Traditional Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis and preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 144-216 parts of kudzuvine root, 72-108 parts of notopterygium root, 48-72 parts of bupleurum chinense, 96-144 parts of radix clematidis, 72-108 parts of gastrodia elata, 48-72 parts of ligusticum wallichii, 48-72 parts of turmeric, 144-216 parts of astragalus membranaceus, 48-72 parts of cassia twig, 72-108 parts of white paeony root, 96-144 parts of caulis spatholobi and 24-36 parts of honey-fried licorice root. The invention further provides a preparation method and application of the traditional Chinese medicine composition. The medicine belongs to a pure traditional Chinese medicine preparation, is reasonable in compatibility, exact in curative effect, high in patient acceptability and less in adverse reaction, cervical spondylosis is mostly treated by acupuncture, massage, plaster, ointment external application and the like in the market at present, the cervical spondylosis is relatively less treated by oral medicine, great convenience can be brought to patients, especially office workers, and the medicine is worthy of popularization and application. Time and traffic cost caused by going back and forth to hospitals is saved, and a new thought is provided for clinical treatment of cervical spondylosis.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis and a preparation method and application thereof, belonging to the field of traditional Chinese medicine. Background Art

[0002] Wind-cold-dampness arthralgia is called arthralgia in Neijing. Arthralgia means blockage, which means that qi and blood are stagnant and blocked. It can roughly contain four meanings: 1. Refers to the pathogenesis: For example, Hua Tuo Zhongzang Jing Lunbi says: "Arthralgia means blockage". It refers to blockage. The pain and numbness mentioned in Neijing are all caused by blockage; 2. Refers to the name of the disease: Arthralgia. In the Neijing, there is a distinction between broad and narrow meanings. The broad meaning refers to the symptoms caused by the obstruction of qi and blood in the meridians by evil qi, which leads to poor circulation and distribution, or abnormal qi transformation of the viscera and organs. The narrow meaning refers to the symptoms caused by the obstruction of qi and blood and the stagnation of qi distribution, which leads to stiffness, pain, numbness, and poor flexion and extension of limb joints and muscles, and even swelling and deformation, which may affect the function of the viscera in severe cases. ③ Refers to symptoms: It can be interpreted as pain, numbness, or numbness, such as "swollen throat and paralysis" in "Suwen". ④ Refers to constitution: As "Suwen·Ni Diao Lun" said: "The human body is not cold because of the clothes, nor is there cold air in the body. Why does the cold come from inside? Qi Bo said: This person has a lot of paralysis qi, less yang qi and more yin qi, so the body is cold as if coming out of water." This paralysis should be interpreted as a constitution with strong yin and weak yang, which is easy to suffer from paralysis. Through the summarization and conclusion of the predecessors of traditional Chinese medicine, the modern textbook "Internal Medicine of Traditional Chinese Medicine" has condensed and refined a more standardized definition of Bi syndrome. It is because the body's positive energy is weakened, the Yang is not solid, and it is affected by external evils such as wind, cold, dampness, and heat. The evil qi invades the skin and muscles, blocks the meridians, affects the circulation of Qi and blood, and the distribution of essence and energy, and causes muscle, tendon, bone, and joint pain, numbness, and difficulty in flexion and extension, and even swelling. In severe cases, the function of internal organs is affected as the main clinical manifestation of the disease.

[0003] The TCM etiology and pathogenesis of wind-cold-dampness arthralgia include: ① Weakness of vital energy: The causes of weak vital energy may include irregular diet and daily life and overwork. "Suwen Jingzhu Jiejie·Volume 3" says: "The yang of the fu organs is shallow, so the arthralgia is caused by diet and daily life. However, the yu is the gateway of the six fu organs, and wind, cold and dampness are easy to enter. If there is no problem of improper diet, the entry will only reach the skin. However, if the daily life is not regular, and the hunger and fullness are not regular, the qi of the six fu organs is not solid first, and then the wind, cold and dampness can enter." It points out that because the qi of the six fu organs is not solid, and there is irregular diet, irregular daily life, cold and dampness invade the body, blocking the qi and blood meridians, causing the six fu organs to be affected by evil, and then the six fu organs arthralgia. The formation and development of the five zang-organs arthralgia is also closely related to irregular diet and irregular daily life. For example, "Suwen·Arthralgia Theory" says: "When the yin qi is quiet, the spirit is hidden, and when it is agitated, it disappears", pointing out that due to factors such as diet and work and rest, the positive qi is dissipated, the spirit is weakened, the yang is not solid, and the wind, cold and dampness invade the body and cause illness. There is also "Suwen·Five Zangs Formation" saying: "If you lie down and the wind blows, the blood will coagulate in the skin, which is arthralgia", which means that irregular daily life, fatigue damages the positive qi, lying in the wind, evil qi invades, and evil guest stagnates the meridians and blood, forming arthralgia. As for the aspect of excessive mental fatigue, it should belong to the category of traditional seven emotions causing arthralgia. For example, "Lingshu·The Beginning of All Diseases" says: "Worrying and thinking hurts the heart", which means that excessive thinking consumes the heart and blood, the qi and blood are weakened, the liver and spleen are damaged, the qi and blood are lacking in the source of production and transformation, the positive qi is deficient, and the yang cannot be solidified, so the evil qi takes advantage of the opportunity to enter the body, resulting in arthralgia. Just as it is said in the Suwen·Five Zang Organs Formation Chapter: "Heart Bi is caused by external diseases, thinking and feeling weak, so the evil follows it." ② Sensing external evil: Suwen·Bi Lun Chapter says: "Huangdi asked: How does Bi come about? Qi Bo replied: The three Qi of wind, cold and dampness come together and become Bi... If they do not combine with wind, cold and dampness, they will not become Bi." There is also "The so-called Bi is caused by the heavy feeling of wind, cold and dampness at different times." Here Qi Bo said that the three Qi of wind, cold and dampness, which are the six evils of the sky, are mixed and mixed. Although they have different weights, they are all external evils that invade the skin surface. If there is no external evil, the body is relatively balanced and it is not easy to cause Bi syndrome. Therefore, the wind evil is the external cause of Bi syndrome. Wind is the first of the six evil spirits and the leader of all diseases. It has many changes, is good at moving and is prone to mixing with other evil spirits, and can cause diseases. There are many types of wind. For example, "Suwen·Wind Theory" says: "Wind is the leader of all diseases. When it changes, it becomes other diseases. There is no fixed method, but it causes wind." When the body's positive energy is weak, it cannot tightly guard the outside, the surrounding Wei Yang is weakened, and the pores are open and leaked without limit, then it is affected by wind evil. Wind evil enters the skin, then enters the meridians, and then enters the five internal organs. According to the characteristics of arthralgia, there are uncertain sites of onset, no fixed location of pain, or it is difficult to locate the specific location of the whole body. This type of arthralgia is a manifestation of the dominance of wind, which is called wandering arthralgia. As "Suwen·Arthralgia Theory" says: "The dominant wind is wandering arthralgia", the most important manifestation is pain in wandering parts.

