CN115245549B - A traditional Chinese medicine composition for improving damp-heat constitution gouty arthritis - Google Patents

Abstract

The invention relates to a traditional Chinese medicine composition for improving damp-heat constitution and its preparation method and application. The traditional Chinese medicine composition is made of the following raw materials in parts by weight: 10-20 parts of atractylodes rhizome, 10-20 parts of Achyranthes bidentata, 10-20 parts of coix seed, 10-20 parts of magnolia officinalis, 10-20 parts of Tianzhuzi, and 10-20 parts of Zhidanxingxing. The acupoint application of the traditional Chinese medicine composition of the present invention is composed of the traditional Chinese medicine composition in a ratio of 1:1:1:1:1:1, and the selected acupoints are mainly Yanglingquan, Zhigou and Ququan. The traditional Chinese medicine composition of the present invention has the characteristics of easy carrying, safety and non-toxicity, and is suitable for any crowd, especially suitable for those with damp-heat constitution. Adhering to long-term regular application has obvious effects on improving damp-heat constitution and regulating the overall state of the body, and promoting the transformation of damp-heat constitution into a peaceful state.

Description

A Chinese medicine composition for improving gouty arthritis of damp-heat constitution

Technical Field

The present invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for improving physical fitness.

Background Art

The theory of "constitution" originated from the Yellow Emperor's Classic of Internal Medicine. In April 2009, the Chinese Association of Traditional Chinese Medicine divided constitution into the following categories in the "Classification and Determination of Constitution in Traditional Chinese Medicine": peaceful constitution, qi deficiency constitution, yang deficiency constitution, yin deficiency constitution, phlegm-damp constitution, damp-heat constitution, blood stasis constitution, qi stagnation constitution, and special constitution. According to TCM research, TCM constitution refers to the inherent characteristics of the human body in terms of morphological structure, physiological function and psychological state formed on the basis of innate endowment and acquired acquisition. It is comprehensive and relatively stable, and often determines the specificity of the human body's physiological response, susceptibility to certain pathogenic factors and tendency to produce pathological types, thereby affecting the syndrome type and disease outcome of acquired diseases.

In damp-heat constitution, dampness is what is commonly referred to as water dampness, which can be divided into external dampness and internal dampness. External dampness is caused by external water dampness invading the human body due to damp climate, wading in the rain, or dampness in the house; internal dampness is a pathological product, often related to digestive function. Traditional Chinese medicine believes that the spleen has the function of "transporting and transforming water dampness". If the body is weak and has indigestion or overeating, eating too much greasy and sweet food, the spleen cannot normally transport and transform it, causing "water dampness to stagnate inside"; and people with spleen deficiency are also prone to invasion of external dampness, which often blocks the spleen and stomach and causes dampness to be generated from the inside, so the two are both independent and related. The so-called heat is a kind of heat phenomenon. The heat in damp-heat exists at the same time as dampness, or because it is hot and humid in summer and autumn, dampness and heat invade the human body together, or because dampness is left for a long time and turns into heat, or because of "yang heat constitution", dampness "turns into heat from yang", so it is common for dampness and heat to exist at the same time.

TCM acupoint patch therapy is an external treatment method that grinds Chinese medicine into ointment and then applies it to the acupoints on the body surface. It is one of the external treatment methods commonly used in TCM from ancient times to the present. TCM acupoint patch therapy is based on the guidance of TCM theory and the principle of "external treatment of internal diseases". It uses Chinese medicine of corresponding constitution type, with pungent and warm, running and meridian-draining drugs, and applies them to relevant acupoints, so that the drugs can enter the acupoints and meridians through the skin pores, and exert the "return to meridians" and functional effects of the drugs through the running of meridian qi and blood, directly reaching the relevant internal organs, aiming to adjust the body constitution and enhance disease resistance. This method uses Chinese medicine with strong smell and combined with acupoints on the body surface to administer drugs, and exerts its efficacy through transdermal penetration and absorption of drugs and acupoint-specific treatment. That is, the drugs are absorbed through the skin and mucous membranes, part of which directly acts on the acupoints on the body surface to stimulate the acupoints and meridians; the other part is absorbed into the systemic blood circulation to reach an effective blood drug concentration to exert its effect.

Chinese patent document CN111450205A discloses a Chinese medicine composition for treating damp-heat constitution, its preparation and application. The active components of the Chinese medicine composition include the following raw materials in parts by weight: 150-450 parts of Astragalus, 100-300 parts of Atractylodes, 80-120 parts of Atractylodes, 50-150 parts of Pseudostellaria, 70-230 parts of Dioscorea, 80-130 parts of Lotus Seed, 80-120 parts of White Lablab, 50-150 parts of Poria, 80-30 parts of Patchouli, 80-120 parts of Cyperus, 20 parts of Coix Seed. 50-350 parts, 150-450 parts of dandelion, 70-120 parts of hawthorn, 80-130 parts of cassia seed, 70-130 parts of lotus leaf, 80-120 parts of dried orange peel, 80-120 parts of honeysuckle, 80-120 parts of malt sprout, 150-250 parts of bitter orange, 70-130 parts of platycodon, 40-80 parts of liquorice, 80-120 parts of chicken gizzard, 80-120 parts of sophora japonica, 100-300 parts of magnolia officinalis flower, 50-150 parts of white peony root, 25-40 parts of coptis root, 80-120 parts of poria. All the medicines work together to remove dampness and clear away heat, and have a significant regulating effect on damp-heat constitution, restoring and maintaining a relatively healthy and peaceful quality for a long time. Chinese patent document CN104524110A discloses a Chinese medicine composition with the effect of strengthening the spleen and removing dampness. The raw materials of the Chinese medicine composition include coix seed, red bean, Euryale ferox, yam and bitter almond, and may also include patchouli and honeysuckle. The Chinese medicine composition of the present invention has the functions of regulating the spleen and stomach, removing dampness and clearing heat, and can adjust the damp-heat constitution, and has a significant effect of strengthening the spleen and removing dampness. The composition of the present invention is easy to take, meets the fast-paced life needs of modern people, and is safe and effective without any toxic and side effects. However, there is no report on a Chinese medicine composition for improving damp-heat constitution of the present invention, its preparation method and application.

Qi depression constitution is a physical state formed by long-term emotional depression and stagnation of Qi, characterized by introverted and unstable personality, melancholy and fragility, sensitivity and suspicion. People with this physical state are mostly middle-aged and young people, and more often women. They are often lonely and introverted, easily sentimental, and narrow-minded. The main disease of people with Qi depression constitution is the liver, and also affects the heart, stomach, large intestine, and small intestine. It is easy to hurt emotions and diet, and it is easy to produce Qi stagnation, such as depression, insomnia, plum pit qi, panic, etc. Modern research shows that this kind of constitution is prone to tumors. Conditioning treatment should be used to regulate emotions and dredge Qi.

Polycystic ovary syndrome (PCOS) is a common disease caused by complex endocrine and metabolic abnormalities in women of childbearing age. It is characterized by chronic anovulation (ovulation dysfunction or loss) and hyperandrogenism (excess production of male hormones in women). The main clinical manifestations are irregular menstrual cycles, infertility, hirsutism and/or acne. It is the most common female endocrine disease.

TCM acupoint application is an external treatment method that grinds Chinese medicine into ointment and applies it to the acupoints on the body surface. It is one of the external treatment methods commonly used in TCM from ancient times to the present. TCM acupoint application therapy is based on the guidance of TCM theory and the principle of "external treatment of internal diseases". It uses Chinese medicine of corresponding constitution type, with pungent, warm, running and meridian-draining drugs, and applies them to relevant acupoints, so that the drugs can enter the acupoints and meridians through the skin pores, and exert the "return to meridians" and functional effects of the drugs through the running of meridian qi and blood, directly reaching the relevant internal organs, aiming to adjust the body constitution and enhance disease resistance. This method uses Chinese medicine with strong smell and combined with acupoints on the body surface to administer drugs, and exerts its efficacy through transdermal penetration and absorption of drugs and acupoint-specific treatment. That is, the drugs are absorbed through the skin and mucous membranes, part of which directly acts on the acupoints on the body surface to stimulate the acupoints and meridians; the other part is absorbed into the blood circulation of the whole body to reach an effective blood drug concentration to exert its effect.

Chinese patent document CN111249420A discloses a Chinese medicine composition for treating qi stagnation constitution, its preparation and application. The active components of the Chinese medicine composition include the following raw materials in parts by weight: 150-450 parts of wheat, 40-80 parts of liquorice, 80-120 parts of jujube, 80-120 parts of bupleurum, 120-180 parts of fructus aurantii, 40-80 parts of dried tangerine peel, 40-80 parts of green peel, 120-180 parts of cyperus, 80-120 parts of rose, 80-120 parts of green calyx plum, 80-120 parts of julibrissin, 70-230 parts of spinach seed, 20-20 parts of amomum villosum 40 parts, white peony root 50-150 parts, lotus seed 80-120 parts, atractylodes 80-120 parts, hawthorn 80-120 parts, citron 80-120 parts, forsythia suspensa 80-120 parts, lily 80-120 parts, platycodon 80-120 parts, chuanxiong 80-120 parts, angelica 80-120 parts, malt sprout 80-120 parts, tuckahoe 80-120 parts, tremella 80-120 parts, bamboo shavings 50-150 parts and poria 80-120 parts. All the medicines work together to promote qi and relieve depression, and effectively regulate qi stagnation constitution. Chinese patent document CN110038066A discloses a Chinese medicine composition for treating chronic fatigue syndrome and its preparation method. The preparation is prepared from the following raw materials in weight ratio: 15-25 parts of Astragalus, 10-20 parts of Codonopsis, 10-20 parts of Atractylodes, 6-15 parts of Lycium barbarum, and 6-15 parts of Radix Glycyrrhizae Preparata. The Chinese medicine composition can effectively improve chronic fatigue syndrome and qi deficiency constitution, and the Chinese medicine composition can be used to prepare medicine for treating chronic fatigue syndrome or qi stagnation constitution. However, there is no report on the Chinese medicine composition for improving qi stagnation constitution and its preparation method and application.

Qi deficiency constitution refers to the situation that when the organs of the human body are dysfunctional and the transformation of qi is insufficient, it is easy to have qi deficiency symptoms, which are often manifested as low voice, thin or overweight body, pale complexion, shortness of breath, laziness, lack of energy, fatigue, spontaneous sweating, especially when moving, pale red tongue, tooth marks on the edge of the tongue, white fur, weak pulse, and various causes of disease. Different symptoms are seen due to different parts of the heart, lung, spleen and kidney qi deficiency. The tendency of disease: easy to catch cold, qi deficiency dizziness, visceral prolapse, weak resistance, women are prone to postpartum weakness and postpartum eye disease after childbirth, and slow recovery after illness. The general principle of treatment is to replenish qi and nourish qi. It should also be based on the syndrome differentiation of the organs and select the prescriptions and medicines that replenish the qi of the organs. According to the theory of the same origin of qi and blood, blood tonic drugs should be added appropriately.

TCM acupuncture points patch is a kind of external treatment method that grinds Chinese medicine into ointment and applies it to the acupuncture points on the body surface. TCM acupuncture points patch therapy is based on the principle of "external treatment of internal diseases", using Chinese medicine corresponding to the body type, with pungent and warm, running and menstruation drugs, applied to the relevant acupuncture points, so that the drugs can penetrate the skin and enter the acupuncture points and meridians, and through the circulation of qi and blood in the meridians, the drugs' "return to the meridians" and functional effects are exerted, reaching the relevant internal organs directly, aiming to adjust the body constitution and enhance disease resistance.

