Traditional Chinese medicine composition for treating cervical spondylosis and preparation method and application thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating cervical spondylosis and a preparation method and application thereof, and belongs to the field of traditional Chinese medicine. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 14.4 to 21.6 parts of radix astragali seu hedysari, 14.4 to 21.6 parts of radix paeoniae alba, 14.4 to 21.6 parts of caulis spatholobi, 14.4 to 21.6 parts of radix puerariae, 14.4 to 21.6 parts of ramulus mori, 7.2 to 10.8 parts of fructus lycii, 7.2 to 10.8 parts of rhizoma gastrodiae, 7.2 to 10.8 parts of rhizoma chuanxiong, 7.2 to 10.8 parts of radix clematidis, 7.2 to 10.8 parts of rhizoma alismatis, 7.2 to 10.8 parts of rhizoma atractylodis macrocephalae and 2.4 to 3.6 parts of radix notoginseng. The invention further provides a preparation method and application of the traditional Chinese medicine composition. Aiming at a compound syndrome type of liver and kidney deficiency combined with phlegm-damp collateral blocking cervical spondylosis, the rhizoma alismatis and bighead atractylodes rhizome pairs are introduced to achieve the effects of clearing damp, promoting diuresis, tonifying spleen and drying dampness together, and the traditional Chinese medicine is specially used for treating phlegm-damp dizziness and is matched with the rhizoma gastrodiae, so that the effects of reducing phlegm, stopping wind and stopping dizziness are remarkably enhanced. Meanwhile, ligusticum wallichii capable of promoting blood circulation and qi circulation is introduced to move upwards to relieve pain and forms synergistic compatibility with caulis spatholobi, herba clematidis and radix puerariae, and the traditional Chinese medicine composition is mild in medicine property, remarkable in curative effect, low in side effect risk and suitable for long-term nursing of cervical spondylosis.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition for treating cervical spondylosis, belonging to the field of traditional Chinese medicine. Background Technology

[0002] Cervical spondylosis is caused by degeneration of the cervical intervertebral discs, leading to dynamic and static instability of the cervical vertebrae and soft tissues. This instability subsequently induces pathological conditions such as disc herniation, ligament hypertrophy and calcification, and bone hyperplasia, stimulating or invading surrounding spinal cord, nerves, and blood vessels, resulting in a series of symptoms and signs. Cervical spondylosis is currently a common disease among middle-aged and elderly people, and its incidence is increasingly affecting younger individuals. Traditional Chinese medicine (TCM) has a long history of treating cervical spondylosis and has enormous potential for development. Domestic and international literature on cervical spondylosis treatment mainly focuses on massage, exercise therapy, and acupuncture, but recommendations are inconsistent. Many domestic guidelines for cervical spondylosis only recommend massage and exercise therapy, without covering TCM herbal remedies or techniques.

[0003] In Traditional Chinese Medicine (TCM), cervical spondylosis is usually classified into different types based on its etiology, symptoms, and constitution. Common types include wind-cold-dampness obstruction, qi stagnation and blood stasis, phlegm-dampness obstruction, liver and kidney deficiency, qi and blood deficiency, spleen and kidney deficiency, and phlegm-fire stagnation. For example, Wu Yicheng et al., "Observation on the efficacy of acupuncture treatment based on TCM syndrome differentiation in the treatment of vertebral artery type cervical spondylosis," *Health Medicine Research and Practice*, July 2022, Vol. 19, No. 7, reported that acupuncture treatment based on TCM syndrome differentiation can effectively relieve the clinical symptoms of CSA patients with dizziness, headache, and insomnia. The main syndrome differentiation types disclosed in the report are qi and blood deficiency, wind-phlegm disturbance, and liver yang hyperactivity. The treatment should be based on the principles of promoting blood circulation, regulating qi, and clearing the meridians. Feng Wenyuan et al., "Experience of Zhao Jirong in Treating Vertebral Artery Type Cervical Spondylosis," *Inner Mongolia Journal of Traditional Chinese Medicine*, Vol. 44, February 2025, No. 2, emphasized that regulating the spleen qi should be integrated throughout the entire treatment process. Due to the complexity of the diagnosis of cervical spondylosis, various treatment methods and prescriptions vary.

