Application of traditional Chinese medicine composition in preparation of medicine for treating and / or preventing cervical spondylosis

By using traditional Chinese medicine compositions, including Panax notoginseng, Chuanxiong, Yanhusuo, Baishao, Achyranthesthumbens, Dog Spinalis, Cooked Rhubarb and Duhuo, drugs to treat and/or prevent cervical spondylosis, the existing traditional Chinese medicines have problems such as slow efficacy in the treatment of cervical spondylosis, requiring long-term use, and bitter taste, achieving significant therapeutic effects.

CN119679854AInactive Publication Date: 2025-03-25JIANGSU KANION PHARMA CO LTD
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Patent Information

Application Number
CN202510154176.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-12
Publication Date
2025-03-25
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The existing traditional Chinese medicines for the treatment of cervical spondylosis have problems such as slow efficacy, long-term use, and bitter taste. The formula and dosage need to be adjusted according to the specific situation of the patient, and the use is complicated.

Method used

Traditional Chinese medicine compositions, including Panax notoginseng, Chuanxiong, Yanhusuo, Baishao, Achyranthesop, Dog Rib, Cooked Rhubarb and Duhuo, are prepared by specific preparation methods such as crushing, flow extract preparation and ethanol extraction, and are used to prepare drugs for the treatment and/or prevention of cervical spondylosis.

Benefits of technology

Traditional Chinese medicine compositions can significantly regulate serum endothelin ET level, improve the expression levels of Agc1, Col2a1, and TIMP-1 mRNA in cervical intervertebral disc tissue, reduce the expression levels of MMP-13 mRNA, delay the degeneration of the cervical intervertebral disc, and have significant effects in treating cervical spondylosis.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to application of a traditional Chinese medicine composition in preparation of a medicine for treating and / or preventing cervical spondylosis. The invention provides application of a traditional Chinese medicine composition in preparation of medicines for preventing and treating cervical spondylosis. The traditional Chinese medicine composition comprises pseudo-ginseng, ligusticum wallichii, corydalis tuber, radix paeoniae alba, radix achyranthis bidentatae, rhizoma cibotii, rheum officinale and radix angelicae pubescentis. According to the traditional Chinese medicine composition, the serum ET content of a cervical spondylosis model rat can be remarkably increased, the mRNA expression level of Agc1, Col2a1 and TIMP-1 in cervical intervertebral disc tissue of the cervical spondylosis model rat is improved, the mRNA expression level of MMP-13 in the intervertebral disc tissue is reduced, and cervical intervertebral disc degeneration is delayed. And the preparation method of the compound combination medicine for treating cervical spondylosis is simple, rapid, efficient and easy to operate. The prepared capsules, tablets, granules, pills, injections and the like are convenient to carry and take.
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Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to the use of a traditional Chinese medicine composition in preparing medicines for treating and / or preventing cervical spondylosis. Background Art

[0002] Cervical spondylosis, also known as cervical spondylosis syndrome, is mainly caused by long-term strain of the cervical spine, bone hyperplasia, or intervertebral disc herniation, ligament thickening, which causes compression of the cervical spinal cord, nerve roots or vertebral arteries, resulting in a series of clinical syndromes of functional disorders.

[0003] Cervical spondylosis has complex etiology and pathology, and its clinical manifestations are diverse, which seriously affect the life of patients. It is a general term for cervical osteoarthritis, hypertrophic cervical spondylitis, cervical radiculopathy, and cervical disc herniation. It is a disease based on degenerative pathological changes. It manifests as a series of pathological changes in the cervical disc degeneration itself and its secondary changes, such as vertebral instability and loosening; nucleus pulposus protrusion or extrusion; bone spur formation; ligament hypertrophy and secondary spinal canal stenosis, etc., which stimulate or compress the adjacent nerve roots, spinal cord, vertebral arteries and cervical sympathetic nerves and other tissues, and cause a syndrome of various symptoms and signs. Among them, the characteristic of disc-type cervical spondylosis is the degeneration of the cervical disc, which may lead to rupture of the disc annulus, protrusion of the nucleus pulposus to the posterolateral side, compression of the nerve roots or spinal cord, and thus produce corresponding clinical symptoms. Spinal cord cervical spondylosis is the most dangerous type. Its pathological principle is that cervical spondylosis causes compression of the spinal cord, which in turn causes symptoms such as inflammation and edema.

