A pharmaceutical composition for treating cervical spondylosis of sympathetic nerve type and a preparation method and use thereof

Abstract

The application provides a medicinal composition for treating sympathetic cervical spondylosis, which is prepared from the following raw medicinal materials in the following proportions: Gualoupi 5-15 parts, Xiebai 5-15 parts, Fabanxia 8-20 parts, Guizhi 5-15 parts, Fushen 10-30 parts, Shenghuangqi 20-60 parts, Chao Wu Zhu 5-15 parts, Shengbaishu 10-30 parts, Muxiang 5-15 parts, Shigai 8-20 parts, Zhizhi 5-15 parts, Longgu 8-20 parts, and Muli 8-20 parts. The application also provides a preparation method and use of the medicinal composition. The medicinal composition has the effects of benefiting qi and activating yang, promoting qi and dredging collaterals, and eliminating swelling and relieving pain, and the compatibility of the medicinal materials can synergistically enhance the effects, so that the medicinal composition has good effects on sympathetic cervical spondylosis and can effectively reduce the clinical recurrence rate. In addition, the medicinal composition has fewer raw medicinal materials, is convenient to prepare and use, has high clinical compliance of patients, and has a good clinical application prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to a kind of drug composition for treating sympathetic cervical spondylosis, belong to the field of traditional Chinese medicine. BACKGROUND

[0002] Cervical spondylosis is a kind of clinical common multiple disease based on degeneration, the incidence rate increases year by year, and sympathetic cervical spondylosis belongs to a kind of clinical common type of cervical spondylosis, mainly involves sympathetic nervous system. Sympathetic nerve is part of autonomic nervous system, usually used to maintain the body's external stress response and internal environment homeostasis. Sympathetic nerve in the neck mainly distributes through cervical sympathetic ganglion, which is adjacent to cervical vertebra, so it is also easy to be affected by degenerative changes of cervical vertebra. In clinical sympathetic cervical spondylosis, pathological changes of cervical vertebra can have a series of effects on sympathetic nerve, thereby causing symptoms including occipital headache, frontal pain, dizziness, hearing loss, palpitation, chest tightness, or upper limb numbness, and these symptoms can continuously aggravate with the progress of the disease, thereby seriously interfering with the daily life of patients.

[0003] Sympathetic cervical spondylosis is a cervical sympathetic nerve disease with recurrent onset of cervical sympathetic nerve excitement or sympathetic nerve inhibition symptoms. The pathogenesis is not clear. Western medicine believes that the onset of the disease may be related to stimulation of the sympathetic nerve, instability of the cervical spine, inflammatory response, and neurohumoral factors. Western medicine treats sympathetic cervical spondylosis with non-steroidal anti-inflammatory drugs, painkillers, muscle relaxants, etc. These drugs can quickly relieve pain, but have side effects such as liver and kidney damage, gastrointestinal irritation, etc. They can only relieve symptoms and are difficult to cure. The disease is prone to recurrence. Traditional Chinese medicine understands the pathogenesis of sympathetic cervical spondylosis from the aspects of zang-fu, qi and blood, emotions, deficiency and excess, meridians, phlegm and blood stasis, etc. The pathogenesis of sympathetic cervical spondylosis is relatively complex. According to the clinical manifestations of patients, it can be discussed from the aspects of “dizziness”, “depression” and “arthritis”. In general, the onset of sympathetic cervical spondylosis is the result of the combined action of internal and external factors. Traditional Chinese medicine emphasizes the combination of disease differentiation and syndrome differentiation, and follows the principles of treating different diseases with the same treatment and treating the same disease with different treatments. In the process of deepening the understanding of cervical spondylosis, in order to standardize clinical diagnosis and treatment, the “Standard for Diagnosis and Treatment of Traditional Chinese Medicine” has been formulated to guide clinical work. The industry standard clearly defines the diagnosis, pathological classification, and efficacy evaluation standard of cervical spondylosis and divides it into five types of traditional Chinese medicine syndromes: wind-cold-damp, qi stagnation and blood stasis, phlegm-dampness blocking collaterals, liver and kidney deficiency, and deficiency of qi and blood. Another more authoritative “Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine (Trial)” divides cervical spondylosis into four types of traditional Chinese medicine syndromes: wind-cold blocking collaterals, qi stagnation and blood stasis, deficiency of qi and blood, and liver yang hyperactivity to guide clinical research. (Zhang Fucheng, et al. Traditional Chinese Medicine Understanding and Treatment Research of Sympathetic Cervical Spondylosis. Journal of Traditional Chinese Medicine and Clinical, February 2020, Volume 32, Issue 2). At present, scholars at home and abroad are still studying the pathogenesis of sympathetic cervical spondylosis in traditional Chinese medicine, and there is no unified and clear view. The treatment methods are also different. For example, patent application CN201310200175.2, entitled “A Traditional Chinese Medicine for Treating Sympathetic Cervical Spondylosis”, discloses a traditional Chinese medicine composition for treating sympathetic cervical spondylosis made from plant Chinese herbal medicines. The characteristic is that the raw materials for preparing effective ingredients are as follows: Gastrodia elata 8-12g, Earthworm 8-12g, Chuanxiong 8-12g, Medlar 8-12g, Adenophora 8-12g. It has the effects of tonifying qi and blood, refreshing the brain and calming the spirit, promoting blood circulation and unblocking collaterals, etc. Application No. 201510687474.2, entitled “A Composition for Treating Sympathetic Cervical Spondylosis and Its Preparation Method”, discloses a composition prepared from the following raw materials in the following weight ratio: Chuanxiong 20-40 parts, Angelica 20-80 parts, Solpugid 5-10 parts, Sichuan Cow's Honeysuckle 80-120 parts, Schisandra 20-40 parts, Blood Red 10-20 parts, Mountain Magnolia 15-25 parts, Crocus 10-18 parts, Alstroemeria 5-15 parts, Lily 40-60 parts, and vinegar 300-500 parts. The composition also has the effects of promoting blood circulation and removing blood stasis, unblocking collaterals, dispelling wind and cold, and relieving pain.

