CN107550926B - A kind of pharmaceutical composition for treating macular degeneration - Google Patents
A kind of pharmaceutical composition for treating macular degeneration Download PDFInfo
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- CN107550926B CN107550926B CN201710814661.1A CN201710814661A CN107550926B CN 107550926 B CN107550926 B CN 107550926B CN 201710814661 A CN201710814661 A CN 201710814661A CN 107550926 B CN107550926 B CN 107550926B
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Abstract
The present invention is pharmaceutical technology field, relates to a kind of pharmaceutical composition, more particularly to a kind of containing using synanthrin as the pharmaceutical composition of main active, this composition is curative for effect in terms for the treatment of macular degeneration, and effect is comprehensive, it is safe, there are great development and application values.
Description
Technical field
The present invention is pharmaceutical technology field, relates to a kind of pharmaceutical composition for treating macular degeneration, this pharmaceutical composition
For using synanthrin as the pharmaceutical composition of main active.
Background technology
Age-related macular degeneration (age-related macular degeneration, AMD) is one kind with the age
Increase and macular disease that incidence is gradually increasing, is mainly drawn by retinal pigment epithelium and Retinal degeneration
The central vision of the irreversibility risen declines or loses.In 10 macular degeneration patient, responsible supply nutrition is regarded
The capilary of nethike embrane will appear leakage, or even form scar, and newborn abnormal blood vessel is also very common, the liquid meeting of vascular leakage
Macula lutea is destroyed, causes metamorphopsia, visual impairment, overstocked scar to be led to that central vision is remarkably decreased, influences quality of life, very
To cecutiency, sometimes, macular degeneration can also be caused by wound, infection or inflammation, this disease also has certain inherent cause.In short, its
Mainly with macular area long-term chronic light injury, choroidal vessels sclerosis, retinal pigment epithelium aging is related.
In western countries, macular degeneration is the main reason for causing 50 years old or more crowd's blindness, and in the U.S., macular degeneration is led
These three common disease blinding number summations are more than glaucoma, cataract and diabetic retinopathy for the blindness of cause.In
State's macular degeneration incidence is not also low, and 60-69 Sui incidence is 6.04%-11.19%.With adding for Chinese population aging
Soon, which has apparent ascendant trend, but common people are inadequate to the understanding of macular degeneration and concern.In recent years, macula lutea becomes
Property drug exploitation gradually paid attention to, but both at home and abroad it is very ideal there are no effect is found, safety again good drug.
Synanthrin, also known as inulin, main component are the similar polysaccharides of a class formation.Synanthrin is distributed very in nature
Extensively, the plant of people's daily consumption：Onion, garlic, banana, wheat etc. all contain synanthrin, also contain chrysanthemum in bacterium and fungi
Sugar, however, synanthrin is primarily present in feverfew in nature, it is that presently found rare several soluble dietaries are fine
Dimension, it is high as drug and health products safety.Numerous reports think, synanthrin have boost metabolism, improve vascular disorder,
Improve intestinal microenvironment, adjusts blood fat, reduce blood glucose, pre- preventing obesity, the physiology such as mineral absorption and vitamin metabolism promoted to live
Property.Although synanthrin has more activity and effect, there is not yet can be used for the document report of fundus macular degeneration treatment.
Invention content
The purpose of the present invention is to provide a kind of pharmaceutical composition, the composition can be used for treating, prevent or improve macula lutea
Denaturation.
Pharmaceutical composition in the present invention is containing using synanthrin as the pharmaceutical composition of main active.
Preferably, synanthrin can be Girasole synanthrin or chicory inulin.
Preferably, pharmacy can also be contained other than containing main active constituent synanthrin in described pharmaceutical composition
Upper acceptable auxiliary material.
The pharmaceutical composition for the treatment of macular degeneration of the present invention, pharmaceutical composition can be prepared into pharmaceutical preparation,
Preferably tablet, capsule, eye drops, Eye ointments, more preferably tablet, capsule.
The pharmaceutical composition of the treatment macular degeneration, the pharmaceutical preparation are to include, and are calculated with weight ratio, jerusalem artichoke
1-50 parts of synanthrin, 50-99 parts of auxiliary material, preferably Girasole synanthrin 10-20 parts, 80-90 parts of auxiliary material.
