A traditional Chinese medicine composition for improving nasal blood flow, its preparation method and application

Abstract

This invention discloses a traditional Chinese medicine composition for improving nasal blood flow, its preparation method, and its application, belonging to the field of traditional Chinese medicine technology. Based on the core pathogenesis of lung yang deficiency, cold stagnation and narrowing of the meridians, lung and nasal microcirculation disorders, and neuroregulation disorders, and addressing the shortcomings of existing rhinitis treatments, this invention provides a traditional Chinese medicine composition made from cinnamon, dried ginger, red ginseng, angelica dahurica, and platycodon grandiflorus. Existing traditional Chinese medicines for clearing nasal passages often only treat the symptoms and not the root cause, leading to frequent relapses; long-term use of Western medicine can easily cause lung and nasal microvascular constriction and neuroregulation disorders, and saline nasal irrigation can also easily induce microcirculatory imbalance, all of which can aggravate rhinitis and secondary discomforts such as palpitations and shortness of breath. This invention, relying on traditional Chinese medicine theory and modern pharmacological research, addresses the above-mentioned technical deficiencies in its formulation, improving lung and nasal microcirculation perfusion, alleviating neurovascular regulation disorders, and compensating for the shortcomings of existing treatments. This invention follows the principles of warming yang and dispelling cold, tonifying qi and clearing the meridians, promoting lung function and clearing nasal passages, and harmonizing the heart and lungs, with a rigorous formulation and mild medicinal properties. It can help broaden the microvascular channels in the lungs and nose, improve iatrogenic damage, reduce the compensatory burden on the heart, and reduce the probability of rhinitis recurrence to a certain extent. The composition is flexible in formulation and easy to prepare, and can be made into a variety of oral dosage forms. It is suitable for various types of rhinitis with lung yang deficiency and for people with nasal microcirculation disorders caused by Western medicine and physical intervention. It has certain clinical application and industrialization potential.

Description

Technical Field

[0002] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition that improves nasal blood flow, particularly a traditional Chinese medicine composition based on warming lung yang, clearing lung and nasal meridians, quantitatively expanding blood flow channels in the microvessels of the lungs and nasal cavity, repairing the dual quantitative damage to nerves and blood vessels caused by Western medicine, making up for the shortcomings of traditional Chinese medicine nasal treatment techniques, and relying on the modern quantitative Western medicine mechanism of five medicinal materials to accurately formulate and regulate lung yang deficiency type rhinitis. It also relates to the preparation method and application of the composition. Background Technology

[0004] The lungs are a delicate organ, located in the upper burner. They are sensitive and intolerant to both cold and heat. The nose is the orifice of the lungs, and the nose is the external manifestation of the lungs. The lungs and nose are connected by meridians and share qi and blood, with their physiology and pathology being highly synchronized. Anatomical studies of human microcirculation have shown that the diameter of alveolar capillaries in normal adults is only 5.0–8.0 μm, with an average of 5.87 μm. These capillaries are extremely small, allowing only red blood cells to pass through in single file, and are highly sensitive to spasms, ischemia, and drug stimulation. In contrast, the diameter of capillaries in normal nasal mucosa is about 20–25 μm, with rich blood supply and active nerve regulation, making them susceptible to changes in vasoconstriction and vasodilation due to nerve reflexes and drug effects [47,51]. The core underlying pathogenesis of chronic rhinitis and allergic rhinitis, which are characterized by prolonged and recurrent attacks, is lung yang deficiency. Deficiency of Yang Qi in the body, external wind-cold invasion, excessive consumption of cold foods, and improper living habits can deplete the Yang Qi in the lungs. Insufficient lung Yang Qi leads to a lack of warmth and reduced blood circulation. Cold pathogens stagnate in the fine blood vessels of the lungs, causing the capillary channels of the lungs to become constricted and narrowed, and the lumen to become narrowed, significantly reducing the space for blood circulation. Modern Western medical research has confirmed that lung Yang deficiency in traditional Chinese medicine is not an abstract TCM syndrome, but has a clear microscopic organic pathological basis. Its core pathological manifestations are low basal metabolism of lung tissue, mitochondrial energy metabolism disorders, insufficient microcirculation perfusion of the lungs and upper airways, and a state of microvascular hyperspasm and hypersensitivity. At the same time, it is accompanied by an imbalance of the hypothalamus-autonomic nervous system-endocrine network, which is the essential pathological basis for the recurrent relapse of chronic airway diseases [37-38]. More importantly, existing Western medical quantitative experiments have confirmed that cold coagulation, hypoxia, low temperature and chronic inflammation can directly induce pathological and quantifiable narrowing of pulmonary microvessels. The diameter of pulmonary microvessels can be significantly reduced by 19% to 57%, the effective blood perfusion volume decreases by more than 30%, and the vascular resistance increases significantly, forming a persistent pulmonary tissue ischemia and hypoxia microenvironment. From the microscopic data level, this confirms the scientific nature of "lung yang deficiency and cold coagulation and narrowing of blood vessels" [47,50].

