CN105641672A

CN105641672A - Composition for treating obesity caused by energy metabolism imbalance and preparation

Info

Publication number: CN105641672A
Application number: CN201610217732.5A
Authority: CN
Inventors: 张德龙
Original assignee: Beijing Yuxintang Biotechnology Co Ltd
Current assignee: Beijing Yuxintang Biotechnology Co Ltd
Priority date: 2016-04-08
Filing date: 2016-04-08
Publication date: 2016-06-08

Abstract

The invention relates to composition for treating obesity caused by energy metabolism imbalance. The composition is mainly prepared from the following raw materials, in parts by weight, green tea leaves, tangerine peel, lotus leaves, hawthorn, poria and semen cassia. The traditional Chinese medicine composition has a good conditioning effect, enables conditioned people to have healthy transformation of spleen-qi and smooth circulation of qi and blood, and discharges surplus fat and grease in bodies, accordingly, the objective of rational control over weight is achieved.

Description

The compositions of the treatment unbalance obesity caused of energy metabolism and preparation

Technical field

The invention belongs to field of pharmaceutical preparations, particularly to a kind of compositions treating the unbalance obesity caused of energy metabolism and preparation thereof.

Background technology

Obesity refers to a degree of substantially overweight blocked up with fat deposit, is that body fat especially triglyceride gathers the too much a kind of state caused. Due to food intake too much or the body fat that changes result in of organism metabolism gather and too much cause excess weight to increase and cause human pathology, physiological change or hide. The health that obesity is not general is too fat to move, but a kind of chronic disease threatening human health, it is metabolic syndrome one group common, ancient. The sorting technique of obesity is a lot, it is generally divided into Simple Obesity (endogenous obesity and acquired obesity), the Secondary Obesity (obesity on--endocrine--metabolism disorder basis that is secondary to nerve, patient shows as obesity on protopathy basis, and obesity now is then the complication of protopathy) and drug induced obesity. Fat not only affect the attractive in appearance of body line, but also the health of direct harmful to human.

In prior art, many treatments by Chinese herbs to obesity are had to study, application documents such as patent 201510511509.7 disclose a kind of go to Hongkong health tea and processing technique thereof with weight losing function, Poria, Semen Cassiae, Rhizoma Alismatis, Folium Nelumbinis, aloe leaf, L-carnitine and green tea are prepared from. And for example beverage of fat-reducing disclosed in patent 201010533873.0, blood fat reducing, reducing blood viscosity and preparation method thereof, tea cream for strengthening spleen and clearing abdominal dropsy and preparation method thereof etc. disclosed in patent 201310494712.9. And the formula of the Metabolic disorder that treatment obesity clinically causes and various medicine also have a lot, but comparatively speaking, the cycle for the treatment of is partially long, takes effect inconspicuous, there is also sensory difference to a certain extent simultaneously. For Metabolic disorder, the feature of splenic and gastric incoordination, inventor, to using treatment by Chinese herbs metabolic disorder, has carried out the summary that studies for a long period of time, it is preferable that go out a kind of Chinese medicine composition evident in efficacy.

Summary of the invention

In order to solve above-mentioned technical problem, the present invention provides compositions and the preparation thereof of the treatment unbalance obesity caused of energy metabolism that a kind of rapid-action, short treating period, cure rate are high.

The concrete technical scheme of the present invention is as follows:

The present invention provides a kind of compositions treating the unbalance obesity caused of energy metabolism, and described compositions is mainly prepared from by the crude drug of following weight portion is processed:

The compositions of the obesity caused that treatment energy metabolism provided by the present invention is unbalance has invigorating spleen to remove dampness, changes the significant curative effects such as turbid blood fat reducing, loosening bowel to relieve constipation, make the strong fortune of temper, QI and blood is smooth, the unnecessary cream fat of collective is able to catharsis, thus reaching the purpose of conservative control body weight, said composition instant effect, effective percentage is high.