[0004] There are currently two main treatments for cervical spondylosis: non-surgical treatment and surgical treatment. Non-surgical treatments include physical therapy, exercise therapy, and drug therapy, which are suitable for most patients and can effectively control symptoms, reduce recurrences, and improve the quality of life. Commonly used therapeutic drugs include ibuprofen tablets and estazolam tablets, which have the effects of anti-inflammatory and analgesic, relieving muscle stiffness and spasms, etc. In addition, Chinese patent medicines such as Jingfukang Granules and Gentongping Granules are also often used as auxiliary treatments, which have the effects of dispersing wind and relieving pain, and promoting blood circulation and unblocking collaterals.

[0005] Traditional Chinese medicine has unique efficacy and advantages in the treatment of cervical spondylosis. First of all, traditional Chinese medicine focuses on overall conditioning, and improves the circulation of qi and blood in the cervical spine by adjusting the internal environment of the body, thereby alleviating the symptoms of cervical spondylosis. Secondly, the side effects of traditional Chinese medicine are relatively small and suitable for long-term use. However, there are still some shortcomings in the current traditional Chinese medicine treatment, such as slow efficacy, the need to take it continuously for a period of time to see the effect, and the taste of some traditional Chinese medicine is bitter, which may be difficult for patients to accept. In addition, the formula and dosage of traditional Chinese medicine need to be adjusted according to the specific situation of the patient, so it needs to be used under the guidance of a professional doctor. Therefore, it is of great significance to further develop traditional Chinese medicine with the function of treating cervical spondylosis. Summary of the invention

[0006] In view of this, the technical problem to be solved by the present invention is to provide an application of a Chinese medicine composition in the preparation of a medicine for treating and / or preventing cervical spondylosis.

[0007] The invention provides application of a traditional Chinese medicine composition in preparing medicine for preventing and treating cervical spondylosis.

[0008] In the present invention, the Chinese medicine composition comprises the following raw materials in parts by weight: 100-400 parts of Panax notoginseng, 200-500 parts of Chuanxiong, 200-500 parts of Corydalis, 200-500 parts of White Peony, 200-500 parts of Achyranthes, 100-400 parts of Cibotium barometz, 100-400 parts of Rhubarb and 100-400 parts of Angelica dahurica.

[0009] In some embodiments, the Chinese medicine composition is made of the following raw materials in parts by weight: 335 parts of Panax notoginseng, 445 parts of Chuanxiong, 445 parts of Corydalis yanhusuo, 445 parts of white peony root, 445 parts of Achyranthes bidentata, 335 parts of Cibotium barometz, 335 parts of Rhubarb and 335 parts of Angelica dahurica.

[0010] In the present invention, the preparation method of the Chinese medicine composition as mentioned above comprises:

[0011] (1) Divide Panax notoginseng into two equal parts, one of which is made into coarse powder and the other into fine powder;

[0012] (2) Grind Corydalis yanhusuo, Chuanxiong and Angelica dahurica into coarse powder, combine with coarse powder of Panax notoginseng, and percolate with 4-8 times the amount of 65%-85% ethanol to make a fluid extract;

[0013] (3) Soak white peony root, Achyranthes bidentata, Cibotium barometz and cooked rhubarb in water and boil them 1-2 times, each time for 30-90 minutes. Concentrate the extract to a relative density of 1.15-1.20 at 50°C, add ethanol to make the alcohol content reach 60%-90%, refrigerate for more than 24 hours, filter, recover ethanol from the filtrate and concentrate it to a relative density of 1.15-1.20, add ethanol to make the alcohol content reach 60%-90%, refrigerate for more than 24 hours, filter, recover ethanol from the filtrate and concentrate it;

[0014] (4) Adding the fluid extract of step (2) to the product prepared in step (3), recovering ethanol and concentrating to a thick paste, drying, adding Panax notoginseng fine powder and mixing evenly to prepare a Chinese medicine composition.

