Cervical spondylosis treatment medicine and preparation method thereof

Abstract

The invention belongs to the technical field of cervical spondylosis treatment medicines, and discloses a cervical spondylosis treatment medicine which comprises the following components in parts by weight: 15 parts of bighead atractylodes rhizome, 10 parts of liquorice, 15 parts of chrysanthemum, 20 parts of poria cocos, 15 parts of gastrodia elata, 15 parts of dried ginger, 20 parts of cassia twig, 15 parts of salvia miltiorrhiza, 15 parts of pawpaw, 15 parts of lycopodium clavatum, 20 parts of caulis spatholobi, 30 parts of earthworm, 15 parts of notopterygium root, 20 parts of kudzu vine root, 15 parts of ligusticum wallichii, 10 parts of schizonepeta and 15 parts of divaricate saposhnikovia root. According to the formula, medicinal materials such as notopterygium root and divaricate saposhnikovia root are integrated to expel wind and remove cold, kudzuvine root is mainly used for specially relieving stiff and pain of the neck, salvia miltiorrhiza, earthworm and the like are matched to deeply promote blood circulation and dredge collaterals, pawpaw and lycopodium clavatum relax tendons and activate collaterals, gastrodia elata stops dizziness, bighead atractylodes rhizome and poria cocos strengthen spleen and strengthen body resistance, chrysanthemum is used for curing dryness, liquorice is used for harmonizing, and multiple targets of eliminating evil, dredging collaterals, activating blood, relaxing tendons, relieving dizziness and strengthening body resistance are systematically The traditional Chinese medicine composition overcomes the defects of incomplete efficacy, poor synergy and neglect of strengthening body resistance of the existing composition, and realizes treatment of both symptoms and root causes.

Description

Technical Field

[0001] The present invention belongs to the technical field of cervical spondylosis treatment drugs, and specifically relates to a cervical spondylosis treatment drug and a preparation method thereof. Background Art

[0002] Cervical spondylosis is a disease caused by degeneration of the cervical intervertebral disc and its secondary changes, which stimulate or compress adjacent spinal cord, nerves, blood vessels and other tissues, causing a series of symptoms and signs. It is common in people who work at a desk for a long time, use electronic devices with their heads down, and have poor neck posture. Its symptoms are diverse. Mild cases may cause neck pain, stiffness, and limited movement. Severe cases may cause numbness, pain, and weakness in the upper limbs, and even dizziness, headache, nausea, vomiting, and unsteady walking, which seriously affect the patient's quality of life and work ability.

[0003] The treatment of cervical spondylosis needs to take into account multiple goals such as eliminating external evil, unblocking meridians, promoting blood circulation and removing blood stasis, relaxing muscles and tendons, calming internal wind and supporting positive energy. The core problem of the drug formulas used to treat cervical spondylosis in the existing technology is the one-sidedness and lack of synergy in the composition and compatibility of the formulas, which makes it difficult to comprehensively cover the complex and changeable pathological links of cervical spondylosis. Cervical spondylosis is often caused by the invasion of wind, cold and dampness, local stasis of qi and blood, obstruction of meridians, stiffness of muscles and tendons, failure of clear yang to rise or internal movement of liver wind causing dizziness, as well as internal and external factors such as spleen deficiency and dysfunction, and insufficient positive energy. The formulas with a single or a few efficacy directions often lose sight of one thing while focusing on another. The existing formulas may focus on eliminating wind, cold and dampness to treat the symptoms, but ignore promoting blood circulation, removing blood stasis and unblocking meridians to improve local microcirculation disorders, resulting in the temporary removal of external evil but not the disappearance of blood stasis, making it difficult to eliminate stiff and painful neck. Although emphasis is placed on promoting blood circulation, there is a neglect of relaxing muscles and tendons to relieve muscle tension and spasm, resulting in the muscles still being contracted despite the smooth flow of qi and blood, and limited improvement in restricted mobility. Liver-calming and wind-extinguishing herbs are added to treat dizziness, but there is a lack of key drugs such as Pueraria root that can raise yang and relieve muscles, and specifically relax the neck tendons and veins. The herbs are not targeted and effective for the hallmark symptoms of stiff neck and shoulder pain in cervical spondylosis. More importantly, most formulas ignore the importance of strengthening the spleen and replenishing qi, and strengthening the body, and fail to effectively solve the fundamental problem of endogenous dampness and qi deficiency and inability to expel evil caused by spleen deficiency and dysfunction, making it difficult to maintain a long-lasting therapeutic effect and prone to recurrence, resulting in unsatisfactory results in treating both the symptoms and the root causes. In addition, the processing technology cannot fully and stably extract various active ingredients, resulting in waste of residual drug residues, so it needs to be improved. Summary of the Invention

[0004] In response to the deficiencies of the prior art, the present invention provides a drug for treating cervical spondylosis and a preparation method thereof, which has the advantage of multi-target synergistic treatment.

[0005] To achieve the above-mentioned purpose, the present invention provides the following technical solution: a drug for treating cervical spondylosis, the formula of which includes the following components in parts by weight: 15 parts of Atractylodes macrocephala, 10 parts of Licorice, 15 parts of Chrysanthemum, 20 parts of Poria, 15 parts of Gastrodia elata, 15 parts of Dried ginger, 20 parts of Cinnamon twig, 15 parts of Salvia miltiorrhiza, 15 parts of Papaya, 15 parts of Lycopodiella cuneata, 20 parts of Millettia reticulata, 30 parts of Earthworm, 15 parts of Notopterygium wilfordii, 20 parts of Pueraria lobata, 15 parts of Chuanxiong, 10 parts of Schizonepeta tenuifolia, and 15 parts of Saposhnikovia divaricata.

[0006] A method for preparing a drug for treating cervical spondylosis, comprising the following specific steps:

[0007] Step 1: Herbal material processing

[0008] Prepare the required medicinal materials. Place all the plant herbs except earthworms in a stainless steel cleaning tank. Add 35°C purified water to completely immerse the herbs. The liquid level should be 3 cm above the herbs layer. Rinse gently with running water for 2 minutes to remove any dust on the surface.

[0009] After washing, all washed herbs are laid flat on a sieve for initial drainage, and then transferred to a temperature-controlled drying device for drying under circulating hot air at 40±2°C for 10 minutes. The goal at this stage is to control the surface adsorbed water content to ≤12% by weight to prevent excessive solvent dilution during subsequent soaking and decoction.

[0010] Subsequently, all the medicinal materials were placed in a medicinal material grinder and mechanically crushed into uniform particles with a particle size of less than 5 mm to improve the subsequent extraction efficiency. After the crushing, the chrysanthemum and schizonepeta, which are light in texture and easy to float on the water surface, were separately placed in a 100-mesh nylon mesh bag and the bag mouth was tied tightly to prevent these lightweight medicinal materials from excessively floating and rolling during the subsequent decoction process, which would affect the extraction efficiency and cause medicinal material loss. After the crushing is completed, the entire particle mixture is transferred to a container, and purified water is added as a solvent, with the water volume being 8 times the total weight of the medicinal materials. The container is placed in a constant temperature water bath for soaking;

[0011] Step 2: The first decoction operation

[0012] After completing the soaking in step 1, the soaking mixture and the solvent are immediately transferred to the decoction pot, and the heating device is started. The initial heating rate is controlled to increase the temperature by 3°C per minute, and the goal is to reach and stabilize at 100°C for 5 minutes to form a stable boiling state. Subsequently, the temperature is adjusted to 90-95°C and maintained in this temperature range for 60 minutes. During this period, a stirring device is used to stir at a low speed of 10 revolutions per minute to ensure that the medicinal materials are evenly heated and prevent local coking or precipitation. During the decoction process, temperature fluctuations and liquid evaporation are continuously monitored. If necessary, a small amount of purified water is added to maintain the solvent volume at not less than 80% of the initial volume. This operation is intended to ensure full contact between the medicinal materials and the solvent, maximize the release efficiency of active ingredients such as alkaloids and flavonoids, and reduce physical losses through low-speed stirring. After the decoction is completed, the heating is immediately stopped and the mixture is allowed to cool naturally to below 50°C in preparation for subsequent filtration.

[0013] Step 3: Second decoction operation stage

[0014] Remove the remaining medicinal materials after the first decoction in step 2, perform preliminary filtration using a double-layer filter cloth, completely collect and retain all the filtrate from the first decoction, transfer all the remaining medicinal residues after filtration back to a clean decoction pot, and add fresh purified water to the decoction pot as the solvent for the second decoction. The amount of water added is accurately controlled to be 6 times the initial weight of the total medicinal materials;

[0015] Turn on the heating device and heat the solvent to 100°C at a rate of 3°C per minute. Maintain the temperature at 100°C for 3 minutes to ensure that it is fully boiling. Then adjust the heating power to continue decocting. During this period, continue to use the stirring device to stir at a low speed of 10 revolutions per minute to ensure that the medicinal residue is heated evenly and prevent local deposition and coking. During the decoction process, monitor the liquid evaporation volume in real time. If the solvent volume is less than 60% of the initial amount added, immediately add an appropriate amount of purified water to ensure that the solvent volume is always maintained at more than 60% of the initial volume.

[0016] After the decoction is completed, the heating is stopped and the mixture is allowed to cool naturally to below 50°C. After the temperature reaches the standard, the mixture is filtered using a double-layer filter cloth to completely collect all the filtrate obtained from the second decoction. The filtered filtrate is transferred to a sterile container for temporary storage, ready for the subsequent merging process;

[0017] Step 4: Liquid filtration and merging stage

[0018] The first decoction filtrate obtained in step 2 and the second decoction filtrate obtained in step 3 are transferred to clean containers respectively. First, the single filtrate is subjected to primary filtration: using 200 mesh nylon filter cloth to cover the filtration device, coarse filtration is performed at a constant temperature of 30°C to 40°C and a constant pressure of 0.1 MPa to completely intercept coarse particulate impurities, medicinal material residues and fibrous substances with a particle size greater than 75 microns. After the coarse filtration is completed, the primary filtrate is immediately subjected to fine filtration using a polyethersulfone microporous filter membrane with a pore size of 0.2 microns under the same temperature and pressure conditions to completely remove particles, microorganisms, colloids and undissolved fibers with a particle size greater than 0.2 microns to obtain a clear and transparent sterile medicinal solution. Both filtrates must independently complete the above double filtration process to ensure no cross contamination;

[0019] After completing the fine filtration of a single filtrate, transfer the first decoction fine filtrate and the second decoction fine filtrate in a volume ratio of 1:1 into the same sterile mixing tank, start the agitator, and continue mixing at a speed of 60 revolutions per minute for at least 10 minutes until the color, density, and component distribution of the medicinal solution are completely uniform; monitor the pH value of the medicinal solution in real time during the mixing process, and finally adjust the pH of the combined medicinal solution to between 7 and 8. This operation must be completed at an environment of 25°C-30°C to avoid temperature fluctuations that may cause component precipitation or denaturation;

[0020] Step 5: Liquid concentration and finished product preparation stage

[0021] The combined medicinal liquid obtained in step 4 is introduced into a vacuum concentrator for concentration. The volume change of the medicinal liquid is monitored in real time during the concentration process. When the volume is reduced to 50% of the initial combined medicinal liquid volume, it is immediately cooled to below 25°C, filled into a sterilized container, and sealed for storage to obtain the final decoction dosage form for treating cervical spondylosis.

[0022] Preferably, the earthworms described in step 1 need to be processed separately and surface rinsed with edible-grade alcohol having a concentration of 45% by volume, the rinsing time being controlled within 30 seconds, and the earthworms are drained after rinsing.

[0023] Preferably, the constant temperature water bath in step 1 is maintained at 25° C., the immersion time is set to 30 minutes, and the mixture is gently stirred every 10 minutes.

[0024] Preferably, the first decoction process in step 2 ensures uninterrupted operation, and the cooling stage needs to prevent external contamination.

[0025] Preferably, the secondary decoction temperature in step 3 needs to be stabilized in the range of 85° C. to 90° C., and the decoction operation is maintained in this temperature range for 30 minutes.

[0026] Preferably, if the combined drug solution in step 4 is not immediately subjected to the concentration step, it must be transferred to a light-proof sealed container within 2 hours and temporarily stored in a refrigerated environment at 4° C., awaiting the concentration step.

[0027] Preferably, the Pueraria root, Poria cocos and Atractylodes macrocephala in step 1 need to be cut into uniform slices with a thickness of ≤3 mm due to their dense texture and large volume.

[0028] Preferably, the initial temperature of the concentration device in step five is set to 50°C, the heating program is started, and the medicinal liquid is gradually heated at a rate of 2°C per minute until the target temperature of 75°C is reached. At this temperature, constant temperature steady-state evaporation is maintained for 45 minutes, and the vacuum system is adjusted to keep the pressure in the evaporation chamber constant at minus 0.08 MPa.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] In terms of formula, it integrates herbs such as Qianghuo and Saposhnikovia divaricata to dispel wind and cold, reuses Pueraria root to specifically relieve stiff neck pain, and is combined with Salvia miltiorrhiza and earthworm to deeply promote blood circulation and dredge meridians, papaya and Achyranthes bidentata to relax muscles and activate meridians, Gastrodia elata to stop dizziness, Atractylodes macrocephala and Poria cocos to strengthen the spleen and strengthen the body, and is supplemented with chrysanthemum to control dryness and licorice to harmonize. It systematically covers the multiple goals of dispelling evil, dredging meridians, activating blood circulation, relaxing muscles, extinguishing wind, and strengthening the body, overcoming the defects of existing prescriptions such as incomplete efficacy, poor synergy and neglect of strengthening the body, and achieves both symptomatic and root cause treatment. In terms of processing, through refined pretreatment, two precise decoctions, double precision filtration and low-temperature vacuum concentration technology, various effective ingredients are efficiently and stably extracted and retained, significantly improving the dissolution rate and bioavailability. DETAILED DESCRIPTION

[0031] Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative work shall fall within the scope of protection of the present invention.

[0032] An embodiment of the present invention provides a drug for treating cervical spondylosis, the formula of which includes the following components in parts by weight: 15 parts of Atractylodes macrocephala, 10 parts of Licorice, 15 parts of Chrysanthemum, 20 parts of Poria, 15 parts of Gastrodia elata, 15 parts of Dried ginger, 20 parts of Cinnamon twig, 15 parts of Salvia miltiorrhiza, 15 parts of Papaya, 15 parts of Lycopodiella cuneata, 20 parts of Millettia reticulata, 30 parts of Earthworm, 15 parts of Notopterygium wilfordii, 20 parts of Pueraria root, 15 parts of Chuanxiong, 10 parts of Schizonepeta tenuifolia, and 15 parts of Saposhnikovia divaricata.

[0033] Through the use of Qianghuo, Fangfeng, Jingjie, Guizhi and dried ginger, they can effectively dispel wind, cold and dampness, expel external evil to treat the symptoms; use Pueraria root to raise yang, relieve muscles, relax tendons and relieve urgency, specifically to relieve neck stiffness and pain; Salvia miltiorrhiza, Chuanxiong, Millettia reticulata and earthworms deeply promote blood circulation, remove blood stasis and dredge the meridians, and improve local blood stasis; papaya, Achyranthes bidentata and Millettia reticulata relax tendons and activate meridians, relieve muscle tension and stiffness; Gastrodia elata calms the liver, extinguishes wind and stops dizziness, and targets symptoms of dizziness; Atractylodes macrocephala and Poria cocos strengthen the spleen and replenish qi to strengthen the body and transport water and dampness; Chrysanthemum clears the head and restrains warm dryness; Licorice harmonizes all the medicines, and the whole prescription combines the functions of dispelling evil and dredging the meridians, promoting blood circulation and relaxing tendons, and strengthening the spleen and strengthening the body.

[0034] A method for preparing a drug for treating cervical spondylosis, comprising the following specific steps:

[0035] Step 1: Herbal material processing

[0036] Prepare the required medicinal materials. Place all the plant herbs except earthworms in a stainless steel cleaning tank. Add 35°C purified water to completely immerse the herbs. The liquid level should be 3 cm above the herbs layer. Rinse gently with running water for 2 minutes to remove any dust on the surface.

[0037] After washing, all washed herbs are laid flat on a sieve for initial drainage, and then transferred to a temperature-controlled drying device for drying under circulating hot air at 40±2°C for 10 minutes. The goal at this stage is to control the surface adsorbed water content to ≤12% by weight to prevent excessive solvent dilution during subsequent soaking and decoction.

[0038] Subsequently, all the medicinal materials were placed in a medicinal material grinder and mechanically crushed into uniform particles with a particle size of less than 5 mm to improve the subsequent extraction efficiency. After the crushing, the chrysanthemum and schizonepeta, which are light in texture and easy to float on the water surface, were separately placed in a 100-mesh nylon mesh bag and the bag mouth was tied tightly to prevent these lightweight medicinal materials from excessively floating and rolling during the subsequent decoction process, which would affect the extraction efficiency and cause medicinal material loss. After the crushing is completed, the entire particle mixture is transferred to a container, and purified water is added as a solvent, with the water volume being 8 times the total weight of the medicinal materials. The container is placed in a constant temperature water bath for soaking;

[0039] Step 2: The first decoction operation

[0040] After completing the soaking in step 1, the soaking mixture and the solvent are immediately transferred to the decoction pot, and the heating device is started. The initial heating rate is controlled to increase the temperature by 3°C per minute, and the goal is to reach and stabilize at 100°C for 5 minutes to form a stable boiling state. Subsequently, the temperature is adjusted to 90-95°C and maintained in this temperature range for 60 minutes. During this period, a stirring device is used to stir at a low speed of 10 revolutions per minute to ensure that the medicinal materials are evenly heated and prevent local coking or precipitation. During the decoction process, temperature fluctuations and liquid evaporation are continuously monitored. If necessary, a small amount of purified water is added to maintain the solvent volume at not less than 80% of the initial volume. This operation is intended to ensure full contact between the medicinal materials and the solvent, maximize the release efficiency of active ingredients such as alkaloids and flavonoids, and reduce physical losses through low-speed stirring. After the decoction is completed, the heating is immediately stopped and the mixture is allowed to cool naturally to below 50°C in preparation for subsequent filtration.

[0041] Step 3: Second decoction operation stage

[0042] Remove the remaining medicinal materials after the first decoction in step 2, perform preliminary filtration using a double-layer filter cloth, completely collect and retain all the filtrate from the first decoction, transfer all the remaining medicinal residues after filtration back to a clean decoction pot, and add fresh purified water to the decoction pot as the solvent for the second decoction. The amount of water added is accurately controlled to be 6 times the initial weight of the total medicinal materials;

[0043] Turn on the heating device and heat the solvent to 100°C at a rate of 3°C per minute. Maintain the temperature at 100°C for 3 minutes to ensure that it is fully boiling. Then adjust the heating power to continue decocting. During this period, continue to use the stirring device to stir at a low speed of 10 revolutions per minute to ensure that the medicinal residue is heated evenly and prevent local deposition and coking. During the decoction process, monitor the liquid evaporation volume in real time. If the solvent volume is less than 60% of the initial amount added, immediately add an appropriate amount of purified water to ensure that the solvent volume is always maintained at more than 60% of the initial volume.

[0044] After the decoction is completed, the heating is stopped and the mixture is allowed to cool naturally to below 50°C. After the temperature reaches the standard, the mixture is filtered using a double-layer filter cloth to completely collect all the filtrate obtained from the second decoction. The filtered filtrate is transferred to a sterile container for temporary storage, ready for the subsequent merging process;

[0045] Step 4: Liquid filtration and merging stage

[0046] The first decoction filtrate obtained in step 2 and the second decoction filtrate obtained in step 3 are transferred to clean containers respectively. First, the single filtrate is subjected to primary filtration: using 200 mesh nylon filter cloth to cover the filtration device, coarse filtration is performed at a constant temperature of 30°C to 40°C and a constant pressure of 0.1 MPa to completely intercept coarse particulate impurities, medicinal material residues and fibrous substances with a particle size greater than 75 microns. After the coarse filtration is completed, the primary filtrate is immediately subjected to fine filtration using a polyethersulfone microporous filter membrane with a pore size of 0.2 microns under the same temperature and pressure conditions to completely remove particles, microorganisms, colloids and undissolved fibers with a particle size greater than 0.2 microns to obtain a clear and transparent sterile medicinal solution. Both filtrates must independently complete the above double filtration process to ensure no cross contamination;

[0047] After completing the fine filtration of a single filtrate, transfer the first decoction fine filtrate and the second decoction fine filtrate in a volume ratio of 1:1 into the same sterile mixing tank, start the agitator, and continue mixing at a speed of 60 revolutions per minute for at least 10 minutes until the color, density, and component distribution of the medicinal solution are completely uniform; monitor the pH value of the medicinal solution in real time during the mixing process, and finally adjust the pH of the combined medicinal solution to between 7 and 8. This operation must be completed at an environment of 25°C-30°C to avoid temperature fluctuations that may cause component precipitation or denaturation;

[0048] Step 5: Liquid concentration and finished product preparation stage

[0049] The combined medicinal liquid obtained in step 4 is introduced into a vacuum concentrator for concentration. The volume change of the medicinal liquid is monitored in real time during the concentration process. When the volume is reduced to 50% of the initial combined medicinal liquid volume, it is immediately cooled to below 25°C, filled into a sterilized container, and sealed for storage to obtain the final decoction dosage form for treating cervical spondylosis.

[0050] By finely pre-treating and crushing the medicinal materials, the subsequent extraction efficiency is improved. Combined with two decoctions of the medicinal materials, the dissolution of the effective ingredients of the medicinal materials is ensured. The two decoction filtrates are then filtered separately to make the medicinal liquid clear without residual residue. Finally, the two medicinal liquids are mixed and introduced into a vacuum concentrator for concentration, thereby efficiently removing water while ensuring the retention rate of active substances.

[0051] Among them, the earthworms in step one need to be treated separately and surface rinsed with edible-grade alcohol with a concentration of 45% by volume. The rinsing time is controlled within 30 seconds and the earthworms are drained after rinsing.

[0052] By using 45% by volume of food-grade alcohol to rinse the earthworm, mucus and irritants that may be present on the surface of the earthworm can be effectively removed.

[0053] In step 1, the temperature of the constant temperature water bath is maintained at 25° C., the immersion time is set to 30 minutes, and the mixture is gently stirred every 10 minutes.

[0054] By placing the medicinal materials in a constant temperature water bath, they can fully absorb water and swell without inducing a thermal reaction, thereby promoting the release of active ingredients during subsequent decoction.

[0055] Among them, the first decoction process in step 2 must ensure uninterrupted operation, and the cooling stage must prevent external contamination.

[0056] The first decoction process ensures uninterrupted operation to maintain extraction efficiency and component stability, avoiding any interruption that affects the initial release of alkaloids and flavonoids.

[0057] Among them, the secondary decoction temperature in step three needs to be stabilized in the range of 85°C to 90°C, and the decoction operation should be maintained in this temperature range for 30 minutes.

[0058] The fat-soluble components and heat-sensitive active substances remaining in the medicinal material residues can be efficiently extracted through decoction, while the thermal degradation of the active ingredients can be avoided through strict temperature upper limit control.

[0059] If the combined drug solution in step 4 is not immediately concentrated, it must be transferred to a light-proof sealed container within 2 hours and temporarily stored in a refrigerated environment at 4°C, awaiting the concentration process.

[0060] The combined drug solution is double-filtered to ensure its physical and chemical stability and biosafety, and its ingredients are homogenized through standardized mixing, providing intermediate products that meet the formulation requirements for subsequent processes.

[0061] Among them, in step 1, Pueraria root, Poria cocos, and Atractylodes macrocephala need to be cut into uniform thin slices with a thickness of ≤3 mm due to their dense texture and large volume.

[0062] By cutting Pueraria root, Poria cocos and Atractylodes macrocephala into uniform thin slices, the effective contact area between the medicinal materials and the solvent is significantly increased, thereby promoting the dissolution of the active ingredients.

[0063] Among them, in step five, the initial temperature of the concentration device is set to 50°C, and the heating program is started. The liquid medicine is gradually heated at a rate of 2°C per minute until the target temperature of 75°C is reached. At this temperature, constant temperature and steady-state evaporation are maintained for 45 minutes. At the same time, the vacuum system is adjusted to keep the pressure in the evaporation chamber constant at minus 0.08 MPa.

[0064] By concentrating the combined medicinal liquid, water can be removed efficiently, while preventing heat-sensitive components such as volatile oils and tanshinones contained in chrysanthemum from being oxidized or decomposed due to high temperature, ensuring that the retention rate of active substances is not less than 95%.

[0065] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus.

[0066] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A drug for treating cervical spondylosis, characterized in that: The formula includes the following components in parts by weight: 15 parts of Atractylodes macrocephala, 10 parts of Licorice, 15 parts of Chrysanthemum, 20 parts of Poria, 15 parts of Gastrodia elata, 15 parts of Dry ginger, 20 parts of Cinnamon twig, 15 parts of Salvia miltiorrhiza, 15 parts of Papaya, 15 parts of Lycopodiella cuneata, 20 parts of Millettia reticulata, 30 parts of Earthworm, 15 parts of Notopterygium wilfordii, 20 parts of Pueraria root, 15 parts of Chuanxiong, 10 parts of Schizonepeta tenuifolia, and 15 parts of Saposhnikovia divaricata.

2. A method for preparing a drug for treating cervical spondylosis, characterized in that: The specific steps are as follows: Step 1: Herbal material processing Prepare the required medicinal materials. Place all the plant herbs except earthworms in a stainless steel cleaning tank. Add 35°C purified water to completely immerse the herbs. The liquid level should be 3 cm above the herbs layer. Rinse gently with running water for 2 minutes to remove any dust on the surface. After washing, all washed herbs are laid flat on a sieve for initial drainage, and then transferred to a temperature-controlled drying device for drying under circulating hot air at 40±2°C for 10 minutes. The goal at this stage is to control the surface adsorbed water content to ≤12% by weight to prevent excessive solvent dilution during subsequent soaking and decoction. Subsequently, all the medicinal materials were placed in a medicinal material grinder and mechanically crushed into uniform particles with a particle size of less than 5 mm to improve the subsequent extraction efficiency. After the crushing, the chrysanthemum and schizonepeta, which are light in texture and easy to float on the water surface, were separately placed in a 100-mesh nylon mesh bag and the bag mouth was tied tightly to prevent these lightweight medicinal materials from excessively floating and rolling during the subsequent decoction process, which would affect the extraction efficiency and cause medicinal material loss. After the crushing is completed, the entire particle mixture is transferred to a container, and purified water is added as a solvent, with the water volume being 8 times the total weight of the medicinal materials. The container is placed in a constant temperature water bath for soaking; Step 2: The first decoction operation After completing the soaking in step 1, the soaking mixture and the solvent are immediately transferred to the decoction pot, and the heating device is started. The initial heating rate is controlled to increase the temperature by 3°C per minute, and the goal is to reach and stabilize at 100°C for 5 minutes to form a stable boiling state. Subsequently, the temperature is adjusted to 90-95°C and maintained in this temperature range for 60 minutes. During this period, a stirring device is used to stir at a low speed of 10 revolutions per minute to ensure that the medicinal materials are evenly heated and prevent local coking or precipitation. During the decoction process, temperature fluctuations and liquid evaporation are continuously monitored. If necessary, a small amount of purified water is added to maintain the solvent volume at not less than 80% of the initial volume. This operation is intended to ensure full contact between the medicinal materials and the solvent, maximize the release efficiency of active ingredients such as alkaloids and flavonoids, and reduce physical losses through low-speed stirring. After the decoction is completed, the heating is immediately stopped and the mixture is allowed to cool naturally to below 50°C in preparation for subsequent filtration. Step 3: Second decoction operation stage Remove the remaining medicinal materials after the first decoction in step 2, perform preliminary filtration using a double-layer filter cloth, completely collect and retain all the filtrate from the first decoction, transfer all the remaining medicinal residues after filtration back to a clean decoction pot, and add fresh purified water to the decoction pot as the solvent for the second decoction. The amount of water added is accurately controlled to be 6 times the initial weight of the total medicinal materials; Turn on the heating device and heat the solvent to 100°C at a rate of 3°C per minute. Maintain the temperature at 100°C for 3 minutes to ensure that it is fully boiling. Then adjust the heating power to continue decocting. During this period, continue to use the stirring device to stir at a low speed of 10 revolutions per minute to ensure that the medicinal residue is heated evenly and prevent local deposition and coking. During the decoction process, monitor the liquid evaporation volume in real time. If the solvent volume is less than 60% of the initial amount added, immediately add an appropriate amount of purified water to ensure that the solvent volume is always maintained at more than 60% of the initial volume. After the decoction is completed, the heating is stopped and the mixture is allowed to cool naturally to below 50°C. After the temperature reaches the standard, the mixture is filtered using a double-layer filter cloth to completely collect all the filtrate obtained from the second decoction. The filtered filtrate is transferred to a sterile container for temporary storage, ready for the subsequent merging process; Step 4: Liquid filtration and merging stage The first decoction filtrate obtained in step 2 and the second decoction filtrate obtained in step 3 are transferred to clean containers respectively. First, the single filtrate is subjected to primary filtration: using 200 mesh nylon filter cloth to cover the filtration device, coarse filtration is performed at a constant temperature of 30°C to 40°C and a constant pressure of 0.1 MPa to completely intercept coarse particulate impurities, medicinal material residues and fibrous substances with a particle size greater than 75 microns. After the coarse filtration is completed, the primary filtrate is immediately subjected to fine filtration using a polyethersulfone microporous filter membrane with a pore size of 0.2 microns under the same temperature and pressure conditions to completely remove particles, microorganisms, colloids and undissolved fibers with a particle size greater than 0.2 microns to obtain a clear and transparent sterile medicinal solution. Both filtrates must independently complete the above double filtration process to ensure no cross contamination; After completing the fine filtration of a single filtrate, transfer the first decoction fine filtrate and the second decoction fine filtrate in a volume ratio of 1:1 into the same sterile mixing tank, start the agitator, and continue mixing at a speed of 60 revolutions per minute for at least 10 minutes until the color, density, and component distribution of the medicinal solution are completely uniform; monitor the pH value of the medicinal solution in real time during the mixing process, and finally adjust the pH of the combined medicinal solution to between 7 and 8. This operation must be completed at an environment of 25°C-30°C to avoid temperature fluctuations that may cause component precipitation or denaturation; Step 5: Liquid concentration and finished product preparation stage The combined medicinal liquid obtained in step 4 is introduced into a vacuum concentrator for concentration. The volume change of the medicinal liquid is monitored in real time during the concentration process. When the volume is reduced to 50% of the initial combined medicinal liquid volume, it is immediately cooled to below 25°C, filled into a sterilized container, and sealed for storage to obtain the final decoction dosage form for treating cervical spondylosis.

3. The method for preparing a drug for treating cervical spondylosis according to claim 2, characterized in that: The earthworms described in step 1 need to be treated separately and surface rinsed with edible-grade alcohol having a concentration of 45% by volume for 30 seconds, and then drained.

4. The method for preparing a drug for treating cervical spondylosis according to claim 2, characterized in that: The temperature of the constant temperature water bath in step 1 was maintained at 25° C., and the immersion time was set to 30 minutes, with gentle stirring every 10 minutes.

5. The method for preparing a drug for treating cervical spondylosis according to claim 2, characterized in that: The first decoction process described in step 2 ensures uninterrupted operation, and the cooling stage needs to be prevented from external contamination.

6. The method for preparing a drug for treating cervical spondylosis according to claim 2, characterized in that: The secondary decoction temperature in step 3 needs to be stabilized in the range of 85°C to 90°C, and the decoction operation should be maintained in this temperature range for 30 minutes.

7. The method for preparing a drug for treating cervical spondylosis according to claim 2, characterized in that: If the combined drug solution described in step 4 is not immediately concentrated, it must be transferred to a light-proof sealed container within 2 hours and temporarily stored in a refrigerated environment at 4°C pending the concentration process.

8. The method for preparing a drug for treating cervical spondylosis according to claim 2, characterized in that: The kudzu root, poria cocos and atractylodes macrocephala described in step 1 need to be cut into uniform slices with a thickness of ≤3 mm due to their dense texture and large volume.

9. The method for preparing a drug for treating cervical spondylosis according to claim 2, characterized in that: The initial temperature of the concentration device in step 5 is set to 50°C, and the heating program is started. The liquid medicine is gradually heated at a rate of 2°C per minute until the target temperature of 75°C is reached. At this temperature, constant temperature steady-state evaporation is maintained for 45 minutes. At the same time, the vacuum system is adjusted to keep the pressure in the evaporation chamber constant at minus 0.08 MPa.