[0004] In nature, all the six evil qi with the characteristics of cold, stagnation, and contraction are called cold evil. Cold is the main contraction and is water vapor. It is connected to the kidney and is the main qi of winter among the four seasons. As the saying goes, "All evils are caused by lust, and all diseases are caused by cold." Cold is a yin evil, and its nature is stagnation and contraction. Its pathogenic characteristics are coagulation and stagnation. Cold evil invades the skin surface, causing the qi and blood in the meridians to stagnate, and the meridians are blocked, thus causing arthralgia. Therefore, "Suwen·Bi Lun Pian" says: "Pain is caused by too much cold qi, and pain is caused by cold." For example, it is said in "Suwen·On Pain": "Cold air enters the meridians and delays the movement, and it cannot move. If it stays outside the meridians, there will be less blood, and if it stays inside the meridians, the qi will not flow, so there will be sudden pain." Diseases caused by cold evil are mostly manifested as pain. If the joints of the limbs are severely painful, it is a sign that cold air is dominant. The cold stagnates in the meridians, the qi is blocked, and the meridians are astringent and stagnant, so there is pain. Therefore, "Suwen·On Bi" says: "If the cold air prevails, it will cause pain and arthritis."

[0005] In nature, the six evil qi with the characteristics of being heavy, sticky, and tending downward are called dampness. It is said in the Complete Works of Liu Chun Medicine: Yu Ji Wei Yi that "dampness hurts people in the dark". Therefore, dampness is hidden, the onset is slow, the initial symptoms are not obvious or mild, and it is not easy for patients to detect. "Dampness is the most common disease, and most people do not feel dampness coming. They only know to avoid cold and wind, but not to avoid dampness". Dampness is heavy, flows downward, stagnates in the skin, tendons, bones, and joints, and is sticky and difficult to move, hindering the distribution of yang qi and the circulation of body fluids, causing abnormal qi and blood circulation, and the skin, tendons, bones, and joints cannot be nourished, so there will be heaviness and pain in the limbs, difficulty in flexion and extension of joints, numbness, etc. "Su Wen: Bi Lun Pian" says: "If dampness prevails, it will cause pain and arthralgia."

[0006] The pathogenesis of wind-cold-dampness arthralgia can be mainly divided into three aspects: imbalance of yin and yang, disharmony of Ying and Wei, and dysfunction of viscera and organs. Disharmony of yin and yang: relative to the balance of yin and yang, it refers to the abnormal rise and fall of yin and yang. The balance of yin and yang is the prerequisite for the balanced operation of the human organs and the general principle of viscera, meridians, qi and blood, Ying and Wei. For wind-cold-dampness arthralgia, the imbalance of yin and yang is mainly manifested as yin excess and yang deficiency - the body's yin and cold are strong inside, yang qi is weak, the defense is lacking, yang is not solid, and the viscera and qi and blood are deficient, which makes it easy to feel the wind, cold and dampness from the outside. The evil qi invades the surface and invades the inside after a long time. The internal yin and cold are often attracted by the external cold and dampness, and the inside and outside are combined. The inside and outside are cold and damp, and the situation of yin excess and yang deficiency is becoming more and more obvious. What's more, the yin evil is strong inside, or it can force yang to escape outside. For example, "Suwen·Four Seasons Acupuncture and Conglun" says: "If there is excess of Jueyin, it will cause Yin Bi, and if there is deficiency, it will cause heat Bi".

[0007] Disharmony between the Ying and Wei: "Suwen·Discussion on Bi" says: "The Emperor said: Can the Qi of the Rong and Wei also cause Bi? Qi Bo said: Rong is the essence of water and grain, which is harmonized in the five internal organs and spread in the six bowels, and then can enter the meridians. Therefore, it runs through the meridians up and down through the five internal organs and connects with the six bowels. Wei is the fierce Qi of water and grain. Its Qi is swift and slippery, and cannot enter the meridians. Therefore, it runs through the skin, between the flesh, is fumigated by the peritoneum, and disperses in the chest and abdomen. If you go against its Qi, you will get sick, and if you follow its Qi, you will recover. It does not combine with wind, cold and dampness, so it does not cause Bi". It mentions that going against its Qi will cause illness. Going against its Qi means that the normal distribution and circulation of Qi is disordered, and there is no way for Qi transformation and evaporation. The entry and exit of the Ying and Wei Qi are disordered, the Wei Qi is difficult to be at peace, and the pores are loose. Then the wind, cold and dampness take the opportunity to invade the body, and it causes Bi syndrome. If the nutritional and health functions are healthy, with the flow of Yang Qi in and out in an orderly manner, and Yang Qi circulates throughout the body unimpeded and unobstructed, like a circle with no end, and the whole body is thriving, then arthritis will not form.

