A traditional Chinese medicine composition and preparation for treating cervical spondylotic radiculopathy and a preparation method thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating nerve root type cervical spondylosis, preparation and preparation method thereof.The traditional Chinese medicine composition includes peach kernel, safflower, chuanqiong, angelica, wind-preventing plant, catmint, turmeric, qianghuo, baizhi, vitex, danshen, suomu, frankincense, myrrh and kudzu root.The traditional Chinese medicine composition can be made into various kinds of pharmaceutical preparations according to conventional process.The composition and its preparation can regulate qi and blood, dredge meridians, improve physiological curvature of cervical vertebra, reduce nerve root compression, relieve neck and shoulder pain, promote local blood circulation, significantly improve upper limb numbness and motor dysfunction, have significant curative effect and long-lasting effect, have the advantages of simple, safe and economical, etc., can be used as an important supplementary means for treating nerve root type cervical spondylosis, help to reduce the treatment burden of patients, meet their diversified treatment needs.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition, preparation, and preparation method for treating cervical spondylosis of the nerve root type. Background Technology

[0002] Cervical spondylotic radiculopathy (CSR) is a chronic degenerative disease characterized by cervical intervertebral disc degeneration, bone hyperplasia, ligament ossification, and joint structural disorder. It is one of the most common degenerative diseases among middle-aged and elderly people. Due to cervical spine instability or degeneration leading to nerve root compression, this disease often manifests as neck and shoulder pain, upper limb numbness, radiating pain, and limited mobility, severely impacting patients' quality of life and work capacity. With the prevalence of sedentary office work, prolonged head-down operation, and electronic device use, coupled with an aging population, the incidence of cervical spondylotic radiculopathy is increasing year by year and showing a significant trend towards affecting younger people, making it one of the major chronic diseases threatening public health.

[0003] Currently, clinical treatment for cervical radiculopathy mainly includes Western medicine, physical rehabilitation, and traditional Chinese medicine intervention. Western medicine treatment primarily includes nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, muscle relaxants, and neurotrophic drugs. While these can control inflammation and relieve pain in the short term, long-term use may cause severe gastrointestinal reactions and liver and kidney damage, and symptoms are prone to relapse after discontinuation, resulting in poor maintenance of efficacy. Conventional physical therapy and rehabilitation methods such as traction, physiotherapy, acupuncture, and electrical stimulation can indeed improve local muscle tension and blood circulation, but their efficacy is overly dependent on individual differences, has a limited duration, and is difficult to maintain long-term. Minimally invasive or surgical decompression is suitable for patients with severe lesions or significant nerve compression. Although it can directly relieve compression, it involves significant trauma, a long recovery period, numerous complications, and a heavy economic burden. Therefore, while current Western medicine treatments can effectively control symptoms in the short term, overall efficacy is unstable, recurrence rates are high, and long-term adherence is poor.

[0004] Numerous studies have indicated that simple drug or surgical interventions are insufficient to fundamentally improve the degenerative mechanisms and resolve microcirculatory disturbances in cervical radiculopathy. Against this backdrop, the integration of traditional Chinese and Western medicine in the treatment of cervical radiculopathy has become a significant trend in recent years. Traditional Chinese medicine considers this disease to fall under the categories of "cervical obstruction" and "stiff neck," with the core pathogenesis being "qi stagnation and blood stasis, meridian obstruction, and malnourishment of tendons and bones." Treatment should focus on "activating blood circulation and removing blood stasis, dispelling wind and unblocking meridians, and tonifying the liver and kidneys." Clinical research and practice have shown that traditional Chinese medicine intervention can improve local blood circulation, reduce inflammatory responses, and regulate nerve function through multi-target comprehensive regulation, demonstrating holistic and long-term stable potential. This theory aligns with the pathological mechanism revealed by modern medicine as "inflammation—oxidative stress—microcirculatory disturbance—nerve function damage."

[0005] However, existing traditional Chinese medicine formulas and integrated traditional Chinese and Western medicine treatments still have certain limitations in practical application: First, insufficient targeting. Most formulas focus on dispelling wind and dampness or simply promoting blood circulation, lacking systematic and targeted formulation design for the common "qi stagnation and blood stasis syndrome" in cervical spondylosis of nerve root type, making it difficult to simultaneously address the dual regulation of "promoting qi and relieving pain" and "removing blood stasis and unblocking collaterals." Second, complex formula structures and inconvenient use. Some traditional formulas contain numerous ingredients, are cumbersome to prepare, and have difficult-to-standardize dosages, resulting in poor patient compliance with long-term use, thus limiting the clinical promotion of these formulas. Third, lack of standardization and quality control. Currently, most formulas are still based on clinical experience, lacking unified preparation processes and quantitative systems for effective components, leading to efficacy that is easily affected by differences in raw materials and processes, resulting in insufficient stability. Fourth, weak mechanistic research. At present, there is a lack of modern scientific verification based on systems pharmacology, inflammatory signaling pathways, and neuroprotective mechanisms, making it difficult to provide sufficient experimental support for their efficacy.

[0006] In long-term clinical practice, traditional Chinese medicine orthopedic physicians have accumulated rich experience based on syndrome differentiation and treatment, especially in the treatment of "qi stagnation and blood stasis syndrome" in cervical spondylosis of the nerve root type, with significant clinical efficacy. Clinical observations show that formulas for promoting blood circulation, removing blood stasis, dispelling wind, and unblocking collaterals can effectively relieve symptoms such as neck and shoulder stiffness, pain, numbness, and limited mobility, significantly improving patients' quality of life. However, these empirical formulas are mostly self-prescribed by physicians. Although their efficacy is certain, they lack systematic pharmacological and standardized process verification, affecting their promotion and industrialization. Based on the above, existing technologies in the treatment of cervical spondylosis of the nerve root type still have problems such as unstable efficacy, inconvenient administration, insufficient standardization, and high costs, making it difficult to meet the needs of long-term clinical management and patient rehabilitation. Summary of the Invention

