CN106668348A - Pharmaceutical composition for treating diabetic retinopathy - Google Patents
Pharmaceutical composition for treating diabetic retinopathy Download PDFInfo
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- CN106668348A CN106668348A CN201611133149.2A CN201611133149A CN106668348A CN 106668348 A CN106668348 A CN 106668348A CN 201611133149 A CN201611133149 A CN 201611133149A CN 106668348 A CN106668348 A CN 106668348A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/27—Asclepiadaceae (Milkweed family), e.g. hoya
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
Abstract
The invention discloses a pharmaceutical composition for treating diabetic retinopathy, and a preparation method thereof. The pharmaceutical composition is prepared by compounding the following bulk pharmaceutical chemicals: parthenocissus himalayana (royle) planch, prolactin, polygalic acid, hydroxyevodiamine and jujubaside B, can be prepared into various dosage forms according to a conventional preparation process, and has a significant curative effect on treating the diabetic retinopathy.
Description
Technical field
The invention belongs to technical field of Chinese medicines, more particularly to a kind of pharmaceutical composition for treating diabetic retinopathy and
Its preparation method.
Background technology
Diabetic retinopathy (diabetic retinopathy, DR) be the big diseases causing blindness of universally acknowledged four it
One, with retinal vascular occlusion circulatory disturbance as major pathologic features.At present doctor trained in Western medicine is removed more to taking routine observation simple type
Outside control blood glucose, special Therapeutic Method is there is no.
DR is one of common microvascular complication of diabetes, such as effectively treatment not in time, can cause blindness.Insulin
Though DR can be prevented to occur, to established DR without obvious effect.Blood glucose, the blood of actively control patient are needed in treatment
Pressure, blood fat situation, to avoiding increasing for clinical symptoms, prevent more complication to occur.If NO releases are reduced, ET increases
Plus, then can accelerate or promote the development of DR.Primary disease belongs to the categories such as Chinese medicine " blurring of vission " " vitreous opacity ".Because it is in sugar
Develop on the basis of urine disease, based on the theory of " many stasis of bloods of prolonged illness " " pathogen usually intruding into collateral in protracted disease ", because blood stasis are hindered in eyeball key, eyeball key loses supports,
And cause optical fundus hypoxic-ischemic and bleeding, and it is bleeding into vitreous body and into the blood stasis from Jing, vicious cycle is formed, therefore it is clinical
It was observed that mostly being recurrent exerbation the characteristics of primary disease retinal hemorrhage.
Three-jaw gold dragon:For Vitaceae Parthenocissuses plant parthenocissus himalayana Plancs Parthenocissus himalayana
(Royle)Planch. the Herb of [ Ampelopsis himalayana Royle ].Autumn, winter harvesting root and stem, cut after cleaning
Piece or cutting, dry.Summer, autumn picking leaves, dry.【Nature and flavor】It is pungent;Temperature.【Indication】Expelling wind and removing dampness;Dissipate blood stasis and smoothing collaterals.Main wind
Pain of dampness syndrome;Traumatic injury;Fracture.【Former phytomorph】Parthenocissus himalayana Plancs fallen leaves woody climber.Multi-branched, branch is sturdy, drabon
Color;Tendril is short and branch, and there is sucker on top.The lobule alternate of palmate 3;The long 5-12cm of common petiole, without hair or hairiness;Blade papery,
Middle lobule is avette or width drape over one's shoulders needle-like avette, long 6-12cm, wide 2-7cm, and tip is tapering or nearly shape of tail, and base portion wedge shape, side life is little
Leaf is asymmetric, tiltedly avette, and lobule is smaller compared with the middle of, and edge has substantially and the sawtooth with tip, above without hair, below or along vein
There is thin pubescence;The long 5-6mm of petiolule.Flower both sexes, cyme be often born in the top of brachyplast or with leaf opposite;Bennet is compared with petiole
It is short;Flower light green, 5 numbers 4 are counted sometimes;Calyx shallow disc shape, full edge;Petal Long Circle;Stamen and petal opposite;Floral disc is not obvious;
Style short cylindrical shape, tip often expands discoid after petal comes off.Berry is spherical, ripe time-varying pitchy, has white lead, seed 1-2
.Record in dictionary of medicinal plant.
