CN104161850B - The preparation method of a kind of Chinese medicine extract and the Chinese medicine extract of preparation thereof and purposes - Google Patents
The preparation method of a kind of Chinese medicine extract and the Chinese medicine extract of preparation thereof and purposes Download PDFInfo
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Abstract
The present invention provides the preparation method of a kind of Chinese medicine extract, the crude drug of described Chinese medicine extract to consist of: the Radix Astragali 30 60 weight portion, Fructus Ligustri Lucidi 9 15 weight portion, Herba Leonuri 9 30 weight portion, Fructus Mume 3 10 weight portion, Rhizoma Coptidis 29 weight portion, Cortex Cinnamomi 15 weight portion, Flos Buddlejae 39 weight portion；Described preparation method includes: Cortex Cinnamomi extracts volatile oil, volatile oil beta cyclodextrin inclusion；The Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae concentration of volume percent be 10% 100% ethanol solution I extract；Fructus Mume and Cortex Cinnamomi medicinal residues, and the Radix Astragali, Fructus Ligustri Lucidi and Flos Buddlejae medicinal residues, use water extraction；Herba Leonuri, Rhizoma Coptidis concentration of volume percent be 10% 100% ethanol solution II extract；The extraction extractum of each several part merges, and is dried, and obtains dry extract, adds volatile oil clathrate compound, mix homogeneously, to obtain final product.Preparation method of the present invention significantly improves activity substance content and the pharmacological action of described Chinese medicine extract.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of Chinese medicine for diabetic retinopathy and carry
Take the preparation method of thing and the Chinese medicine extract of preparation thereof and purposes.
Background technology
Diabetic retinopathy (Diabetic Retinopathy, be called for short DR), be diabetes serious and
One of common ocular complications.Along with the prolongation of diabetic duration, the incidence rate of DR increases the most therewith
High.In more than 8 years persons of the course of disease, diabetic retinopathy incidence rate is about 50%.This disease disease in early days
Shape is inconspicuous, the most out in the cold, and late period does not has again specific control method, and disease is touching, obstinate refractory.
Primary disease loses and controls, and consequence is serious, is to cause blind main cause of being grown up, and blind rate is up to 8-12%,
The quality of life of patient groups is caused serious harmful effect.Therefore, the preventing and treating of DR become work as
Modern medical domain is badly in need of the great brainstorm subject solved, and is increasingly subject to domestic and international medical circle and medicine work
The great attention of person.But, the most still lack the active drug for the treatment of primary disease.In order to meet
The market demand of expanding day, prevents and delays the disease process of diabetic retinopathy, carry
The quality of life of high vast diabetics, play the spy of the advantage disease kinds such as Chinese medicine difficult diseases
Long, the new Chinese medicine carrying out treatment DR has highly important social meaning and economic worth.
In applicant's entitled " a kind of Chinese medicine system treating early diabetic retinopathy in the early time
Agent " in patent (patent No. ZL200610087540.3, authorized announcement date JIUYUE in 2009 16 days),
Disclosing a kind of Chinese medicine preparation treating early diabetic retinopathy, prescription consists of:
Radix Astragali 30-60g, Fructus Ligustri Lucidi 9-15g, Herba Leonuri 9-30g, Fructus Mume 3-10g, Rhizoma Coptidis 2-9g,
Cortex Cinnamomi 2-5g, Flos Buddlejae 3-9g.
This patent document also discloses the preparation method of above-mentioned Chinese medicine preparation, it may be assumed that (1) take corresponding proportioning
Various medicine components seven doses；(2) with cleaning cold water soak 30 minutes；(3) put in boiling machine, add
Entering 2500 milliliters and soak water, decoct 40 minutes, mechanical presses goes out medicine juice；(4) subpackage 14 is close
In envelope plastic bag, 175 milliliters every bag.
Said method is only the simple preparation method of Chinese herbs decoction, does not consider how fully to extract
Effective ingredient in medicine, brings dose big, and mouthfeel is poor, it has not been convenient to carry, unsuitable long term storage
Problem.
Therefore, it is necessary in taking into full account prescription the active component of each herbal medicine kind, structure,
On the basis of difference in physicochemical property, said extracted technique is optimized, to reducing consumption
While, significantly improve drug effect, the medicine preferably treating diabetic retinopathy is provided for patient.
Summary of the invention
For the problems referred to above, it is an object of the present invention to provide one and treat diabetic retinopathy
The preparation method of the Chinese medicine extract become.Compare with the decocting cooking method of prior art, system of the present invention
The Chinese medicine extract that Preparation Method prepares, the content of active substance is higher, drug effect is more notable.
In order to realize foregoing invention purpose, present invention employs following technical scheme:
A kind of preparation method of Chinese medicine extract, the crude drug of described Chinese medicine extract consists of:
Radix Astragali 30-60 weight portion, Fructus Ligustri Lucidi 9-15 weight portion, Herba Leonuri 9-30 weight portion, Fructus Mume 3-10
Weight portion, Rhizoma Coptidis 2-9 weight portion, Cortex Cinnamomi 1-5 weight portion, Flos Buddlejae 3-9 weight portion；
Described preparation method comprises the steps:
(1) each crude drug is prepared according to described weight portion；
(2) Cortex Cinnamomi extracts volatile oil, and Cortex Cinnamomi medicinal residues are standby, volatile oil beta-cyclodextrin inclusion compound, must wave
Hair oil clathrate；
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae concentration of volume percent are the ethanol solution of 10%-100%
I extracts, and ethanol extract reclaims ethanol, and measuring relative density when being concentrated into 80 DEG C is the leaching of 1.20-1.30
Cream, must extract extractum 1；
The Radix Astragali that (4) the Cortex Cinnamomi medicinal residues that Fructus Mume and step (2) obtain, and step (2) obtain,
Fructus Ligustri Lucidi and Flos Buddlejae medicinal residues, with water extraction, after aqueous extract adds the distillation that step (2) obtains
Aqueous solution, measuring relative density when being concentrated into 80 DEG C is the extractum of 1.20-1.30, must extract extractum 2；
(5) Herba Leonuri, Rhizoma Coptidis concentration of volume percent are that the ethanol solution II of 10%-100% extracts,
Ethanol extract reclaims ethanol, and measuring relative density when being concentrated into 80 DEG C is the extractum of 1.20-1.30,
Extract extractum 3；
(6) extractum 1,2,3 will be extracted to merge, and dry, be spray-dried or drying under reduced pressure, leaching must be done
Cream powder, adds the described volatile oil clathrate compound that step (2) obtains, mix homogeneously, to obtain final product.
Preferably, in described step (2), Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water
Amount is 6-16 times of medical material weight, and extraction time is 3-7 hour.
It is furthermore preferred that in described step (2), Cortex Cinnamomi extraction by steam distillation volatile oil, water
Weight is 8 times of medical material weight, 5 hours extraction times.
It is also preferred that in described step (2), anhydrous alcohol solution first used by volatile oil, then sticks with paste with β-ring
Essence aqueous solution carries out inclusion.
It is furthermore preferred that in described step (2), the volume of described dehydrated alcohol is the 1-3 of volatile oil volume
Times, more preferably 2 times of volatile oil volume.
It is furthermore preferred that in described step (2), the weight of beta-schardinger dextrin-is 6-20 times of volatile oil volume,
More preferably 10 times of volatile oil volume.
It is furthermore preferred that in described step (2), described beta-schardinger dextrin-aqueous solution, water weight is that β-ring is stuck with paste
15-40 times of essence weight；It is further preferred that the weight of water is beta-schardinger dextrin-weight 25 times.
