CN110448668A - A kind of Chinese medicine composition keeping gentle constitution, broken wall composition and preparation method thereof - Google Patents
A kind of Chinese medicine composition keeping gentle constitution, broken wall composition and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of Chinese medicine compositions for keeping gentle constitution, broken wall composition and its preparation method and application.The Chinese medicine composition is grouped as by the group of following mass fraction: 7~13 parts of lily, 10~18 parts of Chinese yam, 7~12 parts of Poria cocos, 6~13 parts of frying Semen Lablab Album, 7~12 parts of Semen Nelumbinis, 0.2~2 part of rhizoma zingiberis, 1.5~4 parts of dried orange peel, 4~6.5 parts of frying malt.The effect of the present invention is based on the theories of integration of drinking and medicinal herbs, propose a kind of Traditional Chinese medicine composition formula for keeping gentle constitution, and the party is made between flavour of a drug by reasonable compatibility generates synergistic effect, cautiously grasping pathogenesis distinguishes that body treats, the physique characteristic suitable for gentle constitution, invigorating the spleen excreting dampness, benefiting qi for tranquillization；The broken wall composition that it is compounded with auxiliary material has prevention and treatment simultaneous preferably, and delicious taste takes convenient advantage；And be used as medicine with full constituent, effective component can quick disintegration.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, and in particular to a kind of Chinese medicine composition for keeping gentle constitution, broken wall combination
Object and preparation method thereof.
Background technique
Tcm constitution appraisal procedure and physique typing have it from ancient times, and it is by me that contemporary Constitution Theory in TCM is most representative
The nine body theories that state present age traditional Chinese medical science great master Wang Qi is proposed and founded, gentle constitution are one of tcm constitution somatotypes.By
It is good in native endowment, to raise the day after tomorrow proper, gentle constitution belongs to moderate with posture, it has rosy cheeks, energetic, viscera function
A kind of strong sturdy somatotypes for main feature of state.Gentle constitution person's mind, color, shape, state etc. performance are good, the bodily form
Well-balanced stalwartness, the complexion colour of skin is moist, and the dense gloss of hair, lustrous eyes, the bright profit of nose color, smell tonneau, the sense of taste is normal, and lip color is red
Profit, it is energetic, it is not easy to fatigue, be resistant to fever and chills, sleep peace and, stomach is received well, and two is just normal, and tongue color is light red, and tongue fur is thin white, arteries and veins with
There is mind.
The formation of gentle constitution is native endowment abundance and will raise proper collective effect, locating geographical environment, gas the day after tomorrow
Time feature, diet medication, living habit are associated.Therefore, gentle constitution is also required to improve, due to gentle body
Matter is biased without negative and positive of qi and blood, and conditioning drinks the product for using strengthening the spleen and replenishing qi based on flat mend.
Currently on the market about keep the product of gentle constitution be mostly by Chinese medicine composition by extracting, concentration, granulation,
The processing gained such as dry, only the fractions of Chinese medicine composition are used as medicine, and formula is complicated, and production and processing process is more and grows, raw
Produce it is at high cost, and easily lead to effective component destroy and cause ineffective.
Therefore, developing one kind integration of drinking and medicinal herbs product that is different types of, being suitable for gentle constitution, there is important research to anticipate
Justice and promotional value.
Summary of the invention
It is an object of the invention to overcome in the prior art product it is ineffective, and be formulated that complicated, process is tediously long, is produced into
This high defect or deficiency provides a kind of Chinese medicine composition for keeping gentle constitution.The present invention is based on the theories of integration of drinking and medicinal herbs, mention
A kind of Traditional Chinese medicine composition formula for keeping gentle constitution is gone out, the effect of party is made between flavour of a drug by reasonable compatibility generates association
Same-action, cautiously grasping pathogenesis distinguish that body treats, suitable for the physique characteristic of gentle constitution, invigorating the spleen excreting dampness, benefiting qi for tranquillization；By its preparation
Obtained broken wall composition ingredient can be used as medicine entirely, and relevant corrigent and filler, which is added, can also promote the fast of effective component
Fast disintegration has prevention and treatment simultaneous preferably, and delicious taste takes convenient advantage.
Another object of the present invention is to provide the preparation methods of the Chinese medicine composition of the gentle constitution of above-mentioned holding.
Another object of the present invention is to provide a kind of broken wall compositions for keeping gentle constitution.
