CN106540004A - A kind of pharmaceutical composition for treating diabetic retinopathy - Google Patents
A kind of pharmaceutical composition for treating diabetic retinopathy Download PDFInfo
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- CN106540004A CN106540004A CN201611133154.3A CN201611133154A CN106540004A CN 106540004 A CN106540004 A CN 106540004A CN 201611133154 A CN201611133154 A CN 201611133154A CN 106540004 A CN106540004 A CN 106540004A
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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)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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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)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
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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)
- A61K36/85—Verbenaceae (Verbena family)
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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 kind of treat pharmaceutical composition of diabetic retinopathy and preparation method thereof, pharmaceutical composition of the present invention is with purple teak, Portugal, esculentoside B, three-jaw gold dragon, globe amaranth as bulk drug, proportioning is formed, routinely various formulations can be made by preparation process, treatment diabetic retinopathy is evident in efficacy.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition for treating diabetic retinopathy and
Its preparation method.
Background technology
BDR (diabetic retinopathy, DR) is the big diseases causing blindness of universally acknowledged four
One of, with retinal vascular occlusion dyshaemia as major pathologic features.At present doctor trained in Western medicine is to taking routine observation simple form more,
In addition to control blood sugar, special treatment method is there is no.
DR is one of common microvascular complication of diabetes, such as effectively treatment not in time, can cause blindness.Pancreas islet
Though element can prevent DR to occur, to established DR without obvious effect.Need in treatment actively the blood sugar of control patient,
Blood pressure, blood fat situation, to avoiding increasing for clinical symptoms, prevent more complication to occur.If NO releases are reduced, ET
Increase, then can accelerate or promote the development of DR.The categories such as this disease category traditional Chinese medicine " blurred vision " " vitreous opacity ".Because its be
Develop on Diabetes Foundation, based on the theory of " many stasis of bloods of prolonged illness " " pathogen usually intruding into collateral in protracted disease ", as hemostasis is hindered in eyeball key, eyeball key loses
Support, and cause eyeground hypoxic-ischemic and bleeding, be bleeding into vitreum and into the hemostasis from Jing, form vicious circle, therefore
The characteristics of clinical observation is to this sick fundus hemorrhage mostly is recurrent exerbation.
Three-jaw gold dragon：For Vitaceae Parthenocissus plant parthenocissus himalayana Plancs Parthenocissus himalayana
（Royle）Planch. the complete stool of ［ Ampelopsis himalayana Royle ］.Autumn, winter harvesting root and stem, cut after cleaning
Piece or segment, dry.Summer, autumn picking leaves, dry.【Nature and flavor】It is pungent；Temperature.【Indication】Dispelling wind and eliminating 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 are sturdy, drabon
Color；Tendril is short and branch, and there is sucker on top.3 leaflet alternate of palmate；The long 5-12cm of common petiole, without hair or hairiness；Blade papery,
Middle leaflet 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 are little
Leaf is asymmetric, tiltedly avette, and compared with the middle of, leaflet is smaller, 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, after petal comes off, tip often expands discoid.Berry is spherical, ripe time-varying pitchy, has white powder, seed 1-2
.Record in dictionary of medicinal plant.
