External traditional Chinese medicine composition for treating spinal degeneration as well as preparation method and application of external traditional Chinese medicine composition

Abstract

The invention relates to an external traditional Chinese medicine composition for treating spinal degeneration and a preparation method and application thereof, and relates to the technical field of traditional Chinese medicine, the external traditional Chinese medicine composition for treating spinal degeneration comprises the following raw materials by weight: 7-8 parts of fried fructus viticis, 7-8 parts of corydalis tuber, 7-8 parts of Chinese angelica, 5-6 parts of rheum officinale, 7-8 parts of Chinese redbud bark, 1-2 parts of red sage root, 2-3 parts of pawpaw, 1-2 parts of notopterygium root, and 1-2 parts of red peony root. The traditional Chinese medicine composition is prepared from 1-2 parts of radix angelicae, 1-2 parts of rhizoma wenyujin concisum, 1-2 parts of radix angelicae pubescentis, 1 / 2-1 part of radix gentianae macrophyllae, 1-2 parts of radix trichosanthis, 1-2 parts of radix cyathulae, 1 / 2-1 part of rhizoma chuanxiong, 1-2 parts of radix The formula provided by the invention has the effects of relaxing tendons and activating collaterals, dispelling wind and eliminating dampness, and promoting blood circulation to arrest pain, a safer, more effective and more convenient traditional Chinese medicine preparation is provided for treating spinal degeneration diseases, and a new treatment choice is provided for vast patients.

Description

Technical Field

[0001] The present application relates to the technical field of traditional Chinese medicine, and in particular to an external Chinese medicine composition for treating spinal degeneration, and a preparation method and application thereof. Background Art

[0002] Lumbar degenerative diseases usually include a series of diseases such as lumbar disc herniation, lumbar spinal stenosis, and lumbar spondylolisthesis. The occurrence of these diseases is mainly due to the degeneration of structures such as lumbar discs and facet joints with age, which leads to decreased stability of the lumbar spine, and then causes symptoms such as pain and limited activity. Modern medicine is still unclear about the pathogenesis of lumbar disc herniation (LDH) in lumbar degenerative diseases (LDD). From June 2017 to December 2018, the inventor presided over the "Clinical Study on the Treatment of Limb Fractures with External Use of Harbin Medical Traumatology Bonesetting Powder Combined with Elastic Polymer Tubular Gypsum" of Xinjiang Yili Prefecture Science and Technology Bureau. From March 2017 to December 2019, he participated in the project "Research on Preparation Process and Quality Control of Kazakh Agate Paste In-Hospital Preparation". The "Clinical Study on the Treatment of Lumbar Disc Herniation with "Traumatology Rehabilitation Powder"" submitted to the Yili Prefecture Science and Technology Bureau for approval in 2022 is being implemented. At present, it is believed that the occurrence and development of lumbar disc herniation is related to the apoptosis of nucleus pulposus cells and the matrix remodeling of the intervertebral disc. The function of the intervertebral disc tissue is mainly determined by the interstitial components. Intervertebral disc cells maintain the stability of the microenvironment by secreting and regulating interstitial components. Among them, changes in proteoglycan composition and content, collagen remodeling, and damage and changes in elastin are important mechanisms for the pathogenesis of LDH. Nucleus pulposus chondrocytes are the main active cells in the central nucleus pulposus of adult intervertebral discs. Their apoptosis and calcification cause changes in the morphology of the central nucleus pulposus and reduce their adaptability to the environment. It is generally believed that lumbar disc herniation is caused by intervertebral disc lesions, mechanical stress damage, immune inflammation, and metabolic imbalance of extracellular mechanisms.

[0003] The inventors conducted further research on the treatment of lumbar degenerative diseases with both traditional Chinese and Western medicine. The degree of degeneration of intervertebral discs, articular process cartilages, and paraspinal muscles was quantitatively evaluated by quantitative MRI, and the effects of abnormal changes in the above structures on the biomechanical homeostasis of lumbar motion segments were explored. Through systematic clinical + biomechanical research, the biomechanical mechanisms related to clinical phenomena are clarified. Clinical research and biomechanical research are common research methods for exploring risk factors and mechanisms related to the onset of orthopedic diseases. The study innovatively proposed a method of systematic clinical + biomechanical research, in which clinical and biomechanical mechanism research were carried out simultaneously, and the results of clinical research were used to directly guide biomechanical research as the basis for model construction in biomechanical research. At the same time, the results of biomechanical research were used to explain the mechanism of clinical observation phenomena. "Stepwise reduction of bony density in patients induces a higher risk of annular tears by deteriorating the local biomechanical environment" was published as the corresponding author in the national top spine journal ISSN1925-9430 "the spine joural" (medical zone 1) in December 2023. Modern medical treatments for LDH generally include education, weight loss, physical therapy, medication, and surgical treatment. Medication treatments often use analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), and nerve root injections of cortisol-like drugs, but long-term use can cause gastrointestinal irritation and increase the possibility of infection. Surgery is the treatment of choice when medical treatment is not satisfactory. However, the expert consensus clearly states that surgical treatment should be used after regular conservative treatment and minimally invasive treatment are ineffective. However, we have found in clinical practice that a large number of patients are reluctant to undergo surgical treatment, and some patients even refuse surgical treatment after conservative and minimally invasive treatments fail.

