CN107595954A - A kind of Chinese medicine composition for reducing body fat and treating Central obesity and its application - Google Patents
A kind of Chinese medicine composition for reducing body fat and treating Central obesity and its application Download PDFInfo
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Abstract
The present invention relates to a kind of Chinese medicine composition for reducing body fat and treating Central obesity, the Chinese medicine composition is made up of the bulk drug of parts by weight as described below：24 parts of the coptis, 13 parts of radix scutellariae, 13 parts of giant knotweed, 13 parts of Asian puccoon, 13 parts of honeysuckle flower, 24 parts of rhizoma atractylodis, 13 parts of lotus leaf.The Chinese medicine preparation of the present invention only has 7 taste medicines, and flavour of a drug number is few, cheap, and preparation is simple, available for treatment Central obesity and reduces body fat, the distribution of improvement patient body fat and leptin resistance, is a kind of safely and effectively lipid-lowering medicine.
Description
Technical field
The present invention relates to technical field of traditional Chinese medicines, is a kind of Chinese medicine for reducing body fat and treating Central obesity specifically
Composition and its application.
Background technology
Obesity belongs to a series of feed regulation and control and energetic supersession disorder caused by many factors, is extraordinary for spy with weight
A kind of chronic metabolic diseases of sign.Nearly ten years, fat extensive widespread in the world, China is also wherein.By 2013,
Fat illness rate has respectively reached 36.9% (male) and 38.0% (women)；In teenager, fat illness rate is also on year by year
Rise, Chinese data have reached 12.9% (boy) and 13.4% (girl).Obesity can trigger a series of adjoint diseases, such as high
Pionemia, diabetes B, hypertension, coronary heart disease, Stein-Leventhal syndrome, bone and joint diseases etc., brought to broad masses heavy
Burden (medical expense increase by 3.8%).People progressively deepen to the understanding of obesity in recent years, and body weight is no longer that diagnosis is fat
Sole criterion, fat content and the distribution of body fat dystopy, which turn into, judges one of fat index of the order of severity.Central obesity is
Metabolic syndrome, hypertension, the high risk factor of diabetes B and cardiovascular and cerebrovascular disease.China's Epidemic status in 2010
Display：The fat incidence of disease of adult center of China type is up to 40.7%.Therefore, treatment is fat, and especially Central obesity has weight
Want meaning.
In the therapeutic process of obesity, it is crucial to reduce body fat, corrects the most important thing that Central obesity is then treatment.Such as
What effectively preventing and treating obesity is increasingly becoming clinical research focus.Treatment at present is fat to be used diet intervention, Sport Administration more, takes
Slimming medicine, implement the methods of loss of weight operation.These treatment means have certain loss of weight effect, but there is also shortcoming and not
Foot, compliance is poor, side reaction is more, easily bounce-back etc..Therefore, clinical workers starts to seek more effective, safer subtract
Weighing method.The fat with a long history and curative effect of Chinese traditional treatment is affirmed.Early in《The Yellow Emperor's Canon of Internal Medicine》In just have " fat people " " meat people " " cream people "
Deng the record about obesity.Chinese traditional treatment obesity is widely used basis, and its curative effect also begins to be understood and connect by doctor trained in Western medicine people having a common goal
By.The meta-analysis delivered in authoritative magazine is shown within 2012, and compared to lifestyle modification, the effective percentage of Chinese medicine loss of weight adds
84% (effective percentage is defined as Body weight loss 2kg).National famous physician professor Ding Xueping is contamination more than 60 years of tcm clinical practice, in being good at
The metabolic diseases such as medicine preventing and treating diabetes, obesity, gout, fatty liver.Face during confirmation tramples, he emphasizes the differentiation of disease and dialectical phase knot
Close, the premise that is combined with microcosmic syndrome differentiation of macroscopic syndrome, Selection drug advocate make the part serve the present, the principle that compound is multi-purpose, obtain good
Good curative effect.It is compound that it treats the multiple ancient prescriptions of Empirical formula system of fat (syndrome of dampness-heat stagnating in spleen).Turbid medicine is let out with heat-clearing and damp-drying drug in side
Thing is the three burnt pathogenic fires of logical drop such as monarch, Asian puccoon, cape jasmine, rhizoma atractylodis eliminating dampness fortune spleen, is official in feudal times, and the root of kudzu vine, lotus leaf, which rise, reminds spleen, is altogether assistant
Make.Full side attacks heresy and takes into account spleen soil, has liter in drop, plays mediation Central Region, the work(of clearing away heat and eliminating dampeness altogether.Early-stage Study finds that this can subtract
Few obese patient's body weight, reduces waistline, reduces serum leptin level.