Described step (2) preferably technical scheme is:
Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 6-16 times of Cortex Cinnamomi weight, carries
The time of taking is 3-7 hour；The another device of aqueous solution after distillation is collected, and Cortex Cinnamomi medicinal residues are standby；Volatile oil adds 1-3
The anhydrous alcohol solution of times volume, obtains volatile oil ethanol；Weighing weight is volatile oil volume 6-20
Beta-schardinger dextrin-again, adds the water of beta-schardinger dextrin-weight 15-40 times, mix homogeneously, obtains beta-schardinger dextrin-
Aqueous solution；Under rotating speed 150 revs/min, slowly add volatile oil second to described beta-schardinger dextrin-aqueous solution
Alcohol liquid, after addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Lower oven drying at low temperature, obtains the volatile oil clathrate compound of white loose.
Described step (2) preferred technical scheme is:
Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 10 times of Cortex Cinnamomi weight, extracts
Time is 5 hours；The another device of aqueous solution after distillation is collected, and Cortex Cinnamomi medicinal residues are standby；Volatile oil adds 2 times of bodies
Long-pending anhydrous alcohol solution, obtains volatile oil ethanol；Weigh β that weight is volatile oil volume 10 times-
Cyclodextrin, adds the water of beta-schardinger dextrin-weight 25 times, mix homogeneously, obtains beta-schardinger dextrin-aqueous solution；
Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution, add
After entering, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C low
Temperature is dried, and obtains the volatile oil clathrate compound of white loose.
Preferably, in described step (3), the concentration of volume percent of ethanol solution I is 30%-80%,
More preferably 70%.
It is also preferred that in described step (3), the volume of ethanol solution I be the described Radix Astragali, Fructus Ligustri Lucidi,
6-14 times of Flos Buddlejae medical material gross weight；It is furthermore preferred that the volume of ethanol solution I is the described Radix Astragali, female
Loyal son, 10 times of Flos Buddlejae medical material gross weight.
It is also preferred that in described step (3), extract 2-3 time, each 0.5-2 hour；It is furthermore preferred that
Extract 2 times, each 1.5 hours.
Preferably, in described step (4), the weight of water is 6-16 times of medical material weight；Preferably,
The weight of water is 8 times of medical material weight.
It is also preferred that in described step (4), water extraction 1-3 time, each 1-3 hour；It is furthermore preferred that
Water extraction 2 times, each 2 hours.
Preferably, in described step (5), the concentration of volume percent of ethanol solution II is 30%-80%；
It is furthermore preferred that the concentration of volume percent of ethanol solution II is 60%.
It is also preferred that in described step (5), the volume of ethanol solution II is 6-14 times of medical material weight；
It is furthermore preferred that the volume of ethanol solution II is medical material weight 10 times.
It is also preferred that in described step (5), extract 2-3 time, each 0.5-2 hour；It is furthermore preferred that
Extract 3 times, each 1.5 hours.
As a preferred embodiment of the present invention, the concrete operation step of described preparation method is as follows:
(1) crude drug is prepared according to described weight portion；
(2) Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 6-16 times of Cortex Cinnamomi weight,
Extraction time is 3-7 hour；The another device of aqueous solution after distillation is collected, and Cortex Cinnamomi medicinal residues are standby；Volatile oil adds
The anhydrous alcohol solution of 1-3 times of volume, obtains volatile oil ethanol；Weighing weight is volatile oil volume 6-20
Beta-schardinger dextrin-again, adds the water of beta-schardinger dextrin-weight 15-40 times, mix homogeneously, obtains beta-schardinger dextrin-
Aqueous solution；Under rotating speed 150 revs/min, slowly add volatile oil second to described beta-schardinger dextrin-aqueous solution
Alcohol liquid, after addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Lower oven drying at low temperature, obtains the volatile oil clathrate compound of white loose；
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae volume are the concentration expressed in percentage by volume of medical material weight 6-14 times
For ethanol solution I heating and refluxing extraction 2-3 time of 30%-80%, each 0.5-2 hour, filter, close
And each ethanol extract, reclaim ethanol, measuring relative density when being evaporated to 80 DEG C is 1.20-1.30
Extractum, extractum 1 must be extracted；
The Radix Astragali that (4) the Cortex Cinnamomi medicinal residues that Fructus Mume and step (1) obtain, and step (2) obtain,
Fructus Ligustri Lucidi and Flos Buddlejae medicinal residues, by the water heating and refluxing extraction that volume is medical material weight 6-16 times 1-3 time,
1-3 hour every time, filtering, merge each filtrate, add after the distillation that step (2) obtains is water-soluble
Liquid, stands, and filters, and measuring relative density when filtrate is concentrated into 80 DEG C is the extractum of 1.20-1.30,
Extract extractum 2；
(5) Herba Leonuri, Rhizoma Coptidis volume be the concentration expressed in percentage by volume of medical material weight 6-14 times be 30%-80%
Ethanol solution II extract 2-3 time, each 0.5-2 hour, filtration, merge each ethanol extract,
Reclaiming ethanol, measuring relative density when being evaporated to 80 DEG C is the extractum of 1.20-1.30, must extract leaching
Cream 3；
(6) extractum 1,2,3 will be extracted to merge, and be spray-dried, obtain dry extract, add step (2)
The described volatile oil clathrate compound obtained, mix homogeneously, to obtain final product.
As a preferred embodiment of the present invention, the concrete operation step of described preparation method is such as
Under:
(1) crude drug is prepared according to described weight portion；
(2) Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 10 times of Cortex Cinnamomi weight,
Extraction time is 5 hours；The another device of aqueous solution after distillation is collected, and Cortex Cinnamomi medicinal residues are standby；Volatile oil adds 2
The anhydrous alcohol solution of times volume, obtains volatile oil ethanol；Weighing weight is volatile oil volume 10 times
Beta-schardinger dextrin-, add beta-schardinger dextrin-weight 25 times water, mix homogeneously, obtain beta-schardinger dextrin-water-soluble
Liquid；Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution,
After addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Oven drying at low temperature, obtains the volatile oil clathrate compound of white loose；
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae volume are that the concentration expressed in percentage by volume of medical material weight 10 times is
The ethanol solution I heating and refluxing extraction of 70% 2 times, each 1.5 hours, filters, merges twice ethanol
Extracting solution, reclaims ethanol, and measuring relative density when being evaporated to 80 DEG C is the extractum of 1.20-1.30,
Extractum 1 must be extracted；
The Radix Astragali that (4) the Cortex Cinnamomi medicinal residues that Fructus Mume and step (1) obtain, and step (2) obtain,
Fructus Ligustri Lucidi and Flos Buddlejae medicinal residues, by the water heating and refluxing extraction that volume is medical material weight 8 times 2 times, every time
2 hours, filter, merge twice filtrate, add the aqueous solution after the distillation that step (2) obtains, stand,
Filtering, measuring relative density when filtrate is concentrated into 80 DEG C is the extractum of 1.20-1.30, must extract extractum 2；
(5) Herba Leonuri, Rhizoma Coptidis volume are the second that concentration expressed in percentage by volume is 60% of medical material weight 10 times
Alcoholic solution II extracts 3 times, each 1.5 hours, filters, merges three ethanol extracts, reclaims ethanol,
Measuring relative density when being evaporated to 80 DEG C is the extractum of 1.20-1.30, must extract extractum 3；
(6) extractum 1,2,3 will be extracted to merge, and be spray-dried, dry extract, add step (2)
The described volatile oil clathrate compound obtained, mix homogeneously, to obtain final product.
In above-mentioned preparation method, described crude drug composition is preferably:
Radix Astragali 30g, Fructus Ligustri Lucidi 15g, Herba Leonuri 15g, Fructus Mume 9g, Rhizoma Coptidis 6g, Cortex Cinnamomi 1g, close illiteracy
Flower 6g.
Further object is that the Chinese medicine extraction providing a kind of above-mentioned preparation method to prepare
Thing.
A further object of the invention is, it is provided that above-mentioned Chinese medicine extract is at preparation treatment diabetes view
Application in the medicine of film pathological changes.
In above-mentioned application, described Chinese medicine extract adds or pharmaceutically acceptable is auxiliary described in being added without
Material, is prepared as acceptable preparation clinically.
