Traditional Chinese medicine composition capable of improving osteoarthropathy as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for improving osteoarthropathy and a preparation method and application thereof. The invention discloses a traditional Chinese medicine with the effects of tonifying liver and kidney, expelling wind-damp, dredging channels and collaterals and strengthening muscles and bones. The traditional Chinese medicine is mainly prepared from the following raw medicinal materials: radix puerariae, astragalus membranaceus, rhizoma drynariae, ginseng, Chinese yam, bighead atractylodes rhizome, pawpaw, eucommia ulmoides, angelica sinensis, ligusticum wallichii, notopterygium root, radix angelicae pubescentis, prepared rehmannia root, cistanche, zaocys dhumnade and radix achyranthis bidentatae. The channel tropism of the medicines in the formula is basically and directly related to the liver and the kidney, and the medicines are combined to achieve a good function of strengthening tendons and bones. Clinical research proves that the compound has a remarkable effect on dysfunction caused by osteoarthrosis, stasis-accumulating swelling and pain or muscle and bone injury and the like.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for improving osteoarthritis, its preparation method, and its application. Background Technology

[0002] Osteoarthritis (OA) is a common chronic degenerative disease. Factors such as age, obesity, overuse, trauma, congenital joint abnormalities, and joint deformities can all lead to degenerative damage to articular cartilage, reactive hyperplasia of the joint margins and cartilage, causing symptoms such as joint pain, swelling, and joint inflammation. Currently, there is no specific treatment for OA; treatment is mainly symptomatic. Western medicines such as celecoxib, ibuprofen, and indomethacin, which are nonsteroidal anti-inflammatory drugs (NSAIDs), can easily cause gastrointestinal reactions and liver and kidney damage. Topical anti-inflammatory drugs such as ketoprofen gel and diclofenac sodium spray can relieve pain, but they are prone to causing local skin adverse reactions. Therefore, exploring safe and effective treatment methods is of great significance.

[0003] The traditional Chinese medicine composition "Gu An Shu" is a clinically experienced formula from Tianjin Hongkan Lingshijun Hospital. Clinical data shows that this composition is an effective treatment for osteoarthritis caused by liver and kidney deficiency and wind-cold-dampness obstruction. The formula uses Eucommia ulmoides, Achyranthes bidentata, Rehmannia glutinosa, Cistanche deserticola, and Drynaria fortunei to tonify the liver and kidneys, strengthen tendons and bones, and treat the root deficiency. It uses Notopterygium incisum, Angelica pubescens, Zaocys dhumnades, Chaenomeles speciosa, and Ligusticum chuanxiong to dispel wind and cold, eliminate dampness, unblock meridians, invigorate blood, and relieve pain, treating the superficial excess. Furthermore, it uses Ginseng, Astragalus membranaceus, Atractylodes macrocephala, Dioscorea opposita, and Angelica sinensis to replenish qi and nourish blood, based on the principles of "qi generates blood, and blood carries qi" and "supporting the body's resistance to expel pathogens." Pueraria lobata raises yang, relieves muscle tension, relaxes tendons and invigorates meridians, and specifically treats stiffness and pain in the neck and back. The entire formula combines tonification and purgation, treating both the root and the branch, achieving the effects of tonifying the liver and kidneys, replenishing qi and blood, dispelling wind and dampness, and relieving pain. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition that improves osteoarthritis, its preparation method and application, which is used to treat osteoarthritis, swelling and pain caused by blood stasis or musculoskeletal injury and functional impairment.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0006] A traditional Chinese medicine composition for improving osteoarthritis is made from the following raw medicinal materials in parts by weight: 15-30 parts of kudzu root, 15-20 parts of astragalus root, 15-20 parts of drynaria rhizome, 5-10 parts of ginseng, 5-10 parts of yam, 10-15 parts of atractylodes rhizome, 10-15 parts of papaya, 10-15 parts of eucommia bark, 10-15 parts of angelica root, 10-15 parts of chuanxiong rhizome, 10-15 parts of notopterygium root, 10-15 parts of angelica pubescens root, 5-10 parts of prepared rehmannia root, 5-10 parts of cistanche deserticola, 10-15 parts of zaocys dhumnades, and 10-15 parts of achyranthes root.