[0007] The technical problem to be solved by this invention is to provide a traditional Chinese medicine composition, preparation, and preparation method for treating cervical spondylosis of the nerve root type, which addresses both the symptoms and the root cause, aiming to regulate the body's yin-yang balance, improve the patient's overall constitution, and reduce recurrence. To this end, this invention adopts the following technical solution:

[0008] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating cervical spondylosis of the nerve root type, comprising the following components in parts by weight: 10-20 parts of peach kernel, 10-20 parts of safflower, 10-20 parts of chuanxiong rhizome, 12-20 parts of angelica root, 15-20 parts of saposhnikovia root, 12-15 parts of schizonepeta, 15-20 parts of turmeric, 15-20 parts of notopterygium root, 10-15 parts of angelica root, 10-15 parts of vitex fruit, 15-20 parts of salvia root, 12-15 parts of sappanwood, 10-15 parts of frankincense, 10-15 parts of myrrh, and 20-35 parts of kudzu root.

[0009] In at least one embodiment, the traditional Chinese medicine composition comprises the following components in parts by weight: 10 parts peach kernel, 10 parts safflower, 10 parts chuanxiong rhizome, 12 parts angelica root, 15 parts saposhnikovia root, 12 parts schizonepeta, 15 parts turmeric, 15 parts notopterygium root, 10 parts angelica root, 10 parts vitex fruit, 15 parts salvia root, 12 parts sappanwood, 10 parts frankincense, 10 parts myrrh, and 30 parts kudzu root.

[0010] Secondly, the present invention provides a pharmaceutical preparation, which is a traditional Chinese medicine preparation made from the above-mentioned traditional Chinese medicine composition as raw material.

[0011] In at least one embodiment, the pharmaceutical preparation comprises an aqueous or alcoholic extract of the active pharmaceutical ingredient.

[0012] In at least one embodiment, the pharmaceutical preparation further comprises pharmaceutically acceptable excipients.

[0013] In at least one embodiment, the dosage form of the traditional Chinese medicine preparation includes decoction, oral liquid, ointment, pill, powder, tablet or capsule.

[0014] Thirdly, the present invention provides a method for preparing the above-mentioned pharmaceutical preparation, which involves first obtaining an extract from the raw material by water extraction, and the extract can be used as a pharmaceutical preparation or made into other traditional Chinese medicine dosage forms.

[0015] In at least one embodiment, the water extraction method is as follows: the raw material is decocted with water several times, filtered, and finally the filtrates obtained from each decoction are combined.

[0016] In at least one embodiment, the decoction is performed 1-3 times, each decoction lasts 1-2 hours, and the amount of water added each time is 5-15 times the total weight of the raw materials.

[0017] In at least one embodiment, the ingredients are soaked in water for 20-60 minutes before the first decoction.

[0018] Compared with the prior art, the present invention can achieve at least the following beneficial effects:

[0019] 1. The composition and preparation of the present invention can regulate qi and blood, dredge meridians, improve the physiological curvature of the cervical spine, reduce nerve root compression, relieve neck and shoulder pain, promote local blood circulation, significantly improve upper limb numbness and motor dysfunction, have significant curative effect and long-lasting effect, reduce patients' dependence on conventional drugs, and improve quality of life.

[0020] 2. The herbs such as Chuanxiong and Danggui in the formula of this invention can promote blood circulation, remove blood stasis, clear the meridians and dispel wind, improve the nutritional supply of the cervical intervertebral disc, delay the degeneration of the intervertebral disc and the formation of bone spurs, and have a significant effect on improving the Cobb angle of the C2–C7 cervical spine, thereby relieving pain and numbness caused by nerve root compression from the root.

[0021] 3. This invention improves the symptoms of cervical spondylosis of the nerve root type by promoting blood circulation and removing blood stasis, relaxing muscles and tendons, reducing neck pain and upper limb numbness, improving muscle weakness, promoting nerve blood supply and nerve function recovery, and restoring normal cervical spine function.

[0022] 4. This invention uses natural herbal ingredients, with extremely low side effects and high safety, making it suitable for long-term use. It is also applicable to elderly patients and patients with chronic diseases such as hypertension and diabetes. The drug is inexpensive, with a small economic burden, and is easy to adhere to for long-term treatment.

[0023] 5. This invention integrates traditional Chinese medicine theory with modern pharmacological research, and the synergistic effect of multiple drugs results in definite efficacy, long-lasting effect, good safety and strong economy, providing a safe, effective, economical and long-term new treatment plan for cervical spondylosis of nerve root type. Detailed Implementation

[0024] Cervical radiculopathy (CSR) is a common degenerative spinal disease, mainly characterized by nerve root compression due to cervical degeneration, leading to neurological symptoms such as neck pain, stiffness, radiating pain in the upper limbs, numbness, and decreased muscle strength. This disease severely impacts patients' daily life, work ability, and quality of life. With an aging population and the increase in prolonged poor posture, the incidence of CSR is rising year by year and showing a trend towards affecting younger people. Currently, common treatments include medication, physical therapy, and surgery, but these methods still have limitations to some extent, particularly in relieving chronic pain, improving nerve function, and restoring the physiological curvature of the cervical spine. Against this backdrop, traditional Chinese medicine (TCM) formulas, as a multi-component, multi-target treatment method, can comprehensively improve the symptoms of CSR through mechanisms such as regulating Qi and blood, unblocking meridians, and promoting blood circulation. TCM, through its internal holistic regulatory effects, promotes the functional recovery of the cervical intervertebral discs and facet joints, relieving nerve root compression symptoms. Traditional Chinese medicine (TCM) treatment for cervical spondylosis of the nerve root type has advantages such as simplicity, safety, and economy, and is gradually becoming an important supplementary means of treating this disease, helping to reduce the treatment burden on patients and meet their diverse treatment needs. Based on this, the present invention provides a TCM composition, a TCM preparation, and its preparation method according to the following specific embodiments.