[0005] Narrowing of blood vessels and sluggish blood flow prevent the normal distribution of qi, blood, and body fluids to nourish the lungs and nasal mucosa. Without the nourishment of qi and blood, the lungs and nose become weak and sensitive, easily triggering symptoms of rhinitis such as nasal congestion, itching, runny nose, sneezing, and difficulty breathing when exposed to wind, cold, odors, or other irritants. Furthermore, due to prolonged deficiency of lung yang and continuous constriction of the collaterals, a recurring and persistent pathological condition is formed. Related microcirculation studies have shown that lung yang deficiency is specifically characterized by a reduction in the diameter of pulmonary microvessels, a slowing of blood flow velocity, and an increase in vascular resistance. The overall microcirculation of the nose and lungs is weakened. Compared with lung qi deficiency, lung yang deficiency is characterized by vascular spasm and ischemia-stasis, which directly leads to long-term malnourishment of the nasal passages and persistent inflammation [39-40]. Chronic airway irritation can cause pathological narrowing of pulmonary microarteries and capillaries by 18% to 42%, reducing the effective blood supply area of ​​lung tissue. Through the linkage of pulmonary and nasal microcirculation, it directly causes synchronous ischemia and malnutrition of the nasal mucosa, which is the key microscopic mechanism of persistent recurrence of rhinitis [48,51].

[0006] At present, there are still significant technical shortcomings in the clinical treatment of chronic rhinitis and allergic rhinitis in traditional Chinese medicine. The mainstream treatment relies on pungent and warm nasal-opening drugs such as magnolia flower and cocklebur, which only focus on dispersing and opening the nasal passages and temporarily dilating the local capillaries in the nasal cavity. Although it can temporarily clear the nasal passages and quickly relieve nasal congestion and runny nose, it lacks the core combination of warming yang and consolidating the foundation, and invigorating qi and unblocking the meridians. It cannot be effective against the fundamental pathogenesis of lung yang deficiency and cold stagnation

[65] . The properties of such traditional drugs are dispersed, the effects are superficial and the effects are short-lived. They can only act on the superficial meridians of the nasal cavity and cannot relax the deep microvessels of the lungs. They cannot reverse the core pathology of pathological stenosis of lung microvessels and insufficient microcirculation perfusion. The effect lasts only 4 to 8 hours. After the effect fades, the nasal meridians immediately tighten and narrow again, forming a relapse dilemma of "opening when taking the medicine and blocking when stopping the medicine"

[67] . Clinical studies have confirmed that lung yang deficiency accounts for 68.7% of all types of recurrent rhinitis. For this type of stubborn rhinitis, long-term use of pungent and warm nasal patency-opening drugs will deplete the remaining yang qi in the lungs, further aggravate lung yang deficiency, cold coagulation and narrowing of the meridians, and exacerbate microvascular spasm in the nose and lungs, forming a vicious cycle of "the more open the meridians, the more deficient the meridians, and the more deficient the meridians, the more blocked the meridians," resulting in extremely poor long-term efficacy and inability to achieve a radical cure

[66] . In essence, traditional Chinese medicine treatment focuses on treating the symptoms rather than strengthening the root cause, emphasizing local nasal patency-opening and wind-dispelling, while neglecting warming yang and tonifying qi, and unblocking the meridians and consolidating the vessels. This fails to resolve the root cause of lung meridian spasm and persistent microvascular narrowing, which is an important technical defect of traditional Chinese medicine in treating rhinitis that is difficult to cure and recurs repeatedly [68-69].

[0007] Current Western medicine's conventional treatment for rhinitis mainly relies on antihistamines, antibiotics, nasal decongestants, and hormone preparations. These drugs can only treat the symptoms by reducing inflammation, allergies, and temporarily relieving nasal symptoms. They cannot address the core pathogenesis of lung yang deficiency, pulmonary capillary stenosis, and insufficient blood supply, and cannot fundamentally repair the circulation of qi and blood in the lungs and nose. They only treat the symptoms, not the root cause.

[0008] More importantly, long-term use of the aforementioned Western medicines has a dual irreversible damage mechanism of quantitative vasoconstriction and nerve anesthetic blockade, which continuously aggravates the root cause of rhinitis and cardiopulmonary damage. This is the core iatrogenic cause of modern intractable rhinitis, drug resistance, and chronic incurable diseases. Modern quantitative pharmacological and clinical studies have confirmed that commonly used clinical antibiotics such as macrolides, quinolones, and polymyxins can quantitatively induce pulmonary capillary spasm and contraction by inhibiting nitric oxide synthesis in lung tissue and stimulating vascular smooth muscle tone, resulting in significant narrowing of pulmonary microvascular diameter, a substantial decrease in blood flow and microcirculation perfusion. Long-term use can easily lead to persistent pulmonary ischemia and hypoxia and progressive aggravation of vascular stasis [1-7,62]. H1 antihistamines (such as loratadine, cetirizine, and diphenhydramine) can directly act on pulmonary microvascular smooth muscle, inducing vasoconstriction in a dose-dependent manner, increasing pulmonary vascular resistance, and reducing pulmonary microcirculation perfusion. Under hypoxic conditions, the narrowing effect will be further amplified, exacerbating pulmonary ischemia and stasis [8-12,59].

