A traditional Chinese medicine composition for treating or / and adjuvant treating chest distress and heart pain caused by phlegm and blood stasis, and a preparation method and application thereof

Abstract

This invention provides a traditional Chinese medicine composition for treating and / or adjuvant treatment of phlegm-blood stasis type chest pain and angina pectoris. It is prepared from the following raw materials in the indicated weight ratios: Trichosanthes kirilowii peel 160-240 parts, Panax notoginseng 160-240 parts, amber 160-240 parts, charred hawthorn 160-240 parts, American ginseng 160-240 parts, Salvia miltiorrhiza 160-240 parts, and safflower 160-240 parts. This invention also provides a method for preparing this traditional Chinese medicine composition and its uses. The traditional Chinese medicine composition of this invention is prepared using a traditional decoction process, fully preserving the effective components of the medicinal materials. It is a liquid preparation, convenient to take, and rapidly absorbed. It is mainly used for coronary heart disease, cerebral arteriosclerosis, and internal carotid artery atherosclerosis belonging to the phlegm-blood stasis syndrome. It can effectively relieve symptoms such as chest tightness, chest pain, palpitations, shortness of breath, fatigue, dizziness, headache, irritability, and insomnia. It has good safety and provides a high-quality traditional Chinese medicine preparation for the clinical treatment of the above-mentioned cardiovascular and cerebrovascular diseases.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition for treating or / and adjuvantly treating chest pain and angina caused by phlegm and blood stasis, as well as its preparation method and uses, belonging to the field of traditional Chinese medicine. Background Technology

[0002] The core pathogenesis of phlegm-blood stasis type chest pain and angina pectoris (phlegm and blood stasis obstructing the heart vessels) falls under the categories of "chest pain," "heart pain," and "accumulation syndrome." The descriptions of "heart disease, chest pain... pain in both arms" in the *Suwen* and "heart pain" in the *Lingshu* correspond to its core manifestations of chest tightness and pain. The statement in the *Lingshu* that "accumulation begins with cold, and syncope leads to accumulation" corresponds to the chronic pathological state of phlegm and blood stasis that persists for a long time. Its meaning is mainly divided into three categories: First, the pathogenesis, based on the theory of "body fluids and blood sharing the same origin" in the *Lingshu*, the heart vessels are the main pathway for the circulation of qi, blood, and body fluids. Spleen deficiency leads to the accumulation of body fluids into phlegm, and heart qi deficiency / stagnation / cold coagulation leads to poor blood circulation and blood stasis. Phlegm and blood stasis are mutually causal, intertwined, and obstruct the heart vessels, forming a vicious cycle, which is the core of the recurrent attacks of chest pain and angina pectoris. Second, the syndrome, manifested as blood stasis obstructing the heart and the internal accumulation of phlegm. The symptoms are superimposed. Blood stasis can manifest as fixed and stabbing chest pain, cyanosis of the lips and nails, and a choppy pulse. Phlegm turbidity can manifest as chest tightness, thick and sticky phlegm, heaviness of the limbs, thick and greasy tongue coating, and a slippery pulse. It is also often accompanied by palpitations, shortness of breath, and abdominal distension. This is consistent with the "Pulse stagnates and does not flow" in the "Suwen·Bi Lun" and "The flesh is not firm and is wet" in the "Ling Shu·Wu Bian". Thirdly, the treatment principle is to follow the "Shu Zhen Yao Da Lun" in the "Suwen·Zhi Zhen Yao Da Lun" to "dredge the blood and qi and make it flow smoothly" to promote blood circulation and remove blood stasis, warm and invigorate the heart yang. It also follows the "Warm and transform water and dampness" approach in the "Suwen·Tang Ye Lao Li Lun" to resolve phlegm and remove dampness, strengthen the spleen and replenish qi. It implies the concept of "treating phlegm and blood stasis at the same time", which lays the theoretical foundation for the treatment method of "promoting blood circulation and removing blood stasis, resolving phlegm and unblocking collaterals" in later generations.