Chinese patent document CN107261101A discloses a massage Chinese medicine oil emulsion for qi deficiency constitution, and its components include by weight: 12-20 parts of stir-fried white peony root, 8-12 parts of angelica, 5-13 parts of roasted cassia twig, 5-15 parts of ginseng, 5-13 parts of American ginseng, 8-15 parts of codonopsis, 5-15 parts of pseudostellaria, 3-15 parts of astragalus, 3-15 parts of atractylodes, 2-8 parts of liquorice, 5-10 parts of red dates, 5-12 parts of acanthopanax senticosus, 2-12 parts of gynostemma pentaphyllum, 5-15 parts of rhodiola rosea, 5-15 parts of poria, and 5-15 parts of maltose. The invention uses natural Chinese herbal medicine as the main raw material, and after scientific and reasonable proportioning, it has significant effects of replenishing qi and strengthening the body, especially for people with qi deficiency constitution. Chinese patent document CN103768556A discloses a Chinese medicine composition for treating qi deficiency constitution, and its mass proportion is as follows: 150-300 parts of astragalus, 60-120 parts of raw sun-dried ginseng, 60-120 parts of American ginseng, 150-200 parts of stir-fried atractylodes, 150-300 parts of poria, 150-300 parts of yam, 120-200 parts of stir-fried white peony root, 120-150 parts of stir-fried angelica, 90-120 parts of tangerine peel, 90-120 parts of roasted cassia twig 0 parts, 90-120 parts of Radix Ophiopogonis, 90-120 parts of Fructus Schisandrae Chinensis, 90-120 parts of Saposhnikovia Divaricata, 90-120 parts of Radix Bupleuri, 60-90 parts of Cimicifuga Herba, 5-15 parts of Dried Ginger, 300-500 parts of Stir-fried Semen Coix, 150-300 parts of Jujube, 60-90 parts of Radix Glycyrrhizae Preparata, 100-120 parts of Stir-fried Malt, 250-300 parts of Ejiao, 150-200 parts of Tortoise Shell Glue, and 100-150 parts of Deer Horn Glue. The invention has a reasonable formula, has the effects of tonifying the middle qi, strengthening the spleen and lung, promoting digestion and harmonizing the stomach, and tonifying the kidney and nourishing the essence, can effectively improve or even change the constitution of qi deficiency, has a high content of effective drug ingredients, has no obvious toxic and side effects, has a mild effect, is stable and lasting, is convenient to take, and is easy to store and carry. However, there is no report on the Chinese medicine composition for improving qi deficiency constitution and its preparation method and application.

Summary of the invention

A Chinese medicine composition for improving damp-heat constitution and its preparation method and application

The purpose of the present invention is to provide a Chinese medicine composition for improving damp-heat constitution in view of the deficiencies in the prior art.

Another object of the present invention is to provide a method for preparing the traditional Chinese medicine composition.

Another object of the present invention is to provide an application of the traditional Chinese medicine composition.

A traditional Chinese medicine composition for improving damp-heat constitution is prepared from the following raw materials in parts by weight: 10-20 parts of Atractylodes lancea, 10-20 parts of Rhizoma Cyathulae, 10-20 parts of Semen Coicis, 10-20 parts of Magnolia officinalis, 10-20 parts of Fructus Tetrandrae, and 10-20 parts of processed Glehnia littoralis.

Preferably, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 13-18 parts of Atractylodes lancea, 13-18 parts of Rhizoma Cyathulae, 13-18 parts of Semen Coicis, 13-18 parts of Magnolia officinalis, 13-18 parts of Fructus Tetrandrae, and 13-18 parts of processed Glehnia littoralis.

More preferably, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 15 parts of Atractylodes lancea, 15 parts of Rhizoma Cyathulae, 15 parts of Semen Coicis, 15 parts of Magnolia officinalis, 15 parts of Fructus Tetrandrae, and 15 parts of processed Glehnia littoralis.

To achieve the above second purpose, the technical solution adopted by the present invention is:

The method for preparing any of the above-mentioned traditional Chinese medicine compositions comprises the following steps: weighing Atractylodes lancea: Rhizoma Cyathulae: Semen Coix Lachryma-jobi: Cortex Magnoliae: Fructus Tetrandrae: Radix Glehniae: Radix Glehniae in the ratio of 1:1:1:1:1:1, crushing into powder, and mixing evenly.

To achieve the third purpose, the technical solution adopted by the present invention is:

Use of any of the above-mentioned Chinese medicine compositions in the preparation of medicines for improving damp-heat constitution.

Preferably, the pharmaceutical dosage form is an external preparation.

More preferably, the dosage form of the external preparation is a patch, a paste, an ointment, a gel, a film coating or a cataplasm.

An acupuncture point patch for improving damp-heat constitution, the acupuncture point patch is made of any of the above-mentioned traditional Chinese medicine compositions mixed with a transdermal agent.

Preferably, the transdermal preparation is made of a hot melt matrix and azone in a ratio of 1000:10.

The advantages of the present invention are:

1. The selected drugs in the Chinese medicine composition of the present invention are: Atractylodes macrocephala is warm in nature, pungent and bitter, and enters the spleen, stomach and liver meridians, and has the effect of drying dampness and invigorating the spleen; Magnolia officinalis is warm in nature, bitter and pungent in taste, enters the spleen, stomach, lung and large intestine meridians, and has the effect of drying dampness and eliminating phlegm; Coix seed is cool in nature, sweet and light in taste, enters the spleen, stomach and lung meridians, and has the effect of promoting diuresis, penetrating dampness, invigorating the spleen and stopping diarrhea; Achyranthes bidentata is slightly warm in nature, neutral in nature, bitter, sweet and sour in taste, enters the liver and kidney meridians, and has the effect of leading heat downward; Gardenia jasminoides is neutral in nature, sour and sweet in taste, enters the lung meridian, and has the effect of dispelling wind and dampness and detoxifying; Processed Arisaema is warm in nature, bitter and pungent in taste, enters the lung and liver meridians, and has the effect of drying dampness and resolving phlegm; all the drugs are used together, assisted by ginger juice, and the drugs are led to the meridians, so as to work together to invigorate the spleen, dry dampness and lead heat downward.

2. The acupoints selected for acupoint application of the Chinese medicine composition of the present invention are mainly Yanglingquan, Zhigou and Ququan. Ququan has the effect of clearing away dampness and heat and regulating the lower part of the body. Zhigou belongs to the Shaoyang triple burner meridian of the hand, and Yanglingquan belongs to the Shaoyang gallbladder meridian of the foot. Yanglingquan and Zhigou can reconcile Shaoyang and clear away heat and dampness. The acupoints are combined to achieve the effect of clearing away heat and dampness, soothing the liver and promoting gallbladder, thereby improving the physical condition of the group with damp-heat constitution bias.

3. The acupuncture application of the Chinese medicine composition of the present invention is based on the principle of "external treatment of internal diseases". It uses Chinese medicine of corresponding physical type, and is combined with pungent and warm, moving and menstruation-promoting drugs to apply to relevant acupuncture points, so that the drugs can penetrate the skin pores and enter the acupuncture meridians. Through the operation of meridian qi and blood, the "channel" and functional effects of the drugs are exerted, directly reaching the relevant internal organs, which can adjust the body's physical constitution and enhance disease resistance.

A Chinese medicine composition for improving qi stagnation constitution and its preparation method and application

The purpose of the present invention is to provide a Chinese medicine composition for improving qi stagnation constitution in view of the deficiencies in the prior art.

Another object of the present invention is to provide a method for preparing the traditional Chinese medicine composition.

Another object of the present invention is to provide an application of the traditional Chinese medicine composition.

To achieve the above object, the technical solution adopted by the present invention is:

A traditional Chinese medicine composition for improving qi stagnation constitution is prepared from the following raw materials in parts by weight: 10-20 parts of bupleurum, 10-20 parts of cyperus rotundus, 10-20 parts of fructus aurantii, 5-10 parts of liquorice, 5-10 parts of rose, and 5-10 parts of green-calyx plum.

Preferably, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 12-18 parts of bupleurum, 12-18 parts of cyperus rotundus, 12-18 parts of fructus aurantii, 6-9 parts of liquorice, 6-9 parts of rose, and 6-9 parts of green-calyx plum.

More preferably, the Chinese medicine composition is made of the following raw materials in parts by weight: 15 parts of bupleurum, 15 parts of cyperus rotundus, 15 parts of fructus aurantii, 7.5 parts of liquorice, 7.5 parts of rose, and 7.5 parts of green-calyx plum.

To achieve the above second purpose, the technical solution adopted by the present invention is:

The method for preparing any of the above-mentioned traditional Chinese medicine compositions comprises the following steps: weighing bupleurum: cyperus rotundus: fructus aurantii: liquorice: rose: amaranth in the proportion of 1:1:1:0.5:0.5:0.5, crushing into powder, and mixing evenly.

To achieve the third purpose, the technical solution adopted by the present invention is:

Use of any of the above-mentioned traditional Chinese medicine compositions in the preparation of medicines for improving qi stagnation constitution.

Preferably, the pharmaceutical dosage form is an external preparation.

More preferably, the dosage form of the external preparation is a patch, a paste, an ointment, a gel, a film coating or a cataplasm.

An acupuncture point patch for improving qi stagnation constitution, the acupuncture point patch is made of any of the above-mentioned traditional Chinese medicine compositions mixed with a transdermal agent.

Preferably, the transdermal preparation is made of a hot melt matrix and azone in a ratio of 1000:10.

The advantages of the present invention are:

1. The selected drugs in the Chinese medicine composition of the present invention are: Bupleurum chinense is slightly cold in nature, bitter in taste, and enters the liver, gallbladder, and lung meridians, and has the effect of soothing the liver and relieving depression; Cyperus rotundus is flat in nature, pungent in taste, slightly bitter, and slightly sweet in taste, and enters the liver, spleen, and triple burner meridians, and can soothe the liver and relieve depression, regulate qi and relieve fullness; Fructus Aurantii Immaturus is bitter and slightly sour in taste, slightly cold in nature, and enters the spleen, stomach, and liver meridians, and has the effect of regulating qi and relieving fullness, and relieving stagnation and distension; Rose is sweet and slightly bitter in taste, warm in nature, and enters the liver and spleen meridians, and has the effect of promoting qi and activating blood circulation, soothing the liver and relieving pain; Green calyx plum is flat in nature, sour and astringent in taste, and enters the liver, stomach, and lung meridians, and has the effect of soothing the liver and stomach, and regulating qi; Licorice is flat in nature, sweet in taste, and enters the heart, stomach, spleen, and lung meridians, and harmonizes various drugs. It is harmonized with pungent and warm ginger, and various drugs are used together to work together to promote qi and relieve depression.

2. The acupoints selected for acupoint application of the Chinese medicine composition of the present invention are mainly Tanzhong and Ganshu. Tanzhong is the sea of qi, regulating qi and widening the chest; Ganshu is the acupoint where the liver meridian qi is infused on the back, soothing the liver and regulating qi. The two acupoints are used together to enhance the effect of harmonizing qi and blood, thereby improving the physical condition of people with qi stagnation constitution bias.

3. The acupuncture application of the Chinese medicine composition of the present invention is based on the principle of "external treatment of internal diseases". It uses Chinese medicine of corresponding physical type, and is combined with pungent and warm, moving and menstruation-promoting drugs to apply to relevant acupuncture points, so that the drugs can penetrate the skin pores and enter the acupuncture points and meridians. Through the operation of qi and blood in the meridians, the "channel" and functional effects of the drugs are exerted, directly reaching the relevant internal organs, which can adjust the body's physical constitution and enhance disease resistance.

A Chinese medicine composition for improving qi deficiency constitution and its preparation method and application

The purpose of the present invention is to provide a Chinese medicine composition for improving qi deficiency constitution in view of the deficiencies in the prior art.

Another object of the present invention is to provide a method for preparing the traditional Chinese medicine composition.

Another object of the present invention is to provide an application of the traditional Chinese medicine composition.

To achieve the above object, the technical solution adopted by the present invention is:

A traditional Chinese medicine composition for improving qi deficiency constitution is prepared from the following raw materials in parts by weight: 10-20 parts of astragalus, 10-20 parts of stir-fried atractylodes, 10-20 parts of siler, 5-10 parts of tangerine peel, 10-20 parts of pseudoginseng, and 1-2 parts of ginseng.

Preferably, the Chinese medicine composition is made of the following raw materials in parts by weight: 12-18 parts of astragalus, 12-18 parts of stir-fried atractylodes, 12-18 parts of siler, 6-9 parts of tangerine peel, 12-18 parts of pseudoginseng, and 1.2-1.8 parts of ginseng.

