Traditional Chinese medicine composition for oral administration for femoral head necrosis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for oral administration for femoral head necrosis and a preparation method thereof, and relates to the technical field of medicines, the traditional Chinese medicine composition for oral administration for femoral head necrosis comprises the following raw materials: prepared rehmannia root, astragalus membranaceus, angelica sinensis, salvia miltiorrhiza, oyster, hot rhizoma drynariae, caulis spatholobi and liquorice; wherein the proportions of the raw materials are as follows: 15g of prepared rehmannia root, 30g of astragalus membranaceus, 12g of angelica sinensis, 15g of salvia miltiorrhiza, 30g of oyster, 9g of scalded rhizoma drynariae, 10g of caulis spatholobi and 10g of liquorice. The traditional Chinese medicine can significantly relieve pain, and can improve femoral head blood circulation, promote bone cell regeneration and repair, prevent bone mass loss, delay disease progression and reduce operation probability after being taken for a long time; the traditional Chinese medicine composition is convenient to take, follows a traditional Chinese medicine prescription using method, is directly taken orally by a patient, does not need complex decoction or a special taking mode, is suitable for modern fast-paced life, is beneficial to improvement of treatment compliance, has small burden on the body of the patient and high patient tolerance compared with partial western medicines, and can better insist in treatment and guarantee the continuity and stability of the treatment effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medicine, and in particular to a traditional Chinese medicine combination for treating femoral head necrosis and a preparation method thereof. Background Art

[0002] Avascular necrosis of the femoral head (ONFH) is a common and difficult disease in orthopedics. It is currently believed to be caused by various etiologies, which lead to compression of the intraosseous vascular network, resulting in localized blood flow obstruction to the femoral head, leading to avascular necrosis of the bone tissue. The disease progresses rapidly, and there are no proven hip-preserving treatments. Once the disease reaches the late stage, most patients require total hip arthroplasty (THA). Therefore, how to effectively prevent or delay the onset of ONFH remains a difficult and challenging issue in the field. Traditional Chinese medicine (TCM) has been documented in its understanding and treatment of ONFH since ancient times. With the advancement of TCM techniques and the expansion of relevant clinical trials, a wealth of literature has confirmed the excellent efficacy of TCM in treating ONFH, including its ability to relieve pain and restore joint function. Some medical experts even believe that TCM treatment could become the preferred treatment for early-stage ONFH.

[0003] Currently, modern medicine's treatments for osteonecrosis of the femoral head mainly include conservative treatment and surgical treatment. Conservative treatments often use medications to relieve pain and improve local blood circulation, but these methods often have limited effects in the early stages of the disease and cannot effectively prevent the progression of the disease, making it difficult to fundamentally resolve the series of problems caused by osteonecrosis of the femoral head. Surgical treatments, such as artificial hip replacement, can improve the patient's joint function to a certain extent, but they are invasive, expensive, and carry the risk of postoperative complications. Although there are many types of Traditional Chinese Medicine treatments for osteonecrosis of the femoral head on the market, most lack systematic clinical research verification, and the treatment effects are mixed. In particular, there is still considerable room for improvement in precisely targeting the complex pathological mechanisms of osteonecrosis of the femoral head and fully leveraging the unique advantages of Traditional Chinese Medicine for personalized treatment. Therefore, a Traditional Chinese Medicine combination oral medication for osteonecrosis of the femoral head and its preparation method are proposed to address the shortcomings of existing treatments and provide patients with more effective, safer, and more economical treatment options. Summary of the Invention

[0004] The purpose of the present invention is to provide a Chinese herbal combination oral medicine for femoral head necrosis and a preparation method thereof, so as to solve the problems raised in the above background technology.

[0005] In order to solve the above technical problems, the technical solution adopted by the present invention is:

[0006] In a first aspect, the present invention provides a traditional Chinese medicine combination for internal use for femoral head necrosis, wherein the raw materials of the traditional Chinese medicine combination for internal use for femoral head necrosis are: prepared rehmannia root, astragalus root, angelica root, salvia miltiorrhiza, oyster, drynaria root, millettia reticulata, and liquorice;

[0007] The proportions of the raw materials are: 15g of Rehmannia root, 30g of Astragalus root, 12g of Angelica sinensis, 15g of Salvia miltiorrhiza, 30g of Oyster, 9g of Drynaria fortunei, 10g of Millettia reticulata, and 10g of Licorice root.

[0008] A further improvement of the technical solution of the present invention is that the usage of the Chinese medicine combination for femoral head necrosis is as follows: take an appropriate amount of Chinese medicine granules and place them in a clean cup, add a certain amount of warm boiled water, usually 150-200 ml of warm boiled water, stir evenly, and take it while hot after the granules are completely dissolved. If the water temperature is too high, it can be left for a while and taken when the temperature is suitable.