[0003] The TCM etiologies of phlegm-blood stasis type chest pain include: ① Deficiency of vital energy: Insufficient qi, blood, yin, and yang, leading to malnourishment of the heart vessels. Deficiency of vital energy is the underlying basis for the occurrence of phlegm-blood stasis type chest pain, which is often related to improper diet, old age and physical weakness, and prolonged illness. The *Suwen* (Plain Questions) states, "The pulse is the residence of blood… a thin pulse indicates insufficient qi, a hesitant pulse indicates heart pain," indicating that insufficient qi to propel blood and insufficient blood to nourish the heart vessels are both causes of malnourishment of the heart vessels. Improper diet and overwork damage the spleen and stomach. The spleen is the source of qi and blood production; a weak spleen and stomach result in insufficient qi and blood production, leading to malnourishment of the heart vessels. Old age and physical weakness, or prolonged illness, easily deplete yang qi; insufficient heart yang weakens its warming function, causing slow blood flow and stasis. Yang deficiency also impairs the transformation and transportation of fluids, leading to internal generation of phlegm and dampness. Yin deficiency results in insufficient body fluids and blood, causing malnourishment of the pulse vessels and sluggish blood flow, also contributing to the formation of phlegm and blood stasis. As stated in *Jingyue Quanshu* (Complete Works of Jingyue), "When a person is over forty, their Qi and Yin gradually become deficient. Yin deficiency leads to sluggish blood circulation, and Qi deficiency weakens blood flow, hence this condition is common." This clearly indicates that deficiency of vital energy is a prerequisite for the mutual accumulation of phlegm and blood stasis, and obstruction of the heart vessels. ② Improper diet: Phlegm and dampness are generated internally, obstructing the heart vessels. Improper diet is a significant contributing factor to phlegm-blood stasis type chest pain and heart pain, especially excessive consumption of rich, fatty, and sweet foods and excessive alcohol consumption. *Suwen* (Plain Questions) states, "The alteration of sorghum and millet causes large boils on the feet, and the body feels as if it is holding an empty vessel," indicating that excessive consumption of rich, fatty, and sweet foods easily generates phlegm and dampness. The spleen and stomach govern transformation and transportation; excessive consumption of rich, fatty, and sweet foods disrupts their function, preventing the normal transformation of food essence into Qi and blood, instead leading to the accumulation of dampness and phlegm. Long-term alcohol consumption leads to internal accumulation of damp heat, damaging the spleen and stomach, and exacerbating the accumulation of phlegm and dampness. Phlegm and dampness are tangible pathogenic factors, sticky in nature, easily obstructing the flow of Qi. When the Qi flow in the heart vessels is obstructed, blood circulation is also impeded. Over time, phlegm and blood stasis intertwine, obstructing the heart vessels. The *Danxi Xinfa* (Danxi's Heart Method) states, "Heart pain with a slippery pulse indicates phlegm and fluid retention," and the *Yixue Zhengchuan* (Correct Transmission of Medicine) also says, "Accumulated phlegm and fluid retention, causing blockage and obstruction, also leads to heart pain." Both indicate that the internal generation of phlegm and dampness, obstructing the heart vessels, is an important pathogenesis of chest pain and angina. ③ Emotional imbalance: Qi stagnation and blood stasis, phlegm and blood stasis intertwined. Emotional imbalance is a key factor in inducing or aggravating chest pain and angina of the phlegm-blood stasis type, often related to worry, anger, and depression. The *Suwen* (Plain Questions) chapter "On Pain" states: "Anger causes qi to rise, joy causes qi to relax, grief causes qi to dissipate, fear causes qi to descend, fright causes qi to become disordered, and thought causes qi to stagnate." Emotional distress leads to liver qi stagnation. The liver governs the free flow of qi throughout the body; liver qi stagnation obstructs qi circulation and blood flow, eventually leading to blood stasis. Simultaneously, qi stagnation can affect the spleen and stomach's digestive function, resulting in the internal generation of phlegm and dampness. Phlegm and blood stasis combine, obstructing the heart vessels. Excessive emotional activity, such as violent anger or ecstasy, can disrupt qi flow, causing heart vessel spasms and exacerbating chest pain. The *Miscellaneous Diseases: Origins and Development* chapter "On Heart Diseases" states: "In short, the seven emotions cause heart pain; imbalances in the seven emotions can lead to qi and blood depletion and obstruction of the heart vessels," clearly indicating that emotional imbalances, through qi stagnation, blood stasis, and the mutual binding of phlegm and blood stasis, lead to heart vessel obstruction and trigger chest pain. ④ Invasion of cold pathogens: Cold congeals blood, leading to phlegm and blood stasis. Invasion of cold pathogens is an important exogenous factor in phlegm-blood stasis type chest pain and heart pain. The "Suwen·Tiaojing Lun" states: "When cold qi enters the meridians, it stagnates and does not flow. When it lodges outside the vessels, blood is scarce. When it lodges inside the vessels, qi does not flow, so pain occurs suddenly." This points out that the core of cold pathogens causing disease is cold stagnation and blood stasis.Cold is a yin evil, characterized by stagnation and contraction. When cold evil invades the body, if the body's vital energy is insufficient and the defensive yang is weak, it easily invades the heart vessels, causing them to contract and become constricted, leading to sluggish blood flow and blood stasis. Simultaneously, cold evil damages yang energy; yang deficiency prevents the transformation and transportation of fluids, resulting in the internal generation of phlegm and dampness. The mutual binding of phlegm and blood stasis further aggravates the obstruction of the heart vessels. The *Suwen* (Plain Questions) states, "Pain is caused by excessive cold qi; pain arises from cold," and the *Zhubing Yuanhou Lun* (Treatise on the Origins and Symptoms of Various Diseases) also states, "Heart pain is caused by wind and cold evil qi attacking the heart." Both indicate that invasion of cold evil and blood stasis due to cold are important pathogenic mechanisms of chest pain, especially common in winter or when exacerbated by cold. ⑤ Old disease enters the collaterals: Phlegm and blood stasis become entangled, lingering and difficult to cure. Prolonged or recurrent chest pain easily leads to the binding of phlegm and blood stasis, resulting in a lingering condition. This is a characteristic pathological evolution of chest pain with phlegm and blood stasis. The *Suwen* (Plain Questions) chapter on Bi syndrome states, "When a disease persists for a long time, it penetrates deeply, causing stagnation of the *ying* and *wei* (nutritive and defensive qi), and obstruction of the meridians." Initially, the disease often presents as a condition of qi stagnation, cold coagulation, and phlegm turbidity—all signs of excess. Over time, the body's vital energy is depleted, and pathogenic factors penetrate deeper into the meridians. Phlegm turbidity and blood stasis mutually reinforce each other, becoming inextricably linked: phlegm turbidity obstructs the flow of qi, exacerbating blood stasis; blood stasis hinders the transformation and transportation of body fluids, further increasing phlegm and dampness, creating a vicious cycle. At this point, the obstruction of the heart vessels becomes even more severe, with pain manifesting as fixed, stabbing pain that worsens at night. The condition recurs frequently and is difficult to cure. The *Linzheng Zhinan Yi'an* (Clinical Guidelines and Medical Cases) chapter on chest pain states, "Prolonged pain penetrates the collaterals, causing stagnation of both qi and blood," and "Phlegm and blood stasis intertwine, obstructing the heart vessels; simply activating blood circulation or resolving phlegm is insufficient." This clearly indicates that prolonged illness penetrating the collaterals and the formation of phlegm and blood stasis are key pathogenesis factors contributing to the chronicity and difficulty in treating chest pain and heart pain.