[0008] Disorder of internal organs: Suwen Bilun said: "Yin Qi is hidden when it is quiet, but disappears when it is agitated. Overeating and drinking will damage the stomach and intestines. Excessive Qi causes panting, and Bi gathers in the lungs; excessive Qi causes worry, and Bi gathers in the heart; excessive Qi causes incontinence, and Bi gathers in the kidneys; excessive Qi causes exhaustion, and Bi gathers in the liver; excessive Qi causes muscle failure, and Bi gathers in the spleen." It explains that Bi is closely related to the disappearance of Qi of the five internal organs, and the root cause of the disappearance of Qi of the five internal organs is that the spleen and kidney are in a state of decline, and if the kidney is weak, the essence of the five internal organs will also decline; the spleen Yang is insufficient, cold and dampness are abundant, and the Qi distribution is abnormal, and evil Qi takes advantage of the opportunity to enter, causing Bi syndrome.

[0009] It can be seen from this that the body has a solid body of yin excess and yang deficiency, the rise and fall of the Ying and Wei are out of balance, the circulation of the essence and qi of the viscera is out of balance, and the communication is blocked. Then the wind, cold and dampness of the sky can easily invade the body, and the combination of the two causes of the inside and outside is "combined to form arthralgia". As the "Suwen·Acupuncture Theory" says: "The positive energy is inside, and the evil cannot invade". "Lingshu·The Origin of All Diseases" says: "When the two deficiencies meet, they invade the body", all of which emphasize that the exuberance of Yang Qi, the smooth circulation of Qi and blood, and the fullness of the essence and qi of the viscera play an important role in the occurrence and development of wind, cold and dampness arthralgia.

[0010] In addition to the basic principles of dispelling wind, dispersing cold, removing dampness, and relaxing meridians and unblocking collaterals, the treatment principles and methods for wind-cold-dampness arthralgia should focus on clarifying the essential factors of weak vital energy in arthralgia, and on the basis of the basic principles, combining agents to replenish vital energy. Ancient doctors summarized the treatment methods for arthralgia based on the characteristics of its predominance of pathogenic factors. For example, the "Golden Mirror of Medical Ancestral" says: "If it is caused by blood deficiency, blood heat, and blood stasis, it is necessary to regulate blood circulation; or if it is caused by wind and rheumatism, the limbs are swollen and painful, and cannot be flexed or extended, it is necessary to dispel wind and dampness; or if it is caused by wind and rheumatism, the pain is flowing, and it is hemiplegia and sudden darkness, it is necessary to dispel depression and open knots; or if it is caused by wind and rheumatism, phlegm, and dead blood, the pain is flowing, and the painful area is swollen or red, it is necessary to dispel evil and ventilate; or if it is caused by blood deficiency, yin fire, and pain, and damp-heat pain below the waist, it is necessary to nourish yin and clear heat..." On this basis, Danxi summarized it as pungent and warm to disperse, open the pores, so that blood can flow and qi can be combined, and the disease will be cured. The pungent, warm and dispersing properties are the so-called "Yang Qi combined will disperse Yin condensation", so the treatment of cold should be combined with warming Yang and replenishing fire. Therefore, in the treatment of wind-cold-dampness arthralgia, the emphasis is on replenishing deficiency and dispelling wind, dispersing cold and removing dampness, with the main focus on dispersing evil qi. According to the dominant evil qi, it may be used to relieve depression and dissipate stagnation, dispel wind and regulate dampness, or nourish Yin and clear heat. Wind-cold-dampness arthralgia lasts for a long time and will inevitably affect the essence of the internal organs. Therefore, long-term arthralgia must be weak. At this time, it is necessary to focus on strengthening the body, replenishing the liver and kidneys, strengthening the tendons and bones, and replenishing qi and blood. This is the treatment method at this time. Dispel evil and strengthen the body, attack and supplement at the same time, while dispelling wind, dispersing cold and removing dampness, add products that replenish qi and blood and nourish the liver and kidneys. It is also necessary to focus on nourishing blood and activating blood circulation, in line with the principle of "treating wind by treating blood first, and the wind will disappear when blood circulates".

