CN115245549A

CN115245549A - Traditional Chinese medicine composition for improving physique

Info

Publication number: CN115245549A
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: 2022-10-28
Anticipated expiration: 2042-08-15
Also published as: CN116370560A; CN116370539A; CN115245549B

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 material medicines 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 mangnolia officinalis, 10-20 parts of fructus nandinae domesticae and 10-20 parts of processed arisaema cum bile. The Chinese medicinal composition acupoint application comprises the Chinese medicinal composition according to the proportion of 1. The traditional Chinese medicine composition has the characteristics of convenience in carrying, safety and no toxicity, is suitable for any people, is particularly suitable for people with damp-heat constitution, adheres to long-term regular application, has obvious effects of improving the damp-heat constitution and conditioning the whole state of an organism, and promotes the damp-heat constitution to be transformed to a mild state.

Description

Traditional Chinese medicine composition for improving physique

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 about "constitutions" originates from Huangdi's classic on internal medicine. The 4-month Chinese medical society in 2009 classified and judged the constitutions on the basis of the classification and judgment of traditional Chinese medicine constitutions: mild nature, qi deficiency nature, yang deficiency nature, yin deficiency nature, phlegm dampness nature, damp-heat nature, blood stasis nature, qi stagnation nature, and specific endowment nature. The traditional Chinese medicine researches believe that the constitution of the traditional Chinese medicine refers to the inherent characteristics of the human body in the aspects of morphological structure, physiological function and psychological state formed on the basis of innate endowment and acquired postnatal, has comprehensive and relative stability, often determines the specificity of the human body to physiological reaction, the susceptibility to certain pathogenic factors and the tendency to generate pathological change types, and further influences the syndrome type and the disease outcome of the postnatal disease.

In the damp-heat constitution, the so-called dampness is known as water-dampness, which distinguishes between external dampness and internal dampness. The external dampness is caused by the invasion of external water into human bodies due to the fact that the climate is humid or the weather is involved in water and rain or the rooms are humid; internal dampness is a pathological product and is often associated with digestive function. The traditional Chinese medicine considers that the spleen has the function of transporting and transforming water dampness, and if the body is weak and the dyspepsia is poor or the engorgement is too much, the spleen is too greasy and sweet to transport and transform normally so as to cause the water dampness to stop; moreover, people with spleen deficiency are also prone to invasion of exogenous dampness, and exogenous dampness also often stagnates the spleen and stomach to promote the generation of dampness from inside, so the two are independent and related. Heat is a thermal image. The heat in damp-heat exists with the humidity, or the humidity and heat seal invade the human body due to the heavy heat and humidity in summer and autumn, or the humidity is not removed for a long time, or the humidity is changed from the sun to the heat due to the yang-heat constitution, so the existence of the humidity and the heat is common.

The Chinese medicine physique acupoint application is an external treatment method for applying the Chinese medicine powder to body surface acupoints after being prepared into ointment, and is one of the external treatment methods commonly used in the Chinese medicine from ancient times to present. The traditional Chinese medical physique acupoint plaster therapy is based on the guidance of the traditional Chinese medicine theory, according to the principle of treating internal diseases by external therapy, the traditional Chinese medicines with corresponding physique types are utilized, and medicines with pungent and warm natures, fleeing and meridian dredging functions are matched to be pasted on related acupoints, so that the medicines enter the acupoints and meridians through skin striae, and through the running action of qi and blood of the meridians, the meridian tropism and functional effects of the medicines are exerted, and the traditional Chinese medical physique can be directly reached to related viscera, and the disease resistance can be enhanced. This method is used to treat diseases with a combination of thick thick herbs and meridian points on the body surface, and has therapeutic effects through percutaneous absorption and specific therapy. The medicine is absorbed through skin and mucosa, and part of the medicine directly acts on body surface acupuncture points to stimulate acupuncture points and channels and collaterals; the other part is absorbed into the systemic blood circulation to reach effective blood concentration to play a role.

Chinese patent document CN111450205A discloses a traditional Chinese medicine composition for conditioning and treating damp-heat constitution, and a preparation and an application thereof, wherein 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 wrinkled gianthyssop herb, 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 flower, 100-300 parts of magnolia officinalis flower, 50-150 parts of radix paeoniae alba, 25-40 parts of coptis chinensis and 80-120 parts of poria with hostwood. The medicines are combined to play the effects of eliminating dampness and clearing heat, so that the traditional Chinese medicine composition has a remarkable conditioning effect on damp-heat physique, and can recover and keep relatively healthy peace and mild for a long time. Chinese patent document CN104524110A discloses a Chinese medicinal composition with effects of invigorating spleen and eliminating dampness. The raw materials of the Chinese medicinal composition comprise semen Coicis, 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 nourishing spleen and stomach, eliminating dampness and clearing heat, can adjust the constitution of damp-heat and has obvious effects of strengthening spleen and eliminating dampness. The composition is convenient to take, meets the fast-paced life requirements of modern people, is safe and effective, and has no toxic or side effect. However, the traditional Chinese medicine composition for improving the damp-heat constitution and the preparation method and the application thereof are not reported at present.

Qi depression constitutions are constitutions which are unstable in their constitutions, fragile in depression, and susceptive to suspicion due to long-term emotional disorder and Qi stagnation. People in this constitution are often seen in middle-aged and young years, and have a tendency to be worried about the sensation and narrow qi volume in the rare female and isolated character. The disease of people with qi stagnation is mainly caused by liver, and also involves heart, stomach, large intestine and small intestine. Emotional and dietary disorders are easily damaged, qi movement disorder such as depression, insomnia, globus hystericus, and panic is easily caused, and modern researches on these constitutions show that tumors are likely to occur. For recuperation and treatment, it is advisable to harmonize the emotion and dredge qi.

Polycystic ovarian syndrome (PCOS) is a common disorder of fertility in women caused by a complex endocrine and metabolic abnormality, characterized by chronic anovulation (ovulatory dysfunction or loss) and hyperandrogenism (excess production of male hormones in women), with the predominant clinical manifestations of irregular menstrual cycle, infertility, hirsutism and/or acne, being the most common endocrine disorders in women.

Chinese patent document CN111249420A discloses a traditional Chinese medicine composition for regulating and treating qi stagnation 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 radix bupleuri, 120-180 parts of fructus aurantii, 40-80 parts of dried orange peel, 40-80 parts of green tangerine peel, 120-180 parts of rhizoma cyperi, 80-120 parts of rose, 80-120 parts of flos mume, 80-120 parts of albizia flower, 70-230 parts of spina date seed, 20-40 parts of fructus amomi, 50-150 parts of radix paeoniae alba, 80-120 parts of lotus seed, 80-120 parts of rhizoma atractylodis macrocephalae, 80-120 parts of hawthorn, 80-120 parts of citron, 80-120 parts of fructus forsythiae, 80-120 parts of lily, 80-120 parts of platycodon grandiflorum, 80-120 parts of ligusticum wallichii, 80-120 parts of angelica sinensis, 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 have the functions of promoting qi circulation and relieving depression, and effectively regulate and treat constitution of qi depression. Chinese patent document CN110038066A discloses a traditional Chinese medicine composition for treating chronic fatigue syndrome and a preparation method thereof. The preparation is prepared from the following raw material medicines 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 wolfberry fruit 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 the constitution of qi depression and the preparation method and application thereof are not reported at present.

Qi deficiency (qi deficiency constancy) refers to the condition of qi deficiency when the viscera function of the human body is disordered and the generation of qi is insufficient, which is often manifested as low voice, emaciation or slight fat, pale complexion, shortness of breath, no speaking, lassitude, tiredness, hypodynamia, spontaneous sweating, especially, pale red tongue, tooth marks on the tongue edge, white fur, weak pulse, and the disease is caused by various causes, and different symptoms and disease tendency are caused by different qi deficiency parts of heart, lung, spleen and kidney: susceptible to cold, qi deficiency, dizziness, visceral prolapse, weak plain resistance, female after delivery susceptible to puerperal asthenia, puerperal eye disease, etc., and slow recovery after illness. For treatment, qi-tonifying and qi-nourishing herbs should be used according to the differentiation of syndromes of zang-fu organs. According to the theory of qi and blood homology, blood tonics are added appropriately.

The Chinese medicine physique acupoint plaster is an external treatment method of grinding Chinese medicines into powder, mixing the powder into ointment and sticking the ointment on body surface acupoints. The traditional Chinese medical physique acupoint plaster therapy is characterized in that according to the principle of 'internal disease external treatment', traditional Chinese medicines of corresponding physique types are utilized and matched with medicines with pungent and warm natured properties, fleeing and meridian dredging functions to be pasted on relevant acupoints, so that the medicines enter into acupoints and meridians through skin striae, and through the running action of qi and blood of the meridians and collaterals, the meridian tropism and functional effects of the medicines are exerted to reach relevant viscera, and the aims of adjusting the physique of the organism and enhancing the disease resistance are fulfilled.