[0004] The pathogenesis of phlegm-blood stasis type chest pain and angina pectoris mainly involves the following aspects:

[0005] First, the deficiency of healthy qi is the root cause of the disease, and the loss of nourishment of the heart meridian is the internal basis. The deficiency of healthy qi is the core prerequisite for the occurrence of chest pain due to phlegm and blood stasis syndrome. It is mostly caused by aging, improper diet, and prolonged illness. "Plain Questions - Pulse Manifestations and Precise Discussions" states: "The vessels are the residence of blood. When it is stagnant, there will be chest pain", clearly indicating that insufficient qi and blood and the loss of nourishment of the vessels are important pathogenesis of chest pain. In the elderly, qi and yin are gradually depleted. When qi is deficient, it is unable to promote blood circulation, and blood circulation becomes sluggish, easily forming blood stasis. When yang is deficient, warming and nourishing functions are derelict. It can neither transport water and dampness to generate phlegm nor cause cold coagulation and blood stagnation. When yin is deficient, there is a lack of fluid and blood, the vessels are dry and astringent, and blood stagnation is also the basis for the generation of phlegm and blood stasis. Improper diet and overwork damage the spleen and stomach. The spleen is the source of qi and blood production. When the spleen and stomach are weak, qi and blood production are insufficient, and the heart meridian loses nourishment. In patients with prolonged illness, healthy qi is continuously depleted, the functions of zang-fu organs decline, further aggravating the imbalance of qi, blood, yin and yang, creating conditions for the generation of pathological products such as phlegm turbidity and blood stasis. Second, the internal generation of phlegm turbidity is an important pathological factor, and the blockage of the heart meridian is the key link. The internal generation of phlegm turbidity is mostly caused by improper diet and the failure of the spleen to transport and transform, and it is one of the core pathological factors of chest pain due to phlegm and blood stasis syndrome. "Plain Questions - The Unity of Man and Nature" says: "Excessive consumption of fatty, sweet, and thick-flavored foods and excessive drinking can easily damage the transportation and transformation functions of the spleen and stomach, resulting in the failure of the essence of food and water to be normally transformed into qi and blood, but instead accumulating dampness and generating phlegm." Phlegm and dampness are tangible pathogenic factors, with a sticky nature, easily blocking qi movement. When the qi movement of the heart meridian is not smooth, blood circulation is blocked. Over time, phlegm turbidity and blood stasis are intertwined, blocking the heart meridian. "Danxi's Methods of Treatment - Chest Pain" records: "For chest pain with a slippery pulse, it is due to phlegm retention", clearly indicating that the internal accumulation of phlegm and dampness and the blockage of the heart meridian can directly cause symptoms such as chest pain and chest tightness as if being choked, becoming an important inducement for the onset of chest pain due to phlegm and blood stasis syndrome. Third, the internal obstruction of blood stasis is the core pathological product, and the blockage of the heart meridian is the direct pathogenesis. The internal obstruction of blood stasis is mostly caused by factors such as qi stagnation, cold coagulation, and qi deficiency, and it is the direct pathogenic mechanism of chest pain due to phlegm and blood stasis syndrome. "Plain Questions - Theory of Regulation of the Meridians" states: "When cold qi enters the meridian and lingers, stagnating and not moving, lodging in the vessels, qi will not circulate smoothly, so there will be sudden pain", indicating that the invasion of cold pathogen, qi stagnation, or qi deficiency can all lead to blood stagnation and the generation of blood stasis. As a tangible pathogenic factor, blood stasis blocks the heart meridian, causing abnormal qi and blood circulation, and the heart loses nourishment, resulting in typical symptoms such as fixed and不移 chest pain and stabbing pain. At the same time, the internal obstruction of blood stasis can also hinder the transportation and transformation of body fluids, leading to the accumulation of body fluids into phlegm. And the blockage of qi movement by phlegm turbidity will further aggravate blood stasis, forming a pathological cycle of "phlegm and blood stasis being mutually causal and difficult to resolve", making the disease lingering and difficult to heal. Fourth, emotional disorders and the invasion of cold pathogen are important inducements, aggravating the combination of phlegm and blood stasis. Emotional disorders and the invasion of cold pathogen are the key external factors that induce or aggravate chest pain due to phlegm and blood stasis syndrome. When emotions are not smooth, the liver qi stagnates. The liver is in charge of dredging and dispersing. When qi is stagnant, blood circulation is not smooth, and over time, blood stasis forms. At the same time, qi stagnation affects the transportation and transformation of the spleen and stomach, aggravating the internal generation of phlegm and dampness, and the combination of phlegm and blood stasis becomes even more severe. When emotions are excessive, qi movement is chaotic, the heart meridian spasms, and sudden aggravation of chest pain may occur. Cold pathogen is a yin pathogen, with a nature of stagnation and constriction. After invading the human body, it is easy to damage the heart yang, resulting in the contraction and constriction of the heart meridian, blood circulation becoming sluggish and forming blood stasis. At the same time, yang deficiency cannot transport water and dampness, and phlegm and dampness accumulate, further aggravating the blockage of the heart meridian.The Suwen (Plain Questions) chapter on Bi syndrome states, "Pain is caused by excessive cold; pain arises from cold." This clearly indicates that both cold pathogens and emotional imbalances can exacerbate phlegm and blood stasis, thus inducing or aggravating chest pain and heart pain.

[0006] The TCM treatment principle for angina pectoris and angina pectoris of the phlegm-blood stasis type is based on "treating phlegm and blood stasis simultaneously, addressing both the root cause and the symptoms." The treatment method adheres to the main theme of "activating blood circulation and removing blood stasis, resolving phlegm and unblocking the meridians," while also considering auxiliary treatments such as strengthening the body's resistance, regulating qi, and dispelling cold. Activating blood circulation and removing blood stasis follows the principle of "smoothing the flow of blood and qi" from the *Suwen* (Plain Questions) section of the *Huangdi Neijing* (Yellow Emperor's Inner Classic), selecting medications that can clear stagnation in the heart vessels and improve blood circulation. Resolving phlegm and unblocking the meridians follows the method of "strengthening the spleen and removing dampness, warming and transforming phlegm," using medications that can eliminate phlegm and relieve obstruction in the heart vessels. This approach aligns with the pathological logic that "when phlegm and turbidity are cleared, the Qi mechanism is unblocked; when blood stasis is eliminated, the meridians are unobstructed." Since this disease is often rooted in a deficiency of vital energy, and is also influenced by emotional imbalances and invasion of cold pathogens, it is necessary to appropriately combine Qi-tonifying, Yang-warming, and Yin-nourishing herbs to strengthen the body's foundation. This is supplemented with Qi-regulating and cold-dispelling herbs to harmonize the Qi mechanism, expel cold pathogens, and eliminate the source of phlegm and blood stasis regeneration. Ultimately, the treatment goal of "eliminating blood stasis and phlegm, clearing the heart meridians, and restoring vital energy" is achieved. This approach not only relieves acute symptoms such as chest tightness and chest pain but also addresses the chronic and persistent pathogenesis of this disease, preventing recurrence.

