CN104173504B - A kind of Chinese medicine capsules treating diabetic retinopathy and application thereof - Google Patents
A kind of Chinese medicine capsules treating diabetic retinopathy and application thereof Download PDFInfo
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- CN104173504B CN104173504B CN201410360100.5A CN201410360100A CN104173504B CN 104173504 B CN104173504 B CN 104173504B CN 201410360100 A CN201410360100 A CN 201410360100A CN 104173504 B CN104173504 B CN 104173504B
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Abstract
The present invention provides a kind of Chinese medicine capsules and application thereof.The crude drug of described Chinese medicine consists 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；The preparation method of described capsule includes: Cortex Cinnamomi extracts volatile oil, volatile oil beta cyclodextrin inclusion；Cortex Cinnamomi medicinal residues and remaining ingredients concentration of volume percent be 30% 80% ethanol solution extract；Extraction extractum, again through Macroporous Adsorption Resin, is dried, and obtains dry extract, adds volatile oil clathrate compound, mix homogeneously, adds pharmaceutically acceptable adjuvant, encapsulated dose, to obtain final product.Compared with the prior art, the activity substance content of capsule of the present invention significantly improves, and pharmacological action is with significantly.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of Chinese medicine glue for diabetic retinopathy
Wafer and application thereof.
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, makes herb resource waste serious, but drug action is the most notable；Simultaneously
Water decoction brings dose big, and mouthfeel is poor, it has not been convenient to carry, the problem of unsuitable long term storage.
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 single
While dose, significantly improve drug effect, provide for patient and preferably treat diabetic retinopathy
Medicine.
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 Chinese medicine capsules become.Compare with the water decoction of prior art, Chinese medicine capsules unit of the present invention
The content of the active substance of preparation is higher, drug effect is more notable.
In order to realize foregoing invention purpose, present invention employs following technical scheme:
A kind of Chinese medicine capsules, the crude drug of described Chinese medicine capsules 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 prepared via a method which:
(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) the Cortex Cinnamomi medicinal residues that step (2) obtains merge with remaining ingredients, dense by percent by volume
The ethanol solution I that degree is 30%-80% extracts, and ethanol extract reclaims ethanol extremely without alcohol taste, continues to concentrate
It is the extractum of 1.10-1.20 to measuring relative density when 80 DEG C, obtains extraction extractum；
(4) macroporous adsorbent resin on the extractum that step (3) obtains, washes with water, discards water lotion,
Again with the ethanol solution II eluting that concentration of volume percent is 30%-100%, collect ethanol elution part,
Reclaim ethanol, concentrate, be dried, obtain extract powder；
(5) combining step (4) obtains extract powder and the volatile oil clathrate compound that step (2) obtains,
Add pharmaceutically acceptable adjuvant, mix homogeneously, fill capsule；Or the leaching that step (4) obtains
Cream powder, adds pharmaceutically acceptable adjuvant, mixes, pelletizes, is dried, granulate, adds lubricant
The Benexate Hydrochloride obtained with step (2), mix homogeneously, encapsulated, obtain described Chinese medicine glue
Wafer.
The unit prescription composition of above-mentioned raw materials medicine 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.
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 45
Oven drying at low temperature at DEG C, 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 40%-70%,
More preferably 60%.
It is also preferred that in described step (3), the volume of ethanol solution I is described medical material gross weight
6-14 times；It is furthermore preferred that 10 times that the volume of ethanol solution I is described 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), described macroporous adsorbent resin is selected from nonpolar or low pole is big
One in macroporous adsorbent resin；The more preferably one in AB-8, D101, HP-20 and HPD400.
It is also preferred that in described step (4), the consumption of water is 4-8 times of column volume；It is furthermore preferred that
The consumption of water is 5 times of column volume.
It is also preferred that in described step (4), the concentration of volume percent of described ethanol solution II is
40%-80%；More preferably 70%.
