CN110448654A - It is a kind of to intervene the Chinese medicine composition of damp-heat constitution, broken wall composition and preparation method thereof - Google Patents
It is a kind of to intervene the Chinese medicine composition of damp-heat constitution, broken wall composition and preparation method thereof Download PDFInfo
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- CN110448654A CN110448654A CN201910795018.8A CN201910795018A CN110448654A CN 110448654 A CN110448654 A CN 110448654A CN 201910795018 A CN201910795018 A CN 201910795018A CN 110448654 A CN110448654 A CN 110448654A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/489—Sophora, e.g. necklacepod or mamani
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/532—Agastache, e.g. giant hyssop
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/74—Rubiaceae (Madder family)
- A61K36/744—Gardenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K36/8994—Coix (Job's tears)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
The invention discloses a kind of Chinese medicine compositions for intervening damp-heat constitution, broken wall composition and preparation method thereof.The Chinese medicine composition is grouped as by the group of following parts by weight: 3.5~15 parts of cape jasmine, 5~25 parts of semen coicis, 3~18 parts of honeysuckle, 5~15 parts of wrinkled giant hyssop, 2~12 parts of the sophora bud, 1~10 part of Radix Glycyrrhizae.For the present invention using the medicinal material of dual-purpose of drug and food as primary raw material, complete square the effect of pressing theory of traditional Chinese medical science, pharmacological property and dosage, being made between flavour of a drug by reasonable compatibility, generates synergistic effect, clearing heat and promoting diuresis, a surname's permeabilization are wet with heat-clearing, tonneau dampness elimination declares Qinghua to expel the heat-evil, and heat is let out from down；Cautiously grasping pathogenesis distinguishes that body treats, the physique characteristic suitable for damp-heat constitution；The broken wall composition that it is compounded with auxiliary material is used as medicine with full constituent, effective component can quick disintegration, can allow damp-heat constitution person take for a long time, play clearing heat and promoting diuresis, turbid effect is rushed down in resolving sputum；It is whole with focusing on, it prevents and treats 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 damp-heat 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, the wet matter of the stasis of blood,
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.
Damp-heat constitution is using retention of damp-heat in the interior as the constitution status of main feature.The formation of damp-heat constitution is mainly by following reason:
One is regional disparity, especially Lingnan area, and longer term climatic is moist；Second is that with the quickening pace of modern life becoming the mood of people
Anxiety must be constrained, stagnation of liver qi, depression and stagnation of QI, with the passing of time the stagnation of the circulation of vital energy changes fire, consumption of body fluid by heat, with the passing of time easily raw phlegm wet forms damp and hot or phlegm
Hydrogenoid constitution；Third is that eating and drinking without temperance, long-term partial eclipse delicious food savoury, so that raw in phlegm wet, " overeating greasy food bringing about internal heat, during sweet person makes us
It is full ", then damp and hot, phlegm-dampness constitution easy to form；Fourth is that excessive drinking, modern life mode is unhealthy, and there are many hobby alcohol user,
Wine is hot product, heat that long-term drinking is supporing yang, and interior raw turbid pathogenic factor, and damp and hot intertexture easily forms damp-heat constitution；Fifth is that exercise lack,
Movement can accelerate metabolism, promote the discharge of internal harmful substance, and long-term motion lacks, so that body metabolism slows down, it is turbid
It is raw in poison, aggravate damp and hot performance.Modern doctor thinks, since modern life rhythm is very fast, the speed of social change be will also result in
Competitive pressure is larger in real life and unsound life style by people, has aggravated generation of the damp-heat constitution in crowd
Rate.
Since the prosperity and decline state of internal yin, yang, gas, blood, body fluid is different, to show as the constitution difference between individual
Property.Distinguishing that body opinion is controlled is, from the characteristic of constitution status and different classification of TCM constitution, to hold its health using the constitution of people as cog-nitive target
With the whole element and individual difference of disease, control principle is formulated, corresponding treatment, prevention, health-preserving method are selected, 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, and constitution theory in traditional Chinese medicine is with traditional Chinese medicine
Theory is as leading theoretical, biased constitution of the damp-heat constitution as today's society ranking front three, all with current many diseases
There is close relationship, carries out the joint demand that intervention is clinician and patient for damp-heat constitution.