[0004] Application No.: CN98112028.8, Invention Title: A Medicine for Treating Cervical Spondylosis and its Preparation Process. The invention discloses a formula composed of *Spatholobus suberectus*, *Astragalus membranaceus*, *Paeonia lactiflora*, *Pueraria lobata*, *Clematis chinensis*, *Polygonum multiflorum*, *Salvia miltiorrhiza*, *Carthamus tinctorius*, *Luffa cylindrica*, *Epimedium brevicornu*, *Lycium barbarum*, *Polygonum multiflorum* (processed), *Lilium brownii*, *Panax notoginseng*, and *Morus alba* twigs. The formula is extracted and concentrated into an extract, then dextrin and white sugar are added to form granules, which are then dried. It possesses the effects of nourishing blood and qi, tonifying the kidneys and strengthening the Du meridian, resolving phlegm and promoting blood circulation, and relaxing muscles and tendons. It relieves the pressure on nerve roots and vertebral arteries caused by cervical spondylosis, improves cerebral blood supply, restores cervical spine function, and eliminates symptoms such as headache, dizziness, neck, shoulder, and arm pain, and numbness and weakness of the limbs. It is suitable for treating cervical spondylosis.

[0005] Application No.: CN202411824279.5, Invention Title: A Traditional Chinese Medicine Composition for Treating Cervical Spondylosis and Its Preparation Method, discloses a traditional Chinese medicine composition for treating cervical spondylosis and its preparation method. Made from the following raw materials in the indicated weight ratios: Pinellia ternata 45-55 g, Atractylodes macrocephala 45-55 g, Gastrodia elata 45-55 g, Uncaria rhynchophylla 45-55 g, Poria cocos 45-55 g, Polygonum multiflorum 95-105 g, Salvia miltiorrhiza 95-105 g, Angelica sinensis 45-55 g, Ligusticum chuanxiong 45-55 g, Prunus persica 45-55 g, Carthamus tinctorius 45-55 g, Paeonia lactiflora 45-55 g, Notopterygium incisum 45-55 g, Curcuma longa 45-55 g, Panax notoginseng 25-35 g, Hirudo medicinalis 25-35 g, Pueraria lobata 95-105 g, Ginkgo biloba 95-105 g, Clematis chinensis 95-105 g, Pheretima aspergillum 45-55 g, Drynaria fortunei 45-55 g, Lycopodium clavatum 55-65 g, Haliotis diversicolor 95-105 g, Astragalus membranaceus 115-125 g. g, deer antler powder 25~35 g, chicken blood vine 95~105 g, cinnamon twig 45~55 g, tortoise shell 45~55 g, angelica pubescens 45~55 g, gentian root 45~55 g, white peony root 45~55 g, clematis root 20~30 g, saposhnikovia root 45~55 g.

[0006] Among them, the patent with application number CN98112028.8 has a relatively broad syndrome differentiation, which is more inclined to the "deficiency of both qi and blood, and deficiency of kidney and blood stasis" type of cervical spondylosis. Although the prescription mentions "phlegm-resolving", there is no truly powerful phlegm-resolving and dampness-removing drug to support it, and it is not targeted enough for the "phlegm-dampness" pathogenic factor. The patent with application number CN202411824279.5 has a syndrome differentiation that clearly focuses on "wind-phlegm disturbance" and "severe blood stasis obstructing the collaterals", and can even be said to have the three evils of "wind, phlegm and blood stasis" all prevalent. Moreover, it focuses on attacking the evil and has insufficient tonifying power, which can easily deplete the patient's qi and blood. Summary of the Invention

[0007] This invention provides a traditional Chinese medicine composition for treating cervical spondylosis, especially for treating cervical spondylosis of the type caused by liver and kidney deficiency combined with phlegm and dampness obstruction. This invention also provides a method for preparing the traditional Chinese medicine composition and its uses.

