A traditional Chinese medicine composition, preparation and application for treating qi deficiency and blood stasis type of coronary heart disease angina pectoris or post-PCI angina pectoris

Abstract

The application discloses a traditional Chinese medicine composition, preparation and application for treating coronary heart disease angina pectoris or post-PCI angina pectoris of the type of qi deficiency and blood stasis. The traditional Chinese medicine composition is composed of the following raw medicinal materials in weight: 30-40g of Astragalus membranaceus, 20-30g of Pueraria lobata, 10-15g of Rhodiola, 10-15g of Curcuma zedoary, 10-15g of Acorus gramineus Soland and 10-15g of Notopterygium. The application of the traditional Chinese medicine composition is used in the preparation of a medicine for treating coronary heart disease angina pectoris or post-PCI angina pectoris of the type of qi deficiency and blood stasis. The traditional Chinese medicine composition has the effects of treating both the root cause and symptoms and strengthening the body resistance and eliminating pathogenic factors on the coronary heart disease angina pectoris or post-PCI angina pectoris caused by qi deficiency and blood stasis, and can simultaneously supplement qi and raise yang, activate blood and remove stasis, and not forget to strengthen analgesia and warm and resolve cold phlegm, and give consideration to both the main and the secondary. The traditional Chinese medicine composition is well matched, can significantly improve the chest distress and chest pain symptoms of patients, and the total effective rate of the TCM syndrome curative effect reaches 90%.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine composition and preparation, and particularly relates to a traditional Chinese medicine composition, preparation and application for treating coronary heart disease angina pectoris or PCI postoperative angina pectoris of qi deficiency and blood stasis type. BACKGROUND

[0002] Angina pectoris belongs to the category of "chest impediment" and "heart pain" in traditional Chinese medicine. The symptoms of chest impediment were first recorded in Huangdi Neijing (The Yellow Emperor's Classic of Internal Medicine). It is stated in Suwen (Plain Questions) that "heart disease is chest pain …… pain under the armpit, pain between the clavicle and scapula, and pain in both arms", which is similar to the clinical manifestations of angina pectoris in modern medicine. Zhang Zhongjing clearly proposed the disease name of "chest impediment" in Shanghan Lun (Treatise on Febrile Diseases). It is recorded in Jinkui Yaolue (Synopsis of Golden Chamber) that "chest impediment is a disease with wheezing, coughing, sputum, chest and back pain, shortness of breath …… tightness and pain in the upper chest", which is basically consistent with the symptoms of coronary heart disease angina pectoris. It is also stated in Taiping Shenghui Fang (Peaceful Benevolent Prescriptions) that "heart deficiency causes evil to attack it, and the evil accumulates and does not leave …… the heart feels full and painful, which is called chest impediment". It is pointed out that the occurrence of chest impediment is due to deficiency of heart qi and yang, which cannot solidify, warm and nourish blood vessels, and the internal and external evils invade the body, so the heart is painful, and the pathogenic factor is blood stasis. Research has found that "deficiency in the root and excess in the branch" is the basic pathogenesis of coronary heart disease. The excess in the branch is blood stasis, phlegm turbidity, cold stagnation, qi stagnation and stasis heat, and blood stasis is considered to be the most important syndrome element, followed by phlegm turbidity. The deficiency in the root includes qi deficiency, yin deficiency, yang deficiency and yang collapse, and qi deficiency is the most common syndrome element. There is a mixture of deficiency and excess, with qi deficiency as the root and blood stasis as the branch. Qi deficiency cannot promote blood circulation, so blood vessels are stagnant, and pain occurs when blood vessels are not unobstructed. Qi deficiency causes blood to be unable to be produced, and the heart is unable to be nourished, so pain occurs when the heart is not nourished. PCI is currently a widely recognized effective method for treating high-risk coronary heart disease, but a small number of patients still have different degrees of chest pain recurrence and coronary artery restenosis after successful PCI. Traditional Chinese medicine believes that coronary intervention can damage the local vessels of the dilated part, causing damage to the vessels and aggravating the degree of qi deficiency, slow blood flow, and easy stagnation of blood in the vessels, leading to the formation of stasis and other tangible evils. Therefore, on the basis of qi deficiency and blood stasis as the main symptom factors of chest impediment, the degree of qi deficiency and blood stasis is further aggravated after the operation, which is the main pathogenesis of PCI postoperative angina pectoris. How to better prevent and treat coronary heart disease PCI postoperative angina pectoris has become an important topic in current medical research. While actively applying modern medicine for treatment, combined with traditional Chinese medicine syndrome differentiation and treatment, it can more effectively relieve the clinical symptoms and prognosis of patients after coronary intervention. Existing research shows that traditional Chinese medicine has better clinical effects in improving microcirculatory disturbance after PCI, no-reflow after PCI, and can also improve electrocardiogram performance, reduce organ damage, reduce anxiety and depression symptoms, and further improve the quality of life of patients, which is helpful for the early recovery of patients after PCI, and has great potential for clinical application. SUMMARY

[0003] The first objective of this invention is to provide a traditional Chinese medicine composition for treating angina pectoris in patients with qi deficiency and blood stasis or angina pectoris after PCI. A further objective is to provide the formulation and application of this traditional Chinese medicine composition.

[0004] The first objective of this invention is achieved as follows: the traditional Chinese medicine composition for treating angina pectoris of coronary heart disease of qi deficiency and blood stasis type and angina pectoris after PCI is composed of the following raw materials by weight: Astragalus membranaceus 30-40g, Pueraria lobata 20-30g, Rhodiola rosea 10-15g, Curcuma longa 10-15g, Acorus tatarinowii 10-15g, and Notopterygium incisum 10-15g.

[0005] A further objective is achieved by preparing a traditional Chinese medicine composition for treating angina pectoris of coronary heart disease with qi deficiency and blood stasis or angina pectoris after PCI, by adding medically acceptable excipients to the traditional Chinese medicine composition, and preparing it into any one of the following forms: decoction, granules, pills, tablets, capsules, ointments, syrups, powders, and powders.

[0006] The application of the traditional Chinese medicine composition is in the preparation of drugs for treating angina pectoris of coronary heart disease with qi deficiency and blood stasis type and angina pectoris after PCI.

