CN110384782A - It is a kind of to intervene the Chinese medicine composition of phlegm-dampness constitution, broken wall composition and preparation method thereof - Google Patents
It is a kind of to intervene the Chinese medicine composition of phlegm-dampness constitution, broken wall composition and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of Chinese medicine compositions for intervening phlegm-dampness constitution, broken wall composition and preparation method thereof.The Chinese medicine composition is grouped as by the group of following parts by weight: 4~16 parts of hawthorn, 4~16 parts of lotus leaf, 4~18 parts of Poria cocos, 2~8 parts of dried orange peel, 1~5 part of nutmeg, 1~5 part of fructus amomi, 4~18 parts of hoveniae semoveniae semen.Traditional Chinese medicine composition formula of the invention, using the medicinal material of dual-purpose of drug and food as primary raw material, by theory of traditional Chinese medical science, pharmacological property and dosage, rational proportion, cautiously grasping pathogenesis distinguishes that body treats, and has invigorating spleen to remove dampness, resolving sputum is let out turbid, the effect of clearing damp and promoting diuresis, promoting the circulation of qi qi-regulating, the physique characteristic suitable for phlegm-dampness constitution;The broken wall composition that it is compounded with auxiliary material is used as medicine with full constituent, effective component can quick disintegration, be conducive to improve drug absorption rate, improve drug effect;Phlegm-dampness constitution person can be allowed to take for a long time, have and focus on entirety, prevent and treat and preferably, delicious taste takes convenient advantage.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, and in particular to it is a kind of intervene phlegm-dampness constitution Chinese medicine composition, broken wall combination
Object and preparation method thereof.
Background technique
Constitution is the quality of human body, it be heredity and it is acquired on the basis of show human figure structure, life
The synthesis of reason function and psychological factor, metastable feature.It is by China that contemporary Constitution Theory in TCM is most representative
The nine body theories that contemporary traditional Chinese medical science great master Wang Qi is proposed and founded, including gentle matter, deficiency of vital energy matter, deficiency of yang matter, deficiency of Yin matter, phlegm wet matter,
9 kinds of fundamental types such as damp and hot matter, hemostasis matter, obstruction of the circulation of vital energy matter, special official report matter.Different somatotypes are in body characteristics, physiological characteristic, psychology
Feature, pathological reaction state, morbidity tendency etc. respectively have feature.
Phlegm-dampness constitution sticks the phlegm wets such as tongue fur is greasy with body obesity, abdomen grossness, mouth and shows as main feature.Common eye born of the same parents are micro-
Floating, facial oil is more, more phlegm uncomfortable in chest, loose stool, and urine is micro- mixed, not well, the tongue body hypertrophy of body weight, slippery.Phlegm-dampness constitution
Lattice partial temperature and, it is steady respectful modest, be good at restraining oneself more, it is poor to plum rain season and wet environment adaptability, be susceptible to suffer from wet card.Phlegm-dampness constitution person
Internal more abundant expectorations are wet, and are easy phlegm and blood stasis, block mechanism of qi, strongly fragrant and to change heat closely related with the morbidity of a variety of diseases, including brain
Blood vessel accident, coronary heart disease, diabetes, high blood pressure, metabolic syndrome etc..Its internal turbid damp evil of phlegm is easy sick with wind, the stasis of blood, heat etc.
Reason product is mutually tied, and is the pathologic basis for generating dizziness, is an important factor for high blood pressure occurs.
With the continuous improvement of people's living standards, work rhythm is constantly accelerated, there is phlegm in the continuous aggravation of psychological pressure
The number of hydrogenoid constitution is also increasing.Since the prosperity and decline state of internal yin, yang, gas, blood, body fluid is different, to show as individual
Between constitution otherness.Distinguishing that body opinion is controlled is using the constitution of people as cog-nitive target, from constitution status and different classification of TCM constitution
Characteristic holds the whole element and individual difference of its health and disease, formulates control principle, selects corresponding treatment, prevention, supports
Generation method, to carry out the intervening measure of " suiting measures to different persons ".Constitution theory in traditional Chinese medicine and human life and health have important relationship, Chinese medicine
Physique level has close relationship with current many diseases using tcm theory as leading theory, for phlegm-dampness constitution into
Row intervention is the joint demand of clinician and patient.
Summary of the invention
It is an object of the invention to meet clinician and the needs of patient intervenes phlegm-dampness constitution, provide a kind of dry
The Chinese medicine composition of pre- phlegm-dampness constitution.The present invention is based on the theories of integration of drinking and medicinal herbs, propose a kind of Chinese medicine for intervening phlegm-dampness constitution
Composite formula, party's cautiously grasping pathogenesis distinguish that body treats, the physique characteristic suitable for phlegm-dampness constitution;Phlegm-dampness constitution person is allowed to take for a long time
With invigorating spleen to remove dampness can be played, and turbid effect is rushed down in resolving sputum;It is whole with focusing on, it prevents and treats and preferably, delicious taste is taken convenient excellent
Point.
Another object of the present invention is to provide the preparation methods of the Chinese medicine composition of above-mentioned intervention phlegm-dampness constitution.
Another object of the present invention is to provide a kind of broken wall compositions for intervening phlegm-dampness constitution.
