Traditional Chinese medicine composition for treating cervical spondylosis and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating cervical spondylosis and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 12-18 parts of astragalus membranaceus, 7-11 parts of radix achyranthis bidentatae, 7-11 parts of ramulus mori, 7-11 parts of pawpaw, 6-13 parts of liquorice and 7-11 parts of lycopodium clavatum. According to the compatibility theory of monarch, minister, assistant and guide and drug pairs in traditional Chinese medicine, the basic principle of syndrome differentiation and treatment is followed, the composition is reasonable, the six traditional Chinese medicines are selected, and all the medicines are combined and have a synergistic effect, so that the traditional Chinese medicine has the effects of tonifying kidney and lifting yang, promoting qi to activate blood, dispelling wind and removing obstruction in the meridians and tonifying spleen and soothing the nerves; the traditional Chinese medicine composition has an exact curative effect on cervical vertigo and vertebral artery type and sympathetic nerve type cervical spondylosis caused by kidney deficiency and yang weakness, spleen deficiency and dampness obstruction and meridian obstruction.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating cervical spondylosis and its application. Background Art

[0002] Cervical spondylosis, also known as cervical syndrome, is a disease based on degenerative pathological changes. The types of cervical spondylosis include nerve root type cervical spondylosis, vertebral artery type cervical spondylosis, sympathetic nerve type cervical spondylosis, mixed type cervical spondylosis, etc.

[0003] Vertebral artery type cervical spondylosis refers to a series of syndromes caused by repeated strain, resulting in osteoproliferation of the uncovertebral joint, displacement of small joint hyperplasia, narrowing of the intervertebral space, neck muscle spasm, cervical spine instability and other factors, which stimulate the vertebral artery to spasm, narrow or bend, etc., thereby causing insufficient blood supply of the vertebrobasilar artery and presenting a series of clinical symptoms mainly including dizziness and neck and shoulder pain.

[0004] Sympathetic nerve type cervical spondylosis is a series of syndromes caused by compression or stimulation of the sympathetic nerve due to cervical spine degeneration or instability. Common symptoms include dizziness, headache, palpitation, chest tightness, etc.

[0005] Traditional Chinese medicine believes that the etiology and pathogenesis of cervical spondylosis are based on deficiency, with phlegm and stasis as the symptoms, belonging to the syndrome of deficiency in origin and excess in superficiality. The common etiologies and pathogenesis of cervical spondylosis include invasion of wind-cold-dampness, qi stagnation and blood stasis, spleen-kidney yang deficiency, hyperactivity of liver yang, qi and blood deficiency, phlegm and blood stasis blocking collaterals, liver and kidney deficiency, among which qi and blood deficiency, phlegm and blood stasis blocking collaterals, and liver and kidney deficiency are the most common.

[0006] Most patients with cervical spondylosis can control symptoms, reduce recurrence and improve the quality of life of patients through non-surgical treatments such as physical therapy, exercise therapy, drug therapy, etc. When patients have headache and neck pain symptoms, they can take non-steroidal analgesic drugs to relieve symptoms. Many drugs for treating cervical spondylosis, such as non-steroidal anti-inflammatory drugs and muscle relaxants, may cause gastrointestinal discomfort, such as adverse reactions such as nausea, vomiting, abdominal pain and even gastrointestinal bleeding during long-term use, and may also cause a certain burden on liver and kidney functions. Summary of the Invention

[0007] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating cervical spondylosis and its application according to the deficiencies of the prior art. Based on the theory of monarch, minister, assistant and envoy and the compatibility theory of drug pairs in traditional Chinese medicine, following the basic principles of syndrome differentiation and treatment, the present invention reasonably formulates a prescription. All the drugs cooperate with each other and synergistically enhance the efficacy, and have a significant curative effect on cervical vertigo caused by kidney yang deficiency, spleen deficiency and dampness obstruction, and meridian blockage, especially showing definite curative effects on vertebral artery type and sympathetic nerve type cervical spondylosis.

[0008] In order to achieve the above purpose, the present invention provides the following technical solutions:

[0009] The first object of the present invention is to provide a traditional Chinese medicine composition for treating vertebroarterial type and sympathetic nerve type cervical spondylosis.

[0010] The second object of the present invention is to provide a preparation method of the above-mentioned traditional Chinese medicine composition for treating vertebroarterial type and sympathetic nerve type cervical spondylosis.