Summary of the invention
It is an object of the invention to meet clinician and the needs of patient intervenes damp-heat constitution, provide a kind of dry
The Chinese medicine composition of pre- damp-heat constitution.The present invention is based on the theories of integration of drinking and medicinal herbs, propose a kind of combination for intervening damp-heat constitution
The effect of composition formula, full side is made between flavour of a drug by reasonable compatibility, generates synergistic effect, and clearing heat and promoting diuresis, a surname's permeabilization are wet with clear
Heat, tonneau dampness elimination declare Qinghua to expel the heat-evil, and heat is let out from down；Party's cautiously grasping pathogenesis distinguishes that body treats, the body suitable for damp-heat constitution
Matter feature；Damp-heat constitution person can be allowed to take for a long time, clearing heat and promoting diuresis can be played the role of；It is whole with focusing on, it prevents and treats and suitable,
Mouthfeel is good, takes convenient advantage.
Another object of the present invention is to provide the preparation methods of the Chinese medicine composition of above-mentioned intervention damp-heat constitution.
Another object of the present invention is to provide a kind of broken wall compositions for intervening damp-heat constitution.
Another object of the present invention is to provide the preparation methods of the broken wall composition of above-mentioned intervention damp-heat constitution.
For achieving the above object, the present invention adopts the following technical scheme:
A kind of Chinese medicine composition for intervening damp-heat constitution, is grouped as by the group of following parts by weight:
The present invention intervenes the Chinese medicine composition of damp-heat constitution by cape jasmine, semen coicis, honeysuckle, wrinkled giant hyssop, the sophora bud and Radix Glycyrrhizae group
At.We are using cape jasmine as monarch drug in a prescription, heat-clearing, purging intense heat, cool blood；Wrinkled giant hyssop property is warm but not dry, can dissipate exterior cold again can dampness elimination it is turbid, the sophora bud is clear
Hot cool blood, using clearing heat and expelling damp drug as ministerial drug, assistant assists ministerial drug heat-clearing with semen coicis Li Shui, invigorating the spleen, eliminating impediment, clearing away heat and eliminating pus
Dampness elimination；Honeysuckle is clearing heat and detoxicating, assists cape jasmine clearing heat-fire；Make with Radix Glycyrrhizae coordinating the drug actions of a prescription, and can reconcile cape jasmine bitter taste.Quan Fangtong
The effect of reasonable compatibility makes between flavour of a drug generation synergistic effect is crossed, clearing heat and promoting diuresis, a surname's permeabilization is wet with heat-clearing, and tonneau dampness elimination is to let out
Heat, declares Qinghua, and heat is let out from down.
Chinese medicine composition cautiously grasping pathogenesis of the invention, distinguishes that body treats, the physique characteristic suitable for damp-heat constitution；And it is based on medicine
It eats homologous theory to develop, damp-heat 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.
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 cape jasmine, semen coicis, honeysuckle, the leaves of pulse plants
The fragrant, sophora bud and Radix Glycyrrhizae mix up to 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 damp-heat 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:
Above-mentioned Chinese medicine composition: filler: corrigent=2:(0.5~1.5): (0.5~3).
The absorption rate of traditional Chinese medicine medicine materical crude slice is low at present, the reason is that, most cells in traditional Chinese medicine medicine materical crude slice
It is completely, the dissolution of effective medicinal component is needed across several or even dozens of cell wall, quite a few cell in cell
In effective ingredient cannot pass through cell wall and release, can only be wasted.In addition, inferior health constitution belongs to chronic disease,
The course of disease is longer, needs long-term administration.And the Ultramicro-powder of specified particle diameter is made using suitable formula in Chinese herb by the present invention
Body makes plant cell wall breaking rate 98.5% or more.After the ultrafine powder of specified particle diameter is made in the formula, cape jasmine, semen coicis, gold
Effective ingredient in honeysuckle flower, wrinkled giant hyssop, the sophora bud and Radix Glycyrrhizae 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.Broken wall composition of the invention has effects that adjust body definite, focuses on entirety, prevent and treat and preferably, delicious taste is taken convenient
Advantage.And the full ingredient of broken wall composition of the invention is used as medicine, and combines with suitable filler and corrigent, can make effective component
Quick disintegration is conducive to the absorption rate for improving drug, improves drug effect.
