A traditional Chinese medicine composition for treating femoral head necrosis and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating avascular necrosis of the femoral head. The oral traditional Chinese medicine composition comprises the following raw materials in parts by weight: Astragalus membranaceus 20-40 parts, Ligusticum chuanxiong 10-20 parts, Cinnamomum cassia twig 10-20 parts, Paeonia lactiflora 10-20 parts, Carthamus tinctorius 3-8 parts, Lycopodium clavatum 15-25 parts, Ephedra sinica 3-8 parts, Saposhnikovia divaricata 10-20 parts, Schizonepeta tenuifolia 10-20 parts, Angelica dahurica 10-20 parts, Morus alba leaf 10-20 parts, Notopterygium incisum 10-20 parts, Evodia rutaecarpa 10-20 parts, Acanthopanax senticosus 10-20 parts, Clematis chinensis 15-25 parts, Bletilla striata 10-20 parts, Boswellia carterii 2-5 parts, and Commiphora myrrha 5-15 parts. The external application traditional Chinese medicine composition comprises the following raw materials in parts by weight: 2-5 parts of Panax notoginseng, 2-5 parts of Cremastra appendiculata, 1-3 parts of Scolopendra subspinipes, 5-15 parts of stir-fried Bombyx mori, and 2-5 parts of Eupolyphaga sinensis; 20-40 parts of Astragalus complanatus, 2-5 parts of Aconitum carmichaelii, 20-40 parts of Sargentodoxa cuneata, 15-25 parts of Schizonepeta tenuifolia, 15-25 parts of Saposhnikovia divaricata, 15-25 parts of Angelica sinensis, 20-40 parts of Spatholobus suberectus, 15-20 parts of Erythrina variegata, 5-15 parts of Boswellia carterii, 5-15 parts of Commiphora myrrha, 20-40 parts of Dipsacus asper, 15-25 parts of Carthamus tinctorius, 8-15 parts of Zanthoxylum bungeanum, 15-25 parts of Lycopodium clavatum, 10-20 parts of Clematis chinensis, and 20-40 parts of Clematis armandii. This invention achieves the reversal of ARCO stage II to III femoral head necrosis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition and its application for treating avascular necrosis of the femoral head. Background Technology

[0002] Avascular necrosis of the femoral head (ARCO) is a common and difficult-to-treat orthopedic disease. Its core pathology involves interruption or damage to the blood supply to the femoral head, leading to the death of bone cells and bone marrow components, and subsequent repair failure, ultimately resulting in femoral head collapse and secondary hip osteoarthritis. According to the staging system of the International Society for the Study of Bone Circulation (ISBN), ARCO stage II is characterized by cystic changes and sclerosis within the femoral head, but with an intact outline; stage III presents with a crescent sign or femoral head collapse, representing a critical window to halt disease progression and avoid joint replacement.

[0003] Currently, modern medicine has limited treatment options for ARCO stage II-III avascular necrosis of the femoral head. Non-surgical treatments such as reducing weight-bearing and analgesic medications are unlikely to reverse the progression of necrosis. While hip-preserving surgeries (such as core decompression, bone grafting, and osteotomy) have some efficacy, they suffer from drawbacks including significant trauma, high cost, long recovery period, and uncertain efficacy. Therefore, there is an urgent clinical need for a safe and effective non-surgical treatment plan that can slow down or reverse the progression of avascular necrosis of the femoral head.

[0004] Traditional Chinese medicine (TCM) possesses unique advantages in treating avascular necrosis of the femoral head (ARCO), often addressing the underlying causes of "bone erosion" and "bone obstruction" with the fundamental principles of tonifying the kidneys, promoting blood circulation, and clearing the meridians. Existing TCM formulas for treating ARCO often focus on a single treatment method, either emphasizing blood circulation and removing blood stasis or tonifying the kidneys and strengthening bones. These formulas often fail to adequately address the complex pathogenesis involving "deficiency, blood stasis, phlegm, and dampness," making it difficult to achieve a "reversal" effect in ARCO stages II-III. The pathogenesis of ARCO stages II-III is complex, often rooted in kidney deficiency and essence depletion, with blood stasis obstructing the meridians and phlegm-dampness obstructing the meridians as symptoms. Treatment requires addressing both the root cause and symptoms, and necessitates potent drugs to penetrate the lesion. Therefore, there is an urgent clinical need for a TCM combination that can precisely target ARCO stages II-III to achieve the clinical goal of reversing the necrosis process and preventing further collapse. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the purpose of this invention is to provide a traditional Chinese medicine composition for treating avascular necrosis of the femoral head and its application.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] In a first aspect, the present invention provides an oral traditional Chinese medicine composition for treating avascular necrosis of the femoral head, comprising the following raw materials in parts by weight: Astragalus membranaceus 20-40 parts, Ligusticum chuanxiong 10-20 parts, Cinnamomum cassia twig 10-20 parts, Paeonia lactiflora 10-20 parts, Carthamus tinctorius 3-8 parts, Lycopodium clavatum 15-25 parts, Ephedra sinica 3-8 parts, Saposhnikovia divaricata 10-20 parts, Schizonepeta tenuifolia 10-20 parts, Angelica dahurica 10-20 parts, Morus alba leaf 10-20 parts, Notopterygium incisum 10-20 parts, Evodia rutaecarpa 10-20 parts, Acanthopanax senticosus 10-20 parts, Clematis armandii 15-25 parts, Bletilla striata 10-20 parts, Boswellia carterii 2-5 parts, Commiphora myrrha 5-15 parts, Panax notoginseng 2-5 parts, Cremastra appendiculata 2-5 parts, Scolopendra subspinipes 1-3 parts, Bombyx mori (fried) 5-15 parts, Eupolyphaga sinensis 2-5 parts.

