A pharmaceutical composition for treating cervical spondylosis, preparation and application thereof

Abstract

The application discloses a kind of drug composition for treating cervical spondylosis and its preparation and application, belong to traditional Chinese medicine composition technical field, the drug composition includes the following component by weight fraction: 6-28 parts of cornus officinalis, 6-28 parts of antler, 6-20 parts of cassia twig, 6-30 parts of kudzu root, 10-40 parts of astragalus, 6-16 parts of peach kernel, 6-16 parts of safflower, 6-20 parts of purple salvia miltiorrhiza, 6-20 parts of wine dengue, 6-20 parts of chuanxiong, 6-20 parts of red peony root, 6-20 parts of turmeric, 6-20 parts of frankincense, 6-20 parts of myrrh, 6-20 parts of notopterygium, 6-20 parts of rinkhals, 6-20 parts of sea wind, 6-20 parts of giant knotweed, 6-20 parts of corydalis, 6-15 parts of licorice.The drug composition can be added pharmaceutically acceptable adjuvant, and be made into preparation.The drug composition and preparation can be used for preparing the drug for treating cervical spondylosis mainly with wind, cold and damp.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a pharmaceutical composition, its preparation and application for treating cervical spondylosis mainly caused by wind, cold and dampness. Background Technology

[0002] Neck pain, a type of arthralgia in Traditional Chinese Medicine (TCM), is also known as "Bi" or "Bi syndrome" in ancient times, and corresponds to cervical spondylosis in Western medicine. Neck pain is a common and difficult-to-treat disease in clinical practice. Symptoms include neck stiffness, shoulder and back pain, arm numbness and tingling, dizziness, and numbness in the limbs. In mild cases, it can cause neck pain that affects work; in severe cases, it can cause a feeling of being on a boat, whether standing or lying down, making it impossible to work and seriously affecting the patient's daily life.

[0003] Currently, in the treatment of angina pectoris, Western medicine often uses a combination of glucocorticoids and analgesics, along with physical therapy and medical exercises to improve symptoms. Surgery may be necessary in some cases. However, long-term use of hormones and analgesics has many side effects for patients, and surgery causes significant damage to the body, which most patients find difficult to endure. Summary of the Invention

[0004] The pharmaceutical composition described in this invention can be used to treat wind-cold-dampness arthralgia, and is particularly effective for neck arthralgia caused by wind, cold, and dampness as the main pathogenic factors. The objective of this invention is achieved through the following technical solution: A pharmaceutical composition for treating cervical spondylosis, comprising, by weight, the following components: 6-28 parts of Pyrola rotundifolia, 6-28 parts of deer antler, 6-20 parts of cinnamon twig, 6-30 parts of kudzu root, 10-40 parts of Astragalus membranaceus, 6-16 parts of peach kernel, 6-16 parts of safflower, 6-20 parts of Salvia miltiorrhiza, 6-20 parts of Angelica sinensis (processed with wine), 6-20 parts of Ligusticum chuanxiong, 6-20 parts of Paeonia lactiflora, 6-20 parts of turmeric, 6-20 parts of frankincense, 6-20 parts of myrrh, 6-20 parts of Notopterygium incisum, 6-20 parts of Zaocys dhumnades, 6-20 parts of Piper kadsura, 6-20 parts of Polygonum cuspidatum, 6-20 parts of Corydalis yanhusuo, and 6-15 parts of licorice.

[0005] The pharmaceutical composition, by weight, comprises the following components: 12-18 parts of Pyrola rotundifolia, 12-18 parts of deer antler, 12-18 parts of cinnamon twig, 12-18 parts of kudzu root, 25-33 parts of Astragalus membranaceus, 9-12 parts of peach kernel, 9-12 parts of safflower, 12-16 parts of Salvia miltiorrhiza, 9-12 parts of Angelica sinensis (processed with wine), 9-12 parts of Ligusticum chuanxiong, 9-12 parts of Paeonia lactiflora, 9-12 parts of turmeric, 9-12 parts of frankincense, 9-12 parts of myrrh, 9-12 parts of Notopterygium incisum, 9-12 parts of Zaocys dhumnades, 9-12 parts of Piper kadsura, 9-12 parts of Polygonum cuspidatum, 9-12 parts of Corydalis yanhusuo, and 8-12 parts of licorice.

