CN110496130A - A kind of pharmaceutical composition preventing and treating diabetic retinopathy - Google Patents
A kind of pharmaceutical composition preventing and treating diabetic retinopathy Download PDFInfo
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- CN110496130A CN110496130A CN201910902492.6A CN201910902492A CN110496130A CN 110496130 A CN110496130 A CN 110496130A CN 201910902492 A CN201910902492 A CN 201910902492A CN 110496130 A CN110496130 A CN 110496130A
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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
- A61K31/4965—Non-condensed pyrazines
- A61K31/497—Non-condensed pyrazines containing further 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
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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Abstract
The present invention relates to a kind of for preventing and treating the medical compounds of diabetic retinopathy, 1~5 parts by weight of described pharmaceutical composition Macugen, 0.1~2.5 parts by weight of aspirin, 30~55 parts by weight of organic carboxylic ester, 10~25 parts by weight of glycerol, 5~30 parts by weight of cellulose derivative, wherein the molar ratio of active constituent Macugen and aspirin is 1~3:0.5~1.5.Experimental result shows that the drug combination of Macugen and aspirin shows fabulous synergistic effect in treatment diabetic retinopathy, and the medication of Macugen is small, and Small side effects, safety in utilization is higher, has good potential applicability in clinical practice.
Description
Technical field
The present invention relates to drug field, in particular it relates to a kind of pharmaceutical composition comprising Macugen,
Preparation method, and its application for preventing and treating diabetic retinopathy.
Background technique
Diabetes are a kind of common endocrine metabolism diseases, its main feature is that chronic hyperglycemia with insulin secretion not
Sugar/fat and protein metabolism disorder caused by foot and/or effect defect.According to epidemiological survey, China's diabetes prevalence
Up to 9.7%, estimate national maturity-onset diabetes patient populations up to 92,400,000 people.In addition, being united according to International Diabetes Federation (IDF)
Meter, global diabetic is up to 2.85 hundred million within 2010, it is contemplated that will have nearly 500,000,000 people to suffer from diabetes to the year two thousand thirty whole world.
Diabetes are with disease progression long hair angiogenic complication, and the harm of diabetes is mainly from these complication,
The main reason for being medical expense increase.Diabetic retinopathy (DR) is diabetic microangiopathies in clinical medicine
Cardinal symptom, be mainly manifested in eyeground pathological changes, feature shows as specifically sexually revising, be diabetes major complications it
One.Clinical diagnosis mainly with patient whether there is or not occur retinal neovascularization situation be treatment foundation, DR specifically include proliferative with
Nonproliferative diabetic retinopathy two categories.DR patient clinical symptom is that eyesight sharply declines, and there are high
Blinding risk.Wherein, proliferative diabetic retinopathy damages most serious caused by patient.Therefore clinical to be directed to DR patient
Treatment mainly with prevent and treat PDR generate and inhibit PDR development based on.For diabetic retinopathy, lead in the prior art
Cross research and clinical test, explore a variety of prevention and treatment methods: 1) stringent blood glucose, blood pressure, blood lipid control, regularly eye
Section's inspection and condition assessment and follow-up are to prevent and treat the important means of diabetic retinopathy.However, at present for strictly controlling
There is also disputes for blood glucose processed and the target of control, compare patient by large-scale clinical trials and give stringent or non-critical blood glucose at random
It is found after control, the insufficient support strict glycemic control of the evidence of random experiment, because comparing the reduced rate of diabetic complication
Negative effect (including hypoglycemia, the weight gain and financial burden) benefit undertaken with patient is less than disadvantage, a strict glycemic control
Significant adverse chafing dish be 2~3 times of risk for increasing severe hypoglycemia: the low blood of the minimum test group of glycosylated hemoglobin index
The disease incidence of sugar is just high.And strengthening glycemic control also leads to weight gain 2%.2) ARGON LASER PHOTOCOAGULATION IN is treated, mainly in
Degree visual loss, have tunnel vision, color lower, contrast sensitivity reduce etc. symptoms.Currently, grid laser treatment and full Retinal
Solidifying is still the effective means for treating DR and the macular edema as caused by DR, is the critical treatment means for saving patient's visual function from damage.So