[0008] This invention provides a traditional Chinese medicine composition for treating cervical spondylosis, which is prepared from the following raw materials in the indicated weight ratios: Astragalus membranaceus 14.4-21.6 parts, Paeonia lactiflora 14.4-21.6 parts, Spatholobus suberectus 14.4-21.6 parts, Pueraria lobata 14.4-21.6 parts, Morus alba twig 14.4-21.6 parts, Lycium barbarum 7.2-10.8 parts, Gastrodia elata 7.2-10.8 parts, Ligusticum chuanxiong 7.2-10.8 parts, Clematis chinensis 7.2-10.8 parts, Alisma plantago-aquatica 7.2-10.8 parts, Atractylodes macrocephala 7.2-10.8 parts, Panax notoginseng 2.4-3.6 parts.

[0009] Preferably, it is prepared from the following raw medicinal materials in the following weight ratio: Radix Astragali 18 parts, Radix Paeoniae Alba 18 parts, Lycium barbarum 9 parts, Gastrodia 9 parts, Chuanxiong 9 parts, Radix Tricifuerae 9 parts, Alisma 9 parts, Rhizoma Atractylodis Macrocephalae 9 parts, Sanqi 3 parts.

[0010] The traditional Chinese medicine composition in the application is prepared from the raw medicinal material powder, water or organic solvent extract as the active ingredient, and pharmaceutically acceptable adjuvants or auxiliary ingredients.

[0011] The preparation is a tablet, a capsule, a granule, a pill or an oral liquid.

[0012] The application also provides a preparation method of the traditional Chinese medicine composition for treating cervical spondylosis. a. weighing the raw medicinal materials in the weight ratio; b. powdering, or extracting with water or an organic solvent, concentrating the extract, and then adding pharmaceutically acceptable adjuvants or auxiliary ingredients to prepare a preparation commonly used in pharmacy.

[0013] The application also provides the use of the traditional Chinese medicine composition in the preparation of a medicine for treating cervical spondylosis.

[0014] The medicine is a medicine for treating cervical spondylosis of the type of liver and kidney deficiency combined with phlegm dampness blocking the collaterals.

[0015] The medicine is a medicine for treating cervical spondylosis of the nerve root type, the vertebral artery type and the mixed type.

[0016] The medicine is a medicine with the effects of tonifying qi and nourishing blood, relaxing sinews and dredging collaterals.

[0017] The raw materials of the traditional Chinese medicine composition in the application are matched based on the theory system of traditional Chinese medicine, and it is considered that cervical spondylosis is caused by overwork and internal injury, unfavorable meridian transmission, blood stasis, liver and kidney deficiency, marrow deficiency, and muscle and bone atrophy, leading to cervical spondylopathy. The composition is composed of twelve kinds of traditional Chinese medicines, including Huangqi, Baishao, Jixueteng, Chuanxiong, Lingshenteng, Gegen, Gouqi, Tianma, Zexie, Baizhu, Sanqi and Sangzhi, for treating liver and kidney deficiency and phlegm and blood stasis. In the composition, Huangqi can raise yang and benefit qi, and qi can generate blood; Baishao can nourish blood and soften tendon, and relieve pain; the two medicines can benefit qi and nourish blood, and are the monarch medicines. Jixueteng can nourish blood and activate meridian, Chuanxiong can activate blood and promote flow of qi, Lingshenteng can resolve phlegm and dredge collaterals, Gegen can soothe the channels and relieve convulsions, the four medicines can resolve phlegm and remove blood stasis, dredge collaterals and relieve pain, and are the minister medicines. Tianma can soothe liver and dredge collaterals, Gouqi can nourish liver and kidney, the two medicines can regulate liver and kidney and nourish heart and brain, Zexie can drain water and reduce turbidity, Baizhu can invigorate spleen and dredge yang, the two medicines can clear away heat and remove dampness to stop dizziness, and are the assistant medicines. Sanqi can activate blood and dredge collaterals to relieve pain, and Sangzhi can dispel wind, relax sinew and activate collaterals, and are the ministerial medicines. The combination of the medicines can benefit qi and nourish blood, relax sinew and dredge collaterals, thereby relieving the pressure on nerve root and vertebral artery caused by cervical spondylopathy, improving cerebral ischemia, restoring the physiological function of cervical vertebra, and relieving symptoms such as headache, dizziness, cervical and shoulder pain, upper limb numbness and weakness.