Another object of the present invention is to provide the preparation methods of the broken wall composition of the gentle constitution of above-mentioned holding.
For achieving the above object, the present invention adopts the following technical scheme:
A kind of Chinese medicine composition keeping gentle constitution, is grouped as by the group of following mass fraction:
7~13 parts of lily,
10~18 parts of Chinese yam,
7~12 parts of Poria cocos,
6~13 parts of frying Semen Lablab Album,
7~12 parts of Semen Nelumbinis,
0.2~2 part of rhizoma zingiberis,
1.5~4 parts of dried orange peel,
4~6.5 parts of frying malt.
Chinese medicine composition provided by the invention is by Chinese yam, lily, Poria cocos, Semen Lablab Album (stir-fry), Semen Nelumbinis, rhizoma zingiberis, dried orange peel, wheat
Bud (stir-fry) forms, the flat tonifying lung spleen kidney of Chinese yam in side, not only tonifying Qi but also yin-nourishing, is monarch drug in a prescription；Minister is with Poria cocos, Semen Lablab Album, Semen Nelumbinis, Poria cocos
Invigorating the spleen excreting dampness, resolving sputum Li Shui lead to and adjust three cokes, and Semen Lablab Album invigorating the spleen for eliminating dampness, is clear liver and improved vision at inducing diuresis to remove edema, Semen Nelumbinis invigorating the spleen rising Yang benefit
Wet, three's contract can reach the effect of invigorating the spleen excreting dampness；Assistant is with dried orange peel regulating qi-flowing for strengthening spleen, malt soothing liver-qi stagnation invigorating the spleen, lily yin-nourishing peace
Mind；Make with rhizoma zingiberis cold dispelling.The effect of all medicines share can reach invigorating the spleen excreting dampness, benefiting qi for tranquillization.
The effect of Chinese medicine composition of the invention is made between flavour of a drug by reasonable compatibility generates synergistic effect, and invigorating the spleen is seeped
It is wet, benefiting qi for tranquillization.Our cautiously grasping pathogenesis distinguishes that body treats, the physique characteristic suitable for gentle constitution；And the reason based on integration of drinking and medicinal herbs
Thought develops, and gentle constitution person can be allowed to take for a long time.
Preferably, the Chinese medicine composition is grouped as by the group of following mass fraction:
8.5~11.5 parts of lily,
12~17 parts of Chinese yam,
8~11.5 parts of Poria cocos,
8~11 parts of frying Semen Lablab Album,
8.5~11 parts of Semen Nelumbinis,
0.5~1.5 part of rhizoma zingiberis,
2~3.5 parts of dried orange peel,
4.5~6 parts of frying malt.
It is further preferable that the Chinese medicine composition is grouped as by the group of following mass fraction:
10 parts of lily,
15 parts of Chinese yam,
10 parts of Poria cocos,
10 parts of frying Semen Lablab Album,
10 parts of Semen Nelumbinis,
1 part of rhizoma zingiberis,
3 parts of dried orange peel,
5 parts of frying malt.
Preferably, the Chinese medicine composition is broken wall powder, and the broken wall diameter of particle is not more than 75 μm.
The preparation method of above-mentioned Chinese medicine composition is made by the steps to obtain: lily, Chinese yam, Poria cocos, frying is white
Hyacinth bean, rhizoma zingiberis, dried orange peel and frying malt mix up to the Chinese medicine composition.
The Chinese medicine composition of the application can exist in the form of Chinese medicine wall cell disruption preparation.
Step is prepared by the following procedure to obtain:
Lily, Chinese yam, Poria cocos, frying Semen Lablab Album, rhizoma zingiberis, dried orange peel and frying malt are crushed to partial size no more than 75 respectively
μm broken wall powder state after mix, granulation to get；
Or it is little by partial size is crushed to after the mixing of lily, Chinese yam, Poria cocos, frying Semen Lablab Album, rhizoma zingiberis, dried orange peel and frying malt
In 75 μm of broken wall powder state, granulation to get.
Partial size after the granulation is 20~60 mesh.
A kind of broken wall composition keeping gentle constitution, is grouped as by the group of following mass fraction:
1.1~2.8 parts of above-mentioned Chinese medicine composition,
0.8~3.5 part of antierythrite,
0.4~1.4 part of soluble starch,
500~900ppm of Sucralose.