Chinese patent document CN107261101A discloses a massage Chinese medicinal oil emulsion for qi-deficiency constitution, which comprises the following components in parts by weight: 12-20 parts of fried white paeony root, 8-12 parts of angelica, 5-13 parts of roasted cassia twig, 5-15 parts of ginseng, 5-13 parts of American ginseng, 8-15 parts of codonopsis pilosula, 5-15 parts of radix pseudostellariae, 3-15 parts of astragalus mongholicus, 3-15 parts of bighead atractylodes rhizome, 2-8 parts of liquorice, 5-10 parts of red dates, 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 remarkable effects of tonifying qi and building body through scientific and reasonable proportioning, and is particularly most remarkable for people with qi-deficiency constitution. 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 fried bighead atractylodes rhizome, 150-300 parts of poria cocos, 150-300 parts of Chinese yam, 120-200 parts of fried white peony root, 120-150 parts of fried angelica sinensis, 90-120 parts of dried orange peel, 90-120 parts of fried cassia twig, 90-120 parts of radix ophiopogonis, 90-120 parts of schisandra chinensis, 90-120 parts of divaricate saposhnikovia root, 90-120 parts of radix bupleuri, 60-90 parts of cimicifuga foetida, 5-15 parts of dried ginger, 300-500 parts of fried coix seed, 150-300 parts of Chinese date, 60-90 parts of honey-fried licorice root, 100-120 parts of fried rice sprout, 100-120 parts of fried malt, 250-300 parts of donkey-hide gelatin, 150-200 parts of tortoise-plastron gelatin and 100-150 parts of deer-horn gelatin. The traditional Chinese medicine composition has a reasonable formula, has the effects of tonifying middle-jiao and Qi, strengthening spleen and lung, promoting digestion and harmonizing stomach, tonifying kidney and strengthening vitality, can effectively improve or even change qi-deficiency constitution, and has the advantages of high content of effective medicinal components, no obvious toxic or side effect, mild and stable effect, long-lasting effect, convenience in taking, easiness in storage and carrying. However, the traditional Chinese medicine composition for improving qi-deficiency constitution, and the preparation method and the 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 to provide a traditional Chinese medicine composition for improving damp-heat constitution aiming at the defects in the prior art.

The invention further aims to provide a preparation method of the traditional Chinese medicine composition.

Another object of the present invention is to provide the use of the said Chinese medicinal composition.

The traditional Chinese medicine composition for improving damp-heat constitution is prepared from the following raw material medicines 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 mangnolia officinalis, 10-20 parts of fructus nandinae domesticae and 10-20 parts of processed arisaema cum bile.

Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 13-18 parts of rhizoma atractylodis, 13-18 parts of radix achyranthis bidentatae, 13-18 parts of semen coicis, 13-18 parts of mangnolia officinalis, 13-18 parts of fructus nandinae domesticae and 13-18 parts of processed arisaema cum bile.

More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of semen coicis, 15 parts of mangnolia officinalis, 15 parts of fructus nandinae domesticae and 15 parts of processed arisaema cum bile.

In order to achieve the second object, the invention adopts the technical scheme that:

the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, mangnolia officinalis, fructus nandinae, 1.

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

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

Preferably, the pharmaceutical dosage form is an external preparation.

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

An acupoint application for improving damp-heat constitution is prepared from any one of the traditional Chinese medicine composition mixed transdermal agents.

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

The invention has the advantages that:

1. the rhizoma atractylodis is warm in nature, pungent and bitter in flavor, and has the effects of invigorating spleen, eliminating dampness and invigorating 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 dissolving phlegm; the coix seeds are cool in nature, sweet and light in taste, enter spleen channels, stomach channels and lung channels, and have the effects of promoting diuresis, permeating moisture, tonifying spleen and stopping diarrhea; achyranthes bidentata has mild and mild properties, is bitter, sweet and sour in taste, enters liver and kidney meridians, and has the effect of inducing heat to descend; the nandina domestica is neutral in nature, sour and sweet in taste, enters lung meridian, and has the effects of dispelling wind, removing dampness and detoxifying; the processed rhizoma arisaematis is warm in nature, bitter and pungent in taste, enters lung and liver meridians, and has the effects of eliminating dampness and phlegm; the medicines are combined together, and are matched with ginger juice to guide the medicines to enter meridians, so that the effects of tonifying spleen and eliminating dampness and guiding heat to descend are achieved.

2. The Chinese medicinal composition is applied to acupuncture points, and the selected acupuncture points mainly comprise Yanglingquan, zhigou and Ququan. Ququan has the effects of clearing away damp-heat and regulating lower energizer. The branch meridians belong to the triple energizer meridian of hand Shaoyang, the Yanglingquan belongs to the gallbladder meridian of foot Shaoyang, and the Yanglingquan and branch meridians have the actions of relieving Shaoyang and clearing heat and resolving dampness. All points are mutually operated to achieve the effects of clearing heat, eliminating dampness, soothing liver and benefiting gallbladder, thereby improving the constitution state of the damp-heat constitution group.

3. The Chinese medicinal composition is applied to acupuncture points by using corresponding physique types of Chinese medicaments and matching with medicaments with pungent and warm natured, fleeing and meridian dredging according to the principle of 'treating internal diseases by external application', so that the medicaments enter the acupuncture points and meridians through skin striae, play the channel-entering and functional effects of the medicaments through the running action of qi and blood of the meridians, directly reach the relevant viscera, adjust the physique of the organism and enhance the disease resistance.

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

The invention aims to provide a traditional Chinese medicine composition for improving qi stagnation constitution aiming at the defects in the prior art.

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

the traditional Chinese medicine composition for improving the constitution of qi depression is prepared from the following raw material medicines in parts by weight: 10-20 parts of radix bupleuri, 10-20 parts of rhizoma cyperi, 10-20 parts of fructus aurantii, 5-10 parts of liquorice, 5-10 parts of rose and 5-10 parts of flos mume.

Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12-18 parts of radix bupleuri, 12-18 parts of rhizoma cyperi, 12-18 parts of fructus aurantii, 6-9 parts of liquorice, 6-9 parts of rose and 6-9 parts of flos mume.

More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15 parts of radix bupleuri, 15 parts of rhizoma cyperi, 15 parts of fructus aurantii, 7.5 parts of liquorice, 7.5 parts of rose and 7.5 parts of flos mume.

the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing bupleurum, rhizoma cyperi, bitter orange, liquorice, rose, flos mume =1, and 0.5.

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

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 coating agent or cataplasm.

An acupoint application for improving qi depression constitution is prepared from any one of the above traditional Chinese medicine composition mixed transdermal agents.

The invention has the advantages that:

1. the Chinese medicinal composition adopts medicaments, and the Chinese thorowax root has slightly cold nature and bitter taste, enters liver, gallbladder and lung channels, and has the effects of soothing liver and relieving depression; the accessory ingredient is mild in nature, pungent, slightly bitter and slightly sweet in flavor, enters liver, spleen and triple energizer meridians, and can soothe liver, relieve depression and regulate qi to relieve epigastric distention; the bitter orange is bitter and slightly sour in taste and slightly cold in nature, enters spleen, stomach and liver channels, and has the effects of regulating qi, relieving epigastric distention, activating stagnancy and relieving distension; the rose flower is sweet in taste, slightly bitter and warm in nature, enters liver and spleen channels, and has the effects of promoting qi circulation, activating blood circulation, soothing liver and relieving pain; the flos Pruni mume has mild property, sour and astringent taste, and has effects of calming liver, regulating stomach function, and regulating qi; the liquorice has mild nature and sweet taste, and enters heart, stomach, spleen and lung meridians to coordinate the effects of the other drugs in the recipe. The pungent and warm ginger is used for harmonizing, and the medicines are combined together to play the roles of promoting qi circulation and relieving depression.

2. The Chinese medicinal composition is applied to acupuncture points and selected from Shanzhong acupuncture points and Ganshu acupuncture points. The smell of mutton is the sea of qi, and the qi is regulated to widen the chest; ganshu is the acupoint where liver meridian qi is infused to the back to sooth the liver and regulate qi. The two points are combined to strengthen the effect of regulating qi and blood, thereby improving the physique state of people with qi stagnation and unbalanced physique.

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

The invention aims to provide a traditional Chinese medicine composition for improving qi-deficiency constitution aiming at the defects in the prior art.

the traditional Chinese medicine composition for improving qi-deficiency constitution is prepared from the following raw material medicines in parts by weight: 10-20 parts of astragalus membranaceus, 10-20 parts of fried bighead atractylodes rhizome, 10-20 parts of divaricate saposhnikovia root, 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 material medicines in parts by weight: 12-18 parts of astragalus membranaceus, 12-18 parts of fried bighead atractylodes rhizome, 12-18 parts of divaricate saposhnikovia root, 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 material medicines in parts by weight: 15 parts of astragalus, 15 parts of fried bighead atractylodes rhizome, 15 parts of divaricate saposhnikovia root, 7.5 parts of dried orange peel, 15 parts of heterophylly falsestarwort root and 1.5 parts of ginseng.

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

the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing the following components in percentage by weight, namely astragalus mongholicus, fried bighead atractylodes rhizome, divaricate saposhnikovia root, dried orange peel, heterophylly falsestarwort root, ginseng =1 and 0.1.

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

Preferably, the pharmaceutical dosage form is an external preparation.

An acupoint application for improving qi deficiency constitution is prepared from any one of the above traditional Chinese medicine compositions mixed with transdermal agent.

Preferably, the transdermal agent is made from a hot melt matrix and azone in a ratio of 1000.

The invention has the advantages that:

1. the selected medicines in the traditional Chinese medicine composition have sweet taste and warm nature, enter lung and spleen channels, and have the effects of tonifying qi, strengthening exterior, promoting urination and expelling toxin; the bighead atractylodes rhizome is bitter and sweet in taste and warm in nature, enters spleen and stomach channels, and has the effects of strengthening spleen and tonifying qi, eliminating dampness and promoting diuresis, arresting sweating and the like. Ledebouriella root, radix Saposhnikoviae, pungent and sweet in flavor and warm in nature, enters bladder, liver and spleen meridians and has the effects of relieving exterior syndrome, dispelling wind, eliminating dampness and relieving spasm. The dried orange peel is bitter and pungent in taste and warm in nature, enters lung and spleen meridians, and has the effects of regulating qi, strengthening spleen, eliminating dampness and reducing phlegm and the like. The radix pseudostellariae is sweet in taste, slightly bitter in taste and neutral in nature, and has the effects of tonifying qi and spleen, promoting the production of body fluid and moistening the lung and the like, and spleen and lung channels are entered. Ginseng is sweet in taste, slightly bitter in flavor and neutral in nature, and has the 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 benefiting qi and cultivating vigor, tonifying spleen and lung, and promoting qi circulation and stagnation.