[0011] The third object of the present invention is to provide the use of the above-mentioned traditional Chinese medicine composition for treating vertebroarterial type and sympathetic nerve type cervical spondylosis.

[0012] To achieve the first object, the technical solution adopted by the present invention is:

[0013] The present invention provides a traditional Chinese medicine composition for treating vertebroarterial type and sympathetic nerve type cervical spondylosis, and the traditional Chinese medicine composition is made of astragalus membranaceus, achyranthes bidentata, mulberry twig, papaya and lycopodium clavatum.

[0014] Furthermore, the traditional Chinese medicine composition for treating vertebroarterial type and sympathetic nerve type cervical spondylosis is made of the following raw materials according to weight parts: 12 - 18 parts of astragalus membranaceus, 7 - 11 parts of achyranthes bidentata, 7 - 11 parts of mulberry twig, 7 - 11 parts of papaya, 6 - 13 parts of liquorice and 7 - 11 parts of lycopodium clavatum.

[0015] Still further, the traditional Chinese medicine composition for treating vertebroarterial type and sympathetic nerve type cervical spondylosis is made of the following raw materials according to weight parts: 15 parts of astragalus membranaceus, 9 parts of achyranthes bidentata, 9 parts of mulberry twig, 9 parts of papaya, 11 parts of liquorice and 9 parts of lycopodium clavatum.

[0016] Still further, the traditional Chinese medicine composition for treating vertebroarterial type and sympathetic nerve type cervical spondylosis is made of the following raw materials according to weight parts: 15 parts of astragalus membranaceus, 9 parts of achyranthes bidentata, 9 parts of mulberry twig, 10 parts of papaya, 9 parts of liquorice and 7 parts of lycopodium clavatum.

[0017] The traditional Chinese medicine composition of the present invention further includes pharmaceutically acceptable excipients, and the excipients may include but are not limited to fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, etc.

[0018] Take the Chinese medicinal materials in the above weight parts to prepare the traditional Chinese medicine raw materials of the present invention, and add conventional excipients according to the conventional methods of pharmacy to prepare various clinically acceptable dosage forms, and these dosage forms include but are not limited to decoctions, powders, granules, pills, pellets, dripping pills, tablets, capsules, oral liquids, ointments or decoctions, wherein the tablets can be ordinary tablets, sugar-coated tablets, film-coated tablets, and the capsules can be hard capsules or soft capsules.

[0019] Furthermore, the dosage form of the traditional Chinese medicine composition for treating vertebroarterial type and sympathetic nerve type cervical spondylosis is decoction, granule, tablet or capsule.

[0020] To achieve the second objective, the technical solution adopted by the present invention is as follows:

[0021] The preparation method of the traditional Chinese medicine composition for treating vertebral artery type and sympathetic nerve type cervical spondylosis of the present invention is as follows: After combining the medicinal materials, add 6-10 times the amount of water and decoct for 2 times, 2-3 hours each time, and combine the decoction liquid.

[0022] Further, the preparation method of the present invention is as follows: After combining the medicinal materials, add 8 times the amount of water and decoct for 2 times, 2 hours each time, and combine the decoction liquid.

[0023] To achieve the third objective, the technical solution adopted by the present invention is as follows:

[0024] The present invention provides the use of the traditional Chinese medicine composition for treating vertebral artery type and sympathetic nerve type cervical spondylosis in the preparation of drugs for preventing or treating vertebral artery type cervical spondylosis.

[0025] The present invention provides the use of the traditional Chinese medicine composition for treating vertebral artery type and sympathetic nerve type cervical spondylosis in the preparation of drugs for preventing or treating sympathetic nerve type cervical spondylosis.

[0026] The functions and indications of each medicinal material in the traditional Chinese medicine composition of the present invention are as follows:

[0027] Astragalus membranaceus: Sweet in taste, slightly warm in nature, belonging to the lung and spleen meridians, replenishing qi and ascending yang, securing the exterior and stopping sweating, promoting diuresis and reducing edema, promoting the production of body fluid and nourishing blood, activating qi and dredging collaterals, expelling pus and toxin through dredging, and promoting granulation and muscle growth; used for qi deficiency and weakness, poor appetite and loose stools, qi sinking, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, qi deficiency edema, internal heat and thirst, blood deficiency and sallow complexion, hemiplegia, pain and numbness in arthralgia, difficult ulceration of carbuncle and sore, and non-healing of chronic ulceration.