Hetrostemma oblongifolium Cost.:This product is dicotyledon medicine asclepiadaceae Heterostemma alatum Witht. platymiscium Hetrostemma oblongifolium Cost. Hetrostemma
The Herb of oblongifolium Cost..Autumn harvests, and dries.【Nature and flavor】It is slight bitter, sweet;It is flat.【Return through】Liver Channel.【Function master
Control】Lactogenic.QI and blood stasis after main product;Agalactia.【Former phytomorph】Weak winding liana.Herb has milk, and stem is by 2 row
Pubescence.Leaf opposite;The long 2-4cm of petiole;Blade Long Circle, dilute ovate Long Circle, long 7.5-11cm, wide 3.5-4.5cm, tip is sharp
Point, basal circular;Per side 5-7 bars, arc rises lateral vein.Umbrella shape shape cyme axil is given birth to, and long 2-3cm is blossomed 4-5;Calyx 5
Drastic crack, inner face base portion has body of gland about 10;Corolla outside light green, inner face yellow, spoke shape, diameter 1-1.5cm;Corolla splits levies 5,
Cover to the right;Paracorolla five-pointed star aristiform, the every room 1 of massula, square circular, uprightly.Follicle radish fruit wire lanceolar, is up to
12cm, diameter about 1cm, it is tapering to tip.Seed is up to 2cm, wide about 3mm, white thin,tough silk matter kind hair of the seed tool up to 3cm.Flower
Month phase 8-10, the fruiting period 9-12 month.Record in dictionary of medicinal plant.
Hydroxyevodiamine(Hydroxyevodiamine):CAS 1238-43-3, molecular formula C19H17N3O2, molecular weight
319.36.【Ingredient origin】Fructus Evodiae Evodia rutaecarpa..
Spine Date Seed jujubosideB(Jujuboside B):CAS 55466-05-2, molecular formula C52H84O21, molecular weight
1045.21.【Biological activity】It is anti-sweet to hide agent (1mmol/L suppresses the sweet taste of 0.2M sucrose).【Ingredient origin】Fructus Jujubae
Ziziphus jujuba, Semen Ziziphi Spinosae Ziziphus jujuba var.spinosa.
Polygalacic acid(Polygalacic acid):CAS 22338-71-2, molecular formula C30H48O6, molecular weight 504.70.
【Ingredient origin】Radix Platycodoniss Platycodon grandiflorum.
3 crude drug chemical constitutions:
Spine Date Seed jujubosideB(Phytolaccasaponin B)
Hydroxyevodiamine(Hydroxyevodiamine)Polygalacic acid(Polygalacic acid).
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided a kind of medicine of effectively treatment diabetic retinopathy
Compositions and preparation method thereof.
The present invention adopts the following technical scheme that realization:
The composition and weight portion for making the crude drug of the pharmaceutical composition of the treatment diabetic retinopathy be:
Three-jaw gold dragon 4780-4790 weight portion Hetrostemma oblongifolium Cost. 2650-2670 weight portion Polygalacic acid 30-36 weight portion hydroxyl Wus
Fructus Evodiae alkali 22-26 weight portion Spine Date Seed jujubosideB 17-19 weight portions.
The pharmaceutical composition for the treatment of diabetic retinopathy is preferably used in, is by the crude drug group of following weight portion
Into:
The weight of 33 weight portion Hydroxyevodiamine of three-jaw gold 2660 weight portion Polygalacic acid of imperial 4785 weight portion Hetrostemma oblongifolium Cost. 24
Part weight portion of Spine Date Seed jujubosideB 18.
A kind of pharmaceutical composition for treating diabetic retinopathy, it is characterised in that pharmaceutical composition can adopt preparation
Conventional method prepares piece agent or capsule or drop pill.
A kind of pharmaceutical composition for treating diabetic retinopathy, it is characterised in that pharmaceutical composition and chemical drugs or in
The treatment diabetic retinopathy medicine of medicine composition.