More preferably, the Chinese medicine composition is made of the following raw materials in parts by weight: 15 parts of astragalus, 15 parts of stir-fried atractylodes, 15 parts of siler, 7.5 parts of tangerine peel, 15 parts of pseudostellaria, and 1.5 parts of ginseng.

To achieve the above second purpose, the technical solution adopted by the present invention is:

The method for preparing any of the above-mentioned traditional Chinese medicine compositions comprises the following steps: weighing astragalus: stir-fried atractylodes: siler: dried tangerine peel: pseudostellaria: ginseng in a ratio of 1:1:1:0.5:1:0.1 and crushing them into powder, mixing them evenly, and then adding an appropriate amount of ginger juice to blend into a paste.

To achieve the third purpose, the technical solution adopted by the present invention is:

Use of any of the above-mentioned Chinese medicine compositions in the preparation of medicines for improving qi deficiency constitution.

Preferably, the pharmaceutical dosage form is an external preparation.

More preferably, the dosage form of the external preparation is a patch, a paste, an ointment, a gel, a film coating or a cataplasm.

An acupuncture point patch for improving qi deficiency constitution, the acupuncture point patch is made of any of the above-mentioned traditional Chinese medicine compositions mixed with a transdermal agent.

Preferably, the transdermal preparation is made of a hot melt matrix and azone in a ratio of 1000:10.

The advantages of the present invention are:

1. The selected drugs in the Chinese medicine composition of the present invention are astragalus, which is sweet in taste, warm in nature, and enters the lung and spleen meridians. It has the effects of invigorating qi and strengthening the exterior, diuresis and detoxification; Atractylodes macrocephala is bitter, sweet, warm in nature, and enters the spleen and stomach meridians. It has the effects of invigorating the spleen and replenishing qi, drying dampness and promoting diuresis, and stopping sweating. The flavor of the scutellaria is pungent, sweet, and warm in nature. It enters the bladder, liver, and spleen meridians and has the effects of dispelling wind, overcoming dampness, and stopping spasms. Tangerine peel is bitter, pungent, and warm in nature. It enters the lung and spleen meridians and has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. Pseudostellariae is sweet, slightly bitter, and flat in nature. It enters the spleen and lung meridians and has the effects of invigorating qi and strengthening the spleen, promoting fluid and moistening the lungs. Ginseng is sweet, slightly bitter, and flat in nature. It enters the spleen, lung, and heart meridians. It can greatly replenish vital energy, restore pulse and consolidate, invigorate the spleen and lungs, promote fluid and calm the mind. The whole recipe has the functions of invigorating qi and nourishing the essence, invigorating the spleen and lungs, and promoting qi and removing stagnation.

2. The acupoints selected for the acupoint application of the Chinese medicine composition of the present invention are mainly Qihai, Pishu and Zusanli. Pishu is the acupoint for infusion of meridian qi on the back. Qihai and Zusanli are both key acupoints for replenishing qi and nourishing the essence. The "Illustrated Classic of Acupoints and Acupuncture for the Bronze Man" contains: "Qihai is the sea of vitality for men." This acupoint has the functions of nourishing the vital energy, strengthening the kidney and consolidating the essence, and replenishing and restoring yang. "Qianjin Yaofang" says: "If you want to be at peace, Sanli is often not dry." The three acupoints are used together to enhance the merits of replenishing qi and strengthening the body, prolonging life, thereby improving the physical condition of people with qi deficiency constitution bias.

3. The acupuncture application of the Chinese medicine composition of the present invention is based on the principle of "external treatment of internal diseases". It uses Chinese medicine of corresponding physical type, and is combined with pungent and warm, moving and menstruation-promoting drugs to apply to relevant acupuncture points, so that the drugs can penetrate the skin pores and enter the acupuncture points and meridians. Through the operation of qi and blood in the meridians, the "channel" and functional effects of the drugs are exerted, directly reaching the relevant internal organs, which can adjust the body's physical constitution and enhance disease resistance.

DETAILED DESCRIPTION

A Chinese medicine composition for improving damp-heat constitution and its preparation method and application

The examples are as follows:

Example 1 Preparation of the Chinese medicine composition of the present invention (I)

Weigh 15 parts each of the raw materials Atractylodes lancea, Achyranthes bidentata, Coix seeds, Magnolia officinalis, Gardenia jasminoides, and processed Bile Starch according to the ratio of 1:1:1:1:1:1.

Example 2 Preparation of the Chinese medicine composition of the present invention (II)

Weigh 10 portions each of the raw materials Atractylodes lancea, Achyranthes bidentata, Coix seeds, Magnolia officinalis, Gardenia jasminoides, and processed Bile Starch in the ratio of 1:1:1:1:1:1.

Example 3 Preparation of the Chinese medicine composition of the present invention (III)

Weigh 20 portions each of the raw materials Atractylodes lancea, Achyranthes bidentata, Coix seeds, Magnolia officinalis, Gardenia jasminoides, and processed Bile Starch in the ratio of 1:1:1:1:1:1.

Example 4 Preparation of the Chinese medicine composition of the present invention (IV)

Weigh 11 parts each of the raw materials Atractylodes lancea, Achyranthes bidentata, Coix seeds, Magnolia officinalis, Gardenia jasminoides, and processed Bile Starch according to the ratio of 1:1:1:1:1:1.

Example 5 Preparation of the Chinese medicine composition of the present invention (V)

Weigh 12 portions each of the raw materials Atractylodes lancea, Achyranthes bidentata, Coix seeds, Magnolia officinalis, Gardenia jasminoides, and processed Bile Starch in the ratio of 1:1:1:1:1:1.

Example 6 Preparation of the Chinese medicine composition of the present invention (VI)

Weigh 13 parts each of the raw materials Atractylodes lancea, Achyranthes bidentata, Coix seeds, Magnolia officinalis, Gardenia jasminoides, and processed Bile Starch according to the ratio of 1:1:1:1:1:1.

Example 7 Preparation of the Chinese medicine composition of the present invention (VII)

Weigh 14 portions each of the raw materials Atractylodes lancea, Achyranthes bidentata, Coix seeds, Magnolia officinalis, Gardenia jasminoides, and processed Bile Starch according to the ratio of 1:1:1:1:1:1.

Example 8 Preparation of the Chinese medicine composition of the present invention (VIII)

Weigh 16 portions each of the raw materials processed Arisaema, processed Pinellia, Corydalis, Raw Atractylodes, Atractylodes, and Poria in the ratio of 1:1:1:1:1:1.

Example 9 Preparation of the Chinese medicine composition of the present invention (IX)

Weigh 17 parts each of the raw materials Atractylodes lancea, Achyranthes bidentata, Coix seeds, Magnolia officinalis, Gardenia jasminoides, and processed Bile Starch according to the ratio of 1:1:1:1:1:1.

Example 10 Preparation of the Chinese medicine composition of the present invention (X)

Weigh 18 portions each of the raw materials Atractylodes lancea, Rhizoma Cyathulae, Semen Coicis, Magnolia officinalis, Fructus Gardeniae, and Radix Glechomae Preparata in the ratio of 1:1:1:1:1:1.

Example 11 Preparation of acupuncture point application of the Chinese medicine composition of the present invention

(1) Weigh each raw material medicine in the weight proportion described in any one of Examples 1-10, crush it into powder, and then mix it with appropriate amount of ginger juice and hot melt adhesive matrix to form a paste. The ratio of Chinese medicine powder to hot melt adhesive matrix is generally 1:3.

(2) The above mixture is first made into a fluid extract, and extracted with a suitable solvent (20%-25% ethanol in water), and then part of the solvent is evaporated to adjust the concentration to 1 ml equivalent to 1 g of medicinal material.

(3) Place 1 kg of medical pressure-sensitive hot melt adhesive in a pot and heat to about 80°C to melt. When the temperature drops to about 60-70°C, slowly add the drug powder and stir evenly. When the temperature is about 40°C, add the fluid extract and azone (the ratio of the base to azone in the transdermal agent is about 1000:10), continue stirring, and then spread the paste to make a drug cake with a diameter of 4-5 cm and a thickness of about 2-3 mm.

Example 12 Preparation of the Chinese medicine composition patch of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 1-10, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned drug solution is concentrated under vacuum to remove the aqueous solution, and the obtained extract is vacuum dried;

(3) Weigh 2 g of the above extract, add 2-6 ml of medical glycerin, mix into a paste, and spread evenly on a square medical tape of a fixed size, leaving a certain size around the edges to fix the tape.

Example 13 Preparation of the Chinese medicine composition ointment of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 1-10, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned liquid medicine is concentrated by vacuum decompression to obtain a liquid medicine concentrate;

(3) Add beeswax and yellow vaseline to the concentrate, simmer and stir over low heat, and cool until it becomes a paste.

Example 14 Preparation of the Chinese medicine composition gel of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 1-10, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned liquid medicine is concentrated by vacuum decompression to obtain a liquid medicine concentrate;

(3) Add carbomer to glycerin and grind it to moisten it. Then add a small amount of distilled water to grind it, transfer it to a measuring cup, take appropriate amounts of triethanolamine, ethylparaben, and distilled water to dissolve them, stir them into a gel, add appropriate amount of distilled water and stir evenly; add the above concentrate and grind it evenly.

Example 15 Preparation of the Chinese medicine composition cataplasm of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 1-10, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned liquid medicine is concentrated by vacuum decompression to obtain a liquid medicine concentrate;

(3) Add sorbitol, glycerol and other conventional poultice bases to the concentrate, stir well, apply to the support layer, and add a protective layer.

Example 16 Clinical Experiment on Acupoint Application of the Chinese Medicine Composition of the Present Invention

1 Research subjects

1.1 Sample Source

The samples for this experiment were derived from 30 patients with TCM damp-heat constitution and gouty arthritis who met the inclusion criteria and visited the outpatient and inpatient departments of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from June 2020 to March 2021. They were randomly divided into an intervention group and a control group with 15 patients in each group.

1.2 Diagnostic criteria

1.2.1 Diagnostic criteria for damp-heat constitution in traditional Chinese medicine

According to the conversion results of the integral scale in "Classification and Determination of Constitution in Traditional Chinese Medicine" published by China Traditional Chinese Medicine Press on April 9, 2009 and combined with the doctor's judgment, the subject's constitution was judged to be damp-heat constitution.

Questionnaire for determining damp-heat constitution: ①Does your face or nose feel greasy or shiny? ②Do you easily get acne or boils? ③Do you feel bitter or have a bad taste in your mouth? ④Do you have sticky and uncomfortable stools or a feeling of incomplete defecation? ⑤Do you feel a heat in your urethra when you urinate, and is your urine dark (dark)? ⑥Does your vaginal discharge have a yellow color (leucorrhea is yellowish)? (Female answers only) ⑦Does your scrotum area have moisture? (Male answers only)

The judgment criteria are as follows:

Table 1 Standards for determining TCM constitution

Note: 1. Scoring method: Each item is scored 1, 2, 3, 4, and 5 points respectively according to "never (or) not", "rarely", "sometimes", "often", and "always". 2. Conversion score = (total score of each item - number of items) / (number of items × 4) × 100; the range is 0-100 points.

In this experiment, a damp-heat constitution is judged as one with a damp-heat constitution conversion score of 40 or more.

1.2.2 Diagnostic criteria for gouty arthritis

The TCM diagnosis complies with the provisions of the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" for gout (arthritis); the Western medicine diagnosis complies with the provisions of the "Guidelines for the Diagnosis and Treatment of Primary Gout" for gout and gouty arthritis.

1.3 Inclusion criteria

1. The first diagnosis must be consistent with gout and gouty arthritis, and the patient has no contraindications to treatment;

2. Patients with other diseases who do not require special treatment during treatment and do not affect the implementation of the clinical pathway process of the first diagnosis can enter the pathway;

3. No glucocorticoids, colchicine or non-steroidal anti-inflammatory analgesics were used within 4 weeks before the visit; all patients signed an informed consent form before enrollment.