[0007] There are many clinical methods for treating chest pain and angina pectoris caused by phlegm and blood stasis. The main principle is to treat it based on the theory of phlegm and blood stasis, using methods such as oral Chinese medicine, external Chinese medicine, and acupuncture to achieve the effects of tonifying qi and resolving phlegm, and promoting blood circulation and removing blood stasis. For example, Wang Li. The efficacy of Xuefu Zhuyu Decoction with modifications in the treatment of unstable angina pectoris of coronary heart disease and its influence on inflammatory factors [J]. Journal of Practical Traditional Chinese Internal Medicine, 2025, 39(08):141-143. This study included 80 patients with unstable angina pectoris of coronary heart disease, who were randomly divided into two groups. The study found that adding Xuefu Zhuyu Decoction with modifications could significantly promote the recovery of inflammatory factor levels, thereby improving the efficacy. Liang Xiuxiang. Clinical observation of 126 cases of chest pain and heart pain treated with traditional Chinese medicine [J]. Beijing Journal of Traditional Chinese Medicine, 1997, 16 (3): 28 - 29.: The study included 126 patients with chest pain and heart pain. According to the TCM syndrome differentiation, corresponding Chinese medicine prescriptions were used for treatment. The improvement of symptoms was observed. After treatment, the core symptoms such as chest tightness and palpitations were significantly relieved. Wang Changjian. Clinical observation of 32 cases of chest pain and heart pain of phlegm and blood stasis type treated with modified Gualou Xiebai Banxia Decoction and Xuefu Zhuyu Decoction [J]. New Journal of Traditional Chinese Medicine, 2013, 45 (08): 12 - 14.: The study selected 60 patients with chest pain and heart pain of phlegm and blood stasis type and randomly divided them into two groups. The combination of the two prescriptions played a role in promoting blood circulation and removing blood stasis, clearing the meridians and relieving pain, promoting yang and qi, and resolving phlegm and stagnation. Clinical observation confirmed that the tongue appearance and pulse were significantly improved. Zhao Wenting. Clinical observation on the treatment of phlegm-resolving and blood-stasis-removing formula combined with dual antiplatelet regimen for phlegm-stasis intertwined chest pain and heart pain [J]. Journal of Chengdu Medical College, 2024, 19 (06): 1044-1047.: Through randomized group comparison of 60 cases of phlegm-stasis intertwined chest pain and heart pain, it was found that the treatment group with added phlegm-resolving and blood-stasis-removing formula had better efficacy, which could effectively improve the TCM symptoms of patients, relieve inflammatory response and reduce myocardial damage, confirming the important role of treating phlegm and blood stasis together. Wang Chuanchi. Study on the evolution law of TCM syndrome in different development stages of coronary heart disease [J]. Chinese Journal of Traditional Chinese Medicine, 2019, 34(5): 2101-2106.: The study included a large number of coronary heart disease patients, including many cases of phlegm-stasis intertwined, to explore the evolution law of TCM syndrome in different development stages. The results showed that phlegm-stasis intertwined is a common syndrome in the middle stage of coronary heart disease. The corresponding TCM treatment is mainly based on phlegm-resolving and blood-activating formula, which can delay the progression of the syndrome to a more serious stage. Han Xuejie. Origin and innovation of phlegm-blood stasis syndrome in coronary heart disease [J]. Chinese Journal of Medicine, 2004, 19 (10): 623 - 625. Based on clinical cases, this paper traces the theoretical origin of phlegm-blood stasis syndrome in coronary heart disease and elaborates on its innovative treatment approach. By combining phlegm-resolving and blood-activating methods, it can effectively dredge the heart vessels and relieve pain.Meng Yuhang. Exploring the Prevention and Treatment of Coronary Heart Disease Based on the Theory of Latent Evils of "Phlegm, Blood Stasis, and Toxin" [J]. Chinese Journal of Emergency Medicine, 2020, 29 (2): 294 - 296.: This article combines clinical cases of chest pain with phlegm and blood stasis, and explores the prevention and treatment strategies of coronary heart disease based on the theory of latent evils of "phlegm, blood stasis, and toxin". It proposes that for the syndrome of phlegm and blood stasis, Chinese medicine prescriptions for resolving phlegm and promoting blood circulation can be used for early intervention to prevent phlegm and blood stasis from turning into toxins and aggravating the condition. Zhu Ruowei. Exploring the Medication Rules and Experiences of National Masters of Traditional Chinese Medicine in Treating Chest Pain with Phlegm and Blood Stasis Syndrome Based on Data Mining [J]. Western Journal of Traditional Chinese Medicine, 2024, 37 (03): 28 - 31.: This study retrieved prescriptions from relevant databases for treating chest pain with phlegm and blood stasis syndrome by National Masters of Traditional Chinese Medicine, and conducted statistical analysis on the prescriptions using the Traditional Chinese Medicine Inheritance Assistance Platform V3.0. The results showed that the treatment of this disease mainly focused on promoting blood circulation, removing blood stasis, replenishing qi, and resolving phlegm. High-frequency drugs included Danshen and Chuanxiong, while Trichosanthes kirilowii and Allium macrostemon were commonly used drug pairs.

[0008] In addition to oral Chinese medicine, there are also external Chinese medicine treatments. External Chinese medicine treatments for chest pain and heart pain caused by phlegm and blood stasis use acupoint application, moxibustion, and acupuncture as the core, combined with methods such as iontophoresis of Chinese medicine, hot compress, and cupping. Through the conduction pathway of "body surface-meridians-internal organs", the goal of "resolving phlegm and removing blood stasis, promoting yang and relieving pain" is achieved.