[0018] The application has the following beneficial effects: The application is aimed at the complex syndrome of liver and kidney deficiency combined with phlegm and dampness blocking collaterals, and introduces Zexie and Baizhu to promote water and remove dampness, invigorate the spleen and dry dampness, and is specially used for treating dizziness caused by phlegm and dampness. The combination of Zexie and Baizhu and Tianma can significantly enhance the effect of resolving phlegm, calming wind and stopping dizziness. Meanwhile, Chuanxiong is introduced to activate blood and promote flow of qi, and is upward to the head and eyes to relieve pain, and cooperates with Jixueteng, Lingshenteng and Gegen to form a synergistic combination. The application is aimed at the complex syndrome of liver and kidney deficiency combined with phlegm and dampness blocking collaterals, and can attack evil (resolve phlegm and dredge collaterals) while protecting the root of liver and kidney qi and blood with Huangqi, Baishao and Gouqi, which has the advantages of mild medicinal properties, significant curative effect and low side effect risk, and is very suitable for long-term treatment of chronic cervical spondylosis. DETAILED DESCRIPTION

[0019] Example 1 Preparation of the traditional Chinese medicine composition (hereinafter referred to as “Jingfushu Granules”) in the application Prescription: Huangqi 18g, Baishao 18g, Jixueteng 18g, Gegen 18g, Sangzhi 18g, Gouqi 9g, Tianma 9g, Chuanxiong 9g, Lingshenteng 9g, Zexie 9g, Baizhu 9g and Sanqi 3g.

[0020] Function and indication: The granules have the effects of benefiting qi and nourishing blood, relaxing sinew and dredging collaterals, and are used for treating cervical spondylosis, with symptoms such as headache, dizziness, cervical and shoulder pain, upper limb numbness and weakness.

[0021] Usage and dosage: 1 dose is taken 2 days, 3 times a day, and water is used for decocting, in which Sanqi is powdered and taken.

[0022] Preparation process: The above twelve ingredients, except for the Sanchi powder, are decocted three times with water, each time for 1.0 hour, the decoction is combined, filtered, the filtrate is concentrated to a clear extract with a relative density of 1.10-1.15 (55-60°C), the Sanchi powder and an appropriate amount of dextrin are added, mixed, granulated, and dried to obtain the granules.

[0023] Example 2 Preparation of the tablet of the traditional Chinese medicine composition of the present application Take the prescription: 14.4g of Huangqi, 14.4g of Baishao, 14.4g of Jixueteng, 14.4g of Gegen, 14.4g of Sangzhi, 7.2g of Gouqi, 7.2g of Tianma, 7.2g of Chuanqiong, 7.2g of Lingshenteng, 7.2g of Zexie, 7.2g of Baizhu, and 2.4g of Sanchi; Extract and prepare into granules according to the preparation process of Example 1, and then compress into tablets to obtain the tablets.

[0024] Example 3 Preparation of the oral liquid of the traditional Chinese medicine composition of the present application Take the prescription: 21.6g of Huangqi, 21.6g of Baishao, 21.6g of Jixueteng, 21.6g of Gegen, 21.6g of Sangzhi, 10.8g of Gouqi, 10.8g of Tianma, 10.8g of Chuanqiong, 10.8g of Lingshenteng, 10.8g of Zexie, 10.8g of Baizhu, and 3.6g of Sanchi.

[0025] Extract the clear extract according to the preparation process of Example 1, and then prepare into the oral liquid.

[0026] The beneficial effects of the present application are proved by the following clinical tests.

[0027] Test Example 1 Clinical test of the traditional Chinese medicine composition of the present application The clinical test of the Jifushu granules for treating cervical spondylosis is jointly undertaken by the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, the Suining Hospital of Traditional Chinese Medicine, and the Mianyang Hospital of Traditional Chinese Medicine.