Another object of the present invention is to provide the preparation methods of the broken wall composition of above-mentioned intervention phlegm-dampness constitution.
For achieving the above object, the present invention adopts the following technical scheme:
A kind of Chinese medicine composition for intervening phlegm-dampness constitution, is grouped as by the group of following parts by weight:
The present invention intervenes the composition of phlegm-dampness constitution by hawthorn, lotus leaf, Poria cocos, dried orange peel, nutmeg, fructus amomi, hoveniae semoveniae semen group
At.We are using hawthorn and lotus leaf as monarch drug in a prescription, hawthorn reinforcing spleen to promote digestion, scattered stasis, and lotus leaf energy invigorating the spleen rising Yang dampness removing can be used for water
Swollen, deficiency of food abdominal distension, the two share the effect that can reach invigorating the spleen to clear away damp pathogen.Minister is with Poria cocos, dried orange peel, Poria cocos invigorating the spleen excreting dampness, resolving sputum Li Shui,
It is logical to adjust three burnt, dried orange peel regulating qi-flowing for strengthening spleen, regulating qi-flowing for eliminating phlegm, the two share resolving sputum rush down it is turbid;Assistant is with nutmeg, fructus amomi dampness elimination;Hoveniae semoveniae semen medicine
It is mild-natured and, can clearing away damp-heat diuresis.
The effect of Chinese medicine composition of the invention is made between flavour of a drug by reasonable compatibility generates synergistic effect, invigorating the spleen benefit
Wet, turbid, cautiously grasping pathogenesis is rushed down in resolving sputum, distinguishes that body treats, the physique characteristic suitable for phlegm-dampness constitution;And the theory based on integration of drinking and medicinal herbs is ground
It makes, phlegm-dampness constitution person can be allowed to take for a long time, play invigorating spleen to remove dampness, turbid effect is rushed down in resolving sputum.The present invention has emphasis whole
Body, is prevented and treated and preferably, delicious taste takes convenient advantage.
Preferably, the Chinese medicine composition is grouped as by the group of following parts by weight:
It is highly preferred that the Chinese medicine composition is grouped as by the group of following parts by weight:
The preparation method of above-mentioned Chinese medicine composition is made by the steps to obtain: by hawthorn, lotus leaf, Poria cocos, orange peel,
Nutmeg, fructus amomi and hoveniae semoveniae semen mixing are to get the Chinese medicine composition.
Chinese medicine composition of the invention can both be mixed with the state of medicinal material itself, be ground into powder after can also mixing
(such as being crushed to broken wall state).The Chinese medicine composition of the application can exist in the form of Chinese medicine wall cell disruption preparation.
Preferably, the Chinese medicine composition is broken wall powder, and the broken wall diameter of particle is not more than 75 μm.
It is further preferable that the partial size of the Chinese medicine composition broken wall powder is 20~60 μm.
The invention further relates to it is a kind of intervene phlegm-dampness constitution broken wall composition, by above-mentioned Chinese medicine composition, filler and
Corrigent is prepared;The mass ratio of above-mentioned Chinese medicine composition, filler and corrigent are as follows:
The Chinese medicine composition: filler: corrigent=2:(0.5~2): (0.5~3).
Traditional Chinese medicine medicine materical crude slice utilization rate is low at present, the reason is that, most cells are complete in traditional Chinese medicine medicine materical crude slice
, the dissolution of effective medicinal component needs having in several or even dozens of cell wall, quite a few cell in cell
Effect composition cannot pass through cell wall and release, and can only be wasted.In addition, inferior health constitution belongs to chronic disease, the course of disease compared with
It is long, need long-term administration.And Chinese herb is made the ultrafine powder of specified particle diameter, is made by the present invention using suitable formula
Plant cell wall breaking rate is 98% or more.After the ultrafine powder of specified particle diameter is made in the formula, hawthorn, lotus leaf, Poria cocos, orange peel,
Effective ingredient in nutmeg, fructus amomi and hoveniae semoveniae semen releases completely, can greatly improve body to the absorption benefit of medicinal material
With rate, its bioavilability is made to have qualitative leap.Secondly, the emission of effective ingredient in Chinese medicine, when releasing speed and unit
Between drug absorption all can be higher than traditional Chinese medicine medicine materical crude slice, the type of the medicament effective component released is also than traditional Chinese medicine medicine materical crude slice
More, the drug effect time can significantly shorten, and more comprehensively, action intensity is higher for drug effect.The cell fragment of Chinese herbal ultra-fine powder body
Stronger to the adhesive attraction of intestinal wall since particle is small, the residence time can increase in the intestine, be also beneficial to improve the absorption benefit of drug
With rate.
It is further preferable that the mass ratio of above-mentioned Chinese medicine composition, filler and corrigent are as follows:
The Chinese medicine composition: filler: corrigent=2:1:(2~2.1).
Preferably, the filler is selected from one of soluble starch, resistant dextrin, dextrin or maltodextrin or several
Kind;The corrigent includes one or more of sugar alcohol, Sucralose, stevioside or acesulfame potassium.Wherein, the sugar alcohol is selected from
Antierythrite, D-sorbite, xylitol, lactitol, maltitol, mannitol or isomalt or its any group
It closes.