1.4 Exclusion criteria

1. Patients with diseases that may cause joint lesions, such as rheumatoid arthritis, systemic lupus erythematosus, and suppurative arthritis;

2. Patients with severe primary diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems;

3. Those with poor treatment compliance.

1.5 Shedding Standard

1. The condition worsens during treatment and requires special treatment, resulting in longer treatment time and increased costs;

2. Severe complications and exit pathways;

3. If other diseases occur during treatment and require treatment, exit this path;

4. If the implementation of this pathway is affected by the wishes of the patient and his/her family, the patient will exit this pathway.

2 Research Methods

2.1 Grouping Scheme

The experimental grouping scheme is based on the random number method. The specific operation is as follows: use the EXCEL software "=rand()" to create random numbers, and arrange the obtained data from small to large. The first 15 are the control group and the last 15 are the treatment group, with a total of 30 patients.

2.2 Treatment options

The treatment regimen for the control group was to use etoricoxib tablets, 120 mg orally each time, once a day, divided into 2 courses of treatment, for a total of 60 days.

The treatment plan for the treatment group is to use the Chinese medicine composition of the present invention for acupoint application on the basis of the treatment of the control group, which is divided into 2 courses of treatment, for a total of 60 days.

The Chinese medicine composition acupuncture patch of the present invention is independently developed by the Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, based on the characteristics of damp-heat constitution, combined with the characteristics of meridians, acupuncture points, and drugs. Its main components are: Atractylodes, Rhizoma Cyathulae, Semen Coix, Magnolia officinalis, Fructus Tetraphyllae, and Radix Glechomae Preparata (ratio: 1:1:1:1:1:1), and is uniformly produced by Shandong Yuhetang Pharmaceutical Co., Ltd. in accordance with the production process standards (production batch number: 20191002), with a specification of 4cm×4cm/piece, and each piece (drug core) is about 0.5 grams.

Production process: ① Mix the required Chinese medicine granules in the ratio of 1:1:1:1:1:1 and crush them into powder, then mix with hot melt adhesive matrix. The ratio of Chinese medicine powder to hot melt adhesive matrix is generally 1:3. ② First make the above mixture into a fluid extract, and extract it with a suitable solvent (20%-25% ethanol in water), and then evaporate part of the solvent to adjust the concentration to 1g of medicinal material per 1ml. ③ Put 1kg of medical pressure-sensitive hot melt adhesive into a pot and heat it to about 80℃ to melt. After cooling to about 60-70℃, slowly add the powder and stir evenly. At about 40℃, add the fluid extract and azone (the ratio of the matrix and azone in the transdermal agent is about 1000:10), continue stirring, and then spread the paste.

Usage: ask the patient to bathe the whole body or scrub the limbs, keep the skin warm, and apply the Chinese medicine composition of the present invention to the Yanglingquan and Zhigou acupoints of the human body for 4-8 hours each time, three times a week.

2.3 TCM Constitution Scoring

The changes of constitution transformation scores within and between the two groups of intervention subjects before and after the intervention were compared and observed, among which the TCM Qi deficiency constitution transformation score was the main efficacy indicator.

2.4 Adverse reaction records

Observe whether adverse events or adverse reactions of the application drugs (such as skin itching, skin redness, swelling, heat and pain, skin ulceration, etc.) occur during the acupoint application of the Chinese medicine composition of the present invention. If any, record the time of occurrence and treatment measures in time.

2.5 Criteria for determining the efficacy of clinical interventions

2.5.1 Criteria for determining the efficacy of TCM clinical intervention

The efficacy of TCM clinical intervention is judged based on the TCM damp-heat constitution transformation score. The standard refers to the relevant standards of the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" issued by the State Food and Drug Administration in 2017, and is judged using changes in symptom scores.

Therapeutic index (n) = difference in symptom scores before and after treatment/symptom scores before treatment × 100%.

① Clinical cure: clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%.

② Markedly effective: clinical symptoms and signs disappeared or basically disappeared, and the syndrome score decreased by ≥70%.

③ Effective: Clinical symptoms and signs disappeared or almost disappeared, and the syndrome score decreased by ≥30 but <70%.

④ Ineffective: There is no significant improvement in clinical symptoms and signs, or they may even worsen, and the syndrome score decreases by less than 30%.

2.5.2 Criteria for determining the therapeutic effect of gouty arthritis

1. Evaluation criteria

(1) Marked effect: Clinical symptoms and positive signs completely or basically disappear, joint function returns to normal, and indicators such as SUA return to normal range.

(2) Improvement: Clinical symptoms and positive signs partially disappear, joint function is restored to a certain extent, and indicators such as joint function and SUA are improved.

(3) Ineffectiveness: There is no significant relief of clinical symptoms and signs, and there is no significant improvement in joint function, SUA and other indicators, or even worsening.

2.5.3 Observation indicators

The clinical efficacy, TCM damp-heat constitution transformation score, and serum uric acid (UA), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) levels before and after treatment were compared between the two groups. Laboratory index examination Serum was drawn from gout patients before and 7 days after medication, and UA, ESR, and CRP were tested once each.

3. Results

3.1 Physical Conversion Points

Table 2 Comparison of TCM damp-heat constitution transformation scores between the two groups of patients before and after treatment

Note: Compared with before treatment, *P＜0.05; compared with control group, ^P＜0.05.

3.2 Comparison of clinical efficacy between the two groups: The total effective rate of the observation group was significantly higher than that of the control group (P < 0.05).

Table 3 Comparison of clinical efficacy between the two groups (n)

Group Number of cases (N) Significant effect Improvement invalid Total effective (%) Control group 15 5 7 3 12(80) Treatment Group 15 7 8 0 15(100) ^△

Note: Compared with the control group, ^△ P<0.05

3.3 After treatment, the levels of ESR, CRP and SUA in both groups were significantly reduced (P＜0.05), and the reduction in the observation group was more obvious (P＜0.05).

Table 4 Comparison of observation indicators between the two groups

3.4 Research results of safety indicators

During the treatment period, no adverse reactions to the medication (such as skin itching, skin redness, swelling, heat and pain, skin ulceration, etc.) occurred in the patients.

4 Discussion

4.1 Concept and clinical characteristics of damp-heat constitution

Damp-heat constitution is a physical condition caused by addiction to smoking and drinking, staying up late, improper nourishment, liver depression and qi stagnation, and environmental factors that lead to relatively poor liver, gallbladder, spleen and stomach functions, liver and gallbladder stagnation turning into heat, spleen and stomach stagnation turning into dampness, and damp-heat fumigation.

The damp-heat constitution will be manifested as oily face, acne, bitter and dry mouth, heavy body and drowsiness, sticky stool or dry stool, short yellow urine, wet scrotum for men, increased vaginal discharge for women, red tongue, yellow and greasy tongue coating, slippery and rapid pulse. It is easy to suffer from boils, jaundice, hot stranguria, constipation, cholecystitis, oral ulcers and other diseases. It is difficult to adapt to the damp and hot climate in late summer and early autumn, heavy humidity or high temperature environment.

4.2 Analysis of the formula of the Chinese medicine composition for acupoint application of the present invention

The Chinese medicine composition acupoint application of the present invention is independently developed by Professor Zhang Xiaotian based on the characteristics of damp-heat constitution, combined with the characteristics of meridians, acupoints and drugs. Its main components are Atractylodes, Rhizoma Cynanchum, Semen Coicis, Magnolia officinalis, Fructus Tetraphyllae, and Radix Glechomae Preparata (ratio: 1:1:1:1:1:1), and the whole formula has the functions of strengthening the spleen, drying dampness and guiding heat downward.

Atractylodes: warm in nature, pungent and bitter, enters the spleen, stomach and liver meridians, has the effect of drying dampness and strengthening the spleen;

Magnolia officinalis: warm in nature, bitter and pungent in taste, enters the spleen, stomach, lung and large intestine meridians, and has the effect of drying dampness and eliminating phlegm;

Coix seeds: cool in nature, sweet and light in taste, enter the spleen, stomach, and lung meridians, and have the effects of promoting diuresis, penetrating dampness, strengthening the spleen and stopping diarrhea;

Rhizoma Achyranthis Bidentatae: slightly warm in nature, neutral in nature, bitter, sweet, and sour in taste, enters the liver and kidney meridians, and has the effect of guiding heat downward;

Indian baicalensis: neutral in nature, sour and sweet in taste, enters the lung meridian, has the effects of dispelling wind and dampness, and detoxifying;

Processed Arisaema: warm in nature, bitter and pungent in taste, enters the lung and liver meridians, has the effect of drying dampness and resolving phlegm;

4.3 Acupoint Selection Analysis

The acupoints selected are mainly Ququan, Zhigou and Yanglingquan. Ququan has the effect of clearing dampness and heat and regulating the lower part of the body. Zhigou belongs to the Shaoyang triple burner meridian of the hand, and Yanglingquan belongs to the Shaoyang gallbladder meridian of the foot. Yanglingquan and Zhigou can harmonize the Shaoyang meridian and clear away heat and dampness. The acupoints can achieve the effect of clearing heat and dampness, soothing the liver and promoting gallbladder function, thereby improving the physical condition of people with damp-heat constitution.

Example 17 Animal Experiment

1. Materials and Methods

1.1 Experimental Materials

1.1.1 Experimental animals

Forty SPF Sprague-Dawley (SD) male mice weighing (200±20) g were provided by Shanghai Slake Experimental Animal Co., Ltd. They were housed in an environment with a constant temperature of (22±1)°C and a fixed lighting rhythm of 12:12, and had free access to food and water.

1.1.2 Experimental drugs The present invention group: 15 parts of Atractylodes, 15 parts of Rhizoma Cyperi, 15 parts of Coix seeds, 15 parts of Magnolia bark, 15 parts of Jasmine, 15 parts of processed Gallbladder Star Control group 1: 15 parts of Atractylodes, 15 parts of Rhizoma Cyperi, 15 parts of stir-fried Coix seeds, 15 parts of Amomum, 15 parts of Jasmine, 15 parts of processed Gallbladder Star Control group 2: 15 parts of Atractylodes, 15 parts of Rhizoma Cyperi, 15 parts of Coix seeds, 15 parts of Amomum, 15 parts of Jasmine, 15 parts of Jasmine Control group 3: 15 parts of Atractylodes, 15 parts of Rhizoma Cyperi, 15 parts of stir-fried Coix seeds, 15 parts of Magnolia bark, 15 parts of Jasmine, 15 parts of Jasmine

1.2 Experimental methods

1.2.1 Experimental grouping: 40 mice were divided into the following groups according to the random number table method: the present invention group, control group 1, control group 2, and control group 3, with 10 mice in each group.

1.2.2 Preparation of damp-heat constitution mouse model: The feeding conditions were as follows: mice in the present invention group, control group 1, control group 2, and control group 3 were fed a fat and sweet diet (5% lard, 3% egg yolk, and 5% honey mixed with ordinary feed) and were injected with E. coli endotoxin (2 μg/kg) in the tail vein twice a week for 6 consecutive weeks to establish a damp-heat constitution rat model. After 6 weeks of adaptive feeding, the mice were used for experiments.

As the experiment progressed, rats in each group showed symptoms such as irritability, scratching their heads and faces constantly, rapid breathing, and immobility. In severe cases, the rats stretched their necks and shrank their chests. In addition, the rats had sticky or loose stools with foul odors to varying degrees, red and swollen anuses, and fatigue, less movement, and less food and drink. The damp-heat model established in this experiment conforms to the syndrome manifestation characteristics expressed by the comprehensive information of the four diagnostic methods of traditional Chinese medicine, and is close to the overall and representative characteristics of the damp-heat syndrome in the human body, indicating that the damp-heat syndrome model was successfully established.

1.2.3 Method of administration:

Patching group of the present invention, patch control group 1, patch control group 2, patch control group 3:

The patching group of the present invention: the back of the mouse was depilated with 8% Na ₂ S, the area was about 4cm×4cm, and after local disinfection with 75% alcohol, the patching group of the present invention (15 parts of Atractylodes, 15 parts of Rhizoma Achyranthis Bidentatae, 15 parts of Semen Coicis, 15 parts of Magnolia officinalis, 15 parts of Fructus Tetrandrae, 15 parts of Processed Bile Starch) was fixed on the depilated area (Tanzhong, Ganshu). Then gently press twice, and then wrap the chest and back with a self-adhesive tape to fix it. (Each piece (drug core) is about 0.5 grams) After 8 hours of application, remove it, once a day, for a total of 20 times.