[0028] The clinical verification is carried out by taking the commercially available Chinese patent medicine "Jingfukang granules" with the State Drug Registration Number Z13022204 as the control medicine, using the random single-blind prospective research method, and observing 120 patients with cervical spondylosis of the nerve root type, the vertebral artery type, and the mixed type, including 60 patients in the treatment group and 60 patients in the control group. The "Jingfukang granules" are differentiated into the syndrome type of wind-dampness stagnation, i.e. the combination of external wind-dampness and internal blood stasis, the mutual combination of the two evils of "wind-dampness" and "blood stasis", and the blockage of the meridians. The "Jifushu granules" of the present application are differentiated into the syndrome type of deficiency of the liver and kidney combined with phlegm-dampness blocking the collaterals, i.e. the deficiency of the liver and kidney, the deficiency of qi and blood, the malnutrition of the tendons and bones, the mutual combination of phlegm-dampness and blood stasis, and the blockage of the collaterals.

[0029] The observation results are reported as follows: I. General information 1. Case source: see Table 1 Table 1: Comparison of the outpatient and inpatient case compositions of the two groups

[0030] After statistical treatment, x2=1.875, P>0.05, no statistical significance.

[0031] The two groups of outpatient and inpatient cases were shown to be comparable.

[0032] 2. Gender composition: see Table 2 Table 2: Comparison of gender composition of patients in the two groups

[0033] After statistical treatment, X2=0.833, P>0.05, no statistical significance. The male and female distribution of the two groups was comparable.

[0034] 3. Age distribution: see Table 3 Table 3: Comparison of age distribution and average age of patients in the two groups (years)

[0035] After statistical treatment, t=0.561, P>0.05, no statistical significance.

[0036] The age distribution of the two groups was comparable.

[0037] 4. Disease duration: see Table 4 Table 4: Comparison of disease duration of patients in the two groups (months)

[0038] After statistical treatment, t=0.4712, P>0.05, no statistical significance.

[0039] The disease duration distribution of the two groups was comparable.

[0040] 5. Symptom type distribution: see Table 5 Table 5: Comparison of symptom type distribution of the two groups

[0041] After statistical treatment, X2=1.573, P>0.05, no statistical significance. The symptom type distribution of the two groups was comparable.

[0042] The classification of cervical spondylosis in clinical practice is mainly based on the classification of modern medicine, including cervical type cervical spondylosis, nerve root type cervical spondylosis, spinal cord type cervical spondylosis, vertebral artery type cervical spondylosis, sympathetic nerve type cervical spondylosis, and mixed type cervical spondylosis (commonly nerve root type cervical spondylosis combined with other types).

[0043] TCM syndrome differentiation of cervical spondylosis mainly includes wind-cold-dampness arthralgia type, qi stagnation and blood stasis type, phlegm-dampness blocking collaterals type, liver and kidney deficiency type, qi and blood deficiency type, etc. Among them, the phlegm-dampness blocking collaterals type is characterized by dizziness, heavy feeling in the head, nausea and vomiting, numbness of limbs, poor appetite, and thick and greasy tongue coating. Pathogenesis: Spleen deficiency leads to abnormal transportation and transformation, and phlegm-dampness is generated internally. Phlegm and blood stasis block the collaterals. The liver and kidney deficiency type is characterized by dizziness, tinnitus, deafness, headache, soreness of waist and knees, and atrophy of limbs. Pathogenesis: Liver blood deficiency and kidney essence deficiency cannot nourish the muscles and bones and clear the orifices.

[0044] "Liver and kidney deficiency combined with phlegm-dampness blocking collaterals" belongs to a complex syndrome type, which is often manifested as dizziness, headache (vertebral artery type), upper limb numbness (nerve root type), and a combination of the two in western medicine classification.

[0045] 6. Disease severity analysis: see Table 6 Table 6: Comparison of disease severity between the two groups

[0046] After statistical processing, u = 1.27, P > 0.05, which has no statistical significance.

[0047] The disease severity of the two groups is comparable.

[0048] II. Case selection 1. Diagnostic criteria Refer to the relevant diagnostic content of "TCM Orthopedics" edited by Jan Hongsheng and Leng Xiangyang in April 2015 as the diagnostic classification standard for this disease.