A kind of preparation method of the pharmaceutical composition for treating diabetic retinopathy, it is characterised in that make as follows
It is standby:
The composition and weight portion of crude drug be:Three-jaw gold dragon 4780-4790 weight portion Hetrostemma oblongifolium Cost. 2650-2670 weight portions are remote
Will acid 30-36 weight portion Hydroxyevodiamine 22-26 weight portion Spine Date Seed jujubosideB 17-19 weight portions;
Preparation method:
(1)Three-jaw gold dragon, Hetrostemma oblongifolium Cost., Polygalacic acid, Hydroxyevodiamine, Spine Date Seed jujubosideB are taken by crude drug proportioning, is mixed, used
Used as solvent, 32 DEG C of warm macerating are extracted the ethanol of weight percent concentration 45%, and extraction time is 8 times, and each extraction time is 48 little
When, each solvent load is 39 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, dense
Relative density 1.05 is reduced to, is filtered, medicinal liquid is first washed with water by HP50 macroporous adsorptive resins, then dense with percentage by weight
17% ethanol solution eluting HP50 macroporous adsorptive resins are spent, the ethanol elution of weight percent concentration 17% is collected, ethanol is reclaimed,
Concentrate drying, obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 14 times, carries every time
The time is taken for 0.4 hour, each solvent load is 17 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned
Ethanol is received, relative density 1.16 is concentrated into, is filtered, medicinal liquid is first washed with water by LSD632 macroporous adsorptive resins, then with again
The amount ethanol solution eluting LSD632 macroporous adsorptive resins of percent concentration 86%, collect the ethanol elution of weight percent concentration 86%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Preferred a kind of preparation method of the pharmaceutical composition for treating diabetic retinopathy, it is characterised in that by as follows
It is prepared by step:
The composition and weight portion of crude drug be:The weight of 2660 weight portion Polygalacic acid of the three-jaw imperial 4785 weight portion Hetrostemma oblongifolium Cost. of gold 33
The weight portion of 24 weight portion Spine Date Seed jujubosideB of part Hydroxyevodiamine 18;
Preparation method:
(1)Three-jaw gold dragon, Hetrostemma oblongifolium Cost., Polygalacic acid, Hydroxyevodiamine, Spine Date Seed jujubosideB are taken by crude drug proportioning, is mixed, used
Used as solvent, 32 DEG C of warm macerating are extracted the ethanol of weight percent concentration 45%, and extraction time is 8 times, and each extraction time is 48 little
When, each solvent load is 39 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, dense
Relative density 1.05 is reduced to, is filtered, medicinal liquid is first washed with water by HP50 macroporous adsorptive resins, then dense with percentage by weight
17% ethanol solution eluting HP50 macroporous adsorptive resins are spent, the ethanol elution of weight percent concentration 17% is collected, ethanol is reclaimed,
Concentrate drying, obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 14 times, carries every time
The time is taken for 0.4 hour, each solvent load is 17 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned
Ethanol is received, relative density 1.16 is concentrated into, is filtered, medicinal liquid is first washed with water by LSD632 macroporous adsorptive resins, then with again
The amount ethanol solution eluting LSD632 macroporous adsorptive resins of percent concentration 86%, collect the ethanol elution of weight percent concentration 86%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
A kind of preparation method of the pharmaceutical composition for treating diabetic retinopathy, it is characterised in that pharmaceutical composition can
To prepare piece agent or capsule or drop pill using the conventional method of galenic pharmacy.
A kind of preparation method of the pharmaceutical composition for treating diabetic retinopathy, it is characterised in that pharmaceutical composition with
Chemical drugs or Chinese medicine composition treatment diabetic retinopathy medicine.
Medicine composite for curing diabetic retinopathy is evident in efficacy.