[0008] Preferably, the above-mentioned traditional Chinese medicine composition includes the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Ligusticum chuanxiong 15 parts, Cinnamomum cassia twig 15 parts, Paeonia lactiflora 15 parts, Carthamus tinctorius 5 parts, Lycopodium clavatum 20 parts, Ephedra sinica 5 parts, Saposhnikovia divaricata 15 parts, Schizonepeta tenuifolia 15 parts, Angelica dahurica 15 parts, Morus alba leaf 15 parts, Notopterygium incisum 15 parts, Evodia rutaecarpa 15 parts, Acanthopanax senticosus 15 parts, Clematis armandii 20 parts, Bletilla striata 15 parts, Boswellia carterii 3 parts, Commiphora myrrha 10 parts, Panax notoginseng 3 parts, Cremastra appendiculata 3 parts, Scolopendra subspinipes 2 parts, Bombyx mori (fried) 10 parts, Eupolyphaga sinensis 3 parts.

[0009] In a second aspect, the present invention provides a topical traditional Chinese medicine composition for treating avascular necrosis of the femoral head, comprising the following raw materials in parts by weight: 20-40 parts of Astragalus complanatus, 2-5 parts of Aconitum carmichaelii, 20-40 parts of Sargentodoxa cuneata, 15-25 parts of Schizonepeta tenuifolia, 15-25 parts of Saposhnikovia divaricata, 15-25 parts of Angelica sinensis, 20-40 parts of Spatholobus suberectus, 15-20 parts of Erythrina variegata, 5-15 parts of Boswellia carterii, 5-15 parts of Commiphora myrrha, 20-40 parts of Dipsacus asper, 15-25 parts of Carthamus tinctorius, 8-15 parts of Zanthoxylum bungeanum, 15-25 parts of Lycopodium clavatum, 10-20 parts of Clematis chinensis, and 20-40 parts of Clematis armandii.

[0010] Preferably, the above-mentioned traditional Chinese medicine composition includes the following raw materials in parts by weight: 30 parts of Astragalus complanatus, 3 parts of Aconitum carmichaelii, 30 parts of Sargentodoxa cuneata, 20 parts of Schizonepeta tenuifolia, 20 parts of Saposhnikovia divaricata, 20 parts of Angelica sinensis, 30 parts of Spatholobus suberectus, 18 parts of Erythrina variegata, 10 parts of Boswellia carterii, 10 parts of Commiphora myrrha, 30 parts of Dipsacus asper, 20 parts of Carthamus tinctorius, 12 parts of Zanthoxylum bungeanum, 20 parts of Lycopodium clavatum, 15 parts of Clematis chinensis, and 30 parts of Clematis armandii.

[0011] Preferably, the above-mentioned oral traditional Chinese medicine composition is in the form of pills, capsules, tablets or granules.

[0012] Preferably, the above-mentioned external Chinese medicine composition is characterized in that its dosage form is a tincture, liniment, spray, ointment or patch.

[0013] In a third aspect of the present invention, there is provided a preparation method of the above-mentioned oral Chinese medicinal composition, comprising the following steps: weighing the bulk drugs, mixing and pulverizing the bulk drugs into fine powder, adding auxiliary materials or a binder, and preparing an oral preparation.

[0014] Preferably, after pulverization, the pulverized mixture is passed through an 80-120 mesh sieve.

[0015] Preferably, the oral preparation is a pill, the binder is refined honey, and the preparation method comprises: uniformly mixing the fine powder with the refined honey, preparing a honeyed pill, and drying to obtain the product.

[0016] In a fourth aspect of the present invention, there is provided a preparation method of the above-mentioned external Chinese medicinal composition, comprising the following steps: weighing the bulk drugs, placing the bulk drugs in a container, performing a first extraction by soaking with a first solvent, then adding a second solvent to perform a second extraction, separating dregs to obtain an external liquid preparation.

[0017] Preferably, the first solvent is 95% (v / v) ethanol, and the soaking time is 2-4 days; the second solvent is edible vinegar, after adding the edible vinegar, soaking is continued for 5-9 days, then the dregs are filtered off, and the obtained liquid is an external tincture.

[0018] In a fifth aspect of the present invention, there provided use of the above-mentioned oral Chinese medicinal composition and / or the above-mentioned external Chinese medicinal composition in preparation of a medicament for reversing ARCO stage II to III osteonecrosis of the femoral head.