Pharmaceutically acceptable adjuvant of the present invention, can include but not limited to:
Diluent: be selected from starch, dextrin, pregelatinized Starch, lactose, microcrystalline Cellulose, sulphuric acid
Calcium, calcium hydrogen phosphate, calcium carbonate, magnesium oxide, magnesium carbonate, gel aluminum hydroxide, beta-schardinger dextrin-, manna
Alcohol, sorbitol, methylcellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, methylol are fine
One or more in dimension element sodium.
Binding agent: be selected from distilled water, ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl fibre
One or more in dimension element, methylcellulose and ethyl cellulose, hypromellose.
Lubricant: be selected from Stepanol MG, Polyethylene Glycol, micropowder silica gel, magnesium stearate,
One or more in Pulvis Talci.
Correctives: be selected from saccharin sodium, cyclamate, aspartame, stevioside and essence apoplexy due to endogenous wind
One or more.
The Advantageous Effects of the present invention is: (1) takes into full account the activity one-tenth of each taste crude drug in prescription
Point, it is respectively adopted Different Extraction Method and different solvents and crude drug classification is extracted.Test example 1
Display, boil technique with traditional water decoction compared with, preparation method of the present invention enables to each medical material in prescription
The extraction of each effective constituents more complete, extract the content of effective ingredient in product higher；Thus be
Extract plays clinical therapeutic efficacy and provides material base.(2) preparation method of the present invention, Cortex Cinnamomi is single
Solely extract volatile oil, and use beta-cyclodextrin inclusion compound volatile oil, the most to greatest extent of the present invention
Extract remains volatile oil, and stability of volatile oil improves.Document is had to report, Cortex Cinnamomi volatile oil
There is certain reduction blood glucose effect, and present dose dependent.Therefore, the method for the invention, will have
It is beneficial to the raising of described extract drug effect and holding, and the water decoction of prior art, it is practically free of volatile oil.
Pharmacodynamic experiment (test example 2) is from improving diabetes rat hemorheology, retina blood capillary
Pipe morphology aspect proves, the extract that the method for the invention prepares under different technology conditions,
The effect improving diabetic retinal tissue in rat microangiopathies is all better than water decoction of the prior art, especially
It is preferred embodiment 1, its effect more notable (P < 0.01).Preparation method of the present invention is described,
The therapeutic effect of extract can be significantly improved.
Accompanying drawing explanation
Hereinafter, describe embodiment of the present invention in detail in conjunction with accompanying drawing, wherein:
The block diagram of Fig. 1 is shown that in test example 1, Chinese medicine extract of the present invention and prior art
The Chinese herbs decoction comparison to main pharmacodynamics constituents extraction rate.
Detailed description of the invention
Referring to specific embodiment, the present invention is described.It will be appreciated by those skilled in the art that these
Embodiment is merely to illustrate the present invention, and it limits the scope of the present invention never in any form.
Experimental technique in following embodiment, if no special instructions, is conventional method.Following enforcement
Medicinal raw material used in example, reagent material etc., if no special instructions, be commercially available purchase product.
Embodiment 1The preparation method of a kind of Chinese medicine extract and the Chinese medicine extract of preparation thereof
Crude drug prescription:
Radix Astragali 6kg, Fructus Ligustri Lucidi 3kg, Herba Leonuri 3kg, Fructus Mume 1.8kg, Rhizoma Coptidis 1.2kg, Cortex Cinnamomi
0.2kg, Flos Buddlejae 1.2kg
Specifically comprising the following steps that of described preparation method
(1) ingredients is prepared according to prescription.
(2) Cortex Cinnamomi adds the water of medical material weight 10 times, uses extraction by steam distillation volatile oil, after distillation
The another device of aqueous solution is collected, and medicinal residues are standby；Volatile oil adds the anhydrous alcohol solution of 2 times of volumes；Take weight 10
The beta-schardinger dextrin-of times volatile oil volume, adds the beta-schardinger dextrin-that the water of beta-schardinger dextrin-weight 25 times makes water-soluble
Liquid；Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution,
After addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Oven drying at low temperature, obtains the volatile oil clathrate compound of white loose.
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae add 70% alcohol reflux that volume is medical material weight 10 times and carry
Take 2 times, each 1.5 hours, filter, merge twice ethanol extract, reclaim ethanol, concentrating under reduced pressure
Being the extractum of 1.20-1.30 to measuring relative density when 80 DEG C, must extract extractum 1, medicinal residues are standby.
(4) Radix Astragali that step (2) obtains Cortex Cinnamomi medicinal residues, step (3) obtain, Fructus Ligustri Lucidi and close
Flos Buddlejae medicinal residues and Fructus Mume, add the water reflux, extract, 2 times of medical material gross weight 8 times, each 2 hours, filter,
Merge twice filtrate, add the aqueous solution after the distillation that step (2) obtains, stand, filter, filtrate
Measuring relative density when being evaporated to 80 DEG C is the extractum of 1.20-1.30, must extract extractum 2.
(5) Herba Leonuri, Rhizoma Coptidis add 60% ethanol extraction 3 times that volume is medical material gross weight 10 times, often
Secondary 1.5 hours, filter, merge three ethanol extracts, reclaim ethanol, be evaporated to when 80 DEG C survey
Determine the extractum that relative density is 1.20-1.30, extractum 3 must be extracted.
(6) extractum 1,2,3 will be extracted to merge, and be spray-dried, obtain and always extract extractum, add step 2
The volatile oil clathrate compound obtained, mix homogeneously, obtain described Chinese medicine extract 4.42kg.
Embodiment 2The preparation method of a kind of Chinese medicine extract and the Chinese medicine extract of preparation thereof
Crude drug prescription:
Radix Astragali 6kg, Fructus Ligustri Lucidi 3kg, Herba Leonuri 3kg, Fructus Mume 1.8kg, Rhizoma Coptidis 1.2kg, Cortex Cinnamomi
0.2kg, Flos Buddlejae 1.2kg
Specifically comprising the following steps that of described preparation method
(1) ingredients is prepared according to prescription.
(2) Cortex Cinnamomi adds the water of medical material weight 8 times, uses extraction by steam distillation volatile oil, after distillation
The another device of aqueous solution collect, medicinal residues are standby；Volatile oil adds 1 times of volume anhydrous alcohol solution, takes weight 6
The beta-schardinger dextrin-of times volatile oil volume, adds the beta-schardinger dextrin-that the water of beta-schardinger dextrin-weight 15 times makes water-soluble
Liquid；Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution,
After addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Oven drying at low temperature, obtains the volatile oil clathrate compound of white loose.
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae add 10% alcohol reflux that volume is medical material gross weight 6 times
Extract 2 times, each 0.5 hour, filter, merge twice ethanol extract, reclaim ethanol, reduce pressure dense
Measuring relative density when being reduced to 80 DEG C is the extractum of 1.20-1.30, must extract extractum 1, and medicinal residues are standby.
(4) Radix Astragali that step (2) obtains Cortex Cinnamomi medicinal residues, step (3) obtain, Fructus Ligustri Lucidi and close
Flos Buddlejae medicinal residues and Fructus Mume, add the water reflux, extract, 1 time of medical material gross weight 6 times, and extraction time is 1 hour,
Filtering, filtrate adds the aqueous solution after the distillation that step (2) obtains, and stands, and filters, filtrate decompression
Measuring relative density when being concentrated into 80 DEG C is the extractum of 1.20-1.30, must extract extractum 2.
(5) Herba Leonuri, Rhizoma Coptidis add 10% ethanol extraction 2 times that volume is medical material gross weight 6 times, often
Secondary 0.5 hour, filter, merge twice ethanol extract, reclaim ethanol, be evaporated to when 80 DEG C survey
Determine the extractum that relative density is 1.20-1.30, extractum 3 must be extracted.
(6) extractum 1,2,3 will be extracted to merge, and be spray-dried, obtain and always extract extractum, add step 2
The volatile oil clathrate compound obtained, mix homogeneously, obtain described Chinese medicine extract 4.28kg.
