CN111053829A - Traditional Chinese medicine composition for treating abdominal obesity and preparation and external preparation thereof - Google Patents

Traditional Chinese medicine composition for treating abdominal obesity and preparation and external preparation thereof Download PDF

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CN111053829A
CN111053829A CN202010066282.0A CN202010066282A CN111053829A CN 111053829 A CN111053829 A CN 111053829A CN 202010066282 A CN202010066282 A CN 202010066282A CN 111053829 A CN111053829 A CN 111053829A
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volatile oil
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胡旭光
邓剑壕
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Guangdong Pharmaceutical University
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/232Angelica
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
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    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/14Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

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Abstract

The invention discloses a traditional Chinese medicine composition and an external preparation for treating abdominal obesity, wherein the traditional Chinese medicine composition comprises 1-3 parts of rheum officinale, 1-3 parts of radix puerariae, 3-5 parts of divaricate saposhnikovia root, 3-5 parts of Chinese angelica, 0.5-1.5 parts of rhizoma alismatis, 0.5-1.5 parts of mint, 0.05-0.15 part of menthol, 0.01-0.03 part of divaricate saposhnikovia root volatile oil and 0.01-0.03 part of Chinese angelica volatile oil.

Description

Traditional Chinese medicine composition for treating abdominal obesity and preparation and external preparation thereof
Technical Field
The invention belongs to the technical field of weight losing and fat regulating, and particularly relates to a traditional Chinese medicine composition for treating abdominal obesity, an external preparation and application thereof.
Background
Abdominal obesity refers to fat that accumulates mainly around the mesentery, internal organs and aorta in the abdominal cavity, manifesting as an increase in waist circumference and waist-to-hip ratio. A plurality of domestic surveys show that the abdominal obesity rate is higher than the whole body obesity rate in China, and the characteristic and potential risk of obesity of Chinese people are high in the abdominal obesity rate. Drug therapy is a common method for treating abdominal fat accumulation, and reasonable drug administration can achieve the purpose of effective treatment, which is also the trend of the current abdominal obesity treatment. Although the market has a great demand for slimming products, no effective and stable slimming drug is currently available.
Western medicines are mainly used for losing weight, and are associated with risks in different degrees after long-term use. The traditional Chinese medicine has wide application in the aspects of losing weight and reducing fat, wherein single medicines such as rhizoma alismatis can eliminate phlegm and reduce fat, rhubarb can purge and relax bowels, angelica sinensis can nourish yin and tonify kidney and the like, and traditional Chinese medicine compound formulas such as ledebouriella seseloides powder, radix stephaniae tetrandrae and astragalus decoction, chaulmoogra decoction and the like can be modified and changed according to the constitution of a patient, and therapies such as yang warming, kidney tonifying, qi regulating and phlegm reducing are adopted from the aspects of different organs, so that ideal.
Two different types of adipocytes exist in mammals, namely brown adipocytes and white adipocytes. White adipose tissue is mainly used for storing energy, and brown adipose tissue plays an important role in the aspect of non-shivering heat generation due to the fact that cells contain abundant mitochondria and high-expression uncoupling protein 1(UCP1), and further becomes a new strategy for effectively controlling obesity.
The obesity can cause the blood of the whole body to flow unsmoothly, and can cause the perianal vascular plexus to generate qi stagnation and blood stasis to generate hemorrhoids, so that research, development and innovation of products which can reduce weight and condition the hemorrhoids are urgently needed.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating abdominal obesity, and the other aim of the invention is to provide an external preparation of the traditional Chinese medicine composition for treating abdominal obesity, which has the characteristics of directional weight loss and fat regulation, safety, reliability, no side effect and the like.
In order to achieve the purpose, the invention adopts the following technical scheme:
a traditional Chinese medicine composition for treating abdominal obesity is characterized by comprising the following raw materials in parts by weight: 1-3 parts of rheum officinale, 1-3 parts of kudzu root, 3-5 parts of divaricate saposhnikovia root, 3-5 parts of Chinese angelica, 0.5-1.5 parts of rhizoma alismatis, 0.5-1.5 parts of mint, 0.05-0.15 part of menthol, 0.01-0.03 part of divaricate saposhnikovia root volatile oil and 0.01-0.03 part of Chinese angelica volatile oil.
Preferably, the traditional Chinese medicine composition comprises 2 parts of rheum officinale, 2 parts of kudzuvine root, 4 parts of divaricate saposhnikovia root, 4 parts of Chinese angelica, 1 part of oriental waterplantain rhizome, 1 part of mint and 0.1 part of menthol; 0.01 part of divaricate saposhnikovia root volatile oil and 0.01 part of Chinese angelica volatile oil.
