A composition for treating bone disease and a preparation method thereof

Abstract

The application discloses a kind of treatment bone disease formula and preparation method thereof, the formula is made of following weight parts of raw medicinal materials: eucommia ulmoides 8-15 parts, chuanqiong 8-15 parts, radix angelicae pubescentis 8-15 parts, radix paeoniae alba 8-15 parts, radix paeoniae alba 8-15 parts, 12-20 parts of poria cocos, radix cyathulae 12-20 parts, angelica 8-15 parts, curcuma 8-15 parts, radix astragali 8-15 parts, safflower 15-25 parts.The preparation method of the formula includes that raw medicinal materials are crushed into 100 mesh fine powder, and are mixed with gel matrix prepared by carbomer, triethanolamine and white vinegar to prepare external use gel preparation.The formula of the application has the effects of tonifying liver and kidney, promoting blood circulation to remove blood stasis, relaxing sinew and dredging collaterals, and relieving swelling and pain, is administered by being applied to the acupoint and painful point part of patient, drug penetrates skin and reaches lesion directly, and can be used for treating pain, numbness, chill and activity limitation and other symptoms caused by various bone diseases.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a formula for treating bone diseases and its preparation method. Background Technology

[0002] Bone diseases are common and frequently occurring diseases in clinical practice, mainly including various types of arthritis (such as knee osteoarthritis, hip osteoarthritis, etc.), intervertebral disc herniation, bone hyperplasia, soft tissue injury, fasciitis, tenosynovitis, and various post-fracture sequelae. The clinical manifestations of bone diseases are mainly pain, numbness, coldness, and limited mobility in the affected area, which seriously affect the patient's quality of life.

[0003] Currently, treatment methods for bone diseases mainly fall into two categories: Western medicine and traditional Chinese medicine. Western medicine primarily uses painkillers, anti-inflammatory drugs, and surgery. While painkillers and anti-inflammatory drugs can temporarily relieve symptoms, they cannot fundamentally address the underlying bone disease, and long-term use can lead to significant side effects. Surgical treatment is highly invasive, expensive, has a long recovery period, and carries risks and postoperative complications.

[0004] Traditional Chinese medicine (TCM) offers a variety of treatments for bone diseases, including oral herbal medicine, topical plasters, acupuncture, massage, and cupping. However, traditional oral herbal preparations have a slow onset of action. After oral administration, the drugs need to be absorbed through the gastrointestinal tract and metabolized by the liver, resulting in a low drug concentration at the lesion site and limited therapeutic effect. Traditional topical plasters, while providing localized administration, have limited drug penetration, making it difficult to reach the lesion site deep through the skin. Furthermore, traditional plasters often suffer from low transdermal absorption rates and inconvenience in use. Acupuncture and massage, while providing temporary symptom relief, lack the direct action of the medication and are insufficient for achieving a fundamental cure.

[0005] Bone diseases often originate in soft tissues, fascia, ligaments, annulus fibrosus, and nerves, areas with poor blood supply, making it difficult for drugs to reach the lesions via blood circulation. Therefore, achieving effective drug delivery to bone lesions and increasing local drug concentration and duration of action are core issues in current bone disease treatment. Summary of the Invention

[0006] In view of this, the present invention provides a formula for treating bone diseases and its preparation method, which prepares a topical gel preparation by taking Eucommia ulmoides, Ligusticum chuanxiong, Angelica pubescens, Paeonia lactiflora, Dioscorea opposita, Poria cocos, Achyranthes bidentata, Angelica sinensis, Curcuma longa, Astragalus membranaceus, and Carthamus tinctorius. Combined with acupoint and pain point administration, it achieves effective penetration and continuous release of drugs, thereby treating symptoms such as pain, numbness and limited mobility caused by bone diseases.