2. The Chinese medicinal composition of the invention is mainly applied to acupuncture points of Qihai, pishu and Zusanli, the Pishu is an acupuncture point infused in the back through qi, both the Qihai and the Zusanli are essential acupuncture points for replenishing qi and cultivating vitality, and the acupuncture and moxibustion picture of the acupuncture points of the copper man is carried out in the section: the term "qi sea" refers to the sea where men generate qi. The acupoint has the functions of reinforcing primordial qi, tonifying kidney, controlling nocturnal emission, tonifying and restoring yang. Cloud of Qianjin Yao Fang: "if you want to calm, sanli is not dry. The three points are combined to strengthen the functions of tonifying qi, strengthening the body and prolonging life, thereby improving the physical condition of people with qi deficiency and unbalanced constitution.

Detailed Description

The examples are as follows:

EXAMPLE 1 preparation of the Chinese medicinal composition of the present invention

Weighing 15 parts of the bulk drugs including rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, cortex magnoliae officinalis, fructus nandinae, and rhizoma arisaematis cum bile according to the proportion of 1.

Example 2 preparation of the Chinese medicinal composition of the present invention

Weighing 10 parts of the bulk drugs including rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, cortex magnoliae officinalis, fructus nandinae, and rhizoma arisaematis cum bile according to the proportion of 1.

Example 3 preparation of the Chinese medicinal composition of the present invention

Weighing 20 parts of the bulk drugs including rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, cortex magnoliae officinalis, fructus nandinae, and rhizoma arisaematis cum bile according to the proportion of 1.

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

The preparation method comprises the following steps of weighing 11 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, cortex magnoliae officinalis, fructus nandinae and prepared arisaema cum bile according to a ratio of 1.

Example 5 preparation of the Chinese medicinal composition of the present invention (V)

The preparation method comprises the following steps of weighing 12 parts of rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, cortex magnoliae officinalis, fructus nandinae and prepared arisaema cum bile according to a ratio of 1.

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

13 parts of each of the raw materials including rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, cortex magnoliae officinalis, fructus nandinae and prepared arisaema cum bile are weighed according to the proportion of 1.

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

Weighing 14 parts of the bulk drugs including rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, cortex magnoliae officinalis, fructus nandinae, and rhizoma arisaematis cum bile according to the proportion of 1.

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

Weighing 16 parts of raw material rhizoma arisaematis, processed pinellia ternate, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos according to the proportion of 1.

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

Weighing 17 parts of the bulk drugs including rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, cortex magnoliae officinalis, fructus nandinae, and rhizoma arisaematis cum bile according to the proportion of 1.

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

Weighing 18 parts of the bulk drugs including rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, cortex magnoliae officinalis, fructus nandinae and prepared arisaema cum bile according to the proportion of 1.

EXAMPLE 11 preparation of the Chinese medicinal composition of the present invention for Point application

(1) In any of embodiments 1-10, the raw materials are weighed according to the weight ratio, smashed into powder, mixed with a proper amount of ginger juice and a hot melt adhesive matrix, and blended into paste, wherein the ratio of the traditional Chinese medicine powder to the hot melt adhesive matrix is generally 1:3.

(2) Making the above mixture into fluid extract, extracting with appropriate solvent (water added with 20% -25% ethanol), and evaporating part of the solvent to adjust the concentration to 1g per 1 ml.

(3) Heating 1kg of medical pressure-sensitive thermosol in a pot to about 80 ℃ for melting, then cooling to about 60-70 ℃, slowly adding the medicinal powder, uniformly stirring, adding the fluid extract and azone (the ratio of matrix and azone in the transdermal agent is about 1000.

EXAMPLE 12 preparation of Patches of the Chinese medicinal composition of the present invention

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

(2) Vacuum concentrating the above medicinal liquid under reduced pressure, 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 a square medical adhesive plaster with fixed size, and reserving a certain size at the peripheral edge to fix the adhesive plaster.

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

(2) Vacuum concentrating the above medicinal liquid under reduced pressure to obtain medicinal liquid concentrate;

(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 gel of the Chinese medicinal composition of the present invention

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

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

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

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

Example 16 clinical experiments on acupoint application of the Chinese medicinal composition of the present invention

1 study object

1.1 sample Source

The experimental sample is obtained from 30 traditional Chinese medicine damp-heat constitution and gouty arthritis patients meeting the inclusion standard in an outpatient clinic and an inpatient department of an affiliated eosin hospital of Shanghai medical university from 6 months to 2021 month in 2020, and is randomly divided into 15 patients in an intervention group and a control group respectively.

1.2 diagnostic criteria

1.2.1 diagnostic standards for damp-heat constitution in traditional Chinese medicine

The constitution of the examinee is judged to be damp-heat constitution according to the conversion and classification result of the integral quantity table of classification and judgment of traditional Chinese medicine published by the Chinese medicine publishing company in 2009, 4, 9 and combined with the judgment of a doctor.

Questionnaire for judgment of damp-heat constitution: (1) do you have a greasy feeling or a shiny finish on the face or nose? (2) Do you easily develop acne or sores? (3) Do you feel bitter in the mouth or have a bad smell in the mouth? (4) Do you have sticky stool and feel unsound? (5) Do you feel a sensation of warmth in the urethra and make the urine dark? (6) Do you have yellow color (yellowish white color)? (female answer limited) (7) do you have a moist scrotum area? (Limited Male response)

The criteria are as follows:

TABLE 1 Chinese medicinal constitution judgment Standard Table

Note: 1. the scoring method comprises the following steps: each item is counted in 1, 2, 3, 4 and 5 points according to the terms of "none (or) little", "sometimes", "often" and "always", respectively. 2. Conversion fraction = (each entry total division-the number of entries)/(the number of entries × 4) × 100; the range is 0 to 100 minutes.

In this experiment, the damp-heat constitutions were classified into 40 or more groups.

1.2.2 diagnostic criteria for gouty arthritis disease

The traditional Chinese medicine diagnosis conforms to the regulation of the traditional Chinese medicine disease syndrome diagnosis curative effect standard on gout (arthralgia syndrome); the western medicine diagnosis conforms to the regulation of primary gout diagnosis and treatment guidelines on gout and gouty arthritis.

1.3 inclusion criteria

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

2. patients with other diseases may enter the pathway, but no special treatment is required during treatment nor does it affect the implementation of the clinical pathway routine of the first diagnosis;

3. glucocorticoid, colchicine or non-steroidal anti-inflammatory analgesic drugs are not adopted for treatment within 4 weeks before treatment; and signing an informed consent before group entry.

1.4 exclusion criteria

1. Patients with diseases such as rheumatic arthritis, systemic lupus erythematosus and suppurative arthritis which may cause arthropathy;

2. patients with serious primary diseases such as cardiovascular and cerebrovascular systems, liver and kidney systems, hemopoietic system and the like are combined;

3. and those with poor treatment compliance.

1.5 shedding criterion

1. The disease condition is aggravated during the treatment period, and special treatment is needed, so that the treatment time is prolonged, and the cost is increased;

2. exiting the pathway with serious complications;

3. other diseases appear in the treatment period, and need to be treated, and the treatment process is withdrawn;

4. the execution of the path is influenced by the will of the patient and his family members, and the patient exits the path.

2 research methods

2.1 grouping scheme

The grouping scheme of the experiment is based on a random number method. The specific operation is as follows: random numbers were created with the help of EXCEL software "= rand ()", and the data were arranged from small to large, with the first 15 being control groups and the last 15 being treatment groups, for a total of 30 patients.

2.2 treatment regimens

The control group treatment scheme is that etoricoxib tablets are taken orally by 120mg each time, 1 time a day is divided into 2 treatment courses for 60 days.

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

The Chinese medicinal composition is applied to acupuncture points: the disease control center of the eosin Hospital, affiliated to Shanghai medical university aims at the characteristics of damp-heat physique, combines the characteristics of meridians, acupuncture points and medicines, and is independently researched and developed. The main components of the composition are as follows: rhizoma atractylodis, radix achyranthis bidentatae, semen coicis, mangnolia officinalis, fructus nandinae domesticae and arisaema cum bile. (ratio: 1.

The manufacturing process comprises the following steps: (1) the required traditional Chinese medicine granules are prepared by mixing the following raw materials in proportion of 1. (2) Making the above mixture into fluid extract, extracting with appropriate solvent (water and 20-25% ethanol), and evaporating part of the solvent to adjust the concentration to 1g per 1 ml. (3) Heating 1kg of medical pressure-sensitive thermosol in a pot to about 80 ℃ for melting, then cooling to about 60-70 ℃, slowly adding the medicinal powder, uniformly stirring, adding the fluid extract and azone (the ratio of matrix to azone in the transdermal agent is about 1000.

The using method comprises the following steps: order the patient to keep the skin warm and moist after bathing or scrubbing limbs, the Chinese medicinal composition is applied to the acupoints of Yanglingquan and the branches of the human body for 4-8 hours each time and three times a week.

2.3 Chinese medicine constitution grading conditions

And comparing and observing the change conditions of the transformation and division of the constitutions of the two groups of intervention subjects before and after the intervention, wherein the transformation and division of the constitutions with qi deficiency in the traditional Chinese medicine is a main curative effect index.

