CN113599447A - Traditional Chinese medicine composition for improving phlegm-dampness constitution and preparation method and application thereof - Google Patents

Abstract

The invention relates to a traditional Chinese medicine composition for improving phlegm-dampness 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 processed arisaema tuber, 10-20 parts of processed pinellia tuber, 10-20 parts of corydalis tuber, 10-20 parts of raw atractylodes macrocephala, 10-20 parts of atractylodes rhizome and 10-20 parts of tuckahoe. The Chinese medicinal composition acupoint application is prepared from the Chinese medicinal composition according to the proportion of 1:1:1:1:1:1, and acupoints are selected from Fenglong, Yinlingquan and Chengshan. 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 phlegm-dampness constitution, adheres to long-term regular application, has obvious effects of improving the phlegm-dampness constitution and conditioning the whole state of the organism, and promotes the phlegm-dampness constitution to be converted into a mild state.

Description

Traditional Chinese medicine composition for improving phlegm-dampness constitution and preparation method and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for improving phlegm-dampness constitution and a preparation method and application thereof.

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.

Phlegm-dampness constitution refers to the condition of the disorder of viscera function, which easily causes the disorder of transportation and transformation of qi, blood and body fluids, water-dampness accumulation, accumulation of dampness into phlegm and phlegm-dampness accumulation, usually manifested as obesity, abdominal fullness, chest distress, excessive phlegm, easy drowsiness, bad body weight, preference for eating fat and alcohol wine, swollen tongue body, white and greasy tongue coating, and the onset of diseases due to cold-dampness invasion, improper diet, congenital endowment, senile chronic diseases and lack of exercise, and different symptoms and onset tendencies often appear along with different phlegm-dampness retention parts: susceptible to diabetes, stroke, chest stuffiness, etc., and has poor adaptability to plum rain and heavy damp environments. Dampness and phlegm elimination should be used as a therapeutic method, and Pingsu should be used to regulate and improve phlegm-dampness constitution to prevent phlegm-dampness syndrome.

Phlegm-dampness constitution was recorded in Huangdi's Canon for the earliest time, wherein the characteristics, formation and types of phlegm-dampness constitution were elaborately elucidated, which provides a basis for the development of the theory of phlegm-dampness constitution in traditional Chinese medicine. In the traditional Chinese medicine category, the phlegm-dampness constitution is also called as "fat people" or "people for paste and food". Modern Chinese medicine believes that phlegm-dampness constitution can be continuously acted by heredity and external environment to form the characteristic of 'sticky heavy turbidity'. Individuals with phlegm-dampness constitution are prone to symptoms such as apoplexy, diabetes, vertigo, etc. Compared with other constitutions, phlegm-dampness constitutions are characterized in that body fluids cannot be gasified to form phlegm-dampness, so that lipid in vivo is continuously accumulated, and metabolism disorder of body fluids is caused; the stagnation of qi movement can cause the retention of water and phlegm.

Some students analyze the relationship between hypertension syndrome differentiation and blood dynamic rheology, and the hypertension blood viscosity of the phlegm-dampness-generating physique group is higher than that of other physique groups, the physique is mostly bloated, the blood vessel is narrow, the blood vessel has insufficient elasticity, and phlegm is generated by heat. Is affected by phlegm-heat to cause hyperlipidemia. It is also shown by research that the cholesterol, very low density lipoprotein and triglyceride levels of the phlegm-dampness constitution group are higher than those of other constitution groups, and the factors are closely related to the hyperlipidemia and are influencing factors for causing the hyperlipidemia. This also reflects laterally that the phlegm-damp constitutional population is more susceptible to hyperlipidemia than other constitutional populations. In the traditional Chinese medicine field, blood belongs to microscopic substances and is a benign carrier of the microscopic substances. If the blood circulation is kept normal, the delicate substances can be applied to the whole body. Modern medicine considers the normal metabolism of sugar, lipid and protein in the body as an important basis for maintaining blood circulation. Once the blood circulation is in trouble or the blood pressure is abnormal, the metabolism of sugar, lipid and protein of the body is also in trouble, and symptoms such as diabetes, hyperlipidaemia and the like can exist. Phlegm-dampness can cause angiosclerosis and reduce blood flow velocity, so that blood flow is reduced, vascular diseases are caused, and the probability of hyperlipemia attack is increased. The physical examiners with phlegm-dampness constitution are more prone to hyperlipidemia than other physical examiners.

At present, dyslipidemia has become a high chronic disease in China, and is positively correlated with the morbidity of cardiovascular and cerebrovascular diseases such as obesity, fatty liver, hypertension, atherosclerosis, coronary heart disease, cerebral infarction and the like. Common non-pharmaceutical treatment methods are weight control, physical activity, smoking cessation and alcohol restriction; drug therapy includes drugs that primarily reduce TC (statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, erbituitane and polyglyceryl alcohols), drugs that primarily reduce TG (fibrates, nicotinic acids and high purity fish oil formulations), novel lipid modifying drugs and combinations of lipid modifying drugs.

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 combines the administration of thick traditional Chinese medicines with the body surface meridian point, and exerts its therapeutic effect through percutaneous absorption and specific therapy of acupoints. 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 CN112773878A discloses a traditional Chinese medicine composition for treating metabolic-related fatty liver disease and a preparation method thereof, comprising: poria, rhizoma Atractylodis, Atractylodis rhizoma, pericarpium Citri Tangerinae, fructus crataegi, Saviae Miltiorrhizae radix, rhizoma Wenyujin Concisa, Mori fructus, stigma Maydis, herba Sedi, semen Benincasae, folium Nelumbinis, Monascus purpureus went, semen Cassiae, fructus Amomi, herba Gynostemmatis, and radix Rhodiolae. The invention has better effects on the aspects of improving insulin resistance, inhibiting lipid peroxidation, reducing oxidative stress, inhibiting inflammatory factor release and the like, has the advantages of multiple ways and multiple targets, and adopts treatment methods of resolving phlegm dampness, dispelling liver depression, strengthening spleen and stomach, resolving blood stasis, clearing damp-heat and the like to play a complementary and efficacy-improving function according to the principle of treating the symptoms of acute disease and treating the root cause of chronic disease under the guidance of the treatment concept of syndrome differentiation of traditional Chinese medicine. Chinese patent document CN111298064A discloses a traditional Chinese medicine composition for regulating and treating phlegm-dampness 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: 50-150 parts of poria cocos, 70-130 parts of dried orange peel, 450 parts of coix seed, 70-130 parts of hawthorn, 80-120 parts of eupatorium, 80-120 parts of fingered citron, 80-130 parts of cassia seed, 80-120 parts of chicken's gizzard-membrane, 80-130 parts of platycodon grandiflorum, 80-130 parts of lotus leaf, 250 parts of bitter orange 150-containing materials, 70-230 parts of astragalus membranaceus, 50-150 parts of codonopsis pilosula, 80-120 parts of ligusticum wallichii, 300 parts of bighead atractylodes rhizome, 80-120 parts of white hyacinth bean, 80-130 parts of white paeony root, 80-120 parts of rhizoma cyperi, 40-60 parts of fructus amomi, 70-230 parts of magnolia officinalis flower, 80-120 parts of pawpaw, 80-120 parts of rhizoma atractylodis, 80-140 parts of Chinese yam, 80-120 parts of prepared pinellia ternate, 40-70 parts of liquorice, 70-230 parts of bamboo shavings and 80-120 parts of poria with hostwood. The medicines are combined to play the roles of eliminating phlegm and dampness, have obvious regulation and treatment effects on phlegm-dampness constitution, and can recover and keep relatively healthy and mild constitution for a long time. However, the traditional Chinese medicine composition for improving the phlegm-dampness constitution and the preparation method and the application thereof are not reported at present.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for improving phlegm-dampness 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.

