Acupuncture point application traditional Chinese medicine composition for adjuvant treatment of yang deficiency water flooding type edema and preparation method thereof

Abstract

The invention discloses an acupoint application traditional Chinese medicine composition for adjuvant treatment of yang deficiency water flooding type edema and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compositions and preparations. The traditional Chinese medicine composition is prepared from the following raw materials by weight: 10-20 g of black prepared common monkshood daughter root, 6-12 g of euphorbia kansui, 10-20 g of folium artemisiae argyi, 15-30 g of radix stephaniae tetrandrae, 15-30 g of poria cocos, 6-12 g of carrot, 20-40 g of duckweed, 6-12 g of semen pharbitidis, 20-40 g of shredded corn and 6-12 g of According to the invention, black prepared aconite root and euphorbia kansui are used as monarch drugs; folium artemisiae argyi, radix stephaniae tetrandrae, poria cocos and carrot are used as ministerial Duckweed, semen pharbitidis and corn stigma are used as adjuvant drugs, leech is used as a guide drug, and the drugs are guided to directly reach the disease site. The traditional Chinese medicine composition not only exerts the effects of the medicines, but also mobilizes the synergistic effect of the medicines. The prescription has the effects of warming yang, transforming qi, activating blood and inducing diuresis; the four ministerial drugs are combined to assist the main effect of the monarch drug; and the adjuvant drugs are combined to expel water and diminish swelling, so that the effect of inducing diuresis is enhanced. Compared with single use of diuretic, the acupoint application traditional Chinese medicine composition can remarkably improve edema of patients, is safe and effective, and is worthy of popularization.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions and preparations, and particularly relates to an acupoint-application Chinese medicine composition for auxiliary treatment of edema of yang deficiency and water dissemination type and a preparation method thereof. Background Art

[0002] Edema is a symptom of excessive fluid retention in the interstitial space. The causes of edema include decreased plasma colloid osmotic pressure, increased hydrostatic pressure in capillaries, increased capillary wall permeability, and obstructed lymphatic reflux. Edema is a complex disease with many types. It has both external and internal causes. The organs affected are not limited to the common three organs of the lung, spleen, and kidney. The severity of the disease varies, and there is often confusion and transformation of yin and yang, cold and heat, and deficiency and excess. Edema, as one of the common clinical symptoms, reflects the severity of the disease and is also the focus and difficulty of clinical treatment. Modern medicine treats it by controlling the primary disease, limiting sodium salt intake, applying diuretics, and infusing albumin. However, the use of diuretics also has the problem of causing water and electrolyte disorders, increased uric acid, dyslipidemia, glucose metabolism disorders, and even damage to liver and kidney function. Long-term use of diuretics may cause the body to become dependent on them, which gradually weakens the diuretic effect and requires higher doses to achieve the same effect.

[0003] In view of the above problems, the present invention, under the guidance of the basic theory of traditional Chinese medicine, aims to provide a Chinese medicine composition for acupoint application for auxiliary treatment of edema due to yang deficiency and water dissemination. Summary of the invention

[0004] The primary purpose of the present invention is to provide a Chinese medicine composition for acupoint application for auxiliary treatment of edema caused by yang deficiency and water retention; another purpose is to provide a preparation method of the Chinese medicine composition.

[0005] The primary purpose of the present invention is achieved in this way. The Chinese medicine composition for treating edema is composed of 10-20g of Heishun tablets, 6-12g of Gansui, 10-20g of Artemisia argyi, 15-30g of Stephania tetrandra, 15-30g of Poria, 6-12g of Garlic lily, 20-40g of Duckweed, 6-12g of Pharbitis seeds, 20-40g of Corn silk, and 6-12g of Leech, and is suitable for Yang deficiency and water flooding syndrome.

[0006] Another purpose is achieved by the method for preparing the acupoint application Chinese medicine composition for treating edema due to yang deficiency and water retention, characterized in that medically acceptable excipients are added to the Chinese medicine composition formula to prepare it into an ointment.

[0007] Application of the traditional Chinese medicine composition in preparing medicine for treating edema.

[0008] The Chinese medicine composition is used in preparing medicines for treating yang deficiency and water retention syndrome and concurrent syndromes.

[0009] Edema is mostly caused by external pathogens, improper diet, long-term residence in wetlands or physical weakness after illness, which leads to dysfunction of internal organs, loss of body fluid distribution, retention in the body and overflowing on the skin. Its symptoms are characterized by swelling of the eyelids, head, face, limbs, waist and back and even the whole body. "Suwen·Qi Sheng Tong Tian Lun" says: "Yang Qi is like the sky and the sun". Yang Qi is the basis of the functional activities of the internal organs and the master of water metabolism. The five internal organs and six bowels all rely on the warmth and promotion of the whole body's Yang Qi, and the metabolism of Qi, blood and body fluids cannot be separated from the evaporation and gasification of Yang Qi. "Huangdi Neijing" says: "If it does not grow from the hair, the Yang of the five internal organs is exhausted. The body fluid is full, the soul lives alone, the essence is lonely inside, and the Qi is exhausted outside." The exhaustion of Yang in the five internal organs is the cause of edema. Yin Qi is strong inside, Yang Qi is exhausted, and it cannot enter the abdomen. When the Yang Qi is deficient, it cannot transform Qi and move water. Water remains and fills the whole body. When the Yang Qi is depleted, the water essence cannot move and becomes water vapor. Therefore, the essence is isolated inside. Water fills the skin and the body is swollen. Therefore, the shape cannot be protected by clothes. The limbs are swollen and urgent, which affects the internal organs. This is because the Yin Qi is blocked inside and the water vapor is relaxed outside. In treatment, "remove the old and rotten, slightly move the four poles, warm the clothes, and use the Miao acupuncture to restore the shape. Open the ghost gate, clean the palace, and take the essence in time." According to the severity of the disease, remove blood stasis and eliminate the accumulated water. Ask the patient to move the limbs slightly and wear warm clothes to gradually spread the Yang Qi. Then use the Miao acupuncture method to restore his body shape. Then make the sweat flow smoothly and the urine flow smoothly, so that the Yin essence returns to normal. When the Yang Qi of the five internal organs is distributed and the stagnation of the five internal organs is cleansed, then the essence will naturally be produced, the body will naturally be strong, the bones and muscles will complement each other, and the positive energy will naturally recover.