[0006] Traditional Chinese medicine believes that neck pain is mainly caused by factors such as congenital deficiency, invasion of external pathogens, improper diet, old age and chronic illness, and improper work-rest balance, leading to a weakened constitution and weakened defensive qi; or wind, cold, dampness and heat obstructing the meridians; or internal generation of phlegm and heat, with phlegm and blood stasis; or deficiency of liver and kidney, resulting in malnourishment of tendons and vessels; or deficiency of essence and qi, allowing external pathogens to invade, leading to obstruction of the meridians and poor circulation of qi and blood, thus causing neck pain. However, clinically, invasion of external pathogens and improper work-rest balance are more common, with wind, cold and dampness being the most frequent external pathogens. The "Suwen·Bi Lun" states: "When wind, cold and dampness combine, they form Bi. When wind prevails, it is called wandering Bi; when cold prevails, it is called painful Bi; when dampness prevails, it is called fixed Bi." Generally, wandering Bi is characterized by migratory joint pain, painful Bi is characterized by severe pain that is fixed in location, and fixed Bi is characterized by pain that is localized and heavy, that is, heavy and immobile. However, in clinical practice, all three symptoms are often present simultaneously, such as severe, migratory neck pain accompanied by heaviness and limited mobility. Through years of clinical practice, repeated discussions, and summaries, the inventor believes that the clinical characteristics of cervical spondylosis should not only focus on the current symptoms, but also on the underlying deficiency of liver and kidney due to prolonged illness and repeated flare-ups. Liver and kidney deficiency leads to physical weakness, allowing external pathogens such as wind, cold, and dampness to invade and damage the neck muscles and bones, resulting in insufficient qi and blood. Over time, this damages the meridians throughout the body, obstructing the flow of qi, leading to pain due to blockage, and ultimately causing the disease.

[0007] The drug combination described in this invention is predominantly warm in nature, making it particularly suitable for cervical spondylosis caused by various factors such as exposure to wind, cold, and dampness, old age, physical weakness, overwork, and internal injury, leading to obstruction of the meridians, stagnation of qi and blood, and the resulting numbness and pain in the neck and arms. The formula uses *Pyrola rotundifolia*, deer antler, cinnamon twig, and kudzu root as the principal herbs. *Pyrola rotundifolia* and deer antler enter the liver and kidney meridians, dispelling wind and dampness and strengthening tendons and bones. The combination of these two herbs tonifies the liver and kidneys, relieving numbness and pain. Cinnamon twig combined with kudzu root treats combined Taiyang or Yangming syndromes. Cinnamon twig primarily relieves external symptoms, tonifies the middle jiao, releases exterior pathogens, relieves muscle tension, clears stagnation in the Taiyang meridian, and promotes the flow of qi and blood, harmonizing the tendons and vessels. Kudzu root has antipyretic properties and treats stiffness and spasms in the neck and back. The combination of these two herbs releases external pathogens and nourishes yin to soften tendons. The four herbs together address both the root cause (liver and kidney deficiency leading to pain) and the symptoms (external pathogenic factors causing muscle contracture and spasms), addressing both the root and the symptoms. Secondly, the formula is combined with a large number of qi and blood-nourishing herbs as assistants to mobilize the qi and blood throughout the body, reaching from the head and eyes to the waist and knees. This can resolve various symptoms caused by qi and blood stagnation due to wind, cold, dampness, and obstruction. It invigorates blood to promote qi circulation, and when qi flows, blood flows, and the symptoms naturally subside. Peach kernel combined with safflower invigorates blood and removes blood stasis, moving without lingering. The addition of a large amount of astragalus promotes qi circulation, raises yang, and relieves stagnation and obstruction, tonifying the spleen and replenishing qi, and assisting in blood circulation. Purple salvia miltiorrhiza invigorates blood and removes blood stasis, wine-processed angelica sinensis tonifies and invigorates blood, chuanxiong invigorates blood and promotes qi circulation, red peony invigorates blood and removes blood stasis, and turmeric breaks up blood stasis and promotes qi circulation. The combination of these herbs enhances their potency. Frankincense and myrrh invigorate blood, promote qi circulation, and relieve pain; both are fragrant and easily dispersed, and are often used together. The addition of notopterygium root, black-striped snake, and sea breeze vine unblocks meridians and collaterals, facilitating joint movement and relieving pain; cuspidatum and corydalis strengthen the effect of relieving obstruction. Licorice root, with its sweet and warm properties, harmonizes the various herbs and also acts as a guiding herb.