It is further preferable that the filler is selected from soluble starch, the corrigent is antierythrite and Sucralose.It can
It can play the role of certain thickening and suspending after soluble starch dissolution, the too fast precipitating of wall cell disruption powder be avoided, to form stable and uniform
Suspension, but in view of soluble starch water solubility it is bad, therefore, the additional amount of strict control soluble starch,
Otherwise it is easy to influence broken wall product disintegration of the present invention.Broken wall composition of the invention, which can according to need, is made into sugar-free particle or low
Sugared particle.
In preferred embodiments of the present invention, the corrigent is made of antierythrite and Sucralose.The trichlorine sugarcane
The additive amount of sugar is preferably 900~1100ppm, more preferably 1000ppm (i.e. 1 ‰).Antierythrite sugariness only have sucrose 3~
4 at good water solubility not will increase blood sugar concentration, to cause obesity, be used cooperatively with suitable Sucralose, can make this
Invention broken wall composition side effect is low and good taste.
The invention further relates to the preparation methods of the broken wall composition of above-mentioned intervention phlegm-dampness constitution, are made by the steps
It obtains: according to the ratio, by above-mentioned Chinese medicine composition, filler and corrigent respectively after coarse powder is broken to 80~120 mesh, through Ultramicro-powder
Be broken into partial size and be not more than 75 μm of ultrafine powder, be uniformly mixed to obtain mixed powder, granulation to get.
Preferably, the method for granulating is wet granulation, specific steps are as follows: wetting agent is added in Xiang Suoshu mixed powder, mixes
The mass ratio for closing powder and wetting agent is 1: 0.45~0.50, after mixing, and wet granular, the vertical boiling of transposition is made through 24 meshes of prepackage
In drying bed dry to get.
It is further preferable that the mass ratio of mixed powder and wetting agent is 1:0.49.
Preferably, the wetting agent is the ethanol water of volume fraction 48%~52%.
It is further preferable that it is 50% ethanol water that the wetting agent, which is volume fraction,.
Preferably, the method for granulating is dry granulation, the condition of dry granulation are as follows: 120~140KN of platen pressure, spiral shell
Revolve 20~40rpm of feeding revolving speed, pressure roller 5~10rpm of revolving speed, two-stage granulation 70~120rpm of revolving speed, cooling cycle water temperature 5~10
℃。
It is further preferable that the condition of dry granulation is, and platen pressure 130KN, screw feeding revolving speed 30rpm, pressure roller revolving speed
8rpm, two-stage pelletize revolving speed 100rpm, 8 DEG C of cooling cycle water temperature.
Further, in preferred embodiments of the present invention, the condition of the fluidized drying are as follows: 80 DEG C of inlet air temperature, out
, first only air inlet is opened when beginning and is not turned on heating operation 5min, after leaving air temp is more than 52 DEG C, closes and add by 52 DEG C of air temperature
Thermal continues to enter the wind 10min to get dry particl.
It is further preferable that being pulverized using TC-40 type fluidized bed supersonic jet mill hierarchy system;It is described super
Fine classification revolving speed rotates forward 30.0~32.0HZ.
It is further preferable that being pelletized using oscillating granulator.
After present invention granulation, further include the steps that screening, packing and packaging.
Dry particl of the present invention is sieved through the oscillation screening machine of prepackage 20 mesh of upper layer, 60 mesh of lower layer.
Packing specification of the present invention is 5g/ bags.
Compared with prior art, the invention has the following beneficial effects:
The present invention is using hawthorn and lotus leaf as monarch drug in a prescription, hawthorn reinforcing spleen to promote digestion, scattered stasis, lotus leaf energy invigorating the spleen rising Yang dampness removing, can
For oedema, deficiency of food abdominal distension, the two shares the effect that can reach invigorating the spleen to clear away damp pathogen;Minister is changed with Poria cocos, dried orange peel, Poria cocos invigorating the spleen excreting dampness
Phlegm Li Shui leads to and adjusts three burnt, dried orange peel regulating qi-flowing for strengthening spleen, regulating qi-flowing for eliminating phlegm, the two share resolving sputum rush down it is turbid;Assistant is with nutmeg, fructus amomi dampness elimination;Trifoliate orange
Dulcis medicinal peace, can clearing away damp-heat diuresis;The effect of being made between flavour of a drug by reasonable compatibility, generates synergistic effect, is used for phlegm
The conditioning of hydrogenoid constitution has good effect.The present invention is green safe using the medicinal material of dual-purpose of drug and food as primary raw material, and formula is only
Spy, it is in good taste, it is convenient to take, adjust body effect definite.And the full ingredient of broken wall composition of the invention is used as medicine, with suitable filler
It is combined with corrigent, the quick disintegration of effective component can be made, be conducive to the absorption rate for improving drug, improve drug effect.
Specific embodiment
Below with reference to embodiment, the present invention is further explained.These embodiments are merely to illustrate the present invention rather than limitation
The scope of the present invention.Test method without specific conditions in lower example embodiment usually according to this field normal condition or is pressed
The condition suggested according to manufacturer;Used raw material, reagent etc., unless otherwise specified, being can be from the business such as conventional market
The raw materials and reagents that approach obtains.The variation for any unsubstantiality that those skilled in the art is done on the basis of the present invention
And replacement belongs to scope of the present invention.