[0010] The inventor clinically studied that the pathogenic factors of the disease include invasion of exogenous evil, improper diet, emotional disorder, long-term illness and lack of nourishment, etc., which lead to deficiency of Yang Qi in the five internal organs. If Yang is deficient, Yang cannot transform into Qi, if Qi cannot move blood, blood stasis will occur, if Qi cannot transform into water, water will stagnate, and water stasis will cause edema; if Yang Qi is deficient, Yin and cold are strong inside, and the lung defense fails to warm up, resulting in chills, cold limbs, and pale complexion; if Yang Qi in the spleen and kidney is deficient, the warming, transportation, and consolidation functions are weakened, and the bladder gasification is dysfunctional, resulting in loose stools and less urine; if the kidney Yang is deficient, the waist and the mansion are not nourished, resulting in soreness of the waist and knees, loss of libido or irregular menstruation, and dysuria; if the heart and spleen are not nourished, and Qi and blood are not harmonious, there will be symptoms such as fatigue, lack of appetite, etc. The movement of water in the human body depends on the gasification of the internal organs and the distribution of body fluids, such as the normal functioning of the functions of the agitation of the heart Qi, the regulation of the lung Qi, the transfer of the spleen Qi, the transpiration of the kidney Qi, and the dredging of the liver Qi.

[0011] Based on the Yellow Emperor's Inner Canon of Medicine, which states that "the five Yangs are spread out, dredging the five internal organs, so the essence is generated naturally, the body is strong naturally, the bones and flesh are protected, and the great Qi is balanced", the inventor, Professor Wei Danxia, ​​a famous Chinese medicine doctor in Yunnan Province, guided by his academic thought of "taking Yin and Yang syndrome differentiation as the key, distinguishing the deficiency and excess of the exterior and interior, cold and heat, warming the five internal organs, and the water flowing when the Qi is transformed", implemented the treatment principle of "warming the Yang, transforming Qi, activating blood circulation and promoting water". The five Yangs and the mechanism of water metabolism are adapted to the clinical pathological characteristics of "edema is mostly caused by Yang deficiency and water overflow, insufficient Yang transformation, and excess Yin formation". Professor Wei Danxia believes that after the water enters the stomach, it spreads its essence and moves upward to the spleen. Through the spleen's distribution and transfer of the essence, the liver is responsible for dredging and regulating the qi. When the qi moves, the water moves. The essence returns to the lungs. The lungs are responsible for clearing and regulating. The lung qi moves, regulates the water channels, and reaches the limbs and organs to nourish the muscles and moisturize the skin. The waste and residual water after metabolism are transformed into sweat and discharged from the sweat pores through the transpiration of the yang qi. Another part of the water moves in the body through the meridians with the nutrient qi through the lung's descending function, with the heart as the driving force, to nourish the five internal organs and six bowels, and to infuse the joints and brain marrow. After being used by the body's tissues and organs, it gathers in the kidneys. The kidney is the organ that mainly controls water. The water gathered in the kidneys is secreted into two parts: clear and turbid under the kidney's gasification function. The clear part, through the transpiration and gasification of the yang energy in the kidney, returns to the lungs, and is then distributed throughout the body by the heart and lungs to maintain the normal amount of water in the body; the turbid part, through the warming and promoting action of the yang energy in the kidney, is continuously transformed into urine and transported downward to the bladder. In this way, the water essence is spread all over the body, externally to the skin and fur, and internally to the meridians of the five internal organs, and can be adapted to the changes of cold and heat in the four seasons and the changes of yin and yang in the five internal organs. Professor Wei responded to the concept of "external treatment and internal treatment". The acupoint application of drugs stimulates the meridian acupoints to stimulate the body's positive energy and mobilize the power in the body. Through the dual effects of drugs and meridian acupoints, the effects of warming yang, transforming qi, activating blood circulation and promoting water excretion are exerted. In addition, the drugs are absorbed through the skin and do not undergo liver and kidney metabolism, thus avoiding the first-pass effect of the drugs and the toxic side effects on the kidneys. Based on the above theory, the inventors of the present invention have formulated a prescription for the treatment of the etiology and pathogenesis of edema caused by yang deficiency and water overflow: in the prescription, Heishun Tablet is very hot, pungent and sweet, enters the heart, kidney and spleen meridians, and is toxic; Gan Sui is bitter, cold and toxic, and enters the lung, kidney and large intestine meridians; Heishun Tablet replenishes fire and assists yang, and expels wind, cold and dampness, while Gan Sui drains water, expels fluid, reduces swelling and disperses nodules, and the two drugs assist each other and serve as the main medicine.Artemisia argyi, Stephania tetrandra, Poria cocos, and Garlic are the assistant drugs; Artemisia argyi is pungent, bitter, warm, and slightly toxic. It enters the liver, spleen, and kidney meridians. Artemisia argyi is aromatic, promotes the flow of yang energy, warms the meridians, dispels cold and removes dampness; Stephania tetrandra is cold in nature and bitter in taste. It enters the lungs and bladder, promotes diuresis and reduces swelling, can open the pores, and promote the flow of water to the three burners; Poria cocos is sweet and light in taste, and is neutral in nature. It enters the heart, lungs, spleen, and kidney meridians, strengthens the spleen and stomach, promotes diuresis and removes dampness; Garlic is pungent in nature and warm in nature. It enters the spleen, stomach, lung, and large intestine meridians, promotes the flow of stagnant qi, and warms the spleen and stomach. The four can be used together to increase The main drug is strong, warming the yang, transforming qi and promoting water circulation; duckweed is pungent and cold, entering the lung meridian, promoting perspiration on the lung surface, dispelling wind and promoting water circulation; morning glory seeds are cold, bitter and toxic, entering the lung, kidney and large intestine meridians, purging water and relieving constipation, eliminating phlegm and removing fluid; corn silk is sweet and neutral, entering the bladder, liver and gallbladder meridians, strengthening the spleen, eliminating dampness and promoting urination, soothing the liver and promoting gallbladder, bitter and cold counter-assisting, guiding yang from yin and enhancing the diuretic effect; leech is a messenger, salty, bitter, neutral, slightly toxic, entering the liver meridian, breaking blood, promoting blood circulation and activating collaterals, and guiding the drug directly to the diseased area. The combination is accurate, which not only brings out the effects of each drug flavor, but also mobilizes the synergistic effect between the drugs.