Patching control group 1: Depilate the back of the mouse with 8% Na ₂ S, the area is about 4cm×4cm, and after local disinfection with 75% alcohol, apply the patch control group 1 (15 parts of Atractylodes, 15 parts of Rhizoma Coix, 15 parts of Amomum, 15 parts of Fructus Tetraphyllae, 15 parts of Radix Glechomae Preparata, 15 parts of Radix Glechomae Preparata) to the depilated area (Tanzhong, Ganshu). Then press gently twice, and then wrap the chest and back with adhesive tape to fix. (Each piece (drug core) is about 0.3 grams) Remove it after 8 hours of application, once a day, a total of 20 times.

Patching control group 2: Depilate the back of the mouse with 8% Na ₂ S, the area is about 4cm×4cm, and after local disinfection with 75% alcohol, apply the patch control group 2 (15 parts of Atractylodes, 15 parts of Rhizoma Achyranthis Bidentatae, 15 parts of Semen Coicis, 15 parts of Fructus Amomi, 15 parts of Fructus Dioscoreae, 15 parts of Fructus Dioscoreae) to the depilated area (Tanzhong, Ganshu). Then press gently twice, and then wrap the chest and back with adhesive tape to fix. (Each piece (core) is about 0.1g) Remove it after 8 hours of application, once a day, a total of 20 times.

Patching control group 3: The back of the mouse was depilated with 8% Na ₂ S, the area was about 4cm×4cm, and after local disinfection with 75% alcohol, the patch control group 3 (15 parts of Atractylodes, 15 parts of Rhizoma Coix, 15 parts of Magnolia officinalis, 15 parts of Rhizoma Dioscoreae, 15 parts of Rhizoma Dioscoreae) was fixed on the depilated area (Tanzhong, Ganshu). Then gently press twice, and then wrap the chest and back with a self-adhesive tape to fix it. (Each piece (drug core) is about 0.3 grams) After 8 hours of application, remove it, once a day, for a total of 20 times. Spironolactone 7mg/kg, continuous gavage for 30 days.

1.2.4 Observation and testing indicators

Changes in body weight and blood lipids of mice before and after intervention.

1.2.5 Statistical analysis

SPSS10.0 software was used for one-way analysis of variance.

2. Results

Table 5 Effects of different patches on the body weight of mice (x±s, g)

Group Number of cases (n) Before treatment After treatment F P The present invention group 10 112.97±13.29 132.05±9.98 9.15 0.000 Control group 1 10 118.22±6.87 144.64±10.48 34.38 0.000 Control group 2 10 118.67±7.29 141.63±12.39 ^* 9.69 0.000 Control group 3 10 119.62±7.83 139.54±13.21 ^** 22.24 0.000

^* p<0.05 compared with control group 1, ^** p<0.01 compared with control group 2. Compared with control group 3, ^* p<0.01.

Table 6 Effects of different patches on blood lipids in mice (x±s, mmol/L)

Group Number of cases (n) CHOL HDL-C LDL-C The present invention group 10 2.34±1.37 0.59±0.11 0.35±0.30 Control group 1 10 3.02±1.03 0.40±0.11 0.95±0.30 Control group 2 10 2.93±0.92 0.53±0.12 0.85±0.30 Control group 3 10 2.56±0.31 0.48±0.09 0.55±0.16

^* p<0.05 compared with control group 1, ^** p<0.01 compared with control group 2. ^* p<0.01 compared with control group 3.

discuss

The present invention selects "environment + diet + inducement + biological infection factor" to replicate the damp-heat syndrome model and observe the improvement effect on the damp-heat constitution of mice. After feeding a high-fat diet for 6 weeks, the CHOL, LDL-C, and HDL-C levels in the serum of each group of mice were detected after the experiment. It was found that under a high-fat diet, the CHOL and LDL-C levels in the serum of the model group mice were significantly increased, and the HDL-C level was significantly reduced, and lipid metabolism disorders occurred. This verifies that dietary disorder is one of the key factors causing damp-heat syndrome.

In the embodiment, the weight gain of mice in the group treated with the present invention before and after the intervention was less than that in other groups, and there was a statistical difference. Compared with the control groups 1, 2, and 3CHOL, the LDL-C level of mice in the group treated with the present invention was significantly reduced, and the HDL-C level was increased, and there was statistical significance. The experimental results show that the moist heat patch has a certain lipid-regulating effect.

A Chinese medicine composition for improving qi stagnation constitution and its preparation method and application

Example 18 Preparation of the Chinese medicine composition of the present invention (I)

Weigh 15 parts of the raw materials Bupleurum, 15 parts of Cyperus, 15 parts of Fructus Aurantii Immaturus, 7.5 parts of Licorice, 7.5 parts of Rose, and 7.5 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 19 Preparation of the Chinese medicine composition of the present invention (II)

Weigh 10 parts of the raw materials Bupleurum, 10 parts of Cyperus, 10 parts of Fructus Aurantii Immaturus, 5 parts of Licorice, 5 parts of Rose, and 5 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 20 Preparation of the Chinese medicine composition of the present invention (III)

Weigh 20 parts of the raw materials Bupleurum, 20 parts of Cyperus, 20 parts of Fructus Aurantii Immaturus, 10 parts of Licorice, 10 parts of Rose, and 10 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 21 Preparation of the Chinese medicine composition of the present invention (IV)

Weigh 12 parts of the raw materials Bupleurum, 12 parts of Cyperus, 12 parts of Fructus Aurantii Immaturus, 6 parts of Licorice, 6 parts of Rose, and 6 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 22 Preparation of the Chinese medicine composition of the present invention (V)

Weigh 18 parts of the raw materials Bupleurum, 18 parts of Cyperus, 18 parts of Fructus Aurantii Immaturus, 9 parts of Licorice, 9 parts of Rose, and 9 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 23 Preparation of the Chinese medicine composition of the present invention (VI)

Weigh 11 parts of the raw materials Bupleurum, 11 parts of Cyperus rotundus, 11 parts of Fructus Aurantii Immaturus, 5.5 parts of Licorice, 5.5 parts of Rose, and 5.5 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 24 Preparation of the Chinese medicine composition of the present invention (VII)

Weigh 13 parts of the raw materials Bupleurum, 13 parts of Cyperus, 13 parts of Fructus Aurantii Immaturus, 6.5 parts of Licorice, 6.5 parts of Rose, and 6.5 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 25 Preparation of the Chinese medicine composition of the present invention (VIII)

Weigh 14 parts of the raw materials Bupleurum, 14 parts of Cyperus, 14 parts of Fructus Aurantii Immaturus, 7 parts of Licorice, 7 parts of Rose, and 7 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 26 Preparation of the Chinese medicine composition of the present invention (IX)

Weigh 16 parts of the raw materials Bupleurum, 16 parts of Cyperus, 16 parts of Fructus Aurantii Immaturus, 8 parts of Licorice, 8 parts of Rose, and 8 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 27 Preparation of the Chinese medicine composition of the present invention (X)

Weigh 17 parts of the raw materials Bupleurum, 17 parts of Cyperus, 17 parts of Fructus Aurantii Immaturus, 8.5 parts of Licorice, 8.5 parts of Rose, and 8.5 parts of Prunus mume according to the ratio of 1:1:1:0.5:0.5:0.5.

Example 28 Preparation of acupuncture point application of the Chinese medicine composition of the present invention

(1) Weigh each raw material medicine in the weight proportion described in any one of Examples 18-27, crush it into powder, and then mix it with appropriate amount of ginger juice and hot melt adhesive matrix to form a paste. The ratio of Chinese medicine powder to hot melt adhesive matrix is generally 1:3.

(2) The above mixture is first made into a fluid extract, and extracted with a suitable solvent (20%-25% ethanol in water), and then part of the solvent is evaporated to adjust the concentration to 1 ml equivalent to 1 g of medicinal material.

(3) Place 1 kg of medical pressure-sensitive hot melt adhesive in a pot and heat to about 80°C to melt. When the temperature drops to about 60-70°C, slowly add the drug powder and stir evenly. When the temperature is about 40°C, add the fluid extract and azone (the ratio of the base to azone in the transdermal agent is about 1000:10), continue stirring, and then spread the paste to make a drug cake with a diameter of 4-5 cm and a thickness of about 2-3 mm.

Example 29 Preparation of the Chinese medicine composition patch of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 18-27, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned drug solution is concentrated under vacuum to remove the aqueous solution, and the obtained extract is vacuum dried;

(3) Weigh 2 g of the above extract, add 2-6 ml of medical glycerin, mix into a paste, and spread evenly on a square medical tape of a fixed size, leaving a certain size around the edges to fix the tape.

Example 30 Preparation of the Chinese medicine composition ointment of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 18-27, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) concentrating the above-mentioned drug solution under vacuum to obtain a drug solution concentrate;

(3) Add beeswax and yellow vaseline to the concentrate, simmer over low heat and stir, then cool to form a paste.

Example 31 Preparation of the Chinese medicine composition gel of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 18-27, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) concentrating the above-mentioned drug solution under vacuum to obtain a drug solution concentrate;

(3) Add carbomer to glycerin and grind it to moisten it. Then add a small amount of distilled water to grind it, transfer it to a measuring cup, take appropriate amounts of triethanolamine, ethylparaben, and distilled water to dissolve them, stir them into a gel, add appropriate amount of distilled water and stir evenly; add the above concentrate and grind evenly to obtain the product.

Example 32 Preparation of the Chinese medicine composition cataplasm of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 18-27, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned liquid medicine is concentrated by vacuum decompression to obtain a liquid medicine concentrate;

(3) Add sorbitol, glycerol and other conventional poultice bases to the concentrate, stir well, apply to the support layer, and add a protective layer.

Example 33 Clinical Experiment on Acupoint Application of the Chinese Medicine Composition of the Present Invention

1 Research subjects

1.1 Sample Source

A total of 70 patients with functional constipation (qi constipation type) who were treated in the outpatient and inpatient clinics of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from June 2020 to March 2021 were randomly divided into a treatment group and a control group with 35 cases in each group. One patient in the treatment group dropped out due to poor follow-up compliance, and 34 patients completed the study, including 16 males and 18 females, aged 22 to 70 years old, with an average age of 59 years old; 3 of them had skin allergies to external application of Huoxue Zhitong ointment and developed rashes, which were changed to gauze external application, and the rashes improved and the study was completed. Two patients dropped out of the control group follow-up, and 33 patients completed the study, including 16 males and 17 females, aged 25 to 70 years old, with an average age of 61 years old. There was no statistically significant difference in the baseline data of the two groups of patients (P>0.05), and they were comparable.

1.2 Diagnostic criteria

1.2.1 Diagnostic criteria for qi stagnation constitution in traditional Chinese medicine

According to the conversion results of the integral scale in "Classification and Determination of Constitution in Traditional Chinese Medicine" published by China Traditional Chinese Medicine Press on April 9, 2009 and combined with the doctor's judgment, the subject's constitution was judged to be Qi Yu constitution.

Questionnaire for determining qi stagnation constitution: ① Do you feel depressed and down? ② Do you feel nervous and anxious? ③ Are you sentimental and emotionally fragile? ④ Are you easily afraid or frightened? ⑤ Do you have rib or breast pain? ⑥ Do you sigh for no reason? ⑦ Do you feel a foreign body in your throat and can't spit it out or swallow it?

The judgment criteria are as follows:

Table 7 Standards for determining TCM constitution

Note: 1. Scoring method: Each item is scored 1, 2, 3, 4, and 5 points respectively according to "never (or) not", "rarely", "sometimes", "often", and "always". 2. Conversion score = (total score of each item - number of items) / (number of items × 4) × 100; the range is 0-100 points.

In this experiment, people with a conversion score of 40 or more were judged as having a Qi-Stagnation Constitution.

1.2.2 Diagnostic criteria for functional constipation

1. Disease diagnosis

1. Traditional Chinese Medicine Diagnosis

It is formulated with reference to the relevant contents of "National Standard of the People's Republic of China - TCM Clinical Diagnosis and Treatment Terminology - Syndrome" and "Traditional Chinese Medicine Internal Medicine".