[0007] The inventors discovered that chest pain and angina pectoris are multifactorial diseases, caused by both internal and external factors. The *Suwen* (Plain Questions) chapter on Bi syndrome states, "If the obstruction of the pulse does not subside, and is further aggravated by pathogenic factors, it will lodge internally in the heart. In cases of heart obstruction, the pulse is blocked, and there is restlessness with a throbbing sensation in the epigastrium," suggesting a connection between chest pain and external pathogenic factors and blood stasis. Blood stasis leads to pain. The *Jizhitang Medical Cases* states, "Chest pain radiating to the back is called chest pain… This disease is not only caused by phlegm and turbidity, but also by blood stasis obstructing the passageways." The *Maiyin Zhengzhi* (Pulse Etiology and Treatment) states, "The cause of chest pain is phlegm stagnation and blood stasis," indicating that chest pain, besides blood stasis causing obstruction of the heart's blood vessels due to "blood stagnation and lack of flow," also includes the pathological factor of phlegm stagnation. The *Jingui Yaolue* (Essential Prescriptions of the Golden Chamber) states in its chapter on chest pain, heart pain, and shortness of breath: "When Yang is weak and Yin is wiry, chest pain occurs. The reason for this is extreme deficiency." This clarifies that the pathogenesis of chest pain is deficiency of Yang in the upper Jiao (upper burner), resulting in insufficient warming and propulsion of the chest, ultimately leading to the upward movement of pathogenic factors such as phlegm, blood stasis, and cold, which obstruct the heart vessels and cause heart pain. The *Neijing* (Inner Canon of Medicine) records, "The heart is the great master of the five viscera and six bowels, the abode of the spirit." When the heart Qi is abundant, "its organs are firm and strong, and evil cannot tolerate it." The *Lingshu* (Spiritual Pivot), in its chapter on the nine needles and twelve origins, states, "The Taiyang (Greater Yang) within Yang is the heart." This means that the heart Qi is the Taiyang within Yang. Qi and blood represent Yin and Yang in the human body. "Qi is the commander of blood, and blood is the mother of Qi." "When Qi flows, blood flows; when Qi stagnates, blood stagnates." The *Treatise on Blood Disorders* states, "Knife wounds involve blood in the qi aspect, therefore it is appropriate to replenish qi to generate blood. When qi reaches the affected area, it can regenerate tissue; when qi fills the skin, it can circulate blood." After PCI, blood vessels are damaged, and the body's vital energy is deficient. Qi cannot generate and circulate blood, leading to blood stasis and obstruction of the collaterals, causing heart vessel blockage and recurrence of chest pain. Chest pain due to qi deficiency and blood stasis is rooted in qi deficiency and manifested by blood stasis. Various symptoms of qi deficiency are interdependent; qi deficiency leads to yang deficiency, which in turn generates cold. Cold congeals the body's fluids, hindering their circulation and easily forming phlegm. Therefore, qi deficiency is often accompanied by cold-induced phlegm obstruction. Qi and blood are mutually generative; qi deficiency weakens blood circulation, leading to stasis, while abundant qi promotes the healthy circulation of blood, improves myocardial microcirculation, and prevents blood stasis. Therefore, replenishing qi, activating blood circulation, and removing blood stasis are key to treating this condition. Therefore, based on a review of recent literature reports and clinical experience regarding the treatment of angina pectoris in coronary heart disease and post-PCI angina, the inventors proposed that the pathogenesis of coronary heart disease and post-PCI angina is fundamentally based on qi deficiency and blood stasis, complicated by cold stagnation and phlegm obstruction. They suggested that the treatment of angina pectoris and post-PCI angina should focus on tonifying qi, promoting blood circulation, and removing blood stasis, while also warming and resolving cold phlegm. Based on this, they diligently developed a combination of traditional Chinese medicine for the treatment of angina pectoris and post-PCI angina.

[0008] This formula primarily targets deficiency of vital energy, leading to impaired blood production and circulation, resulting in blood stasis obstructing the meridians, blocking the heart vessels, and causing recurring chest pain. The overall principle of the formula is to tonify qi, invigorate blood, and remove blood stasis. It uses methods to strengthen the body's resistance, tonify heart qi, assist the heart in circulating blood, dispel cold, resolve phlegm, disperse blood stasis, and relieve pain. Astragalus is the principal herb, entering the spleen and lung meridians. It has a ascending and stopping effect, utilizing its function of tonifying spleen qi and raising yang. Kudzu root and Rhodiola rosea are the assistant herbs. Kudzu root not only assists Astragalus in tonifying qi and raising yang, but also unblocks the meridians, relieves spasms and pain. Rhodiola rosea invigorates qi and invigorates blood, strengthening its qi-tonifying and pain-relieving effects. Curcuma, bitter, pungent, and cold, is added as an adjuvant. Its pungent nature allows it to move and disperse, invigorating blood and relieving pain. As a qi-regulating herb in the blood, it can both invigorate blood and regulate qi and relieve stagnation. Acorus tatarinowii is bitter, pungent, and warm, entering the heart meridian, warming yang and resolving phlegm. The formula works synergistically to replenish qi and blood, resolve blood stasis and relieve pain, while also warming and resolving phlegm-cold.

[0009] This invention addresses both the root cause and symptoms of angina pectoris in coronary heart disease caused by Qi deficiency and blood stasis, as well as angina pectoris after PCI. It strengthens the body's resistance and eliminates pathogenic factors. While tonifying Qi and promoting Yang, invigorating blood and removing blood stasis, it also strengthens pain relief and warms and resolves phlegm, thus balancing primary and secondary effects. The precise formulation of this invention can significantly improve patients' symptoms of chest tightness and chest pain, with a total effective rate of 90% according to Traditional Chinese Medicine syndrome differentiation. For some patients with coronary heart disease and those who still experience chest tightness and chest pain after PCI surgery, it not only provides satisfactory short-term efficacy but also improves their quality of life. Detailed Implementation

[0010] The present invention will be further described below with reference to embodiments, but this is not intended to limit the present invention in any way. Any modifications or substitutions made based on the teachings of the present invention shall fall within the protection scope of the present invention.

[0011] This invention discloses a traditional Chinese medicine composition for treating angina pectoris in patients with qi deficiency and blood stasis or angina pectoris after PCI, which is composed of the following raw materials by weight: Astragalus membranaceus 30-40g, Pueraria lobata 20-30g, Rhodiola rosea 10-15g, Curcuma longa 10-15g, Acorus tatarinowii 10-15g, and Notopterygium incisum 10-15g.

[0012] The herbal composition contains 10-15g of Trichosanthes peel, 10-15g of Pinellia ternata, 10-15g of Allium macrostemon, and 10-15g of Cinnamomum cassia. It is suitable for angina pectoris of coronary heart disease with qi deficiency and blood stasis or angina pectoris after PCI complicated by cold stagnation and phlegm obstruction.

[0013] The herbal composition contains 10-15g of Tribulus terrestris, 15-30g of malt, and 10-15g of Poria cocos, and is suitable for angina pectoris of coronary heart disease with qi deficiency and blood stasis type or angina pectoris after PCI with liver qi stagnation and heat syndrome.

[0014] The traditional Chinese medicine composition contains 10-15g of Lindera strychnifolia, 10-15g of Cyperus rotundus, and 10-15g of Alpinia oxyphylla. It is suitable for angina pectoris of coronary heart disease with qi deficiency and blood stasis or angina pectoris after PCI complicated with liver cold and qi stagnation.

[0015] The present invention also provides a preparation of the traditional Chinese medicine composition for treating angina pectoris of coronary heart disease of qi deficiency and blood stasis type or angina pectoris after PCI. The traditional Chinese medicine composition is formulated with medically acceptable excipients and prepared into any one of the following: decoction, granules, pills, tablets, capsules, ointment, syrup, powder and powder.

[0016] The decoction is prepared as follows: Place each raw material in a pot, add water to cover the medicine by 2-3 cm, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes, and take about 150 ml of juice; add an appropriate amount of water again, bring to a boil over high heat, simmer over low heat for 10 minutes, and take about 150 ml of juice. Combine the juices to obtain the decoction.

[0017] The granules are prepared according to the following method:

[0018] 1) Decoction: Weigh each raw material in the formula according to the formula amount, add 6 to 10 times the total weight of the raw materials and decoct 1 to 3 times, 30 to 60 minutes each time, filter and combine the decoctions;

[0019] 2) Concentration: The obtained decoction is concentrated into a thick paste at 75~80℃ and -0.02~-0.06MPa. The density of the thick paste at 50-75℃ is 1.20~1.35g / ml.

[0020] 3) Drying: Dry the thick paste at 75~80℃ and under a vacuum of -0.02~-0.06MPa to obtain a dry paste for later use;

[0021] 4) Pulverize the dry paste and pass it through a 100-mesh sieve to obtain mixed dry paste powder. Add excipients of no less than 1 times the amount of dry paste and mix well. Add an appropriate amount of 70-90% ethanol, wet granulate, and dry to obtain granules.

[0022] The granulation excipient is one or more of dextrin, maltodextrin, or sucrose.

[0023] The pills are prepared according to the following method:

[0024] 1) Decoction: Weigh out half of the Astragalus membranaceus and Pueraria lobata from the prescription and decoct with the remaining herbs. Add 6 to 10 times the total weight of the raw materials and decoct 1 to 3 times, 30 to 60 minutes each time. Filter and combine the decoctions.