[0012] Among them, aconite is very hot, it helps the heart yang to dredge the meridians, warms the spleen yang to dispel the cold, replenishes the kidney yang to benefit the fire, and reaches the skin and fur to eliminate the cold. Corn silk soothes the liver and promotes bile secretion, duckweed goes to the lungs and defends against exterior symptoms, garlic relieves the stagnation of qi in the middle burner, and mugwort circulates the yang qi of the whole body, so that the yang qi of the five internal organs can be spread and spread, and the yin and cold water and fluid can be transformed, and the movement of qi drives the movement of water; morning glory seed is clearing and descending, it goes to the airways, dredges the three burners, and drains water and promotes urination; Ginseng is stern and fierce, it goes to the waterways, dredges the meridians, and is used for attacking and resolving. Stephania tetrandra opens the pores, dredges the three burners, unblocks the waterways, and promotes the circulation of water and fluid. It can clear the meridians and promote the flow of qi; Poria enters the heart, lung, spleen and kidney meridians, and replenishes the essence of the internal organs; it also has the function of leeches entering the meridians, removing blood stasis, promoting blood circulation, and making the blood vessels unobstructed, and when the blood flows, the water flows; in this way, the five yangs are distributed, the turbidity of the five internal organs is cleansed, and the water and drink disappear on their own; in addition, half of the drugs in this prescription are toxic, and there is a great safety hazard when taken orally. However, when applied externally to the acupuncture points on the body, it can be absorbed into the blood through the skin, which can not only play the function of the acupuncture points, but also does not undergo liver and kidney metabolism, and will not interact with other oral drugs. It has high safety performance and is worthy of promotion and use.

[0013] The compatibility characteristics of the present invention: for the treatment of edema of Yang deficiency and water overflow type, warming Yang and transforming Qi, promoting blood circulation and promoting diuresis are the main methods. The self-prescribed prescription Buyang Dizhuo Powder is rich in medicine, and toxic but effective medicines are selected to warm the Yang Qi of the five internal organs. When the Yang of the five internal organs is strong, water is transformed into Qi, and when Qi moves, water moves, so that the five Yangs are spread, the turbidity of the five internal organs is cleaned, and the edema is eliminated. If there are concurrent symptoms of Yin deficiency, five-heart irritability, dry mouth, etc., Anemarrhena asphodeloides is added to the prescription to nourish Yin and moisten dryness, and Rehmannia glutinosa is added to nourish blood and nourish Yin, and the two are used together to increase the power of nourishing Yin; if there is concurrent blood stasis, Salvia miltiorrhiza and Angelica sinensis are added to the prescription to promote blood circulation and remove blood stasis, and strengthen the effect of promoting blood circulation and promoting diuresis; if there is Qi stagnation, Chai Chenpi and Aucklandia lappa are added to soothe the liver and regulate Qi, and promote Qi and relieve depression, so as to achieve the effect of soothing the liver, regulating Qi and eliminating bloating.

[0014] The acupoints of the present invention are selected for the spleen meridian, kidney meridian, bladder meridian and Ren meridian, among which the bladder meridian carries the yang energy of the governor meridian and runs throughout the body, and the lung point is selected to replenish the lung yang, and the heart point is selected to replenish the heart yang; the spleen governs the earth, and the earth nature overcomes water, and the earth can also be cultivated to suppress wood. Sanyinjiao is selected as the intersection point of the liver, spleen and kidney meridians, and the three internal organs are treated together, strengthening the spleen, soothing the liver and benefiting the kidney. The kidney governs water, and the kidney meridian enhances water metabolism. Yongquan is selected, and this place means that the kidney's essence has a spring gushing, and the function is to regulate the water channel; the Ren meridian governs all yin, spreads in the abdomen and communicates with the spleen and stomach, strengthens the earth nature of the center to cultivate the earth and control water, and the Shuifen point is named after the water is diverted here, and is good at dividing and benefiting water and dampness; Shenque point has weak barrier function and strong permeability, and can reconcile yin and yang, strengthen the body and eliminate evil; if there is blood stasis, Xuehai and Geshu are used to promote blood circulation and remove blood stasis; Yinlingquan and Fenglong are used to remove phlegm and dampness; Taichong is used to soothe the liver and regulate qi if there is qi stagnation. Chinese medicine is applied externally, in conjunction with meridians and acupoints, to promote internal regulation through external treatment, and to treat diseases through the dual effects of medicine and meridians.

[0015] The invention has a precise compatibility, simple medicine and special efficacy, is highly accepted by patients for acupoint application, and has the following beneficial effects:

[0016] The acupoint application Chinese medicine composition of the present invention can significantly relieve the symptoms and signs of patients with edema of yang deficiency and water dispersing type, reduce edema, and the total effective rate of TCM syndrome efficacy reaches 90%. The Chinese medicine composition is an external medicine that can avoid damaging kidney function and has high safety. It can be used for auxiliary treatment of edema of yang deficiency and water dispersing type, and is worthy of promotion. DETAILED DESCRIPTION

[0017] The present invention is further described below in conjunction with the embodiments, but the present invention is not limited in any way. Any improvements made according to the teachings of the present invention belong to the protection scope of the present invention.

[0018] The invention discloses a Chinese medicine composition for acupoint application for treating edema of yang deficiency type. The Chinese medicine composition for acupoint application consists of the following raw materials by weight: 10-20g of Heishun Tablets, 6-12g of Kansui, 10-20g of Artemisia argyi, 15-30g of Stephania tetrandra, 15-30g of Poria, 6-12g of Garlic scutellariae, 20-40g of Duckweed, 6-12g of Pharbitidis Seed, 20-40g of Corn Silk and 6-12g of Leech, and is suitable for edema of yang deficiency type.

[0019] The Chinese medicine composition is added with 10-20g of Anemarrhena and 10-20g of Rehmannia root, which is suitable for treating yang deficiency with water retention, concurrent with yin deficiency, fever in the five parts of the body, and dry mouth. Anemarrhena nourishes yin and moistens dryness, while Rehmannia root replenishes blood and nourishes yin, and the two are used together to increase the effect of nourishing yin.