[0009] The theories and practices of external treatment for chest pain and angina pectoris caused by phlegm and blood stasis in Traditional Chinese Medicine (TCM) largely originate from classic ancient texts such as the *Huangdi Neijing* and *Zhenjiu Dacheng*. The *Suwen* (Plain Questions) chapter "On Pain" states that "when cold qi invades the back meridians, the meridians become blocked; when the meridians are blocked, blood is deficient; when blood is deficient, pain occurs. Since the meridians are connected to the heart, the pain is aggravated by the blockage." This indicates that cold pathogens causing meridian obstruction can trigger chest pain. The *Lingshu* (Spiritual Pivot) chapter "On Reversal of Qi" explicitly lists acupoints for treating different types of chest pain, such as Dadu and Taibai for stomach-related chest pain, and Rangu and Taixi for spleen-related chest pain. These acupoints can often be used in combination for chest pain and angina pectoris caused by phlegm and blood stasis. *Zhenjiu Juying* (Collection of Acupuncture and Moxibustion) specifically compiles acupuncture point selection and methods related to chest pain and angina pectoris, providing highly valuable clinical guidance. The book proposes acupuncture treatment for chest pain using acupoints such as Taixi, Rangu, Chize, and Shenmen. It also inherits the theories of the *Neijing* (Inner Canon of Medicine), incorporating the Five Shu Points and Eight Extraordinary Vessels into the treatment of chest pain, providing specific solutions for phlegm-blood stasis type chest pain by unblocking the meridians and resolving phlegm and blood stasis through acupuncture. *The Great Compendium of Acupuncture and Moxibustion* systematically organizes the experience of acupuncture treatment for chest pain throughout history, supplementing many suitable acupoints and acupuncture techniques for chest pain. It also records methods of moxibustion treatment for chest diseases, such as moxibustion on acupoints like Xinshu and Tanzhong. These methods can be directly applied to phlegm-blood stasis type chest pain, using acupuncture stimulation to unblock qi and blood, and resolve phlegm and blood stasis. The book "Waitai Miyao" records methods for treating chest pain by applying ointments or powders to the chest or related acupoints. Some prescriptions contain blood-activating and stasis-removing drugs such as Danshen and Chuanxiong, which are consistent with the external treatment approach for chest pain caused by phlegm and blood stasis. This provides a prescription reference for later generations of external treatment methods such as acupoint application and hot compress with Chinese medicine.

[0010] Current research on traditional Chinese medicine (TCM) for angina pectoris of the phlegm-blood stasis type generally suffers from short observation periods and small sample sizes. Furthermore, some TCM preparations have unpleasant tastes, and given the protracted nature of the disease and the need for long-term medication, patient compliance is significantly affected. In addition, the TCM diagnosis of angina pectoris of the phlegm-blood stasis type is complex, often involving different patterns such as qi deficiency and yin deficiency, and the degree and stage of phlegm-blood stasis vary among individuals. Existing TCM preparations are insufficient to fully meet the diverse clinical treatment needs. Therefore, there is an urgent need to develop TCM preparations that are more clinically relevant, have strong diagnostic adaptability, are convenient to take, and have high patient compliance to improve the clinical efficacy of this disease. Summary of the Invention

[0011] This invention provides a traditional Chinese medicine composition for treating and / or adjunctive treating chest pain and angina pectoris of the phlegm-blood stasis type. This invention also provides a method for preparing the traditional Chinese medicine composition and its uses.

[0012] This invention provides a traditional Chinese medicine composition for treating and / or adjunctive treating chest pain and angina pectoris of the phlegm-blood stasis type. It is prepared from the following raw materials in the indicated weight ratios:

[0013] Trichosanthes peel 160-240 parts, Panax notoginseng 160-240 parts, Salvia miltiorrhiza 160-240 parts, Carthamus tinctorius 160-240 parts, Crataegus pinnatifida 160-240 parts, American ginseng 160-240 parts, Amber 160-240 parts.

[0014] More preferably, it is prepared from the following raw materials in the indicated weight ratios:

[0015] 200 parts of Trichosanthes peel, 200 parts of Panax notoginseng, 200 parts of Salvia miltiorrhiza, 200 parts of Carthamus tinctorius, 200 parts of charred hawthorn, 200 parts of American ginseng, and 200 parts of amber.

[0016] The traditional Chinese medicine composition of the present invention is prepared into a commonly used pharmaceutical formulation by adding pharmaceutically acceptable excipients or auxiliary ingredients, using the raw drug powder, water or organic solvent extract as the active ingredient.

[0017] The preparations mentioned are tablets, capsules, pills, granules, and oral solutions.

[0018] The present invention also provides a method for preparing the traditional Chinese medicine composition for treating and / or adjuvantly treating phlegm-blood stasis type chest pain, which includes the following steps:

[0019] a. Weigh the raw materials according to the specified weight ratio;

[0020] b. The raw drug is ground into powder, or extracted by boiling with water, filtered, concentrated, and then acceptable excipients or auxiliary ingredients are added to prepare commonly used preparations.

[0021] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating or / and adjuvant treating phlegm-blood stasis type chest pain.

[0022] Preferably, the drug is a treatment or / and adjunctive treatment for chest pain and heart pain caused by phlegm and blood stasis syndrome, used to relieve symptoms such as chest tightness, chest pain, palpitations, shortness of breath, fatigue, dizziness, headache, or irritability and insomnia.

[0023] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of drugs with the functions of promoting blood circulation and relieving pain, resolving phlegm and unblocking collaterals, and calming the mind and soothing the nerves.

[0024] This invention relates to a medicine primarily used to treat chest tightness, chest pain, palpitations, shortness of breath, fatigue, dizziness, headache, irritability, and insomnia caused by phlegm and blood stasis in coronary heart disease, cerebral arteriosclerosis, and internal carotid artery atherosclerosis. The formula uses Trichosanthes peel to relieve chest tightness and resolve phlegm, regulate qi and disperse stagnation, and Panax notoginseng powder to resolve blood stasis and relieve pain, serving as the principal herbs. Salvia miltiorrhiza, Carthamus tinctorius, and Crataegus pinnatifida (roasted) invigorate blood circulation, unblock collaterals, promote qi circulation, disperse blood stasis, and relieve pain, serving as the assistant herbs. American ginseng tonifies qi and nourishes yin to prevent excessive qi depletion and damage to the body's vital energy, while amber calms the mind and soothes the nerves, serving as the adjuvant herbs. The entire formula primarily uses qi-regulating and blood-activating herbs, combined with qi-tonifying and mind-calming herbs, to achieve the goal of invigorating blood circulation without harming the body's vital energy, and tonifying deficiency without retaining pathogenic factors. The formula combines disease and syndrome differentiation, with the prescription based on the treatment principle, and the principle established according to the syndrome. The entire formula employs both tonifying and purging methods to achieve the effects of invigorating blood circulation, unblocking collaterals, resolving blood stasis, relieving pain, calming the mind, and soothing the nerves.