The tablet includes being calculated with weight ratio, 1-50 parts of synanthrin, 45-85 parts of filler, 5-20 parts of disintegrant, is glued
Mixture, sweetener etc. are appropriate, preferably 12 parts of synanthrin, 75 parts of filler, 10 parts of disintegrant, and adhesive, sweetener etc. are appropriate.
Preferably, above-mentioned filler is one or more in starch, lactose, microcrystalline cellulose, mannitol；Disintegrant
It is one or more in sodium carboxymethyl starch, crospovidone, croscarmellose sodium；Adhesive ethyl alcohol, starch slurry,
One or more in sodium carboxymethylcellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, sweetener is asparagus fern
It is one or more in acyl phenyalanine methyl ester, sodium cyclohexylsulfamate, stevioside, maltose；Lubricant can also be contained,
It is one or more in magnesium stearate, talcum powder, polyethylene glycol.
The capsule includes being calculated with weight ratio, 2-16 parts of synanthrin, 60-90 parts of filler, 0.5-1 parts of lubricant,
Other are appropriate.
Preferably, above-mentioned filler is one or more in starch, sucrose, lactose, microcrystalline cellulose, mannitol；
Lubricant is one or more in magnesium stearate, talcum powder, superfine silica gel powder.
Clinical test shows that the pharmaceutical composition in the present invention has apparent therapeutic effect to macular degeneration.
Pharmaceutical composition in the present invention has following features in terms for the treatment of macular degeneration：
1, curative for effect.
Currently, there are no specific therapies to improve eyesight or to prevent deteriorating vision for macular degeneration, but it is of the invention
Prepared pharmaceutical composition has fine curative effect to macular degeneration.In the clinic trial experimental study of patient, in eyesight
It improves, subjective symptoms disappears, and Amsier table look-ups restore the effective of normal etc. synanthrin and are better than Qiju Dihuang Wan.
2, safe, toxic side effect is small.
Active constituent synanthrin contained by pharmaceutical composition of the present invention, acute toxicity test shows that toxic side effect is small, safe.
Specific embodiment
The present invention is further described below by way of specific embodiment, but the application range of the present invention is not limited only to following reality
Apply example.In present disclosure, spirit and/or range, replacement and/or combination to the technology of the present invention feature, to this field
Technical staff for be all it is clear that and included in the present invention among.
A kind of tablet that treating macular degeneration of embodiment 1
| Girasole synanthrin | 1mg |
| Soyabean oligosaccharides | 30mg |
| Microcrystalline cellulose | 50mg |
| Lactose | 35mg |
| Crospovidone | 20mg |
| Aspartame | 8mg |
| Sodium cellulose glycolate | 2mg |
Preparation process：Above-mentioned raw materials are uniformly mixed, 5% starch slurry is added, 20 mesh sieve squeezes sieving granulation, 60 DEG C of perseverances
Temperature is 2 hours dry, 20 mesh sieve of dry particl, addition 0.7% mixing of talcum powder, tabletted on tablet press machine.
A kind of tablet that treating macular degeneration of embodiment 2
| Chicory inulin | 10mg |
| Microcrystalline cellulose | 45mg |
| Lactose | 40mg |
| Crospovidone | 5mg |
| Aspartame | 3mg |
| Sodium cellulose glycolate | 2mg |
Preparation process：Above-mentioned raw materials are uniformly mixed, 5% starch slurry is added, 20 mesh sieve squeezes sieving granulation, 60 DEG C of perseverances
Temperature is 2 hours dry, 20 mesh sieve of dry particl, addition 1% mixing of talcum powder, tabletted on tablet press machine.
A kind of tablet that treating macular degeneration of embodiment 3
| Girasole synanthrin | 12mg |
| Microcrystalline cellulose | 30mg |
| Lactose | 45mg |
| Crospovidone | 10mg |
| Aspartame | 2mg |
| Sodium cellulose glycolate | 2mg |
Preparation process：Above-mentioned raw materials are uniformly mixed, 5% starch slurry is added, 20 mesh sieve squeezes sieving granulation, 60 DEG C of perseverances
Temperature is 2 hours dry, 20 mesh sieve of dry particl, addition 0.7% mixing of magnesium stearate, tabletted on tablet press machine.