Soluble starch, antierythrite, Sucralose, which is added, as auxiliary material can not only improve mouthfeel, may additionally facilitate effectively
The quick disintegration of ingredient, while the composition is also suitable beneficial to diabetes patient's long-term use.
Chinese medicine composition and auxiliary material are mixed, and obtain broken wall composition, has and focuses on entirety, prevents and treats and preferably, taste can
Mouthful, take convenient advantage.It is suitable for that gentle constitution person takes for a long time, invigorating the spleen excreting dampness, benefiting qi for tranquillization can be played the role of.With routine
Decoction medicine materical crude slice compare, increase the convenience taken of patient, and full ingredient is used as medicine, utilize the various composition of Chinese medicine comprehensively, easily
In popularization.
We focus on entirety, prevent and treat and preferably, though being good medicine still delicious taste, and take convenience.
It should be understood that 1ppm refer to the component (Sucralose) account for broken wall composition mass fraction be million/
One.
Preferably, the broken wall composition is grouped as by the group of following mass fraction:
1.3~2.5 parts of Chinese medicine composition,
1.3~3.0 parts of antierythrite,
0.7~1.2 part of soluble starch,
600~800ppm of Sucralose.
It is further preferable that the broken wall composition is grouped as by the group of following mass fraction:
2 parts of Chinese medicine composition,
2 parts of antierythrite,
1 part of soluble starch,
Sucralose 700ppm.
The preparation method of above-mentioned broken wall composition, including following preparation step:
Chinese medicine composition, antierythrite, soluble starch and Sucralose are crushed, mixing is pelletized up to the broken wall
Composition.
Preferably, the process of the crushing are as follows: be crushed to partial size no more than 75 μm.
It is different according to the partial size of raw material, coarse crushing can be selected, the combination of ultramicro grinding carries out.
Preferably, coarse crushing is first carried out after mixing by Chinese medicine composition, antierythrite, soluble starch and Sucralose
Mode be crushed to partial size no more than 120 mesh, partial size then will be crushed in the way of ultramicro grinding no more than 75 μm.
It is further preferable that carrying out coarse crushing using Roughpulverizer.
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.
Preferably, the partial size after the granulation is 20~60 mesh.
Granulation both can choose dry granulation, also can choose wet granulation.
Preferably, the granulation is dry granulation, the condition of the dry granulation are as follows: 120~140 KN of platen pressure, spiral shell
Revolve 20~40rpm of feeding revolving speed, pressure roller 5~10rpm of revolving speed, two-stage pelletize revolving speed 100,5~10 DEG C of cooling cycle water temperature.
It is further preferable that the condition of the dry granulation are as follows: platen pressure 130KN, 30 rpm of screw feeding revolving speed, pressure roller
Revolving speed 8rpm, two-stage pelletize 70~120rpm of revolving speed, 8 DEG C of cooling cycle water temperature.
Wet granulation generally selects ethyl alcohol to pelletize as wetting agent, utilizes ethyl alcohol wet process present invention simultaneously provides a kind of
The method of granulation.
Preferably, it is described granulation be wet granulation, the process of the wet granulation are as follows: by smashed Chinese medicine composition,
Antierythrite and soluble starch mix to obtain mixture；Then Sucralose is dissolved using ethyl alcohol；By mixture, dissolved
Sucralose and ethyl alcohol mixing, pelletize to obtain the final product.
Preferably, the partial size after the alcohol granulation is 20~60 mesh.
Preferably, the volume fraction of the ethyl alcohol is 50~70%.
It is further preferable that the volume fraction of ethyl alcohol is 60%.
Preferably, the mass ratio of the mixture and ethyl alcohol is 1:0.35~0.50.
It is further preferable that the mass ratio of the mixture and ethyl alcohol is 1:0.40~0.45.
It is further preferable that being pelletized using oscillating granulator.
Specific pelletization are as follows: 80 DEG C of fluidized drying inlet air temperature of setting, is first only opened when beginning by 52 DEG C of leaving air temp
It enters the wind and is not turned on heating operation 5 minutes, be more than 52 to leaving air temp so as to open heating device after most ethyl alcohol loss
After DEG C, heating device is closed, continues air inlet 10 minutes or so, obtains dry particl.
It preferably, further include screening, packing, the step of packaging after granulation.
The packing specification of broken wall composition is 5g/ bags.