Chinese patent 2014103077429 discloses one kind and is used to treat obesity traditional Chinese herbal decoction, is prepared by following components
Form：Lotus leaf, rhizoma atractylodis, the bighead atractylodes rhizome, golden cypress, the root of bidentate achyranthes, coix seed, the Radix Astragali, cassia twig, pawpaw, Poria cocos, rhizoma alismatis, hawthorn, Asiatic plantain, tiger
Each 10 grams of cane, selfheal, radix glycyrrhizae.Chinese patent 2009100358398 discloses a kind of medicine for treating obesity：Honeysuckle flower 30,
The capsule of weeping forsythia 30, peppermint 40, chrysanthemum 40, duckweed 30, kuh-seng 40, dittany bark 40, the fruit of summer cypress 40, mulberry skin 50, dandelion 50, the leaf of bamboo 40,
Silkworm excrement 50, golden cypress 30, selfheal 20, giant knotweed 40, bark of ash 40, aloe 50, for treating burning hot type simple obesity.It is but existing
Have in technology, reduce body fat on the present invention and treat the Chinese medicine composition of Central obesity, there is not been reported.
The content of the invention
First purpose of the present invention is to be directed to deficiency of the prior art, there is provided one kind reduces body fat and treatment abdomen type
Fat Chinese medicine composition.
Second object of the present invention is to be directed to deficiency of the prior art, there is provided the pharmacy of Chinese medicine composition as described above
Purposes.
To realize above-mentioned first purpose, the present invention adopts the technical scheme that：
A kind of Chinese medicine composition for reducing body fat and treating Central obesity, the Chinese medicine composition is by weighing as described below
The bulk drug of amount part is made：Radix scutellariae 1-3 parts, coptis 2-4 parts, Asian puccoon 1-3 parts, honeysuckle flower 1-3 parts, rhizoma atractylodis 2-4 parts, giant knotweed 1-3 parts,
Lotus leaf 1-3 parts.
As the preferred embodiment of the present invention, the Chinese medicine composition is by the bulk drug of parts by weight as described below
It is made：2 parts of the coptis, 1 part of radix scutellariae, giant knotweed 1-2 parts, 1 part of Asian puccoon, honeysuckle flower 1-2 parts, rhizoma atractylodis 2-3 parts, 1 part of lotus leaf.
As the preferred embodiment of the present invention, the Chinese medicine composition is by the bulk drug of parts by weight as described below
It is made：Coptis 2-4 parts, radix scutellariae 1-3 parts, giant knotweed 1-3 parts, Asian puccoon 1-3 parts, honeysuckle flower 1-3 parts, rhizoma atractylodis 2-4 parts, lotus leaf 1-3 parts.
As the preferred embodiment of the present invention, the Chinese medicine composition is prepared into according to Chinese medicine customary preparation methods
Clinically acceptable pharmaceutical preparation.The pharmaceutical preparation includes granule, powder, capsule, tablet, mixture or oral liquid.
In the present invention, coptis system Sichuan production ranunculaceae plant coptis rhizome portion, radix scutellariae system Pingyi, shandong Province production labiate
Radix scutellariae rhizome portion, giant knotweed system Jiangxi production polygonaceae plant giant knotweed dry rhizome, Xinjiang Uygur Autonomous Regions of Asian puccoon system production Boraginaceae are planted
Thing Asian puccoon dried roots, honeysuckle flower system Shandong production caprifoliaceae plant hair style honeysuckle dry flower, rhizoma atractylodis system Heilungkiang production composite family are planted
Thing Atractylis lancea dry rhizome, Shandong Province of lotus leaf system produce the dried leaf of nymphaeaceae plant lotus.
Chinese prescription of the present invention is the Empirical formula of inventor, takes into account sample, turbid for therapy with expelling the heat-evil：Radix scutellariae, Huang in side
Even, giant knotweed heat-clearing and damp-drying drug is monarch, three medicine taste bitter and colds, rushes down first wood with bitter eliminating dampness, with cold except heat, clear mutually fire, Chinese medicine；It is purple
Grass, honeysuckle flower three burnt pathogenic fires of logical drop, rhizoma atractylodis eliminating dampness fortune spleen is official in feudal times；Lotus leaf, which rises, reminds spleen, makes for assistant.Full side attacks heresy and takes into account spleen
Soil, there is liter in drop, play mediation Central Region, the work(of clearing away heat and eliminating dampeness altogether.
To realize above-mentioned second purpose, the present invention adopts the technical scheme that：
As above application of any described Chinese medicine composition in the medicine for reducing body fat is prepared.