A kind of tablet that treating macular degeneration of embodiment 4
| Chicory inulin | 50mg |
| Soyabean oligosaccharides | 5mg |
| Microcrystalline cellulose | 20mg |
| Lactose | 25mg |
| Crospovidone | 15mg |
| Aspartame | 3mg |
| Sodium cellulose glycolate | 2mg |
Preparation process：Above-mentioned raw materials are uniformly mixed, 5% starch slurry is added, 20 mesh sieve squeezes sieving granulation, 60 DEG C of perseverances
Temperature is 2 hours dry, 20 mesh sieve of dry particl, addition 1% mixing of magnesium stearate, tabletted on tablet press machine.
A kind of tablet that treating macular degeneration of embodiment 5
| Girasole synanthrin | 40mg |
| Soyabean oligosaccharides | 20mg |
| Microcrystalline cellulose | 60mg |
| Lactose | 20mg |
| Crospovidone | 20mg |
| Aspartame | 3mg |
| Sodium cellulose glycolate | 2mg |
Preparation process：Above-mentioned raw materials are uniformly mixed, 5% starch slurry is added, 20 mesh sieve squeezes sieving granulation, 60 DEG C of perseverances
Temperature is 2 hours dry, 20 mesh sieve of dry particl, addition 1% mixing of magnesium stearate, tabletted on tablet press machine.
A kind of tablet that treating macular degeneration of embodiment 6
| Chicory inulin | 20mg |
| Microcrystalline cellulose | 60mg |
| Lactose | 150mg |
| Crospovidone | 35mg |
| Aspartame | 8mg |
| Sodium cellulose glycolate | 2mg |
Preparation process：Above-mentioned raw materials are uniformly mixed, 5% starch slurry is added, 20 mesh sieve squeezes sieving granulation, 60 DEG C of perseverances
Temperature is 2 hours dry, 20 mesh sieve of dry particl, addition 1% mixing of magnesium stearate, tabletted on tablet press machine.
A kind of capsule that treating macular degeneration of embodiment 7
| Girasole synanthrin | 100mg |
| Soybean lecithin | 300mg |
| Superfine silica gel powder | 5mg |
| Lactose | 200mg |
| Starch | 500mg |
| 50% ethyl alcohol | 800mg |
| Polyoxyethylene sorbitan monoleate | 180mg |
| 70% syrup | 400mg |
| Talcum powder | 5mg |
Preparation process：It is allowed to Girasole synanthrin and soybean lecithin to be dissolved in 20 times of anhydrous second under the conditions of 50 DEG C of return stirrings
In alcohol, reaction after sixty minutes, ethyl alcohol is evaporated, 50 DEG C vacuum drying 10 hours Girasole synanthrin phosphatide complexes, ground 120
Mesh sieves；Girasole synanthrin phosphatide complexes and superfine silica gel powder, lactose, starch mixing are taken, and take 50% ethyl alcohol and polyoxyethylene sorbitan monoleate mixed
It is added in said mixture after even, mixing, then does adhesive softwood with 70% syrup, cross the sieve pelleting of 20 mesh, 55 DEG C dry
Dry 6 hours, 20 mesh sieves are crossed, 0.05 gram of talcum powder is added, hard capsule case is packed by every Girasole synanthrin containing 0.02g, obtains glue
Wafer.
A kind of capsule that treating macular degeneration of embodiment 8
| Chicory inulin | 20mg |
| Superfine silica gel powder | 5mg |
| Lactose | 400mg |
| Starch | 500mg |
| 50% ethyl alcohol | 800mg |
| Polyoxyethylene sorbitan monoleate | 180mg |
| 70% syrup | 400mg |
| Talcum powder | 5mg |
Preparation process：Chicory inulin and superfine silica gel powder, lactose, starch mixing, take 50% ethyl alcohol and polyoxyethylene sorbitan monoleate mixing
It is added in said mixture afterwards, mixing, then does adhesive softwood with 70% syrup, cross the sieve pelleting of 20 mesh, 55 DEG C of dryings 6
Hour, 20 mesh sieves are crossed, 0.05 gram of talcum powder is added, hard capsule case is packed by every chicory inulin containing 0.004g, obtains capsule
Agent.
A kind of capsule that treating macular degeneration of embodiment 9
| Girasole synanthrin | 60mg |
| Soybean lecithin | 300mg |
| Superfine silica gel powder | 7mg |
| Lactose | 100mg |
| Starch | 600mg |
| 50% ethyl alcohol | 750mg |
| Poloxamer | 180mg |
| 70% syrup | 400mg |
| Talcum powder | 5mg |
Preparation process：It is allowed to Girasole synanthrin and soybean lecithin to be dissolved in 20 times of anhydrous second under the conditions of 50 DEG C of return stirrings
In alcohol, reaction after sixty minutes, ethyl alcohol is evaporated, 50 DEG C vacuum drying 10 hours Girasole synanthrin phosphatide complexes, ground 120
Mesh sieves；Girasole synanthrin phosphatide complexes and superfine silica gel powder, lactose, starch mixing are taken, and take 50% ethyl alcohol and poloxamer mixing
It is added in said mixture afterwards, mixing, then does adhesive softwood with 70% syrup, cross the sieve pelleting of 20 mesh, 55 DEG C of dryings 6
Hour, 20 mesh sieves are crossed, 0.05 gram of talcum powder is added, hard capsule case is packed by every Girasole synanthrin containing 0.012g, obtains capsule
Agent.
A kind of capsule that treating macular degeneration of embodiment 10
| Chicory inulin | 160mg |
| Magnesium stearate | 10mg |
| Lactose | 220mg |
| Starch | 400mg |
| 50% ethyl alcohol | 500mg |
| Polyoxyethylene sorbitan monoleate | 180mg |
| 70% syrup | 400mg |
| Talcum powder | 5mg |
Preparation process：Chicory inulin and magnesium stearate, lactose, starch mixing, and take 50% ethyl alcohol and polyoxyethylene sorbitan monoleate mixed
It is added in said mixture after even, mixing, then does adhesive softwood with 70% syrup, cross the sieve pelleting of 20 mesh, 55 DEG C dry
Dry 6 hours, 20 mesh sieves are crossed, 0.05 gram of talcum powder is added, hard capsule case is packed by every chicory inulin containing 0.032g, obtains glue
Wafer.
A kind of capsule that treating macular degeneration of embodiment 11
| Girasole synanthrin | 200mg |
| Magnesium stearate | 300mg |
| Lactose | 200mg |
| Starch | 600mg |
| 50% ethyl alcohol | 800mg |
| Poloxamer | 180mg |
| 70% syrup | 400mg |
| Talcum powder | 5mg |
Preparation process：Girasole synanthrin and magnesium stearate, lactose, starch mixing, and take 50% ethyl alcohol and poloxamer mixing
It is added in said mixture afterwards, mixing, then does adhesive softwood with 70% syrup, cross the sieve pelleting of 20 mesh, 55 DEG C of dryings 6
Hour, 20 mesh sieves are crossed, 0.05 gram of talcum powder is added, hard capsule case is packed by every Girasole synanthrin containing 0.040g, obtains capsule
Agent.
A kind of eye drops that treating macular degeneration of embodiment 12
| Girasole synanthrin | 0.25g |
| Sodium chloride | 0.9g |
| Methyl hydroxybenzoate | 0.023g |
| Propylben | 0.011g |
| Distilled water adds to | 100ml |
Methyl hydroxybenzoate, propyl ester are taken, adds boiling distillation water dissolution, dissolves in synanthrin and sodium chloride when with 60 DEG C, filter, add distillation
Water is filling to enough, 100 DEG C, 30min sterilizings.
A kind of Eye ointments that treating macular degeneration of embodiment 13
| Girasole synanthrin | 0.1g |
| Ophthalmically acceptable matrix adds to | 100g |
Take synanthrin be placed in sterile mortar plus the dissolving of 10ml waters for injection after, be added after matrix grinding appropriate absorbs, then
Gradually plus remaining matrix, it grinds well to obtain the final product.
14 clinical example of embodiment
1 test method
1.1 experiment groupings
80 subjects are divided into test-meal group and Qiju Dihuang Wan control group, wherein 60 people of test-meal group using random double-blind method,
20 people of control group, test-meal group were divided into as 3 groups, every group of each 20 people, age 45-65 Sui.It is grouped as follows:
1 group of test-meal group, male 10 people, 10 people of female, average age 57.3 years old；
2 groups of test-meal group, male 9 people, 11 people of female, average age 56.5 years old；
3 groups of test-meal group, male 12 people, 8 people of female, average age 58.2 years old；
Control group, male 8 people, 12 people of female, average age 58.2 years old.
The factors such as age, gender, the eyesight of the above each group case are almost the same, P > 0.05, no significant difference, and having can
Than property, experiment is used and is compareed between itself cross-reference and group.
1.2 diagnostic criteria
Test-meal group and Qiju Dihuang Wan control group case press the senile Huang that Chinese Society of Ophthalmology retinopathy group is formulated
Spot denaturation clinical criteria is diagnosed.Treatment group and control group totally 116, make a definite diagnosis through fluorescence fundus angiography.
1.3 treatments and observation method
Tablet in the embodiment of the present invention 1 is taken in 1 group of test-meal, and 3 times a day, 2 tablets once (every contains synanthrin 1mg), when taking
Between be 6 months.
Tablet in the embodiment of the present invention 3 is taken in 2 groups of test-meal, and 3 times a day, 2 tablets once (every contains synanthrin 12mg), when taking
Between be 6 months.
Tablet in the embodiment of the present invention 4 is taken in 3 groups of test-meal, and 3 times a day, 2 tablets once (every contains synanthrin 50mg), when taking
Between be 6 months.
Control group takes Qiju Dihuang Wan, takes to specifications, 2 times a day, each 6g.Inspect periodically eyesight, eye
Bottom and fluorescence fundus angiography and Amsier table look-ups, 1 year tracing study time.
2 results
Two groups are compared after 1 year.
2.1 eyesights compare
Criterion：
Eyesight improves：After treatment 2 rows are improved than former eyesight；Deteriorating vision：More former visual impairment after treatment.
Pretherapy and post-treatment 2 groups of patient's vision distribution situations are shown in Table 1.
Two groups of eyesight variations after table 1 is treated
The data statistics of table 1 is the results show that treatment group's eyesight variation effect is substantially better than control group.It can be with by above-mentioned data
Find out, treatment group's improvement ratio is all higher than 50%, and treats 2 groups of improvement ratios and reach 80.0%, and control group is only 26.7%, is controlled
The more significant difference of both treatment group and control group improvement rate, P < 0.05 are comparable.
The disappearance of 2.2 subjective symptoms is compared
Subjective symptoms, which disappears, after table 2 is treated changes
Treatment group's subjective symptoms layer chromatography is all higher than 50% it can be seen from the above-mentioned data of table 2, and treats 2 groups certainly
Feel that symptom layer chromatography reaches 86.7%, control group is only 16.7%, the more significant difference of both treatment group and control group,
P < 0.05, are comparable.
2.3 Amsier table look-up results contrasts
In 120 eyes for the treatment of group, first visit checks that 86 eye Amsier table look-ups are abnormal, and Amsier table look-ups are extensive after treatment
It is multiple normally to have 60 eyes；In 40 eyes of control group, 30 eye Amsier table look-ups of first visit are abnormal, the Amsier table look-ups after treatment
Restore 5 eyes of normal person, the two compares significant difference, P < 0.05.The clinical observation of 60 86 eyes for the treatment of group, regarding
Power improves, and subjective symptoms disappears, and Amsier table look-ups restore normal etc. and have significant difference, P < 0.05 compared with control group.
15 acute toxicity test of embodiment
Toxicity test
1. material
1.1 experimental animal
Healthy mice 20, weight 18g-20g, half male and half female.
