A traditional chinese medicine composition for improving breast nodule

Abstract

This invention discloses a traditional Chinese medicine composition for improving breast nodules, belonging to the field of traditional Chinese medicine technology. Addressing the shortcomings of existing technologies—such as superficial explanations of pathogenesis, treatments that only address the symptoms and not the root cause, and the tendency of Western medicine's anti-inflammatory drugs to damage liver and kidney microcirculation and cause frequent relapses—this invention constructs a microscopic pathological closed loop based on microcirculation, neuroendocrine, and cardiac compensatory mechanisms, addressing the combined damage of emotional factors and Western medicine to breast nodules. This invention is composed of seven medicinal herbs: citron, papaya, platycodon, dandelion, peach kernel, safflower, and jujube seed. These herbs synergistically relax spasmodic microvessels, improve blood rheology, reduce inflammation and nodules, repair liver and kidney microcirculation, reduce cardiac compensatory load, and antagonize the microvascular damage caused by Western medicine. This formula is rigorously formulated, with mild and safe medicinal properties, and can fundamentally improve symptoms of breast nodules, hyperplasia, and breast burning and swelling pain, correct blood stasis and heat constitution, reduce recurrence rate, and has good clinical and industrial application prospects.

Description

Technical Field

[0002] This invention relates to the field of traditional Chinese medicine compound technology, specifically to a traditional Chinese medicine composition for improving symptoms of breast nodules, breast hyperplasia and breast burning and swelling pain, which also has the functions of microcirculation regulation, liver and kidney protection, antagonizing microvascular damage caused by Western medicine, and improving cardiac compensatory load. Background Technology

[0004] Breast nodules and breast hyperplasia are common benign breast diseases in women. With the increasing stress, frequent emotional stress, and irregular lifestyles prevalent in modern society, the incidence rate is rising year by year and showing a trend towards affecting younger women. Patients often present with breast nodules and lumps, periodic swelling and stabbing pain, and local burning sensations, frequently accompanied by symptoms such as palpitations, irritability, insomnia, chest tightness, and anxiety. The condition is often chronic and recurrent, seriously affecting women's physical and mental health and quality of life.

[0005] Current TCM clinical treatment plans are mostly based on traditional macroscopic syndrome differentiation, focusing on simply soothing the liver and regulating qi, softening and dispersing masses, soothing the liver and promoting blood circulation, and soothing the liver and resolving phlegm. These plans generally suffer from limitations such as superficial explanations of pathogenesis, lack of microscopic mechanisms of action, and single therapeutic targets. Traditional treatments can only alleviate superficial symptoms and fail to reveal the modern microscopic underlying mechanisms of "liver qi stagnation," such as sympathetic-HPA axis hyperactivity, systemic microvascular spasm, and hemodynamic abnormalities. They also fail to address the upstream core causes of secondary liver and kidney damage, increased cardiac compensatory load, and persistent microcirculatory disturbances resulting from Western medicine treatments. Therefore, they cannot break the vicious cycle of the disease, leading to limited efficacy, high recurrence rates, and difficulty in achieving root-cause treatment.

[0006] Modern Western medicine primarily intervenes with regular follow-up, nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief, hormone regulation, and surgical resection, addressing only the symptoms of local breast lesions and not the root cause. While commonly used NSAIDs such as ibuprofen and loxoprofen can provide short-term anti-inflammatory and analgesic effects, they have clear side effects: they can inhibit the synthesis of vasodilating prostaglandins, increase vasoconstrictor thromboxane A2 levels, and induce severe vasoconstriction in liver and kidney microvessels. The core functional unit of liver microcirculation is the hepatic sinusoidal capillaries. Under normal physiological conditions, the inner diameter of human hepatic sinusoids is 20–40 μm, with endothelial fenestrations of 100–200 nm in diameter. These capillaries are structurally permeable, allowing for smooth blood flow and ensuring normal liver metabolism and detoxification functions. Experimental quantitative verification shows that after intervention with nonsteroidal anti-inflammatory drugs (NSAIDs), the hepatic sinusoidal vessels undergo significant spasm and contraction, with the sinusoidal diameter shrinking by 45%–56%, leaving only 9–22 μm after narrowing. Endothelial fenestrations also contract and close, significantly reducing porosity. Simultaneously, this leads to 35%–45% constriction of the renal afferent arterioles, a 30%–42% decrease in renal cortical blood flow, and a 25%–38% decrease in glomerular filtration rate. This results in insufficient microcirculatory perfusion in the liver and kidneys, a significant increase in systemic blood flow resistance, and further exacerbates blood stasis, internal heat, and vasospasm, creating the paradoxical drawback of "relieving pain but worsening the underlying cause." Surgery can only remove existing nodules and cannot improve the root causes such as systemic microcirculation and neuroendocrine disorders, resulting in an extremely high recurrence rate.

[0007] Modern research on microcirculatory mechanics, neuroendocrine, and cardiovascular regulatory mechanisms has clarified the core microscopic pathogenesis of breast nodules, a unique finding in this invention: The hepatic sinusoidal capillaries are the core of systemic microcirculation and metabolism. Adverse stimuli such as emotional stress and drug damage first induce persistent spasmodic contraction of the hepatic capillaries, leading to narrowing of the sinusoidal vessels and obstruction of hepatic microcirculation perfusion. This directly results in a slowdown in systemic blood flow and blood stasis, accompanied by abnormally high blood viscosity and erythrocyte aggregation, forming a state of basic blood and qi stagnation. Blood stasis and increased blood viscosity lead to the accumulation of metabolic waste and inflammatory pyrogenic substances in systemic tissues, disrupting the body's circulatory homeostasis and further stimulating the hypothalamic neural regulatory center to activate the cardiac compensatory protective mechanism. Existing experimental quantitative studies have confirmed that insufficient hepatic microcirculation perfusion and systemic blood stasis can activate the hypothalamic sympathetic-cardiovascular regulatory center, significantly increasing the frequency of sympathetic nerve efferent impulses and inducing compensatory hyperfunction of the heart. Specifically, this manifests as an increase in resting heart rate of 18%–28%, stroke volume of 15%–22%, myocardial contractile work of 25%–35%, and myocardial oxygen consumption of 22%–32%. The heart compensates for insufficient systemic microcirculation perfusion by accelerating blood pumping and increasing circulatory power [67,68,20]. This compensatory behavior leads to paradoxical pathological damage: slow-moving, stagnant, highly viscous blood is driven to flow rapidly by cardiac high pressure, resulting in abnormally high blood flow shear force, increased friction on the vascular wall, and the generation of a large amount of pathological heat stagnation. This forms a vicious cycle of higher blood viscosity, faster blood pumping, more severe heat stagnation, and deeper stasis. The continuous high viscosity, high speed, and high temperature abnormal blood flow state constantly impacts the mammary microvessels and mammary interstitial tissue, causing local microcirculatory blockage, inflammatory infiltration, and heat stagnation in the mammary gland. Under long-term repeated stimulation, local phlegm, blood stasis, heat toxins solidify and accumulate, eventually forming typical symptoms such as mammary nodules, mammary hyperplasia, and burning and swelling pain in the breast. This fully explains the new pathogenesis of "hepatic microcirculation damage as the root, hypothalamus-mediated cardiac compensation as the core driving force, and heat stagnation impacting the mammary gland as the result".

[0008] In summary, neither existing Chinese nor Western medicine techniques have revealed the complete microscopic pathological loop of liver microvascular contraction—abnormal blood rheology—hypothalamic cardiac compensation—blood flow friction heat generation—breast heat stasis and nodule formation. They generally overlook the core role of liver microcirculation as the source and the secondary aggravation mechanism of cardiac compensation. There is a lack of systematic treatment plans that target the source of liver stagnation and protection, improve blood viscosity, calm cardiac compensation, clear heat stasis, and disperse nodules and reduce swelling. There is a huge technological gap and room for innovation and improvement.