It is also preferred that in described step (4), the 3-8 that consumption is column volume of described ethanol solution II
Times；More preferably 5 times of column volume.
Preferably, in described step (5), drying means is selected from drying, being spray-dried or drying under reduced pressure；
More preferably drying under reduced pressure.
As a preferred embodiment of the present invention, described Chinese medicine capsules is prepared via a method which:
(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 45
Oven drying at low temperature at DEG C, obtains the volatile oil clathrate compound of white loose；
(3) the Cortex Cinnamomi medicinal residues that step (2) obtains merge with remaining ingredients, are medical material weight with volume
Measure the ethanol solution I heating and refluxing extraction that concentration expressed in percentage by volume is 30%-80% 2-3 time of 6-14 times, often
Secondary 0.5-2 hour, filter, merge each ethanol extract, reclaim ethanol to without alcohol taste, addition step
(2) aqueous solution after the distillation obtained, measuring relative density when continuing to be evaporated to 80 DEG C is
1.10-1.20 extractum, obtain extraction extractum；
(4) nonpolar or low pole macroporous adsorbent resin on the extractum that step (3) obtains, with 4-8 times
The water elution of column volume, discards water lotion, then by concentration expressed in percentage by volume 40%-80% of 3-8 times of column volume
Ethanol solution II eluting, collect ethanol elution part, reclaim ethanol, concentrating under reduced pressure, be dried, obtain leaching
Cream powder；
(5) combining step (4) obtains extract powder and the volatile oil clathrate compound that step (2) obtains,
Add pharmaceutically acceptable adjuvant, mix homogeneously, fill capsule；Or the leaching that step (4) obtains
Cream powder, adds pharmaceutically acceptable adjuvant, mixes, pelletizes, is dried, granulate, adds lubricant
The Benexate Hydrochloride obtained with step (2), mix homogeneously, encapsulated, obtain described Chinese medicine glue
Wafer.
As a preferred embodiment of the present invention, described Chinese medicine capsules is made by the following method
Standby:
(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) the Cortex Cinnamomi medicinal residues that step (2) obtains merge with remaining ingredients, are medical material weight with volume
Measure the ethanol solution heating and refluxing extraction that concentration expressed in percentage by volume is 60% 2 times of 10 times, each 1.5 little
Time, filter, merge twice ethanol extract, reclaim ethanol extremely without alcohol taste, add step (2) and obtain
Distillation after aqueous solution, when continuing to be evaporated to 80 DEG C measure relative density be the leaching of 1.10-1.20
Cream, obtains extraction extractum；
(4) macroporous adsorbent resin on the extractum that step (3) obtains, with the water elution of 5 times of column volumes,
Discard water lotion, then the ethanol solution eluting by the concentration expressed in percentage by volume 70% of 5 times of column volumes, collect second
Alcohol elution fraction, reclaims ethanol, concentrating under reduced pressure, is dried, obtains extract powder；
(5) combining step (4) obtains extract powder and the volatile oil clathrate compound that step (2) obtains,
Add pharmaceutically acceptable adjuvant, mix homogeneously, fill capsule；Or the leaching that step (4) obtains
Cream powder, adds pharmaceutically acceptable adjuvant, mixes, pelletizes, is dried, granulate, adds lubricant
The beta cyclodextrin clathrate obtained with step (2), mix homogeneously, fill capsule, obtain described Chinese medicine
Capsule.
Pharmaceutically acceptable adjuvant of the present invention selected from starch, dextrin, pregelatinized Starch, lactose,
Microcrystalline Cellulose, calcium sulfate, calcium hydrogen phosphate, calcium carbonate, magnesium oxide, magnesium carbonate, gel aluminum hydroxide,
Beta-schardinger dextrin-, mannitol, sorbitol, methylcellulose, hydroxypropyl methyl cellulose, polyethylene pyrrole
Pyrrolidone, Carboxymethyl cellulose sodium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, the poly-second of crosslinking
One or more in alkene pyrrolidone, Polyethylene Glycol, sodium lauryl sulphate.