[0011] There are many treatment methods in clinical practice, including oral administration of Chinese medicine, external application of Chinese medicine, fumigation or scraping, cupping or plastering, etc., as well as acupuncture and physical therapy. The key is to strengthen the body, remove dampness and dredge the meridians, so as to achieve the purpose of warming yang and removing arthralgia. Because the classical prescriptions carry the essence of the treatment of arthralgia by the predecessors, they are widely and flexibly used in clinical practice, with remarkable curative effects. Various scholars have added or subtracted the compatibility of classical prescriptions such as Wutou Decoction and Guizhi Shaoyao Zhimu Decoction, and the curative effect is quite good. For example, Huang Qiting. Clinical observation on different compatibility of modified Wutou Decoction for the treatment of cold-damp arthralgia [D]. Fuzhou: Fujian College of Traditional Chinese Medicine, 2009: 1. Through random grouping and comparative treatment of 60 cases of cold-damp arthralgia, it was found that the Wutou Decoction plus liver-kidney tonifying drugs had better curative effect, which confirmed that the essence of cold-damp arthralgia is liver-kidney deficiency, so liver-kidney tonifying drugs were added. Zhang Kangyong and Nan Shunmei used modified Wutou decoction to treat 83 cases of Bi syndrome. According to the dominant evil qi, they selected ingredients to dispel dampness, dispel cold, resolve phlegm and clear heat, and found that the treatment of Bi syndrome had a good effect. Wang Tao, Lin Jing, Di Shunan, Kuang Haixue. Clinical observation on the treatment of cold-damp type rheumatoid arthritis with Wutou decoction and its sub-prescriptions [J]. New Chinese Medicine, 2016, (8) 130-131. By using Wutou decoction and its sub-prescriptions to treat 60 patients with cold-damp type rheumatoid arthritis, it was found that Wutou decoction was effective in treating such patients and could significantly improve the levels of inflammatory factors such as IL-17 in serum. Lei Kunmei. Clinical experience in treating 42 cases of Bi syndrome with classical prescription Wutou decoction [J]. Journal of Yunnan University of Traditional Chinese Medicine, 1999, (22): 42-43. When using Wutou decoction, aconite is used more often, taking its meaning of being powerful and defeating the enemy, taking its meaning of replenishing fire and supporting yang, dispelling cold and removing dampness, and combining it with ingredients of promoting blood circulation and removing blood stasis, it has a significant effect in treating wind-cold-dampness Bi syndrome. Wang Aihua, Liang Xiaojuan. Treatment of Bi syndrome with Guizhi Shaoyao Zhimu Decoction [J]. World Latest Medical Information Abstracts, 2015, (15): 103-104. Inspired by the Golden Chamber, Guizhi Shaoyao Zhimu Decoction was applied to treat Bi syndrome through clinical additions and subtractions, and satisfactory treatment effects were achieved. It was even developed into tablets for the treatment of ankylosing spondylitis. Wang Junmin. Treatment of Bi syndrome with Guizhi Shaoyao Zhimu Decoction in 26 cases [J]. Jiangxi Traditional Chinese Medicine, 1998, (29): 61. For patients with Bi syndrome with rheumatism as the main symptom, no obvious cold or heat, or the initial onset of heat, Guizhi Shaoyao Zhimu Decoction can be used for treatment, which can often be effective. Zhao Xiaoting. Clinical and experimental study on the treatment of Bi syndrome with Guizhi Shaoyao Zhimu Decoction [D]. Guangzhou: Guangzhou University of Chinese Medicine, 2009: 2. Through experimental research, it was found that Guizhi Shaoyao Zhimu Decoction has a certain effect on improving the clinical symptoms of Bi syndrome and can significantly reduce the level of serum inflammatory factors. Lei Yan, Wang Xinchang. Clinical application of Huangqi Guizhi Wuwu Decoction in rheumatic diseases [J]. Heilongjiang Traditional Chinese Medicine, 2014, (6): 40-41. A summary and analysis of Huangqi Guizhi Wuwu Decoction in the treatment of arthralgia syndrome was made, and it was concluded that it has a clear effect on rheumatoid arthritis, Raynaud's syndrome, ankylosing spondylitis, etc., and its function is to invigorate qi, promote yang, and eliminate arthralgia.Regarding the mechanism of Huangqi Guizhi Wuwu Decoction in treating Bi syndrome, Chen Cangbin and Gao Ying. Experience in treating Bi syndrome with Huangqi Guizhi Wuwu Decoction [J]. Heilongjiang Medicine, 1997, (10): 177. They believe that the main internal cause of Bi syndrome is deficiency of Qi and blood, and the external cause is invasion of wind, cold, dampness and heat. Therefore, Huangqi Guizhi Wuwu Decoction is used to harmonize Ying and Wei, regulate blood and eliminate Bi, and play the role of warming Yang and relieving Bi. Lai Zhangfeng. Research on the compatibility rules of Guizhi Fuzi prescriptions in treating Bi disease [D]. Kunming: Yunnan University of Traditional Chinese Medicine, 2016: 2. Through the study of the compatibility rules of Guizhi Fuzi prescriptions in treating Bi syndrome, it is concluded that the method of supporting Yang is the fundamental method for treating wind, cold and dampness Bi. Therefore, Guizhi Fuzi prescriptions are used to warm and transform cold and dampness, and are also widely used in syndromes such as phlegm and blood stasis, liver and kidney deficiency, etc. Ai Xiangqian, Zhang Shiyu. Experience of using Fuzi Decoction to treat cold-damp arthralgia [J]. Guangming Chinese Medicine, 2011, (26): 356-357. Using Fuzi Decoction to treat cold-damp arthralgia is intended to warm and replenish Yang Qi, strengthen the positive Qi and eliminate cold and dampness, and the effect is remarkable. Zhu Chen, Dang Hong. Professor Zhu Liangchun's development of the treatment method of "Treatise on Febrile Diseases" on warming the kidney and strengthening the governor vessel arthralgia [J]. New Chinese Medicine, 2013, (45): 159. It is believed that the occurrence of wind-cold-damp arthralgia is due to insufficient Yang Qi, the pathogenic factors penetrate deeply and stay, the kidney Yang is weak, and the internal organs are weak, so the wind-cold-dampness pathogens flow into the muscles, tendons, and internal organs. Therefore, Danggui Sini Decoction and Danggui Buxue Decoction are used in treatment to clear the meridians, warm the Yang and dispel the cold. Yang Qinjun, Guo Jinchen, Yang Tianping. Clinical application progress of Duhuo Jishe Decoction in treating Bi syndrome [J]. Journal of Jiangxi University of Traditional Chinese Medicine, 2015, (27): 113-116, disclosed the application of Duhuo Jishe Decoction in treating wind-cold-dampness Bi syndrome in modern times, which can treat rheumatoid arthritis, knee osteoarthritis, ankylosing spondylitis and other diseases. Its purpose is to nourish the liver and kidney, strengthen the tendons and bones, and dispel wind, cold and dampness. Li Huaimin. Examples of Duhuo Jishe Decoction in treating Bi syndrome [J]. Chinese Folk Therapy, 2013, (04): 39-40. When using Duhuo Jishe Decoction to treat Bi syndrome, it is combined with Simiao Decoction or Shentong Zhuyu Decoction with modifications, which can warm the meridians and dispel cold, promote qi and dredge the collaterals, and achieve relatively satisfactory therapeutic effects.

