm, 3-4 parts of white peony root, 2-5 parts of herba lycopi, 3-6 parts of charred triplet, 2-5 parts of radix curcumae, 3-7 parts of liquorice, 2-4 parts of moutan bark and 2-4 parts of concha arcae.
Further, a compound traditional Chinese medicine preparation for treating liver fibrosis and early cirrhosis: the active ingredients of the active ingredients comprise the following raw materials in parts by weight: 9 parts of red sage root, 4 parts of dragon bone, 5 parts of turtle shell, 7 parts of achyranthes root, 6 parts of stiff silkworm, 3 parts of white peony root, 2 parts of herba lycopi leaf, 4 parts of charred triplet, 3 parts of radix curcumae, 6 parts of liquorice, 2 parts of tree peony bark and 2 parts of concha arcae.
Further, the traditional Chinese medicine preparation is in the form of tablets, capsules, powder or granules.
Further, a preparation method of a compound traditional Chinese medicine preparation for treating liver fibrosis and early cirrhosis comprises the following steps:
S1, cleaning all medicinal materials, respectively mechanically crushing the red sage root, the dragon bone, the turtle shell, the achyranthes and the stiff silkworm according to the proportion, carrying out infrared heating drying after crushing, grinding to powder with the particle size of 200-300 meshes, adding an extraction solvent for extraction for 1-3 times, extracting at the temperature of 55-65 ℃ for 1-3 hours each time at the interval of 20-40 minutes each time, merging the extracting solutions, filtering and concentrating to obtain a medicinal liquid I;
S2, mixing the white paeony root, the herba lycopi leaf and the charred triplet, drying in vacuum, crushing, extracting the crushed mixed medicine with supercritical carbon dioxide for 2-4 hours, filtering after extraction is finished, and taking out supernatant to obtain liquid medicine II;
s3, freeze-drying radix curcumae, liquorice, moutan bark and concha arcae at the temperature of-25 to-10 ℃ for 5-8 hours, grinding after drying, adding 3-6 times of water by mass for extraction at the temperature of 50-80 ℃ for 60-120 minutes, centrifuging after extraction, collecting supernatant, and concentrating the supernatant to obtain an aqueous extract;
S4, mixing the liquid medicine I, the liquid medicine II and the water extract, putting the mixture into a magnetic stirrer, and stirring the mixture for 20-40min under the action of magnetic force to obtain the traditional Chinese medicine composition.
Further, the infrared heating and drying temperature of the S1 is 40-80 ℃, and the drying time is 40-80min.
Further, the extraction solvent of S1 is ethanol and ethyl acetate with volume of (4-6): 10.
Further, the mass-volume ratio g/mL of the powder of S1 to the extraction solvent is 12-22:50.
Further, the supercritical carbon dioxide extraction pressure in the step S2 is 15-30MPa, and the extraction temperature is 55-65 ℃.
Further, the stirring power in the step S4 is 10-40W, and the stirring speed is 2000-5000rpm.
Compared with the prior art, the invention has the beneficial effects that:
The principal drugs of the prescription, such as the red sage root, the dragon bone, the turtle shell, the achyranthes and the stiff silkworm, have the effects of promoting blood circulation by removing blood stasis, nourishing blood and tranquillizing, suppressing hyperactive liver and subsiding yang, strengthening tendons and bones, dispelling wind and relieving spasm, and the like, and can improve liver microcirculation, protect liver cells, relieve liver disease symptoms and inhibit liver fibrosis. The ministerial drugs of white peony root, herba lycopi leaf and charred triplet have the effects of nourishing blood, softening liver, activating blood, dissolving stasis, strengthening spleen, promoting digestion and the like, and can further improve liver function and relieve liver disease symptoms. The adjuvant materials of radix Curcumae and Glycyrrhrizae radix have effects of dispersing stagnated liver qi for relieving qi stagnation, clearing heat and removing toxic substances, and can regulate immunity and inhibit inflammatory reaction. The cortex moutan and Concha arcae have effects of clearing heat, cooling blood, astringing, stopping bleeding, etc., and can relieve liver disease symptoms and inhibit liver fibrosis.
The traditional Chinese medicines are matched and act together according to the compatibility of monarch, minister, assistant and guide, and are respectively prepared and extracted to extract the active ingredients of the medicines according to monarch, minister, assistant and guide, so that the effective functions of the medicines are fully exerted, and the effects of activating blood circulation to remove blood stasis, promoting qi circulation to relieve pain, nourishing blood and tranquillizing, strengthening tendons and bones, dispelling wind and relieving spasm, reducing phlegm and resolving masses, improving liver microcirculation, regulating liver function, protecting liver cells, inhibiting inflammatory reaction, liver fibrosis and the like are achieved, and the curative effect of protecting liver is further exerted.