Preferably, the parts by weight of the crude drug preparing described compositions are:

Preferably, prepare described compositions and also include the crude drug of following weight portion:

Crude drug is by adding above-mentioned Six-element Chinese medicine, and the compatibility making the magistral medicines of the present invention is more scientific, and each crude drug synergism plays invigorating spleen to remove dampness, changes effect of turbid blood fat reducing, controls body weight effect more preferably.Additionally, after adding above-mentioned Six-element medicine, the compositions of the present invention is except can treating the obesity that metabolic imbalance causes, it is also possible to be used for treating hypertension, hyperglycemia and hyperlipidemic conditions, and therapeutic effect is good.

The further formula of the reasonably optimizing present invention, the parts by weight preparing the raw materials used medicine of described compositions are:

Or, preparing the raw materials used parts by weight of described compositions is:

In order to take and easy to carry, the present invention provides the preparation that the compositions by the treatment unbalance obesity caused of energy metabolism and adjuvant are made, and described preparation includes tablet, capsule, granule or pill, and the weight ratio of described compositions and adjuvant is 1:2.5-6.

Further improve, described preparation is granule, and described adjuvant is grouped into by the one-tenth of following parts by weight: the sodium lauryl sulphate of the pregelatinized starch of 92-220 part, the para aminobenzoic acid sodium salt of 60-160 part, the polyvinylpyrrolidone of 66-135 part, the magnesium stearate of 45-92 part and 20-58 part. Wherein, pregelatinized starch and para aminobenzoic acid sodium salt, as substrate, help the molding of granule, improve the stability of preparation; And pregelatinized starch and polyvinylpyrrolidone with the use of, make granule be evenly distributed when granulating, improve its mouldability, help the dissolution of granule simultaneously. Magnesium stearate helps grain forming, and it coordinates the use of sodium lauryl sulphate, the problem improving the prolonged disintegration that the hydrophobicity of magnesium stearate causes.

In improvement project further, described adjuvant also includes the tween 80 that parts by weight are the cross-linking sodium carboxymethyl cellulose of 52-105 part, the sodium laurylsulfate of 62-90 part and 22-41 part. Three mixes use and has synergism, significantly improves the disintegrate of granule and the dissolution of medicine, and further enhancing the bioavailability of Chinese medicine composition.

By the optimization to supplementary product consumption, obtaining following formula further, the weight portion preparing described preparation composition therefor and adjuvant is:

The preparation method that another aspect of the present invention additionally provides the compositions of the treatment unbalance obesity caused of energy metabolism, comprises the steps:

A) extraction of crude drug:

A-1). taking the Pericarpium Citri Reticulatae of described weight portion, Fructus Crataegi, Poria, Rhizoma Alismatis, Herb Gynostemmae Pentaphylli and Radix et Rhizoma Thalictri and add alcohol reflux three times, first time adds the ethanol of 15 times amount 85%, reflux, extract, 2.5h; Second time adds the ethanol of 9 times amount 85%, reflux, extract, 2h; Third time adds the ethanol of 5 times amount 85%, reflux, extract, 1h; Merge back into flow liquid, filter, merge to obtain solution 1;

A-2). green tea, Folium Nelumbinis are sent into microwave oven, controls temperature 115 DEG C and carry out microwave baking 1h, pulverized 80 orders, and obtained fine powder 1;

A-3). take the Semen Cassiae of described weight portion, Radix Ophiopogonis, Rhizoma Zingiberis and the Rhizoma Atractylodis Macrocephalae and carry out soak by water 2 times, first time 20 times amount soak by water 4h, second time 15 times amount soak by water 1.5h, merging filtrate, temperature is that to be concentrated into relative density under 55 DEG C of conditions be 1.00-1.15g/ml, cooling, add 75% ethanol, standing 24h, filter, filtrate is be concentrated into the thick paste that relative density is 1.00-1.15g/ml under 55 DEG C of conditions in temperature, add water to total amount 60%, stand 20h, take supernatant, obtain solution 2;

A-3). by solution 1 and solution 2 mix homogeneously, temperature be 45 DEG C, pressure carry out vacuum drying under-0.05MPa condition, prepare fine powder 2, by fine powder 1 and fine powder 2 mix homogeneously, obtain crude drug fine powder;

B) crude drug fine powder and described adjuvant are crossed 100 mesh sieves respectively, standby;

C) configuration of intermixture:

C-1) polyvinylpyrrolidone is dissolved in water, prepares the aqueous povidone solution of 10%; With ethanol solution dilute pregelatinized starch, para aminobenzoic acid sodium salt, magnesium stearate, the cross-linking sodium carboxymethyl cellulose of 1/2 recipe quantity, 1/2 recipe quantity sodium laurylsulfate and 1/2 recipe quantity tween 80 be placed in mortar, grind, add in the compositions of micropowders, continue to grind 1h, rotating speed is 200rmp, crossing 120 mesh sieves after grinding, mixed-powder is granulated, and obtains granule medicament;

C-2) by step c-1) granule medicament add the cross-linking sodium carboxymethyl cellulose of 1/2 recipe quantity, 1/2 recipe quantity sodium laurylsulfate and 1/2 recipe quantity tween 80, stirring is to being completely dissolved, it is simultaneously introduced aqueous povidone solution, continue stirring and dissolving, prepare mixed liquor;

C-3) in crude drug fine powder add step c-1) mixed liquor, mixing, prepare granule.

The preparation method of granule provided by the invention can by the extracts active ingredients in each raw material of Chinese medicine medicine out, reduce the consumption of the composition not played a role, further increase the curative effect of compositions, realizing while saving cost, keep the advantages such as yield height, superior product quality, technique are simple, be suitable for industrialized production.

On the other hand, the preparation method that present invention also offers granule, the method comprises the steps:

A) compositions is prepared, standby;

B) take the stearic acid of described parts by weight, Cera Flava, octadecanol put water-bath heating, temperature 70��90 DEG C, and stirring is to fine melt, for oil phase;

C) compositions and glycerol, sucrose fatty acid ester, polyoxyethylene castor oil, benzalkonium bromide, the limonene that take step a) put water-bath, are dissolved in purified water, and heating is to 70��90 DEG C, for aqueous phase;

D) slowly being poured into by the oil phase in step b) in the oil phase of step c), stirring while adding, until during cooling 45 DEG C, continuing stirring, namely fill obtains granule.

Further, described compositions in preparation for treating application in the medicine of the obesity that energy metabolism is unbalance, splenic and gastric incoordination causes.

The source of crude drug of the present invention is as follows:

Green tea: refer to the young leaves or bud of taking Camellia sinensis, not fermented, through completing, shaping, the technique such as drying and the beverage that makes.

Pericarpium Citri Reticulatae: the crust of mandarin orange.

Folium Nelumbinis: this product is the dried leaves of nymphaeaceae plant lotus NelumbonuciferaGaertn.. .

Fructus Crataegi: this product is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae CrataeguspinnatifidaBge.var.majorN.E.Br. or Fructus Crataegi CrataeguspinnatifidaBge..

Poria: this product is the dry sclerotia of On Polyporaceae Poria Poriacocos (Schw.) Wolf.

Semen Cassiae: this product is leguminous plant Semen Cassiae CassiaobtusifoliaL. or the dry mature seed of little Semen Cassiae CassiatoraL..

Radix Ophiopogonis: this product is the dried root of liliaceous plant Radix Ophiopogonis (dwarf lilyturf) Ophiopogonjaponicus (Thunb.) Ker-Gawl..

Rhizoma Alismatis: formal name used at school: Alismaplantago-aquaticaLinn., perennial aquatic or swampweed basis.

Rhizoma Zingiberis: for the dry rhizome of zingiber Zingiberoj-jicinaleRosc..

Herb Gynostemmae Pentaphylli: cucurbitaceae genus gynostemma Herb Gynostemmae Pentaphylli Gynostemmapentaphyllum (Thunb.) Makino, is used as medicine with root stock.

Radix et Rhizoma Thalictri: for the leafy Thalictrum aquilegifolium L. var. sibiricum Regel ThalictrumfoliolosumDC. of Ranunculaceae thalictrum spp and plateau Thalictrum aquilegifolium L. var. sibiricum Regel T.cultratumWall.T.deciternatumBoiv, is used as medicine with root.

The Rhizoma Atractylodis Macrocephalae: this product is the dry rhizome of feverfew Rhizoma Atractylodis Macrocephalae AtractylodesmacrocephalaKoidz..