Embodiment 3The preparation method of a kind of Chinese medicine extract and the Chinese medicine extract of preparation thereof
Crude drug prescription:
Radix Astragali 6kg, Fructus Ligustri Lucidi 3kg, Herba Leonuri 3kg, Fructus Mume 1.8kg, Rhizoma Coptidis 1.2kg, Cortex Cinnamomi
0.2kg, Flos Buddlejae 1.2kg
Specifically comprising the following steps that of described preparation method
(1) ingredients is prepared according to prescription.
(2) Cortex Cinnamomi adds the water of medical material weight 12 times, uses extraction by steam distillation volatile oil, after distillation
The another device of aqueous solution collect, medicinal residues are standby；Volatile oil adds 3 times of volume anhydrous alcohol solutions, takes weight 20
The beta-schardinger dextrin-of times volatile oil volume, adds the beta-schardinger dextrin-that the water of beta-schardinger dextrin-weight 40 times makes water-soluble
Liquid；Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution,
After addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Oven drying at low temperature, obtains the volatile oil clathrate compound of white loose.
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae add 100% ethanol that volume is medical material gross weight 14 times and return
Stream extracts 3 times, each 2 hours, filters, merges three ethanol extracts, reclaims ethanol, reduce pressure dense
Measuring relative density when being reduced to 80 DEG C is the extractum of 1.20-1.30, must extract extractum 1, and medicinal residues are standby.
(4) Radix Astragali that step (2) obtains Cortex Cinnamomi medicinal residues, step (3) obtain, Fructus Ligustri Lucidi and close
Flos Buddlejae medicinal residues and Fructus Mume, add the water reflux, extract, 3 times of medical material gross weight 16 times, each 3 hours, filter
Cross, merge three filtrates, add the aqueous solution after the distillation that step (2) obtains, stand, filter,
Filtrate reduced in volume is the extractum of 1.20-1.30 to measuring relative density when 80 DEG C, must extract extractum 2.
(5) Herba Leonuri, Rhizoma Coptidis add 100% ethanol extraction 3 times that volume is medical material gross weight 14 times,
Each 2 hours, filter, merge three ethanol extracts, reclaim ethanol, be evaporated to when 80 DEG C survey
Determine the extractum that relative density is 1.20-1.30, extractum 3 must be extracted.
(6) extractum 1,2,3 will be extracted to merge, and be spray-dried, obtain and always extract extractum, add step 2
The volatile oil clathrate compound obtained, mix homogeneously, obtain described Chinese medicine extract 4.02kg.
Embodiment 4The preparation method of a kind of Chinese medicine extract and the Chinese medicine extract of preparation thereof
Crude drug prescription "
Radix Astragali 6kg, Fructus Ligustri Lucidi 3kg, Herba Leonuri 3kg, Fructus Mume 1.8kg, Rhizoma Coptidis 1.2kg, Cortex Cinnamomi
0.2kg, Flos Buddlejae 1.2kg
Concretely comprising the following steps of described preparation method:
(1) ingredients is prepared according to prescription.
(2) Cortex Cinnamomi, adds the water of medical material weight 8 times, uses extraction by steam distillation volatile oil, after distillation
The another device of aqueous solution is collected, and medicinal residues are standby；Volatile oil adds the anhydrous alcohol solution of 2 times of volumes；Take weight 20
The beta-schardinger dextrin-of times volatile oil volume, adds the beta-schardinger dextrin-that the water of beta-schardinger dextrin-weight 30 times makes water-soluble
Liquid；Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution,
After addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Oven drying at low temperature, obtains the volatile oil clathrate compound of white loose.
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae add 30% alcohol reflux 2 of medical material gross weight 12 times
Secondary, each 2 hours, filter, merge twice ethanol extract, reclaim ethanol, be evaporated to 80 DEG C
Time measure relative density be the extractum of 1.20-1.30, extractum 1 must be extracted, medicinal residues are standby；
(4) Radix Astragali that step (2) obtains Cortex Cinnamomi medicinal residues, step (3) obtain, Fructus Ligustri Lucidi and close
Flos Buddlejae medicinal residues and Fructus Mume, add the water reflux, extract, 3 times of medical material gross weight 10 times, each 1 hour, filter
Cross, merge three filtrates, add the aqueous solution after the distillation that step (2) obtains, stand, filter,
Filtrate reduced in volume is the extractum of 1.20-1.30 to measuring relative density when 80 DEG C, must extract extractum 2；
(5) Herba Leonuri, Rhizoma Coptidis add 30% ethanol extraction 3 times of medical material gross weight 8 times, each 1 little
Time, filter, merge three ethanol extracts, reclaim ethanol, be evaporated to mensuration when 80 DEG C the closeest
Degree is the extractum of 1.20-1.30, must extract extractum 3；
(6) extractum 1,2,3 will be extracted to merge, and be spray-dried, obtain and always extract extractum, add step 2
The volatile oil clathrate compound obtained, mix homogeneously, obtain described Chinese medicine extract 4.45kg.
Embodiment 5The preparation method of a kind of Chinese medicine extract and the Chinese medicine extract of preparation thereof
Crude drug prescription:
Radix Astragali 6kg, Fructus Ligustri Lucidi 3kg, Herba Leonuri 3kg, Fructus Mume 1.8kg, Rhizoma Coptidis 1.2kg, Cortex Cinnamomi
0.2kg, Flos Buddlejae 1.2kg
Concretely comprising the following steps of described preparation method:
(1) ingredients is prepared according to prescription.
(2) Cortex Cinnamomi adds the water of medical material volume 12 times, uses extraction by steam distillation volatile oil, after distillation
The another device of aqueous solution is collected, and medicinal residues are standby；Volatile oil adds 2 times amount anhydrous alcohol solutions, takes weight 9 times
The beta-schardinger dextrin-of volatile oil volume, adds the beta-schardinger dextrin-aqueous solution that the water of beta-schardinger dextrin-weight 35 times is made；
Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution, add
After entering, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C low
Temperature is dried, and obtains the volatile oil clathrate compound of white loose.
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae add 80% alcohol reflux 3 of medical material gross weight 8 times
Secondary, each 0.5 hour, filter, merge three ethanol extracts, reclaim ethanol, be evaporated to 80 DEG C
Time measure relative density be the extractum of 1.20-1.30, extractum 1 must be extracted, medicinal residues are standby；
(4) Radix Astragali that step (2) obtains Cortex Cinnamomi medicinal residues, step (3) obtain, Fructus Ligustri Lucidi and close
Flos Buddlejae medicinal residues and Fructus Mume, add the water reflux, extract, 1 time of medical material gross weight 12 times, and extraction time is 3 little
Time, filter, add the aqueous solution after the distillation that step (2) obtains, stand, filter, filtrate decompression
Measuring relative density when being concentrated into 80 DEG C is the extractum of 1.20-1.30, must extract extractum 2；
(5) Herba Leonuri, Rhizoma Coptidis add 80% ethanol extraction 3 times of medical material gross weight 10 times, each 1 little
Time, filter, merge three ethanol extracts, reclaim ethanol, be evaporated to mensuration when 80 DEG C the closeest
Degree is the extractum of 1.20-1.30, must extract extractum 3；
(6) extractum 1,2,3 will be extracted to merge, and be spray-dried, obtain and always extract extractum, add step 2
The volatile oil clathrate compound obtained, mix homogeneously, obtain described Chinese medicine extract 4.36kg.
Comparative example 1The preparation method of a kind of Chinese medicine composition and the Chinese herbs decoction of preparation thereof
Crude drug prescription:
Radix Astragali 6kg, Fructus Ligustri Lucidi 3kg, Herba Leonuri 3kg, Fructus Mume 1.8kg, Rhizoma Coptidis 1.2kg, Cortex Cinnamomi
0.2kg, Flos Buddlejae 1.2kg
The preparation method of described Chinese medicine composition, concretely comprises the following steps:
(1) ingredients is prepared according to prescription.