Purple teak：Stem, leaf of this product for Verenaceae Tectona plant teak Tectona grandis L.f..Spring, the summer,
Autumn can harvest, and chopping is dried.【Nature and flavor】Bitter；Micro-pungent；Tepor.【Indication】With middle preventing or arresting vomiting；Dispelling wind and arresting itching.Main evil
The heart；Vomiting；Rubella itch.【Chemical analysis】Leaf contains teak terpinum (tectograndino1), teak naphthoquinones
(tectograndone), chlorophyll (chlorophyll) a and b, carotenoid and phenolic compound (phenolic
compounds).Seed oil fatty acid composition：Sad (carplic acid), capric acid (capricacid), laurate
(lauric acid), tetradecanoic acid (myristic acid), brown eleostearic acid (palmitic acid), stearic acid (stearic
Acld), oleic acid (oleic acid), linoleic acid (linoleic acid), leukotrienes (linolenic acid) and arachidic acid
(arachidicacid) etc., wherein with linolenic acid content highest (＞ 53%).Root rake alcohol containing drawing (lapachol), madder color
(mujistin), dehydrogenation-α-drawing rake quinone (dehydro- α-lapachone), β-drawing rake quinone (β-lapachone), takes out wood category alcohol
(tec-tol), tectoquinone (tecgnuinone), dehydrogenation take out wood category alcohol (dehydrotecd), cupreol (β-
SitO6terol), 1- hydroxy-2-methyls-anthraquinone (1-hydroxy-2-methyl-anthraquinone), obtusifoline
(obiusifolin), betulic acid (betulinicacid) and Pa Qiba stars (nachybasin).【Pharmacological action】Anticancer is made
With；Suppress nitric oxide synthesis, antiprotozoan effect.Record in dictionary of medicinal plant.
Portugal：Dry fruit of this product for myrtle Hainan Pu peach Syzygium cumini (L.) Skeels.Autumn
Season gathers, and removes branches and leaves, dries.【Nature and flavor】Puckery, bitter, temperature is pungent.【Function with cure mainly】Warm kidney dispelling cold.For " three is evil " disease, kidney is trembled with fear
Disease, stranguria with turbid discharge.【Proterties】This product is rounded, oblique square is circular, long 1～2cm, wide 0.5～1cm.Surface sepia is to black, exocarp
Shrinkage reticulates line, and exocarp comes off sometimes, and surface is more smooth, and endocarp is fallow, and top carries place calyx, like bottleneck shape,
The visible withered style in center, 1 piece of seed, yellowish-brown is hard.Gas delicate fragrance, it is lightly seasoned.Record Tibetan medicine standard is issued in the Ministry of Public Health
（First）, standard number：WS3-BC-0112-95.
Globe amaranth：Dry capitulum of this product for Gorgon euryale section plant globe amaranth Gomphrena globosa L..Autumn is spent
Harvest when in full bloom, dry.【Nature and flavor】It is sweet, put down.【Function with cure mainly】Eliminating the phlegm, relievings asthma.For chronic bronchitis, asthmatic gas
Guan Yan.【Proterties】This product is spherical in shape or square is circular, 1.5～2cm of diameter, rose, pink or white.Phyllary 2 is green
Color, heart-shaped or avette, two mask hairs, following surface are close.Flower imbricate arrangement, often spends 1 avette dry film matter shape bract of tool；Little bud
Piece 2, triangular shape lanceolar, rose or white, film quality have gloss；Perianth 5, wire lanceolar, color are shallow, close long by white
Pubescence；Stamen 5, filigree Colaesce, flower pesticide micro stretching go out；Gynoecium 1.Utricle is spherical, inside has brown seed 1.Body is light.Gas is micro-, lightly seasoned.
Record in Shanghai City Chinese medicine standard 1994 (Shanghai Health Bureau).
Esculentoside B（Phytolaccasaponin B）：CAS 66656-92-6, molecular formula C48H76O21, molecular weight
989.10.【Biologically active】Anti-inflammatory, anti rheumatism action.【Ingredient origin】Phytolacca acinosa Phytolacca esculenta [Syn.
Phytolacca acinosa]。
1 bulk drug chemical constitution：
Esculentoside B（Phytolaccasaponin B）.
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 bulk drug of the pharmaceutical composition of the treatment diabetic retinopathy be：
Purple teak 120-160 weight portions Portugal 80-100 weight portion esculentoside B20-30 weight portions three-jaw gold dragon 60-80 weights
Amount part globe amaranth 40-70 weight portions.
The pharmaceutical composition for the treatment of diabetic retinopathy is preferably used in, is by the bulk drug group of following weight portion
Into：
The imperial 70 weight portion globe amaranth of 140 weight portion Portugal of purple teak, 90 weight portion esculentoside B25 weight portions three-jaw gold 50
Weight portion.