[0007] The technical solution provided by this invention is as follows: In a first aspect, the present invention provides a formulation for treating bone diseases, the active ingredients of which comprise the following raw materials in parts by weight: Eucommia ulmoides 8-15 parts, Ligusticum chuanxiong 8-15 parts, Angelica pubescens 8-15 parts, Paeonia lactiflora 8-15 parts, Dioscorea opposita 8-15 parts, Poria cocos 12-20 parts, Achyranthes bidentata 12-20 parts, Angelica sinensis 8-15 parts, Curcuma longa 8-15 parts, Astragalus membranaceus 8-15 parts, Carthamus tinctorius 15-25 parts.

[0008] Furthermore, its active ingredients include the following raw materials in parts by weight: Eucommia ulmoides 10 parts, Ligusticum chuanxiong 10 parts, Angelica pubescens 10 parts, Paeonia lactiflora 10 parts, Dioscorea opposita 10 parts, Poria cocos 15 parts, Achyranthes bidentata 15 parts, Angelica sinensis 10 parts, Curcuma longa 10 parts, Astragalus membranaceus 10 parts, Carthamus tinctorius 20 parts.

[0009] In a second aspect, the present invention provides a method for preparing a formula for treating bone diseases as described in any of the preceding claims, comprising the following steps: S1. Weigh out Eucommia ulmoides, Ligusticum chuanxiong, Angelica pubescens, Paeonia lactiflora, Dioscorea opposita, Poria cocos, Achyranthes bidentata, Angelica sinensis, Curcuma longa, Astragalus membranaceus, and Carthamus tinctorius. Grind each raw material into a fine powder of 100 mesh, mix them evenly, and obtain fine powder of Chinese medicine. S2. Weigh out carbomer, add it to water and stir to fully disperse the carbomer, then add triethanolamine to quickly transform the solution into a gel. S3. Add the fine powder of traditional Chinese medicine obtained in step S1 to the gel obtained in step S2 and stir evenly. S4. Add white vinegar to the mixture obtained in step S3 and stir well.

[0010] Furthermore, the method of use is to apply it twice a day, morning and evening, to the painful points of bone disease and surrounding acupoints. After application, a medical cold compress can be applied externally, and the cold compress should be changed every two days.

[0011] Thirdly, the present invention provides the use of a formulation for treating bone diseases as described in any of the preceding claims in the preparation of a medicament for treating bone diseases.

[0012] The components and their main effects in the traditional Chinese medicine composition used in this invention are as follows: Eucommia ulmoides: Sweet in taste and warm in nature, it enters the liver and kidney meridians. It has the effects of tonifying the liver and kidneys and strengthening tendons and bones, and is used for symptoms such as kidney deficiency, lower back pain, and weakness of tendons and bones.

[0013] Chuanxiong (Ligusticum striatum): It has a pungent taste and warm properties, and enters the liver, gallbladder, and pericardium meridians. It has the effects of promoting blood circulation, regulating qi, dispelling wind, and relieving pain. It is used for injuries from falls and blows, and pain due to blood stasis.

[0014] Angelica pubescens: It has a pungent and bitter taste, is slightly warm in nature, and enters the kidney and bladder meridians. It has the effects of dispelling wind and dampness and relieving pain, and is used for symptoms such as wind-cold-dampness arthralgia, and lower back and knee pain.

[0015] White peony root: bitter and sour in taste, slightly cold in nature, and enters the liver and spleen meridians. It has the effects of nourishing blood and regulating menstruation, calming the liver and relieving pain.

[0016] Yam: Sweet in taste, neutral in nature, and enters the spleen, lung, and kidney meridians. It has the effects of tonifying the spleen and stomach, promoting body fluid production and benefiting the lungs, and tonifying the kidneys and astringing essence.

[0017] Poria cocos: It has a sweet and bland taste, is neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind.

[0018] Achyranthes bidentata: It has a sweet and slightly bitter taste, is neutral in nature, and enters the liver and kidney meridians. It has the effects of removing blood stasis and promoting menstruation, facilitating joint movement, and promoting urination.

