CN109200053A - A kind of anti-epileptic external drug and application thereof - Google Patents
A kind of anti-epileptic external drug and application thereof Download PDFInfo
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- CN109200053A CN109200053A CN201811369912.0A CN201811369912A CN109200053A CN 109200053 A CN109200053 A CN 109200053A CN 201811369912 A CN201811369912 A CN 201811369912A CN 109200053 A CN109200053 A CN 109200053A
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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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
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Abstract
The invention belongs to field of medicaments, in particular to a kind of anti-epileptic external drug and application thereof.The active constituent of the anti-epileptic external drug is carbamazepine and Amlexanox.The weight part ratio of carbamazepine and Amlexanox is 4~10 parts by weight of carbamazepine, 1 parts by weight of Amlexanox in the anti-epileptic external drug.The dosage form of the anti-epileptic external drug is preferably external-use gel preparation.The external drug auxiliary material of the external-use gel preparation are as follows: Carbopol 941, glycerol, triethanolamine and purified water.The effect that carbamazepine is used alone is better than to the antiepileptic efficacy of epilepsy animals when above-mentioned anti-epileptic external drug percutaneous dosing.
Description
Technical field
The invention belongs to field of medicaments, and in particular to a kind of anti-epileptic external drug and application thereof.
Background technique
Epilepsy is commonly called as " epilepsy ", is the reignition that brain excitatory neuron is unexpected, excessive, causes brain function prominent
A kind of disease that hair property, transitory perturbation cause, patient often show as of short duration sensory disturbance, limbs twitch, the loss of consciousness,
Referred to as epileptic attack.China epileptic is up to 9,000,000 or so according to estimates.
Carbamazepine (Carbamazepine) belongs to sodium channel modulators, can block sodium ion dependence action potential
It quickly provides to play antiepileptic efficacy, is the first-line drug for treating epilepsy and generalized tonic-clonic breaking-out.It is clinical main
Dosage form is oral tablet, and required dosage is larger, initial dose 100mg, and anti-epileptic effect can be played by needing to gradually rise dosage
Fruit, usual human body daily dosage are up to 300mg, even higher than 600 mg, thus cause many central nervous system ill-effects
Including anxiety, amentia etc., cardiovascular system adverse reaction is also than more serious including arrhythmia cordis etc..Also there is Karma at present
The listing of Xiping injection, specification 200mg are mainly used for the invalid situation of oral carbamazepine.
At the same time, the internal metabolism of carbamazepine has many limitations.Firstly, carbamazepine itself belongs to liver drug enzyme
Inducer can induce own metabolism, its half-life period of prolonged application can decline 2~3 times, be unfavorable for the performance of drug effect.Secondly, making
For a kind of medicine for central nervous system, carbamazepine has been demonstrated to induce the expression of intracerebral outlet transporter to raise, such as P-
Glycoprotein etc., this can further hinder carbamazepine to enter brain tissue performance drug effect.
About carbamazepine these it is insufficient overcome, mainly have following research direction at present: one is passing through blood-brain barrier
Promote the intracerebral concentration that open drug improves carbamazepine, borneol, compound danshen dripping pills, Rhizoma Acori Graminei extract, Xifeng Capsule are demonstrate,proved
It is bright carbamazepine to be promoted to enter brain tissue.Another research direction is to change administration route, and existing research person develops Karma
Xiping rectal suppository, nose micro emulsion etc. improve carbamazepine bioavilability to avoid hepato-enteric circulation.Also there is researcher using pH/
Magnetic doubling sensitivity gelled pill load carbamazepine is to high oral administration biaavailability.American documentation literature US6486152B1
The external preparation that carbamazepine is disclosed for antipsoriatic treatment method, and then discloses a kind of carbamazepine includes cream
Cream, gel etc..
Amlexanox (Amlexanox) is mainly used as antianaphylaxis disease at present, has and inhibits the free reaction of histamine
Effect, but exact antiallergy mechanism is unclear.Its current preparation formulation is mainly external preparation such as paste and oral system
Agent.Seem heating trend occur in recent years about the new active research of Amlexanox.Its focus is mainly Amlexanox pair
The regulating and controlling effect of TBK1 and IKK ε, this signal pathway is considered taking part in fat induced insulin resistance, thus prompts ammonia
Carry out Xanthones promise and be possible to have therapeutic effect to diabetes B, relevant clinical test comes into the II phase, and clinical test results make us
It inspires.Also studies have found that, Amlexanox can regulate and control osteoblast and osteoclast, to osteoporosis and rheumatoid arthritis
There may be potential therapeutic effect.There are also researches show that Amlexanoxs to play antitumous effect by HIPPO approach.It closes
Also there is research in the anti-ischemia reperfusion injury of Amlexanox, its preventive administration aggravates cerebral infarction, treatment as the result is shown
Property administration reduce cerebral infarction instead.Certainly since Amlexanox can not be brain by blood-brain barrier, the administration route of the studies above
Erebro ventricular injection.
Since 2013, Amlexanox is found to have the rush effect of reading over, and is possibly used for many because non-sense mutation causes
Disease, therefore wide application prospect is considered to have, such as hypertension, obesity, latent malnutrition epidermolysis pine
Solve disease (Atanasova VS, Jiang Q, Prisco M, Gruber C, Pi ó n Hofbauer J, Chen M, Has
C4, Bruckner-Tuderman L, McGrath JA, Uitto J, South AP. Amlexanox Enhances
Premature Termination Codon Read-Through in COL7A1 and Expression of Full
Length Type VII Collagen: Potential Therapy for Recessive Dystrophic
Epidermolysis Bullosa. J Invest Dermatol. 2017;137 (9): 1842-1849.), senile disease
Etc. (Loudon JA. Repurposing Amlexanox as a ' Run the Red Light Cure-All ' with
Readthrough–a ‘No-Nonsense’ Approach to Personalised Medicine. J Bioanal
Biomed 2013,5:4.).But Amlexanox can not pass through the drawbacks of blood-brain barrier, and to limit its possible in central nervous system
Broad prospect of application in disease of uniting.In recent years, a kind of antihistamine chlorine imidazoles to pass into silence for a long time is found to can inhibit zebra
The drawbacks of epileptic attack of fish, Amlexanox can not pass through blood-brain barrier, limits its antiepileptic efficacy that may be played, certainly,
This also results in the raising of Amlexanox safety, and rare cental system adverse reaction occurs.And other antihistamine drugs are often
It is easy to cause CNS inhibition, there is sedation effect, this will be unfavorable for being used in combination for antihistamine drug and antiepileptic.
Summary of the invention
For the above-mentioned prior art, an object of the present invention is to provide a kind of anti-epileptic external drug, especially containing card
The anti-epileptic external drug in horse Xiping, to overcome carbamazepine to be metabolized drawback.
To achieve the above object, the technical solution of the present invention is as follows:
A kind of anti-epileptic external drug is made of carbamazepine, Amlexanox and external drug auxiliary material.
Preferably, in the anti-epileptic external drug weight part ratio of carbamazepine and Amlexanox be carbamazepine 4~
10 parts by weight, 1 parts by weight of Amlexanox.
Preferably, the weight part ratio of carbamazepine and Amlexanox is 4 weight of carbamazepine in the anti-epileptic external drug
Measure part, 1 parts by weight of Amlexanox.
Preferably, the weight part ratio of carbamazepine and Amlexanox is 8 weight of carbamazepine in the anti-epileptic external drug
Measure part, 1 parts by weight of Amlexanox.
Preferably, the weight part ratio of carbamazepine and Amlexanox is 10 weight of carbamazepine in the anti-epileptic external drug
Measure part, 1 parts by weight of Amlexanox.
Preferably, the anti-epileptic external drug is external-use gel preparation.
Preferably, the external drug auxiliary material of the external-use gel preparation are as follows: Carbopol 941, glycerol, triethanolamine and purifying
Water.
Preferably, in the external-use gel preparation external drug auxiliary material weight part ratio are as follows: 4 parts by weight of Carbopol 941,
125 parts by weight of glycerol, 10 parts by weight of triethanolamine, 325 parts by weight of purified water.
Preferably, the weight part ratio of Carbopol 941 and Amlexanox is Carbopol 941 8 in the external-use gel preparation
Parts by weight, 5 parts by weight of Amlexanox.
Preferably, the preparation method of the external-use gel preparation includes the following steps:
(1) it takes recipe quantity Carbopol 941 to add purified water that 4% solution is made, is sufficiently swollen；5 times of weight of Carbopol 941 are added
Glycerol is ground to complete wetting, and addition recipe quantity triethanolamine, which stirs evenly, is made clear gel matrix；
(2) recipe quantity carbamazepine, Amlexanox is taken to be added in surplus glycerol, clear gel matrix, side is added in gained mixed liquor
Edged stirring, is then added surplus purified water, continues to stir evenly, external-use gel preparation is made.
Another aspect of the present invention additionally provides the above-mentioned external drug containing carbamazepine, Amlexanox and controls in preparation epilepsy
Treat the purposes in drug.
Zooscopy is the results show that the antiepileptic efficacy of carbamazepine, Amlexanox percutaneous dosing is better than carbamazepine list
The effect of only percutaneous dosing.Prompt Amlexanox percutaneous dosing may have an impact the blood concentration of carbamazepine, to send out
The effect of waving.This is beneficial to the dosage for reducing carbamazepine, to mitigate its adverse reaction.