[0007] In some embodiments, the traditional Chinese medicine composition is made from the following raw medicinal materials in parts by weight: 15 parts of kudzu root, 15 parts of astragalus root, 15 parts of drynaria rhizome, 5 parts of ginseng, 5 parts of yam, 10 parts of atractylodes rhizome, 10 parts of papaya, 10 parts of eucommia bark, 10 parts of angelica root, 10 parts of chuanxiong rhizome, 10 parts of notopterygium root, 10 parts of angelica pubescens root, 5 parts of prepared rehmannia root, 5 parts of cistanche deserticola, 10 parts of zaocys dhumnades, and 10 parts of achyranthes root.

[0008] In some embodiments, the traditional Chinese medicine composition is made from the following raw medicinal materials in parts by weight: 20 parts of kudzu root, 20 parts of astragalus root, 20 parts of drynaria rhizome, 10 parts of ginseng, 10 parts of yam, 15 parts of atractylodes rhizome, 15 parts of papaya, 15 parts of eucommia bark, 15 parts of angelica root, 15 parts of chuanxiong rhizome, 15 parts of notopterygium root, 15 parts of angelica pubescens root, 10 parts of prepared rehmannia root, 10 parts of cistanche deserticola, 15 parts of zaocys dhumnades, and 15 parts of achyranthes root.

[0009] In some embodiments, the traditional Chinese medicine composition is made from the following raw medicinal materials in parts by weight: 20 parts of kudzu root, 15 parts of astragalus root, 20 parts of drynaria rhizome, 10 parts of ginseng, 5 parts of yam, 15 parts of atractylodes rhizome, 10 parts of papaya, 15 parts of eucommia bark, 10 parts of angelica root, 15 parts of chuanxiong rhizome, 10 parts of notopterygium root, 15 parts of angelica pubescens root, 5 parts of prepared rehmannia root, 10 parts of cistanche deserticola, 10 parts of zaocys dhumnades, and 15 parts of achyranthes root.

[0010] In some embodiments, the traditional Chinese medicine composition is made from the following raw medicinal materials in parts by weight: 30 parts of kudzu root, 15 parts of astragalus root, 15 parts of drynaria rhizome, 5 parts of ginseng, 5 parts of yam, 10 parts of atractylodes rhizome, 10 parts of papaya, 10 parts of eucommia bark, 10 parts of angelica root, 10 parts of chuanxiong rhizome, 15 parts of notopterygium root, 10 parts of angelica pubescens root, 5 parts of prepared rehmannia root, 10 parts of cistanche deserticola, 15 parts of zaocys dhumnades, and 10 parts of achyranthes root.

[0011] Based on the above-mentioned traditional Chinese medicine composition, the present invention also proposes a preparation process of the traditional Chinese medicine composition, including the following steps: take the traditional Chinese medicine composition, add water and decoct twice, add 10 times the amount of water for the first decoction and 8 times the amount of water for the second decoction, decoct for 1 hour each time, combine the decoctions, filter, concentrate the filtrate under reduced pressure to form an extract, add an appropriate amount of excipients, granulate in a fluidized bed, and package to obtain the final product.

[0012] Preferably, the relative density of the herbal extract is 1.15-1.25 (20°C).

[0013] Preferably, the excipient is maltodextrin.

[0014] Preferably, the ratio of drug to excipient is 1:5.

[0015] Based on the above-mentioned traditional Chinese medicine composition and preparation process, the present invention also proposes the application of Gu'anshu granules in the treatment of osteoarthritis, swelling and pain due to blood stasis, or functional impairment caused by musculoskeletal injury.