[0019] Angelica sinensis: sweet and pungent in taste, warm in nature, and enters the liver, heart, and spleen meridians. It has the effects of nourishing blood, promoting blood circulation, regulating menstruation, and relieving pain.

[0020] Turmeric: It has a pungent and bitter taste, is warm in nature, and enters the liver and spleen meridians. It has the effects of promoting blood circulation, regulating qi, and relieving pain.

[0021] Astragalus: Sweet in taste, slightly warm in nature, and enters the spleen and lung meridians. It has the effects of tonifying qi and raising yang, promoting diuresis and reducing swelling, and promoting tissue regeneration and detoxification.

[0022] Safflower: It has a pungent taste and warm properties, and enters the heart and liver meridians. It has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain.

[0023] The beneficial effects of this invention are as follows: 1. In the formula of this invention, Eucommia ulmoides tonifies the liver and kidneys and strengthens tendons and bones; Ligusticum chuanxiong invigorates blood circulation, promotes qi flow, dispels wind, and relieves pain; Angelica pubescens dispels wind-dampness and relieves pain. These three herbs serve as the principal herbs, addressing the pathogenesis of bone disease characterized by kidney deficiency as the root cause and blood stasis as the manifestation, treating the condition by simultaneously tonifying the liver and kidneys and invigorating blood circulation. Paeonia lactiflora nourishes blood, regulates menstruation, soothes the liver, and relieves pain; Achyranthes bidentata removes blood stasis, unblocks meridians, and promotes joint mobility; Angelica sinensis tonifies and invigorates blood; Curcuma longa breaks up blood stasis, promotes qi flow, unblocks meridians, and relieves pain; Carthamus tinctorius invigorates blood circulation, removes blood stasis, and relieves pain. These five herbs serve as the assistant herbs, enhancing the effects of invigorating blood circulation, removing blood stasis, unblocking meridians, and relieving pain. Dioscorea opposita and Poria cocos strengthen the spleen and replenish qi to aid the generation of qi and blood; Astragalus membranaceus tonifies qi, raises yang, and promotes tissue regeneration. These three herbs serve as the adjuvant herbs, aiding blood circulation by replenishing qi. The combined effects of these herbs are to tonify the liver and kidneys, invigorate blood circulation, remove blood stasis, relax muscles and tendons, unblock meridians, reduce swelling, and relieve pain.

[0024] 2. This invention formulates the drug into a topical gel preparation, which is applied to acupoints and pain points on the patient's skin. The drug penetrates directly to the lesion site through the skin, avoiding the first-pass effect and gastrointestinal irritation of oral administration, and improving the drug concentration and bioavailability at the lesion site. The gel formulation has good spreadability and adhesion, enabling sustained drug release.

[0025] 3. This invention uses a combination of acupoint and pain point administration, which not only treats the direct site of pain, but also unblocks the corresponding meridians through acupoint administration, thereby improving the therapeutic effect. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with the embodiments of this invention. Obviously, the described embodiments are only a part of the embodiments of this invention, not all of them. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention. Experimental methods in the following embodiments that do not specify specific conditions are generally performed under conventional conditions or as recommended by the manufacturer. Unless otherwise stated, percentages and parts are weight percentages and parts by weight.

[0027] Unless otherwise specified, the technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. It should be noted that the terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the exemplary embodiments of this application. Example 1

[0028] This embodiment provides a formula for treating bone diseases, the active ingredients of which include the following raw materials in parts by weight: Eucommia ulmoides 10g, Ligusticum chuanxiong 10g, Angelica pubescens 10g, Paeonia lactiflora 10g, Dioscorea opposita 10g, Poria cocos 15g, Achyranthes bidentata 15g, Angelica sinensis 10g, Curcuma longa 10g, Astragalus membranaceus 10g, Carthamus tinctorius 20g.