The obesity that the compositions of the present invention is mainly used in treatment metabolic imbalance, splenic and gastric incoordination causes. After with the addition of Radix Ophiopogonis, Rhizoma Alismatis, Rhizoma Zingiberis, Herb Gynostemmae Pentaphylli, Radix et Rhizoma Thalictri and the Rhizoma Atractylodis Macrocephalae, it may also be used for treatment three-hypers disease. Using compositions and the preparation thereof of the present invention, conditioning effect is good, makes the strong fortune of conditioning person's temper, and QI and blood is smooth, and the unnecessary cream fat of collective is able to catharsis, thus reaching the purpose of conservative control body weight.

Accompanying drawing explanation

Fig. 1 is the dissolution rate curve chart of the vitro release determination test of the present composition.

Detailed description of the invention

Embodiment 1 compositions

A kind of compositions treating the unbalance obesity caused of energy metabolism, said composition is prepared from by the crude drug of following weight is processed:

Embodiment 2 compositions

Embodiment 3 compositions

Preparation method:

1) taking the Pericarpium Citri Reticulatae of described weight portion, Fructus Crataegi and Poria and add alcohol reflux three times, first time adds the ethanol of 15 times amount 85%, reflux, extract, 2.5h; Second time adds the ethanol of 9 times amount 85%, reflux, extract, 2h; Third time adds the ethanol of 5 times amount 85%, reflux, extract, 1h; Merge back into flow liquid, filter, merge to obtain solution 1, temperature be 45 DEG C, pressure carry out vacuum drying under-0.05MPa condition, prepare fine powder 1;

2). green tea, Folium Nelumbinis are sent into microwave oven, controls temperature 115 DEG C and carry out microwave baking 1h, pulverized 80 orders, and obtained fine powder 2;

3). by fine powder 1 and fine powder 2 mixing and stirring, cross 100 mesh sieves respectively, obtain compositions.

Embodiment 4 compositions

A kind of compositions treating the unbalance obesity caused of energy metabolism, said composition is prepared from by the crude drug of following weight portion is processed:

Embodiment 5 compositions

Preparation method:

A) extraction of crude drug:

A-3). by solution 1 and solution 2 mix homogeneously, temperature be 45 DEG C, pressure carry out vacuum drying under-0.05MPa condition, prepare fine powder 2, by fine powder 1 and fine powder 2 mix homogeneously, obtain crude drug fine powder.

Embodiment 6 compositions

Preparation method: prepare by method described in embodiment 5.

Embodiment 7 granule

Preparation method:

1) crude drug fine powder and described adjuvant are crossed 100 mesh sieves respectively, standby;

2) configuration of intermixture:

A) polyvinylpyrrolidone is dissolved in water, prepares the aqueous povidone solution of 10%; With ethanol solution dilute pregelatinized starch, para aminobenzoic acid sodium salt, magnesium stearate, lauryl sulphate acid are placed in mortar, grind, add in the compositions of micropowders, continuing to grind 1h, rotating speed is 200rmp, crosses 120 mesh sieves after grinding, mixed-powder is granulated, it is simultaneously introduced aqueous povidone solution, continues stirring and dissolving, prepare mixed liquor;

B) crude drug fine powder adds the mixed liquor of step a), mixing, prepares granule.

Embodiment 8 granule

Preparation method: prepare according to the preparation method of embodiment 8, obtain granule.

Embodiment 9 granule

Preparation method:

2) configuration of intermixture:

A) polyvinylpyrrolidone is dissolved in water, prepares the aqueous povidone solution of 10%; With ethanol solution dilute pregelatinized starch, para aminobenzoic acid sodium salt, magnesium stearate, lauryl sulphate acid, the cross-linking sodium carboxymethyl cellulose of 1/2 recipe quantity, 1/2 recipe quantity sodium laurylsulfate and 1/2 recipe quantity tween 80 be placed in mortar, grind, add in the compositions of micropowders, continue to grind 1h, rotating speed is 200rmp, crossing 120 mesh sieves after grinding, mixed-powder is granulated, and obtains granule medicament;

B) by step c-1) granule medicament add the cross-linking sodium carboxymethyl cellulose of 1/2 recipe quantity, 1/2 recipe quantity sodium laurylsulfate and 1/2 recipe quantity tween 80, stirring is to being completely dissolved, it is simultaneously introduced aqueous povidone solution, continue stirring and dissolving, prepare mixed liquor;

C) crude drug fine powder adds the mixed liquor of step a), mixing, prepares granule.