[0009] In a second aspect, the present invention further provides a method for preparing a Chinese medicine combination for internal use for treating femoral head necrosis, the method comprising the following steps:

[0010] Step 1: pretreatment of raw materials;

[0011] Step 2: Extraction;

[0012] Step 3: Concentration;

[0013] Step 4: drying;

[0014] Step 5: granulation;

[0015] Step 6: Granulation and grading;

[0016] Step 7: Packaging.

[0017] Preferably: the step 1, raw material pretreatment includes: selecting Chinese herbal medicine slices that meet the quality standards, first purifying them to remove impurities, mud and sand, etc. According to the characteristics of the medicinal materials, some need to be cut into suitable slices, segments, blocks, etc. for subsequent extraction.

[0018] Preferably, the step 2, extraction, comprises: using a multifunctional extraction tank for extraction operation, selecting a suitable extraction process according to the properties of the active ingredients contained in the medicinal materials, if the water-soluble components are mostly water-soluble, a water extraction process is adopted, adding an appropriate amount of water, heating to a suitable temperature and maintaining for a certain time to allow the active ingredients to be fully dissolved, and for fat-soluble components, an alcohol extraction process can be selected. During the extraction process, the temperature, pressure, time and other parameters are precisely controlled to ensure the extraction effect. After the extraction is completed, the extract is filtered, the medicinal residue is removed, and a clarified extract is obtained.

[0019] Preferably, the step 3, concentration, comprises: transferring the extract to a vacuum concentrator, utilizing a vacuum environment to lower the boiling point of the solution, and concentrating under low temperature conditions to effectively reduce the degradation and loss of heat-sensitive components and ensure the efficacy; and concentrating the extract to a thick paste with an appropriate relative density by adjusting the vacuum degree and heating temperature, thereby providing a suitable material state for subsequent granulation.

[0020] Preferably, the step 4, drying, comprises: conveying the concentrated thick paste to a spray drying tower, spraying the thick paste into fine droplets through an atomizer, rapidly contacting with hot air, instantly evaporating the water in the droplets, and drying into powder, quickly converting the thick paste into a dry raw material powder, and the obtained powder has uniform particle size and good fluidity, which is conducive to subsequent granulation.

[0021] Preferably, the step 5, granulation, comprises: uniformly mixing the dried powder with an appropriate amount of auxiliary materials, adding an appropriate amount of adhesive to form a soft material, placing the soft material in a swing granulator, and mechanically transmitting the soft material through screens of different apertures to form granules by extruding. The screen of appropriate aperture can be selected according to product requirements to control the particle size;

[0022] The step 5, granulation, further comprises: adding the dry powder, auxiliary materials and binder solution into a one-step granulator together, fluidizing the materials with the airflow in the equipment, spraying the binder at the same time, completing granulation during the fluidization and mixing process, and then drying, completing the mixing, granulation and drying operations in one step.

[0023] Preferably, the step six, granulation and grading, includes: if the prepared granules are sticky or uneven in size, granulation is required, and the granules that are too large or too small are removed by an oscillating screen or other equipment to make the granules uniform in size. For traditional Chinese medicine granules with strict particle size requirements, a grading screen can be used for grading to separate the granules into different specifications to ensure that the product quality meets the standards.

[0024] Preferably, the step seven, packaging, comprises: using a granule packaging machine for packaging, setting the packaging dosage according to product specifications, quantitatively loading qualified Chinese medicine granules into the packaging material, and completing operations such as sealing and labeling.

[0025] Due to the adoption of the above technical solution, the present invention has the following technical advancements compared to the prior art:

[0026] 1. The present invention provides a Chinese medicine combination for internal use of femoral head necrosis and a preparation method thereof, which can significantly relieve pain. Long-term use can also improve blood circulation in the femoral head, promote bone cell regeneration and repair, prevent bone loss, delay disease progression, and reduce the probability of surgery. It is easy to take and follows the use of traditional Chinese medicine prescriptions. Patients can take it directly orally without complicated decoction or special taking methods. It is suitable for modern fast-paced life and is conducive to improving treatment compliance. It has shown good adaptability in clinical trials. Most of the drugs are natural Chinese medicinal materials, and reasonable combination reduces adverse reactions. Compared with some Western medicines, it has less burden on the patient's body and high patient tolerance, which can better adhere to the treatment and ensure the continuity and stability of the treatment effect.