2.4 adverse events recording

And observing whether adverse events or adverse reactions (such as skin pruritus, red, swollen and hot pain of skin, skin ulceration and the like) of the applied medicine occur or not during the application of the traditional Chinese medicine composition on the acupuncture points, and if so, timely recording the occurrence time and treatment measures.

2.5 criteria for clinical intervention efficacy

2.5.1 Chinese medicine clinical intervention curative effect judgment standard

The clinical intervention curative effect judgment of the traditional Chinese medicine is carried out according to the transformation of the damp-heat constitution of the traditional Chinese medicine, and the standard of the clinical intervention curative effect judgment of the traditional Chinese medicine refers to the relevant standard of 'the standard of curative effect of diagnosis of traditional Chinese medicine diseases' issued by the State drug administration in 2017 for judging the symptom integral change.

Efficacy index (n) = difference in integral of symptoms before and after treatment/integral of symptoms before treatment × 100%.

(1) The clinical cure is as follows: clinical symptoms and physical signs disappear or basically disappear, and the syndrome score is reduced by more than or equal to 95 percent.

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

(3) The method has the following advantages: clinical symptoms and physical signs disappear or basically disappear, and the syndrome score is reduced by more than or equal to 30 but less than 70 percent.

(4) And (4) invalidation: the clinical symptoms and physical signs are not obviously improved or even aggravated, and the syndrome score is reduced by less than 30%.

2.5.2 therapeutic criteria for gouty arthritis

(I) evaluation criteria

(1) The effect is shown: clinical symptoms and positive signs completely or basically disappear, the joint function returns to normal, and indexes such as SUA and the like return to a normal range.

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

(3) And (4) invalidation: clinical symptoms and physical signs are not obviously relieved, and indexes such as joint function, SUA and the like are not obviously improved or even aggravated.

2.5.3 Observation index

Clinical effects before and after treatment of the two groups of patients were compared, and the transformation scores of the traditional Chinese medicine damp-heat physique before and after treatment were compared with the levels of blood Uric Acid (UA), erythrocyte Sedimentation Rate (ESR) and C-reactive protein (CRP). Laboratory index examination gout patients' sera were extracted before and 7d after administration, respectively, and UA, ESR, CRP were each tested 1 time.

3. As a result, the

3.1 constitutional transformation division

TABLE 2 comparison of transformation ratios of damp-heat constitutions of traditional Chinese medicine before and after treatment of two groups of patients

Note: p <0.05 compared to pre-treatment; p <0.05 compared to control.

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

TABLE 3 comparison of the two groups of clinical effects (n)

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

Note: compared with the control group, the compound of the formula, ^△ P<0.05

3.3 after the treatment, the ESR, CRP and SUA levels are all obviously reduced (P is less than 0.05), and the reduction degree of the observed group is more obvious (P is less than 0.05).

TABLE 4 comparison of two sets of observations

3.4 results of the study of safety indices

The patients have no adverse reaction (such as skin pruritus, red and swollen skin, heat pain, skin ulceration, etc.) of the applied medicine during the treatment period.

4 discussion of

4.1 concept and clinical features of constitutions of Damp-heat

The constitution of damp-heat is a constitution state formed by smoking and drinking, frequent staying up all night, improper nourishing, liver depression and qi stagnation, relative obstruction of liver-gallbladder and spleen-stomach functions caused by environmental factors, stagnation of liver-gallbladder and heat transformation, stagnation of spleen-stomach and dampness transformation, and damp-heat fumigation.

The damp-heat constitution can be manifested as greasy and dirty face, acne, bitter taste, dry mouth, heavy body, tiredness, sticky stool, dry stool, scanty and yellow urine, damp scrotum, increased vaginal discharge, reddened tongue, yellow and greasy coating, and slippery and rapid pulse. Susceptible to skin ulcer, furuncle, jaundice, stranguria due to heat, constipation, cholecystitis, and oral ulcer. The environment with high humidity or high temperature is difficult to adapt to the humid and hot climate in late summer and early autumn.

4.2 Point application and composition analysis of the Chinese medicinal composition

The Chinese medicinal composition acupoint application is developed by combining characteristics of channels, collaterals, acupoints and medicaments according to characteristics of damp-heat constitution by professor Zhang Xiaotian. The main components of the medicine are rhizoma atractylodis, achyranthes bidentata, coix seed, officinal magnolia bark, common nandina seed and prepared arisaema cum bile. (proportion: 1.

Rhizoma atractylodis: the taste is warm, pungent and bitter, and the liver-meridian entered spleen, stomach and liver meridians, and has the efficacy of drying dampness and strengthening spleen;

magnolia officinalis: warm in nature, bitter and pungent in flavor, and has the effects of eliminating dampness and eliminating phlegm, and the spleen, stomach, lung and large intestine meridians entered;

coix seed: cool in nature, sweet and light in flavor, and has effects of promoting diuresis, permeating moisture, invigorating spleen and relieving diarrhea;

achyranthes bidentata: mild in nature, bitter, sweet and sour in taste, entering liver and kidney meridians, and has the efficacy of inducing heat to descend;

the method comprises the following steps of (1) Geranium: the wine has mild nature and sour and sweet taste, enters lung meridian, and has the effects of dispelling wind, removing dampness and detoxifying;

preparing the rhizoma arisaematis: warm in nature, bitter and pungent in flavor, entering lung and liver meridians, and has the effects of eliminating dampness and phlegm;

4.3 Point selection analysis

The acupoints are selected from Ququan, zhigou and Yanglingquan, and Ququan has the effects of clearing away damp-heat and regulating lower energizer. The branch meridians belong to the triple energizer meridian of hand Shaoyang, the Yanglingquan belongs to the gallbladder meridian of foot Shaoyang, and the Yanglingquan and branch meridians have the actions of relieving Shaoyang and clearing heat and resolving dampness. All points are mutually operated to achieve the effects of clearing heat, eliminating dampness, soothing liver and benefiting gallbladder, thereby improving the constitution state of the damp-heat constitution group.

Example 17 animal experiments

1. Materials and methods

1.1 Experimental materials

1.1.1 Experimental animals

40 male SPF-grade Sprague-Dawley (SD) mice, which were provided by Shanghai Si Rick laboratory animals Co., ltd., in a body mass of 200. + -.20 g, were kept at a constant temperature of 22. + -. 1 ℃ and a fixed illumination rhythm of 12: 12, and were allowed to freely take food and water.

1.1.2 Experimental drugs the invention groups: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of semen coicis, 15 parts of mangnolia officinalis, 15 parts of fructus nandinae, and 15 parts of processed arisaema cum bile of a control group 1: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of fried semen coicis, 15 parts of fructus amomi, 15 parts of fructus nandinae, and 15 parts of processed arisaema cum bile of a contrast 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 fructus nandinae, 15 parts of concretio silicea bambusae and 15 parts of concretio silicea bambusae as a control group 3: 15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of fried semen coicis, 15 parts of mangnolia officinalis, 15 parts of fructus nandinae domesticae and 15 parts of concretio silicea bambusae

1.2 Experimental methods

1.2.1 experimental groups: the 40 mice were classified according to the random number table method: the invention group, the comparison group 1, the comparison group 2 and the comparison group 3 are 10 in each group.

1.2.2 preparation of Damp-heat constitution mouse model: the feeding conditions of mice in the invention group, the control group 1, the control group 2 and the control group 3 are fed with fat and sweet diet (5% lard, 3% egg yolk and 5% honey are mixed in common feed) and tail vein injection of escherichia coli endotoxin (2 microgram/kg), and the mice are continuously fed for 6 weeks 2 times a week to establish a damp-heat quality rat model. Adapted feeding was performed 6 weeks later for experiments.

Along with the experiment, each group of rats has the symptoms of dysphoria, ceaselessly scratching the head and face, accelerated breathing, static and motionless, stretching the neck and contracting the chest of severe patients and the like, and has different degrees of viscous stool or loose diarrhea with foul odor and filth, red swelling and filth of the anus, lassitude, less movement, less eating and less drinking. The damp-heat model established in the experiment accords with the syndrome performance characteristics expressed by the comprehensive Chinese medicine four-diagnosis information, is close to the characteristics of integrity, representation and the like of the damp-heat syndrome of the human body, prompts the success of damp-heat syndrome modeling, and indicates the success of modeling.

1.2.3 methods of administration:

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

application of the invention group: adding the mouse back 8% Na ₂ S depilating, the area is about 4cm multiplied by 4cm, after local disinfection with 75% alcohol, the paste of the invention (15 parts of rhizoma atractylodis, 15 parts of radix achyranthis bidentatae, 15 parts of semen coicis, 15 parts of magnolia officinalis, 15 parts of fructus nandinae domesticae and 15 parts of processed arisaema cum bile) is stuck and fixed at the depilatory (goalkeeper and liver shu). Then lightly pressing for 2 times, and then wrapping the chest and back with adhesive sticker for fixation. (about 0.5 g of each tablet (drug core)) is applied for 8h and then removed, 1 time per day, and 20 times of application are carried out.

Application control group 1: the mouse was backed with 8% Na ₂ S depilating, the area is about 4cm × 4cm, sterilizing with 75% alcohol, and fixing the patch of control group 1 (rhizoma Atractylodis 15 parts, achyranthis radix 15 parts, parched Coicis semen 15 parts, fructus Amomi 15 parts, fructus Pelargonii Hortori 15 parts, and processed Arisaema cum bile 15 parts) on the depilatory site (SHANZHONG and GANSHU). Then lightly pressing for 2 times, and then wrapping the chest and back with adhesive sticker for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8h and then taken out, 1 time per day, and 20 times in total.