Embodiment 10 granule

Preparation method: prepare according to the preparation method of embodiment 9, obtain granule.

Comparative examples 1 granule

Preparation method:

2) configuration of intermixture:

A) with ethanol solution dilute pregelatinized starch, magnesium stearate, lauryl sulphate acid are placed in mortar, grind, add in the compositions of micropowders, continuing to grind 1h, rotating speed is 200rmp, crosses 120 mesh sieves after grinding, mixed-powder is granulated, it is simultaneously introduced aqueous povidone solution, continues stirring and dissolving, prepare mixed liquor;

Comparative examples 2 granule

Preparation method:

2) configuration of intermixture:

A) with ethanol solution dilute pregelatinized starch, para aminobenzoic acid sodium salt, polyvinylpyrrolidone, magnesium stearate are placed in mortar, grind, add in the compositions of micropowders, continuing to grind 1h, rotating speed is 200rmp, crosses 120 mesh sieves after grinding, mixed-powder is granulated, it is simultaneously introduced aqueous povidone solution, continues stirring and dissolving, prepare mixed liquor;

Test example 1 stability test

Accelerated test

Take the embodiment of the present invention 7 and the granule of comparative examples 1, it is randomly divided into 3 batches respectively, it is numbered sample 1, sample 2, sample 3, sample 4, sample 5 and sample 6 respectively, by above 6 batch samples all at 40 DEG C �� 2 DEG C, place 6 months when relative humidity is 75% �� 5%, testing, 1 month period, 2 months, 3 months, 6 the end of month are separately sampled once, by the regulation in Chinese Pharmacopoeia, detect the character of nuciferine, content (labelled amount %), dissolution and have related substance (%).

Can be seen that, from result, the granule that the embodiment of the present invention 7 provides, accelerated result of the test it can be seen that place after 6 months, the character of described ointment, amount, the dissolution containing nuciferine and have related substance that obvious change does not all occur; And the granule of comparative examples 1 was placed after 6 months, ointment color and luster is deepened, and the content of nuciferine declines, and dissolution is uneven, and relevant amount of substance dramatically increases; Showing that the granule of embodiment 7 is compared with comparative examples 1, stability is higher, namely with the addition of para aminobenzoic acid sodium salt, polyvinylpyrrolidone composition improves mouldability and the stability of granule.

5.3 long term tests

Separately take 6 batch samples in 5.2 all at temperature 25 DEG C �� 2 DEG C, place 12 months when relative humidity is 60% �� 10%, sampling in every 3 months is once, sampled respectively at 0 month, 1 month, 3 months, 6 months, 9 months, 12 months, detect the character of granule, the content (labelled amount %) of nuciferine, dissolution and have related substance (%).

The granule that the embodiment of the present invention 7 provides is can be seen that from result, through long-term test results it can be seen that place after 12 months, the character of described granule, amount, the dissolution containing nuciferine and have related substance that obvious change does not all occur; And the granule color and luster of comparative examples 1 is deepened, and the content of nuciferine is remarkably decreased, and dissolution is uneven, and relevant amount of substance dramatically increases; Show that para aminobenzoic acid sodium salt, polyvinylpyrrolidone composition improve mouldability and the stability of ointment.

Test example 2 melting

With reference to the regulation in 2010 editions annex I N granules of Chinese Pharmacopoeia, the granule of the present invention being carried out melting detection, detection method is as follows:

Taking test sample 10g, add hot water 200ml, stir 5min, granule should all dissolve or slight haze, but must not have foreign body.

The granule of Example 7, embodiment 9 and comparative examples 2, as test sample, carries out melting test by said method, and result of the test is in Table 1;

The melting result of the test of table 1 granule

As can be seen from Table 1, the granule of the embodiment of the present invention 7 has good melting, and melting is higher than comparative examples 2, it follows that the addition of sodium lauryl sulphate and para aminobenzoic acid sodium salt can further improve the melting of granule, makes granule dissolve more complete; When lacking para aminobenzoic acid sodium salt, the melting of granule is remarkably decreased.