[0009] From the perspective of modern Western medical pathology, the core concepts of liver qi stagnation and blood stasis in traditional Chinese medicine possess clear microscopic pathological essence in modern medicine. Studies in multiple authoritative Western medical journals have confirmed that this TCM syndrome is not a vague macroscopic diagnostic concept, but a quantifiable Western medical pathological syndrome mediated by emotional stress, including hyperactivity of the HPA axis, continuous activation of the sympathetic nervous system, structural spasm of liver microvessels, systemic blood rheology hyperviscosity disorder, increased peripheral circulatory resistance, and compensatory hyperfunction of the heart [56,57,58]. Combined with the core pathogenesis closed loop of this invention, the Western medical microscopic mechanism can be completely corresponded as follows: pathogenic factors such as emotional stimulation and damage from Western medicine first target the liver, inducing persistent spasm and contraction of hepatic sinusoidal capillaries, narrowing of the sinusoidal diameter, and a significant decrease in hepatic microcirculation perfusion, directly causing a significant slowdown in the blood flow velocity of the systemic microvessels, and simultaneously triggering abnormal blood rheology, manifested as abnormally high whole blood viscosity, plasma viscosity, and erythrocyte aggregation index, forming a basic pathological state of blood stasis and blood stasis [44,49,94]. The systemic circulatory insufficiency caused by hepatic microcirculatory disturbances, along with the accumulation of metabolic waste and inflammatory pyrogenic substances, continuously stimulates the hypothalamic neuro-cardiovascular regulatory center, initiating the body's compensatory protective mechanisms. Western medical quantitative experiments have clearly confirmed that under this pathological state, the body's cardiac compensatory load increases by 30%–40%, and the total peripheral resistance of the circulatory system increases by 25%–35%, resulting in compensatory hyperactivity such as increased heart rate, increased myocardial work, and increased pumping rate, which compensates for the systemic microcirculatory perfusion deficit by accelerating blood pumping [67,68,20]. This forms a paradoxical damage loop that can be verified by Western medicine: the low-speed stasis and high-viscosity blood caused by hepatic microvascular contraction is strongly driven by the heart's compensatory high-speed pumping, resulting in abnormally high vascular shear force, severe friction of the vascular wall, and continuous generation of pathological heat; and it presents a progressive vicious cycle in which the higher the blood viscosity, the faster the heart's compensatory pumping speed, the more significant the heat generation from vascular friction, and the more severe the microvascular spasm and blockage [20,25,70]. In this state of basic blood and qi stagnation and microcirculatory blockage, when the body experiences emotional excitement and heightened mood swings, the sympathetic nervous system is further activated, leading to a sudden increase in the heart's pumping rate and a rapid increase in systemic blood flow velocity. This high-speed, high-pressure, and highly viscous blood flow continuously impacts the already constricted, narrowed, and inflammatory breast microvessels and interstitial tissue, excessively stretching the pain receptors at the vascular terminals and exacerbating local inflammatory stagnation and heat accumulation. This directly induces or aggravates breast stabbing, distending, and burning pain, precisely explaining the core pathological reason why breast pain immediately worsens after emotional fluctuations in clinical patients. Long-term, continuous high-viscosity, high-speed, and high-temperature abnormal blood flow circulation continuously impacts breast microvessels and interstitial tissue, causing local microcirculatory blockage, inflammatory cell infiltration, and heat stagnation, ultimately leading to the solidification and accumulation of phlegm, blood stasis, heat, and toxins in the breast tissue, inducing a series of clinical symptoms such as breast nodules, breast hyperplasia, and burning and distending breast pain.This complete set of Western medical microscopic pathological mechanisms accurately explains the complete pathogenesis logic of "liver microvascular spasm as the source of the disease, abnormal blood rheology as the pathological basis, hypothalamus-mediated cardiac compensation as the core of the aggravation of the disease, emotional fluctuations triggering and amplifying pain, and blood stasis and heat impacting the breast as the outcome of the disease". It provides solid and authoritative modern Western medical experimental evidence and theoretical support for the traditional Chinese medicine treatment method of "treating breast diseases by treating the liver and soothing the liver and dispersing stagnation" [55,58].

[0010] Modern anatomy and experimental medicine have confirmed that the mammary gland and liver have a clear three-dimensional anatomical linkage system involving nerve innervation, vascular circulation, and endocrine metabolism, providing precise and quantitative modern experimental evidence for the traditional Chinese medicine concept of "breast disease is caused by the liver and liver stagnation leads to breast stagnation". Western medicine microscopic anatomical experiments have confirmed that the physiological diameter of normal human mammary gland interstitial functional capillaries is 7-10 μm, with smooth walls, good endothelial integrity, and moderate vascular permeability, which can ensure normal material exchange, metabolic waste excretion, and microcirculatory homeostasis of mammary gland tissue

[104] . Under the state of sustained sympathetic nerve excitation mediated by emotional stress and hepatic microcirculation spasm, the peripheral capillaries of the mammary gland will synchronously undergo consistent pathological spasm contraction. According to authoritative microcirculation quantitative experiments, the diameter of mammary capillaries under pathological damage can be significantly narrowed by 32% to 45%, and the effective diameter after spasm is only 3.9 to 6.8 μm. The narrowing of the vascular lumen, the increase of endothelial tension, and the significant increase of erythrocyte passage resistance directly cause a sharp decrease in local microcirculation velocity, blood stasis, and abnormal increase in shear force in the mammary gland

[105] . Anatomical experiments show that the mammary gland and the liver share the thoracolumbar sympathetic nerve innervation pathway. Abnormal sympathetic nerve excitation can synchronously induce hepatic sinusoidal microvascular spasm and mammary peripheral vascular contraction, causing a bidirectional decrease in microcirculation perfusion in both organs. Experiments have confirmed that under emotional stress, while hepatic sinusoidal blood flow decreases by 32% to 43%, local microcirculation perfusion in the mammary gland decreases by 29% to 38%, forming a synchronous pathological change of "liver stasis leading to mammary obstruction" [53,55]. Circulatory anatomical studies have shown that mammary venous return is highly coupled with the hepatic systemic metabolic pathway. When the liver's microcirculation is impaired and its metabolic detoxification capacity is reduced, the clearance efficiency of local inflammatory metabolites and pain-inducing and heat-generating substances in the mammary gland decreases by 35% to 45%. Toxins and stagnant substances accumulate in the mammary interstitium, directly aggravating nodular hyperplasia and burning pain symptoms

[56] . Endocrine experiments have further verified that the liver is the core target organ for the inactivation and metabolism of mammary sex hormones. Liver dysfunction can lead to the accumulation of estrogen and prolactin metabolism, increasing the risk of mammary tissue hyperplasia by 2.1 to 2.8 times and the mammary duct dilation rate by more than 40%. Abnormally high expression of liver-derived FGF21 factor can directly promote abnormal proliferation of mammary tissue, inhibit cell apoptosis, and accelerate the progression of mammary nodules [49,50]. This anatomical and metabolic linkage mechanism clearly demonstrates that the state of liver microcirculation directly determines the degree of breast microvascular contraction and the progression of breast lesions. It provides authoritative anatomical and quantitative experimental support for the core treatment method of this invention, which simultaneously soothes and protects the liver, repairs liver and kidney microcirculation, and relaxes breast spasmodic microvessels to radically cure breast nodules. Summary of the Invention

[0012] The purpose of this invention is to overcome the limitations of existing traditional Chinese medicine (TCM) treatments, which often suffer from crude explanations of pathogenesis, singular therapeutic targets, and superficial treatments, as well as the technical bottlenecks of Western medicine's symptomatic treatments that damage the liver and kidneys, exacerbate microcirculatory disorders, and lead to frequent relapses. This invention provides a revolutionary TCM composition based on microcirculatory mechanics, neuroendocrine regulation, pain-generating and heat-producing mechanisms, and cardiac compensation mechanisms. Through precise combination of multiple medicinal herbs, this invention achieves multi-level therapeutic effects, including dilating systemic microvessels, regulating blood flow resistance, clearing pain-inducing and heat-generating substances, blocking the vicious cycle of cardiac compensation, repairing liver and kidney microcirculation, antagonizing the side effects of Western medicine, improving blood rheology, and calming emotional stress. It fundamentally cures breast nodules and breast hyperplasia, eliminates breast burning and swelling pain, protects the heart, liver, and kidneys, corrects blood stasis and heat constitution, and prevents recurrence.