[0004] Lumbar degenerative diseases belong to the category of "lumbar arthralgia" in traditional Chinese medicine. The Neijing first proposed the etiology and pathogenesis of arthralgia, namely "the three qi of wind, cold and dampness are mixed and combined to form arthralgia". External evil enters through the skin and fur, and pain occurs when it is blocked. Insufficiency of liver and kidney, evil stagnates inside. The Neijing says "the righteous qi is inside, and evil cannot interfere. Where evil gathers, its qi must be weak", "the bone is the house of marrow. If you cannot stand for a long time, you will shake when you walk, and your bones will be exhausted". The waist is where the kidneys are located. The kidneys are responsible for bone and marrow production. If the congenital body is insufficient, the kidney essence will be lost due to strain, chronic disease, old age, or atrial and ventricular disorder, and pain will occur because of the loss of kidney essence. "The Standard of Diagnosis and Treatment" says: "There is wind, cold, sprain, blood stasis, and phlegm accumulation, all of which are solid, and kidney deficiency is the root cause". Liver and kidney deficiency, malnutrition of tendons and bones, lack of nourishment, pain, which is attributed to deficiency. Moreover, due to external pathogens, strain, sprains and falls, the metabolism of qi, blood and body fluids is disordered, which leads to pain due to blockage. This is attributed to excess. Blood stasis blocking the collaterals is the key factor in the onset of the disease.

[0005] At present, the main etiology and pathogenesis of lumbar arthritis are basically divided into two types. One is caused by deficiency, which is mostly caused by liver and kidney deficiency in middle-aged and elderly patients, who have no bone nourishment and tendons, and the invasion of wind, cold and dampness causes qi and blood stasis, which leads to bone degeneration over time; the other is caused by illness, which is mostly caused by sprains and falls, qi stagnation and blood stasis, which leads to liver and kidney deficiency, disharmony of blood vessels, and gradually develops lumbar arthritis. The traditional Chinese medicine has a history of more than 2,000 years in the treatment of this disease. In the long-term treatment practice and experience accumulation, it has been confirmed that the treatment of this disease with traditional Chinese medicine has the advantages of diverse methods, taking both symptoms and root causes into consideration, simple medication, convenient and economical, high efficiency, and few side effects. In addition, recent studies have shown that the compliance of patients with lumbar disc herniation is low, and some patients even reduce the dosage of drugs on their own to save money. It is difficult for patients with lumbar disc herniation to receive surgical treatment during the first diagnosis and treatment activities. Some patients even delay the early treatment of the disease due to rejection of surgical treatment, which makes the symptoms more aggravated. Therefore, choosing effective, low-cost and accepted early treatment is the optimal treatment method that people pursue.

[0006] In the Qing Dynasty, Wu Shiji proposed in "Lihua Pianwen": "The principle of external treatment is the principle of internal treatment, and the medicine for external treatment is also the medicine for internal treatment." "The Origin of Medicine" says that "the method of surgery is the most important external treatment." Traditional Chinese medicine external treatment has a long history and has its own characteristics and advantages in the treatment of patients with lumbar disc herniation. "There are various methods for the treatment of lumbar disc herniation with traditional Chinese medicine external treatment. The commonly used methods with more clinical reports include acupuncture, needle knife, massage, hot compress, fumigation, plaster application, external application of plaster, and Chinese medicine ion introduction. Summary of the invention

[0007] In order to solve the above problems, the present application provides a Chinese medicine composition for external use for treating spinal degeneration, and a preparation method and application thereof.

[0008] In a first aspect, the present application provides a Chinese medicine composition for external use for treating spinal degeneration, wherein the Chinese medicine composition for external use for treating spinal degeneration comprises the following raw materials in parts by weight:

[0009] Stir-fry 7-8 parts of Vitex rotundus, 7-8 parts of Corydalis yanhusuo, 7-8 parts of Angelica sinensis, 5-6 parts of Rhubarb, 7-8 parts of Bauhinia bark, 1-2 parts of Salvia miltiorrhiza, 2-3 parts of papaya, 1-2 parts of Notopterygium wilfordii, 1-2 parts of Red Peony Root, 1-2 parts of Angelica dahurica, 1-2 parts of Curcuma longa, 1-2 parts of Duhuo, 1 / 2-1 parts of Gentiana macrophylla, 1-2 parts of Radix Trichosanthis, 1-2 parts of Cyathula officinalis, 1 / 2-1 parts of Ligusticum chuanxiong, 1-2 parts of Clematis chinensis, 1-2 parts of Stephania tetrandra, and 1-2 parts of Saposhnikovia divaricata.

[0010] Furthermore, the external Chinese medicine composition for treating spinal degeneration comprises the following raw materials in parts by weight:

[0011] Stir-fry 8 parts of Vitex Mandibonis, 8 parts of Corydalis, 8 parts of Angelica, 6 parts of Rhubarb, 8 parts of Bauhinia Cortex, 2 parts of Salvia Miltiorrhiza, 3 parts of Chaenomeles sinensis, 2 parts of Notopterygium, 2 parts of Red Peony Root, 2 parts of Angelica Dahurica, 2 parts of Curcuma Sinensis, 2 parts of Angelicae Pubescentis, 1 part of Gentiana Macrophylla, 2 parts of Radix Trichosanthis, 2 parts of Cyathulae Bidentatae, 1 part of Ligusticum chuanxiong, 2 parts of Radix Clematidis, 2 parts of Tetrandrakia Tetrandrae, and 2 parts of Saposhnikovia divaricata.

