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WO2021042276A1 - Association médicamenteuse pour le traitement de l'arthrose - Google Patents

Association médicamenteuse pour le traitement de l'arthrose Download PDF

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Publication number
WO2021042276A1
WO2021042276A1 PCT/CN2019/104251 CN2019104251W WO2021042276A1 WO 2021042276 A1 WO2021042276 A1 WO 2021042276A1 CN 2019104251 W CN2019104251 W CN 2019104251W WO 2021042276 A1 WO2021042276 A1 WO 2021042276A1
Authority
WO
WIPO (PCT)
Prior art keywords
weight
parts
mailuoshutong
joint
osteoarthritis
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.)
Ceased
Application number
PCT/CN2019/104251
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English (en)
Chinese (zh)
Inventor
张贵民
李元森
程国良
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.)
Lunan Pharmaceutical Group Corp
Original Assignee
Lunan Pharmaceutical Group Corp
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 Lunan Pharmaceutical Group Corp filed Critical Lunan Pharmaceutical Group Corp
Priority to PCT/CN2019/104251 priority Critical patent/WO2021042276A1/fr
Priority to CN201980031449.5A priority patent/CN114340650A/zh
Publication of WO2021042276A1 publication Critical patent/WO2021042276A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • 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
    • A61K35/62—Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
    • 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
    • A61K36/8994—Coix (Job's tears)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis

Definitions

  • the invention belongs to the field of traditional Chinese medicine, and specifically relates to a combined medicine for treating osteoarthritis.
  • Osteoarthritis also known as proliferative osteoarthritis, osteoproliferation, degenerative arthropathy, senile arthritis, hypertrophic arthritis, is due to the degeneration of the cartilage, intervertebral discs, ligaments and other soft tissues that make up the joints. Degeneration, formation of bone spurs on the edges of the joints, hypertrophy of the synovial membrane and other changes, and bone destruction, causing secondary bone hyperplasia, leading to joint deformation, and when subjected to abnormal loads, a disease that causes symptoms such as joint pain and restricted mobility , There are two kinds of primary and secondary. Bone hyperplasia is a frequently-occurring and common disease, and it is a disease that causes joint pain.
  • the main purpose of treating osteoarthritis is to relieve pain, improve function, and improve the quality of life.
  • Treatment options include various formulations of non-steroidal anti-inflammatory drugs (NSAIDs) (emulsions, ointments, patches, etc.), general pain medications, supplementation of glucosamine chondroitin, local injection of sodium hyaluronate to lubricate joint pain, acupuncture and severe cases Perform joint replacement surgery, etc.
  • NSAIDs non-steroidal anti-inflammatory drugs
  • Chinese patent CN1201787C discloses a Chinese medicinal composition for the treatment of thrombophlebitis, which comprises astragalus, honeysuckle, cork, atractylodes, coix seed, scrophulariaceae, angelica, white peony root, licorice, leeches, centipede, whole scorpion 12 Taste medicinal materials, the Chinese medicinal composition has the functions of clearing away heat and detoxification, removing blood stasis and dredging collaterals, diminishing swelling and swelling. It has a good clinical effect in the treatment of thrombophlebitis, and at the same time, it also has certain prevention and treatment of thromboangiitis obliterans Therapeutic effect. The product based on this patent has been put on the market.
  • the product is called "Mailuo Shutong Granules/Pills". It is mainly used clinically for thrombotic superficial phlebitis caused by damp heat and stasis blocking the veins, and lower limbs caused by deep vein thrombosis in the non-acute stage. Swelling, pain, dark red complexion, or accompanied by cords.
  • One of the objectives of the present invention is to provide the use of a combined medicine of Celecoxib and Mailuoshutong Pills or Mailuoshutong granules in the preparation of medicines for treating joint diseases.
  • joint diseases are mainly manifested as one or more of joint pain and tenderness, joint stiffness, joint swelling, limited joint movement, and joint deformities.
  • the above-mentioned joint diseases mainly refer to osteoarthritis.
  • the aforementioned osteoarthritis is primary osteoarthritis or secondary osteoarthritis.
  • the secondary osteoarthritis mainly refers to one or more secondary to including but not limited to meniscus injury, intra-articular or peri-articular fracture, joint ligament injury, femoral head necrosis, congenital deformity or joint infection Osteoarthritis caused by this disease.
  • the osteoarthritis is mainly manifested as one or more of articular cartilage degeneration and injury, articular cartilage stripping, reactive hyperplasia of joint edges and subchondral bone, bone hyperplasia, meniscus injury, and synovitis .
  • the onset of osteoarthritis includes but is not limited to one or more of the hands, knees, hips, feet, and spine.
  • the weight ratio of celecoxib to Mailuoshutong pills in the combined drug is 1:180; the weight ratio of celecoxib to Mailuoshutong granules in the combined drug is 1:300.
  • the second object of the present invention is to provide the composition of the Mailuoshutong Pills or Mailuoshutong granules, that is, the Mailuoshutong Pills or Mailuoshutong granules are prepared from the following components:
  • the Mailuoshutong pill or Mailuoshutong granule is prepared from the following components:
  • Angelica 250-450 parts by weight White peony 250-450 parts by weight, licorice 50-150 parts by weight
  • the Mailuoshutong pill is prepared from the following components:
  • the Mailuoshutong granules are prepared from the following components:
  • the third object of the present invention is to provide a method for preparing the above-mentioned Mailuoshutong granules or Mailuoshutong pills, and the specific operations are as follows:
  • step 2) Take the prescription amount of astragalus, phellodendron, coix seed, licorice, 1/2 prescription amount of leech, centipede, whole scorpion and mix the distilled medicinal residue obtained in step 1), add water and decoct twice, combine the decoction, spare;
  • step 3 Take the decoction obtained in step 2) and mix with the distilled aqueous solution in step 1), filter, and concentrate the filtrate to a clear paste with a relative density of 1.10-1.20 (80°C). Add ethanol to make the alcohol content reach 60%. Place, filter, recover ethanol under reduced pressure and concentrate to a clear paste with a relative density of 1.10 to 1.18 (80°C) or a thick paste with a relative density of 1.30 to 1.35 (80°C), dry, and pulverize into fine powder to obtain extract powder ,spare;
  • step 5 Add the volatile oil obtained in step 1) to cyclodextrin to make an inclusion compound, mix it with the extract powder obtained in step 3), the powder and celecoxib obtained in step 4), and add it directly or pharmaceutically acceptable through conventional procedures.
  • the excipients are made into clinically acceptable dosage forms;
  • step 3 Or mix the extract powder obtained in step 3), the medicinal powder obtained in step 4), and celecoxib, granulate, spray into the volatile oil obtained in step 1) and mix well, and add pharmaceutically acceptable excipients directly or by conventional procedures Made into a clinically acceptable dosage form.
  • the combined medicine of the present invention has obvious therapeutic effect.
  • Animal experiments show that the combined drug of the present invention can effectively reduce the content of IL-1 ⁇ , TNF- ⁇ , MMP-3 and other inflammatory factors in the serum of rats with knee osteoarthritis, reduce inflammation, and the effect is significantly better than that of monotherapy.
  • the dosage of the drug is smaller than that of the single prescription, which improves the safety of the drug; clinical trials show that the total effectiveness of the combined drug of the present invention is 92.9%, which is significantly better than 88.1% of the Mailuoshutong pill group and 83.3% of the celecoxib group.
  • the levels of inflammatory factors IL-1 ⁇ , TNF- ⁇ , and MMP-3 decreased significantly, which relieved the pain of the patient and improved the quality of life of the patient.
  • step (1) Take the fine powder obtained in step (1), the inclusion compound obtained in step (2), and the fine powder extract obtained in step (3) and mix, add starch, mix and granulate, dry, make 1000g, and fill it into capsules.
  • step (2) Take the fine powder obtained in step (1), the inclusion compound obtained in step (2), and the fine powder extract obtained in step (3) and mix, add starch, mix and granulate, dry, make 1000g, and fill it into capsules.
  • step (3) Take the fine powder obtained in step (1), the inclusion compound obtained in step (2), and the fine powder extract obtained in step (3) and mix, add starch, mix and granulate, dry, make 1000g, and fill it into capsules.
  • step (1) Take the fine powder obtained in step (1) and mix the fine powder of the extract obtained in step (3), add the formula amount of ⁇ -cyclodextrin, aspartame, sodium carboxymethyl starch, and dextrin and mix well to prepare Granulate, dry, spray into the volatile oil obtained in step (2), mix well to make 1000g, and get it.