[0004] At present, the mechanism of the disease lacks deep research, and it is necessary to explore an economical and effective traditional Chinese medicine. SUMMARY

[0005] The present application aims to provide a pharmaceutical composition for treating sympathetic cervical spondylosis and its preparation method and use.

[0006] The present application provides a pharmaceutical composition for treating sympathetic cervical spondylosis, which is prepared from the following raw materials in the weight ratio:

[0007] Gualoupi 5-15 parts, Xiebai 5-15 parts, Banxia 8-20 parts, Guizhi 5-15 parts, Fushen 10-30 parts, Huangqi 20-60 parts, Wuzhuyu 5-15 parts, Baizhu 10-30 parts, Muxiang 5-15 parts, Shichangpu 8-20 parts, Yuanzhi 5-15 parts, Longgu 8-20 parts, and Muli 8-20 parts.

[0008] Further preferably, it is prepared from the following raw materials in the weight ratio:

[0009] Gualoupi 10 parts, Xiebai 10 parts, Banxia 15 parts, Guizhi 10 parts, Fushen 20 parts, Huangqi 40 parts, Wuzhuyu 10 parts, Baizhu 20 parts, Muxiang 10 parts, Shichangpu 15 parts, Yuanzhi 10 parts, Longgu 15 parts, and Muli 15 parts.

[0010] Among them, the Banxia is Fa Banxia; the Huangqi is raw Huangqi; the Wuzhuyu is fried Wuzhuyu; the Baizhu is raw Baizhu; and the Yuanzhi is prepared Yuanzhi.

[0011] The pharmaceutical composition of the present application is prepared from the raw drug powder of the raw drug, the water or organic solvent extract of the raw drug as the active ingredient, and the pharmaceutically acceptable excipient or auxiliary ingredient.

[0012] Among them, the preparation is an oral preparation.

[0013] Among them, the oral preparation is a plaster, a decoction, a powder, a tablet, a pill, a capsule, a granule, an oral liquid, or a tea bag.

[0014] The present application also provides a preparation method of the pharmaceutical composition, which is characterized by comprising the following steps:

[0015] The raw drugs in the weight ratio are directly powdered, or extracted by adding water or an organic solvent, and then a pharmaceutically acceptable excipient or auxiliary ingredient is added, and the preparation is obtained.

[0016] The present application also provides the use of the pharmaceutical composition in the preparation of a medicine for treating sympathetic cervical spondylosis.

[0017] The medicine is a medicine for treating sympathetic cervical spondylosis with qi deficiency and obstruction.