[0025] 2) Concentration: The obtained decoction is concentrated into a thick paste at 75~80℃ and -0.02~-0.06MPa vacuum. The density of the thick paste is 1.20~1.35g / ml at 50~75℃.

[0026] 3) Drying: The thick paste is dried at 75~80℃ and under a vacuum of -0.02~-0.06MPa to obtain a dry paste. The dry paste is then pulverized and passed through a 100-mesh sieve to obtain a dry paste powder.

[0027] 4) Grind half of the Astragalus membranaceus and Pueraria lobata in the formula into powder, pass it through a 100-mesh sieve, mix the resulting powder with the dry ointment powder, and make pills with water or ethanol of 30% or less concentration to obtain pills.

[0028] This invention further provides the application of the aforementioned traditional Chinese medicine composition in the preparation of drugs for treating angina pectoris in patients with qi deficiency and blood stasis or angina pectoris after PCI.

[0029] The present invention further provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a drug for treating angina pectoris after PCI.

[0030] Example 1

[0031] Formula: Astragalus membranaceus 40g, Curcuma longa 10g, Pueraria lobata 30g, Rhodiola rosea 10g, Acorus tatarinowii 10g, Notopterygium incisum 10g. Place all ingredients in a pot according to the formula, add water to cover the herbs by 2-3cm, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes, collecting approximately 150ml of liquid. Add an appropriate amount of water again, bring to a boil over high heat, then simmer over low heat for 10 minutes, collecting approximately 150ml of liquid. Combine the liquids to obtain the decoction.

[0032] Example 2

[0033] Formula: Astragalus membranaceus 30g, Curcuma longa 15g, Pueraria lobata 20g, Rhodiola rosea 15g, Acorus tatarinowii 15g, Notopterygium incisum 10g. Weigh each ingredient according to the formula amount, add water at a ratio of 1:6 to 1:10 (medicine to water weight), and decoct 1 to 3 times, 30 to 60 minutes each time. Filter and combine the decoctions. Concentrate the resulting decoction at 75-80℃ and -0.02 to -0.06 MPa vacuum to form a thick paste. The density of the thick paste at 60-65℃ is 1.30 g / ml. Dry the thick paste at 75-80℃ and -0.02 to -0.06 MPa vacuum to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Add 25g of dextrin and mix well. Add 75% to 80% ethanol, wet granulate, and dry to obtain granules.

[0034] Example 3

[0035] Formula: Astragalus membranaceus 35g, Curcuma longa 10g, Pueraria lobata 25g, Rhodiola rosea 10g, Acorus tatarinowii 10g, Notopterygium incisum 10g. Weigh out half of the Astragalus membranaceus and Pueraria lobata from the prescription and decoct them with the remaining herbs. Add water at a ratio of 1:6 to 1:10 (herbs to water) and decoct 1 to 3 times, each time for 30 to 60 minutes. Filter and combine the decoctions. Concentrate the resulting decoction at 75 to 80°C and under a vacuum of -0.02 to -0.06 MPa to form a thick paste. The density of the thick paste at 60 to 65°C is 1.30 g / ml. Dry the thick paste at 75 to 80°C and under a vacuum of -0.02 to -0.06 MPa to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Grind half of the Astragalus membranaceus and Pueraria lobata from the prescription into powder and pass it through a 100-mesh sieve. Mix the resulting powder with the water extract and dry the powder. Make pills with water to obtain pills.

[0036] Example 4

[0037] Formula: Astragalus membranaceus 30g, Curcuma longa 15g, Pueraria lobata 20g, Rhodiola rosea 15g, Acorus tatarinowii 15g, Notopterygium incisum 10g, Trichosanthes kirilowii peel 15g, Pinellia ternata 15g, Allium macrostemon 15g, Cinnamomum cassia twig 15g. Place all ingredients in a pot, add water to cover the herbs by 2-3cm, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes, collecting approximately 150ml of liquid. Add more water, bring to a boil over high heat, then simmer over low heat for 10 minutes, collecting approximately 150ml of liquid. Combine the liquids to obtain a decoction. This formula is suitable for angina pectoris of coronary heart disease of the Qi deficiency and blood stasis type, or angina pectoris after PCI complicated by cold stagnation and phlegm obstruction.

[0038] Example 5

[0039] Formula: Astragalus membranaceus 40g, Curcuma longa 15g, Pueraria lobata 30g, Rhodiola rosea 15g, Acorus tatarinowii 15g, Notopterygium incisum 15g, Trichosanthes kirilowii peel 10g, Pinellia ternata 10g, Allium macrostemon 10g, Cinnamomum cassia twig 15g. Weigh each raw material in the formula according to the prescribed amount, and decoct with water at a ratio of 1:6 to 1:10 (medicine to water weight) 1 to 3 times, 30 to 60 minutes each time. Filter and combine the decoctions. Concentrate the resulting decoction at 75 to 80℃ and under a vacuum of -0.02 to -0.06 MPa to form a thick paste. The density of the thick paste at 60 to 65℃ is 1.30 g / ml. Dry the thick paste at 75 to 80℃ and under a vacuum of -0.02 to -0.06 MPa to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Add 30 g of dextrin and mix well. Add 75% to 80% ethanol, granulate by wet method, and dry to obtain granules. This formula is suitable for angina pectoris of coronary heart disease of the Qi deficiency and blood stasis type or angina pectoris after PCI complicated by cold coagulation, Qi stagnation, and phlegm obstruction.

[0040] Example 6

[0041] Formula: Astragalus membranaceus 40g, Curcuma longa 15g, Pueraria lobata 30g, Rhodiola rosea 15g, Acorus tatarinowii 15g, Notopterygium incisum 15g, Trichosanthes kirilowii peel 10g, Pinellia ternata 10g, Allium macrostemon 10g, Cinnamomum cassia twig 15g. Weigh out equal amounts of Astragalus membranaceus and Pueraria lobata from the prescription, and decoct them with the remaining herbs in water. Add water at a ratio of 1:6 to 1:10 (herbs to water by weight) 1 to 3 times, each time for 30 to 60 minutes. Filter and combine the decoctions. Concentrate the resulting decoction at 75-80℃ and -0.02 to -0.06 MPa vacuum to form a thick paste. The density of the thick paste at 60-65℃ is 1.30 g / ml. Dry the thick paste at 75-80℃ and -0.02 to -0.06 MPa vacuum to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Grind half the amount of Astragalus membranaceus and Pueraria lobata from the prescription into powder, pass it through a 100-mesh sieve, and mix the resulting powder with the water extract. Dry the resulting dry paste powder and make pills using water. This formula is suitable for angina pectoris of coronary heart disease of the Qi deficiency and blood stasis type, or angina pectoris after PCI complicated by cold stagnation and phlegm obstruction.

[0042] Example 7

[0043] Formula: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g, Tribulus terrestris 15g, Hordeum vulgare 30g, Poria cocos 15g. Place all ingredients in a pot, add water to cover the herbs by 2-3cm, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes, collecting approximately 150ml of liquid. Add an appropriate amount of water again, bring to a boil over high heat, simmer for 10 minutes, collecting approximately 150ml of liquid. Combine the liquids to obtain a decoction. This formula is suitable for angina pectoris of coronary heart disease of the Qi deficiency and blood stasis type, or angina pectoris after PCI complicated by liver stagnation and heat syndrome.

[0044] Example 8

[0045] Formula: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g, Tribulus terrestris 15g, Hordeum vulgare 30g, Poria cocos 15g. Weigh each raw material in the formula according to the prescribed amount, and decoct with water at a ratio of 1:6 to 1:10 (medicine to water weight) 1 to 3 times, 30 to 60 minutes each time. Filter and combine the decoctions. Concentrate the resulting decoction at 75 to 80℃ and under a vacuum of -0.02 to -0.06 MPa to form a thick paste. The density of the thick paste at 60 to 65℃ is 1.30 g / ml. Dry the thick paste at 75 to 80℃ and under a vacuum of -0.02 to -0.06 MPa to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Add 30 g of dextrin and mix well. Add 75% to 80% ethanol, granulate by wet method, and dry to obtain granules. This formula is suitable for angina pectoris of coronary heart disease of the Qi deficiency and blood stasis type or angina pectoris after PCI complicated with liver stagnation and heat syndrome.