[0008] The whole formula has the effects of promoting blood circulation and removing blood stasis, dredging meridians and collaterals, dispelling wind and dampness, warming yang and dispelling cold, reducing swelling and promoting tissue regeneration, relieving numbness and pain, and regulating qi and blood.

[0009] The pharmaceutical composition may be formulated into granules, tablets, powders, pills, or other preparations by adding pharmaceutically acceptable excipients.

[0010] The pharmaceutical composition and its preparations can be used to treat various symptoms of cervical spondylosis caused by wind-cold-dampness stagnation, such as stiff neck, shoulder and back pain, numbness and tingling in the arms, dizziness, numbness in the limbs, lower back and leg pain, and migraine.

[0011] Compared with the prior art, the present invention has the following beneficial effects: 1. The pharmaceutical composition of the present invention addresses both the symptoms and the root cause, treats both qi and blood, unblocks meridians, and has a specific analgesic effect.

[0012] 2. The pharmaceutical composition of the present invention is mainly warm in nature and has excellent clinical therapeutic effect on various symptoms of cervical spondylosis caused by wind-cold-dampness stagnation. Detailed Implementation

[0013] The present invention will be further described below with reference to the embodiments, but the present invention is not limited to the embodiments. Example 1

[0014] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 6g of Pyrola rotundifolia, 6g of deer antler, 6g of cinnamon twig, 6g of kudzu root, 10g of Astragalus membranaceus, 6g of peach kernel, 6g of safflower, 6g of Salvia miltiorrhiza, 6g of Angelica sinensis (processed with wine), 6g of Ligusticum chuanxiong, 6g of Paeonia lactiflora, 6g of turmeric, 6g of frankincense, 6g of myrrh, 6g of Notopterygium incisum, 6g of Zaocys dhumnades, 6g of Piper kadsura, 6g of Polygonum cuspidatum, 6g of Corydalis yanhusuo, 6g of licorice, 6g of Angelica pubescens, and 9g of Pogostemon cablin. Example 2

[0015] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 10g of Pyrola rotundifolia, 10g of deer antler, 10g of cinnamon twig, 15g of kudzu root, 10g of astragalus root, 6g of peach kernel, 6g of safflower, 8g of salvia miltiorrhiza, 8g of Angelica sinensis (processed with wine), 8g of Ligusticum chuanxiong, 8g of red peony root, 8g of turmeric, 8g of frankincense, 8g of myrrh, 8g of Notopterygium incisum, 8g of Zaocys dhumnades, 8g of Piper kadsura, 8g of Polygonum cuspidatum, 8g of Corydalis yanhusuo, and 8g of licorice. Example 3

[0016] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 9g of Pyrola rotundifolia, 9g of deer antler, 9g of cinnamon twig, 9g of kudzu root, 15g of Astragalus membranaceus, 10g of peach kernel, 10g of safflower, 9g of Salvia miltiorrhiza, 9g of Angelica sinensis (processed with wine), 9g of Ligusticum chuanxiong, 9g of Paeonia lactiflora, 9g of turmeric, 9g of frankincense, 9g of myrrh, 9g of Notopterygium incisum, 9g of Zaocys dhumnades, 9g of Piper kadsura, 9g of Polygonum cuspidatum, 9g of Corydalis yanhusuo, 10g of licorice, 6g of Eucommia ulmoides, and 9g of Dipsacus asper. Example 4

[0017] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 12g of Pyrola rotundifolia, 12g of deer antler, 12g of cinnamon twig, 12g of kudzu root, 20g of Astragalus membranaceus, 12g of peach kernel, 12g of safflower, 12g of Salvia miltiorrhiza, 12g of Angelica sinensis (processed with wine), 12g of Ligusticum chuanxiong, 12g of Paeonia lactiflora, 12g of turmeric, 12g of frankincense, 12g of myrrh, 12g of Notopterygium incisum, 10g of Zaocys dhumnades, 12g of Piper kadsura, 12g of Polygonum cuspidatum, 12g of Corydalis yanhusuo, 8g of licorice, 10g of Eucommia ulmoides, and 10g of Dipsacus asper. Example 5