[0049] (1) Symptoms: such as headache, dizziness, neck pain, shoulder and arm pain, scapular pain, arm numbness, nausea and vomiting, etc. The main symptoms meet the clinical manifestations of cervical spondylosis, and the symptoms of neck strain and cold are aggravated. Except for other diseases, the syndrome types are: whiplash type (or cervical type); arthralgia type (or nerve root type); flaccid syndrome type (or spinal cord type); dizziness and syncope type (or vertebral artery type); five sense type (or sympathetic nerve type) and mixed type.

[0050] (2) Signs: There is stiffness in the neck, and the movement is limited. There is one or more pressure points on the transverse process of the cervical spine, or the spinous process, or the posterior cervical muscle group, or the superior angle of the scapula. There are string-like indurations on both sides of the spinous process. The brachial plexus traction test is positive, the intervertebral foramen compression test is positive, the vertebral artery distortion test is positive, and the lateral bending test is positive.

[0051] (3) X-ray film: The cervical spine may show changes in its physiological curvature, osteophyte formation at the vertebral body margins, disordered and unclear intervertebral joint structures in lateral and oblique views, significant narrowing of the intervertebral space, changes in the intervertebral foramen (such as narrowing of the intervertebral foramen, facet joint hyperplasia, uncinate process osteophytes, displacement of the anterior and posterior margins of the vertebral body), spinous process deviation, and calcification of the nuchal ligament.

[0052] Spinal cord type: CT scan confirmed cervical disc herniation, compressing the spinal cord.

[0053] 2. Admission criteria and treatment recipients Patients aged 18 to 65 years who meet the diagnostic criteria for cervical spondylosis of the nerve root type, vertebral artery type, and mixed type as described below are included in the verification subjects. "Liver and kidney deficiency combined with phlegm and dampness obstructing the collaterals" is a complex syndrome, which in Western medicine often manifests as dizziness, headache (vertebral artery type), numbness of the upper limbs (nerve root type), and a combination of both.

[0054] Cervical spondylosis, nerve root type: Patients experience pain in the head, neck, shoulders, and arms, as well as numbness in the upper limbs and fingers. The pain can be dull, aching, burning, or aching, and in some cases, acute onset can cause severe pain, making it difficult to sit or lie down. Head and neck movements, coughing, sneezing, etc., can worsen the symptoms, and there is obvious radiating pain and tingling numbness.

[0055] Examination revealed neck stiffness, limited range of motion, tenderness around the spinous process and in the shoulder and arm, positive intervertebral foramen compression test and brachial plexus traction test, and decreased arm function.

[0056] X-ray images show: changes in cervical spine physiological degree, narrowing of intervertebral space, smaller intervertebral foramen, formation of osteophytes on the anterior and posterior margins of vertebral body, or calcification of supraspinous ligament.

[0057] Cervical spondylosis vertebral artery type: The main symptom of this type of vertigo is dizziness. Flexion, extension, and rotation of the head and neck, or changes in body position, can trigger or worsen the dizziness. During an attack, the patient experiences lightheadedness, unsteadiness, and difficulty standing. Other symptoms include headache, tinnitus, nausea, vomiting, blurred vision, and sudden collapse.

[0058] Physical examination revealed discomfort, stiffness and pain in the neck and occipital region, limited range of motion, and positive results in neck flexion, lateral bending, and arterial tortuosity tests.

[0059] X-ray findings: changes in the shape of the intervertebral foramen, narrowing of the intervertebral space, osteophyte formation of the uncovertebral joints or intervertebral joints, or calcification of the nuchal ligament.

[0060] Cervical spondylosis (mixed type): Patients who exhibit symptoms and signs related to both of the above types are classified as this type.

[0061] 3. Exclusion criteria (1) Patients under 18 years of age and over 65 years of age.

[0062] (2) Not eligible for inclusion, not taking the medication as prescribed.

[0063] III. Treatment Method 1. Grouping Method: Single-blind control method was used for random grouping, with 60 cases in the treatment group and 60 cases in the control group.