[0046] Example 9

[0047] Formula: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g, Tribulus terrestris 15g, Hordeum vulgare 15g, Poria cocos 10g.

[0048] Weigh out half of the Astragalus membranaceus and Pueraria lobata from the prescription and decoct them with the remaining herbs in water. Add water at a ratio of 1:6 to 1:10 (herbs to water by weight) and decoct 1 to 3 times, each time for 30 to 60 minutes. Filter and combine the decoctions. Concentrate the resulting decoction at 75-80℃ and -0.02 to -0.06 MPa vacuum to form a thick paste. The density of the thick paste at 60-65℃ is 1.30 g / ml. Dry the thick paste at 75-80℃ and -0.02 to -0.06 MPa vacuum to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Grind half of the Astragalus membranaceus and Pueraria lobata from the prescription into powder, pass it through a 100-mesh sieve, and mix the resulting powder with the water extract. Dry the resulting dry paste powder and then make pills with water to obtain pills. This formula is suitable for angina pectoris of coronary heart disease of the Qi deficiency and blood stasis type or angina pectoris after PCI complicated by liver stagnation and heat syndrome.

[0049] Example 10

[0050] Formula: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g, Cyperus rotundus 15g, Lindera strychnifolia 15g, Alpinia oxyphylla 15g. Place all ingredients in a pot, add water to cover the herbs by 2-3cm, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes, collecting approximately 150ml of liquid. Add an appropriate amount of water again, bring to a boil over high heat, simmer for 10 minutes, collecting approximately 150ml of liquid. Combine the liquids to obtain a decoction. This formula is suitable for angina pectoris of coronary heart disease with qi deficiency and blood stasis type, or angina pectoris after PCI complicated by liver cold and qi stagnation syndrome.

[0051] Example 11

[0052] Formula: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g, Cyperus rotundus 15g, Lindera strychnifolia 15g, Alpinia oxyphylla 15g. Weigh each raw material in the formula according to the prescribed amount, and decoct with water at a ratio of 1:6 to 1:10 (medicine to water weight) 1 to 3 times, 30 to 60 minutes each time. Filter and combine the decoctions. Concentrate the resulting decoction at 75 to 80℃ and under a vacuum of -0.02 to -0.06 MPa to form a thick paste. The density of the thick paste at 60 to 65℃ is 1.30 g / ml. Dry the thick paste at 75 to 80℃ and under a vacuum of -0.02 to -0.06 MPa to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Add 35 g of dextrin and mix well. Add 75% to 80% ethanol, granulate by wet method, and dry to obtain granules. This formula is suitable for angina pectoris of coronary heart disease of the Qi deficiency and blood stasis type or angina pectoris after PCI with concurrent liver cold and Qi stagnation syndrome.

[0053] Example 12

[0054] Formula: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g, Cyperus rotundus 10g, Lindera strychnifolia 10g, Alpinia oxyphylla 10g. Weigh out half of the Astragalus membranaceus and Pueraria lobata from the prescription and decoct them with the remaining herbs. Add water at a ratio of 1:6 to 1:10 (herbs to water) and decoct 1 to 3 times, each time for 30 to 60 minutes. Filter and combine the decoctions. Concentrate the resulting decoction at 75 to 80°C under a vacuum of -0.02 to -0.06 MPa to form a thick paste. The density of the thick paste at 60 to 65°C is 1.30 g / ml. Dry the thick paste at 75 to 80°C under a vacuum of -0.02 to -0.06 MPa to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Grind half of the Astragalus membranaceus and Pueraria lobata from the prescription into powder, pass it through a 100-mesh sieve, and mix the resulting powder with the water extract. Dry the resulting dry paste powder and then make pills with water to obtain pills. This formula is suitable for angina pectoris of coronary heart disease with qi deficiency and blood stasis type or angina pectoris after PCI with liver cold and qi stagnation syndrome.

[0055] Case 1

[0056] Ms. Zhao, 58 years old, presented on September 15, 2022, with a history of palpitations, chest tightness, pain, and fatigue for over a month. One month prior, she experienced palpitations, chest tightness, and chest pain without any obvious cause, accompanied by fatigue, dizziness, and lightheadedness. The palpitations were paroxysmal, lasting several minutes each time, and were more pronounced after activity. The chest pain was a dull, stabbing pain that worsened with cold. She had previously visited Kunming Yan'an Hospital, where a coronary CT scan revealed severe stenosis of approximately 95% in the left anterior descending artery and coronary artery myocardial bridging. Coronary artery disease was suspected, but oral medication provided little relief. One week prior, she underwent PCI at Yunnan Fuwai Cardiovascular Hospital due to sudden chest pain. Post-operatively, she regularly took secondary prevention medication for coronary artery disease, but continued to experience palpitations, fatigue, chest tightness, chest pain, sweating, occasional dizziness, and no headaches. Symptoms were exacerbated by temperature changes, and she experienced poor mental state, anxiety, poor appetite and sleep, and normal bowel movements. The tongue is dark red with a thin, white, greasy coating, and the pulse is wiry, thready, and slippery. The patient has a history of hypertension for more than 5 years, with the highest blood pressure reaching 190 / 100 mmHg.

[0057] Based on the patient's symptoms and pulse, the diagnosis is Qi deficiency and blood stasis syndrome, complicated by cold stagnation, Qi stagnation, and phlegm obstruction. The prescription is: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g, Trichosanthes kirilowii peel 15g, Pinellia ternata 15g, Allium macrostemon 15g, Cinnamomum cassia 15g. A total of 3 doses are prescribed, one dose per day, three times daily, decocted in water and taken warm half an hour after meals. Avoid sour and cold foods, fruits, and fungi.

[0058] On the second visit, the patient reported that the symptoms of chest tightness and chest pain had improved compared to before, but he still felt weak, and occasionally experienced palpitations, sweating, dizziness, and lightheadedness. Since taking the medication, his sleep had improved slightly, but he felt fullness and discomfort in his stomach, especially after eating. Therefore, 10g of Platycodon grandiflorus, 15g of Perilla frutescens stem, and 10g of Citrus reticulata peel were added to the original prescription. He was given 3 more doses and then returned for a follow-up visit.

[0059] On the third visit, the patient reported that palpitations, chest tightness, fatigue, and sweating had significantly improved compared to before. There were no symptoms of dizziness or lightheadedness. The patient's mental state was good, appetite and sleep were good, and bowel movements were normal.

[0060] Commentary: The patient is nearly sixty years old and his heart qi is gradually weakening. Weak heart qi weakens the heart's ability to circulate blood, leading to impaired blood flow, internal blood stasis, and obstruction of blood vessels. This blockage causes pain, hence the symptoms of palpitations, fatigue, chest tightness, and a dull, stabbing pain in the chest. Prolonged qi deficiency affects the heart's yang, which in turn generates cold, thus the patient's symptoms are more pronounced when the temperature drops. Cold congeals the body's fluids, causing stagnation and phlegm formation. This phlegm obstructs the mind, resulting in dizziness and lightheadedness. Furthermore, phlegm dampness impairs the spleen's function, leading to poor appetite. Astragalus membranaceus is the principal herb in this formula, entering the spleen and lung meridians. It has a ascending and stabilizing effect, primarily used to tonify spleen qi and raise yang, thus boosting qi and generating qi. Kudzu root and Rhodiola rosea are the assistant herbs. Kudzu root assists astragalus in tonifying qi and raising yang, while also clearing the meridians, relieving spasms and pain. Rhodiola rosea invigorates qi and blood, strengthening its qi-tonifying and pain-relieving effects. Turmeric, being pungent, disperses and invigorates blood, relieving pain. Acorus tatarinowii warms yang and resolves phlegm. Trichosanthes kirilowii and Allium macrostemon promote yang and relieve pain, combined with Pinellia ternata to resolve phlegm and dampness, thus calming qi stagnation. Cinnamomum cassia assists yang and promotes diuresis, serving as adjuvant herbs. In the second consultation, the patient's chest tightness and pain symptoms significantly improved, but palpitations and fatigue persisted, accompanied by abdominal distension and discomfort. Therefore, Platycodon grandiflorus, Perilla frutescens, and Citrus reticulata were added, focusing on regulating qi, eliminating dampness and resolving phlegm to unblock heart qi, while also improving the patient's dizziness. After treatment, the patient's symptoms improved, and their mental state improved.