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:(2~2.2).
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
500~the 900ppm of additive amount, more preferably 700ppm (i.e. 0.7 ‰) of sugar.Antierythrite sugariness only has 3~4 one-tenth of sucrose, water
Dissolubility is good, not will increase blood sugar concentration, to cause obesity, is used cooperatively with suitable Sucralose, and the present invention can be made broken
Wall composition side effect is low and good taste, is also adapted for diabetes patient's long-term use.
The invention further relates to the preparation methods of the broken wall composition of above-mentioned intervention damp-heat 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 ultra micro
Be ground 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, the specific steps of wet granulation are as follows: moistens the ultrafine powder
The mass ratio of humectant dissolution, ultrafine powder and wetting agent is 1: 0.35~0.45, after mixing, is pre-installed 24 meshes and is made wet
Grain, dry in the vertical boiling-bed drying of transposition to get.
It is further preferable that the mass ratio of mixed powder and wetting agent is 1:0.42.
Preferably, the wetting agent is the ethanol water of volume fraction 57%~63%.
It is further preferable that the wetting agent is the ethanol water of volume fraction 60%.
It is further preferable that the method for granulating is dry granulation, the parameter of dry granulation is the condition of dry granulation are as follows: pressure
120~140KN of roller pressure, screw feeding 20~40rpm of revolving speed, pressure roller 5~10rpm of revolving speed, two-stage granulation revolving speed 70~
120rpm, 5~10 DEG C of cooling cycle water temperature.
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
52 DEG C of air temperature, 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, closing
Heating device 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 cape jasmine as monarch drug in a prescription, heat-clearing, purging intense heat, cool blood；Wrinkled giant hyssop property is warm but not dry, and can dissipate exterior cold again can dampness elimination
Turbid, sophora bud clearing heat and cooling blood, using clearing heat and expelling damp drug as ministerial drug, assistant is with semen coicis Li Shui, invigorating the spleen, eliminating impediment, clearing away heat and eliminating pus, auxiliary
Ministerial drug clearing away heat and eliminating dampeness；Honeysuckle is clearing heat and detoxicating, assists cape jasmine clearing heat-fire；Make with Radix Glycyrrhizae coordinating the drug actions of a prescription, and can reconcile cape jasmine hardship
Taste.The effect of full side is made between flavour of a drug by reasonable compatibility generates synergistic effect, and clearing heat and promoting diuresis, a surname's permeabilization is wet with heat-clearing, leads to
Sharp dampness elimination declares Qinghua to expel the heat-evil, and heat is let out from down, and the conditioning for damp-heat constitution has good effect.The present invention is eaten with medicine
Dual-purpose medicinal material is primary raw material, green safe, and formula is unique, in good taste, convenient to take, adjusts body effect definite.And the present invention
The full ingredient of broken wall composition be used as medicine, combined with suitable filler and corrigent, the quick disintegration of effective component can be made, favorably
In the absorption rate for improving drug, drug effect is improved.
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 damp-heat constitution, formulas such as table 1.