[0009] Western medicine has a high degree of correlation and consistency in quantitative contraction damage to lung and nasal microvessels. While contracting lung microvessels, it can precisely induce synchronous pathological narrowing of nasal mucosal capillaries, which greatly aggravates insufficient blood supply to the nasal cavity and the state of mucosal ischemia and malnutrition [19-28]. Quantitative experimental data show that macrolides and quinolone antibiotics can induce sustained contraction of nasal mucosal microvessels by activating the endothelin-1 pathway in nasal mucosa and inhibiting nitric oxide synthesis. The steady-state diameter of nasal microvessels can be narrowed by 20% to 35%. Long-term use directly causes persistent ischemia and hypoxia of the nasal mucosa, mucosal dryness and atrophy, and damage to the barrier function [19-23,63]. Second-generation antihistamines such as loratadine and cetirizine can stably contract nasal and pulmonary microvessels, with an average diameter narrowing of 21% to 38%, an increase in peripheral vascular resistance of 27% to 42%, and a decrease in local microcirculation blood perfusion of 25% to 45%. Under high stress and hypoxia, the maximum narrowing can reach 45%, which continuously damages the normal physiological blood supply system of the nasal cavity [24-28,59].

[0010] In addition, routinely used antihistamines and antibiotics have clear pathological damaging effects such as nerve anesthesia, central nervous system depression, and peripheral nerve blockade, which, together with vasoconstriction, create a double superimposed damage, completely paralyzing the self-repair ability of the nasal and lung microcirculation [53,56]. Modern Western medical research has confirmed that second-generation antihistamines such as loratadine and cetirizine can cross the mucosal nerve barrier, reversibly block the transmission of sensory nerve impulses in the respiratory tract, produce a local nerve anesthesia effect, significantly weaken the normal vasomotor reflex regulation ability of nasal and lung microvessels, and cause the blood vessels to lose their self-dilution and repair function, and remain in a state of pathological spasm and constriction [53,55]. Macrolides and quinolone antibiotics can interfere with the body's γ-aminobutyric acid (GABA) nerve pathway and damage the peripheral nerve endings of the respiratory tract, causing local nerve desensitization and nerve regulation failure in the nasal and lung areas, making it impossible to autonomously relax the spasmodic microvessels, and solidify the pathological pattern of vascular stenosis and blood stasis [54,57]. The neuroparalytic effect mediated by this type of drug will continuously disrupt the homeostasis of the hypothalamus-autonomic nervous system, destroy the self-balancing mechanism of the pulmonary and nasal microcirculation, and superimpose quantitative vascular constriction damage, forming stubborn and irreversible microcirculatory disorders, leading to the complete failure of conventional treatment and repeated and prolonged illness [55,58]. Long-term use of antihistamines will also lead to a 33% to 40% decrease in the effective dilation amplitude of nasal mucosal microvessels, a complete decline in the autonomic vasomotor regulation function of blood vessels, and further loss of microcirculatory repair ability

[60] .

[0011] The lungs open into the nose. Deficiency of blood supply to the lungs, abnormal nerve regulation, and vasoconstriction can directly lead to a sharp reduction in nasal blood supply and paralysis of vascular regulation, resulting in persistent ischemia and malnutrition of the nasal mucosa. This also induces damage to the normal physiological functions of the nasal mucosa, decline in glandular secretion, and mucosal atrophy and degeneration. Not only can it not cure rhinitis, but it will also continuously aggravate the condition and solidify drug resistance. Clinical studies have confirmed that lung yang deficiency is the core constitutional basis for recurrent chronic rhinitis, drug resistance, and poor efficacy of conventional treatment. The microcirculatory disturbance and nerve regulation disorder of the upper airway caused by lung yang deficiency are key inducing factors for damage to the nasal mucosal barrier and recurrent and prolonged inflammation [43-44]. In particular, when the smooth muscle of the pulmonary microvessels is in a state of hypersensitive spasm, the diameter of the terminal capillaries can shrink to less than 50% of the normal diameter, causing local blood stasis and near interruption of perfusion. After the double damage of vasoconstriction caused by Western medicine and nerve paralysis, the pathological condition of pulmonary and nasal ischemia shows an irreversible aggravation

[49] .

[0012] Currently, saline nasal irrigation is a common clinical and daily practice to relieve nasal congestion. However, this method only provides a temporary and false nasal clearing effect. Long-term use can continuously damage the nasal microcirculation and aggravate the root cause of rhinitis, which is an important factor in the recurrence and increasing stubbornness of rhinitis [29-32]. During saline nasal irrigation, osmotic pressure stimulation and water flow physical stimulation directly act on the abundant sensory nerve endings on the surface of the nasal mucosa. The abnormal stimulation signals generated can be transmitted upward to the hypothalamus autonomic nerve regulation center through the peripheral nerve reflex pathway. As the higher regulation center of nasal vasomotor function, the hypothalamus can activate the body's protective compensatory regulation mechanism through the sympathetic nerve pathway, precisely instructing the capillaries on the surface of the nasal cavity to reflexively and violently contract, forcibly squeezing the blood in the superficial blood vessels of the nasal cavity back to the deep tissues of the nasal cavity, so that the surface mucosa of the nasal cavity is in a state of temporary blood supply, quickly eliminating the congestion and edema of the nasal mucosa, and allowing the body to quickly obtain the intuitive feeling of nasal patency and comfort [29-30, 33-36].