[0019] In the oral Chinese medicinal composition of the present invention: Astragalus membranaceus is sweet in flavor and slightly warm in nature; it acts on the spleen and lung meridians; it has the effects of invigorating qi and elevating yang, consolidating the exterior and stopping sweating, inducing diuresis to alleviate edema, engendering liquid and nourishing blood, activating stagnation and unblocking bi, drawing out toxicity and draining pus, and astringing sores and promoting tissue regeneration.

[0020] Ligusticum chuanxiong Hort is pungent in flavor and warm in nature; it acts on the liver, gallbladder and pericardium meridians; it has the effects of activating blood and moving qi, dispelling wind and stopping pain.

[0021] Cinnamomum cassia twig is pungent and sweet in flavor, and warm in nature; it acts on the heart, lung and bladder meridians; it has the effects of inducing perspiration to relax muscles, warming and unblocking vessels and meridians, assisting yang to transform qi.

[0022] Red peony root is bitter in flavor and slightly cold in nature; it acts on the liver meridian; it has the effects of clearing heat and cooling blood, dispelling stasis and stopping pain.

[0023] Carthamus tinctorius L. is pungent in flavor and warm in nature; it acts on the heart and liver meridians; it has the effects of activating blood and unblocking meridians, dispelling stasis and stopping pain.

[0024] Lycopodium clavatum L. is slightly bitter and pungent in flavor, and warm in nature; it acts on the liver, spleen and kidney meridians; it has the effects of dispelling wind and eliminating dampness, and relaxing muscles and activating collaterals.

[0025] Ephedra is pungent and slightly bitter in flavor, and warm in nature; it acts on the lung and bladder meridians; it has the effects of inducing perspiration and dissipating cold, ventilating lung to relieve asthma, and inducing diuresis to alleviate edema.

[0026] Saposhnikovia divaricata is pungent and sweet in flavor, and slightly warm in nature; it acts on the bladder, liver and spleen meridians; it has the effects of dispelling wind and relieving exterior, removing dampness and stopping pain, and arresting convulsion.

[0027] Schizonepeta: pungent, slightly warm; enters the lung and liver meridians; relieves exterior syndromes, disperses wind, promotes rash eruption, and eliminates sores.

[0028] Angelica dahurica: pungent, warm; enters the lung, stomach, and large intestine meridians; relieves exterior syndromes and dispels cold, dispels wind and relieves pain, clears nasal passages, dries dampness and stops leukorrhea, reduces swelling and drains pus.

[0029] Mulberry leaves: sweet, bitter, and cold; enter the lung and liver meridians; dispel wind-heat, clear the lungs and moisten dryness, clear the liver and improve eyesight.

[0030] Notopterygium root: pungent, bitter, warm; enters the bladder and kidney meridians; relieves exterior syndromes, dispels cold, eliminates wind and dampness, and relieves pain.

[0031] Evodia rutaecarpa: pungent, bitter, and hot; enters the liver, spleen, stomach, and kidney meridians; dispels cold and relieves pain, relieves nausea and vomiting, and assists yang to stop diarrhea.

[0032] Acanthopanax senticosus: pungent, slightly bitter, warm; enters the spleen, kidney, and heart meridians; invigorates qi and strengthens the spleen, tonifies the kidneys and calms the mind.

[0033] Pearl-like herb: pungent, warm; enters the liver and kidney meridians; dispels wind and dampness, invigorates blood and relieves pain, promotes bone healing and tendon regeneration.

[0034] Bletilla striata: bitter, sweet, astringent, slightly cold; enters the lung, liver, and stomach meridians; astringent and hemostatic, reduces swelling and promotes tissue regeneration.

[0035] Frankincense: pungent, bitter, and warm; enters the heart, liver, and spleen meridians; promotes blood circulation, relieves pain, reduces swelling, and promotes tissue regeneration.

[0036] Myrrh: pungent, bitter, neutral; enters the heart, liver, and spleen meridians; disperses blood stasis, relieves pain, reduces swelling, and promotes tissue regeneration.

[0037] Panax notoginseng: sweet and slightly bitter, warm; enters the liver and stomach meridians; disperses blood stasis, stops bleeding, reduces swelling and relieves pain.

[0038] Mountain Cremastrae: Sweet and slightly pungent, cool; enters the liver and spleen meridians; clears heat and detoxifies, resolves phlegm and dissipates nodules.

[0039] Centipede: pungent, warm; enters the liver meridian; calms wind and relieves spasms, unblocks meridians and relieves pain, attacks toxins and dissipates nodules.

[0040] Stir-fried silkworm pupae: salty, pungent, neutral; enters the liver, lung, and stomach meridians; relieves wind and stops spasms, dispels wind and relieves pain, resolves phlegm and dissipates nodules.

[0041] Ground beetle: Salty, cold; enters the liver meridian; breaks up blood stasis and promotes tendon and bone healing.

[0042] This formula heavily utilizes Astragalus membranaceus as the principal herb. Its sweet and warm properties greatly tonify the Qi of the spleen and lungs, and abundant Qi can generate and circulate blood. Addressing the root cause of femoral head necrosis—"Qi deficiency leading to insufficient propulsion, resulting in blood stasis and malnourishment of tendons and bones"—Astragalus membranaceus tonifies Qi to guide blood circulation, providing fundamental impetus for bone repair. It comprehensively improves the body's overall condition and blood perfusion to the femoral head, supporting the body's resistance to expel pathogenic factors.