[0025] First, this invention provides a traditional Chinese medicine composition for treating cervical spondylosis of the nerve root type (hereinafter referred to as "Cervical Spondylosis Formula No. 1"), comprising the following components by weight: 10-20 parts peach kernel, 10-20 parts safflower, 10-20 parts chuanxiong rhizome, 12-20 parts angelica root, 15-20 parts saposhnikovia root, 12-15 parts schizonepeta, 15-20 parts turmeric, 15-20 parts notopterygium root, 10-15 parts angelica root, 10-15 parts vitex fruit, 15-20 parts salvia root, 12-15 parts sappanwood, 10-15 parts frankincense, 10-15 parts myrrh, and 20-35 parts kudzu root. The above composition is most commonly prepared as a decoction, but can also be further processed into various traditional Chinese medicine preparations; the dosage of the components in the formula can be flexibly adjusted according to the individual patient's condition during administration. Here, the inventor also provides a most commonly used formula, by weight, which specifically includes the following components: 10 parts peach kernel, 10 parts safflower, 10 parts chuanxiong rhizome, 12 parts angelica root, 15 parts saposhnikovia root, 12 parts schizonepeta, 15 parts turmeric, 15 parts notopterygium root, 10 parts angelica root, 10 parts vitex fruit, 15 parts salvia root, 12 parts sappanwood, 10 parts frankincense, 10 parts myrrh, and 30 parts kudzu root.

[0026] The above-mentioned components are common Chinese medicinal materials in this field. Their sources can be found in the Chinese Pharmacopoeia, the Dictionary of Traditional Chinese Medicine, etc., as detailed below:

[0027] Peach kernel is the dried, mature seed of the peach or wild peach plant, belonging to the Rosaceae family. It is neutral in nature, bitter and sweet in taste, and enters the heart, liver, and large intestine meridians. Its functions include promoting blood circulation and removing blood stasis, moistening the intestines and relieving constipation, and stopping coughs and asthma.

[0028] Safflower is the dried flower of the safflower plant (Carthamus tinctorius), belonging to the Asteraceae family. It is warm in nature, pungent in taste, and enters the heart and liver meridians. Its functions include promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain.

[0029] - Chuanxiong (Ligusticum striatum) is the dried rhizome of the plant Ligusticum striatum, belonging to the Apiaceae family. It is warm in nature, pungent in taste, and enters the liver, gallbladder, and pericardium meridians. Its functions include promoting blood circulation, regulating qi, dispelling wind, and relieving pain.

[0030] Angelica sinensis is the dried root of the plant Angelica sinensis, belonging to the Apiaceae family. It is warm in nature, sweet and pungent in taste, and enters the liver, heart, and spleen meridians. Its functions include nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements.

[0031] - Saposhnikovia root, the dried root of the plant Saposhnikovia divaricata, belonging to the Apiaceae family. It is slightly warm in nature, pungent and sweet in taste, and enters the bladder, liver, and spleen meridians. Its functions include dispelling wind and relieving exterior syndromes, eliminating dampness and relieving pain, and stopping spasms.

[0032] -Nepeta cataria, the dried aerial parts of the plant Nepeta cataria, belonging to the Lamiaceae family. It is slightly warm in nature, pungent in taste, and enters the lung and liver meridians. Its functions include dispelling wind and relieving exterior symptoms, promoting rash eruption and eliminating sores, and stopping bleeding (when charred).

[0033] Turmeric is the dried rhizome of the turmeric plant (Zingiberaceae family). It is warm in nature, pungent and bitter in taste, and enters the spleen and liver meridians. Its functions include promoting blood circulation, regulating qi, and relieving pain.

[0034] Notopterygium root (Qianghuo) is the dried rhizome and root of *Notopterygium incisum* or *Notopterygium latanifolium*, both belonging to the Apiaceae family. It is warm in nature, pungent and bitter in taste, and enters the bladder and kidney meridians. Its functions include relieving exterior syndromes, dispelling cold, eliminating wind and dampness, and relieving pain.

[0035] - Angelica dahurica is the dried root of Angelica dahurica or Angelica dahurica var. hainanensis, both belonging to the Apiaceae family. It is warm in nature, pungent in taste, and enters the lung, stomach, and large intestine meridians. Its functions include relieving exterior syndromes and dispelling cold, dispelling wind and relieving pain, clearing nasal passages, drying dampness and stopping leukorrhea, and reducing swelling and draining pus.

[0036] Vitex trifolia fruit, the dried, mature fruit of Vitex trifolia or Vitex negundo, a plant in the Verbenaceae family. It is slightly cold in nature, pungent and bitter in taste, and enters the bladder, liver, and stomach meridians. Its functions are to disperse wind-heat and clear the head and eyes.

[0037] -Salvia miltiorrhiza, the dried root and rhizome of the plant Salvia miltiorrhiza in the Lamiaceae family. It is slightly cold in nature, bitter in taste, and enters the heart and liver meridians. Its functions include promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling.

[0038] - Sappanwood is the dried heartwood of the legume Sappanwood. It is neutral in nature, sweet, salty, and pungent in taste, and enters the heart, liver, and spleen meridians. Its functions include promoting blood circulation, removing blood stasis, reducing swelling, and relieving pain.

[0039] Frankincense is the resin exuded from the bark of the frankincense tree (Boswellia carterii) and related species, belonging to the Burseraceae family. It is warm in nature, pungent and bitter in taste, and enters the heart, liver, and spleen meridians. Its functions include promoting blood circulation, relieving pain, reducing swelling, and promoting tissue regeneration.

[0040] Myrrh is the oleoresin exuded from the bark of the myrrh tree (a plant in the Burseraceae family) and related species. It is neutral in nature, pungent and bitter in taste, and enters the heart, liver, and spleen meridians. Its functions include dispersing blood stasis, relieving pain, reducing swelling, and promoting tissue regeneration.