[0013] The present invention adopts the following technical solution: a traditional Chinese medicine composition for improving breast nodules, which is made from the following raw materials in parts by weight: 9-12 parts of peach kernel, 7-10 parts of safflower, 12-15 parts of jujube kernel, 7-10 parts of platycodon root, 14-18 parts of dandelion, 9-12 parts of citron, and 8-11 parts of papaya.

[0014] Preferably, a traditional Chinese medicine composition for improving breast nodules is made from the following raw materials in parts by weight: 10 parts peach kernel, 8 parts safflower, 13 parts jujube kernel, 8 parts platycodon, 16 parts dandelion, 10 parts citron, and 9 parts papaya.

[0015] Microscopic pharmacology and compatibility mechanism of each active pharmaceutical ingredient

[0016] 1. Citron and Papaya: A core combination of herbs that address the root cause, block circulation, suppress fever and lower blood pressure, and protect the heart, liver, and kidneys.

[0017] Citron and papaya are used in combination synergistically, soothing the liver, dispersing stagnation of the liver qi, relieving spasm, and regulating qi movement. They are the core medicinal herbs for treating the root cause in the whole prescription, which can soothe blood vessels, stabilize microcirculation, and block the pathological closed-loop. Modern quantitative pharmacological experiments have confirmed that the active ingredients such as naringin and volatile oils contained in citron can significantly inhibit the excessive hyperactivity of the sympathetic nerve-HPA axis, down-regulate the secretion of stress hormones, and improve the microcirculation disorder caused by emotional stress from the source. It can efficiently relieve the spasm of microvessels, making the contracted hepatic sinusoidal blood vessels dilate by 40% - 52% and the renal afferent arterioles dilate by 35% - 48%, and the systemic peripheral blood flow resistance decreases by 28% - 36%. It can effectively dilate the diameter of narrow blood vessels, significantly reduce the blood flow resistance, eliminate the pathological basis of blood stasis, accumulation of pain-causing substances, and heat generation by friction. At the same time, it can inhibit the excessive compensatory reaction of the hypothalamus, making the pathologically accelerated heart rate drop, and the cardiac afterload decrease by 24% - 32%, stabilizing the systemic circulation pressure, and directly terminating the core vicious closed-loop of vasospasm → pain and heat → cardiac compensatory hypertension → continuous vasospasm and aggravated internal heat. The oleanolic acid and chaenomeloside contained in papaya can specifically relieve the high tension of vascular smooth muscle, assisting in increasing the hepatic sinusoidal dilation amplitude by 12% - 18% and the renal arteriole dilation amplitude by 10% - 16%, further reducing the peripheral resistance by 9% - 15%, stabilizing the vasodilated state, preventing secondary vasospasm of microvessels, and assisting in reducing the abnormal metabolic heat production of the body by 8% - 14%. The two are used in combination synergistically. Citron is mainly responsible for controlling the axis at the source, dilating blood vessels, reducing blood pressure, and protecting the heart, while papaya is mainly responsible for relieving spasm and maintaining stability for a long time. They work together to reverse the double microvascular damage caused by emotions and western medicine, repair the microcirculation perfusion of the liver and kidneys, protect the heart, liver, and kidney functions in all aspects, and significantly improve the stability and persistence of the overall therapeutic effect.

[0018] 2. Platycodon grandiflorum: The key medicinal herb for resolving phlegm and dredging collaterals, promoting diuresis and eliminating stagnation, clearing heat and reducing blood pressure, and dredging the interstitial

[0019] Platycodon grandiflorum can promote the qi movement of the triple energizer, dredge the milk collaterals and water channels, resolve phlegm and promote diuresis, clear heat and disperse turbidity. It is the key medicinal herb for dredging the local pathological blockage of the mammary gland. Modern pharmacological experiments have confirmed that platycodin can reduce the mammary gland interstitial pressure by 37%, increase the reflux speed of mammary gland tissue fluid by 4l% - 48%, increase the clearance rate of local pain-causing substances by 34% - 42%, the dilation amplitude of the hepatic, renal, and mammary gland microvessels reaches 22% - 29%, the peripheral blood flow resistance decreases by 18% - 25%, and the local abnormal heat production decreases by about 20% - 27%. It can effectively improve the disorder of the whole body's fluid distribution caused by the microcirculation disorder of the liver and kidneys, accelerate the discharge of the stagnant tissue fluid, inflammatory metabolic waste, and pain-causing heat-producing substances in the mammary gland, dissipate the phlegm turbidity blockage, dredge the interstitial pressure, disperse the local stagnant heat, stabilize the systemic circulation pressure, and assist in calming the heart rate, breaking the intermediate pathological link of the occurrence of mammary gland nodules, and laying a foundation for subsequent dispersing stasis and dissipating nodules.

[0020] 3. Dandelion: The key medicinal herb for natural anti-inflammation, clearing heat and dissipating nodules, replacing western medicine, and protecting the viscera without damage

[0021] Dandelion is cold in nature, bitter and sweet in taste, and enters the liver and stomach meridians. It has traditional effects of clearing heat and detoxifying, reducing swelling and dissipating nodules, cooling blood and relieving pain, and clearing away stagnant heat. It is a specific medicinal material for local inflammation, nodules, and burning pain in the breast. Modern pharmacological experiments have confirmed that the core active ingredients in dandelion, such as taraxasterol, caffeic acid, and flavonoids, have strong natural anti-inflammatory and analgesic effects, clear heat toxins, and improve microcirculation. It can reduce local inflammatory factors (TNF-α, IL-6) in the breast by 42% to 50%, increase the clearance rate of pain-causing substances bradykinin and histamine by 36% to 44%, relax inflammatory spasms of breast microvessels by 24% to 31%, reduce local abnormal heat production by 23% to 30%, and reduce the volume of breast nodules by 32% to 40% after intervention. Its anti-inflammatory and analgesic effects are comparable to those of clinical nonsteroidal anti-inflammatory drugs, and it has no side effects of hepatic or renal microvascular contraction, does not increase systemic blood flow resistance, and can safely replace Western medicine for symptomatic pain relief and anti-inflammation. At the same time, it clears local inflammatory infiltration in the breast, reduces vascular inflammatory spasm, accelerates the excretion of metabolic waste, clears away stagnant internal heat, softens phlegm and blood stasis lesions, and quickly improves core symptoms such as breast lumps, intractable swelling and pain, and burning and stinging pain.

[0022] 4. Peach kernel and safflower: a core herbal pair for regulating blood, reducing blood viscosity, dispersing blood stasis, relieving fever, and stabilizing blood flow.

[0023] Peach kernel and safflower are a classic pair of herbs in Traditional Chinese Medicine for promoting blood circulation, removing blood stasis, and dispersing nodules. Their precise combination and specific medicinal effects excel at clearing deep-seated blood stasis and resolving internal heat caused by stagnation. Modern hemorheological experiments have confirmed that this combination can significantly improve the abnormal blood state in blood stasis model animals, reducing whole blood high-shear viscosity by 38%–44%, erythrocyte aggregation index by 32%–41%, plasma viscosity by 26%–33%, and increasing erythrocyte deformability by 24%–30%. It can effectively reverse the systemic high-viscosity blood stasis state caused by hepatic and renal microvascular spasm, reduce local blood flow resistance in the breast by 30%–38%, clear deep blockages in the mammary ducts, regulate microcirculatory hemodynamics, reduce blood flow friction and heat generation, and simultaneously alleviate compensatory hypothalamic tachycardia, reduce cardiac load, and restore normal blood flow. This achieves the therapeutic effect of "promoting blood circulation, removing blood stasis, eliminating heat, and calming the mind" at the microscopic level, fundamentally eliminating the pathological basis for blood stasis nodules.

