CN115245549B

CN115245549B - Traditional Chinese medicine composition for improving gouty arthritis with damp-heat constitution

Info

Publication number: CN115245549B
Application number: CN202210973140.1A
Authority: CN
Inventors: 张晓天; 韦硕硕; 王燕; 余佩思; 王莹; 黄正阳; 王雪莹
Original assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Current assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Priority date: 2022-08-15
Filing date: 2022-08-15
Publication date: 2023-07-25
Anticipated expiration: 2042-08-15
Also published as: CN116370539A; CN116370560A; CN115245549A

Abstract

The invention relates to a traditional Chinese medicine composition for improving damp-heat constitution, and a preparation method and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of rhizoma atractylodis, 10-20 parts of radix achyranthis bidentatae, 10-20 parts of semen coicis, 10-20 parts of magnolia officinalis, 10-20 parts of pelargonium, and 10-20 parts of bile-producing star. The Chinese medicinal composition acupoint application disclosed by the invention is prepared from the Chinese medicinal composition according to a ratio of 1:1:1:1:1:1, wherein the selected acupoints are mainly composed of Yanglingquan, zhanggou and Ququan. The traditional Chinese medicine composition has the characteristics of convenient carrying, safety and innocuity, is suitable for any crowd, is especially suitable for people with damp-heat constitution, adheres to the body for a long time regularly, has obvious effects of improving the damp-heat constitution and conditioning the whole body state, and promotes the transition of the damp-heat constitution to a mild state.

Description

Traditional Chinese medicine composition for improving gouty arthritis with damp-heat constitution

Technical Field

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

Background

The theory of constitutions originates from Huangdi's interior channel. The Chinese society of medicine in 4 months in 2009 divides constitutions into: mild nature, qi deficiency nature, yang deficiency nature, yin deficiency nature, phlegm dampness nature, damp heat mass, blood stasis nature, qi stagnation nature and specific nature. The traditional Chinese medicine researches show that the constitution of the traditional Chinese medicine refers to the inherent characteristics of the human body in terms of morphological structure, physiological function and psychological state formed on the basis of congenital endowment and acquired congenital endowment, has comprehensiveness and relative stability, often determines the specificity of the human body to physiological reaction, and susceptibility to certain pathogenic factors and tendency of generating pathological change types, thereby influencing the syndrome type and disease state prognosis of acquired diseases.

Among the constitutions of damp-heat, so-called water-dampness is the distinction between external-dampness and internal-dampness. The external wetting is caused by the invasion of external water into human bodies due to the moist weather or the rain of the water or the moist living room; interior dampness is a pathological product, often associated with digestive functions. The traditional Chinese medicine considers that the spleen has the function of transporting and transforming water dampness, and if people suffer from deficiency and dyspepsia or have overeating, the spleen can not transport and transform normally to cause water dampness to stop; people with spleen deficiency are easy to invade by external dampness, and the external dampness also often blocks spleen and stomach to enable dampness to grow from the interior, so that the spleen and the stomach are independent and related. The term "heat" is a thermal image. The heat in damp-heat is present simultaneously with damp, or the damp and heat invade the human body due to the damp weight in the summer and autumn, or the heat is transformed due to the long-term retention of the damp, or the damp is transformed from yang to heat due to the constitution of yang, so it is common that the damp and the heat exist simultaneously.

The Chinese medicine physique acupoint application is one of the external treatment methods of grinding Chinese medicine into powder, making into ointment and applying onto body surface acupoint. The traditional Chinese medicine physique acupoint plaster therapy is based on the guidance of traditional Chinese medicine theory, according to the principle of external treatment of internal diseases, traditional Chinese medicines with corresponding physique types are used, medicines with pungent and warm, channeling and channel dredging are adhered to relevant acupoints, so that the medicines enter the acupoints and channels through skin striae and skin, and the effects of channel qi and blood circulation of the medicines are exerted, so that the effects of channel tropism and functions of the medicines are exerted, and the medicines directly reach relevant viscera, and aim at adjusting the physique of a human body and enhancing the disease resistance. The method uses the traditional Chinese medicine with smell and thickness to be combined with the meridian points on the body surface for administration, and exerts the curative effect through percutaneous permeation and absorption of the medicine and specific treatment of the acupoints. Namely, the medicine is absorbed through skin and mucous membrane, and a part of the medicine directly acts on the body surface acupoints to stimulate the acupoints and channels; the other part is absorbed into the whole blood circulation to reach the effective blood concentration to play a role.

The Chinese patent document CN111450205A discloses a traditional Chinese medicine composition for regulating and treating damp-heat constitution, a preparation and application thereof, wherein the active components of the traditional Chinese medicine composition comprise the following raw material medicines in parts by weight: 150-450 parts of astragalus membranaceus, 100-300 parts of bighead atractylodes rhizome, 80-120 parts of rhizoma atractylodis, 50-150 parts of radix pseudostellariae, 70-230 parts of Chinese yam, 80-130 parts of lotus seed, 80-120 parts of white hyacinth bean, 50-150 parts of poria cocos, 80-30 parts of agastache rugosus, 80-120 parts of eupatorium, 250-350 parts of coix seed, 150-450 parts of dandelion, 70-120 parts of hawthorn, 80-130 parts of semen cassiae, 70-130 parts of lotus leaf, 80-120 parts of dried orange peel, 80-120 parts of honeysuckle, 80-120 parts of rice sprout, 150-250 parts of fructus aurantii, 70-130 parts of platycodon grandiflorum, 40-80 parts of liquorice, 80-120 parts of endothelium corneum gigeriae galli, 80-120 parts of sophora japonica, 100-300 parts of magnolia officinalis flowers, 50-150 parts of white paeony root, 25-40 parts of coptis chinensis and 80-120 parts of poria cocos. The medicines have the effects of resolving dampness and clearing heat, have obvious curative effect on damp-heat constitution, recover and keep relatively healthy peace and quality for a long time. Chinese patent document CN104524110A discloses a traditional Chinese medicine composition with the effects of strengthening spleen and eliminating dampness. The Chinese medicinal composition comprises Coicis semen, semen Phaseoli, semen euryales, rhizoma Dioscoreae and semen Armeniacae amarum, and optionally herba Agastaches and flos Lonicerae. The clinical observation shows that the traditional Chinese medicine composition has the effects of regulating and nourishing spleen and stomach, eliminating dampness and clearing heat, and can regulate the constitution of damp-heat, and has obvious effects of strengthening spleen and eliminating dampness. The composition disclosed by the invention is convenient to take, meets the requirements of modern fast-paced life, is safe and effective, and has no toxic or side effect. However, the traditional Chinese medicine composition for improving damp-heat constitution and the preparation method and application thereof are not reported at present.

Qi stagnation constitution (Qi depression constitution) is a constitution state mainly represented by unstable internal constitution, depression and weakness, and sensitivity due to long-term emotional disorder and qi stagnation. The patients in the physical condition are mostly seen in the middle-aged and young, and women are mostly seen with the symptoms of frequent and isolated interior, easy and good feeling and narrow air quantity. The pathogenesis of qi stagnation is mainly liver, and also heart, stomach, large intestine and small intestine. Yi Shangqing and diet are prone to qi stagnation, such as depression, insomnia, globus hystericus, panic, etc., and modern researches on such constitutions are prone to tumor. For conditioning, it should be used to regulate emotion and dredge qi movement.

Polycystic ovary syndrome (PCOS) is a complex disorder of endocrine and metabolic abnormalities common to women of childbearing age, characterized by chronic anovulation (anovulation dysfunction or loss) and hyperandrogenism (excessive production of male hormone in women), and is characterized by irregular menstrual cycles, infertility, hirsutism and/or acne, the most common female endocrine disorder.

Chinese patent document CN111249420A discloses a traditional Chinese medicine composition for regulating and treating qi depression constitution, and a preparation and application thereof. The active components of the traditional Chinese medicine composition comprise the following raw material medicines in parts by weight: 150-450 parts of wheat, 40-80 parts of liquorice, 80-120 parts of Chinese date, 80-120 parts of bupleurum, 120-180 parts of fructus aurantii, 40-80 parts of dried orange peel, 40-80 parts of green tangerine peel, 120-180 parts of nutgrass galingale rhizome, 80-120 parts of rose, 80-120 parts of green calyx plum, 80-120 parts of flos albiziae, 70-230 parts of wild jujube seed, 20-40 parts of fructus amomi, 50-150 parts of white peony root, 80-120 parts of lotus seed, 80-120 parts of bighead atractylodes rhizome, 80-120 parts of hawthorn fruit, 80-120 parts of citron, 80-120 parts of weeping forsythia, 80-120 parts of lily, 80-120 parts of platycodon root, 80-120 parts of szechuan lovage rhizome, 80-120 parts of Chinese angelica, 80-120 parts of rice sprout, 80-120 parts of poria cocos, 80-120 parts of tremella, 50-150 parts of bamboo shavings and 80-120 parts of poria with hostwood. The medicines together play the roles of promoting qi circulation and resolving stagnation, and effectively regulate and treat qi stagnation constitution. Chinese patent document CN110038066A discloses a Chinese medicinal composition for treating chronic fatigue syndrome and a preparation method thereof. The preparation is prepared from the following raw materials in parts by weight: 15-25 parts of astragalus membranaceus, 10-20 parts of codonopsis pilosula, 10-20 parts of bighead atractylodes rhizome, 6-15 parts of medlar and 6-15 parts of honey-fried licorice root. The traditional Chinese medicine composition can effectively improve chronic fatigue syndrome and qi deficiency constitution, and can be used for preparing medicines for treating chronic fatigue syndrome or qi stagnation constitution. However, the traditional Chinese medicine composition for improving qi stagnation constitution and the preparation method and application thereof are not reported at present.

Qi deficiency constitution (qi deficiency constitution) refers to the symptoms of Qi deficiency, such as low voice, emaciation or obesity, pale complexion, shortness of breath, no speaking, listlessness, debilitation, spontaneous perspiration, pale tongue with red color, tooth trace on the tongue, white coating, weak pulse, and attack due to various causes, different symptoms and attack tendency due to different Qi deficiency parts of heart, lung, spleen and kidney: is prone to common cold, qi deficiency and dizziness, viscera drooping, weak resistance, postpartum deficiency and disease of eyes, etc., and is slow to recover after childbirth. For the treatment of general principles of qi-tonifying and qi-nourishing, they should be used in combination with qi-tonifying herbs for viscera based on syndrome differentiation. According to the theory of homology of qi and blood, add blood-replenishing herbs.

The Chinese medicine physique acupoint plaster is one external treatment method of grinding Chinese medicine into powder, and applying the powder to body surface acupoint. The traditional Chinese medicine physique acupoint plaster therapy is to apply the traditional Chinese medicine with pungent and warm, fleeing and channel-dredging medicines to relevant acupoints according to the principle of external treatment of internal diseases, so that the medicine enters acupoints and collaterals through skin striae and skin, plays the effect of channel-dredging and functional functions of the medicine, reaches relevant viscera, and aims at regulating the physique of the organism and enhancing the disease resistance.