[0027] 2. The present invention provides a Chinese herbal combination oral medicine for femoral head necrosis and a preparation method thereof. It can significantly improve the bone microstructure of the femoral head by precisely regulating the proliferation and differentiation process of osteoblasts and effectively inhibiting the excessive activity of osteoclasts, thereby promoting the synthesis and mineralization of bone matrix, enhancing the density and strength of trabeculae, reducing bone loss caused by the disease, effectively alleviating the pain, limited movement and other symptoms caused by femoral head necrosis, delaying the development of femoral head collapse and deformation, helping patients restore hip joint function, improving the quality of life, providing patients with femoral head necrosis with practical and effective treatment methods, and improving the overall prognosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a schematic flow chart of the preparation method of the present invention. DETAILED DESCRIPTION

[0029] The present invention is described in further detail below in conjunction with the embodiments:

[0030] In a first aspect, the present invention provides a Chinese herbal combination for internal use for femoral head necrosis, wherein the raw materials of the Chinese herbal combination for internal use for femoral head necrosis are: prepared rehmannia root, astragalus root, angelica root, salvia miltiorrhiza, oyster, drynaria root, millettia reticulata, and liquorice;

[0031] The proportions of the raw materials are: 15g of Rehmannia root, 30g of Astragalus root, 12g of Angelica sinensis, 15g of Salvia miltiorrhiza, 30g of Oyster, 9g of Drynaria fortunei, 10g of Millettia reticulata, and 10g of Licorice root.

[0032] The usage of this Chinese medicine combination oral medicine for femoral head necrosis is: take an appropriate amount of Chinese medicine granules and place them in a clean cup, add a certain amount of warm boiled water, usually 150-200 ml, stir evenly, and take it while hot after the granules are completely dissolved. If the water temperature is too high, you can let it sit for a while and take it when the temperature is suitable.

[0033] In a second aspect, the present invention further provides a method for preparing a Chinese medicine combination for internal use for treating femoral head necrosis, the method comprising the following steps:

[0034] Step 1: pretreatment of raw materials;

[0035] Step 2: Extraction;

[0036] Step 3: Concentration;

[0037] Step 4: drying;

[0038] Step 5: granulation;

[0039] Step 6: Granulation and grading;

[0040] Step 7: Packaging.

[0041] Step 1, raw material pretreatment, includes: selecting Chinese herbal medicine slices that meet quality standards, first purifying them to remove impurities, mud and sand, etc. According to the characteristics of the medicinal materials, some need to be cut into suitable slices, sections, blocks, etc. for subsequent extraction.

[0042] Step 2, extraction, includes: using a multifunctional extraction tank for extraction operation, selecting a suitable extraction process based on the properties of the active ingredients contained in the medicinal materials, if the water-soluble components are mostly water-soluble, using a water extraction process, adding an appropriate amount of water, heating to a suitable temperature and maintaining for a certain time to allow the active ingredients to be fully dissolved, and for fat-soluble components, an alcohol extraction process can be used. During the extraction process, the temperature, pressure, time and other parameters are precisely controlled to ensure the extraction effect. After the extraction is completed, the extract is filtered, the medicinal residue is removed, and a clarified extract is obtained.

[0043] Step three, concentration, includes: transferring the extract to a vacuum concentrator, using the vacuum environment to lower the boiling point of the solution, and concentrating under low temperature conditions to effectively reduce the degradation and loss of heat-sensitive components and ensure the efficacy. By adjusting the vacuum degree and heating temperature, the extract is concentrated to a thick paste with an appropriate relative density, providing a suitable material state for subsequent granulation.

[0044] Step 4, drying, includes: conveying the concentrated thick paste to a spray drying tower, spraying the thick paste into fine droplets through an atomizer, and rapidly contacting the thick paste with hot air. The water in the droplets evaporates instantly and dries into powder, quickly converting the thick paste into dry raw material powder. The obtained powder has uniform particle size and good fluidity, which is conducive to subsequent granulation.

[0045] The fifth step, granulation, comprises: uniformly mixing the dried powder with an appropriate amount of auxiliary materials (such as starch, dextrin, etc.), adding an appropriate amount of adhesive (such as ethanol solution, syrup, etc.) to form a soft material, placing the soft material in a swing granulator, and mechanically driving the soft material through screens of different apertures to form granules by extruding. The screen of appropriate aperture can be selected according to product requirements to control the particle size;

[0046] In addition, step five, granulation, can also be performed as follows: dry powder, excipients and binder solution are added together into a one-step granulator, the airflow in the equipment fluidizes the material, and the binder is sprayed in at the same time, granulation is completed during the fluidization and mixing process, and then drying is performed, completing the mixing, granulation and drying operations in one step.