Lubricant of the present invention is selected from Stepanol MG, micropowder silica gel, magnesium stearate, poly-second two
One or more in alcohol, Pulvis Talci.
It is a further object of the invention to provide above-mentioned Chinese medicine capsules at preparation treatment diabetes view
Application in the medicine of film pathological changes.
The Advantageous Effects of the present invention is: (1) present invention is extracting and refined aspect, takes into full account
The active component of each herbal medicine in prescription, and introduce the macroporous adsorbent resin separation means of advanced person in prescription
Effective ingredient refines.In prescription of the present invention the Radix Astragali, Fructus Ligustri Lucidi, Fructus Mume, Flos Buddlejae mainly containing saponin,
The main composition Han alkaloids in flavones ingredient, Rhizoma Coptidis and Herba Leonuri, employing Flavonoids by Macroporous Adsorption Resin can
To refine saponin, flavone, alkaloids composition simultaneously, operating procedure is simple so that main
Effective ingredient is wanted to be enriched with.(2) former preparation process (soak by water), patient's oral dose is big, single
175ml taken by secondary need.And crude drug of the present invention is the big compound recipe of Chinese medicine, unit prescription total amount is 82g,
Even if using conventional water to put forward-ol to sink or alcohol extraction-water precipitating method, paste volume is the biggest (left up to 20g
Right).Calculating with every capsule dress 0.4g, be added without adjuvant, daily measuring also will be more than 50.This
Bright described preparation method, the extract after refining, add adjuvant, daily amount generally 12 is (about
0.4g/ grain).Therefore, Chinese medicine capsules of the present invention both ensure that the effective dose of active ingredient, drops again
Low oral dose, improves the compliance of the diabetics needing Long-term taking medicine.(3) Cortex Cinnamomi is extracted and waves
Hair oil, and use beta-schardinger dextrin-technology to carry out inclusion, remain the content of volatile oil to greatest extent, protect
(having document to report, Cortex Cinnamomi volatile oil has certain reduction blood glucose effect, and presents to have deposited its effective substance
Dose dependent), thus ensure that giving full play to of its drug effect；Traditional water decoction is boiled then almost without appointing
What retains volatile oil.(4) capsule of the present invention, it is simple to store, carry and take.(5) this
Bright described capsule can cover the bad smell of medicine.(6) capsule steady quality of the present invention, is subject to
Light, air, moisture impact less.
Pharmacodynamic experiment (test example 2) is from improving diabetes rat hemorheology, retina blood capillary
Pipe morphology aspect proves, the capsule 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).Illustrate that capsule of the present invention is with former
Preparation (water decoction) compares, and has more preferable curative effect.
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, capsule of the present invention and the water of prior art
Decoct comparison in 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 1A kind of Chinese medicine capsules
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-water that the water of beta-schardinger dextrin-weight 25 times is made
Solution；Under rotating speed 150 revs/min, slowly add volatile oil ethanol to described beta-schardinger dextrin-aqueous solution
Liquid, after addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing 45
Oven drying at low temperature at DEG C, obtains the volatile oil clathrate compound of white loose.
(3) the Cortex Cinnamomi medicinal residues that step (2) obtains and remaining every medical material add volume is medical material weight 10
The ethanol solution reflux, extract, that concentration expressed in percentage by volume is 60% again 2 times, each 1.5 hours, filters,
Merge twice ethanol extract, reclaim ethanol extremely without alcohol taste, after adding the distillation that step (2) obtains
Aqueous solution, continuing to be evaporated to measure relative density when 80 DEG C is the extractum of 1.10-1.20, obtains extraction
Extractum.
(4) AB-8 macroporous resin on the extraction extractum that step (3) obtains, with the water of 5 times of column volumes
Eluting, discards water lotion, then with the ethanol solution eluting that concentration expressed in percentage by volume is 70% of 5 times of column volumes,
Collect ethanol elution part, reclaim ethanol, drying under reduced pressure, obtain extract powder.