[0064] 2. Medication Method; (1) Treatment group: Oral administration of the Jingfushu granules, 1 bag (24.5 g of crude drug) each time, three times a day, 1 hour after meals, without other drugs and treatment methods.

[0065] (2) Control group: Oral administration of Jingfukang granules, 2 bags each time (marketed, 1-2 bags per day according to the instructions, using the maximum dose), twice a day, 1 hour after meals, without other drugs and treatment methods.

[0066] 3. Observation Time The observation time of both groups was 1 week per course of treatment, with continuous observation for 3 courses of treatment for 21 days. Those who have reached the clinical cure standard within 3 courses of treatment can stop taking the medicine.

[0067] 4. Recording Method: The physician responsible for clinical observation was in charge of recording every 2 days for the first 1-9 days of treatment and every 3 days for the last 9-21 days. Symptoms, signs, side effects and adverse reactions of the drug were recorded in detail, and the contents required by the clinical observation table were filled in one by one.

[0068] 5. The degree of the above symptoms and signs is indicated by mild "+", moderate "++", and severe "+++". The disappearance of symptoms and signs is indicated by "-".

[0069] IV. Treatment Effect 1. Efficacy Evaluation Standard According to the course of treatment and efficacy evaluation standard specified in the "Jingfushu Granule Clinical Verification Implementation Plan". The efficacy evaluation standard is divided into four levels: clinical cure, significant effect, effectiveness and ineffectiveness.

[0070] Clinical cure: disappearance of main symptoms and positive signs, recovery of daily workers; Significant effect: significant improvement in main symptoms and disappearance of most positive signs, enabling workers to adhere to work; Effective: improvement in main symptoms and reduction of positive signs; Ineffective: no improvement in symptoms and signs.

[0071] 2. Treatment Results (1) Comparison of overall efficacy of the two groups: see Table 7 Table 7: Comparison of overall efficacy of the two groups

[0072] After statistical treatment, u=3.828, t=2.195, t=2.856, t=2.355, P<0.05, with statistical significance.

[0073] The therapeutic effect of the treatment group was better than that of the control group.

[0074] (2) Comparison of therapeutic effects of two groups of syndromes a Comparison of therapeutic effects of two groups of nerve root type: see Table 8 Table 8: Comparison of therapeutic effects of nerve root type After statistical treatment, u=2.09, P<0.05, with statistical significance. The therapeutic effect of the treatment group was better than that of the control group.

[0075] b Comparison of therapeutic effects of two groups of vertebral artery type: see Table 9 Table 9: Comparison of therapeutic effects of vertebral artery type After statistical treatment, u=2.24, P<0.05, with statistical significance. The therapeutic effect of the treatment group was better than that of the control group.

[0076] c Comparison of therapeutic effects of two groups of mixed type: see Table 10 Table 10: Comparison of therapeutic effects of mixed type

[0077] After statistical treatment, u=2.41, P<0.05, with statistical significance. The therapeutic effect of the treatment group was better than that of the control group.

[0078] (3) Analysis of drug onset time: see Table 11 Table 11: Comparison of drug onset time of two groups

[0079] After statistical treatment, t=4.52, P<0.05, with statistical significance.

[0080] The average onset time of the treatment group was shorter than that of the control group.

[0081] Five, safety Only 2 patients in the treatment group had mild epigastric discomfort, without special treatment, nor drug withdrawal, and then disappeared.

[0082] Seven, discussion 1. The test adopts a random single-blind prospective research method, and totally observes 120 patients, wherein 60 patients are in the treatment group and 60 patients are in the control group. The total effective rate of the treatment group is 96.67%, and the total cure and significant efficiency is 60%. The total effective rate of the control group is 85%, and the total cure and significant efficiency is 25%. After statistical processing, the total curative effect of the two groups has significant difference (P<0.05), and the curative effect of the "Jingfushu Granule" is better than that of the control group.

[0083] 2. The "Jingfushu Granule" has the functions of relaxing tendons and collaterals, activating collaterals, relieving pain, tonifying qi and blood, and tonifying kidney and strengthening bones. It has obvious effect on meridian obstruction caused by strain and rheumatism, and has especially definite curative effect on cervical spondylosis patients with liver and kidney deficiency and qi and blood deficiency.