Detailed Description
In order to better understand the technical content of the present invention, the following provides specific examples to further illustrate the present invention.
The experimental methods used in the embodiment of the invention are conventional methods unless otherwise specified.
Materials, reagents, and the like used in the examples of the present invention are commercially available unless otherwise specified.
Example 1
A compound Chinese medicinal preparation for treating liver fibrosis and early stage liver cirrhosis: the active ingredients of the composition comprise the following raw materials in parts by weight: 5g of red sage root, 2g of dragon bone, 3g of turtle shell, 5g of achyranthes root, 4 g of stiff silkworm, 2g of white peony root, 1 g of herba lycopi leaf, 2g of charred triplet, 1 g of radix curcumae, 2g of liquorice, 1 g of tree peony bark and 1 g of concha arcae.
Example 2
A compound Chinese medicinal preparation for treating liver fibrosis and early stage liver cirrhosis: the active ingredients of the composition comprise the following raw materials in parts by weight: 12g of red sage root, 8g of dragon bone, 7 g of turtle shell, 10g of achyranthes root, 8g of stiff silkworm, 5g of white peony root, 6g of herba lycopi leaf, 8g of charred triplet, 6g of radix curcumae, 8g of liquorice, 5g of tree peony bark and 5g of concha arcae;
the following preparation methods were employed in the above examples 1-2:
S1, cleaning all medicinal materials, respectively mechanically crushing the red sage root, the dragon bone, the turtle shell, the achyranthes and the stiff silkworm according to the proportion, carrying out infrared heating and drying after crushing, grinding the crushed materials, wherein the infrared heating and drying temperature is 40 ℃, the drying time is 40min, grinding the crushed materials to powder with the particle size of 200 meshes, adding an extraction solvent for extraction for 1 time, wherein the mass-volume ratio g/mL of the powder to the extraction solvent is 12:50, the extraction solvent is ethanol and ethyl acetate with the volume of 4:10, the extraction temperature is 55 ℃ each time, the extraction time is 1h each time is 20min, merging the extraction solutions, filtering and concentrating to obtain a liquid medicine I;
S2, mixing the white paeony root, the herba lycopi leaf and the charred triplet, carrying out vacuum drying and crushing, carrying out supercritical carbon dioxide extraction on the crushed mixed medicine for 2 hours at the extraction pressure of 15MPa and the extraction temperature of 55 ℃, filtering after extraction is completed, and taking out supernatant to obtain liquid medicine II;
S3, freeze-drying radix curcumae, liquorice, moutan bark and concha arcae at the temperature of-25 ℃ for 5 hours, grinding after drying, adding 3 times of water for extraction at the temperature of 50 ℃ for 60 minutes, centrifuging after extraction, collecting supernatant, and concentrating the supernatant to obtain an aqueous extract;
S4, mixing the liquid medicine I, the liquid medicine II and the water extract, putting the mixture into a magnetic stirrer, stirring for 20min under the action of magnetic force, wherein the stirring power is 10W and the stirring speed is 2000rpm, and mixing the mixture to obtain the traditional Chinese medicine composition.
Example 3
A compound Chinese medicinal preparation for treating liver fibrosis and early stage liver cirrhosis: the active ingredients of the composition comprise the following raw materials in parts by weight: 8 g of red sage root, 3g of dragon bone, 4 g of turtle shell, 6 g of achyranthes root, 5g of stiff silkworm, 3g of white peony root, 2g of herba lycopi leaf, 3g of charred triplet, 2g of radix curcumae, 3g of liquorice, 2g of tree peony bark and 2g of concha arcae.
Example 4
A compound Chinese medicinal preparation for treating liver fibrosis and early stage liver cirrhosis: the active ingredients of the composition comprise the following raw materials in parts by weight: 10g of red sage root, 5g of dragon bone, 6 g of turtle shell, 8g of achyranthes root, 7 g of stiff silkworm, 4 g of white peony root, 5g of herba lycopi, 6 g of charred triplet, 5g of radix curcumae, 7 g of liquorice, 4 g of tree peony bark and 4 g of concha arcae;
the following preparation methods were employed for the above examples 3-4:
S1, cleaning all medicinal materials, respectively mechanically crushing the red sage root, the dragon bone, the turtle shell, the achyranthes and the stiff silkworm according to the proportion, carrying out infrared heating and drying after crushing, grinding the crushed materials, wherein the infrared heating and drying temperature is 80 ℃, the drying time is 80 minutes, grinding the crushed materials to powder with the particle size of 300 meshes, adding an extraction solvent for extraction for 3 times, wherein the mass-volume ratio g/mL of the powder to the extraction solvent is 22:50, the extraction solvent is ethanol and ethyl acetate with the volume of 6:10, the extraction temperature is 65 ℃ each time, the extraction time is 3 hours each time interval is 40 minutes, merging the extraction solutions, filtering and concentrating to obtain a liquid medicine I;
s2, mixing the white paeony root, the herba lycopi leaf and the charred triplet, carrying out vacuum drying and crushing, carrying out supercritical carbon dioxide extraction on the crushed mixed medicine for 4 hours at the extraction pressure of 30MPa and the extraction temperature of 65 ℃, filtering after extraction is completed, and taking out supernatant to obtain liquid medicine II;
S3, freeze-drying radix curcumae, liquorice, moutan bark and concha arcae at the temperature of-10 ℃ for 8 hours, grinding after drying, adding 6 times of water for extraction at the temperature of 80 ℃ for 120 minutes, centrifuging after extraction, collecting supernatant, and concentrating the supernatant to obtain an aqueous extract;
S4, mixing the liquid medicine I, the liquid medicine II and the water extract, putting the mixture into a magnetic stirrer, stirring for 40min under the action of magnetic force, wherein the stirring power is 40W and the stirring speed is 5000rpm, and mixing the mixture to obtain the traditional Chinese medicine composition.
Example 5
A compound Chinese medicinal preparation for treating liver fibrosis and early stage liver cirrhosis: the active ingredients of the active ingredients comprise the following raw materials in parts by weight: 9g of red sage root, 4 g of dragon bone, 5g of turtle shell, 7 g of achyranthes root, 6g of stiff silkworm, 3g of white peony root, 2g of herba lycopi leaf, 4 g of charred triplet, 3g of radix curcumae, 6g of liquorice, 2g of tree peony bark and 2g of concha arcae;
The following preparation method was adopted in the above example 5:
s1, cleaning all medicinal materials, respectively mechanically crushing the red sage root, the dragon bone, the turtle shell, the achyranthes and the stiff silkworm according to the proportion, carrying out infrared heating and drying after crushing, grinding the crushed materials, wherein the infrared heating and drying temperature is 60 ℃, the drying time is 60 minutes, grinding the crushed materials to powder with the particle size of 250 meshes, adding an extraction solvent for extraction for 2 times, wherein the mass-volume ratio g/mL of the powder to the extraction solvent is 17:50, the extraction solvent is ethanol and ethyl acetate with the volume of 5:10, the extraction temperature is 60 ℃ each time, the extraction time is 2 hours, the extraction liquid is combined each time interval is 30 minutes, filtering and concentrating to obtain a liquid medicine I;
s2, mixing the white paeony root, the herba lycopi leaf and the charred triplet, carrying out vacuum drying and crushing, carrying out supercritical carbon dioxide extraction on the crushed mixed medicine for 3 hours at the extraction pressure of 22MPa and the extraction temperature of 60 ℃, filtering after extraction is completed, and taking out supernatant to obtain liquid medicine II;
S3, freeze-drying radix curcumae, liquorice, moutan bark and concha arcae at the temperature of-18 ℃ for 7 hours, grinding after drying, adding 5 times of water for extraction at the temperature of 70 ℃ for 90 minutes, centrifuging after extraction, collecting supernatant, and concentrating the supernatant to obtain an aqueous extract;
S4, mixing the liquid medicine I, the liquid medicine II and the water extract, putting the mixture into a magnetic stirrer, stirring for 30min under the action of magnetic force, wherein the stirring power is 3W and the stirring speed is 3000rpm, and mixing the mixture to obtain the traditional Chinese medicine composition.
1. Animal experiment
1. Grouping: 70 experimental mice are selected and randomly divided into 7 groups, and the groups correspond to the implementation groups 1-5, the control group and the commercially available traditional Chinese medicine group;
2. Modeling: the method for constructing the fibrosis model of the mice comprises the following steps: the preparation volume ratio is 4:1 (CCl 4) and vegetable oil, injecting into the abdominal cavity of a mouse according to 0.3mL/100g, and injecting 2 times per week for 10 weeks, and inducing a hepatic fibrosis model;