Examples 1 to 5
The present embodiment provides a series of Chinese medicine compositions for intervening phlegm-dampness constitution, formulas such as table 1.
The formula (g) of the Chinese medicine composition of 1 Examples 1 to 5 of table
Formula | Hawthorn | Lotus leaf | Poria cocos | Dried orange peel | Nutmeg | Fructus amomi | Hoveniae semoveniae semen |
Embodiment 1 | 10 | 10 | 10 | 5 | 3 | 3 | 10 |
Embodiment 2 | 8 | 12 | 8 | 3 | 4 | 2 | 12 |
Embodiment 3 | 12 | 8 | 12 | 7 | 2 | 4 | 8 |
Embodiment 4 | 4 | 16 | 4 | 8 | 1 | 5 | 4 |
Embodiment 5 | 16 | 4 | 18 | 2 | 5 | 1 | 18 |
Each Chinese medicine composition is prepared via a method which to obtain: taking each component of above-mentioned formulation dosage, Chinese medicine is obtained after mixing
Composition.
Embodiment 6~20
1, the present embodiment provides a series of preparation method of broken wall compositions for intervening phlegm-dampness constitution, formulas such as table 2.
The formula (100g) of the broken wall composition of 2 embodiment 6~20 of table
Note: the dosage of broken wall composition in embodiment 6 are as follows: 2 (embodiments 1), the meaning indicated are what embodiment 6 was selected
Chinese medicine composition comes from embodiment 1, and dosage is 2 (× 100g), remaining embodiment and so on.
2, embodiment 6~18 uses wet granulation, comprising the following steps:
(1) Chinese medicine composition corresponding in embodiment 6~18, antierythrite and soluble starch coarse powder are broken to partial size about
For 120 mesh, (classification revolving speed rotating forward then is pulverized using TC-40 type fluidized bed supersonic jet mill hierarchy system
30.0~32.0HZ) partial size is crushed to no more than 75 μm.
(2) above-mentioned Chinese medicine composition, antierythrite and soluble starch are weighed by recipe quantity, opens mixing dry-mixed 1~2
Minute makes each material be uniformly mixed to obtain mixed powder;The Sucralose of recipe quantity is weighed, is in advance 50% ethyl alcohol work with volume fraction
For wetting agent dissolution;Using 50% ethyl alcohol as wetting agent, the additional amount of wetting agent is mixed powder: 50% ethyl alcohol=1: 0.49 is left
The right side mixes mixed powder, dissolved Sucralose and wetting agent, is pelletized with the oscillating granulator of 24 meshes of prepackage, is made wet
Particle is packed into the hopper of vertical boiling-bed drying, sets 80 DEG C of fluidized drying inlet air temperature, 52 DEG C of leaving air temp, first when beginning
It only opens air inlet and is not turned on heating operation 5 minutes, so as to heating device be opened after most ethyl alcohol loss, to leaving air temp
After 52 DEG C, heating device is closed, continues air inlet 10 minutes or so, obtains dry particl.
(3) dry particl is sieved through the oscillation screening machine of prepackage 20 mesh of upper layer, 60 mesh of lower layer, obtains broken wall composition grain.
It is dispensed according to 5g/ bags, packaging.
3, the preparation method of embodiment 19 is identical as embodiment 6~18, and difference is not plus relevant auxiliary materials (are not added with and fill out
Fill agent and corrigent).It is dispensed according to 2g/ bags, packaging.
4, the formula of embodiment 20 is same as Example 6, and difference is to use dry granulation, specifically includes the following steps:
(1) Chinese medicine composition corresponding in embodiment 20, antierythrite and soluble starch coarse powder are broken to partial size is about
Then 120 mesh are pulverized (classification revolving speed rotating forward using TC-40 type fluidized bed supersonic jet mill hierarchy system
30.0~32.0HZ) partial size is crushed to no more than 75 μm.
(2) Chinese medicine composition, antierythrite and soluble starch are weighed by recipe quantity, open mixing makes for dry-mixed 1~2 minute
Each material is uniformly mixed to obtain mixed powder;Particle is made by dry method in transfer roller pressure type dry granulating machine;The wherein item of dry granulation
Part are as follows: platen pressure 130KN, screw feeding revolving speed 30rpm, pressure roller revolving speed 8rpm, two-stage granulation revolving speed 100rpm, cooling cycle
8 DEG C of water temperature.
(3) the oscillation screening machine through prepackage 20 mesh of upper layer, 60 mesh of lower layer sieves, and obtains broken wall composition grain.By its
It is dispensed according to 5g/ bags, packaging.
1 traditional Chinese medicine medicine materical crude slice of comparative example
This comparative example provides a kind of traditional prepared slices of Chinese crude drugs, and formula is consistent with embodiment 1, and difference is, selects and decocts
The mode boiled obtains, specific as follows: each component in formula is mixed, according to clinical Chinese medicine decoction method, is put into stainless-steel pan,
It shakeouts, adds water about 1000mL to not having 1~2cm of medical surfaces, after impregnating 120min, decoct 2 times, decoct 20min after boiling every time
Medical fluid is poured out, 2 medical fluids are merged, is concentrated under reduced pressure as the medicinal extract of every milliliter of 1g containing primary crude drug, 4 DEG C of preservations are spare.