(2) take ingredients, with cleaning cold water soak 30 minutes, put in boiling machine, add 71.43
Rising and soak water, decoct 40 minutes, mechanical presses goes out medicine juice, is evaporated to 18.74 liters, obtains described
Chinese herbs decoction；Then it is spray-dried, obtains dry extract 4.16kg.
Test example 1The comparison of the Chinese herbs decoction of Chinese medicine extract of the present invention and prior art
Test sample:
1) Chinese medicine extract prepared by embodiment of the present invention 1-5
2) dry extract of Chinese herbs decoction prepared by comparative example
Test method:
1) assay of astragaloside
Chromatographic condition: with octadecylsilane chemically bonded silica as filler；With acetonitrile-water (35:65) it is
Flowing phase；Evaporative light scattering detector detects.
The preparation of reference substance solution: take astragaloside reference substance appropriate, accurately weighed, add methanol and make often
The 1ml solution containing 0.3mg, to obtain final product.
The preparation of need testing solution: take test sample 3g, accurately weighed, precision adds methanol 100ml, claims
Determine weight, be heated to reflux 1 hour, let cool, more weighed weight, supply weight with methanol, shake up, mistake
Filter, discards just filtrate, accurate absorption subsequent filtrate 50ml, is evaporated, and the 25ml that adds water makes dissolving, satisfies with water
Extract 4 times with n-butyl alcohol shaking, each 25ml, merge n-butyl alcohol, fully wash with ammonia solution 3 times,
40ml, discards ammoniacal liquor every time, and n-butyl alcohol liquid is evaporated, and residue adds methanol and dissolves, and is transferred to 5ml measuring bottle
In, add methanol to scale, shake up, to obtain final product.
The preparation of medical material need testing solution: [contain by version " Chinese Pharmacopoeia " page 283 Milkvetch Roots in 2010
It is fixed to measure] prepared by " preparation of need testing solution " method under item.
Algoscopy: precision draws reference substance solution 10 μ l, 30 μ l, need testing solution 20 μ l respectively, injects
Chromatograph of liquid, measures, and calculates with external standard two-point method logarithmic equation, to obtain final product.
Total amount × 100% Han astragaloside in extraction ratio=astragaloside total amount/input medical material
2) assay of linarin
Chromatographic condition: with octadecylsilane chemically bonded silica as filler, with methanol-water-acetic acid (45:
54.5:0.5) for flowing phase, detection wavelength is 326nm.
The preparation of reference substance solution: take linarin reference substance appropriate, accurately weighed, add methanol and make every 1
The ml solution containing 0.3mg, to obtain final product.
The preparation of need testing solution: take test sample 1g, accurately weighed, precision adds 50% ethanol 50ml,
Weighed weight, supersound process 30 minutes, let cool, more weighed weight, supply weight with 50% methanol,
Shake up, filter, take subsequent filtrate, to obtain final product.
The preparation of medical material need testing solution: by version " Chinese Pharmacopoeia " page 308 Flos Buddlejae medical materials in 2010
Under [assay] item prepared by " preparation of need testing solution " method.Algoscopy: precision is drawn respectively
Reference substance solution and each 10 μ l of need testing solution, inject chromatograph of liquid, measures, to obtain final product.
Total amount × 100% Han linarin in extraction ratio=linarin total amount/input medical material
3) assay of berberine
Chromatographic condition: with octadecylsilane chemically bonded silica as filler, with acetonitrile-0.05mol/L phosphoric acid
Potassium dihydrogen (50:50) (every 100ml adds sodium lauryl sulphate 0.4g, then with phosphorus acid for adjusting pH value
It is 4.0) it is flowing phase, detection wavelength is 345nm
The preparation of reference substance solution: take berberine hydrochloride reference substance appropriate, accurately weighed, add methanol and make
Every 1ml solution containing 0.1mg, to obtain final product.
The preparation of need testing solution: take test sample 0.3g, accurately weighed, precision adds methanol 50ml,
Weighed weight, supersound process 30 minutes, let cool, more weighed weight, the weight of less loss is supplied with methanol,
Shake up, filter, take subsequent filtrate, to obtain final product.
The preparation of medical material need testing solution: [contain by version " Chinese Pharmacopoeia " page 285 Rhizoma Coptidis in 2010
It is fixed to measure] prepared by " preparation of need testing solution " method under item.
Algoscopy: precision draws reference substance solution and each 10 μ l of need testing solution respectively, injects liquid chromatograph
Instrument, measures, to obtain final product.
Total amount × 100% Han berberine in extraction ratio=berberine total amount/input medical material
4) assay of leonurine
Chromatographic condition and system suitability are with octadecylsilane chemically bonded silica as filler, with second
0.1% phosphoric acid solution (24:76) of nitrile-0.4% perfluorooctane sulfonate is flowing phase, and detection wavelength is 277nm.
The preparation of reference substance solution: take leonurine reference substance appropriate, accurately weighed, add methanol and make often
The 1ml solution containing 0.03mg, as reference substance solution.
The preparation of need testing solution: take test sample 2g, accurately weighed, precision adds 75% methanol 25ml,
Weighed weight, supersound process 30 minutes, let cool, more weighed weight, supply less loss with 75% methanol
Weight, shakes up, and filters, takes subsequent filtrate, to obtain final product.
The preparation of medical material need testing solution: by version " Chinese Pharmacopoeia " page 272 Herba Leonuri medical materials in 2010
Under [assay] item prepared by " preparation of need testing solution " method.
Algoscopy: precision draws reference substance solution and each 10 μ l of need testing solution respectively, injects liquid chromatograph
Instrument, measures, to obtain final product.
Total amount × 100% Han leonurine in extraction ratio=leonurine total amount/input medical material
5) assay of cinnamic aldehyde
Chromatographic condition: with octadecylsilane chemically bonded silica as filler；With acetonitrile-water (35:75) it is
Flowing phase；Detection wavelength is 290nm.
The preparation of reference substance solution: take cinnamic aldehyde reference substance appropriate, accurately weighed, add methanol and make every 1ml
Containing the solution of l0 μ g, to obtain final product.
The preparation of need testing solution: take test sample 0.5g, accurately weighed, put in tool plug conical flask, essence
Close addition methanol 25ml, weighed weight, supersound process (power 350W, frequency 35kHz) 10 minutes,
Stand overnight, with method supersound process once, more weighed weight, supply the weight of less loss with methanol, shake up,
Filter, to obtain final product.
The preparation of medical material need testing solution: [contain by version " Chinese Pharmacopoeia " page 127 Cortex Cinnamomi medical materials in 2010
It is fixed to measure] prepared by " preparation of need testing solution " method under item.
Algoscopy: precision draws reference substance solution and each 10 μ l of need testing solution respectively, injects liquid phase color
Spectrometer, measures, to obtain final product.
Total amount × 100% Han cinnamic aldehyde in extraction ratio=cinnamic aldehyde total amount/input medical material
Result of the test: be shown in Table 1 and Fig. 1.
1) table 1 shows, preparation method of the present invention, the extract of preparation under different technical parameters,
The extraction ratio of each composition of detection is above the compositions of the comparative example of same materials medicine prescription；Especially
Cinnamic aldehyde, does not measures in the water decoction dry extract of comparative example.
2) embodiment 1 is higher than other embodiments to the extraction ratio of astragaloside, linarin and berberine.
Conclusion (of pressure testing):
1) preparation method of the present invention can significantly improve the extraction efficiency of prior art, makes the present invention
The Chinese medicine extract of preparation has relatively reliable pharmacodynamic substances basis when clinical practice.
2) astragaloside, linarin and berberine are treatment diabetes and the having of diabetic retinopathy
Effect composition.The extraction ratio of above-mentioned three kinds of compositions is implemented by preparation method described in embodiment 1 apparently higher than other
The preparation method of example, illustrates that the preparation method described in embodiment 1 is currently preferred method.