The Chinese patent document CN107261101A discloses a traditional Chinese medicine oil emulsion for massage of qi deficiency physique, which comprises the following components in parts by weight: 12-20 parts of 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 dangshen, 5-15 parts of radix pseudostellariae, 3-15 parts of astragalus, 3-15 parts of bighead atractylodes rhizome, 2-8 parts of liquorice, 5-10 parts of red date, 5-12 parts of acanthopanax, 2-12 parts of gynostemma pentaphylla, 5-15 parts of rhodiola rosea, 5-15 parts of poria cocos and 5-15 parts of maltose. The invention takes natural Chinese herbal medicines as main raw materials, has obvious effects of tonifying qi and strengthening body through scientific and reasonable proportioning, and is especially obvious for people with qi deficiency constitution. The Chinese patent document CN103768556A discloses a traditional Chinese medicine composition for regulating and treating qi deficiency constitution, which comprises the following components in parts by mass: 150-300 parts of astragalus membranaceus, 60-120 parts of sun-dried ginseng, 60-120 parts of American ginseng, 150-200 parts of stir-fried bighead atractylodes rhizome, 150-300 parts of poria cocos, 150-300 parts of Chinese yam, 120-200 parts of stir-fried white paeony root, 120-150 parts of stir-fried Chinese angelica, 90-120 parts of dried orange peel, 90-120 parts of roasted cassia twig, 90-120 parts of dwarf lilyturf tuber, 90-120 parts of shizandra berry, 90-120 parts of divaricate saposhnikovia root, 90-120 parts of radix bupleuri, 60-90 parts of rhizoma cimicifugae, 5-15 parts of dried ginger, 300-500 parts of stir-fried coix seed, 150-300 parts of jujube, 60-90 parts of roasted liquorice, 100-120 parts of stir-fried rice sprout, 100-120 parts of stir-fried malt, 250-300 parts of donkey-hide gelatin, 150-200 parts of tortoise plastron glue and 100-150 parts of deer horn glue. The invention has reasonable formula, has the effects of tonifying middle-jiao and Qi, strengthening spleen and lung, promoting digestion and harmonizing stomach, tonifying kidney and cultivating primordial qi, can effectively improve and even change the constitution of qi deficiency, has high content of effective medicinal components, no obvious toxic or side effect, mild and stable and durable action, is convenient to take, and is easy to store and carry. However, the traditional Chinese medicine composition for improving qi deficiency constitution and the preparation method and application thereof are not reported at present.

Disclosure of Invention

Traditional Chinese medicine composition for improving damp-heat constitution and preparation method and application thereof

The invention aims at overcoming the defects in the prior art and provides a traditional Chinese medicine composition for improving damp-heat constitution.

Still another object of the present invention is to provide a method for preparing the Chinese medicinal composition.

Another object of the present invention is to provide the use of the said Chinese medicinal 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 rhizoma atractylodis, 10-20 parts of radix achyranthis bidentatae, 10-20 parts of semen coicis, 10-20 parts of magnolia officinalis, 10-20 parts of pelargonium, and 10-20 parts of bile-producing star.

Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 13-18 parts of rhizoma atractylodis, 13-18 parts of radix achyranthis bidentatae, 13-18 parts of coix seed, 13-18 parts of magnolia officinalis, 13-18 parts of pelargonium, and 13-18 parts of bile-producing star.

More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of semen coicis, 15 parts of magnolia officinalis, 15 parts of pelargonium, and 15 parts of bile-producing star.

In order to achieve the second purpose, the invention adopts the following technical scheme:

the preparation method of the traditional Chinese medicine composition as claimed in any one of the above, comprising the following steps: weighing rhizoma Atractylodis, radix Achyranthis bidentatae, semen Coicis, cortex Magnoliae officinalis, and semen Pelargonii Graveolentis, and making bile star=1:1:1:1:1, pulverizing into powder, and mixing.

In order to achieve the third object, the present invention adopts the following technical scheme:

the application of the traditional Chinese medicine composition in preparing medicines for improving damp-heat constitution.

Preferably, the pharmaceutical dosage form is an external preparation.

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

An acupoint application for improving damp-heat constitution is prepared by mixing the above Chinese medicinal composition with transdermal agent.

Preferably, the transdermal agent is made from a thermoflux matrix and azone in a ratio of 1000:10.

The invention has the advantages that:

1. the Chinese medicinal composition has the advantages that the selected medicaments are warm in nature, pungent and bitter in taste, and enter spleen, stomach and liver channels, so that the Chinese medicinal composition has the effects of drying dampness and strengthening spleen; the magnolia officinalis is warm in nature, bitter and pungent in taste, enters spleen, stomach, lung and large intestine channels, and has the effects of eliminating dampness and resolving phlegm; the coix seed is cool in nature, sweet and light in taste, enters spleen, stomach and lung channels, and has the effects of promoting diuresis, penetrating moisture, strengthening spleen and stopping diarrhea; the radix achyranthis bidentatae has slightly warm nature, flat nature, bitter, sweet and sour taste, enters liver and kidney meridians, and has the efficacy of guiding heat downwards; the pelargonium is flat in nature, sour and sweet in taste, enters lung meridian, and has the effects of dispelling wind, removing dampness and detoxifying; the arisaema tuber has warm nature, bitter and pungent taste, enters lung and liver channels, and has the effects of eliminating dampness and resolving phlegm; all the medicines are combined together, and ginger juice is added to guide the medicines to enter meridians, so that the effects of strengthening spleen, eliminating dampness and guiding heat downwards are achieved.

2. The acupoint application of the traditional Chinese medicine composition mainly comprises Yangling spring, supporting ditches and trowelling. The Ququan has the effects of clearing damp-heat, and regulating the lower energizer. The branch channel belongs to the triple energizer meridian of hand shaoyang, the yanglingquan belongs to the gallbladder meridian of foot shaoyang, and the yanglingquan and the branch channel purgation can clear heat and resolve dampness. The combination of the acupoints has the effects of clearing heat and eliminating dampness, soothing liver and promoting bile flow, thereby improving the constitution state of the damp-heat constitution with the proper constitution.

3. According to the principle of external treatment of internal diseases, the traditional Chinese medicine composition acupoint application of the invention utilizes traditional Chinese medicines of corresponding physique types, and is matched with medicines for pungent and warm, channeling and dredging channels to be applied to relevant acupoints, so that the medicines enter acupoints and channels through skin striae, and the functions of channels and collaterals and qi and blood are utilized to exert the effects of channel returning and functions of the medicines, and the medicines directly reach relevant viscera, thereby being capable of adjusting physique of organisms and enhancing disease resistance.

Traditional Chinese medicine composition for improving qi stagnation constitution and preparation method and application thereof

The invention aims at overcoming the defects in the prior art and provides a traditional Chinese medicine composition for improving qi stagnation constitution.

In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:

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 radix bupleuri, 10-20 parts of nutgrass galingale rhizome, 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 prepared from the following raw materials in parts by weight: 12-18 parts of bupleurum, 12-18 parts of nutgrass galingale rhizome, 12-18 parts of bitter orange, 6-9 parts of liquorice, 6-9 parts of rose and 6-9 parts of green calyx plum.

More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of bupleurum, 15 parts of nutgrass galingale rhizome, 15 parts of bitter orange, 7.5 parts of liquorice, 7.5 parts of rose, and 7.5 parts of green calyx plum.

the preparation method of the traditional Chinese medicine composition as claimed in any one of the above, comprising the following steps: weighing bupleurum, nutgrass galingale rhizome, bitter orange, liquorice, rose flower and green calyx plum=1:1:1:0.5:0.5:0.5 according to the proportion, crushing the mixture into powder, and uniformly mixing the powder.

the application of the traditional Chinese medicine composition in preparing the medicine for improving qi stagnation constitution.

Preferably, the pharmaceutical dosage form is an external preparation.

An acupoint application for improving qi stagnation constitution is prepared by mixing the above Chinese medicinal composition with transdermal agent.

The invention has the advantages that:

1. the Chinese medicinal composition has the effects of soothing liver and relieving depression, and has the advantages of being slightly cold in nature, bitter in taste, and capable of returning liver, gall and lung channels; the nutgrass galingale rhizome has flat property, is pungent, slightly bitter and slightly sweet, has liver, spleen and triple warmer channels, and can sooth liver, relieve depression and regulate qi to relieve the middle warmer; bitter orange is bitter and slightly sour in taste, slightly cold in nature, enters spleen, stomach and liver channels, and has the effects of regulating qi, relieving middle-jiao, promoting the circulation of qi and relieving distention; the rose flower has sweet and slightly bitter taste, warm nature, and liver and spleen meridian tropism, and has the effects of promoting qi and blood circulation, soothing liver and relieving pain; the calyx Mei Xingping is sour and astringent in taste, enters meridians of liver, stomach and lung, and has the effects of calming liver, harmonizing stomach and regulating qi movement; licorice root, radix Glycyrrhizae is neutral in nature and sweet in taste, enters heart, stomach, spleen and lung meridians and harmonizes the herbs. The pungent and warm ginger is used for harmonizing, and the medicines are combined to play the roles of promoting qi circulation and resolving depression.

2. The acupoint application of the traditional Chinese medicine composition mainly comprises the steps of Danzhong and Ganshu. Among the mutton smells, sea of qi, regulate qi and relieve chest stuffiness; ganshu is the acupoint on the back where liver meridian qi is infused, and it soothes liver and regulates qi. The combination of the two acupoints enhances the effects of qi and blood, thereby improving the physical condition of people with qi stagnation and poor physical condition.

Traditional Chinese medicine composition for improving qi deficiency constitution and preparation method and application thereof

The invention aims at overcoming the defects in the prior art and provides a traditional Chinese medicine composition for improving qi deficiency physique.

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 membranaceus, 10-20 parts of stir-fried bighead atractylodes rhizome, 10-20 parts of radix saposhnikoviae, 5-10 parts of dried orange peel, 10-20 parts of radix pseudostellariae and 1-2 parts of ginseng.

Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 12-18 parts of astragalus membranaceus, 12-18 parts of stir-fried bighead atractylodes rhizome, 12-18 parts of radix sileris, 6-9 parts of dried orange peel, 12-18 parts of radix pseudostellariae and 1.2-1.8 parts of ginseng.