Performance test
(1) citric acid dissolution determination
Respectively by embodiment 6~11 and embodiment 19,20 groups of embodiment, according to dissolution rate and drug release determination method (China
Pharmacopeia 0,931 second method of version general rule in 2015), using water 900mL as dissolution medium, revolving speed is 75 turns per minute, is operated according to methods, and is passed through
When 10min, solution 2mL is taken, crosses 0.45 μm of miillpore filter immediately, precision measures 10 μ L of subsequent filtrate, as test solution.
Measurement: it is measured according to the method under Chinese Pharmacopoeia 2015 version hawthorn [assay] items, calculates the amount of dissolution of citric acid.
As a result it calculates:
In formula:
X --- sample dissolution limitation;
CCitric acid--- the concentration of citric acid, mg/mL in test solution;
C --- citric acid index value in sample, mg/g;
M --- sample quality, g.
As the result is shown: embodiment 6~11 and 19 groups of embodiment, 20 groups of the embodiment dissolution rates by citric acid at 10 minutes
Respectively 87%, 80%, 85%, 82%, 79%, 86%, 65%, 91%, the dissolution of embodiment 19 is only 65%.By tying above
Fruit is it is found that embodiment 6~11, the dissolution rate conspicuousness of embodiment 20 illustrate addition of the present invention higher than embodiment 19 (P < 0.01)
Filler soluble starch, corrigent antierythrite and Sucralose can effectively promote the fast of after broken wall treatment particle
Speed disintegration and ingredient dissolution, the more simple broken wall particle of effective component dissolution rate are fast.And embodiment 6 (87%), implementation
Example 8 (85%), embodiment 11 (86%) dissolution rate are above embodiment 7 (80%), embodiment 9 (82%), embodiment 10
(79%), illustrate that embodiment 6, embodiment 8, the broken wall composition of embodiment 11 and the proportion of filler and corrigent are preferable, but
Embodiment 8, embodiment 11 increase separately the proportion of soluble starch, antierythrite again on the basis of embodiment 6, and citric acid is molten
Out-degree illustrates that the proportion of 6 broken wall composition of embodiment and filler and corrigent is best there is no increasing.
In addition, experiment discovery embodiment 6 and embodiment 20 are being formulated under the same conditions, embodiment 20 uses dry granulation
The dissolution rate of acquired product is significantly improved than the dissolution rate of 6 wet granulation of embodiment, illustrates the present invention using dry granulation
Product dissolution rate is higher.
(2) sensory testing
The medicinal extract (2g) of 1 traditional Chinese medicine medicine materical crude slice of broken wall composition (5g) made from Example 6~14 and comparative example,
The warm water of 100mL is added, stirring carries out subjective appreciation by 20 professional subjective appreciation persons, and subjective appreciation standards of grading are shown in Table 3,
Results of sensory evaluation is shown in Table 4.
3 subjective appreciation standards of grading of table
4 results of sensory evaluation of table
Group | Color (divides) | Smell (divides) | Mouthfeel (is divided) |
6 groups of embodiment | 2.69±0.62 | 4.69±0.56 | 4.73±0.55 |
7 groups of embodiment | 2.12±0.51 | 4.22±0.53 | 4.11±0.54 |
8 groups of embodiment | 2.59±0.54 | 4.18±0.45 | 4.62±0.48 |
9 groups of embodiment | 2.44±0.52 | 4.30±0.56 | 4.15±0.47 |
10 groups of embodiment | 2.23±0.45 | 4.16±0.49 | 4.12±0.43 |
11 groups of embodiment | 2.51±0.44 | 4.54±0.38 | 4.47±0.42 |
12 groups of embodiment | 2.56±0.33 | 4.56±0.53 | 4.21±0.34 |
13 groups of embodiment | 2.55±0.38 | 4.54±0.28 | 4.25±0.38 |
14 groups of embodiment | 2.41±0.36 | 4.23±0.33 | 4.39±0.34 |
1 group of comparative example | 2.01±0.35 | 3.54±0.38 | 3.45±0.37 |
It can be seen from the above result that the color of embodiment 6~14, smell, mouthfeel are preferable, the scoring of embodiment 6 is best, says
The proportion of bright 6 broken wall composition of embodiment and filler and corrigent is best.In addition, on the whole, the color of embodiment 6~14
Pool, smell, mouthfeel are significantly better than comparative example 1, illustrate that a small amount of fill out is added in Chinese medicine composition of the invention after broken wall treatment
Agent and corrigent are filled, the bitter taste of traditional Chinese medicine medicine materical crude slice can be effectively improved, and was unlikely to sweet tea, it is in good taste, it is convenient to take.
(3) to the influence of phlegm-dampness constitution state rat
1, by test product
Embodiment 6, embodiment 15~19 and comparative example 1.
2, experimental animal
SD rat, half male and half female, weight are 180~220g.