2. Western medicine diagnosis

Refer to the Rome III diagnostic criteria for functional constipation.

1.3 Inclusion criteria

3.1) Those who meet the Western medical diagnostic criteria for chronic functional constipation;

2) Those who meet the TCM diagnosis of Qi constipation;

3) Aged 18 to 70;

4) The subjects are aware of the study and voluntarily sign the informed consent.

1.4 Shedding Standard

1. The condition worsens during treatment and requires special treatment, resulting in longer treatment time and increased costs;

2. Severe complications and exit pathways;

3. If other diseases occur during treatment and require treatment, exit this path;

4. If the implementation of this pathway is affected by the wishes of the patient and his/her family, the patient will exit this pathway.

2 Research Methods

2.1 Grouping Scheme

The experimental grouping scheme is based on the random number method. The specific operation is as follows: use the EXCEL software "=rand()" to create random numbers, and arrange the obtained data from small to large. The first 35 are the control group and the last 35 are the treatment group, with a total of 70 patients.

2.2 Treatment options

The treatment plan for the control group was to give Simotang oral liquid (Hunan Hansen Pharmaceutical Co., Ltd., batch number: 1610103, specification: 10 mL/vial) orally, 2 vials (20 mL) each time, 3 times/d.

The treatment plan for the treatment group is to use the Chinese medicine composition of the present invention for acupoint application, which is divided into 2 courses of treatment, a total of 60 days.

The Chinese medicine composition acupuncture patch of the present invention is independently developed by the Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, based on the characteristics of qi deficiency constitution, combined with the characteristics of meridians, acupuncture points, and drugs. Its main components are bupleurum, cyperus, fructus aurantii, licorice, rose, and green calyx plum (ratio: 1:1:1:0.5:0.5:0.5), and it is uniformly produced by Shandong Yuhetang Pharmaceutical Co., Ltd. according to the production process standards (production batch number: 20191002), with a specification of 4cm×4cm/piece, and each piece (drug core) is about 0.5 grams.

Production process: ① Mix the required Chinese medicine granules in the ratio of 1:1:1:0.5:0.5:0.5 and crush them into powder, then mix with hot melt adhesive matrix. The ratio of Chinese medicine powder to hot melt adhesive matrix is generally 1:3. ② First make the above mixture into a fluid extract, and extract it with a suitable solvent (20%-25% ethanol in water), and then evaporate part of the solvent to adjust the concentration to 1g of medicinal material per 1ml. ③ Put 1kg of medical pressure-sensitive hot melt adhesive into a pot and heat it to about 80℃ to melt. After cooling to about 60-70℃, slowly add the powder and stir evenly. At about 40℃, add the fluid extract and azone (the ratio of the matrix and azone in the transdermal agent is about 1000:10), continue stirring, and then spread the paste.

Usage: ask the patient to bathe the whole body or scrub the limbs, keep the skin warm, and apply the Chinese medicine composition of the present invention to the Tanzhong and Ganshu points of the human body for 4-8 hours each time, three times a week.

2.3 TCM Constitution Scoring

The changes of constitution transformation scores within and between the two groups of intervention subjects before and after the intervention were compared and observed, among which the TCM Qi deficiency constitution transformation score was the main efficacy indicator.

2.4 Adverse reaction records

Observe whether adverse events or adverse reactions of the application drugs (such as skin itching, skin redness, swelling, heat and pain, skin ulceration, etc.) occur during the acupoint application of the Chinese medicine composition of the present invention. If any, record the time of occurrence and treatment measures in time.

2.5 Criteria for determining the efficacy of clinical interventions

Main symptoms: time of first bowel movement, interval between bowel movements, duration of each bowel movement, stool quality, and stool sensation are scored according to levels (mild = 0 points, moderate = 2 points, severe = 4 points); Concomitant symptoms: abdominal distension, abdominal pain, anal fissure, bloody stool, sweating due to straining, loss of appetite. The presence of any one symptom is 0.5 points, and none is 0 points.

2.6 Efficacy criteria

Cured: normal bowel movement, all other symptoms disappear. Remarkable effect: constipation is significantly improved, the interval time and stool quality are close to normal, or the stool is slightly dry and the interval time between bowel movements is within 72 hours, most of other symptoms disappear, and the score is reduced by 2/3; Effective: the interval time between bowel movements is shortened by 1 day, or the dry stool quality is improved, other symptoms are improved, and the score is reduced by 1/3, but less than 2/3; Ineffective: constipation and other symptoms are not improved or the score is reduced by less than 1/3.

2.7 Safety evaluation

The electrocardiogram, routine blood and stool tests, occult blood, liver function and kidney function of the two groups of patients were observed before and after treatment.

2.8 Statistical methods

SPSS 24.0 statistical software was used for statistics. If the data met the normal distribution, the mean ± standard deviation was used. To describe. To compare the two groups of data, if they were in accordance with normal distribution, the independent sample t test was used; to compare the data before and after the intervention, if they were in accordance with normality, the paired t test was used; the chi-square test was used for count data; if the data did not conform to normal distribution or the data were rank data, the rank sum test was used. P < 0.05 was considered statistically significant.

3 Results

3.1 Clinical efficacy

There was a statistically significant difference in clinical efficacy between the two groups (Z=-4.425, P<0.01). The cure, marked effect and total effective rates of the treatment group were all higher than those of the control group. The clinical efficacy of the treatment group was more obvious than that of the control group, as shown in Table 8.

Table 8 Comparison of clinical efficacy between the two groups

3.2 Syndrome score

After treatment, the symptom scores of the two groups of patients were improved compared with those before treatment, and the differences were statistically significant (P<0.01); after treatment, the difference between the two groups was statistically significant (P<0.05), and the treatment group was more obvious in improving the symptom scores than the control group, as shown in Table 9.

Table 9 Comparison of syndrome scores between the two groups

3.3 Physical Conversion Points

After treatment, the TCM Qi-stagnation constitution conversion scores of the two groups of patients were improved compared with those before treatment, and the differences were statistically significant (P<0.01); the difference between the two groups after treatment was statistically significant (P<0.05), and the treatment group had a significant improvement in the TCM Qi-stagnation constitution conversion score, as shown in Table 10.

Table 10 Comparison of TCM Qi-stagnation Constitution Transformation Score between the Two Groups of Patients Before and After Treatment

4 Discussion

4.1 Concept and clinical characteristics of Qi stagnation constitution

Qi stagnation constitution is a physical state formed due to long-term emotional depression and stagnation of Qi, with introverted and unstable personality, melancholy and fragility, sensitivity and suspicion as the main manifestations. People in this physical state are mostly middle-aged and young people, and more common in women. They are often lonely and introverted, easily sentimental, and narrow-minded. The main disease of people with Qi stagnation constitution is the liver, and also affects the heart, stomach, large intestine, and small intestine. It is easy to hurt emotions and diet, and it is easy to produce Qi stagnation, such as depression, insomnia, plum pit qi, panic, etc. Modern research shows that this kind of constitution is prone to tumors.

Conditioning treatment should be used to regulate emotions and unblock the Qi. Qi deficiency constitution often presents: thin or slightly fat body, pale complexion, shortness of breath and laziness, fatigue, frequent spontaneous sweating, especially when moving, pale red tongue, tooth marks on the tongue edge, white fur, weak pulse. Qi deficiency of the five internal organs can be seen clinically, and the heart, lungs, spleen and kidneys are common. In addition to the common clinical manifestations of qi deficiency syndrome mentioned above, the corresponding lesions of heart, lungs, spleen and kidney qi deficiency are also seen with different symptoms. Tendency to disease: prone to colds, qi deficiency dizziness, visceral ptosis, weak resistance, and slow recovery after illness.

4.2 Analysis of the formula of the Chinese medicine composition for acupoint application of the present invention

The Chinese medicine composition acupoint application of the present invention is independently developed by Professor Zhang Xiaotian based on the characteristics of qi stagnation constitution, combined with the characteristics of meridians, acupoints and drugs. Its main components are bupleurum, cyperus, fructus aurantii, liquorice, rose and green calyx plum (ratio: 1:1:1:0.5:0.5:0.5), and the whole formula has the functions of soothing the liver and regulating qi, promoting qi and regulating menstruation, and promoting blood circulation and removing blood stasis.

Bupleurum: bitter and pungent in taste, slightly cold in nature, and enters the liver and gallbladder meridians. It is an essential medicine for treating liver qi stagnation, and can relieve fever, relieve liver qi depression, and raise yang qi. It is often used to treat chest and flank or lower abdominal distension and pain caused by liver failure to release qi, depression, menstrual disorders, and dysmenorrhea in women.

Cyperus rotundus: Spicy, slightly bitter, slightly sweet, neutral in nature. It enters the liver, spleen, and triple burner meridians. It soothes the liver and relieves depression, regulates qi and relieves fullness, regulates menstruation and relieves pain. It is used for liver depression and qi stagnation, chest and flank pain, hernia pain, breast pain, spleen and stomach qi stagnation, abdominal distension, fullness and pain, irregular menstruation, amenorrhea and dysmenorrhea. Cyperus rotundus has a good effect of soothing the liver and relieving depression. It is an important medicine for promoting qi and relieving depression in the liver. It is often used in combination with Bupleurum chinense and Citrus aurantium in clinical practice.

Citrus aurantium: bitter, pungent, sour, slightly cold in nature. It enters the spleen and stomach meridians. It has the effects of regulating qi, relieving fullness, and relieving stagnation and swelling. It is often used clinically to treat chest and flank qi stagnation, fullness and pain, indigestion, phlegm and fluid retention, and sagging organs.

Licorice: neutral in nature, sweet in taste. Enters the heart meridian, stomach meridian, spleen meridian, and lung meridian. It nourishes the spleen and replenishes qi, relieves cough and expectoration, relieves urgency and pain, and harmonizes the properties of the medicine.

Rose: warm in nature, sweet and slightly bitter in taste, belongs to the liver meridian and spleen meridian. It promotes qi and relieves depression, harmonizes qi and relieves pain. It is mainly used in clinical treatment of liver and stomach qi pain, menstrual disorders, liver wind headache, liver depression and vomiting blood, chronic cholecystitis, and chest tightness caused by qi depression.

Green-calyx plum: slightly sour and astringent, neutral in nature. Enters the liver, stomach, and lung meridians. Its aromatic aroma promotes the flow of qi into the liver and stomach, making it a good medicine for treating liver and stomach qi pain. It is also often used to resolve depression, open the chest and relieve qi, resolve phlegm and disperse knots, and is a good health product for people with liver qi stagnation. It is suitable for people with flank pain, abdominal distension, belching, loss of appetite, stomach pain, and indigestion caused by liver and stomach qi stagnation. It is suitable for people with irritability, depression, neurasthenia, plum pit qi, sore throat, and chronic pharyngitis caused by emotional discomfort, liver qi stagnation, and phlegm qi stagnation.

4.3 Acupoint Selection Analysis

The acupoints selected are mainly Tanzhong and Ganshu. Tanzhong is the place where the pericardium meridian qi gathers. The Yellow Emperor's Classic of Internal Medicine mentions: "Tanzhong is the official of the minister, and joy comes out of it." Modern research shows that stimulating this acupoint can effectively treat various qi diseases by regulating nerve function, relaxing smooth muscles, dilating coronary blood vessels and the diameter of the digestive tract. Ganshu is the back-shu point of the liver. "Qianjin Fang" says: "Ganshu, Pishu, Zhishi, the main two flank pain." It is commonly used in modern times to treat acute and chronic hepatitis, cholecystitis, conjunctivitis, night blindness, myopia, etc. The two acupoints are used together to widen the chest and regulate qi, promote blood circulation and relieve pain, and remove numbness and dredge the meridians, thereby improving the physical condition of people with qi stagnation constitution bias.

Example 34 Animal Experiment

1. Materials and Methods

1.1 Experimental Materials

1.1.1 Experimental animals

Forty SPF Sprague-Dawley (SD) male mice weighing (200±20) g were provided by Shanghai SLAC Laboratory Animal Co., Ltd. They were housed in an environment with a constant temperature of (22±1)°C and a fixed lighting rhythm of 12:12, and had free access to food and water.