More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of astragalus, 15 parts of stir-fried bighead atractylodes rhizome, 15 parts of divaricate saposhnikovia root, 7.5 parts of dried orange peel, 15 parts of radix pseudostellariae and 1.5 parts of ginseng.

the preparation method of the traditional Chinese medicine composition as claimed in any one of the above, comprising the following steps: the preparation method comprises the steps of weighing astragalus membranaceus, stir-fried bighead atractylodes rhizome, saposhnikovia divaricata, dried orange peel and radix pseudostellariae in proportion, wherein ginseng=1:1:1:0.5:1:0.1, crushing into powder, uniformly mixing, and adding a proper amount of ginger juice to blend into paste.

the application of the traditional Chinese medicine composition in preparing the medicine for improving qi deficiency constitution.

Preferably, the pharmaceutical dosage form is an external preparation.

An acupoint application for improving qi deficiency constitution is prepared by mixing the above Chinese medicinal composition with transdermal agent.

The invention has the advantages that:

1. the selected medicines in the traditional Chinese medicine composition provided by the invention have sweet astragalus root taste and warm nature, enter lung and spleen channels, and have the effects of tonifying qi, consolidating exterior, promoting urination and expelling toxin; the bighead atractylodes rhizome is bitter and sweet in taste, warm in nature, enters spleen and stomach meridians, and has the effects of strengthening spleen and replenishing qi, drying dampness and promoting diuresis, and stopping sweat. Has effects of relieving exterior syndrome, dispelling pathogenic wind, eliminating dampness, and relieving spasm. Dried orange peel is bitter and pungent in flavor, warm in nature, enters meridians and spleen meridians, and has the effects of regulating qi, strengthening spleen, eliminating dampness, resolving phlegm and the like. Radix pseudostellariae is sweet in taste, slightly bitter, flat in nature, and enters spleen and lung channels, and has the effects of replenishing qi to invigorate the spleen, promoting fluid production, moistening lung and the like. Ginseng has sweet and slightly bitter taste, and has effects of invigorating primordial qi, restoring pulse, relieving depletion, invigorating spleen, benefiting lung, promoting fluid production, and tranquilizing mind. The whole formula has the effects of tonifying qi, nourishing primordial qi, tonifying spleen and lung and promoting qi circulation for stagnation.

2. The Chinese medicinal composition is applied to acupoints, wherein the selected acupoints are mainly qi sea, pishu and Zusanli, the Pishu is the acupoint infused on the back by meridian qi, the qi sea and Zusanli are all essential acupoints for invigorating qi and cultivating primordial energy, and the acupuncture pattern of the acupoints of copper people is carried in: the "qi-sea" refers to the sea where men are producing qi. This acupoint has the functions of invigorating primordial qi, invigorating kidney, stopping nocturnal emission, and invigorating yang. Cloud of Qianjin Fang: if you want to be safe, three will not be dry. The three acupoints are combined to strengthen the body and prolong life, so that the physique state of people with qi deficiency and biased physique is improved.

Detailed Description

Examples are as follows:

EXAMPLE 1 preparation of the Chinese medicinal composition of the invention (I)

Weighing 15 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and arisaema cum bile respectively according to the proportion of 1:1:1:1:1:1.

EXAMPLE 2 preparation of the Chinese medicinal composition of the invention (II)

Weighing 10 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and arisaema cum bile respectively according to the proportion of 1:1:1:1:1:1.

EXAMPLE 3 preparation of the Chinese medicinal composition of the present invention (III)

Weighing 20 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and arisaema cum bile respectively according to the proportion of 1:1:1:1:1:1.

EXAMPLE 4 preparation of the Chinese medicinal composition of the present Invention (IV)

11 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and arisaema cum bile are weighed according to the proportion of 1:1:1:1:1:1.

EXAMPLE 5 preparation of the Chinese medicinal composition of the present invention (five)

Weighing 12 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and bile-making star according to the proportion of 1:1:1:1:1:1.

EXAMPLE 6 preparation of the Chinese medicinal composition of the present invention (six)

13 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and arisaematis cum bile are weighed according to the proportion of 1:1:1:1:1:1.

EXAMPLE 7 preparation of the Chinese medicinal composition of the present invention (seven)

Weighing 14 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and arisaema cum bile respectively according to the proportion of 1:1:1:1:1:1.

EXAMPLE 8 preparation of the Chinese medicinal composition of the present invention (eight)

16 parts of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw bighead atractylodes rhizome, rhizoma atractylodis and poria cocos are weighed according to the proportion of 1:1:1:1:1:1.

EXAMPLE 9 preparation of the Chinese medicinal composition of the present invention (nine)

Weighing 17 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and arisaema cum bile respectively according to the proportion of 1:1:1:1:1:1.

EXAMPLE 10 preparation of the Chinese medicinal composition of the present invention (ten)

Weighing 18 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and arisaema cum bile respectively according to the proportion of 1:1:1:1:1:1.

EXAMPLE 11 preparation of the acupoint application of the Chinese medicinal composition of the present invention

(1) The weight portion of each raw material medicine in any one of the embodiments 1-10 is weighed, smashed into powder, and then mixed with a proper amount of ginger juice and hot melt adhesive matrix to be blended into paste, wherein the ratio of the traditional Chinese medicine powder to the hot melt adhesive matrix is generally 1:3.

(2) Preparing the mixture into fluid extract, extracting with proper solvent (20% -25% ethanol in water), and evaporating part of the solvent to adjust the concentration to 1g of medicinal material per 1 ml.

(3) Heating medical pressure-sensitive thermosol 1kg in a pot to about 80deg.C for melting, cooling to about 60-70deg.C, slowly adding the medicinal powder, stirring, adding fluid extract and azone (matrix and azone in a ratio of about 1000:10) at about 40deg.C, stirring, and making into medicinal cake with diameter of 4-5cm and thickness of about 2-3 mm.

EXAMPLE 12 preparation of the Chinese medicinal composition Patch of the invention

(1) Weighing the raw materials according to the weight ratio of any one of the embodiments 1-10, adding 8-10 times of water, decocting twice for 60 minutes each time, filtering while the raw materials are hot, and combining the two decoction liquid medicines for standby;

(2) Concentrating the above medicinal liquid under vacuum, removing water solution, and vacuum drying the obtained extract;

(3) Weighing 2g of the extract, adding 2-6ml of medicinal glycerol, blending into paste, uniformly spreading on square medical adhesive plaster with fixed size, and fixing the adhesive plaster with certain size left at the peripheral edge.

EXAMPLE 13 preparation of the Chinese medicinal composition ointment of the invention

(2) Concentrating the above medicinal liquid under reduced pressure to obtain concentrated solution;

(3) Adding Cera flava and yellow vaseline into the concentrated solution, decocting with slow fire, stirring, and cooling to obtain paste.

EXAMPLE 14 preparation of the gel of the Chinese medicinal composition of the present invention

(3) Adding carbomer into glycerol, grinding to moisten, adding a small amount of distilled water, grinding, transferring to a measuring cup, dissolving triethanolamine, ethylparaben, and distilled water, stirring to gel, and adding distilled water; adding the concentrated solution, and grinding uniformly.

EXAMPLE 15 preparation of the Chinese medicinal composition cataplasm of the invention

(3) Adding conventional cataplasm matrix such as sorbitol and glycerol into the concentrated solution, stirring, coating on support layer, and adding protective layer.

EXAMPLE 16 clinical experiment of acupoint application of the Chinese medicinal composition of the present invention

1 subject of study

1.1 sample Source

The experimental samples are from 30 cases of patients with gouty arthritis who meet the inclusion standard in the clinic and hospitalization department of the traditional Chinese medicine wet-heat constitution of the Shanghai university affiliated dado hospital, and are randomly divided into 15 cases of patients in an intervention group and a control group, wherein the patients are treated in the period from 6 months in 2020 to 3 months in 2021.

1.2 diagnostic criteria

1.2.1 diagnosis Standard of damp-heat constitution in traditional Chinese medicine

According to the conversion and separation results of the integral scale of Chinese medicine constitution classification and determination published by Chinese medicine publishing company of 4 months and 9 days in 2009, and combining with the judgment of doctors, the constitution of the subject is judged to be damp-heat constitution.

Determination questionnaire for damp-heat constitution: (1) do you feel greasy or shiny on the face or nose? (2) Do you easily get acne or sore furuncle? (3) Do you feel bitter in mouth or have an off-flavor in the mouth? (4) Is you uncomfortable with stool and feeling of endless stool? (5) Do you feel fever and dark urine in the urinary tract? (6) Do you yellow with leucorrhea (yellow with white color? (limit female response) (7) do you scrotum site wet? (Limited Male answer)

The criteria are as follows:

table 1 Chinese medicine physique judging standard table

Note that: 1. the scoring method comprises the following steps: each entry counts 1, 2, 3, 4, 5 in turn according to "none", "few", "sometimes", "often" always ", respectively. 2. Conversion score = (total score of each entry-number of entries)/(number of entries×4) ×100; in the range of 0-100 minutes.

In the experiment, the constitution of damp-heat is determined as constitution of damp-heat by converting the constitution into 40 or more.

1.2.2 criteria for diagnosis of gouty arthritis disease

The diagnosis of the traditional Chinese medicine accords with the regulation of gout (arthralgia syndrome) of the traditional Chinese medicine disease diagnosis curative effect standard; western diagnosis accords with the regulation of gout and gouty arthritis of 'primary gout diagnosis and treatment guide'.

1.3 inclusion criteria

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

2. patients with other diseases, but without special treatment during treatment and without affecting the clinical pathway procedure implementation of the first diagnosis, may enter the pathway;

3. no glucocorticoid, colchicine or non-steroidal anti-inflammatory analgesic drugs are used for treatment within 4 weeks before the visit; informed consent was signed before group entry.

1.4 exclusion criteria

1. Patients with diseases possibly causing arthropathy, such as rheumatic arthritis, systemic lupus erythematosus, suppurative arthritis, etc.;

2. combining serious primary diseases such as cardiovascular and cerebrovascular systems, liver and kidney systems, hematopoietic systems and the like;

3. poor treatment compliance.

1.5 drop criteria

1. The illness state is aggravated during the treatment period, special treatment is needed, and the treatment time is prolonged, and the cost is increased;

2. serious complications occur and exit the path;

3. other diseases appear during the treatment period and need to be treated, and the route is exited;

4. The execution of the present route is affected by the intention of the patient and the family members thereof, and the present route is exited.

2 study method

2.1 grouping scheme

The experimental grouping scheme groups according to a random number method. The specific operation is as follows: random numbers were established by means of EXCEL software "=rand ()", the resulting data were arranged from small to large, the first 15 being control groups and the last 15 being treatment groups for a total of 30 patients.

2.2 treatment regimen

The control group treatment scheme is to use etoricoxib tablets, and the dosage of the etoricoxib tablets is 120mg each time, and the dosage is divided into 2 treatment courses for 1 time every day for 60 days.

The treatment scheme of the treatment group is that the traditional Chinese medicine composition is applied to the acupuncture points on the basis of the treatment of the control group, and the treatment scheme is divided into 2 treatment courses for 60 days.