As above application of any described Chinese medicine composition in the medicine for preparing treatment Central obesity.
As the preferred embodiment of the present invention, the medicine also includes pharmaceutically acceptable carrier or auxiliary material.
The pharmaceutically acceptable carrier or auxiliary material for example can be：Mannitol, sorbierite, sodium pyrosulfite, sulfurous acid
Hydrogen sodium, sodium thiosulfate, menthol, cysteine hydrochloride, TGA, methionine, injection Vitamin B_6 DTA disodiums, EDTA calcium
Sodium, the carbonate of monovalence alkali metal, acetate, phosphate or its aqueous solution, amino acid, sodium chloride, potassium chloride, sodium lactate, wood
Sugar alcohol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, Aspartame, mannitol, silicon spread out
Biology, cellulose and its derivates, alginates, gelatin, polyvinylpyrrolidone, glycerine, POLYSORBATE 80, agar, calcium carbonate, carbonic acid
It is hydrogen calcium, surfactant, polyethylene glycol, cyclodextrin, beta-schardinger dextrin, phospholipid material, kaolin, talcum powder, calcium stearate, hard
Fatty acid magnesium.
As the preferred embodiment of the present invention, the medicine is granule, and specific preparation method is as follows：
(1) bulk drug is taken by weight, takes total weight parts half bulk drug, adds the water of 3~8 times of amounts, and it is small to soak 0.3~1
Shi Hou, 30~60min is decocted, then add the water of 3~8 times of amounts, decocted 15~45min, filtering, merge decoction liquor, be concentrated under reduced pressure, subtract
Dry dry extract is pressed dry, is crushed, sieving, obtains extract powder；
(2) second half crude drug pulverizes and sieves, and sterilizing, is mixed with extract powder, adds auxiliary material, with 60~70% after being well mixed
Particle, Cord blood is made as adhesive in ethanol.
As the preferred embodiment of the present invention, the auxiliary material is mannitol, lactose, sucrose, Aspartame and thin
Lotus brain.
The invention has the advantages that：
1st, the present invention passes through clinical test, it was demonstrated that can reduce the body fat content (FM% ↓) of obese patient.
2nd, the present invention passes through clinical test, it was demonstrated that it can improve the body fat distribution (abdominal fat content ↓) of obese patient.
3rd, the present invention passes through zoopery, it was demonstrated that can reduce the fat mass (white adipose amount ↓) of fat mouse.
4th, the present invention passes through zoopery, it was demonstrated that can reduce the leptin resistance (Serum leptin levels ↓) of fat mouse.
5th, in Chinese medicine preparation of the invention, the proportioning of the Chinese medicine material is to screen to obtain by Experimental comparison, is had
The advantages of good effect, significant effect.
6th, in Chinese medicine preparation of the invention, Asian puccoon, honeysuckle flower and remaining Chinese medicine have synergy, significantly improve Chinese traditional medicine composition
The effect for reducing fat of thing, curative effect are more notable.
7th, Chinese medicine preparation of the invention only has 7 taste medicines, and flavour of a drug number is few, cheap, prepares simply, available for treatment abdomen type
Fat and reduction body fat, improves the distribution of patient's body fat and leptin resistance, is a kind of safely and effectively lipid-lowering medicine.
Brief description of the drawings
Accompanying drawing 1 is subject's changes of weight (kg) in embodiment 14.In figure：* paired t-test is represented compared with pre-treatment, p
＜ 0.05.
Accompanying drawing 2 is to compare (kg) between subject's changes of weight difference group in embodiment 14.
Accompanying drawing 3 is that subject's body fat changes (kg) in embodiment 14.In figure：* paired t-test and phase before treatment are represented
Than p ＜ 0.05；
Accompanying drawing 4 is that subject's waistline changes (cm) in embodiment 15.In figure：* paired t-test is represented compared with pre-treatment, P
﹤ 0.05；# represents variance analysis compared with control group, P ﹤ 0.05.
Accompanying drawing 5 is that subject's stomach fat amount changes (kg) in embodiment 15.In figure：* before representing paired t-test and treating
Compare, P ﹤ 0.05.
Accompanying drawing 6 is to compare (g) between fat mouse weight group after intervening in embodiment 16.In figure：△Expression and Normal group
The same period compares, P<0.05；◇Represent compared with model group, P<0.05.
Accompanying drawing 7 is to compare (g) between fat mouse Fat distribution group after intervening in embodiment 16.In figure：△Expression and normal control
The group same period compares, P<0.05；◇Represent compared with model group, P<0.05.