[0013] However, this method of nasal irrigation is a typical example of pseudo-nasal irrigation through neuroreflexion. It does not repair the core root cause of lung yang deficiency, nor does it truly broaden the inherent blood flow channels in the nasal cavity. It only achieves temporary relief by forcibly blocking the surface blood supply through hypothalamic-mediated nerve reflexes [33-34]. After the nasal nerve stimulation subsides and the body's regulation recovers, the constricted capillaries will quickly dilate, and blood will refill the nasal mucosa, causing edema and nasal congestion symptoms to recur immediately. Long-term and repeated saline nasal irrigation will continuously disturb the homeostasis of hypothalamic regulation of nasal microcirculation, causing abnormal hypersensitivity of nasal mucosal nerves and disorder of microvascular vasomotor function, repeatedly aggravating the state of cold stagnation and blood stasis in the lungs and nose, leading to increasingly sensitive and stubborn rhinitis [31-32, 35-36]. People with lung yang deficiency already have problems with autonomic nerve imbalance and low vascular regulation ability, making them more sensitive to external physical stimuli and more prone to microvascular disorders and compensatory hyperactivity [41-42]. Furthermore, external cold stimulation and nerve reflex stimulation can simultaneously induce bilateral contraction of lung and nasal microvessels, with an average narrowing of the vessel diameter by 22% to 35%, directly confirming the linkage pathology of synchronous spasm and ischemia of lung and nasal blood vessels

[51] .

[0014] The nasal cavity is chronically in a state of ischemia and hypoxia, neuroregulation failure, and pathological vascular constriction. The signal of insufficient local microcirculation perfusion can be transmitted to the hypothalamic autonomic nervous regulation center via the neural reflex pathway, initiating the systemic compensatory regulation mechanism. By activating sympathetic nerve excitability, the compensatory function of the cardiovascular system is upregulated, actively accelerating the heart contraction frequency, increasing myocardial contractility and cardiac output, and increasing vascular perfusion pressure, in an attempt to compensate for the local ischemic defects in the nasal cavity and lungs [37-40]. In order to continuously meet the body's compensatory needs, the heart has to be in a state of high-frequency contraction and overloaded pumping work for a long time. Over time, this continuously increases the workload of the heart, causing myocardial fatigue and autonomic nervous system dysfunction, which in turn leads to secondary problems such as palpitations, chest tightness, shortness of breath, and fast resting heart rate. Modern Western medical research has clearly confirmed that the state of lung yang deficiency can induce hypothalamic-sympathetic compensatory hyperactivity, continuously increasing the cardiac load and forming a specific pathological chain of upper airway ischemia-central compensation-cardiac strain [41,46]. Meanwhile, persistent spasm and narrowing of pulmonary microvessels, and a sharp reduction in blood perfusion, coupled with the vasomotor dysfunction and quantitative vasoconstriction damage caused by the nerve paralysis of Western medicine, are direct microscopic causes of compensatory cardiac tachycardia and increased cardiac output [49,52]. Ultimately, a new vicious cycle is formed: nerve blockade by Western medicine + quantitative vasoconstriction → paralysis and ischemia of pulmonary and nasal microcirculation → compensatory hyperbaric pressure of the hypothalamus → high-frequency cardiac pumping → cardiac strain. This not only leads to persistent and increasingly stubborn rhinitis with drug resistance, but also continuously accumulates organic damage to the cardiopulmonary system, posing significant clinical limitations and safety risks.

[0015] In summary, there is an urgent clinical need for a traditional Chinese medicine composition that can directly address the root cause of lung yang deficiency, clear the lung and nasal meridians, significantly expand the blood flow channels between the lungs and nasal cavity, repair the dual damage to nerves and blood vessels caused by Western medicine, compensate for the technical shortcomings of traditional magnolia-based formulas that only treat the symptoms and not the root cause, invigorate qi and promote blood circulation to nourish the lungs and nose, and at the same time avoid the various side effects of saline nasal irrigation that induce microcirculation disorders and aggravate rhinitis. This composition can regulate the constitution of rhinitis from the root and break the vicious cycle of nerve-vascular-cardiopulmonary pathology. Summary of the Invention

[0017] I. Raw materials for the composition

[0018] A traditional Chinese medicine composition for improving nasal blood flow is composed of the following raw materials in parts by weight: 5-20 parts cinnamon, 5-20 parts dried ginger, 3-10 parts red ginseng, 5-20 parts angelica dahurica, and 5-20 parts platycodon grandiflorus; preferably 10 parts cinnamon, 10 parts dried ginger, 5 parts red ginseng, 9 parts angelica dahurica, and 9 parts platycodon grandiflorus.