Compared with prior art, the invention has the following beneficial effects:
Chinese medicine composition provided by the invention is by Chinese yam, lily, Poria cocos, Semen Lablab Album (stir-fry), Semen Nelumbinis, rhizoma zingiberis, dried orange peel, wheat
Bud (stir-fry) forms, the flat tonifying lung spleen kidney of Chinese yam in side, not only tonifying Qi but also yin-nourishing, is monarch drug in a prescription；Minister is with Poria cocos, Semen Lablab Album, Semen Nelumbinis, Poria cocos
Invigorating the spleen excreting dampness, resolving sputum Li Shui lead to and adjust three cokes, and Semen Lablab Album invigorating the spleen for eliminating dampness, is clear liver and improved vision at inducing diuresis to remove edema, Semen Nelumbinis invigorating the spleen rising Yang benefit
Wet, three's contract can reach the effect of invigorating the spleen excreting dampness；Assistant is with dried orange peel regulating qi-flowing for strengthening spleen, malt soothing liver-qi stagnation invigorating the spleen, lily yin-nourishing peace
Mind；Make with rhizoma zingiberis cold dispelling.The effect of all medicines share can reach invigorating the spleen excreting dampness, benefiting qi for tranquillization.
The effect of Chinese medicine composition of the invention is made between flavour of a drug by reasonable compatibility generates synergistic effect, and invigorating the spleen is seeped
It is wet, benefiting qi for tranquillization.Our cautiously grasping pathogenesis distinguishes that body treats, the physique characteristic suitable for gentle constitution；And the reason based on integration of drinking and medicinal herbs
Thought develops, and gentle constitution person can be allowed to take for a long time.
It is mixed to get broken wall composition with auxiliary material and focuses on entirety, is prevented and treated and suitable, and be used as medicine with full ingredient, effective component
Can quick disintegration, though be good medicine still delicious taste, and take conveniently.
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 keeping gentle constitution, formulas such as table 1.
The formula (100g) of the Chinese medicine composition of 1 Examples 1 to 5 of table
| Formula | Lily | Chinese yam | Poria cocos | Semen Lablab Album (stir-fry) | Semen Nelumbinis | Rhizoma zingiberis | Dried orange peel | Malt (stir-fry) |
| Embodiment 1 | 10 | 15 | 10 | 10 | 10 | 1 | 3 | 5 |
| Embodiment 2 | 8.5 | 17 | 8 | 11 | 8.5 | 1.5 | 2 | 6 |
| Embodiment 3 | 11.5 | 12 | 11.5 | 8 | 11 | 0.5 | 3.5 | 4.5 |
| Embodiment 4 | 7 | 18 | 7 | 13 | 7 | 2 | 1.5 | 6.5 |
| Embodiment 5 | 13 | 10 | 12 | 6 | 12 | 0.2 | 4 | 4 |
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 6~15
The present embodiment provides a series of broken wall compositions for keeping gentle constitution, formulas such as table 2.
The formula (100g) of the broken wall composition of 2 embodiment 6~15 of table
Note: the dosage of Chinese medicine composition in embodiment 6 are as follows: 2 (embodiments 1), the meaning indicated are the selection of embodiment 6
Chinese medicine composition come from embodiment 1, dosage be 2 (× 100g), remaining embodiment and so on.
Broken wall composition is prepared via a method which to obtain.
It is about 120 mesh that Chinese medicine composition, Chinese medicine composition, antierythrite and soluble starch coarse powder, which are broken to partial size, so
Pulverized afterwards using TC-40 type fluidized bed supersonic jet mill hierarchy system (classification revolving speed rotates forward 30.0~
Partial size 32.0HZ) is crushed to no more than 300 mesh.
Above-mentioned Chinese medicine composition, antierythrite, soluble starch are weighed by recipe quantity, opens dry-mixed 1~2 point of mixing
Clock makes each material be uniformly mixed to obtain mixed powder, the Sucralose of recipe quantity is weighed, in advance with appropriate 60% ethyl alcohol (volume fraction)
It is dissolved as wetting agent；Using 60% ethyl alcohol as wetting agent, the additional amount of wetting agent is mixed powder: 60% ethyl alcohol=1: 0.41,
Mixed powder, dissolved Sucralose and wetting agent are mixed, is pelletized with the oscillating granulator of 24 meshes of prepackage, wet granular is made
It 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 only open when beginning
It opens air inlet and is not turned on heating operation 5 minutes, so as to open heating device after most ethyl alcohol loss, be more than to leaving air temp
After 52 DEG C, heating device is closed, continues air inlet 10 minutes or so, obtains dry particl.