[0041] Kudzu root is the dried root of the kudzu plant (Pueraria lobata), a legume. It is cool in nature, sweet and pungent in taste, and enters the spleen, stomach, and lung meridians. Its functions include relieving muscle tension and reducing fever, promoting body fluid production and quenching thirst, promoting rash eruption, raising yang and stopping diarrhea, clearing the meridians and activating blood circulation, and detoxifying alcohol.

[0042] In this invention's prescription: Ligusticum chuanxiong and Saposhnikovia divaricata are the principal herbs, primarily used to invigorate blood circulation, remove blood stasis, dispel wind, and relieve pain. Ligusticum chuanxiong is pungent and warm, dispersing and excelling at promoting qi and blood circulation, dispelling wind, and relieving pain, making it a key herb for treating qi stagnation and blood stasis. Saposhnikovia divaricata is pungent, sweet, and slightly warm, dispelling wind, relieving exterior symptoms, eliminating dampness, and relieving pain. It assists Ligusticum chuanxiong in clearing the meridians and collaterals, ensuring smooth flow of qi and blood, resolving stagnation, eliminating wind-evil, and relieving pain. The combination of these two herbs not only invigorates qi and blood circulation but also dispels wind and clears the meridians, treating both the root cause and the symptoms, making them the main herbs in the prescription. Peach kernel, safflower, frankincense, myrrh, sappanwood, and salvia miltiorrhiza are the assistant herbs. All these herbs invigorate blood circulation, remove blood stasis, reduce swelling, and relieve pain, assisting the principal herbs in strengthening their effects of removing blood stasis, clearing the meridians, reducing swelling, and relieving pain. Peach kernel and safflower work synergistically to break up blood stasis and promote new blood production; frankincense and myrrh work together to invigorate blood circulation, relieve pain, reduce swelling, and calm pain; sappanwood and salvia miltiorrhiza help to clear the meridians and remove blood stasis. The combined use of the assistant herbs enhances the overall formula's ability to invigorate blood circulation, remove blood stasis, reduce swelling, and relieve pain, thus clearing blockages and alleviating pain. Kudzu root, Notopterygium root, Angelica dahurica, Curcuma longa, Angelica sinensis, and Schizonepeta tenuifolia serve as adjuvant herbs. Kudzu root relaxes muscles and tendons, relieves stiffness in the neck and shoulders; Notopterygium root dispels wind and dampness, clears the meridians, and relieves pain, effectively treating upper limb and neck pain; Angelica dahurica dispels wind and relieves pain, clears the orifices, and disperses nodules; Curcuma longa promotes qi circulation, breaks up blood stasis, relieves pain, and clears the meridians; Angelica sinensis nourishes and invigorates blood, harmonizes the body's vital energy; Schizonepeta tenuifolia dispels wind and relieves stagnation, and penetrates the meridians. The synergistic effect of these herbs promotes the flow of qi and blood in the meridians, dispels wind and dampness, and relieves pain and soothes the neck. The adjuvant herbs not only assist the principal and assistant herbs in invigorating blood circulation, removing blood stasis, clearing the meridians, and relieving pain, but also harmonize qi and blood, dispel wind, and nourish the meridians. The combined effects of all the herbs in the formula work together to invigorate blood circulation, remove blood stasis, dispel wind, clear the meridians, reduce swelling, and relieve pain. The principal herb promotes qi and blood circulation, dispels wind, and relieves pain; the assistant herbs help remove blood stasis, unblock the meridians, reduce swelling, and alleviate pain; the adjuvant herbs further regulate qi and blood, dispel wind, and nourish the meridians, thus addressing both the root cause and the symptoms, and harmonizing qi and blood. The combined effects of these herbs ensure that qi and blood flow smoothly, the meridians are unblocked, and pain is relieved. They dispel wind and dampness, unblock the meridians, and thus achieve the effects of clearing the meridians, relieving neck pain, and restoring the smooth flow of qi and blood.

[0043] Using the above composition as the raw material, not only can it be formulated into decoctions, but it can also be formulated into other common traditional Chinese medicine preparations according to conventional processes. These traditional Chinese medicine preparations include liquid, semi-solid, or solid dosage forms. These forms of pharmaceutical preparations contain the traditional Chinese medicine composition of this invention or its extracts as active ingredients, and may also contain pharmaceutically acceptable excipients. The extracts are mainly water extracts or alcohol extracts. The active ingredient can be compounded with commonly used non-toxic pharmaceutical excipients to formulate decoctions, oral liquids, drops, ointments, pills, powders, tablets, capsules, and any other usable dosage forms.

[0044] Secondly, this invention provides a method for preparing a traditional Chinese medicine preparation for treating cervical spondylosis of the nerve root type. The method involves first obtaining an extract from the aforementioned raw materials using a water extraction method, and then using the extract as a pharmaceutical preparation, or preparing the extract into other traditional Chinese medicine dosage forms. The water extraction method involves soaking the raw materials in water, then decocting them several times, and finally combining the decoctions obtained from each decoction. The resulting decoction is the soup. The amount of water added is 5-15 times the total weight of the raw materials; the soaking time is 20-60 minutes; the number of decoctions is 1-3 times; and the decoction time is 1-2 hours. It should be noted that the soaking is only performed before the first decoction; after each decoction, the liquid must be filtered and reserved for later use. The dregs after decoction are then added to 5-15 times their weight of water for the next decoction (when multiple decoctions are required); the decoction time is generally started from the time of boiling.

[0045] Furthermore, the present invention provides several specific embodiments to further illustrate the composition and preparation method of the active pharmaceutical ingredient in the above-mentioned pharmaceutical preparation for treating cervical radiculopathy, specifically as follows:

[0046] Example 1

[0047] (1) Weigh the raw materials according to the following weight parts: 10 parts of peach kernel, 10 parts of safflower, 10 parts of chuanxiong rhizome, 12 parts of angelica root, 15 parts of saposhnikovia root, 12 parts of schizonepeta, 15 parts of turmeric, 15 parts of notopterygium root, 10 parts of angelica root, 10 parts of vitex fruit, 15 parts of salvia root, 12 parts of sappanwood, 10 parts of frankincense, 10 parts of myrrh, and 30 parts of kudzu root;

[0048] (2) Soak the raw materials in water, then decoct them several times, and finally combine the decoctions obtained from each decoction and filter them to obtain a decoction; wherein, the amount of water added is 10 times the total weight of the raw materials; the soaking time is 40 minutes; the number of decoctions is 2; and the decoction time is 1.5 hours.

