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

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and discloses a traditional Chinese medicine composition for treating cervical spondylosis and a preparation method thereof. The traditional Chinese medicine composition is prepared from radix astragali, radix puerariae, radix salviae miltiorrhizae, peach kernels, flos carthami, rhizoma chuanxiong, radix notoginseng, radix paeoniae rubra, radix angelicae sinensis, radix bupleuri, radix rehmanniae, radix achyranthis bidentatae, fructus aurantii, radix platycodonis and radix glycyrrhizae. The traditional Chinese medicine composition has the advantages that various medicines in the traditional Chinese medicine composition are mutually synergistic in efficacy, the treatment effect is furthest played, and the traditional Chinese medicine composition has the effects of tonifying qi, activating blood, dispersing blood stasis, relieving pain, treating both symptoms and root causes and low recurrence rate, can be used for treating various types of cervical spondylosis in acute and chronic stages, and is small in irritation to intestines and stomach, good in tolerance and high in safety. The invention further provides a preparation method of the traditional Chinese medicine preparation. The preparation method is simple and convenient in technological process, high in efficiency, low in operation cost and suitable for batch production.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating cervical spondylosis and a preparation method thereof. BACKGROUND

[0002] Cervical spondylosis is a syndrome, also known as cervical syndrome. It is common in the elderly and is caused by long-term accumulation of working environment, professional nature and living habits. It is a group of symptoms caused by degenerative changes in human intervertebral discs, extreme fatigue of cervical muscle tissue, cervical osteophyte, or change of normal physiological curve of cervical vertebra. Cervical spondylosis has a high incidence and is harmful. Lightly, it often causes head, neck, shoulder and arm numbness. Heavily, it can cause limb weakness, incontinence and paralysis, etc. It is a thorny and intractable disease for both traditional Chinese medicine and western medicine. Cervical spondylosis is divided into: cervical type (soft tissue type), nerve root type, spinal cord type, sympathetic type, vertebral artery type, and other types according to the different affected tissues and structures. If two or more types exist at the same time, it is called "mixed type".

[0003] Modern medical research believes that the transverse foramen, the vertebral foramen and the intervertebral space all have certain gaps. For example, the nerve root only occupies about 50% of the intervertebral foramen, and has a relatively large range of motion. Generally, it is difficult to compress blood vessels, nerves and spinal cord. Only when bone spurs or other causes cause local congestion and edema, making the lumen narrow, can the above-mentioned tissues be compressed and cause the disease.

[0004] Current treatment methods for cervical spondylosis mainly include oral drugs, traction and surgery, etc. However, these methods have certain limitations: drug treatment often has a long cycle and slow effect, and long-term drug use may increase the burden on the gastrointestinal tract; traction therapy has a limited effect maintenance time, and often needs to be repeated once the muscle is contracted again or the joint activity is limited; and surgical treatment has greater trauma, significant pain and high risk. Therefore, it is of great clinical significance to explore a safe and effective, long-acting and easy-to-use traditional Chinese medicine prevention and treatment scheme. SUMMARY

[0005] The present application is made according to the traditional Chinese medicine theory and combined with the experience of clinicians for many years through a large number of experimental researches. The present application aims to provide a traditional Chinese medicine composition for treating cervical spondylosis and a preparation method thereof. The method adopts blood and qi nourishing and blood-activating and stasis-removing methods to achieve the purpose of treating cervical spondylosis.

[0006] The first aspect of the present application aims to provide a traditional Chinese medicine composition.

[0007] The second aspect of the present application aims to provide a traditional Chinese medicine preparation comprising the traditional Chinese medicine composition of the first aspect of the present application. The third aspect of the present application aims to provide a preparation method of the traditional Chinese medicine preparation of the second aspect of the present application.

[0008] The fourth aspect of the present application aims to provide the use of the traditional Chinese medicine composition of the first aspect of the present application and / or the traditional Chinese medicine preparation of the second aspect of the present application in the preparation of an anti-inflammatory and / or analgesic drug.

[0009] The fifth aspect of the present application aims to provide the use of the traditional Chinese medicine composition of the first aspect of the present application and / or the traditional Chinese medicine preparation of the second aspect of the present application in the preparation of a drug for treating cervical spondylosis.

[0010] To achieve the above-mentioned purposes, the technical solution adopted by the present application is:

[0011] The first aspect of the present application provides a traditional Chinese medicine composition, which comprises: Astragalus, Pueraria, Salvia miltiorrhiza, Semen Persicae, Carthamus tinctorius, Chuanxiong, Panax notoginseng, Red peony root, Angelica, Bupleurum, Rehmannia, Radix Astragali seu Hedysari, Fructus Aurantii, Platycodon and Glycyrrhiza.

[0012] In some embodiments of the present application, the composition comprises Astragalus 5-15 parts by weight; further 8-14 parts; and further 10-12 parts.

[0013] In some embodiments of the present application, the composition comprises Pueraria 10-20 parts by weight; further 12-16 parts; and further 14-15 parts.

[0014] In some embodiments of the present application, the composition comprises Salvia miltiorrhiza 5-10 parts by weight; further 5-8 parts; and further 6-7 parts.

[0015] In some embodiments of the present application, the composition comprises Semen Persicae 5-10 parts by weight; further 5-8 parts; and further 6-7 parts.

[0016] In some embodiments of the present application, the composition comprises Carthamus tinctorius 4-10 parts by weight; further 5-8 parts; and further 6-7 parts.

[0017] In some embodiments of the present application, the composition comprises Chuanxiong 5-10 parts by weight; further 5-9 parts; and further 7-8 parts.

[0018] In some embodiments of the present application, the composition comprises Panax notoginseng 1-6 parts by weight; further 3-6 parts; and further 4-5 parts.

[0019] In some embodiments of the present application, the composition comprises Red peony root 4-10 parts by weight; further 5-8 parts; and further 6-7 parts.

[0020] In some embodiments of the present application, the composition comprises Angelica 4-10 parts by weight; further 4-8 parts, and more further 5-6 parts.

[0021] In some embodiments of the present application, the composition comprises Bupleurum 1-6 parts by weight; further 3-6 parts, and more further 4-5 parts.

[0022] In some embodiments of the present application, the composition comprises Rehmannia 5-10 parts by weight; further 5-9 parts, and more further 7-8 parts.

[0023] In some embodiments of the present application, the composition comprises Radix Achyranthis 4-10 parts by weight; further 4-7 parts, and more further 5-6 parts.

[0024] In some embodiments of the present application, the composition comprises Fructus Aurantii 1-6 parts by weight; further 3-6 parts, and more further 4-5 parts.

[0025] In some embodiments of the present application, the composition comprises Radix Platycodonis 1-6 parts by weight; further 3-6 parts, and more further 4-5 parts.

[0026] In some embodiments of the present application, the composition comprises Radix Glycyrrhizae 1-6 parts by weight; further 2-5 parts, and more further 2-4 parts.

[0027] In a second aspect of the present application, a traditional Chinese medicine preparation is provided, comprising the traditional Chinese medicine composition of the first aspect of the present application.

[0028] In some embodiments of the present application, the traditional Chinese medicine preparation further comprises a pharmaceutically acceptable excipient.

[0029] In some embodiments of the present application, the excipient comprises at least one of a sustained-release agent, a diluent, a lubricant, an emulsifier, a plasticizer, a flow aid, a filler, a binder, a humectant, an absorption promoter, and a surfactant.

[0030] In some embodiments of the present application, the dosage form of the traditional Chinese medicine preparation comprises one of a decoction, a granule, a tablet, a capsule, a dripping pill, an oral liquid, a powder, a plaster, and a suspension.

[0031] In some preferred embodiments of the present application, the traditional Chinese medicine preparation is a decoction and / or a capsule.

[0032] In a third aspect of the present application, a preparation method of the traditional Chinese medicine preparation of the second aspect of the present application is provided, comprising the following steps: weighing the composition according to the weight parts, decocting with water, collecting the liquid, and obtaining the traditional Chinese medicine preparation.

[0033] In some embodiments of the present application, the mass ratio of the water to the composition is (5-20):1.

[0034] In some embodiments of the present application, the decocting time is 1-5 hours.

[0035] In some embodiments of the present application, the decocting times is 1-3 times, further 2-3 times.

[0036] In some embodiments of the present application, when the decocting times is 2 times, the mass ratio of the water to the composition in the first decocting is (5-12):1, further (8-12):1, and more further (9-11):1; and the mass ratio of the water to the composition in the second decocting is (5-10):1, further (6-10):1, and more further (7-9):1.

[0037] In some embodiments of the present application, when the decocting times is 2 times, the decocting time in the first decocting is 1-3 hours, further 1.5-3 hours, and more further 1.5-2.5 hours; and the decocting time in the second decocting is 0.5-2 hours, further 1-2 hours, and more further 1.5-2 hours.

[0038] In some embodiments of the present application, when the traditional Chinese medicine preparation is a capsule, the preparation method further comprises concentrating the filtrate into a concentrated liquid after the filtrate is combined; and purifying the concentrated liquid to obtain an extract, mixing the extract with excipients, drying, pulverizing into fine powder, and filling into capsules.

[0039] In some embodiments of the present application, the filtrate concentration method comprises at least one of normal pressure evaporation concentration, vacuum concentration, thin film concentration, and multi-effect evaporation concentration.

[0040] In some preferred embodiments of the present application, the filtrate concentration method comprises vacuum concentration.

[0041] In some more preferred embodiments of the present application, the filtrate concentration method comprises low-temperature vacuum concentration.

[0042] In some embodiments of the present application, the filtrate is concentrated into a concentrated liquid with a relative density of 0.8-1.5.

[0043] In some preferred embodiments of the present application, the filtrate is concentrated into a concentrated liquid with a relative density of 0.95-1.35.

[0044] In some more preferred embodiments of the present application, the filtrate is concentrated into a concentrated liquid with a relative density of 1.05-1.15.

[0045] In some embodiments of the present invention, the temperature of the concentrate is 50~90°C.

[0046] In some preferred embodiments of the present invention, the temperature of the concentrate is 55~85°C.

[0047] In some more preferred embodiments of the present invention, the temperature of the concentrate is 60~80°C.

[0048] In some embodiments of the present invention, the method for preparing the capsules further includes purifying the concentrate.

[0049] In some embodiments of the present invention, the method for purifying the concentrate includes at least one of alcohol precipitation, membrane separation, and chromatography.

[0050] In some preferred embodiments of the present invention, the method for purifying the concentrate is alcohol precipitation.

[0051] In some embodiments of the present invention, after the concentrate is cooled, ethanol is added, stirred, allowed to stand, and the ethanol is recovered from the filtrate and then concentrated into an extract.

[0052] In some embodiments of the present invention, the ethanol concentration is 60-70% v / v.

[0053] In some preferred embodiments of the present invention, the ethanol concentration is 63-68% v / v.

[0054] In some more preferred embodiments of the present invention, the ethanol concentration is 65% v / v.

[0055] In some embodiments of the present invention, the ethanol is added and then allowed to stand for 22 to 26 hours.

[0056] In some preferred embodiments of the present invention, the ethanol is added and then allowed to stand for 23 to 25 hours.

[0057] In some more preferred embodiments of the present invention, the ethanol is added and then allowed to stand for 24 hours.

[0058] In some embodiments of the present invention, the ethanol recovery method includes atmospheric distillation, vacuum distillation, and rectification distillation.

[0059] In some preferred embodiments of the present invention, the ethanol recovery method includes vacuum distillation.

[0060] In some embodiments of the present invention, the excipients of the capsule include at least one of microcrystalline cellulose, starch, lactose, dextrin, sodium carboxymethyl starch, micronized silica gel, talc, and magnesium stearate.

[0061] In some embodiments of the present invention, the drying method after mixing the extract and the adjuvant includes at least one of atmospheric drying, vacuum drying, freeze drying, spray drying, air drying, and microwave drying.

[0062] In some preferred embodiments of the present invention, the drying method after mixing the extract and the adjuvant is vacuum drying.

[0063] In some preferred embodiments of the present invention, the drying method after mixing the extract and the adjuvant is low-temperature vacuum drying.

[0064] In some embodiments of the present invention, the comminution method includes at least one of dry comminution, wet comminution, and low-temperature comminution.

[0065] In some preferred embodiments of the present invention, the comminution method is low-temperature comminution.

[0066] The object of the fourth aspect of the present invention is to provide the use of the traditional Chinese medicine composition of the first aspect of the present invention or the traditional Chinese medicine preparation of the second aspect of the present invention in the preparation of drugs for anti-inflammatory and / or analgesic.

[0067] The object of the fifth aspect of the present invention is to provide the use of the traditional Chinese medicine composition of the first aspect of the present invention or the traditional Chinese medicine preparation of the second aspect of the present invention in the preparation of drugs for treating cervical spondylosis.

[0068] In some embodiments of the present invention, the cervical spondylosis is one of cervical type, nerve root type, spinal cord type, sympathetic type, vertebral artery type, and mixed type.

[0069] The beneficial effects of the present invention are as follows: The formula of the traditional Chinese medicine composition of the present invention is obtained through repeated clinical applications and practices. According to the principle of "no pain when the meridians are unobstructed" in traditional Chinese medicine, aiming at the pathological mechanism of cervical spondylosis, following the principle of "sovereign, ministerial, assistant, and courier", the ascending and descending are coordinated, so that various drugs synergize with each other in terms of drug efficacy, maximizing the therapeutic effect, replenishing qi and activating blood circulation, removing stasis and relieving pain, and having obvious analgesic and anti-inflammatory effects. It can be used for the treatment of acute and chronic stages of various types of cervical spondylosis. It can not only solve the dizziness and strong pain in the neck in the acute stage, but also restore the limb flexion and extension disorders and numbness in the chronic stage. The total clinical effective rate is greater than 90%; it treats both the symptoms and the root causes, and has a low recurrence rate. Moreover, the traditional Chinese medicine composition has little irritation to the gastrointestinal tract, good tolerance, high safety, can be taken for a long time, and is suitable for patients with a long course of disease. The various medicinal materials in the traditional Chinese medicine composition are relatively inexpensive and easy to obtain, reducing the economic burden on patients.

[0070] The preparation method of the traditional Chinese medicine preparation provided by the present invention has a simple technological process, determines the optimal extraction process, and the extraction process has high extraction efficiency and low operating cost, suitable for batch production. BRIEF DESCRIPTION OF THE DRAWINGS

[0071] The following further describes the present invention in conjunction with the accompanying drawings and embodiments, where: Figure 1 This is the process flow diagram of the capsule for treating cervical spondylosis of the present invention. The processes within the background frame must be operated in a clean area (Grade D). Specific embodiments

[0072] The following will clearly and completely describe the concept of the present invention and the technical effects generated in conjunction with the embodiments, so as to fully understand the purpose, features and effects of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, other embodiments obtained by those skilled in the art without creative efforts all fall within the scope of protection of the present invention.

[0073] For those conditions not specified in the embodiments, they are carried out according to conventional conditions or the conditions recommended by the manufacturer. For reagents or instruments whose manufacturers are not specified, they are all conventional products that can be obtained through commercial purchase.

[0074] According to the principle of traditional Chinese medicine that "smoothness leads to painlessness", aiming at the pathological mechanism of cervical spondylosis, following the principle of "sovereign, ministerial, adjuvant, and messenger", the ascending and descending are coordinated to promote and enhance the efficacy of the drugs. The sovereign drugs are Astragalus membranaceus and Pueraria lobata. Astragalus membranaceus greatly tonifies the qi of the spleen and lung, and sufficient qi can promote blood circulation. Pueraria lobata can relieve the muscles and release the exterior, soothe the tendons and veins, effectively relieve the strong pain and stiffness of the neck, and at the same time can lift the clear yang, and has a good effect on dizziness and headache caused by cervical spondylosis. The ministerial drugs are Salvia miltiorrhiza, Prunus persica, Carthamus tinctorius, Ligusticum chuanxiong, Panax notoginseng, and Paeonia lactiflora. The six drugs work synergistically to strongly dispel the stasis in the neck. Salvia miltiorrhiza promotes blood circulation and cools blood, Prunus persica and Carthamus tinctorius break blood and remove stasis, Ligusticum chuanxiong is the "qi drug in blood" that can promote qi and activate blood circulation, Panax notoginseng dispels stasis and relieves pain, and Paeonia lactiflora cools blood and disperses stasis. They jointly solve the core pathological product of "blood stasis". The adjuvant drugs are Angelica sinensis, Rehmannia glutinosa, Bupleurum chinense, Fructus Aurantii, Platycodon grandiflorum, and Achyranthes bidentata. Angelica sinensis nourishes blood and promotes blood circulation, Rehmannia glutinosa nourishes yin and blood, Bupleurum chinense and Fructus Aurantii, one ascending and one descending, soothe the qi of the whole body, and when qi moves, blood moves. Platycodon grandiflorum carries the drugs upward and guides the power of all drugs directly to the diseased area of the neck. Achyranthes bidentata guides blood downward and provides an outlet for the stasis, ensuring that the medicinal power can accurately "reach the neck upward and communicate with the whole body downward". The messenger drug is Glycyrrhiza uralensis. The main role of Glycyrrhiza uralensis is to reconcile the properties of all drugs in the formula, relieve the drastic properties of the blood-activating drugs, and play a role of coordination and balance. The traditional Chinese medicine preparation prepared with the traditional Chinese medicine composition of the present application has the treatment principle of "nourishing blood and qi, promoting blood circulation and removing stasis", and is effective in treating acute and chronic stages of various types of cervical spondylosis.

[0075] All the medicinal materials used in the present invention are varieties included in the Chinese Pharmacopoeia 2025 Edition.

[0076] Astragalus membranaceus is a plant of the legume family, Astragalus membranaceus (Fisch.) Bunge var. mongholicus (Bunge) Hsiao & K. T. Fu or Astragalus membranaceus (Fisch.) Bunge Astragalus membranaceusThe dried root of the plant is sweet and warm in nature; it enters the lung and spleen meridians; it tonifies qi and raises yang, strengthens the exterior and stops sweating, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves pain, promotes the elimination of toxins and pus, and promotes wound healing and tissue regeneration.

[0077] Kudzu root, a legume, is a type of wild kudzu. Puerariae Lobatae Radix The dried root of the plant is sweet, pungent, and cool in nature; it enters the spleen, stomach, and lung meridians; it relieves muscle tension and reduces fever, promotes the production of body fluids and quenches thirst, promotes rash eruption, raises yang and stops diarrhea, unblocks meridians and collaterals, and detoxifies alcohol.

[0078] Danshen is a plant belonging to the Lamiaceae family, named Salvia miltiorrhiza. Salviae Miltiorrhizae Radix et Rhizoma The dried roots and rhizomes of the plant are bitter and slightly cold in nature; they enter the heart and liver meridians; they invigorate blood circulation, remove blood stasis, regulate menstruation, relieve pain, clear the heart and eliminate irritability, cool the blood and reduce swelling.

[0079] Peach kernel, a type of fruit from the Rosaceae family, specifically the peach or wild peach. Persicae Semen The dried, mature seeds are bitter and sweet in taste, and neutral in nature; they enter the heart, liver, and large intestine meridians; they invigorate blood circulation, remove blood stasis, moisten the intestines and promote bowel movements, and relieve cough and asthma.

[0080] Safflower, a plant in the Asteraceae family. Carthami Flos The dried tubular flowers are pungent and warm in nature; they enter the heart and liver meridians; they invigorate blood circulation, regulate menstruation, disperse blood stasis, and relieve pain.

[0081] Chuanxiong, a plant of the Apiaceae family. Chuanxiong Rhizoma The dried rhizome is pungent and warm in nature; it enters the liver, gallbladder, and pericardium meridians; it invigorates blood circulation, promotes qi circulation, dispels wind, and relieves pain.

[0082] Panax notoginseng, a plant belonging to the Araliaceae family. Notoginseng Radix et Rhizoma The dried roots and rhizomes of the plant are sweet and slightly bitter in taste, and warm in nature; they enter the liver and stomach meridians; they disperse blood stasis, stop bleeding, reduce swelling, and relieve pain.

[0083] Red peony refers to the plant *Paeonia lactiflora* or *Paeonia veitchii*, both belonging to the Ranunculaceae family. Paeoniae Rubra Radix The dried root is bitter, slightly cold in nature; it enters the liver meridian; it clears heat and cools the blood, disperses blood stasis and relieves pain.

[0084] Angelica sinensis, a plant belonging to the Apiaceae family. Angelicae Sinensis Radix The dried root of the plant is sweet, pungent, and warm in nature; it enters the liver, heart, and spleen meridians; it nourishes and invigorates blood, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements.

[0085] Bupleurum, also known as Chinese bupleurum or narrow-leaved bupleurum, are plants belonging to the Apiaceae family. Bupleuri Radix The dried root of the plant is pungent, bitter, and slightly cold in nature; it enters the liver, gallbladder, and lung meridians; it disperses and reduces fever, soothes the liver and relieves depression, and raises yang qi.

[0086] Rehmannia glutinosa, also known as raw rehmannia, is a plant belonging to the Scrophulariaceae family. Rehmanniae Radix The dried tuberous root is sweet and cold in nature; it enters the heart, liver, and kidney meridians; it clears heat and cools the blood, nourishes yin and generates fluids.

[0087] Achyranthes bidentata, a plant belonging to the Amaranthaceae family. Achyranthis Bidentatae Radix The dried root of the plant has a bitter, sweet, and sour taste, and is neutral in nature; it enters the liver and kidney meridians; it removes blood stasis and unblocks the meridians, tonifies the liver and kidneys, strengthens tendons and bones, promotes urination and relieves strangury, and guides blood downward.

[0088] Citrus aurantium, also known as bitter orange or its cultivated varieties, is a plant belonging to the Rutaceae family. Aurantii Fructus The dried, unripe fruit has a bitter, pungent, and sour taste, and is slightly cold in nature; it enters the spleen and stomach meridians; it regulates qi, relieves chest congestion, and promotes the flow of qi and eliminates bloating.

[0089] Platycodon grandiflorus, a plant belonging to the Campanulaceae family. Platycodonis Radix The dried root of the plant is bitter and pungent in taste, and neutral in nature; it enters the lung meridian; it promotes lung function, soothes the throat, eliminates phlegm, and drains pus.

[0090] Licorice, also known as Glycyrrhiza uralensis, is a legume belonging to the genus Glycyrrhiza, including Glycyrrhiza inflata and Glycyrrhiza glabra. Glycyrrhizae Radix et Rhizoma The dried roots and rhizomes of the plant are sweet and neutral in nature; they enter the heart, lung, spleen, and stomach meridians; they tonify the spleen and replenish qi, clear heat and detoxify, resolve phlegm and stop cough, relieve spasms and pain, and harmonize the effects of other herbs.

[0091] The features and performance of the present invention will be further described in detail below with reference to embodiments.

[0092] Example 1 A composition comprising the following active pharmaceutical ingredient in parts by weight: Astragalus membranaceus 11.1 parts, Pueraria lobata 14.8 parts, Salvia miltiorrhiza 6.7 parts, Prunus persica 6.7 parts, Carthamus tinctorius 6.7 parts, Ligusticum chuanxiong 7.4 parts, Panax notoginseng 4.4 parts, Paeonia lactiflora 6.7 parts, Angelica sinensis 5.9 parts, Bupleurum chinense 4.4 parts, Rehmannia glutinosa 7.4 parts, Achyranthes bidentata 5.9 parts, Citrus aurantium 4.4 parts, Platycodon grandiflorus 4.4 parts, and Glycyrrhiza uralensis 3.0 parts.

[0093] Example 2 A composition comprising the following active pharmaceutical ingredient in parts by weight: Astragalus membranaceus 8 parts, Pueraria lobata 15 parts, Salvia miltiorrhiza 7 parts, Prunus persica 8 parts, Carthamus tinctorius 7 parts, Ligusticum chuanxiong 7 parts, Panax notoginseng 3 parts, Paeonia lactiflora 8 parts, Angelica sinensis 5 parts, Bupleurum chinense 4 parts, Rehmannia glutinosa 7 parts, Achyranthes bidentata 6 parts, Citrus aurantium 4 parts, Platycodon grandiflorus 4 parts, Glycyrrhiza uralensis 3 parts.

[0094] Example 3 A composition comprising the following active pharmaceutical ingredient in parts by weight: Astragalus membranaceus 12 parts, Pueraria lobata 15 parts, Salvia miltiorrhiza 6 parts, Prunus persica 6 parts, Carthamus tinctorius 6 parts, Ligusticum chuanxiong 8 parts, Panax notoginseng 4 parts, Paeonia lactiflora 8 parts, Angelica sinensis 6 parts, Bupleurum chinense 6 parts, Rehmannia glutinosa 8 parts, Achyranthes bidentata 7 parts, Citrus aurantium 3 parts, Platycodon grandiflorus 6 parts, Glycyrrhiza uralensis 4 parts.

[0095] Example 4 A composition comprising the following active pharmaceutical ingredient in parts by weight: Astragalus membranaceus 8 parts, Pueraria lobata 12 parts, Salvia miltiorrhiza 8 parts, Prunus persica 6 parts, Carthamus tinctorius 8 parts, Ligusticum chuanxiong 5 parts, Panax notoginseng 6 parts, Paeonia lactiflora 5 parts, Angelica sinensis 5 parts, Bupleurum chinense 6 parts, Rehmannia glutinosa 6 parts, Achyranthes bidentata 4 parts, Citrus aurantium 5 parts, Platycodon grandiflorus 3 parts, Glycyrrhiza uralensis 2 parts.

[0096] Example 5 An oral medication for treating cervical spondylosis is prepared by the following method: Weigh each raw material according to the weight proportions in Example 1, add water and decoct twice. The first decoction is made with 10 times the amount of water for 2 hours, and the second decoction is made with 8 times the amount of water for 1.5 hours. Combine the extracts, filter, and the oral medication is obtained.

[0097] Example 6 An oral medication for treating cervical spondylosis is prepared by the following method: According to the weight proportions of Example 2, weigh each raw material and decoct it twice with water. The first decoction is made with 10 times the amount of water for 2 hours, and the second decoction is made with 8 times the amount of water for 1.5 hours. Combine the extracts, filter, and the oral medication is obtained.

[0098] Example 7 An oral medication for treating cervical spondylosis is prepared by the following method: According to Example 3, weigh out each raw material, add water and decoct twice. First, decoct with 10 times the amount of water for 2 hours, and second, decoct with 8 times the amount of water for 1.5 hours. Combine the extracts, filter, and obtain the oral medication.

[0099] Example 8 An oral medication for treating cervical spondylosis is prepared by the following method: According to Example 4, weigh out each raw material, add water and decoct twice. First, decoct with 10 times the amount of water for 2 hours, and second, decoct with 8 times the amount of water for 1.5 hours. Combine the extracts, filter, and obtain the oral medication.

[0100] Example 9 A capsule for treating cervical spondylosis is prepared by the following method: Process flow as follows Figure 1 As shown, each raw material was weighed according to the weight proportions of Example 1, and decocted twice with water. The first decoction was made with 10 times the amount of water for 2 hours, and the second decoction was made with 8 times the amount of water for 1.5 hours. The extracts were combined, filtered, and the filtrate was concentrated to a relative density of 1.05~1.10 (60~80℃). The solution was cooled, and ethanol was added to make the alcohol concentration 65% (volume ratio) while stirring continuously. The solution was allowed to stand for 24 hours, filtered, and the filtrate was concentrated under reduced pressure and the ethanol was recovered. The solution was then concentrated into an extract, dried under reduced pressure at low temperature, pulverized into a fine powder, passed through a 40-mesh sieve, and encapsulated to obtain the final product.

[0101] Example 10 Extraction of a composition includes the following steps: weigh each raw material according to the weight parts of Example 1, decoct with water twice, first decoct with 10 times the amount of water for 1.5 hours, and second decoct with 8 times the amount of water for 1 hour, combine the extracts, filter, concentrate the filtrate to a concentration of 1.05~1.10 (60~80℃), cool, add ethanol to make the alcohol concentration 65% (volume ratio) while stirring continuously, let stand for 24 hours, filter, concentrate the filtrate under reduced pressure and recover the ethanol, concentrate into an extract, dry under reduced pressure at low temperature to obtain a dry extract.

[0102] Example 11 Extraction of a composition includes the following steps: weigh each raw material according to the weight parts of Example 1, decoct with water twice, first decoct with 8 times the amount of water for 1.5 hours, then decoct with 7 times the amount of water for 1 hour, combine the extracts, filter, concentrate the filtrate to a concentration of 1.05~1.10 (60~80℃), cool, add ethanol to make the alcohol concentration 65% (volume ratio) while stirring continuously, let stand for 24 hours, filter, concentrate the filtrate under reduced pressure and recover the ethanol, concentrate into an extract, dry under reduced pressure at low temperature to obtain a dry extract.

[0103] Example 12 Extraction of a composition includes the following steps: weigh each raw material according to the weight parts of Example 1, decoct with water twice, first decoct with 6 times the amount of water for 1.5 hours, then decoct with 5 times the amount of water for 1 hour, combine the extracts, filter, concentrate the filtrate to a concentration of 1.05~1.10 (60~80℃), cool, add ethanol to make the alcohol concentration 65% (volume ratio) while stirring continuously, let stand for 24 hours, filter, concentrate the filtrate under reduced pressure and recover the ethanol, concentrate into an extract, dry under reduced pressure at low temperature to obtain a dry extract.

[0104] Example 13 Extraction of a composition includes the following steps: weigh each raw material according to the weight parts of Example 1, decoct with water twice, first decoct with 10 times the amount of water for 2 hours, and second decoct with 8 times the amount of water for 1.5 hours, combine the extracts, filter, concentrate the filtrate to a concentration of 1.05~1.10 (60~80℃), cool, add ethanol to make the alcohol concentration 65% (volume ratio) while stirring continuously, let stand for 24 hours, filter, concentrate the filtrate under reduced pressure and recover the ethanol, concentrate into an extract, dry under reduced pressure at low temperature to obtain a dry extract.

[0105] Example 14 Extraction of a composition includes the following steps: weigh each raw material according to the weight parts of Example 1, decoct with water twice, first decoct with 8 times the amount of water for 2 hours, and second decoct with 7 times the amount of water for 1.5 hours, combine the extracts, filter, concentrate the filtrate to a concentration of 1.05~1.10 (60~80℃), cool, add ethanol to make the alcohol concentration 65% (volume ratio) while stirring continuously, let stand for 24 hours, filter, concentrate the filtrate under reduced pressure and recover the ethanol, concentrate into an extract, dry under reduced pressure at low temperature to obtain a dry extract.

[0106] Example 15 Extraction of a composition includes the following steps: weigh each raw material according to the weight parts of Example 1, decoct with water twice, first decoct with 6 times the amount of water for 2 hours, and second decoct with 5 times the amount of water for 1.5 hours, combine the extracts, filter, concentrate the filtrate to a concentration of 1.05~1.10 (60~80℃), cool, add ethanol to make the alcohol concentration 65% (volume ratio) while stirring continuously, let stand for 24 hours, filter, concentrate the filtrate under reduced pressure and recover the ethanol, concentrate into an extract, dry under reduced pressure at low temperature to obtain a dry extract.

[0107] Example 16 Extraction of a composition includes the following steps: weigh each raw material according to the weight parts of Example 1, decoct with water twice, first decoct with 10 times the amount of water for 2.5 hours, and second decoct with 8 times the amount of water for 2 hours, combine the extracts, filter, concentrate the filtrate to a concentration of 1.05~1.10 (60~80℃), cool, add ethanol to make the alcohol concentration 65% (volume ratio) while stirring continuously, let stand for 24 hours, filter, concentrate the filtrate under reduced pressure and recover the ethanol, concentrate into an extract, dry under reduced pressure at low temperature to obtain a dry extract.

[0108] Example 17 Extraction of a composition includes the following steps: weigh each raw material according to the weight parts of Example 1, decoct with water twice, first decoct with 8 times the amount of water for 2.5 hours, then decoct with 7 times the amount of water for 2 hours, combine the extracts, filter, concentrate the filtrate to a relative density of 1.05~1.10 (60~80℃), cool, add ethanol to make the alcohol concentration 65% (volume ratio) while stirring continuously, let stand for 24 hours, filter, concentrate the filtrate under reduced pressure and recover the ethanol, concentrate into an extract, dry under reduced pressure at low temperature to obtain a dry extract.

[0109] Example 18 Extraction of a composition includes the following steps: weigh each raw material according to the weight parts of Example 1, decoct with water twice, first decoct with 6 times the amount of water for 2.5 hours, then decoct with 5 times the amount of water for 2 hours, combine the extracts, filter, concentrate the filtrate to a relative density of 1.05~1.10 (60~80℃), cool, add ethanol to make the alcohol concentration 65% (volume ratio) while stirring continuously, let stand for 24 hours, filter, concentrate the filtrate under reduced pressure and recover the ethanol, concentrate into an extract, dry under reduced pressure at low temperature to obtain a dry extract.

[0110] Comparative Example 1 A composition comprising the following active pharmaceutical ingredient in parts by weight: Salvia miltiorrhiza 7 parts, peach kernel 7 parts, safflower 7 parts, chuanxiong rhizome 7 parts, Panax notoginseng 4 parts, red peony root 7 parts, angelica sinensis 6 parts, bupleurum root 4 parts, rehmannia root 7 parts, achyranthes root 6 parts, immature bitter orange peel 4 parts, platycodon root 4 parts, licorice root 3 parts.

[0111] Comparative Example 2 A composition comprising the following active pharmaceutical ingredient in parts by weight: Astragalus membranaceus 11 parts, Pueraria lobata 15 parts, Panax notoginseng 4 parts, Paeonia lactiflora 7 parts, Angelica sinensis 6 parts, Bupleurum chinense 4 parts, Rehmannia glutinosa 7 parts, Achyranthes bidentata 6 parts, Citrus aurantium 4 parts, Platycodon grandiflorus 4 parts, Glycyrrhiza uralensis 3 parts.

[0112] Comparative Example 3 A composition comprising the following active pharmaceutical ingredient in parts by weight: Astragalus membranaceus 11 parts, Pueraria lobata 15 parts, Salvia miltiorrhiza 7 parts, Prunus persica 7 parts, Carthamus tinctorius 7 parts, Ligusticum chuanxiong 7 parts, Panax notoginseng 4 parts, Paeonia lactiflora 7 parts, Achyranthes bidentata 6 parts, Platycodon grandiflorus 4 parts, Glycyrrhiza uralensis 3 parts.

[0113] Comparative Example 4 An oral medication for treating cervical spondylosis is prepared by the following method: Weigh out each raw material in 1 part by weight according to the comparative ratio, add water and decoct twice. First decoct with 10 times the amount of water for 2 hours, and second decoct with 8 times the amount of water for 1.5 hours. Combine the extracts, filter, and the oral medication is obtained.

[0114] Comparative Example 5 An oral medication for treating cervical spondylosis is prepared by the following method: Weigh out each raw material in 2 parts by weight according to the comparative ratio, add water and decoct twice. The first decoction is made with 10 times the amount of water for 2 hours, and the second decoction is made with 8 times the amount of water for 1.5 hours. Combine the extracts, filter, and the oral medication is obtained.

[0115] Comparative Example 6 An oral medication for treating cervical spondylosis is prepared by the following method: Weigh out each raw material in 3 parts by weight according to the comparative ratio, add water and decoct twice. First decoct with 10 times the amount of water for 2 hours, and second decoct with 8 times the amount of water for 1.5 hours. Combine the extracts, filter, and the oral medication is obtained.

[0116] Comparative Example 7 Jingfukang granules (batch number: 20111005, Jingfukang Pharmaceutical Group Co., Ltd.) liquid is prepared by the following method: Dissolve 1g of granules in 5mL of hot water to obtain the cervical spondylosis granule solution, and let it cool to room temperature for later use.

[0117] Effect Example 1. Optimization of preparation methods for oral medication solutions or capsules Extraction process study: Orthogonal design and comprehensive scoring method were used to optimize the extraction process. Decoction time (A) and number of decoctions (B) were selected as optimization factors, with three levels for each factor, based on L9(3). 4 The experiment was designed using an orthogonal experimental table. The factors and levels are set as shown in Table 1. The index to be examined was the yield of dry extract, which was calculated as follows: Yield of dry extract = weight of dry extract / weight of raw material × 100%.

[0118] Table 1. Levels of Water Extraction Process Factors

[0119] Table 2 Results of orthogonal experiments on water extraction process

[0120] Table 3. Results of ANOVA for Water Extraction Process

[0121] Note: F0.01(2,4)=18.0, F0.05(2,4)=6.94 Table 2 shows that the order of influence of each factor on the determination results is B (water volume) > A (decoction time). The optimal extraction process is A2B1, that is, decoction for 2 hours with 10 times the amount of water for the first time, and decoction for 1.5 hours with 8 times the amount of water for the second time. Table 3 shows that factor B (water volume) has a significant effect on the determination results. P <0.05); Factor A (decoction time) had no significant effect on the test results. P >0.05). In summary, considering economic factors such as energy saving, time saving, and cost reduction, A2B1 is selected, that is, the optimal extraction process is to decoct with 10 times the amount of water for 2 hours in the first step and 8 times the amount of water for 1.5 hours in the second step. At this time, the maximum amount of dry extract is obtained and the extraction yield is the highest.

[0122] 2. Drug efficacy evaluation (1) Analgesic effect 1) Method Ninety Kunming mice, weighing 20-22g, were acclimatized for one week. They were then randomly divided into nine groups of ten mice each: experimental group, model group, and control group. Experimental groups 1-7 were administered the drug solution by gavage (corresponding to Examples 5-8 and Comparative Examples 4-6, respectively). The model group was administered an equal volume of physiological saline by gavage, and the control group was administered Jingfukang granules by gavage (Comparative Example 7). The gavage dose for each group was 0.5 mL per mouse, and the treatment continued for one week. On the last day after treatment, each group of mice was intraperitoneally injected with 0.2 mL of freshly prepared 0.6% acetic acid solution. The number of writhing movements of the mice within 20 minutes was recorded, and the results are shown in Table 4.

[0123] 2) Results Table 4 Analgesic effect of the composition (torsion test) (±s, n=10)

[0124] As can be seen from the experimental results in Table 4, the number of twisting movements in experimental groups 1-7 and the control group were significantly different from those in the model group. P <0.05, indicating that the drugs in both the experimental and control groups had significant analgesic effects; the number of writhing movements in experimental groups 1-3 was significantly different from that in the control group ( P <0.05), the number of writhing movements in experimental group 4 was similar to that in the control group, indicating that the analgesic effect of experimental groups 1-3 was better than that of the positive control group; the number of writhing movements in experimental groups 5-7 was more than that in the control group, indicating that the analgesic effect of experimental groups 5-7 was not as good as that in the control group; the number of writhing movements in experimental groups 5-7 was more than that in experimental groups 1-4, which indicates that the analgesic effect of the composition lacking the principal drug (Astragalus membranaceus, Pueraria lobata), the main assistant drug (Salvia miltiorrhiza, Prunus persica, Carthamus tinctorius, Ligusticum chuanxiong), and the main adjuvant drug (Angelica sinensis, Rehmannia glutinosa, Bupleurum chinense, Citrus aurantium) is far inferior to that of the composition of the present invention, and even inferior to that of the control group.

[0125] (2) Anti-inflammatory effect 1) Method Mice were then randomly divided into 9 groups of 10 mice each: experimental group, model group, and control group. Experimental groups 1-7 were administered the drug solution via gavage (corresponding to the gavage solutions in Examples 5-8 and Comparative Examples 4-6, respectively). The model group was administered an equal volume of physiological saline via gavage. The control group was administered Jingfukang granules via gavage (Comparative Example 7). The dosage for each mouse was 0.5 mL, administered for 3 consecutive days. One hour after the last administration, 0.05 mL of xylene was applied to both the inner and outer surfaces of the left ear of each mouse. One hour later, the mice were sacrificed, and both ears were removed. Circular ear pieces were punched from the same location using a 7 mm punch. The ears were weighed using an analytical balance, and the degree of ear swelling and the swelling inhibition rate were calculated using the following formula. The results are shown in Table 5.

[0126] Ear swelling degree = (Weight of left ear film - Weight of right ear film) / Medium weight of right ear film × 100%; Swelling inhibition rate = (average swelling degree of model group - average swelling degree of drug treatment group) / average swelling degree of model group × 100%.

[0127] 2) Results Table 5. Effects of the composition on xylene-induced ear swelling in mice ( (±s, n=10)

[0128] As can be seen from the experimental results in Table 5, the ear swelling degree and swelling inhibition rate of experimental groups 1-7 and the control group were significantly different from those of the model group. P <0.05, indicating that the drugs in experimental groups 1-7 and the control group all had significant anti-inflammatory effects; the number of writhing movements in experimental groups 1-4 was significantly different from that in the control group ( P <0.05 indicates that the anti-inflammatory effect of experimental groups 1-4 is worse than that of the positive control group; the swelling inhibition rate of experimental groups 5-7 is lower than that of the control group, indicating that the analgesic effect of experimental groups 5-7 is not as good as that of the control group; the swelling inhibition rate of experimental groups 5-7 is lower than that of experimental groups 1-4, which indicates that the anti-inflammatory effect of the composition lacking the principal drug (Astragalus membranaceus, Pueraria lobata), the main assistant drug (Salvia miltiorrhiza, Prunus persica, Carthamus tinctorius, Ligusticum chuanxiong), and the main adjuvant drug (Angelica sinensis, Rehmannia glutinosa, Bupleurum chinense, Citrus aurantium) is far inferior to that of the composition of the present invention, and even inferior to that of the control group.

[0129] 3. Clinical trials (1) Clinical data A total of 453 patients with cervical spondylosis were randomly selected from January 2018 to December 2022 as the study subjects, including 248 males and 205 females, with a mean age of (46±18) years and a mean course of disease of (5±4.6) years. Among them, there were 189 cases of vertebral artery type cervical spondylosis, 153 cases of nerve root type cervical spondylosis, 48 ​​cases of cervical type cervical spondylosis, 54 cases of mixed type cervical spondylosis, and 9 cases of sympathetic and spinal cord type cervical spondylosis.

[0130] (2) Diagnostic criteria, inclusion criteria, and exclusion criteria Diagnostic criteria: The Western medicine diagnostic criteria meet the classification of cervical spondylosis, are confirmed by imaging examination, and have clinical symptoms. Physical examination shows positive brachial plexus traction test, positive cervical compression test, and positive intervertebral foramen compression test. The TCM diagnostic criteria meet the relevant diagnosis of Bi syndrome in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine", with syndromes including wind-cold obstruction, qi and blood deficiency, blood stasis due to overwork, liver and kidney deficiency, and phlegm-dampness obstruction of collaterals.

[0131] Inclusion criteria: ① Subjects: Patients with cervical spondylosis, including the following types: vertebral artery type, nerve root type, cervical type, mixed type, sympathetic and spinal cord type; ② Age: 18-70 years old; ③ No gender restriction; ④ Confirmed by the attending physician that adverse reactions during the trial will not affect the patient's treatment; ⑤ Signed informed consent form.

[0132] Exclusion criteria: ① Participation in other clinical trials within 4 weeks prior to the start of this study; ② Respiratory depression, (pulmonary) airway obstruction, or tissue hypoxia; ③ Biliary tract disease; ④ Heart disease (i.e., grade II or above cardiac function); ⑤ Blood pressure higher than normal; ⑥ Significantly abnormal liver or kidney function (i.e., indicators more than twice the normal value); ⑦ Brain disease or impaired judgment; ⑧ Allergy to the composition of this invention; ⑨ Pregnant or lactating women; ⑩ Drug or alcohol abuse.

[0133] (3) Treatment methods The capsules in Example 9 are taken 3 times a day, 2.5g (5 capsules) each time, with warm water after meals. The above syndrome types are treated for one month as a course of treatment. During the treatment period, other therapies are discontinued, acupuncture is not performed, no Western medicine is taken, and spicy, cold, and greasy foods are avoided.

[0134] (4) Efficacy evaluation criteria Cured: All clinical symptoms and signs have disappeared, and the patient can resume physical labor.

[0135] Significant effect: Symptoms and signs improve significantly or most symptoms and signs disappear.

[0136] Improvement: Symptoms and signs lessen or partially disappear.

[0137] Ineffective: No change in symptoms and signs.

[0138] Symptoms, weight, microcirculation, and hemorheology were observed before and after treatment as one of the reference standards for efficacy evaluation.

[0139] Effective rate = (cured + significantly effective + improved) / total number of patients × 100%.

[0140] (5) Treatment effect After one course of treatment, the efficacy of each group was statistically analyzed.

[0141] Table 6 Clinical Treatment Results

[0142] The treatment results are shown in Table 6. The observation of 453 patients with cervical spondylosis showed that the total cure rate was 70.6% and the total effective rate was 98.0%, indicating that the composition of the present invention has a definite curative effect on cervical spondylosis and the symptoms of the disease were greatly improved after application.

[0143] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention. Furthermore, unless otherwise specified, the embodiments of the present invention and the features thereof can be combined with each other.

Claims

1. A traditional Chinese medicine composition, characterized in that, The composition includes: Astragalus membranaceus, Pueraria lobata, Salvia miltiorrhiza, Prunus persica, Carthamus tinctorius, Ligusticum chuanxiong, Panax notoginseng, Paeonia lactiflora, Angelica sinensis, Bupleurum chinense, Rehmannia glutinosa, Achyranthes bidentata, Citrus aurantium, Platycodon grandiflorus, and Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The composition comprises 5 to 15 parts by weight of Astragalus membranaceus; And / or, by weight, the composition comprises 10 to 20 parts of kudzu root; And / or, by weight, the composition comprises 5 to 10 parts of Salvia miltiorrhiza; And / or, by weight, the composition comprises 5 to 10 parts of peach kernels; And / or, by weight, the composition comprises 4 to 10 parts of safflower; And / or, by weight, the composition comprises 5 to 10 parts of Ligusticum chuanxiong; And / or, by weight, the composition comprises 1 to 6 parts of Panax notoginseng; And / or, by weight, the composition comprises 4 to 10 parts of Paeonia lactiflora.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The composition comprises 4 to 10 parts by weight of Angelica sinensis; And / or, by weight, the composition comprises 1 to 6 parts of Bupleurum chinense; And / or, by weight, the composition comprises 5 to 10 parts of raw Rehmannia glutinosa; And / or, by weight, the composition comprises 4 to 10 parts of Achyranthes bidentata; And / or, the composition comprises 1 to 6 parts by weight of Citrus aurantium; And / or, the composition comprises 1 to 6 parts by weight of Platycodon grandiflorus; And / or, the composition comprises 1 to 6 parts by weight of licorice.

4. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine composition included in any one of claims 1 to 3.

5. The traditional Chinese medicine preparation according to claim 4, characterized in that, The traditional Chinese medicine preparation also includes pharmaceutically usable excipients; the excipients are preferably at least one of sustained-release agents, diluents, lubricants, emulsifiers, plasticizers, flow aids, fillers, binders, humectants, absorption promoters and surfactants.

6. The traditional Chinese medicine preparation according to claim 4, characterized in that, The dosage forms of the traditional Chinese medicine preparations include one of the following: decoction, granules, tablets, capsules, pills, oral liquid, powder, ointment, and suspension.

7. The method for preparing the traditional Chinese medicine preparation according to any one of claims 4 to 6, characterized in that, The preparation method of the traditional Chinese medicine preparation includes the following steps: weigh the composition according to the specified weight parts, add water and decoct, collect the liquid, and thus obtain the traditional Chinese medicine preparation.

8. The preparation method according to claim 7, characterized in that, The mass ratio of water to the composition is (5~20):1; and / or the decocting time is 1~5 hours.

9. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine preparation according to any one of claims 4 to 6 in the preparation of anti-inflammatory and / or analgesic drugs.

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine preparation according to any one of claims 4 to 6 in the preparation of a medicament for treating cervical spondylosis.

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