3, experimental method
72 SD rats are taken, random taking-up 8 is only used as Normal group, and Normal group is 20~28 DEG C, phase in temperature
It in the environment of being 50%~60% to humidity, is fed with normal diet, remaining carries out modeling, high glucose and high fat feed (basis
Feed 55%, lard 15%, sucrose 20.5%, yolk powder 9%, cholate 0.5%) it feeds and lives in temperature 18 DEG C~20
DEG C, in the environment of relative humidity 85%~95%, continuous 12 weeks, then removes and be placed in natural environment, by it according to random digit
Method is randomly divided into model control group and 6 groups of embodiment, 15~19 groups of embodiment and 1 group of comparative example, and removal is placed in natural environment 12h
After start to gavage, one time a day, wherein model control group gives physiological saline, 6 groups of embodiment, 15~19 groups of embodiment, comparative example
1 group is given corresponding formula, dosage are as follows: embodiment 6 and 15~18 dosage of embodiment are respectively 1.52g/kg weight (sample
Stomach-filling after adding water to be suspended), 19 dosage of embodiment is 0.91g/kg (guaranteeing identical as the amount of all compositions of embodiment 6);Comparison
The rat dosage of 1 group of example (traditional Chinese medicine medicine materical crude slice) is 0.91g/kg (medicinal extract that concentration is 1g/mL after adding water to cook);Model comparison
Group gives isodose physiological saline, once a day.Continuous gavage 30 days.
4, observation index
Animal behavioral study: observation each group rat spirit, activity condition etc. (according to 5 marking scales of table to the symptom of rat into
Row scoring;Abdomen arterial blood extracting places 4h, 6000rpm centrifugation, and 5min takes serum, and full-automatic biochemical detects total cholesterol (TC), sweet
Oily three rouge (TG).
5, statistical procedures
All data are all made of SPSS18.0 statistical software and are analyzed.Measurement dataIt indicates, is examined between group with t
It tests, P < 0.05 represents significant difference.
6, experimental result
5 experimental rat Biological Characterization of table scoring observation table
The symptom score and TC, TG of 6 each group rat of table compare
Group | Symptom score (is divided) | TC(mmol/L) | TG(mmol/L) |
Normal group | 1.05±0.56 | 3.34±0.43 | 1.35±0.33 |
Model control group | 4.52±0.68 | 5.95±0.45 | 3.69±0.57 |
6 groups of embodiment | 1.52±0.65① | 3.56±0.57① | 1.37±0.36① |
15 groups of embodiment | 1.85±0.28①②③ | 4.36±0.56①②③ | 1.78±0.33①②③ |
16 groups of embodiment | 2.12±0.46①②③ | 4.25±0.23①②③ | 1.80±0.23①②③ |
17 groups of embodiment | 2.56±0.32①②③ | 4.51±0.26①②③ | 1.89±0.35①②③ |
18 groups of embodiment | 2.65±0.89①②③ | 4.53±0.54①②③ | 1.97±0.44①②③ |
19 groups of embodiment | 2.06±0.65①②③ | 3.93±0.68①②③ | 1.72±0.42①②③ |
1 group of comparative example | 2.35±0.34①②③ | 4.15±0.27①②③ | 2.39±0.48①②③ |
Note: compared with model control group,①P<0.05;Compared with 6 groups of embodiment,②P<0.05;Compared with Normal group
,③P<0.05。
After modeling, there is apathetic depressed, cutis laxa in rat, and hair is withered, excrement is shapeless, half congealed to rush down and adjoint
Blood lipid (TC, TG) increase, belong to typical phlegm-dampness constitution, illustrate modeling success.As shown in Table 6, take embodiment 6 formula and
The symptom of rat significantly improves after the formula of embodiment 15~19, comparative example 1 are formulated, and symptom score and TC, TG are compared with model pair
According to a group decline (P < 0.05), wherein 6 groups of declines of embodiment are the most obvious (P < 0.05), and 6 groups of symptom scores of embodiment and TC, TG
No significant difference (P > 0.05) compared with Normal group.Illustrate that embodiment 6 is formulated, embodiment 15~19 is formulated and right
Ratio 1 can improve the clinical symptoms of phlegm-dampness constitution rat, reduce phlegm-dampness constitution Serum Lipids in Experimental HypercholesterolemicRats;And in general, implement
Example 15~16, which is formulated, is formulated the improvement of phlegm-dampness constitution better than embodiment 17~18, and wherein with the improvement of embodiment 6
Effect is best.
(4) security test
1) method
SPF grades of kunming mices 16, half male and half female are taken, 18~22g of weight is randomly divided into 2 groups, and every group 8,12 is small on an empty stomach
When after respectively with the maximum dosage-feeding gastric infusion of permission.Control group gives distilled water 0.4mL/10g weight;6 groups of embodiment are adopted
With 6 gained broken wall composition product of embodiment, 1g crude drug/mL concentration original liquid (for maximum concentration) 0.4mL/10g body is given
Weight, continuous 3 times, every minor tick 4 hours;After administration to the weight of animals, the state of mind, hair, autonomic activities, food ration, excrement,
The general status such as mouth and nose secretion are observed, and record the adverse reaction and death condition of animal, are observed continuously 7 days.