Test example 3 vitro release determination test

The drug release rate detection of granule of the present invention: check with reference to 2010 editions " Chinese Pharmacopoeia " annex XIXD vitro drug release degree.

Take the granule of above example 7,9 respectively, put in medicament dissolution instrument, separately sampled in 1h, 2h, 4h, 6h, 12h, 16h, 24h, detect dissolution percentage rate by high performance liquid chromatography, and calculate the cumulative release percentage rate of granule, result is shown in Fig. 1.

As can be seen from the figure the granule of embodiment 7,9, it discharges sustainable 24h, and Release Performance meets slow releasing agent feature in vitro.

Test example 4 toxicity detection

Choosing rabbit 250, male and female half and half, body weight is 2-2.5kg. This rabbit is randomly divided into five groups, often group 50, label group one, group two, group three, group four and group five respectively, the compositions of the embodiment of the present invention 3 to embodiment 6 is filled respectively and feeds the group one rabbit to group five, this diet tea adopts warm water to fill after being in harmonious proportion and feeds rabbit, and the dosage of every rabbit is 2kg, every day 2 times, after taking three months continuously, observe the situation of rabbit. The movable diet of rabbit is all normal, and therefore, said composition has no side effect.

Test example 5 treats the clinical trial of the obesity that metabolic imbalance causes

1, physical data

Meet the diagnostic criteria of the obesity that the metabolic imbalance of tcm diagnosis causes, namely body weight is above standard more than 20% or BMI of body weight more than or equal to 26, informed consent is also ready that subject enrollment is obesity clinical volunteers, totally 150, age is 12 years old-60 years old, 30.4 years old mean age, M-F is 1:1. It is randomly divided into treatment A group, treatment B group and matched group, often organizes 60 people, three groups of influence factors such as age, symptom, through statistical procedures, there was no significant difference, meet packet condition.

2, Therapeutic Method

Treatment A group: take made compositions in the embodiment of the present invention 1, meal one hour after oral medicine, each 1 bag, be used in conjunction 30 days, 15 days be a course for the treatment of.

Treatment B group: take made compositions in the embodiment of the present invention 4, dosage regimen is with treatment A group.

Matched group: (Chongqing Dinglian Pharmaceutical Co., Ltd. produces to use orlistat; The quasi-word H20100050 of traditional Chinese medicines), take in meal one hour after, each 1, be used in conjunction 30 days, within 15 days, be a course for the treatment of.

3, evaluation of clinical curative effect standard

Efficacy evaluation is carried out, according to the criterion of therapeutical effect of the Simple Obesity that the obesity research academic conference discussion of the 5th, the whole nation held in Beijing for 1997 is formulated after 2 courses for the treatment of, it may be assumed that

(1) clinical cure: Body Mass Index drops to less than 26, related symptoms disappears;

(2) effective: Body Mass Index declines be more than or equal to 4, and related symptoms disappears substantially;

(3) effective: Body Mass Index declines be more than or equal to 2, and related symptoms alleviates;

(4) invalid: Body Mass Index drop-out value is less than 2, and related symptoms does not alleviate.

4, therapeutic outcome, as shown in table 2.

The therapeutic effect of table 2 treatment group and matched group compares

As shown in Table 2, the therapeutic effect for the treatment of group of the present invention is all good than matched group, and wherein the compositions therapeutic effect of embodiment 4 is best, is secondly embodiment 1, it was demonstrated that the present invention is safe and effective for the obesity treating Metabolic disorder.

Test example 6 treats the clinical trial that blood pressure and blood lipoid is high

According to the auxiliary hyperglycemic of " health food inspection and assessment technique specification ", hypolipemic function human trial evaluation method, the compositions of embodiment 1 and embodiment 4 is evaluated, specific as follows:

1, test method:

Select 66 example type ��diabetes mellitus people, wherein male 37 people, women 29 people, the range of age 38-75 year, without complication such as severe cardiac Liver and kidney, take contrast design after in before test-meal.