The traditional Chinese medicine composition is applied to acupuncture points: the Chinese medicine is independently developed by combining the characteristics of meridians, acupoints and medicines aiming at the characteristics of damp-heat physique by the center of a disease treatment center of an attached dawn hospital of Shanghai traditional Chinese medicine university. The main components of the composition are as follows: rhizoma Atractylodis, achyranthis radix, coicis semen, cortex Magnolia officinalis, fructus Pelargonii Graveolentis, and rhizoma arisaematis cum bile. (ratio: 1:1:1:1:1:1), manufactured uniformly by Shandong, and Taurus pharmaceutical Co., ltd, according to the manufacturing flow standard (production lot number: 20191002), in a specification of 4 cm. Times.4 cm/tablet, about 0.5 g per tablet (drug core).

The manufacturing process comprises the following steps: (1) the traditional Chinese medicine granules are mixed according to the proportion of 1:1:1:1:1:1 and smashed into powder, and then the hot melt adhesive matrix is mixed, wherein the proportion of the traditional Chinese medicine powder to the hot melt adhesive matrix is generally 1:3. (2) Preparing the mixture into fluid extract, extracting with proper solvent (20% -25% ethanol in water), and evaporating part of the solvent to adjust the concentration to 1g of medicinal material per 1 ml. (3) Heating medical pressure-sensitive thermosol 1kg in a pot to about 80deg.C for melting, cooling to about 60-70deg.C, slowly adding the medicinal powder, stirring, adding fluid extract and azone (matrix and azone in a ratio of about 1000:10) at about 40deg.C, stirring, and spreading.

The using method comprises the following steps: after the patient is instructed to bath or scrub the limbs, the skin is kept warm, and the traditional Chinese medicine composition is applied to the Yanglingquan and the Zhuangou of the human body by the acupoints for 4-8 hours each time and three times each week.

2.3 scoring of physique in TCM

The change of the constitution transformation of each group of two groups of intervention subjects before and after intervention is compared and observed, wherein the constitution transformation of the traditional Chinese medicine qi deficiency is divided into main curative effect indexes.

2.4 adverse reaction recording

Observing whether adverse events or adverse reactions (such as skin itching, skin redness, swelling, pain, skin crumbling and the like) of the applied medicine occur during the acupoint application of the traditional Chinese medicine composition, and if the adverse events occur, recording the occurrence time and the treatment measures in time.

2.5 clinical intervention efficacy decision criterion

2.5.1 Chinese medicine clinical intervention curative effect criterion

The traditional Chinese medicine clinical intervention curative effect judgment is judged according to the traditional Chinese medicine damp-heat constitution transformation score, and the standard is judged by using symptom integral change according to the relevant standard of the traditional Chinese medicine disease diagnosis curative effect standard issued by the national drug administration in 2017.

Efficacy index (n) =symptom score difference before and after treatment/symptom score before treatment x 100%.

(1) Clinical recovery: the clinical symptoms and signs disappear or disappear basically, and the integral of symptoms is reduced by more than or equal to 95 percent.

(2) The effect is shown: the clinical symptoms and signs disappear or disappear basically, and the integral of symptoms is reduced by more than or equal to 70 percent.

(3) The method is effective: the clinical symptoms and signs disappear or disappear basically, and the integral of symptoms is reduced by more than or equal to 30 percent but less than 70 percent.

(4) Invalidation: the clinical symptoms and signs are not obviously improved or even aggravated, and the integral of symptoms is reduced by less than 30 percent.

2.5.2 therapeutic efficacy criterion for gouty arthritis

Evaluation criterion (one)

(1) The effect is shown: the clinical symptoms and positive signs completely or basically disappear, the joint functions are recovered to be normal, and indexes such as SUA and the like are recovered to be in a normal range.

(2) Improvement: the clinical symptoms and positive signs are partially disappeared, the joint function is recovered to a certain extent, and indexes such as joint function, SUA and the like are improved.

(3) Invalidation: the clinical symptoms and physical signs are not obviously relieved, and the indexes of joint function, SUA and the like are not obviously improved, even aggravated.

2.5.3 observations index

The clinical efficacy of the two groups of patients before and after treatment was compared, the wet heat constitution transformation score and the blood Uric Acid (UA), erythrocyte Sedimentation Rate (ESR), C-reactive protein (CRP) levels of the traditional Chinese medicine before and after treatment. Laboratory index checks serum from gout patients was withdrawn 7d before and after dosing, each 1 time UA, ESR, CRP.

3. Results

3.1 transformation score of constitutions

Table 2 the conversion rate of damp-heat constitution in traditional Chinese medicine before and after treatment of two groups of patients

Note that: p < 0.05 compared to pre-treatment; compared with the control group, the ratio of P < 0.05.

3.2 comparing the clinical curative effects of the two groups, the total effective rate of the observed group is obviously higher than that of the control group (P is less than 0.05).

Table 3 comparison of two clinical efficacy (n)

Group of	Example number (N)	Has obvious effect	Improvement of	Invalidation of	Total availability (%)
						Control group	15	5	7	3	12(80)
Treatment group	15	7	8	0	15(100) ^△

Note that: in comparison with the control group, ^△ P<0.05

3.3 the ESR, CRP, SUA level was significantly reduced (P < 0.05) after both treatment groups, and the observed group was significantly reduced (P < 0.05).

Table 4 comparison of two sets of observations

3.4 results of the study on safety indicators

The patients have no adverse reaction (such as skin itching, skin redness, swelling, pain, skin ulcer, etc.) of the applied medicine during the treatment period.

Discussion 4

4.1 concept and clinical characteristics of damp-heat constitutions

The damp-heat constitution is a constitution state formed by fumigating and steaming smoking and drinking, staying up all night, improper nourishing, liver depression and qi stagnation, relatively unsmooth liver and gall functions caused by environmental factors, liver and gall depression and heat transformation, spleen and stomach accumulation and dampness transformation and damp-heat transformation.

The constitution of damp-heat is manifested as greasy dirt, easy acne, bitter taste, dry mouth, heavy body, drowsiness, difficult stool, dry knot, short and yellow urine, easy scrotum dampness in men, frequent female leukorrhagia, reddened tongue, yellow and greasy coating, and slippery and rapid pulse. Is susceptible to sore, furuncle, jaundice, stranguria due to heat, constipation, cholecystitis, canker sore, etc. The method is difficult to adapt to humid and hot climates in late summer and early autumn and environments with high wet weight or air temperature.

4.2 analysis of the composition of the acupoint application of the Chinese medicinal composition of the invention

The traditional Chinese medicine composition acupoint application is independently developed by Zhang Xiaotian teaching aiming at the characteristics of damp-heat physique and combining the characteristics of meridians, acupoints and medicines. The main components of the medicine are rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, magnolia officinalis, pelargonium, and bile-producing star. (ratio: 1:1:1:1:1:1), the whole formula has the effects of strengthening spleen, eliminating dampness and guiding heat downwards.

Rhizoma atractylodis: warm in nature, pungent and bitter in taste, enters spleen, stomach and liver channels, and has the effects of drying dampness and strengthening spleen;

Cortex Magnoliae officinalis: warm nature, bitter and pungent taste, spleen, stomach, lung and large intestine channels, and has the effects of eliminating dampness and resolving phlegm;

semen Coicis: cool, sweet and light in taste, and has the effects of invigorating spleen, stomach and lung meridian, promoting diuresis, penetrating moisture, strengthening spleen and relieving diarrhea;

achyranthes bidentata: slightly warm nature, mild nature, bitter, sweet and sour taste, and has the efficacy of guiding heat downwards after entering liver and kidney meridians;

and (3) the common stonecrop herb: neutral nature, sour and sweet taste, and lung meridian tropism, and has the effects of dispelling wind, removing dampness and detoxifying;

making arisaema tuber: warm nature, bitter and pungent taste, and has the effects of eliminating dampness and resolving phlegm, and can enter lung and liver channels;

4.3 Point selection analysis

The selected acupoints are mainly composed of Ququan, zhuan and Yangling quan, and Ququan has the effects of clearing damp-heat and regulating the lower energizer. The branch channel belongs to the triple energizer meridian of hand shaoyang, the yanglingquan belongs to the gallbladder meridian of foot shaoyang, and the yanglingquan and the branch channel purgation can clear heat and resolve dampness. The combination of the acupoints has the effects of clearing heat and eliminating dampness, soothing liver and promoting bile flow, thereby improving the constitution state of the damp-heat constitution with the proper constitution.

EXAMPLE 17 animal experiments

1. Materials and methods

1.1 Experimental materials

1.1.1 laboratory animals

SPF-class Sprague-Dawley (SD) male mice 40, with a mass (200+ -20) g, supplied by Shanghai Lai laboratory animal Co., ltd, were kept at a constant temperature (22+ -1) C and a 12:12 fixed lighting rhythm, and were free to ingest food and water.

1.1.2 experimental drugs the group of the invention: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of coix seed, 15 parts of magnolia officinalis, 15 parts of pelargonium, 15 parts of bile-producing star and a control group 1: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of fried coix seed, 15 parts of fructus amomi, 15 parts of pelargonium, 15 parts of prepared bile star and 2 parts of control group: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of coix seed, 15 parts of fructus amomi, 15 parts of tabasheer and 15 parts of tabasheer, and 3 parts of a control group: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of stir-fried coix seed, 15 parts of magnolia officinalis, 15 parts of tabasheer and 15 parts of tabasheer

1.2 Experimental methods

1.2.1 experimental group: the 40 mice were divided into groups according to the random number table method: the invention group, the control group 1, the control group 2 and the control group 3, and each group comprises 10.

1.2.2 manufacturing of a mouse model with damp-heat constitution: the feeding conditions were that the mice of the present invention, control group 1, control group 2, control group 3 were given a fat diet (5% lard, 3% egg yolk, 5% honey blended into normal feed) and were given an E.coli endotoxin (2. Mu.g/kg) by tail intravenous injection 2 times per week for 6 consecutive weeks to establish a wet thermal mass rat model. After 6 weeks of adaptive feeding, the animals were used for experiments.

With the experiment, the rats in each group have symptoms of dysphoria, continuous scratching of the head and face, rapid breathing, static and restless, severe neck stretching, chest shrinking and the like, and have symptoms of sticky stool or loose stool with foul smell, red and swollen anus with less movement, less food intake and less drinking. The damp-heat model established by the experiment accords with the expression characteristics of the syndrome expressed by four diagnostic information of comprehensive traditional Chinese medicine, is close to the characteristics of integrity, characterization and the like of the damp-heat syndrome of human body, prompts successful modeling of the damp-heat syndrome, and shows successful modeling.