[0020] The Chinese medicine composition is added with 10-20g of salvia miltiorrhiza and 10-15g of angelica sinensis, which is suitable for treating yang deficiency with water retention and blood stasis, so as to achieve the effects of promoting blood circulation and removing blood stasis, promoting the circulation of water when blood flows, and strengthening the effects of promoting blood circulation and promoting diuresis.

[0021] The Chinese medicine composition is added with 6-12g of dried tangerine peel and 6-12g of costus root, which is suitable for treating yang deficiency with water retention and concurrent qi stagnation, so as to achieve the effects of soothing the liver and regulating qi, promoting qi circulation and relieving depression, and achieving the effects of soothing the liver and regulating qi and eliminating abdominal distension.

[0022] The present invention also provides a method for preparing the acupoint application Chinese medicine composition for treating edema due to yang deficiency and water retention, characterized in that medically acceptable auxiliary materials are added to the Chinese medicine composition formula to prepare it into an ointment.

[0023] The auxiliary material is one or a combination of more than one of dextrin, maltodextrin, starch or sucrose.

[0024] The ointment is prepared by the following steps:

[0025] 1) The garlic is mashed into a paste for later use, and the remaining medicinal materials are mixed and crushed into 100 mesh to obtain a medicinal powder;

[0026] 2) Add the powder to boiling water at a weight ratio of 1:1.2-1.4, then add the muddled garlic, starch paste, and borneol dissolved in alcohol in sequence, stir together, and knead repeatedly until uniform to obtain an ointment;

[0027] The mass ratio of the medicinal powder to borneol is 100:1.

[0028] In the step 2), the starch paste is prepared by dissolving benzoic acid in 75% alcohol, adding the solution to water and boiling, adding corn starch solution, and boiling until the paste becomes viscous;

[0029] The mass ratio of the medicinal powder, corn starch and benzoic acid is 1000:120-140:1.

[0030] The present invention further provides the use of the traditional Chinese medicine composition in preparing a drug for auxiliary treatment of edema.

[0031] The edema is edema of Yang deficiency and water overflow type and its associated symptoms

[0032] Example 1

[0033] Prescription: Heishunpian 10g, Artemisia argyi 10g, Duckweed 20g, Garlic allium 6g, Stephania tetrandra 15g, Poria 15g, Pharbitis seed 6g, Gelsemium elegans 6g, Corn silk 20g, Leech 6g.

[0034] The preparation method is as follows:

[0035] 1. Mash the garlic into a paste and set aside. Mix the remaining medicinal materials and crush them into 100 mesh to obtain the medicinal powder.

[0036] 2. Take 1kg of medicinal powder and prepare 1.2L of boiling water, 1g of benzoic acid dissolved in 75% alcohol, 120g of corn starch diluted and dissolved in water and cooked until sticky, and 10g of borneol dissolved in 75% alcohol; stir the boiling water, crushed medicinal powder, muddy garlic, dissolved benzoic acid, starch paste and dissolved borneol together, knead repeatedly until a uniform ointment is obtained. After the preparation is completed, put it into a sealed container and put it in the refrigerator for later use.

[0037] Example 2

[0038] The formula of the acupoint patch for edema caused by yang deficiency is prepared from the following raw materials in the following weight proportions: 20g of Heishun tablets, 15g of mugwort leaves, 30g of duckweed, 10g of garlic, 20g of Stephania tetrandra, 30g of Poria, 10g of Pharbitis seeds, 10g of Gelsemium elegans, 30g of corn silk, and 10g of leech.

[0039] The production method is:

[0040] 1. Mash the garlic into a paste and set aside. Mix the remaining medicinal materials and crush them into 100 mesh to obtain the powder.

[0041] 2. Take 1kg of medicinal powder and prepare 1.4L of boiling water, 1g of benzoic acid dissolved in 75% alcohol, 140g of corn starch diluted and dissolved in water and cooked until sticky, and 10g of borneol dissolved in 75% alcohol; stir the boiling water, crushed medicinal powder, muddy garlic, dissolved benzoic acid, starch paste and dissolved borneol together, knead repeatedly until a uniform ointment is obtained. After the preparation is completed, put it into a sealed container and put it in the refrigerator for later use.

[0042] 3. Take 2g of ointment and flatten it into a diameter of about 2cm and place it on the dressing to make an acupuncture patch for immediate use.

[0043] Usage: Before applying the patch, clean the Sanyinjiao, Xinshu, Yongquan, Shuifen, Shenque, Feishu, Yinlingquan, Fenglong and other acupoints with 0.9% saline solution, wipe dry, and then align the thickest center point of the patch with the corresponding acupoints for application. Apply once a day, 6 hours each time, 7 times in a row as a course of treatment; a total of 3 courses of treatment.

[0044] The acupoints selected are the spleen meridian, kidney meridian, bladder meridian, and Ren meridian. The bladder meridian selects Feishu to replenish lung yang, and Xinshu to replenish heart yang; the spleen meridian selects Sanyinjiao as the meeting point of the liver, spleen, and kidney meridians, treating all three organs at the same time, strengthening the spleen, soothing the liver, and benefiting the kidney; the kidney governs water, and the kidney meridian enhances water metabolism, so the Yongquan point is selected. This place is the essence of the kidney and has the meaning of a spring, and its function is to regulate the water channels; the Ren meridian selects the Shuifen point, which is named after the water is diverted here, and it is good at dividing water and dampness; the Shenque point has weak barrier function and strong permeability, and can reconcile yin and yang, strengthen the body and eliminate evil; if there is phlegm and dampness, use Yinlingquan and Fenglong to resolve phlegm and eliminate dampness.

[0045] Example 3

[0046] The formula of the acupoint patch for edema caused by yang deficiency and concurrent yin deficiency, fever in the five hearts, dry mouth, etc. is prepared from the following raw materials in proportion by weight: 20g of Heishun tablets, 12g of Ginseng, 15g of Artemisia argyi, 15g of Stephania tetrandra, 15g of Poria, 10g of Garlic lily, 20g of Duckweed, 6g of Pharbitis seeds, 20g of corn silk, 6g of Leech, 10g of Anemarrhena asphodeloides, and 10g of Rehmannia glutinosa.