(5) volatile oil clathrate compound that the extract powder that step (4) obtains obtains with step (2) merges,
Obtain total extract, add micropowder silica gel 2.5g, mix homogeneously, encapsulated, 0.32g/ capsule, there are
To capsule 0.78kg.
Consumption usage: oral, one time 4,3 times on the one；One after each meal or follow the doctor's advice.
Embodiment 2A kind of Chinese medicine capsules
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) take Cortex Cinnamomi, add the water of medical material weight 8 times, use extraction by steam distillation volatile oil, steam
The another device of aqueous solution after evaporating is collected, and medicinal residues are standby；Volatile oil adds 1 times of volume anhydrous alcohol solution, takes weight
The beta-schardinger dextrin-of 6 times of volatile oil volumes of amount, adds β-ring paste that the water of beta-schardinger dextrin-weight 15 times is made
Essence aqueous solution；Under rotating speed 150 revs/min, slowly add volatile oil to described beta-schardinger dextrin-aqueous solution
Ethanol, after addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing exists
Oven drying at low temperature at 45 DEG C, obtains the volatile oil clathrate compound of white loose.
(3) the Cortex Cinnamomi medicinal residues that step (2) obtains and remaining every medical material add volume is medical material weight 6 times
The ethanol solution reflux, extract, that concentration expressed in percentage by volume is 30% 2 times, each 0.5 hour, filter, close
And twice ethanol extract, reclaim ethanol to without alcohol taste, the water after the distillation that addition step (2) obtains
Solution, measuring relative density when continuing to be evaporated to 80 DEG C is the extractum of 1.10-1.20, must extract leaching
Cream.
(4) D101 macroporous resin on the extraction extractum that step (3) obtains, with the water of 4 times of column volumes
Eluting, discards water lotion, then with the ethanol solution eluting that concentration expressed in percentage by volume is 30% of 8 times of column volumes,
Collect ethanol elution part, reclaim ethanol, drying under reduced pressure, obtain extract powder.
(5) take the extract powder that step (4) obtains, add starch 140g, lactose 140g, calcium sulfate
25g, calcium hydrogen phosphate 25g, mix homogeneously, with 80% ethanol as binding agent, wet granulation, be dried,
Granulate, adds Benexate Hydrochloride and micropowder silica gel 2.5g that step 2 obtains, mix homogeneously, fills glue
Capsule, 0.42g/ grain, prepare capsule 1kg altogether.
Consumption usage: oral, one time 4,3 times on the one；One after each meal or follow the doctor's advice.
Embodiment 3A kind of Chinese medicine capsules
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) take Cortex Cinnamomi, add the water of medical material weight 12 times, use extraction by steam distillation volatile oil, steam
The another device of aqueous solution after evaporating is collected, and medicinal residues are standby；Volatile oil adds 3 times of volume anhydrous alcohol solutions, takes weight
The beta-schardinger dextrin-of 20 times of volatile oil volumes of amount, adds β-ring paste that the water of beta-schardinger dextrin-weight 40 times is made
Essence aqueous solution；Under rotating speed 150 revs/min, slowly add volatile oil to described beta-schardinger dextrin-aqueous solution
Ethanol, after addition, continue stirring 1.5 hours, cold preservation 12 hours, filter, by filter thing exists
Oven drying at low temperature at 45 DEG C, obtains the volatile oil clathrate compound of white loose.
(3) the Cortex Cinnamomi medicinal residues that step (2) obtains and remaining every medical material add volume is medical material weight 14
The ethanol solution reflux, extract, that concentration expressed in percentage by volume is 80% again 3 times, each 2 hours, filters, closes
And three ethanol extracts, reclaim ethanol to without alcohol taste, the water after the distillation that addition step (2) obtains
Solution, measuring relative density when continuing to be evaporated to 80 DEG C is the extractum of 1.10-1.20, must extract leaching
Cream.