1.1.2 Experimental drugs The present invention group: 15 parts of bupleurum, 15 parts of cyperus, 15 parts of aurantium, 7.5 parts of liquorice, 7.5 parts of rose, 7.5 parts of green-calyx plum Control group 1: 15 parts of bupleurum, 15 parts of citron, 15 parts of aurantium, 7.5 parts of raw malt, 7.5 parts of rose, 7.5 parts of green-calyx plum Control group 2: 15 parts of bupleurum, 15 parts of cyperus, 15 parts of aurantium, 7.5 parts of raw malt, 7.5 parts of rose, 7.5 parts of green-calyx plum Control group 3: 15 parts of bupleurum, 15 parts of citron, 15 parts of aurantium, 7.5 parts of liquorice, 7.5 parts of rose, 7.5 parts of green-calyx plum

1.1.3 Main reagents: 8% Na ₂ S, 75% alcohol;

1.1.4 Main instruments: measuring cylinder; stopwatch.

1.2 Experimental methods

1.2.1 Experimental groups: 40 rats were divided into the present invention group, control group 1, control group 2, and control group 3 according to the random number table method, with 10 rats in each group.

1.2.2 The model of Qi-stagnation constitution mice was established by referring to the methods of Zhu Qingjing (Xiong Zhenfang, Zhu Qingjing. Effects of Chaihu Shugan Powder on rats with chronic restraint stress-induced liver depression syndrome [J]. Chinese Journal of Integrated Traditional and Western Medicine for Digestion, 2004, (04): 220-221.), Tang Yiting (Tang Yiting, Chen Jiaxu. Regulation of hypothalamus-pituitary-adrenal axis in rats with chronic restraint stress by three Chinese herbal compound prescriptions [J]. Journal of Beijing University of Chinese Medicine, 2002 (03): 23-26.). At the beginning of the experiment, the rats were restrained and placed in the restraint box. The front end of the active part was adjusted to a suitable position so that the rats would not produce strong resistance to the tension. The restraint was performed for 6 hours every day (9:00-15:00) for 6 consecutive weeks. This indicated that the model was successfully established.

1.2.3 Method of administration:

Patching group of the present invention, patch control group 1, patch control group 2, patch control group 3:

Patching group of the present invention: Depilate the back of the mouse with 8% Na2S, the area is about 4cm×4cm, and after local disinfection with 75% alcohol, the patch group of the present invention (15 parts of Bupleurum, 15 parts of Cyperus, 15 parts of Citrus aurantium, 7.5 parts of Licorice, 7.5 parts of Rose, 7.5 parts of Prunus mume) is fixed on the depilated area (Tanzhong, Ganshu). Then press gently twice, and then wrap the chest and back with a self-adhesive tape to fix it. (Each piece (drug core) is about 0.3 grams) Remove it after 8 hours of application, once a day, a total of 20 times.

Patching control group 1: Depilate the back of the mouse with 8% Na ₂ S, the area is about 4cm×4cm, and after local disinfection with 75% alcohol, apply the patch control group 1 (15 parts of Bupleurum, 15 parts of Citron, 15 parts of Citrus aurantium, 7.5 parts of Malt, 7.5 parts of Rose, 7.5 parts of Prunus mume) to the depilated area (Tanzhong, Ganshu). Then press gently twice, and then wrap the chest and back with a self-adhesive tape to fix it. (Each piece (core) is about 0.3 grams) Remove it after 8 hours of application, once a day, a total of 20 times.

Patching control group 2: Depilate the back of the mouse with 8% Na ₂ S, the area is about 4cm×4cm, and after local disinfection with 75% alcohol, apply the patch control group 2 (15 parts of Bupleurum, 15 parts of Cyperus, 15 parts of Citrus aurantium, 7.5 parts of Malt, 7.5 parts of Rose, 7.5 parts of Prunus mume) to the depilated area (Tanzhong, Ganshu). Then press gently twice, and then wrap the chest and back with adhesive tape to fix. (Each piece (drug core) is about 0.3 grams) Remove it after 8 hours of application, once a day, a total of 20 times.

Patching control group 3: Depilate the back of the mouse with 8% Na2S, the area is about 4cm×4cm, and after local disinfection with 75% alcohol, apply the patch control group 3 (15 parts of Bupleurum, 15 parts of Citron, 15 parts of Citrus aurantium, 7.5 parts of Licorice, 7.5 parts of Rose, 7.5 parts of Prunus mume) to the depilated area (Tanzhong, Ganshu). Then press gently twice, and then wrap the chest and back with adhesive tape to fix. (Each piece (drug core) is about 0.3 grams) Remove it after 8 hours of application, once a day, a total of 20 times.

1.2.4 Observation and testing indicators

Mouse forced swimming test: 10 cm of 21-23℃ water is placed in a measuring cylinder, and an opaque plate is placed between the measuring cylinders to prevent the mice from seeing each other. One hour after the last injection, the mouse is put into the measuring cylinder and stays for 6 minutes. The immobility time after the last 4 minutes is calculated, and five mice are measured at the same time. The criteria for judging immobility: stop struggling, vertical position, float without moving, and only do some necessary activities to keep its head above water.

Mouse tail suspension test: On the third day after forced swimming and one hour after the last drug administration, use tape to fix the mouse to a horizontally placed rod 30 mm away from the tip of the tail, with a board in the middle to prevent each other from seeing each other. The mouse is about 100 mm away from the nearest object. Hang for 6 minutes, record the immobility time of the last 4 minutes, and measure 5 mice each time.

1.2.5 Statistical analysis

SPSS10.0 software was used for one-way analysis of variance, and t-test was used for comparison between the two groups.

2. Results

Table 11 Effects of different patches on immobility time in the forced swimming model of mice (x±s)

Group Number of cases (n) Immobility time (n) The present invention group 10 79.02±38.54 Control group 1 10 79.69±40.99 Control group 2 10 80.69±41.99 Control group 3 10 79.49±41.98

The difference between the present invention group and control group 1 and control group 3 was P<0.05, and the difference between the present invention group and control group 2 was P<0.01.

Table 12 Effects of different patches on the immobility time of the tail suspension model in mice (x±s)

Group Number of cases (n) Immobility time (n) The present invention group 10 42.64±30.88 Control group 1 10 44.02±26.54 Control group 2 10 45.69±27.99 Control group 3 10 47.69±29.90

Compared with control group 1 and control group 2, the difference between the present invention group and control group 1 was P<0.05; compared with control group 1, the difference between the present invention group and control group 1 was P<0.01.

The mice showed a tendency to reduce the immobility time in forced swimming. The experimental results show that the present invention has the effect of improving qi stagnation constitution.

A Chinese medicine composition for improving qi deficiency constitution and its preparation method and application example

Example 35 Preparation of the Chinese medicine composition of the present invention (I)

According to the ratio of 1:1:1:0.5:1:0.1, weigh 15 parts of raw materials astragalus, 15 parts of stir-fried atractylodes, 15 parts of siler, 7.5 parts of dried tangerine peel, 15 parts of pseudoginseng, and 1.5 parts of ginseng.

Example 36 Preparation of the Chinese medicine composition of the present invention (II)

Weigh 10 parts of raw materials astragalus, 10 parts of stir-fried atractylodes, 10 parts of siler, 5 parts of dried tangerine peel, 10 parts of pseudoginseng, and 1 part of ginseng in the ratio of 1:1:1:0.5:1:0.1.

Example 37 Preparation of the Chinese medicine composition of the present invention (III)

Weigh 20 parts of raw materials astragalus, 20 parts of stir-fried atractylodes, 20 parts of siler, 10 parts of dried tangerine peel, 20 parts of pseudoginseng, and 2 parts of ginseng in the ratio of 1:1:1:0.5:1:0.1.

Example 38 Preparation of the Chinese medicine composition of the present invention (IV)

According to the ratio of 1:1:1:0.5:1:0.1, weigh 12 parts of raw materials astragalus, 12 parts of stir-fried atractylodes, 12 parts of siler, 6 parts of dried tangerine peel, 12 parts of pseudoginseng, and 1.2 parts of ginseng.

Example 39 Preparation of the Chinese medicine composition of the present invention (V)

According to the ratio of 1:1:1:0.5:1:0.1, weigh 18 parts of raw materials astragalus, 18 parts of stir-fried atractylodes, 18 parts of siler, 9 parts of dried tangerine peel, 18 parts of pseudoginseng, and 1.8 parts of ginseng.

Example 40 Preparation of the Chinese medicine composition of the present invention (VI)

According to the ratio of 1:1:1:0.5:1:0.1, weigh 11 parts of raw materials astragalus, 11 parts of stir-fried atractylodes, 11 parts of siler, 5.5 parts of dried tangerine peel, 11 parts of pseudoginseng, and 1.1 parts of ginseng.

Example 41 Preparation of the Chinese medicine composition of the present invention (VII)

According to the ratio of 1:1:1:0.5:1:0.1, weigh 13 parts of raw materials astragalus, 13 parts of stir-fried atractylodes, 13 parts of siler, 6.5 parts of dried tangerine peel, 13 parts of pseudoginseng, and 1.3 parts of ginseng.

Example 42 Preparation of the Chinese medicine composition of the present invention (VIII)

According to the ratio of 1:1:1:0.5:1:0.1, weigh 14 parts of raw materials astragalus, 14 parts of stir-fried atractylodes, 14 parts of siler, 7 parts of dried tangerine peel, 14 parts of pseudoginseng, and 1.4 parts of ginseng.

Example 43 Preparation of the Chinese medicine composition of the present invention (IX)

According to the ratio of 1:1:1:0.5:1:0.1, weigh 16 parts of raw materials astragalus, 16 parts of stir-fried atractylodes, 16 parts of siler, 8 parts of dried tangerine peel, 16 parts of pseudoginseng, and 1.6 parts of ginseng.

Example 44 Preparation of the Chinese medicine composition of the present invention (X)

According to the ratio of 1:1:1:0.5:1:0.1, weigh 19 parts of raw materials astragalus, 19 parts of stir-fried atractylodes, 19 parts of siler, 9.5 parts of dried tangerine peel, 19 parts of pseudoginseng, and 1.9 parts of ginseng.

Example 45 Preparation of acupuncture point application of the Chinese medicine composition of the present invention

(1) Weigh each raw material medicine in the weight proportion described in any one of Examples 35-44, crush it into powder, and then mix it with appropriate amount of ginger juice and hot melt adhesive matrix to form a paste. The ratio of Chinese medicine powder to hot melt adhesive matrix is generally 1:3.

(2) The above mixture is first made into a fluid extract, and extracted with a suitable solvent (20%-25% ethanol in water), and then part of the solvent is evaporated to adjust the concentration to 1 ml equivalent to 1 g of medicinal material.

(3) Place 1 kg of medical pressure-sensitive hot melt adhesive in a pot and heat to about 80°C to melt. When the temperature drops to about 60-70°C, slowly add the drug powder and stir evenly. When the temperature is about 40°C, add the fluid extract and azone (the ratio of the base to azone in the transdermal agent is about 1000:10), continue stirring, and then spread the paste to make a drug cake with a diameter of 4-5 cm and a thickness of about 2-3 mm.

Example 46 Preparation of the Chinese medicine composition patch of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 35-44, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned drug solution is concentrated under vacuum to remove the aqueous solution, and the obtained extract is vacuum dried;

(3) Weigh 2 g of the above extract, add 2-6 ml of medical glycerin, mix into a paste, and spread evenly on a square medical tape of a fixed size, leaving a certain size around the edges to fix the tape.

Example 47 Preparation of the Chinese medicine composition ointment of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 35-44, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned liquid medicine is concentrated by vacuum decompression to obtain a liquid medicine concentrate;

(3) Add beeswax and yellow vaseline to the concentrate, simmer and stir over low heat, and cool until it becomes a paste.

Example 48 Preparation of the Chinese medicine composition gel of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 35-44, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned liquid medicine is concentrated by vacuum decompression to obtain a liquid medicine concentrate;

(3) Add carbomer to glycerin and grind it to moisten it. Then add a small amount of distilled water to grind it. Transfer it to a measuring cup, take appropriate amounts of triethanolamine, ethylparaben, and distilled water to dissolve them, stir them into a gel, add appropriate amount of distilled water and stir evenly; add the above concentrate and grind evenly to obtain the product.