[0047] Step six, granulation and grading, includes: if the prepared granules are sticky or uneven in size, granulation is required. Vibrating screens and other equipment are used to remove oversized or undersized particles to make the particle size uniform. For traditional Chinese medicine granules with strict particle size requirements, grading screens can be used for grading, and the particles can be divided into different specifications to ensure that the product quality meets the standards.

[0048] Step seven, packaging, includes: using a granule packaging machine for packaging, setting the packaging dosage according to product specifications, quantitatively loading qualified Chinese medicine granules into packaging materials (such as aluminum-plastic composite bags, paper bags, etc.), and completing sealing, labeling and other operations.

[0049] Case 1

[0050] A 31-year-old male patient presented with six months of bilateral hip pain and limited mobility. He had no history of trauma, alcohol abuse, or hormone use. Diagnosis: bilateral avascular necrosis of the femoral head; ARCO stage: bilateral III-A. Symptoms: stabbing pain in both hip joints, limited mobility, good appetite and sleep, and normal bowel movements. His tongue was red with petechiae, his tongue coating was yellow, and his pulse was deep. Diagnosis: liver and kidney deficiency with blood stasis. Treatment should focus on tonifying the liver and kidneys, promoting qi circulation, and alleviating pain.

[0051] Rehmannia root 15g, Chinese angelica 12g, white peony root 12g, Chuanxiong 12g, Millettia reticulata 12g, Achyranthes bidentata 12g, vinegared pangolin 12g, vinegared Tripterygium wilfordii 12g, vinegared Curcuma 9g, scalded Drynaria fortunei 12g, processed Morinda officinalis 9g, Salvia miltiorrhiza 12g, oyster 30g, honeysuckle 12g, and liquorice 10g;

[0052] A total of 7 sets, herbal prescription, decoction pieces, twice a day, oral, 200mI / time, general type, decoction;

[0053] Follow-up visit: The patient took the medicine smoothly and without any adverse reaction. He continued to take 14 doses and observe.

[0054] Third visit: The patient reported that the hip pain was relieved and the movement was improved. After slightly adding or subtracting the above prescription, he took 14 more doses of the medicine.

[0055] After taking the medicine continuously for half a year, the patient's pain was significantly relieved; X-ray and MRI showed that the necrotic area had not developed or expanded. The patient then stopped taking the medicine intermittently for another year, and his condition remained stable, with no recurrence during follow-up.

[0056] Case 2

[0057] A 49-year-old female patient presented with a year-long complaint of bilateral hip pain and limited mobility. She had previously used steroids for three months. The diagnosis was bilateral avascular necrosis of the femoral head; ARCO stage: bilateral III-B. Symptoms included dull, persistent pain in both hip joints, joint stiffness, difficulty walking for extended periods, and the use of crutches. She also presented with restlessness, insomnia, thirst, dry throat, flushed complexion, a red tongue with a yellow, greasy coating, and a thready pulse. The diagnosis was kidney deficiency and blood stasis; treatment was focused on tonifying the liver and kidneys and promoting qi and blood circulation.

[0058] Rehmannia root 15g, Chinese angelica 12g, white peony root 12g, Chuanxiong 12g, Millettia reticulata 12g, Achyranthes bidentata 12g, Angelica dahurica 12g, Morus alba 12g, Gentiana macrophylla 9g, Drynaria fortunei 12g, Saposhnikovia divaricata 9g, Codonopsis pilosula 12g, Poria 30g, Eucommia ulmoides 12g, Licorice root 10g;

[0059] A total of 7 sets, herbal prescription, decoction pieces, twice a day, oral, 200mI / time, general type, decoction;

[0060] Follow-up visit: The irritability was slightly reduced, and the thirst and dry throat were significantly relieved. The above prescription was modified and continued for 7 doses for observation.

[0061] Third visit: The patient reported that his hip pain had improved, but he still had weakness in his lower limbs and took 14 doses of medicine again.

[0062] Four examinations: There is still a slight pain in the hip, but the weakness has improved; continue to take the medicine.

[0063] After taking the medicine intermittently for one year, the patient's pain and difficulty in moving were completely relieved; the collapsed area on X-ray had hardened and stabilized. The patient's condition was stable and the follow-up was good.

[0064] Case 3

[0065] A 65-year-old male patient presented with complaints of left hip pain and limited mobility for over ten years. He had no history of trauma, alcohol abuse, or hormone use. Diagnosis: avascular necrosis of the left femoral head; ARCO stage: left III-C. Symptoms: heavy, persistent pain in the left hip joint, difficulty flexing and extending, worse at night. Appetite was good, sleep was poor, and bowel movements were normal. His tongue was dark red with a yellow coating, and his pulse was deep and slippery. The diagnosis was: phlegm and blood stasis combined with kidney yin deficiency. Treatment should focus on removing blood stasis and resolving phlegm, while nourishing yin and unblocking the meridians.

