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CN-122005724-A - Compound preparation for treating osteoarthritis and preparation method thereof

CN122005724ACN 122005724 ACN122005724 ACN 122005724ACN-122005724-A

Abstract

The invention discloses a compound preparation for treating osteoarthritis and a preparation method thereof, which belong to the technical field of traditional Chinese medicine preparations and comprise the following raw materials, by mass, 15-19 parts of achyranthes bidentata, 13-15 parts of salted eucommia ulmoides, 11-13 parts of angelica sinensis, 9-11 parts of stir-fried rhizoma atractylodis with bran, 11-13 parts of coix seed, 5-7 parts of poria cocos, 4-6 parts of safflower with wine, 4-6 parts of vinegar corydalis, 4-6 parts of white paeony root, 8-10 parts of rhizoma drynariae with sand and 4-6 parts of honey-moxibustion licorice root. The compound preparation for treating osteoarthritis and the preparation method thereof can quickly relieve joint pain and stiffness, realize long-acting repair and regulation, and block the pathological process of osteoarthritis from multiple ways by cooperatively regulating intestinal flora and systemic immunity through targeting colon. Clinical verification shows that the traditional Chinese medicine composition has a curative effect obviously superior to that of a conventional preparation and first-line western medicines, is better in safety, and provides an innovative treatment option for patients, which has quick response, lasting effect and treatment of both symptoms and root causes.

Inventors

  • Lou Du
  • ZHAO LE
  • WANG HUI
  • LOU BINGYAN

Assignees

  • 河南国祯药业有限公司

Dates

Publication Date
20260512
Application Date
20260225

Claims (10)

  1. 1. A compound preparation for treating osteoarthritis is characterized by comprising, by mass, 15-19 parts of achyranthes bidentata, 13-15 parts of salted eucommia ulmoides, 11-13 parts of angelica sinensis, 9-11 parts of rhizoma atractylodis stir-fried with bran, 11-13 parts of coix seed, 5-7 parts of poria cocos, 4-6 parts of safflower wine, 4-6 parts of vinegar-processed rhizoma corydalis, 4-6 parts of white paeony root, 8-10 parts of rhizoma drynariae scalded by sand and 4-6 parts of honey-processed liquorice.
  2. 2. The method for preparing the compound preparation for treating osteoarthritis as claimed in claim 1, which is characterized by comprising the following steps: Step one, mixing and crushing bran-fried rhizoma atractylodis, coix seeds, poria cocos, white paeony root and honey-fried licorice root, leaching, and heating for secondary leaching to obtain leaching liquor; step two, adding cyclodextrin into the leaching solution, and concentrating to obtain a first concentrated solution; mixing and crushing the wine achyranthes root, the salted eucommia bark, the Chinese angelica, the wine safflower, the vinegar corydalis tuber and the sand-scalding drynaria rhizome, then carrying out reflux extraction to obtain an extracting solution, and concentrating the extracting solution to obtain a second concentrated solution; Step four, dripping the second concentrated solution into the first concentrated solution under the stirring condition, regulating the pH value to obtain a compound, and drying the compound at a low temperature to obtain a dry paste compound; step five, mixing the compound accounting for 15-25% of the total mass of the compound with quick release auxiliary materials, preparing a core by adopting centrifugal granulation, and wrapping the core with a gastric-soluble protective coating; Step six, mixing the rest compound with the slow-release material to obtain a coating material, uniformly coating the coating material on the surface of the core by adopting a fluidized bed bottom spraying technology, and forming a layer of intermediate layer on the surface of the core to obtain pellets; And step seven, performing pH-dependent enteric coating on the pellets, forming an enteric layer on the surfaces of the pellets, and then wrapping a composite coating outside the enteric layer to finally obtain the compound preparation.
  3. 3. The method for preparing the compound preparation for treating osteoarthritis according to claim 2, wherein in the first step, the leaching temperature is 50-55 ℃, the leaching time is 30-40min, the temperature is raised to 62-68 ℃, and the secondary leaching time is 1-1.5h.
  4. 4. The method for preparing a compound preparation for treating osteoarthritis according to claim 2, wherein in the second step, cyclodextrin accounts for 0.5-1.5% of the total amount of the bran-fried rhizoma atractylodis, semen coicis, poria cocos, radix paeoniae alba and honey-fried licorice root, and the cyclodextrin is hydroxypropyl-beta-cyclodextrin, and the concentration is 1.05-1.10.
  5. 5. The method for preparing the compound preparation for treating osteoarthritis according to claim 2, wherein in the third step, the reflux extraction is performed by adopting a low-concentration ethanol aqueous solution for temperature-controlled dynamic reflux extraction, stirring is kept during the reflux extraction, the temperature is 60-65 ℃, the mass percent of ethanol in the low-concentration ethanol aqueous solution is 20-30%, the stirring speed is 200-400rpm during the extraction, and the concentration is 1.15-1.20.
  6. 6. The method for preparing a compound preparation for treating osteoarthritis as claimed in claim 2, wherein in the fourth step, the stirring speed is 500-800rpm, and the pH is adjusted to 4.5-5.5.
  7. 7. The method for preparing the compound preparation for treating osteoarthritis as claimed in claim 2, wherein in the fifth step, the quick-release auxiliary material is croscarmellose sodium, the particle size of the core is 0.2-0.4mm, and the coating enables the core to gain 1-2%.
  8. 8. The method of claim 2, wherein in the seventh step, the composite coating is composed of a composite of a colonic bacteria group enzyme sensitive material and a pH sensitive material.
  9. 9. The method of claim 8, wherein in the seventh step, the pH sensitive material is one of synthetic acrylic resin and hydroxypropyl methylcellulose phthalate, and the colonic bacteria enzyme sensitive material is one of pectin and salts thereof, azo polymers, chitosan and derivatives thereof.
  10. 10. The method for preparing a compound preparation for treating osteoarthritis as claimed in claim 8, wherein in the seventh step, the mass ratio of the colonic flora enzyme sensitive material to the pH sensitive material is 1:4-2:3.