[0012] In addition to Chinese medicine, acupuncture is also widely used in the treatment of wind-cold-dampness arthralgia. According to the different lesion sites and different types of arthralgia of wind-cold-dampness arthralgia, "Lingshu·Guanzhen" proposed different acupuncture methods. The treatment of walking arthralgia uses the Baoci method and the Miaoci method; the treatment of cold arthralgia uses Yangci, Qici, Zhizhenci, and Huozhencuici. Later generations summarized the corresponding main acupoints according to the characteristics of the pathogenesis of wind-cold-dampness arthralgia, such as the 19 acupoints for treating limb arthralgia proposed in "Zhenjiu Jiayi Jing", and the selection of Chize and Yangfu for wind arthralgia in "Zhenjiu Dacheng·Bijuemen"; Quchi, Lieque, Huantiao, Fengshi, Weizhong, Shangqiu, Zhongfeng, and Linqi for body cold arthralgia (compiled by Huang Longxiang, Yang Jizhou. Acupuncture Dacheng [M] Beijing, People's Medical Publishing House, 2006, 6: 364). In the Acupuncture and Moxibustion Zisheng Jing, acupoints such as Tianjing, Jianjing, Chize, Yangfu, Weizhong and Huantiao are selected for the treatment of rheumatism (Xie Yuhe. Discussion and Analysis of the Origin and Development of Academic Thoughts on Bi Syndrome [D]. Guangzhou: Guangzhou University of Chinese Medicine, 2012: 2).

[0013] External treatments for wind-cold-dampness arthralgia are widely used because they are simple, effective and inexpensive. Fumigation, cupping or plastering are commonly used. Although the methods vary, they are all methods for promoting yang and supporting yang. For example, Ma Dengbin. Simple external treatments for arthralgia syndrome [J]. Guangming Journal of Traditional Chinese Medicine: 1996(3): 6, used decoctions of vines such as Qingfengteng to treat wind-cold-dampness arthralgia, dispelling wind and relieving pain, removing dampness and activating blood circulation, and expelling wind and chasing cold, with good results. Zhang Yuejuan et al. used scraping and cupping therapy, combined with Wanying Pain Relief Plaster to treat cold-dampness arthralgia pain, with obvious results.

[0014] Application number: CN201210367270.7, invention name: Neck pain recovery pills for treating cervical spondylosis, discloses a neck pain recovery pill for treating cervical spondylosis. In terms of weight, the neck pain recovery pills are prepared from 55-75 parts of raw materials Panax notoginseng, 60-80 parts of Chuanxiong, 130-150 parts of Corydalis, 140-160 parts of White Peony, 60-80 parts of Clematidis, 100-120 parts of Puerariae, 55-75 parts of Notopterygium, 25-55 parts of Crataegus, 50-80 parts of Stir-fried Atractylodes, 65-90 parts of Angelicae Sinensis, 60-80 parts of Gastrodia and 55-80 parts of Cinnamomum cassia. The neck pain recovery pills (decoction) for treating cervical spondylosis of the present invention have been used in clinical practice and have effectively solved the pain of most patients with cervical spondylosis.

[0015] The currently reported prescriptions have a short observation period, a small sample size, and relatively simple intervention measures, which are somewhat different from clinical practice. The taste of Chinese medicine preparations is poor, and patient compliance is affected to a certain extent. In addition, due to the complexity of TCM dialectics of cervical spondylosis, current drugs cannot meet clinical needs. Summary of the invention

[0016] The present invention provides a Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis, and also provides a preparation method and use of the Chinese medicine composition.

[0017] The present invention provides a traditional Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis, which is prepared from the following raw materials in weight proportion:

[0018] 144-216 parts of Pueraria root, 72-108 parts of Notopterygium root, 48-72 parts of Bupleurum root, 96-144 parts of Clematidis root, 72-108 parts of Gastrodia elata, 48-72 parts of Chuanxiong, 48-72 parts of Curcuma longa, 144-216 parts of Astragalus, 48-72 parts of Cassia twig, 72-108 parts of White Peony Root, 96-144 parts of Millettia reticulata, and 24-36 parts of Radix Glycyrrhizae Preparata.

[0019] More preferably, it is prepared from the following bulk drugs in the following weight ratio:

[0020] 180 parts of Puerariae Radix, 90 parts of Notopterygium, 60 parts of Bupleurum chinense, 120 parts of Clematidis Radix, 90 parts of Gastrodia elata, 60 parts of Chuanxiong Rhizome, 60 parts of Curcuma longa, 180 parts of Astragalus, 60 parts of Cinnamomum cassia twig, 90 parts of White Peony Root, 120 parts of Millettia Spatholobi, and 30 parts of Radix Glycyrrhizae Preparata.

[0021] The Chinese medicine composition of the present invention is prepared into a commonly used pharmaceutical preparation by adding pharmaceutically acceptable excipients or auxiliary ingredients into the raw medicine powder, water or organic solvent extract of the raw medicine as active ingredients.

[0022] The preparation is tablet, capsule, pill, granule or oral liquid.

[0023] The present invention also provides a method for preparing the Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis, which comprises the following steps:

[0024] a. Weigh the APIs of various weight ratios;

[0025] b. Add water to boil, filter, concentrate, and then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used pharmaceutical preparation.

[0026] The present invention also provides use of the traditional Chinese medicine composition in preparing medicine for treating wind-cold arthralgia type cervical spondylosis.

[0027] Preferably, the medicine is a medicine for treating arthralgia caused by exogenous wind, cold and dampness, and is used to relieve the symptoms of stiff neck, cold pain and discomfort.

[0028] The present invention also provides use of the traditional Chinese medicine composition in preparing medicines having the functions of dispelling wind and cold, promoting qi and removing dampness, unblocking meridians and relieving pain.