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 will be real
It applies example 6~14 to be dispensed according to 5g/ bags, embodiment 15 is dispensed according to 2g/ 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 15, and difference is, selects and decocts
The mode boiled obtains, specific as follows: Chinese medicine composition each component in formula being mixed, according to clinical Chinese medicine decoction method, is put into
It in stainless-steel pan, shakeouts, adds water about 2000mL to not having 1~2cm of medical surfaces, after impregnating 120min, decoct 2 times, boil every time
20min is decocted afterwards and pours out medical fluid, is merged 2 medical fluids, is concentrated under reduced pressure into 200mL.
Comparative example 2
This comparative example provides a kind of traditional Chinese medical concrete particle, is formulated substantially the same manner as Example 6 consistent, difference
It is, does not add Sucralose.Its preparation process is as follows: decocting to obtain by Chinese medicine composition according to the decocting method of comparative example 1
The prepared slices of Chinese crude drugs (medicinal extract for being concentrated into 1g/mL), then weigh soluble starch, the antierythrite of formula ratio, by the prepared slices of Chinese crude drugs, can
Soluble starch and antierythrite obtain Chinese medical concrete particle in the way of the wet granulation in embodiment 6.
Performance test
(1) to the influence of mouse anti-reflecting fatigue ability under excessive fatigue state
One, experimental principle
The carry out mouse anti-reflecting fatigue effect experiment of the gentle constitution of holding prepared below using embodiment, to illustrate it
Gentle constitution can be maintained under the conditions of influence (the overworking) of extraneous factor and avoid the occurrence of sub-health state to biased body
Qualitative change, the effect for state of keeping fit.
Two, experimental material
1. by test product
Embodiment 6~15, comparative example 1
2. experimental animal
SPF grades healthy mice 96, half male and half female, 18~22g of weight.
3. experimental method
96 SPF grades of healthy mices are divided into 12 groups at random, every group 8, respectively 6~15 groups of embodiment, 1 group of comparative example
And blank control group, in strict accordance with recommending human body to take, mode is preventative to give 15 days to given the test agent, wherein embodiment 6~15
Group gives the formula of embodiment 6~15, and 1 group of comparative example is given the formula of comparative example 1, and model control group gives physiological saline；Administration
Dosage are as follows: 6~14 dosage of embodiment is respectively 1.52g/kg weight (stomach-filling after sample adds water to be suspended)；15 dosage of embodiment is
The mouse dose of 0.91g/kg (identical as the amount of Chinese medicine composition contained by embodiment 6), 1 group of comparative example (traditional Chinese medicine medicine materical crude slice) is
0.91g/kg (concentration is the medicinal extract of 1g/mL after adding water to cook, identical as the amount of Chinese medicine composition contained by embodiment 6)；Blank pair
Isodose physiological saline is given according to group, once a day, carries out following experiment:
(1) tired transfer rod instrument experiment: after the 16th day, last dose 1 hour, every group of mouse being individually placed in transfer rod instrument,
It is in static(al) tense situation to mouse muscle, starts to carry out tired rotating stick test, revolving speed is set as 30rpm.Every group of mouse carries out
Experiment before training appropriate is carried out to it, after mouse falls 3 times in transfer rod instrument, start recording mouse due to muscular fatigue from turn
Time under falling on stick instrument, 3 times parallel [Jia Xiaoyong, Hou Guangpo, Tian Lianying wait chronic fatigue syndrome morbidity related mechanism
Inquire into the Hebei [J] medicine, 2015,37 (16): 2463.].Observe the time under every group of mouse falls
(2) mice burden swimming is tested: after the 18th day, last dose 1 hour, by the tail portion system of every group of mouse to bear a heavy burden
Object, weight are calculated by the 10% of mouse weight, and mouse is put into the bath went swimming of depth 25cm, 30 DEG C of temperature or so water temperatures
[Guangzhou immunologic intervention clinical research [D] of Lin Yumin moxibustion on chronic Tiredness model rat: Traditional Chinese Medicine University Of Guangzhou,
2014.], every mouse is recorded Zi entering after water to the time no longer struggled that sinks under water.