[0015] In some embodiments, step (2) of the method for preparing the traditional Chinese medicine composition comprises: grinding Corydalis yanhusuo, Chuanxiong rhizome and Angelica pubescens into coarse powder, combining the powder with Panax notoginseng coarse powder, and percolating with 6 times the amount of 75% ethanol to prepare a fluid extract.

[0016] In some embodiments, step (3) of the method for preparing the Chinese medicine composition comprises: soaking white peony root, Achyranthes bidentata, Cibotium barometz and cooked rhubarb in water and then boiling for 60 minutes, concentrating the extract to a relative density of 1.15-1.20 at 50°C, adding ethanol to make the alcohol content reach 60%, refrigerating for more than 24 hours, filtering, recovering ethanol from the filtrate and concentrating it to a relative density of 1.15-1.20 at 50°C, adding ethanol to make the alcohol content reach 80%, refrigerating for more than 24 hours, filtering, recovering ethanol from the filtrate and concentrating it.

[0017] In some embodiments, the preparation method further comprises: step (5): adding conventional excipients to the traditional Chinese medicine composition of step (4) to prepare a clinically acceptable dosage form.

[0018] Preferably, step (5) of the preparation method is: after crushing the Chinese medicine composition of step (4), adding an appropriate amount of starch, granulating with 10% polyacrylic acid No. 4 resin, and encapsulating.

[0019] In the present invention, the prevention and treatment includes improving the estrogen level and / or improving the expression level of cervical spondylosis related genes.

[0020] Cervical spondylosis is caused by a variety of factors and has various symptoms. Endothelin ET can promote vascular smooth muscle cell proliferation and thrombosis. When cervical spondylosis is in a pathological state, ET expression regulation is disordered, resulting in abnormal expression and release of ET. Excessive release of ET acts on the blood vessels around the cervical spine, causing strong contraction and spasm of local blood vessels. The experiment of the present invention shows that the Chinese medicine composition as described above can have the effect of regulating ET levels. In the present invention, the Chinese medicine composition can regulate the level of endothelin in serum and restore it to normal levels.

[0021] There is a close relationship between the expression levels of aggrecan (Agc1), type II procollagen gene (Col2a1), matrix metalloproteinase-13 (MMP-13) and matrix metalloproteinase inhibitor-1 (TIMP-1) in cervical disc tissue and cervical spondylosis. Aggrecan (Agc1) is an important proteoglycan component in the intervertebral disc and plays a key role in maintaining the normal function and structure of the intervertebral disc. Type II procollagen gene (Col2a1) is the main collagen component of the cervical intervertebral disc. Matrix metalloproteinase-13 (MMP-13) is an enzyme that can degrade collagen and other extracellular matrix components in the intervertebral disc. Matrix metalloproteinase inhibitor-1 (TIMP-1) can inhibit the activity of MMPs, including MMP-13. The experiment of the present invention shows that the Chinese medicine composition as described above can increase the expression level of Agc1, Col2a1, TIMP-1 mRNA, especially the expression level of Agc1, Col2a1, TIMP-1 mRNA in cervical intervertebral disc tissue. In addition, the Chinese medicine composition as described above can also reduce the expression level of MMP-13 mRNA, especially the expression level of MMP-13 mRNA in cervical intervertebral disc tissue.

[0022] In the present invention, the cervical spondylosis is cervical spondylosis due to intervertebral disc degeneration or cervical spondylotic myelopathy.

[0023] Furthermore, the present invention also provides a medicine for preventing and treating cervical spondylosis, which comprises the following raw materials in parts by weight, or is made from the following raw materials in parts by weight:

[0024] 100~400 parts of Panax notoginseng, 200~500 parts of Chuanxiong, 200~500 parts of Corydalis, 200~500 parts of White Peony Root, 200~500 parts of Achyranthes Bidentata, 100~400 parts of Cibotium barometz, 100~400 parts of Rhubarb and 100~400 parts of Angelica dahurica.