[0019] II. Properties, Flavors, Channels Entered, and Modern Quantitative Pharmacological Effects of Each Raw Material

[0020] Cinnamon: It is extremely hot in nature, pungent and sweet in taste, and enters the kidney, spleen, heart, and liver meridians. It can warm and tonify the lung and kidney yang, warm and unblock the meridians throughout the body, warm and disperse the cold stagnation in the lungs and nose, help relax the constricted microvessels of the lungs and nose, broaden the channels for qi and blood circulation, and guide yang to the nasal passages to strengthen the root cause. Modern pharmacological studies have shown that the main active ingredient of cinnamon is cinnamaldehyde, which accounts for 65% to 80% of the volatile oil content. It can exert vasodilatory and antispasmodic effects to a certain extent by activating the NO / cGMP endothelial relaxation pathway, opening potassium ion channels, and mildly inhibiting calcium ion influx [7,18]. Related animal experiments have shown that cinnamaldehyde has a concentration-dependent vasodilatory effect on spasmodic respiratory vascular contraction. It can help achieve a certain proportion of vasodilatory relief for vasoconstriction induced by low temperature, cold coagulation, and chemical stimulation. Its vasodilatory half-maximal effective concentration (EC50) can reach 1.16 × 10⁻ 5 At a low dose of g / mL, it can mildly improve the state of microvascular hyperspasm[3]. At the same time, cinnamaldehyde can gently upregulate the body's energy metabolism level, which helps to improve the pathological characteristics of low metabolism and insufficient microcirculation in the lung yang deficiency model. It has a certain auxiliary repair effect on vascular hypersensitivity and neuroregulation disorder caused by drug intervention, and can help reverse the pathological narrowing of lung and nasal microvessels, and help warm yang, consolidate the foundation, unblock the collaterals and prevent recurrence[13,18].

[0021] Dried ginger: It is hot in nature and pungent in taste, and enters the spleen, stomach and lung meridians. It specifically enters the lung meridian to warm the middle and dispel cold, warm the lungs and resolve phlegm, break the stagnation of cold evil on the lung collaterals, relieve the microvascular spasm and narrowing caused by cold stagnation, clear the obstruction of cold and dampness for the circulation of qi and blood, and work with cinnamon to warm and tonify lung yang and dredge blood pathways. Modern quantitative experiments have confirmed that the core components of dried ginger, 6-gingerol and shogaol, can upregulate thyroid function, improve the body's basal metabolism, and improve symptoms of lung yang deficiency, aversion to cold and metabolic decline; at the same time, it can inhibit the influx of calcium ions into pulmonary vascular smooth muscle, effectively relax pulmonary microvascular spasm, reduce peripheral vascular resistance, significantly improve pulmonary microcirculation perfusion, and specifically improve the problems of blood vessel stenosis and slow blood flow caused by cold stagnation in the lung collaterals [70,72,75].

[0022] Red ginseng: slightly warm in nature, sweet and slightly bitter in taste, and enters the spleen, lung, and heart meridians. It greatly replenishes the original qi and nourishes the qi of the lungs and spleen. When qi flows, blood flows. It uses the original qi to promote the circulation of blood in the lungs and nose, making up for the weakness of lung yang in transporting blood, increasing blood mobility, and allowing qi and blood to flow smoothly in narrowed blood vessels, nourishing the lungs and nasal mucosa. Modern Western medicine quantitative research shows that the core ginsenosides Rb1 and Rg1 of red ginseng can activate the eNOS / NO endothelial relaxation pathway, achieving a 24.3% to 29.7% diameter expansion of pathologically constricted pulmonary microvessels, and increasing the perfusion of blood flow in the lungs and nose by more than 30%. At the same time, it can specifically repair the respiratory peripheral nerve paralysis and nerve regulation failure caused by Western medicine, downregulate abnormal sympathetic nerve excitation, reduce the compensatory high-frequency pumping load of the heart, and has multiple effects of invigorating qi and expanding blood vessels, nerve repair, and cardiopulmonary regulation, solving the technical shortcomings of simply warming yang and expanding blood vessels, and qi deficiency and weakness in promoting blood flow [88,89,90,91].

[0023] Angelica dahurica: warm in nature, pungent in taste, and enters the lung, stomach, and large intestine meridians. It is aromatic and penetrating, specifically opening the nasal passages, dispelling wind and cold, clearing the meridians and removing blood stasis, directly reaching the local meridians of the nasal passages, clearing nasal congestion, nasal itching, runny nose and other nasal discomfort symptoms. Quantitative pharmacological experiments have confirmed that the coumarin active ingredients of Angelica dahurica can dilate lung and nasal microvessels through endothelial-dependent pathways. For pathological narrowing of blood vessels induced by low temperature and drugs, the diameter can be expanded by 27% to 33%, and the maximum dilation is 31.6%. It can effectively reduce pulmonary vascular circulation resistance, increase nasal mucosal blood flow by more than 28%, accurately reverse upper airway vascular stenosis caused by Western medicine and cold coagulation, and quickly open the superficial blood channels of the nasal cavity and repair the ischemic and stagnant state of the nasal mucosa [82,83].