[0028] Achyranthes bidentata: Sweet and slightly bitter in taste, neutral in nature, belonging to the liver and kidney meridians, promoting blood circulation to remove blood stasis, expelling wind and removing dampness; used for blood stasis amenorrhea, dysmenorrhea and traumatic injury, pain in the waist and knees due to wind-dampness, joint discomfort, hematuria due to strangury.

[0029] Mulberry twig: Slightly bitter in taste, neutral in nature, belonging to the liver meridian, expelling wind and dampness, promoting joint movement; used for wind-damp arthralgia, soreness and numbness in the shoulders, arms and joints.

[0030] Chaenomeles sinensis: Sour in taste, warm in nature, belonging to the liver and spleen meridians, relaxing tendons and activating collaterals, regulating the stomach and resolving dampness; used for damp arthralgia with muscle spasm, soreness and heaviness in the waist and knee joints, vomiting and diarrhea with cramps, and beriberi edema.

[0031] Licorice: Nature and flavor: Sweet, flat. Meridian tropism: Belonging to the heart, lung, spleen and stomach meridians, licorice mainly plays the role of harmonizing the properties of medicinal herbs, strengthening the spleen and replenishing qi, reducing toxicity and enhancing efficacy.

[0032] Lycopodium clavatum: Slightly bitter and pungent in taste, warm in nature, belonging to the liver, spleen and kidney meridians, expelling wind and removing dampness, relaxing tendons and activating collaterals; used for wind-cold-damp arthralgia, pain due to muscle spasm, and externally for traumatic injury and swelling pain.

[0033] Based on the theory of monarch, minister, assistant, and guide in traditional Chinese medicine and the compatibility theory of medicinal pairs, following the basic principles of syndrome differentiation and treatment, the prescription is rationally formulated, and the above six traditional Chinese medicines are selected. When combined, these medicines work synergistically to enhance the efficacy, with the functions of tonifying the kidney and promoting yang, promoting qi circulation and activating blood circulation, dispelling wind and dredging collaterals, strengthening the spleen and calming the mind. It shows definite curative effects on cervicogenic vertigo, vertebral artery type and sympathetic nerve type cervical spondylosis caused by kidney yang deficiency, spleen deficiency with damp obstruction, and blocked collaterals.

[0034] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0035] After the traditional Chinese medicine composition of the present invention intervenes in the vertebral artery type cervical spondylosis model, it significantly increases the Vm of the vertebral artery and decreases PI and RI, indicating that the traditional Chinese medicine composition of the present invention can improve the blood flow of the vertebral artery. The plasma viscosity, whole blood high shear relative index, whole blood low shear relative index, and red blood cell aggregation index at each shear rate of the traditional Chinese medicine composition group of the present invention are significantly decreased, indicating that the traditional Chinese medicine composition of the present invention has a positive effect in improving hemorheology, diluting blood viscosity, and maintaining the stability of red blood cell deformation, and has a significant curative effect on vertebral artery type cervical spondylosis.

[0036] The traditional Chinese medicine composition of the present invention significantly improves the quality of life of patients with sympathetic cervical spondylosis and has a significant curative effect on sympathetic cervical spondylosis.

[0037] The traditional Chinese medicine composition of the present invention has the characteristics of definite curative effect, quick onset, high cure rate, and no side effects, providing a new option for the clinical treatment of vertebral artery type cervical spondylosis and sympathetic nerve type cervical spondylosis. Description of the Drawings

[0038] Figure 1 Comparison of Vm of the left vertebral artery in each group. Different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0039] Figure 2 Comparison of PI of the left vertebral artery in each group. Different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0040] Figure 3 Comparison of RI of the left vertebral artery in each group. Different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0041] Figure 4 Comparison of low shear rates in each group. Different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0042] Figure 5 Comparison of medium shear rates in each group. Different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0043] Figure 6For the comparison of shear rates in each group, different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0044] Figure 7 For the comparison of high shear rates in each group, different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0045] Figure 8 For the comparison of whole blood low shear relative indices in each group, different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0046] Figure 9 For the comparison of whole blood high shear relative indices in each group, different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0047] Figure 10 For the comparison of red blood cell aggregation indices in each group, different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0048] Figure 11 For the comparison of plasma viscosities in each group, different lowercase letters above the bar graph indicate significant differences between different groups (P < 0.05).

[0049] Figure 12 For the comparison of SF-36 scale scores in each group, compared with before treatment, ** P < 0.01, compared with the control group, ## P < 0.01.