The formula (g) of the Chinese medicine composition of 1 Examples 1 to 5 of table
| Formula | Cape jasmine | Semen coicis | Honeysuckle | Wrinkled giant hyssop | The sophora bud | Radix Glycyrrhizae |
| Embodiment 1 | 5 | 15 | 10 | 10 | 6 | 5 |
| Embodiment 2 | 4 | 8 | 5 | 5 | 3 | 3 |
| Embodiment 3 | 10 | 22 | 16 | 15 | 11 | 9 |
| Embodiment 4 | 3.5 | 5 | 3 | 5 | 2 | 1 |
| Embodiment 5 | 15 | 25 | 18 | 15 | 12 | 10 |
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 damp-heat 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) by Chinese medicine composition, antierythrite and soluble starch corresponding in embodiment 6~18, respectively through coarse crushing
It is about 120 mesh to partial size, is then pulverized (classification using TC-40 type fluidized bed supersonic jet mill hierarchy system
Revolving speed rotates forward 30.0~32.0HZ) partial size is crushed to no more than 75 μm；
(2) each Chinese medicine composition, sugar alcohol and soluble starch are weighed by above-mentioned recipe quantity, opens and mixes dry-mixed 1~2min
It is uniformly mixed each material, obtains mixed powder；Sucralose (the preparatory appropriate volume score 60% of Sucralose of recipe quantity is added
Ethanol water is dissolved as wetting agent)；Using 60% ethanol water as wetting agent, then wetting agent is added into mixed powder,
The additional amount of wetting agent is mixed powder: 60% ethyl alcohol=1:0.42, is pelletized with the oscillating granulator of 24 meshes of prepackage, is made wet
Grain is packed into the hopper of vertical boiling-bed drying, sets 80 DEG C of fluidized drying inlet air temperature, and 52 DEG C of leaving air temp, when beginning first only
It opens air inlet and is not turned on heating operation 5min, so as to heating device is opened after most ethyl alcohol loss, it is super to leaving air temp
After crossing 52 DEG C, heating device is closed, continues to enter the wind 10min, 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 product particle.It will
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, opens dry-mixed 1~2 minute of mixing
Each material is set to be uniformly mixed to obtain mixed powder；Particle is made by dry granulation in transfer roller pressure type freeze drying granulator, wherein doing
The condition of method granulation is platen pressure 130KN, screw feeding revolving speed 30rpm, pressure roller revolving speed 8rpm, two-stage granulation revolving speed
100rpm, 8 DEG C of cooling cycle water temperature.
(3) particle 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 will
It is dispensed according to 5g/ bags, packaging.
Comparative example 1
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, Gardenoside dissolution determination
Embodiment 6~11 and embodiment 19,20 groups of embodiment are shone into dissolution rate and drug release determination method (Chinese Pharmacopoeia respectively
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, through 10 points
Zhong Shi takes solution 2mL, crosses 0.45 μm of miillpore filter immediately, precision measures 10 μ L of subsequent filtrate, as test solution.
Reference substance solution preparation: precision weighs Gardenoside reference substance, add methanol be made every 1mL contain 30 μ g mixing it is molten
Liquid, shake up to get.
Measurement: it is measured according to the method under Chinese Pharmacopoeia 2015 version cape jasmine [assay] items, calculates the dissolution of Gardenoside
Amount.
As a result it calculates:
In formula:
X-sample dissolution limitation；
CGardenosideThe concentration of Gardenoside, mg/mL in-test solution；
Gardenoside index value, mg/g in C-sample；
M-sample quality, g.
As the result is shown: 19 groups of embodiment 6~11 and embodiment, 20 groups of embodiment Gardenoside dissolution rates point when passing through 10 minutes
Not Wei 87%, 78%, 86%, 81%, 77%, 86%, 68%, 90%, the dissolution of embodiment 19 is only 68%.By tying above
The dissolution rate conspicuousness of embodiment 6~11 is higher than embodiment 19 (P < 0.01) known to fruit, illustrates that present invention addition filler can
Soluble starch, corrigent antierythrite and Sucralose, can effectively promote after broken wall treatment the fater disintegration of particle and
Ingredient dissolution, the more simple broken wall particle of effective component dissolution rate are fast.And embodiment 6 (87%), embodiment 8
(86%), the dissolution rate of embodiment 11 (86%) is above embodiment 7 (78%), embodiment 9 (81%), embodiment 10
(77%), 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 antierythrite, soluble starch again on the basis of embodiment 6, and Gardenoside 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 improved than the dissolution rate of 6 wet granulation of embodiment, illustrates that the present invention uses the product of dry granulation
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 | 2.73±0.45 | 4.68±0.36 | 4.73±0.35 |
| 7 groups of embodiment | 2.22±0.31 | 4.37±0.50 | 4.21±0.34 |
| 8 groups of embodiment | 2.49±0.52 | 4.18±0.45 | 4.32±0.38 |
| 9 groups of embodiment | 2.43±0.51 | 4.32±0.36 | 4.35±0.37 |
| 10 groups of embodiment | 2.23±0.35 | 4.18±0.39 | 4.02±0.43 |
| 11 groups of embodiment | 2.54±0.34 | 4.41±0.38 | 4.47±0.42 |
| 12 groups of embodiment | 2.53±0.33 | 4.36±0.53 | 4.21±0.34 |
| 13 groups of embodiment | 2.52±0.31 | 4.44±0.28 | 4.35±0.38 |
| 14 groups of embodiment | 2.41±0.32 | 4.27±0.33 | 4.35±0.34 |
| 1 group of comparative example | 2.01±0.31 | 3.85±0.36 | 3.72±0.35 |
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, the color of embodiment 6~14, smell, mouth
Sense is significantly better than comparative example 1, illustrates that a small amount of filler and flavoring is added in Chinese medicine composition of the invention after broken wall treatment
Agent, can be effectively improved the bitter taste of traditional Chinese medicine medicine materical crude slice, and be unlikely to sweet tea, in good taste, convenient to take.