[0043] Acanthopanax senticosus and cinnamon twig are used together as assistant herbs to help the principal herbs warm and tonify kidney yang, strengthen tendons and bones; Acanthopanax senticosus invigorates qi and spleen, tonifies the kidneys and calms the mind; cinnamon twig warms and unblocks the meridians, and assists yang in transforming qi. Astragalus membranaceus, Acanthopanax senticosus, and cinnamon twig, when used together, invigorate qi and tonify the kidneys, warm yang and unblock the meridians.

[0044] Centipede, ground beetle, frankincense, myrrh, Panax notoginseng, Ligusticum chuanxiong, and safflower form the "attacking" force among the assistant herbs. Centipede and ground beetle, being insect-based medicines, are adept at penetrating and dispersing, effectively clearing stubborn blood stasis from the collaterals, and possessing a powerful ability to break up blood stasis and expel it, specifically targeting stagnant and dried blood deeply embedded in the bones and meridians. Frankincense, myrrh, Panax notoginseng, Ligusticum chuanxiong, and safflower work together to invigorate blood circulation, promote qi flow, disperse blood stasis, relieve pain, and reconnect tendons and bones. This group of assistant herbs focuses on resolving blood stasis and obstructing the collaterals, striving to remove necrotic tissue and promote new tissue growth.

[0045] Adjuvant:

[0046] The Wind-Dispelling, Dampness-Eliminating, and Meridian-Clearing Group consists of: Saposhnikovia divaricata, Notopterygium incisum, Lycopodium clavatum, Clematis chinensis, and Ephedra sinica. This group of herbs dispels wind and cold, eliminates dampness and relieves pain, relaxes muscles and tendons, and promotes blood circulation. Targeting the concurrent symptoms of "cold-dampness obstruction," it relieves the contracture and pain of muscles and tendons around the joints, clearing external obstacles for the flow of Qi and blood.

[0047] The Cold-Dispelling and Pain-Relieving Group consists of Schizonepeta tenuifolia, Angelica dahurica, and Evodia rutaecarpa. Schizonepeta tenuifolia: pungent and dispersing, it dispels wind and releases the exterior. Its light and ascending nature helps the medicinal effects reach the body surface, dispersing wind-evil from the muscles, bones, skin, and hair. It works synergistically with Saposhnikovia divaricata and Notopterygium incisum to enhance the wind-dispelling and evil-relieving effects. Angelica dahurica: pungent and warm, it dispels wind, relieves pain, reduces swelling, and drains pus. Its pungent and ascending properties can help the principal and assistant herbs reach the head and face, but in this formula, its pungent and warming properties are utilized to assist in dispelling wind and cold, relieving pain, and is especially effective for arthralgia with cold and dampness. Evodia rutaecarpa: dispels cold and relieves pain, assisting the principal and assistant herbs in warming and dispersing cold stagnation in the bone marrow.

[0048] The heat-clearing, dryness-relieving, yin-protecting, and blood-nourishing group consists of red peony root and mulberry leaf. Red peony root clears heat, cools the blood, disperses blood stasis, and relieves pain; mulberry leaf moistens and nourishes. Together, they can counteract the potential harm of excessive pungent, warm, and aromatic herbs (such as cinnamon twig, notopterygium root, and chuanxiong rhizome) that might cause yin-damage and blood-depletion, making the entire formula warm and gentle without being overly drying.

[0049] Phlegm-resolving and nodule-dispersing group: stir-fried silkworm pupae and mountain wormwood. This formula is designed for chronic illnesses with stubborn phlegm and blood stasis, and can resolve phlegm, disperse nodules, unblock meridians, and relieve pain.

[0050] Stomach-protecting and tissue-regenerating group: Bletilla striata. It has astringent and hemostatic properties, reduces swelling and promotes tissue regeneration. Internally, it can protect the gastric mucosa, prevent blood-activating and stasis-removing drugs from damaging the stomach, and help promote tissue regeneration and heal sores.

[0051] This invention's external herbal composition utilizes 95% alcohol for initial extraction, which fully extracts the fat-soluble active ingredients from the medicinal materials. The subsequent addition of aged vinegar not only extracts water-soluble components but also, due to the astringent properties of acetic acid, guides the medicine deep into the muscles and bones. The resulting tincture exhibits far superior penetrability compared to the oily matrix of traditional plasters, enabling deep transdermal absorption of the medicinal components.

[0052] This formula utilizes aconite, Sichuan pepper, and clematis as the core of its external application, characterized by their strong pungent and hot properties, aiming to powerfully warm the meridians, dispel cold, eliminate wind and dampness, quickly relieve local cold pain, and break the "cold stagnation" state around the affected hip. It is combined with spatholobus suberectus, chicken blood vine, safflower, frankincense, and myrrh to invigorate blood and remove blood stasis; angelica sinensis to invigorate blood, relieve pain, nourish blood, and promote new blood growth; and clematis chinensis, lycopodium clavatum, and erythrina variegata to dispel wind and unblock the meridians, forming a powerful combination of drugs targeting local "cold, stasis, dampness, and pain." The combined use of schizonepeta tenuifolia and saposhnikovia divaricata enhances the effects of dispelling wind and cold, eliminating dampness and relieving spasms, thus alleviating joint stiffness. Astragalus complanatus and Dipsacus asperoides are used locally to tonify the kidneys and strengthen bones, supporting bone repair.