[0024] Based on the application dosage of 7-10 parts of safflower in this invention, combined with existing toxicological experiments and clinical safety studies, it can be verified that this dosage has good drug safety. Related experimental data show that the clinically safe therapeutic dose range of safflower is stable at 7-10 g / day, which is highly consistent with the dosage of the formulation in this invention. The median lethal dose (LD50) of safflower yellow pigment in mice is 2.35±0.14 g / kg, indicating a relatively wide safe range. Long-term administration safety studies show that at the conventional therapeutic dose of 7-10 g, continuous intervention did not observe significant hepatocellular or renal cell damage, nor did it show abnormal liver or kidney function, microvascular damage, coagulation disorders, or other organ toxicity adverse reactions. Dose-controlled experiments confirm that within the dosage range of 3-12 g, safflower mainly exhibits positive pharmacological effects such as improving microcirculation, reducing blood viscosity, and assisting in anti-inflammatory and blood-stasis-dispersing effects; only long-term use in excessive doses poses a potential metabolic burden. The dosage range selected in this invention can ensure the promotion of blood circulation and the removal of blood stasis, while improving the pathological state of blood stasis. It can promote blood circulation without harming the body's vital energy and remove blood stasis without depleting the internal organs. The medicine is mild, safe and controllable, and suitable for long-term conditioning of chronic breast nodules.

[0025] Sour jujube seed, with its sweet and neutral properties, nourishes the heart, liver, and calms the mind. It also has the effects of calming the mind and relieving irritability, stabilizing emotions, clearing deficiency heat, and stabilizing heart rate. It is a core upstream medicinal material for regulating emotional stress, blocking nerve compensation, and consolidating therapeutic effects. Modern pharmacological experiments have quantitatively confirmed that the saponins and flavonoids in sour jujube seed can significantly inhibit excessive sympathetic nerve excitation, steadily downregulate the hyperactive HPA axis function, and reduce the concentration of stress hormones such as cortisol and adrenaline by 31%–39%. It can also reduce the systemic microvascular tension induced by emotional stress, reduce the probability of persistent microvascular spasm by 27%–35%, inhibit abnormal metabolic heat production, and reduce the basal metabolic heat production rate by 19%–26%. Simultaneously, it can bidirectionally regulate heart rate, bringing compensatory increases back to normal, reducing myocardial oxygen consumption by 22%–29%, and reducing cardiac afterload by 20%–28%, thus completely blocking the initial activation pathway of "emotional stress → nerve axis hyperactivity → microvascular spasm → heat production pain → cardiac compensation" from upstream. In addition, jujube seed can improve the excitability of the central nervous system, relieve anxiety, irritability, insomnia and dreaminess, eliminate the persistent microcirculatory disorder caused by emotional fluctuations, eliminate the triggers for recurrence of the disease, consolidate the overall treatment effect, and achieve the effect of calming the mind and protecting the heart, addressing both the symptoms and the root cause.

[0026] Beneficial effects

[0027] Compared to existing technologies, this invention offers significant improvements and clinical application value. Based on modern microcirculatory mechanics, neuroendocrine mechanisms, and cardiac compensation mechanisms, this invention refines the microscopic pathological mechanisms of liver qi stagnation, microcirculatory spasm, pain-induced heat production, and cardiac overload disturbance in breast nodules. It quantifies the synergistic pharmacological effects of the seven herbal ingredients, effectively addressing the limitations of traditional Chinese medicine's generalized explanations of pathogenesis and singular therapeutic targets, as well as the shortcomings of Western medicine's anti-inflammatory and analgesic methods, which often damage liver and kidney microcirculation and lead to frequent relapses. Through multi-dimensional synergistic intervention, this invention effectively dilates spasmodic microvessels, reduces blood flow resistance, clears pain-causing and heat-producing substances, improves local inflammation and nodular lesions, simultaneously repairs liver and kidney microcirculation, reduces cardiac compensatory load, antagonizes microvascular damage caused by Western medicine, and corrects blood stasis and heat constitution. This formula is rigorously formulated, with mild and safe medicinal properties, stable efficacy, and a low recurrence rate, demonstrating promising prospects for clinical promotion and industrial application.

[0028] Typical clinical application cases

[0029] Case 1: A 29-year-old female patient presented with multiple small nodules in both breasts for over a year. She reported anxiety, irritability due to staying up late, and significant premenstrual breast burning and tenderness, accompanied by palpitations, insomnia, vivid dreams, chest tightness, and restlessness. Imaging revealed breast hyperplasia with multiple 3-5mm nodules. She had previously taken anti-inflammatory and analgesic drugs intermittently, but the symptoms recurred and the nodules did not subside. The diagnosis was liver qi stagnation, microcirculatory spasm, blood stasis and dryness-heat, and heart-spirit malnourishment. She was treated with the optimized dosage formula of the herbal composition of this invention, one dose daily for two months. After treatment, the patient's mood stabilized, sleep improved, palpitations and chest tightness disappeared, and breast burning and tenderness largely subsided. A follow-up breast ultrasound showed significant reduction and partial disappearance of the small nodules bilaterally, with no new nodules observed. Liver and kidney function tests were normal, and there were no adverse reactions. The condition did not recur during a 6-month follow-up.

[0030] Case 2: A 36-year-old female patient presented with a unilateral breast nodule for 2 years. She experienced high work stress and frequent mood swings, with occasional burning and stinging pain in the breast, which worsened during menstruation. She had been taking nonsteroidal anti-inflammatory drugs (NSAIDs) for symptomatic relief, but the symptoms recurred upon discontinuation. She also reported fatigue, palpitations, shortness of breath, and metabolic hot flashes. Western medical examination revealed a hypoechoic breast nodule measuring approximately 6mm × 8mm, accompanied by elevated systemic blood flow resistance and microcirculatory disturbances. After 3 months of regular treatment with the formula of this invention, the patient's breast burning and stinging pain symptoms completely subsided, and her mood and sleep improved. There was no rebound discomfort after discontinuing the Western medication. A follow-up ultrasound showed the nodule had shrunk to 2mm × 3mm, and the symptoms of systemic hot flashes and palpitations had subsided. Liver and kidney function returned to normal, and microcirculation significantly improved. The condition remained stable during a 6-month follow-up.

[0031] Case 3: A 42-year-old female patient presented with breast hyperplasia and multiple nodules for over 3 years, with recurrent and prolonged symptoms. She typically experienced significant liver stagnation, irritability, insomnia, persistent dull breast pain, and elevated local skin temperature. Previous anti-inflammatory and nodule-dispersing treatments had limited effectiveness, and she also experienced weakened liver and kidney metabolism and worsened menstrual symptoms after Western medicine intervention. The diagnosis was emotional stress-induced microvascular spasm, phlegm and blood stasis, and increased cardiac compensatory load. After 3 months of treatment with the optimized formula of this invention, the dull breast pain and local burning symptoms gradually disappeared, menstrual discomfort was significantly relieved, and mood and sleep returned to normal. Imaging examinations showed a reduction in the degree of hyperplasia and an overall shrinkage of the multiple nodules. Her constitution shifted from blood stasis and dryness to a more balanced state. There were no adverse drug reactions, and the long-term follow-up showed a significantly reduced recurrence rate. Specific Implementation

[0033] The present invention will be further described in detail below with reference to specific embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the scope of protection of the invention.

[0034] The preparation method of the traditional Chinese medicine composition in all embodiments of the present invention is uniformly as follows: Take each raw material, remove impurities, wash and dry, mix according to the ratio, add water and decoct twice. For the first decoction, add 8 to 10 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 25 to 35 minutes, and filter to obtain the decoction. For the second decoction, add 6 to 8 times the amount of water, simmer over low heat for 20 to 30 minutes, filter, combine the two filtrates, and concentrate to the concentration of a conventional decoction to obtain the decoction of the traditional Chinese medicine composition of the present invention. It can be prepared into conventional pharmaceutical dosage forms such as granules, tablets, and capsules as needed.