[0012] In a second aspect, the present application provides a method for preparing the external Chinese medicine composition for treating spinal degeneration according to any one of the first aspects, the preparation method comprising the following steps:

[0013] Mixing and grinding the various Chinese medicinal materials to obtain a first medicinal powder;

[0014] Mixing the first medicine powder and the first auxiliary material to obtain the external Chinese medicine composition; or,

[0015] The various Chinese medicinal materials are mixed and crushed to obtain a first medicinal powder; honey or vaseline or paraffin is then added to obtain a paste-like mixture.

[0016] Furthermore, the weight ratio of the first medicinal powder to honey is (1-2.2):(2-2.1); the weight ratio of the composition, vaseline and hot water is: 1:0.4:2.

[0017] Furthermore, the first auxiliary material includes at least one of honey or vaseline; the mixture is mixed into fine powder or ultrafine powder by stirring, and then cooled. Micron-level crushing can increase the stability and bioavailability of the drug. The micron-level crushing methods include mechanical crushing, air flow crushing, and ultrasonic crushing.

[0018] In a third aspect, the present application provides the use of the external Chinese herbal composition for treating spinal degeneration as described in any one of the first aspect, and / or the external Chinese herbal composition for treating spinal degeneration prepared by the preparation method as described in any one of the second aspect in the preparation of products for treating spinal degenerative diseases.

[0019] In a fourth aspect, the present application provides a traditional Chinese medicine preparation for treating spinal degeneration, wherein the traditional Chinese medicine preparation for treating spinal degeneration comprises the external Chinese medicine composition for treating spinal degeneration described in any one of the first aspect, and / or the external Chinese medicine composition for treating spinal degeneration prepared by the preparation method described in any one of the second aspect.

[0020] Furthermore, the dosage form of the traditional Chinese medicine preparation for treating spinal degeneration includes at least one of a patch and an ointment.

[0021] The above technical solution provided by the embodiment of the present application has at least the following advantages compared with the prior art:

[0022] The embodiments of the present application provide a topical Chinese medicine composition for treating spinal degeneration, and its preparation method and application. The topical Chinese medicine composition rationally combines multiple Chinese medicines through the principle of compatibility of monarch, minister, assistant and envoy, so that each medicine produces a synergistic effect and acts together on the part of spinal degeneration. Through multiple mechanisms of action such as warming the meridians, promoting blood circulation and removing blood stasis, dispelling wind and dampness, relaxing muscles and activating collaterals, it improves local blood circulation, promotes metabolism, and reduces inflammatory reactions, thereby achieving the purpose of relieving and treating spinal degeneration. It can be made into topical preparations such as patches and ointments, providing a safer, more effective and convenient Chinese medicine preparation for the treatment of spinal degeneration, and providing a new treatment option for the majority of patients. Specifically:

[0023] 1) In the Chinese medicine formula provided by the present invention: the main medicine (main drug): stir-fried Vitex Mandi, Corydalis yanhusuo, and Angelica sinensis have the effects of warming and unblocking meridians, promoting blood circulation and removing blood stasis, and are the main drugs in the prescription for treating spinal degeneration. Vitex Mandi has the effects of dispersing wind-heat and clearing the head, and Corydalis yanhusuo can promote blood circulation, promote qi circulation, and relieve pain. These two medicinal ingredients may have analgesic effects and can relieve the pain symptoms caused by spinal degeneration; Angelica sinensis can nourish blood, promote blood circulation, regulate menstruation and relieve pain; these three together play a major therapeutic role; assistant medicines: rhubarb, Bauhinia bark, and Salvia miltiorrhiza; rhubarb can purge heat and clear the intestines, cool blood and detoxify; Bauhinia bark can promote blood circulation, promote qi circulation, and detoxify; Salvia miltiorrhiza can promote blood circulation and remove blood stasis, unblock meridians and relieve pain. These medicines assist the monarch medicine, enhance the therapeutic effect, and enhance the effects of promoting blood circulation, removing blood stasis, unblocking meridians and relieving pain; adjuvant medicines: papaya, notopterygium, red peony root, angelica dahurica, turmeric, angelica pubescens, gentiana macrophylla, radix trichosanthis, chuanxiong, ligusticum chuanxiong, radix clematis, stephania tetrandra, and saposhnikovia divaricata. These medicines have the effects of dispelling wind and dampness, relaxing muscles and tendons, activating meridians, strengthening tendons and bones. When used together with the monarch and minister medicines, they can enhance the efficacy, harmonize the medicinal properties, and assist the monarch and minister medicines to better play their roles.

[0024] 2) The external Chinese medicine composition for treating spinal degeneration provided by the present invention can be made into external preparations such as patches and ointments. The application forms of Chinese medicine external preparations, such as ointments and patches, can directly act on the lesion site and use the principle of transdermal absorption to improve the local permeability and effect of the drug, thereby providing a safer, more effective and more convenient Chinese medicine preparation for treating spinal degeneration, and providing a new treatment option for patients.

[0025] 3) The present invention selects Chinese medicinal materials with high permeability and stability as raw materials, optimizes the extraction process, improves the extraction rate and stability of drug components, scientifically combines, enhances drug efficacy, reduces side effects, innovates preparation dosage forms, and improves convenience and comfort of use. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application.

[0027] Figure 1A schematic flow chart of a method for preparing a topical Chinese medicine composition for treating spinal degeneration provided in Example 1 of the present application.

[0028] Figure 2 This is a schematic diagram of the process of using an external Chinese medicine composition for effect testing in Example 1 of the present application. DETAILED DESCRIPTION

[0029] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0030] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in this application can be purchased from the market or prepared by existing methods.