Specific embodiment
Below with reference to embodiment, the present invention will be further explained.The form of percutaneous drug administration preparation is more, as cream,
Ointment, paste etc. are used equally for percutaneous dosing.Therefore, carbamazepine, Amlexanox external drug are not limited to external-use gel system
Agent.
1 carbamazepine of embodiment/Amlexanox compound gel 1
Prescription:
Carbamazepine 20g
Amlexanox 5g
Carbopol 941 8g
Glycerol 250g
Triethanolamine 20g
Purified water 650g
Preparation:
(1) it takes recipe quantity Carbopol 941 to add purified water that 4% solution is made, is sufficiently swollen；40g glycerol is added, grinds
It is milled to complete wetting, addition recipe quantity triethanolamine, which stirs evenly, is made clear gel matrix；
(2) recipe quantity carbamazepine, Amlexanox is taken to be added in surplus glycerol, clear gel matrix, side is added in gained mixed liquor
Edged stirring, is then added surplus purified water, continues to stir evenly, external-use gel preparation is made.
2 carbamazepines of embodiment/Amlexanox compound gel 2
Prescription:
Carbamazepine 40g
Amlexanox 5g
Carbopol 941 8g
Glycerol 250g
Triethanolamine 20g
Purified water 650g
Preparation:
(2) it takes recipe quantity Carbopol 941 to add purified water that 4% solution is made, is sufficiently swollen；40g glycerol is added, grinds
It is milled to complete wetting, addition recipe quantity triethanolamine, which stirs evenly, is made clear gel matrix；
(2) recipe quantity carbamazepine, Amlexanox is taken to be added in surplus glycerol, clear gel matrix, side is added in gained mixed liquor
Edged stirring, is then added surplus purified water, continues to stir evenly, external-use gel preparation is made.
3 carbamazepines of embodiment/Amlexanox compound gel 3
Prescription:
Carbamazepine 50g
Amlexanox 5g
Carbopol 941 8g
Glycerol 250g
Triethanolamine 20g
Purified water 650g
Preparation:
(3) it takes recipe quantity Carbopol 941 to add purified water that 4% solution is made, is sufficiently swollen；40g glycerol is added, grinds
It is milled to complete wetting, addition recipe quantity triethanolamine, which stirs evenly, is made clear gel matrix；
(2) recipe quantity carbamazepine, Amlexanox is taken to be added in surplus glycerol, clear gel matrix, side is added in gained mixed liquor
Edged stirring, is then added surplus purified water, continues to stir evenly, external-use gel preparation is made.
4 carbamazepine of embodiment, Amlexanox are individually and the antiepileptic efficacy of Combined with Percutaneous administration compares
SPF grades of KM mouse, 50, male, 25-30g.Mouse is randomly divided into 5 groups, every group 10.Model group modeling is simultaneously percutaneous
Solvent is given as model comparison；Other components are not for percutaneous administration of different drugs.Specific dosage regimen and modeling scheme are as follows:
Each group back of mice shaving sterilizes in order to be administered.
Model control group smears dimethyl sulfoxide, one time a day, continuous 3 times in shaving position.
Carbamazepine control group smears carbamazepine dimethyl sulfoxide mixed liquor in shaving position, is often only given Karma daily
Xiping 4mg, continuous 3 times.
Amlexanox control group smears Amlexanox, dimethyl sulfoxide mixed liquor in shaving position, is often only given ammonia daily
Carry out Xanthones promise 4mg, continuous 3 times.
Carbamazepine/Amlexanox low dose group is smeared carbamazepine, Amlexanox, dimethyl sulfoxide in shaving position and is mixed
Liquid is closed, is often only given 2 mg of carbamazepine, 0.5 mg of Amlexanox daily；Continuous 3 times.
Carbamazepine/Amlexanox high dose group is smeared carbamazepine, Amlexanox, dimethyl sulfoxide in shaving position and is mixed
Liquid is closed, is often only given 4 mg of carbamazepine, 0.5 mg of Amlexanox daily；Continuous 3 times.
1 hour after the last administration, mouse was induced experimental by the dose subcutaneous injection 3- mercaptopropionic acid of 60mg/kg weight
Epilepsy.Record mouse gives Myoclonic seizures incubation period and the death rate in 3- mercaptopropionic acid 30min.
Each group mouse clonicity/tonic seizures rate, Myoclonic seizures incubation period and mortality statistics result is seen below
Table:
Each group mouse clonicity/tonic seizures rate is 100%, illustrates modeling success.From mortality analysis, model pair
It is 100% according to group and the Amlexanox control group death rate.The each group death rate containing carbamazepine is lower than 30%.Prompt Amlexanox list
Only percutaneous dosing lacks antiepileptic efficacy.