[0053] The beneficial effects of this invention are:

[0054] 1. This invention's oral Chinese medicine composition uses Astragalus membranaceus as the principal ingredient to invigorate Qi and strengthen the body's foundation, laying the groundwork for treatment. Acanthopanax senticosus and Cinnamomum cassia are used to tonify Yang and nourish the kidneys, addressing the root cause. Insect-derived medicines, combined with bosom, myrrh, and Panax notoginseng, break up blood stasis and treat the symptoms. The assistant herbs combine tonifying and purging effects, resulting in a powerful combination. The adjuvant herbs are numerous and clearly defined: Saposhnikovia divaricata, Notopterygium incisum, Schizonepeta tenuifolia, and Angelica dahurica are used to dispel wind and cold and reach the exterior; Paeonia lactiflora and Morus alba are used to control dryness and protect Yin; Cremastra appendiculata is used to resolve phlegm; and Bletilla striata is used to protect the stomach. The entire formula works synergistically to invigorate Qi and nourish the kidneys, warm Yang and unblock the meridians, expel insects and ants, break up blood stasis, dispel wind and dampness, and relieve pain. This deeply aligns with the complex pathogenesis of ARCO stage II-III femoral head necrosis, characterized by the intertwined "deficiency, stasis, phlegm, dampness, and cold."

[0055] 2. The external herbal composition of this invention uses Aconitum carmichaelii, Zanthoxylum bungeanum, and Clematis chinensis as the principal ingredients, which have a strong effect in warming the meridians, dispelling cold, and relieving pain, and can quickly alleviate severe pain. It uses a large group of blood-activating herbs, including Sargentodoxa cuneata, Spatholobus suberectus, Carthamus tinctorius, Boswellia carterii, Commiphora myrrha, and Angelica sinensis, as the assistant ingredients, which strongly improve local microcirculation. It is further supplemented with Schizonepeta tenuifolia, Saposhnikovia divaricata, Erythrina variegata, Lycopodium clavatum, and Clematis chinensis to dispel wind, eliminate dampness, and unblock the meridians. Finally, it uses Astragalus complanatus and Dipsacus asper to locally tonify the kidneys and strengthen bones. The use of an alcohol-vinegar composite solvent greatly enhances the transdermal absorption capacity of the medicinal solution, allowing the medicinal power to reach deep into the lesion of the hip joint, forming a local high-concentration treatment area.

[0056] 3. The oral formula regulates the body holistically, tonifying Qi and kidneys to strengthen bones, and using insect-induced expulsion to clear blockages and unblock meridians, addressing the root cause. The external formula targets the affected area directly, warming and dispersing cold stagnation, breaking up blood stasis and clearing the meridians, addressing the symptoms. The external formula quickly opens local channels, improving blood supply efficiency, allowing the Qi, blood, and medicinal components delivered by the oral formula to reach the lesion more effectively. The oral formula strengthens the foundation from within, enhancing bone regeneration capacity, enabling the improved local blood supply from the external formula to be converted into new bone formation. Through the dual effects of systemic and local treatment, addressing both the root cause and symptoms, the external and oral formulas synergistically promote angiogenesis, necrotic bone absorption, and new bone formation in the necrotic area, achieving reversal of ARCO stage II-III. Detailed Implementation

[0057] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all 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.

[0058] To enable those skilled in the art to better understand the technical solution of this application, the technical solution of this application will be described in detail below with reference to specific embodiments.

[0059] Example 1:

[0060] Preparation of oral Chinese medicine compositions

[0061] Weigh out the following ingredients: Astragalus membranaceus 20 parts, Ligusticum chuanxiong 10 parts, Cinnamomum cassia twig 10 parts, Paeonia lactiflora 10 parts, Carthamus tinctorius 3 parts, Lycopodium clavatum 15 parts, Ephedra sinica 3 parts, Saposhnikovia divaricata 10 parts, Schizonepeta tenuifolia 10 parts, Angelica dahurica 10 parts, Morus alba leaf 10 parts, Notopterygium incisum 10 parts, Evodia rutaecarpa 10 parts, Acanthopanax senticosus 10 parts, Clematis armandii 15 parts, Bletilla striata 10 parts, Boswellia carterii 2 parts, Commiphora myrrha 5 parts, Panax notoginseng 2 parts, Cremastra appendiculata 2 parts, Scolopendra subspinipes 1 part, Bombyx mori 5 parts, Eupolyphaga sinensis 2 parts.

[0062] Mix and pulverize the above-mentioned raw materials into fine powder, pass through a 100-mesh sieve, take about 1.2 times the total weight of the powdered medicine and mix it thoroughly with the powdered medicine to make honey pills.