[0016] Compared with the prior art, the beneficial effects of the present invention are as follows: The bone-soothing granules of the present invention are mainly composed of a variety of traditional Chinese medicinal materials such as kudzu root, eucommia bark, achyranthes root, prepared rehmannia root, cistanche, and drynaria rhizome. They have the effects of promoting blood circulation, removing blood stasis, clearing the meridians, and relieving pain. They are suitable for treating diseases such as liver and kidney deficiency and wind-cold-dampness arthralgia. Through multiple effects such as tonifying the liver and kidneys, dispelling wind and dampness, clearing the meridians, and strengthening tendons and bones, they comprehensively treat bone and joint problems. While treating local symptoms, they regulate the circulation of qi and blood throughout the body and improve the overall health of patients. The combination of natural medicinal materials and their rational application result in fewer side effects with long-term use and high safety. Experimental data supports its rationality. It has significant efficacy in diseases such as liver and kidney deficiency and wind-cold-dampness arthralgia and has wide applicability. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without exceeding the scope of protection claimed by the present invention.

[0018] Figure 1 The total ion flow chromatograms are shown for the composition in positive (A) and negative (B) ion modes. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] Unless otherwise stated, all technical and scientific terms and abbreviations used herein have the meanings commonly understood by one of ordinary skill in the field of this invention or the field of application of such terms. While any methods, conditions, substances, or materials similar to or equivalent to those disclosed herein may be used in the practice of this invention, preferred methods, conditions, substances, or materials are described herein.

[0021] This invention is intended to cover all options, variations, and equivalents that may be included in the field of prior art as defined in the claims. Those skilled in the art will recognize many similar or equivalent methods and substances described herein that can be applied in the practice of this invention. This invention is by no means limited to the description of methods and substances.

[0022] Example 1

[0023] A traditional Chinese medicine composition 1 for improving osteoarthritis is prepared from the following raw medicinal materials in parts by weight:

[0024] 15 parts of kudzu root, 15 parts of astragalus root, 15 parts of drynaria rhizome, 5 parts of ginseng, 5 parts of yam, 10 parts of atractylodes rhizome, 10 parts of papaya, 10 parts of eucommia bark, 10 parts of angelica root, 10 parts of chuanxiong rhizome, 10 parts of notopterygium root, 10 parts of angelica pubescens root, 5 parts of prepared rehmannia root, 5 parts of cistanche deserticola, 10 parts of zaocys dhumnades, and 10 parts of achyranthes root.

[0025] Example 2

[0026] A traditional Chinese medicine composition 2 for improving osteoarthritis is prepared from the following raw medicinal materials in parts by weight:

[0027] 20 parts of kudzu root, 20 parts of astragalus root, 20 parts of drynaria rhizome, 10 parts of ginseng, 10 parts of yam, 15 parts of atractylodes rhizome, 15 parts of papaya, 15 parts of eucommia bark, 15 parts of angelica root, 15 parts of chuanxiong rhizome, 15 parts of notopterygium root, 15 parts of angelica pubescens root, 10 parts of prepared rehmannia root, 10 parts of cistanche deserticola, 15 parts of zaocys dhumnades, and 15 parts of achyranthes root.

[0028] Example 3

[0029] A traditional Chinese medicine composition 3 for improving osteoarthritis is prepared from the following raw medicinal materials in parts by weight:

[0030] 20 parts of kudzu root, 15 parts of astragalus root, 20 parts of drynaria rhizome, 10 parts of ginseng, 5 parts of yam, 15 parts of atractylodes rhizome, 10 parts of papaya, 15 parts of eucommia bark, 10 parts of angelica root, 15 parts of chuanxiong rhizome, 10 parts of notopterygium root, 15 parts of angelica pubescens root, 5 parts of prepared rehmannia root, 10 parts of cistanche deserticola, 10 parts of zaocys dhumnades, and 15 parts of achyranthes root.