(3) mouse normal pressure resistant anoxia is tested: continuing the gastric infusion of 19d, the 20th day, after last dose 1h, equal abdomen
Chamber injects 1% isoprel of 20mg/kg concentration, after 20 min, it is wide that whole mouse is put into built-in 10g soda lime 250ml
In mouth bottle, a bottle fills 1, then covers and is sealed, and record mouse twitches the death time.
Three, 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.
Four, experimental result
Influence of the table 3 to mouse roating bar tolerance time, walking weight load, hypoxia endurance time
Note: compared with model control group,①P < 0.05, compared with 6 groups of embodiment,②P<0.05
This research experiment result (table 3) display, takes roating bar tolerance time, swimming with a load attached to the body after embodiment 6~15 and comparative example 1
Swimming time and hypoxia endurance time are all remarkably higher than blank group (P < 0.05), embodiment 6, embodiment 8 and embodiment 10, embodiment 15
Four groups are compared no significant difference (P > 0.05), illustrate to increase with composite formula, roating bar tolerance time, swimming with a load attached to the body
Time and hypoxia endurance time increase be not significant, but the roating bar tolerance time of embodiment 6, walking weight load and hypoxia endurance time are aobvious
Work property is higher than embodiment 7, embodiment 9 and embodiment 11~14 (P < 0.05).This result of study is additionally shown in and embodiment 6 simultaneously
The identical situation of formula under, roating bar tolerance time, walking weight load and the hypoxia endurance time conspicuousness of comparative example 1 are lower than real
Example 6 (P < 0.05) is applied, illustrates that the full ingredient administration effect of broken wall composition is decocted better than water.
(2) sensory testing
Broken wall composition (5g) made from Example 6~14, broken wall composition (2g) made from embodiment 15 are added
The warm water of 100mL, decoction liquor 200mL made from stirring and comparative example 1, carries out subjective appreciations by 20 professional subjective appreciation persons,
Subjective appreciation standards of grading are shown in Table 4, and results of sensory evaluation is shown in Table 5, and overall assessment the results are shown in Table 6.
4 subjective appreciation standards of grading of table
5 results of sensory evaluation of table
6 overall assessment result of table
| Group | It is bad | Generally | It is good |
| 6 groups of embodiment | 0 | 1 | 19 |
| 7 groups of embodiment | 2 | 2 | 16 |
| 8 groups of embodiment | 1 | 2 | 17 |
| 9 groups of embodiment | 1 | 2 | 17 |
| 10 groups of embodiment | 2 | 2 | 16 |
| 11 groups of embodiment | 1 | 1 | 18 |
| 12 groups of embodiment | 1 | 2 | 17 |
| 13 groups of embodiment | 2 | 1 | 17 |
| 14 groups of embodiment | 2 | 2 | 16 |
| 15 groups of embodiment | 2 | 3 | 15 |
| 1 group of comparative example | 3 | 5 | 12 |
It can be seen from the above result that the color of embodiment 6~14, smell, mouthfeel are preferable, the mouthfeel of embodiment 15 is slightly poor, real
The scoring for applying example 6 is best.
(3) content of hesperidin measures
The accurate Chinese medical concrete particle for weighing embodiment 6, the broken wall composition grain of embodiment 15 and comparative example 2 respectively
10g is molten with water 900mL according to dissolution rate and drug release determination method (four general rules of Chinese Pharmacopoeia version in 2015,0,931 second method)
Medium out, revolving speed are 75 turns per minute, operate according to methods, when through 10 minutes, take solution 2mL, cross 0.45 μm of miillpore filter, essence immediately
Close 10 μ L of measurement subsequent filtrate, as test solution.
Reference substance solution preparation: precision weighs that aurantiamarin reference substance is appropriate, adds methanol that every 1mL is made respectively mixed containing 0.4mg
Close solution, shake up to get.
Measurement: it is measured according to the method under Chinese Pharmacopoeia 2015 version dried orange peel [assay] items, calculates the dissolution of aurantiamarin
Amount.
As a result it calculates:
In formula:
X-sample dissolution limitation；
CAurantiamarinThe concentration of aurantiamarin, mg/mL in-test solution；
Aurantiamarin index value, mg/g in C-sample；
M-sample quality, g；
Dissolution rate when embodiment 6 and 2 particle of comparative example pass through 10 minutes as the result is shown is respectively 87% and 89%, reality
The content of hesperidin for applying example 15 is 68%, with significant difference (P < 0.01) compared with embodiment 6 and embodiment 15, and in fact
It is not significant (P > 0.05) to apply difference between example 6 and comparative example 2.Illustrate that addition soluble starch and antierythrite can be effective
Promote the fater disintegration of particle and ingredient dissolution after broken wall treatment, it is fast to dissolve out more simple broken wall particle, and with biography
It is suitable that system extracts extract granule.