[0066] Rehmannia root 15g, Chinese angelica 12g, white peony root 12g, Chuanxiong 12g, Atractylodes macrocephala 12g, Poria 12g, Artemisia capillaris 12g, Pinellia 12g, ginger 9g, scalded Drynaria fortunei 12g, dried tangerine peel 9g, cinnamon twig 12g, liquorice root 10g;

[0067] A total of 7 sets, herbal prescription, decoction pieces, twice a day, oral, 200mI / time, general type, decoction;

[0068] Follow-up visit: The patient took the medicine smoothly and without any adverse reaction. He continued to take 14 doses and observe.

[0069] Third visit: The patient reported that the hip pain was slightly relieved, but flexion and extension were still difficult; after adding and subtracting the above prescription, he took 14 more doses of medicine.

[0070] Four examinations: Hip pain improved, activities allowed; continue taking medication;

[0071] Six months later, the patient's pain was significantly relieved; X-rays showed no progression in the collapsed area, the condition was stable, and the medication had been stopped.

[0072] The present invention also provides clinical comparative research data, which are as follows:

[0073] 1. Research subjects: 160 hospitalized patients diagnosed with avascular necrosis of the femoral head in the Department of Orthopedics II, Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University from June 2018 to June 2021 were randomly divided into an observation group and a control group, with 80 cases in each group; the age ranged from 25 to 61 years, with an average age of (42.22±10.71) years; the disease course ranged from 4 to 24 months, with an average course of (14.31±6.31) months;

[0074] 2. Diagnostic criteria:

[0075] (1) Clinical features: Pain is often felt in the hip, buttocks, or groin area, occasionally accompanied by knee pain and limited internal rotation of the hip joint. Patients often have a history of hip trauma, corticosteroid use, alcoholism, or occupational history such as diving.

[0076] (2) MRI: MRI examination has a high sensitivity for femoral head necrosis, showing localized subchondral low signal on T1WI or double line sign on T2WI.

[0077] (3) X-ray images: The anteroposterior and frog-leg positions of the hip joint are the basic X-ray positions for diagnosing femoral head necrosis. In the early stages, it usually manifests as sclerosis, cystic changes, and a "crescent sign." Sclerosis is often visible between the necrotic area and the normal area. In the late stages, the femoral head loses its original spherical structure due to collapse and presents as degenerative arthritis.

[0078] (IV) CT scan signs: Usually, signs such as the absence of the femoral head star sign, loss and fracture of trabeculae in the weight-bearing area, sclerotic bands surrounding cystic areas or subchondral bone fractures, and the presence of interlaced necrotic and repaired bone can be seen;

[0079] (5) Radionuclide examination: In the acute phase of femoral head bone scan (99Tcm-MDP, 99Tcm-DPD, etc.), the necrotic area is a cold area; in the necrotic repair phase, there is a cold area in the hot area, that is, a "doughnut-like" change;

[0080] (VI) Femoral tissue biopsy and pathological manifestations: Pathologically, the disease is divided into early, middle, and late stages of blood circulation changes. Early stage of blood circulation changes (venous stasis stage): At this time, blood supply is obstructed, and some signs of cell necrosis appear. The number of vacant osteocyte pits in the trabeculae exceeds 50%, and the adjacent trabeculae are involved, and the bone marrow is partially necrotic. Stimulated by the pathogenic factors of osteonecrosis, bone marrow stem cells gradually differentiate into hypertrophic adipocytes, with cell diameters exceeding 10 μm. Thrombosis occurs in small veins, venous dilation, venous sinus congestion, and interstitial edema. Due to poor blood return, intraosseous venous congestion and high pressure occur. Mid-stage of blood circulation changes (arterial ischemia stage): Venous thrombosis is further aggravated, and compressed stenosis of arterial and venous vessels or arterial thrombosis occurs, leading to insufficient blood supply to the arterial system and then to arterial ischemia. This stage manifests as subchondral bone fractures, expansion of the necrotic area, local cystic changes, and collapse of some areas of the femoral head. The necrotic bone tissue enters the main repair stage, and new blood vessels and new fibrous tissue can be seen growing into the necrotic area, forming granulation tissue. Late stage of blood circulation changes (arterial occlusion stage): Arterial endothelial proliferation and thickening, arterial diameter reduction, and even further loss of arterial structure, leading to complete arterial occlusion; the scope and degree of femoral head collapse increase, manifesting as hip osteoarthritis;

[0081] (VII) Digital Subtraction Angiography: This examination demonstrates reduced, damaged, and interrupted blood supply to the femoral head and plays an important role in preventing osteonecrosis following femoral neck fracture. In non-traumatic femoral head necrosis, venous stasis and blood flow obstruction occur in the early stages, arterial ischemia in the mid-term, and arterial occlusion in the late stages. It is recommended that DSA examinations be performed on patients undergoing hip-preserving surgery after a clear diagnosis of osteonecrosis to provide a basis for the development of surgical plans.