[0050] Figure 13 Comparison of the clinical efficacy between two groups. Specific implementation manners

[0051] The following will describe the implementation schemes of the present invention in detail with reference to the embodiments. However, those skilled in the art will understand that the following embodiments are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention.

[0052] Example 1

[0053] A traditional Chinese medicine composition for preventing or treating vertebral artery type and sympathetic nerve type cervical spondylosis is made from the following raw materials: 15 g of astragalus membranaceus, 9 g of achyranthes bidentata, 9 g of morus alba twig, 9 g of chaenomeles sinensis, 11 g of licorice, and 9 g of lycopodium clavatum.

[0054] The preparation method is as follows: After combining the medicinal materials, add 8 times the amount of water and decoct twice, 2 h each time, and combine the decoction liquids.

[0055] Example 2

[0056] A traditional Chinese medicine composition for preventing or treating vertebroarterial type and sympathetic nerve type cervical spondylosis, which is made from the following raw materials: 15 g of Astragalus membranaceus, 9 g of Achyranthes bidentata, 9 g of Ramulus mori, 10 g of Chaenomeles sinensis, 9 g of Glycyrrhiza uralensis, and 7 g of Lycopodium clavatum.

[0057] The preparation method is as follows: After combining the medicinal materials, add 6 times the amount of water and decoct for 2 times, 3 h each time, and combine the decoction liquids.

[0058] Example 3

[0059] A traditional Chinese medicine composition for preventing or treating vertebroarterial type and sympathetic nerve type cervical spondylosis, which is made from the following raw materials: 12 g of Astragalus membranaceus, 11 g of Achyranthes bidentata, 7 g of Ramulus mori, 11 g of Chaenomeles sinensis, 6 g of Glycyrrhiza uralensis, and 9 g of Lycopodium clavatum.

[0060] The preparation method is as follows: After combining the medicinal materials, add 10 times the amount of water and decoct for 2 times, 2 h each time, and combine the decoction liquids.

[0061] Example 4

[0062] A traditional Chinese medicine composition for preventing or treating vertebroarterial type and sympathetic nerve type cervical spondylosis, which is made from the following raw materials: 18 g of Astragalus membranaceus, 11 g of Achyranthes bidentata, 11 g of Ramulus mori, 9 g of Chaenomeles sinensis, 13 g of Glycyrrhiza uralensis, and 11 g of Lycopodium clavatum.

[0063] The preparation method is as follows: After combining the medicinal materials, add 9 times the amount of water and decoct for 2 times, 2.5 h each time, and combine the decoction liquids.

[0064] Example 5

[0065] A traditional Chinese medicine composition for preventing or treating vertebroarterial type and sympathetic nerve type cervical spondylosis, which is made from the following raw materials: 18 g of Astragalus membranaceus, 7 g of Achyranthes bidentata, 1'1 g of Ramulus mori, 7 g of Chaenomeles sinensis, 12 g of Glycyrrhiza uralensis, and 11 g of Lycopodium clavatum.

[0066] The preparation method is as follows: After combining the medicinal materials, add 7 times the amount of water and decoct for 2 times, 3 h each time, and combine the decoction liquids.

[0067] Example 6

[0068] A traditional Chinese medicine composition for preventing or treating vertebroarterial type and sympathetic nerve type cervical spondylosis, which is made from the following raw materials: 15 g of Astragalus membranaceus, 9, 9 g of Ramulus mori, 11 g of Chaenomeles sinensis, 12 g of Glycyrrhiza uralensis, and 7 g of Lycopodium clavatum.

[0069] The preparation method is as follows: After combining the medicinal materials, add 8 times the amount of water and decoct for 2 times, 2 h each time, and combine the decoction liquids.

[0070] Comparative Example 1

[0071] A traditional Chinese medicine composition for preventing or treating vertebroarterial type and sympathetic nerve type cervical spondylosis, which is made from the following raw materials: 11 g of Astragalus membranaceus, 10 g of Achyranthes bidentata, 10 g of Ramulus mori, 10 g of Chaenomeles sinensis, 6 g of Glycyrrhiza uralensis, and 10 g of Lycopodium clavatum.

[0072] The preparation method was the same as that in Example 1.