[0049] Example 2

[0050] (1) Weigh the raw materials according to the following weight parts: 10 parts of peach kernel, 15 parts of safflower, 20 parts of chuanxiong rhizome, 12 parts of angelica root, 18 parts of saposhnikovia root, 15 parts of schizonepeta, 15 parts of turmeric, 18 parts of notopterygium root, 15 parts of angelica root, 10 parts of vitex fruit, 18 parts of salvia root, 15 parts of sappanwood, 10 parts of frankincense, 12 parts of myrrh, and 35 parts of kudzu root;

[0051] (2) Soak the raw materials in water, then decoct them several times, and finally combine the decoctions obtained from each decoction, filter them, and then further process them into oral liquid using conventional existing processes; wherein, the amount of water added is 5 times the total weight of the raw materials; the soaking time is 30 minutes; the number of decoctions is 3; and the decoction time is 1 hour.

[0052] Example 3

[0053] (1) Weigh the raw materials according to the following weight parts: 15 parts of peach kernel, 20 parts of safflower, 10 parts of chuanxiong rhizome, 17 parts of angelica root, 20 parts of saposhnikovia root, 12 parts of schizonepeta, 18 parts of turmeric, 20 parts of notopterygium root, 10 parts of angelica dahurica root, 13 parts of vitex fruit, 20 parts of salvia root, 12 parts of sappanwood, 12 parts of frankincense, 15 parts of myrrh, and 20 parts of kudzu root;

[0054] (2) Soak the raw materials in water, then decoct them several times, and finally combine the decoctions, filter them, and then make pills using conventional existing processes; wherein, the amount of water added is 10 times the total weight of the raw materials; the soaking time is 60 minutes; the number of decoctions is 1; and the decoction time is 1.5 hours.

[0055] Example 4

[0056] (1) Weigh the raw materials according to the following weight parts: 20 parts of peach kernel, 10 parts of safflower, 15 parts of chuanxiong rhizome, 20 parts of angelica root, 15 parts of saposhnikovia root, 14 parts of schizonepeta, 20 parts of turmeric, 15 parts of notopterygium root, 12 parts of angelica root, 15 parts of vitex fruit, 15 parts of salvia root, 13 parts of sappanwood, 15 parts of frankincense, 10 parts of myrrh, and 30 parts of kudzu root;

[0057] (2) Soak the raw material in water, then decoct it several times, and finally combine the decoctions obtained from each decoction, filter them and further process them into tablets using conventional existing processes; wherein, the amount of water added is 15 times the total weight of the raw material; the soaking time is 20 minutes; the number of decoctions is 2; and the decoction time is 2 hours.

[0058] Experiment 1: Animal Experiment

[0059] 1. Laboratory animals

[0060] Eight-week-old SD (Sprague–Dawley) rats [body weight (180±20)g] underwent tail and forelimb truncation to ensure they were standing and placed in upright cages. Minimally invasive nerve root compression was applied at the C5-C6 cervical vertebrae using continuous nerve root ligation with 9-0 nylon sutures or silicone blocks. The compression level was approximately 30–60g of continuous pressure. Compression was maintained for 2–6 weeks. A flexible brace was used to maintain the rats' necks in a 30° forward flexion for 8 hours daily for 6 weeks to simulate the effects of prolonged head-down posture or cervical spine compression on nerve roots, establishing a rat model of cervical radiculopathy. Animal experiments were approved by the Experimental Animal Ethics Committee of Guangxi University of Chinese Medicine and followed the "Guidelines for the Care and Use of Laboratory Animals".

[0061] 2. Experimental grouping and intervention

[0062] Ninety rats with cervical spondylosis of the nerve root type were divided into three groups: Group A (n=18) treated with the complete Cervical Spondylosis Formula No. 1, Group B (n=18) treated with Cervical Spondylosis Formula No. 1 without Chuanxiong, Group C (n=18) treated with Cervical Spondylosis Formula No. 1 without Fangfeng, and Group D (n=18) treated with Cervical Spondylosis Formula No. 1 without Danshen. The above were the study groups. The remaining 18 rats without additional treatment were the control group.

[0063] 3. Statistical Results

[0064] (1) There were no statistically significant differences in body weight, sex ratio, and baseline curvature among the groups (P>0.05), and the baselines were balanced and comparable.

[0065] (2) Comparison of improvement in cervical curvature. There was a statistically significant difference between the study group and the control group (P<0.05); there was a statistically significant difference between group A and groups B, C, and D (P<0.05); there was no statistically significant difference between groups B, C, and D (P>0.05).

[0066] Trial Example 2: Clinical Trial

[0067] 1. General Information

[0068] From July 2020 to June 2023, 61 patients with cervical spondylosis of the nerve root type, classified as Qi deficiency and blood stasis according to TCM syndrome differentiation, were included in this study at the Department of Spinal Surgery, First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine. Among them, 35 were male and 26 were female; their ages ranged from 40 to 65 years, with a mean age of (53.37 ± 4.83) years; their disease duration ranged from 6 months to 3 years, with a mean duration of (14.73 ± 3.98) months; and their pre-treatment cervical physiological curvature (C2–C7 Cobb angle) ranged from 0° to +10°, with a mean of (+4.3° ± 3.1). Based on whether they had taken the TCM formula for cervical spondylosis, all patients were divided into two groups: Group A (n=25) received routine treatment including analgesics, short-term nonsteroidal anti-inflammatory drugs, muscle relaxants, cervical traction, manual therapy, neuropathic pain medication, short-term cervical collar protection, and rehabilitation training, combined with posture correction and deep cervical flexor muscle training. Group B (n=36) received treatment with the traditional Chinese medicine formula No. 1 for cervical spondylosis in addition to the treatment given to Group A.