[0047] The production method is:

[0048] 1. Mash the garlic into a paste and set aside. Mix the remaining medicinal materials and crush them into 100 mesh to obtain the medicinal powder.

[0049] 2. Take 1kg of medicinal powder and prepare 1.3L of boiling water, 1g of benzoic acid dissolved in 75% alcohol, 130g of corn starch diluted and dissolved in water and cooked until sticky, and 10g of borneol dissolved in 75% alcohol; stir the boiling water, crushed medicinal powder, muddy garlic, dissolved benzoic acid, starch paste and dissolved borneol together, knead repeatedly until a uniform ointment is obtained. After the preparation is completed, put it into a sealed container and put it in the refrigerator for later use.

[0050] 3. Take 2g of ointment and flatten it into a diameter of about 2cm and place it on the dressing to make an acupuncture patch for immediate use.

[0051] Usage: Before applying the patch, clean the Sanyinjiao, Xinshu, Yongquan, Shuifen, Shenque, Feishu, Xuehai, Geshu and other acupoints with 0.9% saline solution, wipe dry, and then align the thickest center point of the patch with the corresponding acupoints for application. Apply once a day, 6 hours each time, 7 times in a row as a course of treatment; a total of 3 courses of treatment.

[0052] The acupoints selected are spleen meridian, kidney meridian, bladder meridian, and Ren meridian. The bladder meridian selects Feishu to replenish lung yang and Xinshu to replenish heart yang; the spleen meridian selects Sanyinjiao as the intersection point of liver, spleen, and kidney meridians, and treats the three organs at the same time, strengthening the spleen, soothing the liver, and benefiting the kidney; the kidney governs water, and the kidney meridian enhances water metabolism, and selects Yongquan, which means the essence of the kidney, and has the function of regulating water channels; the Ren meridian selects Shuifen acupoint, which is named after the water is diverted here, and is good at dividing water and dampness; Shenque acupoint has weak barrier function and strong permeability, which can reconcile yin and yang, strengthen the body and eliminate evil; Xuehai and Geshu activate blood circulation and remove blood stasis. If there is also qi stagnation, use Taichong to soothe the liver and regulate qi.

[0053] Example 4

[0054] The formula of the acupoint patch for edema due to yang deficiency and blood stasis is prepared from the following raw materials in proportion by weight: Formula: 20g of Heishun Tablets, 10g of Gan Sui, 20g of Artemisia argyi, 20g of Stephania tetrandra, 30g of Poria, 12g of Garlic, 30g of Duckweed, 10g of Pharbitis Seed, 30g of Corn Silk, 10g of Leech, 10g of Salvia miltiorrhiza, and 15g of Angelica sinensis

[0055] The production method is:

[0056] 1. Mash the garlic into a paste and set aside. Mix the remaining medicinal materials and crush them into 100 mesh to obtain the powder.

[0057] 2. Take 1kg of medicinal powder and prepare 1.4L of boiling water, 1g of benzoic acid dissolved in 75% alcohol, 140g of corn starch diluted and dissolved in water and cooked until sticky, and 10g of borneol dissolved in 75% alcohol; stir the boiling water, crushed medicinal powder, muddy garlic, dissolved benzoic acid, starch paste and dissolved borneol together, knead repeatedly until a uniform ointment is obtained. After the preparation is completed, put it into a sealed container and put it in the refrigerator for later use.

[0058] 3. Take 2g of ointment and flatten it into a diameter of about 2cm and place it on the dressing to make an acupuncture patch for immediate use.

[0059] Usage: Before applying the patch, clean the Sanyinjiao, Xinshu, Yongquan, Shuifen, Shenque, Feishu, Xuehai, Geshu and other acupoints with 0.9% saline solution, wipe dry, and then align the thickest center point of the patch with the corresponding acupoints for application. Apply once a day, 6 hours each time, 7 times in a row as a course of treatment; a total of 3 courses of treatment.

[0060] Acupoints selected from the spleen meridian, kidney meridian, bladder meridian, and Ren meridian. The bladder meridian selects Feishu to replenish lung yang, and Xinshu to replenish heart yang; the spleen meridian selects Sanyinjiao as the meeting point of the liver, spleen, and kidney meridians, treating all three organs at the same time, strengthening the spleen, soothing the liver, and benefiting the kidney; the kidney governs water, and the kidney meridian enhances water metabolism, and the Yongquan point is selected. This place is the essence of the kidney and has the meaning of a spring, and its function is to regulate the water channels; the Ren meridian selects the Shuifen point, which is named after the water is diverted here, and it is good at dividing water and dampness; the Shenque point has weak barrier function and strong permeability, and can harmonize yin and yang, strengthen the body and eliminate evil; Xuehai and Geshu can promote blood circulation and remove blood stasis.

[0061] Example 5

[0062] The formula of the acupuncture patch for edema due to yang deficiency and qi stagnation is prepared from the following raw materials in proportion by weight: Formula: 15g of Heishun Tablets, 12g of Gan Sui, 10g of Artemisia argyi, 15g of Stephania tetrandra, 15g of Poria, 6g of Garlic stalks, 20g of Duckweed, 6g of Pharbitis seeds, 20g of Corn Silk, 6g of Leech, 10g of Tangerine Peel, 10g of Aucklandia lappa

[0063] The production method is:

[0064] 1. Mash the garlic into a paste and set aside. Mix the remaining medicinal materials and crush them into 100 mesh to obtain medicinal powder / .

[0065] 2. Take 1kg of medicinal powder and prepare 1.3L of boiling water, 1g of benzoic acid dissolved in 75% alcohol, 130g of corn starch diluted and dissolved in water and cooked until sticky, and 10g of borneol dissolved in 75% alcohol; stir the boiling water, crushed medicinal powder, muddy garlic, dissolved benzoic acid, starch paste and dissolved borneol together, knead repeatedly until a uniform ointment is obtained. After the preparation is completed, put it into a sealed container and put it in the refrigerator for later use.

[0066] 3. Take 2g of ointment and flatten it into a diameter of about 2cm and place it on the dressing to make an acupuncture patch for immediate use.