[0031] Example 4

[0032] A traditional Chinese medicine composition 4 for improving osteoarthritis is prepared from the following raw medicinal materials in parts by weight:

[0033] 30 parts of kudzu root, 15 parts of astragalus root, 15 parts of drynaria rhizome, 5 parts of ginseng, 5 parts of yam, 10 parts of atractylodes rhizome, 10 parts of papaya, 10 parts of eucommia bark, 10 parts of angelica root, 10 parts of chuanxiong rhizome, 15 parts of notopterygium root, 10 parts of angelica pubescens root, 5 parts of prepared rehmannia root, 10 parts of cistanche deserticola, 15 parts of zaocys dhumnades, and 10 parts of achyranthes root.

[0034] Example 5

[0035] A preparation process for a traditional Chinese medicine composition for improving osteoarthritis includes the following steps: Take kudzu root, astragalus root, drynaria rhizome, ginseng, yam, atractylodes rhizome, papaya, eucommia bark, angelica root, chuanxiong rhizome, notopterygium root, angelica pubescens root, prepared rehmannia root, cistanche deserticola root, zaocys dhumnades, and achyranthes root, weighing them according to the dosages described in any one of Examples 1-4. Soak the herbs in 10 times their weight of water (i.e., 10 times the total weight of the herbs in water), let stand for 30 minutes to allow the herbs to fully absorb water, then decoct with warm water twice. For the first decoction, add water and bring to a boil, then simmer for 60 minutes. For the second decoction, add 8 times the weight of water and simmer for 60 minutes. Combine the two decoctions, filter to remove the dregs, and obtain an aqueous extract. After the extract is concentrated under reduced pressure to a relative density of 1.15-1.25 (20℃), fluidized bed granulation is used with a drug-to-excipient ratio of 1.15, an inlet air temperature of 60-70℃, a material temperature of 40-50℃, an atomization pressure of 0.2-0.3MPa, and a spray pump speed that maintains the fluidization state and controls the gradual growth of particles.

[0036] Example 6: Study on the pharmacodynamic material basis

[0037] A certain amount of extract from the compound medicinal materials was weighed, and the active ingredients in the prescription were analyzed by UPLC-Q-TOF-MS. The chromatographic conditions for the UPLC-Q-TOF-MS method were as follows: Shimadzu Nexera UPLC LC-20A liquid chromatography system, Waters Endeavorsil C18-A column (2.1 mm × 100 mm, 1.8 μm), column temperature 30 ℃, mobile phase A was an aqueous solution containing 0.1% formic acid, and mobile phase B was acetonitrile. Gradient elution (0–4 min, 5% B; 4–30 min, 5%–40% B; 30–50 min, 40%–80% B; 50–60 min, 80% B; 60–62 min, 80%–5% B; 62–68 min, 5% B), flow rate 0.2 mL / min, sample pan temperature 10℃, injection volume 2 μL; mass spectrometry conditions: electrospray ionization (ESI), positive and negative ion scanning; capillary voltage 2.5 kV, orifice voltage 40 V; ion source temperature 100℃, desolvation gas temperature 350℃; orifice gas flow rate 50 L / Hr, desolvation gas flow rate 800 L / Hr; mass scan range 100–1000, signal acquisition frequency 10 s. Detection results are shown in [link to data]. Figure 1 .

[0038] The raw data obtained by the above methods were processed by software for baseline filtering, peak identification, integration, retention time correction, peak alignment, and normalization. Compound identification was based on precise mass number, secondary fragments, and isotopic distribution. Qualitative fractions of secondary fragments were matched with theoretical fragments in a database to obtain the compositional information of the composition, as shown in Table 1.