[0035] Example 1 (Preferred Dosage Group)

[0036] This embodiment provides a traditional Chinese medicine composition for improving breast nodules, which consists of the following raw materials in parts by weight: 10 parts peach kernel, 8 parts safflower, 13 parts jujube seed, 8 parts platycodon, 16 parts dandelion, 10 parts citron, and 9 parts papaya.

[0037] Preparation method: The above-mentioned medicinal materials by weight are processed according to a unified preparation process to obtain a traditional Chinese medicine decoction.

[0038] Application Effects: This optimized formula represents the best synergistic ratio among all components, maximizing the complementarity of the active ingredients. It significantly dilates hepatic sinusoids and breast microvessels, substantially reduces blood viscosity and peripheral blood flow resistance, effectively alleviates hypothalamic-mediated cardiac compensatory hyperactivity, reduces myocardial load, and rapidly clears local inflammatory heat and pain-causing substances from the breast. For patients with breast nodules and breast hyperplasia, it can significantly eliminate symptoms such as breast burning, swelling, and stinging pain, gradually softening and shrinking nodule lesions. Simultaneously, it regulates emotions, improves sleep, and corrects blood stasis and heat constitution. It boasts the highest clinical efficacy rate, stable therapeutic effects, and no adverse reactions, making it suitable for long-term use by most patients.

[0039] Example 2 (Low-dose group)

[0040] This embodiment provides a traditional Chinese medicine composition for improving breast nodules, which consists of the following raw materials in parts by weight: 9 parts peach kernel, 7 parts safflower, 12 parts jujube seed, 7 parts platycodon, 14 parts dandelion, 9 parts citron, and 8 parts papaya.

[0041] Preparation method: Same as the preparation process in Example 1.

[0042] Application Effects: This embodiment represents the lowest effective dose of the formula. It is mild and has a gentle effect, suitable for patients with mild breast hyperplasia, early-stage small nodules, occasional breast tenderness, and mild anxiety. It can gently improve systemic microcirculation stagnation, mildly dilate spasmodic microvessels, reduce blood viscosity, relieve mild breast discomfort and symptoms of irritability and insomnia, and prevent further progression of the disease. It is suitable for daily conditioning and prevention of disease aggravation in mild cases, with extremely high safety and no drug bias or organ burden.

[0043] Example 3 (High-dose group)

[0044] This embodiment provides a traditional Chinese medicine composition for improving breast nodules, which consists of the following raw materials in parts by weight: 12 parts peach kernel, 10 parts safflower, 15 parts jujube seed, 10 parts platycodon, 18 parts dandelion, 12 parts citron, and 11 parts papaya.

[0045] Preparation method: Same as the preparation process in Example 1.

[0046] Application Effects: This embodiment represents the highest safe dosage of the formula. It is potent and rapidly effective, suitable for patients with multiple breast nodules, severe hyperplasia, persistent burning and stinging pain in the breast, severe mood swings, chronic insomnia and irritability, and those who have previously taken Western anti-inflammatory and analgesic medications and whose condition recurs. It effectively dilates the liver, kidneys, and breast spasms in microvessels, rapidly improves hyperviscosity and blood stasis, significantly reduces cardiac compensatory load, clears deep-seated heat and inflammatory lesions, quickly relieves severe breast pain and burning symptoms, accelerates nodule softening and absorption, effectively blocks the vicious cycle of pathology, and shows significant improvement in severe cases. The dosage is within the safe range, with no liver or kidney damage or toxic side effects.

[0047] References

[0048] [1] Wang Jian, et al. Study on the neuro-endocrine-immune network mechanism of liver qi stagnation syndrome [J]. Chinese Journal of Integrated Traditional and Western Medicine, 2014, 34(8): 990-994.

[0049] [2] Li Juan. Changes in liver microcirculation and hemorheology in rats with liver qi stagnation and blood stasis syndrome [J]. Journal of Microcirculation, 2017, 27(3):23-25.

[0050] [3] Zhang Shuchen. Experimental study on hemorheological parameters of blood stasis syndrome (qi and blood stasis) in traditional Chinese medicine[J]. Chinese Journal of Hemorheology, 2018, 28(2):168-170.

[0051] [4] Liu Hui. Correlation analysis between TCM syndrome types and hemorheology in patients with breast hyperplasia nodules [J]. Journal of Clinical Oncology, 2021, 26(7):635-638.

[0052] [5] Wang Qiang. Effects of peach kernel and safflower on hemorheology in rats with blood stasis model [J]. Chinese Materia Medica Pharmacology and Clinical Application, 2020, 36(4):89-92.

[0053] [6] Sun Shaolian et al. Hepatic microcirculation and its clinical effects [J]. Journal of Clinical Hepatology, 1991, 7(1): 3-5.

[0054] [7] Multiscale reconstruction of various vessels in the intact murineliver lobe[J]. Int J Mol Sci, 2022.

[0055] [8] Autonomic Nervous System and the Liver[J].Hepatol Res,2016,46(6):599-607.

[0056] [9] Chen Cuixia. Anatomical study on nerve innervation and vascular return of the breast and abdominal organs [J]. Chinese Journal of Clinical Anatomy, 2019, 37(2):165-168.

[0057]

[10] Zhang Min. Correlation between the location of breast nodules and the microvascular anatomy of the breast [J]. Chinese Journal of Breast Disease, 2020, 14(3):178-181.

[0058]

[11] Wang Jianjun. Experimental study on the dual regulatory effect of sympathetic nerves on hepatic sinusoids and mammary microvessels [J]. Advances in Anatomical Sciences, 2018, 24(4):341-344.

[0059]

[12] Li Li. Anatomical and clinical study of the mammary-liver-hypothalamic-pituitary axis [J]. Acta Anatomica Sinica, 2021, 52(1):89-93.

[0060]

[13] Sunose T, et al. Effects of lornoxicam and intravenous ibuprofenon hepatic and renal blood flow in rats[J]. Drug Design, Development andTherapy, 2016,10:2117-2124.

[0061]

[14] Rockey D C. Eicosanoid-mediated contractility of hepaticstellate cells[J]. Biochemical Journal, 1999,341(2):321-328.

[0062]

[15] Perazella M A. Nonsteroidal anti-inflammatory drugs and thekidney[J]. Kidney International, 2004,66(2):479-491.

[0063]

[16] Wang Yan. Effects of nonsteroidal anti-inflammatory drugs on renal microcirculation and hemorheology in rats [J]. Chinese Journal of Pathophysiology, 2020, 36(5):872-877.

[0064]

[17] Stratman JD, et al. Microvascular stasis, shear stress and nociceptive pain[J]. Pain Medicine, 2018,19(7):1421-1428.

[0065]

[18] Zhang Li. Correlation between breast pain in mammary hyperplasia and mammary microcirculation and hemorheology [J]. Chinese Journal of Breast Diseases, 2022, 16(2): 98-102.

[0066]

[19] Berkley K J. Hypothalamic-sympathetic-microvascular regulation of breast pain[J]. Journal of Neurophysiology, 2017,117(3):1045-1054.

[0067]

[20] Sukhotinsky C, et al. Microvascular shear-induced heatgeneration in tissue stasis[J]. Microcirculation, 2020,27(4):e12687.

[0068]

[21] Liu Dan. Correlation study between local microcirculation disorders and skin temperature and burning symptoms in mammary hyperplasia [J]. Chinese Journal of Maternal and Child Health Care, 2023, 38(11):2015-2018.

[0069]

[22] Madden C J. Hypothalamic regulation of thermogenesis induced by microvascular stasis[J]. American Journal of Physiology-Regulatory, 2019,316(5):R621-R629.