  • the inventors conducted relevant animal and clinical trials. It is worth noting that the following animal and clinical trials only take the knee joint in osteoarthritis as an example. Pharmacodynamics description, the inventor has also conducted research on other joint diseases, and the research results show that the combined drug of the present invention can achieve the same treatment as knee osteoarthritis for other types of osteoarthritis and joint diseases. Or a similar effect. The following animal and clinical trials cannot limit the present invention.
  • Seventy rats were divided into blank group, model group, celecoxib group, Mailuoshutong pill group, Mailuoshutong granule group, combined medication 1 group, combined medication 2 groups, each with 10 rats.
  • Each group of rats used the modified Hulth modeling method to establish a rat knee osteoarthritis model.
  • the specific operations are as follows:
  • the left lower limb of the rat was depilated. Fasting for 12 hours before surgery and water for 4 hours. After the rat is anesthetized, lie supine and fixed on the rat board. After routine disinfection of the rat’s left knee, take the inner side of the rat’s left knee joint as the operating point and make a longitudinal incision from the side of the patellar tendon. The range is about 1cm. The cross is cut before the internal test. The ligament, the internal meniscus was removed, and the drawer test was performed.
  • the blank group was treated with sham operation, only the joint cavity was opened, the ligaments and meniscus were not damaged, and the wound was sutured and bandaged.
  • each rat was injected with gentamicin intramuscularly, and the wound was disinfected to prevent wound infection.
  • the celecoxib group, the example 1 group, the example 2 group, the combination medicine group 1 and the combination medicine group 2 were given corresponding drugs respectively; the model group and the blank group were given the same amount of normal saline.
  • the intragastric administration was continued for 8 weeks.
  • the dosage is as follows:
  • Celecoxib group 18mg/kg
  • Combination medication group 1 Celecoxib 9mg/kg + Mailuoshutong pill 1.62g/kg;
  • Combination medication group 2 Celecoxib 9mg/kg + Mailuoshutong granules 2.7g/kg;
  • a total of 126 patients with knee osteoarthritis admitted to the orthopedic clinic from June 2016 to August 2018 were selected and randomly divided into celecoxib group, mailuoshutong group and combination group according to different treatment methods, each with 42 People; 19 males and 23 females in the celecoxib group, aged 56-78 years old, with an average age of 66.7 ⁇ 13.5 years, 26 cases of one knee, 16 cases of double knees, according to Kellgren-Lawrence grading standard [6]: Grade I 19 cases, 15 cases of grade II, 8 cases of grade III; Mailuoshutong group 17 males, 25 females, aged 56-79 years, an average of 67.5 ⁇ 14.2 years, 23 cases of one knee, 19 cases of double knees, according to Kellgren- Lawrence grading standard: 20 cases of grade I, 15 cases of grade II, 7 cases of grade III; combined group: 20 males, 22 females, aged 55-79 years, average 64.8 ⁇ 14.8 years, 25 cases with one knee, 17 cases with double knees According to the Kell
  • Inclusion criteria 1Comply with the diagnostic criteria for knee osteoarthritis in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2007 Edition)" of the Orthopedic Branch of the Chinese Medical Association; 2X-rays show narrowing of the joint space, hardening of articular cartilage or cystic degeneration; 3Knee Joint pain for more than one month and friction sound when moving; 4Sign informed consent.
  • Exclusion criteria 1Combined with rheumatism and rheumatoid arthritis; 2Patients with insufficient liver and kidney function, severe cardiovascular and cerebrovascular diseases, or drug allergies; 3Patients ⁇ 80 years old, with communication disorders, and unconsciousness.
  • the celecoxib group took celecoxib (celecoxib, Pfizer Pharmaceutical Co., Ltd., National Medicine Standard: J20120063), 0.2g per day;
  • the Mailuoshutong pill group took the Mailuoshutong pill (Lunan Houpe Pharmaceutical Co., Ltd., specifications : 12g/bottle, Standard Chinese Medicine: Z19991025), one bottle each time, three times a day; the combined group was treated with Mailuoshutong pills on the basis of oral celecoxib, and the dosage was the same as above.
  • Three groups of patients were treated continuously for 4 weeks.
  • IL-1 ⁇ interleukin-1 ⁇
  • TNF- ⁇ tumor necrosis factor- ⁇
  • MMPs matrix metalloproteinases
  • the WOMAC scale includes three items: joint pain, stiffness, and functional activity. The score is based on questioning. There are 24 questions in total, each with a score of 0 to 4. The higher the WOMAC score, the more severe the symptoms.
  • the international DOA scoring standard—Leguesne Index 4 is used for scoring.
  • the scoring content includes knee joint rest pain, exercise pain, tenderness, joint mobility, morning stiffness and walking ability. The higher the score, the more severe the symptoms [9].
  • the results of the levels of inflammatory factors in the three groups of patients before and after treatment are shown in Table 2. It can be seen from Table 2 that there was no significant difference in the levels of IL-1 ⁇ , TNF- ⁇ , and MMP-3 in the three groups before treatment (P>0.05); after treatment, the levels of IL-1 ⁇ , TNF- ⁇ and MMP-3 in the three groups were more significant. The levels of IL-1 ⁇ , TNF- ⁇ , and MMP-3 in the combined group decreased significantly before treatment. The levels of IL-1 ⁇ , TNF- ⁇ , and MMP-3 were lower than those in the celecoxib group and the Mailuoshutong group.
  • the difference between the elecoxib group and the Mailuoshutong group was statistically significant (P ⁇ 0.05), and the difference in the levels of the factors between the celecoxib group and the Mailuoshutong group after treatment was also statistically significant (P ⁇ 0.05) ; The differences in the levels of each factor before and after treatment in the three groups were statistically significant (P ⁇ 0.05).
  • the DOA score results of the clinical signs of the three groups of patients before and after treatment are shown in Table 4. It can be seen from Table 4 that there was no statistically significant difference in the clinical sign scores of the three groups before treatment (P>0.05); the clinical sign scores after treatment were significantly lower than those before treatment, and the sign scores of the combined group were significantly lower than Mailuoshu after treatment.
  • Mailuoshutong pill combined with celecoxib can improve the cure rate of patients, reduce the level of inflammatory factors, relieve the pain of patients, and improve the quality of life of patients, which is suitable for clinical application.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Rheumatology (AREA)
  • Microbiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Mycology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une association médicamenteuse pour le traitement de l'arthrose se rapportant au domaine de la médecine. L'association médicamenteuse comprend du célécoxib, et des pilules de dragage de veine et/ou des granules de dragage de veine. Les pilules de dragage de veine ou les granules de dragage de veine sont préparées avec du Radix astragali, Flos lonicerae, Cortex phellodendri, Rhizoma atractylodis, Semen coicis, Radix scrophulariae, Radix angelicae sinensis, Radix paeoniae alba, Radix glycyrrhizae, Hirudo, scolopendra, Scorpio, et d'autres substances médicinales. Des expériences cliniques et sur les animaux montrent que l'association médicamenteuse présente un bon effet thérapeutique sur les maladies articulaires, en particulier l'arthrose, peut visiblement réduire les facteurs inflammatoires, réduire la réponse inflammatoire, améliorer visiblement les symptômes cliniques et améliorer la qualité de vie de patients, et est appropriée pour une promotion et une utilisation supplémentaires.
PCT/CN2019/104251 2019-09-03 2019-09-03 Association médicamenteuse pour le traitement de l'arthrose Ceased WO2021042276A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/CN2019/104251 WO2021042276A1 (fr) 2019-09-03 2019-09-03 Association médicamenteuse pour le traitement de l'arthrose
CN201980031449.5A CN114340650A (zh) 2019-09-03 2019-09-03 一种治疗骨性关节炎的联合用药物