[0031] In view of the main defects of existing treatments for spinal degeneration diseases, the present invention provides a Chinese medicine composition for external use for treating spinal degeneration having at least the following characteristics:

[0032] 1. Therapeutic effect problem: Existing drugs for treating spinal degeneration may not achieve the desired therapeutic effect, or the therapeutic effect may be unstable; the Chinese medicine combination prescription provided by the present invention uses a variety of carefully matched Chinese herbal medicines and has been clinically used for many years, aiming to provide a more effective and stable therapeutic effect.

[0033] 2. Drug safety issues: Some existing drugs for treating spinal degeneration may have serious side effects and low safety to the human body; the present invention uses natural Chinese herbal medicines and a reasonable ratio to reduce drug side effects and improve drug safety. No serious skin allergies, drug toxicity, or other problems have occurred clinically.

[0034] 3. Drug action mechanism: The drugs in the prior art may have a single action mechanism and cannot fully address the various causes and pathological processes of spinal degeneration; the Chinese medicine combination prescription provided by the present invention combines multiple Chinese herbal medicines and may have multiple action mechanisms, which can more comprehensively address the complex causes and pathological processes of spinal degeneration. Clinical and experimental research is still ongoing.

[0035] 4. Issue of long-term treatment effect: Some existing drugs for treating spinal degeneration may only focus on short-term efficacy and ignore long-term treatment effects; the Chinese medicine combination prescription provided by the present invention pays more attention to long-term treatment effects and achieves long-term stable treatment effects by adjusting the internal environment of the body.

[0036] 5. Individual difference problem: Different patients have different responses and efficacy to drugs, which may lead to some drugs being effective for some patients but not effective for others. The Chinese medicine combination prescription provided by the present invention may be more inclusive and universal by comprehensively considering the characteristics and effects of multiple Chinese herbal medicines to meet the needs of different patients.

[0037] 6. Drug resistance problem: Long-term use of certain drugs may cause the body to develop drug resistance, which gradually weakens the efficacy of the drugs. The Chinese medicine combination prescription provided by the present invention can reduce the occurrence of drug resistance and maintain long-term efficacy through its unique formula and the synergistic effect of multiple ingredients.

[0038] 7. Problems in combining traditional therapies with modern medicine: Traditional Chinese medicine therapies and modern medicine may not be sufficiently integrated in some aspects; the Chinese medicine combination prescription provided by the present invention can be committed to combining traditional Chinese medicine theories with modern medical research results to create a drug combination that better meets modern treatment needs.

[0039] 8. Patient quality of life issues: Spinal degeneration not only affects the patient's physical health, but may also affect the patient's quality of life; the Chinese medicine combination prescription provided by the present invention can improve the patient's quality of life by improving the patient's pain, stiffness and other symptoms.

[0040] In order to solve the above problems or achieve the above beneficial effects, the technical solutions provided by the present invention are as follows:

[0041] In a first aspect, the present application provides a Chinese medicine composition for external use for treating spinal degeneration, wherein the Chinese medicine composition for external use for treating spinal degeneration comprises the following raw materials in parts by weight:

[0042] Stir-fry 7-8 parts of Vitex rotundus, 7-8 parts of Corydalis yanhusuo, 7-8 parts of Angelica sinensis, 5-6 parts of Rhubarb, 7-8 parts of Bauhinia bark, 1-2 parts of Salvia miltiorrhiza, 2-3 parts of papaya, 1-2 parts of Notopterygium wilfordii, 1-2 parts of Red Peony Root, 1-2 parts of Angelica dahurica, 1-2 parts of Curcuma longa, 1-2 parts of Duhuo, 1 / 2-1 parts of Gentiana macrophylla, 1-2 parts of Radix Trichosanthis, 1-2 parts of Cyathula officinalis, 1 / 2-1 parts of Ligusticum chuanxiong, 1-2 parts of Clematis chinensis, 1-2 parts of Stephania tetrandra, and 1-2 parts of Saposhnikovia divaricata.

[0043] The embodiments of the present application provide a topical Chinese medicine composition for treating spinal degeneration, and its preparation method and application. The topical Chinese medicine composition rationally combines multiple Chinese medicines through the principle of compatibility of monarch, minister, assistant and envoy, so that each medicine produces a synergistic effect and acts together on the part of spinal degeneration. Through multiple mechanisms of action such as warming the meridians, promoting blood circulation and removing blood stasis, dispelling wind and dampness, relaxing muscles and activating collaterals, it improves local blood circulation, promotes metabolism, and reduces inflammatory reactions, thereby achieving the purpose of relieving and treating spinal degeneration. It can be made into topical preparations such as patches and ointments, providing a safer, more effective and convenient Chinese medicine preparation for the treatment of spinal degeneration, and providing a new treatment option for the majority of patients. Specifically:

[0044] 1) In the Chinese medicine formula provided by the present invention: the main medicine (main drug): stir-fried Vitex Mandi, Corydalis yanhusuo, and Angelica sinensis have the effects of warming and unblocking meridians, promoting blood circulation and removing blood stasis, and are the main drugs in the prescription for treating spinal degeneration. Vitex Mandi has the effects of evacuating wind-heat and clearing the head, and Corydalis yanhusuo can promote blood circulation, promote qi circulation, and relieve pain. These two medicinal ingredients may have analgesic effects and can relieve the pain symptoms caused by spinal degeneration; Angelica sinensis can replenish blood, promote blood circulation, regulate menstruation and relieve pain; these three together play a major therapeutic role; assistant medicines: rhubarb, Bauhinia bark, and Salvia miltiorrhiza; rhubarb can purge heat and clear the intestines, cool blood and detoxify; Bauhinia bark can promote blood circulation, promote qi circulation, and detoxify; Salvia miltiorrhiza can promote blood circulation and remove blood stasis, unblock menstruation and relieve pain. These medicines assist the monarch medicine, enhance the therapeutic effect, and enhance the effects of promoting blood circulation, removing blood stasis, unblocking meridians and relieving pain; adjuvant medicines: papaya, notopterygium, red peony root, angelica dahurica, turmeric, angelica pubescens, gentiana macrophylla, radix trichosanthis, chuanxiong, ligusticum chuanxiong, radix clematis, stephania tetrandra, and saposhnikovia divaricata. These medicines have the effects of dispelling wind and dampness, relaxing muscles and tendons, activating meridians, strengthening tendons and bones. When used together with the monarch and minister medicines, they can enhance the efficacy, harmonize the medicinal properties, and assist the monarch and minister medicines to better play their roles.

[0045] 2) The external Chinese medicine composition for treating spinal degeneration provided by the present invention can be made into external preparations such as patches and ointments. The application forms of Chinese medicine external preparations, such as ointments, patches, etc., can directly act on the lesion site, and the principle of transdermal absorption can improve the local permeability and effect of the drug, thereby providing a safer, more effective and convenient Chinese medicine preparation for treating spinal degeneration, and providing a new treatment option for patients.

[0046] 3) The present invention selects Chinese medicinal materials with high permeability and stability as raw materials, optimizes the extraction process, improves the extraction rate and stability of drug components, scientifically combines, enhances drug efficacy, reduces side effects, innovates preparation dosage forms, and improves convenience and comfort of use.

[0047] In some specific embodiments, the external Chinese medicine composition for treating spinal degeneration comprises the following raw materials in parts by weight:

[0048] Stir-fry 8 parts of Vitex Mandibonis, 8 parts of Corydalis, 8 parts of Angelica, 6 parts of Rhubarb, 8 parts of Bauhinia Cortex, 2 parts of Salvia Miltiorrhiza, 3 parts of Chaenomeles sinensis, 2 parts of Notopterygium, 2 parts of Red Peony Root, 2 parts of Angelica Dahurica, 2 parts of Curcuma Sinensis, 2 parts of Angelicae Pubescentis, 1 part of Gentiana Macrophylla, 2 parts of Radix Trichosanthis, 2 parts of Cyathulae Bidentatae, 1 part of Ligusticum chuanxiong, 2 parts of Radix Clematidis, 2 parts of Tetrandrakia Tetrandrae, and 2 parts of Saposhnikovia divaricata.

[0049] In the second aspect, based on the same inventive concept, the present application provides a method for preparing the external Chinese medicine composition for treating spinal degeneration according to any one of the first aspects, the preparation method comprising the following steps:

[0050] Mixing and grinding the various Chinese medicinal materials to obtain a first medicinal powder;

[0051] Mixing the first medicine powder and the first auxiliary material to obtain the external Chinese medicine composition; or,

[0052] The various Chinese medicinal materials are mixed and crushed to obtain a first medicinal powder; honey or vaseline or paraffin is then added to obtain a paste-like mixture.

[0053] The preparation method of the external Chinese medicine composition for treating spinal degeneration provided in the embodiment of the present application is simple to operate and suitable for mass industrial production.

[0054] In some specific embodiments, the weight ratio of the first medicinal powder to honey is (1-2.2):(2-2.1); the weight ratio of the composition, vaseline and hot water is: 1:0.4:2.

[0055] In some specific embodiments, the first auxiliary material includes at least one of honey or vaseline; the mixture is mixed into fine powder or ultrafine powder by stirring, and then cooled. Micron-level crushing can increase the stability and bioavailability of the drug. The micron-level crushing methods include mechanical crushing, air flow crushing, and ultrasonic crushing.

[0056] It should be noted that, unless otherwise specified or specified, the various components involved in the external Chinese medicine composition for treating spinal degeneration provided in the embodiments of the present application can be commercially available products; at the same time, the steps and parameters involved in the preparation method can be carried out according to existing processes unless otherwise specified or specified.

[0057] In the third aspect, based on the same inventive concept, the present application provides the topical Chinese medicine composition for treating spinal degeneration as described in any one of the first aspect, and / or the use of the topical Chinese medicine composition for treating spinal degeneration prepared by the preparation method described in any one of the second aspect in the preparation of products for treating spinal degenerative diseases.

[0058] In the fourth aspect, based on the same inventive concept, the present application provides a Chinese medicine preparation for treating spinal degeneration, wherein the Chinese medicine preparation for treating spinal degeneration comprises the external Chinese medicine composition for treating spinal degeneration described in any one of the first aspect, and / or the external Chinese medicine composition for treating spinal degeneration prepared by the preparation method described in any one of the second aspect.

[0059] In some specific embodiments, the dosage form of the Chinese medicine preparation for treating spinal degeneration includes at least one of a patch and an ointment.

[0060] The present application will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are intended only to illustrate the present application and are not intended to limit the scope of the present application. The experimental methods for which specific conditions are not specified in the following examples are usually measured according to national standards. If there is no corresponding national standard, then the conditions recommended by the manufacturer are followed.