[0025] It is mainly used to promote blood circulation and relieve pain, resolve phlegm and unblock collaterals, calm the mind and soothe the nerves. It is mainly used for chest tightness, chest pain, palpitations, shortness of breath, fatigue, dizziness, headache, irritability and insomnia caused by phlegm and blood stasis in coronary heart disease, cerebral arteriosclerosis and carotid artery atherosclerosis.

[0026] This invention relates to a pure traditional Chinese medicine preparation with a rational formulation, definite efficacy, high patient acceptance, and few adverse reactions. The TCM diagnosis of phlegm-blood stasis type chest pain is complex, often involving different syndromes such as qi deficiency and yin deficiency. Furthermore, the degree and stage of phlegm-blood stasis vary among individuals. Existing TCM preparations are insufficient to fully meet the diverse clinical treatment needs. This invention provides a TCM preparation that is more clinically relevant, has strong diagnostic compatibility, is convenient to take, and has high patient compliance, thereby improving the clinical efficacy of this disease. Detailed Implementation

[0027] Example 1: Preparation of the oral liquid of traditional Chinese medicine of the present invention

[0028] Weigh out the raw materials: 200g of Trichosanthes peel, 200g of Panax notoginseng, 200g of Salvia miltiorrhiza, 200g of Carthamus tinctorius, 200g of charred hawthorn, 200g of American ginseng, and 200g of amber, and prepare 1000ml of oral liquid.

[0029] The specific preparation process is as follows:

[0030] Step 1: Prepare medicinal materials: Weigh and select equal amounts of the main medicinal materials, including Trichosanthes peel, Panax notoginseng, Salvia miltiorrhiza, Carthamus tinctorius, Crataegus pinnatifida, Panax quinquefolius, and Amber, as well as the excipient ethylparaben.

[0031] Step 2, Soaking: Put the main medicinal materials prepared in Step 1 into the extraction tank, and add 10 times the amount of water to soak for 0.5 hours;

[0032] Step 3, heating and cooking: Steam is introduced into the extraction tank from Step 2 through a jacketed kettle and heated to boiling, then extracted by gentle boiling for 1.5 hours;

[0033] Step 4, Filtration and Extraction: After filtering the medicinal liquid through the extraction tank, pump it into the storage tank. Add 8 times the amount of water to the dregs and extract by gentle boiling for 1.5 hours. Then, filter the medicinal liquid through the extraction tank again and pump it into the storage tank. Add 8 times the amount of water to the dregs and extract by gentle boiling for 1.5 hours in the same way, and obtain the filtrate.

[0034] Step 5, Concentration: Combine the filtrate from the storage tank in Step 4 and slowly introduce it into the concentration tank. When the liquid level rises to a level sufficient to form a circulation, heat and cook the filtrate inside the concentration tank through a jacketed kettle and slowly open the steam valve to obtain a concentrated liquid.

[0035] Step 6, Centrifugal Filtration: The concentrate obtained in Step 5 after being concentrated in the concentration tank is centrifuged and filtered to obtain centrifuged liquid;

[0036] Step 7, Mixing and Preparation: Add the centrifuged liquid obtained in Step 6 into the mixer, and add the auxiliary materials prepared in Step 1 into the mixer and mix them together. Finally, add water into the mixer and stir evenly to obtain a homogeneous liquid.

[0037] Step 8, Filling: The mixed liquid obtained in Step 7 is filled into containers using the filling production line.

[0038] Step 9, Packaging: The semi-finished product from Step 8 is packaged separately through the packaging line.

[0039] Usage and dosage

[0040] Dosage and administration: Oral administration, 10-20ml each time (the dosage of raw medicine is 14-28g each time), 3 times a day. Shake well before use.

[0041] Example 2: Preparation of the traditional Chinese medicine composition of the present invention

[0042] Weigh out the raw materials:

[0043] 160g of Trichosanthes peel, 160g of Panax notoginseng, 160g of Salvia miltiorrhiza, 160g of Carthamus tinctorius, 160g of charred hawthorn, 160g of American ginseng, and 160g of amber are decocted in water, filtered, and starch is added to the concentrated liquid. The mixture is then granulated and sized to prepare granules.

[0044] Example 3: Preparation of the traditional Chinese medicine composition of the present invention

[0045] 240g of Trichosanthes peel, 240g of Panax notoginseng, 240g of Salvia miltiorrhiza, 240g of Carthamus tinctorius, 240g of charred hawthorn, 240g of American ginseng, and 240g of amber are added to water, decocted, filtered, and starch is added to the concentrated liquid. The mixture is then granulated, sized, and filled into capsules to prepare capsules.

[0046] The following clinical trials demonstrate the beneficial effects of this invention.

[0047] Example 1: Clinical Trial of the Drug of the Invention

[0048] I. Experimental Objective: To preliminarily evaluate the efficacy and safety of the traditional Chinese medicine composition of the present invention (hereinafter referred to as "Shuangshen Tongxin Compound") prepared in Example 1.

[0049] II. Number of participants:

[0050] Treatment group: 50 subjects

[0051] Control group 1: 50 subjects

[0052] Control group 2: 50 subjects.

[0053] Please specify which type of participant is included in the following inclusion criteria?

[0054] Among them, the subjects were diagnosed with coronary heart disease after PCI in Western medicine, and their TCM syndrome was classified as phlegm and blood stasis syndrome.

[0055] III. Selection and Exclusion Criteria:

[0056] 1. Selection criteria:

[0057] (1) Western medicine diagnostic criteria:

[0058] The diagnostic criteria for stable angina after PCI are based on the "Guidelines for the Diagnosis and Treatment of Chronic Stable Angina":

[0059] (1) Stable angina is a type of exertional angina. The condition is stable for one month or more, and paroxysmal chest pain is the main clinical manifestation.