Application control group 2: the mouse was backed with 8% Na ₂ S depilating, the area is about 4cm × 4cm, after local sterilization with 75% alcohol, the application 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 fructus Pelargonii Hortori, 15 parts of concretio silicea Bambusae seu Schizostachyi) is fixed on the depilated part (Tanzhong, ganshu). Pressing gently for 2 times, and using pressure sensitive adhesive clothAnd (5) winding the chest and the back for fixation. (about 0.1 g of each tablet (drug core)) is applied for 8h and then taken out, 1 time per day, and 20 times in total.

Application control group 3: adding the mouse back 8% Na ₂ S depilating, the area is about 4cm × 4cm, after topical disinfection with 75% alcohol, the application control group 3 (rhizoma Atractylodis 15 parts, achyranthis radix 15 parts, parched Coicis semen 15 parts, cortex Magnolia officinalis 15 parts, fructus Pelargonii Hortori 15 parts, concretio silicea Bambusae seu Schizostachyi 15 parts) is fixed on the depilated part (SHANZHONG, GANSHU). Then lightly pressing for 2 times, and then wrapping the chest and back with adhesive sticker for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8h and then taken out, 1 time per day, and 20 times in total. Spironolactone 7mg/kg, and the stomach was drenched continuously for 30 days.

1.2.4 Observation detection index

The weight change and blood fat change of the mice before and after intervention.

1.2.5 statistical treatment

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

2. Results

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

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

TABLE 6 Effect of different patches on mouse blood lipid (x. + -. S, mmol/L)

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

discussion of the related Art

According to the invention, an environment, a diet, a cause and a biological infection factor are selected to duplicate a damp-heat syndrome model, and the improvement effect on the damp-heat constitution of the mouse is observed. After the experiment is finished, the contents of CHOL, LDL-C and HDL-C in the serum of each group of mice are detected, and the serum of the model group of mice is obviously increased, the serum of the model group of mice is obviously reduced and the level of HDL-C is obviously reduced under the high-fat diet, so that the lipid metabolism disorder is generated. Therefore, the diet is proved to be one of the key factors causing damp-heat syndrome.

In the examples, the degree of weight gain before and after intervention on mice in the group of the invention is smaller than that of the other groups, and the statistical difference exists. Compared with the control groups 1, 2 and 3CHOL, the mice applied and intervened by the group of the invention have obviously reduced LDL-C level and increased HDL-C level, and have statistical significance. The experimental result shows that: the damp-heat plaster has certain lipid regulating effect.

EXAMPLE 18 preparation of the Chinese medicinal composition of the present invention

Weighing 15 parts of radix bupleuri, 15 parts of rhizoma cyperi, 15 parts of fructus aurantii, 7.5 parts of liquorice, 7.5 parts of rose and 7.5 parts of flos mume calyx mume according to the proportion of 1.

EXAMPLE 19 preparation of the Chinese medicinal composition of the present invention

Weighing 10 parts of radix bupleuri, 10 parts of rhizoma cyperi, 10 parts of fructus aurantii, 5 parts of liquorice, 5 parts of rose and 5 parts of flos mume calycis according to the proportion of 1.

EXAMPLE 20 preparation of the Chinese medicinal composition of the present invention

Weighing 20 parts of radix bupleuri, 20 parts of rhizoma cyperi, 20 parts of fructus aurantii, 10 parts of liquorice, 10 parts of rose and 10 parts of flos mume calycis according to the proportion of 1.

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

Weighing 12 parts of radix bupleuri, 12 parts of rhizoma cyperi, 12 parts of fructus aurantii, 6 parts of liquorice, 6 parts of rose and 6 parts of flos mume calycis according to the proportion of 1.

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

Weighing 18 parts of radix bupleuri, 18 parts of rhizoma cyperi, 18 parts of fructus aurantii, 9 parts of liquorice, 9 parts of rose and 9 parts of flos mume calycis according to the proportion of 1.

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

Weighing 11 parts of radix bupleuri, 11 parts of rhizoma cyperi, 11 parts of fructus aurantii, 5.5 parts of liquorice, 5.5 parts of rose and 5.5 parts of flos mume calyx mume according to the proportion of 1.

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

Weighing 13 parts of radix bupleuri, 13 parts of rhizoma cyperi, 13 parts of fructus aurantii, 6.5 parts of liquorice, 6.5 parts of rose and 6.5 parts of flos mume calyx mume according to the proportion of 1.

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

The preparation method comprises the following steps of weighing 14 parts of radix bupleuri, 14 parts of rhizoma cyperi, 14 parts of fructus aurantii, 7 parts of liquorice, 7 parts of rose and 7 parts of flos mume according to the proportion of 1.

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

Weighing 16 parts of radix bupleuri, 16 parts of rhizoma cyperi, 16 parts of fructus aurantii, 8 parts of liquorice, 8 parts of rose and 8 parts of flos mume calycis according to a proportion of 1.

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

Weighing 17 parts of radix bupleuri, 17 parts of rhizoma cyperi, 17 parts of fructus aurantii, 8.5 parts of liquorice, 8.5 parts of rose and 8.5 parts of flos mume calyx mume according to the proportion of 1.

EXAMPLE 28 preparation of the Point application of the Chinese medicinal composition of the present invention

(1) In any of embodiments 18-27, the raw materials are weighed according to the weight ratio, smashed into powder, and then mixed with a proper amount of ginger juice and a hot melt adhesive matrix to blend into paste, wherein the ratio of the traditional Chinese medicine powder to the hot melt adhesive matrix is generally 1:3.

(2) Making the above mixture into fluid extract, extracting with appropriate solvent (water and 20-25% ethanol), and evaporating part of the solvent to adjust the concentration to 1g per 1 ml.

EXAMPLE 29 preparation of Patches of the Chinese medicinal composition of the present invention

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

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

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

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

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

Example 33 clinical experiments on acupoint application of the Chinese medicinal composition of the present invention

1 study object

1.1 sample Source

70 patients with functional constipation (air-secret type) at the outpatient service and hospitalization of the Shanghai medical university affiliated eosin Hospital, 6/month to 2021/month in 2020 were randomly divided into 35 patients each for the treatment group and the control group. Poor follow-up compliance in the treatment groups dropped out of 1 and completed 34 studies, 16 of which were male and 18 of which were female; age 22-70 years, average 59 years; wherein, 3 people externally apply the blood-activating pain-relieving ointment to the skin to cause skin rash due to skin allergy, and the application is changed into external application of gauze to improve the skin rash, thus completing the research. The control group followed up 2 cases and completed 33 cases of study; 16 of the men and 17 of the women; the age is 25-70 years, and the average age is 61 years. The baseline data comparison of the 2 patients was not statistically significant (P > 0.05) and was comparable.

1.2 diagnostic criteria

1.2.1 Chinese medicine diagnosis Standard for Qi stagnation constitutions

The constitution of the subject was judged to be the constitution of qi stagnation according to the score quantitative table conversion classification result of "classification and judgment of traditional Chinese medical constitution" published by traditional Chinese medicine publishing house in 2009, 4, 9 and combined with the judgment of a doctor.

Questionnaire for judging constitution of qi stagnation: (1) do you feel stuffy and happy, and have a low mood? (2) Do you feel easy to be nervous, anxious? (3) Is you good at feeling and feelings fragile? (4) Is you afraid or frightened easily? (5) Do you distend pain in the rib or breast? (6) Do you think about nothing about exclamations? (7) Do you feel a foreign body sensation in the throat, and do you not vomit and do not get down the pharynx?

The criteria are as follows:

TABLE 7 Chinese medicinal constitution standard table

Note: 1. the scoring method comprises the following steps: each item is counted in 1, 2, 3, 4 and 5 points according to the terms of "none (or) little", "sometimes", "often" and "always", respectively. 2. Conversion fraction = (total fraction of each entry-number of entries)/(number of entries × 4) × 100; the range is 0 to 100 minutes.

In this experiment, the transformation of qi-stagnation constitutions into 40 or more was judged as qi-stagnation constitutions.

1.2.2 functional Constipation disease diagnostic criteria

(I) disease diagnosis

1. Diagnostics of traditional Chinese medicine

Reference is made to the relevant contents of the national standard of the people's republic of China, the syndrome part of the Chinese medical clinical diagnosis and treatment term and the internal science of Chinese medicine.

2. Western diagnosis

Reference is made to the roman iii diagnostic standard for functional constipation.

1.3 inclusion criteria

3.1 Those who meet the criteria for western diagnosis of chronic functional constipation;

2) The syndrome differentiation and diagnosis of qi secret traditional Chinese medicine are met;

3) Those aged 18-70 years;

4) The subjects were informed and voluntarily signed an informed consenter.

1.4 criteria for shedding

2. exiting the pathway with serious complications;

3. other diseases appear during treatment and need treatment, and the patient exits from the path;

2 research methods

2.1 grouping scheme

The grouping scheme of the experiment is based on a random number method. The specific operation is as follows: random numbers were created with the help of EXCEL software "= rand ()", and the data were arranged from small to large, with the first 35 being control groups and the last 35 being treatment groups, for a total of 70 patients.

2.2 treatment regimens

The control treatment regimen was oral administration of Simotang oral liquid (Hunan Hansen pharmaceutical Co., ltd., lot: 1610103, specification: 10m L/ramus) 2 (20 m L) at a time, 3 times/d.

The treatment plan of the treatment group is to apply the Chinese medicinal composition to acupuncture points, and the treatment plan is divided into 2 treatment courses for 60 days.

The Chinese medicinal composition is applied to acupuncture points: the traditional Chinese medicine preparation is prepared by combining the characteristics of meridians, acupuncture points and medicines according to the characteristics of qi-deficiency constitution by the preventive treatment center of the eosin Hospital of Shanghai university of medicine. The main components of the traditional Chinese medicine composition are bupleurum, rhizoma cyperi, fructus aurantii, liquorice, rose and flos cupressae praecox (the proportion is 1.