[0061] Example 1

[0062] This example provides a Chinese medicine composition for external use for treating spinal degeneration, such as Figure 1 and Figure 2 As shown, the external Chinese medicine composition for treating spinal degeneration comprises the following raw materials in parts by weight:

[0063] Stir-fry 8 parts of Vitex Mandibonis, 8 parts of Corydalis, 8 parts of Angelica, 6 parts of Rhubarb, 8 parts of Bauhinia Cortex, 2 parts of Salvia Miltiorrhiza, 3 parts of Chaenomeles sinensis, 2 parts of Notopterygium, 2 parts of Red Peony Root, 2 parts of Angelica Dahurica, 2 parts of Curcuma Sinensis, 2 parts of Angelicae Pubescentis, 1 part of Gentiana Macrophylla, 2 parts of Radix Trichosanthis, 2 parts of Cyathulae Bidentatae, 1 part of Ligusticum chuanxiong, 2 parts of Radix Clematidis, 2 parts of Tetrandrakia Tetrandrae, and 2 parts of Saposhnikovia divaricata.

[0064] The preparation method of the above-mentioned external Chinese medicine composition for treating spinal degeneration comprises the following steps:

[0065] Mixing and grinding the various Chinese medicinal materials to obtain a first medicinal powder;

[0066] Mixing the first medicinal powder and the first auxiliary material to obtain the external Chinese medicine composition;

[0067] The weight ratio of the first medicinal powder to the first auxiliary material is 1.5:2, and the first auxiliary material is honey.

[0068] Research methods: Selection of research subjects: The subjects of this test were patients diagnosed with lumbar disc herniation in the orthopedic outpatient clinic of the Ili Kazakh Autonomous Prefecture Traditional Chinese Medicine Hospital from March to November 2021.

[0069] Determination and grouping of sample cases: After preliminary tests, according to the sample size calculation method for comparison of multiple sample rates, the minimum sample size for each group is no less than 33 cases. According to the requirements of this test, the minimum sample size n = 33 × 2 = 66 cases is obtained; according to the statistical processing principle of actual sample size = minimum sample size × 20%, the actual sample size of this test is finally determined to be 80 cases. According to the test design, the above 80 samples are divided into 2 groups according to the random grouping scheme formulated in advance, namely treatment group 1 and treatment group 2, wherein treatment group 1 uses Xiaotong patch (Qizheng, a commercially available product) for external use, and treatment group 2 uses the external Chinese medicine composition for treating spinal degeneration provided in Example 1 to make a patch.

[0070] Diagnostic criteria:

[0071] Western medicine diagnostic criteria: Refer to the relevant content in the "Clinical Diagnosis and Treatment Guidelines - Orthopedics" (edited by the Chinese Medical Association, People's Medical Publishing House, 2009): (1) Lumbar pain combined with "sciatica", radiating to the calf or foot, and positive straight leg raising test; (2) There is obvious tenderness on the side of the L4, L5 or L5, S1 intervertebral ligament, and radiating pain to the calf or foot; (3) The skin sensation of the anterior or posterior lateral side of the calf is reduced, the toe muscle strength is reduced, and the Achilles tendon reflex on the affected side is reduced or absent; (4) X-ray examination: scoliosis, shallow lumbar lordosis, the diseased intervertebral disc may be narrowed, and there is bone hyperplasia at the corresponding edge. CT or MRI examination can show the location and degree of intervertebral disc herniation; Note: Comprehensive clinical and X-ray examinations, if 1+4 or 2+4 or 3+4 are met, lumbar disc herniation can be diagnosed.

[0072] TCM diagnostic criteria for lumbar disc herniation: TCM diagnostic criteria: refer to "Standards for Diagnosis and Efficacy of Diseases and Syndromes of Traditional Chinese Medicine Industry of the People's Republic of China ZY / T001.1-94"; (1) History of lumbar trauma, chronic strain or cold and dampness. Most patients have a history of chronic low back pain before the onset of the disease; (2) It often occurs in young and middle-aged people; (3) Low back pain radiates to the buttocks and lower limbs, and the pain worsens when abdominal pressure increases (such as coughing and sneezing); (4) Scoliosis, loss of lumbar physiological lordosis, tenderness at the vertebral level of the lesion, and radiates to the lower limbs, and limited lumbar movement; (5) Sensation is hypersensitive or dull in the affected nerve innervation area of ​​the lower limbs, and muscle atrophy may occur in patients with a long course of disease. Straight leg raising or strengthening test is positive, knee and Achilles tendon reflexes are weakened or disappeared, and the dorsiflexion force of the big toe is weakened; (6) X-ray examination: Scoliosis, loss of lumbar physiological lordosis, the lesioned intervertebral disc may be narrowed, and there is osteophyte hyperplasia on the adjacent edge. CT and MRI examinations can show the location and degree of intervertebral disc herniation; according to the characteristics of the disease in this area, the diagnostic criteria of TCM syndromes are improved and optimized - blood stasis and qi stagnation type: main symptoms: stabbing pain in waist and legs, pain in a certain place, lighter during the day and heavier at night, secondary symptoms: stiff waist, limited pitch and rotation, and refusal to press the painful area. The tongue is dark purple, or there are ecchymosis, and the pulse is tight or astringent.

[0073] Inclusion criteria: (1) Meet the Western medical diagnostic criteria for lumbar disc herniation; (2) Meet the traditional Chinese medicine diagnostic criteria for lumbar disc herniation; (3) Meet the traditional Chinese medicine syndrome diagnostic criteria for blood stasis and qi stagnation; (4) Patients aged 18 to 75 years diagnosed with lumbar disc herniation; (5) Understand the purpose of the trial and sign the informed consent.