Specific embodiment
Embodiment 1:Pharmaceutical composition for the treatment of diabetic retinopathy and preparation method thereof
Treatment diabetic retinopathy pharmaceutical composition crude drug composition and weight portion be:Three-jaw gold dragon 4785g
Hetrostemma oblongifolium Cost. 2660g Polygalacic acid 33g Hydroxyevodiamine 24g Spine Date Seed jujubosideB 18g;
Preparation method:
(1)Three-jaw gold dragon, Hetrostemma oblongifolium Cost., Polygalacic acid, Hydroxyevodiamine, Spine Date Seed jujubosideB are taken by crude drug proportioning, is mixed, used
Used as solvent, 32 DEG C of warm macerating are extracted the ethanol of weight percent concentration 45%, and extraction time is 8 times, and each extraction time is 48 little
When, each solvent load is 39 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, dense
Relative density 1.05 is reduced to, is filtered, medicinal liquid is first washed with water by HP50 macroporous adsorptive resins, then dense with percentage by weight
17% ethanol solution eluting HP50 macroporous adsorptive resins are spent, the ethanol elution of weight percent concentration 17% is collected, ethanol is reclaimed,
Concentrate drying, obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 14 times, carries every time
The time is taken for 0.4 hour, each solvent load is 17 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned
Ethanol is received, relative density 1.16 is concentrated into, is filtered, medicinal liquid is first washed with water by LSD632 macroporous adsorptive resins, then with again
The amount ethanol solution eluting LSD632 macroporous adsorptive resins of percent concentration 86%, collect the ethanol elution of weight percent concentration 86%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2:Pharmaceutical composition for the treatment of diabetic retinopathy and preparation method thereof
Treatment diabetic retinopathy pharmaceutical composition crude drug composition and weight portion be:Three-jaw gold dragon 4780g
Hetrostemma oblongifolium Cost. 2670g Polygalacic acid 30g Hydroxyevodiamine 26g Spine Date Seed jujubosideB 17g;
Preparation method:
(1)Three-jaw gold dragon, Hetrostemma oblongifolium Cost., Polygalacic acid, Hydroxyevodiamine, Spine Date Seed jujubosideB are taken by crude drug proportioning, is mixed, used
Used as solvent, 32 DEG C of warm macerating are extracted the ethanol of weight percent concentration 45%, and extraction time is 8 times, and each extraction time is 48 little
When, each solvent load is 39 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, dense
Relative density 1.05 is reduced to, is filtered, medicinal liquid is first washed with water by HP50 macroporous adsorptive resins, then dense with percentage by weight
17% ethanol solution eluting HP50 macroporous adsorptive resins are spent, the ethanol elution of weight percent concentration 17% is collected, ethanol is reclaimed,
Concentrate drying, obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 14 times, carries every time
The time is taken for 0.4 hour, each solvent load is 17 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned
Ethanol is received, relative density 1.16 is concentrated into, is filtered, medicinal liquid is first washed with water by LSD632 macroporous adsorptive resins, then with again
The amount ethanol solution eluting LSD632 macroporous adsorptive resins of percent concentration 86%, collect the ethanol elution of weight percent concentration 86%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3:Pharmaceutical composition for the treatment of diabetic retinopathy and preparation method thereof
Treatment diabetic retinopathy pharmaceutical composition crude drug composition and weight portion be:Three-jaw gold dragon 4790g
Hetrostemma oblongifolium Cost. 2650g Polygalacic acid 36g Hydroxyevodiamine 22g Spine Date Seed jujubosideB 19g;
Preparation method:
(1)Three-jaw gold dragon, Hetrostemma oblongifolium Cost., Polygalacic acid, Hydroxyevodiamine, Spine Date Seed jujubosideB are taken by crude drug proportioning, is mixed, used
Used as solvent, 32 DEG C of warm macerating are extracted the ethanol of weight percent concentration 45%, and extraction time is 8 times, and each extraction time is 48 little
When, each solvent load is 39 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, dense
Relative density 1.05 is reduced to, is filtered, medicinal liquid is first washed with water by HP50 macroporous adsorptive resins, then dense with percentage by weight
17% ethanol solution eluting HP50 macroporous adsorptive resins are spent, the ethanol elution of weight percent concentration 17% is collected, ethanol is reclaimed,
Concentrate drying, obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 14 times, carries every time
The time is taken for 0.4 hour, each solvent load is 17 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned
Ethanol is received, relative density 1.16 is concentrated into, is filtered, medicinal liquid is first washed with water by LSD632 macroporous adsorptive resins, then with again
The amount ethanol solution eluting LSD632 macroporous adsorptive resins of percent concentration 86%, collect the ethanol elution of weight percent concentration 86%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 4:The preparation of tablet
The pharmaceutical composition 724g of Example 1, adds starch 828g, mixes, and granulation is dried, plus Microcrystalline Cellulose 250g, Hard Fat
Sour magnesium 10g, mixes, and is pressed into 5000, obtains final product medicinal composition tablets.