1.2.3 methods of administration:

the present invention group, the application control group 1, the application control group 2, and the application control group 3:

the group of the invention is applied: the back of the mice was treated with 8% Na ₂ S dehairing, wherein the area is about 4cm multiplied by 4cm, using 75% alcoholAfter local disinfection, the groups (15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of coix seeds, 15 parts of magnolia officinalis, 15 parts of pelargonium, 15 parts of bile-producing star) applied with the invention are stuck and fixed on dehairing parts (Danzhong and Ganshu). Then lightly pressing for 2 times, and winding the chest and back with adhesive tape for fixation. (about 0.5 g of each tablet (drug core)) is applied for 8 hours, and then taken out, and applied for 20 times daily, 1 time.

Pasting a control group 1: the back of the mice was treated with 8% Na ₂ S dehairing, wherein the area is about 4cm multiplied by 4cm, and after local disinfection by 75% alcohol, the patch control group 1 (15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of stir-fried coix seed, 15 parts of fructus amomi, 15 parts of pelargonium, 15 parts of bile-producing star) is stuck and fixed at dehairing positions (Danzhong and Ganshu). Then lightly pressing for 2 times, and winding the chest and back with adhesive tape for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8 hours, and then taken out, and applied for 20 times a day, 1 time a day.

Pasting a control group 2: the back of the mice was treated with 8% Na ₂ S dehairing, wherein the area is about 4cm multiplied by 4cm, and after local disinfection by 75% alcohol, the patch control group 2 (15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of semen coicis, 15 parts of fructus amomi, 15 parts of pelargonium graveolens and 15 parts of tabasheer) is stuck and fixed on dehairing places (Danzhong and Ganshu). Then lightly pressing for 2 times, and winding the chest and back with adhesive tape for fixation. (about 0.1 g of each tablet (drug core)) is applied for 8 hours, and then taken out, and applied for 20 times daily, 1 time.

Pasting a control group 3: the back of the mice was treated with 8% Na ₂ S dehairing, namely, after the dehairing area is about 4cm multiplied by 4cm, local disinfection is carried out by 75% alcohol, the pasting control group 3 (15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of fried coix seed, 15 parts of magnolia officinalis, 15 parts of pelargonium, 15 parts of tabasheer) is pasted and fixed at dehairing positions (Danzhong and Ganshu). Then lightly pressing for 2 times, and winding the chest and back with adhesive tape for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8 hours, and then taken out, and applied for 20 times a day, 1 time a day. Spironolactone 7mg/kg, was continuously lavaged for 30 days.

1.2.4 observing and detecting index

Weight change and blood lipid change of mice before and after intervention.

1.2.5 statistical treatments

Single-factor analysis of variance was performed using SPSS10.0 software.

2. Results

TABLE 5 influence of different patches on mouse body weight (x.+ -. S, g)

Group of	Example number (n)	Before treatment	After treatment	F	P
						The 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, shi 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 the control group 1, ^** p<0.01 compared to control group 2. In comparison with the control group 3, ^* p<0.01。

TABLE 6 influence of different patches on blood lipid of mice (x+ -s, mmol/L)

Group of	Example number (n)	CHOL	HDL-C	LDL-C
					The 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 the control group 1, ^** p<0.01 compared to control group 2. In comparison with the control group 3, ^* p<0.01.

discussion of the invention

The invention selects an environment, diet, inducement and biological infective factor model for duplicating damp-heat syndrome type, and observes the improvement effect on the damp-heat constitution of mice. After the mice are fed with the high-fat feed for 6 weeks, the contents of CHOL, LDL-C and HDL-C in the serum of each group of mice are detected after the experiment is finished, and the obvious increase of the levels of CHOL, LDL-C and HDL-C in the serum of the mice in the model group under the high-fat diet is found, so that the lipid metabolism disorder appears. Thus, it was verified that diet loss is one of the key factors responsible for damp-heat syndrome.

In the examples, the mice interfered with by the group of the present invention had a smaller degree of weight gain before and after intervention than the other groups, and were statistically different. Compared with the control groups 1, 2 and 3CHOL, the group-applied intervention mice have the advantages that the LDL-C level is obviously reduced, the HDL-C level is increased, and the method has statistical significance. The experimental result shows that: the damp-heat patch has a certain lipid regulating effect.

EXAMPLE 18 preparation of the Chinese medicinal composition of the present invention (I)

15 parts of bupleurum chinense, 15 parts of nutgrass galingale rhizome, 15 parts of bitter orange, 7.5 parts of liquorice, 7.5 parts of rose, and 7.5 parts of green calyx plum are weighed according to the proportion of 1:1:1:0.5:0.5:0.5.

EXAMPLE 19 preparation of the Chinese medicinal composition of the present invention (II)

Weighing 10 parts of bupleurum chinense, 10 parts of nutgrass galingale rhizome, 10 parts of bitter orange, 5 parts of liquorice, 5 parts of rose, and 5 parts of green calyx plum according to the proportion of 1:1:0.5:0.5:0.5.

EXAMPLE 20 preparation of the Chinese medicinal composition of the present invention (III)

Weighing 20 parts of bupleurum chinense, 20 parts of nutgrass galingale rhizome, 20 parts of bitter orange, 10 parts of liquorice, 10 parts of rose, and 10 parts of green calyx plum according to the proportion of 1:1:0.5:0.5:0.5.

EXAMPLE 21 preparation of the Chinese medicinal composition of the present Invention (IV)

Weighing 12 parts of bupleurum chinense, 12 parts of nutgrass galingale rhizome, 12 parts of bitter orange, 6 parts of liquorice, 6 parts of rose, and 6 parts of green calyx plum according to the proportion of 1:1:1:0.5:0.5:0.5.

EXAMPLE 22 preparation of the Chinese medicinal composition of the present invention (five)

18 parts of bupleurum chinense, 18 parts of nutgrass galingale rhizome, 18 parts of bitter orange, 9 parts of liquorice, 9 parts of rose, and 9 parts of green calyx plum are weighed according to the proportion of 1:1:1:0.5:0.5:0.5.

EXAMPLE 23 preparation of the Chinese medicinal composition of the present invention (six)

11 parts of bupleurum chinense, 11 parts of nutgrass galingale rhizome, 11 parts of bitter orange, 5.5 parts of liquorice, 5.5 parts of rose, and 5.5 parts of green calyx plum are weighed according to the proportion of 1:1:1:0.5:0.5:0.5.

EXAMPLE 24 preparation of the Chinese medicinal composition of the present invention (seven)

13 parts of bupleurum chinense, 13 parts of nutgrass galingale rhizome, 13 parts of bitter orange, 6.5 parts of liquorice, 6.5 parts of rose, and 6.5 parts of green calyx plum are weighed according to the proportion of 1:1:1:0.5:0.5:0.5.

EXAMPLE 25 preparation of the Chinese medicinal composition of the present invention (eight)

14 parts of bupleurum chinense, 14 parts of nutgrass galingale rhizome, 14 parts of bitter orange, 7 parts of liquorice, 7 parts of rose and 7 parts of green calyx plum are weighed according to the proportion of 1:1:1:0.5:0.5:0.5.

EXAMPLE 26 preparation of the Chinese medicinal composition of the present invention (nine)

16 parts of bupleurum, 16 parts of nutgrass galingale rhizome, 16 parts of bitter orange, 8 parts of liquorice, 8 parts of rose, and 8 parts of green calyx plum are weighed according to the proportion of 1:1:1:0.5:0.5:0.5.

EXAMPLE 27 preparation of the Chinese medicinal composition of the present invention (ten)

Weighing 17 parts of bupleurum chinense, 17 parts of nutgrass galingale rhizome, 17 parts of bitter orange, 8.5 parts of liquorice, 8.5 parts of rose, and 8.5 parts of green calyx plum according to the proportion of 1:1:1:0.5:0.5:0.5.

EXAMPLE 28 preparation of the acupoint application of the Chinese medicinal composition of the invention

(1) The weight portion of any one of the examples 18-27 is to weigh each raw material medicine, break into powder, mix with a proper amount of ginger juice and hot melt adhesive matrix to form paste, the ratio of the traditional Chinese medicine powder to the hot melt adhesive matrix is generally 1:3.

EXAMPLE 29 preparation of the Chinese medicinal composition Patch of the invention

(1) Weighing the raw materials according to the weight ratio of any one of the embodiments 18-27, adding 8-10 times of water, decocting twice for 60 minutes each time, filtering while the raw materials are hot, and combining the two decoction liquid medicines for standby;

EXAMPLE 30 preparation of the Chinese medicinal composition ointment of the present invention

EXAMPLE 31 preparation of the gel of the Chinese medicinal composition of the present invention

EXAMPLE 32 preparation of the Chinese medicinal composition cataplasm of the invention

Example 33 clinical trials of acupoint application of the Chinese medicinal composition of the invention

1 subject of study

1.1 sample Source

70 cases of functional constipation (qi-Mi) patients treated by the doctor's doctor of the Shanghai medical university affiliated with dawn hospital from 6 months in 2020 to 3 months in 2021 were randomly divided into 35 cases of treatment group and control group. Treatment groups follow-up compliance poor shed 1, completed study 34, 16 men and 18 women; age 22-70 years, average 59 years; wherein, the skin allergy of the external blood activating and pain relieving ointment for 3 people is changed into the external gauze application, and the skin rash is improved, thus completing the study. 2 cases of follow-up shedding of the control group are carried out, and 33 cases of study are completed; of these, 16 men and 17 women; age 25-70 years, mean 61 years. The baseline data of the 2 groups of patients were statistically significant (P > 0.05) and comparable.

1.2 diagnostic criteria

1.2.1 diagnosis Standard for constitution of Qi stagnation in traditional Chinese medicine

According to the conversion and separation results of the integral scale of Chinese medicine constitution classification and determination published by Chinese medicine publishing company of 4 months and 9 days 2009, and the judgment of doctors, the constitution of the subject is judged to be qi depression constitution.

Qi stagnation constitution judgment questionnaire: (1) is you stuffy and low mood? (2) Do you feel mental stress, anxiety? (3) Is you how sadly feeling and feeling fragile? (4) Is you easily afraid or frightened? (5) Do you's rib or breast pain? (6) Is you't have no reason to exclame a mark? (7) Do you feel foreign body sensation in the throat, and vomiting and throat failure?

The criteria are as follows:

table 7 Chinese medicine physique judging standard table

In the experiment, the constitution with qi depression is determined as constitution with qi depression by converting qi depression into constitution with qi depression of 40 or more.

1.2.2 functional Constipation disease diagnostic criteria

Disease diagnosis

1. Diagnosis of traditional Chinese medicine

The relevant content formulation is made by referring to the national standard of the people's republic of China, the clinical diagnosis and treatment terminology of traditional Chinese medicine and the relevant content formulation of the traditional Chinese medicine science.

2. Western diagnosis

Reference is made to roman iii diagnostic criteria for functional constipation.

1.3 inclusion criteria

3.1 A patient who meets the Western diagnosis standard of chronic functional constipation;

2) Meets the diagnosis of qi secret traditional Chinese medicine;

3) Age 18-70 years old;

4) The subject is informed and voluntarily signs an informed consent.