And laser therapy itself has certain risk, exists including other centrocecal scotoma formation, decrease of contrast sensitivity, central fovea of macula
Accidentally injure the formation and the identical equal adverse reactions of retina choroid with choroidal neovascularization (CNV).3) vitrectomy is right
In macula lutea water, vitreous hemorrhage and serious PDR, feasible vitrectomy.With the development of the relevant technologies, 23G, 25G
Even 27G vitreum cutting technique is carried out, and leads operation on vitreous to actually enter the minimally invasive epoch, significantly reduces and play a game
The damage of portion's retardance, effectively reduces every postoperative complication.However vitrectomy is a Xiang Anggui and complicated
Treatment, needs to be operated by veteran ophthalmologist, oculist.4) Chinese medicine is treated: multinomial clinical display, in conventional diabetes treatment
On the basis of plus with have function of promoting blood circulation to disperse blood clots compound danshen dripping pills, can improve to some extent diabetic retinopathy trouble
The eyesight of person reduces visual field gray value, reduces retina microangioma quantity, improves and eliminates the pathological changes such as blood stove；Chinese medicine is multiple
The square Qi-ming granule treatment DR non-proliferative phase is safe and effective.As a result: test group obvious effective rate 40.2%, total effective rate 81.3%；In addition,
Compound anisodine injection, MAILUONING ZHUSHEYE, Radix Salviae Miltiorrhizae rhizome of chuanxiong piperazine injection etc. are also proved to varying degrees by clinical test
The symptom of DR can be improved.However, different Chinese medicine is often directed to the concrete type of diabetic retinopathy, and treating
There are apparent individual difference in journey, curative effect is slower, and majority is only to carry out centainly to corresponding lesion to a certain extent
Improve.
5) vascular endothelial growth factor (VEGF) be a kind of solubility generated in treat retinal ischemic angiogenic growth because
Son specifically acts on vascular endothelial cell vegf receptor, plays an important role to revascularization and vascular permeability increase.
When treat retinal ischemic aggravates, retinal pigment epithelium, gangliocyte synthesis and secretion of VEGF increase, and make vitreum VEGF
Content increases.The study found that the increase of VEGF content promotes the growth of retinal neovascularization, thus aggravated PDR into
Exhibition.More and more experiments have shown that the treatment DR of anti vegf agents is effective, may more have than simple laser therapy center oedema
Effect, it is more safer than vascular endothelial growth factor blocking agent.Most typical represent of VEGF inhibitor is exactly Macugen
(Pegaptanib sodium) is the inhibitor of selective vascular endothelial growth factor 165 (VFGF-165), initially a kind of
Treat age-related macular (age related macular degeneration, AMD) and other neovascular eyes
The newtype drug of disease obtains U.S. FDA approval in December, 2004 and is applied to clinical ophthalmology, and clinical research shows that Macugen is resistance to
It is good by property, but will appear eye-blurred, entophthamia, eye traumas, fatigue, heart disease, injection site pain, cornea after medication
The adverse reactions such as inflammation, intraocular inflammation, detachment of retina, macular edema, dim spot, subconjunctival hemorrhage, nettle rash.
6) anti-inflammatory medicaments.Research finds that inflammatory reaction takes part in the progress of DR, and finds that aspirin etc. is non-very early
Non-steroidal anti-inflammatory drug can reduce the disease incidence of DR, but use aspirin can not be as being effectively prevented and treated DR merely
Drug.
Applicant has found by years of researches, makes as the Macugen of VEGF inhibitor and combining for aspirin
With synergistic effect can be obtained for treatment diabetic retinopathy, and therapeutic effect greatly improves, due to Ah Si
The use of woods, can bring entophthamia, eye traumas, heart disease when can also largely alleviate Macugen independent medication
The side effects such as disease, keratitis, intraocular inflammation, macular edema have good potential applicability in clinical practice.
Based on above-mentioned discovery, the present invention provides a kind of Macugen compositions, overcome in the prior art above-mentioned
Deficiency, becomes that a kind of therapeutic effect is more preferable, newtype drug of the higher diabetic retinopathy of safety.
Summary of the invention
An object of the present invention is to provide a kind of novel pharmaceutical composition comprising Macugen, the combination
Object is more preferable for the therapeutic effect of diabetic retinopathy, safety in utilization is higher.
For this purpose, including following component the present invention provides a kind of pharmaceutical composition:
Wherein, the molar ratio of active constituent Macugen and aspirin is 1~3:0.5~1.5.
Further, the organic carboxylic ester is selected from dimethyl succinate, diethyl succinate, glycerol triacetate, wine
Stone dimethyl phthalate, ethyl tartrate, dimethyl glutarate or ethyl glutarate.
Further, cellulose derivative is selected from microcrystalline cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose or hydroxypropyl
Base cellulose.
Preferably, in pharmaceutical composition of the present invention, the active constituent Macugen and aspirin
Molar ratio be 1~2:0.5~1
Further, preferably, pharmaceutical composition of the present invention includes following components:
In a preferred embodiment of the invention, described pharmaceutical composition includes following components:
In another preferred embodiment of the invention, the pharmaceutical composition includes following components:
Further, the pharmaceutical composition optionally also includes other a effective amount of active pharmaceutical ingredients, the work
Property drug ingedient is in anti-tumor drug, anti-inflammatory drug, immunosuppressor, neovascularization inhibitor and glaucoma
At least one；Preferably, the active pharmaceutical ingredient is selected from Chlorambucil, melphalan, cyclophosphamide, different ring phosphorus
Amide, carmustine, lomustine, Semustine, chloramphenicol, cis-platinum, carboplatin, oxaliplatin, fluorouracil, mitoxantrone,
Irinotecan, topotecan, vincaleukoblastinum, vincristine, eldisine, Vinorelbine, Etoposide, Teniposide, taxol,
Docetaxel, bleomycin, methotrexate (MTX), gemcitabine, capecitabine, hydroxycarbamide, mitomycin, Gefitinib, Shu Ni
For Buddhist nun, dexamethasone, dexamethasone acetate, prednisone, prednisone acetate, fluocinolone acetonide, Fluocinonide, Triamcinolone acetonide, methyl
Prednisolone, methylprednisolone second propionic ester, Halobetasol Propionate, cortisone, hydrocortisone, cyclosporine, thunder pa are mould
Element, tacrolimus, mycophenolate mofetil, fujimycin 506, mizoribine, salicylazosulfapyridine, imuran, methopterin, bevacizumab,
Before Lucentis, VEGF Trap, latanoprost, Travoprost, Bimatoprost, Bimatoprost, his fluorine
Column parathyrine, pilocarpinum, atropine, hyoscyamine, betaxolol, metoprolol, Bunolol, metipranolol, Propranolol,
Timolol, Befunolol, acetazolamide, Dorzolamide, brinzolamide, Aplonidine, Brimonidine, Dipivefrine, croak second
At least one of pyridine, Glamidole, Dasatinib and their pharmaceutically acceptable salts；It is highly preferred that the active medicine
Ingredient in dexamethasone, Latanoprost, Dasatinib, Triamcinolone acetonide and their pharmaceutically acceptable salts at least one
Kind.
In addition, described pharmaceutical composition is also optionally comprising the other carriers or excipients.
For take orally, sublingual administration, subcutaneous administration, intramuscular delivery, intravenous administration, cutaneous penetration, local administration or
In the pharmaceutical composition of rectally, be used alone or the active constituent that is used together with other active components can with it is traditional
Pharmaceutical carrier mixing, is administered in the form of unit dosage forms are administered to animal or people.Administration unit dosage forms appropriate include oral
Form, such as tablet, capsule, pill, powder agent, granule, chewing gum and oral administration solution or suspension, local administration
Form, the form of cutaneous penetration, the form of subcutaneous administration, the form of intramuscular delivery, the form of intravenous administration or intraocular and straight
The form of enteral administration.
When preparing chip solid composition, wetting can be added in the active constituent for being micronized or not being micronized
Agent, such as NaLS, and by they and pharmaceutically acceptable excipient, such as silica, starch, lactose, magnesium stearate, cunning
Mountain flour or the like is mixed.It can be coated with sucrose, various polymer or other substances appropriate to tablet or right
It is handled, and with the activity for extending or being sustained, and continuously discharges the active constituent of predetermined amount.
By one or more of active constituents and a diluent, such as ethylene glycol or glyceride mixing, then will obtain
Mixture, which is added in soft capsule or hard capsule, can be obtained capsule preparations.
One or more active constituents can be contained in syrup or the preparation of spirit form, while adding sweetener, preferably
The sweetener, methyl p-hydroxybenzoate, propylparaben of heat are not generated as preservative and flavoring agent and are fitted
When colorant.