(4) safety evaluatio
SPF grades of kunming mices 16, half male and half female are taken, weight 18-22g 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 products obtained therefrom of embodiment, 1g crude drug/mL concentration original liquid (for maximum concentration) 0.4mL/10g weight is given, continuous 3 times,
Every minor tick 4 hours；To the weight of animals, the state of mind, hair, autonomic activities, food ration, excrement, mouth and nose secretion after administration
Equal general status are observed, and record the adverse reaction and death condition of animal, are observed continuously 7 days.
The result shows that compared with the control group, after 6 groups of animal gastric infusions of embodiment, reaction that no other abnormalities were observed；In
Before administration, administration after the 3rd day, administration after the 5th day and administration after the 7th day, weigh respectively to animal, the results show that when each
Between point the weight of animals without obvious group difference, mouse is dissected in off-test, and visually observing main organs color and morphology has
Without change, does 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) human test tests
It is flat for choosing somatotypes according to " Traditional Chinese Medicine Constitution Classification and judgement " and " Wang Qi Constitution in Chinese Medicine Questionnaire (2009 editions) "
With constitutional type volunteer 60, be included in standard: meeting gentle constitution judgement person；Age 18~65 years old；Occupation is for a long time in outdoor
Worker (rural migrant worker, fireman, traffic police) or long-term sitting and the worker that stays up late (IT worker).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
Food is upper should restraining, should not polyorexia satiety, often not eat supercooling overheat or sordid food, eat less it is excessively greasy and it is pungent it
Object；Control group 2 gives the traditional Chinese medicine medicine materical crude slice of comparative example 1, and (3 times a day, every time 1 bag, every bag of 2g, decocted by the big pharmacy of middle intelligence is unified
It boils to 200mL, takes while it is hot, continuously take 3 months).(3 times a day, test group 1 gives the broken wall composition medicine of embodiment 6
It 1 bag every time, every bag of 5g, takes orally, continuously takes 3 months).
The case where according to the standards of grading of the gentle constitution in table 7 to before and after the test of each volunteer, carries out constitution scale and comments
Point, appraisal result such as table 8.
Meanwhile control group and test group are given 3 months, follow-up 3 months, observe fever in 3 months, cough, have a running nose, pharynx
The disease incidence of larynx swelling and pain.Test result such as table 9.
Table 7 " Wang Qi Constitution in Chinese Medicine Questionnaire (2009 editions) "-gentle matter standards of grading
Note: the entry for indicating * needs first inversely to score, i.e., and 1 → 5,2 → 4,3 → 3,4 → 2,5 → 1, then calculated with formula
Conversion point, such as: are you energetic such as answering does not have, and corresponds to 1, then remembers 5 points.
The test of table 8 front and back appraisal result (conversion point)
| Drug | Before entering group | After intervention | |
| Control group 1 | / | 55.45±11.34 | 41.41±8.54 |
| Control group 2 | Comparative example 1 | 54.34±8.67 | 46.45±7.56 |
| Test group | Embodiment 6 | 54.66±7.98 | 55.45±4.34 |
* original point=each entry score value is added；
Convert score=((original point-entry number)/(entry number × 4)) × 100
The Follow-up results of 9 control group of table and test group
| Drug | Fever | Cough | It has a running nose | Abscess of throat | |
| Control group 1 | / | 2 | 3 | 3 | 4 |
| Control group 2 | Comparative example 1 | 1 | 1 | 2 | 1 |
| Test group 1 | Embodiment 6 | 0 | 0 | 0 | 1 |
It can be seen from the above result that test group can significantly keep gentle constitution, reduction fever, cough, rhinorrhea, throat are swollen
The incidence of the common diseases such as pain, effect are better than traditional Chinese medicine medicine materical crude slice group, are better than diet intervention group.
(6) body case is adjusted
Certain male 35 years old, throughout the year in outside work, occupation is traffic police, and exposing to the weather is caught a cold once in a while, is easy insomnia, and often have
Point is tired, and after taking 6 side March of embodiment (each 5g, 3 times a day), sleep quality is significantly improved, without feeling again in half a year
It emits, tired symptom significantly improves.