Description

Compound preparation for treating osteoarthritis and preparation method thereof Technical Field The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a compound preparation for treating osteoarthritis and a preparation method thereof. Background Osteoarthritis (Osteoarthritis OA) refers to one of chronic and progressive joint diseases with higher rate of teratogenicity and disability in the global scope at present caused by various factors such as age, obesity, inflammation, trauma and the like, and the bone joint disease takes degeneration and destruction of articular cartilage, subchondral bone sclerosis or cystic changes, joint edge hyperosteogeny, synovial hyperplasia and the like as main pathological characteristics. The incidence of OA is concentrated in middle-aged and elderly people, the clinical incidence is gradually increased with the increase of age, and the incidence of men is 10% and the incidence of women is 18% in people over 60 years old. At present, western medicines such as anti-inflammatory and analgesic medicines are used for treatment in clinic, but clinical researches indicate that long-term administration has poor prognosis for patients and certain damage to intestines, stomach and cardiovascular diseases of the patients. Because western medicines have great side effects, people have great demands for traditional Chinese medicine for effectively treating osteoarthritis, however, the traditional Chinese medicine compound preparation has the defects of complex components of traditional water decoction or crude extract, low dissolution rate of active ingredients and poor stability, and most of the traditional Chinese medicine compound preparation has decoction, and the medicines are released indiscriminately in gastrointestinal tracts. Disclosure of Invention The invention aims to provide a compound preparation for treating osteoarthritis and a preparation method thereof, which can quickly relieve joint pain and stiffness, realize long-acting repair and regulation, and block the pathological process of osteoarthritis from multiple ways by targeting colon to cooperatively regulate intestinal flora and systemic immunity. Clinical verification shows that the traditional Chinese medicine composition has the curative effect obviously superior to that of the conventional preparation and first-line western medicines, has better safety, and provides an innovative treatment option for patients, which has quick response, lasting effect and treatment of both symptoms and root causes The invention provides a compound preparation for treating osteoarthritis, which comprises the following raw materials, by mass, 15-19 parts of achyranthes bidentata, 13-15 parts of salted eucommia ulmoides, 11-13 parts of Chinese angelica, 9-11 parts of bran-fried rhizoma atractylodis, 11-13 parts of coix seed, 5-7 parts of poria cocos, 4-6 parts of wine safflower, 4-6 parts of vinegar corydalis tuber, 4-6 parts of white paeony root, 8-10 parts of sand-scalded rhizoma drynariae and 4-6 parts of honey-fried licorice root. The invention also provides a preparation method of the compound preparation for treating osteoarthritis, which comprises the following steps: Step one, mixing and crushing bran-fried rhizoma atractylodis, coix seeds, poria cocos, white paeony root and honey-fried licorice root, leaching, and heating for secondary leaching to obtain leaching liquor; step two, adding cyclodextrin into the leaching solution, and concentrating to obtain a first concentrated solution; mixing and crushing the wine achyranthes root, the salted eucommia bark, the Chinese angelica, the wine safflower, the vinegar corydalis tuber and the sand-scalding drynaria rhizome, then carrying out reflux extraction to obtain an extracting solution, and concentrating the extracting solution to obtain a second concentrated solution; Step four, dripping the second concentrated solution into the first concentrated solution under the stirring condition, regulating the pH value to obtain a compound, and drying the compound at a low temperature to obtain a dry paste compound; step five, mixing the compound accounting for 15-25% of the total mass of the compound with quick release auxiliary materials, preparing a core by adopting centrifugal granulation, and wrapping the core with a gastric-soluble protective coating; Step six, mixing the rest compound with the slow-release material to obtain a coating material, uniformly coating the coating material on the surface of the core by adopting a fluidized bed bottom spraying technology, and forming a layer of intermediate layer on the surface of the core to obtain pellets; And step seven, performing pH-dependent enteric coating on the pellets, forming an enteric layer on the surfaces of the pellets, and then wrapping a composite coating outside the enteric layer to finally obtain the compound preparation. Preferably, in the first step, the leachin