3. administration: the pharmaceutical compositions of examples 1-5 of the present invention were used in combination with 2.25mg/kg of lavage, the control group was lavaged with physiological saline at 1mg/kg, the commercial group was lavaged with the commercial Chinese medicinal composition at 2.25mg/kg, 3 times daily on average, for 4 weeks continuously;
4. And (3) detection: detecting liver fibrosis and liver cirrhosis degree of a mouse according to serology, taking a liver tissue sample, using a corresponding kit to detect hyaluronic acid, laminin, type III procollagen and type IV collagen in the liver, and simultaneously taking abdominal blood to detect glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST) and total bilirubin content;
5. Test results:
table 1: mouse liver tissue index test results
Table 2: results of serological detection in mice
ALT(U/L) AST(U/L) Total bilirubin (mu mol/L)
Example 1 32.8 22.7 8.69
Example 2 33.5 20.1 7.26
Example 3 32.6 31.8 8.21
Example 4 31.8 28.6 5.58
Example 5 33.4 29.6 9.11
Control group 58.9 66.2 28.69
Commercial group 38.9 40.3 12.6
The detection results of the table 1 and the table 2 show that the pharmaceutical composition of the invention effectively reduces the damage degree of CCl 4 induced liver cells of mice with liver damage, and the hyaluronic acid, laminin, type III procollagen and type IV collagen tend to be at normal level, maintains the synthesis and degradation balance of type III procollagen, and reduces the hyaluronic acid content, laminin and collagen content of hepatic fibrosis mice; simultaneously, the serum ALT, AST and total bilirubin levels can be reduced, the damage state of mouse liver cells induced by CCl 4 can be reduced, the intrahepatic inflammation can be effectively inhibited, the immunity can be regulated, the hepatic fibrosis inducement can be removed, and the liver cirrhosis formation can be prevented.
2. Clinical trial
1. General data: according to the technical requirements of clinical research on new traditional Chinese medicines, 49 patients with male 28 and 21 female clinical observations are collected according to diagnosis standards, exclusion standards and case rejection standards, and the differentiation of traditional Chinese medicine is that the patients with qi stagnation and phlegm coagulation and qi and yin deficiency.
2. Diagnostic criteria for traditional Chinese medicine: making relevant content in the medical guide of the combination of traditional Chinese medicine and Western medicine for liver fibrosis;
3. the treatment method comprises the following steps: the medicines of the embodiments 4 and 5 of the invention are taken by the patient, the adult takes the medicines 3 times a day, 2 tablets each time, warm boiled water within half an hour after meal, 7 days is a treatment course, and 3 to 4 treatment courses are continuously taken.
4. Standard of efficacy:
The effect is shown: clinical symptoms are obviously reduced, liver function indexes are improved, glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST), bilirubin and the like are reduced, and imaging examination shows that liver morphology, structure and blood flow change are improved; symptoms such as hypochondriac distending pain, dry and bitter taste, anorexia and the like are obviously reduced or eliminated, liver function indexes are recovered to be normal or obviously improved, and simultaneously four traditional Chinese medicine diagnosis manifestations such as tongue quality, tongue fur, pulse condition and the like are also obviously improved;
The method is effective: clinical symptoms are improved, liver function indexes are improved, glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST), bilirubin and the like have a descending trend, and imaging examination shows that liver morphology, structure and blood flow change are improved; symptoms such as hypochondriac distending pain, dry and bitter taste, anorexia and the like are reduced, liver function indexes are improved, and four diagnostic manifestations of traditional Chinese medicine such as tongue quality, tongue fur and pulse condition are also improved;
Invalidation: the clinical symptoms are not improved or aggravated, liver function indexes are not changed or worsened, and imaging examination shows that liver morphology, structure and blood flow changes are not improved or worsened, and liver function indexes, tongue fur, pulse conditions and the like are not improved or further worsened.
5. The results show that:
The results show that the medicines are reasonably combined to effectively treat diseases such as hepatic fibrosis and early liver cirrhosis, and the treatment obvious efficiency is 82.1% and 85.7% and the total effective rate is 96.4% and 95.2% through the tests of 2 groups of examples.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, alternatives, and improvements that fall within the spirit and scope of the invention.