Certain male, 36 years old, IT worker lacked movement, and long-term sedentary occupation, poor sleeping quality is tired once in a while, is taking reality
It applies (each 5g, 3 times a day) after 6 side March of example, sleep quality significantly improves, and tired symptom significantly improves.
The present invention is based on the theory of integration of drinking and medicinal herbs, a kind of Chinese medicine composition for keeping gentle constitution and broken wall combination are proposed
The effect of composition formula, the party is made between flavour of a drug by reasonable compatibility, generates synergistic effect, and cautiously grasping pathogenesis distinguishes that body treats, and is applicable in
In the physique characteristic of gentle constitution, invigorating the spleen excreting dampness, benefiting qi for tranquillization has prevention and treatment simultaneous suitable, and delicious taste takes convenient advantage,
And be used as medicine with full constituent, effective component can quick disintegration.
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 keeping gentle constitution, which is characterized in that be grouped as by the group of following mass fraction:
7~13 parts of lily,
10~18 parts of Chinese yam,
7~12 parts of Poria cocos,
6~13 parts of frying Semen Lablab Album,
7~12 parts of Semen Nelumbinis,
0.2~2 part of rhizoma zingiberis,
1.5~4 parts of dried orange peel,
4~6.5 parts of frying malt.
2. Chinese medicine composition according to claim 1, which is characterized in that be grouped as by the group of following mass fraction:
8.5~11.5 parts of lily,
12~17 parts of Chinese yam,
8~11.5 parts of Poria cocos,
8~11 parts of frying Semen Lablab Album,
8.5~11 parts of Semen Nelumbinis,
0.5~1.5 part of rhizoma zingiberis,
2~3.5 parts of dried orange peel,
4.5~6 parts of frying malt.
3. Chinese medicine composition according to claim 1, which is characterized in that be grouped as by the group of following mass fraction:
10 parts of lily,
15 parts of Chinese yam,
10 parts of Poria cocos,
10 parts of frying Semen Lablab Album,
10 parts of Semen Nelumbinis,
1 part of rhizoma zingiberis,
3 parts of dried orange peel,
5 parts of frying malt.
4. Chinese medicine composition according to claim 1, which is characterized in that the Chinese medicine composition is broken wall powder,
The broken wall diameter of particle is not more than 75 μm.
5. the preparation method of any Chinese medicine composition of Claims 1 to 4, which is characterized in that be made by the steps
It arrives: lily, Chinese yam, Poria cocos, frying Semen Lablab Album, rhizoma zingiberis, dried orange peel and frying malt is mixed to get the Chinese medicine composition.
6. preparation method according to claim 5, which is characterized in that step is prepared by the following procedure and obtains:
Lily, Chinese yam, Poria cocos, frying Semen Lablab Album, rhizoma zingiberis, dried orange peel and frying malt are crushed to partial size respectively and are not more than 75 μm
Mixed after broken wall powder state, granulation to get；
Or partial size is crushed to after mixing lily, Chinese yam, Poria cocos, frying Semen Lablab Album, rhizoma zingiberis, dried orange peel and frying malt no more than 75
μm broken wall powder state, granulation to get；
Partial size after the granulation is 20~60 mesh.
7. a kind of broken wall composition for keeping gentle constitution, which is characterized in that be grouped as by the group of following mass fraction:
Any 1.1~2.8 parts of the Chinese medicine composition of Claims 1 to 4,
0.8~3.5 part of antierythrite,
0.4~1.4 part of soluble starch,
500~900ppm of Sucralose.
8. broken wall composition according to claim 7, which is characterized in that be grouped as by the group of following mass fraction:
1.3~2.5 parts of Chinese medicine composition,
1.3~3.0 parts of antierythrite,
0.7~1.2 part of soluble starch,
600~800ppm of Sucralose.
9. broken wall composition according to claim 8, which is characterized in that be grouped as by the group of following mass fraction:
2 parts of Chinese medicine composition,
2 parts of antierythrite,
1 part of soluble starch,
Sucralose 700ppm.
10. the preparation method of the claim 7~9 broken wall composition, which is characterized in that including following preparation step: will in
After drug composition, antierythrite, soluble starch and Sucralose crush, mixing is pelletized up to the broken wall composition.
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