Table 1 comparative example contrasts table with embodiment active ingredient
Test example 2The diabetic retinal tissue in rat pathological changes that STZ is induced by Chinese medicine extract of the present invention
Impact
Diabetic retinopathy is the optical fundus microangiopathies that diabetes long-run development causes, and it is the most sick
Reason change is directly or indirectly to affect its hemorheological property because of long term hyperglycemia, ultimately causes retinal vessel
The damage of structure and changing function.The diabetes rat model of STZ induction is the most relatively to generally acknowledge
Diabetes model, after long-term modeling, gradually form diabetic retinopathy.This test uses once
The method of abdominal cavity note STZ prepares diabetes rat model, by pharmaceutical intervention preparation more of the present invention
The impact on diabetic retinal tissue in rat microangiopathies of method and the extract prepared by prior art.
1, experimental technique
1.1 animal packets
Take SPF level SD rat, after adaptability raises 1 week, be randomly divided into 2 groups: blank group (15
Only), diabetic groups (120).After all animal fasting 16h, blank group rats by intraperitoneal injection
(i.p.) 0.01mol/L of 55mg/kg, pH4.4 citrate buffer solution；Diabetes rats lumbar injection
1%STZ55mg/kg (is dissolved in the citrate buffer solution of 0.01mol/L, pH4.4) temporarily.Modeling 1
After week, tail venous blood sampling surveys fasting glucose, with blood glucose >=16.7mmol/L for model Success criteria.Blood glucose is not
Rat up to standard adds STZ40mg/kg again, again detects its fasting glucose, screen twice modeling after 7 days
Successfully rat (twice success rate is 88%).The rat of diabetes standard will be met by blood glucose, body weight
Level is randomly divided into 7 groups again, model group, embodiment 1 group, embodiment 2 groups, embodiment 3 groups, reality
Execute example 4 groups, embodiment 5 groups, comparative example group, often group 15.
This prescription people's dosage is: people's crude drug every day amount 82g/60kg, i.e. 1.4g/kg.According to conversion
Coefficient table, finding rat body weight conversion factor is 6.25, and the dose,equivalent of conversion rat is
6.25 × 1.4g/kg=8.75g/kg, i.e. 8.75g crude drug amount/kg.In addition to model group, the dosage of each group
Being converted to crude drug is all 8.75g crude drug amount/kg.
1.2 pharmaceutical intervention
(extract that embodiment 1 prepares adds deionized water and makes 0.236g/ml embodiment 1 group
Solution, dosage: 10ml/kg), embodiment 2 groups (extract that embodiment 2 prepares,
Add deionized water and make the solution of 0.228g/ml, dosage: 10ml/kg), embodiment 3 groups (real
Execute the extract that example 3 prepares, add deionized water and make the solution of 0.214g/ml, dosage:
10ml/kg), (extract that embodiment 4 prepares adds deionized water and makes embodiment 4 groups
The solution of 0.237g/ml, dosage: 10ml/kg), (embodiment 5 prepares embodiment 5 groups
Extract, adds deionized water and makes the solution of 0.233g/ml, dosage: 10ml/kg), comparative example
(pharmaceutical composition that comparative example prepares adds deionized water and makes the solution of 0.222g/ml, gives group
Pharmaceutical quantities: 10ml/kg), model group and blank group give the deionized water of respective volume, and gavage is given
Medicine, is administered once daily, and is administered 3 months altogether.The drinking-water of abundance, food, every day is given during administration
Change bedding and padding.
1.3 Indexs measure
1.3.1 hemorheology detection
At the end of experiment, rat aorta takes blood, anticoagulant heparin, 3000r/min, is centrifuged 15min,
Leave and take blood plasma.The whole blood viscosity under different shear rate and plasma viscosity is measured with blood viscosity instrument；With red carefully
Born of the same parents deform gathering instrument and measure erythrocyte aggregation index, and experimental result is shown in Table 2.
1.3.2 retinal capillary morphological change
Rat retina surface preparation technic is used to observe its retinal capillary morphological change.Rat anesthesia
After, rinse blood with normal saline through heart perfusion, when eyeball from ruddy become pale after, win band
There is the eyeball of optic nerve, be fixed on 4 DEG C of 4%PFA48-72h.Eyeball, flowing water is taken out from 4%PFA
Rinse 10min gently, put in the culture dish filling PBS；Cut from corpus ciliare rear portion along pot tip edge annular
Open sclera, remove cornea and crystalline lens, by rear eyecup to be cut into 3 pieces depending on Fructus Citri tangerinae lobe sample centered by nipple, little
The heart isolates retina；PBS (0.01mol/L pH7.4) rinses l0min, is placed in 0.15mol/L pH7.4
Soaked overnight in glycine buffer；3% trypsin matching while using) 37 DEG C of air bath agitators disappear
Change retina 2-4h, observe at any time, treat that internal limiting membrane edge floats, will separate with retina remainder
Time, terminate digestion；Transfer retina in 0.1MPBS, is inhaled blowing gently and is removed internal limiting membrane, more repeatedly
Featheriness, suction are beaten, and are only left the vasoganglion of layer of transparent, and drift takes and is laid in anticreep and carry on the sheet of slope, puts room
After temperature natural drying, deposit in 4 DEG C of section boxes in case PAS dyes, neutral gum sealing, standby.
2, experimental result
2.1 each process group impacts hemorheological on diabetes rat
2.1.1 compare with blank group, the erythrocyte aggregation index of model group rats, whole blood viscosity (height cuts,
In cut, undercut), plasma viscosity level all dramatically increase (P < 0.01), illustrate modeling success.
2.1.2 comparing with model group, the erythrocyte of embodiment 1,2,3,4,5 groups and comparative example group gathers
Aggregate index number, whole blood viscosity (in cut, undercut), plasma viscosity level are all notable or pole significantly reduces (P < 0.05
Or P < 0.01), wherein the decline of every Testing index of embodiment 1,4,5 groups is more notable, declines journey
Degree is all higher than comparative example group.Embodiment 1 group compares with comparative example group, has pole significant difference (P < 0.01)；
Embodiment 4,5 groups compares with comparative example group, has significant difference (P < 0.05).Each group of effect size
It is ordered as: 5 groups of ＞ embodiments of 1 group of ＞ embodiment of embodiment, 3 groups of ＞ embodiments of 4 groups of ＞ embodiments 2 groups
＞ comparative example group.
Embodiment 1-5 is identical with the crude drug prescription of comparative example, and difference is preparation method, and
The difference of the extract caused by different preparation methoies.The extraction that preparation method of the present invention prepares
Thing effect in terms of improving diabetes rat hemorheology is better than water decoction prepared by prior art.Cause
This, preparation method of the present invention is to improve the reason place of curative effect of medication.The improvement of preparation method just,
Just drug action is significantly improved.Particularly, the therapeutic effect of the extract of embodiment 1 preparation is obvious
It is better than other each embodiment group.Therefore, the preparation method of embodiment 1 is that the present invention is most preferred, secondly
It is embodiment 5 and the preparation method of embodiment 4.
Table 2 impact hemorheological on diabetes rat
Note: "**" represent compared with blank group, p < 0.01；“#" represent compared with model group, p < 0.05, "##" represent and mould
Type group is compared, p < 0.01；“▲" represent compared with comparative example group, p < 0.05, "▲▲" represent compared with comparative example group, p < 0.01.
2.2 each process group impacts morphologic on rat retina blood capillary
Analyze through inner nuclear layer retina diagosis, each process group rat retina blood capillary morphological observations
As follows:
Blank group: the retinal capillary of rat is distributed rule, moves towards soft, caliber even thickness；
Retina arteriovenous is through wherein, and tremulous pulse dyeing is relatively deep, and vein dyeing is shallower；Endotheliocyte is positioned at hair
The central authorities of thin blood vessel, core is relatively big, dyes shallower；Pericyte is positioned at outside the tube chamber of blood capillary, and core is relatively
Little, dye deeper.