[0084] 3. Only 2 patients in the treatment group have mild stomach discomfort, and no special treatment and drug withdrawal are needed, and the discomfort can be relieved by themselves.

[0085] 4. The "Jingfushu Granule" is convenient and safe to use, and has no special contraindication.

[0086] Eight, Conclusion According to the verification results of the "Jingfushu Granule" for 60 cases of cervical spondylosis (nerve root type, vertebral artery type and mixed type), the following is summarized: 1. The "Jingfushu Granule" has definite curative effect, and the total effective rate is 96.67%, and the total cure and significant efficiency is 60%. After statistical processing, the total curative effect of the two groups has significant difference (P<0.05). Therefore, the total curative effect of the "Jingfushu Granule" is better than that of the "Jingfukang Granule".

[0087] 2. The curative effect of the "Jingfushu Granule" is significant. The average onset time is shorter than that of the "Jingfukang Granule" (P≤0.05).

[0088] 3. The "Jingfushu Granule" is a pure traditional Chinese medicine preparation, is convenient to use, has no toxic side effect, and provides a wider selection range for clinical doctors.

Claims

1. A traditional Chinese medicine composition for treating cervical spondylosis, characterized in that: It is prepared from the following raw medicinal materials in the following weight ratio: ​ Radix Astragali 14.4-21.6 parts, Radix Paeoniae Alba 14.4-21.6 parts, Caulis Spatholobi 14.4-21.6 parts, Radix Puerariae 14.4-21.6 parts, Ramulus Mori 14.4-21.6 parts, Fructus Lycii 7.2-10.8 parts, Gastrodia 7.2-10.8 parts, Rhizoma Chuanxiong 7.2-10.8 parts, Radix Aristolochiae 7.2-10.8 parts, Rhizoma Alismatis 7.2-10.8 parts, Rhizoma Atractylodis Macrocephalae 7.2-10.8 parts, Radix Notoginseng 2.4-3.6 parts.

2. The Chinese medicine composition for treating cervical spondylosis according to claim 1, characterized in that: It is prepared from the following raw medicinal materials in the following weight ratio: Radix Astragali 18 parts, Radix Paeoniae Alba 18 parts, Caulis Spatholobi 18 parts, Radix Puerariae 18 parts, Ramulus Mori 18 parts, Fructus Lycii 9 parts, Gastrodia 9 parts, Rhizoma Chuanxiong 9 parts, Radix Aristolochiae 9 parts, Rhizoma Alismatis 9 parts, Rhizoma Atractylodis Macrocephalae 9 parts, Radix Notoginseng 3 parts.

3. The Chinese medicine composition for treating cervical spondylosis according to claim 1 or 2, characterized in that: It is prepared from the raw medicinal material in the form of crude powder, water or organic solvent extract as the active ingredient, and pharmaceutically acceptable adjuvants or auxiliary ingredients.

4. The Chinese medicine composition for treating cervical spondylosis according to claim 3, characterized in that: The preparation is tablet, capsule, granule, pill, oral liquid.

5. A method for preparing the Chinese medicinal composition for treating cervical spondylosis according to any one of claims 1-4, characterized in that: It comprises the following steps: a. weighing each raw medicinal material in the following weight ratio; b. powdering, or extracting with water or organic solvent, concentrating the extract, and then adding pharmaceutically acceptable adjuvants or auxiliary ingredients to prepare a commonly used pharmaceutical preparation.

6. Use of the traditional Chinese medicine composition of any one of claims 1-4 in the preparation of a medicament for treating cervical spondylosis.

7. Use according to claim 6, characterized in that: The medicament is for treating cervical spondylosis of the type of deficiency of liver and kidney combined with obstruction of collaterals by phlegm-dampness.

8. Use according to claim 7, characterized in that: The medicament is for treating cervical spondylosis of the nerve root type, vertebral artery type, and mixed type.

9. Use according to claim 7 or 8, characterized in that: The medicament is for tonifying qi and nourishing blood, and for relaxing sinews and unblocking collaterals.

Images