Accompanying drawing 8 be 4 groups of rat white adipocytes after intervening in embodiment 16 (kidney week and epididymis) form observation (HE ×
400).In figure, A：The turbid side's group of expelling the heat-evil；B：Orlistat group；C：Model control group；D：Normal group (kidney week)；E：Expel the heat-evil
Change turbid side's group；F：Orlistat group；G：Model control group；H：Normal group (epididymis).
Accompanying drawing 9 is to compare (pg/L) between fat mouse Serum Leptin Levels group after intervening in embodiment 17.In figure：With Normal group
Compare,**P<0.01；◇Compared with model control group,◇P<0.05。
Embodiment
The invention will be further elucidated with reference to specific embodiments.It should be understood that these embodiments are merely to illustrate this hair
Bright rather than limitation the scope of the present invention.In addition, it is to be understood that after the content of the invention recorded has been read, art technology
Personnel can make various changes or modifications to the present invention, and these equivalent form of values equally fall within the application appended claims and limited
Fixed scope.
The preparation (one) of 1 Chinese medicine composition of the present invention of embodiment
Bulk drug is taken by weight：Coptis 2-4 parts, radix scutellariae 1-3 parts, giant knotweed 1-3 parts, Asian puccoon 1-3 parts, honeysuckle flower 1-3 parts are grey
Art 2-4 parts, lotus leaf 1-3 parts.
The preparation (two) of 2 Chinese medicine composition of the present invention of embodiment
Bulk drug is taken by weight：2 parts of the coptis, 1 part of radix scutellariae, 1 part of giant knotweed, 1 part of Asian puccoon, 1 part of honeysuckle flower, 2 parts of rhizoma atractylodis, lotus leaf
1 part.
The preparation (three) of 3 Chinese medicine composition of the present invention of embodiment
Bulk drug is taken by weight：2 parts of the coptis, 1 part of radix scutellariae, 1 part of giant knotweed, 1 part of Asian puccoon, 2 parts of honeysuckle flower, 2 parts of rhizoma atractylodis, lotus leaf
1 part.
The preparation (four) of 4 Chinese medicine composition of the present invention of embodiment
Bulk drug is taken by weight：4 parts of the coptis, 3 parts of radix scutellariae, 3 parts of giant knotweed, 3 parts of Asian puccoon, 3 parts of honeysuckle flower, 4 parts of rhizoma atractylodis, lotus leaf
3 parts.
The preparation (five) of 5 Chinese medicine composition of the present invention of embodiment
Bulk drug is taken by weight：4 parts of the coptis, 1 part of radix scutellariae, 3 parts of giant knotweed, 3 parts of Asian puccoon, 3 parts of honeysuckle flower, 4 parts of rhizoma atractylodis, lotus leaf
3 parts.
The preparation (six) of 6 Chinese medicine composition of the present invention of embodiment
Bulk drug is taken by weight：2 parts of the coptis, 1 part of radix scutellariae, 3 parts of giant knotweed, 3 parts of Asian puccoon, 3 parts of honeysuckle flower, 4 parts of rhizoma atractylodis, lotus leaf
3 parts.
The preparation (seven) of 7 Chinese medicine composition of the present invention of embodiment
Bulk drug is taken by weight：2 parts of the coptis, 1 part of radix scutellariae, 3 parts of giant knotweed, 1 part of Asian puccoon, 3 parts of honeysuckle flower, 4 parts of rhizoma atractylodis, lotus leaf
3 parts.
The preparation (eight) of 8 Chinese medicine composition of the present invention of embodiment
Bulk drug is taken by weight：2 parts of the coptis, 1 part of radix scutellariae, 3 parts of giant knotweed, 1 part of Asian puccoon, 1 part of honeysuckle flower, 4 parts of rhizoma atractylodis, lotus leaf
3 parts.
The preparation (nine) of 9 Chinese medicine composition of the present invention of embodiment
Bulk drug is taken by weight：2 parts of the coptis, 1 part of radix scutellariae, 3 parts of giant knotweed, 1 part of Asian puccoon, 1 part of honeysuckle flower, 2 parts of rhizoma atractylodis, lotus leaf
3 parts.
The preparation of 10 Chinese medicinal composition granules of the present invention of embodiment
Any described Chinese medicine compositions of Example 1-9, take total weight parts half bulk drug, add 3-8 times of water to measure, soak
After steeping half an hour, 45min is decocted, 3-8 times is added water and measures, decocted 30min, filtering, merge decoction liquor, be concentrated under reduced pressure, decompression is dry
It is dry to obtain dry extract, it is ground into fine powder (crossing 80 mesh).Second half crude drug crushed 80 mesh, be sterilized (irradiation dose 8k) with CO60, with
Extract powder mixes, and adds mannitol, lactose, cane sugar powder, Aspartame, menthol, is made after being well mixed with 60~70% ethanol
Particle, Cord blood is made for adhesive.