[0061] Case 2

[0062] Ms. Bai, 73 years old, presented on November 2, 2022, with a history of recurrent chest pain for six months, worsening over the past two months. For the past six months, she had experienced recurrent chest tightness and pain, characterized by paroxysmal, angina-like pain, often occurring after exertion and not significantly relieved by rest. She had previously been hospitalized in our department, where coronary angiography revealed: no significant stenosis in the RCA (Rear Anterior Depression), TIMI flow grade 3; LM (Left Anterior Depression): essentially normal; LAD (Left Anterior Depression): 70% stenosis in the proximal segment, TIMI flow grade 3; LCX (Left Anterior Depression): irregular intima, TIMI flow grade 3. A stent was implanted in the left anterior descending artery. After stent implantation, her chest pain symptoms significantly improved, and she has been regularly taking secondary prevention medications for coronary artery disease outside the hospital. Two months ago, the patient experienced a recurring episode of chest pain, accompanied by chest tightness, shortness of breath, and fatigue. The pain was paroxysmal and colicky, lasting from a few seconds to several minutes, and may be accompanied by palpitations and sweating. The patient also frequently felt irritable and restless, had poor sleep, was easily awakened at night, and had difficulty falling back asleep. Appetite was poor, but bowel movements were normal. The tongue was dark red with a white coating, and the pulse was thready, wiry, and slippery.

[0063] Based on the patient's symptoms and pulse, the diagnosis is Qi deficiency and blood stasis syndrome, complicated by liver stagnation transforming into heat. The prescription is: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g, Tribulus terrestris 15g, Hordeum vulgare 30g, Poria cocos 15g. Three doses, one dose daily, three times a day, decocted in water and taken warm half an hour after meals. Avoid sour and cold foods, fruits, and fungi.

[0064] At the second visit, the patient reported that the symptoms of shortness of breath, fatigue, palpitations, and sweating had improved compared to before. However, the patient still felt a dull chest pain after activity, and the restlessness had improved compared to before. Since taking the medication, the patient's sleep had improved, but the appetite was poor. The original prescription was continued for 3 more doses before the follow-up visit.

[0065] On the third visit, the patient reported that there were no obvious chest pain symptoms, and that shortness of breath, fatigue, palpitations, and sweating had significantly improved compared to before. Appetite and sleep were good, and bowel movements were normal.

[0066] Commentary: The patient presented with chest pain, chest tightness, shortness of breath, and fatigue, accompanied by palpitations and sweating during attacks, suggesting that the underlying condition was Qi deficiency with blood stasis as the manifestation. Sweat is considered the fluid of the heart; Qi deficiency in the heart leads to palpitations and sweating. Blood stasis obstructs the meridians, hindering the flow of Qi and blood, hence the chest pain. The patient's recurrent chest pain, even after PCI, caused considerable irritability and emotional distress, disrupting the liver and gallbladder's function of regulating Qi. Over time, this Qi stagnation transformed into heat, disturbing the mind and causing restlessness and frequent awakenings at night. The circulation of Qi and blood also depends on the liver and gallbladder's function of regulating Qi; liver stagnation hinders the flow of blood to the heart, resulting in recurrent palpitations, chest tightness, and pain. This formula primarily tonifies Qi, invigorates blood, and dispels blood stasis, while also clearing the liver and calming the mind to prevent heat from disturbing the spirit. The formula uses Astragalus membranaceus as the principal herb, which enters the spleen and lung meridians. It has a ascending and stabilizing effect, tonifying the spleen and raising yang, thus boosting qi and generating qi. Kudzu root and Rhodiola rosea are the assistant herbs. Kudzu root assists Astragalus membranaceus in tonifying qi and raising yang, while also clearing the meridians, relieving spasms and pain. Rhodiola rosea invigorates qi and blood, strengthening its qi-tonifying and pain-relieving effects. Turmeric, being pungent, disperses and invigorates blood, relieving pain. Acorus tatarinowii and Poria cocos open the orifices, resolve phlegm, calm the mind and soothe the nerves. Tribulus terrestris calms the liver and relieves depression, while raw barley malt can both soothe the liver and relieve depression, promote qi circulation and digestion, and clear heat from stagnation. The combination of these two herbs clears liver fire. In the second consultation, the patient's shortness of breath, fatigue, palpitations, and sweating improved compared to the first time. However, the patient still felt a dull chest pain after activity, and the restlessness had improved. Therefore, the formula was continued to consolidate the treatment and further alleviate the patient's chest pain symptoms.

[0067] Case 3

[0068] Mr. Li, male, 56 years old, visited the Department of Cardiovascular Medicine at Kunming Municipal Hospital of Traditional Chinese Medicine on February 20, 2023, due to "palpitations and chest tightness for more than half a month." He was admitted to the hospital and diagnosed with "1. Stable angina pectoris of coronary atherosclerotic heart disease; 2. Grade 1 hypertension, very high risk group." After treatment, his symptoms improved, and he was discharged. After discharge, he regularly took medication for secondary prevention of coronary heart disease. One month after discharge, he experienced chest tightness and pain again, with shortness of breath and fatigue even with slight activity. He did not experience dizziness, headache, palpitations, or sweating. The symptoms improved after a few minutes of rest, but the improvement was not significant, so he returned to the hospital for treatment. The patient is usually prone to anxiety and fatigue, has cold extremities, poor mental state, slightly poor appetite and sleep, normal urination, and slightly dry and difficult bowel movements. His tongue is dark red with a white coating, and the veins under the tongue are tortuous. His pulse is wiry and thready.

[0069] Based on the patient's symptoms and tongue and pulse examination, the patient is considered to have Qi deficiency and blood stasis syndrome, complicated by liver cold and Qi stagnation syndrome. The prescription is as follows: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g, Lindera strychnifolia 15g, Cyperus rotundus 15g, and Alpinia oxyphylla 15g. Three doses are prescribed, one dose per day, divided into three administrations, taken warm half an hour after meals. Avoid sour and cold foods, fruits, and fungi.

[0070] On the second visit, the patient reported that the symptoms of chest tightness and difficulty breathing had improved compared to before, but still felt weak, had no sweating, palpitations, dizziness, and headache. His appetite was slightly better than before, but his sleep had not improved significantly, and his bowel movements were still difficult. Therefore, 20g of Angelica sinensis, 15g of Ziziphus jujuba var. spinosa, and 15g of Albizia julibrissin were added to the original prescription and taken orally at the original dosage. He returned for a follow-up visit after taking 3 doses.

[0071] At the third consultation, the patient reported that after taking the Chinese medicine, there were no obvious symptoms such as chest tightness, difficulty breathing, or fatigue. Therefore, the patient did not return for a follow-up visit and stopped taking the Chinese medicine. One month after stopping the medication, the patient experienced fatigue and night sweats, with symptoms that worsened significantly after activity. There was no palpitation, so the patient returned for another consultation. The patient usually drank plenty of water, had a good appetite and sleep, and regular bowel movements. The original prescription was modified by removing jujube seed and albizia bark, and the patient continued to take the medicine orally for 3 more doses at the original dosage. A follow-up phone call later revealed that the patient's condition was stable and the chest pain had not recurred.