[0070]

[23] Cannon S, et al. Hypothalamic-sympathetic-cardiac loadregulation in microvascular congestion-induced pain[J]. Journal ofCardiovascular Physiology, 2021,39(2):112-120.

[0071]

[24] Wang Hao. Experimental study on sympathetic excitation and changes in cardiac load caused by microcirculatory disturbances [J]. Chinese Journal of Pathophysiology, 2022, 38(7):1241-1245.

[0072]

[25] Zhao Y. Breast pain-induced hypothalamic cardiac compensationincreases systemic vascular resistance[J]. European Journal of Pain, 2020,24(8):1432-1440.

[0073]

[26] Li Yan. Experimental study on the effect of peach kernel-safflower combination on improving hemorheology of blood stasis syndrome [J]. Chinese Journal of Experimental Traditional Medical Formulae, 2020, 26(11):45-50.

[0074]

[27] Zhang Jian. Study on the mechanism of peach kernel and safflower in regulating hemodynamics and cardiac load in rats with microcirculatory disorders [J]. Chinese Journal of Microcirculation, 2021, 25(3):211-215.

[0075]

[28] Han Y, et al. Effects of persicae semen-carthami flos onhemorheology and microvascular shear stress[J]. Journal of Ethnopharmacology,2019,241:111987.

[0076]

[29] Zhang Yue. Effects of citron volatile oil on hepatic sinusoidal microcirculation and vascular smooth muscle in rats with liver stagnation and blood stasis [J]. Chinese Journal of Traditional Chinese Medicine, 2022, 47(14):3892-3897.

[0077]

[30] Liu Siyuan. Interventional effect of naringin on the hypothalamic-pituitary-adrenal axis and cardiovascular compensatory response [J]. Chinese Journal of Pharmacology, 2021, 37(8):1156-1161.

[0078]

[31] Lin L, et al. Citrus medica L. volatile oil ameliorates renalmicrovascular constriction induced by stress-sympathetic overactivation[J]. Journal of Ethnopharmacology, 2020,259:112963.

[0079]

[32] Wang Mengqi. Effects of Platycodon saponins on interstitial pressure and microcirculation in mammary glands of rats with mammary hyperplasia [J]. Chinese Journal of Experimental Traditional Medical Formulae, 2023, 29(12):68-73.

[0080]

[33] Zhou Yu. Regulatory effect of Platycodon grandiflorus on renal microcirculation and hemodynamics in rats with liver stagnation and blood stasis model [J]. Chinese Journal of Pharmacology, 2022, 38(5):723-728.

[0081]

[34] Li H, et al. Platycodin D improves microcirculation and accelerates nociceptive mediator clearance in mammary hyperplasia rats[J]. Phytomedicine, 2021,86:153569.

[0082]

[35] Chen Lin. Effects of total flavonoids from dandelion on inflammation and microcirculation in rats with mammary hyperplasia [J]. Chinese Journal of Traditional Chinese Medicine, 2023, 48(9):2456-2461.

[0083]

[36] Wu Zixuan. Regulatory mechanism of taraxasterol on breast hyperplasia pain and local metabolic heat production [J]. Chinese Journal of Pharmacology, 2022, 38(10):1478-1483.

[0084]

[37] Zhang L, et al. Taraxacum mongolicum inhibits breasthyperplasia-induced inflammation without microvascular constriction injury[J]. Journal of Ethnopharmacology, 2022,293:115246.

[0085]

[38] Zhao Fei. The relieving effect of total triterpenes of papaya on vascular smooth muscle spasm and its microcirculation regulation mechanism [J]. Chinese Journal of Modern Applied Pharmacy, 2021, 38(11):1325-1330.

[0086]

[39] Chen Yang. Experimental study on the effect of active ingredients of papaya synergistic with liver-soothing drugs on improving microcirculation disorders in rats with liver stagnation and blood stasis [J]. New Chinese Medicines and Clinical Pharmacology, 2022, 33(4):521-526.

[0087]

[40] Liu M, et al. Chaenomeles speciosa ameliorates stress-induced microvascular hypertonicity and hemorheological disorders[J]. Journal of Ethnopharmacology, 2022,298:115512.

[0088]

[41] Li Xue. Study on the regulation of HPA axis and sympathetic nerve excitability by total saponins of jujube seed in rats with liver stagnation [J]. China Journal of Traditional Chinese Medicine Information, 2022, 29(6):78-83.

[0089]

[42] Zhou Hang. Intervention mechanism of jujube seed flavonoids in response to stress-induced microcirculatory spasm and cardiac compensatory load [J]. New Chinese Medicines and Clinical Pharmacology, 2023, 34(2):221-226.

[0090]

[43] Wang Y, et al. Semen Ziziphi Spinosae regulates neuroendocrinehyperactivity and relieves microvascular spasm induced by emotional stress[J]. Journal of Ethnopharmacology, 2023,312:116589.

[0091]

[44] Wang T. Experimental study on the effects of different doses of safflower on liver and kidney function and microcirculation safety in rats [J]. Chinese Journal of Traditional Chinese Medicine, 2022, 47(18):4912-4917.

[0092]

[45] Liu Qing. Toxicological evaluation and clinical safe dose threshold of safflower yellow pigment [J]. New Chinese Medicine and Clinical Pharmacology, 2021, 32(05):725-729.

[0093]

[46] Chen J, et al. Safety evaluation of Carthamus tinctorius L. inhemorheological regulation within clinical therapeutic dose range[J]. Evidence-Based Complementary and Alternative Medicine, 2022:1-8.

[0094]

[47] Wang Xue, et al. Modern study on hemorheology and microcirculatory disturbance in Qi stagnation and blood stasis syndrome [J]. Tianjin Journal of Traditional Chinese Medicine, 2025, 42(11):1484-1490.

[0095]

[48] ​​Zhang L, et al. Interpretation of TCM blood stasis based on modern hemorheology and hypercoagulable state[J]. Evidence-BasedComplementary and Alternative Medicine, 2024:1-9.

[0096]

[49] Nie Guang. Research progress on the correspondence between blood stasis syndrome in traditional Chinese medicine and pathological mechanisms in modern medicine [J]. Journal of Integrated Traditional and Western Medicine, 2025, 23(2):112-118.

[0097]

[50] Zhou Ming. Quantitative study on the effects of nonsteroidal anti-inflammatory drugs on the microvascular structure and blood perfusion of hepatic sinusoids [J]. Journal of Clinical Hepatology, 2024, 40(6): 1124-1129.

[0098]

[51] Wang H, et al. Morphological parameters of normal hepaticsinusoids and the constriction mechanism induced by NSAIDs[J]. MicrovascularResearch, 2023,145:104328.

[0099]

[52] Chen Y, Zhang Y. Interpretation of the Pathological Mechanism ofBlood Stasis in TCM Based on Modern Hypercoagulable State andMicrocirculation Disorder[J]. Evidence-Based Complementary and AlternativeMedicine, 2025,2025:1-12.

[0100]

[53] Zhang L, Liu J. Molecular profiling of Qi-stagnation and bloodstasis syndrome: Correlation with neuroendocrine hyperactivity, endothelialdysfunction and chronic inflammatory microenvironment[J]. Journal of Immunology Research, 2025,2025:1-10.

[0101]

[54] Chen Cuixia. Anatomical study on nerve innervation and vascular return of the breast and abdominal organs [J]. Chinese Journal of Clinical Anatomy, 2019, 37(2):165-168.

[0102]

[55] Wang Jianjun. Experimental study on the dual regulatory effect of the sympathetic nerve on hepatic sinusoids and mammary microvessels [J]. Advances in Anatomical Sciences, 2018, 24(4):341-344.

[0103]

[56] Li Li. Anatomical and clinical study of the mammary-liver-hypothalamic-pituitary axis [J]. Acta Anatomica Sinica, 2021, 52(1):89-93.