[0063] Preparation of External Traditional Chinese Medicine Composition

[0064] Weigh out the following ingredients: 20 parts of Astragalus complanatus, 2 parts of Aconitum carmichaelii, 20 parts of Sargentodoxa cuneata, 15 parts of Schizonepeta tenuifolia, 15 parts of Saposhnikovia divaricata, 15 parts of Angelica sinensis, 20 parts of Spatholobus suberectus, 15 parts of Erythrina variegata, 5 parts of Boswellia carterii, 5 parts of Commiphora myrrha, 20 parts of Dipsacus asper, 15 parts of Carthamus tinctorius, 8 parts of Zanthoxylum bungeanum, 15 parts of Lycopodium clavatum, 10 parts of Clematis chinensis, and 20 parts of Clematis armandii.

[0065] Mix the above-mentioned raw materials and place them in a 10L glass or ceramic container. Add 1000ml of 95% alcohol, seal the container, and soak in a cool place for 3 days, stirring once in the morning and once in the evening. After 3 days, add 1500ml of aged vinegar, seal the container again, and continue soaking for 7 days, stirring once a day. After the soaking period, filter the mixture through gauze, press out the residue, and combine the filtrates. Let the resulting liquid stand for 24 hours, collect the supernatant, and dispense it into brown glass bottles. Seal the bottles and store them away from light to obtain the external tincture.

[0066] Example 2:

[0067] Preparation of oral Chinese medicine compositions

[0068] Astragalus membranaceus 40 parts, Ligusticum chuanxiong 20 parts, Cinnamomum cassia 20 parts, Paeonia lactiflora 20 parts, Carthamus tinctorius 8 parts, Lycopodium clavatum 25 parts, Ephedra sinica 8 parts, Saposhnikovia divaricata 20 parts, Schizonepeta tenuifolia 20 parts, Angelica dahurica 20 parts, Morus alba 20 parts, Notopterygium incisum 20 parts, Evodia rutaecarpa 20 parts, Acanthopanax senticosus 20 parts, Clematis armandii 25 parts, Bletilla striata 20 parts, Boswellia carterii 5 parts, Commiphora myrrha 15 parts, Panax notoginseng 5 parts, Cremastra appendiculata 5 parts, Scolopendra subspinipes 3 parts, Bombyx mori 15 parts, Eupolyphaga sinensis 5 parts.

[0069] Mix and pulverize the above-mentioned raw materials into fine powder, pass through a 100-mesh sieve, take about 1.2 times the total weight of the powdered medicine and mix it thoroughly with the powdered medicine to make honey pills.

[0070] Preparation of External Traditional Chinese Medicine Composition

[0071] Weigh out the following ingredients: 40 parts of Astragalus complanatus, 5 parts of Aconitum carmichaelii, 40 parts of Sargentodoxa cuneata, 25 parts of Schizonepeta tenuifolia, 25 parts of Saposhnikovia divaricata, 25 parts of Angelica sinensis, 40 parts of Spatholobus suberectus, 20 parts of Erythrina variegata, 15 parts of Boswellia carterii, 15 parts of Commiphora myrrha, 40 parts of Dipsacus asper, 25 parts of Carthamus tinctorius, 15 parts of Zanthoxylum bungeanum, 25 parts of Lycopodium clavatum, 20 parts of Clematis chinensis, and 40 parts of Clematis armandii.

[0072] Mix the above-mentioned raw materials and place them in a 10L glass or ceramic container. Add 2000ml of 95% alcohol, seal the container, and soak in a cool place for 3 days, stirring once in the morning and once in the evening. After 3 days, add 2500ml of aged vinegar, seal the container again, and continue soaking for 7 days, stirring once a day. After the soaking period, filter the mixture through gauze, press out the residue, and combine the filtrates. Let the resulting liquid stand for 24 hours, collect the supernatant, and dispense it into brown glass bottles. Seal the bottles and store them away from light to obtain the external tincture.

[0073] Example 3:

[0074] Preparation of oral Chinese medicine compositions

[0075] Astragalus membranaceus 30 parts, Ligusticum chuanxiong 15 parts, Cinnamomum cassia 15 parts, Paeonia lactiflora 15 parts, Carthamus tinctorius 5 parts, Lycopodium clavatum 20 parts, Ephedra sinica 5 parts, Saposhnikovia divaricata 15 parts, Schizonepeta tenuifolia 15 parts, Angelica dahurica 15 parts, Morus alba 15 parts, Notopterygium incisum 15 parts, Evodia rutaecarpa 15 parts, Acanthopanax senticosus 15 parts, Clematis armandii 20 parts, Bletilla striata 15 parts, Boswellia carterii 3 parts, Commiphora myrrha 10 parts, Panax notoginseng 3 parts, Cremastra appendiculata 3 parts, Scolopendra subspinipes 2 parts, Bombyx mori 10 parts, Eupolyphaga sinensis 3 parts.

[0076] Mix and pulverize the above-mentioned raw materials into fine powder, pass through a 100-mesh sieve, take about 1.2 times the total weight of the powdered medicine and mix it thoroughly with the powdered medicine to make honey pills.