[0072] Commentary: The patient presents with chest tightness, shortness of breath, and fatigue even with slight exertion. The tongue is dark red with a white coating, and the pulse is thready and wiry. This suggests that the patient's illness is superficially due to Qi deficiency, but fundamentally due to blood stasis. The body's Qi comprises Yuan Qi, Zong Qi, Ying Qi, and Wei Qi. Zong Qi, stored in the chest, "circulates through the heart vessels and drives respiration," also known as the "Great Qi of the Chest." Yu Jiayan stated, "The five viscera and six bowels, the major and minor meridians, circulate ceaselessly day and night, relying entirely on the Great Qi of the Chest for regulation." It further states, "It governs Ying and Wei, the viscera and bowels, and the meridians, ensuring their uninterrupted circulation and continuous flow, allowing for the agility of all joints; this is entirely due to the Great Qi of the Chest." Zong Qi originates from the lungs, travels along the throat to the respiratory tract, and propels respiration. The patient's prolonged illness has resulted in a deficiency of Zong Qi, which is insufficient to propel respiration, hence the chest tightness and shortness of breath after slight exertion. The patient's dark red tongue with tortuous veins under the tongue indicates significant blood stasis. Qi deficiency hinders blood circulation, and blood stasis causes pain, hence the chest pain. Prolonged anxiety can easily lead to stagnation of liver qi, hindering the free flow of qi and suppressing the yang qi, resulting in cold extremities. This formula treats the condition by using Astragalus membranaceus as the principal herb, which enters the spleen and lung meridians, promoting qi circulation and relieving stagnation. It is used to tonify spleen qi and raise yang, thus boosting qi and generating qi. Kudzu root and Rhodiola rosea serve as assistant herbs. Kudzu root assists Astragalus membranaceus in tonifying qi and raising yang, while also clearing the meridians, relieving spasms and pain. Rhodiola rosea invigorates qi and blood, strengthening its qi-tonifying and pain-relieving effects. Turmeric, being pungent, disperses and invigorates blood, relieving pain. Acorus tatarinowii warms yang and resolves phlegm. Lindera strychnifolia warms yang, and when combined with Cyperus rotundus, it enhances the warming, qi-regulating, and pain-relieving effects. Alpinia oxyphylla warms the kidneys, invigorates yang, strengthens the spleen, calms the mind, and promotes sleep. At the second visit, the patient's symptoms of chest tightness and shortness of breath had significantly improved, but he still complained of poor sleep and constipation. Therefore, Albizia bark and Ziziphus jujuba seed were added to strengthen the heart and calm the mind. Given the patient's long-term illness and weakened constitution, and the continued constipation, it was noted that most laxatives are detrimental to qi. Therefore, the dosage of Angelica sinensis was increased to 20g to enhance its function of moistening the intestines and promoting bowel movements while also replenishing blood and qi. At the third visit, the patient continued taking the medication and did not experience significant chest tightness, but still experienced fatigue and sweating. The original prescription was continued, and a follow-up phone call showed that the patient's symptoms had improved.

[0073] The clinical efficacy trials of the present invention are described in detail below:

[0074] 1. Materials and Methods

[0075] Sixty patients with angina pectoris due to Qi deficiency and blood stasis or post-PCI angina pectoris, admitted to the inpatient and outpatient departments of the Department of Cardiovascular Medicine at the Third Affiliated Hospital of Yunnan University of Traditional Chinese Medicine between November 2022 and October 2023, were selected as the study subjects. Due to the possibility of dropouts and exclusions, the number of participants was expanded by 20%, resulting in a total of 72 cases. Patients were randomly assigned to either a TCM treatment group or a Western medicine control group (n=36 each). The minimum number of cases observed throughout the entire course of treatment was 60.

[0076] 1.1 Western Medicine Diagnostic Criteria:

[0077] 1.1.1 The diagnostic criteria for coronary heart disease were formulated with reference to the 2018 Guidelines for the Diagnosis and Treatment of Stable Coronary Artery Disease and the 8th edition of Practical Internal Medicine.

[0078] (1) Electrocardiogram shows typical ST-T depression, T wave inversion or flattening or old myocardial infarction; or Holter monitoring suggests myocardial ischemia.

[0079] (2) The exercise stress test was positive;

[0080] (3) Coronary angiography shows that at least one artery has a stenosis of >50%; (If any one of the above three criteria is met, CHD can be diagnosed)

[0081] (4) Combine cardiovascular disease risk factors and typical angina pectoris attack characteristics to rule out chest pain caused by other systemic diseases.

[0082] 1.1.2 The angina classification criteria are based on the CCS (Canadian Cardiovascular Society) angina classification criteria.

[0083] 1.1.3 Diagnostic criteria for chest pain after PCI: Severe stenosis and / or occlusion confirmed by coronary angiography, coronary artery stenting, TIMI flow grade 3 after PCI, and chest pain and tightness still present after standard use of routine secondary prevention medications after PCI for coronary heart disease.

[0084] 1.2 Traditional Chinese Medicine Diagnostic Criteria: The TCM diagnostic criteria refer to the diagnostic criteria for "Qi deficiency and blood stasis syndrome" in the 2014 "Expert Consensus on TCM Diagnosis and Treatment of Chest Pain after Percutaneous Coronary Intervention (PCI)".

[0085] (1) Main symptoms: chest tightness and chest pain, which are aggravated by exertion;

[0086] (2) Secondary symptoms: palpitations, shortness of breath, fatigue, sweating, reluctance to speak, and cyanosis of the lips;

[0087] (3) Tongue and pulse characteristics: The tongue is dark, the coating is thin and white or there are ecchymosis and petechiae, and the pulse is weak or intermittent.

[0088] Diagnostic criteria: One primary symptom, two or more secondary symptoms, and at least one of the following tongue and pulse characteristics.

[0089] 2. Case selection

[0090] 2.1 Inclusion criteria:

[0091] (1) Patients who meet the diagnostic criteria of both traditional Chinese medicine and Western medicine;

[0092] (2) Clinical evidence of angina pectoris symptoms and myocardial ischemia;

[0093] (3) Patients with CCS angina pectoris classification I-III;

[0094] (4) Age between 18 and 75 years old;

[0095] (5) Patients who use routine secondary prevention medications for coronary heart disease and after PCI;

[0096] (6) The patient is willing to accept treatment and can sign an informed consent form.

[0097] 2.2 Exclusion criteria:

[0098] (1) Recurrent myocardial infarction after PCI, or serious complications such as acute or subacute thrombosis and bleeding in the stent;

[0099] (2) Those with severe heart, lung, liver, or kidney dysfunction, or those with serious primary diseases such as endocrine system, blood system, or malignant tumors;

[0100] (3) Those with a history of allergies to relevant drugs;

[0101] (4) Pregnant and lactating women;

[0102] 2.3 Exclusion criteria: Cases that do not meet the inclusion criteria after inclusion will be excluded.

[0103] (1) Those who have not received treatment according to the treatment plan or have not received the prescribed course of treatment, and whose efficacy cannot be determined.

[0104] (2) Incomplete data affects the judgment of validity and safety.

[0105] (3) Those who develop other lesions during the trial and need to take medications that may affect the trial.

[0106] (4) No adverse drug reactions during medication, but treatment is interrupted due to other unforeseen reasons (such as the occurrence of other diseases that force the treatment to be stopped).

[0107] 2.4 Case Exit (Dropout) Criteria

[0108] (1) Patients who naturally dropped out or were lost to follow-up during the observation period.