1.4 drop criteria

2. serious complications occur and exit the path;

2 study method

2.1 grouping scheme

The experimental grouping scheme groups according to a random number method. The specific operation is as follows: random numbers were established by means of EXCEL software "=rand ()", the resulting data were arranged from small to large, the first 35 being control groups and the last 35 being treatment groups for a total of 70 patients.

2.2 treatment regimen

The control treatment regimen was given four ground soup oral liquid (Hunan Hansen pharmaceutical Co., ltd., lot number: 1610103, specification: 10m L/piece) 2 pieces (20 m L) at a time, 3 times/d.

The treatment scheme of the treatment group is that the traditional Chinese medicine composition is applied to the acupoint and is divided into 2 treatment courses for 60 days.

The traditional Chinese medicine composition is applied to acupuncture points: the Chinese medicine composition is developed by combining the characteristics of channels and collaterals, acupoints and medicines according to the characteristics of qi deficiency physique of a center for treating disease of a related dawn hospital of Shanghai traditional Chinese medicine university. The main components of the medicine are bupleurum, nutgrass galingale rhizome, bitter orange, liquorice, rose and green calyx plum (the proportion is 1:1:1:0.5:0.5:0.5), and the medicine is uniformly manufactured by Shandong Yu and Tang pharmaceutical company Limited according to the standard of manufacturing flow (production batch number: 20191002), wherein the specification is 4cm multiplied by 4 cm/tablet, and each tablet (medicine core) is about 0.5 g.

The manufacturing process comprises the following steps: (1) the required traditional Chinese medicine granules are proportioned and smashed into powder according to the proportion of 1:1:1:0.5:0.5:0.5, and then the hot melt adhesive matrix is mixed, wherein the proportion of the traditional Chinese medicine powder to the hot melt adhesive matrix is generally 1:3. (2) Preparing the mixture into fluid extract, extracting with proper solvent (20% -25% ethanol in water), and evaporating part of the solvent to adjust the concentration to 1g of medicinal material per 1 ml. (3) Heating medical pressure-sensitive thermosol 1kg in a pot to about 80deg.C for melting, cooling to about 60-70deg.C, slowly adding the medicinal powder, stirring, adding fluid extract and azone (matrix and azone in a ratio of about 1000:10) at about 40deg.C, stirring, and spreading.

The using method comprises the following steps: after the patient is instructed to bath or scrub the limbs, the skin is kept warm, and the Chinese medicinal composition is applied to the acupuncture points of the patient's body for 4-8 hours each time and three times each week.

2.3 scoring of physique in TCM

2.4 adverse reaction recording

2.5 clinical intervention efficacy decision criterion

The main symptoms are first defecation time, defecation interval time, defecation time and defecation quality of each time, and defecation sense are graded and scored (light=0 score, medium=2 score, heavy=4 score); and the combined symptoms are as follows: 1 symptom of abdominal distention, abdominal pain, anal fissure hematochezia, struggle for sweat, and inappetence is 0.5 score, but not 0 score.

2.6 Standard of efficacy

And (3) healing: normal stool and other symptoms all disappeared. The effect is shown: constipation is obviously improved, the interval time and the stool quality are close to normal, or the stool is slightly dry and the interval time of defecation is less than 72 hours, other symptoms are mostly disappeared, and the integral is reduced by 2/3; the defecation interval time is shortened by 1 day, or the dry stool is improved, other symptoms are improved, and the integral is reduced by 1/3, but less than 2/3; invalidation: constipation and other symptoms are not improved or the integral value is reduced by less than 1/3.

2.7 evaluation of safety

Electrocardiogram and blood, stool convention and occult blood, liver function and kidney function of 2 groups of patients before and after treatment are observed.

2.8 statistical methods

Statistics were performed using SPSS24.0 statistics software. If the data satisfies the normal distribution, the mean ± standard deviationTo describe it. Comparing the two groups of data, conforming to normal distribution, and performing t-test by using independent samples; comparing the data before and after the intervention, conforming to the normalization, and adopting paired t test; the counting data is checked by X2; if the data does not conform to the normal distribution or the data is hierarchical, rank sum test is used. P <0.05 is statistically significant.

3 results

3.1 clinical efficacy

The comparison difference of the two groups of clinical curative effects has statistical significance (Z= -4.425 and P < 0.01), the cure, the obvious effect and the total effective rate of the treatment group are all higher than those of the control group, and the clinical curative effect of the treatment group is obvious compared with that of the control group, as shown in Table 8.

Table 8 comparison of two clinical efficacy

3.2 integration of syndrome

The integral of the symptoms after treatment of the two groups of patients is improved compared with that before treatment, and the difference has statistical significance (P < 0.01); the comparison difference between the two groups after treatment is statistically significant (P < 0.05), and the treatment group is obvious in improving the syndrome integral compared with the control group, as shown in Table 9.

TABLE 9 integral comparison of two sets of syndromes

3.3 transformation score of constitutions

The transformation of the constitution of the traditional Chinese medicine qi depression after the treatment of the two groups of patients is improved compared with that before the treatment, and the difference has statistical significance (P < 0.01); the comparison difference between 2 groups after treatment has statistical significance (P < 0.05), and the treatment group has obvious transformation score for improving the constitution of the traditional Chinese medicine qi stagnation, and is shown in the table 10.

Table 10 the conversion rate of the constitution of the qi depression of the traditional Chinese medicine before and after the treatment of the two groups of patients is higher

Discussion 4

4.1 concept and clinical characteristics of qi stagnation constitution

Qi stagnation constitution is a constitution state mainly represented by unstable internal constitution, depression and weakness, and sensitivity due to long-term emotional disorder and qi stagnation. The patients in the physical condition are mostly seen in the middle-aged and young, and women are mostly seen with the symptoms of frequent and isolated interior, easy and good feeling and narrow air quantity. The pathogenesis of qi stagnation is mainly liver, and also heart, stomach, large intestine and small intestine. Yi Shangqing and diet are prone to qi stagnation, such as depression, insomnia, globus hystericus, panic, etc., and modern researches on such constitutions are prone to tumor.

For conditioning, it should be used to regulate emotion and dredge qi movement. Qi deficiency constitutions often occur: emaciation or obesity, pale complexion, shortness of breath, lazy speaking, tiredness, hypodynamia, frequent spontaneous sweating, pale-red tongue, tooth marks on the tongue, white coating and weak pulse. The qi deficiency of the five zang organs is clinically seen in the common symptoms of heart, lung, spleen and kidney, and the qi deficiency of the heart, lung, spleen and kidney is accompanied by the corresponding pathological changes except the common clinical manifestations of the qi deficiency. Predisposition to disease: is easy to suffer from common cold, qi deficiency and dizziness, viscera drooping, weak resistance and slow recovery after illness.

The traditional Chinese medicine composition acupoint application is independently developed by Zhang Xiaotian teaching aiming at the characteristics of qi depression constitution and combining the characteristics of channels, collaterals, acupoints and medicines. The main components of the Chinese medicinal composition are bupleurum, nutgrass galingale rhizome, bitter orange, liquorice, rose and green calyx plum (the proportion is 1:1:1:0.5:0.5:0.5), and the whole prescription has the effects of soothing liver, regulating qi, promoting qi circulation, regulating menstruation, activating blood and removing blood stasis.

Bupleurum root: bitter and pungent in flavor, slightly cold in nature, enter liver and gallbladder meridians. It is indicated for chest and hypochondrium pain or lower abdominal distention and pain, emotional depression, female menstrual disorder and dysmenorrhea due to liver-qi stagnation, etc. because it is an essential herb for relieving exterior syndrome and allaying fever, soothing liver and relieving depression and lifting yang qi.

And (3) rhizoma cyperi: pungent, slightly bitter, slightly sweet, and neutral in nature. It enters liver, spleen and triple energizer meridians. Liver soothing, qi stagnation relieving, qi regulating, middle energizer regulating, menstruation regulating and pain relieving. Can be used for treating liver depression, qi stagnation, chest and hypochondrium distending pain, hernia pain, breast distending pain, spleen and stomach qi stagnation, abdominal distention and fullness pain, menoxenia, amenorrhea and dysmenorrhea. Xiang Fu is good in liver qi-moving and depression-relieving herbs, so it is often combined with chai Hu and Zhi Hu in clinic.

Fructus Aurantii: bitter, pungent and sour in flavor and slightly cold in nature. Enter spleen and stomach meridians. Has the effects of regulating qi-flowing, relieving middle-jiao, promoting digestion, and relieving flatulence. It is used for treating qi stagnation in chest and hypochondrium, distention and pain, indigestion, internal retention of phlegm and fluid, and organ prolapse.

Licorice root: neutral in nature and sweet in taste. It enters heart meridian, stomach meridian, spleen meridian and lung meridian. Invigorating spleen and replenishing qi, relieving cough and eliminating phlegm, relieving spasm and pain, and harmonizing drug property.

Rose: warm nature, sweet and slightly bitter in taste, enter liver meridian and spleen meridian. Promoting qi circulation, resolving stagnation, regulating qi and relieving pain. Is used for treating liver and stomach qi pain, menoxenia, liver wind headache, liver depression hematemesis, chronic cholecystitis, and qi depression chest distress.

All-grass of Japanese apricot: slightly sour and astringent, and neutral in nature. It enters liver, stomach and lung meridians. It has effects of activating qi-flowing, entering liver and stomach, and can be used for treating liver and stomach qi pain, relieving emotional depression, promoting chest stuffiness, eliminating phlegm, and resolving hard mass, and is a good health product for patients with liver qi stagnation. Is suitable for patients with hypochondriac pain, gastric and abdominal distention and fullness, belch, inappetence, gastralgia and dyspepsia due to stagnation of liver-stomach qi. Uncomfortable feeling, depression of the mood, depression and depression due to stagnation of liver-qi and stagnation of phlegm-qi, neurasthenia, globus hystericus, uncomfortable throat and chronic pharyngitis.

4.3 Point selection analysis

The selection of the points mainly includes Danzhong and Ganshu, wherein Danzhong is the area where the pericardial meridian qi gathers, and the "Huangdi Nei Jing" mentions that: the ministerial drugs are used for leading the patients to feel happy and happy. Modern researches show that the acupoint can achieve the aim of effectively treating various qi diseases by regulating the nerve function, relaxing smooth muscle, expanding coronary blood vessels, the internal cavity diameter of digestive tract and the like. Ganshu is the back transport point of the liver, qian jin Fang (Qian jin Fang): "Ganshu, pishu, zhi Chan" and Zhi Chan are used to treat pain in hypochondrium. The traditional Chinese medicine composition is commonly used for treating acute and chronic hepatitis, cholecystitis, conjunctivitis, night blindness, myopia and the like. The two acupoints are used together to relieve chest stuffiness, regulate qi, promote blood circulation, relieve pain, remove arthralgia and dredge collaterals, so as to improve the physical condition of people with qi stagnation and poor physical condition.

