CN103301115B - A kind of pharmaceutical composition for treating epilepsy - Google Patents
A kind of pharmaceutical composition for treating epilepsy Download PDFInfo
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- CN103301115B CN103301115B CN201310254648.7A CN201310254648A CN103301115B CN 103301115 B CN103301115 B CN 103301115B CN 201310254648 A CN201310254648 A CN 201310254648A CN 103301115 B CN103301115 B CN 103301115B
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- composition
- chlocibutamine
- levetiracetam
- treating epilepsy
- epileptic
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Abstract
The present invention relates to a kind of composition for treating epilepsy, belong to pharmaceutical technology field.A kind of compound medicament composition for treating epilepsy, it is characterised in that contain chlocibutamine and Levetiracetam.The invention provides a kind of composition, to improve the compliance of patient, reaches the purpose of control epileptic attack, while reduce the side effect of central nervous system depressant clinical application.A kind of safe and effective clinical application is provided for epileptic.
Description
Technical field：The present invention relates to a kind of composition for treating epilepsy, belong to pharmaceutical technology field.
Background technology：Epilepsy is due to chronic brain diseases caused by Different types of etiopathogenises, with cerebral neuron paradoxical discharge from
And transience central nervous system function is caused to be characterized extremely.There is document announcement, domestic epidemiology survey is shown, domestic insane
The incidence of disease of epilepsy is close to 1 ‰, and illness rate is about 4 ‰~9 ‰.The existing epileptic in China up to more than 5,000,000, at present control
The best approach of epileptic attack is still based on drug therapy, and its medication purpose is to reduce or prevents breaking-out.At present, there is no
The method of prevention and the healing of effect, therefore the treatment of epilepsy is often lifelong, and because most drug has adverse reaction,
And some side effects or irreversible, long-term use makes patient be difficult to receive, thus cause treatment interruption and the state of an illness repeatedly.
Levetiracetam is a kind of pyrrolidinone derivatives, its chemical constitution and existing antiepileptic non-correlation.
The precise mechanism of Levetiracetam antiepileptic action is unclear.
It is an object of the invention to provide a kind of composition, improves the compliance of patient, reaches control epileptic attack
Purpose, while reduce the generation of side effect.For epileptic provide it is a kind of safely, effectively and inexpensive clinical application.
Applicant has found through overtesting, chlocibutamine and Levetiracetam compatibility, is achieved in terms of epilepsy is treated imaginary
Less than synergy.
Technical scheme：
A kind of compound medicament composition for treating epilepsy, it is characterised in that contain chlocibutamine and Levetiracetam.
Currently preferred technical scheme is：It is 250~750mg containing Levetiracetam in the composition of unit dose,
75~200mg of chlocibutamine.
Currently preferred technical scheme is：It is 300~650mg containing Levetiracetam in the composition of unit dose,
80~180mg of chlocibutamine.
Currently preferred technical scheme is：It is 350~550mg containing Levetiracetam in the composition of unit dose,
80~150mg of chlocibutamine.
Currently preferred technical scheme is：It is 400~500mg containing Levetiracetam in the composition of unit dose,
100~150mg of chlocibutamine.
The conventional amount used of the present composition is oral 1, twice a day.
It is prepared by the pharmaceutical preparation preparation method of the present composition routinely.
The present composition can also be prepared as sustained release preparation.
The present composition can be prepared as controlled release preparation.Unit dose is selected according to internal insoluble drug release situation.
The beneficial effects of the invention are as follows a kind of composition is provided, pass through chlocibutamine and sulfonamides as carbonic anhydrase inhibitors
Compatibility, unexpected synergy is achieved in terms of epilepsy is treated.On the premise of therapeutic effect is ensured, sulfanilamide (SN) can be reduced
The side effect of class carbonic anhydrase inhibitor clinical application, improves clinical therapeutic efficacy.
Embodiment 1, chlocibutamine 200g, Levetiracetam 250g, prepare 1000 according to a conventional method.
Embodiment 2, chlocibutamine 75g, Levetiracetam 750g, prepare 1000 according to a conventional method.
Embodiment 3, chlocibutamine 90g, Levetiracetam 500g, prepare 1000 according to a conventional method.
Embodiment 4, chlocibutamine 100g, Levetiracetam 300g, prepare 1000 according to a conventional method.
Embodiment 5, chlocibutamine 100g, Levetiracetam 400g, prepare 1000 according to a conventional method.
Embodiment 6, chlocibutamine 150g, Levetiracetam 400g, prepare 1000 according to a conventional method.
Embodiment 7, chlocibutamine 80g, Levetiracetam 250g, prepare 1000 according to a conventional method.
Test example 1：
Inclusion criteria：At more than 18 years old age, meet epileptic attack class definition (1985)；There is no treatment history, epileptic attack
Frequency monthly 2 times or more；Confirm there are epileptiform discharges through EEG(electrocardiogram) examination；It is ready to participate in experiment and has preferable compliance.
Exclusion standard：Non-epileptic seizures；It is associated with the serious diseases such as angiocarpy, liver, kidney and hemopoietic system；Have medicine and
Alcohol abuse history；Prepare gestation or women breast-feeding their children；Affected the treatment with activity mental patient etc. or security judgement person.
80, man 48, female 32.8 groups are randomly divided into, every group of 10 people, respectively chlocibutamine group, Levetiracetam
Group, Zonisamide group, 1 group to 6 groups of embodiment.Continuous use 2 months, during medication, the previous moon as adjustment period, takes latter
Judgement of the breaking-out situation of individual month as therapeutic effect.
Observation index：The total inspection phase is 8 weeks.Observe once within every 2 weeks and check rehabilitation diary, every four weeks progress blood routine,
EEG(electrocardiogram) examination after being treated before routine urinalysis, Liver and kidney function and Electrocardioscopy, and treatment, and with regard to epileptic attack number, medicine agent
Amount, adverse reaction extremely degree record and curative effect evaluation are once.
Chlocibutamine group, chlocibutamine piece is taken, 200mg/ pieces, 2 times a day, 1 tablet once.
Levetiracetam group：500mg/ pieces, 1 tablet once, three times a day.Initial treatment dosage is each 500mg, daily 2
It is secondary, according to tolerance, it is gradually increased to 3 times a day, 1 tablet once.
The tablet 2 times of 1 group of -6 group of embodiment daily corresponding embodiment, 1 tablet once.
Judgment criteria：Breaking-out control, without breaking-out in the observation period；Effective, attack times reduce 75%-99% in the observation period；
Effectively, observation period attack times are reduced between 74%-50%；Effect is poor, and observation period attack times reduce below 26%-49%；
Invalid, observation period attack times reduce less than 25%；Deteriorate, attack times increase by more than 25%.
Data prove in table：The positive effect of present composition treatment epilepsy is higher than the folk prescription medicine of control group, illustrates chlorine
The reasonable compatibility of osmanthus butylamine and central nervous system depressant is acted synergistically.
Test example 2, Mr. Wang, female, 62 years old, clinical definite was epileptic, medical history 6 years, once takes phenobarbital, O'Casey
Equality medicine, it is impossible to which effectively control breaking-out, patient and family are tormented by the disease deeply.Before this on-test, take left second and draw west
It is smooth 3 times a day, each 500mg/ pieces, 1,3 months, the moon attack times do not improve.Through soliciting patient and family members' opinion, have in arms
The phychology tried, takes the composition of the embodiment of the present invention 7, and day takes medicine 2 times, 1 time 1.Second month plays record number of incidences
Broken out 5 times for the moon.Patient is substantially eliminated because taking the sleepy of other drugs appearance, poor appetite, weak, motion mistake simultaneously
Adjust, readme can feel good.
Above test example proves that the present composition has prominent synergy to treatment epileptic condition.Illustrate chlorine osmanthus fourth
The combination of amine and Levetiracetam has unexpected Clinical practice effect.
Claims (3)
1. a kind of compound medicament composition for treating epilepsy, it is characterised in that in the composition of unit dose, west is drawn containing left second
Smooth is 300~650mg, 80~180mg of chlocibutamine.
2. the composition according to claim 1, it is characterised in that in the composition of unit dose, contain Levetiracetam
350~550mg, 80~150mg of chlocibutamine.
3. the composition according to claim 1, it is characterised in that in the composition of unit dose, contain Levetiracetam
400~500mg, 100~150mg of chlocibutamine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310254648.7A CN103301115B (en) | 2013-06-15 | 2013-06-15 | A kind of pharmaceutical composition for treating epilepsy |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310254648.7A CN103301115B (en) | 2013-06-15 | 2013-06-15 | A kind of pharmaceutical composition for treating epilepsy |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103301115A CN103301115A (en) | 2013-09-18 |
| CN103301115B true CN103301115B (en) | 2018-03-20 |
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ID=49127123
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310254648.7A Active CN103301115B (en) | 2013-06-15 | 2013-06-15 | A kind of pharmaceutical composition for treating epilepsy |
Country Status (1)
| Country | Link |
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| CN (1) | CN103301115B (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101991561A (en) * | 2010-11-11 | 2011-03-30 | 迪沙药业集团有限公司 | 3,4-dichlorophenyl-propenoyl-sec-butylamine composition |
-
2013
- 2013-06-15 CN CN201310254648.7A patent/CN103301115B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101991561A (en) * | 2010-11-11 | 2011-03-30 | 迪沙药业集团有限公司 | 3,4-dichlorophenyl-propenoyl-sec-butylamine composition |
Non-Patent Citations (2)
| Title |
|---|
| A Review of Pharmacology and Clinical Use of Piperine and Its Derivatives;Yi Quan Pei;《Epilepsia》;19830430;177-182 * |
| 左乙拉西坦-一种具有全新作用机制的抗癫痫新药;田国红等;《中国新药与临床杂志》;20061031;第25卷(第10期);782-786 * |
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| Publication number | Publication date |
|---|---|
| CN103301115A (en) | 2013-09-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20171120 Address after: 264205 No. 1 South Qingdao Road, Weihai economic and Technological Development Zone, Shandong, China Applicant after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Applicant after: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. Address before: 264205 No. 1 South Qingdao Road, Weihai economic and Technological Development Zone, Shandong, China Applicant before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Applicant before: WEIHAI DIZHIYA PHARMACEUTICAL Co.,Ltd. Applicant before: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. |
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| GR01 | Patent grant | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20191115 Address after: 264205 No. 1 South Qingdao Road, Weihai economic and Technological Development Zone, Shandong, China Co-patentee after: Dijia Pharmaceutical Group Co.,Ltd. Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Co-patentee after: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. Address before: 264205 No. 1 South Qingdao Road, Weihai economic and Technological Development Zone, Shandong, China Co-patentee before: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. |
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| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20210826 Address after: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee after: Dijia Pharmaceutical Group Co.,Ltd. Address before: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee before: Dijia Pharmaceutical Group Co.,Ltd. Patentee before: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. |
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| TR01 | Transfer of patent right |