[0069] 2. Diagnostic criteria:

[0070] (1) CSR diagnostic criteria

[0071] Referring to the Chinese Association of Rehabilitation Medicine's *Guidelines for the Diagnosis, Treatment and Rehabilitation of Cervical Spondylotic Disease* (2016 edition) and *Guidelines for Clinical Practice of Traditional Chinese Medicine Rehabilitation: Cervical Spondylotic Disease* (2020 edition), the diagnostic criteria for cervical radiculopathy (CSR) are as follows: Clinical symptoms: Patients experience symptoms related to cervical radiculopathy, including radiating pain, numbness, tingling sensations, and muscle weakness in the neck and shoulder, usually distributed along a specific nerve root. ① Physical signs: Patients with cervical radiculopathy typically present with a positive Spurling's test, a positive brachial plexus traction test, and limited neck movement, indicating compression of the cervical nerve root. ② Imaging examinations: Imaging examinations such as X-ray, CT, and MRI reveal evidence of cervical degenerative changes (such as intervertebral disc degeneration, narrowing of the intervertebral space, and osteophyte formation) and nerve root compression. Common imaging findings include intervertebral disc herniation, spinal stenosis, and nerve root compression. Diagnostic Criteria: When clinical symptoms and imaging results are consistent, cervical radiculopathy can be diagnosed. ③ Patients with only imaging changes but no related symptoms should not be diagnosed with cervical radiculopathy. ④ Diagnosis of impaired nerve function: Radicular signs: When patients present with dermatometra-like pain and numbness, reflex changes, decreased muscle strength, sensory loss, and other neurological abnormalities, and these symptoms are consistent with the specific nerve root compression site, cervical radiculopathy can be diagnosed. ⑤ Imaging Verification: Nerve root compression is confirmed through imaging examinations (such as MRI, CT, etc.). MRI shows nerve root compression or spinal canal stenosis, and sometimes intramedullary T2 hyperintensity is visible, further supporting the diagnosis of nerve root compression. Exclusion of Other Diseases: When diagnosing cervical radiculopathy, it is necessary to exclude other diseases that may cause similar symptoms, such as frozen shoulder, peripheral neuropathy, tumors, infections, etc. If the symptoms are related to other diseases, corresponding examinations are needed to rule them out. C5 Root Type: The main symptoms are shoulder pain and upper arm weakness, which may be accompanied by sensory loss, manifested as weakness in abduction. C6 root type: The main symptoms are forearm pain and thumb weakness, accompanied by loss of sensation, which may affect the elbow, forearm, and hand. C7 root type: The main symptoms are pain and weakness in the middle and index fingers, possibly accompanied by loss of sensation, manifesting as weakness in finger flexion, affecting the fingers and wrist. C8 root type: The main symptoms are weakness in the little finger and elbow, accompanied by numbness and loss of pain sensation in the fingers.

[0072] (2) Traditional Chinese Medicine syndrome differentiation (diagnosis)

[0073] According to the "Guidelines for Clinical Practice of Traditional Chinese Medicine Rehabilitation - Cervical Spondylosis," cervical spondylosis of the nerve root type falls under the category of "cervical spondylosis" in TCM diagnosis. The TCM syndrome types and diagnostic criteria for cervical spondylosis are as follows: ① Liver and Kidney Deficiency Syndrome. Main symptoms: soreness or weakness in the neck and shoulders, limited range of motion, and significant discomfort when turning the head; secondary symptoms: soreness and weakness in the lower back and knees, dizziness and tinnitus, blurred vision or decreased finger dexterity, chronic illness and physical weakness, aggravated by exertion, possibly accompanied by numbness in the limbs; tongue and pulse: pale or reddish tongue, little coating, thready or deep weak pulse. ② Liver and Kidney Yin Deficiency Syndrome. Main symptoms: dull or soreness in the neck and shoulders, weakness and soreness during activity, especially aggravated by rest; secondary symptoms: emaciation, dizziness and tinnitus, five-center heat (hot palms and soles), insomnia and dreaminess, aggravated by exertion, and more pronounced at night; red tongue, little coating, thready and rapid pulse. ③ Spleen and Kidney Yang Deficiency Syndrome. Primary symptoms: cold pain and stiffness in the neck and shoulders, soreness and weakness in neck and shoulder movement, and obvious cold sensation; Secondary symptoms: aversion to cold and cold limbs, pale complexion, obvious stiffness in the morning, relieved after activity, poor appetite, loose stools or chronic diarrhea, and heaviness and weakness in the limbs; Tongue and pulse: pale and swollen tongue or with teeth marks, white and slippery coating, slow or deep and weak pulse. ④ Kidney deficiency and blood stasis syndrome. Primary symptoms: stabbing or distending pain in the neck and shoulders, with a fixed location of pain, obvious resistance when pressed, limited movement, and difficulty turning the neck; Secondary symptoms: numbness and weakness in the upper limbs, unsteady gait, symptoms aggravated by prolonged illness or trauma, accompanied by tinnitus, forgetfulness, etc.; dark purple tongue with petechiae or ecchymosis, and thready and hesitant or wiry and hesitant pulse. ⑤ Qi deficiency and blood stasis syndrome. Primary symptoms: Fixed or recurrent stabbing pain in the neck and shoulders, often occurring periodically, and symptoms worsening after activity; Secondary symptoms: Fatigue, weakness, lethargy, sallow or pale complexion, numbness or weakness in the limbs, and easy fatigue; pale and dark tongue with a thin white coating, and a weak pulse.

[0074] 3. Case inclusion criteria

[0075] ① Meets the diagnostic criteria for CSR; ② Belongs to the TCM syndrome differentiation of liver and kidney deficiency, liver and kidney yin deficiency, spleen and kidney yang deficiency, kidney deficiency and blood stasis, or qi deficiency and blood stasis; ③ Be eligible for follow-up after surgery.