Preferably, the traditional Chinese medicine composition is prepared according to the following method: extracting the divaricate saposhnikovia root volatile oil: weighing radix Saposhnikoviae, pulverizing, sieving with 40 mesh sieve, placing in round bottom flask, adding 8 times volume of water, soaking for 2 hr, steam distilling for 8 hr to collect volatile oil, extracting with diethyl ether to obtain crude oil, adding appropriate amount of anhydrous sodium chloride to remove small amount of water, standing, and filtering to obtain radix Saposhnikoviae volatile oil; extracting angelica volatile oil: weighing radix Angelicae sinensis, pulverizing, sieving with 40 mesh sieve, placing in round bottom flask, adding 10 times volume of water, soaking for 1 hr, steam distilling for 5 hr, collecting volatile oil, extracting with diethyl ether to obtain crude oil, adding appropriate amount of anhydrous sodium chloride to remove small amount of water, standing, and filtering to obtain radix Angelicae sinensis volatile oil.
The invention also aims to provide an external preparation of the traditional Chinese medicine composition for treating abdominal obesity, which is prepared from the traditional Chinese medicine composition and a pharmaceutically acceptable external preparation matrix.
Preferably, the external preparation is a patch.
Preferably, the pharmaceutically acceptable external preparation matrix is one or more selected from gelatin, carbomer, triethanolamine, polyvinylpyrrolidone and glycerol.
Preferably, the external preparation is prepared by the following steps:
(1) preparing a substrate: weighing carbomer according to the prescription amount, adding a proper amount of distilled water, soaking overnight to prepare carbomer gel with the concentration of 3%, adding triethanolamine, and adjusting the pH value to 6.5 to be used as phase A; weighing gelatin in a formula amount in a proper container, adding water with the volume being 1-1.5 times of that of the gelatin for soaking, placing the gelatin in a water bath for heating to dissolve after the gelatin is fully swelled, adding glycerol in the formula amount, stirring uniformly, heating the mixture in the water bath to 60 ℃, and preparing glycerol gelatin as a phase B; dissolving polyvinylpyrrolidone with appropriate amount of distilled water to obtain 50% polyvinylpyrrolidone water solution, heating in water bath to 60 deg.C to obtain phase C;
(2) extracting a raw material extract: weighing radix et rhizoma Rhei, radix Puerariae, Alismatis rhizoma, radix Saposhnikoviae, radix Angelicae sinensis, and herba Menthae according to formula, decocting with 10 times of water for 45min, filtering, and collecting filtrate; decocting the residue with 8 times of water for 1 hr, and filtering to obtain filtrate; mixing the two filtrates, concentrating in a rotary evaporator to one eighth volume to obtain raw material extract;
(3) and (3) preparation forming: weighing the active pharmaceutical ingredient extract according to the formula ratio, adding the active pharmaceutical ingredient extract into the glue solution A phase under stirring, adding B, C phase which is subjected to water bath at 60 ℃ in advance, stirring at a low speed of 100r/min to form paste, finally adding menthol mixed with absolute ethyl alcohol, angelica volatile oil and radix sileris volatile oil, quickly grinding uniformly, removing bubbles by ultrasonic waves for 15min, coating the paste on non-woven fabrics, pressurizing by using plate glass, placing the non-woven fabrics in a constant-temperature drying box at 40 ℃ for curing for 20min, cooling to room temperature, covering a polyethylene film, sealing and packaging to obtain the emplastrum.
Preferably, the use of said formulation for the preparation of a medicament for the treatment of hemorrhoids.
Furthermore, the invention has shown that the cataplasm containing the angelica volatile oil and the radix sileris volatile oil in the traditional Chinese medicine composition has obvious inhibition effect on the weight, waist circumference, waist height ratio, abdominal skin lower body fat percentage and abdominal body fat percentage of the obese mouse through experimental example 1, obviously improves the blood fat level of the obese mouse, the expression levels of PGC-1 α and UCP1, shows that the angelica volatile oil and the radix sileris volatile oil synergistically promote the traditional Chinese medicine composition to improve the blood fat, the abdominal skin lower body fat percentage and the abdominal body fat percentage of the obese mouse, and discloses that the angelica volatile oil and the radix sileris volatile oil synergistically promote the meridian operation of the traditional Chinese medicine composition and promote fat metabolism.