Example 49 Preparation of the Chinese medicine composition cataplasm of the present invention

(1) Weigh each raw material drug according to the weight ratio described in any one of Examples 35-44, add 8-10 times the amount of water, decoct twice, each time for 60 minutes, filter while hot, and combine the two decoctions for later use;

(2) the above-mentioned liquid medicine is concentrated by vacuum decompression to obtain a liquid medicine concentrate;

(3) Add sorbitol, glycerol and other conventional poultice bases to the concentrate, stir well, apply to the support layer, and add a protective layer.

Example 50 Clinical Experiment on Acupoint Application of the Chinese Medicine Composition of the Present Invention

1 Research subjects

1.1 Sample Source

The samples for this experiment were derived from 30 patients with TCM Qi deficiency constitution and chronic diarrhea who met the inclusion criteria and visited the outpatient and inpatient departments of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from June 2020 to March 2021. They were randomly divided into a control group and a treatment group with 15 patients in each group.

1.2 Diagnostic criteria

1.2.1 Diagnostic criteria for Qi deficiency constitution in traditional Chinese medicine

According to the conversion results of the integral scale in "Classification and Determination of Constitution in Traditional Chinese Medicine" published by China Traditional Chinese Medicine Press on April 9, 2009 and combined with the doctor's judgment, the subject's constitution was judged to be Qi deficiency constitution.

Questionnaire for determining qi deficiency constitution: ①Are you easily fatigued? ②Are you easily short of breath (shortness of breath, choking)? ③Are you easily flustered? ④Are you easily dizzy or feel dizzy when standing up? ⑤Are you more likely to catch a cold than others? ⑥Do you like quietness and are too lazy to talk? ⑦Do you speak in a low, weak voice? ⑧Do you sweat easily when you are a little more active?

The judgment criteria are as follows:

Table 13 Standards for determining TCM constitution

Note: 1. Scoring method: Each item is scored 1, 2, 3, 4, and 5 points respectively according to "never (or) not", "rarely", "sometimes", "often", and "always". 2. Conversion score = (total score of each item - number of items) / (number of items × 4) × 100; the range is 0-100 points.

In this experiment, people with a Qi deficiency constitution conversion score of 40 points or more were judged as having a Qi deficiency constitution.

2.2 Treatment options

The treatment plan for the treatment group is to use the Chinese medicine composition of the present invention for acupoint application, which is divided into 2 courses of treatment, a total of 60 days.

The Chinese medicine composition acupuncture patch of the present invention is independently developed by the Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, based on the characteristics of qi deficiency constitution, combined with the characteristics of meridians, acupuncture points, and drugs. Its main components are astragalus, stir-fried white atractylodes, saposhnikovia, tangerine peel, Pseudostellaria heterophylla, and ginseng (ratio: 1:1:1:0.5:1:0.1), and is uniformly produced by Shandong Yuhetang Pharmaceutical Co., Ltd. according to the production process standards (production batch number: 20191002), with a specification of 4cm×4cm/piece, and each piece (drug core) is about 0.5 grams.

Production process: ① Mix the required Chinese medicine granules in the ratio of 1:1:1:0.5:1:0.1 and crush them into powder, then mix with the hot melt adhesive matrix. The ratio of Chinese medicine powder to hot melt adhesive matrix is generally 1:3. ② First make the above mixture into a fluid extract, and extract it with a suitable solvent (20%-25% ethanol in water), and then evaporate part of the solvent to adjust the concentration to 1g of medicinal materials per 1ml. ③ Put 1kg of medical pressure-sensitive hot melt adhesive into a pot and heat it to about 80℃ to melt. After cooling to about 60-70℃, slowly add the powder and stir evenly. At about 40℃, add the fluid extract and azone (the ratio of the matrix and azone in the transdermal agent is about 1000:10), continue stirring, and then spread the paste.

Usage: ask the patient to bathe the whole body or scrub the limbs, keep the skin warm, and apply the Chinese medicine composition of the present invention to the Qihai, Pishu and Zusanli acupoints of the human body for 4-8 hours each time, three times a week.

2.3 TCM Constitution Scoring

The changes of constitution transformation scores within and between the two groups of intervention subjects before and after the intervention were compared and observed, among which the TCM Qi deficiency constitution transformation score was the main efficacy indicator.

2.4 Adverse reaction records

Observe whether adverse events or adverse reactions of the application drugs (such as skin itching, skin redness, swelling, heat and pain, skin ulceration, etc.) occur during the acupoint application of the Chinese medicine composition of the present invention. If any, record the time of occurrence and treatment measures in time.

2.5 Criteria for determining the efficacy of clinical interventions

2.5.1 Criteria for determining the efficacy of TCM clinical intervention

The efficacy of TCM clinical intervention is judged based on the TCM Qi deficiency constitution transformation score. The standard refers to the relevant standards of the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" issued by the State Food and Drug Administration in 2017, and is judged using changes in symptom scores.

Therapeutic index (n) = difference in symptom scores before and after treatment/symptom scores before treatment × 100%.

① Clinical cure: clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%.

② Markedly effective: clinical symptoms and signs disappeared or basically disappeared, and the syndrome score decreased by ≥70%.

③ Effective: Clinical symptoms and signs disappeared or almost disappeared, and the syndrome score decreased by ≥30 but <70%.

④ Ineffective: There is no significant improvement in clinical symptoms and signs, or they may even worsen, and the symptom score decreases by less than 30%.

3.3 Physical Conversion Points

After treatment, the physical transformation scores of both groups of patients decreased. There was no significant difference in the control group compared with before treatment, P>0.05; there were significant differences in the treatment group before and after treatment, both within-group and between-group comparisons, P<0.05.

Table 14 Comparison of TCM Qi deficiency constitution transformation scores between the two groups of patients before and after treatment

Note: Compared with before treatment, *P＜0.05; compared with control group, ^P＜0.05.

3.3 Research results of safety indicators

During the treatment period, no adverse reactions to the medication (such as skin itching, skin redness, swelling, heat and pain, skin ulceration, etc.) occurred in the patients.

4 Discussion

4.1 Concept and clinical characteristics of Qi deficiency constitution

Qi deficiency constitution is mostly caused by congenital deficiency, long-term eating disorders, emotional disorders, long-term illness, fatigue, and old age and physical weakness, which leads to damage to the heart, lung, spleen, and kidney functions. The heart controls the blood vessels, the lungs control the qi of the whole body, the kidneys store the original qi, and the spleen and stomach are the "source of qi generation and transformation". Therefore, qi deficiency constitution can easily lead to a decrease in the function of promoting blood circulation, insufficient qi generation in the body, and a decrease in the body's defense against external evil, protection of the skin, and maintenance of the position of internal organs.

Qi deficiency constitution often presents: thin or slightly fat body, pale complexion, shortness of breath, laziness, fatigue, frequent spontaneous sweating, especially when moving, pale red tongue, tooth marks on the tongue edge, white fur, weak pulse. Qi deficiency of the five internal organs can be seen clinically, and the heart, lungs, spleen and kidney are the most common. In addition to the common clinical manifestations of qi deficiency syndrome mentioned above, the corresponding lesions of heart, lungs, spleen and kidney qi deficiency are also seen, and different symptoms are seen. Tendency to disease: prone to colds, qi deficiency dizziness, visceral ptosis, weak resistance, and slow recovery after illness.

Since cytokines are closely related to the onset of fatigue symptoms, most people with Qi deficiency have immune system dysfunction or a decline in immune system function. A decline in human immune function can lead to a decline in the body's ability to defend, identify, and eliminate foreign pathogens and self-antigenic foreign bodies, making it difficult to maintain the physiological balance of the body's internal environment, leading to the occurrence of diseases.

4.2 Analysis of the formula of the Chinese medicine composition for acupoint application of the present invention

The Chinese medicine composition acupoint application of the present invention is independently developed by Professor Zhang Xiaotian based on the characteristics of phlegm-damp constitution, combined with the characteristics of meridians, acupoints and drugs. Its main components are astragalus, stir-fried white atractylodes, saposhnikovia, tangerine peel, Pseudostellaria baicalensis and ginseng (ratio: 1:1:1:0.5:1:0.1), and the whole formula has the functions of replenishing qi, nourishing the spleen and lungs, and promoting qi and removing stagnation.

Astragalus: sweet, slightly warm; enters the spleen and lung meridians. It replenishes qi and strengthens the exterior, removes toxins and pus, promotes urination, and promotes tissue regeneration. It is used for qi deficiency and fatigue, chronic diarrhea and prolapse of the anus, spontaneous sweating, edema, uterine prolapse, proteinuria in chronic nephritis, diabetes, and wounds that do not heal for a long time.

Atractylodes macrocephala: warm in nature, sweet and bitter in taste. Enters the spleen meridian and stomach meridian. Strengthens the spleen, replenishes qi, dries dampness and promotes diuresis, stops sweating, and stabilizes pregnancy. It is a qi-tonifying drug under the category of tonic drugs.

Saposhnikovia: warm in nature, sweet and pungent in taste. Enters the bladder meridian, liver meridian, spleen meridian. It has the functions of dispelling wind and removing dampness. It belongs to the category of pungent and warm antipyretic drugs under the category of antipyretic drugs.

Tangerine peel: Spicy, bitter, warm in nature. Enters the spleen and lung meridians. Regulates qi and stimulates appetite, dries dampness and resolves phlegm, treats spleen and stomach diseases. It is a qi-regulating drug.

Radix Pseudostellariae: neutral in nature, sweet and slightly bitter in taste. Enters the spleen meridian and lung meridian. Replenishes qi and strengthens the spleen, produces body fluid and moistens the lungs. It is a qi-tonifying drug under the category of tonic drugs.

Ginseng: warm in nature, sweet and slightly bitter in taste. It enters the heart meridian, lung meridian, spleen meridian, and kidney meridian. It greatly replenishes vital energy, restores pulse and consolidates the body, replenishes the spleen and lungs, and promotes the production of body fluids and calms the mind. It is a Qi-tonifying drug under the category of tonic drugs.

4.3 Acupoint Selection Analysis

The acupoints selected are mainly Qihai, Pishu and Zusanli. Pishu is the acupoint where the meridian qi is infused on the back. Qihai and Zusanli are both important acupoints for replenishing qi and nourishing the essence. The "Bronze Man Acupoint Acupoints and Acupuncture Illustrated Manual" states: "Qihai is the sea of vitality for men." This acupoint can nourish the original qi, strengthen the kidney and consolidate the essence, and replenish and restore yang. "Qianjin Yaofang" says: "If you want to be at peace, Sanli is always wet." The three acupoints are used together to enhance the function of replenishing qi and strengthening the body, prolonging life, and thus improve the physical condition of people with qi deficiency constitution.

The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims (4)

1. A Chinese medicine composition for improving damp-heat constitution gouty arthritis, characterized in that, said Chinese medicine composition is made of the following crude drugs in parts by weight: 10-20 parts of Atractylodes Rhizome, 10-20 parts of Achyranthes bidentata, 10-20 parts of Coix Seed, 10-20 parts of Magnolia Officinalis, 10-20 parts of Pediatric Rhizoma, 10-20 parts of Zhidanxing, and the dosage form of said Chinese medicine composition is an external preparation. 2. The traditional Chinese medicine composition according to claim 1, characterized in that, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 13-18 parts of Atractylodes Rhizome, 13-18 parts of Achyranthes bidentata, 13-18 parts of Coix Seed, 13-18 parts of Magnolia officinalis, 13-18 parts of Tianzhuzi, and 13-18 parts of Zhidanxingxing. 3. The Chinese medicine composition according to claim 2, characterized in that, said Chinese medicine composition is made of the following raw materials in parts by weight: 15 parts of Atractylodes Rhizome, 15 parts of Achyranthes bidentata, 15 parts of Coix Seed, 15 parts of Magnolia officinalis, 15 parts of Tianzhuzi, and 15 parts of Zhidanxing. 4. The application of the Chinese medicine composition described in any one of claims 1-3 in the preparation of gouty arthritis medicine for improving damp-heat constitution.