[0018] The application further provides use of the medicine composition in preparation of a medicine with heat-clearing and dampness-dissolving, qi-moving, collateral-unblocking, swelling-dissolving, and pain-relieving functions.

[0019] In the medicine composition, the Gualoupi is the dried mature pericarp of Trichosanthes kirilowii Maxim. or Trichosanthes rosthornii Harms; the Xiebai is the dried bulb of Allium macrostemon Bge. or Allium chinensis G.Don; and the Shenghuangqi is the root of Astragalus membranaceus (Fisch.) Bge. Var. mongholicus (Bge.) Hsiao or A. membranaceus (Fisch.) Bge.

[0020] The medicine composition is a combination for treating dizziness, headache, stiff neck, chest distress, and palpitation caused by sympathetic cervical spondylosis. In the medicine composition, the Gualoupi, Xiebai, and Shenghuangqi are used as the monarch drug, the Gualoupi can relieve chest and qi, the Xiebai can warm and move yang qi, and the Shenghuangqi can benefit qi and produce saliva. In the medicine composition, the Huangqi is particularly used in a large amount to move qi and relieve arthralgia, benefit qi and produce saliva, and relieve stiff neck. In addition, the Guizhi, Muxiang, Banxia, Longgu, Muli, Fushen, and Baizhu are used as the ministerial drug, the Guizhi, Muxiang, and Banxia can enhance the effect of warming yang, resolving phlegm, moving qi, relieving arthralgia, and stopping pain, the Longgu and Muli can calm the nerves and tranquilize the mind, and are suitable for chest distress, palpitation, and insomnia, and can enhance the effect of calming the nerves and resolving phlegm, the Fushen and Baizhu can protect the acquired spleen, the Yuanzhi and Shichangpu are used as the auxiliary drug, and the Yuanzhi and Shichangpu can resolve phlegm and tranquilize the mind, and assist the Fushen and Baizhu, and the Wuzhuyu is used as the ministerial drug, and the Wuzhuyu belonging to the liver meridian can warm and supplement the yin, and move qi and blood, and can relieve insomnia, palpitation, and headache caused by qi stagnation and blood stasis.

[0021] The traditional Chinese medicine combined preparation of the present application has proper compatibility of each medicine, synergistic effect, and the effects of benefiting qi, unblocking yang, promoting qi and unblocking collaterals, and removing swelling and relieving pain, and can be used for treating qi stagnation and blood stasis type of sympathetic nervous type of cervical spondylosis, such as dizziness and headache, tinnitus and blurred vision, upper limb numbness and weakness, etc., and has good curative effect on sympathetic nervous type of cervical spondylosis, and has small adverse reactions and low recurrence rate. In addition, the raw material components of the traditional Chinese medicine combined preparation of the present application are few, and the preparation and use are convenient, and the compliance and cooperation degree of patients are good, and the present application has good prospects in clinical application. DETAILED DESCRIPTION

[0022] The raw materials and equipment used in the detailed description of the present application are known products, which can be obtained by purchasing commercially available products.

[0023] Example 1, preparation of the pharmaceutical composition of the present application

[0024] 1, formula: Gualoupi 10g, Xiebai 10g, Fabanxia 15g, Guizhi 10g, Fushen 20g, Shenghuangqi 40g, Chao Wu Zhu 10g, Shengbaishu 20g, Muxiang 10g, Shichangpu 15g, Zhizhi 10g, Longgu 15g, Muli 15g.

[0025] 2, preparation method: the above traditional Chinese medicinal materials are mixed and powdered, and then the powder is obtained.

[0026] Example 2, preparation of the pharmaceutical composition of the present application

[0027] 1, formula: Gualoupi 15g, Xiebai 15g, Fabanxia 20g, Guizhi 15g, Fushen 30g, Shenghuangqi 60g, Chao Wu Zhu 15g, Shengbaishu 30g, Muxiang 15g, Shichangpu 20g, Zhizhi 15g, Longgu 20g, Muli 20g.

[0028] 2, preparation method: same as example 1.

[0029] Example 3, preparation of the pharmaceutical composition of the present application

[0030] 1, formula: Gualoupi 5g, Xiebai 5g, Fabanxia 8g, Guizhi 5g, Fushen 10g, Shenghuangqi 20g, Chao Wu Zhu 5g, Shengbaishu 10g, Muxiang 5g, Shichangpu 8g, Zhizhi 5g, Longgu 8g, Muli 8g.