[0060] ①Location of pain: Located behind the sternum, in the left anterior chest area, not limited to a specific area, and may radiate to the neck and throat, left arm, and the inner side of the left fingers, etc. It is not only located in the chest, but may also be located in the upper abdomen, etc.

[0061] ② Nature of the pain: It is often described as a feeling of pressure, burning, squeezing, or tightness. Some patients only experience chest discomfort, and the subjective feeling varies greatly from person to person, but it is not like a sharp pain such as needle pricks or stabbing.

[0062] ③ Duration: Paroxysmal attacks, generally lasting from several minutes to more than ten minutes, mostly 3-5 minutes, and not exceeding 30 minutes.

[0063] ④ Triggering factors: Mostly triggered by physical labor or emotional excitement, such as brisk walking or running. Symptoms can usually be relieved after rest. Symptoms occur at the time of exertion or emotional excitement, rather than after exertion or emotional excitement.

[0064] ⑤ Relief method: Sublingual administration of nitrate drugs such as nitroglycerin provides relief within minutes.

[0065] (2) A history of myocardial infarction lasting more than 3 months.

[0066] (3) Previous history of coronary revascularization > 6 months (such as PCI history or coronary artery bypass grafting history).

[0067] (4) Undergo coronary angiography, and the angiography results show that at least one coronary artery has stenosis ≥50%.

[0068] (5) The exercise stress test showed a positive result.

[0069] A diagnosis can be made if (1) is present and any one of (2) to (5) is present.

[0070] (2) Traditional Chinese Medicine diagnostic criteria:

[0071] Based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" edited by Zheng Xiaoyu in 2002, the following TCM diagnostic criteria for angina pectoris in coronary heart disease of the phlegm-blood stasis type are formulated:

[0072] Main symptom: Chest tightness or chest pain

[0073] Secondary symptoms: ① palpitations and shortness of breath; ② coughing up phlegm; ③ heaviness in the head and body; ④ purplish lips

[0074] Tongue and pulse: The tongue is dark purple (or has ecchymosis, spots, or tortuous and bluish-purple veins under the tongue), and the pulse is deep, slippery, wiry, and hesitant.

[0075] A diagnosis can be made based on the presence of two or more primary and secondary symptoms, combined with tongue and pulse examination.

[0076] 2. Exclusion criteria:

[0077] (1) Those whose chest pain is confirmed by examination to be caused by other heart diseases, severe neurosis, menopausal syndrome or other diseases;

[0078] (2) Patients with severe arrhythmia (persistent atrial fibrillation, second-degree or higher atrioventricular block) or severe acute or chronic heart failure (NYHA class IV), sick sinus syndrome, or glaucoma; patients with heart rate <55 beats / min or blood pressure higher than 170 / 110 mmHg.

[0079] (3) Patients with coronary heart disease who have undergone coronary artery bypass grafting or interventional therapy and whose blood vessels have been completely reconstructed, but who do not have typical angina pectoris;

[0080] (4) Patients with serious primary diseases of the liver, kidneys, hematopoietic system, etc., with liver function (ALT, AST) > 60u / L or renal insufficiency (decompensated stage);

[0081] (5) Pregnant or lactating women;

[0082] (6) Those who have undergone surgery within the past 4 weeks or have a tendency to bleed;

[0083] (7) Those with contraindications to external counterpulsation;

[0084] (8) Individuals with limb movement disorders;

[0085] (9) Individuals with mental illness or other conditions that prevent them from cooperating with the test;

[0086] (10) Co-infection, connective tissue disease, immune system disease, tumor;

[0087] (11) Individuals who have participated in other clinical trials within the past month;

[0088] (12) Individuals with allergic constitutions or allergies to any component of the test drug;

[0089] (13) Those with poor compliance or who are not expected to complete this study;

[0090] (14) Those who refuse or are unable to sign the informed consent form.

[0091] Those who meet the above inclusion criteria will be included in the research project.

[0092] IV. Conventional Western medicine treatments:

[0093] Enteric-coated aspirin tablets (specification: 100mg, batch number: National Drug Approval Number HJ20160685) 100mg once daily (taken on an empty stomach)

[0094] Clopidogrel sulfate tablets (specification: 75mg, batch number: H20140965) 75mg once daily;

[0095] Metoprolol succinate extended-release tablets (specifications: 47.5mg; 95mg, batch number: National Drug Approval Number J20150044) 47.5mg once daily;

[0096] Atorvastatin Calcium Tablets (Specifications: 10mg; 20mg, Batch No.: National Drug Approval Number H20133127) 20mg once a night before bedtime.

[0097] Control group 1: In addition to routine Western medicine treatment, Gualou Xiebai Banxia Decoction was administered, 100ml each time, 3 times a day.

[0098] Control group 2: Received conventional Western medicine treatment;

[0099] Treatment group: In addition to routine Western medicine treatment, Shuangshen Tongxin Mixture was administered orally, 10ml each time, 3 times a day.

[0100] V. Evaluation Criteria:

[0101] Key efficacy indicators: Angina symptom scores (severity, duration, and frequency of attacks) were observed in three groups before and after treatment. Electrocardiogram (ECG) changes were compared and analyzed. The efficacy evaluation and scores of traditional Chinese medicine (TCM) syndromes were compared between the two groups. Lipid profiles included total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C), which were recorded. BNP, echocardiography, and cardiac function tests (LVEF, LVESD, LVEDD) were performed once before and once after treatment. The Seattle Angina Scale (SAQ) was used for assessment before treatment, one month after treatment, and two months after treatment.

[0102] Safety evaluation standards

[0103] Level 1: Safe, no adverse reactions.

[0104] Grade 2: Relatively safe. If adverse reactions occur, no treatment is required and medication can continue.

[0105] Level 3: There are safety concerns and moderate adverse reactions. After treatment, medication can continue.

[0106] Level 4: Trial discontinued due to adverse reaction.

[0107] VI. Statistical Methods:

[0108] SPSS 29.0 software was used for data processing. Measurement data were expressed as mean (±) and standard deviation (X ± s). Independent t-tests were used for within-group comparisons, paired t-tests were used for between-group comparisons, nonparametric tests were performed for non-normal distributions, chi-square tests were used for categorical data, and rank-sum tests were used for ordinal data. P < 0.05 was considered statistically significant, and P < 0.01 was considered highly statistically significant.