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

the traditional Chinese medicine composition for improving phlegm-dampness constitution is prepared from the following raw material medicines in parts by weight: 10-20 parts of processed arisaema tuber, 10-20 parts of processed pinellia tuber, 10-20 parts of corydalis tuber, 10-20 parts of raw atractylodes macrocephala, 10-20 parts of atractylodes rhizome and 10-20 parts of tuckahoe.

Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 13-18 parts of processed arisaema consanguineum, 13-18 parts of processed pinellia ternate, 13-18 parts of corydalis tuber, 13-18 parts of raw bighead atractylodes rhizome, 13-18 parts of rhizoma atractylodis and 13-18 parts of poria cocos.

More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15 parts of processed arisaema consanguineum, 15 parts of processed pinellia ternate, 15 parts of corydalis tuber, 15 parts of raw bighead atractylodes rhizome, 15 parts of rhizoma atractylodis and 15 parts of poria cocos.

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 the processed arisaema tuber, the processed pinellia tuber, the rhizoma corydalis, the raw white atractylodes rhizome, the rhizoma atractylodis and the tuckahoe in proportion, crushing into powder and mixing uniformly.

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 phlegm-dampness constitution.

Preferably, the pharmaceutical dosage form is an external preparation.

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

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

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

The invention has the advantages that:

1. the processed arisaema tuber in the traditional Chinese medicine composition is bitter, pungent and warm in property and enters the lung, spleen and liver meridians; prepared pinellia tuber, rhizoma Pinelliae Preparada is pungent and warm and dry, and is the main drug for treating damp phlegm in the book of materia medica from Xin (New materia Medica), the two drugs are matched to play the role of eliminating dampness and resolving phlegm; corydalis tuber, pungent and bitter in flavor and warm in nature, enters liver and spleen meridians and is the essential herb for moving qi; the rhizoma atractylodis is pungent in flavor and warm in nature, enters spleen and kidney channels, and has the effects of eliminating dampness and strengthening spleen; the bighead atractylodes rhizome is bitter and sweet in taste, warm in nature and capable of invigorating qi and spleen after entering spleen; poria cocos, is sweet and bland, and has the effects of excreting dampness and invigorating the spleen; the three medicines are combined, the spleen qi is sufficient to have the effect of eliminating dampness, and the damp turbidity is removed to have the effect of tonifying spleen, so that the effects of tonifying qi, tonifying spleen and excreting dampness are achieved together. The whole formula has the effects of invigorating spleen and replenishing qi, and eliminating dampness and reducing phlegm.

2. The Chinese medicinal composition is applied to acupuncture points, and acupuncture point selection is mainly carried out on Fenglong, Yinlingquan and Chengshan. Fenglong is a point of stomach meridian and collaterals of foot yangming channel, which distinguishes spleen meridian to dredge qi movement of spleen and stomach meridians, has the effects of invigorating spleen, reducing phlegm, harmonizing stomach, lowering adverse qi, eliminating phlegm and inducing resuscitation, and is the most obvious point of essential phlegm elimination due to the function of eliminating phlegm turbidity. Yin Ling quan is the spleen meridian point of foot Taiyin, which is the essential point for removing dampness and promoting diuresis, and can communicate the exterior and interior by matching with the essential point for eliminating phlegm and Fenglong of foot Yangming stomach, so as to strengthen the effect of invigorating spleen and eliminating dampness, and eliminate water, body fluid, phlegm and dampness. The substance in Chengshan acupoint is spleen earth, which belongs to the bladder meridian of foot taiyang and can stimulate yang qi of bladder meridian of taiyang to assist the discharge of damp.

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.

Detailed Description

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

Weighing 15 parts of raw material medicines of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos according to the proportion of 1:1:1:1:1: 1.

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

Weighing 10 parts of raw material medicines of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos according to the proportion of 1:1:1:1:1: 1.

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

Weighing 20 parts of raw material medicines of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos according to the proportion of 1:1:1:1:1: 1.

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

Weighing 11 parts of raw material medicines of arisaema consanguineum schott, processed pinellia ternate, corydalis tuber, raw bighead atractylodes rhizome, rhizoma atractylodis and poria cocos according to the proportion of 1:1:1:1:1: 1.

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

Weighing 12 parts of raw material medicines of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos according to the proportion of 1:1:1:1:1: 1.

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

13 parts of raw material medicines of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos are weighed according to the proportion of 1:1:1:1:1: 1.

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

14 parts of raw material medicines of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos are weighed according to the proportion of 1:1:1:1:1: 1.

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

Weighing 16 parts of raw material medicines of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos according to the proportion of 1:1:1:1:1: 1.

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

17 parts of raw material medicines of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos are weighed according to the proportion of 1:1:1:1:1: 1.

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

Weighing 18 parts of raw material medicines of rhizoma arisaematis preparata, rhizoma pinelliae preparata, rhizoma corydalis, raw rhizoma atractylodis macrocephalae, rhizoma atractylodis and poria cocos according to the proportion of 1:1:1:1:1: 1.

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

(1) In any of embodiments 1-10, the raw materials are weighed according to the weight part 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 and 20-25% ethanol), and evaporating part of the solvent to adjust the concentration to 1g per 1 ml.

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

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 the ointment 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 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 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 to obtain medicinal liquid concentrate;

(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 15 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 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 to obtain medicinal liquid concentrate;

(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 86 old patients with phlegm-dampness constitution and increased blood lipid margin, which meet the inclusion standard, in the outpatient service and the inpatient department of the auxiliary eosin hospital of Shanghai medical university from 6 months to 3 months of 2021 in 2020, and is randomly divided into 43 patients in a pretreatment group and a control group.