[0018] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 15g of Pyrola rotundifolia, 15g of deer antler, 12g of cinnamon twig, 15g of kudzu root, 25g of Astragalus membranaceus, 12g of peach kernel, 9g of safflower, 12g of Salvia miltiorrhiza, 15g of Angelica sinensis (processed with wine), 15g of Ligusticum chuanxiong, 15g of Paeonia lactiflora, 12g of turmeric, 12g of frankincense, 12g of myrrh, 12g of Notopterygium incisum, 10g of Zaocys dhumnades, 15g of Piper kadsura, 15g of Polygonum cuspidatum, 15g of Corydalis yanhusuo, 10g of licorice, 12g of Coix lacryma-jobi, and 12g of Poria cocos. Example 6

[0019] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 15g of Pyrola rotundifolia, 10g of deer antler, 15g of cinnamon twig, 20g of kudzu root, 30g of astragalus root, 12g of peach kernel, 9g of safflower, 15g of salvia miltiorrhiza, 20g of Angelica sinensis (processed with wine), 15g of Ligusticum chuanxiong, 15g of red peony root, 12g of turmeric, 12g of frankincense, 12g of myrrh, 12g of Notopterygium incisum, 10g of Zaocys dhumnades, 20g of Piper kadsura, 15g of Polygonum cuspidatum, 15g of Corydalis yanhusuo, and 12g of licorice. Example 7

[0020] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 20g of Pyrola rotundifolia, 20g of deer antler, 20g of cinnamon twig, 25g of kudzu root, 30g of Astragalus membranaceus, 15g of peach kernel, 10g of safflower, 20g of Salvia miltiorrhiza, 20g of Angelica sinensis (processed with wine), 20g of Ligusticum chuanxiong, 20g of Paeonia lactiflora, 15g of turmeric, 15g of frankincense, 15g of myrrh, 15g of Notopterygium incisum, 15g of Zaocys dhumnades, 12g of Piper kadsura, 15g of Polygonum cuspidatum, 15g of Corydalis yanhusuo, 12g of licorice, 12g of Eucommia ulmoides, and 15g of Dipsacus asper. Example 8

[0021] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 20g of Pyrola rotundifolia, 20g of deer antler, 20g of cinnamon twig, 25g of kudzu root, 30g of Astragalus membranaceus, 15g of peach kernel, 10g of safflower, 20g of Salvia miltiorrhiza, 20g of Angelica sinensis (processed with wine), 20g of Ligusticum chuanxiong, 20g of Paeonia lactiflora, 15g of turmeric, 15g of frankincense, 15g of myrrh, 15g of Notopterygium incisum, 15g of Zaocys dhumnades, 12g of Piper kadsura, 15g of Polygonum cuspidatum, 15g of Corydalis yanhusuo, and 15g of licorice. Example 9

[0022] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 25g of Pyrola rotundifolia, 25g of deer antler, 20g of cinnamon twig, 25g of kudzu root, 30g of Astragalus membranaceus, 9g of peach kernel, 9g of safflower, 10g of Salvia miltiorrhiza, 15g of Angelica sinensis (processed with wine), 15g of Ligusticum chuanxiong, 18g of Paeonia lactiflora, 18g of turmeric, 18g of frankincense, 18g of myrrh, 18g of Notopterygium incisum, 18g of Zaocys dhumnades, 15g of Piper kadsura, 18g of Polygonum cuspidatum, 15g of Corydalis yanhusuo, 15g of licorice, 12g of Angelica pubescens, and 12g of Pogostemon cablin. Example 10

[0023] A pharmaceutical composition for treating cervical spondylosis comprises the following components: 28g of Pyrola rotundifolia, 28g of deer antler, 20g of cinnamon twig, 30g of kudzu root, 40g of Astragalus membranaceus, 16g of peach kernel, 16g of safflower, 20g of Salvia miltiorrhiza, 20g of Angelica sinensis (processed with wine), 20g of Ligusticum chuanxiong, 20g of Paeonia lactiflora, 20g of turmeric, 20g of frankincense, 20g of myrrh, 20g of Notopterygium incisum, 20g of Zaocys dhumnades, 20g of Piper kadsura, 20g of Polygonum cuspidatum, 20g of Corydalis yanhusuo, and 15g of licorice. Example 11

[0024] A formulation of a pharmaceutical composition for treating cervical spondylosis is prepared by taking the pharmaceutical composition described in any one of Examples 1-10, soaking it in water, decocting it twice, combining the decoctions, filtering, concentrating it into a thick paste, drying it, pulverizing it into a fine powder, adding an appropriate amount of dextrin, starch or other suitable excipients, mixing it well, and preparing it into tablets, powders or other formulations. Example 12

[0025] A formulation of a pharmaceutical composition for treating cervical spondylosis is prepared according to the following steps: Weigh out the prepared Chinese herbal medicine pieces according to the proportions of the pharmaceutical composition described in any one of Examples 1-10; Powdering: After drying the deer antler, cinnamon twig, kudzu root, turmeric, frankincense, myrrh, black-striped snake, and corydalis slices, pulverize them and pass them through a 100-mesh sieve. Collect the sieved fine powder for later use. The coarse powder that does not pass through the sieve (the proportion of which does not exceed 5% of the total powder) is added to the subsequent boiling and extraction steps.

[0026] Extraction by decoction: Take Astragalus membranaceus, peach kernel, safflower, purple salvia miltiorrhiza, wine-processed angelica sinensis, chuanxiong rhizome, red peony root, notopterygium incisum, sea pine, Japanese knotweed, licorice root, and crushed unsieved medicinal materials, put them into a decoction vessel, add an appropriate amount of water to soak for 1 hour, decoct twice, 1 hour each time, combine the filtrates, filter, and concentrate the filtrate into a thick paste for later use.

[0027] Mixing: Thoroughly mix the thick paste and the powder.

[0028] Pelletizing: The evenly mixed medicine is pressed into cakes, strips, and then pellets using pelletizing equipment. The pellet diameter is generally controlled between 0.3 and 0.5 cm.

[0029] Drying: Place the prepared pills on a tray, spread them out evenly, with a thickness not exceeding 2cm, and control the oven temperature at 60-80℃. Initially set the temperature to 60℃, turn the pills over every once in a while, and gradually increase the temperature to 80℃ after a certain period of time until drying is complete. Remove the pills and let them cool completely.

[0030] Inspection: Moisture content must not exceed 9.0%.

[0031] Repackaging: The qualified pellets are repackaged according to requirements.

[0032] In this embodiment, the raw materials are processed by water extraction to form pills. The active ingredients in the pills decompose more slowly, have a longer-lasting effect, and are more stable than liquid dosage forms. They are also convenient to carry and take, resulting in better patient compliance.

[0033] Application Examples - The pharmaceutical composition described in this invention is used to treat cervical spondylosis.

[0034] I. Research Methods Patients who met the inclusion criteria for cervical spondylosis within the past five years were selected and treated with the drug composition described in this invention. The clinical efficacy and adverse reactions were observed.

[0035] II. Research Subjects Patients with cervical spondylosis caused by wind-cold-dampness stagnation.

[0036] III. Diagnostic Criteria 1. Diagnostic criteria in Traditional Chinese Medicine Traditional Chinese medicine (TCM) does not have a specific disease name for cervical spondylosis. Based on its clinical manifestations, cervical spondylosis falls under the TCM categories of "neck pain," "spasm syndrome," and "atrophy syndrome." The TCM diagnostic criteria are as follows: Diagnostic points: Prolonged desk work with the head down, or poor sleep habits, and a family history of cervical spondylosis may be present. Symptoms may include stiffness, limited range of motion, numbness, radiating or tingling pain in the neck, shoulders, and upper limbs, dizziness, fatigue, and weakness. Exclude conditions such as stiff neck, muscle weakness, cancer, and other acute neck injuries caused by trauma.

[0037] Main symptoms: Pain in the neck, shoulders, and both upper limbs, with the location shifting; a feeling of heaviness in the head; neck stiffness; limited head and neck movement; stabbing pain in the neck, shoulders, and upper limbs, with the pain located in a fixed position; numbness in the limbs; aversion to cold and wind; the above symptoms are more severe at night than during the day; the above symptoms worsen when the temperature drops suddenly. The tongue is pale, with a thin white or thin greasy coating, and the pulse is floating, wiry and tense, or soft and slow.

[0038] 2. Western Medicine Diagnostic Criteria Clinical manifestations: Patients with spinal cord type cervical spondylosis present with typical cervical spinal cord damage manifestations, mainly characterized by limb motor dysfunction, sensory abnormalities, and reflex abnormalities; patients with nerve root type cervical spondylosis have more typical nerve root symptoms such as numbness and pain in the arms, the extent of which corresponds to the area innervated by the cervical spinal nerves; patients with vertebral artery type and sympathetic type cervical spondylosis present with a series of sympathetic nerve symptoms such as dizziness, blurred vision, tinnitus, numbness in the hands, hearing impairment, tachycardia, and precordial pain; patients with cervical type cervical spondylosis often experience abnormal sensations such as pain in the occipital, neck, and shoulder areas, which may be accompanied by corresponding tender points.

[0039] Imaging examinations: Degenerative changes in the cervical spine, mainly characterized by intervertebral joint instability, bilateral, bilateral processes, incisional signs, or osteophyte formation; or clear signs of spinal cord compression, corresponding to clinical symptoms.

[0040] IV. Inclusion Criteria It meets the Western medicine diagnostic criteria for cervical spondylosis and the TCM diagnostic criteria for wind-cold-dampness syndrome.

[0041] Age 18-65 years old.

[0042] No other medications or external treatments were used.

[0043] V. Exclusion Criteria Pregnant women or women planning to become pregnant soon, and breastfeeding women.

[0044] Patients with serious diseases of the heart, liver, kidneys and hematopoietic system.

[0045] Mentally ill patients.

[0046] People with allergies or who are allergic to multiple medications.

[0047] Those who have recently received similar treatments, such as those with related or antagonistic effects, making it difficult to determine the efficacy of the medication.

[0048] VI. Medication Use and Administration The drug used is a pill prepared according to the preparation method described in Example 12 of the pharmaceutical composition of the present invention. The dosage of the specific drug in the pharmaceutical composition can be adjusted within the scope of the present invention according to the different clinical symptoms of the patient.

[0049] Dosage: Twice daily, for 7 days as one course of treatment.

[0050] VII. Criteria for Evaluating Therapeutic Effect Significant effect: All original symptoms disappear, muscle strength returns to normal, neck and limb function returns to normal, and the patient can participate in normal labor and work.

[0051] Effective: All existing symptoms are alleviated, neck and shoulder pain is reduced, and neck and limb function is improved.

[0052] Ineffective: Symptoms did not improve.

[0053] VIII. Summary of Clinical Efficacy A total of 123 patients who sought medical treatment within five years were observed, of whom 34 showed significant improvement, 77 showed improvement, and 12 showed no improvement.

[0054]

[0055] IX. Adverse Reactions Clinical applications have shown no toxic side effects or adverse reactions.

[0056] 10. Typical Cases 1. Ms. Wang, 35 years old, presented with a complaint of "neck stiffness and pain, accompanied by numbness in all ten fingers, dizziness, and vertigo for over half a month." She had experienced occasional stiffness and pain in her neck and shoulders for about six months. In the past two weeks, she experienced neck stiffness and pain, sometimes radiating down her upper arm and forearm to the tip of her middle finger, accompanied by numbness in the fingertip. She reported that changes in weather or exposure to cold triggered and worsened these symptoms. Two weeks prior, improper sleeping posture led to neck muscle stiffness and pain, which was subsequently accompanied by occasional dizziness and vertigo.

[0057] Clinical examination: Stiff neck muscles with tenderness; numbness in all ten fingers; dizziness and vertigo for over half a month; occasional nausea and vomiting. History of penicillin allergy. Poor mental state, frequent fatigue and drowsiness, poor sleep quality, fatigue upon waking, poor appetite, normal bowel movements; slightly dark tongue with a thin white coating; wiry and tense pulse. Three days ago, a CT scan at another hospital showed: Brain CT scan showed no obvious abnormalities. Mild cervical lordosis; posterior central herniation of the C3-4, C4-5, C5-6, and C6-7 intervertebral discs, compressing the dural sac but not nerve roots; intact vertebral bone structure with smooth edges; no hyperplasia or hypertrophy of the bilateral uncovertebral joints and facet joints; no narrowing of the joint spaces.

[0058] Diagnosis: Neck pain - wind-cold-dampness arthralgia.

[0059] Treatment principle: Dispel wind and dampness, remove blood stasis and unblock the meridians. Administer orally 14 packets of the pills prepared from the drug composition described in Example 6, twice daily, one packet each time.