[0076] 4. Case exclusion criteria

[0077] ① Patients with serious primary diseases of the liver, kidneys, endocrine system, hematopoietic system, or mental illness; ② Patients taking other medications that may affect the efficacy or evaluation during the observation period; ③ Patients with critical illnesses who are difficult to evaluate the efficacy; ④ Patients who are included but do not meet the inclusion criteria.

[0078] 5. Observation indicators and evaluation criteria

[0079] Pain assessment was conducted using the Visual Analogue Scale (VAS) and the Activities of Daily Living (ADL) scale. A VAS pain score reduction of 4 points or more and an ADL score improvement of 20 points or more were considered excellent; a VAS pain score reduction of 2 points or more and an ADL score improvement of 10 points or more were considered good; a VAS pain score reduction of 1 point or more and an ADL score improvement of 5 points or more were considered fair; and no decrease or increase in VAS pain score and no increase or decrease in ADL score were considered poor. The TCM efficacy evaluation criteria adopted the "General Principles for Clinical Research of New Traditional Chinese Medicines" for cervical spondylosis: a reduction of 95% or more in pain, fatigue, and other symptoms and signs was considered clinically cured; 70%–94% was considered significantly effective; 30%–69% was considered effective; and less than 30% was considered ineffective. Cervical spine X-ray findings were not considered at this stage. The Visual Analogue Scale (VAS) pain score and the Activities of Daily Living Scale were used to score all patients at 1, 6 and 12 months after drug treatment. The improvement of cervical physiological curvature (C2–C7 Cobb angle) at 12 months after treatment was calculated. The efficacy of treatment was evaluated for all patients at 12 months after treatment using the efficacy evaluation criteria for cervical spondylosis of nerve root type in the "General Principles of Clinical Research of New Traditional Chinese Medicine".

[0080] 6. Treatment methods

[0081] Based on the diagnosis and classification of cervical spondylosis radiculopathy (CSR) and the assessment of pain severity, appropriate non-surgical treatment methods were determined. According to the symptoms of patients with CSR, postural correction and deep neck flexor muscle training were initially selected as the basic treatment. Symptomatic treatment included short-course non-steroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs, muscle relaxants, gabapentin, pregabalin, short-term cervical collars, and appropriate rehabilitation training. The traditional Chinese medicine treatment group received an additional treatment based on this regimen, using the following formula for cervical spondylosis: Peach kernel 10g, Safflower 10g, Ligusticum chuanxiong 10g, Angelica sinensis 12g, Saposhnikovia divaricata 15g, Schizonepeta tenuifolia 12g, Curcuma longa 15g, Notopterygium incisum 15g, Angelica dahurica 10g, Vitex trifolia 10g, Salvia miltiorrhiza 15g, Sappanwood 12g, Frankincense 10g, Myrrh 10g, and Pueraria lobata 30g. Usage: Soak the above medicines in 1000 mL of water for 30 minutes, bring to a boil over high heat, then simmer over low heat until reduced to 250 mL. Pour out and set aside. Add another 500 mL of water and simmer until reduced to 200 mL. Pour out and mix with the previous decoction. Take twice a day, morning and evening, while warm.

[0082] 7. Statistical Results:

[0083] (1) Comparison of general data

[0084] There were no statistically significant differences between the two groups in terms of age, gender, disease duration, and other general information (P > 0.05); the baselines between the groups were balanced and comparable.

[0085] (2) Comparison of pain scores on the Visual Analogue Scale (VAS) and scores on the Activities of Daily Living Scale

[0086] There were no statistically significant differences in visual analog scale (VAS) pain scores and activities of daily living (ADL) scores between the two groups before treatment and at the first month after treatment (P > 0.05). However, at the sixth and twelfth months after treatment, there were statistically significant differences in VAS pain scores and ADL scores (P < 0.05). Within each group, there were statistically significant differences in VAS pain scores and ADL scores at different time points (P < 0.05), and pairwise comparisons between different time points also showed statistically significant differences (P < 0.05).

[0087] (3) Comparison of the degree of improvement in cervical physiological curvature (C2–C7 Cobb angle)

[0088] The improvement in cervical physiological curvature (C2–C7 Cobb angle) between the two groups at 12 months after treatment was statistically significant (P<0.05).

[0089] (4) Comparison of the therapeutic effects of traditional Chinese medicine on diseases

[0090] The difference in the efficacy of traditional Chinese medicine in treating diseases between the two groups at 12 months post-surgery was statistically significant (P < 0.05).

[0091] 8. Security

[0092] No significant adverse events occurred in either group of patients during the treatment period.

[0093] 9. Typical Cases

[0094] Case 1:

[0095] In December 2020, Mr. Tang, a 71-year-old male, presented to our outpatient clinic with a history of neck and shoulder pain for over six months, which had worsened and was accompanied by limited neck movement for one month. The patient reported experiencing neck and shoulder discomfort without any obvious cause six months prior, initially as intermittent dull pain that gradually worsened. Over the past month, the pain became more pronounced, accompanied by limited neck movement and stiffness when turning the head. No numbness or radiating pain was observed in the upper limbs. During this period, the patient had taken oral painkillers (specific details unknown), with limited effectiveness. He was admitted to our hospital with a preliminary diagnosis of "cervical radiculopathy." The patient had a history of hypertension for over ten years. Physical examination revealed a decreased cervical lordosis, mild stiffness, limited extension, and a reduction of approximately 30% in lateral rotation. No significant tenderness was found in the spinous processes of the cervical vertebrae. Mild tension was observed in the bilateral trapezius muscles. Muscle strength and tendon reflexes were normal, and Hoffmann's sign was negative. Auxiliary examinations: X-ray showed a Cobb angle of approximately 8° between C2 and C7, indicating a decrease in the physiological curvature of the cervical spine. MRI showed mild intervertebral disc degeneration, but no spinal cord compression. Based on the patient's clinical presentation, signs, and imaging examinations, a diagnosis of cervical radiculopathy (CSR) was made. Treatment plan: Routine analgesics, cervical traction, hot compress therapy, deep cervical flexor muscle training, and guidance on posture correction were administered. After three months of standardized medication and conservative treatment, the neck symptoms did not improve. Therefore, the traditional Chinese medicine formula "Cervical Spondylosis Formula No. 1" was added to the existing treatment. After three months of use, the patient reported significant relief of neck pain. A follow-up cervical spine X-ray three months later showed that the Cobb angle between C2 and C7 had increased from 8° to 21°, and the cervical lordosis had returned to the lower limit of normal. MRI showed no new lesions, and the symptoms were significantly relieved. The patient's neck function stabilized, with no recurrence of neck and shoulder pain, and a significant improvement in quality of life.