[0025] The dosage form of the drug is tablet, capsule, granule, pill, injection, decoction, suspension, dispersant, syrup, suppository, gel, aerosol, patch or oral solution.

[0026] The medicine also includes other active ingredients that can treat and / or improve cervical spondylosis. The other active ingredients that can treat and / or improve cervical spondylosis include but are not limited to Yaotongning.

[0027] Furthermore, the present invention also provides a method for preventing and treating cervical spondylosis, which comprises administering the above-mentioned drug. The administration method of the present invention includes but is not limited to oral administration and / or injection.

[0028] The present invention provides an application of a Chinese medicine composition in the preparation of a medicine for preventing and treating cervical spondylosis, wherein the Chinese medicine composition comprises Panax notoginseng, Rhizoma Chuanxiong, Rhizoma Corydalis, Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Rhizoma Cibotii, Rhizoma Rhei and Radix Angelicae Pubescentis. The Chinese medicine composition can significantly increase the serum ET content of rats with cervical spondylosis model, improve the expression levels of Agc1, Col2a1 and TIMP-1 mRNA in the cervical intervertebral disc tissue of rats with cervical spondylosis model, reduce the expression level of MMP-13 mRNA in the intervertebral disc tissue, and delay the degeneration of the cervical intervertebral disc. Moreover, the preparation method of the compound combination medicine for treating cervical spondylosis is simple, rapid, efficient and easy to operate. The prepared capsules, tablets, granules, pills, injections and the like are easy to carry and convenient to take. DETAILED DESCRIPTION

[0029] The present invention provides the use of a Chinese medicine composition in the preparation of a drug for treating and / or preventing cervical spondylosis. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It should be particularly noted that all similar replacements and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the method and application of this article without departing from the content, spirit and scope of the present invention to realize and apply the technology of the present invention.

[0030] The test materials used in the present invention are all common commercial products and can be purchased in the market.

[0031] The present invention will be further described below in conjunction with embodiments:

[0032] Example 1 Preparation of Chinese medicine composition

[0033] Panax notoginseng 335g, Ligusticum chuanxiong 445g, Corydalis 445g, White Peony 445g, Achyranthes bidentata 445g, Cibotium barometz 335g, Rhubarb 335g, Angelica dahurica 335g.

[0034] Take half of the above eight ingredients and grind them into fine powder, and store them in another container; grind the other half of the Panax notoginseng into coarse powder. Grind Corydalis, Chuanxiong, and Angelica dahurica into coarse powder, combine them with the coarse powder of Panax notoginseng, and percolate with 6 times the amount of 75% ethanol to make a fluid extract; soak white peony root, Achyranthes bidentata, Cibotium barometz and cooked rhubarb in water and boil for 60 minutes, concentrate the extract to a relative density of 1.15-1.20 at 50°C, add ethanol to make the alcohol content reach 60%, refrigerate for more than 24 hours, filter, recover ethanol from the filtrate and concentrate it to a relative density of 1.15-1.20 at 50°C, add ethanol to make the alcohol content reach 80%, refrigerate for more than 24 hours, filter, recover ethanol from the filtrate and concentrate it to an appropriate volume, add the above fluid extract, recover ethanol and concentrate it to a thick paste, dry, add Panax notoginseng fine powder, mix well, grind, add appropriate amount of starch, granulate with 10% polyacrylic acid No. 4 resin, and encapsulate to make 1000 capsules.

[0035] Experimental Example 2 Therapeutic effect of Chinese herbal medicine composition on rats with cervical spondylosis model of intervertebral disc degeneration in dynamic and static force imbalance rats

[0036] 1. Experimental Materials

[0037] 1.1 Animals

[0038] Wistar rats, male, SPF grade, 60, weighing 180-200 g, were purchased from Qinglongshan Animal Breeding Farm, Jiangning District, Nanjing.

[0039] Breeding environment: room temperature 20~26ºC, relative humidity controlled at 40~70%, animal breeding density 5 / cage.