The preparation of the Chinese medicine composition tablet/capsule of the present invention of embodiment 11
Any described Chinese medicine compositions of Example 1-9, take total weight parts half bulk drug, add 3-8 times of water to measure, soak
After steeping half an hour, 45min is decocted, 3-8 times is added water and measures, decocted 30min, filtering, merge decoction liquor, be concentrated under reduced pressure, decompression is dry
It is dry to obtain dry extract, it is ground into fine powder (crossing 80 mesh).Second half crude drug crushed 80 mesh, be sterilized (irradiation dose 8k) with CO60, with
Extract powder mixes, and adds pharmaceutical aids, and vacuum drying crushes granulation, and tabletted or filling is encapsulated.
The preparation of the Chinese medicine composition mixture/oral liquid of the present invention of embodiment 12
Any described Chinese medicine compositions of Example 1-9, take total weight parts half bulk drug, add 3-8 times of water to measure, soak
After steeping half an hour, 45min is decocted, 3-8 times is added water and measures, decocted 30min, filtering, merge decoction liquor, be concentrated under reduced pressure, decompression is dry
It is dry to obtain dry extract, it is ground into fine powder (crossing 80 mesh).Second half crude drug crushed 80 mesh, be sterilized (irradiation dose 8k) with CO60, with
Extract powder mixes, and adds appropriate pharmaceutical aids, mixture, oral liquid or syrup is made.
The preparation of the Chinese medicine composition syrup of the present invention of embodiment 13
Any described Chinese medicine compositions of Example 1-9,8-10 times of dosing material total amount measure water, decoct twice, first time 2
Hour, second 1 hour, filtering, merging filtrate, filtrate stood more than 12 hours, took supernatant concentration to add while hot to appropriate
Preservative and simple syrup, add water to 1000ml, stir evenly, packing, after autoclaving, produce.
Improvement result of 14 Chinese medicine composition of the present invention of embodiment to obese patient's body fat content
1. research method：
Studied using random, control method.
1.1 random device：Random digits table is used to the research object for meeting inclusive criteria, by 1：1 ratio is divided at random
Group.Establishment case first is randomly assigned table, is randomly assigned table according to case, obtains clinical research random number, include treatment respectively
Group and control group.
1.2 sample content：This research considers that case reason, the case load such as come off is set as 34 pairs, and totally 68 (with body weight
Drop 3% is effective, and effective percentage is estimated as 90%, α=0.05, β=0.2, Noninferior solution design).
2. case selection method
Seminar takes the open method recruited, and collects in September, 2016 and is gone to a doctor in March, 2017 SHUGUANG HOSPITAL division of endocrinology
Obese patient.
2.1 diagnostic criteria
2.1.1 Western medicine diagnostic criteria
Formulated with reference to Department of Disease Control of Ministry of Health of the People's Republic of China in 2003《Chinese Adult is overweight and obesity is pre-
Anti- control guide diagnostic criteria, i.e. body mass index (BMI) >=28kg/m2 are obesity.
2.1.2 tcm diagnosis standard
Reference《New Chinese medicine guideline of clinical investigations》In " damp-heat retention in spleen " demonstrate,prove dialectical standard：Possess 3 (tongues of primary symptom
As indispensability)；Or primary symptom 2 (tongue picture is indispensable), add time disease 2, you can dialectical is syndrome of dampness-heat stagnating in spleen.Primary symptom includes：It is vexed that gastral cavity abdomen is swollen,
Thirsty few drink, deficiency of food is indigestion and loss of appetite, and big loose stool is without refreshing；Secondary disease includes：The tired weight of limbs, hiding fever or no relieving of symptom after perspiration, distention and fullness in the abdomen, are disliked
The heart is intended to vomit, and the jaundice of body mesh, color are distinct；Tongue vein includes：Tongue is red, yellow and greasy fur, soft and rapid pulse.
2.2 inclusive criteria：
Meet the patient of above-mentioned simple obesity diagnostic criteria；Meet the patient of syndrome of dampness-heat stagnating in spleen standard；Age was at 18 years old
Person between by 65 years old；Western medicine of losing weight disables more than 2 weeks；Once use life style loss of weight and nearly three months Body weight loss amplitudes<
3%；Sign the obese patient of informed consent form.