[0029] The medicine of the present invention mainly treats wind-cold in the surface, and wind-cold evil spirit invades the muscle surface, and the guest is in the solar meridian, and the meridian qi is not smooth, and causes stiff neck, cold pain and discomfort. In the raw material prescription, Notopterygium root and Cinnamomum cassia are the main medicines, and the two are all products of pungent and warm drying, and their pungent and dispersing wind, bitter and damp, warm and cold, can all dispel wind and dispel cold, and promote joints. Minister uses white peony root, kudzu vine, and clematis to relax muscles and dredge collaterals, relieve urgency and stop pain, wind-cold invasion causes cold coagulation meridians for a long time, blood stasis is blocked, and Chuanxiong, turmeric, and Millettia spatholobi are assisted to promote blood circulation and qi, dispel wind and stop pain, and gastrodia elata dispel wind and dredge collaterals, stop wind and stop spasm, and chronic illness must be depressed, and northern bupleurum is used to relieve liver depression and regulate liver wood, and astragalus is used to replenish qi and consolidate the surface, and expel evil spirits and go out of the surface, so as to reconcile all medicines with Radix Glycyrrhizae Preparata. All medicines are used together, and the merits of dispelling wind and dispersing cold, promoting qi and removing dampness, and dredge collaterals and stopping pain are played together.

[0030] It is mainly used to dispel wind and cold, promote qi and remove dampness, and relieve pain. It is mainly used for arthralgia caused by exogenous wind, cold and dampness, such as stiff neck, cold pain and discomfort. It is widely used in clinical practice with significant efficacy, good safety and low price.

[0031] The medicine of the present invention is a pure Chinese medicine preparation with reasonable compatibility, definite efficacy, high patient acceptance and fewer adverse reactions. Currently, cervical spondylosis is mostly treated on the market by acupuncture, massage, plaster and external application of ointment, and there are relatively few oral medications for the treatment of cervical spondylosis. The medicine can bring great convenience to patients, especially office workers, and save the time and transportation costs generated by going to and from the hospital, providing a new idea for the clinical treatment of cervical spondylosis. DETAILED DESCRIPTION

[0032] Example 1 Preparation of Chinese medicine oral liquid of the present invention

[0033] Weigh the raw materials: 180g of Pueraria root, 90g of Notopterygium root, 60g of Bupleurum chinense, 120g of Clematidis, 90g of Gastrodia elata, 60g of Ligusticum chuanxiong, 60g of Curcuma longa, 180g of Astragalus, 60g of Cinnamomum cassia twig, 90g of White Peony Root, 120g of Millettia spatholobi, and 30g of Radix Glycyrrhizae to prepare 1000ml of oral solution.

[0034] The specific preparation process is as follows:

[0035] Step 1, prepare medicinal materials: weigh and select equal weight proportions of the main medicinal materials of Pueraria root, Notopterygium root, Bupleurum root, Clematis root, Gastrodia elata, Chuanxiong, Curcuma longa, Astragalus root, Cinnamon twig, White peony root, Millettia spatholobi, and Radix glycyrrhizae by electronic balance, and proportions of the auxiliary material ethylparaben;

[0036] Step 2: Soaking: put the main medicinal materials prepared in step 1 into the extraction tank, and add 10 times the amount of water for soaking for 0.5h;

[0037] Step 3, heating and steaming: passing steam into the extraction tank in step 2 through a sandwich pot, heating and steaming until boiling, and extracting at a low boiling temperature for 1.5 hours;

[0038] Step 4, filtering and extracting: After filtering the medicinal liquid through the extraction tank, pump it into the liquid storage tank, add 8 times the amount of water of the decoction piece to the medicinal residue and extract it with slight boiling for 1.5 hours; then, filter the medicinal liquid through the extraction tank and pump it into the liquid storage tank, add 8 times the amount of water of the decoction piece to the medicinal residue and extract it with slight boiling for 1.5 hours in the same way, and obtain the filtrate;

[0039] Step 5, concentration: the filtrate in the liquid storage tank in step 4 is combined together, and the filtrate is slowly introduced into the concentration tank. When the liquid medicine rises enough to form a circulation, the filtrate in the concentration tank is heated and boiled by slowly opening the steam valve through the sandwich pot to obtain a concentrated solution;

[0040] Step 6, centrifugal filtration: the concentrated liquid after being concentrated in the concentration tank in step 5 is centrifuged through a centrifuge to obtain a centrifuge;

[0041] Step 7: Mixing preparation: put the centrifuge obtained in step 6 into a mixer, and put the auxiliary materials prepared in step 1 into the mixer to mix together, and finally, add water into the mixer and stir evenly to obtain a mixed solution;

[0042] Step 8: Filling: Fill the mixed solution obtained in step 7 through a filling production line;

[0043] Step nine, packaging: the semi-finished product after filling in step eight is packaged through the packaging line.

[0044] Usage and Dosage

[0045] Dosage and Administration: Oral administration, 10-20 ml each time (each dose of the original medicine is 11.4-22.8 g), twice a day, shake well before use.

[0046] Example 2 Preparation of the Chinese medicine composition of the present invention

[0047] Weigh the API:

[0048] 144g of Pueraria root, 72g of Notopterygium root, 48g of Bupleurum root, 96g of Clematidis root, 72g of Gastrodia elata, 48g of Ligusticum chuanxiong, 48g of Curcuma longa, 144g of Astragalus membranaceus, 48g of Cinnamomum cassia twig, 72g of White Peony Root, 96g of Millettia spatholobi, and 24g of Radix Glycyrrhizae are decocted with water and filtered, starch is added to the concentrated solution, and granulation and whole-graining are carried out to prepare granules.