2) result
The result shows that compared with the control group, after 6 groups of animal gastric infusions of embodiment, the appearance activity of most of animal subtracts
It is few, look burnout, in addition to this, reaction that no other abnormalities were observed;After 2 hours, animal is returned to normal, with control group ratio
Compared with Non Apparent Abnormality.During observation after 2 hours, the state of mind of animal is good, hair color is bright and clean, it is movable freely, breathing it is equal
Even, food ration, excrement shows no obvious abnormalities, secretion without exception in mouth and nose, no animal dead.Before administration, the 3rd after being administered
It, administration after the 5th day and administration after the 7th day, weigh respectively to animal, the results show that each equal nothing of time point the weight of animals
Mouse is dissected in obvious group difference, off-test, and visually observing main organs color and morphology, whether there is or not changes, do not observe
It substantially change.6 groups of intragastric administration on mice embodiment of maximum dosage-feeding on the one is that 120g crude drug/kg weight (is equivalent to clinical application
1025.6 times), have no overt toxicity.
(5) phlegm wet human body improves test
1) method
By taking the broken wall composition that embodiment 6 provides as an example, its effect is tested.
It is phlegm according to " Traditional Chinese Medicine Constitution Classification and judgement " and " Wang Qi Constitution in Chinese Medicine Questionnaire (2009 editions) " selection somatotypes
It hydrogenoid constitution type volunteer 60, is included in standard: meeting phlegm-dampness constitution judgement person;Age 18~65 years old.It excludes: merging severe cardiac,
The infull person of Liver and kidney function;Merge more than two constitution persons;Merge mental disease and cognition dysfunction person;To this research drug
Allergy sufferers;Nursing period, the gestational period person;Participating in other clinical investigators.60 volunteers are divided into control group 1 at random
Group, 2 groups of control group and test group (embodiment 6), every group 20.Control group 1 (life style instructs group) is given only life style
Guidance, specifically include avoid on diet pungent-warm grow it is greasy, based on light;Daily life is avoided heat wet, not stayed up late, overstrain, is kept
Sufficient and regular sleep;On feelings will is taken good care of oneself, answer exercise intensity preferably big, such as middle-distance race swims, climbs the mountain, is various ball, military
Art.Control group 2 give 1 traditional Chinese medicine medicine materical crude slice of comparative example (3 times a day, each 2g is added water to cook to 200mL, is taken while it is hot, by
The middle big pharmacy of intelligence is uniformly boiled medicine, and is taken 3 months).Test group gives the broken wall composition medicine (3 times a day, every time 1 of embodiment 6
Bag, every bag of 5g take 3 months).
After taking 3 months, according to the standards of grading of the phlegm-dampness constitution in table 7 to before and after the test of each volunteer the case where is carried out
Constitution scale score, and test front and back skin oil and fat increment rate is measured, measuring method: with skin oil and fat tester
SM815 measures 3h inner skin fat content under 20 DEG C of environment, calculates sebum increment rate, calculates sebum respectively at patients before and after intervention and increases
Add rate, wherein sebum increment rate=(fat content-starting fat content after 3h)/starting fat content.
7 standards of grading of table
2) result
As a result such as table 8.
The test of table 8 front and back constitution scale score (conversion point) and skin oil and fat increment rate compare
Note: compared with control group 1,①P<0.05;Compared with control group 2,②P<0.05;
Original point=each entry score value is added;
Convert score=((original point-entry number)/(entry number × 4)) × 100.
It can be seen from the above result that test group (embodiment 6) can significantly improve the clinical symptoms and body of phlegm-dampness constitution patient
Sign, reduces skin oil and fat increment rate, and effect is better than traditional Chinese medicine medicine materical crude slice group, instructs group better than life style, illustrate the present invention
Broken wall composition for phlegm-dampness constitution conditioning have good effect, be suitable for phlegm-dampness constitution patient, and adjust body effect it is true
It cuts.
(6) body case is adjusted
Adjust body case 1: certain male, 40 years old.High medical with three, facial oil secreted Sheng, and forehead is especially apparent, and needed at any time
Carry oil-Absorbing Sheets.It is easy sweating, after movement more so, and sweat sticks more.Upper eyelid edema, sweet sense in mouth, the obvious partially fat (body of body
High 173cm, weight 95kg), often feeling body is heavy, uncomfortable in chest, abundant expectoration, and especially pregnant burden is very heavy.Appetite is medium, but eats
Meal speed is fast, has a liking for dessert, fat meat, barbecue etc., and physical examination in recent years shows the various problems such as fatty liver, hyperlipidemia, hypertension, draws
Rise and pay attention to, then come go to a doctor, the greasy tongue nature of white thickness of tongue fur it is purple, while there is indentation, pulse condition cunning.Debate the body for belonging to phlegm wet, phlegm wet Yong Sheng card.Using
It is improved according to broken wall composition product prepared by embodiment 6, each 5g, 3 times a day, after 6 months, all diseases, which are accused, to be cured, constitution
It returns to normal.
Tune body case 2: certain female, 45 years old.Medical with hypertension, body is partially fat (height 165cm, weight 77kg), often feels
Body is heavy, dizzy, uncomfortable in chest, abundant expectoration, and belly burden is very heavy, and facial oil secreted Sheng, and the white thickness of tongue fur is greasy, while there is indentation.It debates
Belong to the body of phlegm wet.It is improved using the broken wall composition product prepared according to embodiment 6, each 5g, 3 times a day, 3 months
Afterwards, all diseases are accused and are cured, and constitution returns to normal.