Claims (10)

1. A compound Chinese medicinal preparation for treating hepatic fibrosis and early liver cirrhosis is characterized in that: the active ingredients of the composition comprise the following raw materials in parts by weight: 5-12 parts of red sage root, 2-8 parts of dragon bone, 3-7 parts of turtle shell, 5-10 parts of achyranthes root, 4-8 parts of stiff silkworm, 2-5 parts of white peony root, 1-6 parts of herba lycopi, 2-8 parts of charred triplet, 1-6 parts of radix curcumae, 2-8 parts of liquorice, 1-5 parts of moutan bark and 1-5 parts of concha arcae.
2. The compound traditional Chinese medicine preparation for treating hepatic fibrosis and early cirrhosis according to claim 1, which is characterized in that: the active ingredients of the composition comprise the following raw materials in parts by weight: 8-10 parts of red sage root, 3-5 parts of dragon bone, 4-6 parts of turtle shell, 6-8 parts of achyranthes root, 5-7 parts of stiff silkworm, 3-4 parts of white peony root, 2-5 parts of herba lycopi, 3-6 parts of charred triplet, 2-5 parts of radix curcumae, 3-7 parts of liquorice, 2-4 parts of moutan bark and 2-4 parts of concha arcae.
3. The compound traditional Chinese medicine preparation for treating hepatic fibrosis and early cirrhosis according to claim 1, which is characterized in that: the active ingredients of the composition comprise the following raw materials in parts by weight: 9 parts of red sage root, 4 parts of dragon bone, 5 parts of turtle shell, 7 parts of achyranthes root, 6 parts of stiff silkworm, 3 parts of white peony root, 2 parts of herba lycopi leaf, 4 parts of charred triplet, 3 parts of radix curcumae, 6 parts of liquorice, 2 parts of tree peony bark and 2 parts of concha arcae.
4. The compound traditional Chinese medicine preparation for treating hepatic fibrosis and early cirrhosis according to claim 1, wherein the compound traditional Chinese medicine preparation is characterized in that: the traditional Chinese medicine preparation is in the form of tablets, capsules, powder or granules.
5. The method for preparing the compound Chinese medicinal preparation for treating hepatic fibrosis and early cirrhosis according to claim 1, which is characterized in that: the method comprises the following steps:
S1, cleaning all medicinal materials, respectively mechanically crushing the red sage root, the dragon bone, the turtle shell, the achyranthes and the stiff silkworm according to the proportion, carrying out infrared heating drying after crushing, grinding to powder with the particle size of 200-300 meshes, adding an extraction solvent for extraction for 1-3 times, extracting at the temperature of 55-65 ℃ for 1-3 hours each time at the interval of 20-40 minutes each time, merging the extracting solutions, filtering and concentrating to obtain a medicinal liquid I;
S2, mixing the white paeony root, the herba lycopi leaf and the charred triplet, drying in vacuum, crushing, extracting the crushed mixed medicine with supercritical carbon dioxide for 2-4 hours, filtering after extraction is finished, and taking out supernatant to obtain liquid medicine II;
s3, freeze-drying radix curcumae, liquorice, moutan bark and concha arcae at the temperature of-25 to-10 ℃ for 5-8 hours, grinding after drying, adding 3-6 times of water by mass for extraction at the temperature of 50-80 ℃ for 60-120 minutes, centrifuging after extraction, collecting supernatant, and concentrating the supernatant to obtain an aqueous extract;
S4, mixing the liquid medicine I, the liquid medicine II and the water extract, putting the mixture into a magnetic stirrer, and stirring the mixture for 20-40min under the action of magnetic force to obtain the traditional Chinese medicine composition.
6. The method for preparing the compound Chinese medicinal preparation for treating hepatic fibrosis and early cirrhosis according to claim 5, which is characterized in that: the infrared heating and drying temperature of the S1 is 40-80 ℃, and the drying time is 40-80min.
7. The method for preparing the compound Chinese medicinal preparation for treating hepatic fibrosis and early cirrhosis according to claim 5, which is characterized in that: the extraction solvent of S1 is ethanol and ethyl acetate with volume of (4-6) being 10.
8. The method for preparing the compound Chinese medicinal preparation for treating hepatic fibrosis and early cirrhosis according to claim 5, which is characterized in that: the mass volume ratio g/mL of the powder of the S1 to the extraction solvent is 12-22:50.
9. The method for preparing the compound Chinese medicinal preparation for treating hepatic fibrosis and early cirrhosis according to claim 5, which is characterized in that: the supercritical carbon dioxide extraction pressure in the S2 is 15-30MPa, and the extraction temperature is 55-65 ℃.
10. The method for preparing the compound Chinese medicinal preparation for treating hepatic fibrosis and early cirrhosis according to claim 5, which is characterized in that: the stirring power in the step S4 is 10-40W, and the speed is 2000-5000rpm.
CN202410441423.0A 2024-01-31 2024-04-12 Compound traditional Chinese medicine preparation for treating liver fibrosis and early liver cirrhosis and preparation method thereof Pending CN118286376A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202410130325.5A CN117838821A (en) 2024-01-31 2024-01-31 Compound traditional Chinese medicine preparation for treating liver fibrosis and early liver cirrhosis and preparation method thereof
CN2024101303255 2024-01-31