[0073] Comparative Example 2

[0074] A traditional Chinese medicine composition for preventing or treating vertebral artery type and sympathetic nerve type cervical spondylosis is made from the following raw materials: 20 g of Astragalus membranaceus, 8 g of Achyranthes bidentata, 8 g of Mori Ramulus, 8 g of Chaenomelis Fructus, 9 g of Glycyrrhiza uralensis, and 7 g of Lycopodiastrum casuarinoides.

[0075] The preparation method was the same as that in Example 1.

[0076] Comparative Example 3

[0077] A traditional Chinese medicine composition for preventing or treating vertebral artery type and sympathetic nerve type cervical spondylosis is made from the following raw materials: 13 g of Achyranthes bidentata, 13 g of Mori Ramulus, 13 g of Chaenomelis Fructus, and 12 g of Lycopodiastrum casuarinoides.

[0078] The preparation method was the same as that in Example 1.

[0079] Comparative Example 4

[0080] A traditional Chinese medicine composition for preventing or treating vertebral artery type and sympathetic nerve type cervical spondylosis is made from the following raw materials: 18 g of Astragalus membranaceus, 11 g of Mori Ramulus, 11 g of Chaenomelis Fructus, and 11 g of Lycopodiastrum casuarinoides.

[0081] Pharmacodynamic Example The therapeutic effect of the traditional Chinese medicine composition of the present invention on rats with vertebral artery type cervical spondylosis

[0082] 1. Experimental method

[0083] 64 clean-grade SD rats, half male and half female, with a body weight of 200 ± 20 g, were allowed to drink and eat freely, and the room temperature in the breeding room was maintained at 20 - 25°C. After 7 days of quarantine and passing the inspection, 8 rats were randomly selected as the normal control group, and the remaining rats were subjected to modeling.

[0084] The modeling method was as follows: The rats were anesthetized by intraperitoneal injection of 3.5% chloral hydrate at 10 ml / kg. The rats were placed in the right lateral position, and a needle was inserted vertically into the cervical vertebra from the upper edge of the left humerus, and 5 ml / kg of Xizhiling injection was injected into the muscles around the transverse foramen of the 3rd - 5th cervical vertebrae on the left side of the rats. The injection was repeated after 1 week.

[0085] 4 weeks after modeling, the rats were grouped for drug administration. The modeled rats were randomly divided into a model control group, an Example 1 group, an Example 2 group, a Comparative Example 1 group, a Comparative Example 2 group, a Comparative Example 3 group, and a Comparative Example 4 group, with 8 rats in each group. Each group was intragastrically administered the corresponding decoction, and the dosage was 4.2 g / kg. The normal control group and the model control group were intragastrically administered an equal volume of normal saline. The drug was administered once a day for 2 consecutive weeks.

[0086] 2. Index detection

[0087] 2.1 Transcranial Doppler ultrasound (TCD) detection of the left vertebral artery in rats

[0088] After the last administration, the rats were fasted and water-deprived for 12 h, then anesthetized by intraperitoneal injection of 3.5% sodium pentobarbital. The skin of the occipital posterior and neck was prepared. The mean blood flow velocity (Vm), pulsatility index (PI), and resistance index (RI) of the left vertebral artery were measured by TCD.

[0089] 2.2 Detection of hemorheology in rats

[0090] After the last administration, the rats were fasted and water-deprived for 12 h, then anesthetized by intraperitoneal injection of 3.5% sodium pentobarbital. 5 ml of blood was taken from the inferior vena cava and placed in a heparin tube. The low shear rate (1 / s), medium shear rate (5 / s), medium shear rate (30 / s), and high shear rate (200 / s) of whole blood viscosity were detected, and the relative index of whole blood low shear, relative index of whole blood high shear, and erythrocyte aggregation index were measured; the whole blood was centrifuged at 3000 r / min for 10 min at 25 °C, and the plasma was taken to measure plasma viscosity.

[0091] 3. Statistical methods

[0092] Graphpad Prism 9.0 software was used for data processing. Measurement data were expressed as , one-way ANOVA was used for comparison among multiple groups, and SNK-q was used for pairwise comparison between groups. P < 0.05 was considered statistically significant.

[0093] 4. Experimental results

[0094] 4.1 TCD of the left vertebral artery blood flow in rats of each group

[0095] Compared with the normal control group, the Vm of the left vertebral artery in the model control group of rats was significantly decreased. Compared with the model control group, the Vm of the left vertebral artery in the Example 1 group and the Example 2 group were both significantly increased, and the Example 1 group had the best effect on improving the Vm of the left vertebral artery, which was significantly better than each group of comparative examples. The results are shown in Figure 1 .