[0096] Case 2:

[0097] In October 2021, Ms. Wei, a 54-year-old female, presented with a 3-year history of lower limb weakness and difficulty walking, and a 6-month history of spinal stiffness and limited neck movement. Three years prior, she developed bilateral knee pain and weakness without any obvious cause, accompanied by difficulty walking. Symptoms worsened with activity and were slightly relieved by rest. She initially visited a local hospital, where knee X-rays showed degenerative changes. Oral analgesics and physical therapy provided little improvement. Over the past six months, she developed spinal stiffness, particularly with significantly limited neck movement, accompanied by difficulty raising both arms. During this period, her lower limb weakness worsened further, reducing her walking distance to less than 50 meters. She reported poor mental state, low mood, decreased appetite, and relatively good sleep since the onset of the illness, with a weight loss of approximately 4 kg within one year. Physical examination revealed a forward-flexed posture, limited cervical spine movement (significantly restricted flexion, extension, and rotation of the neck), decreased chest mobility, and a positive Schober test. The patient was admitted to our outpatient department with a preliminary diagnosis of "ankylosing spondylitis." Ancillary examinations included spinal X-rays, which revealed typical "bamboo spine" changes in the thoracic, lumbar, and cervical vertebrae, straightening of the cervical lordosis, multiple bony bridges between C2 and C7, and narrowing of the intervertebral spaces; the sacroiliac joint spaces were also blurred. MRI showed inflammatory bone marrow edema and synovial thickening in the cervical, lumbar, and sacroiliac joints, consistent with the active phase of ankylosing spondylitis. C-reactive protein was 24 mg / L elevated, erythrocyte sedimentation rate was 42 mm / h elevated, and HLA-B27 gene was positive. Treatment plan: 1. Nonsteroidal anti-inflammatory drugs combined with anti-TNF-α biologics to control the inflammatory response; 2. Comprehensive treatment including thermotherapy, joint mobilization, and rehabilitation exercises. After four months of regular and systematic treatment, the patient's pain and stiffness symptoms did not improve significantly, neck movement remained significantly limited, morning stiffness lasted for about one hour, and inflammatory markers did not fluctuate much. Therefore, in addition to the original treatment, the patient was treated with the traditional Chinese medicine "Cervical Spondylosis Formula No. 1". After three months of medication, the patient's morning stiffness was significantly reduced, neck and shoulder pain was reduced by about 50%, and both upper limbs could be raised horizontally. The patient reported significant relief from lower limb and knee pain, a significantly increased walking distance, and a significant improvement in neck mobility. A follow-up cervical spine X-ray showed that the C2–C7 Cobb angle increased from 5° before treatment to 17°, the physiological curvature of the cervical spine was significantly restored, and spinal mobility was improved.

Claims

1. A traditional Chinese medicine composition for treating cervical radiculopathy, characterized in that, The formula includes the following components by weight: 10-20 parts peach kernel, 10-20 parts safflower, 10-20 parts chuanxiong rhizome, 12-20 parts angelica root, 15-20 parts saposhnikovia root, 12-15 parts schizonepeta, 15-20 parts turmeric, 15-20 parts notopterygium root, 10-15 parts angelica root, 10-15 parts vitex fruit, 15-20 parts salvia root, 12-15 parts sappanwood, 10-15 parts frankincense, 10-15 parts myrrh, and 20-35 parts kudzu root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients include the following components by weight: 10 parts peach kernel, 10 parts safflower, 10 parts chuanxiong rhizome, 12 parts angelica root, 15 parts saposhnikovia root, 12 parts schizonepeta, 15 parts turmeric, 15 parts notopterygium root, 10 parts angelica root, 10 parts vitex fruit, 15 parts salvia root, 12 parts sappanwood, 10 parts frankincense, 10 parts myrrh, and 30 parts kudzu root.

3. A pharmaceutical preparation for treating cervical radiculopathy, characterized in that, It is a traditional Chinese medicine preparation made using the traditional Chinese medicine composition described in claim 1 or 2 as the raw material.

4. The pharmaceutical preparation according to claim 3, characterized in that, This includes the aqueous or alcoholic extracts of the active pharmaceutical ingredient.

5. The pharmaceutical preparation according to claim 4, characterized in that, It also includes pharmaceutically acceptable excipients.

6. The pharmaceutical preparation according to claim 3, characterized in that, The dosage forms of the traditional Chinese medicine preparations include decoctions, oral liquids, ointments, pills, powders, tablets, or capsules.

7. A method for preparing a pharmaceutical formulation as described in claim 3, characterized in that: First, the raw material is extracted using a water extraction method to obtain an extract, which is then used as a pharmaceutical preparation or formulated into other traditional Chinese medicine dosage forms.

8. The preparation method according to claim 6, characterized in that, The water extraction method is as follows: the raw material is decocted with water several times, filtered, and finally the filtrates obtained from each decoction are combined.

9. The preparation method according to claim 8, characterized in that: The decoction is performed 1-3 times, with each decoction lasting 1-2 hours, and the amount of water added for each decoction is 5-15 times the total weight of the raw materials.

10. The preparation method according to claim 8, characterized in that: Before decocting for the first time, soak the ingredients in water for 20-60 minutes.