[0040] 1.2 Drugs

[0041] The Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.; Yaotongning granules (Jingfukang Pharmaceutical Group Co., Ltd.; batch number: 520381); sodium pentobarbital (Beijing Chemical Reagent Company, batch number: 211122); normal saline (Chenxin Pharmaceutical Co., Ltd., batch number: 2101282721); rat endothelin (ET) ELISA kit (Shanghai Zhenke Biotechnology Co., Ltd., batch number: ZK-6589); aggrecan (aggrecan-1Agc1), type II procollagen gene (typeⅡprocollagen geneCol2a1), matrix metalloproteinase-13 (matrix metalloproteinase-13MMP-13) and matrix metalloproteinase inhibitor-1 (tissue inhibitor of metalloproteinases-1TIMP-1) primers (Dalian Haojia Biotechnology Co., Ltd.).

[0042] 1.3 Instruments

[0043] Refrigerator (Haier Company, model: BCD-216SZ); electronic balance (Sartorius Scientific Instruments, model: BSA224S-CW); purified water instrument (Millipore, Germany, model: Milli-Q Plus); animal weight scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: CX-SC-DA); multi-function microplate reader (MD Company, USA, model: Flexstation 3); A28132 real-time fluorescence quantitative PCR instrument (Thermo Fisher Scientific, USA)

[0044] 2. Dosage design

[0045] The daily dosage of the Chinese medicine composition is 6.4, 3.2, and 1.6 g crude drug / kg for rats, the clinical dosage is 30Z, and the experimental dosage is converted according to the body surface coefficient of animals and humans (humans are calculated as 70 kg, and the dosage is 0.429 g crude drug / kg). The medium dose is approximately equivalent to the clinical equivalent dose, the high dose is one time the medium dose, and the low dose is 1 / 2 of the medium dose). The positive drug Yaotongning capsule is used in rats at a dosage of 0.2 g granules / kg, which is equivalent to the clinical equivalent dose. The control group was given the same volume of distilled water.

[0046] 3. Experimental Methods

[0047] After the back of the rat's neck was trimmed and cleaned, a longitudinal incision of about 2.0-2.5 cm was made in the middle of the back of the neck. After the skin was cut, the splenius cervicis and the longissimus capitis, cervicis capitis, and atlas muscles were transversely cut, the iliocostalis cervicis and the semispinalis capitis muscles were removed, and then the supraspinal and interspinous ligaments were removed in sequence; after the operation, the incision was sutured and the rats were raised normally for 2 months to establish a rat model of cervical spondylosis with dynamic and static imbalance of intervertebral disc degeneration.

[0048] Detection indicators:

[0049] 1) Serum endothelin (ET) determination

[0050] 2) Detection of gene expression of aggrecan-1Agc1, type II procollagen geneCol2a1, matrix metalloproteinase-13MMP-13 and tissue inhibitor of metalloproteinase-1TIMP-1 in cervical disc tissue.

[0051] 4. Statistical methods

[0052] The results were statistically analyzed using t-test.

[0053] 5. Experimental Results

[0054] 5.1 Effects of static and dynamic imbalance on serum ET levels in rats with cervical spondylosis model of intervertebral disc degeneration

[0055] Compared with the normal control group, the serum endothelin ET level of the model group rats was significantly increased (P<0.01). Compared with the model group, the positive drug Yaotongning capsule group could significantly reduce the serum endothelin ET content (P<0.01), and the Chinese medicine composition Yaobitong capsule medium and high dose groups could significantly reduce the serum endothelin ET content (P<0.05, P<0.01), indicating that the Chinese medicine composition can regulate the serum endothelin content of rats with cervical spondylosis model of intervertebral disc degeneration in dynamic and static imbalance rats close to normal levels. The results are shown in Table 1.