[0049] Example 3 Preparation of the Chinese medicine composition of the present invention

[0050] Add water to 216g of Pueraria root, 108g of Notopterygium root, 72g of Bupleurum root, 144g of Clematidis root, 108g of Gastrodia elata, 72g of Ligusticum chuanxiong, 72g of Curcuma longa, 216g of Astragalus membranaceus, 72g of Cinnamomum cassia twig, 108g of White Peony Root, 144g of Millettia spatholobi and 36g of Radix Glycyrrhizae Preparata, boil and filter, add starch to the concentrated solution, granulate and shape the granules, put them into capsules to prepare capsules.

[0051] The beneficial effects of the present invention are demonstrated by clinical trials as follows.

[0052] Test Example 1 Clinical trial of the drug of the present invention

[0053] 1. Experimental purpose: To preliminarily evaluate the efficacy and safety of the Chinese medicine composition of the present invention prepared in Example 1 (hereinafter referred to as "Fenghan Jingshu Mixture").

[0054] 2. Number of subjects:

[0055] Test group: 52 subjects

[0056] Control group: 51 subjects.

[0057] Among them, the subjects were diagnosed with cervical spondylosis of the cervical type in Western medicine and wind-cold arthralgia type in traditional Chinese medicine.

[0058] 3. Inclusion and Exclusion Criteria:

[0059] 1. Selection criteria:

[0060] (1) Western medicine diagnostic criteria:

[0061] Combined with the expert consensus on the classification, diagnosis and non-surgical treatment of cervical spondylosis in the Chinese Journal of Surgery (2018).

[0062] 1) Cervical spondylotic radiculopathy

[0063] Cause: Nerve root compression.

[0064] Symptoms: Neck and shoulder pain, radiating pain in the upper limbs, numbness, and weakness.

[0065] 2) Cervical spondylotic myelopathy

[0066] Cause: Spinal cord compression.

[0067] Symptoms: numbness and weakness in the lower limbs, unsteady walking, and in severe cases, urinary and bowel problems.

[0068] 3) Vertebral artery type cervical spondylosis

[0069] Cause: Compression or spasm of the vertebral artery.

[0070] Symptoms: dizziness, headache, blurred vision, and in severe cases, fainting.

[0071] 4) Sympathetic cervical spondylosis

[0072] Cause: Sympathetic nerve stimulation.

[0073] Symptoms: Headache, dizziness, palpitations, nausea, blurred vision.

[0074] 5) Mixed cervical spondylosis

[0075] Cause: Multiple factors work together.

[0076] Symptoms: Multiple symptoms mentioned above coexist.

[0077] 6) Cervical spondylosis

[0078] Cause: Injury or strain of neck muscles and ligaments.

[0079] Symptoms: Neck pain, stiffness, and limited movement.

[0080] 7) Esophageal compression type cervical spondylosis

[0081] Cause: Osteophyte at the anterior edge of the cervical spine compresses the esophagus.

[0082] Symptoms: difficulty swallowing.

[0083] Imaging examination: Degenerative changes of the cervical spine are mainly characterized by instability of the intervertebral joints, bilateral, biprotrusive, notch signs or bone hyperplasia; or there are clear signs of spinal cord compression, which correspond to the clinical symptoms.

[0084] Laboratory examination: There are currently no laboratory examination indicators for diagnosis and prognosis evaluation of cervical spondylosis, some inflammation and oxygen free radical metabolism, such as superoxide dismutase, etc.

[0085] (2) TCM diagnostic criteria:

[0086] There is no disease name corresponding to cervical spondylosis in traditional Chinese medicine. According to its clinical manifestations, cervical spondylosis belongs to the categories of "neck pain", "spasm" and "paralysis" in traditional Chinese medicine.

[0087] Diagnostic points: Long-term work with head bent over the desk, or bad sleeping habits, and family history of cervical spondylosis. Symptoms may include stiffness of the neck, shoulders and upper limbs, limited mobility, numbness, stringy pain or tingling, dizziness, fatigue, etc. Exclude diseases such as "stiff neck", "paralysis", "cancer" and other acute neck injuries caused by trauma.

[0088] Dialectical classification:

[0089] 1) Wind-cold arthralgia type

[0090] Neck and shoulder pain, aggravated by cold and relieved by heat, limited movement, may be accompanied by headache and chills.

[0091] 2) Qi stagnation and blood stasis type

[0092] Fixed-position tingling in the neck and shoulders, aggravated at night, limited movement, and possibly numbness in the upper limbs.

[0093] 3) Liver and kidney deficiency

[0094] Neck and shoulder pain, dizziness, tinnitus, waist and knee weakness, may be accompanied by blurred vision and insomnia.

[0095] 4) Phlegm-dampness blocking the collaterals

[0096] Heaviness and pain in the neck and shoulders, dizziness, heaviness in the head, chest tightness and nausea, may be accompanied by numbness in the upper limbs.

[0097] 5) Qi and blood deficiency type

[0098] Dull pain in the neck and shoulders, fatigue, pale complexion, palpitations and shortness of breath, possibly accompanied by dizziness.

[0099] 6) Damp-heat obstruction type

[0100] Burning pain in the neck and shoulders, aggravated by heat, may be accompanied by dry mouth and yellow urine.

[0101] 7) Cold stagnation and blood stasis type

[0102] Cold pain in the neck and shoulders, aggravated by cold and relieved by heat, may be accompanied by numbness of the upper limbs.

[0103] 2. Exclusion criteria:

[0104] (1) Patients who do not meet the diagnostic criteria; (2) Those whose clinical symptoms, signs, and lumbar spine imaging findings are inconsistent; (3) Those with other serious underlying diseases, such as cerebral infarction, sequelae of cerebral hemorrhage, etc., which affect the implementation of the treatment plan; (4) Those with incomplete medical history and unwillingness to cooperate. Patients who meet any of the above items can be excluded.

[0105] Those who meet the above inclusion criteria will be included in the project.

[0106] 4. Positive control drug:

[0107] Celecoxib Capsules (Shijiazhuang Pharmaceutical Group)

[0108] Specification: 0.1; 0.2g

[0109] Batch number: National Medicine Approval No. H20203296.