[0074] Exclusion criteria: (1) Patients who do not meet the Western medicine and traditional Chinese medicine diagnostic criteria for lumbar disc herniation; (2) Patients who do not meet the diagnostic criteria of the blood stasis and qi stagnation type of traditional Chinese medicine syndrome; (3) Patients with other lumbar diseases such as spinal stenosis and cone instability; (4) Patients with other diseases affecting the waist, such as infection, psoriasis, syphilitic neuropathy, ochronosis, metabolic bone disease, acute trauma, etc.; (5) Women who are pregnant or preparing to become pregnant; (6) Patients with allergic constitution and allergies to multiple drugs; (7) Patients with serious life-threatening primary diseases such as cardiovascular, liver, kidney, hematopoietic system, endocrine system, and mental illness; (8) Patients with poor compliance and difficulty in making an accurate evaluation of the effectiveness and safety of the drugs; (9) Patients who have been taking other drugs for the treatment of lumbar disc herniation for a long time and are in the drug effect period and have not been washed off.

[0075] Exclusion criteria: (1) patients who did not meet the inclusion criteria or met the exclusion criteria and were mistakenly included; (2) patients who had never used the trial drug; (3) patients who had no data after randomization; (4) patients who were using contraindicated drugs.

[0076] Experimental drugs: (1) Drugs used for treatment of group 1: Xiaotong patch (Qi Zheng); (2) Drugs used for treatment of group 2: The external Chinese medicine composition for treating spinal degeneration provided in Example 1 was made into a patch.

[0077] Intervention plan: All patients in each experimental group were assigned to each group according to the corresponding random principle after enrollment, and were given corresponding drug intervention treatment. During the treatment, the drug was evenly applied on a 15*20cm gauze and then applied to the waist. It was retained on the affected area for 4 hours and then removed and the residual drug was cleaned with warm water. The above treatment method was used once a day, one week as a course of treatment, and two courses of treatment were continued. The "Standards for Diagnosis and Efficacy of Chinese Medicine Diseases and Syndromes", VAS score, lumbar JOA score scale, and Oswestry score scale were used to comprehensively evaluate the treatment effect 1 week and 2 weeks after treatment.

[0078] Trial drug packaging: Put 2 weeks of medication into a large box and add 30% more medication (5 patches). Trial drugs use a unified packaging and labeling format. The outer packaging label includes: clinical research approval number, drug number, drug name, function, etc.

[0079] Random coding of trial drugs: SAS statistical software was used to simulate the generation of random numbers. The trial group and the control group were allocated at a 1:1 ratio. The sponsor grouped the patients according to the random numbers and used the corresponding drugs.

[0080] Efficacy evaluation criteria: refer to the "Efficacy Criteria for Diagnosis and Treatment of TCM Diseases and Syndromes" and divide into four levels: clinical control, marked effect, effective, and ineffective. The details are as follows: (1) Clinical control: pain and other symptoms disappear, activities are normal, and the score is reduced by ≥90%; (2) Marked effect: pain symptoms basically disappear, functions are basically normal, and can participate in normal activities and work, and the score is reduced by ≥70%, <90%; (3) Effective: pain basically disappears, activities are slightly limited, and the ability to participate in activities or work is improved, and the score is reduced by ≥30%, <70%; (4) Ineffective: those who do not meet the effective standard. Note: The calculation formula uses the nimodipine method: [(pre-treatment score - post-treatment score) ÷ pre-treatment score] × 100%.

[0081] The evaluation criteria for the efficacy of the main symptoms and signs were formulated with reference to the "Effectiveness Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes", and were divided into four levels: clinical control, marked effect, improvement, and ineffectiveness. The details are as follows: (1) Clinical control: the main symptoms or signs disappeared or basically disappeared; (2) Marked effect: the main symptoms or signs improved significantly; (3) Improvement: the main symptoms or signs improved; (4) Ineffectiveness: the main symptoms or signs did not improve significantly.

[0082] The lumbar spine JOA scoring system was used to evaluate before and after treatment, and the results were assessed using the nimodipine method.

[0083] Oswestry was used to evaluate the improvement of patients' quality of life before and after treatment, and the nimodipine method was used to assess the results.

[0084] Quality control: Selection of diagnostic physicians: In order to ensure and meet the inclusion and exclusion of cases required for this test, after admission, the patient must be diagnosed with both Chinese and Western medicine by a TCM physician with the title of attending physician or above before the patient can be included in this test.

[0085] Selection of clinical observers: To ensure the smooth progress of this test and reduce bias and errors caused by human factors, clinical observers must undergo training and pass the assessment before the test is implemented before they can join the test group to undertake related work.

[0086] Statistical method: Two members of the test group entered the observation data using Microsoft Office Excel 2003 software; the statistical software used was SPSS 24.0 for Windows. Measurement data were expressed as mean ± standard deviation. Paired t-test was used for comparison between two groups and before and after treatment. One-way analysis of variance or analysis of variance for repeated measures was used for comparison between multiple groups. 2 Test or Wilcoxon rank-sum test; non-parametric test-comparison of multiple group rank / frequency table data was used for rank data, and the test level was α=0.05 (two-sided).

[0087] The test results are shown in Table 1.