[0056] Table 1 Effect of Yaobitong capsule on serum ET content in rats with cervical spondylosis model of intervertebral disc degeneration in dynamic and static imbalance rats

[0057]

[0058] Note: Compared with the normal control group, ##P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0059] 5.2 Effects on the expression of Agc1, Col2a1, MMP-13, and TIMP-1 mRNA in cervical disc tissue of rats with cervical spondylosis model of intervertebral disc degeneration in dynamic and static force imbalance rats

[0060] Compared with the normal control group, the expression levels of Agc1, Col2a1, and TIMP-1 mRNA in the cervical disc tissue of the model group rats were significantly reduced (P<0.01), and the expression level of MMP-13 mRNA was significantly increased (P<0.01). Compared with the model group, the positive drug Yaotongning capsule group could significantly increase the expression levels of Agc1, Col2a1, and TIMP-1 mRNA (P<0.01), and reduce the expression level of MMP-13 mRNA (P<0.01); similarly, the medium and high dose groups of the Chinese medicine composition could significantly increase the expression levels of Agc1, Col2a1, and TIMP-1 mRNA (P<0.05, P<0.01), and reduce the expression level of MMP-13 mRNA (P<0.05, P<0.01), indicating that the Chinese medicine composition can delay the degeneration of the cervical disc in the model of cervical spondylosis in rats with dynamic and static imbalance. The results are shown in Table 2.

[0061] Table 2 Effects on the expression of Agc1, Col2a1, MMP-13 and TIMP-1 mRNA in cervical disc tissue of rats with cervical spondylosis model of intervertebral disc degeneration in dynamic and static imbalance rats

[0062]

[0063] Note: Compared with the normal control group, ##P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0064] 6. Experimental conclusion

[0065] The Chinese medicine composition of 3.2 and 6.4 g crude drug / kg can significantly reduce the serum endothelin ET content in rats with cervical spondylosis model with dynamic and static force imbalance, and delay cervical disc degeneration, indicating that the Chinese medicine composition has a certain therapeutic effect on rats with cervical spondylosis model with dynamic and static force imbalance.

[0066] Experimental Example 3 Therapeutic effect of Chinese medicine composition on rats with cervical spondylotic myelopathy model

[0067] 1. Experimental Materials

[0068] 1.1 Animals

[0069] Wistar rats, male, SPF grade, 60, weighing 180-200 g, were purchased from Hangzhou Medical College.

[0070] Breeding environment: room temperature 20~26ºC, relative humidity controlled at 40~70%, animal breeding density 5 / cage.

[0071] 1.2 Drugs

[0072] The Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.; Yaotongning granules (Jingfukang Pharmaceutical Group Co., Ltd.; batch number: 520381); sodium pentobarbital (Beijing Chemical Reagent Company, batch number: 211122); normal saline (Chenxin Pharmaceutical Co., Ltd., batch number: 2101282721); rat endothelin (ET) ELISA kit (Shanghai Zhenke Biotechnology Co., Ltd., batch number: ZK-6589); aggrecan (aggrecan-1Agc1), type II procollagen gene (typeII procollagen geneCol2a1), matrix metalloproteinase-13 (matrix metalloproteinase-13MMP-13) and matrix metalloproteinase inhibitor-1 (tissue inhibitor of metalloproteinases-1TIMP-1) primers (Dalian Haojia Biotechnology Co., Ltd.).

[0073] 1.3 Instruments

[0074] Refrigerator (Haier Company, model: BCD-216SZ); electronic balance (Sartorius Scientific Instruments, model: BSA224S-CW); purified water instrument (Millipore, Germany, model: Milli-Q Plus); animal weight scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: CX-SC-DA); multi-function microplate reader (MD Company, USA, model: Flexstation 3); A28132 real-time fluorescence quantitative PCR instrument (Thermo Fisher Scientific, USA)

[0075] 2. Dosage design

[0076] The daily dosage of the Chinese medicine composition is 6.4, 3.2, and 1.6 g crude drug / kg for rats, the clinical dosage is 30Z, and the experimental dosage is converted according to the body surface coefficient of animals and humans (humans are calculated as 70 kg, and the dosage is 0.429 g crude drug / kg). The medium dose is approximately equivalent to the clinical equivalent dose, the high dose is one time the medium dose, and the low dose is 1 / 2 of the medium dose). The positive drug Yaotongning capsule is used in rats at a dosage of 0.2 g granules / kg, which is equivalent to the clinical equivalent dose. The control group was given the same volume of distilled water.