Experimenter being randomly divided into 2 groups, often organizes 33 people, the former diet control of experimenter and activity are constant, and packet situation is:

Group 1: the compositions of edible embodiment 1;

Group 2: the compositions of edible embodiment 4;

Daily twice, organize 1 each 3g, organize 2 each 8g, take after diluting by warm water.

Monitor the change of patient's blood pressure, defecation, body weight, and measure the blood glucose (with glucose oxidase method) of empty stomach and 2 hours after the meal; Measure blood fat (T-CHOL TC, triglyceride TG and high density lipoprotein HDL-C).

2, effect criterion:

Effective: fundamental symptoms disappears, decline less than 30% before relatively treating with the blood glucose of 2 hours after the meal on an empty stomach; TC reduces > 20%; TG reduces > 30%; HDL-C rising > 0.208mmol/L.

Effective: fundamental symptoms is obviously improved, decline less than 10% before relatively treating with the blood glucose of 2 hours after the meal on an empty stomach; TC reduces > 10%; TG reduces > 15%; HDL-C rising > 0.104mmol/L;

Invalid: fundamental symptoms is not improved, it is dropped by less than 10% before relatively treating with the blood glucose of 2 hours after the meal on an empty stomach; Blood fat standard is not up to effective standard person.

3, result of the test:

Compared with before test-meal, after test-meal 30 days, the blood pressure of patient, defecation, body weight there are no significant difference, but fasting glucose, after the meal 2 hours blood glucoses all have obvious reduction, and concrete outcome is in Table 3.

The blood glucose test results of table 3 test-meal sufferer

From the above results, relative to group 1, the compositions blood sugar decreasing effect of group 2 is notable.

The sufferer of edible group 2, compared with before test-meal, after test-meal 30 days, all has obvious reduction before the relatively test-meal of the cholesterol of patient, triglyceride, has obvious rising before high density lipoprotein relatively test-meal, and concrete outcome is in Table 4.

The lipids detection result of table 4 test-meal sufferer

From the above results, relative to group 1, the compositions lipid-lowering effect of group 2 is notable.

Test example 7 treats the clinical trial of hypertension

1, test method:

Select 34 examples to be diagnosed as the patient of hypertension, the curative effect of medicine of the present invention is carried out clinical observation.

Diagnostic criteria: shrinking pressure equal to or higher than 160mmHg, diastolic pressure equals to or higher than 95mmHg, both have one verified, can make a definite diagnosis.

Experimenter being randomly divided into 2 groups, often organizes 17 people, packet situation is:

Group 1: the compositions of edible embodiment 1;

Group 2: the compositions of edible embodiment 4;

Daily twice, organize 1 each 3g, organize 2 each 8g, take after diluting by warm water. Between experimental period, diet is front with quantity of motion and test keeps consistent, and indices is respectively tested once when test-meal experiment starts and terminates.

2, effect criterion:

Effective: diastolic pressure more than decline 10mmHg, and reach normal range; Though diastolic pressure is not near normally, but decline 20mmHg or more than, need to possess one of which;

Effective: diastolic pressure declines not as good as 10mmHg, but to reach normal range; Diastolic pressure relatively treats the front 10��19mmHg that declines, but not up to normal range; Shrink the pressure front decline 30mmHg of relatively treatment, need to possess one of which;

Invalid: not up to above standard.

3, result of the test

Each group case treatment comparitive study result is in Table 5.

Blood pressure measurement before and after table 5 test-meal

From the above results, relative to group 1, the compositions blood pressure lowering effect of group 2 all shows as significantly.

Model case

Huang, female, 23 years old, certain company personnel, height 155cm, body weight was 62kg. Drinking the compositions of the embodiment of the present invention 3, lose weight after drinking continuously one month 3.2kg, drinks the 6.7kg that loses weight after two months continuously, and lose weight after drinking continuously three months 10.3kg, and generation without any side effects.

High certain, man, 35 years old, certain university student enrollment, height 156cm, body weight 66kg.Drink the compositions of the embodiment of the present invention 6 preparation, lose weight after drinking continuously one month 3.1kg, drink the 6.3kg that loses weight after two months continuously, lose weight after drinking continuously three months 8.4kg, lose weight after drinking half a year continuously 14.7kg, substantially return to normal type and generation without any side effects.