Example 34 animal experiment

1. Materials and methods

1.1 Experimental materials

1.1.1 laboratory animals

SPF-grade Sprague-Dawley (SD) male mice 40 animals, with a mass (200+ -20) g, supplied by Shanghai Laike laboratory animal Co., ltd., were kept at a constant temperature (22+ -1) C and a 12:12 constant lighting rhythm, and were free to ingest food and water.

1.1.2 experimental drugs the group of the invention: 15 parts of bupleurum, 15 parts of nutgrass galingale rhizome, 15 parts of bitter orange, 7.5 parts of liquorice, 7.5 parts of rose, 7.5 parts of green calyx plum and 1 part of a control group: 15 parts of bupleurum, 15 parts of citron, 15 parts of fructus aurantii, 7.5 parts of raw malt, 7.5 parts of rose, 7.5 parts of green calyx plum and 2 parts of a control group: 15 parts of bupleurum, 15 parts of nutgrass galingale rhizome, 15 parts of bitter orange, 7.5 parts of raw malt, 7.5 parts of China rose and 7.5 parts of green calyx plum, and 3 parts of a control group: 15 parts of bupleurum, 15 parts of citron, 15 parts of fructus aurantii, 7.5 parts of liquorice, 7.5 parts of China rose and 7.5 parts of green calyx plum

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

1.1.4 main instruments: a measuring cylinder; a stopwatch.

1.2 Experimental methods

1.2.1 experimental group: the 40 rats are divided into groups according to a random number table method: the invention group, the control group 1, the control group 2 and the control group 3, and each group comprises 10.

1.2.2 manufacturing of a mouse model with qi depression constitution: with reference to Zhu Qingjing (Xiong Zhenfang, zhu Qingjing. Influence of Bupleurum soothing liver powder on rats with chronic constraint stress liver depression [ J ]. Chinese and Western medicine combined J.A.of digestion, 2004, (04): 220-221.), tang Yiting (Tang Yiting, chen Guxu. Adjustment of hypothalamus-pituitary-adrenal axis of rats with chronic constraint stress [ J ]. University of Beijing Chinese medicine, 2002 (03): 23-26.), etc., the rats were placed in constraint boxes at the beginning of the experiment by the constraint method, and the front end active part was adjusted to a proper position so that the rats did not generate strong stress, 6h (9:00-15:00) per day for 6 weeks. Indicating successful molding.

1.2.3 methods of administration:

the group of the invention is applied: the back of the mice is dehaired by 8% Na2S, the area is about 4cm multiplied by 4cm, after the mice are locally disinfected by 75% alcohol, the groups (15 parts of bupleurum, 15 parts of nutgrass galingale rhizome, 15 parts of fructus aurantii, 7.5 parts of liquorice, 7.5 parts of rose and 7.5 parts of Japanese apricot) applied with the invention are stuck and fixed on dehaired parts (Danzhong and Ganshu). Then lightly pressing for 2 times, and winding the chest and back with adhesive tape for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8 hours, and then taken out, and applied for 20 times a day, 1 time a day.

Application controlGroup 1: the back of the mice was treated with 8% Na ₂ S dehairing, namely, after the dehairing area is about 4cm multiplied by 4cm, local disinfection is carried out by 75% alcohol, the paste control group 1 (15 parts of radix bupleuri, 15 parts of citron, 15 parts of fructus aurantii, 7.5 parts of raw malt, 7.5 parts of rose and 7.5 parts of green calyx plum) is pasted and fixed at dehairing positions (Danzhong and Ganshu). Then lightly pressing for 2 times, and winding the chest and back with adhesive tape for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8 hours, and then taken out, and applied for 20 times a day, 1 time a day.

Pasting a control group 2: the back of the mice was treated with 8% Na ₂ S dehairing, namely, after the dehairing area is about 4cm multiplied by 4cm, local disinfection is carried out by 75% alcohol, the control group 2 (15 parts of radix bupleuri, 15 parts of nutgrass galingale rhizome, 15 parts of fructus aurantii, 7.5 parts of raw malt, 7.5 parts of China rose and 7.5 parts of green calyx plum) is stuck and fixed at dehairing positions (Danzhong and Ganshu). Then lightly pressing for 2 times, and winding the chest and back with adhesive tape for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8 hours, and then taken out, and applied for 20 times a day, 1 time a day.

Pasting a control group 3: the backs of the mice were dehaired with 8% Na2S, the area was about 4 cm. Times.4 cm, and after local disinfection with 75% alcohol, the patch control group 3 (bupleurum root 15 parts, citron 15 parts, bitter orange 15 parts, licorice root 7.5 parts, china rose flower 7.5 parts, and Japanese apricot 7.5 parts) was fixed on the dehaired sites (Danzhong, ganshu). Then lightly pressing for 2 times, and winding the chest and back with adhesive tape for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8 hours, and then taken out, and applied for 20 times a day, 1 time a day.

1.2.4 observing and detecting index

Forced swimming test in mice: the measuring cylinder is filled with water at 21-23 ℃ for 10cm, and an opaque plate is arranged between the measuring cylinders to prevent the mice from seeing each other. 1 hour after the last dose, the mice were put into a measuring cylinder and left for 6min, the immobility time of 4min after calculation was measured simultaneously for five mice. Judging the motionless standard: stop struggling, vertical body position, do not float, do some necessary activities only and make its head expose the surface of water.

Mouse tail suspension test: on day 3 after forced swimming, 1 hour after last drenching, it was fixed on a horizontally placed stick with tape at a distance of 30mm from the tip of the mouse tail, with the middle being separated by a plate to prevent each other from seeing. The mice were about 100mm from the nearest object. The suspension was continued for 6min, and the immobility time was recorded for 4min, 5 per measurement.

1.2.5 statistical treatments

SPSS10.0 software was used to perform one-way analysis of variance and comparison between the two groups was tested using t-test.

2. Results

TABLE 11 influence of different patches on the immobility time of the forced swimming model of mice (x.+ -. S)

Group of	Example number (n)	Time of immobility (n)
			The 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 P of the invention group is less than 0.05 compared with the control group 1 and the control group 3, and the P of the invention group is less than 0.01 compared with the control group 2.

TABLE 12 influence of different patches on the immobility time of mouse tail suspension model (x.+ -. S)

Group of	Example number (n)	Time of immobility (n)
			The 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

The P of the invention group is less than 0.05 compared with the control group 1 and the control group 2, and the P of the invention group is less than 0.01 compared with the control group 1.

The trend of decreasing immobility time was shown in forced swimming in mice. The experimental result shows that: the invention has the function of improving the constitution of qi depression.

Traditional Chinese medicine composition for improving qi deficiency constitution and preparation method and application examples thereof

EXAMPLE 35 preparation of the Chinese medicinal composition of the present invention

15 parts of astragalus membranaceus, 15 parts of stir-fried bighead atractylodes rhizome, 15 parts of divaricate saposhnikovia root, 7.5 parts of dried orange peel, 15 parts of radix pseudostellariae and 1.5 parts of ginseng are weighed according to the proportion of 1:1:1:0.5:1:0.1.

EXAMPLE 36 preparation of the Chinese medicinal composition of the present invention (II)

10 parts of astragalus membranaceus, 10 parts of stir-fried bighead atractylodes rhizome, 10 parts of divaricate saposhnikovia root, 5 parts of dried orange peel, 10 parts of radix pseudostellariae and 1 part of ginseng are weighed according to the proportion of 1:1:1:0.5:1:0.1.

EXAMPLE 37 preparation of the Chinese medicinal composition of the present invention (III)

Weighing 20 parts of astragalus membranaceus, 20 parts of stir-fried bighead atractylodes rhizome, 20 parts of divaricate saposhnikovia root, 10 parts of dried orange peel, 20 parts of radix pseudostellariae and 2 parts of ginseng according to the proportion of 1:1:1:0.5:1:0.1.

EXAMPLE 38 preparation of the Chinese medicinal composition of the present Invention (IV)

12 parts of astragalus membranaceus, 12 parts of stir-fried bighead atractylodes rhizome, 12 parts of divaricate saposhnikovia root, 6 parts of dried orange peel, 12 parts of radix pseudostellariae and 1.2 parts of ginseng are weighed according to the proportion of 1:1:1:0.5:1:0.1.

EXAMPLE 39 preparation of the Chinese medicinal composition of the present invention (five)

18 parts of astragalus membranaceus, 18 parts of stir-fried bighead atractylodes rhizome, 18 parts of divaricate saposhnikovia root, 9 parts of dried orange peel, 18 parts of radix pseudostellariae and 1.8 parts of ginseng are weighed according to the proportion of 1:1:1:0.5:1:0.1.

EXAMPLE 40 preparation of the Chinese medicinal composition of the present invention (six)

11 parts of astragalus membranaceus, 11 parts of stir-fried bighead atractylodes rhizome, 11 parts of radix saposhnikoviae, 5.5 parts of dried orange peel, 11 parts of radix pseudostellariae and 1.1 parts of ginseng are weighed according to the proportion of 1:1:1:0.5:1:1:0.1:0.1.

EXAMPLE 41 preparation of the Chinese medicinal composition of the present invention (seventh)

13 parts of astragalus membranaceus, 13 parts of stir-fried bighead atractylodes rhizome, 13 parts of divaricate saposhnikovia root, 6.5 parts of dried orange peel, 13 parts of radix pseudostellariae and 1.3 parts of ginseng are weighed according to the proportion of 1:1:1:0.5:1:0.1.

EXAMPLE 42 preparation of the Chinese medicinal composition of the present invention (eight)

14 parts of astragalus membranaceus, 14 parts of stir-fried bighead atractylodes rhizome, 14 parts of divaricate saposhnikovia root, 7 parts of dried orange peel, 14 parts of radix pseudostellariae and 1.4 parts of ginseng are weighed according to the proportion of 1:1:1:0.5:1:0.1.

EXAMPLE 43 preparation of the Chinese medicinal composition of the present invention (nine)

16 parts of astragalus membranaceus, 16 parts of stir-fried bighead atractylodes rhizome, 16 parts of divaricate saposhnikovia root, 8 parts of dried orange peel, 16 parts of radix pseudostellariae and 1.6 parts of ginseng are weighed according to the proportion of 1:1:1:0.5:1:0.1.

EXAMPLE 44 preparation of the Chinese medicinal composition of the present invention (ten)

19 parts of astragalus membranaceus, 19 parts of stir-fried bighead atractylodes rhizome, 19 parts of divaricate saposhnikovia root, 9.5 parts of dried orange peel, 19 parts of radix pseudostellariae and 1.9 parts of ginseng are weighed according to the proportion of 1:1:1:0.5:1:0.1.