[0082] If (1) and (2) are met, the patient can be diagnosed with femoral head necrosis, and (3) to (7) are examination methods for auxiliary diagnosis and treatment.

[0083] Staging: The Association Research Circulation Osseous (ARCO) staging system was used.

[0084] Classification: Use coronal T1-weighted MRI or coronal CT scan reconstruction images, select the midline, and determine the site of necrosis. Draw a line along the anterior and posterior margins of the round ligament to divide this plane into three columns: the medial column (30%), the central column (40%), and the lateral column (30%).

[0085] The Chinese classification (China-Japan Friendship Hospital classification) is based on whether the necrotic lesion occupies the three columns: M type, necrotic lesions occupy the medial column; C type, necrotic lesions occupy the central column and medial column; L type, necrotic lesions occupy all three columns. The lateral type is further divided into three subtypes based on whether the necrotic lesion occupies the lateral column: L1 type, necrotic lesions occupy part of the lateral column, with some lateral column remaining; L2 type, necrotic lesions occupy all lateral columns and part of the central column, with the medial column unaffected; L3 type, necrotic lesions occupy the entire femoral head.

[0086] TCM syndrome differentiation standards

[0087] Refer to the classification of femoral head necrosis in the textbook of higher medical colleges: "Integrated Traditional Chinese and Western Medicine Traumatology"

[0088] 1) Qi stagnation and blood stasis syndrome: distending pain or stabbing pain in the hip area, the pain is fixed and does not move, the pain is aggravated by sitting or lying for a long time, and the pain is relieved after appropriate exercise, the tongue is dark, the tongue coating is thin white, and the pulse is deep and stringy.

[0089] 2) Kidney deficiency and blood stasis syndrome: Hip pain is mild, aggravated by activity, relieved by rest, spontaneous sweating, night sweats, forgetfulness and insomnia, fever in the five hearts: muscle atrophy of the affected limb, general fatigue, pale tongue, thin white fur, and thready and wiry pulse.

[0090] 3) Phlegm and blood stasis syndrome: Hip joint pain, irritability, heaviness in the limbs, thick yellow sputum, yellow and greasy tongue coating, and slippery and rapid pulse.

[0091] 3. Pathology inclusion

[0092] 3.1 Case inclusion criteria

[0093] Patients of all ethnicities and genders, aged 18 years (≥18 years) to 60 years (≤60 years);

[0094] Patients who meet the Western medical diagnostic criteria for ONFH;

[0095] Patients whose ONFH is diagnosed as kidney deficiency and blood stasis according to TCM syndrome differentiation;

[0096] Patients who passed ethical review and signed informed consent.

[0097] 3.2 Case Exclusion Criteria

[0098] Patients who are not of the appropriate age;

[0099] Pregnant or lactating women, those with allergic constitution or allergic to this drug;

[0100] Patients with transient synovitis, slipped capital femoral epiphysis, bone tuberculosis, etc.

[0101] Patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems, and mental illnesses;

[0102] Patients who do not meet the inclusion criteria, have poor compliance, cannot follow the trial protocol; or cannot provide effective feedback and evaluation of the intervention results.

[0103] 4. Intervention plan

[0104] (1) Basic treatment: Both groups of patients received the following regimen: calcitriol capsules (0.25 μg, bid, po) + alendronate sodium tablets (10 mg, qw, po) + atorvastatin calcium (10 mg, qn, po); in addition, they received protective weight-bearing (weight control, cane or crutches), with a course of 6 weeks, and were observed for two courses.

[0105] (2) Experimental group: Oral administration of Bone-Erosion Eight-Flavor Drink (drug provided by the Preparation Room of the Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University).

[0106] Ingredients: Prepared Rehmannia root 15g, Astragalus root 30g, Angelica sinensis 15g, Salvia miltiorrhiza 15g, Oyster 30g (pre-decocted), Drynaria fortunei 10g, Millettia reticulata 10g, Licorice root 10g. Decoction warm and take once daily, twice daily. One course of treatment is six weeks, and two courses should be taken consecutively.