Further, the invention discovers through test example 2 that, compared with the prior art, the release degree of the patches provided by examples 4-6 in 1.5 days reaches 100%, and zero-order release is achieved through skin, which indicates that the external preparation has the possibility of long-term stability and high treatment efficiency, and the release degree of comparative examples 1-2 in 1.5 days reaches 70%, indicating that the lack of angelica volatile oil and the lack of radix sileris volatile oil can not achieve good transdermal absorption effect.
Furthermore, according to the invention, as shown in the test example 3, compared with the traditional Chinese medicine composition lacking the angelica volatile oil and the radix sileris volatile oil, the cataplasm containing the traditional Chinese medicine composition lacking the angelica volatile oil and the radix sileris volatile oil has the significant effect of treating hemorrhoids of more than 70 percent, which indicates that the external preparation of the traditional Chinese medicine composition has the effect of treating hemorrhoids.
Compared with the prior art, the invention has the following advantages that 1) the external preparation prepared from the traditional Chinese medicine composition for treating abdominal obesity has the effects of directionally losing weight and regulating fat, reducing the periabdominal fat percentage and the abdominal fat percentage, and improving the expression of UCP1 and PGC1 α in fat of obese mice, 2) the external preparation of the traditional Chinese medicine composition for treating abdominal obesity does not contain an organic transdermal enhancer, and angelica volatile oil, divaricate saposhnikovia root volatile oil and menthol contained in the composition are all natural transdermal absorption enhancers, so that the permeation promoting effect is strong, and 3) the external preparation of the traditional Chinese medicine composition for treating abdominal obesity has the effect of treating hemorrhoids and has no side effect.
Detailed Description
The present invention will be described in further detail with reference to the following examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples.
Example 1 the Chinese medicinal composition of the present invention
The embodiment 1 of the invention provides a traditional Chinese medicine composition for treating abdominal obesity, which comprises the following components in parts by weight: 1 part of rhubarb, 3 parts of kudzu root, 5 parts of divaricate saposhnikovia root, 5 parts of Chinese angelica, 1.5 parts of oriental waterplantain rhizome, 1.5 parts of mint, 0.15 part of menthol, 0.03 part of divaricate saposhnikovia root volatile oil and 0.03 part of Chinese angelica volatile oil.
Example 2 the Chinese medicinal composition of the present invention
The embodiment 2 of the invention provides a traditional Chinese medicine composition for treating abdominal obesity, which comprises the following components in parts by weight: 3 parts of rhubarb, 1 part of kudzu root, 3 parts of divaricate saposhnikovia root, 3 parts of Chinese angelica, 0.5 part of oriental waterplantain rhizome, 0.5 part of mint, 0.05 part of menthol, 0.01 part of divaricate saposhnikovia root volatile oil and 0.01 part of Chinese angelica volatile oil.
Example 3 the Chinese medicinal composition of the present invention
The embodiment 3 of the invention provides a traditional Chinese medicine composition for treating abdominal obesity, which comprises the following components in parts by weight: 2 parts of rhubarb, 2 parts of kudzu root, 4 parts of divaricate saposhnikovia root, 4 parts of Chinese angelica, 1 part of oriental waterplantain rhizome, 1 part of mint, 0.1 part of menthol, 0.02 part of divaricate saposhnikovia root volatile oil and 0.02 part of Chinese angelica volatile oil.
Example 4 cataplasm of the Chinese medicinal composition of the present invention
The embodiment 4 of the invention provides a cataplasm of a traditional Chinese medicine composition for treating abdominal obesity, which comprises the following components in parts by weight: 2 parts of rheum officinale, 2 parts of kudzu roots, 4 parts of divaricate saposhnikovia roots, 4 parts of Chinese angelica, 1 part of rhizoma alismatis, 1 part of mint, 0.1 part of menthol, 0.02 part of divaricate saposhnikovia root volatile oil, 0.02 part of Chinese angelica volatile oil, 3 parts of carbomer, 30 parts of polyvinylpyrrolidone, 3 parts of glycerol, 0.5 part of gelatin, 0.5 part of triethanolamine, 5 parts of absolute ethyl alcohol and 8 parts of distilled water.