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. (2) Making the above mixture into fluid extract, extracting with appropriate solvent (water and 20-25% ethanol), and evaporating part of the solvent to adjust the concentration to 1g per 1 ml. (3) Heating 1kg of medical pressure-sensitive thermosol in a pot to about 80 ℃ for melting, then cooling to about 60-70 ℃, slowly adding the medicinal powder, uniformly stirring, adding the fluid extract and azone (the ratio of matrix to azone in the transdermal agent is about 1000.

The using method comprises the following steps: order the patient to keep the skin warm and moist after bathing or scrubbing the limbs, the Chinese medicinal composition is applied to the acupoints of the Danzhong and Ganshu of the human body for 4-8 hours each time and three times a week.

2.3 Chinese medicine constitution grading conditions

2.4 adverse events recording

Observing whether adverse events or adverse reactions (such as skin pruritus, red and swollen skin, thermal pain, skin ulceration and the like) of the applied medicine occur during the application of the traditional Chinese medicine composition on the acupuncture points, and recording the occurrence time and treatment measures in time if the adverse events occur.

2.5 criteria for clinical intervention efficacy

The chief symptoms are that the first defecation time, the defecation interval time, the defecation time and the defecation quality are graded and scored according to grades (light =0 points, medium =2 points and heavy =4 points); and (3) concurrent evidence: abdominal distension, abdominal pain, anal fissure and hematochezia, sweating in effort, and anorexia show 1 symptom which is 0.5 point but not 0 point.

2.6 therapeutic criteria

And (3) healing: the stool is normal, and other symptoms disappear completely. The effect is shown: the constipation is obviously improved, the interval time and the stool quality are close to normal, or the stool is slightly dry and the defecation interval time is less than 72 hours, most other symptoms disappear, and the integral is reduced by 2/3; effectively, the defecation interval time is shortened by 1 day, or the stool quality is improved, other symptoms are improved, and the integral is reduced by l/3 but less than 2/3; and (4) 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, blood and stool routine and occult blood, liver function and kidney function of 2 groups of patients before and after observation and treatment.

2.8 statistical methods

Statistics were performed using SPSS24.0 statistics software. If the data satisfy normal distribution, use mean ± standard deviation

The description is made. Comparing the two groups of data, conforming to normal distribution, and testing by using an independent sample t; comparing data before and after intervention, and adopting pairing t test to meet normality; the counting data is tested by adopting X2; if the data does not conform to normal distribution or the data is level data, then the rank sum test is used. P <0.05 is statistically significant.

3 results

3.1 clinical efficacy

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

TABLE 8 comparison of the two clinical effects

3.2 integration of syndrome

The syndrome score of the two groups of patients after treatment is improved compared with that before treatment, and the differences have statistical significance (P is less than 0.01); the comparative difference between the two groups after treatment has statistical significance (P < 0.05), and the treatment group has more obvious improvement on syndrome score than the control group, which is shown in Table 9.

TABLE 9 integral comparison of two syndromes

3.3 transformation of constitutions into different types

After treatment, the transformation of the traditional Chinese medicine qi-stagnation physique of two groups of patients is improved compared with that before treatment, and the difference has statistical significance (P is less than 0.01); the comparative difference between the treated groups 2 has statistical significance (P is less than 0.05), and the conversion of the treatment groups in improving the qi-stagnation constitution of the traditional Chinese medicine is obvious, which is shown in the table 10.

TABLE 10 conversion ratio of Chinese medicinal constitution with qi stagnation before and after treatment

Discussion 4

4.1 concept and clinical features of constitutions of qi stagnation

Qi stagnation constitutions are constitutional states mainly manifested as unstable constitutions, fragile melancholy and susceptiveness due to long-term emotional disorder and qi stagnation. People in this constitution are often seen in middle-aged and young years, and have a tendency to be worried about the sensation and narrow qi volume in the rare female and isolated character. The disease of people with qi stagnation is mainly caused by liver, and also involves heart, stomach, large intestine and small intestine. Emotional and dietary disorders are easily damaged, qi movement disorder such as depression, insomnia, globus hystericus and panic occurs, and modern researches on this type of constitution are prone to tumor.

For recuperation and treatment, it is advisable to harmonize the emotion and dredge qi. Constitutions of qi deficiency often appear: emaciation or slight fat, pale complexion, shortness of breath, no desire to speak, tiredness, lassitude, spontaneous sweating, especially with exertion, pale red tongue with teeth marks on the edge, white coating, and weak pulse. The deficiency of five zang organs is clinically seen, and the common symptoms of heart, lung, spleen and kidney are different due to the corresponding pathological changes of deficiency of heart, lung, spleen and kidney, except the common clinical manifestations of qi deficiency. The incidence tendency is as follows: susceptible to cold, dizziness due to qi deficiency, and visceral prolapse, and is weak in Pinggu resistance and slow in recovery after illness.

The Chinese medicinal composition acupoint application is prepared by combining characteristics of meridians, acupoints and medicaments according to characteristics of qi depression constitution taught by Zhang Xiaotian and independently researching and developing. The traditional Chinese medicine composition mainly comprises the following components of radix bupleuri, rhizoma cyperi, fructus aurantii, liquorice, rose and flos mume (the ratio is 1.

Bupleurum root: bitter and pungent in flavor, slightly cold in nature, entering liver and gallbladder meridians. Relieving exterior syndrome and bringing down fever, soothing liver and relieving qi stagnation, and lifting yang qi are the essential herbs for treating stagnation of liver qi, and are commonly used for treating distending pain in chest and hypochondrium or lower abdomen, depression, female menstrual disorder, dysmenorrhea, etc. caused by liver qi loss and qi stagnation.

Rhizoma cyperi: pungent, slightly bitter, slightly sweet and neutral in nature. It enters liver, spleen and triple energizer meridians. To soothe the liver, relieve depression, regulate qi, relieve epigastric distention, regulate menstruation and alleviate pain. Can be used for treating stagnation of qi due to depression of the liver, distending pain in chest and hypochondrium, hernia pain, breast pain, stagnation of qi in spleen and stomach, abdominal distention, distention and pain, menoxenia, and amenorrhea and dysmenorrhea. Cyperus rotundus has good effect of soothing liver and relieving qi stagnation, and is the essential herb for liver qi circulation and relieving qi stagnation, and it is clinically combined with chai Hu and Zhi Qiao.

Fructus aurantii: bitter, pungent, sour and slightly cold in nature. It enters spleen and stomach meridians. Has the effects of regulating qi, relieving epigastric distention, activating stagnancy and relieving flatulence. It is clinically used to treat qi stagnation in chest and hypochondrium, fullness and pain, indigestion, phlegm-fluid retention, and viscera prolapse.

Licorice root: mild in nature and sweet in taste. They enter heart, stomach, spleen and lung meridians. Invigorating spleen and replenishing qi, relieving cough and eliminating phlegm, relieving spasm and relieving pain, and harmonizing drug property.

And (3) rose: it is warm in nature, sweet in taste and slightly bitter in flavor, entering liver and spleen meridians. Move qi and relieve depression, regulate qi and alleviate pain. It can be used for treating liver and stomach pain, menoxenia, liver wind headache, liver stagnation hematemesis, chronic cholecystitis, qi stagnation, and chest distress.

And (3) green calyx plum: slightly sour and astringent taste, mild nature. It enters liver, stomach and lung meridians. The medicine has the effects of aromatic circulation of qi and entering liver and stomach, is a good medicine for treating qi pain of liver and stomach, is also commonly used for relieving depression, opening chest and guiding qi downward, reducing phlegm and resolving masses, and is a good health care product for people with liver qi stagnation. It is suitable for treating hypochondriac pain, abdominal distention, belch, anorexia, gastralgia, and dyspepsia due to stagnation of liver-qi and stomach-qi. Emotional discomfort, stagnation of liver-qi, and phlegm-qi stagnation, neurasthenia, globus hystericus, laryngopharynx discomfort, and chronic pharyngitis.

4.3 Point selection analysis

The selection of acupoints mainly involves Tanzhong and Ganshu, where the Tanzhong is the accumulation of meridian qi, which is mentioned in Huangdi's classic: the Danzhong person, the minister and envoy officer, pleased to enjoy the Yan. Modern research shows that the stimulation of the acupoint can achieve the effective treatment aim on various qi diseases through the functions of regulating nerve function, relaxing smooth muscle, expanding coronary vessels, expanding the inner cavity diameter of the digestive tract and the like. Ganshu is the back Shu point of the liver, qianjin Fang: "Ganshu, pishu and Shichang, which are the main hypochondriac regions with acute pain. Modern times, it is commonly used to treat acute and chronic hepatitis, cholecystitis, conjunctivitis, nyctalopia, myopia, etc. The two points are combined to play the roles of relieving chest stuffiness and regulating qi, promoting blood circulation to stop pain, and eliminating arthralgia and dredging collaterals, thereby improving the physique state of people with qi stagnation and unbalanced physique.

Example 34 animal experiments

1. Materials and methods

1.1 Experimental materials

1.1.1 Experimental animals

SPF grade Sprague-Dawley (SD) male mice, 40, with a body mass of 200 + -20 g, provided by Shanghai Si Rick laboratory animals Co., ltd, were kept at a constant temperature of 22 + -1 deg.C and a fixed illumination rhythm of 12: 12, and were allowed free access to food and water.