Publications (1)

Publication Number Publication Date
CN118286376A true CN118286376A (en) 2024-07-05

Family

ID=90536108

Family Applications (2)

Application Number Title Priority Date Filing Date
CN202410130325.5A Pending CN117838821A (en) 2024-01-31 2024-01-31 Compound traditional Chinese medicine preparation for treating liver fibrosis and early liver cirrhosis and preparation method thereof
CN202410441423.0A Pending CN118286376A (en) 2024-01-31 2024-04-12 Compound traditional Chinese medicine preparation for treating liver fibrosis and early liver cirrhosis and preparation method thereof

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CN202410130325.5A Pending CN117838821A (en) 2024-01-31 2024-01-31 Compound traditional Chinese medicine preparation for treating liver fibrosis and early liver cirrhosis and preparation method thereof

Country Status (1)

Country Link
CN (2) CN117838821A (en)

Also Published As

Publication number Publication date
CN117838821A (en) 2024-04-09

Similar Documents

Publication Publication Date Title
CN106279462B (en) The preparation method of the extracting method of astragalus polyose and astragalus polysaccharides oral liquid for animals
CN103341010B (en) Chinese medicine preparation for treating jaundiced hepatitis and preparation method thereof
CN114869953B (en) Composition for resisting fatigue and enhancing immunity and treating rheumatism and preparation method thereof
CN105943953A (en) Health product for treating diabetes and preparation method thereof
CN118286376A (en) Compound traditional Chinese medicine preparation for treating liver fibrosis and early liver cirrhosis and preparation method thereof
CN109908209A (en) A kind of pharmaceutical composition and its preparation method and application for treating allergic rhinitis
CN113288991A (en) Traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression and preparation method thereof
CN112107636A (en) Formula and preparation process of traditional Chinese medicine preparation for treating osteoarthropathy
CN112870267A (en) New medicine for treating tumor and preparation method thereof
CN101574426B (en) Chinese patent medicament for treating liver diseases and method for preparing same
CN108743667A (en) A kind of Chinese medicine for treating rhinitis composition, preparation method and pharmaceutical preparation
CN100469375C (en) Medicine for treating hepatitis and its preparing method
CN113181256B (en) Traditional Chinese medicine composition for treating liver fibrosis
CN108635560A (en) A kind of Chinese medicine and preparation method thereof for treating lymthoma
CN115501280B (en) Traditional Chinese medicine composition for improving fatty liver as well as preparation method, extract, application and preparation thereof
CN110038071A (en) A kind of Chinese medicine composition and preparation method and application with anti-herpesvirus
CN115381874B (en) Traditional Chinese medicine composition and granule for treating chicken noninfectious diarrhea and preparation method thereof
CN102631486B (en) Health care composition
CN108126134B (en) Traditional Chinese medicine compound composition for treating liver injury, preparation method and application thereof
CN113995782B (en) Application of composition containing selfheal to preparation of medicine for treating thyroid nodules
CN111888440A (en) Chinese medicinal preparation for preventing and treating senile dementia and production method thereof
CN118453809A (en) Traditional Chinese medicine composition for preventing and/or treating fatty liver
CN105796684B (en) Composition, traditional Chinese medicine composition and application thereof
CN1101854A (en) Chinese medicine for treating liver and kidney diseases and its preparing process
CN104784567B (en) A kind of pharmaceutical composition for the treatment of urinary system infection

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination