CN103315987B - A kind of pharmaceutical composition for treating epilepsy - Google Patents
A kind of pharmaceutical composition for treating epilepsy Download PDFInfo
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- CN103315987B CN103315987B CN201310254723.XA CN201310254723A CN103315987B CN 103315987 B CN103315987 B CN 103315987B CN 201310254723 A CN201310254723 A CN 201310254723A CN 103315987 B CN103315987 B CN 103315987B
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- Prior art keywords
- sabril
- composition
- chlocibutamine
- 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 sabril.The present invention provides a kind of composition, to improve the compliance of patient, achievees the purpose that to 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 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, 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 since most drugs are there are adverse reaction,
And some side effects or irreversible, long-time service makes patient be difficult to receive, thus cause treatment interruption and the state of an illness repeatedly.
Sabril is the depressant of GABA primary degrading enzyme GABA medium enzymes, it can make cerebrospinal fluid GABA is horizontal to improve.
The medicine has the characteristics that safely, effectively and easily application in European extensive use, effective to all types of epileptic attacks,
It is more preferable to part breaking-out effect.But sabril should not be used in absence seizure, myoclonic seizure.
The object of the present invention is 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 that chlocibutamine and sabril compatibility, achieve in terms of epilepsy is treated and expect not through overtesting
The synergistic effect arrived.
Technical solution：
A kind of compound medicament composition for treating epilepsy, it is characterised in that contain chlocibutamine and sabril.
Currently preferred technical solution is：In the composition of unit dose, contain 300~1500mg of sabril, chlorine
Osmanthus 75~200mg of butylamine.
Currently preferred technical solution is：In the composition of unit dose, contain 400~1200mg of sabril, chlorine
Osmanthus 80~180mg of butylamine.
Currently preferred technical solution is：In the composition of unit dose, contain 500~1000mg of sabril, chlorine
Osmanthus 80~150mg of butylamine.
Currently preferred technical solution is：In the composition of unit dose, contain 700~900mg of sabril, chlorine osmanthus
100~150mg of butylamine.
The conventional amount used of the present composition is to take orally 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, by chlocibutamine and the compatibility of sabril, controlling
Unexpected synergistic effect is achieved in terms for the treatment of epilepsy., can sabril clinical application on the premise of therapeutic effect is ensured
Side effect, improve clinical therapeutic efficacy.
Embodiment 1, chlocibutamine 200g, sabril 300g, prepares 1000 according to a conventional method.
Embodiment 2, chlocibutamine 75g, sabril 1500g, prepares 1000 according to a conventional method.
Embodiment 3, chlocibutamine 90g, sabril 500g, prepares 1000 according to a conventional method.
Embodiment 4, chlocibutamine 100g, sabril 600g, prepares 1000 according to a conventional method.
Embodiment 5, chlocibutamine 100g, sabril 800g, prepares 1000 according to a conventional method.
Embodiment 6, chlocibutamine 75g, sabril 300g, prepares 1000 according to a conventional method.
Test example 1：
Inclusion criteria：At more than 18 years old age, meet part breaking-out 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；Affect the treatment with activity mental patient etc. or security judgement person.
70, man 34, female 36.Be randomly divided into 7 groups, every group of 10 people, be respectively chlocibutamine group, sabril group,
1 group to 6 groups of embodiment.Continuous use 2 months, during medication, the previous moon as adjustment period, takes the breaking-out situation of the latter moon
Judgement as therapeutic effect.
Observation index：The total inspection phase is 8 weeks.Observe every 2 weeks once and check rehabilitation diary, every four weeks progress blood routine,
EEG(electrocardiogram) examination after treatment before routine urinalysis, Liver and kidney function and ECG examination, 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, takes chlocibutamine piece, 200mg/ pieces, 2 times a day, 1 tablet once.
Sabril group：500mg/ pieces, 1 tablet once, 2 times a day, can increase by 0.5 gram daily later, to 3 times a day, often
Secondary 2.
The tablet 2 times of 1 group of -5 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
Osmanthus butylamine is acted synergistically with sabril compatibility.
Test example 2, Mr. Wang, female, 62 years old, clinical definite was epilepsy part breaking-out patient, and medical history 6 years, once took benzene bar ratio
Appropriate, 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, patient
Valproic acid 200mg/ is taken, 1 tablet each time, three times a day, the moon breaks out 9 times or so.After be changed to take sabril 500mg/ pieces
3 times a day, 2 tablets once, takes 3 months, the moon attack times 7 times.Through soliciting patient and family members' opinion, the heart tried is had in arms
State, takes 6 composition of the embodiment of the present invention, and day takes medicine 2 times, 1 time 1.Second month plays record number of incidences as moon breaking-out 4
It is secondary.
Above test example proves that the present composition has prominent synergy to treatment epileptic condition.Illustrate chlorine osmanthus fourth
The combination of amine and sabril has unexpected Clinical practice effect.
Claims (4)
1. a kind of compound medicament composition for treating epilepsy, contains chlocibutamine and sabril, it is characterised in that unit dose
Composition in, contain 300~1500mg of sabril, 75~200mg of chlocibutamine.
2. composition according to claim 1, it is characterised in that in the composition of unit dose, containing sabril 400~
1200mg, 80~180mg of chlocibutamine.
3. composition according to claim 1, it is characterised in that in the composition of unit dose, containing sabril 500~
1000mg, 80~150mg of chlocibutamine.
4. composition according to claim 1, it is characterised in that in the composition of unit dose, containing sabril 700~
900mg, 100~150mg of chlocibutamine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310254723.XA CN103315987B (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 |
|---|---|---|---|
| CN201310254723.XA CN103315987B (en) | 2013-06-15 | 2013-06-15 | A kind of pharmaceutical composition for treating epilepsy |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103315987A CN103315987A (en) | 2013-09-25 |
| CN103315987B true CN103315987B (en) | 2018-05-11 |
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ID=49185223
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310254723.XA Expired - Fee Related CN103315987B (en) | 2013-06-15 | 2013-06-15 | A kind of pharmaceutical composition for treating epilepsy |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103315987B (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101838216A (en) * | 2010-05-24 | 2010-09-22 | 威海迪素制药有限公司 | Preparation method of chlocibutamine |
| CN102258508A (en) * | 2011-04-14 | 2011-11-30 | 威海迪素制药有限公司 | Application of arylacrylic acid derivatives in epilepsy resistance |
-
2013
- 2013-06-15 CN CN201310254723.XA patent/CN103315987B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101838216A (en) * | 2010-05-24 | 2010-09-22 | 威海迪素制药有限公司 | Preparation method of chlocibutamine |
| CN102258508A (en) * | 2011-04-14 | 2011-11-30 | 威海迪素制药有限公司 | Application of arylacrylic acid derivatives in epilepsy resistance |
Non-Patent Citations (1)
| Title |
|---|
| A Review of Pharmacology and Clinical Use of Piperine and Its Derivatives;Yin Quan Pei;《Epilepsia 》;19830430;第24卷;177-182 * |
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| Publication number | Publication date |
|---|---|
| CN103315987A (en) | 2013-09-25 |
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Legal Events
| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| TA01 | Transfer of patent application right | ||
| 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 Industry Group Corp., 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 Industry Group Corp., Ltd. Applicant before: Weihai Dizhiya Pharmaceutical Co., Ltd. Applicant before: Weihai Disu Pharmaceutical Co., Ltd. |
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| GR01 | Patent grant | ||
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| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20180511 Termination date: 20200615 |