1.2 experimental drug
Experimental group：By Girasole synanthrin 12mg, microcrystalline cellulose 30mg, lactose 45mg, crospovidone 10mg, asparagus fern acyl benzene
After methyl lactamine 2mg, sodium cellulose glycolate 2mg mixing, 5% starch slurry is added, 20 mesh sieve squeezes sieving and pelletizes, 60 DEG C
0.7% mixing of magnesium stearate, the tablet being pressed on tablet press machine is added in freeze-day with constant temperature 2 hours, 20 mesh sieve of dry particl.
Control group：By microcrystalline cellulose 30mg, lactose 45mg, crospovidone 10mg, aspartame
After 2mg, sodium cellulose glycolate 2mg mixing, 5% starch slurry is added, 20 mesh sieve squeezes sieving granulation, 60 DEG C of freeze-day with constant temperature 2
Hour, 0.7% mixing of magnesium stearate, the tablet being pressed on tablet press machine is added in 20 mesh sieve of dry particl.
2. experimentation
Mouse is randomly divided into experimental group and control group, every group each 10, is administered using the mode of gavaging, interior for 24 hours point of 3 filling
Clothes.The variation of mouse indices is observed, and by mouse dissect, observes the pathological change of the organa parenchymatosums such as its internal organ.
3. experimental result
Experimental data shows that the indices observed by experimental mice are incited somebody to action compared with the control group without significant difference
Each organ changes without apparent pathologic after mouse dissect, with control group indifference.
4. conclusion
It is non-toxic by the pharmaceutical composition of the present invention of active constituent of synanthrin, it is safe in clinical application.
The effect of 16 people of embodiment and toxicity assessment：
Randomly select medical patient 60,49~65 years old age, male 28 people, 32 people of female, progress curative effect and toxicity assessment；
1,60 normal persons take tablet in the embodiment of the present invention 3, and curative effect all improves.
2, toxicity assessment：Before medication and drug administration continues respectively to make a physical examination, physical examination project later in one month：
(1) general physical examination project：Temperature pulse respiration；
(2) blood, urine, stool routine examination inspection, it is each before and after treatment to make once；
(3) liver function AST, ALT；Renal function BUN, CR and blood glucose；Heart function CPK, LDH, EKG；Coagulation function and blood are small
Plate.
Show that 60 patients do not occur abnormal symptom according to physical examination result analysis.
As can be seen that pharmaceutical composition toxic side effect of the present invention is smaller, safely and effectively from curative effect and toxicity assessment.
Claims (6)
1. it is a kind of using synanthrin be the pharmaceutical composition of sole active agent prepare treatment, prevent or improve macular degeneration drug in
Purposes, the synanthrin be Girasole synanthrin or chicory inulin.
2. purposes as described in claim 1, which is characterized in that the pharmaceutical composition is tablet or capsule.
3. purposes as claimed in claim 2, which is characterized in that the tablet or capsule is contained in terms of parts by weight, synanthrin
1-50 parts, 50-99 parts of auxiliary material.
4. purposes as claimed in claim 3, which is characterized in that the tablet or capsule is contained in terms of parts by weight, synanthrin
10-20 parts, 80-90 parts of auxiliary material.
5. purposes as claimed in claim 2, which is characterized in that the tablet includes, in terms of parts by weight, synanthrin 1-50
Part, 45-85 parts of filler, 5-20 parts of disintegrant, adhesive, appropriate sweetener.
6. purposes as claimed in claim 5, which is characterized in that the tablet includes, in terms of parts by weight, 12 parts of synanthrin,
75 parts of filler, 10 parts of disintegrant, adhesive, appropriate sweetener.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710814661.1A CN107550926B (en) | 2017-09-12 | 2017-09-12 | A kind of pharmaceutical composition for treating macular degeneration |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710814661.1A CN107550926B (en) | 2017-09-12 | 2017-09-12 | A kind of pharmaceutical composition for treating macular degeneration |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20040180090A1 (en) * | 2003-03-12 | 2004-09-16 | Demarco Peter | Treatment of macular degeneration |
| CN102379867B (en) * | 2011-11-09 | 2013-02-27 | 沈阳双鼎科技有限公司 | Use of chicoric acid in treatment of fundus lesion |
| ES2760351T3 (en) * | 2015-08-04 | 2020-05-13 | Suedzucker Ag | Prophylactic use of inulin against sinusitis |
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