[0088] Table 1

[0089]

[0090] In summary, the embodiments of the present application provide a Chinese medicine composition for external use for treating spinal degeneration, and its preparation method and application. The Chinese medicine composition for external use rationally combines multiple Chinese medicines through the principle of compatibility of monarch, minister, assistant and envoy, so that each medicine produces a synergistic effect and acts together on the degenerative part of the spine. Through multiple mechanisms of action such as warming and unblocking meridians, promoting blood circulation and removing blood stasis, dispelling wind and dampness, relaxing muscles and activating collaterals, improving local blood circulation, promoting metabolism, and reducing inflammatory reactions, the purpose of alleviating and treating spinal degeneration is achieved. It can be made into external preparations such as patches and ointments, providing a safer, more effective and convenient Chinese medicine preparation for treating spinal degeneration, and providing new treatment options for patients.

[0091] Various embodiments of the present application may be presented in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present application; therefore, the range description should be considered to have specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, the range description from 1 to 6 should be considered to have specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6, which apply regardless of the range. In addition, whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range.

[0092] In the present application, in the absence of any contrary description, the directional words used, such as "upper" and "lower", are specifically the directions of the drawings in the accompanying drawings. In addition, in the description of the present specification, the terms "including", "comprising", etc. refer to "including but not limited to". In this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply that there is any such actual relationship or order between these entities or operations. In this article, "and / or" describes the association relationship of the associated objects, indicating that there may be three relationships, for example, A and / or B, which can represent: A exists alone, A and B exist at the same time, and B exists alone. Wherein A, B can be singular or plural. In this article, "at least one" refers to one or more, and "plural" refers to two or more. "At least one", "at least one of the following" or similar expressions refer to any combination of these items, including any combination of singular or plural items. For example, "at least one of a, b, or c", or "at least one of a, b, and c", can both mean: a, b, c, ab (i.e., a and b), ac, bc, or abc, where a, b, c can be single or plural, respectively.

[0093] The above description is only a specific implementation of the present application, so that those skilled in the art can understand or implement the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to the embodiments shown herein, but will conform to the widest range consistent with the principles and novel features applied for herein.

Claims

1. A Chinese medicine composition for external use for treating spinal degeneration, characterized in that: The external Chinese medicine composition for treating spinal degeneration comprises the following raw materials in parts by weight: Stir-fry 7-8 parts of Vitex rotundus, 7-8 parts of Corydalis yanhusuo, 7-8 parts of Angelica sinensis, 5-6 parts of Rhubarb, 7-8 parts of Bauhinia bark, 1-2 parts of Salvia miltiorrhiza, 2-3 parts of papaya, 1-2 parts of Notopterygium wilfordii, 1-2 parts of Red Peony Root, 1-2 parts of Angelica dahurica, 1-2 parts of Curcuma longa, 1-2 parts of Duhuo, 1 / 2-1 parts of Gentiana macrophylla, 1-2 parts of Radix Trichosanthis, 1-2 parts of Cyathula officinalis, 1 / 2-1 parts of Ligusticum chuanxiong, 1-2 parts of Clematis chinensis, 1-2 parts of Stephania tetrandra, and 1-2 parts of Saposhnikovia divaricata.

2. The external Chinese medicine composition for treating spinal degeneration according to claim 1, characterized in that: The external Chinese medicine composition for treating spinal degeneration comprises the following raw materials in parts by weight: Stir-fry 8 parts of Vitex Mandibonis, 8 parts of Corydalis, 8 parts of Angelica, 6 parts of Rhubarb, 8 parts of Bauhinia Cortex, 2 parts of Salvia Miltiorrhiza, 3 parts of Chaenomeles sinensis, 2 parts of Notopterygium, 2 parts of Red Peony Root, 2 parts of Angelica Dahurica, 2 parts of Curcuma Sinensis, 2 parts of Angelicae Pubescentis, 1 part of Gentiana Macrophylla, 2 parts of Radix Trichosanthis, 2 parts of Cyathulae Bidentatae, 1 part of Ligusticum chuanxiong, 2 parts of Radix Clematidis, 2 parts of Tetrandrakia Tetrandrae, and 2 parts of Saposhnikovia divaricata.

3. A method for preparing the external Chinese medicine composition for treating spinal degeneration according to claim 1 or 2, the preparation method comprising the following steps: Mixing and grinding the various Chinese medicinal materials to obtain a first medicinal powder; Mixing the first medicinal powder and the first auxiliary material to obtain the external Chinese medicine composition; or, The various Chinese medicinal materials are mixed and crushed to obtain a first medicinal powder; honey or vaseline or paraffin is then added to obtain a paste-like mixture.

4. The method for preparing the external Chinese medicine composition for treating spinal degeneration according to claim 3, characterized in that: The weight ratio of the first medicinal powder to honey is (1-2.2):(2-2.1); the weight ratio of the composition, vaseline and hot water is: 1:0.4:

2.

5. The method for preparing the external Chinese medicine composition for treating spinal degeneration according to claim 3, characterized in that: The first auxiliary material includes at least one of water, honey and paraffin oil.

6. Use of the Chinese medicinal composition for external use for treating spinal degeneration according to claim 1 or 2, and / or the Chinese medicinal composition for external use obtained by the preparation method according to any one of claims 3 to 5 in preparing products for treating spinal degenerative diseases.

7. A Chinese medicine preparation for treating spinal degeneration, characterized in that: The Chinese medicine preparation for treating spinal degeneration comprises the external Chinese medicine composition for treating spinal degeneration according to claim 1 or 2, and / or the external Chinese medicine composition obtained by the preparation method according to any one of claims 3 to 5.

8. The Chinese medicinal preparation for treating spinal degeneration according to claim 7, characterized in that: The dosage form of the traditional Chinese medicine preparation for treating spinal degeneration includes at least one of a patch and an ointment.

Images