[0060] Half a month later, the patient returned for a follow-up visit, reporting that after finishing the medication, neck discomfort had improved, pain had largely disappeared, and the patient could move freely. Numbness in the ten fingers had lessened, dizziness and vertigo had significantly improved, and sleep had also improved. The patient was instructed to continue taking the medication for another course (14 sachets), and to pay attention to posture while working, and to keep the neck warm and protected from wind.

[0061] On the third visit, the patient reported that there was basically no pain in the neck, but there were tender points. The numbness in the ten fingers had been significantly reduced, and the dizziness and vertigo had disappeared. The patient came for a visit to continue the treatment to consolidate the results. The patient was instructed to continue taking the medicine for two more courses, a total of 28 sachets.

[0062] Later, due to seasonal changes, the patient's neck pain and discomfort recurred. There were no other special symptoms. After returning to the clinic, the patient continued to take the pills prepared from the drug composition described in Example 6 for two courses of treatment, totaling 28 bags.

[0063] 2. Mr. Zhao, male, 50 years old, presented with a 3-day history of headache accompanied by neck muscle stiffness and pain. The patient reported that he caught a chill three days prior due to a sudden change in weather, and had experienced frequent headaches over the past three days, with headaches becoming the primary symptom, accompanied by neck muscle stiffness, pain, and limited mobility. He had previously sought treatment at a clinic for bone setting and acupuncture, but without significant improvement. An MRI scan showed straightening of the cervical spine's physiological curvature, with no other significant changes. Current examination revealed: significant posterior headache, stiff neck muscles with high muscle tone and obvious tenderness, accompanied by limited mobility, fatigue, poor mental state, fair appetite, poor sleep, and normal bowel movements. His tongue was dark with a white, greasy coating, and his pulse was soft and slow.

[0064] Diagnosis: Neck pain - wind-cold-dampness arthralgia.

[0065] Treatment principle: Dispel wind and dampness, unblock meridians and relieve pain. Administer orally 14 packets of the pills prepared from the drug composition described in Example 9, twice daily, one packet each time.

[0066] The patient returned for a second visit half a month later, reporting that her headache had disappeared and her neck muscle stiffness had improved after finishing the previous medication, although the tender points remained. She requested continued treatment. Based on the changes in her symptoms at different stages, appropriate modifications to the prescription were selected. This time, she was prescribed 28 packets of pills made from the drug composition described in Example 4, taken twice daily, one packet each time, for a total of two courses of treatment.

[0067] On the third visit, the patient, having worked at a desk for several days and neglecting to keep his neck warm while sleeping, returned with symptoms of "stiff and painful neck muscles, and limited mobility." Symptoms included: stiff and painful neck muscles, limited mobility, obvious tenderness, irritability, pale tongue with a thin white coating, and a wiry pulse. The diagnosis and treatment were the same as before. Based on the patient's actual symptoms, 14 packets of the pills prepared from the drug composition described in Example 5 were prescribed orally, twice daily, one packet each time.

[0068] Two weeks later, the patient returned requesting to continue taking two more courses of treatment to consolidate the therapeutic effect. A follow-up visit revealed that the patient experienced no particular discomfort in their neck, provided they kept it warm as usual.

[0069] 3. Ms. Guan, female, 31 years old. She presented with a complaint of "recurrent neck and shoulder discomfort for over 3 months, accompanied by dizziness for 10 days." The patient reported that for the past 3 months, due to prolonged desk work, she experienced neck and shoulder pain, stiffness, a pulling sensation, occasional dizziness, and a stiff neck, which affected her sleep, causing morning fatigue and poor mental state. Half a month ago, she caught a cold after being caught in the rain while traveling. After recovering from the cold, she began experiencing neck and shoulder discomfort and dizziness. Current symptoms include: neck and shoulder pain, stiffness, a pulling sensation, dizziness, lightheadedness, frequent awakenings after falling asleep, vivid dreams, good appetite, and normal bowel movements. Her tongue is slightly dark with a white coating, and her pulse is wiry and rapid.

[0070] Diagnosis: Neck pain - wind-cold-dampness arthralgia.

[0071] Treatment principle: Dispel wind and dampness, remove blood stasis and open the orifices. Administer orally 14 packets of the pills prepared from the drug composition described in Example 5, twice daily, one packet each time.