[0077] Preparation of External Traditional Chinese Medicine Composition

[0078] Weigh out the following ingredients: 30 parts of Astragalus complanatus, 3 parts of Aconitum carmichaelii, 30 parts of Sargentodoxa cuneata, 20 parts of Schizonepeta tenuifolia, 20 parts of Saposhnikovia divaricata, 20 parts of Angelica sinensis, 30 parts of Spatholobus suberectus, 18 parts of Erythrina variegata, 10 parts of Boswellia carterii, 10 parts of Commiphora myrrha, 30 parts of Dipsacus asper, 20 parts of Carthamus tinctorius, 12 parts of Zanthoxylum bungeanum, 20 parts of Lycopodium clavatum, 15 parts of Clematis chinensis, and 30 parts of Clematis armandii.

[0079] Mix the above-mentioned raw materials and place them in a 10L glass or ceramic container. Add 1500ml of 95% alcohol, seal the container, and soak in a cool place for 3 days, stirring once in the morning and once in the evening. After 3 days, add 2000ml of aged vinegar, seal the container again, and continue soaking for 7 days, stirring once a day. After the soaking period, filter the mixture through gauze, press out the residue, and combine the filtrates. Let the resulting liquid stand for 24 hours, collect the supernatant, and dispense it into brown glass bottles. Seal the bottles and store them away from light to obtain the external tincture.

[0080] To verify the efficacy of the drug of this invention in reversing ARCO stage II to III femoral head necrosis, a randomized, controlled clinical trial was conducted.

[0081] 1. Case selection: A total of 120 patients with ARCO stage II and III avascular necrosis of the femoral head who met the diagnostic criteria were included and randomly divided into a treatment group and a control group, with 60 patients in each group. There were no statistically significant differences between the two groups in terms of age, gender, etiology, and ARCO stage distribution (P>0.05).

[0082] Diagnostic and staging criteria: Based on X-ray, CT and MRI examinations, the patient meets the diagnostic criteria for avascular necrosis of the femoral head and is determined to be in stage II or III according to the ARCO international staging criteria.

[0083] Exclusion criteria: Stage IV patients; patients with severe heart, liver, or kidney dysfunction; pregnant or lactating women; patients allergic to any component of this product.

[0084] 2. Treatment methods:

[0085] Treatment group: Patients were treated with the oral honey pill combined with external tincture method described in Example 3 of this invention. Oral administration: Take one honey pill (9g per pill) prepared in Example 3, three times a day, taken with warm water after meals. External application: Patients first underwent acupuncture treatment, three times a week. After 2-3 days of acupuncture, apply an appropriate amount of the external tincture prepared in Example 3 to the affected area, 3-5 times a day.

[0086] Control group: Oral administration of commercially available traditional Chinese medicine for promoting blood circulation and removing blood stasis (Tongluo Shenggu Capsules) according to the instructions, combined with routine hot compress therapy.

[0087] Both groups underwent a 6-month treatment course.

[0088] 3. Observation indicators:

[0089] Key efficacy endpoints: Harris hip score and visual analog scale (VAS) scores before and after treatment.

[0090] Key imaging indicators: MRI examinations before and after treatment to observe changes in the area of ​​necrosis, bone marrow edema, and crescent sign; X-ray examinations to observe the shape of the femoral head, joint space, and degree of collapse.

[0091] ARCO stage reversal rate: "Reversal" is defined as a significant reduction in the necrotic area, blurring or disappearance of the sclerotic zone, and disappearance of the crescent sign on MRI after treatment, with no new collapses or improvement in existing collapses on X-ray (such as restoration of collapse height). The proportion of cases achieving ARCO stage reversal (including reversal from stage III to stage II, or basic healing of stage II lesions) in both groups was statistically analyzed.

[0092] Safety indicators: routine blood and urine tests, liver and kidney function tests, and adverse reaction records.

[0093] 4. Experimental Results:

[0094] Harris score and VAS score improvement: After 6 months of treatment, the Harris score in the treatment group increased from an average of (45.2±8.1) points to (78.5±9.3) points, and the VAS score decreased from (7.5±1.2) points to (2.1±1.0) points, with the improvement being significantly better than that in the control group (P<0.01).

[0095] Imaging improvement: Follow-up MRI showed that 51 patients (85%) in the treatment group had a smaller necrotic area and reduced bone marrow edema, compared to only 19 patients (31.7%) in the control group.

[0096] ARCO stage reversal rate: In the treatment group, 28 patients (46.7%) achieved ARCO stage reversal, including 18 patients who reversed from stage II to stage I or achieved healing, and 10 patients who reversed from stage III to stage II. In the control group, only 5 patients (8.3%) achieved stage reversal, all of whom reversed from stage II to stage I. The difference between the two groups was statistically significant (P<0.001).

[0097] Overall effective rate: The criteria for effectiveness were the near disappearance of pain, significant improvement in function, and no or improved progression on imaging. The overall effective rate in the treatment group was 91.7% (55 cases), while that in the control group was 66.7% (40 cases) (P<0.01).

[0098] Safety: No drug-related abnormalities were observed in liver and kidney function or routine blood and urine tests in either group during treatment. Three patients in the treatment group experienced mild local skin redness and itching at the beginning of topical application, which subsided spontaneously after reducing the frequency of application and did not affect continued treatment.