[0067] Usage: Before applying the patch, clean the Sanyinjiao, Xinshu, Yongquan, Shuifen, Shenque, Feishu, Taichong and other acupoints with 0.9% saline solution, wipe dry, and then align the thickest center point of the patch with the corresponding acupoints for application. Apply once a day, 6 hours each time, 7 times in a row as a course of treatment; a total of 3 courses of treatment.

[0068] Acupoints selected from the spleen meridian, kidney meridian, bladder meridian, and Ren meridian. The bladder meridian selects Feishu to replenish lung yang, and Xinshu to replenish heart yang; the spleen meridian selects Sanyinjiao as the meeting point of the liver, spleen, and kidney meridians, treating all three organs at the same time, strengthening the spleen, soothing the liver, and benefiting the kidney; the kidney governs water, and the kidney meridian enhances water metabolism, so the Yongquan point is selected. This place is the essence of the kidney and has the meaning of a spring, and its function is to regulate the water channels; the Ren meridian selects the Shuifen point, which is named after the water is diverted here, and it is good at dividing water and dampness; the Shenque point has weak barrier function and strong permeability, and can harmonize yin and yang, strengthen the body and eliminate evil; Taichong soothes the liver and regulates qi.

[0069] Case 1

[0070] Patient Duan, male, 71 years old, came to the clinic with elevated blood creatinine for more than 9 years and worsening edema in both lower limbs for more than 10 days. The patient complained that he had slight edema in both lower limbs in the past, but did not pay attention to it. In the past 10 days, the edema in both lower limbs was obvious, the face was swollen, accompanied by hiccups, nausea and vomiting, and he usually felt cold and cold limbs, fatigue, sore waist and knees, dizziness from time to time, good appetite, poor sleep, increased nocturia, more than 10 times a night, dry stool, pale and fat tongue with teeth marks, greasy white fur, and weak pulse. Physical examination: moderate edema in both lower limbs, calf circumference 36.5cm, ankle circumference 24cm.

[0071] The patient's syndrome is yang deficiency and water flooding, and the treatment is mainly to warm the yang and transform qi, promote diuresis and reduce swelling. Western medicine gave furosemide 20 mg orally, and then gave acupoint patch treatment prepared in Example 2 of the present invention, and selected Sanyinjiao, Xinshu, Yongquan, Shuifen, Shenque, Feishu, Yinlingquan, and Fenglong acupoints for patch medicine along the spleen meridian, kidney meridian, Renmai, and bladder meridian. Once a day, each time for 6 hours, for 7 consecutive days of intervention. After one week of treatment, all symptoms were reduced, the effect was significant, and the patient's edema subsided significantly, the calf circumference was 34.2cm, and the ankle circumference was 21.8cm.

[0072] Note: The patient has been ill for a long time and has been malnourished, resulting in deficiency of Yang Qi in the five internal organs. Yang deficiency means Yang cannot transform into Qi, and if Qi cannot circulate into water, water and dampness will stagnate inside the body and cause edema. Yang Qi deficiency causes excessive Yin and cold inside the body, and the lungs fail to be warm, resulting in chills and cold limbs. Yang deficiency and instability cause bladder Qi transformation dysfunction, resulting in frequent urination at night. Kidney Yang deficiency causes malnutrition of the waist, resulting in soreness and weakness in the waist and knees. Malnutrition of the heart and spleen, and disharmony of Qi and blood cause fatigue, weakness and poor sleep. If water and dampness invade the body, symptoms such as dizziness, hiccups, nausea and vomiting will occur. In the Buyang Dizhuo Powder formula, the aconite is very hot and helps to transform yang into qi; the gelsemium elegans is pungent and can move through the water channels, clear the meridians, and eliminate diuresis and dampness; the corn silk soothes the liver and promotes bile secretion; the duckweed moves through the lungs and defends the body to relieve exterior symptoms; the garlic relieves stagnant qi in the middle burner; the mugwort circulates the yang of the whole body; the morning glory seeds and stephania tetrandra open the three burners and eliminate diuresis; the poria replenishes the essence of the internal organs; the leech enters the meridians, removes blood stasis, and promotes qi and blood circulation. In addition, the yang of the five internal organs can be spread and circulated, and the function of the meridians and acupoints allows the five yang to be spread, the turbidity of the five internal organs to be cleared, and the water and drink to disappear.

[0073] 1. Clinical Data

[0074] 1. General Information

[0075] Patients who were outpatients or inpatients of the Department of Nephrology and Rheumatology of Kunming Hospital of Traditional Chinese Medicine from October 2023 to November 2024 and met the diagnostic criteria for edema due to yang deficiency and water retention were selected as the observation subjects.

[0076] 2. Case selection

[0077] (1) Diagnostic criteria:

[0078] Western medicine diagnostic criteria: Refer to the diagnostic criteria for edema in Diagnostics (10th edition) (China Traditional Chinese Medicine Press):

[0079] Edema: Excess fluid accumulates in the gaps between human tissues, causing tissue swelling. Depending on the range of involvement, it can be divided into systemic edema and tissue edema.

[0080] TCM diagnostic criteria: Refer to the diagnostic criteria for Yang deficiency and water retention syndrome in the Trial Implementation of the Guidelines for Clinical Research of New Chinese Medicines (2002):

[0081] Main symptoms: swollen face and limbs, chills and cold limbs, fatigue, loose stools, and sore waist and knees.

[0082] Secondary symptoms: poor appetite, loss of libido or irregular menstruation, dizziness, palpitations

[0083] Tongue and pulse: pale, fat tongue with teeth marks, white or greasy white tongue coating, deep and weak or deep and moist pulse.

[0084] The diagnosis can be made if the disease contains 3 main symptoms or 2 main symptoms and 1 secondary symptom.

[0085] (2) Inclusion criteria:

[0086] ① Meet the above-mentioned diagnostic criteria of traditional Chinese and Western medicine;

[0087] ② Aged between 18 and 85 years old;

[0088] ③Not participating in other clinical trials;

[0089] ④Sign the informed consent form.