[0029] This embodiment provides a method for preparing a formula for treating bone diseases, including the following steps: S1. Weigh out Eucommia ulmoides, Ligusticum chuanxiong, Angelica pubescens, Paeonia lactiflora, Dioscorea opposita, Poria cocos, Achyranthes bidentata, Angelica sinensis, Curcuma longa, Astragalus membranaceus, and Carthamus tinctorius. Grind each raw material into a fine powder of 100 mesh. Take the fine powder from the sieve and mix it evenly to obtain fine powder of Chinese medicine. S2. Add 150g of water to a container, add 2g of carbomer to the water, stir to fully disperse the carbomer in the water, then add 2.5g of triethanolamine while stirring to quickly transform the solution into a gel. S3. Add the fine powder of traditional Chinese medicine obtained in step S1 to the gel obtained in step S2, stir evenly, so that the fine powder of traditional Chinese medicine is evenly dispersed in the gel. S4. Add 2g of white vinegar to the mixture obtained in step S3 and stir well to obtain a gel preparation for treating bone diseases.

[0030] Instructions for use: Apply the above-mentioned gel preparation to the patient's pain point and surrounding acupoints twice a day, once in the morning and once in the evening. Continue treatment until the pain subsides, then repeat the treatment for two to three more times to consolidate the results. Continue medication continuously throughout the treatment period. Example 2

[0031] This embodiment provides a formula for treating bone diseases, the active ingredients of which include the following raw materials in parts by weight: Eucommia ulmoides 8g, Ligusticum chuanxiong 8g, Angelica pubescens 8g, Paeonia lactiflora 8g, Dioscorea opposita 8g, Poria cocos 12g, Achyranthes bidentata 12g, Angelica sinensis 8g, Curcuma longa 8g, Astragalus membranaceus 8g, Carthamus tinctorius 15g.

[0032] This embodiment provides a method for preparing a formula for treating bone diseases, which is consistent with the preparation method in Example 1. Example 3

[0033] This embodiment provides a formula for treating bone diseases, the active ingredients of which include the following raw materials in parts by weight: Eucommia ulmoides 15g, Ligusticum chuanxiong 15g, Angelica pubescens 15g, Paeonia lactiflora 15g, Dioscorea opposita 15g, Poria cocos 20g, Achyranthes bidentata 20g, Angelica sinensis 15g, Curcuma longa 15g, Astragalus membranaceus 15g, Carthamus tinctorius 25g.

[0034] This embodiment provides a method for preparing a formula for treating bone diseases, which is consistent with the preparation method in Example 1.

[0035] Typical Case Case 1: Mr. Zhang, male, 58 years old, suffered from bilateral knee pain for many years due to long-term heavy physical labor. The pain worsened when going up and down stairs, accompanied by knee swelling and limited range of motion. He had tried oral analgesics and topical ointments multiple times, but the effects were unsatisfactory, and the symptoms recurred. Physical examination revealed mild swelling in both knee joints, significant tenderness around the patella, and limited knee flexion and extension. The gel preparation prepared in Example 1 of this invention was applied to the painful points around the knee joints and related acupoints such as Zusanli and Yanglingquan, twice a day, once in the morning and once in the evening. After 3 days of treatment, the pain was significantly reduced and the swelling subsided; after 7 days of treatment, knee joint mobility was significantly improved; after 30 days of continuous treatment, the knee pain basically disappeared, and mobility was restored, with no significant discomfort when going up and down stairs. No recurrence was observed during a 3-month follow-up.

[0036] Case 2: Ms. Li, 45 years old, suffered from neck and shoulder pain and stiffness due to prolonged desk work, accompanied by numbness in her right upper limb. Symptoms worsened at night, affecting her sleep. Physical examination revealed straightening of the cervical spine's physiological curvature, significant tenderness between and lateral to the C5-C6 spinous processes, and a positive right brachial plexus traction test. She was diagnosed with cervical radiculopathy. The gel preparation prepared in Example 1 of this invention was applied to the painful points in the neck and acupoints such as Fengchi and Jianjing, twice daily, once in the morning and once in the evening. After 2 days of treatment, the neck and shoulder pain was significantly reduced; after 5 days, the numbness in her right upper limb disappeared; after 15 days of continuous treatment, the neck and shoulder pain essentially disappeared, and she slept well at night. No recurrence was observed during a 2-month follow-up.