Song, man, 16 years old, certain high school student, height 164cm, body weight 88kg. Drink the diet tea of the embodiment of the present invention 6 preparation, lose weight after drinking continuously one month 2.5kg, drink the 5.5kg that loses weight after two months continuously, lose weight after drinking continuously three months 8.9kg, lose weight after drinking continuously four months 12.1kg, finds no any discomfort symptom during drinking.

Claims

1. the compositions treating the unbalance obesity caused of energy metabolism, it is characterised in that described compositions is prepared from by the crude drug of following weight portion is processed:

Green tea 1-45 Pericarpium Citri Reticulatae 1-50 Folium Nelumbinis 1-35 Fructus Crataegi 1-40

Poria 1-40 Semen Cassiae 1-35.

2. the compositions treating the unbalance obesity caused of energy metabolism as claimed in claim 1, it is characterised in that the parts by weight of the crude drug preparing described compositions are:

Green tea 10-25 Pericarpium Citri Reticulatae 15-30 Folium Nelumbinis 10-25 Fructus Crataegi 9-23

Poria 9-23 Semen Cassiae 8-20.

3. the compositions treating the unbalance obesity caused of energy metabolism as claimed in claim 2, it is characterised in that prepare described compositions and also include the crude drug of following weight portion:

Radix Ophiopogonis 6-18 Rhizoma Alismatis 5-15 Rhizoma Zingiberis 5-15 Herb Gynostemmae Pentaphylli 4-12.

Radix et Rhizoma Thalictri 6-20 Rhizoma Atractylodis Macrocephalae 4-12.

4. the compositions of the treatment unbalance obesity caused of energy metabolism as according to any one of claim 2-3, it is characterised in that the parts by weight preparing the raw materials used medicine of described compositions are:

Green tea 22 Pericarpium Citri Reticulatae 25 Folium Nelumbinis 18 Fructus Crataegi 18

Poria 20 Semen Cassiae 16

5. the preparation that prepared by the treatment compositions of the unbalance obesity caused of energy metabolism according to any one of claim 1-3 and adjuvant, it is characterized in that, described preparation includes tablet, capsule, granule or pill, and the weight ratio of described compositions and adjuvant is 1:2.5-6.

6. preparation as claimed in claim 5, it is characterized in that, described preparation is granule, and described adjuvant is grouped into by the one-tenth of following parts by weight: the sodium lauryl sulphate of the pregelatinized starch of 92-220 part, the para aminobenzoic acid sodium salt of 60-160 part, the polyvinylpyrrolidone of 66-135 part, the magnesium stearate of 45-92 part and 20-58 part.

7. preparation as claimed in claim 6, it is characterised in that described adjuvant also includes the tween 80 that parts by weight are the cross-linking sodium carboxymethyl cellulose of 52-105 part, the sodium laurylsulfate of 62-90 part and 22-41 part.

8. preparation as claimed in claim 7, it is characterised in that the weight portion preparing described preparation composition therefor and adjuvant is:

9. a preparation method for preparation as described in claim 8, said method comprising the steps of:

A) extraction of crude drug:

C) configuration of intermixture:

C-1) polyvinylpyrrolidone is dissolved in water, prepares the aqueous povidone solution of 10%; With ethanol solution dilute pregelatinized starch, para aminobenzoic acid sodium salt, magnesium stearate, lauryl sulphate acid, the cross-linking sodium carboxymethyl cellulose of 1/2 recipe quantity, 1/2 recipe quantity sodium laurylsulfate and 1/2 recipe quantity tween 80 be placed in mortar, grind, add in the compositions of micropowders, continue to grind 1h, rotating speed is 200rmp, crossing 120 mesh sieves after grinding, mixed-powder is granulated, and obtains granule medicament;

C-3) crude drug fine powder adds step c-1) mixed liquor, mixing, dry, prepare granule.

10. the compositions of the treatment unbalance obesity caused of energy metabolism according to any one of claim 1-4 in preparation for treating application in the medicine of the obesity that energy metabolism is unbalance, splenic and gastric incoordination causes.