2.3 exclusion standard
Due to gonad axis, hypothalamic pituitary adrenal axis, Thyroid Gland Axis Function extremely caused by obesity；It is fat caused by various kinds of drug；It is pregnant
It is pregnent and women breast-feeding their children；Merge the severe primary diseases such as severe digestive system disease, cardiovascular and cerebrovascular, liver kidney；Previously in three months
Generation severe infections/ketosis, or take cortex hormone of aadrenaline, beta-blocker；Receive loss of weight operation in nearly 1 year；Refusal
Diet and exercise habit are adjusted under guidance；The obese patient of nearly glycosylated hemoglobin >=9% in March.
2.4 the rejecting of case and come off：All cases for not meeting inclusive criteria and being included by mistake；Though meet inclusive criteria but
The not case of medication after including；To this observation related drugs allergy sufferers during experiment.Subject's compliance is poor, occurs seriously not
Good event, generation severe complication or special physiological change should not continue reception test, not by case of regulation medication etc., be
Come off case.Actual conditions should be combined during statistical analysis to handle, and adverse reactions people such as occurs, should be counted by adverse reaction.The course for the treatment of
Completion, curative effect should be counted.
3. therapeutic scheme
3.1 Primary Care：Standard life style carries out Primary Care, including diet intervention under (running through whole experimental period)
Intervene with motion.Diet intervention：Diet guide is by Shuguang Hospital dietician according to patient's feelings
Condition, carry out diet guide and give recipe (there are two kinds of selections of 1500Kcal and 1800Kcal)；Motion is intervened：It is required that patient is daily
Maintenance light extremely middle physical exertion 40-60 minutes, at least 5 days weekly.
3.2 GP TH：On the basis of keeping original therapeutic scheme constant, Chinese herbs group gives the Chinese medicine group of the present invention
(preparation method is as follows for granule prepared by compound：2 parts of the coptis, 1 part of radix scutellariae, 2 parts of giant knotweed, 1 part of Asian puccoon, 2 parts of honeysuckle flower, rhizoma atractylodis 3
Part, 1 part of lotus leaf.Total weight parts half bulk drug is taken, adds the water of 5 times of amounts, after soaking 0.5 hour, decocts 45min, then add 5 times of amounts
Water, decoct 30min, filtering, merge decoction liquor, be concentrated under reduced pressure, be dried under reduced pressure to obtain dry extract, crush, cross 80 mesh sieves, obtain medicinal extract
Powder.Second half crude drug crushed 80 mesh sieves, sterilizing, be mixed with extract powder, add auxiliary material, with 60~70% ethanol after being well mixed
Particle is made as adhesive.), daily 1 dose, decocting, divide 2 times orally；Control group gives orlistat, when having meal 2 times a day
Take, each 120mg.
3.3 courses for the treatment of and follow-up：The course for the treatment of is set to 12 weeks.Every follow-up in 4 weeks once, determines body mass index, waist-to-hipratio every time.
4. ethics requirement and subject's informed consent：This clinical test must comply with Declaration of Helsinki (version in 2000)
Clinical experimental study specification relevant with China, regulation are carried out.Before on-test, the examination is agreed to by Ethics Committee of our unit
This testing program can be implemented after proved recipe case.Before this research of each subject enrollment, research doctor is had a responsibility for written
Form, specify Xiang itself or its represent it is complete, comprehensively introduce object of this investigation, program and possible risk.Patient should be allowed to know
Road they have the right to exit this research at any time.It must give every subject a written patient's informed consent form before selected.
5. observe result：
5.1 subject's changes of body mass
As a result as shown in Fig. 1-2, table 1.Before and after treatment, Chinese medicine group and control group body weight, body mass index are decreased obviously,
And changes of weight difference does not have group difference in organizing before and after treatment, prompt both weight loss effects similar.
The subject's changes of body mass of table 1
Note：* paired t-test is represented compared with pre-treatment, p ＜ 0.05；
5.2 subject's Fat distributions change
As a result as shown in Fig. 3, table 2.Fat distribution declines before and after two groups of subjects, but Fat distribution fall
Without group difference, the turbid side of expelling the heat-evil and orlistat is prompted all to have the function that to mitigate Fat distribution, the fat reducing effect phase of the two
Seemingly.
The subject's Fat distribution of table 2 changes
Note：* paired t-test is represented compared with pre-treatment, P ﹤ 0.05；
The improvement result that 15 Chinese medicine composition of the present invention of embodiment is distributed to obese patient's body fat
The content such as clinical testing procedure and intervening measure is the same as embodiment 14.