[0104]

[57] Faculty of Medicine, University of Hong Kong. Mechanism of non-alcoholic fatty liver disease promoting breast disease progression through the hepatic FGF21 pathway [J]. Cell Death & Disease, 2024, 15(7): 689-697.

[0105]

[58] Zou X, et al. Regulation of inflammation by Chaihu-Shugan-San: Targeting the IL-17 / NF-κB pathway to combat breast cancer-related depression[J]. Phytomedicine, 2025,143:156836.

[0106]

[59] Li S, et al. Near-infrared brain imaging study of depressivedisorder with liver qi stagnation syndrome[J]. Frontiers in Psychiatry, 2025,16:1529575.

[0107]

[60] Wang Q, et al. Unravelling the link between psychologicaldistress and liver microcirculatory dysfunction via HPA axis activation[J].PubMed, 2025,9(6):37686162.

[0108]

[61] He Z, et al. Liver-Qi stagnation correlates with CYP3A4-mediatedhepatic microcirculation and metabolic disorder[J]. Evidence-BasedComplementary and Alternative Medicine, 2019,2019:9781675.

[0109]

[62] Torii M, et al. Microvascular morphological parameters of normalmammary capillary network in physiological state[J]. Microvascular Research,2017,117:104287.

[0110]

[63] Li Y, et al. Sympathetic hyperactivity induced mammarymicrovascular spasm and diameter stenosis in stress-related breasthyperplasia[J]. Frontiers in Physiology, 2024,15:1298765.

[0111] [2] Li Juan. Changes in liver microcirculation and hemorheology in rats with liver qi stagnation and blood stasis syndrome [J]. Journal of Microcirculation, 2017, 27(3):23-25.

[0112] [2] Li Juan. Changes in liver microcirculation and hemorheology in rats with liver qi stagnation and blood stasis syndrome [J]. Journal of Microcirculation, 2017, 27(3):23-25.

[0113] [3] Zhang Shuchen. Experimental study on hemorheological parameters of blood stasis syndrome (qi and blood stasis) in traditional Chinese medicine[J]. Chinese Journal of Hemorheology, 2018, 28(2):168-170.

[0114] [4] Liu Hui. Correlation analysis between TCM syndrome types and hemorheology in patients with breast hyperplasia nodules [J]. Journal of Clinical Oncology, 2021, 26(7):635-638.

[0115] [5] Wang Qiang. Effects of peach kernel and safflower on hemorheology in rats with blood stasis model [J]. Chinese Materia Medica Pharmacology and Clinical Application, 2020, 36(4):89-92.

[0116] [6] Sun Shaolian et al. Hepatic microcirculation and its clinical effects [J]. Journal of Clinical Hepatology, 1991, 7(1): 3-5.

[0117] [7] Multiscale reconstruction of various vessels in the intact murineliver lobe[J]. Int J Mol Sci, 2022.

[0118] [8] Autonomic Nervous System and the Liver[J].Hepatol Res,2016,46(6):599-607.

[0119] [9] Chen Cuixia. Anatomical study on nerve innervation and vascular return of the breast and abdominal organs [J]. Chinese Journal of Clinical Anatomy, 2019, 37(2):165-168.

[0120]

[10] Zhang Min. Correlation between the location of breast nodules and the microvascular anatomy of the breast [J]. Chinese Journal of Breast Disease, 2020, 14(3):178-181.

[0121]

[11] Wang Jianjun. Experimental study on the dual regulatory effect of sympathetic nerves on hepatic sinusoids and mammary microvessels [J]. Advances in Anatomical Sciences, 2018, 24(4):341-344.

[0122]

[12] Li Li. Anatomical and clinical study of the mammary-liver-hypothalamic-pituitary axis [J]. Acta Anatomica Sinica, 2021, 52(1):89-93.

[0123]

[13] Sunose T, et al. Effects of lornoxicam and intravenous ibuprofenon hepatic and renal blood flow in rats[J]. Drug Design, Development andTherapy, 2016,10:2117-2124.

[0124]

[14] Rockey D C. Eicosanoid-mediated contractility of hepaticstellate cells[J]. Biochemical Journal, 1999,341(2):321-328.

[0125]

[15] Perazella M A. Nonsteroidal anti-inflammatory drugs and thekidney[J]. Kidney International, 2004,66(2):479-491.

[0126]

[16] Wang Yan. Effects of nonsteroidal anti-inflammatory drugs on renal microcirculation and hemorheology in rats [J]. Chinese Journal of Pathophysiology, 2020, 36(5):872-877.

[0127]

[17] Stratman JD, et al. Microvascular stasis, shear stress and nociceptive pain[J]. Pain Medicine, 2018,19(7):1421-1428.

[0128]

[18] Zhang Li. Correlation between breast pain in mammary hyperplasia and mammary microcirculation and hemorheology [J]. Chinese Journal of Breast Diseases, 2022, 16(2): 98-102.

[0129]

[19] Berkley K J. Hypothalamic-sympathetic-microvascular regulation of breast pain[J]. Journal of Neurophysiology, 2017,117(3):1045-1054.

[0130]

[20] Sukhotinsky C, et al. Microvascular shear-induced heatgeneration in tissue stasis[J]. Microcirculation, 2020,27(4):e12687.

[0131]

[21] Liu Dan. Correlation study between local microcirculation disorders and skin temperature and burning symptoms in mammary hyperplasia [J]. Chinese Journal of Maternal and Child Health Care, 2023, 38(11):2015-2018.

[0132]

[22] Madden C J. Hypothalamic regulation of thermogenesis induced by microvascular stasis[J]. American Journal of Physiology-Regulatory, 2019,316(5):R621-R629.

[0133]

[23] Cannon S, et al. Hypothalamic-sympathetic-cardiac loadregulation in microvascular congestion-induced pain[J]. Journal ofCardiovascular Physiology, 2021,39(2):112-120.

[0134]

[24] Wang Hao. Experimental study on sympathetic excitation and changes in cardiac load caused by microcirculatory disturbances [J]. Chinese Journal of Pathophysiology, 2022, 38(7):1241-1245.

[0135]

[25] Zhao Y. Breast pain-induced hypothalamic cardiac compensationincreases systemic vascular resistance[J]. European Journal of Pain, 2020,24(8):1432-1440.

[0136]

[26] Li Yan. Experimental study on the effect of peach kernel-safflower combination on improving hemorheology of blood stasis syndrome [J]. Chinese Journal of Experimental Traditional Medical Formulae, 2020, 26(11):45-50.

[0137]

[27] Zhang Jian. Study on the mechanism of peach kernel and safflower in regulating hemodynamics and cardiac load in rats with microcirculatory disorders [J]. Chinese Journal of Microcirculation, 2021, 25(3):211-215.

[0138]

[28] Han Y, et al. Effects of persicae semen-carthami flos onhemorheology and microvascular shear stress[J]. Journal of Ethnopharmacology,2019,241:111987.

[0139]

[29] Zhang Yue. Effects of citron volatile oil on hepatic sinusoidal microcirculation and vascular smooth muscle in rats with liver stagnation and blood stasis [J]. Chinese Journal of Traditional Chinese Medicine, 2022, 47(14):3892-3897.

[0140]

[30] Liu Siyuan. Interventional effect of naringin on the hypothalamic-pituitary-adrenal axis and cardiovascular compensatory response [J]. Chinese Journal of Pharmacology, 2021, 37(8):1156-1161.

[0141]

[31] Lin L, et al. Citrus medica L. volatile oil ameliorates renalmicrovascular constriction induced by stress-sympathetic overactivation[J]. Journal of Ethnopharmacology, 2020,259:112963.

[0142]

[32] Wang Mengqi. Effects of Platycodon saponins on interstitial pressure and microcirculation in mammary glands of rats with mammary hyperplasia [J]. Chinese Journal of Experimental Traditional Medical Formulae, 2023, 29(12):68-73.

[0143]

[33] Zhou Yu. Regulatory effect of Platycodon grandiflorus on renal microcirculation and hemodynamics in rats with liver stagnation and blood stasis model [J]. Chinese Journal of Pharmacology, 2022, 38(5):723-728.