[0072] The patient returned for a second visit after more than a month, reporting that their neck and shoulder discomfort and dizziness had improved after taking the medication. They were advised to continue treatment for consolidation and were given another 14 packets of the same medication. A follow-up visit revealed no significant discomfort.

[0073] The above typical cases demonstrate that the pharmaceutical composition described in this invention can achieve the technical effects described in this invention, without limiting the invention in any way. The above typical cases represent only a portion of clinical observations, and the pharmaceutical compositions used are only a portion of the total. In actual clinical use, the dosage of specific drugs in the pharmaceutical composition can be adjusted within the scope of this invention according to the different clinical symptoms of the patients.

[0074] In clinical practice, prescriptions can be adjusted and modified according to different patients: Angelica pubescens has the functions of dispelling wind and dampness, relieving pain and relieving exterior syndromes. If a patient suffers from neck pain due to external pathogens, it can be used in combination with Notopterygium incisum. As recorded in "Ben Cao Qiu Zhen", "Notopterygium incisum has the function of releasing exterior syndromes, while Angelica pubescens has the power to help release exterior syndromes." Patchouli is pungent and warm, and can resolve dampness and invigorate the spleen, stimulate clear yang, and help to promote the body's resistance and expel pathogens.

[0075] If prolonged illness leads to kidney yang deficiency, symptoms such as aversion to cold, cold limbs, pale complexion, lethargy, and frequent urination with clear urine can be treated by adding Eucommia ulmoides and Dipsacus asper to nourish the liver and kidneys, strengthen bones, and treat liver and kidney deficiency and weak tendons and bones, thus achieving the effect of treating both the symptoms and the root cause.

[0076] If the patient experiences phlegm-dampness entering the collaterals, causing neck and back pain, or if the pain is triggered by wading through water or being exposed to rain, Poria cocos and Coix seed can be added. Poria cocos is sweet and bland; its sweetness can replenish the body's vital energy after prolonged illness, while its blandness can drain dampness and promote urination. Coix seed can promote urination and drain dampness, strengthen the spleen and relieve numbness, and drain pus and eliminate carbuncles, making it a commonly used medicine for treating dampness-related arthralgia. The combined effect of the two is to relieve neck pain caused by phlegm-dampness entering the collaterals.

Claims

1. A pharmaceutical composition for treating cervical spondylosis, characterized in that, By weight, it consists of the following components: 6-28 parts of Pyrola rotundifolia, 6-28 parts of deer antler, 6-20 parts of cinnamon twig, 6-30 parts of kudzu root, 10-40 parts of astragalus root, 6-16 parts of peach kernel, 6-16 parts of safflower, 6-20 parts of salvia miltiorrhiza, 6-20 parts of Angelica sinensis (processed with wine), 6-20 parts of Ligusticum chuanxiong, 6-20 parts of red peony root, 6-20 parts of turmeric, 6-20 parts of frankincense, 6-20 parts of myrrh, 6-20 parts of Notopterygium incisum, 6-20 parts of Zaocys dhumnades, 6-20 parts of Piper kadsura, 6-20 parts of Polygonum cuspidatum, 6-20 parts of Corydalis yanhusuo, and 6-15 parts of licorice.

2. A pharmaceutical composition for treating cervical spondylosis, characterized in that, Based on the pharmaceutical composition described in claim 1, 6-12 parts of Angelica pubescens and 9-12 parts of Pogostemon cablin are further added.

3. A pharmaceutical composition for treating cervical spondylosis, characterized in that, The pharmaceutical composition according to claim 1 is further modified by adding 6-12 parts of Eucommia ulmoides and 9-15 parts of Dipsacus asper.

4. A pharmaceutical composition for treating cervical spondylosis, characterized in that, The pharmaceutical composition according to claim 1 is further modified by adding 9-20 parts of coix seed and 9-15 parts of poria cocos.

5. A formulation of the pharmaceutical composition according to claims 1 to 4, characterized in that, The pharmaceutical composition is formulated by adding pharmaceutically acceptable excipients to the pharmaceutical composition.

6. The use of a pharmaceutical composition according to any one of claims 1 to 4, characterized in that, The use of the pharmaceutical composition in the preparation of a medicament for treating cervical spondylosis.

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