The preparation method of the cataplasm comprises the following steps:
(1) preparing a substrate: weighing carbomer according to the prescription amount, adding a proper amount of distilled water, soaking overnight to prepare carbomer gel with the concentration of 3%, adding triethanolamine, and adjusting the pH value to 6.5 to be used as phase A; weighing gelatin in a formula amount in a proper container, adding water with the volume being 1-1.5 times of that of the gelatin for soaking, placing the gelatin in a water bath for heating to dissolve after the gelatin is fully swelled, adding glycerol in the formula amount, stirring uniformly, heating the mixture in the water bath to 60 ℃, and preparing glycerol gelatin as a phase B; dissolving PVP in appropriate amount of distilled water to obtain 50% PVP aqueous solution, heating in water bath to 60 deg.C to obtain phase C;
(2) extracting a raw material extract: weighing radix et rhizoma Rhei, radix Puerariae, Alismatis rhizoma, radix Saposhnikoviae, radix Angelicae sinensis, and herba Menthae according to formula, decocting with 10 times of water for 45min, filtering, and collecting filtrate; decocting the residue with 8 times of water for 1 hr, and filtering to obtain filtrate; mixing the two filtrates, concentrating in a rotary evaporator to one eighth volume to obtain raw material extract;
(3) and (3) preparation forming: weighing 10g of original drug extract, adding into the phase A under stirring, adding B, C phase which is subjected to water bath at 60 deg.C in advance, stirring at low speed of 100r/min to obtain paste, adding anhydrous ethanol, menthol and volatile oil, quickly grinding, performing ultrasonic treatment for 15min, coating on non-woven fabric, pressurizing with plate glass, aging in a constant temperature drying oven at 40 deg.C for 20min, cooling to room temperature, covering with polyethylene film, sealing, and packaging to obtain cataplasma.
Example 5 cataplasm of the Chinese medicinal composition of the present invention
The embodiment 5 of the invention provides a traditional Chinese medicine composition for treating abdominal obesity, which comprises the following components in parts by weight: 3 parts of rheum officinale, 1 part of kudzu root, 3 parts of divaricate saposhnikovia root, 3 parts of Chinese angelica, 0.5 part of rhizoma alismatis, 0.5 part of mint, 0.05 part of menthol, 0.01 part of divaricate saposhnikovia root volatile oil, 0.01 part of Chinese angelica volatile oil, 3 parts of carbomer, 30 parts of polyvinylpyrrolidone, 3 parts of glycerol, 0.5 part of gelatin, 0.5 part of triethanolamine, 5 parts of absolute ethyl alcohol and 8 parts of distilled water.
The preparation method of the cataplasma is the same as that of example 4.
Example 6 cataplasm of the Chinese medicinal composition of the present invention
The embodiment 6 of the invention provides cataplasm of a traditional Chinese medicine composition for treating abdominal obesity, which comprises the following components of 1 part of rheum officinale, 3 parts of radix puerariae, 5 parts of divaricate saposhnikovia root, 5 parts of angelica sinensis, 1.5 parts of rhizoma alismatis, 1.5 parts of mint, 0.15 part of menthol, 0.03 part of divaricate saposhnikovia root volatile oil, 0.03 part of angelica volatile oil, 3 parts of carbomer, 30 parts of polyvinylpyrrolidone, 3 parts of glycerol, 0.5 part of gelatin, 0.5 part of triethanolamine, 5 parts of absolute ethyl alcohol and 8 parts of distilled water.
The preparation method of the cataplasma is the same as that of example 4.
Comparative example 1
The invention provides cataplasm of a traditional Chinese medicine composition for treating abdominal obesity in a comparative example 1, wherein the cataplasm comprises the following components in parts by weight: 2 parts of rheum officinale, 2 parts of kudzu roots, 4 parts of divaricate saposhnikovia roots, 4 parts of Chinese angelica, 1 part of rhizoma alismatis, 1 part of mint, 0.1 part of menthol, 0.04 part of divaricate saposhnikovia root volatile oil, 3 parts of carbomer, 30 parts of polyvinylpyrrolidone, 3 parts of glycerol, 0.5 part of gelatin, 0.5 part of triethanolamine, 5 parts of absolute ethyl alcohol and 8 parts of distilled water.
The preparation method of the cataplasma is the same as that of example 4.
Comparative example 2
The invention provides cataplasm of a traditional Chinese medicine composition for treating abdominal obesity in a comparative example 2, wherein the cataplasm comprises the following components in parts by weight: 2 parts of rheum officinale, 2 parts of kudzu roots, 4 parts of divaricate saposhnikovia roots, 4 parts of Chinese angelica, 1 part of rhizoma alismatis, 1 part of mint, 0.1 part of menthol, 0.04 part of Chinese angelica volatile oil, 3 parts of carbomer, 30 parts of polyvinylpyrrolidone, 3 parts of glycerol, 0.5 part of gelatin, 0.5 part of triethanolamine, 5 parts of absolute ethyl alcohol and 8 parts of distilled water.
The preparation method of the cataplasma is the same as that of example 4.