The powder or particle that can be dispersed in water can contain one or more active constituents, while be mixed with dispersing agent or profit
Humectant or suspending agent, such as polyvinylpyrrolidone, or it is mixed with sweetener or taste modulators.
The present invention also provides the pharmaceutical compositions described in one kind to be used to prepare prevention or treatment diabetic retinopathy
Become the purposes of drug.
Pharmaceutical composition provided by the invention regards diabetic keratopathy using the combination of Macugen and aspirin
The therapeutic effect of retinopathy greatly improves, and test result is shown, rat test the results show that its for diabetes and glycosuria
The therapeutic activity of characteristic of disease retinal disease has significant synergies, and pharmaceutical activity is administered alone better than Macugen；
And in dosage, the amount ratio routine independent medication dosage of the Macugen in the composition can reduce by 30~50%, with Ah
The combination for taking charge of a woods, can bring entophthamia, eye traumas, heart disease, angle when can effectively reduce Macugen independent medication
The side effects such as film inflammation, intraocular inflammation, macular edema, medication is safer, has good potential applicability in clinical practice.
Embodiment
Embodiment 1-2: preparing preparation of the invention using following component, and is used to prepare into Pharmaceutical composition 1 and 2.
Table 1: each ingredient components ratio in Examples 1 and 2 composition
| Embodiment 1 | Constituent content (%w/w) | Embodiment 2 | Embodiment 2 (%w/w) |
| Macugen | 1.5 | Macugen | 1.8 |
| Aspirin | 0.6 | Aspirin | 0.4 |
| Glycerol triacetate | 40 | Ethyl tartrate | 45 |
| Glycerol | 20 | Glycerol | 15 |
| Hydroxymethyl cellulose | 12 | Microcrystalline cellulose | 10 |
| Sodium laurate | 5 | Potassium sorbate | 5 |
| Xylitol | 8 | Magnesium stearate | 3 |
| Starch | 12.9 | Starch | 19.8 |
Embodiment 3: pharmacy test in the compounds of this invention rat body:
Method: survey fasting blood-glucose randomly selects 10 lower than 7mmol/L person and is only used as normal control after rat adaptive feeding
Group, remaining rat, which is injected intraperitoneally with STZ (citrate buffer solution is made into 1% concentration, filtration sterilization) according to 30mg/kg, induces glycosuria
Disease, taking tail blood to survey FPG >=11.1mmol/L after 2 weeks is diabetes rat.Diabetes rat is randomly divided into 5 groups, every group 15
Only: diabetic controls group, embodiment 1 (Macugen/aspirin) 1 group of composition (1.5+0.6mg/kg/d), composition 2
Group (1.8+0.4mg/kg/d), Macugen group (2.0mg/kg/d) and aspirin group (2.0mg/kg/d).Daily stomach-filling
Administration.The 12nd week after blood glucose rise, tail blood is taken to survey blood glucose.Every group takes 10 rats, takes bilateral eyeball, is placed in ice physiological saline
In, retinal tissue is removed, precision balance is weighed, and 10% tissue blood plasma of support, 3000r/min are centrifuged 10 minutes, take under ice bath
Supernatant carries out nitricoxide synthase (NOS) and aldose reductase (AR) determination of activity, and (NOS is not with having milligram histone per minute
Generating 1mmol NO is that an enzyme activity unit indicates；The active measurement ultraviolet determination method of AR), protein determination coomassie is bright
Blue colorimetric method.AR unit enzymatic activity is 1 μm of ol NADPH of every every kind of mg homogenate proteins consumption.Result is measured with means standard deviationIt indicates, statistical method is examined using t.As a result: in the pathogenesis of diabetic retinopathy, AR increased activity,
NOS expression enhancing.In this experiment, the 12nd week after blood glucose in diabetic rats increases, model group NOS closes AR value and is all remarkably higher than just
Normal control group shows that the diabetes rat has suffered from early stage retinopathy.The NOS and AR of aspirin group diabetes rat
Value is not significantly different compared with model group diabetes rat, and 2 two groups of embodiment of the present invention 1, embodiment diabetes rats
NOS and AR value is either compared with model group, or compared with aspirin group, and compared with Macugen group, has
Significant statistical difference shows that Macugen has with aspirin composition and cooperates with prevention and treatment diabetic retinopathy
Effect.
Table 2: the present composition 1 and 2 pair diabetic retinal tissue in rat protection (N=10)
Claims (10)
1. a kind of pharmaceutical composition includes following component:
Wherein, the molar ratio of active constituent Macugen and aspirin is 1~3:0.5~1.5.
2. pharmaceutical composition according to claim 1, wherein the organic carboxylic ester is selected from dimethyl succinate, fourth two
Diethyl phthalate, glycerol triacetate, dimethyl tartrate, ethyl tartrate, dimethyl glutarate or ethyl glutarate.
3. pharmaceutical composition according to claim 1 or 2, wherein the cellulose derivative is selected from microcrystalline cellulose,
Hydroxymethyl cellulose, hydroxyethyl cellulose or hydroxypropyl cellulose.
4. pharmaceutical composition according to claim 1-3, wherein the active constituent Macugen and Ah
The molar ratio for taking charge of a woods is 1~2:0.5~1
5. pharmaceutical composition according to claim 1-4, it includes following components:
6. pharmaceutical composition according to claim 1-5, it includes following components:
7. pharmaceutical composition according to claim 1-6, it includes following components:
8. pharmaceutical composition according to claim 1-7 optionally also includes other a effective amount of active drugs
Object ingredient, the active pharmaceutical ingredient are selected from anti-tumor drug, anti-inflammatory drug, immunosuppressor, neovascularization inhibitor and blueness
At least one of light eye therapeutic agent；Preferably, the active pharmaceutical ingredient be selected from Chlorambucil, melphalan,
Cyclophosphamide, ifosfamide, carmustine, lomustine, Semustine, chloramphenicol, cis-platinum, carboplatin, oxaliplatin, fluorine urine
Pyrimidine, Irinotecan, topotecan, vincaleukoblastinum, vincristine, eldisine, Vinorelbine, Etoposide, replaces mitoxantrone
Buddhist nun moor glycosides, taxol, Docetaxel, bleomycin, methotrexate (MTX), gemcitabine, capecitabine, hydroxycarbamide, mitomycin,
Gefitinib, Sutent, dexamethasone, dexamethasone acetate, prednisone, prednisone acetate, fluocinolone acetonide, Fluocinonide,
Triamcinolone acetonide, methylprednisolone, methylprednisolone second propionic ester, Halobetasol Propionate, cortisone, hydrocortisone,
Cyclosporine, rapamycin, tacrolimus, mycophenolate mofetil, fujimycin 506, mizoribine, salicylazosulfapyridine, imuran, first ammonia
Petrin, bevacizumab, Lucentis, VEGF Trap, latanoprost, Travoprost, Bimatoprost, than horse before
Column parathyrine, his fluorine prostaglandin, pilocarpinum, atropine, hyoscyamine, betaxolol, metoprolol, Bunolol, U.S.A are replaced
Luo Er, Propranolol, timolol, Befunolol, acetazolamide, Dorzolamide, brinzolamide, Aplonidine, Brimonidine,
At least one of Dipivefrine, guanethidine, Glamidole, Dasatinib and their pharmaceutically acceptable salts；It is highly preferred that
The active pharmaceutical ingredient is selected from dexamethasone, Latanoprost, Dasatinib, Triamcinolone acetonide and they are pharmaceutically acceptable
At least one of salt.
9. any one of -8 described pharmaceutical composition according to claim 1, wherein the composition also optionally includes other described
Carrier or excipients.
10. pharmaceutical composition according to claim 1-8 is used to prepare prevention or treatment diabetic retinal
The purposes of lesion drug.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017091706A1 (en) * | 2015-11-23 | 2017-06-01 | Acceleron Pharma Inc. | Methods for treating eye disorders |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017091706A1 (en) * | 2015-11-23 | 2017-06-01 | Acceleron Pharma Inc. | Methods for treating eye disorders |
| CN108697793A (en) * | 2015-11-23 | 2018-10-23 | 阿塞勒隆制药公司 | The method for treating disease of eye |
Non-Patent Citations (2)
| Title |
|---|
| BRESSLER N. M.等: "Changes in retinal neovascularization after pegaptanib (Macugen) therapy in diabetic individuals", 《世界核心医学期刊文摘·眼科学》 * |
| 滕荣建等: "拜阿司匹林治疗糖尿病视网膜病变的临床疗效和安全性研究", 《中国现代医生》 * |
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