1.2 diagnostic criteria

1.2.1 diagnostic standard for phlegm-dampness constitution in traditional Chinese medicine

The constitution of the subject is judged to be phlegm-damp 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 company in 4-9 th of 2009 and by combining the judgment of a doctor.

Questionnaire for determining phlegm-dampness constitution: do you feel oppression in the chest or fullness in the abdomen? (ii) do you feel heavy and uncomfortable or uncomfortable? (iii) is your abdomen fat and soft? (iv) do you have a phenomenon of excessive fat secretion in the frontal region? Is you swollen (still slight swelling) with the upper eyelid? Is you sticky in the mouth? Seventhly, do you feel phlegm blocking at all times, especially in the throat? Is you thick and greasy tongue coating or has a thick and thick tongue coating feeling?

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 ═ (total of each item-number of items)/(number of items × 4) × 100; the range is 0 to 100 minutes.

In this experiment, the phlegm-dampness constitution was judged to be the phlegm-dampness constitution by dividing the phlegm-dampness constitution into 40 or more.

1.2.2 criterion for blood lipid edge elevation

According to the 'Chinese adult dyslipidemia prevention and treatment guidelines' of 2016, the judgment standard of the rise of the blood lipid margin is made as follows:

TC: more than or equal to 5.2mmol/L and less than 6.2 mmol/L;

TG: more than or equal to 1.7mmol/L and less than 2.3 mmol/L;

LDL-C: is more than or equal to 3.4mmol/L and less than 4.1 mmol/L.

The main purpose of this experiment is to treat marginal elevation of triglyceride, so the criteria for determining marginal elevation of blood lipid in the storage case are as follows: TC: less than 6.2 mmol/L; TG: more than or equal to 1.7mmol/L and less than 2.3 mmol/L; LDL-C: less than 4.1 mmol/L;

1.3 inclusion criteria

(1) The age is more than or equal to 60 years and less than or equal to 85 years;

(2) the subjects in the group accord with the diagnosis standard of phlegm-dampness constitution in traditional Chinese medicine, and the subjects except for the phlegm-dampness constitution can also have other 7 types of biased constitution;

(3) triglyceride margination elevation consistent with western medicine;

(4) the subjects agree with the informed consent, voluntarily participate in the experiment, voluntarily execute the intervention regulation, and cooperate with the completion of the traditional Chinese medicine physique evaluation before and after the intervention and the basic information acquisition required by other experiments.

1.4 exclusion criteria

(1) The patients who have been diagnosed with primary dyslipidemia and insist on taking lipid-lowering drugs;

(2) patients with secondary dyslipidemia due to some primary morbidity or to the effects of drug administration on lipid metabolism;

(3) those with mental illness and alcohol and drug dependence;

(4) cannot accurately describe the symptoms of the patients;

(5) are participating in other clinical trials;

(6) poor compliance, no coordination with treatment, and withdrawal in midway.

1.5 rejection Standard

(1) During the group entering period, other therapeutic drugs are used by the patient to influence the experimental result;

(2) during enrollment, the applicator was not used as specified in the experiment;

(3) basic information and observation project index acquisition needed before and after are incomplete;

(4) those with severe adverse events occurred during the group entry.

1.6 termination and shedding criteria

(1) Deactivating the applicator during the enrollment for various reasons;

(2) the treatment is over, but the examinee is not followed up as required;

(3) the appearance of other diseases during enrollment required treatment and interfered with the present investigator.

2 research methods

2.1 sample size calculation

The sample amount calculation formula:

n₁＝kn₂

referring to the retrospective data and literature research data of the department of China, the effective rate of an intervention group is about 86%, the effective rate of a control group is about 53%, the calculated effective rate of a planned collection case is 72, the considered ineffective case of abscission is not more than 20%, and the calculated effective rate of the collection case is 86. (1: 1, 43 cases for the intervention group and the control group, respectively).

2.2 packet scheme

The experimental grouping scheme is grouped according to 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 43 named intervention group and the last 43 named control group.

2.3 intervention protocol

2.3.1 control intervention protocol

Control intervention protocol the control intervention protocol was a dietary guide as follows:

(1) controlling food intake, and regulating hunger and satiety.

(2) The food is based on light weight and has increased intake of low calorie, low fat, and cellulose-rich food such as vegetables, fruits, and roughage.

(3) Limit the intake of high calorie, high fat foods such as lard, fat meat, snacks, desserts, and animal viscera.

(4) The cooking mode mainly adopts less salt and less oil, and is mainly used for steaming, boiling, stewing and boiling, so that chafing dish, frying and roasting are avoided.

(5) Foods with the effects of invigorating spleen, promoting diuresis, eliminating phlegm and eliminating phlegm are added into the diet, such as: white radish, water chestnut, laver, onion, hyacinth bean, small red bean, white gourd, Chinese toon, Chinese yam, polished round-grained rice, millet, coix seed, gordon euryale seed, tuckahoe and the like.

2.3.2 intervention protocol for intervention groups

The intervention scheme of the intervention group is diet guidance and Chinese medicine intervention (the Chinese medicine composition is applied to acupuncture points).

Diet guidance was performed as in the control group.

The Chinese medicinal composition is applied to acupuncture points: the traditional Chinese medicine is prepared by combining the characteristics of meridians, acupuncture points and medicines according to the characteristics of phlegm-dampness constitution by the preventive treatment center of the eosin Hospital, affiliated to Shanghai medical university. The main components of the medicine are prepared arisaema consanguineum schott, processed pinellia ternate, rhizoma corydalis, raw white atractylodes rhizome, rhizoma atractylodis and poria cocos (the proportion is 1:1), and the medicine is prepared by Shandong bright and Tang pharmaceutical industry Co Ltd company according to the manufacturing flow standard (production batch number: 20191002), the specification is 7cm multiplied by 7cm per tablet, and each tablet (medicine core) is about 1 g.

The manufacturing process comprises the following steps: firstly, the required traditional Chinese medicine granules are mixed according to the proportion of 1:1 and smashed into powder, and then hot melt adhesive matrix is mixed, wherein the proportion of the traditional Chinese medicine powder and the hot melt adhesive matrix is generally 1: 3.② preparing the mixture into fluid extract, extracting with proper solvent (adding 20-25% ethanol in water), evaporating part of solvent to adjust the concentration to 1ml corresponding to 1g of the medicinal material. ③ putting 1kg of the medical pressure-sensitive thermosol into a pot, heating to about 80 ℃ for melting, then cooling to about 60-70 ℃, slowly adding the medicinal powder, stirring uniformly, adding the fluid extract and the azone (the ratio of the matrix to the azone in the transdermal agent is about 1000: 10) at about 40 ℃, stirring continuously, and then spreading the ointment.