3, to the influence of damp-heat constitution state rat
(1) experimental material
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 forage feed
10d is subsequently placed in 33 DEG C ± 2 DEG C of temperature, in the environment of relative humidity 75% ± 5%, total 10d when 11 of every morning 9.The
Start stomach-filling when the 11 day morning 9, give Escherichia coli 1 time by 1mL/200g, for 24 hours after reinforce infecting 1 time (1mL/200g) again, move
It is placed in natural environment out, it is randomly divided into model control group, 6 groups of embodiment, 15~19 groups of embodiment according to random number method
And 1 group of comparative example, removal starts to gavage after being placed in natural environment 12h, one time a day, wherein dosage are as follows: embodiment 6, real
Applying 15~18 dosage of example is respectively 1.52g/kg weight (stomach-filling after sample adds water to be suspended)；19 groups of dosage of embodiment are 0.91g/kg
(identical as the amount of composition contained by embodiment 6), the dosage of comparative example 1 (traditional Chinese medicine medicine materical crude slice) are that 0.91g/kg (adds water
Concentration is the medicinal extract of 1g/mL after decoction)；Model control group gives isodose physiological saline, and every group gavages 30d, and in last
Stomach-filling 12h is put to death, and extracting arterial blood is spare.
(4) observation index
Animal behavioral study: observation each group rat spirit, activity condition etc., and according to table 5 to the behavior situation of each group rat
It scores；Each group SOD in serum (superoxide dismutase) and MDA (malonaldehyde) expression
(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
6 each group rat symptom score of table and SOD, MDA level compare
| Group | Symptom score (is divided) | SOD(U/L) | MDA(μmol/L) |
| Normal group | 1.59±0.56 | 7.23±0.62 | 5.46±0.64 |
| Model control group | 4.52±0.68 | 2.85±0.99 | 8.56±0.58 |
| 6 groups of embodiment | 1.76±0.35① | 7.06±0.57① | 5.53±0.45① |
| 15 groups of embodiment | 2.25±0.28①②③ | 5.86±0.56①②③ | 6.25±0.66①②③ |
| 16 groups of embodiment | 2.32±0.46①②③ | 5.75±0.23①②③ | 6.23±0.47①②③ |
| 17 groups of embodiment | 2.66±0.32①②③ | 5.21±0.26①②③ | 6.68±0.58①②③ |
| 18 groups of embodiment | 2.75±0.49①②③ | 5.33±0.54①②③ | 6.64±0.47①②③ |
| 19 groups of embodiment | 2.16±0.65①②③ | 6.27±0.68①②③ | 5.92±0.46①②③ |
| 1 group of comparative example | 2.30±0.34①②③ | 6.05±75.27①②③ | 6.14±0.33①②③ |
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
This research experiment result (table 6) display, there is lassitude after the test in model group, activity is reduced, cutis laxa,
Subcutaneous fat-free, the touching bone grabbed, excrement is shapeless, and half congealed the symptoms such as to rush down, the performance damp and hot with clinic is very approximate, illustrate modeling at
Function.Damp-heat constitution is exactly a kind of state characterized by body redox dysfunction, improves body SOD and MDA level, can
To improve damp-heat constitution.After this result of study (table 6) shows that embodiment 6, embodiment 15~19 and comparative example 1 are administered, rat
Clinical symptoms and sign significantly improve, and symptom score is remarkably decreased (P < 0.05) compared with model group, and SOD in serum level is compared with mould
Type group significantly increases (P < 0.05), and MDA level is remarkably decreased compared with model group, and 6 groups of symptom scores of embodiment and SOD, MDA
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 damp-heat constitution rat, and up-regulation damp-heat constitution rat SOD is horizontal, lower damp-heat constitution rat
MDA is horizontal；And in general, the formula of embodiment 15~16 is formulated the improvement of damp-heat constitution better than embodiment 17~18,
And it is wherein best with the improvement of embodiment 6, it is better than not adding filler and corrigent group, is better than traditional medicine materical crude slice group.