(4) HP-20 macroporous resin on the extraction extractum that step (3) obtains, with the water of 8 times of column volumes
Eluting, discards water lotion, then washes with the ethanol solution that concentration expressed in percentage by volume is 100% of 3 times of column volumes
De-, collect ethanol elution part, reclaim ethanol, drying under reduced pressure, obtain extract powder.
(5) extract powder obtained in step (4), add microcrystalline Cellulose 220g, mannitol 30g,
-sorbitol 20g, low-substituted hydroxypropyl cellulose 20g, mix homogeneously, with 0.3% hydroxypropyl methyl fiber
Element 90% ethanol solution is binding agent, wet granulation, dry, granulate, the β that addition step 2 obtains-
Cyclodextrin clathrate and magnesium stearate 10g, mix homogeneously, encapsulated, 0.42g/ grain, there are capsule
1kg。
Consumption usage: oral, one time 4,3 times on the one；One after each meal or follow the doctor's advice.
Embodiment 4A kind of Chinese medicine capsules
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 concretely comprising the following steps of described preparation method "
(1) ingredients is prepared according to prescription.
(2) take Cortex Cinnamomi, add the water of medical material weight 8 times, use extraction by steam distillation volatile oil, distillation
After the another device of aqueous solution collect, medicinal residues are standby；Volatile oil adds the anhydrous alcohol solution of 2 times of volumes；Take weight
The beta-schardinger dextrin-of 20 times of volatile oil volumes of amount, adds β-ring that the water of beta-schardinger dextrin-weight 30 times is made
Dextrin in aqueous solution；Under rotating speed 150 revs/min, slowly add volatilization to described beta-schardinger dextrin-aqueous solution
Oil ethanol, after addition, continues stirring 1.5 hours, cold preservation 12 hours, filters, will filter to obtain thing
Oven drying at low temperature at 45 DEG C, obtains the volatile oil clathrate compound of white loose.
(3) the Cortex Cinnamomi medicinal residues that step (2) obtains and remaining every medical material add volume is medical material weight 14
The ethanol solution reflux, extract, that concentration expressed in percentage by volume is 40% again 2 times, each 1.5 hours, filters,
Merge twice ethanol extract filtrate, reclaim ethanol to without alcohol taste, the distillation that addition step (2) obtains
After aqueous solution, when continuing to be evaporated to 80 DEG C measure relative density be the extractum of 1.10-1.20,
Extract extractum.
(4) AB-8 macroporous resin on the extraction extractum that step (3) obtains, with the water of 5 times of column volumes
Eluting, discards water lotion, then with the ethanol solution eluting that concentration expressed in percentage by volume is 50% of 5 times of column volumes,
Collect ethanol elution part, reclaim ethanol, drying under reduced pressure, obtain extract powder.
(5) extract powder that step (4) obtains, adds lactose 100g, dextrin 150g, carboxymethyl shallow lake
Powder sodium 20g, mix homogeneously, with the aqueous solution containing 0.05% Carboxymethyl cellulose sodium as binding agent, spraying
Granulation, dry, granulate, add Benexate Hydrochloride and Pulvis Talci 4g that step 2 obtains, mixing
Uniformly, encapsulated, 0.42g/ grain, there are capsule 1kg.
Consumption usage: oral, one time 4,3 times on the one；One after each meal or follow the doctor's advice.
Comparative example 1A kind of Chinese herbs decoction
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 1Chinese medicine capsules of the present invention is compared with the prior art
Test sample:
1) the Chinese medicine capsules content that prepared by embodiment of the present invention 1-5
2) the Chinese herbs decoction dry extract that 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, the capsule that embodiment of the present invention 1-4 prepares, each composition of detection
Amount and extraction ratio be above the decoct of comparative example of same materials medicine prescription；Especially cinnamic aldehyde, right
The water decoction of ratio is not measured.