1.1.2 Experimental drugs the invention groups: 15 parts of radix bupleuri, 15 parts of rhizoma cyperi, 15 parts of fructus aurantii, 7.5 parts of liquorice, 7.5 parts of rose, 7.5 parts of cupressus mume, 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, 7.5 parts of plum blossom bud: 15 parts of radix bupleuri, 15 parts of rhizoma cyperi, 15 parts of fructus aurantii, 7.5 parts of raw malt, 7.5 parts of Chinese rose flower and 7.5 parts of flos cupressae praecox, wherein the weight ratio of the Chinese medicinal materials to the green calyx is 3: 15 parts of radix bupleuri, 15 parts of citron, 15 parts of fructus aurantii, 7.5 parts of liquorice, 7.5 parts of Chinese rose and 7.5 parts of flos mume

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

1.1.4 Main instruments: a measuring cylinder; and a stopwatch.

1.2 Experimental methods

1.2.1 experimental groups: the 40 rats are classified according to the random number table method: the invention group, the comparison group 1, the comparison group 2 and the comparison group 3 are 10 in each group.

1.2.2 mouse model with qi depression constitution: referring to Zhu Qingjing (Xiong Zhenfang, zhu Qingjing. Influence of bupleurum root dispersing stagnated liver qi on chronic restraint stress liver depression syndrome rats [ J ]. Chinese journal of digestion by combination of Chinese and Western medicine, 2004, (04): 220-221.), tang Yiting (Tang Yiting, chen Guxu. Regulation of hypothalamus-pituitary-adrenal axis of chronic restraint stress rats [ J ]. Beijing university of traditional Chinese medicine, 2002 (03): 23-26.), etc., a restraint method is given at the beginning of the experiment, rats are put into a restraint box, the front end activity part is adjusted to a proper position, so that the rats do not generate strong stress of resistance, 6h (00-15 00) per day, and the duration is 6 weeks. Indicating that the molding is successful.

1.2.3 methods of administration:

application of the invention group: depilating mouse back with 8% Na2S solution with area of 4cm × 4cm, sterilizing with 75% ethanol, and fixing the patch (bupleuri radix 15 parts, rhizoma Cyperi 15 parts, fructus Aurantii 15 parts, glycyrrhrizae radix 7.5 parts, flos Rosae Rugosae 7.5 parts, flos Pruni mume 7.5 parts) on the depilated part (SHANZHONG, GANSHU). Then lightly pressing for 2 times, and then wrapping the chest and back with adhesive sticker for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8h and then removed, 1 time per day, and 20 times of application are carried out.

Application control group 1: the mouse was backed with 8% Na ₂ S depilating, the area is about 4cm × 4cm, sterilizing with 75% alcohol, and fixing the patch of control group 1 (bupleuri radix 15 parts, fructus Citri 15 parts, fructus Aurantii 15 parts, fructus Hordei Germinatus 7.5 parts, flos Rosae Rugosae 7.5 parts, and flos Pruni mume 7.5 parts) on the depilatory site (SHANZHONG, GANSHU). Then lightly pressing for 2 times, and then wrapping the chest and back with adhesive sticker for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8h and then taken out, 1 time per day, and 20 times in total.

Application control group 2: the mouse was backed with 8% Na ₂ S depilating, the area is about 4cm × 4cm, after local sterilization with 75% alcohol, the application control group 2 (15 parts of radix bupleuri, 15 parts of rhizoma Cyperi, 15 parts of fructus Aurantii, 7.5 parts of fructus Hordei Germinatus, 7.5 parts of flos Rosae chinensis, and 7.5 parts of flos Pruni mume) is fixed on the depilated part (SHANZHONG and GANSHU). Then lightly pressing for 2 times, and then wrapping the chest and back with non-setting adhesive cloth for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8h and then taken out, 1 time per day, and 20 times in total.

Application control group 3: depilating mouse back with 8% Na2S solution with area of about 4cm × 4cm, topically sterilizing with 75% ethanol, and fixing the control group 3 (bupleuri radix 15 parts, fructus Citri 15 parts, fructus Aurantii 15 parts, glycyrrhrizae radix 7.5 parts, flos Rosae chinensis 7.5 parts, flos Pruni mume 7.5 parts) on the depilated part (SHANZHONG, GANSHU). Then lightly pressing for 2 times, and then wrapping the chest and back with adhesive sticker for fixation. (about 0.3 g of each tablet (drug core)) is applied for 8h and then removed, 1 time per day, and 20 times of application are carried out.

1.2.4 Observation and detection indexes

Forced swimming test of mice: the measuring cylinders are filled with water of 10cm at the temperature of 21-23 ℃, and an opaque plate is arranged between the measuring cylinders to prevent the mice from seeing each other. 1 hour after the last drench, the mice were put into a graduated cylinder and left for 6min, and the immobility time 4min after calculation was calculated and five mice were measured simultaneously. Judging the standard of immobility: stopping struggling, standing vertically, not floating, and only doing some necessary movements to make its head out of the water.

Mouse tail suspension test: on day 3 after forced swimming and 1 hour after the last drench, the mice were fixed with tape to a horizontally placed rod 30mm from their mouse tips, separated by plates to prevent them from seeing each other. The mouse is about 100mm from the nearest object. Hang for 6min, record the 4min after the motionless time, each time measure 5.

1.2.5 statistical treatment

Single-factor analysis of variance was performed using SPSS10.0 software, and comparisons between groups were tested using t.

2. Results

TABLE 11 influence of different patches on the immobility time of mouse model for forced swimming (x + -s)

Group of	Example number (n)	Time of immobility (n)
			Group of the invention	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 Effect of different patches on immobility time of mouse tail suspension model (x. + -. S)

Group of	Example number (n)	Dead time (n)
			Group of the invention	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.

A trend towards reduced immobility time was shown in forced swimming of mouse 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 embodiment thereof

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

Weighing 15 parts of astragalus, 15 parts of 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 according to the proportion of 1.

EXAMPLE 36 preparation of the Chinese medicinal composition of the present invention

The weight ratio of the raw materials to the raw materials is 1.

EXAMPLE 37 preparation of the Chinese medicinal composition of the present invention

The preparation method comprises the following steps of 1, 1.

EXAMPLE 38 preparation of the Chinese medicinal composition of the present invention

Weighing 12 parts of radix astragali, 12 parts of fried rhizoma atractylodis macrocephalae, 12 parts of radix sileris, 6 parts of dried orange peel, 12 parts of radix pseudostellariae and 1.2 parts of ginseng according to the proportion of 1.

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

Weighing 18 parts of radix astragali, 18 parts of fried rhizoma atractylodis macrocephalae, 18 parts of radix sileris, 9 parts of dried orange peel, 18 parts of radix pseudostellariae and 1.8 parts of ginseng according to the proportion of 1.

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

Weighing 11 parts of astragalus, 11 parts of fried bighead atractylodes rhizome, 11 parts of divaricate saposhnikovia root, 5.5 parts of dried orange peel, 11 parts of heterophylly falsestarwort root and 1.1 parts of ginseng according to the proportion of 1.

EXAMPLE 41 preparation of the Chinese medicinal composition of the present invention

Weighing 13 parts of astragalus root, 13 parts of 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 according to the proportion of 1.

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

14 parts of bulk drugs of astragalus, 14 parts of 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.

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

Weighing 16 parts of astragalus, 16 parts of 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 according to the proportion of 1.

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

19 parts of raw material medicaments of astragalus, 19 parts of 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.

EXAMPLE 45 preparation of the Point application of the Chinese medicinal composition of the present invention

(1) In any of examples 35-44, the raw materials are weighed according to the weight ratio, smashed into powder, mixed with a proper amount of ginger juice and a hot melt adhesive matrix, and blended into paste, wherein the ratio of the traditional Chinese medicine powder to the hot melt adhesive matrix is generally 1:3.

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

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

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

(2) Vacuum concentrating the above medicinal liquid under reduced pressure to obtain concentrated medicinal liquid;

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 present invention

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

Example 50 clinical experiments on acupoint application of the Chinese medicinal composition of the present invention

1 study object

1.1 sample Source

The experimental samples were obtained from 30 patients with qi-deficiency constitution and chronic diarrhea of traditional Chinese medicine meeting the inclusion standard in the outpatient service and the inpatient department of the affiliated eosin hospital of Shanghai medical university from 6 months to 3 months of 2021 in 2020, and were randomly divided into 15 patients in the control group and the treatment group.

1.2 diagnostic criteria

1.2.1 diagnostic standard for Qi-deficiency constitution of traditional Chinese medicine

The constitution of the subject is judged to be qi-deficiency constitution according to the conversion and classification result of the integral quantity table of Chinese medicinal constitution Classification and judgment published by Chinese medicinal publishing Co.4-9-2009 and by combining the judgment of a doctor.

Questionnaire for qi-deficiency constitution determination: (1) is you tired easily? (2) Do you easily breathe short (shortness of breath, no breath getting up)? (3) Do you look easy to worry? (4) Is you dizzy or dizzy when standing up? (5) Is you more susceptible to colds than others? (6) Do you like quiet, lazy speaking? (7) Do you speak poorly and feebly? (8) Do you move a little bit more and easily give off false sweat?

The criteria are as follows:

TABLE 13 Chinese medicinal constitution standard table

Note: 1. the scoring method comprises the following steps: each item is counted in turn according to "none (or) little", "few", "sometimes", "often" and "always" for 1, 2, 3, 4 and 5 points. 2. Conversion fraction = (each entry total division-the number of entries)/(the number of entries × 4) × 100; the range is 0-100 minutes.

In this experiment, transformation of qi-deficiency constitutions into more than 40 points was judged as qi-deficiency constitutions.

2.2 treatment regimens

The Chinese medicinal composition is applied to acupuncture points: the qi-deficiency constitution-preventing traditional Chinese medicine is developed by combining the characteristics of meridians, acupuncture points and medicines according to the characteristics of qi-deficiency constitution by the preventive treatment center of the eosin light hospital affiliated to Shanghai medical university. The main components of the medicine are astragalus, stir-fried bighead atractylodes rhizome, divaricate saposhnikovia root, dried orange peel, radix pseudostellariae and ginseng (the proportion is 1.