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 dripping 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 bulk drug be：Purple teak 120-160 weight portions Portugal 80-100 weight portion esculentoside B20-
30 weight portion three-jaws gold dragon 60-80 weight portion globe amaranth 40-70 weight portions；
Preparation method：
（1）Purple teak, Portugal, esculentoside B, three-jaw gold dragon, globe amaranth are taken by bulk drug proportioning, is mixed, is used percentage by weight
33% ethanol of concentration is taken in 29.5 DEG C of temperature extractions as solvent, and extraction time is 9 times, and each extraction time is 45 hours, every time
60 times for bulk drug gross weight of solvent load, filtration obtain dregs of a decoction A and extract A, and extract A reclaims ethanol, are concentrated into relative
Density 1.11, filtration, liquid are first washed with water by CD180 large pore resin absorption columns, then with 18% second of weight percent concentration
Alcoholic solution elutes CD180 large pore resin absorption columns, collects 18% ethanol eluate of weight percent concentration, reclaims ethanol, and concentration is dry
It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with 53% ethanol of weight percent concentration as solvent, heating and refluxing extraction 13 times, is carried every time
The time is taken for 0.6 hour, 29 times for dregs of a decoction A weight of each solvent load, filtration obtain dregs of a decoction B and extract B, and extract B is returned
Ethanol is received, relative density 1.09 is concentrated into, is filtered, liquid is first washed with water by LS300 large pore resin absorption columns, then with again
Amount percent concentration 63% ethanol solution wash-out LS300 large pore resin absorption columns, collect 63% ethanol elution of weight percent concentration
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 bulk drug be：140 weight portion Portugal of purple teak, 90 weight portion esculentoside B25 weight portions three
Imperial 70 weight portion globe amaranth, 50 weight portion of pawl gold；
Preparation method：
（1）Purple teak, Portugal, esculentoside B, three-jaw gold dragon, globe amaranth are taken by bulk drug proportioning, is mixed, is used percentage by weight
33% ethanol of concentration is taken in 29.5 DEG C of temperature extractions as solvent, and extraction time is 9 times, and each extraction time is 45 hours, every time
60 times for bulk drug gross weight of solvent load, filtration obtain dregs of a decoction A and extract A, and extract A reclaims ethanol, are concentrated into relative
Density 1.11, filtration, liquid are first washed with water by CD180 large pore resin absorption columns, then with 18% second of weight percent concentration
Alcoholic solution elutes CD180 large pore resin absorption columns, collects 18% ethanol eluate of weight percent concentration, reclaims ethanol, and concentration is dry
It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with 53% ethanol of weight percent concentration as solvent, heating and refluxing extraction 13 times, is carried every time
The time is taken for 0.6 hour, 29 times for dregs of a decoction A weight of each solvent load, filtration obtain dregs of a decoction B and extract B, and extract B is returned
Ethanol is received, relative density 1.09 is concentrated into, is filtered, liquid is first washed with water by LS300 large pore resin absorption columns, then with again
Amount percent concentration 63% ethanol solution wash-out LS300 large pore resin absorption columns, collect 63% ethanol elution of weight percent concentration
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
Piece agent or capsule or dripping pill are prepared with the conventional method using 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 bulk drug composition and weight portion be：Purple teak 140g Portugals
90g esculentoside B25g three-jaws gold dragon 70g globe amaranth 50g；
Preparation method：
（1）Purple teak, Portugal, esculentoside B, three-jaw gold dragon, globe amaranth are taken by bulk drug proportioning, is mixed, is used percentage by weight
33% ethanol of concentration is taken in 29.5 DEG C of temperature extractions as solvent, and extraction time is 9 times, and each extraction time is 45 hours, every time
60 times for bulk drug gross weight of solvent load, filtration obtain dregs of a decoction A and extract A, and extract A reclaims ethanol, are concentrated into relative
Density 1.11, filtration, liquid are first washed with water by CD180 large pore resin absorption columns, then with 18% second of weight percent concentration
Alcoholic solution elutes CD180 large pore resin absorption columns, collects 18% ethanol eluate of weight percent concentration, reclaims ethanol, and concentration is dry
It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with 53% ethanol of weight percent concentration as solvent, heating and refluxing extraction 13 times, is carried every time
The time is taken for 0.6 hour, 29 times for dregs of a decoction A weight of each solvent load, filtration obtain dregs of a decoction B and extract B, and extract B is returned
Ethanol is received, relative density 1.09 is concentrated into, is filtered, liquid is first washed with water by LS300 large pore resin absorption columns, then with again
Amount percent concentration 63% ethanol solution wash-out LS300 large pore resin absorption columns, collect 63% ethanol elution of weight percent concentration
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 bulk drug composition and weight portion be：Purple teak 160g Portugals
80g esculentoside B30g three-jaws gold dragon 60g globe amaranth 70g；
Preparation method：
（1）Purple teak, Portugal, esculentoside B, three-jaw gold dragon, globe amaranth are taken by bulk drug proportioning, is mixed, is used percentage by weight
33% ethanol of concentration is taken in 29.5 DEG C of temperature extractions as solvent, and extraction time is 9 times, and each extraction time is 45 hours, every time
60 times for bulk drug gross weight of solvent load, filtration obtain dregs of a decoction A and extract A, and extract A reclaims ethanol, are concentrated into relative
Density 1.11, filtration, liquid are first washed with water by CD180 large pore resin absorption columns, then with 18% second of weight percent concentration
Alcoholic solution elutes CD180 large pore resin absorption columns, collects 18% ethanol eluate of weight percent concentration, reclaims ethanol, and concentration is dry
It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with 53% ethanol of weight percent concentration as solvent, heating and refluxing extraction 13 times, is carried every time
The time is taken for 0.6 hour, 29 times for dregs of a decoction A weight of each solvent load, filtration obtain dregs of a decoction B and extract B, and extract B is returned
Ethanol is received, relative density 1.09 is concentrated into, is filtered, liquid is first washed with water by LS300 large pore resin absorption columns, then with again
Amount percent concentration 63% ethanol solution wash-out LS300 large pore resin absorption columns, collect 63% ethanol elution of weight percent concentration
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 bulk drug composition and weight portion be：Purple teak 120g Portugals
100g esculentoside B20g three-jaws gold dragon 80g globe amaranth 40g；
Preparation method：
（1）Purple teak, Portugal, esculentoside B, three-jaw gold dragon, globe amaranth are taken by bulk drug proportioning, is mixed, is used percentage by weight
33% ethanol of concentration is taken in 29.5 DEG C of temperature extractions as solvent, and extraction time is 9 times, and each extraction time is 45 hours, every time
60 times for bulk drug gross weight of solvent load, filtration obtain dregs of a decoction A and extract A, and extract A reclaims ethanol, are concentrated into relative
Density 1.11, filtration, liquid are first washed with water by CD180 large pore resin absorption columns, then with 18% second of weight percent concentration
Alcoholic solution elutes CD180 large pore resin absorption columns, collects 18% ethanol eluate of weight percent concentration, reclaims ethanol, and concentration is dry
It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with 53% ethanol of weight percent concentration as solvent, heating and refluxing extraction 13 times, is carried every time
The time is taken for 0.6 hour, 29 times for dregs of a decoction A weight of each solvent load, filtration obtain dregs of a decoction B and extract B, and extract B is returned
Ethanol is received, relative density 1.09 is concentrated into, is filtered, liquid is first washed with water by LS300 large pore resin absorption columns, then with again
Amount percent concentration 63% ethanol solution wash-out LS300 large pore resin absorption columns, collect 63% ethanol elution of weight percent concentration
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
1 pharmaceutical composition 55g of Example, adds starch 105g, mixes, and granulation is dried, plus microcrystalline cellulose 53g, stearic acid
Magnesium 0.5g, mixes, is pressed into 500, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
2 pharmaceutical composition 209g of Example, adds starch 252g, mixes, and granulation is dried, whole grain, adds appropriate stearic acid
Magnesium, mixes, encapsulated 1000, obtains final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 168g water-baths and boil molten, add 3 pharmaceutical composition 11g of embodiment, fully stir
Mix uniform, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is 6 DEG C, and drip internal-and external diameter is 7.0/
2.0 (mm/mm), drip are 2.3cm away from liquid level, and drop speed is per dividing 49 drops as optimum condition, to blot the cold of dripping pill surface with cotton
Solidifying agent, obtains final product medicament composition dropping pills.