[0109] (2) Subjects who have complications or special physiological changes that make them unsuitable to continue the trial and withdraw from the trial on their own.

[0110] 2.5 Termination of Experiment Criteria:

[0111] (1) Those who cannot adhere to treatment.

[0112] (2) Those who experience allergic reactions or other serious adverse reactions during the test.

[0113] 3. Research Methods

[0114] 3.1 Randomization method: A total of 72 cases meeting the inclusion criteria were included in this study. SPSS 26.0 software was used to randomly code the patients and the 72 enrolled patients were randomly divided into a treatment group and a control group, with 36 patients in each group.

[0115] 3.2 Treatment Plan:

[0116] 3.2.1 Basic treatment: low-salt, low-fat diet; quit smoking and drinking; avoid overwork in daily life and exercise appropriately; regulate mental and psychological state and maintain a cheerful mood.

[0117] 3.2.2 Control Group Treatment: Following the 2018 Guidelines for the Diagnosis and Treatment of Stable Coronary Artery Disease and the Chinese Guidelines for Percutaneous Coronary Intervention (2016), patients received routine secondary prevention medications for coronary artery disease and post-PCI procedures, including antiplatelet drugs, lipid-lowering drugs, beta-blockers, and ACEIs / ARBs. Nitroglycerin tablets were administered sublingually during angina attacks. Patients with hypertension or diabetes received appropriate antihypertensive and hypoglycemic treatments. Drug dosages were adjusted based on the patients' lipid, blood pressure, and blood glucose levels and symptoms during treatment.

[0118] 3.2.3 Treatment group: Combined treatment with the granules prepared in Example 2.

[0119] The specific prescription is as follows: Astragalus membranaceus 30g, Pueraria lobata 20g, Curcuma longa 15g, Rhodiola rosea 15g, Notopterygium incisum 10g, Acorus tatarinowii 15g (Usage: three times a day, one packet each time, taken with warm water after meals).

[0120] 3.3 Evaluation time point: The treatment course for this clinical study was 4 weeks. Safety indicators were checked within 3 days before the trial and within 7 days after the trial. Adverse events were monitored during treatment or followed up after treatment.

[0121] 4. Observation indicators:

[0122] 4.1 Safety Indicator Observation:

[0123] (1) General indicators: blood pressure, heart rate, pulse, body temperature, etc.;

[0124] (2) Biochemical tests before and after treatment: liver function, kidney function, blood routine and other biochemical indicators;

[0125] 4.2 Observation of adverse reactions

[0126] (1) Local symptoms: Allergic reactions such as skin redness and itching;

[0127] (2) Systemic symptoms: dizziness, nausea, sweating, etc.;

[0128] 4.3 Therapeutic efficacy observation indicators:

[0129] (1) Evaluation of TCM syndrome efficacy

[0130] The evaluation of TCM syndrome efficacy was formulated with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines" and the "Expert Consensus on TCM Diagnosis and Treatment of Chest Pain after Percutaneous Coronary Intervention (PCI)". The frequency, severity and duration of symptom attacks before and after treatment were evaluated in both groups of patients, and the results were divided into markedly effective, effective, ineffective and aggravated.

[0131] The efficacy index (nimodipine count method) = (pre-treatment score - post-treatment score) / pre-treatment score × 100%.

[0132] Effective = Therapeutic efficacy index ≥ 70%;

[0133] Significant efficacy = efficacy index ≥30% and <70%;

[0134] Ineffective = efficacy index <30%;

[0135] Worsening = Therapeutic effect index < 0%.

[0136] (2) Seattle Angina Scale Assessment

[0137] (3) Electrocardiogram efficacy: (Evaluated and formulated with reference to the relevant standards of the 1974 "Standards for Evaluation of the Efficacy of Electrocardiogram in Coronary Artery Disease and Angina Pectoris");

[0138] ①Significant effect: Abnormal electrocardiogram returns to normal or "normal range", or the electrocardiogram exercise stress test changes from positive to negative;

[0139] ② Effective: The depressed ST segment recovers by more than 0.05mV after treatment, but does not reach the normal level; the inverted T wave becomes shallower by ≥25% in the main leads, or the T wave changes from flat to upright; and severe arrhythmias and atrioventricular block are improved.

[0140] ③ Ineffective: The electrocardiogram or exercise test is basically the same as before treatment;

[0141] ④ Worsening: The depressed ST segment decreases by more than 0.05mV compared to before treatment, the inverted T wave in the main leads deepens by ≥50%, or the upright T wave becomes flat, the flat T wave becomes inverted, or even arrhythmia, intraventricular or atrioventricular block occurs.

[0142] (4) Determination of nitroglycerin discontinuation rate

[0143] Judgment criteria:

[0144] Discontinue medication: Discontinue nitroglycerin after treatment.

[0145] Dosage reduction: The dosage after treatment is reduced by ≥50% compared to the dosage before treatment.

[0146] Unchanged: The dosage after treatment is reduced by less than 50% compared to the dosage before treatment.

[0147] Worsening: Increased dosage of nitroglycerin after treatment.

[0148] Nitroglycerin discontinuation / reduction rate = (Number of cases discontinuing treatment + Number of cases reducing dosage) / Number of cases using the drug before treatment × 100%

[0149] 5. Statistical methods:

[0150] (1) The experimental data were organized and summarized in an Excel spreadsheet, and analyzed using SPSS 26.0 statistical software for statistical processing.

[0151] (2) Measurement data: Data that conforms to a normal distribution are tested using t-test or independent samples t-test, and the data are expressed as mean ± standard deviation (±S); data that do not conform to a normal distribution are tested using nonparametric tests, and the data are described using the median.

[0152] (3) Count data: X-rays were used for comparisons between groups. 2 The test showed that P < 0.05, indicating a statistically significant difference.

[0153] 6. Results

[0154] 6.1 Research completion status:

[0155] In this clinical study, 5 patients dropped out in the treatment group and 31 patients completed the study, while 3 patients dropped out in the control group and 33 patients completed the study. A total of 64 patients were completed, with an overall dropout rate of 11%.

[0156] 6.2 Comparison of TCM efficacy scores between the two groups of patients after treatment

[0157] 6.2.1 Evaluation of individual symptom scores after treatment (results are shown in Table 1)

[0158] Table 1 Comparison of TCM symptoms between the two groups before and after treatment

[0159]

[0160] Note: 1 is the control group (N=33); 2 is the treatment group (N=31).

[0161] The TCM symptom scores of the two groups of patients before treatment were statistically analyzed (P > 0.05), indicating comparability. Table 1 shows that the symptom scores of both groups improved after treatment compared to before treatment, and the differences were statistically significant. P <0.05). However, intergroup comparisons showed that the symptom scores of the treatment group were significantly different from those of the control group after treatment (P<0.05). This indicates that the treatment group had a more significant advantage over the control group in improving TCM symptoms.

[0162] 6.2.2 Evaluation of TCM syndrome efficacy (Results are shown in Table 1)

[0163] Table 2 Comparison of TCM efficacy between the two groups after treatment (%)

[0164]

[0165] As shown in Table 2, the total effective rate in the treatment group was 90.32%, while that in the control group was 81.82%. Chi-square test analysis showed that the difference in effective rates between the two groups after treatment was statistically significant. P <0.05), indicating that the treatment group was superior to the control group in improving the efficacy of traditional Chinese medicine.

[0166] 6.3 Comparison of Seattle Angina Scale scores before and after treatment between the two groups of patients (results are shown in Table 3).

[0167] Table 3 Comparison of Seattle Angina Scale scores before and after treatment.

[0168]

[0169] Note: PL (Physical Activity Limitation), AS (Angina Stability), AF (Angina Attack Frequency), TS (Treatment Satisfaction), DS (Disease Awareness).