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

2.4 intervention course

The two groups intervene in 3 courses of treatment, which is 90 days.

2.5 Chinese and Western medical observation indexes

2.5.1 basic case

Analyzing and observing basic information of two groups of intervention objects: basic information such as sex, age, height, weight, BMI index, waist circumference, hip circumference, waist-hip ratio and the like.

2.5.2 Chinese medicine constitution grading conditions

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 phlegm-dampness constitutions of the traditional Chinese medicine is a main curative effect index.

2.5.3 Western medicine blood lipid index

As main efficacy indexes, the change conditions of Triglyceride (TG), serum Total Cholesterol (TC) and low-density lipoprotein cholesterol (LDL-c) of two groups of intervention subjects before and after intervention and between the intervention subjects are compared and observed.

2.5.4 adverse reaction 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.

2.6 Observation indicator data Collection

2.6.1 general case Collection

The experimental waistline measuring method comprises the following steps: measuring by using a soft tape measure around the midpoint of a connecting line of the 12 th rib of the human body and the anterior superior iliac spine as a horizontal line; the hip circumference measuring method comprises the following steps: measurements were made using a soft tape measure with a horizontal line around the most elevated part of the hip.

2.6.2 Collection of the Chinese medical constitution questionnaire

In the experiment, the constitution judgment before and after intervention is carried out on an intervention group and a control group by adopting 60 Chinese medicine constitution judgment questions published by the State administration of traditional Chinese medicine in the 'Chinese medicine constitution classification judgment Table'.

2.6.3 Western medicine blood lipid index collection

The experimental blood lipid index requires the patients to eat normally before collection, avoids eating greasy and high-sugar foods and drinking alcohol and the like two days before blood drawing, and collects blood after fasting for 12 hours so as to avoid influencing results.

2.7 criteria for clinical intervention efficacy

2.7.1 Standard of the therapeutic Effect of clinical intervention of traditional Chinese medicine

The traditional Chinese medicine clinical intervention curative effect judgment is carried out according to the traditional Chinese medicine phlegm-dampness constitution conversion classification, and the standard thereof refers to the relevant standard of 'traditional Chinese medicine disease diagnosis curative effect standard' issued by the State drug administration of 2017 and uses symptom integral change for judgment.

The efficacy index (n) is the difference of integral of symptoms before and after treatment/integral of symptoms before treatment × 100%.

The clinical recovery: clinical symptoms and physical signs disappear or basically disappear, and the syndrome score is reduced by more than or equal to 95 percent.

Secondly, effect is displayed: clinical symptoms and physical signs disappear or basically disappear, and the syndrome score is reduced by more than or equal to 70 percent.

③ effective: 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.

Fourthly, 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.

2.7.2 Western medicine clinical intervention curative effect judgment standard

The clinical research guiding principle for treating the hyperlipidaemia in the guiding principle of clinical research of new traditional Chinese medicines released by the national drug administration in 2002 is taken as an evaluation standard.

Clinical control: the blood lipid indexes are checked to be normal.

Secondly, effect is displayed: the blood fat detection reaches any one of TC reduction more than or equal to 20 percent, TG reduction more than or equal to 40 percent and LDL-c reduction more than or equal to 20 percent.

③ effective: the blood fat detection reaches any one of the following items, TC is reduced by more than or equal to 10 percent but less than 20 percent, TG is reduced by more than or equal to 20 percent but less than 40 percent, and LDL-c is reduced by more than or equal to 10 percent but less than 20 percent.

Fourthly, invalidation: and the blood lipid detection does not meet the above standard.

2.8 statistical methods

The EXCEL2019 software is applied to the experiment to input and manage data, and SPSS26.0 statistical software is adopted to process all statistical data. In the experiment, a hypothesis testing level alpha is set to be 0.05, and meanwhile, double-sided hypothesis testing is adopted for all analysis; note that P < 0.05 is statistically significant for differences.

Firstly, carrying out normality test on measurement data (such as weight, waist circumference, hip circumference, waist-hip ratio, physique transformation score and the like), wherein a person conforming to normal distribution is represented by mean +/-standard deviation, and non-normal distribution is described by median (minimum-maximum); the statistical inferences are classified into the following three types: (1) the method is in accordance with normal distribution and uniform in variance, the inter-group comparison uses independent sample t test, and the intra-group comparison uses matched sample t test; (2) using a correction t test to conform to normal distribution but vary in variance; (3) data are distributed non-normally, with independent sample rank sum test for inter-group comparisons and paired sample rank sum test for intra-group comparisons.

Counting data (such as age, number of men and women) are described by frequency, frequency or composition ratio; the statistical inference is divided into the following two cases: (1) the total number of cases is more than 40, all the lattices are more than 5, and X is adopted²Checking; (2) the total number of cases is more than 40, 1 is less than or equal to one or a part of the cases are less than 5, and correction X is adopted²And (6) checking.

The grade data (such as the item grade of the phlegm-dampness constitution) are described by frequency, frequency or composition ratio, and the statistical inference of the grade data adopts independent sample rank sum test among groups; paired sample rank sum test was used within the group.

3 results of the experiment

3.1 general case analysis

86 patients meeting the inclusion criteria are collected from 6 months to 3 months of 2021 in 2020, and are divided into 43 cases in the intervention group and 43 cases in the control group according to the completely random principle. The intervention group consisted of 11 men and 32 women; the age range is 60-84 years; during an intervention period with a cycle of 3 months, in which 1 female patient in the intervention group was given due to missed weaning, the subjects who finally completed the study were 42, with a weaning rate of 1.16%. Control group 19 men and 24 women; the age range is 60-84 years; during the 3-month cycle of intervention, there were no shedding patients, and 43 subjects who finally completed the study.

The mean age of 43 patients in the intervention group was 69.88 + -6.05 years, the mean age of 43 patients in the control group was 68.02 + -4.80 years, and the age range of both groups was 60-84 years. The age-baseline data for the two groups of patients were comparable by two independent sample t-tests.

The two groups of patients had 30 cases in male and 56 cases in female; and male and female sex were 11 (25.6%) and 32 (74.4%) of 43 patients in the intervention group, respectively; in the control group, 43 patients had 19 (44.2%) and 24 (55.8%) patients, respectively. The gender of the two groups of patients was comparable to baseline data by chi-square test.

3.2 comparison of Secondary efficacy index before and after intervention in two groups of patients

In the intervention period, 1 female patient is lost due to the loss of visit in the intervention group, and 42 subjects completing the study in the final intervention group are 42, so that the comparison of the secondary efficacy index is carried out by taking 42 subjects in the intervention group and 43 subjects in the control group as statistics.