[0107] 5. Observation indicators

[0108] 5.1 Efficacy Observation Indicators

[0109] (1) Harris hip score

[0110] (2) Criteria for determining efficacy

[0111] The clinical efficacy of the two groups was evaluated before and after treatment according to the Traditional Chinese Medicine (TCM) criteria for diagnosis and treatment of orthopedics. Cured: No limping, no hip pain, no lower limb shortening, complete or substantial recovery of function, and virtually no X-ray findings of femoral head collapse, osteonecrosis, and bone hyperplasia and sclerosis. Improved: Symptoms alleviated, hip joint function improved, lower limb shortening by approximately 1 cm, and X-ray findings of femoral head enlargement or flattening, but with improvement in osteonecrosis and bone hyperplasia and sclerosis. Ineffective: No improvement in symptoms or changes in X-ray findings.

[0112] (3) Imaging observation indicators

[0113] On anteroposterior hip X-rays, the patient is evaluated based on femoral head morphology, necrotic area, and osteoarthritis. These three indicators are scored separately, and the imaging efficacy score is calculated: the imaging efficacy score = femoral head morphology score + necrotic area score + osteoarthritis score. The highest score is 10 and the lowest is 0, with higher scores indicating more severe disease.

[0114] 6. Statistical methods

[0115] SPSS 21.0 software was used for statistical analysis. Continuous variables were expressed as mean ± standard deviation. Statistical description was performed. For data that conformed to the normal distribution, the grouped t-test was used to compare the means between groups, and the paired t-test was used to compare the means within groups. For data that did not conform to the normal distribution, the rank sum test was used. P < 0.05 was considered statistically significant.

[0116] 7. Results

[0117] 7.1 Comparison of clinical efficacy between the two groups based on X-ray film scores The difference in clinical efficacy between the two groups was statistically significant (P < 0.05), with the treatment group having a significantly better clinical efficacy than the control group (see Table 1).

[0118] Table 1 Comparison of clinical efficacy between the two groups of patients based on X-ray scores

[0119]

[0120] 7.2 Comparison of Harris hip scores before and after treatment in the two groups. One year after treatment, the hip function, deformity, range of motion, and pain scores in both groups were significantly improved (P < 0.05). One year after treatment, the hip function, pain, and range of motion scores in the observation group were significantly higher than those in the control group (P < 0.05). See Table 2.

[0121] Table 2 Comparison of Harris hip scores between the two groups before and after treatment

[0122]

[0123] Note: Compared with before treatment, *P < 0.05; compared with the control group, #P < 0.05

[0124] In summary, there was a significant difference in improving the symptoms of difficulty walking between the treatment group and the control group.

[0125] In summary, the effects of the present invention are: it can significantly relieve pain, and long-term use can also improve blood circulation in the femoral head, promote bone cell regeneration and repair, prevent bone loss, delay disease progression, and reduce the probability of surgery; it is easy to take, follows the use method of traditional Chinese medicine prescriptions, and patients can take it directly orally without complicated decoction or special taking methods. It is suitable for modern fast-paced life and is conducive to improving treatment compliance. It has shown good adaptability in clinical trials. Most of the drugs are natural Chinese medicinal materials, and reasonable compatibility reduces adverse reactions. Compared with some Western medicines, it has less burden on the patient's body, and the patient has high tolerance, which can better adhere to the treatment. , ensuring the continuity and stability of the treatment effect, by precisely regulating the proliferation and differentiation process of osteoblasts, and effectively inhibiting the excessive activity of osteoclasts, thereby significantly improving the bone microstructure of the femoral head, can promote the synthesis and mineralization of bone matrix, enhance the density and strength of trabeculae, reduce bone loss caused by the disease, effectively relieve the pain, limited movement and other symptoms caused by femoral head necrosis, delay the development of femoral head collapse and deformation, help patients restore hip joint function, improve the quality of life, provide patients with femoral head necrosis with practical and effective treatment methods, and improve the overall prognosis.

[0126] The above generally describes the present invention in detail. However, it is obvious to those skilled in the art that modifications or improvements may be made based on the present invention. Therefore, modifications or improvements that do not depart from the spirit of the present invention are within the scope of protection of the present invention.

Claims

1. A Chinese herbal combination for internal use for femoral head necrosis, characterized by: The raw materials of the traditional Chinese medicine combination for internal use for femoral head necrosis are: prepared rehmannia root, astragalus root, angelica root, salvia miltiorrhiza, oyster, drynaria root, millettia reticulata, and liquorice; The proportions of the raw materials are: 15g of Rehmannia root, 30g of Astragalus root, 12g of Angelica sinensis, 15g of Salvia miltiorrhiza, 30g of Oyster, 9g of Drynaria fortunei, 10g of Millettia reticulata, and 10g of Licorice root.