[0170] The scores of the two groups of patients on the angina pectoris scale before treatment were statistically comparable (P > 0.05). Table 3 shows that all indicators of the angina pectoris scale in both groups improved significantly after treatment compared to before treatment (P < 0.01). However, intergroup comparisons showed that the treatment group had a higher angina pectoris scale score than the control group after treatment (P < 0.05). Specifically, the treatment group showed a significantly higher advantage over the control group in terms of physical activity limitation, angina attack frequency, and disease awareness (P < 0.01).

[0171] 6.4 Comparison of electrocardiogram efficacy between the two groups of patients after treatment (results are shown in Table 4)

[0172] Table 4 Comparison of ECG efficacy after treatment

[0173]

[0174] Note: Total effective rate of electrocardiogram treatment = significant effective rate + effective rate.

[0175] As shown in Table 4, the total effective rate of the treatment group was 87.1%, while that of the control group was 72.8%. The chi-square test showed that P < 0.05, which was statistically significant, indicating that the treatment group was superior to the control group in terms of improving electrocardiogram.

[0176] 6.5 Comparison of nitroglycerin discontinuation rates between the two groups after treatment (results are shown in Table 5).

[0177] Table 5 Comparison of nitroglycerin discontinuation rates after treatment

[0178]

[0179] Note: Nitroglycerin discontinuation / reduction rate = (Number of cases discontinued after treatment + Number of cases reduced dosage) / Number of cases using the drug before treatment x%.

[0180] Table 5 shows that the total reduction and discontinuation rate of nitroglycerin in the treatment group was 90.3%, while that in the control group was 81.1%. The difference between the two groups was statistically significant (P < 0.05). This indicates that the treatment group was superior to the control group in terms of nitroglycerin reduction and discontinuation rate.

[0181] 6.6 Comparison of safety indicators between the two groups of patients before and after treatment (results are shown in Table 6)

[0182] Table 6 Comparison of safety indicators before and after treatment

[0183]

[0184] There were no significant differences in liver and kidney function, platelet count, and other indicators between the two groups of patients before and after treatment (P>0.05), indicating that the granules prepared in Example 2 used in this experiment had no significant effect on the patients' liver and kidney function or platelet count and had a certain degree of safety.

[0185] This study compared the TCM symptom scores, Seattle Angina Scale scores, changes in electrocardiogram efficacy, nitroglycerin discontinuation rate, liver and kidney function, and platelet counts before and after treatment in the treatment and control groups. The results showed that, compared with conventional Western medicine treatment, the addition of the patented product Qiyu Xintongshu to conventional Western medicine treatment significantly improved the severity of angina, improved electrocardiogram results, reduced nitroglycerin dosage, and alleviated symptoms related to Qi deficiency and blood stasis syndrome. No significant abnormalities were observed in liver and kidney function or other safety indicators in either the control or treatment groups during the study. This indicates that the addition of Qiyu Xintongshu to conventional Western medicine treatment is both effective and safe for angina pectoris in patients with Qi deficiency and blood stasis type coronary heart disease and angina pectoris after PCI.

Claims

1. A traditional Chinese medicine composition for treating qi deficiency and blood stasis type of coronary heart disease angina pectoris or post-PCI angina pectoris, characterized in that, The raw medicinal materials are prepared by weight: 30~40g of Huangqi, 20~30g of Gegen, 10~15g of Hongtian, 10~15g of Yujin, 10~15g of Shichangpu, and 10~15g of Qianghuo.

2. A traditional Chinese medicine composition for treating coronary heart disease angina pectoris or post-PCI angina pectoris with cold congealing and qi stagnation and phlegm obstruction, characterized in that The raw medicinal materials are prepared by weight: 30~40g of Huangqi, 20~30g of Gegen, 10~15g of Hongtian, 10~15g of Yujin, 10~15g of Shichangpu, and 10~15g of Qianghuo; 10~15g of Gualoupi, 10~15g of Fabanxia, 10~15g of Xiebai, and 10~15g of Guizhi.

3. A traditional Chinese medicine composition for treating coronary heart disease angina pectoris or post-PCI angina pectoris with liver stagnation and heat syndrome of qi deficiency and blood stasis, characterized in that The raw medicinal materials are prepared by weight: 30~40g of Huangqi, 20~30g of Gegen, 10~15g of Hongtian, 10~15g of Yujin, 10~15g of Shichangpu, and 10~15g of Qianghuo; 10~15g of Jixi, 15~30g of Maidai, and 10~15g of Fushen.

4. A traditional Chinese medicine composition for treating coronary heart disease angina pectoris or post-PCI angina pectoris with liver cold and qi stagnation, characterized in that The raw medicinal materials are prepared by weight: 30~40g of Huangqi, 20~30g of Gegen, 10~15g of Hongtian, 10~15g of Yujin, 10~15g of Shichangpu, and 10~15g of Qianghuo; 10~15g of Wuyao, 10~15g of Xiangfu, and 10~15g of Yizhi.

5. A preparation of the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, The medicinal composition is prepared into any one of the following forms: a decoction, granules, pills, tablets, capsules, a paste, a syrup, a powder, and a powder by adding a medically acceptable excipient.

6. The preparation of the traditional Chinese medicine composition according to claim 5, characterized in that, The decoction is prepared by the following method: the raw medicinal materials are placed in a pot, water is added to cover the medicinal materials by 2~3cm, and soaked for 30min; then boiled with a large fire, and then changed to a small fire for 30min; about 150mL of juice is obtained; then a proper amount of water is added, boiled with a large fire, and then boiled with a small fire for 10min; about 150mL of juice is obtained, and the juice is combined to obtain the decoction.

7. The preparation of the traditional Chinese medicine composition according to claim 5, characterized in that, The granules are prepared by the following method: 1) decoction: the raw medicinal materials are weighed according to the prescription, and then added with 6~10 times the weight of water for decoction 1~3 times, each time for 30~60min, and the decoction liquid is combined; 2) concentration: the obtained decoction liquid is concentrated into a thick paste under the conditions of 75~80℃ and -0.02~-0.06MPa vacuum degree, and the density of the thick paste is 1.20~1.35g / mL at 50~75℃; 3) drying: the thick paste is dried into a dry paste under the conditions of 75~80℃ and -0.02~-0.06MPa vacuum degree, and the dry paste is used for later use; 4) the dry paste is crushed and passed through a 100 mesh sieve to obtain a mixed dry paste powder, and then a excipient is added for mixing, and then 70~90% of ethanol is added for wet granulation, and then the granules are obtained after drying.

8. The preparation of traditional Chinese medicine composition according to claim 7, characterized in that, The granulation excipient is one or a combination of more than one of dextrin, malt dextrin, or sucrose.

9. The preparation of traditional Chinese medicine composition according to claim 5, characterized in that, The pills are prepared by the following method: 1) decoction: half of Huangqi and Gegen in the prescription are weighed and decocted with the remaining medicinal materials, and then added with water for decoction according to the weight ratio of 1:6~1:10, and then decocted 1~3 times, each time for 30~60min, and then filtered and combined the decoction liquid; 2) concentration: the obtained decoction liquid is concentrated into a thick paste under the conditions of 75~80℃ and -0.02~-0.06MPa vacuum degree, and the density of the thick paste is 1.20~1.35g / mL at 50~75℃; 3) drying: the thick paste is dried into dry paste at 75-80℃ under vacuum of -0.02 to -0.06 MPa, the dry paste is crushed and passed through a 100-mesh sieve to obtain dry paste powder; 4) the other half of the amount of Huangqi and Gegen in the prescription is powdered and passed through a 100-mesh sieve, the obtained powder is mixed with the dry paste powder, and the mixture is granulated with water or ethanol with a concentration of 30% or below to obtain the pills.

10. Use of the traditional Chinese medicine composition of any one of claims 1-4 in the preparation of a medicament for treating angina pectoris of coronary heart disease of qi deficiency and blood stasis type or post-PCI angina pectoris.

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