4, safety evaluatio
(1) method
Taking SPF grades of kunming mices 16, half male and half female, 18~22g of weight is randomly divided into 2 groups, and every group 8, on an empty stomach 12
Respectively with the maximum dosage-feeding gastric infusion of permission after hour.Control group gives distilled water 0.4 mL/10g weight；6 groups of embodiment
Using 6 gained broken wall composition product of embodiment, 1g crude drug/mL concentration original liquid (for maximum concentration) 0.4mL/10g is given
Weight, continuous 3 times, every minor tick 4 hours；To the weight of animals, the state of mind, hair, autonomic activities, food ration, excrement after administration
Just, 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 state of mind of animal is good, hair color
It is bright and clean, movable freely, eupnea, food ration, excrement show no obvious abnormalities, secretion without exception in mouth and nose, no animal dead.
Before administration, be administered after the 3rd day, administration after the 5th day and administration after the 7th day, weigh respectively to animal, the results show that respectively
Time point the weight of animals without obvious group difference, dissect mouse, visually observe main organs color and morphology by off-test
Whether there is or not changes, do not observe and substantially change.6 groups of intragastric administration on mice embodiment of maximum dosage-feeding on the one is 120g crude drug/kg weight
(1025.6 times that are equivalent to clinical application), have no overt toxicity.
5, damp and hot 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 wet for choosing somatotypes according to " Traditional Chinese Medicine Constitution Classification and judgement " and " Wang Qi Constitution in Chinese Medicine Questionnaire (2009 editions) "
Hot constitutional type volunteer 60, is included in standard: meeting damp-heat 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 is given only the guidance of life style, specifically includes drink
On food based on light；Daily life is avoided heat wet, not stayed up late, overstrain, and sufficient and regular sleep is kept；It takes good care of oneself in feelings will
On, answer exercise intensity preferably big, such as middle-distance race swims, climbs the mountain, various ball, wushus.Control group 2 gives the tradition of comparative example 1
(3 times a day, each 2g is added water to cook to 200mL, is taken while it is hot the prepared slices of Chinese crude drugs, is uniformly boiled medicine by the big pharmacy of middle intelligence, is taken 3
Month).Test group gives the broken wall composition medicine (3 times a day, every time 1 bag, every bag of 5g takes 3 months) of embodiment 6.
After taking 3 months, score according to constitution of the table 7 to damp-heat constitution volunteer, according to wet in table 8 and table 9
(reference: Qin Yuehua " the damp and hot tune body side Wang Qi " intervenes the research of damp-heat constitution effect assessment to the symptom scores standard of hot constitution
[D] Beijing University of Chinese Medicine, 2019.) to before and after the test of each volunteer the case where carries out symptom and sign scores.
Table 7 " Wang Qi Constitution in Chinese Medicine Questionnaire (2009 editions) " (damp-heat constitution) marking scales
The 8 damp-heat constitution primary symptom shape table of integrals of table
The table 9 damp-heat constitution time symptom table of integrals
(2) result
Appraisal result such as table 10.
The test of table 10 front and back result
Note: compared with control group 1,①P < 0.05, compared with control group 2,②P<0.05；
Constitution scale score point is evaluated according to conversion: 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 can significantly improve the clinical symptoms and sign of damp-heat constitution patient, effect
Better than traditional Chinese medicine medicine materical crude slice group, group is instructed better than life style.Illustrate the tune of broken wall composition of the invention for damp-heat constitution
Reason has good effect, is suitable for damp-heat constitution patient, and adjust body effect definite.