[0031] 2, preparation method: same as example 1.

[0032] The beneficial effects of the pharmaceutical composition of the present application are proved by the following specific test examples.

[0033] Test example 1, clinical treatment effect of the pharmaceutical composition of the present application

[0034] 1, clinical data

[0035] The cases of this study were derived from the outpatients and inpatients of the Department of Massage with cervical spondylosis of sympathetic nerve type, and were divided into the test group (taking the drugs of the implementation groups 1-3 respectively) and the control group (methylcobalamin tablets) according to the random number table method. Among them, the test group included 91 patients, including 40 male patients and 51 female patients, with an average age of 37.58±5.17 years and an average disease duration of 5.31±2.17 years. The control group included 30 patients, including 14 male patients and 16 female patients, with an average age of 39.32±5.12 years and an average disease duration of 4.91±2.06 years.

[0036] 1.1 Diagnostic criteria

[0037] (1) Western medicine inclusion criteria:

[0038] According to the standard of the Third Symposium on Cervical Spondylosis in 2018: (1) Clinical manifestations: dizziness, blurred vision, tinnitus, hand numbness, hearing impairment, tachycardia, precordial pain and a series of sympathetic nervous symptoms; physical examination can show positive cervical rotation test. (2) Imaging manifestations: X-ray film can show segmental instability; MR can show cervical disc degeneration. (3) Except for brain-heart-ear and exogenous dizziness, etc.

[0039] (2) Chinese medicine inclusion criteria:

[0040] Refer to the SCS diagnostic criteria in the Standard for Diagnosis and Treatment of Chinese Medicine Syndromes: (1) Clinical manifestations: ① sympathetic nervous symptoms, including dizziness, headache, blurred vision, occipital pain, chest tightness, palpitation, high blood pressure, cold extremities, sweating, insomnia, etc.; ② symptoms of sympathetic nervous inhibition, including dizziness, blurred vision, ptosis, bradycardia, low blood pressure, etc. (2) Signs: soft tissue tenderness around the interspinal or paravertebral facet joints of the cervical spine. (3) Imaging manifestations: segmental instability of the cervical spine. Those who meet the above clinical symptoms, signs and imaging manifestations, and exclude other diseases such as internal medicine, ophthalmology, otolaryngology, etc. can be diagnosed.

[0041] 1.2 Exclusion criteria:

[0042] (1) Not meeting the above diagnostic criteria; (2) Age <20 or >70 years old; (3) Cervical spine fracture and / or fracture not healed; (4) Severe mental or conscious disorder; (5) Coagulation dysfunction; (6) With severe heart, lung, liver and kidney multiple organ failure; (7) Pregnancy or lactation.

[0043] 2. Treatment method:

[0044] Test group: Patients take the preparation combination preparation powder of the implementation groups 1-3 of the application, 10-15g each time; take with warm water, 3 times a day, 7 days a course, a total of 4 courses.

[0045] Control group: The combined formulation consisted of 25mg of mecobalamin tablets mixed with starch excipients, prepared into 500g of a mixed formulation, which was then ground into powder. The administration method and dosage were the same as in the treatment group.

[0046] 3. Criteria for judging therapeutic efficacy:

[0047] The Clinical Symptoms and Cervical Spondylosis Clinical Evaluation Scale (CASCS) was used for evaluation. The scale assessment included three dimensions: subjective symptoms (18 points), daily living, working, and social adaptability (9 points), and clinical signs (73 points), for a total score of 100 points. Improvement rate = (Post-treatment score - Pre-treatment score) ÷ (100 - Pre-treatment score) × 100%

[0048] (1) Significant effect: Cervical sympathetic nerve symptoms were significantly improved compared with those before treatment, with a clinical score improvement rate of 60%-<100%;

[0049] (2) Improvement: Cervical sympathetic nerve symptoms were mildly relieved compared with those before treatment, with a clinical score improvement rate of 30%-<60%;

[0050] (3) Ineffective: There was basically no change in cervical sympathetic nerve symptoms before and after treatment, and the improvement rate of clinical scores was <30%.

[0051] Effectiveness rate = (Number of cases showing significant improvement + Number of cases showing improvement) / Total number of cases × 100%

[0052] 4. Treatment efficacy

[0053] (1) The clinical efficacy results of the pharmaceutical composition of the present invention are shown in the table below.