Model group: the arrangement of rat retina blood capillary is abnormal disorderly, moves towards the most irregular；Partly hair
Carefully vessel lumen thickness, or sections is expanded or is degenerated, and expands in capsule sample, or vascular deterioration, tube chamber
Locking, forms acellular capillary, occurs without perfusion area；The blood vessel sclerotic conditions that dries up is obvious；View
Film venectasia phenomenon is obvious；Pericyte's number reduces simultaneously.But have no capillary hemangioma.
Comparing with model group, it is obvious that the retinal capillary of the rat of comparative example group moves towards irregular phenomenon
Reducing, pericyte's increased number, acellular capillary number reduces.
Compare with model group, the retinal capillary trend of the rat of 2,3 groups of comparative example groups of embodiment
Irregular phenomenon significantly reduces, pericyte's increased number, and acellular capillary number reduces.Embodiment
1, the retinal capillary of 4,5 groups of rats moves towards normal, and pericyte's increased number is acellular
Blood capillary number reduces, and the quantity of minimizing is superior to comparative example group.
Therefore, the Chinese medicine extract that preparation method of the present invention prepares is to diabetic retinal tissue in rat
Microangiopathies has improvement result, and is better than decoct prepared by prior art.The improvement of preparation method is described
Significantly improve the pharmacological action of compound.
In a word, the Pharmaceutical Data of test example 1 proves, embodiment prepared by the method for the invention 1,2,
3, in the Chinese medicine extract of 4,5, the content of effective substance becomes accordingly higher than the water decoction of existing preparation technology
Point.From the point of view of determining the pharmacodynamic substances basis that medicine effect is strong and weak, the present invention is according to each medical material
Feature designs and passes through the extraction process optimized and is better than the preparation technology of water decoction.
Additionally, the effect experiment result of test example 2 also demonstrates that, embodiment prepared by the method for the invention
1, the Chinese medicine extract of 2,3,4,5 is to diabetes rat hemorheology and retinal capillary shape
The improvement result of state is superior to water decoction group prepared by prior art, and preparation method of the present invention is described
The extract prepared has the effect improving diabetic retinal tissue in rat microangiopathies, and is better than existing
Water decoction prepared by technology, the technology of preparing of the present invention significantly improves the pharmacological action of compound.
Embodiment 6A kind of Chinese medicine granules
Crude drug prescription:
Radix Astragali 6kg, Fructus Ligustri Lucidi 3kg, Herba Leonuri 3kg, Fructus Mume 1.8kg, Rhizoma Coptidis 1.2kg, Cortex Cinnamomi
0.2kg, Flos Buddlejae 1.2kg
According to preparation method step (1)-(5) described in embodiment 1 prepare volatile oil clathrate compound,
Extract extractum 1,2,3；United extraction extractum 1,2,3, is always extracted extractum, with dextrin 1.58kg,
Aspartame 30g, the method using spray granulation, make granule, add the volatilization that step (2) obtains
Oil clathrate, obtains granule 6kg, pack, every bag of 5g, altogether system 1200 bags.
Specific description of embodiments of the present invention above is not limiting as the present invention, and those skilled in the art can
To make various change or deformation according to the present invention, without departing from the spirit of the present invention, all should be belonged to this
Invention scope of the following claims.
Claims (31)
1. a preparation method for Chinese medicine extract, the crude drug of described Chinese medicine extract consists of:
Radix Astragali 30-60 weight portion, Fructus Ligustri Lucidi 9-15 weight portion, Herba Leonuri 9-30 weight portion, Fructus Mume 3-10
Weight portion, Rhizoma Coptidis 2-9 weight portion, Cortex Cinnamomi 1-5 weight portion, Flos Buddlejae 3-9 weight portion；
It is characterized in that, described preparation method comprises the steps:
(1) each crude drug is prepared according to described weight portion；
(2) Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 6-16 times of medical material weight,
Extraction time is 3-7 hour, and the another device of aqueous solution after distillation is collected, and Cortex Cinnamomi medicinal residues are standby, and volatile oil is used
Beta-cyclodextrin inclusion compound, obtains volatile oil clathrate compound；
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae concentration of volume percent are the ethanol solution of 10%-100%
I extracts, and ethanol extract reclaims ethanol, and measuring relative density when being concentrated into 80 DEG C is the leaching of 1.20-1.30
Cream, must extract extractum 1；
The Radix Astragali that (4) the Cortex Cinnamomi medicinal residues that Fructus Mume and step (1) obtain, and step (2) obtain,
Fructus Ligustri Lucidi and Flos Buddlejae medicinal residues, with water extraction, after aqueous extract adds the distillation that step (2) obtains
Aqueous solution, measuring relative density when being concentrated into 80 DEG C is the extractum of 1.20-1.30, must extract extractum 2；
(5) Herba Leonuri, Rhizoma Coptidis concentration of volume percent are that the ethanol solution II of 10%-100% extracts,
Ethanol extract reclaims ethanol, and measuring relative density when being concentrated into 80 DEG C is the extractum of 1.20-1.30,
Extract extractum 3；
(6) extractum 1,2,3 will be extracted to merge, drying, drying under reduced pressure or spray drying, and obtain and always carry
Take extract powder, add the described volatile oil clathrate compound that step (2) obtains, mix homogeneously, to obtain final product.
Preparation method the most according to claim 1, it is characterised in that in described step (2),
Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 8 times of medical material weight, extraction time 5
Hour.
Preparation method the most according to claim 1, it is characterised in that in described step (2),
Anhydrous alcohol solution first used by volatile oil, then carries out inclusion with beta-schardinger dextrin-aqueous solution.
Preparation method the most according to claim 3, it is characterised in that in described step (2),
The volume of described dehydrated alcohol is 1-3 times of volatile oil volume.
Preparation method the most according to claim 4, it is characterised in that in described step (2),
The volume of described dehydrated alcohol is 2 times of volatile oil volume.
Preparation method the most according to claim 1, it is characterised in that in described step (2),
The weight of beta-schardinger dextrin-is 6-20 times of volatile oil volume.
Preparation method the most according to claim 6, it is characterised in that in described step (2),
The weight of beta-schardinger dextrin-is 10 times of volatile oil volume.
Preparation method the most according to claim 3, it is characterised in that in described step (2),
Described beta-schardinger dextrin-aqueous solution, water weight is 15-40 times of beta-schardinger dextrin-weight.
Preparation method the most according to claim 8, it is characterised in that in described step (2),
Described beta-schardinger dextrin-aqueous solution, water weight is 25 times of beta-schardinger dextrin-weight.
Preparation method the most according to claim 1, it is characterised in that described step (2)
Technical scheme is:
Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 6-16 times of Cortex Cinnamomi weight, carries
The time of taking is 3-7 hour；The another device of aqueous solution after distillation is collected, and Cortex Cinnamomi medicinal residues are standby；Volatile oil adds 1-3
The anhydrous alcohol solution of times volume, obtains volatile oil ethanol；Weighing weight is volatile oil volume 6-20
Beta-schardinger dextrin-again, adds the water of beta-schardinger dextrin-weight 15-40 times, mix homogeneously, obtains beta-schardinger dextrin-
Aqueous solution；Under rotating speed 150 revs/min, slowly add volatile oil second to described beta-schardinger dextrin-aqueous solution
Alcohol liquid, after addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Lower oven drying at low temperature, obtains the volatile oil clathrate compound of white loose.
11. preparation methoies according to claim 1, it is characterised in that described step (2)
Technical scheme is:
Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 6-16 times of Cortex Cinnamomi weight, carries
The time of taking is 3-7 hour；The another device of aqueous solution after distillation is collected, and Cortex Cinnamomi medicinal residues are standby；Volatile oil adds 2
The anhydrous alcohol solution of times volume, obtains volatile oil ethanol；Weighing weight is volatile oil volume 10 times
Beta-schardinger dextrin-, add beta-schardinger dextrin-weight 25 times water, mix homogeneously, obtain beta-schardinger dextrin-water-soluble
Liquid；Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution,
After addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Oven drying at low temperature, obtains the volatile oil clathrate compound of white loose.
12. preparation methoies according to claim 1, it is characterised in that in described step (3),
The concentration of volume percent of ethanol solution I is 30%-80%.