6, body case is adjusted
Adjust body case 1: certain male, 28 years old, because frequent micturition, urgent urination, urodynia recurrent exerbation more than 1 year are gone to a doctor.Quarter examines, frequent micturition, urgent urination,
Urodynia recurrent exerbation, is diagnosed as chronic non-bacterial prostatitis.With scanty drak urine, dampness of scrotum, facial oiliness, especially
The block T is always glossy shinny, and acne, dark sore stack.Bitter taste from morning, ozostomia are defecated viscous not well, hang the punching of basin difficulty, usually
Feel that body is heavy, sleepy, red tongue body yellow and greasy fur, rapid pulse.It distinguishes as damp-heat constitution, using the broken wall group prepared according to embodiment 6
Composition powder is improved, each 5g, 3 times a day, after taking 3 months, obtains strong, constitution returns to normal.
Tune body case 2: certain female, student at school, 20 years old.Main suit's face acnes more than 2 years, usually study was nervous, insomnia and dreamful sleep, warp
Preceding acne aggravates.Existing lip week, two cheek acnes are more, and rash color is red, Whiteheads, there is a small amount of tumour.Tcm constitution is recognized as damp and hot
Constitution.It is improved using the broken wall composition product prepared according to embodiment 6, each 5g, 3 times a day, Cuo after taking 1 month
Sore mitigates, and the past premenstrual acne aggravates, this occurs without new acne.It takes again 2 months afterwards, face acnes all disappear, before menstruation
Do not occur new acne, has rosy cheeks.
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 formula of the invention is using cape jasmine as monarch drug in a prescription, heat-clearing, purging intense heat, cool blood；Wrinkled giant hyssop property is warm but not dry, can
Dissipate exterior cold again can dampness elimination it is turbid, sophora bud clearing heat and cooling blood, using clearing heat and expelling damp drug as ministerial drug, help with semen coicis Li Shui, invigorating the spleen, remove
Numbness, clearing away heat and eliminating pus assist ministerial drug clearing away heat and eliminating dampeness；Honeysuckle is clearing heat and detoxicating, assists cape jasmine clearing heat-fire；Make to reconcile with Radix Glycyrrhizae all
Medicine, and can reconcile cape jasmine bitter taste.The effect of full side is made between flavour of a drug by reasonable compatibility, which generates, to act synergistically, clearing heat and promoting diuresis,
Declare permeabilization wet with heat-clearing, tonneau dampness elimination declares Qinghua to expel the heat-evil, and heat is let out from down.Composition cautiously grasping pathogenesis of the invention, distinguishes that body is applied
It controls, the physique characteristic suitable for damp-heat constitution；And the theory based on integration of drinking and medicinal herbs develops, and damp-heat constitution person can be allowed long-term
It takes, plays invigorating spleen to remove dampness, turbid effect is rushed down in resolving sputum；It is in good taste with green safe, formula uniqueness, it is convenient to take, adjust body function
Imitate definite advantage.And the full ingredient of broken wall composition of the invention is used as medicine, and combines, can make with suitable filler and corrigent
The quick disintegration of effective component is conducive to the absorption rate for improving drug, improves 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 damp-heat constitution, which is characterized in that be grouped as by the group of following parts by weight:
2. Chinese medicine composition according to claim 1, which is characterized in that be grouped as by the group of following parts by weight:
3. Chinese medicine composition according to claim 2, which is characterized in that be grouped as by the group of following parts by weight:
5 parts of cape jasmine,
15 parts of semen coicis,
10 parts of honeysuckle,
10 parts of wrinkled giant hyssop,
6 parts of the sophora bud,
5 parts of Radix Glycyrrhizae.
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 damp-heat constitution, which is characterized in that by any Chinese traditional medicine composition of Claims 1 to 4
Object, filler and corrigent are prepared；
The mass ratio of any Chinese medicine composition of Claims 1 to 4, filler and corrigent are as follows:
Any Chinese medicine composition of Claims 1 to 4: filler: corrigent=2:(0.5~1.5): (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:(2~2.2).
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 500~
900ppm。
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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| CN111671030A (en) * | 2020-07-23 | 2020-09-18 | 广东致公药业有限公司 | Honeysuckle citron solid beverage |
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