[0099] 5. Conclusion: The traditional Chinese medicine composition provided by this invention showed a significantly higher ARCO stage reversal rate (46.7%) than the conventional control group (8.3%) in treating ARCO stage II-III femoral head necrosis. Furthermore, it demonstrated comprehensive and significant superiority in terms of imaging improvement, symptom relief, and functional recovery. This strongly confirms the outstanding efficacy and clinical value of this invention in reversing the structural pathological changes of femoral head necrosis.

[0100] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An oral traditional Chinese medicine composition for treating avascular necrosis of the femoral head, characterized in that, The raw materials include the following parts by weight: Astragalus membranaceus 20-40 parts, Ligusticum chuanxiong 10-20 parts, Cinnamomum cassia twig 10-20 parts, Paeonia lactiflora 10-20 parts, Carthamus tinctorius 3-8 parts, Lycopodium clavatum 15-25 parts, Ephedra sinica 3-8 parts, Saposhnikovia divaricata 10-20 parts, Schizonepeta tenuifolia 10-20 parts, Angelica dahurica 10-20 parts, Morus alba leaf 10-20 parts, Notopterygium incisum 10-20 parts, Evodia rutaecarpa 10-20 parts, Acanthopanax senticosus 10-20 parts, Clematis armandii 15-25 parts, Bletilla striata 10-20 parts, Boswellia carterii 2-5 parts, Commiphora myrrha 5-15 parts, Panax notoginseng 2-5 parts, Cremastra appendiculata 2-5 parts, Scolopendra subspinipes 1-3 parts, Bombyx mori (fried) 5-15 parts, Eupolyphaga sinensis 2-5 parts.

2. The oral traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials include the following parts by weight: Astragalus membranaceus 30 parts, Ligusticum chuanxiong 15 parts, Cinnamomum cassia 15 parts, Paeonia lactiflora 15 parts, Carthamus tinctorius 5 parts, Lycopodium clavatum 20 parts, Ephedra sinica 5 parts, Saposhnikovia divaricata 15 parts, Schizonepeta tenuifolia 15 parts, Angelica dahurica 15 parts, Morus alba 15 parts, Notopterygium incisum 15 parts, Evodia rutaecarpa 15 parts, Acanthopanax senticosus 15 parts, Clematis armandii 20 parts, Bletilla striata 15 parts, Boswellia carterii 3 parts, Commiphora myrrha 10 parts, Panax notoginseng 3 parts, Cremastra appendiculata 3 parts, Scolopendra subspinipes 2 parts, Bombyx mori 10 parts, Eupolyphaga sinensis 3 parts.

3. A topical traditional Chinese medicine composition for treating avascular necrosis of the femoral head, characterized in that, The raw materials include the following parts by weight: 20-40 parts of Astragalus complanatus, 2-5 parts of Aconitum carmichaelii, 20-40 parts of Sargentodoxa cuneata, 15-25 parts of Schizonepeta tenuifolia, 15-25 parts of Saposhnikovia divaricata, 15-25 parts of Angelica sinensis, 20-40 parts of Spatholobus suberectus, 15-20 parts of Erythrina variegata, 5-15 parts of Boswellia carterii, 5-15 parts of Commiphora myrrha, 20-40 parts of Dipsacus asper, 15-25 parts of Carthamus tinctorius, 8-15 parts of Zanthoxylum bungeanum, 15-25 parts of Lycopodium clavatum, 10-20 parts of Clematis chinensis, and 20-40 parts of Clematis armandii.

4. The topical traditional Chinese medicine composition according to claim 3, characterized in that, The raw materials include the following parts by weight: 30 parts of Astragalus complanatus, 3 parts of Aconitum carmichaelii, 30 parts of Sargentodoxa cuneata, 20 parts of Schizonepeta tenuifolia, 20 parts of Saposhnikovia divaricata, 20 parts of Angelica sinensis, 30 parts of Spatholobus suberectus, 18 parts of Erythrina variegata, 10 parts of Boswellia carterii, 10 parts of Commiphora myrrha, 30 parts of Dipsacus asper, 20 parts of Carthamus tinctorius, 12 parts of Zanthoxylum bungeanum, 20 parts of Lycopodium clavatum, 15 parts of Clematis chinensis, and 30 parts of Clematis armandii.

5. The oral traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Its dosage forms are pills, capsules, tablets or granules.

6. The external application traditional Chinese medicine composition according to claim 3 or 4, characterized in that, Its dosage forms include tinctures, liniments, sprays, ointments, or patches.

7. A method for preparing the oral traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: After weighing the active pharmaceutical ingredient, mix and pulverize it into a fine powder, add excipients or binders, and prepare an oral formulation.

8. A method for preparing the external application traditional Chinese medicine composition according to claim 3 or 4, characterized in that, Includes the following steps: The raw material is weighed and placed in a container. It is then soaked in a first solvent for a first extraction, followed by the addition of a second solvent for a second extraction. The residue is then separated to obtain a topical liquid preparation.

9. The use of the oral Chinese medicine composition of claim 1 or 2 and / or the topical Chinese medicine composition of claim 3 or 4 in the preparation of a medicament for reversing ARCO stage II to III femoral head necrosis.