[0039] Table 1 Mass Spectrometry Information of Chemical Composition

[0040]

[0041]

[0042] The results showed that genipinic acid and pinoresinol diglucoside are characteristic components of Eucommia ulmoides, possessing the effects of tonifying the liver and kidneys, strengthening tendons and bones, anti-inflammatory, and analgesic properties, and are core substances for treating kidney deficiency and lower back pain. Echinacoside is a characteristic component of Cistanche deserticola and Rehmannia glutinosa, possessing the effects of tonifying kidney yang, nourishing essence and blood, anti-oxidation, and neuroprotection. Verbena isoflavone glucoside and astragaloside are core components of Astragalus membranaceus, possessing the effects of invigorating qi and consolidating the exterior, and tonifying qi and raising yang, and can improve fatigue and pain caused by qi deficiency. Ferulic acid and vanillic acid are active components of Angelica sinensis and Ligusticum chuanxiong, with the main effects of promoting blood circulation and nourishing blood, regulating qi and relieving pain, and improving numbness and pain caused by blood deficiency and blood stasis. Puerarin, daidzin, and a series of pueraria lobata derivatives are characteristic components of pueraria lobata, possessing the effects of relieving muscle tension and fever, promoting body fluid and relaxing muscles, and are particularly good at relieving stiffness and pain in the neck and back, and are representative components that modern pharmacology has confirmed can dilate blood vessels and improve microcirculation. Iso-orange Peucedanum praeruptorum is a characteristic coumarin component of umbelliferous herbs such as Notopterygium incisum and Angelica pubescens. Its main functions are to dispel wind and dampness, relieve cold and pain, and it is a direct and effective component for treating rheumatic pain. Ursolic acid is one of the main active components of papaya, and it has the effects of relaxing muscles and tendons, harmonizing the stomach and resolving dampness. Naringin is a characteristic component of Drynaria fortunei, and it has the effects of promoting blood circulation, healing injuries, tonifying the kidneys and strengthening bones, and is effective for traumatic injuries and muscle weakness.

[0043] Example 7 Clinical Application

[0044] 1. Mr. Qin, male, 64 years old, had suffered from right hip pain for over 30 years, which had worsened in the past week. The patient developed right hip pain due to an injury more than 30 years ago and received conservative treatment. Over the past 30 years, he experienced intermittent right-sided pain, which worsened after exertion. He intermittently took traditional Chinese medicine, which provided some relief. One week ago, after exertion, he felt the right-sided pain had worsened, the location of the pain was fixed, and it was more pronounced at night, severely affecting lower limb movement. He also experienced lower back and knee weakness, poor bowel movements, and palpable tenderness on the right side. Pain worsened with hip flexion in the right lower limb. His tongue was dark purple with ecchymosis on the edges, and the coating was thin and white. His pulse was deep, thready, and hesitant. He then came to our hospital for treatment and was prescribed the aforementioned Gu An Shu granules, one packet three times daily, dissolved in 100ml of water, taken three times a day (morning, noon, and evening). After six courses of treatment, the patient felt relief in his right hip joint pain, the nighttime pain was tolerable, the lower back and knee weakness improved, sleep was better, and bowel movements were normal.

[0045] 2. Ms. Zhang, 35 years old, had been experiencing lower back pain for over 5 years. She had been receiving conservative treatment, but the pain was intermittent and relieved by rest. Two weeks ago, the pain returned while walking, becoming persistent and unbearable. She also experienced cold intolerance, fatigue, dryness, and a pale complexion. She was of medium build, with tenderness at the spinous processes of L4-L5. Her tongue was dark with a white coating, and her pulse was thready and rapid. The diagnosis was lower back pain and kidney blood stasis. She came to our hospital for treatment and was prescribed the aforementioned Gu An Shu granules, one packet three times daily, dissolved in 100ml of water, three times a day (morning, noon, and evening). After eight courses of treatment, her complexion improved, her lower back pain lessened and became more tolerable, and her lower back and knee weakness improved.