EXAMPLE 45 preparation of the acupoint application of the Chinese medicinal composition of the invention

(1) The weight portion of any one of the embodiments 35-44 is to weigh each raw material medicine, break into powder, mix with a proper amount of ginger juice and hot melt adhesive matrix to form paste, the ratio of the traditional Chinese medicine powder to the hot melt adhesive matrix is generally 1:3.

EXAMPLE 46 preparation of the Chinese medicinal composition Patch of the invention

(1) Weighing the raw materials according to the weight ratio of any one of the embodiments 35-44, adding 8-10 times of water, decocting twice for 60 minutes each time, filtering while the raw materials are hot, and combining the two decoction liquid medicines for standby;

EXAMPLE 47 preparation of the Chinese medicinal composition ointment of the present invention

EXAMPLE 48 preparation of the gel of the Chinese medicinal composition of the present invention

EXAMPLE 49 preparation of the Chinese medicinal composition cataplasm of the invention

Example 50 clinical trials of acupoint application of the Chinese medicinal composition of the invention

1 subject of study

1.1 sample Source

The experimental samples are from 30 cases of patients meeting the inclusion standard of traditional Chinese medicine qi deficiency constitution and chronic diarrhea in the clinic and hospitalization department of the affiliated dawn hospital of Shanghai traditional Chinese medicine university at 6 months of 2020 to 3 months of 2021, and are randomly divided into 15 cases of patients in a control group and a treatment group.

1.2 diagnostic criteria

1.2.1 diagnosis Standard of Qi deficiency constitution in traditional Chinese medicine

According to the results of conversion and separation of integral scale of Chinese medicine constitution classification and judgment published by Chinese medicine publishing company of 4 months and 9 days 2009, and combining with judgment of doctor, judging that the constitution of the subject is qi deficiency constitution.

Qi deficiency constitution judgment questionnaire: (1) do you get tired easily? (2) Do you get shortness of breath (shortness of breath, no ascending of qi? (3) Do you easily get palpitation? (4) Do you easily dizziness or stand up to be dizzy? (5) Do you get cold more easily than others? (6) Do you like to be calm and lazy to speak? (7) Do you speak low voice weakness? (8) Do you get a little more active and get a tendency to sweating due to deficiency?

The criteria are as follows:

table 13 Chinese medicine physique judging standard table

In the experiment, the constitution with qi deficiency is determined as constitution with qi deficiency by converting qi deficiency into 40 or more.

2.2 treatment regimen

The traditional Chinese medicine composition is applied to acupuncture points: the Chinese medicine composition is developed by combining the characteristics of channels and collaterals, acupoints and medicines according to the characteristics of qi deficiency physique of a center for treating disease of a related dawn hospital of Shanghai traditional Chinese medicine university. The main components of the medicine are astragalus root, stir-fried atractylodes macrocephala, divaricate saposhnikovia root, dried orange peel, radix pseudostellariae and ginseng (the proportion is 1:1:1:0.5:1:0.1), which are uniformly manufactured by Shandong Guangdong and Tang pharmaceutical industry limited company according to the standard of manufacturing flow (production batch number is 20191002), the specification is 4cm multiplied by 4cm per tablet, and each tablet (medicine core) is about 0.5 g.

The manufacturing process comprises the following steps: (1) the required traditional Chinese medicine granules are proportioned and smashed into powder according to the proportion of 1:1:1:0.5:1:0.1, and then the hot melt adhesive matrix is mixed, wherein the proportion of the traditional Chinese medicine powder to the hot melt adhesive matrix is generally 1:3. (2) Preparing the mixture into fluid extract, extracting with proper solvent (20% -25% ethanol in water), and evaporating part of the solvent to adjust the concentration to 1g of medicinal material per 1 ml. (3) Heating medical pressure-sensitive thermosol 1kg in a pot to about 80deg.C for melting, cooling to about 60-70deg.C, slowly adding the medicinal powder, stirring, adding fluid extract and azone (matrix and azone in a ratio of about 1000:10) at about 40deg.C, stirring, and spreading.

The using method comprises the following steps: after the patient has been instructed to bath or scrub the limbs, the skin is kept warm, and the Chinese medicinal composition of the invention is applied to the acupoints of the Qihai, pishu and Zusanli of the human body for 4-8 hours each time and three times each week.

2.3 scoring of physique in TCM

2.4 adverse reaction recording

2.5 clinical intervention efficacy decision criterion

2.5.1 Chinese medicine clinical intervention curative effect criterion

The traditional Chinese medicine clinical intervention curative effect judgment is judged according to the traditional Chinese medicine qi deficiency constitution transformation score, and the standard is judged by using symptom integral change according to the relevant standard of the traditional Chinese medicine disease diagnosis curative effect standard issued by the national medicine supervision and administration in 2017.

3.3 transformation score of constitutions

After treatment, the constitution transformation fraction of two groups of patients is reduced, the difference between the control group and the treatment is not obvious, and P is more than 0.05; the difference between the intra-group comparison and the inter-group comparison before and after treatment is significant, and P is less than 0.05.

The conversion rate of qi deficiency constitution of traditional Chinese medicine before and after treatment of the patients with the two groups of the exterior 14 is relatively high

3.3 results of the study on safety indicators

Discussion 4

4.1 concept and clinical characteristics of Qi deficiency constitution

The qi deficiency constitution is mainly caused by congenital deficiency, long-term eating disorder, emotional disorder, chronic diseases and fatigue, and the old and weak causes the damage of heart, lung, spleen and kidney functions, and the heart governs blood vessels, the lung governs qi of the whole body, the kidney stores primordial qi, and the spleen and stomach are the sources of qi and biochemistry, so the qi deficiency constitution easily causes the hypofunction of promoting blood circulation, the generation of internal qi is insufficient, the body defends exogenous evil, defends the muscle surface, and maintains the disease symptoms of hypofunction of viscera position.

Qi deficiency constitutions often occur: emaciation or obesity, pale complexion, shortness of breath, lazy speaking, tiredness, hypodynamia, frequent spontaneous sweating, pale-red tongue, tooth marks on the tongue, white coating and weak pulse. The qi deficiency of the five zang organs is clinically seen in the common symptoms of heart, lung, spleen and kidney, and the qi deficiency of the heart, lung, spleen and kidney is accompanied by the corresponding pathological changes except the common clinical manifestations of the qi deficiency. Predisposition to disease: is easy to suffer from common cold, qi deficiency and dizziness, viscera drooping, weak resistance and slow recovery after illness.

Since cytokines are closely related to the occurrence of fatigue symptoms, most people with qi deficiency constitution have immune system dysfunction or decline of immune system function. The decline of the immune function of the human body can lead to the decline of the body in the ability of defending, recognizing and eliminating the external pathogen and the self-antigen foreign matter, and the environmental physiological balance in the body is difficult to maintain, so that the disease is generated.

The traditional Chinese medicine composition acupoint application is independently developed by Zhang Xiaotian teaching aiming at the characteristics of phlegm-dampness constitution and combining the characteristics of channels, acupoints and medicines. The main components of the Chinese medicinal composition are astragalus root, stir-fried atractylodes macrocephala, divaricate saposhnikovia root, dried orange peel, radix pseudostellariae and ginseng (the proportion is 1:1:1:0.5:1:0.1), and the whole prescription has the effects of tonifying qi and cultivating primordial qi, tonifying spleen and lung and promoting qi circulation and resolving stagnation.

Radix astragali: sweet taste and slightly warm nature; enter spleen and lung meridians. Tonify qi, strengthen superficies, expel pus, promote urination and promote tissue regeneration. Can be used for treating qi deficiency, debilitation, chronic diarrhea, rectocele, spontaneous perspiration, edema, uterine prolapse, chronic nephritis, albuminuria, diabetes, and chronic open sore.

White atractylodes rhizome: warm nature, sweet and bitter. Enter spleen meridian and stomach meridian. Invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, relieving sweating, and preventing miscarriage. Belongs to qi-tonifying herbs in the category of deficiency-tonifying herbs.

Wind prevention: warm nature, sweet and pungent. Enter bladder meridian, liver meridian and spleen meridian. Release exterior, dispel wind, dehumidify. Belongs to the category of drugs for relieving exterior syndrome.

Dried orange peel: pungent and bitter in flavor and warm in nature. Enter spleen meridian and lung meridian. Regulating qi-flowing, stimulating appetite, eliminating dampness and resolving phlegm, and treating spleen and stomach diseases. Belongs to a qi-regulating medicine.

Radix pseudostellariae: neutral in nature, sweet and slightly bitter. Enter spleen meridian and lung meridian. Replenishing qi to invigorate the spleen, promoting fluid production and moistening the lung. Belongs to qi-tonifying herbs in the category of deficiency-tonifying herbs.

Ginseng: warm nature, sweet and slightly bitter. It enters heart meridian, lung meridian, spleen meridian and kidney meridian. Greatly invigorating primordial qi, restoring pulse, relieving depletion, invigorating spleen, benefiting lung, promoting salivation, and tranquilizing mind. Belongs to qi-tonifying herbs classified under deficiency-tonifying herbs.

4.3 Point selection analysis

The points selected are mainly the Qi-sea, pishu and Zusanli, the Pishu is the acupoint infused on the back by the Qi-channel, the Qi-sea and Zusanli are the essential points for invigorating Qi and cultivating Yuan, and the "Curen Yu acupoint acupuncture pattern Jing" carries: the "qi-sea" refers to the sea where men are producing qi. This acupoint has the functions of invigorating primordial qi, invigorating kidney, stopping nocturnal emission, and invigorating yang. Cloud of Qianjin Fang: if you want to be safe, three will not be dry. The three acupoints are combined to strengthen the body and prolong life, so that the physique state of people with qi deficiency and biased physique is improved.

The foregoing is merely a preferred embodiment of the present invention, and it should be noted that modifications and additions may be made to those skilled in the art without departing from the method of the present invention, which modifications and additions are also to be considered as within the scope of the present invention.

Claims

1. The traditional Chinese medicine composition for improving the gouty arthritis with damp-heat constitution is characterized by being prepared from the following raw materials in parts by weight: 10-20 parts of rhizoma atractylodis, 10-20 parts of radix achyranthis bidentatae, 10-20 parts of semen coicis, 10-20 parts of magnolia officinalis, 10-20 parts of pelargonium, and 10-20 parts of bile-producing star, wherein the traditional Chinese medicine composition is in the form of an external preparation.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 13-18 parts of rhizoma atractylodis, 13-18 parts of radix achyranthis bidentatae, 13-18 parts of coix seed, 13-18 parts of magnolia officinalis, 13-18 parts of pelargonium, and 13-18 parts of bile-producing star.

3. The traditional Chinese medicine composition according to claim 2, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of semen coicis, 15 parts of magnolia officinalis, 15 parts of pelargonium, and 15 parts of bile-producing star.

4. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in preparing a medicament for improving gout arthritis with damp-heat constitution.