Embodiment 5:The preparation of capsule
The pharmaceutical composition 60g of Example 2, adds starch 70g, mixes, and granulation is dried, granulate, adds appropriate magnesium stearate,
Mix, encapsulated 500, obtain final product medicament composition capsule.
Embodiment 6:The preparation of drop pill
Weigh (80 DEG C) heating of polyethylene glycol 6000 213g water-baths and boil molten, add the g of 3 pharmaceutical composition of embodiment 14, fully stir
Mix uniform, with liquid paraffin as coolant, put glass tubing(4*80cm)In, chilling temperature is -6 DEG C, and drip internal-and external diameter is 7.0/
2.0 (mm/mm), drip is 2.5cm away from liquid level, and drop speed, as optimum condition, with cotton the cold of drop pill surface is blotted with per point 63 drops
Solidifying agent, obtains final product medicament composition dropping pills.
Embodiment 7:The pharmaceutical composition for the treatment of diabetic retinopathy
Treatment diabetic retinopathy pharmaceutical composition crude drug composition and weight portion be:
The weight portion of 30 weight portion Hydroxyevodiamine of Polygalacic acid, 20 weight portion Spine Date Seed jujubosideB 45.
Embodiment 8:The pharmaceutical composition for the treatment of diabetic retinopathy
Treatment diabetic retinopathy pharmaceutical composition crude drug composition and weight portion be:
The weight portion of 20 weight portion Hydroxyevodiamine of Polygalacic acid, 20 weight portion Spine Date Seed jujubosideB 20.
Embodiment 9:The pharmaceutical composition for the treatment of diabetic retinopathy
Treatment diabetic retinopathy pharmaceutical composition crude drug composition and weight portion be:
The weight portion of 40 weight portion Hydroxyevodiamine of Polygalacic acid, 20 weight portion Spine Date Seed jujubosideB 35.
Experimental example 1:The experimental study for the treatment of diabetic retinopathy
1 clinical data
1.1 case selection
1. age 18~70 years old;2. meet the diagnosis of 2 patients with type Ⅰ DM, and meet diagnosis and the parting standard of simple type DR.
1.2 exclusion standard
1. proliferous type DR patient;2. serious refractive media muddiness person;3. systemic infection disease and malignant tumor person are merged;4. ketone
Disease acidosis, hyperosmolality syndrome person;5. severe cardiac hepatic and kidney function obstacle person;6. trimester of pregnancy and women breast-feeding their children;7. once row optical fundus
Laser therapy or to this class ingredient allergy sufferers;8. psychiatric patient and without independent behavior ability person;9. mismatch treatment,
Person lost to follow-up before treatment end.
1.3 physical data
20 patients are pressed into into a group sequencing and are equally divided into two groups.Observation group 10, man 5, female 5;Age 50~
68 years old, average (54.85 ± 8.14) year;The course of disease 1~5 year, average (4.12 ± 1.23) year.Matched group 10, man 5,
Female 5;51~67 years old age, average (54.94 ± 8.05) year;The course of disease 1~5 year, average (4.25 ± 1.34) year.Two groups
Physical data no significant difference (P > 0.05), can be contrasted.
2 methods
2.1 matched group
Carry out health education in diabetes, to nurse one's health diet and suitable exercise based on, keep it is happy, strictly give up alcohol.According to
Patient's concrete condition carries out glucose-lowering treatment using oral antidiabetic drug or insulin, and the symptomatic treatment such as hypertension and hyperlipemia.
2.2 observation group
Add pharmaceutical composition on the basis of matched group(The pharmaceutical composition of embodiment 1)Treatment, orally, each 1.2g, daily 3
It is secondary.
2.3 observation item
Situation is changed using fluoroscopic visualization inspection observation patient's retinal hemorrhage, microangioma, fluorescence leakage scope.Lab testing
Index is mainly monitored in fasting glucose (FPG), 2h-plasma glucose (2 hPG), T-CHOL (TC), triglyceride (TG), blood plasma
Pi Su (ET-1), nitric oxide (NO) and DDi content change situation.Two groups of patients unite after continuously treating 3 months
Meter curative effect.