Comparative example 3
The embodiment 4 of the invention provides a cataplasm of a traditional Chinese medicine composition for treating abdominal obesity, which comprises the following components in parts by weight: 2 parts of rheum officinale, 2 parts of kudzu roots, 4 parts of divaricate saposhnikovia roots, 4 parts of Chinese angelica, 1 part of rhizoma alismatis, 1 part of mint, 0.1 part of menthol, 0.03 part of divaricate saposhnikovia root volatile oil, 0.01 part of Chinese angelica volatile oil, 3 parts of carbomer, 30 parts of polyvinylpyrrolidone, 3 parts of glycerol, 0.5 part of gelatin, 0.5 part of triethanolamine, 5 parts of absolute ethyl alcohol and 8 parts of distilled water.
The preparation method of the cataplasma is the same as that of example 4.
Comparative example 4
The embodiment 4 of the invention provides a cataplasm of a traditional Chinese medicine composition for treating abdominal obesity, which comprises the following components in parts by weight: 2 parts of rheum officinale, 2 parts of kudzu roots, 4 parts of divaricate saposhnikovia roots, 4 parts of Chinese angelica, 1 part of rhizoma alismatis, 1 part of mint, 0.1 part of menthol, 0.01 part of divaricate saposhnikovia root volatile oil, 0.03 part of Chinese angelica volatile oil, 3 parts of carbomer, 30 parts of polyvinylpyrrolidone, 3 parts of glycerol, 0.5 part of gelatin, 0.5 part of triethanolamine, 5 parts of absolute ethyl alcohol and 8 parts of distilled water.
The preparation method of the cataplasma is the same as that of example 4.
Test example 1 pharmacodynamic test of obese mice
1.1 Experimental animals
Kunming mice, SPF grade, male, body mass (18-22) g, purchased from Guangdong province medical laboratory animal center.
1.2 drugs and reagents
The cataplasma of examples 4-6 was collected. The positive control external patch is a slimming Ailukang slimming patch, and is cut to about 1cm according to the administration area of the self-made proved external patch with the same administration area2The acupoint paste is ready for use. Total cholesterol, triglyceride, high density lipoprotein cholesterol, low density lipoprotein cholesterol and glucose assay kits were purchased from Beijing Boaosen Biochemical technologies.
1.4 test methods:
80 Kunming mice were randomly weighed and divided into 8 groups, namely a blank control group, a model group, administration groups of examples 4 to 6, and an Allocon patch group. The experiment was started one week after acclimatization. Except for the blank group, the other groups of mice were injected with chlorpromazine injection 0.1ml/10g per abdominal cavity for 1 day, and the model was continuously molded for 14 days.
The corresponding medicine external plaster is applied the next day after the molding is successful, medical cotton balls are used as carriers, 0.01ml/g of medicine is respectively dipped in each mouse, the mouse is fixed on the abdomen for 6 hours by medical adhesive plaster, and the medicine is changed for 1 time in 24 hours for 28 consecutive days.
At the end of the experiment, the mice in each group were fasted for 12h, and body length and waist circumference, body weight were measured and recorded, and waist height ratio was calculated.
Blood is taken from the orbit, serum is separated, the content of TC, TG, HDL-C, LDL-C and GLU in the serum of each group of mice is respectively measured according to the requirements of the kit, the fat tissue in the abdominal cavity of the mice is separated, the wet weight is weighed, the fat rate of the subcutaneous body and the fat rate of the abdominal cavity of the mice are calculated, and the expression quantity of PGC-1 α and UCP1 genes in the fat tissue of the rat is measured.
Figure BDA0002376056380000081
Figure BDA0002376056380000082
1.5 results
1.5.1 Effect on body weight, waist circumference and waist height ratio in Abdominal obese mice
As shown in Table 1, compared with a model group, the traditional Chinese medicine composition cataplasm containing the angelica volatile oil and the radix sileris volatile oil can obviously reduce the weight, waist circumference and waist height ratio of obese mice, has better effect than the traditional Chinese medicine composition cataplasm lacking the angelica volatile oil and the radix sileris volatile oil, and has synergistic inhibition effect on the weight, waist circumference and waist height ratio of the obese mice.