[0037] Case 3: Mr. Wang, male, 62 years old, had suffered from lumbar disc herniation for many years, causing lower back pain and radiating pain in his left lower limb, making walking difficult and requiring the use of crutches. He had previously received various treatments, including acupuncture, massage, and physiotherapy, but the effects were not lasting. Physical examination revealed limited lumbar mobility, significant tenderness between the L4 and L5 spinous processes, a positive straight leg raise test on the left side, and decreased sensation on the lateral aspect of the left lower leg. He was diagnosed with lumbar disc herniation. The gel preparation prepared in Example 1 of this invention was applied to the painful points in the lower back and acupoints such as Shenshu, Dachangshu, and Huantiao, twice daily, once in the morning and once in the evening. After 3 days of treatment, the lower back pain and radiating pain in the lower limb were significantly reduced; after 7 days of treatment, the pain was further relieved, and he could walk without frequent stops, with a significant improvement in his range of motion; after 60 days of continuous treatment, the lower back pain and radiating pain in the lower limb had basically disappeared, and he was able to live independently. No recurrence was observed during a 6-month follow-up.

[0038] The above descriptions are merely embodiments of the present invention, and common knowledge such as specific technical solutions and / or characteristics are not described in detail here. It should be noted that those skilled in the art can make various modifications and improvements without departing from the technical solutions of the present invention, and these should also be considered within the scope of protection of the present invention. These modifications and improvements will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. A formula for treating bone diseases, characterized in that, Its active ingredients include the following raw materials in parts by weight: Eucommia ulmoides 8-15 parts, Ligusticum chuanxiong 8-15 parts, Angelica pubescens 8-15 parts, Paeonia lactiflora 8-15 parts, Dioscorea opposita 8-15 parts, Poria cocos 12-20 parts, Achyranthes bidentata 12-20 parts, Angelica sinensis 8-15 parts, Curcuma longa 8-15 parts, Astragalus membranaceus 8-15 parts, Carthamus tinctorius 15-25 parts.

2. The formula for treating bone diseases according to claim 1, characterized in that, Its active ingredients include the following raw materials in parts by weight: Eucommia ulmoides 10 parts, Ligusticum chuanxiong 10 parts, Angelica pubescens 10 parts, Paeonia lactiflora 10 parts, Dioscorea opposita 10 parts, Poria cocos 15 parts, Achyranthes bidentata 15 parts, Angelica sinensis 10 parts, Curcuma longa 10 parts, Astragalus membranaceus 10 parts, Carthamus tinctorius 20 parts.

3. A method for preparing a formula for treating bone diseases as described in claim 1 or 2, characterized in that, Includes the following steps: S1. Weigh out Eucommia ulmoides, Ligusticum chuanxiong, Angelica pubescens, Paeonia lactiflora, Dioscorea opposita, Poria cocos, Achyranthes bidentata, Angelica sinensis, Curcuma longa, Astragalus membranaceus, and Carthamus tinctorius. Grind each raw material into a fine powder of 100 mesh, mix them evenly, and obtain fine powder of Chinese medicine. S2. Weigh out carbomer, add it to water and stir to fully disperse the carbomer, then add triethanolamine to quickly transform the solution into a gel. S3. Add the fine powder of traditional Chinese medicine obtained in step S1 to the gel obtained in step S2 and stir evenly. S4. Add white vinegar to the mixture obtained in step S3 and stir well.

4. The use of the formulation for treating bone diseases as described in claim 1 or 2 in the preparation of a medicament for treating bone diseases.