2. The Chinese medicine combination for treating femoral head necrosis according to claim 1, characterized in that: The usage of this Chinese medicine combination oral medicine for femoral head necrosis is: take an appropriate amount of Chinese medicine granules and place them in a clean cup, add a certain amount of warm boiled water, usually 150-200 ml, stir evenly, and take it while hot after the granules are completely dissolved. If the water temperature is too high, you can let it sit for a while and take it when the temperature is suitable.

3. A method for preparing a Chinese herbal combination oral medicine for treating femoral head necrosis, for preparing the Chinese herbal combination oral medicine for treating femoral head necrosis according to any one of claims 1 to 2, characterized in that: The preparation method of the traditional Chinese medicine combination for internal use for femoral head necrosis comprises the following steps: Step 1: pretreatment of raw materials; Step 2: Extraction; Step 3: Concentration; Step 4: drying; Step 5: granulation; Step 6: Granulation and grading; Step 7: Packaging.

4. The method for preparing a Chinese medicine combination for internal use for femoral head necrosis according to claim 3, characterized in that: The step 1, raw material pretreatment, includes: selecting Chinese herbal medicine slices that meet the quality standards, first purifying them to remove impurities, mud and sand, etc. According to the characteristics of the medicinal materials, some need to be cut into suitable slices, segments, blocks, etc. for subsequent extraction.

5. The method for preparing a Chinese medicine combination for internal use for femoral head necrosis according to claim 4, characterized in that: The step 2, extraction, includes: using a multifunctional extraction tank to perform extraction operations, selecting a suitable extraction process based on the properties of the active ingredients contained in the medicinal materials, if the water-soluble components are mostly water-soluble, using a water extraction process, adding an appropriate amount of water, heating to a suitable temperature and maintaining it for a certain time to allow the active ingredients to be fully dissolved, and for fat-soluble components, an alcohol extraction process can be selected. During the extraction process, parameters such as temperature, pressure, and time are precisely controlled to ensure the extraction effect. After the extraction is completed, the extract is filtered, the medicinal residue is removed, and a clarified extract is obtained.

6. The method for preparing a Chinese medicine combination for internal use for femoral head necrosis according to claim 5, characterized in that: The step three, concentration, includes: transferring the extract to a vacuum concentrator, utilizing a vacuum environment to lower the boiling point of the solution, and concentrating under low temperature conditions, thereby effectively reducing the degradation and loss of heat-sensitive components and ensuring the efficacy of the drug. By adjusting the vacuum degree and heating temperature, the extract is concentrated into a thick paste with an appropriate relative density, providing a suitable material state for subsequent granulation.

7. The method for preparing a Chinese medicine combination for internal use for femoral head necrosis according to claim 6, characterized in that: The fourth step, drying, comprises: conveying the concentrated thick paste to a spray drying tower, spraying the thick paste into fine droplets through an atomizer, and rapidly contacting the thick paste with hot air, causing water in the droplets to evaporate instantly and dry into powder, thereby rapidly converting the thick paste into dry raw material powder. The obtained powder has uniform particle size and good fluidity, which is conducive to subsequent granulation.

8. The method for preparing the Chinese medicinal combination for internal use for femoral head necrosis according to claim 7, characterized in that: The step 5, granulation, comprises: uniformly mixing the dried powder with an appropriate amount of auxiliary materials, adding an appropriate amount of adhesive to form a soft material, placing the soft material in a swing granulator, and mechanically driving the soft material through screens of different apertures to form granules by extruding. The screen of appropriate aperture can be selected according to product requirements to control the particle size; The step 5, granulation, further comprises: adding the dry powder, auxiliary materials and binder solution into a one-step granulator together, fluidizing the materials with the airflow in the equipment, spraying the binder at the same time, completing granulation during the fluidization and mixing process, and then drying, completing the mixing, granulation and drying operations in one step.

9. The method for preparing a traditional Chinese medicine combination for internal use for femoral head necrosis according to claim 8, characterized in that: The step six, granulation and grading, includes: if the prepared granules are sticky or uneven in size, granulation is required, and granules that are too large or too small are removed through equipment such as an oscillating screen to make the granules uniform in size. For traditional Chinese medicine granules with strict particle size requirements, grading screens can be used for grading to classify the granules into different specifications to ensure that the product quality meets the standards.

10. The method for preparing the Chinese herbal combination oral medicine for femoral head necrosis according to claim 9, characterized in that: The step seven, packaging, includes: using a granule packaging machine for packaging, setting the packaging dosage according to product specifications, quantitatively loading qualified traditional Chinese medicine granules into the packaging material, and completing operations such as sealing and labeling.

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