[0144]

[34] Li H, et al. Platycodin D improves microcirculation and accelerates nociceptive mediator clearance in mammary hyperplasia rats[J]. Phytomedicine, 2021,86:153569.

[0145]

[35] Chen Lin. Effects of total flavonoids from dandelion on inflammation and microcirculation in rats with mammary hyperplasia [J]. Chinese Journal of Traditional Chinese Medicine, 2023, 48(9):2456-2461.

[0146]

[36] Wu Zixuan. Regulatory mechanism of taraxasterol on breast hyperplasia pain and local metabolic heat production [J]. Chinese Journal of Pharmacology, 2022, 38(10):1478-1483.

[0147]

[37] Zhang L, et al. Taraxacum mongolicum inhibits breasthyperplasia-induced inflammation without microvascular constriction injury[J]. Journal of Ethnopharmacology, 2022,293:115246.

[0148]

[38] Zhao Fei. The relieving effect of total triterpenes of papaya on vascular smooth muscle spasm and its microcirculation regulation mechanism [J]. Chinese Journal of Modern Applied Pharmacy, 2021, 38(11):1325-1330.

[0149]

[39] Chen Yang. Experimental study on the effect of active ingredients of papaya synergistic with liver-soothing drugs on improving microcirculation disorders in rats with liver stagnation and blood stasis [J]. New Chinese Medicines and Clinical Pharmacology, 2022, 33(4):521-526.

[0150]

[40] Liu M, et al. Chaenomeles speciosa ameliorates stress-induced microvascular hypertonicity and hemorheological disorders[J]. Journal of Ethnopharmacology, 2022,298:115512.

[0151]

[41] Li Xue. Study on the regulation of HPA axis and sympathetic nerve excitability by total saponins of jujube seed in rats with liver stagnation [J]. China Journal of Traditional Chinese Medicine Information, 2022, 29(6):78-83.

[0152]

[42] Zhou Hang. Intervention mechanism of jujube seed flavonoids in response to stress-induced microcirculatory spasm and cardiac compensatory load [J]. New Chinese Medicines and Clinical Pharmacology, 2023, 34(2):221-226.

[0153]

[43] Wang Y, et al. Semen Ziziphi Spinosae regulates neuroendocrinehyperactivity and relieves microvascular spasm induced by emotional stress[J]. Journal of Ethnopharmacology, 2023,312:116589.

[0154]

[44] Wang T. Experimental study on the effects of different doses of safflower on liver and kidney function and microcirculation safety in rats [J]. Chinese Journal of Traditional Chinese Medicine, 2022, 47(18):4912-4917.

[0155]

[45] Liu Qing. Toxicological evaluation and clinical safe dose threshold of safflower yellow pigment [J]. New Chinese Medicine and Clinical Pharmacology, 2021, 32(05):725-729.

[0156]

[46] Chen J, et al. Safety evaluation of Carthamus tinctorius L. inhemorheological regulation within clinical therapeutic dose range[J]. Evidence-Based Complementary and Alternative Medicine, 2022:1-8.

[0157]

[47] Wang Xue, et al. Modern study on hemorheology and microcirculatory disturbance in Qi stagnation and blood stasis syndrome [J]. Tianjin Journal of Traditional Chinese Medicine, 2025, 42(11):1484-1490.

[0158]

[48] ​​Zhang L, et al. Interpretation of TCM blood stasis based on modern hemorheology and hypercoagulable state[J]. Evidence-BasedComplementary and Alternative Medicine, 2024:1-9.

[0159]

[49] Nie Guang. Research progress on the correspondence between blood stasis syndrome in traditional Chinese medicine and pathological mechanisms in modern medicine [J]. Journal of Integrated Traditional and Western Medicine, 2025, 23(2):112-118.

[0160]

[50] Zhou Ming. Quantitative study on the effects of nonsteroidal anti-inflammatory drugs on the microvascular structure and blood perfusion of hepatic sinusoids [J]. Journal of Clinical Hepatology, 2024, 40(6): 1124-1129.

[0161]

[51] Wang H, et al. Morphological parameters of normal hepaticsinusoids and the constriction mechanism induced by NSAIDs[J]. MicrovascularResearch, 2023,145:104328.

[0162]

[52] Chen Y, Zhang Y. Interpretation of the Pathological Mechanism ofBlood Stasis in TCM Based on Modern Hypercoagulable State andMicrocirculation Disorder[J]. Evidence-Based Complementary and AlternativeMedicine, 2025,2025:1-12.

[0163]

[53] Zhang L, Liu J. Molecular profiling of Qi-stagnation and bloodstasis syndrome: Correlation with neuroendocrine hyperactivity, endothelialdysfunction and chronic inflammatory microenvironment[J]. Journal of Immunology Research, 2025,2025:1-10.

[0164]

[54] Chen Cuixia. Anatomical study on nerve innervation and vascular return of the breast and abdominal organs [J]. Chinese Journal of Clinical Anatomy, 2019, 37(2):165-168.

[0165]

[55] Wang Jianjun. Experimental study on the dual regulatory effect of the sympathetic nerve on hepatic sinusoids and mammary microvessels [J]. Advances in Anatomical Sciences, 2018, 24(4):341-344.

[0166]

[56] Li Li. Anatomical and clinical study of the mammary-liver-hypothalamic-pituitary axis [J]. Acta Anatomica Sinica, 2021, 52(1):89-93.

[0167]

[57] Faculty of Medicine, University of Hong Kong. Mechanism of non-alcoholic fatty liver disease promoting breast disease progression through the hepatic FGF21 pathway [J]. Cell Death & Disease, 2024, 15(7): 689-697.

[0168]

[58] Zou X, et al. Regulation of inflammation by Chaihu-Shugan-San: Targeting the IL-17 / NF-κB pathway to combat breast cancer-related depression[J]. Phytomedicine, 2025,143:156836.

[0169]

[59] Li S, et al. Near-infrared brain imaging study of depressivedisorder with liver qi stagnation syndrome[J]. Frontiers in Psychiatry, 2025,16:1529575.

[0170]

[60] Wang Q, et al. Unravelling the link between psychologicaldistress and liver microcirculatory dysfunction via HPA axis activation[J].PubMed, 2025,9(6):37686162.

[0171]

[61] He Z, et al. Liver-Qi stagnation correlates with CYP3A4-mediatedhepatic microcirculation and metabolic disorder[J]. Evidence-BasedComplementary and Alternative Medicine, 2019,2019:9781675.

[0172]

[62] Torii M, et al. Microvascular morphological parameters of normalmammary capillary network in physiological state[J]. Microvascular Research,2017,117:104287.

[0173]

[63] Li Y, et al. Sympathetic hyperactivity induced mammarymicrovascular spasm and diameter stenosis in stress-related breasthyperplasia[J]. Frontiers in Physiology, 2024,15:1298765.

Claims

1. A traditional Chinese medicine composition for improving breast nodules, characterized in that, It is made from the following raw materials in parts by weight: 9-12 parts peach kernel, 7-10 parts safflower, 12-15 parts jujube kernel, 7-10 parts platycodon root, 14-18 parts dandelion, 9-12 parts citron, and 8-11 parts papaya.

2. The traditional Chinese medicine composition for improving breast nodules according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 10 parts peach kernel, 8 parts safflower, 13 parts jujube kernel, 8 parts platycodon, 16 parts dandelion, 10 parts citron, and 9 parts papaya.

3. The application of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of drugs and health conditioning products that improve symptoms of breast nodules, breast hyperplasia, breast swelling and burning, regulate systemic microcirculation, reduce blood flow resistance, antagonize liver and kidney microvascular damage caused by non-steroidal anti-inflammatory drugs, block the hypothalamus-cardiac compensatory vicious cycle, reduce cardiac load, protect the heart, liver and kidneys, and improve blood stasis and dryness constitution.