The average body weight before intervention of two groups of patients is respectively 64.8 +/-9.1 kg and 65.8 +/-9.8 kg, the average waist circumference is respectively 92.1 +/-8.0 cm and 92.1 +/-7.6 cm, the average hip circumference is respectively 97.6 +/-8.7 cm and 98.1 +/-7.6 cm, the average waist-hip ratio is respectively 0.94 +/-0.05 and 0.94 +/-0.06, and the body weight, waist circumference, hip circumference and waist-hip ratio baseline data of the two groups of patients are comparable.

After the intervention treatment course of three months, the weight, the waistline and the hip circumference of the two groups of patients are reduced compared with the prior treatment course, the curative effect of the intervention group is better than that of the control group, and the differences between the two groups of patients in the prognosis group and the intervention group are statistical; the waist-hip ratio of the two groups of patients has no obvious change before and after intervention, and the difference between the two groups has no statistical significance.

In the pre-intervention group, 42 patients had 1 person with too low weight (2.4%), 20 persons with normal weight (47.6%), 15 persons with overweight (35.7%) and 6 persons with obesity (14.3%), respectively; in 43 patients in the control group, the BMI index baseline data of two groups of patients respectively have 1 person with low weight (2.3%), 21 persons with normal weight (48.8%), 16 persons with overweight (37.2%) and 5 persons with obesity (11.3%).

The BMI index degree of the two groups of patients is reduced compared with that before intervention, wherein the weight of the patients in the intervention group is increased to 22, which accounts for 52.4 percent of that in the intervention group; the number of obese people is reduced to 4, which accounts for 9.5 percent of the intervention group; the proportion of the rest people with too low weight (2.4%) and overweight people (35.7%) is unchanged, the BMI index degree of the intervention group is improved earlier before and after intervention, and the difference has statistical significance. The number of people with normal body weight is increased to 22 after the intervention of the control group, and accounts for 51.2 percent of the control group; the overweight people are reduced to 15 people, and account for 34.9 percent of the control group; the proportion of the rest of the patients with too low body weight (2.3%) and obese people (11.6%) is unchanged, the BMI index degree of the control groups before and after intervention is improved earlier, and the difference has statistical significance. However, there was no difference in the degree of BMI index after the prognosis for both groups of patients.

3.3 comparison of the main efficacy indexes before and after intervention of two groups of patients

In the intervention period, 1 female patient is lost due to the loss of visit in the intervention group, and 42 final subjects completing the study in the intervention group are 42, so that the intervention group is compared with the intervention group in 42 cases and the control group in 43 cases as statistics in the comparison of main efficacy indexes.

TABLE 2 comparison of the transformation of phlegm-dampness constitution before and after intervention in two groups of patients

Note: the change of the phlegm-dampness constitution of the traditional Chinese medicine before the intervention of the two groups of patients is detected by two independent samples t, the P is 0.498 and more than 0.05, and the difference has no statistical significance; and (3) adopting paired sample rank sum test for comparison between groups before and after intervention of other data, adopting independent sample rank sum test for comparison between groups, wherein P is less than 0.05, and the difference has statistical difference.

As can be seen from Table 2, the conversion scores of the phlegm-dampness constitutions of the traditional Chinese medicine before the intervention of the intervention group and the control group are 54.69 +/-9.47 and 56.03 +/-8.72 respectively, the conversion scores of the phlegm-dampness constitutions of the traditional Chinese medicine before the intervention of the two groups are not statistically different, and the baseline data is comparable; after intervention, the Chinese medicine phlegm-dampness constitution transformation score of the intervention pre-intervention group is 50.00, and the minimum value and the maximum value are 25.00 and 78.13 respectively; the transformation score of the phlegm-dampness constitution of the traditional Chinese medicine in the control group is reduced to 52.69 +/-11.30, and the differences of the comparison between the two groups before and after intervention and the comparison between the two groups are respectively detected by the matched sample rank sum test and the independent sample rank sum test.

3.4 comparison of blood lipid before and after intervention in two groups of subjects

TABLE 3 comparison of blood lipid profiles before and after intervention in two groups of patients

Note: indicating that one or two groups of data groups in the two groups of measurement data are compared and an independent sample rank sum test is adopted; the method comprises the following steps of (1) indicating that one or two groups of data in two groups of measurement data are compared and matched sample rank sum test is adopted, and independent sample rank sum test is adopted in comparison between the groups; the other data groups are compared and selected to be tested with matched samples t, and the groups are compared and selected to be tested with independent samples t; p is more than 0.05, and the difference has no statistical significance.

As can be seen from Table 3, the baseline data of the four blood lipid indicators, triglyceride, total cholesterol, HDL cholesterol and LDL cholesterol, before intervention in the two groups of patients were comparable. After intervention, the intervention group patients are reduced in triglyceride, total cholesterol and low density lipoprotein cholesterol in comparison with the prior three indexes, and the comparison difference between the group and the group has statistical significance; the triglyceride level of the control group of patients is reduced compared with the former, and the comparison before and after the group has no obvious difference in the two indexes of total cholesterol and low density lipoprotein cholesterol; the HDL cholesterol levels in both groups of patients did not change significantly before and after intervention.

3.5 effective rate comparison before and after intervention of two groups of patients

TABLE 4 comparison of effective rates of blood lipid indicators before and after intervention in two groups of patients

Note: 1. total effective rate ═ 100% total cases (significant + significant). Index data with statistical difference, P < 0.05 by pearson chi-square test; data from Pearson chi-square test, P > 0.05, with no statistical difference.

As can be seen from Table 4, the triglyceride index shows 20 persons after intervention of intervention group, accounting for 47.6%; 14 persons are effective, accounting for 33.3%; the total effective number of people is 34, accounting for 81.0%. After intervention, the control group showed 9 persons, accounting for 20.9%; 12 effective people, accounting for 27.9%; the total effective number of people is 21, and accounts for 48.8%. The two groups of efficacy comparisons after intervention were statistically different.

The total cholesterol index shows 12 persons after intervention of intervention group, accounting for 28.6 percent; the effect is 10 people, accounting for 23.8%; the total effective number of people is 22, accounting for 52.4%. The control group shows 3 persons after intervention, accounting for 7.0 percent; effective 5 persons, accounting for 11.6%; the total effective number of people is 8, accounting for 18.6 percent. The two groups of intervention curative effects have statistical difference, and the two groups of curative effects after intervention have statistical difference compared.

After intervention of intervention group in low density lipoprotein cholesterol index, the effect is 9 persons, accounting for 21.4%; 11 persons are effective, accounting for 26.2%; the total effective number of people is 20, and accounts for 47.6%. The control group shows 5 persons after intervention, accounting for 11.6 percent; effective 6 persons, accounting for 14.0%; the total effective number of people is 11, accounting for 25.6%. The two groups of efficacy comparisons after intervention were not statistically different.