2) capsule of embodiment 1, amount and the extraction ratio of its astragaloside, linarin and berberine are bright
Aobvious higher than other embodiments, next to that the capsule of embodiment 4.
Conclusion (of pressure testing):
1), in capsule of the present invention, the content of active ingredient and extraction ratio are obviously higher than comparative example.
Therefore, capsule of the present invention has relatively reliable pharmacodynamic substances basis.
2) astragaloside, linarin and berberine are treatment diabetes and the having of diabetic retinopathy
Effect composition.In capsule described in embodiment 1 and 4, the content of above-mentioned three kinds of compositions is above embodiment
2 and 3.Therefore, the capsule described in embodiment 1 and 4 is currently preferred, the most real
Execute the capsule described in example 1.
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 capsules 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 capsule and decoct 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 (100).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 90%).The rat of diabetes standard will be met by blood glucose, body weight
Level is randomly divided into 6 groups again, model group, embodiment 1 group, embodiment 2 groups, embodiment 3 groups, reality
Execute example 4 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
(Capsule content that embodiment 1 prepares adds deionized water and makes embodiment 1 group
The solution of 0.083g/ml, dosage: 5ml/kg), (embodiment 2 prepares embodiment 2 groups
Capsule content, adds deionized water and makes the solution of 0.107g/ml, dosage: 5ml/kg), real
(Capsule content that embodiment 3 prepares adds deionized water and makes 0.107g/ml to execute example 3 groups
Solution, dosage: 5ml/kg), embodiment 4 groups is (in the capsule that embodiment 4 prepares
Tolerant, add deionized water and make the solution of 0.107g/ml, dosage: 5ml/kg), comparative example group (right
The dry extract that ratio prepares, adds deionized water and makes the solution of 0.222g/ml, dosage:
10ml/kg), model group and blank group give the deionized water of respective volume, gastric infusion, every day
It is administered once, is administered 3 months altogether.Give the drinking-water of abundance, food during administration, change bedding and padding every day.
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 aggregation of embodiment 1,2,3,4 groups and comparative example group refers to
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 1,2,3,4 groups is more notable, under
Fall degree is all higher than comparative example group.Embodiment 1 group compares with comparative example group, has pole significant difference
(P<0.01)；Embodiment 2,3,4 groups compares with comparative example group, has significant difference (P < 0.05).
Being ordered as of each group of effect size: 1 group of ＞ embodiment of embodiment, 3 groups of ＞ embodiments 2 of 4 groups of ＞ embodiments
Group ＞ comparative example group.
Embodiment 1-4 is identical with the crude drug prescription of comparative example, and difference is preparation method, and
The difference of the dosage form caused by different preparation methoies.The results show, capsule of the present invention is changing
Effect in terms of kind diabetes rat hemorheology is better than water decoction prepared by prior art.Particularly,
The therapeutic effect of capsule described in embodiment 1 is significantly stronger than other each embodiment group.Therefore, embodiment 1
It is that the present invention is most preferred, next to that embodiment 4, is embodiment 3 again, is embodiment 2 again.
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.
Comparing with model group, the retinal capillary trend of 1,2,3,4 groups of rats of embodiment is basic
Normally, pericyte's increased number, acellular capillary number reduces, and the quantity of minimizing is superior to contrast
Example group.
Therefore, diabetic retinal tissue in rat microangiopathies is had improvement to make by Chinese medicine capsules of the present invention
With, and it is better than decoct prepared by prior art.Illustrate that the improvement of dosage form significantly improves compound
Pharmacological action.
In a word, the Pharmaceutical Data of test example 1 proves, the Chinese medicine capsules Chinese medicine of embodiment of the present invention 1-4
The content of effective substance and extraction ratio are higher than the corresponding composition of water decoction of existing preparation technology.From determining that medicine is made
From the point of view of strong and weak pharmacodynamic substances basis, the present invention designs and through excellent according to the feature of each medical material
The extraction process changed is better than the preparation technology of water decoction.