[0109] VII. Results and Conclusions:

[0110] result:

[0111] Table 1 Comparison of baseline data among the three groups before medication

[0112]

[0113] Note: Before medication, the baseline scores of the three groups were compared. The p-value was >0.05, indicating no statistically significant difference. The three groups were comparable.

[0114] Table 2 Comparison of angina symptom scores before and after treatment in the three groups

[0115]

[0116] Note: For the comparison of angina symptom scores before and after treatment in the three groups, the P value was <0.05. For the comparison of angina symptom scores between the three groups before and after treatment, the P value was <0.001. The differences were statistically significant.

[0117] Table 3 Comparison of ECG changes before and after treatment in the three groups

[0118]

[0119] Note: There was no statistically significant difference in electrocardiogram changes before and after treatment among the three groups (P > 0.05).

[0120] Table 4 Comparison of blood lipid changes before and after treatment in the three groups

[0121]

[0122] Note: There was no statistically significant difference in blood lipid changes before and after treatment among the three groups (P > 0.05).

[0123] Table 5 Comparison of changes in echocardiogram results before and after treatment in the three groups

[0124]

[0125] Note: In the comparison of LVEF, LVESD, and LVEDD before and after treatment in the three groups of echocardiogram results, the P values ​​were all <0.05, indicating statistically significant differences.

[0126] Table 6 Comparison of Seattle Angina Scale (SAQ) scores before and after treatment in the three groups

[0127]

[0128] Note: For the Seattle Angina Scale (SAQ) scores, the differences between the three groups before and 2 months after treatment were statistically significant (P < 0.05). The differences between the groups were also statistically significant (P < 0.05).

[0129] Table 7 Comparison of TCM syndrome scores among the three groups

[0130]

[0131] Note: The comparison of TCM symptom scores before and after treatment in the three groups showed a statistically significant difference (P < 0.05).

[0132] Table 8 Comparison of TCM syndrome efficacy scores between the two groups

[0133]

[0134] Note: The total effective rate of the treatment group was higher than that of control group 1 and control group 2. The overall χ² of the three groups was 12.896, P < 0.05, and the difference was statistically significant.

[0135] Safety indicators:

[0136] Two patients in the treatment group experienced mild gastrointestinal reactions, manifested as dull pain in the upper abdomen, which were significantly relieved after symptomatic treatment. In the control group, one patient developed subcutaneous bruising and two patients experienced minor gingival bleeding. Under the guidance of a specialist, it was recommended to reduce the dosage of enteric-coated aspirin and clopidogrel orally, and the symptoms were significantly reduced after the dosage was reduced.

[0137] in conclusion:

[0138] Both the treatment and control groups showed improvement in angina symptoms, and statistically significant changes were observed in Seattle Angina Scale (SAQ) scores, TCM syndrome scores, and cardiac function before and after treatment within each group. However, the treatment group showed significantly better results than the two control groups after two months. All three groups had some impact on patients' blood lipid levels and electrocardiogram changes, but there were no significant differences among the three groups. This suggests that adding Shuangshen Tongxin Mixture to routine Western medicine treatment for patients with phlegm-blood stasis type coronary artery disease after PCI can effectively alleviate the clinical symptoms and pain intensity of angina, reduce the frequency and duration of angina attacks, and also has a significant therapeutic effect on improving cardiac function.

[0139] In summary, Shuangshen Tongxin Mixture can effectively improve the clinical symptoms and cardiac function of patients with phlegm-blood stasis type coronary heart disease after PCI, effectively improve their quality of life, and produce few adverse reactions. Its clinical safety is reliable and worthy of promotion and application in clinical practice.

Claims

1. A traditional Chinese medicine composition for treating or / and adjuvant treating chest pain and heart pain of phlegm and blood stasis type, characterized in that, Prepared from the following raw materials in the indicated weight ratios: Trichosanthes peel 160-240 parts, Panax notoginseng 160-240 parts, Salvia miltiorrhiza 160-240 parts, Carthamus tinctorius 160-240 parts, Crataegus pinnatifida 160-240 parts, American ginseng 160-240 parts, Amber 160-240 parts.

2. The traditional Chinese medicine composition for treating or / and adjuvant treatment of phlegm-blood stasis type chest pain according to claim 1, characterized in that, Prepared from the following active pharmaceutical ingredients in the indicated weight ratios: 200 parts of Trichosanthes peel, 200 parts of Panax notoginseng, 200 parts of Salvia miltiorrhiza, 200 parts of Carthamus tinctorius, 200 parts of charred hawthorn, 200 parts of American ginseng, and 200 parts of amber.

3. The traditional Chinese medicine composition of claim 1 or 2 for treating or / and adjuvant treating chest pain and heart pain of phlegm and blood stasis type, characterized in that, It is prepared into a pharmaceutically commonly used formulation by adding pharmaceutically acceptable excipients or auxiliary ingredients to the active ingredient, which is the original drug powder, water or organic solvent extract of the active pharmaceutical ingredient.

4. The traditional Chinese medicine composition of claim 3 for treating or / and adjuvant treating chest pain due to phlegm and blood stasis, characterized in that: The preparations mentioned are tablets, capsules, pills, granules, and oral solutions.

5. The preparation method of the traditional Chinese medicine composition for treating or / and adjuvant treating chest pain and angina pectoris of phlegm and blood stasis type according to any one of claims 1-4, characterized in that: It includes the following steps: a. Weigh the raw materials according to the specified weight ratio; b. The raw drug is ground into powder, or extracted by boiling with water, filtered, concentrated, and then acceptable excipients or auxiliary ingredients are added to prepare commonly used preparations.

6. Use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicament for treating or / and adjuvant treatment of phlegm-blood stasis type chest pain.

7. Use according to claim 6, characterized in that, The drug is used to treat chest pain and heart pain caused by phlegm and blood stasis syndrome, and is used to relieve symptoms such as chest tightness, chest pain, palpitations, shortness of breath, fatigue, dizziness, headache, or irritability and insomnia.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicine having the functions of promoting blood circulation and relieving pain, resolving phlegm and unblocking collaterals, and calming the mind and soothing the nerves.

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