[0110] Dosage: 200 mg orally twice a day.

[0111] V. Evaluation criteria:

[0112] Main efficacy indicators:

[0113] Pain VAS score

[0114] Cervical spine mJOA score

[0115] Safety indicators:

[0116] Evaluate adverse events, skin allergies and abnormal laboratory values ​​during the study, and assess changes in vital signs, physical examinations, and electrocardiograms. Safety monitoring begins at enrollment, especially blood and urine routine tests, liver function tests, and possible adverse reactions.

[0117] 6. Statistical methods:

[0118] SPSS 29.0 software was used to process the quantitative data. The data were expressed as n(%) and subjected to t test. The count data were expressed as n(%) and subjected to χ2 test. P<0.05 indicated statistically significant differences.

[0119] VII. Results and Conclusions

[0120] result:

[0121] Table 1 Comparison of VAS scores and cervical mJOA scores between the two groups before medication

[0122]

[0123] Note: Before medication, there was no significant difference in VAS scores and cervical mJOA scores between the two groups, P value>0.05, and the two groups were comparable.

[0124] Table 2 Comparison of VAS scores in the two groups before and after 2 weeks and 4 weeks of medication

[0125]

[0126] Note: The VAS scores of the two groups were compared before and after 2 weeks and 4 weeks of medication, and the P values ​​were <0.05, indicating statistically significant differences.

[0127] Table 3 Comparison of cervical mJOA scores before and after 2 weeks and 4 weeks of medication in the two groups

[0128]

[0129] Note: There was no significant difference in cervical mJOA scores between the two groups before and after 2 weeks of medication (P>0.05). There was a significant difference in cervical mJOA scores between the two groups before and after 4 weeks of medication (P<0.05).

[0130] Table 4 Comparison of VAS scores between the two groups after 2 weeks and 4 weeks of medication

[0131]

[0132] Note: Comparison of VAS scores between the two groups at 2 weeks and 4 weeks of medication showed that P < 0.05 at 2 weeks, with a statistically significant difference; at 4 weeks, P > 0.05, with no statistically significant difference.

[0133] Table 5 Comparison of cervical mJOA scores between the two groups after 2 weeks and 4 weeks of medication

[0134]

[0135] Note: There was no statistically significant difference in cervical mJOA scores between the two groups at 2 weeks and 4 weeks of medication, P>0.05.

[0136] Safety indicators:

[0137] One patient in the experimental group developed a gastrointestinal reaction, manifested as diarrhea, and the symptoms were relieved after symptomatic treatment. One patient in the control group developed a skin allergy, and the drug was immediately stopped. The symptoms improved after anti-allergic treatment.

[0138] in conclusion:

[0139] Both the experimental group and the control group can improve the VAS score. The pain VAS score of the control group was better than that of the experimental group at 2 weeks. There was no statistically significant difference between the two groups at 4 weeks. Both groups can improve the mJOA score of the cervical spine of patients, and there is no significant difference between the two groups. It is suggested that Fenghan Jingshuhe and celecoxib capsules can relieve the pain symptoms of patients in the short term. At the same time, celecoxib capsules take effect faster than Fenghan Jingshuhe, indicating that Fenghan Jingshuhe and celecoxib capsules can improve the mJOA score of the cervical spine of patients (patients with wind-cold arthralgia type cervical spondylosis) and relieve the clinical symptoms of patients. In summary, Fenghan Jingshuhe can effectively improve the pain of patients without the side effects of celecoxib. It is safer to use clinically, and can improve the spinal cord function of patients to a certain extent, improve the quality of life of patients, and is worthy of clinical promotion.

Claims

1. A Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis, characterized in that: It is prepared from the following raw materials in the following weight ratio: 144-216 parts of Pueraria root, 72-108 parts of Notopterygium root, 48-72 parts of Bupleurum root, 96-144 parts of Clematidis root, 72-108 parts of Gastrodia elata, 48-72 parts of Chuanxiong, 48-72 parts of Curcuma longa, 144-216 parts of Astragalus, 48-72 parts of Cassia twig, 72-108 parts of White Peony Root, 96-144 parts of Millettia reticulata, and 24-36 parts of Radix Glycyrrhizae Preparata.

2. The Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis according to claim 1, characterized in that: It is prepared from the following raw materials in the following weight ratio: 180 parts of Puerariae Radix, 90 parts of Notopterygium, 60 parts of Bupleurum chinense, 120 parts of Clematidis Radix, 90 parts of Gastrodia elata, 60 parts of Chuanxiong Rhizome, 60 parts of Curcuma longa, 180 parts of Astragalus, 60 parts of Cinnamomum cassia twig, 90 parts of White Peony Root, 120 parts of Millettia Spatholobi, and 30 parts of Radix Glycyrrhizae Preparata.

3. The Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis according to claim 1 or 2, characterized in that: The raw drug powder, water or organic solvent extract of the raw drug are used as active ingredients, and pharmaceutically acceptable auxiliary materials or auxiliary ingredients are added to prepare a commonly used pharmaceutical preparation.

4. The Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis according to claim 3, characterized in that: The preparation is tablet, capsule, pill, granule or oral liquid.

5. A method for preparing the Chinese medicine composition for treating wind-cold arthralgia type cervical spondylosis according to any one of claims 1 to 4, characterized in that: It includes the following steps: a. Weigh the APIs of various weight ratios; b. Add water to boil, filter, concentrate, and then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used pharmaceutical preparation.

6. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating wind-cold arthralgia type cervical spondylosis.

7. The use according to claim 6, characterized in that: The medicine is used for treating arthralgia caused by exogenous wind, cold and dampness, and is used for alleviating the symptoms of stiff neck, cold pain and discomfort.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of medicines having the effects of dispelling wind and cold, promoting qi and removing dampness, and unblocking meridians and relieving pain.

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