The manufacturing process comprises the following steps: (1) the required traditional Chinese medicine granules are prepared by mixing and crushing the following components in a ratio of 1 to 1. (2) Making the above mixture into fluid extract, extracting with appropriate solvent (water and 20-25% ethanol), and evaporating part of the solvent to adjust the concentration to 1g per 1 ml. (3) Heating 1kg of medical pressure-sensitive thermosol in a pot to about 80 ℃ for melting, then cooling to about 60-70 ℃, slowly adding the medicinal powder, uniformly stirring, adding the fluid extract and azone (the ratio of matrix to azone in the transdermal agent is about 1000.

The using method comprises the following steps: order the patient to take bath or scrub the limbs, keep the skin warm and moist, and apply the Chinese medicinal composition to the acupoints of Qihai, pishu and Zusanli of human body for 4-8 hours each time and three times a week.

2.3 Chinese medicine constitution grading conditions

2.4 adverse events recording

2.5 criteria for clinical intervention efficacy

2.5.1 Chinese medicine clinical intervention curative effect judgment standard

The traditional Chinese medicine clinical intervention curative effect judgment is carried out according to the transformation of qi-deficiency constitution of traditional Chinese medicine, and the standard thereof refers to the relevant standard of 'traditional Chinese medicine disease diagnosis curative effect standard' issued by the national drug supervision administration in 2017 for judging by applying the symptom integral change.

(3) The method has the following advantages: the clinical symptoms and physical signs disappear or basically disappear, and the syndrome score is reduced by more than or equal to 30 percent but less than 70 percent.

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

3.3 transformation of constitutions into different types

After treatment, the constitutional transformation of the two groups of patients is reduced, and compared with the control group before treatment, the difference is not significant, and P is more than 0.05; the differences of the treatment groups before and after treatment, the comparison in the groups and the comparison between the groups have significance, and P is less than 0.05.

TABLE 14 comparison of transformation ratios of qi-deficiency constitution before and after treatment of two groups of patients

Note: p <0.05 compared to pre-treatment; p <0.05 compared to control.

3.3 results of the study of safety indices

Discussion 4

4.1 concept and clinical features of constitutions with qi deficiency

The qi-deficiency constitution is mainly caused by congenital deficiency, long-term eating disorder, emotional disorder, long-term illness and fatigue, the elderly and the weak cause damage to the heart, the lung, the spleen and the kidney functions, and the qi and the blood vessels are managed by the heart, the qi of the whole body is managed by the lung, the kidney stores primordial qi, and the spleen and the stomach are the 'source of qi generation', so the qi-deficiency constitution easily causes the decline of the function of promoting blood circulation, the insufficient generation of the qi in the body, the defense of the body against exogenous pathogenic factors, the protection of the muscle surface and the maintenance of the function of the viscera position.

Qi deficiency constitutions often appear: emaciation or slight fat, pale complexion, shortness of breath, no desire to speak, tiredness, lassitude, spontaneous sweating, especially with exertion, pale red tongue with teeth marks on the edge, white coating, and weak pulse. The deficiency of five zang organs is clinically seen, and the common symptoms of heart, lung, spleen and kidney are different due to the corresponding pathological changes of deficiency of heart, lung, spleen and kidney, except the common clinical manifestations of qi deficiency. The incidence tendency is as follows: susceptible to cold, dizziness due to qi deficiency, and visceral prolapse, and is weak in Pinggu resistance and slow in recovery after illness.

Since cytokines are closely related to the occurrence of fatigue symptoms, most people with qi deficiency have immune system dysfunction or immune system function decline. The decrease of human immunity can lead to the decrease of the body's ability to defend, recognize and eliminate foreign pathogens and self-antigenic foreign matters, and it is difficult to maintain the physiological balance of the environment in the body, resulting in the occurrence of diseases.

The Chinese medicinal composition acupoint application is prepared by combining the characteristics of meridians, acupoints and medicaments according to the characteristics of phlegm-dampness constitution by the professor Zhang Xiaotian and through independent research and development. The main components of the formula are astragalus, fried rhizoma atractylodis macrocephalae, radix sileris, dried orange peel, radix pseudostellariae and ginseng (the proportion is 1.

Astragalus root: sweet in flavor and slightly warm in nature; it enters spleen and lung meridians. Tonify qi, strengthen superficies, expel toxin, expel pus, induce diuresis, and promote granulation. Can be used for treating deficiency of vital energy, asthenia, chronic diarrhea, proctoptosis, spontaneous perspiration, edema, uterine prolapse, albuminuria due to chronic nephritis, diabetes, and unhealed wound.

White atractylodes rhizome: warm in nature, sweet and bitter in taste. It enters spleen and stomach meridians. Invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, arresting sweating, and preventing miscarriage. They belong to the category of qi tonics under deficiency-tonifying herbs.

Wind prevention: warm in nature, sweet and pungent in flavor. It enters bladder meridian, liver meridian and spleen meridian. Relieving exterior syndrome, dispelling pathogenic wind, and removing dampness. They belong to the category of exterior-releasing herbs with pungent-warm property.

Dried orange peel: pungent and bitter in flavor and warm in nature. It enters spleen and lung meridians. Regulate qi, stimulate appetite, dry dampness, resolve phlegm, treat spleen and stomach diseases. Belongs to qi-regulating herbs.

Radix pseudostellariae: mild in nature, sweet and slightly bitter in taste. It enters spleen and lung meridians. Replenishing qi to invigorate the spleen, promoting the production of body fluid and moistening the lung. They belong to the category of qi tonics under deficiency-tonifying herbs.

Ginseng: warm in nature, sweet and slightly bitter in taste. They enter heart, lung, spleen and kidney meridians. Tonify primordial qi, recover pulse to arrest collapse, tonify spleen and lung, promote fluid production and induce tranquilization. They belong to qi tonics classified under deficiency tonics.

4.3 Point selection analysis

The selected acupoints are qi sea, pishu and Zusanli, the spleen shu is the acupoints infused on the back through qi, and both qi sea and Zusanli are the essential points for tonifying qi and cultivating primordial qi, as carried in the "acupuncture and moxibustion map of Yu acupoints of copper people": the qi sea is also the sea where men generate qi. The acupoint has the functions of reinforcing primordial qi, tonifying kidney, controlling nocturnal emission, tonifying and restoring yang. Cloud of Qianjin Yao Fang: "if you want to calm, sanli is not dry. The three points are combined to strengthen the functions of tonifying qi, strengthening the body and prolonging life, thereby improving the physical condition of people with qi deficiency and unbalanced constitution.

The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for improving damp-heat constitution is characterized by being prepared from the following raw material medicines 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 mangnolia officinalis, 10-20 parts of fructus nandinae domesticae and 10-20 parts of processed arisaema cum bile.

2. The traditional Chinese medicine composition according to claim 1, which 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 semen coicis, 13-18 parts of mangnolia officinalis, 13-18 parts of fructus nandinae domesticae and 13-18 parts of processed arisaema cum bile.

3. The traditional Chinese medicine composition according to claim 2, which 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 mangnolia officinalis, 15 parts of fructus nandinae domesticae and 15 parts of processed arisaema cum bile.

4. Use of the composition of any one of claims 1-3 for the manufacture of a medicament for improving wet heat constitution.

5. The traditional Chinese medicine composition for improving the constitution of qi depression is characterized by being prepared from the following raw material medicines in parts by weight: 10-20 parts of radix bupleuri, 10-20 parts of rhizoma cyperi, 10-20 parts of fructus aurantii, 5-10 parts of liquorice, 5-10 parts of rose and 5-10 parts of flos mume.

6. The traditional Chinese medicine composition according to claim 5, which is prepared from the following raw materials in parts by weight: 12-18 parts of radix bupleuri, 12-18 parts of rhizoma cyperi, 12-18 parts of fructus aurantii, 6-9 parts of liquorice, 6-9 parts of rose and 6-9 parts of flos mume.

7. The traditional Chinese medicine composition according to claim 6, which is prepared from the following raw materials in parts by weight: 15 parts of radix bupleuri, 15 parts of rhizoma cyperi, 15 parts of fructus aurantii, 7.5 parts of liquorice, 7.5 parts of rose and 7.5 parts of flos mume.

8. Use of the Chinese medicinal composition of any one of claims 5 to 7 for the preparation of a medicament for improving the constitution of qi stagnation.

9. The traditional Chinese medicine composition for improving qi-deficiency constitution is characterized by comprising the following raw material medicines in parts by weight: 10-20 parts of astragalus membranaceus, 10-20 parts of fried bighead atractylodes rhizome, 10-20 parts of divaricate saposhnikovia root, 5-10 parts of dried orange peel, 10-20 parts of radix pseudostellariae and 1-2 parts of ginseng.

10. The traditional Chinese medicine composition according to claim 9, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12-18 parts of astragalus membranaceus, 12-18 parts of fried bighead atractylodes rhizome, 12-18 parts of divaricate saposhnikovia root, 6-9 parts of dried orange peel, 12-18 parts of radix pseudostellariae and 1.2-1.8 parts of ginseng.

11. The traditional Chinese medicine composition according to claim 10, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15 parts of astragalus, 15 parts of fried bighead atractylodes rhizome, 15 parts of divaricate saposhnikovia root, 7.5 parts of dried orange peel, 15 parts of heterophylly falsestarwort root and 1.5 parts of ginseng.

12. Use of the composition of any one of claims 9-11 for the preparation of a medicament for improving qi-deficiency constitution.