[0096] Compared with the normal control group, the PI and RI in the model control group of rats were significantly increased. Compared with the model control group, the PI and RI in the Example 1 group and the Example 2 group were both significantly decreased, and the Example 1 group had the best effect on reducing the PI and RI, which was significantly better than each group of comparative examples. The results are shown in Figure 2 、 Figure 3 .

[0097] 4.2 Effects on hemorheology indexes in rats

[0098] Compared with the normal control group, the whole blood viscosity, plasma viscosity, whole blood high / low shear relative index, and red blood cell aggregation index of the rats in the model control group were significantly increased at low, medium, and high shear rates. Compared with the model control group, the whole blood viscosity, plasma viscosity, whole blood high shear relative index, whole blood low shear relative index, and red blood cell aggregation index of the Example 1 group and the Example 2 group were significantly decreased at low, medium, and high shear rates. The Example 1 group had the best effect in reducing hemorheological indexes, which was significantly better than each group of comparative examples. The results are shown in Figures 4 - 11 。

[0099] After the intervention of the traditional Chinese medicine composition of the present invention on the vertebral artery type cervical spondylosis model, the Vm of the vertebral artery was significantly increased, and the PI and RI were decreased, indicating that the traditional Chinese medicine composition of the present invention can improve the blood flow of the vertebral artery. The plasma viscosity, whole blood high shear relative index, whole blood low shear relative index, and red blood cell aggregation index of each shear rate in the traditional Chinese medicine composition group of the present invention were significantly decreased, indicating that the traditional Chinese medicine composition of the present invention has a positive effect in improving hemorheology, diluting blood viscosity, and maintaining the stability of red blood cell deformation, providing an effective product for alleviating and curing vertebral artery type cervical spondylosis.

[0100] Clinical Example Observation on the Clinical Efficacy of the Traditional Chinese Medicine Composition of the Present Invention in Sympathetic Cervical Spondylosis

[0101] I. Data and Methods

[0102] 1. General Information

[0103] 70 patients with sympathetic cervical spondylosis admitted to our hospital were selected as the research objects and randomly divided into a control group and a treatment group, with 35 people in each group. Among them, there were 13 males and 22 females in the control group, with an average age of (53.6 ± 10.7) years; there were 20 males and 15 females in the treatment group, with an average age of (51.4 ± 9.5) years.

[0104] There was no significant difference in the general information of each group of patients (P > 0.05), and they were comparable.

[0105] 2. Inclusion Criteria

[0106] Those who met the diagnostic criteria for sympathetic cervical spondylosis and gave informed consent; those without neck diseases such as neck fractures and disc herniations; those with abnormal cervical blood flow velocity.

[0107] 3. Exclusion Criteria

[0108] Those with drug allergies; female patients who are inconvenient to be included during lactation or pregnancy; psychiatric patients; patients with severe systemic diseases.

[0109] 4. Treatment Methods

[0110] The patients in the control group were treated with traction. The initial traction weight was 4 kg, which could be gradually increased according to the physical condition and disease condition, generally not exceeding 15 kg. Each session lasted for 20 minutes and was performed twice a day; Mecobalamin, 0.5 mg was taken orally each time, three times a day, for 30 days of treatment.

[0111] The patients in the treatment group took the decoction of Example 1 orally, once in the morning and once in the evening.

[0112] Both groups were treated for 30 days.

[0113] 5. Observation indicators

[0114] 5.1 SF-36 scale score

[0115] The SF-36 scale was used to analyze the improvement of the patients' quality of life. The SF-36 scale includes 8 dimensions: mental health, emotional role, social function, physical function, general health, bodily pain, physical role, and vitality. The higher the total score, the better the quality of life.

[0116] 5.2 Clinical efficacy

[0117] Refer to the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes and Diseases". Cure: The cervical spine function is restored, symptoms and signs disappear, and normal work and life can be carried out. Marked effect: The cervical spine function is basically restored, symptoms and signs are obvious, but it does not affect the patient's normal work and life. Effective: There are still obstacles in the cervical spine function, symptoms and signs are improved but not obvious, and it can have a greater impact on daily life. Ineffective: After treatment, the symptoms and signs have not improved or even worsened.

[0118] 6. Statistical method

[0119] SPSS 21.0 software was used for data processing. The obtained data were expressed as , and normal distribution test and homogeneity of variance test were performed on the data of each group. One-way analysis of variance was used for comparison between groups, and P < 0.05 was considered statistically significant.