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 form DR.
1.2 exclusion standard
1. proliferous type DR patient；2. serious refractive media muddiness person；3. general infection disease and malignant tumour person are merged；4. ketone
Disease acid poisoning, hyperosmolality syndrome person；5. severe cardiac hepatic and kidney function obstacle person；6. the gestational period and women breast-feeding their children；7. once row eyeground
Laser therapy or to this class drug ingedient 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
26 patients are pressed into into a group sequencing and are equally divided into two groups.Observation group 13, man 7, female 6；Age 51～69
Year, average (54.32 ± 8.32) year；The course of disease 1～5 year, average (4.32 ± 1.32) year.Control group 13, man 7, female 6
Example；51～68 years old age, average (55.03 ± 8.11) year；The course of disease 1～5 year, average (4.31 ± 1.31) year.Two groups general
Data no significant difference (P ＞ 0.05), can be contrasted.
2 methods
2.1 control group
Health education in diabetes is carried out, based on nursing one's health diet and suitable exercise, is kept happy, is strictly given up alcohol.According to
Patient's concrete condition carries out glucose-lowering treatment using OHA or insulin, and the symptomatic treatment such as hypertension and hyperlipemia.
2.2 observation group
Add pharmaceutical composition on the basis of control group（1 pharmaceutical composition of embodiment）Treatment, orally, each 1.4g, daily 3
It is secondary.
2.3 observation item
Situation is changed using fluoroscopic visualization inspection observation patient's fundus hemorrhage, microaneurysm, fluorescence leakage scope.Laboratory examination
Index is mainly monitored in fasting blood-glucose (FPG), 2h-plasma glucose (2 hPG), T-CHOL (TC), triglycerides (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 analysis is carried out using 15. 0 statistical softwares of SPSS.Ranked data adopt rank test, measurement data to adopt t
Inspection.
3 criterions of therapeutical effect and treatment results
3.1 criterion of therapeutical effect
It is effective:Fundus hemorrhage, microaneurysm etc. are significantly reduced, and fluorescence leakage disappears, and eyesight improves more than 2 rows earlier above；
Effectively:Fundus hemorrhage, microaneurysm are reduced, and fluorescence leakage scope diminishes, and improve 1 row before vision stability or relatively treatment
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 control group total effective rate are respectively 87. 50%, 72. 50%, and difference is statistically significant
(P ＜ 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 | 13 | 8 | 4 | 1 | 92.31* |
| Control group | 13 | 4 | 4 | 5 | 61.54 |
Note:Compare with control group, * P ＜ 0.05.
3.3 blood sugar and Blood Lipid situation compare
After two groups of treatments, FPG, 2hPG, TC and TG level is reduced, 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 levels, nitric oxide and DDi situation of change compare
After two groups of treatments, ET-1 and DDi decline, and are declined with observation group and are become apparent from, are compared 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, 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 bulk drug of the pharmaceutical composition
Composition and weight portion be：
Purple teak 120-160 weight portions Portugal 80-100 weight portion esculentoside B20-30 weight portions three-jaw gold dragon 60-80 weights
Amount part globe amaranth 40-70 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 bulk drug of pharmaceutical composition be：
The imperial 70 weight portion globe amaranth of 140 weight portion Portugal of purple teak, 90 weight portion esculentoside B25 weight portions three-jaw gold 50
Weight portion.