In above-described embodiment, the filler also can choose resistant dextrin, dextrin in addition to it can choose soluble starch
Or the fillers such as maltodextrin, wherein effect is best when filler is soluble starch, it can be simultaneously after soluble starch dissolution
Play the role of thickening and suspending;The sugar alcohol can also select sorb according to sugariness difference in addition to it can choose antierythrite
Sugar alcohol, xylitol, lactitol, maltitol, mannitol or isomalt or any combination thereof;It is examined for mouthfeel
Consider, the Sucralose in the corrigent is alternatively at sweeteners such as stevioside or acesulfame potassiums.
In conclusion the present invention is using hawthorn and lotus leaf as monarch drug in a prescription, and hawthorn reinforcing spleen to promote digestion, scattered stasis, lotus leaf energy invigorating the spleen liter
Positive dampness removing, can be used for oedema, deficiency of food abdominal distension, and the two shares the effect that can reach invigorating the spleen to clear away damp pathogen;For minister with Poria cocos, dried orange peel, Poria cocos is strong
Spleen excreting dampness, resolving sputum Li Shui lead to and adjust three burnt, dried orange peel regulating qi-flowing for strengthening spleen, regulating qi-flowing for eliminating phlegm, the two share resolving sputum rush down it is turbid;Assistant is with nutmeg, sand
Renhua is wet;Hoveniae semoveniae semen medicinal peace, can clearing away damp-heat diuresis;The effect of being made between flavour of a drug by reasonable compatibility, generates collaboration and makees
With the conditioning for phlegm-dampness constitution has good effect.The present invention is using the medicinal material of dual-purpose of drug and food as primary raw material, green peace
Entirely, formula is unique, in good taste, convenient to take, adjusts body effect definite.And the full ingredient of broken wall composition of the invention is used as medicine, and it is suitable
The filler and corrigent of amount combine, and can make the quick disintegration of effective component, are conducive to the absorption rate for improving drug, improve
Drug effect.
The above embodiment is a preferred embodiment of the present invention, but embodiments of the present invention are not by above-described embodiment
Limitation, other any changes, modifications, substitutions, combinations, simplifications made without departing from the spirit and principles of the present invention,
It should be equivalent substitute mode, be included within the scope of the present invention.
Claims (10)
1. a kind of Chinese medicine composition for intervening phlegm-dampness constitution, which is characterized in that be grouped as by the group of following parts by weight:
4~16 parts of hawthorn,
4~16 parts of lotus leaf,
4~18 parts of Poria cocos,
2~8 parts of dried orange peel,
1~5 part of nutmeg,
1~5 part of fructus amomi,
4~18 parts of hoveniae semoveniae semen.
2. Chinese medicine composition according to claim 1, which is characterized in that be grouped as by the group of following parts by weight:
8~12 parts of hawthorn,
8~12 parts of lotus leaf,
8~12 parts of Poria cocos,
3~7 parts of dried orange peel,
2~4 parts of nutmeg,
2~4 parts of fructus amomi,
8~12 parts of hoveniae semoveniae semen.
3. Chinese medicine composition according to claim 2, which is characterized in that be grouped as by the group of following parts by weight:
4. Chinese medicine composition according to claim 1, which is characterized in that the Chinese medicine composition is broken wall powder, described
Broken wall diameter of particle is not more than 75 μm.
5. a kind of broken wall composition for intervening phlegm-dampness constitution, which is characterized in that by any Chinese traditional medicine composition of Claims 1 to 4
Object, filler and corrigent are prepared;The quality of any Chinese medicine composition of Claims 1 to 4, filler and corrigent
Than are as follows:
Any Chinese medicine composition of Claims 1 to 4: filler: corrigent=2:(0.5~2): (0.5~3).
6. broken wall composition according to claim 5, which is characterized in that any Chinese traditional medicine composition of Claims 1 to 4
The mass ratio of object, filler and corrigent are as follows:
Any Chinese medicine composition of Claims 1 to 4: filler: corrigent=2:1:(2~2.1).
7. broken wall composition according to claim 6, which is characterized in that the filler is selected from soluble starch, resistance
One or more of dextrin, dextrin or maltodextrin;The corrigent includes sugar alcohol, Sucralose, stevioside or acesulfame potassium
One or more of.
8. broken wall composition according to claim 7, which is characterized in that the filler is soluble starch;It is described to rectify
Taste agent is antierythrite and Sucralose.
9. broken wall composition according to claim 8, which is characterized in that the additive amount of the Sucralose be 900~
1100ppm。
10. the preparation method of any broken wall composition of claim 5~9, which is characterized in that be made by the steps
It arrives:
According to the ratio, any Chinese medicine composition of claim 5~9, filler and corrigent are broken to 100 through coarse powder respectively~
After 120 mesh, the ultrafine powder for being not more than 75 μm through pulverizing into partial size is uniformly mixed to obtain mixed powder, and granulation is to get described broken
Wall composition.
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