[0077] 3. Experimental Methods

[0078] The model was established by using a water-swelling material (polyvinyl alcohol acrylamide interpenetrating network hydrogel) to compress the spinal cord: rats were anesthetized by intraperitoneal injection of 2% sodium pentobarbital, and the hair in the surgical area of ​​the back of the neck was removed with a shaver, followed by routine iodine disinfection. The highest point of the rat's posterior cervical spinous process was used as the surface location (T2), and then this was used as the lowest point. A 2-3 cm long midline incision was made behind the rat's cervical spine, and the skin was cut layer by layer to expose the cervical and shoulder muscle groups. The midline incision of the muscle groups was pulled apart to expose the entire C5-T2 vertebral plate, and the water-swelling material (1.5×0.7×0.3mm) was implanted under the C5-C7 vertebral plate, and then the muscles and skin were sutured layer by layer, and penicillin was injected. In the sham operation group, the same volume of water-swelling material was implanted in the same segment and then removed without causing compression.

[0079] Detection indicators:

[0080] 1. Serum endothelin ET determination

[0081] 2. Detection of gene expression of cervical intervertebral disc aggrecan (aggrecan-1Agc1), type II procollagen gene (type IIprocollagen geneCol2a1), matrix metalloproteinase-13 (matrix metalloproteinase-13MMP-13) and tissue inhibitor of metalloproteinase- 1 (TIMP-1).

[0082] 4. Statistical methods

[0083] The results were statistically analyzed using t-test.

[0084] 5. Experimental Results

[0085] 5.1 Effects on serum ET levels in rats with cervical spondylotic myelopathy

[0086] Compared with the normal control group, the serum endothelin ET level of the model group rats was significantly increased (P<0.01). Compared with the model group, the positive drug Yaotongning capsule group can significantly reduce the serum endothelin ET content (P<0.01), and the medium and high dose groups of the Chinese medicine composition can also significantly reduce the serum endothelin ET content (P<0.05, P<0.01), indicating that the Chinese medicine composition can regulate the serum ET content of the cervical spondylotic myelopathy model rats to close to the normal level. The results are shown in Table 3.

[0087] Table 3 Effect of Yaobitong capsule on serum ET content in rats with cervical spondylotic myelopathy

[0088]

[0089] Note: Compared with the normal control group, ##P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0090] 5.2 Effects on the expression of Agc1, Col2a1, MMP-13, and TIMP-1 mRNA in cervical disc tissue of rats with cervical spondylotic myelopathy model

[0091] Compared with the normal control group, the expression levels of Agc1, Col2a1, and TIMP-1 mRNA in the cervical disc tissue of the rats in the model group were significantly reduced (P<0.01), and the expression level of MMP-13 mRNA was significantly increased (P<0.01). Compared with the model group, the positive drug Yaotongning capsule group could significantly increase the expression levels of Agc1, Col2a1, and TIMP-1 mRNA (P<0.01), and reduce the expression level of MMP-13 mRNA (P<0.01); similarly, the medium and high dose groups of the Chinese medicine composition could significantly increase the expression levels of Agc1, Col2a1, and TIMP-1 mRNA (P<0.05, P<0.01), and reduce the expression level of MMP-13 mRNA (P<0.05, P<0.01), indicating that the Chinese medicine composition can delay the degeneration of the cervical disc in the rats with cervical spondylotic myelopathy model. The results are shown in Table 4.

[0092] Table 4 Effects on the expression of Agc1, Col2a1, MMP-13 and TIMP-1 mRNA in cervical disc tissue of rats with cervical spondylotic myelopathy model

[0093]

[0094] Note: Compared with the normal control group, ##P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0095] 6. Experimental conclusion

[0096] The Chinese medicine composition at 3.2 and 6.4 g crude drug / kg can significantly reduce the serum endothelin ET content in rats with cervical spondylotic myelopathy model and delay cervical disc degeneration, indicating that the Chinese medicine composition has a certain therapeutic effect on rats with cervical spondylotic myelopathy model.