Claims

1. A traditional Chinese medicine composition for improving osteoarthritis, characterized in that... It is made from the following raw medicinal materials in parts by weight: 15-30 parts of kudzu root, 15-20 parts of astragalus root, 15-20 parts of drynaria rhizome, 5-10 parts of ginseng, 5-10 parts of yam, 10-15 parts of atractylodes rhizome, 10-15 parts of papaya, 10-15 parts of eucommia bark, 10-15 parts of angelica root, 10-15 parts of chuanxiong rhizome, 10-15 parts of notopterygium root, 10-15 parts of angelica pubescens root, 5-10 parts of prepared rehmannia root, 5-10 parts of cistanche deserticola, 10-15 parts of zaocys dhumnades, and 10-15 parts of achyranthes root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that... It is made from the following raw medicinal materials in parts by weight: 15 parts kudzu root, 15 parts astragalus root, 15 parts drynaria rhizome, 5 parts ginseng, 5 parts yam, 10 parts atractylodes rhizome, 10 parts papaya, 10 parts eucommia bark, 10 parts angelica root, 10 parts chuanxiong rhizome, 10 parts notopterygium root, 10 parts angelica pubescens root, 5 parts prepared rehmannia root, 5 parts cistanche deserticola, 10 parts zaocys dhumnades, and 10 parts achyranthes root.

3. The traditional Chinese medicine composition according to claim 1, characterized in that... It is made from the following raw medicinal materials in parts by weight: 20 parts kudzu root, 20 parts astragalus root, 20 parts drynaria rhizome, 10 parts ginseng, 10 parts yam, 15 parts atractylodes rhizome, 15 parts papaya, 15 parts eucommia bark, 15 parts angelica root, 15 parts chuanxiong rhizome, 15 parts notopterygium root, 15 parts angelica pubescens root, 10 parts prepared rehmannia root, 10 parts cistanche deserticola, 15 parts zaocys dhumnades, and 15 parts achyranthes root.

4. The traditional Chinese medicine composition according to claim 1, characterized in that... It is made from the following raw medicinal materials in parts by weight: 20 parts kudzu root, 15 parts astragalus root, 20 parts drynaria rhizome, 10 parts ginseng, 5 parts yam, 15 parts atractylodes rhizome, 10 parts papaya, 15 parts eucommia bark, 10 parts angelica root, 15 parts chuanxiong rhizome, 10 parts notopterygium root, 15 parts angelica pubescens root, 5 parts prepared rehmannia root, 10 parts cistanche, 10 parts black-striped snake, and 15 parts achyranthes root.

5. The traditional Chinese medicine composition according to claim 1, characterized in that... It is made from the following raw medicinal materials in parts by weight: 30 parts kudzu root, 15 parts astragalus root, 15 parts drynaria rhizome, 5 parts ginseng, 5 parts yam, 10 parts atractylodes rhizome, 10 parts papaya, 10 parts eucommia bark, 10 parts angelica root, 10 parts chuanxiong rhizome, 15 parts notopterygium root, 10 parts angelica pubescens root, 5 parts prepared rehmannia root, 10 parts cistanche deserticola, 15 parts zaocys dhumnades, and 10 parts achyranthes root.

6. A preparation process for a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition according to any one of claims 1-6 is characterized in that, Take the Chinese herbal composition, add water and decoct twice. Add 10 times the amount of water for the first decoction and 8 times the amount of water for the second decoction. Each decoction is 1 hour. Combine the decoctions, filter, concentrate the filtrate under reduced pressure to form an extract, add appropriate excipients, granulate in a fluidized bed, and package to obtain the final product.

7. The preparation process according to claim 6, characterized in that... The relative density of the herbal extract is 1.15-1.25 (20℃).

8. The preparation process according to claim 6, characterized in that... The excipient is maltodextrin.

9. The preparation process according to claim 6, characterized in that... The ratio of the drug to the excipient is 1:

5.

10. The application of granules prepared by the preparation process of the traditional Chinese medicine composition according to any one of claims 6-8 in the treatment of osteoarthritis, swelling and pain due to blood stasis, or functional impairment caused by musculoskeletal injury.

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