TABLE 5 comparison of the effective rates of the phlegm-dampness constitution transformation of traditional Chinese medicine before and after intervention of two groups of patients

Note: 1. total effective rate (clinical control + significant + effective)/total count 100%. 2. The difference is statistically significant by the calibration chi-square test, when P is 0.014 < 0.05.

The number of effective reduction people of the traditional Chinese medicine phlegm-dampness constitution transformation is 14 after intervention, and accounts for 33.3%; the effective number of the control group is 4, accounting for 9.3%. After the two groups of interventions, the number of the effective descendents of the phlegm-dampness constitution transformation of the traditional Chinese medicine is statistically different, and the intervention scheme of the intervention group is better than that of the control group.

3.6 results of the study of safety indices

Neither group of patients experienced adverse effects of drug application (such as skin pruritus, red swelling and pain of skin, and skin ulceration) during intervention.

Discussion 4

4.1 concept and clinical features of phlegm-dampness constitution

Phlegm-dampness constitution refers to the condition of retention of water in the body, accumulation of dampness and generation of phlegm due to congenital heredity or postnatal overeating of fat, sweet and thick greasy food, dysfunction of viscera, emotional disorder, exogenous dampness, aging and body weakness, etc., and is characterized by the fact that the body is sticky and turbid, and is characterized by obesity, loose and full belly, greasy and greasy facial skin, profuse phlegm and chest distress, and heavy body, and often accompanied by swollen tongue, sticky or sweet mouth and white and greasy coating. The main pathological features are 'heavy, turbid, sticky and stagnant'; the pathogenic characteristics are accompanied with turbid phlegm and damp pathogen, which are mainly reflected in the tendency to stagnate clear yang and block qi movement; heavy, turbid, sticky and greasy, difficult to resolve; mind and mind are confused; the superficial pathogen is apt to cause swelling and fat.

4.2 Western medicine dyslipidemia determination

According to the Chinese adult dyslipidemia prevention and treatment guidelines (2016 revised edition): dyslipidemia refers to any dyslipidemia in serum, such as TC, TG, HDL-c and LDL-c in the general sense; the narrow definition refers to the increase of TC and/or TG content, which is commonly called hyperlipidemia. The indexes of the normal value of the blood fat are as follows: TC < 5.2mmol/l (200mg/dl), TG < 1.7mmol/l (150mg/dl), LDL-c < 3.4mmol/l (130mg/dl), non-LDL-c < 4.1mmol/l (160mg/dl), HDL-c > 1.0mmol/l (40 mg/dl); otherwise, the blood lipid is abnormal.

4.3 understanding of dyslipidemia in traditional Chinese medicine

There is no dictionary alga matched with dyslipidemia in traditional Chinese medicine, but the records can be traced to chest impediment, dizziness, headache, stroke and other chapters, and are related to turbid phlegm and blood stasis. The pathogenesis of the liver-qi deficiency syndrome is related to the blood vessels of the whole body, the reasons of the disease are related to congenital endowments such as different, acquired improper diet, emotional disorder, old and weak constitution, and the pathogenesis is summarized as improper diet, overeating, fatness, greasiness, spleen failure in transportation, phlegm and fluid accumulation or emotional disorder, abnormal qi activity, liver failure in smoothing flow, fluid retention and blood stasis or kidney essence deficiency, kidney yang deficiency, abnormal qi transformation and phlegm-blood stasis.

4.4 analysis of the comprehensive intervention scheme of Chinese medicine

4.4.1 Point application and formulation analysis of the Chinese medicinal composition of the present invention

The Chinese medicinal composition acupoint application is prepared by combining the characteristics of channels, collaterals, acupoints and medicaments by Zhang Xiaotian professor aiming at the characteristics of phlegm-dampness constitution and carrying out independent research and development. The main components of the traditional Chinese medicine composition are prepared arisaema consanguineum schott, prepared pinellia ternate, rhizoma corydalis, raw bighead atractylodes rhizome, rhizoma atractylodis and poria cocos (proportion: 1:1:1:1: 1).

Preparing the rhizoma arisaematis: the rhizoma arisaematis processed with bile has the characteristics of no dryness and toxicity, cool nature, bitter taste, and capability of entering lung and spleen channels, and has the functions of clearing heat and eliminating phlegm. The book Jing Yuan (Source of menstrual flow) has a word: both nan xing and ban Xia are herbs for phlegm, however nan xing is specialized in moving meridians and collaterals, so it is guided to … … for apoplexy and paralysis. Modern pharmacological research experiment-mouse trachea segment phenol red method has proved that rhizoma arisaematis preparata has the effect of reducing phlegm.

Processing pinellia ternate: it is also called Fa ban Xia, a medicine prepared from raw ban Xia through calcium lime and licorice root, pungent and warm with dryness, and Ben Cao in Xin (materia Medica) it is the main herb for treating damp phlegm, enters lung and spleen and stomach meridians, excels at drying dampness and resolving phlegm, and is good at treating the diseases caused by phlegm-fluid retention. The modern pharmacology is shown by adopting an HPLC method and a mouse trachea segment phenol red experiment: the four active ingredients of inosine, guanosine, adenosine and succinic acid are phlegm eliminating substances in the processed pinellia tuber.

Rhizoma corydalis: pungent and bitter in flavor and warm in nature, the "hygienic treasures" is recorded: xuan Hu is pungent in flavor and pungent in flavor, breaking blood and curing qi. They enter liver and spleen meridians and mainly disperse and penetrate, so they are the essential herb for moving qi, and their properties can directly contact and permeate into body through skin to directly reach the diseased region. Meanwhile, in the book "blood syndrome and blood stasis", the following is emphasized: the theory of phlegm-stasis homology is proposed, and it indicates that phlegm is the initial stage of stasis, and that phlegm turbidity develops deeply into stasis, while yanhusuo breaks blood and cures qi simultaneously to treat phlegm-stasis. Modern pharmacological research proves that the corydalis tuber contains rich steroids, organic acids and volatile oil and can assist the absorption of the medicine.

Raw rhizoma atractylodis macrocephalae: bitter and sweet in property, warm in nature, entering spleen and stomach meridians, and has the effects of strengthening spleen, tonifying qi, eliminating dampness and inducing diuresis. The record of the Ben Jing Yuan (the origin of menstrual flow): unprocessed Bai Zhu can remove dampness, benefit dryness, resolve phlegm and induce diuresis. Modern pharmacological research finds that the decoction of the white atractylodes rhizome and the refined extract of the white atractylodes rhizome can regulate the condition of blood fat disorder, and particularly shows that TG, TC and LDL-c are effectively reduced, and the content of HDL-c is obviously increased.