[0097] The above are only preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. Application of a Chinese medicine composition in the preparation of a drug for preventing and treating cervical spondylosis; The Chinese medicine composition comprises the following raw materials in parts by weight: 100-400 parts of Panax notoginseng, 200-500 parts of Chuanxiong, 200-500 parts of Corydalis, 200-500 parts of White Peony, 200-500 parts of Achyranthes, 100-400 parts of Cibotium barometz, 100-400 parts of Rhubarb and 100-400 parts of Angelica dahurica.

2. The use according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 335 parts of Panax notoginseng, 445 parts of Chuanxiong, 445 parts of Corydalis yanhusuo, 445 parts of white peony root, 445 parts of Achyranthes bidentata, 335 parts of Cibotium barometz, 335 parts of Rheum officinale and 335 parts of Angelica dahurica.

3. The use according to claim 1 or 2, characterized in that: The preparation method of the Chinese medicine composition comprises: (1) Divide Panax notoginseng into two equal parts, one of which is made into coarse powder and the other into fine powder; (2) Grind Corydalis yanhusuo, Chuanxiong and Angelica dahurica into coarse powder, combine with coarse powder of Panax notoginseng, and percolate with 4-8 times the amount of 65%-85% ethanol to make a fluid extract; (3) Soak white peony root, Achyranthes bidentata, Cibotium barometz and Rhubarb in water and boil for 1-2 times, each time for 30-90 minutes. Concentrate the extract to a relative density of 1.15-1.20 at 50°C, add ethanol to make the alcohol content reach 60%-90%, refrigerate for more than 24 hours, filter, recover ethanol from the filtrate and concentrate it to a relative density of 1.15-1.20, add ethanol to make the alcohol content reach 60%-90%, refrigerate for more than 24 hours, filter, recover ethanol from the filtrate and concentrate it; (4) Adding the fluid extract of step (2) to the product prepared in step (3), recovering ethanol and concentrating to a thick paste, drying, adding Panax notoginseng fine powder and mixing evenly to prepare a Chinese medicine composition.

4. The use according to claim 3, characterized in that: Step (2) comprises: grinding Corydalis yanhusuo, Chuanxiong and Angelica pubescens into coarse powder, combining the powder with Panax notoginseng coarse powder, and percolating with 6 times the amount of 75% ethanol to prepare a fluid extract; Step (3) comprises: soaking white peony root, Achyranthes bidentata, Cibotium barometz and Rhubarb in water and then boiling for 60 minutes, concentrating the extract to a relative density of 1.15-1.20 at 50°C, adding ethanol to make the alcohol content reach 60%, refrigerating for more than 24 hours, filtering, recovering ethanol from the filtrate and concentrating it to a relative density of 1.15-1.20 at 50°C, adding ethanol to make the alcohol content reach 80%, refrigerating for more than 24 hours, filtering, recovering ethanol from the filtrate and concentrating it.

5. The use according to any one of claims 1 to 4, characterized in that: The prevention and treatment includes improving the estrogen level and / or improving the expression level of cervical spondylosis related genes.

6. The use according to claim 5, characterized in that: The female hormone is estradiol.

7. The use according to claim 5, characterized in that: The cervical spondylosis related genes include: Agc1, Col2a1, MMP-13 and / or TIMP-1 mRNA.

8. The use according to any one of claims 1 to 7, characterized in that: Cervical spondylosis is cervical spondylosis due to disc degeneration or cervical spondylotic myelopathy.

9. A drug for preventing and treating cervical spondylosis, characterized in that: The invention comprises the following raw materials in parts by weight, or is made from the following raw materials in parts by weight: 100~400 parts of Panax notoginseng, 200~500 parts of Chuanxiong, 200~500 parts of Corydalis, 200~500 parts of White Peony Root, 200~500 parts of Achyranthes Bidentata, 100~400 parts of Cibotium barometz, 100~400 parts of Rhubarb and 100~400 parts of Angelica dahurica.

10. The drug according to claim 9, characterized in that It also includes other active ingredients that have the function of treating and / or improving cervical spondylosis.

Citation Information

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