[0024] Platycodon grandiflorus: neutral in nature, bitter and pungent in taste, and enters the lung meridian. It promotes lung function and soothes the throat, opens up lung qi, and carries medicine upwards, leading other medicines directly to the upper jiao (lungs and nose); when lung qi is properly dispersed, qi mechanism is smooth and blood vessels are unblocked, thus helping to widen the blood channels in the nasal cavity from the qi mechanism level. Modern microscopic experiments have verified that total saponins of Platycodon grandiflorus can target and dilate deep pulmonary microvessels, dilating pathological narrowed blood vessels caused by ischemia and inflammation by an average of 25.8% to 30.2%, effectively reversing 20% ​​to 30% of pathological narrowing of blood vessels, and increasing lung tissue perfusion by more than 32%; at the same time, it can stabilize the balance of vasoconstriction and vasodilation, reduce blood viscosity, and promote the upward movement of qi and blood, thus achieving the core functions of deep vasodilation, enhanced drug loading and efficacy, and stable microcirculation homeostasis [84,85,86].

[0025] III. Principles of Formulation and Compatibility

[0026] This formula addresses the limitations and pathological characteristics of existing clinical treatments for rhinitis. It focuses on the pathological chain of lung yang deficiency, cold stagnation and narrowing of the meridians, poor microcirculation, neuroregulation disorders, and secondary cardiopulmonary discomfort. The formula follows the basic principles of warming yang and dispelling cold, unblocking meridians and expanding blood vessels, invigorating qi and promoting blood circulation, clearing the lungs and opening the nasal passages, and protecting the heart and lungs. The five medicinal herbs are rationally combined, each with its specific function, and their pharmacological effects complement each other, aiming to improve the shortcomings of existing treatments to a certain extent and form a relatively complete conditioning approach.

[0027] This invention selects cinnamon and dried ginger as the main warming yang components. With optimized dosage and combination, the two have synergistic medicinal properties and specifically target the lung meridian. The aim is to gently warm and tonify lung yang and dispel cold stagnation, thereby improving the state of lung yang deficiency and cold binding the meridians from the pathogenesis level. It also helps to relax the constricted microvessels of the lungs and nose, and broaden the channels for qi and blood circulation. It is expected to compensate to some extent for the shortcomings of traditional pungent and warm orifice-opening formulas, such as superficial medicinal effects, easy depletion of yang qi, and easy relapse in the long term, and reduce the possibility of repeated constriction of the meridians.

[0028] Red ginseng is used as an auxiliary ingredient to tonify lung qi and promote blood circulation, aiming to improve the condition of lung deficiency and weakness in blood circulation, as well as qi deficiency and blood stasis. This component is expected to help improve microcirculation perfusion, while moderately regulating the respiratory nerve regulation state, alleviating abnormal sympathetic nerve excitation, reducing the compensatory burden on the heart, and helping to consolidate the conditioning effect of warming yang and unblocking the meridians. To a certain extent, it can improve the limitations of simply warming yang and expanding the meridians while qi deficiency and weakness in blood circulation are addressed.

[0029] With Angelica dahurica as an adjuvant, its pungent and warm properties allow it to penetrate directly into the nasal passages, focusing on clearing the meridians and dispersing blood stasis, thus helping to improve nasal discomfort symptoms such as nasal congestion, nasal itching, and runny nose. It can quickly relieve superficial nasal congestion to a certain extent, achieving a symptomatic relief effect and enhancing the overall conditioning experience.

[0030] Platycodon grandiflorus is used as the guiding herb to promote lung function, relieve stagnation, and carry the medicine upwards. It can regulate the Qi mechanism of the lungs, guide the medicine to act on the lung and nose in the upper part of the body, and at the same time help to relax the deep microvessels of the lungs and harmonize the flow of Qi and blood. This helps to consolidate the overall conditioning effect and stabilize the microcirculation of the lungs and nose.

[0031] The combination of Angelica dahurica and Platycodon grandiflorus creates a synergistic effect that regulates both superficial and deep layers of the body. Compared to using either herb alone, it is expected to enhance the effects of clearing the lung and nasal meridians and improving microcirculation. The entire formula is balanced, with appropriate warming and cooling properties, addressing both the root cause and the symptoms. It can improve problems such as cold stagnation and meridian contraction, qi deficiency and blood stasis, and neuroregulation disorders to a certain extent, avoiding some of the drawbacks of existing treatments. It can also help regulate the constitution of those with lung yang deficiency rhinitis, reducing the probability of recurrence and secondary discomfort. The combination demonstrates a certain degree of rationality and clinical suitability.

[0032] IV. Preparation Method

[0033] Weigh each Chinese medicinal herb according to the above weight proportions, remove impurities, and wash with clean water; put all the herbs into a clay pot, add an appropriate amount of water, the water level should be 2-3 cm above the surface of the herbs, and soak at room temperature for 30 minutes; bring to a boil over high heat, then simmer over low heat for 25-35 minutes, filter out the liquid and drink it warm.

[0034] The dregs can be boiled again with an appropriate amount of water. The two decoctions are mixed and divided equally, and taken warm in the morning and evening, one dose per day. When using the optimized ratio, the decoction process and method of administration remain unchanged, and the efficacy is more stable.

[0035] This composition can also be made into commonly used Chinese medicine preparations such as herbal tea, granules, tablets, and capsules according to conventional Chinese medicine manufacturing processes. The preferred formulation can be directly used in the industrial production of various preparations.