[0054] Table 1. Clinical efficacy results of the pharmaceutical compositions of the present invention

[0055] cases markedly effective (cases) improved (cases) ineffective (cases) effective rate example 1 32 12 17 3 90.63％ example 2 30 10 15 5 83.33％ example 3 29 12 11 6 79.31％ control group 1 30 4 11 15 50.00％

[0056] (2) The recurrence rate of this traditional Chinese medicine combination preparation was shown in Table 3 after a 3-month follow-up period following treatment.

[0057] Table 3. Recurrence rate after treatment with the traditional Chinese medicine combination preparation of the present invention

[0058]

[0059]

[0060] Experimental results: The traditional Chinese medicine combination preparation prepared in this invention has a good therapeutic effect on improving the clinical symptoms of sympathetic cervical spondylosis. At the same time, this traditional Chinese medicine combination preparation has the advantage of low recurrence rate. Among them, the ratio and dosage of experimental group 1 have the best effect.

[0061] In summary, the prepared traditional Chinese medicine combined preparation of the present application has the effects of benefiting qi and unblocking yang, promoting qi and unblocking collaterals, and eliminating swelling and relieving pain. The combination of multiple drugs has a synergistic effect. The prepared traditional Chinese medicine combined preparation has a good improvement effect on clinical symptoms caused by qi deficiency and blockage type of cervical spondylosis of sympathetic nerves, such as dizziness and headache, blurred vision and tinnitus, upper limb numbness, abnormal sweating, and the like. In clinical follow-up, the recurrence rate is low. The prepared traditional Chinese medicine combined preparation is convenient to prepare and use, has high patient compliance, and has a good clinical application prospect.

[0062]

[0063]

Claims

1. A pharmaceutical composition for treating sympathetic type cervical spondylosis, characterized by comprising: It is a preparation prepared from raw medicinal materials in the following weight ratio: ​ Gualoupi 5-15 parts, Xiebai 5-15 parts, Banxia 8-20 parts, Guizhi 5-15 parts, Fushen 10-30 parts, Huangqi 20-60 parts, Wuzhuyu 5-15 parts, Baizhu 10-30 parts, Muxiang 5-15 parts, Shichangpu 8-20 parts, Yuanzhi 5-15 parts, Longgu 8-20 parts, Muli 8-20 parts.

2. The pharmaceutical composition of claim 1, wherein: It is a preparation prepared from raw medicinal materials in the following weight ratio: Gualoupi 10 parts, Xiebai 10 parts, Banxia 15 parts, Guizhi 10 parts, Fushen 20 parts, Huangqi 40 parts, Wuzhuyu 10 parts, Baizhu 20 parts, Muxiang 10 parts, Shichangpu 15 parts, Yuanzhi 10 parts, Longgu 15 parts, Muli 15 parts.

3. The pharmaceutical composition according to claim 1 or 2, characterized in that: The Banxia is prepared pinellia; the Huangqi is raw astragalus; the Wuzhuyu is fried evodia; the Baizhu is raw atractylodes; the Yuanzhi is prepared milkvetch root.

4. The pharmaceutical composition according to claim 1 or 2, characterized by: It is a preparation prepared from raw medicinal materials in the following weight ratio:

5. The pharmaceutical composition of claim 4, wherein: The preparation is an oral preparation.

6. The pharmaceutical composition of claim 4, wherein: The oral preparation is a plaster, a decoction, a powder, a tablet, a pill, a capsule, a granule, an oral liquid, a tea bag.

7. A process for the preparation of a pharmaceutical composition as claimed in any one of claims 1 to 5, wherein: It includes the following steps: Take each raw medicinal material in the following weight ratio, directly powder, or add water or organic solvent extraction, and then add pharmaceutically acceptable excipients or auxiliary ingredients, and you get it.

8. Use of the pharmaceutical composition of any one of claims 1-5 in the preparation of a medicament for treating sympathetic type cervical spondylosis.

9. Use according to claim 8, characterized in that: The medicament is a medicament for treating qi deficiency and obstruction syndrome of sympathetic type cervical spondylosis.

10. Use according to claim 8, characterized in that: The medicament is a medicament for treating cervical and shoulder pain, palpitation, chest tightness, headache, insomnia and other symptoms caused by sympathetic type cervical spondylosis.

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