13. preparation methoies according to claim 12, it is characterised in that in described step (3),
The concentration of volume percent of ethanol solution I is 70%.
14. preparation methoies according to claim 1, it is characterised in that in described step (3),
The volume of ethanol solution I be the described Radix Astragali, Fructus Ligustri Lucidi, 6-14 times of Flos Buddlejae medical material gross weight.
15. preparation methoies according to claim 14, it is characterised in that in described step (3),
The volume of ethanol solution I be the described Radix Astragali, Fructus Ligustri Lucidi, 10 times of Flos Buddlejae medical material gross weight.
16. preparation methoies according to claim 1, it is characterised in that in described step (3),
Extract 2-3 time, each 0.5-2 hour.
17. preparation methoies according to claim 16, it is characterised in that in described step (3),
Extract 2 times, each 1.5 hours.
18. preparation methoies according to claim 1, it is characterised in that in described step (4),
The weight of water is 6-16 times of medical material weight.
19. preparation methoies according to claim 18, it is characterised in that in described step (4)
The weight of water is 8 times of medical material weight.
20. preparation methoies according to claim 1, it is characterised in that in described step (4),
Water extraction 1-3 time, each 1-3 hour.
21. preparation methoies according to claim 20, it is characterised in that in described step (4),
Water extraction 2 times, each 2 hours.
22. preparation methoies according to claim 1, it is characterised in that in described step (5),
The concentration of volume percent of ethanol solution II is 30%-80%.
23. preparation methoies according to claim 22, it is characterised in that in described step (5),
The concentration of volume percent of ethanol solution II is 60%.
24. preparation methoies according to claim 1, it is characterised in that in described step (5),
The volume of ethanol solution II is 6-14 times of medical material weight.
25. preparation methoies according to claim 24, it is characterised in that in described step (5),
The volume of ethanol solution II is 10 times of medical material weight.
26. preparation methoies according to claim 1, it is characterised in that in described step (5),
Extract 2-3 time, each 0.5-2 hour.
27. preparation methoies according to claim 26, it is characterised in that in described step (5),
Extract 3 times, each 1.5 hours.
28. preparation methoies according to claim 1, it is characterised in that the tool of described preparation method
Body operating procedure is as follows:
(1) crude drug is prepared according to described weight portion；
(2) Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 6-16 times of Cortex Cinnamomi weight,
Extraction time is 3-7 hour；The another device of aqueous solution after distillation is collected, and Cortex Cinnamomi medicinal residues are standby；Volatile oil adds
The anhydrous alcohol solution of 1-3 times of volume, obtains volatile oil ethanol；Weighing weight is volatile oil volume 6-20
Beta-schardinger dextrin-again, adds the water of beta-schardinger dextrin-weight 15-40 times, mix homogeneously, obtains beta-schardinger dextrin-
Aqueous solution；Under rotating speed 150 revs/min, slowly add volatile oil second to described beta-schardinger dextrin-aqueous solution
Alcohol liquid, after addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Lower oven drying at low temperature, obtains the volatile oil clathrate compound of white loose；
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae volume are the concentration expressed in percentage by volume of medical material weight 6-14 times
For ethanol solution I heating and refluxing extraction 2-3 time of 30%-80%, each 0.5-2 hour, filter, close
And each ethanol extract, reclaim ethanol, measuring relative density when being evaporated to 80 DEG C is 1.20-1.30
Extractum, extractum 1 must be extracted；
The Radix Astragali that (4) the Cortex Cinnamomi medicinal residues that Fructus Mume and step (1) obtain, and step (2) obtain,
Fructus Ligustri Lucidi and Flos Buddlejae medicinal residues, by the water heating and refluxing extraction that volume is medical material weight 6-16 times 1-3 time,
1-3 hour every time, filtering, merge each filtrate, add after the distillation that step (2) obtains is water-soluble
Liquid, stands, and filters, and measuring relative density when filtrate is concentrated into 80 DEG C is the extractum of 1.20-1.30,
Extract extractum 2；
(5) Herba Leonuri, Rhizoma Coptidis volume be the concentration expressed in percentage by volume of medical material weight 6-14 times be 30%-80%
Ethanol solution II extract 2-3 time, each 0.5-2 hour, filtration, merge each ethanol extract,
Reclaiming ethanol, measuring relative density when being evaporated to 80 DEG C is the extractum of 1.20-1.30, must extract leaching
Cream 3；
(6) extractum 1,2,3 will be extracted to merge, and be spray-dried, obtain dry extract, add step (2)
The described volatile oil clathrate compound obtained, mix homogeneously, to obtain final product.
29. preparation methoies according to claim 1, it is characterised in that the tool of described preparation method
Body operating procedure is as follows:
(1) crude drug is prepared according to described weight portion；
(2) Cortex Cinnamomi extraction by steam distillation volatile oil, the weight of water is 10 times of Cortex Cinnamomi weight,
Extraction time is 5 hours；The another device of aqueous solution after distillation is collected, and Cortex Cinnamomi medicinal residues are standby；Volatile oil adds 2
The anhydrous alcohol solution of times volume, obtains volatile oil ethanol；Weighing weight is volatile oil volume 10 times
Beta-schardinger dextrin-, add beta-schardinger dextrin-weight 25 times water, mix homogeneously, obtain beta-schardinger dextrin-water-soluble
Liquid；Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution,
After addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing at 45 DEG C
Oven drying at low temperature, obtains the volatile oil clathrate compound of white loose；
(3) Radix Astragali, Fructus Ligustri Lucidi, Flos Buddlejae volume are that the concentration expressed in percentage by volume of medical material weight 10 times is
The ethanol solution I heating and refluxing extraction of 70% 2 times, each 1.5 hours, filters, merges twice ethanol
Extracting solution, reclaims ethanol, and measuring relative density when being evaporated to 80 DEG C is the extractum of 1.20-1.30,
Extractum 1 must be extracted；
The Radix Astragali that (4) the Cortex Cinnamomi medicinal residues that Fructus Mume and step (1) obtain, and step (2) obtain,
Fructus Ligustri Lucidi and Flos Buddlejae medicinal residues, by the water heating and refluxing extraction that volume is medical material weight 8 times 2 times, every time
2 hours, filter, merge twice filtrate, add the aqueous solution after the distillation that step (2) obtains, stand,
Filtering, measuring relative density when filtrate is concentrated into 80 DEG C is the extractum of 1.20-1.30, must extract extractum 2；
(5) Herba Leonuri, Rhizoma Coptidis volume are the second that concentration expressed in percentage by volume is 60% of medical material weight 10 times
Alcoholic solution II extracts 3 times, each 1.5 hours, filters, merges three ethanol extracts, reclaims ethanol,
Measuring relative density when being evaporated to 80 DEG C is the extractum of 1.20-1.30, must extract extractum 3；
(6) extractum 1,2,3 will be extracted to merge, and be spray-dried, obtain dry extract, add step (2)
The described volatile oil clathrate compound obtained, mix homogeneously, to obtain final product.
30. according to the preparation method according to any one of claim 1 to 29, it is characterised in that institute
State crude drug to consist of:
Radix Astragali 30g, Fructus Ligustri Lucidi 15g, Herba Leonuri 15g, Fructus Mume 9g, Rhizoma Coptidis 6g, Cortex Cinnamomi 1g, close illiteracy
Flower 6g.
The Chinese medicine extract that the arbitrary described preparation method of 31. claims 1 to 30 prepares.
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Address after: 100101 No. 232 water source road, Miyun Economic Development Zone, Beijing, China Co-patentee after: Beijing Red Sun Pharmaceutical Co., Ltd. Patentee after: Beijing Handian Pharmaceutical Co., Ltd. Address before: 100101 Miyun Economic Development Zone, water source road, No. 232, Beijing Co-patentee before: Beijing Red Sun Pharmaceutical Co., Ltd. Patentee before: Beijing Handian Pharmaceutical Co., Ltd. |