[0036] V. Application

[0037] This traditional Chinese medicine composition can be used to improve nasal blood flow and regulate nasal blood circulation and nerve regulation disorders caused by lung yang deficiency. It is especially suitable for people with chronic rhinitis, allergic rhinitis, hypertrophic rhinitis with lung yang deficiency, and those for whom traditional magnolia flower-based nasal-opening formulas only provide temporary relief without warming yang and strengthening the body, leading to easy relapse. It is also suitable for people who have suffered nerve damage from long-term use of Western medicine, quantitative contraction of lung and nasal microvessels, insufficient nasal blood supply, microcirculatory disorders, and secondary discomfort such as palpitations, chest tightness, and shortness of breath. The optimized composition has a wider range of applications in the preparation of traditional Chinese medicine preparations that regulate nasal microcirculation, repair respiratory nerve damage, reverse pathological vascular constriction, warm and open the lung and nasal meridians, and reduce the compensatory burden on the heart.

[0038] VI. Beneficial Effects

[0039] 1. Addressing both the root cause and symptoms, this formula is beneficial for improving recurring symptoms: Based on the core pathogenesis of lung yang deficiency and cold stagnation of the meridians, this formula can, to some extent, compensate for the shortcomings of traditional pungent and warm nasal-opening formulas, which only provide temporary symptom relief, lack the effect of strengthening the body's foundation, easily deplete yang qi, and are prone to recurrence. By improving the microcirculation of the lungs and nose through the formula's approach of warming yang, strengthening the body's foundation, and invigorating qi and unblocking the meridians, this formula helps stabilize the homeostasis of qi and blood in the nasal cavity, and has a positive effect on reducing the risk of prolonged recurrence of rhinitis and optimizing long-term conditioning effects.

[0040] 2. Assist in repairing iatrogenic damage and improving the condition of intractable diseases: This composition can, to some extent, improve the pathological narrowing of nasal microvessels caused by long-term use of antibiotics and antihistamines. It also has an auxiliary repairing effect on damage caused by Western medicine, such as respiratory nerve regulation disorders and abnormal local nerve perception. It helps to improve the local ischemia and intractable condition of the nasal cavity caused by Western medicine intervention, and can provide new ideas for the clinical treatment of intractable rhinitis.

[0041] 3. Mild in nature, with good application and promotion potential: This composition has a rigorous formulation, mild in nature, and high safety. While repairing pulmonary and nasal microcirculation and regulating nerve function, it can also help improve cardiac compensatory load abnormalities induced by nasal ischemia, relieving secondary discomfort such as palpitations and shortness of breath. Furthermore, its preparation process is simple, and it can be adapted to various oral dosage forms. It is suitable for most people with lung-yang deficiency type rhinitis and related discomfort, possessing certain potential for clinical application and industrial production.

[0042] VII. Clinical Cases

[0043] Case 1

[0044] The patient, Ms. Zhang, 32 years old, had a 6-year history of chronic allergic rhinitis. She had long used nasal decongestants and antihistamines to relieve symptoms on her own, and had also taken traditional Chinese medicine formulas containing magnolia flower buds, which only provided short-term relief, and the symptoms recurred upon discontinuation. Initially, nasal congestion and sneezing symptoms could be relieved temporarily, but the effectiveness of subsequent medications gradually decreased, and typical signs of drug resistance appeared.

[0045] Symptoms presented at the time of consultation: persistent nasal congestion, runny nose, frequent nasal itching, aggravated by cold exposure, accompanied by dryness of the nasal mucosa. The patient reported chronic palpitations, chest tightness, and shortness of breath, experiencing shortness of breath with slight exertion, a slightly rapid heart rate, and frequent awakenings at night due to shortness of breath. The diagnosis was lung yang deficiency, cold stagnation in the lung and nasal meridians, compounded by long-term use of antihistamines and Western medicine, resulting in nasal and pulmonary nerve anesthesia, quantitative vasoconstriction, regulatory dysfunction, pulmonary capillary stenosis, insufficient blood supply to the nasal cavity, microcirculatory disturbances, and secondary compensatory overload of the heart.

[0046] The optimal ratio of this composition (10 parts cinnamon, 10 parts dried ginger, 5 parts red ginseng, 9 parts angelica dahurica, and 9 parts platycodon grandiflorus) was selected. One dose was taken daily according to the conventional decoction method, divided into morning and evening warm doses. After 4 weeks of continuous treatment, the patient's symptoms of nasal congestion, nasal itching, and runny nose were completely relieved, the dryness of the nasal mucosa disappeared, and the symptoms of palpitations, chest tightness, and shortness of breath were significantly improved. The heart rate returned to normal. During the 6-month follow-up, the rhinitis did not recur and there were no cardiopulmonary discomforts.

[0047] Case 2

[0048] The patient, Mr. Li, male, 45 years old, had a history of chronic hypertrophic rhinitis for 8 years. He had been treated with antibiotics and hormones for a long time, and had also taken traditional Chinese medicine such as Magnolia officinalis to clear the nasal passages many times. However, the treatment only provided temporary relief and did not address the root cause. His rhinitis recurred repeatedly and became increasingly resistant to the medication. He also gradually developed cardiopulmonary discomfort symptoms such as chest tightness, palpitations, dizziness, and fatigue.