Additionally, the effect experiment result of test example 2 also demonstrates that, the Chinese medicinal capsule of embodiment of the present invention 1-4-
Agent improvement result morphologic to diabetes rat hemorheology and retinal capillary is superior to existing
There is water decoction prepared by technology, illustrate that Capsule content of the present invention has and improve diabetes rat view
The effect of film microangiopathies, and it is better than water decoction prepared by prior art, the improvement of dosage form of the present invention is also
Significantly improve the pharmacological action of compound.
Embodiment 5A kind of Chinese medicine capsules
Crude drug prescription: Radix Astragali 12kg, Fructus Ligustri Lucidi 3kg, Herba Leonuri 2kg, Fructus Mume 2kg, Rhizoma Coptidis
1.8kg, Cortex Cinnamomi 1kg, Flos Buddlejae 2kg
Chinese medicine capsules 1.12kg is prepared according to preparation method step (1)-(5) described in embodiment 1,
Capsule weight: 0.4g/ grain.Difference is that the micropowder silica gel added in step (5) is 3.6g.
Consumption usage: oral, one time 4,3 times on the one；One after each meal or follow the doctor's advice.
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 (6)
1. treat a Chinese medicine capsules for diabetic retinopathy, the crude drug group of described Chinese medicine capsules
Become:
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 prepared via a method which:
(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, 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 times
The anhydrous alcohol solution of volume, obtains volatile oil ethanol；Weigh β that weight is volatile oil volume 6-20 times-
Cyclodextrin, 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 ethanol to described beta-schardinger dextrin-aqueous solution, added
Bi Hou, continues stirring 1.5 hours, cold preservation 12 hours, filters, will filter to obtain thing oven drying at low temperature at 45 DEG C,
Obtain the volatile oil clathrate compound of white loose；
(3) the Cortex Cinnamomi medicinal residues that step (2) obtains merge with remaining ingredients, are medical material weight with volume
The concentration expressed in percentage by volume of 6-14 times is ethanol solution I heating and refluxing extraction 2-3 time of 30%-80%, each 0.5-2
Hour, filter, merge each ethanol extract, reclaim ethanol extremely without alcohol taste, add what step (2) obtained
Aqueous solution after distillation, measuring relative density when continuing to be evaporated to 80 DEG C is the extractum of 1.10-1.20,
Extract extractum；
(4) nonpolar or low pole macroporous adsorbent resin on the extractum that step (3) obtains, with 4-8 times of cylinder
Long-pending water elution, discards water lotion, then the ethanol by concentration expressed in percentage by volume 40%-80% of 3-8 times of column volume
Solution II eluting, collects ethanol elution part, reclaims ethanol, concentrating under reduced pressure, is dried, obtains extract powder；
(5) combining step (4) obtains extract powder and the volatile oil clathrate compound that step (2) obtains, add
Pharmaceutically acceptable adjuvant, mix homogeneously, fill capsule；Or the extract powder that step (4) obtains, add
Enter pharmaceutically acceptable adjuvant, mix, pelletize, be dried, granulate, add lubricant and step (2)
The beta cyclodextrin clathrate obtained, mix homogeneously, encapsulated, obtain described Chinese medicine capsules.
Chinese medicine capsules the most according to claim 1, it is characterised in that at the unit of described crude drug
Side consists of:
Radix Astragali 30g, Fructus Ligustri Lucidi 15g, Herba Leonuri 15g, Fructus Mume 9g, Rhizoma Coptidis 6g, Cortex Cinnamomi 1g, Flos Buddlejae
6g。
Capsule the most according to claim 1, it is characterised in that in described step (4), described
Macroporous adsorbent resin one in AB-8, D101, HP-20 and HPD400.