TABLE 1 Effect on mouse body weight, waist circumference and waist height ratio
Group of Body weight (g) Waist circumference (cm) Waist height ratio
Blank control group 40.22±2.87 7.13±0.45 0.76±0.04
Model set 53.44±3.18** 8.26±0.44* 0.85±0.05*
Example 4 41.02±2.73# 7.21±0.28## 0.72±0.03#
Example 5 41.37±3.12# 7.30±0.32# 0.71±0.04#
Example 6 42.35±2.69# 7.35±0.30# 0.71±0.06
Comparative example 1 50.44±3.11 8.06±0.44 0.81±0.05
Comparative example 2 48.44±2.18 8.16±0.44 0.78±0.33
Comparative example 3 47.86±2.03 8.15±0.19 0.77±0.16
Comparative example 4 46.46±1.83 8.09±0.64 0.79±0.25
Ailukang acupoint plaster set 41.32±4.44# 7.30±0.27# 0.70±0.03#
Note: p compared to blank control group<0.05;**P<0.01; in comparison with the set of models,#P<0.05;##P<0.01。
1.5.2 Effect on blood fat and body fat of abdominal obesity mice
As shown in tables 2-3, the cataplasm containing the angelica volatile oil and the radix sileris volatile oil can reduce TC, TG and LDL levels of abdominal obesity mice, improve HDL-C content, and remarkably reduce abdominal peridermal lower body fat percentage and abdominal cavity body fat percentage of the mice, and has an effect superior to that of a traditional Chinese medicine composition cataplasm lacking the angelica volatile oil and the radix sileris volatile oil, so that the angelica volatile oil and the radix sileris volatile oil synergistically promote the traditional Chinese medicine composition to improve blood fat, abdominal peridermal lower body fat percentage and abdominal cavity body fat percentage of the obese mice, and the angelica volatile oil and the radix sileris volatile oil synergistically promote meridian operation of the traditional Chinese medicine composition and promote fat metabolism.
TABLE 2 Effect on blood lipids in mice
Group of TC(mmol) TG(mmol) HDL(mmol) LDL(mmol)
Blank control group 4.52±0.34 1.39±0.24 4.00±0.38 0.22±0.08
Model set 5.03±0.32* 1.85±0.13* 1.19±0.19** 0.57±0.15**
Example 4 4.25±0.36# 1.32±0.46# 3.43±0.40## 0.34±0.09#
Example 5 4.39±0.26# 1.23±0.15## 3.21±0.29# 0.40±0.03#
Example 6 4.40±0.72# 1.43±0.10 3.12±0.42# 0.51±0.12
Comparative example 1 4.83±0.42 1.65±0.13 2.39±0.19 0.47±0.05
Comparative example 2 4.73±0.55 1.77±0.13 2.59±0.19 0.44±0.17
Comparative example 3 4.78±0.62 1.78±0.22 2.72±0.33 0.45±0.67
Comparative example 4 4.81±0.88 1.79±0.43 2.71±0.31 0.46±0.53
Ailukang acupoint plaster set 4.38±0.20# 1.49±0.11## 3.30±0.59## 0.35±0.11#
Note: p compared to blank control group<0.05;**P<0.01; in comparison with the set of models,#P<0.05;##P<0.01。
TABLE 3 Effect on body fat percentage in mice
Group of Fat percentage of the abdominal circumference subcutaneous body (%) Abdominal body fat percentage (%)
Blank control group 0.93±0.39 1.98±0.71
Model set 1.48±0.45* 2.39±0.54*
Example 4 0.98±0.32# 1.72±0.52#
Example 5 1.03±0.32# 1.83±0.38#
Example 6 1.11±0.56# 1.99±0.83#
Comparative example 1 1.28±0.25 2.09±0.51
Comparative example 2 1.35±0.41 2.11±0.14
Comparative example 3 1.36±0.22 2.21±0.34
Comparative example 4 1.38±0.25 2.18±0.15
Ailukang acupoint plaster set 1.17±0.47# 1.97±0.52#
Note: p compared to blank control group<0.05; in comparison with the set of models,#P<0.05。
1.5.3 Effect on expression of fat PGC-1 α, UCP1 genes
As shown in Table 4, the results show that the cataplasm containing the Chinese angelica volatile oil and the divaricate saposhnikovia root volatile oil of the invention can promote the expression of PGC-1 α and UCP1 genes of abdominal obesity mice, while the Chinese medicinal composition external patch lacking the Chinese angelica volatile oil and lacking the divaricate saposhnikovia root volatile oil has no obvious effect on the expression of mRNA of PGC-1 α and UCP1 of the mice, and the Chinese angelica volatile oil and the divaricate saposhnikovia root volatile oil can synergistically promote the expression of PGC-1 α and UCP1 genes in fat of the obesity mice.