Rhizoma atractylodis: it is pungent, bitter and warm in nature, enters spleen, stomach and liver meridians, can dispel wind-damp pathogen externally and resolve dampness of spleen and stomach internally, so it is the key herb for treating dampness in both interior and exterior of body. Modern pharmacological studies have confirmed that water extracts and n-butanol parts of rhizoma atractylodis before and after stir-frying with bran can increase the content of gastrin in the established damp-blocking middle-jiao type rat after drug intervention, accelerate the propulsion rate of small intestine, increase spleen quality and urine volume, and make the rat grasp well in a water-damp retention state in vivo, thus proving the efficacy of strengthening spleen and eliminating dampness.

Tuckahoe, poria cocos: sweet and bland in taste, neutral in nature, entering lung and spleen channels, and has the effects of excreting dampness, promoting diuresis, invigorating spleen and reducing phlegm. The Chinese literature of "Shibuzhai medical book" is characterized by: poria cocos, a principal drug for treating phlegm. Modern pharmacological research proves that the effective component poria cocos can activate in-vivo NA⁺-K⁺ATP enzyme and competitive aldosterone receptor regulate the metabolism of body water and make sputum not generate; meanwhile, the medicine can stimulate the healthy qi of the human body, improve the circulation of qi and blood and promote the discharge of turbid phlegm.

In conclusion, the prepared arisaema cum bile and the prepared pinellia tuber in the whole formula are matched with the prepared pinellia tuber to eliminate dampness and phlegm; corydalis tuber promotes the circulation of qi and removes stasis, treats phlegm and blood stasis at the same time; cangbu shu can tonify qi, invigorate spleen, dry dampness, and poria cocos, sweet in taste and bland in nature can moisten and invigorate spleen. The whole formula has the effects of invigorating spleen and replenishing qi, and eliminating dampness and reducing phlegm.

4.4.2 Point selection analysis

The Chinese medicinal composition applied to the acupuncture points correspondingly selects the acupuncture points as follows: fenglong, Yinlingquan and Tianshu. Fenglong: pertaining to the stomach meridian of foot Yangming, 8 cun above the lateral malleolus, 1 cun outside the Zuokou, and 2 cun outside the anterior tibial eminence. It is recorded in Ling Shu & Jing Mai (Ling Shu & Jing Mai), which is the collateral points, separately walks the spleen meridian, connects the two meridians of the spleen and stomach, can activate qi movement of the spleen and stomach, and has the effects of invigorating spleen, resolving phlegm, harmonizing stomach, descending adverse qi, regulating qi and blood, and eliminating phlegm for resuscitation, wherein the most significant effect of eliminating phlegm is the main point of phlegm, just as Yulong Ge: "excessive phlegm should be found in abundance. The modern clinical research shows that stimulation of Fenglong acupoint can greatly promote the expression levels of Janus kinase 2, signal transduction and transcription activator 3 and zinc finger protein 36 in macrophage, prevent the macrophage from converting into foam cell, and reduce the accumulation of subcutaneous fat, so as to regulate lipid metabolism and lower blood fat level.

Spring of Yinlingquan: it belongs to the spleen meridian of foot taiyin and is located in the depression between the medial border of tibia and the medial border of tibia. The Shu He Ye is the essential point for removing dampness and moving water, just as the Yin Ling opens the water channel in Ju Er, Tong Xuan Zhi Yao Fu (the book of two and passing the Xuan means). It is combined with the phlegm-eliminating essential point of ZUYANGMENGWEI to communicate the exterior and interior, strengthen the effect of invigorating spleen to eliminate dampness, and eliminate dampness and dampness. Clinical tests prove that common acupuncture, electric acupuncture, moxibustion, acupoint catgut embedding and other stimulation methods can be applied to Yinlingquan to achieve the effects of reducing phlegm-damp constitution and improving blood fat.

And (3) pivot: it pertains to the stomach meridian of foot Yangming, and is located in the abdomen, transverse to the umbilicus, 2 cun lateral to the anterior midline. Beginning with the point of the Yijing and Jiu Jia Yi Jing, it is the place where the qi of the large intestine meridian collects, and can clear and descend the turbid, regulate the ascending and descending of the qi-moving machine, regulate the intestines, and communicate the upper and lower parts, and smooth the three jiao. The clinical multi-purpose acupoint application, acupoint catgut embedding, acupuncture and the like are matched with other acupoints to achieve the curative effects of intervening obesity, improving insulin resistance, reducing blood fat and the like.

In conclusion, Fenglong and Yinlingquan are coordinated with the points on the exterior and interior meridians to communicate the two meridians of the spleen and stomach, communicate the exterior and interior, link the whole body, promote the qi movement of the spleen and stomach, and play the roles of tonifying spleen and reducing phlegm together; the Tianshu has the effects of dredging the local part, regulating intestines, communicating the upper and lower parts, and smoothing the triple energizer. The three points are combined together, and the whole body and the part act together.

4.5 analysis of study results

4.5.1 analysis of comparison results of weight, waist circumference, hip circumference and waist-hip ratio before and after intervention of two groups of patients

The weight, waist circumference, hip circumference and waist-hip ratio of the two groups of patients before intervention are respectively tested by two independent samples t, and four groups of baseline data have comparability. After the three-month intervention period, the body weight, the waist circumference and the hip circumference of the two groups of patients are reduced compared with the prior one, and the difference has statistical significance, which shows that the simple diet guidance and the traditional Chinese medicine intervention scheme have the effect of improving the body weight, the waist circumference and the hip circumference of the patients. Meanwhile, the comparison difference between two groups of patients with dry prognosis has statistical significance, and the combination of the mean value plus or minus standard deviation value shows that the curative effect of the intervention group is superior to that of the control group, which shows that the systemic and local effects generated after the traditional Chinese medicines with dampness and phlegm eliminating are absorbed through the skin can further improve the weight, the waistline and the hip circumference of the patients.

The difference between the waist-hip ratio of two groups of patients before and after intervention and between the groups has no statistical significance, which shows that the simple diet guidance and the traditional Chinese medicine intervention scheme have no obvious effect on the improvement of the waist-hip ratio of the patients.

4.5.2 analysis of results comparing BMI index levels before and after intervention in two groups of patients

The BMI indexes of two groups of patients are classified according to four grades of low body weight, normal body weight, overweight and obesity, and the BMI index baseline data of the two groups of patients before intervention is comparable through two independent sample rank sum tests. After three months of intervention period, the BMI indexes of the two groups of patients are close to the normal range compared with the BMI indexes of the two groups of patients, and the difference has statistical significance, which indicates that the BMI indexes of the patients can be improved by simple diet guidance and traditional Chinese medicine intervention schemes. However, the BMI index degree of the two groups of patients after dry prognosis has no difference in comparison, which shows that the simple diet guidance and the traditional Chinese medicine intervention scheme have no obvious curative effect difference on improving the BMI index degree of the patients within the intervention period of 3 months.