[0120] II. Results

[0121] 1. Comparison of SF-36 scale scores

[0122] Before treatment, there was no statistically significant difference in the SF-36 scale scores between the two groups of patients; after treatment, the SF-36 scale scores of the patients in the treatment group were higher than those in the control group, and the difference was statistically significant. The results are shown in Figure 12 .

[0123] 2. Comparison of clinical efficacy between the two groups

[0124] Table 1 Comparison of clinical efficacy

[0125] Group Number of cases / case Total effective rate / % Control group 35 94.3 Treatment group 35 80.0

[0126] From Figure 13 and Table 1, it can be seen that the total effective rate of the control group was 80.0%, and the total effective rate of the treatment group was 94.3%. The clinical efficacy of the treatment group was significantly better than that of the control group.

[0127] The traditional Chinese medicine composition of the present invention significantly improves the quality of life of patients with sympathetic cervical spondylosis, has a significant effect on sympathetic cervical spondylosis, and provides a better product for clinically alleviating and curing sympathetic cervical spondylosis.

[0128] In the above text, the present invention has been described in detail with general descriptions and specific embodiments. However, based on the present invention, some modifications or improvements can be made, which are obvious to those skilled in the art. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection required by the present invention.

Claims

1. A traditional Chinese medicine composition for treating cervical spondylosis, characterized in that, The traditional Chinese medicine composition for treating cervical spondylosis is prepared from the following raw materials in parts by weight: 12-18 parts of astragalus membranaceus, 7-11 parts of achyranthes bidentata, 7-11 parts of morus alba twig, 7-11 parts of chaenomeles sinensis, 6-13 parts of licorice, and 7-11 parts of lycopodium clavatum.

2. The traditional Chinese medicine composition for treating cervical spondylosis according to claim 1, wherein, The traditional Chinese medicine composition for treating cervical spondylosis is prepared from the following raw materials in parts by weight: 15 parts of astragalus membranaceus, 9 parts of achyranthes bidentata, 9 parts of morus alba twig, 9 parts of chaenomeles sinensis, 11 parts of licorice, and 9 parts of lycopodium clavatum.

3. The traditional Chinese medicine composition for treating cervical spondylosis according to claim 1, wherein, The traditional Chinese medicine composition for treating cervical spondylosis is prepared from the following raw materials in parts by weight: 15 parts of astragalus membranaceus, 9 parts of achyranthes bidentata, 9 parts of morus alba twig, 10 parts of chaenomeles sinensis, 9 parts of licorice, and 7 parts of lycopodium clavatum.

4. A traditional Chinese medicine composition for treating cervical spondylosis according to any one of claims 1-3, characterized in that, The cervical spondylosis is of the vertebral artery type and the sympathetic nerve type; the traditional Chinese medicine composition further comprises pharmaceutically acceptable excipients.

5. The traditional Chinese medicine composition for treating cervical spondylosis according to claim 4, wherein, The traditional Chinese medicine composition for treating cervical spondylosis is a clinically acceptable dosage form.

6. The traditional Chinese medicine composition for treating cervical spondylosis according to claim 5, characterized in that, The dosage form of the traditional Chinese medicine composition for treating cervical spondylosis is decoction, powder, granule, pill, granule, dripping pill, tablet, capsule, oral liquid, ointment or decoction.

7. A traditional Chinese medicine composition for treating cervical spondylosis according to any one of claims 1-3, characterized in that, The preparation method of the traditional Chinese medicine composition for treating cervical spondylosis is as follows: after combining the medicinal materials, add 6-10 times the amount of water and decoct twice, each time for 2-3 hours, and combine the decoction liquid.

8. A traditional Chinese medicine composition for treating cervical spondylosis according to any one of claims 1 to 3, characterized in that, The preparation method of the traditional Chinese medicine composition for treating cervical spondylosis is as follows: after combining the medicinal materials, add 8 times the amount of water and decoct twice, each time for 2 hours, and combine the decoction liquid.

9. Use of a traditional Chinese medicine composition for treating cervical spondylosis according to any one of claims 1-3 in the preparation of a drug for preventing or treating vertebral artery type cervical spondylosis.

10. Use of a traditional Chinese medicine composition for treating cervical spondylosis according to any one of claims 1-3 in the preparation of a drug for preventing or treating sympathetic nerve type cervical spondylosis.

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