2.4 statistical method
Data analysiss are carried out using the statistical softwares of SPSS 15. 0.Ranked data adopt rank test, measurement data to adopt t
Inspection.
3 criterions of therapeutical effect and therapeutic outcome
3.1 criterion of therapeutical effect
It is effective:Retinal hemorrhage, microangioma etc. are significantly reduced, and fluorescence leakage disappears, and vision is improved earlier above more than 2 rows;
Effectively:Retinal hemorrhage, microangioma are reduced, and fluorescence leakage scope diminishes, and before vision stability or relatively treatment 1 row is improved
More than;
It is invalid:Not up to above standard even adds severe one.
3. 2 Clinical efficacy comparison
As shown in table 1.Observation group and matched group total effective rate are respectively 100%, 60.00%, statistically significant (the P < of difference
0.05) 。
1 two groups of Clinical efficacy comparisons of table [ example (%) ]
Group | Number of cases | It is effective | Effectively | It is invalid | Total effective rate |
Observation group | 10 | 7 | 3 | 0 | 100* |
Matched group | 10 | 3 | 3 | 4 | 60.00 |
Note:Compare with matched group, * P < 0.05.
3.3 blood glucose and Blood Lipid situation compare
FPG, 2hPG, TC and TG level is reduced after two groups of treatments, and with this group before treatment, difference has statistics to anticipate
Adopted (P < 0.01);Compare between group, difference not statistically significant (P > 0.05).
3.4 endothelin level, nitric oxide and DDi situation of change compare
ET-1 and DDi decline after two groups of treatments, are declined with observation group and are become apparent from, and compare between group, and difference has statistics
Learn meaning (P < 0.05).Two groups of NO levels are raised, and are raised with observation group and are become apparent from, and are compared between group, and difference is statistically significant
(P < 0.05).
Claims (8)
1. a kind of pharmaceutical composition for treating diabetic retinopathy, it is characterised in that make the crude drug of the pharmaceutical composition
Composition and weight portion be:
Three-jaw gold dragon 4780-4790 weight portion Hetrostemma oblongifolium Cost. 2650-2670 weight portion Polygalacic acid 30-36 weight portion hydroxyl Wus
Fructus Evodiae alkali 22-26 weight portion Spine Date Seed jujubosideB 17-19 weight portions.
2. a kind of pharmaceutical composition for treating diabetic retinopathy according to claim 1, it is characterised in that make this
The composition and weight portion of the crude drug of pharmaceutical composition be:
The weight portion of 33 weight portion Hydroxyevodiamine of three-jaw gold 2660 weight portion Polygalacic acid of imperial 4785 weight portion Hetrostemma oblongifolium Cost. 24
The weight portion of Spine Date Seed jujubosideB 18.
3. a kind of pharmaceutical composition for treating diabetic retinopathy according to claim 1, it is characterised in that medicine group
Compound can adopt the conventional method of galenic pharmacy to prepare piece agent or capsule or drop pill.
4. a kind of pharmaceutical composition for treating diabetic retinopathy according to claim 1, it is characterised in that medicine group
The treatment diabetic retinopathy medicine that compound is constituted with chemical drugs or Chinese medicine.