TABLE 4 Effect on the relative expression levels of mouse PGC-1 α and UCP1mRNA
Figure BDA0002376056380000091
Figure BDA0002376056380000101
Note: p compared to blank control group<0.05;**P<0.01; in comparison with the set of models,#P<0.05。
test example 2 Release test in cataplasma of the Chinese medicinal composition of the present invention
The permeability experiments of the nude mice of examples 4-6 and comparative examples 1-4 are respectively carried out, and the specific steps are as follows: taking two-week-old nude mice, cutting off the neck, killing, peeling the skin, carefully removing subcutaneous fat, and refrigerating at-30 ℃ for later use; adopting Franz transdermal diffusion cell to carry out transdermal experiment, the water bath temperature is 32 ℃, the stirring speed is 300rpm, and the transdermal area is 2.5cm2The volume of the receiving pool is 15ml, the receiving liquid is phosphate buffer solution with pH7.4, the paste is tightly attached to the stratum corneum of the skin, the sampling and the fluid infusion are performed at regular time, and the sample is analyzed by high pressure liquid chromatography.
As shown in table 5, compared with the prior art, the release rate of the patches provided in examples 4 to 6 reaches 100% within 1.5 days, and zero-order release is achieved through the skin, which indicates that the external preparation has the possibility of long-term stability and high treatment efficiency, and the external preparations in comparative examples 1 to 4 cannot be completely released within 1.5 days, which indicates that the external preparation cannot achieve good transdermal absorption effect due to the lack of the angelica volatile oil and the lack of the radix sileris volatile oil, and the transdermal absorption effect can be achieved only when the weight parts of the radix sileris volatile oil and the angelica volatile oil are 0.02 part.
TABLE 5 Release test Effect
Figure BDA0002376056380000102
Test example 3 evaluation of therapeutic efficacy on obese people
1 test subject
180 obese patients with external hemorrhoids were recruited in society and school.
2. Method of producing a composite material
The cataplasm is randomly divided into 9 groups, the test group is given with the cataplasm prepared in the example 4, the model group is given with the cataplasm which only has auxiliary materials and does not have medicine, the cataplasm is pasted on the navel of a patient before sleeping, and the cataplasm can be pasted on Guanyuan acupoint, Tianshu and Damai acupoint, and the using time of each time is not less than 6 hours. Measuring height, weight and waist circumference before administration; measurements were taken 1 time per week and 4 weeks with continuous dosing. Determining the obesity index (BMI), BMI weight (Kg)/height2(m2). The waist circumference of male is 85cm, the waist circumference of female is 80cm, and the BMI is 24Kg/m2It is called overweight when the BMI is 28Kg/m2It is called obesity.
3. Hemorrhoid curative effect judgment index
The effect is shown: the hemorrhoid symptoms are healed and recovered to be normal
Improvement: the symptoms of the hemorrhoids are relieved and gradually improved
And (4) invalidation: no significant reduction of hemorrhoid symptoms
4. Results
The results are shown in table 6, the Chinese medicinal composition cataplasm containing the angelica volatile oil and the saposhnikovia divaricata volatile oil has a remarkable inhibiting effect on the body weight and waist circumference of obese men and women, and the effect is superior to that of the Chinese medicinal composition lacking the angelica volatile oil and lacking the saposhnikovia divaricata volatile oil, so that the angelica volatile oil and the saposhnikovia divaricata volatile oil synergistically promote the Chinese medicinal composition to reduce the waist circumference and body weight of obese people, and when the weight parts of the angelica volatile oil and the saposhnikovia divaricata volatile oil are 0.02 part; as can be seen from Table 7, compared with the traditional Chinese medicine composition lacking the volatile oil of Chinese angelica and the volatile oil of divaricate saposhnikovia root, the cataplasm of the traditional Chinese medicine composition containing the volatile oil of Chinese angelica and the volatile oil of divaricate saposhnikovia root has the obvious effect of more than 70 percent on external hemorrhoids, and the curative effect on hemorrhoids is the best when the weight parts of the volatile oil of Chinese angelica and the volatile oil of divaricate saposhnikovia root are 0.
TABLE 6 Effect on body weight and waist circumference of obese people
Figure BDA0002376056380000111
Figure BDA0002376056380000121
Note: in comparison with the set of models,#P<0.05。
TABLE 7 Observation of the therapeutic effects on hemorrhoids
Group of Number of examples Display efficiency Good rate of conversion Inefficiency of
Example 4 20 80% 16% 4%
Example 5 20 72% 24% 4%
Example 6 20 70% 28% 2%
Comparative example 1 20 20% 10% 70%
Comparative example 2 20 24% 12% 64%
Comparative example 3 20 26% 10% 64%
Comparative example 4 20 28% 12% 60%
Ailukang acupoint plaster set 20 0 14% 86%
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims (8)

1. A traditional Chinese medicine composition for treating abdominal obesity is characterized by comprising the following raw materials in parts by weight: 1-3 parts of rheum officinale, 1-3 parts of kudzu root, 3-5 parts of divaricate saposhnikovia root, 3-5 parts of Chinese angelica, 0.5-1.5 parts of rhizoma alismatis, 0.5-1.5 parts of mint, 0.05-0.15 part of menthol, 0.01-0.03 part of divaricate saposhnikovia root volatile oil and 0.01-0.03 part of Chinese angelica volatile oil.