As a result as shown in Fig. 4-5, table 3.Pretherapy and post-treatment Chinese medicine group has decline with control group waistline, compares two groups of decline
Amplitude, find：The waistline fall of Chinese medicine group is better than orlistat group；Treatment by Chinese herbs postabdomen fat content reduces, and four
Limb Lean mass does not change.
Table 3-1 subject waistline changes
Note：* paired t-test is represented compared with pre-treatment, P ﹤ 0.05；# represents variance analysis compared with control group, P ﹤
0.05。
Table 3-2 subject's stomach fat amount changes
Note：* paired t-test is represented compared with pre-treatment, P ﹤ 0.05.
Improvement result of 16 Chinese medicine composition of the present invention of embodiment to obese rat fat mass
1. materials and methods：
1.1 Experimental agents：Treatment group's medicine is that (preparation method is as follows for Chinese medicine composition of the present invention：1 part of radix scutellariae, the coptis 2
Part, 1 part of Asian puccoon, 2 parts of honeysuckle flower, 3 parts of rhizoma atractylodis, 2 parts of giant knotweed, 1 part of lotus leaf.Total weight parts half bulk drug is taken, adds the water of 5 times of amounts,
After immersion 0.5 hour, 45min is decocted, then adds the water of 5 times of amounts, 30min is decocted, filtering, merges decoction liquor, be concentrated under reduced pressure, depressurize
Dry dry extract, crush, cross 80 mesh sieves, obtain extract powder.Second half crude drug crushed 80 mesh sieves, sterilizing, be mixed with extract powder
Uniformly.)；Control group medicine is that orlistat (is purchased from company of Roche Group, lot number:E2183E5.)
1.2 experimental animals and feed：From 3 week old (weight about 80g) SPF levels male SD rat 60, Shanghai is purchased from
This Rec Experimental Animal Center [production licence number:SCXK (Shanghai) 2012-0002], feed dynamic in Shanghai Univ. of Traditional Chinese Medicine's experiment
Thing center.(irradiation is bred as material 49.5%, lard 20.4%, decocts sugar for normal diet (big mouse irradiation is bred as material) and high lipid food
15.0%, casein 12.3%, premix 2.0%, maltodextrin 0.8%.Energy 460.5kcal is provided per 100g), by upper
This Rec Experimental Animal Center of sea provides.
1.3 experimental method
1.3.1 modeling：Obese model rat is replicated using alimentary obesity modeling method.After rat adaptability is fed 1 week,
Randomly select 8 and be incorporated into Normal group, experiment whole process gives normal diet to feed.Remaining is incorporated into modeling group, gives high lipid food to feed
Support.First 2 weeks, high lipid food and normal diet ratio (1 were adjusted weekly:2→2:1), after 2 weeks, whole high lipid foods are fed.Weekly
Survey weight.To 16 weeks, 24 rat modelings were successful (weight is defined as into mould more than normal rat 20%).
1.3.2 packet：24 obese rats are randomly divided into 3 groups, i.e. model control group, orlistat group, expelling the heat-evil is turbid
Square group, every group 8.
1.3.3 interference method：1. Normal group:The sodium chloride solutions of 3ml 0.9%, gavage, 1 time/d；2. model comparison
Group：The sodium chloride solutions of 3ml 0.9%, gavage, 1 time/d；3. orlistat group：Orlistat suspension 3ml, gavage, 1 time/d；
4. the turbid side's group of expelling the heat-evil：Chinese medicine composition of the present invention, gavage, 1 time/d.The daily dosage of rat is according to humans and animals body surface area
Conversion, conversion factor 6.3.Each group rat is intervened 4 weeks, free water during intervention.
1.4 sample collection：After experiment terminates, fasting 12h, anaesthetized through 3% yellow Jackets intraperitoneal injection, abdominal aorta
Blood is taken, 3000r/min is centrifuged 10 minutes, separates serum, and -70 DEG C of preservations are to be measured.Epididymal adipose tissues and kidney are taken out in sacrificed by decapitation, abdominal cavity
All fat, the tissue fluid on surface is sucked with filter paper, is fixed with 10% formaldehyde.
1.5 observation index and method：Patients before and after intervention, electronic balance measurement rat weight is respectively adopted.Utilize metabolic cage
Record food-intake.Fat distribution is carried out serial using DEXA methods measure (AM General company, Lunar Prodigy Advance)
Transversal scanning, data analysis use enCORE2006VlO.50.086 softwares.Serum leptin levels are (beautiful using ELISA method detection
Milipore companies of state, lot number:1501252), operated in strict accordance with kit specification.Adipocyte morphologic observation method：Gu
After determining adipose tissue, 75% Gradient elution using ethanol, routine paraffin wax embedding, coronal section, thickness is 4-6 μm, HE dyeing, 400 times
Light Microscopic observation.The tectology state of the image viewing adipocyte in 3-4 visual field of random acquisition.