[0090] (3) Case exclusion criteria

[0091] ① Those who do not meet the inclusion criteria;

[0092] ② Patients with severe heart, liver, hematopoietic system, endocrine system, nervous system diseases, malignant tumors, and mental illness;

[0093] ③ Those who have contraindications or allergies to the drugs in the trial;

[0094] ④Women who are preparing for pregnancy, pregnant or breastfeeding;

[0095] ⑤ Participants in other clinical trials;

[0096] (4) Criteria for exclusion of cases

[0097] ① Cases that were found not to meet the inclusion criteria after inclusion were excluded.

[0098] ② Those who have not been treated according to the treatment plan or have not received the prescribed course of treatment, and the efficacy of the treatment cannot be determined.

[0099] ③The data is incomplete, which affects the judgment of effectiveness and safety.

[0100] ④ Those who develop other diseases during the trial and need to take drugs that may affect this trial.

[0101] (5) Case withdrawal (dropout) criteria

[0102] ① Patients who dropped out naturally or were lost to follow-up during the observation.

[0103] ② Subjects who develop complications or special physiological changes and are not suitable to continue the trial and withdraw from the trial on their own initiative.

[0104] (6) Termination criteria

[0105] ① Those who cannot persist in treatment.

[0106] ② Allergic reactions or other serious adverse reactions occur during the trial.

[0107] 2. Treatment Methods

[0108] 1. Grouping:

[0109] The 60 patients who participated in the observation were divided into a treatment group and a control group by random number table method according to the principle of randomized controlled trial. There were 30 cases in the treatment group and 30 cases in the control group.

[0110] 2. Treatment plan:

[0111] Both groups received basic treatment: rest; low-salt diet (<3g / d); low-fat diet, preferably food rich in polyunsaturated fatty acids or soluble fiber; high-protein diet 0.8-1.0g / (kg / d);

[0112] Control group: 1) General treatment: ① Antihypertensive and urinary protein-lowering treatment: patients with hypertension were given oral ACEI and ARB drugs, and blood pressure <130 / 80 mmHg was appropriate; ② Hypoglycemic treatment: patients with diabetes were given hypoglycemic drugs or insulin injections; ③ Lipid-lowering treatment: patients with elevated blood lipids were given lipid-lowering treatment such as atorvastatin calcium tablets; ④ Anticoagulant treatment: anticoagulant treatment such as indobufen or low molecular weight heparin sodium was given as appropriate to reduce the risk of thromboembolism; ⑤ The use of hormones and immunosuppressants maintained the original treatment plan for nephrotic syndrome; ⑥ Others: correction of anemia, protection of gastric mucosa, acid correction and calcium supplementation, etc.

[0113] 2) Diuretic and anti-edema treatment: Take furosemide 20 mg orally once a day.

[0114] Treatment group: Based on the western medicine treatment of the control group, the ointment of the Chinese medicine composition in Example 2 was applied to the acupoints. 2g of the ointment was flattened to a diameter of about 2cm and placed on the dressing patch to prepare an acupoint patch for immediate use. The acupoints were selected along the spleen meridian, kidney meridian, conception meridian, and bladder meridian for drug application. Once a day, 6 hours each time, for 7 consecutive days.

[0115] Main acupoints: Sanyinjiao, Xinshu, Yongquan, Shuifen, Shenque, and Feishu.

[0116] Acupoint combination: For blood stasis blocking the collaterals, pair with Geshu and Xuehai; for phlegm-dampness blocking the collaterals, pair with Yinlingquan and Fenglong; for qi stagnation, pair with Taichong.

[0117] 3. Observation items;

[0118] (1) Safety indicators

[0119] ① General physical examination items: basic vital signs such as T, R, P, BP, etc.

[0120] ② Routine examination of blood and stool.

[0121] ③Liver and kidney function tests.

[0122] ④Electrocardiogram examination.

[0123] ⑤Possible adverse reactions of the drug and its related detection indicators.

[0124] (2) Efficacy observation indicators

[0125] ① Observe the changes of TCM symptom scores before and after treatment in the treatment group and the control group. TCM symptom scores were based on the Principles of Clinical Research on New Chinese Medicines published by the State Traditional Chinese Medicine Science and Technology Press in 2002. Main symptoms: puffy face and limbs, chills and cold limbs, fatigue, loose stools, sore waist and knees. Secondary symptoms: poor appetite, loss of libido or irregular menstruation, dizziness, palpitations. The main symptoms were scored as 0, 2, 4, and 6 points respectively, and the secondary symptoms were scored as 0, 1, 2, and 3 points respectively. The tongue and pulse were scored as 1 point each.

[0126] ②Observe the calf circumference and ankle circumference of the treatment group and the control group before and after treatment.

[0127] (3) Efficacy evaluation criteria

[0128] ① Clinical efficacy evaluation: A Clinically cured: TCM clinical symptoms and signs disappeared or basically disappeared, and the syndrome score decreased by ≥95%. B Markedly effective: TCM clinical symptoms and signs improved significantly, and the syndrome score decreased by ≥70%. C Effective: TCM clinical symptoms and signs improved, and the syndrome score decreased by ≥30%. D Ineffective: TCM clinical symptoms and signs did not improve significantly, or even worsened, and the syndrome score decreased by less than 30%. Note: The calculation formula (nimodipine method) is: [(pre-treatment score - post-treatment score) ÷ pre-treatment score] × 100%.

[0129] ② Clinical symptom assessment: A Complete relief: edema symptoms and signs completely disappear; B Basic relief: edema symptoms and signs basically disappear. C Effective: edema symptoms and signs significantly improved; D Ineffective: edema symptoms and signs did not change, urine protein and plasma albumin did not change significantly compared with before treatment.

[0130] 4. Safety evaluation:

[0131] Level 1: safe, no adverse reactions: no abnormalities in safety index examination

[0132] Level 2: relatively safe, with mild adverse reactions, no treatment is required and medication can continue, and no abnormalities are found in safety index examinations

[0133] Level 3: There are safety issues, moderate adverse reactions, or mild abnormalities in safety index examinations

[0134] Level 4: The trial was terminated due to serious adverse reactions; or the safety index examination was obviously abnormal

[0135] 5. Statistical methods:

[0136] All data of this experiment were processed using SPSS27.0 statistical software, where measurement data were expressed as "mean ± standard deviation" (Xˉ±S). The data of the treatment group and the control group were tested using an independent sample t-test. If the difference between the two groups conformed to the normal distribution, a paired t-test was used. If it did not conform to the normal distribution, a Wilcoxon signed rank test was used. The rank sum test was used for the rank data in the treatment group and the control group, and the chi-square test was used for the count data. p < 0.05 indicated that the difference in the test was statistically significant.