[0049] Symptoms at presentation: severe bilateral nasal obstruction, decreased sense of smell, pale and ischemic nasal mucosa, accompanied by chest tightness, shortness of breath, rapid heartbeat, cold extremities, and general weakness. The diagnosis was lung yang deficiency and constriction of the lung and nasal meridians. Long-term use of antibiotics and Western medicine caused nerve paralysis, vasoconstriction, and impaired regulatory function. Repeated saline nasal irrigation further aggravated lung meridian constriction, nasal blood supply disorders, and microcirculatory imbalance, inducing compensatory cardiac strain.

[0050] When this composition is prepared and taken according to conventional methods with the preferred ratio, one dose is taken daily. After 5 weeks of continuous treatment, the patient's nasal ventilation returned to normal, the sense of smell improved significantly, the nasal mucosa became rosy, the symptoms of chest tightness and palpitations completely disappeared, and the patient's cold intolerance improved significantly. After 8 months of follow-up, the rhinitis condition was stable, with no recurrence or drug resistance.

[0051] Case 3

[0052] Patient Wang, female, 28 years old, had a 4-year history of allergic rhinitis. Due to frequent use of antihistamines and nasal hormones, as well as regular use of traditional Chinese medicine with magnolia flower as the main ingredient to open the nasal passages and long-term saline nasal irrigation, she could only get temporary relief. The symptoms would relapse immediately after stopping the medication. Gradually, she developed nasal mucosal atrophy, nasal dryness and stinging, accompanied by symptoms such as palpitations, arrhythmia, shortness of breath and lethargy. Her rhinitis would immediately flare up when exposed to wind and cold, and her nasal congestion would be unbearable. She is a typical case of intractable rhinitis caused by Western medicine damage.

[0053] Diagnosis and diagnosis: Lung yang deficiency and malnourishment of the nasal cavity. Traditional magnolia flower-based prescriptions only expand local meridians, do not warm yang and consolidate the foundation, and cannot repair nerve and blood vessel damage. Long-term intervention by Western medicine has caused anesthesia of the nasal and pulmonary nerves, quantitative and continuous contraction of microvessels, and insufficient blood perfusion in the nasal cavity. Hypothalamic compensatory regulation has led to excessive cardiac load.

[0054] Take one dose daily according to the preferred proportions of this composition and the conventional decoction method. After three weeks of continuous treatment, symptoms such as nasal dryness and stinging, nasal congestion, and sneezing all disappeared, the atrophy of the nasal mucosa was repaired, and symptoms of palpitations and arrhythmia were completely relieved. During a one-year follow-up, the rhinitis did not recur, and the cardiopulmonary function was in good condition.

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Claims

1. A traditional Chinese medicine composition for improving nasal blood passage, characterized in that, It is made from the following Chinese medicinal materials in parts by weight: 5-20 parts cinnamon, 5-20 parts dried ginger, 3-10 parts red ginseng, 5-20 parts angelica dahurica, and 5-20 parts platycodon grandiflorus.

2. The traditional Chinese medicine composition for improving nasal blood passage according to claim 1, characterized in that, It is made from the following preferred weight parts of Chinese medicinal materials: 10 parts cinnamon, 10 parts dried ginger, 5 parts red ginseng, 9 parts angelica dahurica, and 9 parts platycodon grandiflorus.

3. A method for preparing the traditional Chinese medicine composition for improving the nasal blood passage according to any one of claims 1-2, characterized in that, Includes the following steps: (1) Weigh each raw material according to the set weight ratio, remove impurities, and wash with clean water; (2) Place all the medicinal materials together in a decoction container, add water until the water level is 2-3 cm above the surface of the medicinal materials, and soak at room temperature for 30 minutes; (3) First bring to a boil over high heat, then simmer over low heat for 25-35 minutes, filter out the liquid to obtain the decoction; (4) The remaining dregs can be boiled again with water. The two decoctions should be mixed evenly, divided equally, and taken warm in the morning and evening, one dose per day.

4. The preparation method according to claim 3, characterized in that: The traditional Chinese medicine composition can be processed into any one of the commonly used oral preparations in clinical practice, such as herbal tea, granules, tablets, or capsules, according to conventional pharmaceutical processes for traditional Chinese medicine.

5. The use of the traditional Chinese medicine composition according to any one of claims 1 to 2 in the preparation of a traditional Chinese medicine preparation for improving nasal blood flow and treating rhinitis of the lung yang deficiency type.

6. The application according to claim 5, characterized in that: The aforementioned traditional Chinese medicine preparations are used to treat chronic rhinitis, allergic rhinitis, and hypertrophic rhinitis belonging to the lung yang deficiency syndrome; to improve the pulmonary and nasal microvascular contraction, nerve block, nasal mucosal ischemia and atrophy, and nasal microcirculation and nerve regulation disorders caused by long-term use of antihistamines, antibiotics, nasal hormone preparations, and long-term saline nasal irrigation; at the same time, to improve secondary symptoms such as hypothalamic compensatory cardiac overload, palpitations, chest tightness, shortness of breath, and fast resting heart rate induced by nasal ischemia and nerve disorders; and also to regulate the constitution of rhinitis patients for whom traditional magnolia flower-based nasal-opening formulas only have a temporary effect and relapse upon discontinuation of medication.