2. experimental result：
As a result as shown in Fig. 6-8, table 4.The turbid side's group of expelling the heat-evil, orlistat group and model control group rat constitution before intervention
Amount is above Normal group (P<0.05) modeling success, is prompted.The turbid side's group of expelling the heat-evil and orlistat group rat after intervening 4 weeks
Weight, Fat distribution are below model control group (P<0.05), and the turbid side's group of expelling the heat-evil and orlistat group rat weight,
Fat distribution no difference of science of statistics (P>0.05).
The comparison (n=8) of each group rat weight of table 4 and body fat
Note：△Represent compared with the Normal group same period, P<0.05；◇Represent compared with model group, P<0.05；
Improvement result of 17 Chinese medicine composition of the present invention of embodiment to obese rat Serum Leptin Levels
The content such as the method for zoopery and intervening measure is the same as embodiment 16.
As a result as shown in Fig. 9, table 5.Each group obese model serum leptin is above Normal group (P<O.Ol), carry
Show that obese rat model has leptin resistance.After intervening 4 weeks, the turbid side's group serum leptin concentration of expelling the heat-evil is less than model group (P
<0.05), orlistat group leptin is higher than model group (P<0.05).
The comparison (n=8) of each group serum leptin after table 5 is intervened
Note：Compared with Normal group,**P<0.01；Compared with model control group,◇P<0.05。
Described above is only the preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
Member, on the premise of the inventive method is not departed from, can also make some improvement and supplement, and these are improved and supplement also should be regarded as
Protection scope of the present invention.
Claims (10)
1. it is a kind of reduce body fat and treat Central obesity Chinese medicine composition, it is characterised in that the Chinese medicine composition be by
The bulk drug of parts by weight as described below is made：Coptis 2-4 parts, radix scutellariae 1-3 parts, giant knotweed 1-3 parts, Asian puccoon 1-3 parts, honeysuckle flower 1-3 parts,
Rhizoma atractylodis 2-4 parts, lotus leaf 1-3 parts.
2. Chinese medicine composition according to claim 1, it is characterised in that the Chinese medicine composition is by weight as described below
The bulk drug of part is made：Coptis 2-4 parts, radix scutellariae 1-3 parts, giant knotweed 1-3 parts, Asian puccoon 1-3 parts, honeysuckle flower 1-3 parts, rhizoma atractylodis 2-4 parts, lotus
Leaf 1-3 parts.
3. Chinese medicine composition according to claim 1, it is characterised in that the Chinese medicine composition is by weight as described below
The bulk drug of part is made：Coptis 2-4 parts, radix scutellariae 1-3 parts, giant knotweed 1-3 parts, Asian puccoon 1-3 parts, honeysuckle flower 1-3 parts, rhizoma atractylodis 2-4 parts, lotus
Leaf 1-3 parts.
4. according to the Chinese medicine composition described in claim 1-3, it is characterised in that be prepared into and face according to Chinese medicine customary preparation methods
Acceptable pharmaceutical preparation on bed.
5. Chinese medicine composition according to claim 4, it is characterised in that the pharmaceutical preparation is granule, powder, capsule
Agent, tablet, mixture or oral liquid.
6. application of the Chinese medicine composition in the medicine for reducing body fat is prepared described in claim 1-3.
7. application of the Chinese medicine composition in the medicine for preparing treatment Central obesity described in claim 1-3.
8. according to the application described in claim 6,7, it is characterised in that the medicine also includes pharmaceutically acceptable carrier or auxiliary
Material.
9. according to the application described in claim 6,7, it is characterised in that the medicine is granule, and preparation method is as follows：
(1) bulk drug is taken by weight, takes total weight parts half bulk drug, adds the water of 3~8 times of amounts, after soaking 0.3~1 hour,
30~60min is decocted, then adds the water of 3~8 times of amounts, 15~45min is decocted, filtering, merges decoction liquor, be concentrated under reduced pressure, decompression is dry
It is dry to obtain dry extract, crush, sieving, obtain extract powder；
(2) take second half crude drug to pulverize and sieve, sterilize, mixed with extract powder, add auxiliary material, with 60~70% second after being well mixed
Particle is made as adhesive in alcohol, both.
10. application according to claim 9, it is characterised in that the auxiliary material includes mannitol, lactose, sucrose, A Siba
Sweet tea and menthol.
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Application publication date: 20180119 |