4.5.3 analysis of the results of the differential analysis of the transformation and the differentiation of the phlegm-dampness constitution of the TCM before and after the intervention of the two groups of patients

Before intervention, the transformation of phlegm-dampness constitution of traditional Chinese medicine is subjected to t test of two independent samples, and the difference has no statistical significance, which indicates that the baseline data is comparable. After patients are intervened for march by a simple diet guidance and a traditional Chinese medicine intervention scheme, the general trends of the transformation and division of the phlegm-dampness constitution of the two groups of traditional Chinese medicine are reduced compared with the former trends, and the comparison between the two groups of patients before and after intervention has difference, which shows that the two groups of intervention schemes have curative effect on improving the phlegm-dampness constitution of the traditional Chinese medicine. Wherein the effective person (the reduction is more than or equal to 30%) for intervening the group mass transformation and the differentiation reduction is 14 persons, and the effective rate is 33.3%; the effective patients (the reduction is more than or equal to 30%) are divided into 4 persons according to the body mass transformation of the control group, the effective rate is 9.3%, and the data of the two groups after intervention are different, which shows that the curative effect of the traditional Chinese medicine intervention scheme is better than that of the simple diet guidance. Further shows that the traditional Chinese medicine composition can correct the phlegm-dampness constitution of the old by applying the acupoint application.

4.5.4 comparison of blood lipid before and after intervention

Results analysis results after independent sample t test or independent sample rank sum test on three blood lipid index baseline data of TG, TC and LDL-c before intervention of two groups of patients prove that P is more than 0.05 among the groups, and all blood lipids are comparable.

The TG was significantly reduced in the two groups of patients with dry prognosis compared to that before intervention, and the comparison between the two groups and the comparison between the dry prognosis groups were different. Meanwhile, by combining the effective degrees of the two groups of decline indexes, the intervention group is found to have 20 effective dry prognosis (accounting for 47.6%), 14 effective dry prognosis (accounting for 33.3%) and 34 total effective dry prognosis (accounting for 81.0%); after intervention, the control group showed 9 effective persons (accounting for 20.9%), 12 effective persons (accounting for 27.9%) and 21 effective persons (accounting for 48.8%). It was concluded that both intervention regimens were effective in improving TG levels in patients, but the control intervention regimen was inferior to the intervention group.

The comparison in the two index groups of the intervention group is reduced aiming at the comparison of TC and LDL-c before and after the intervention, and the difference has statistical significance; the average values of the two indexes in the control group are slightly floated, and the contrast between the two groups after intervention has difference. Indicating that the intervention group is effective in improving the TC and LDL-c levels in the patients. But the efficiency is found by combining the reduction of two indexes: (1) in TC indexes, after intervention of intervention groups, 12 persons (accounting for 28.6%) are effective, 10 persons (accounting for 23.8%) are effective, and the total effective number is 22 persons (accounting for 52.4%); after intervention, the control group shows 3 effective persons (accounting for 7.0 percent), 5 effective persons (accounting for 11.6 percent) and 8 total effective persons (accounting for 18.6 percent), and the effective rates of the indexes in the group are different. Therefore, the following conclusion is reached: the intervention group can effectively improve the TC index of the patient, while the control group has poor improvement effect. (2) In the LDL-c index, 9 effective persons (accounting for 21.4 percent), 11 effective persons (accounting for 26.2 percent) and 20 effective persons (accounting for 47.6 percent) are shown after intervention of intervention groups; after the intervention of the control group, 5 persons (accounting for 11.6 percent) are effective, 6 persons (accounting for 14.0 percent) are effective, the total effective number is 11 persons (accounting for 25.6 percent), and the comparison of the effective rates of the two groups after the intervention has no statistical difference. Therefore, the results are obtained: although it could not be determined that the intervention group had an effective reduction in LDL-c over the control group, the intervention group had some relief in improving the patient's LDL-c level.

In conclusion, the traditional Chinese medicine intervention scheme is better than the simple diet therapy in improving the physicochemical level of the blood fat of patients, so that the blood fat tends to be normal, and the improvement effect is that TG is more than TC and LDL-c in turn.

5 conclusion

The simple diet guidance and the traditional Chinese medicine intervention scheme can effectively improve the weight, waist circumference, hip circumference and BMI index of the elderly patients with phlegm-dampness constitution and elevated blood fat margin.

The traditional Chinese medicine intervention scheme can effectively improve the phlegm-dampness constitution, the qi deficiency constitution and the damp-heat constitution conversion and TG, TC and LDL-c of the patients, and is superior to the simple diet guidance in the aspects of the phlegm-dampness constitution, the qi deficiency constitution and the damp-heat constitution conversion and TC and LDL improvement.

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 (9)

1. The traditional Chinese medicine composition for improving phlegm-dampness constitution is characterized by being prepared from the following raw material medicines in parts by weight: 10-20 parts of processed arisaema tuber, 10-20 parts of processed pinellia tuber, 10-20 parts of corydalis tuber, 10-20 parts of raw atractylodes macrocephala, 10-20 parts of atractylodes rhizome and 10-20 parts of tuckahoe.

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 processed arisaema consanguineum, 13-18 parts of processed pinellia ternate, 13-18 parts of corydalis tuber, 13-18 parts of raw bighead atractylodes rhizome, 13-18 parts of rhizoma atractylodis and 13-18 parts of poria cocos.

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 processed arisaema consanguineum, 15 parts of processed pinellia ternate, 15 parts of corydalis tuber, 15 parts of raw bighead atractylodes rhizome, 15 parts of rhizoma atractylodis and 15 parts of poria cocos.

4. A method for preparing the Chinese medicinal composition of any one of claims 1 to 3, which comprises the following steps: weighing the processed arisaema tuber, the processed pinellia tuber, the rhizoma corydalis, the raw white atractylodes rhizome, the rhizoma atractylodis and the tuckahoe in proportion, crushing into powder and mixing uniformly.

5. Use of the composition of any one of claims 1-3 for the manufacture of a medicament for improving phlegm-dampness constitution.

6. The use according to claim 5, wherein the pharmaceutical dosage form is an external preparation. .

7. The use of claim 6, wherein the external preparation is in the form of a patch, paste, ointment, gel, film coating agent or cataplasm.

8. An acupoint application for improving phlegm-dampness constitution is characterized in that the acupoint application is prepared by mixing any one of the traditional Chinese medicine compositions with a transdermal agent.

9. The point application of claim 8, wherein the transdermal agent is made from a hot melt matrix and azone in a ratio of 1000: 10.