Capsule the most according to claim 1, it is characterised in that described Chinese medicine capsules is by as follows
Prepared by method:
(1) crude drug is prepared according to described weight portion；
(2) Cortex Cinnamomi extraction by steam distillation volatile oil, the aqueous solution another device collection after distillation, Cortex Cinnamomi medicine
Slag is standby；Volatile oil adds the anhydrous alcohol solution of 2 times of volumes, obtains volatile oil ethanol；Weighing weight is
The beta-schardinger dextrin-that volatile oil volume is 10 times, 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 volatilization to described beta-schardinger dextrin-aqueous solution
Oil ethanol, 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) the Cortex Cinnamomi medicinal residues that step (2) obtains merge with remaining ingredients, are medical material weight with volume
The concentration expressed in percentage by volume of 10 times is the ethanol solution heating and refluxing extraction 2 times of 60%, each 1.5 hours, filter
Cross, merge twice ethanol extract, reclaim ethanol extremely without alcohol taste, after adding the distillation that step (2) obtains
Aqueous solution, continuing to be evaporated to measure relative density when 80 DEG C is the extractum of 1.10-1.20, obtains extraction extractum；
(4) in AB-8, D101, HP-20 and HPD400 it is selected from the extractum that step (3) obtains
Kind macroporous adsorbent resin, with the water elution of 5 times of column volumes, discard water lotion, then with 5 times of column volumes
The ethanol solution eluting of concentration expressed in percentage by volume 70%, collection ethanol elution part, recovery ethanol, concentrating under reduced pressure,
It is dried, obtains extract powder；
(5) combining step (4) obtains extract powder and the volatile oil clathrate compound that step (2) obtains, add
Pharmaceutically acceptable adjuvant, mix homogeneously, fill capsule；Or the extract powder that step (4) obtains, add
Enter pharmaceutically acceptable adjuvant, mix, pelletize, be dried, granulate, add lubricant and step (2)
The beta cyclodextrin clathrate obtained, mix homogeneously, encapsulated, obtain described Chinese medicine capsules.
5. the Chinese medicine capsules described in claim 1 or 4, it is characterised in that described pharmaceutically can accept
Adjuvant selected from starch, dextrin, pregelatinized Starch, lactose, microcrystalline Cellulose, calcium sulfate, calcium hydrogen phosphate,
Calcium carbonate, magnesium oxide, magnesium carbonate, gel aluminum hydroxide, beta-schardinger dextrin-, mannitol, sorbitol, methyl
Cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, Carboxymethyl cellulose sodium, carboxymethyl starch
Sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, Polyethylene Glycol, sodium lauryl sulphate
In one or more；
Described lubricant is selected from Stepanol MG, micropowder silica gel, magnesium stearate, Polyethylene Glycol, Talcum
One or more in powder.
6. the Chinese medicine capsules according to any one of claim 1 to 5 is at preparation treatment diabetic retinopathy
Application in the medicine become.
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| CN103182049A (en) * | 2011-12-29 | 2013-07-03 | 山东阿如拉药物研究开发有限公司 | Preparation method of pharmaceutical composition preparation treating apoplexy sequelae |
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| CN103182049A (en) * | 2011-12-29 | 2013-07-03 | 山东阿如拉药物研究开发有限公司 | Preparation method of pharmaceutical composition preparation treating apoplexy sequelae |
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| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CP02 | Change in the address of a patent holder | ||
| CP02 | Change in the address of a patent holder |
Address after: 105500 No. 232 water source road, Miyun Economic Development Zone, Beijing, China Patentee after: Beijing Handian Pharmaceutical Co., Ltd. Address before: 100101 Beijing city Chaoyang District Anxiang Lane No. 11 building B603-2 room Patentee before: Beijing Handian Pharmaceutical Co., Ltd. |
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| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20171128 Address after: 105500 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: 105500 No. 232 water source road, Miyun Economic Development Zone, Beijing, China Patentee before: Beijing Handian Pharmaceutical Co., Ltd. |