5. a kind of preparation method of the pharmaceutical composition for treating diabetic retinopathy, it is characterised in that make as follows
It is standby:
The composition and weight portion of crude drug be:Three-jaw gold dragon 4780-4790 weight portion Hetrostemma oblongifolium Cost. 2650-2670 weight portions are remote
Will acid 30-36 weight portion Hydroxyevodiamine 22-26 weight portion Spine Date Seed jujubosideB 17-19 weight portions;
Preparation method:
(1)Three-jaw gold dragon, Hetrostemma oblongifolium Cost., Polygalacic acid, Hydroxyevodiamine, Spine Date Seed jujubosideB are taken by crude drug proportioning, is mixed, used
Used as solvent, 32 DEG C of warm macerating are extracted the ethanol of weight percent concentration 45%, and extraction time is 8 times, and each extraction time is 48 little
When, each solvent load is 39 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, dense
Relative density 1.05 is reduced to, is filtered, medicinal liquid is first washed with water by HP50 macroporous adsorptive resins, then dense with percentage by weight
17% ethanol solution eluting HP50 macroporous adsorptive resins are spent, the ethanol elution of weight percent concentration 17% is collected, ethanol is reclaimed,
Concentrate drying, obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 14 times, carries every time
The time is taken for 0.4 hour, each solvent load is 17 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned
Ethanol is received, relative density 1.16 is concentrated into, is filtered, medicinal liquid is first washed with water by LSD632 macroporous adsorptive resins, then with again
The amount ethanol solution eluting LSD632 macroporous adsorptive resins of percent concentration 86%, collect the ethanol elution of weight percent concentration 86%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. a kind of preparation method of the pharmaceutical composition for treating diabetic retinopathy according to claim 5, its feature
It is to prepare as follows:
The composition and weight portion of crude drug be:The weight of 2660 weight portion Polygalacic acid of the three-jaw imperial 4785 weight portion Hetrostemma oblongifolium Cost. of gold 33
The weight portion of 24 weight portion Spine Date Seed jujubosideB of part Hydroxyevodiamine 18;
Preparation method:
(1)Three-jaw gold dragon, Hetrostemma oblongifolium Cost., Polygalacic acid, Hydroxyevodiamine, Spine Date Seed jujubosideB are taken by crude drug proportioning, is mixed, used
Used as solvent, 32 DEG C of warm macerating are extracted the ethanol of weight percent concentration 45%, and extraction time is 8 times, and each extraction time is 48 little
When, each solvent load is 39 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, and extracting solution A reclaims ethanol, dense
Relative density 1.05 is reduced to, is filtered, medicinal liquid is first washed with water by HP50 macroporous adsorptive resins, then dense with percentage by weight
17% ethanol solution eluting HP50 macroporous adsorptive resins are spent, the ethanol elution of weight percent concentration 17% is collected, ethanol is reclaimed,
Concentrate drying, obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 71% as solvent, heating and refluxing extraction 14 times, carries every time
The time is taken for 0.4 hour, each solvent load is 17 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned
Ethanol is received, relative density 1.16 is concentrated into, is filtered, medicinal liquid is first washed with water by LSD632 macroporous adsorptive resins, then with again
The amount ethanol solution eluting LSD632 macroporous adsorptive resins of percent concentration 86%, collect the ethanol elution of weight percent concentration 86%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. a kind of preparation method of the pharmaceutical composition for treating diabetic retinopathy according to claim 5, its feature
It is that pharmaceutical composition can adopt the conventional method of galenic pharmacy to prepare piece agent or capsule or drop pill.
8. a kind of preparation method of the pharmaceutical composition for treating diabetic retinopathy according to claim 5, its feature
It is pharmaceutical composition and chemical drugs or Chinese medicine composition treatment diabetic retinopathy medicine.
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CN201611133149.2A CN106668348A (en) | 2016-12-10 | 2016-12-10 | Pharmaceutical composition for treating diabetic retinopathy |
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CN201611133149.2A CN106668348A (en) | 2016-12-10 | 2016-12-10 | Pharmaceutical composition for treating diabetic retinopathy |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108186890A (en) * | 2018-03-28 | 2018-06-22 | 山东中医药大学附属医院 | A kind of pharmaceutical composition for treating diabetes |
WO2021194110A1 (en) * | 2020-03-27 | 2021-09-30 | 경희대학교 산학협력단 | Composition for preventing or treating metabolic diseases, containing jujuboside a as active ingredient |
CN115006421A (en) * | 2022-07-01 | 2022-09-06 | 上海健康医学院 | Application of jujuboside B in preparation of angiogenesis inhibiting medicine |
-
2016
- 2016-12-10 CN CN201611133149.2A patent/CN106668348A/en not_active Withdrawn
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108186890A (en) * | 2018-03-28 | 2018-06-22 | 山东中医药大学附属医院 | A kind of pharmaceutical composition for treating diabetes |
WO2021194110A1 (en) * | 2020-03-27 | 2021-09-30 | 경희대학교 산학협력단 | Composition for preventing or treating metabolic diseases, containing jujuboside a as active ingredient |
CN115006421A (en) * | 2022-07-01 | 2022-09-06 | 上海健康医学院 | Application of jujuboside B in preparation of angiogenesis inhibiting medicine |
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