2. The traditional Chinese medicine composition for treating abdominal obesity according to claim 1, wherein the traditional Chinese medicine composition comprises 2 parts of rheum officinale, 2 parts of radix puerariae, 4 parts of radix sileris, 4 parts of angelica sinensis, 1 part of rhizoma alismatis, 1 part of mint and 0.1 part of menthol; 0.01 part of divaricate saposhnikovia root volatile oil and 0.01 part of Chinese angelica volatile oil.
3. The traditional Chinese medicine composition for treating abdominal obesity according to claim 1 or 2, characterized in that the traditional Chinese medicine composition is prepared according to the following method:
extracting the divaricate saposhnikovia root volatile oil: weighing radix Saposhnikoviae, pulverizing, sieving with 40 mesh sieve, placing in round bottom flask, adding 8 times volume of water, soaking for 2 hr, steam distilling for 8 hr to collect volatile oil, extracting with diethyl ether to obtain crude oil, adding appropriate amount of anhydrous sodium chloride to remove small amount of water, standing, and filtering to obtain radix Saposhnikoviae volatile oil;
extracting angelica volatile oil: weighing radix Angelicae sinensis, pulverizing, sieving with 40 mesh sieve, placing in round bottom flask, adding 10 times volume of water, soaking for 1 hr, steam distilling for 5 hr, collecting volatile oil, extracting with diethyl ether to obtain crude oil, adding appropriate amount of anhydrous sodium chloride to remove small amount of water, standing, and filtering to obtain radix Angelicae sinensis volatile oil.
4. An external preparation prepared from the traditional Chinese medicine composition for treating abdominal obesity according to claim 1 or 2, which is characterized by being prepared from the traditional Chinese medicine composition and a pharmaceutically acceptable external preparation matrix.
5. The external preparation according to claim 4, wherein the external preparation is a patch.
6. The external preparation as claimed in claim 4, wherein the pharmaceutically acceptable external preparation base is selected from one or more of gelatin, carbomer, triethanolamine, polyvinylpyrrolidone and glycerol.
7. The external preparation according to claim 4, which is prepared by the steps of:
(1) preparing a substrate: weighing carbomer according to the prescription amount, adding a proper amount of distilled water, soaking overnight to prepare carbomer gel with the concentration of 3%, adding triethanolamine, and adjusting the pH value to 6.5 to be used as phase A; weighing gelatin in a formula amount in a proper container, adding water with the volume being 1-1.5 times of that of the gelatin for soaking, placing the gelatin in a water bath for heating to dissolve after the gelatin is fully swelled, adding glycerol in the formula amount, stirring uniformly, heating the mixture in the water bath to 60 ℃, and preparing glycerol gelatin as a phase B; dissolving polyvinylpyrrolidone with appropriate amount of distilled water to obtain 50% polyvinylpyrrolidone water solution, heating in water bath to 60 deg.C to obtain phase C;
(2) extracting a raw material extract: weighing radix et rhizoma Rhei, radix Puerariae, Alismatis rhizoma, radix Saposhnikoviae, radix Angelicae sinensis, and herba Menthae according to formula, decocting with 10 times of water for 45min, filtering, and collecting filtrate; decocting the residue with 8 times of water for 1 hr, and filtering to obtain filtrate; mixing the two filtrates, concentrating in a rotary evaporator to one eighth volume to obtain raw material extract;
(3) and (3) preparation forming: weighing the active pharmaceutical ingredient extract according to the formula ratio, adding the active pharmaceutical ingredient extract into the glue solution A phase under stirring, adding B, C phase which is subjected to water bath at 60 ℃ in advance, stirring at a low speed of 100r/min to form paste, finally adding menthol, angelica volatile oil and radix sileris volatile oil which are mixed by absolute ethyl alcohol, quickly grinding uniformly, removing bubbles by ultrasonic waves for 15min, coating the paste on non-woven fabrics, pressurizing by using plate glass, placing the non-woven fabrics in a constant-temperature drying box at 40 ℃ for curing for 20min, cooling to room temperature, covering a polyethylene film, sealing and packaging to obtain the emplastrum.
8. Use of the external preparation according to any one of claims 1 to 7 for the preparation of a medicament for the treatment of hemorrhoids.
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