Applications Claiming Priority (1)

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PCT/CN2019/104251 WO2021042276A1 (fr) 2019-09-03 2019-09-03 Association médicamenteuse pour le traitement de l'arthrose

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WO2021042276A1 true WO2021042276A1 (fr) 2021-03-11

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PCT/CN2019/104251 Ceased WO2021042276A1 (fr) 2019-09-03 2019-09-03 Association médicamenteuse pour le traitement de l'arthrose

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Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115845003B (zh) * 2022-11-15 2024-01-26 山东新时代药业有限公司 一种中药组合物在制备治疗关节炎药物中的应用

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1425448A (zh) * 2002-08-07 2003-06-25 鲁南制药股份有限公司 一种治疗血栓性静脉炎的药物
CN101002741A (zh) * 2005-09-26 2007-07-25 刘凤鸣 塞来昔布的缓释制剂
WO2009063367A1 (fr) * 2007-11-15 2009-05-22 Pfizer Products Inc. Formes galéniques comprenant du célécoxib permettant un soulagement de la douleur à la fois rapide et prolongé
CN101618161A (zh) * 2008-07-05 2010-01-06 鲁南厚普制药有限公司 一种治疗血栓性静脉炎的中药组合物及其制备方法
CN103908642A (zh) * 2014-04-30 2014-07-09 翟峰 一种治疗风湿寒性关节痛的药物及其制备方法
CN109718341A (zh) * 2017-10-31 2019-05-07 鲁南制药集团股份有限公司 一种治疗无菌性股骨头坏死的中药组合物

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1425448A (zh) * 2002-08-07 2003-06-25 鲁南制药股份有限公司 一种治疗血栓性静脉炎的药物
CN101002741A (zh) * 2005-09-26 2007-07-25 刘凤鸣 塞来昔布的缓释制剂
WO2009063367A1 (fr) * 2007-11-15 2009-05-22 Pfizer Products Inc. Formes galéniques comprenant du célécoxib permettant un soulagement de la douleur à la fois rapide et prolongé
CN101618161A (zh) * 2008-07-05 2010-01-06 鲁南厚普制药有限公司 一种治疗血栓性静脉炎的中药组合物及其制备方法
CN103908642A (zh) * 2014-04-30 2014-07-09 翟峰 一种治疗风湿寒性关节痛的药物及其制备方法
CN109718341A (zh) * 2017-10-31 2019-05-07 鲁南制药集团股份有限公司 一种治疗无菌性股骨头坏死的中药组合物

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