Compare from Myoclonic seizures incubation period, Amlexanox control group and model control group without significant difference (p > 0.05),
Also the independent percutaneous dosing of prompt Amlexanox lacks antiepileptic efficacy.Carbamazepine/Amlexanox high dose group Myoclonic seizures
Incubation period is significantly higher than carbamazepine control group (p < 0.01), and the addition of Amlexanox is prompted to improve the anti-epileptic of carbamazepine
Effect.Carbamazepine/Amlexanox low dose group Myoclonic seizures incubation period is significantly higher than model control group (p < 0.01), but slightly
Lower than carbamazepine control group, halve with carbamazepine dosage related.
Claims (10)
1. a kind of anti-epileptic external drug, which is characterized in that the anti-epileptic external drug is by carbamazepine, Amlexanox and outer
It is made of excipient substance.
2. anti-epileptic external drug according to claim 1, which is characterized in that Karma west in the anti-epileptic external drug
The weight part ratio of gentle Amlexanox is 4~10 parts by weight of carbamazepine, 1 parts by weight of Amlexanox.
3. anti-epileptic external drug according to claim 2, which is characterized in that Karma west in the anti-epileptic external drug
The weight part ratio of gentle Amlexanox is 4 parts by weight of carbamazepine, 1 parts by weight of Amlexanox.
4. anti-epileptic external drug according to claim 2, which is characterized in that Karma west in the anti-epileptic external drug
The weight part ratio of gentle Amlexanox is 8 parts by weight of carbamazepine, 1 parts by weight of Amlexanox.
5. according to claim 1 to anti-epileptic external drug described in 4, which is characterized in that the anti-epileptic external drug is outer
Use gel preparation.
6. anti-epileptic external drug according to claim 5, which is characterized in that the external drug of the external-use gel preparation
Auxiliary material are as follows: Carbopol 941, glycerol, triethanolamine and purified water.
7. anti-epileptic external drug according to claim 6, which is characterized in that external drug in the external-use gel preparation
The weight part ratio of auxiliary material are as follows: 4 parts by weight of Carbopol 941,125 parts by weight of glycerol, 10 parts by weight of triethanolamine, 325 weight of purified water
Measure part.
8. anti-epileptic external drug according to claim 7, which is characterized in that carbomer in the external-use gel preparation
941 with the weight part ratio of Amlexanox be 8 parts by weight of Carbopol 941,5 parts by weight of Amlexanox.
9. anti-epileptic external drug according to claim 8, which is characterized in that the preparation method of the external-use gel preparation
Include the following steps:
It takes recipe quantity Carbopol 941 to add purified water that 4% solution is made, is sufficiently swollen；The sweet of 5 times of weight of Carbopol 941 is added
Oil is ground to complete wetting, and addition recipe quantity triethanolamine, which stirs evenly, is made clear gel matrix；Take recipe quantity Karma western
Flat, Amlexanox is added in surplus glycerol, and clear gel matrix is added in gained mixed liquor, stirring while adding, and surplus is then added
Purified water continues to stir evenly, and external-use gel preparation is made.
10. anti-epileptic external drug described in claim 1-9 is preparing the purposes in epilepsy therapy drug.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113116826A (en) * | 2021-04-20 | 2021-07-16 | 河北医科大学 | A topical carbamazepine nanometer preparation and its preparation method |
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| CN101564374A (en) * | 2008-04-25 | 2009-10-28 | 北京和润创新医药科技发展有限公司 | Medicinal in situ forming eye gel |
| CN103189060A (en) * | 2010-08-05 | 2013-07-03 | 里尔法律与医疗卫生第二大学 | Compound useful for the treatment of nonsense-mutation-mediated diseases and pharmaceutical composition comprising said compound |
| CN103316016A (en) * | 2013-07-15 | 2013-09-25 | 于法周 | Pharmaceutical composition containing carbamazepine and application thereof |
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2018
- 2018-11-17 CN CN201811369912.0A patent/CN109200053A/en active Pending
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| CN101564374A (en) * | 2008-04-25 | 2009-10-28 | 北京和润创新医药科技发展有限公司 | Medicinal in situ forming eye gel |
| CN103189060A (en) * | 2010-08-05 | 2013-07-03 | 里尔法律与医疗卫生第二大学 | Compound useful for the treatment of nonsense-mutation-mediated diseases and pharmaceutical composition comprising said compound |
| CN103316016A (en) * | 2013-07-15 | 2013-09-25 | 于法周 | Pharmaceutical composition containing carbamazepine and application thereof |
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| DAIKI MORI, ET AL.: "Poly I:C enhances production of nitric oxide in response to interferon-γ via upregulation of interferon regulatory factor 7 in vascular endothelial cells", 《MICROVASCULAR RESEARCH》 * |
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| CN113116826A (en) * | 2021-04-20 | 2021-07-16 | 河北医科大学 | A topical carbamazepine nanometer preparation and its preparation method |
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