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 dripping 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 bulk drug be：Purple teak 120-160 weight portions Portugal 80-100 weight portion esculentoside B20-
30 weight portion three-jaws gold dragon 60-80 weight portion globe amaranth 40-70 weight portions；
Preparation method：
（1）Purple teak, Portugal, esculentoside B, three-jaw gold dragon, globe amaranth are taken by bulk drug proportioning, is mixed, is used percentage by weight
33% ethanol of concentration is taken in 29.5 DEG C of temperature extractions as solvent, and extraction time is 9 times, and each extraction time is 45 hours, every time
60 times for bulk drug gross weight of solvent load, filtration obtain dregs of a decoction A and extract A, and extract A reclaims ethanol, are concentrated into relative
Density 1.11, filtration, liquid are first washed with water by CD180 large pore resin absorption columns, then with 18% second of weight percent concentration
Alcoholic solution elutes CD180 large pore resin absorption columns, collects 18% ethanol eluate of weight percent concentration, reclaims ethanol, and concentration is dry
It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with 53% ethanol of weight percent concentration as solvent, heating and refluxing extraction 13 times, is carried every time
The time is taken for 0.6 hour, 29 times for dregs of a decoction A weight of each solvent load, filtration obtain dregs of a decoction B and extract B, and extract B is returned
Ethanol is received, relative density 1.09 is concentrated into, is filtered, liquid is first washed with water by LS300 large pore resin absorption columns, then with again
Amount percent concentration 63% ethanol solution wash-out LS300 large pore resin absorption columns, collect 63% ethanol elution of weight percent concentration
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 bulk drug be：140 weight portion Portugal of purple teak, 90 weight portion esculentoside B25 weight portions three
Imperial 70 weight portion globe amaranth, 50 weight portion of pawl gold；
Preparation method：
（1）Purple teak, Portugal, esculentoside B, three-jaw gold dragon, globe amaranth are taken by bulk drug proportioning, is mixed, is used percentage by weight
33% ethanol of concentration is taken in 29.5 DEG C of temperature extractions as solvent, and extraction time is 9 times, and each extraction time is 45 hours, every time
60 times for bulk drug gross weight of solvent load, filtration obtain dregs of a decoction A and extract A, and extract A reclaims ethanol, are concentrated into relative
Density 1.11, filtration, liquid are first washed with water by CD180 large pore resin absorption columns, then with 18% second of weight percent concentration
Alcoholic solution elutes CD180 large pore resin absorption columns, collects 18% ethanol eluate of weight percent concentration, reclaims ethanol, and concentration is dry
It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with 53% ethanol of weight percent concentration as solvent, heating and refluxing extraction 13 times, is carried every time
The time is taken for 0.6 hour, 29 times for dregs of a decoction A weight of each solvent load, filtration obtain dregs of a decoction B and extract B, and extract B is returned
Ethanol is received, relative density 1.09 is concentrated into, is filtered, liquid is first washed with water by LS300 large pore resin absorption columns, then with again
Amount percent concentration 63% ethanol solution wash-out LS300 large pore resin absorption columns, collect 63% ethanol elution of weight percent concentration
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 dripping 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611133154.3A CN106540004A (en) | 2016-12-10 | 2016-12-10 | A kind of pharmaceutical composition for treating diabetic retinopathy |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611133154.3A CN106540004A (en) | 2016-12-10 | 2016-12-10 | A kind of pharmaceutical composition for treating diabetic retinopathy |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106540004A true CN106540004A (en) | 2017-03-29 |
Family
ID=58397122
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201611133154.3A Withdrawn CN106540004A (en) | 2016-12-10 | 2016-12-10 | A kind of pharmaceutical composition for treating diabetic retinopathy |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106540004A (en) |
-
2016
- 2016-12-10 CN CN201611133154.3A patent/CN106540004A/en not_active Withdrawn
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Application publication date: 20170329 |