[0137] 3. Test results

[0138] A total of 62 cases that met the criteria were included in this trial, including 32 cases in the treatment group and 30 cases in the control group. In the clinical trial, 2 patients in the treatment group withdrew from the treatment due to allergic reactions. After the completion of the trial, there were 30 cases in each of the treatment group and the control group.

[0139] 1. General data analysis

[0140] Comparison of gender and age between the two groups of patients before treatment: Before treatment, the two groups of patients had no statistical difference in gender, and the two groups were comparable. Before treatment, the two groups of patients had no statistical difference in age, and the two groups were comparable. After independent sample t test, the p values ​​were all > 0.05, indicating that there was no statistical difference in age and disease course between the two groups, and the two groups were comparable (see Table 1 and Table 2).

[0141] Table 1 Comparison of gender between the two groups of patients

[0142]

[0143] Table 2 Comparison of age between the two groups of patients

[0144]

[0145] 2. Comparison of clinical efficacy

[0146] 2.1 Comparison of edema degree: Rank sum test was used for graded data. ① Comparison of edema degree between the two groups before treatment, Z = -0.472, P = 0.637 > 0.05, no statistical difference, comparable. ② Comparison of edema degree between the two groups after treatment, Z = 2.515, P = 0.012 < 0.05, statistical difference. This shows that the treatment group is better in reducing edema degree (see Table 3):

[0147] Table 3 Comparison of edema degree between the two groups of patients before and after treatment (cases)

[0148]

[0149] 2.2 Comparison of total TCM syndrome scores between the two groups: The two groups of patients were compared in terms of TCM syndrome scores. After independent sample t-test, the p-values ​​of the two groups before treatment were > 0.05, indicating that there was no statistical difference in the TCM syndrome scores between the two groups before treatment and the two groups were comparable; the p-values ​​of the two groups after treatment were < 0.05, indicating that there was a statistical difference in the TCM syndrome scores between the two groups after treatment, and the treatment group was significantly better than the control group (see Table 4).

[0150] Table 4 Comparison of TCM syndrome scores between the two groups of patients

[0151]

[0152] 2.3 Comparison of TCM syndrome efficacy between the two groups: After treatment, the two groups of patients were compared with each other. The chi-square test p = 0.007 values ​​were all < 0.05, and there was a statistically significant difference in the treatment effect between the two groups; the total effective rate of the treatment group and the control group were 90% and 80% respectively, indicating that the treatment group had a better effect in improving TCM syndrome. (See Table 5)

[0153] Table 5 Comparison of TCM syndrome efficacy between the two groups of patients

[0154]

[0155] 3. Safety observation

[0156] No serious adverse reactions occurred in either group of patients. The only symptoms were redness of the skin at the application site, without itching, tingling or other discomfort, which was considered a normal reaction to the application.

[0157] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for acupoint application for auxiliary treatment of edema due to yang deficiency and water retention, characterized in that: The acupoint application Chinese medicine composition consists of the following raw materials by weight: 10-20g of Heishun tablets, 6-12g of Gansui, 10-20g of Artemisia argyi, 15-30g of Stephania tetrandra, 15-30g of Poria, 6-12g of Garlic sphagnum, 20-40g of Duckweed, 6-12g of Pharbitis seeds, 20-40g of Corn silk, and 6-12g of Leech, and is suitable for edema of Yang deficiency type.

2. The acupoint application Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is added with 10-20g of Anemarrhena and 10-20g of Rehmannia root, which is suitable for treating yang deficiency with water retention, concurrent with yin deficiency, fever in the five parts of the body, and dry mouth. Anemarrhena nourishes yin and moistens dryness, while Rehmannia root replenishes blood and nourishes yin, and the two are used together to increase the effect of nourishing yin.

3. The Chinese medicine composition for acupoint application according to claim 1, characterized in that: The Chinese medicine composition is added with 10-20g of salvia miltiorrhiza and 10-15g of angelica sinensis, which is suitable for treating yang deficiency with water retention and blood stasis, so as to achieve the effects of promoting blood circulation and removing blood stasis, promoting the circulation of water when blood flows, and strengthening the effects of promoting blood circulation and promoting diuresis.

4. The Chinese medicine composition for acupoint application according to claim 1, characterized in that: The Chinese medicine composition is added with 6-12g of dried tangerine peel and 6-12g of costus root, which is suitable for treating yang deficiency with water retention and concurrent qi stagnation, so as to achieve the effects of soothing the liver and regulating qi, promoting qi circulation and relieving depression, and achieving the effects of soothing the liver and regulating qi and eliminating abdominal distension.

5. A method for preparing the Chinese medicine composition for acupoint application for treating edema due to yang deficiency and water retention as claimed in any one of claims 1 to 4, characterized in that: Medically acceptable auxiliary materials are added into the formula of the traditional Chinese medicine composition to prepare a medicinal ointment.

6. The preparation method according to claim 5, characterized in that: The auxiliary material is one or a combination of more than one of dextrin, maltodextrin, starch or sucrose.

7. The preparation method according to claim 5, characterized in that: The ointment is prepared by the following steps: 1) Mash the garlic into a paste and set aside. Mix the remaining medicinal materials and grind them into 100 mesh to obtain medicinal powder; 2) Add the powder to boiling water at a weight ratio of 1:1.2-1.4, then add the garlic paste, starch paste, and borneol dissolved in alcohol in sequence, stir together, and knead repeatedly until uniform to obtain an ointment; The mass ratio of the medicinal powder to borneol is 100:

1.

8. The preparation method according to claim 7, characterized in that: In the step 2), the starch paste is prepared by dissolving benzoic acid in 75% alcohol, adding the mixture into water and boiling, adding corn starch solution, and boiling until the mixture becomes viscous; The mass ratio of the medicinal powder, corn starch and benzoic acid is 1000:120-140:

1.

9. Use of the Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a drug for auxiliary treatment of edema.

10. The use according to claim 8, characterized in that: The edema is yang deficiency and water flooding type edema and its associated symptoms.

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