CN103315989B - A kind of pharmaceutical composition - Google Patents
A kind of pharmaceutical composition Download PDFInfo
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- CN103315989B CN103315989B CN201310254650.4A CN201310254650A CN103315989B CN 103315989 B CN103315989 B CN 103315989B CN 201310254650 A CN201310254650 A CN 201310254650A CN 103315989 B CN103315989 B CN 103315989B
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- urethane
- composition
- chlocibutamine
- epilepsy
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Abstract
The present invention relates to a kind of composition for treating epilepsy, belong to pharmaceutical technology field.The present invention provides a kind of compound medicament composition for treating epilepsy, it is characterised in that chlocibutamine and non-urethane compatibility, unexpected synergistic effect is achieved in terms of epilepsy is treated.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 non-urethane 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.
Non- urethane is a kind of widely applied antiepileptic, single application or can share therapy section with other antiepileptics
Divide property epileptic attack.The common side effect of this product for gastrointestinal reaction Nausea and vomiting, apocleisis etc., and nervous system reaction it is dizzy,
Insomnia, sleepy, diplopia etc..
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.A kind of safe and effective clinical application is provided for epileptic.
Applicant has found that chlocibutamine and non-urethane compatibility, achieve unexpected in terms of epilepsy is treated through overtesting
Synergistic effect.
Technical solution：
A kind of compound medicament composition for treating epilepsy, it is characterised in that contain chlocibutamine and non-urethane.
Currently preferred technical solution is：Contain non-900~1800mg of urethane, chlocibutamine in the composition of unit dose
75~200mg.
Currently preferred technical solution is：Contain non-1000~1600mg of urethane, chlorine osmanthus fourth in the composition of unit dose
85~180mg of amine.
Currently preferred technical solution is：Contain non-1200~1500mg of urethane, chlorine osmanthus fourth in the composition of unit dose
100~150mg of amine.
Currently preferred technical solution is：Contain non-urethane 1300mg, chlocibutamine in the composition of unit dose
100mg。
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 providing a kind of composition, by chlocibutamine and the reasonable compatibility of non-urethane,
On the premise of ensureing therapeutic effect, the side effect of the clinical application of non-urethane is reduced, improves clinical therapeutic efficacy.
Embodiment 1, chlocibutamine 200g, non-urethane 900g, prepares 1000 according to a conventional method.
Embodiment 2, chlocibutamine 75g, non-urethane 1800g, prepares 1000 according to a conventional method.
Embodiment 3, chlocibutamine 160g, non-urethane 1000g, prepares 1000 according to a conventional method.
Embodiment 4, chlocibutamine 100g, non-urethane 1600g, prepares 1000 according to a conventional method.
Embodiment 5, chlocibutamine 100g, non-urethane 1300g, prepares 1000 according to a conventional method.
Embodiment 6, chlocibutamine 75g, non-urethane 900g, prepares 1000 according to a conventional method.
Test example 1：
Inclusion criteria：At more than 18 years old age, meet epilepsy part breaking-out class definition (1985)；There is no treatment history, epilepsy
Seizure 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
Property.
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 32, female 38.7 groups are randomly divided into, every group of 10 people, are respectively the non-urethane group of chlocibutamine group, implement
1 group to 5 groups of example.Continuous use 2 months, during medication, the previous moon as adjustment period, takes the breaking-out situation conduct of the latter moon
The judgement of 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.
Non- urethane group, takes non-urethane, 400mg/ pieces, 3 tablets once, three times a day.
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 and the reasonable compatibility of non-urethane are acted synergistically.
Test example 2, Lee, female, 46 years old, clinical definite was partial epilepsy, and medical history 6 years, once took barbital, oka
The medicines such as Xiping, it is impossible to which effectively control breaking-out, patient and family are tormented by the disease deeply.Before this on-test, patient takes non-
Urethane 400mg/ pieces, 3 tablets once, and three times a day, the moon breaks out 8 times or so.Take chlocibutamine 2 times a day, each 200mg/ pieces 2
Piece 3 months, the moon attack times do not improve.Through soliciting patient and family members' opinion, the phychology tried is had in arms, take of the invention real
Apply the composition of example 6, day takes medicine 2 times, 1 time 1.Second month plays record number of incidences and breaks out 5 times for the moon.Patient is basic at the same time
On eliminate nausea, dizzy phenomenon because taking other drugs appearance, readme can feel good.
Test example 3, it is high certain, man, 48 years old, clinical definite was partial epilepsy, and medical history 7 years, once took a variety of anti-epileptics
Medicine, it is impossible to which effectively control breaking-out, patient and family are tormented by the disease deeply.Before this on-test, patient takes non-urethane
400mg/ pieces, 3 tablets once, and three times a day, the moon breaks out 8 times or so.Take chlocibutamine 2 times a day, each 200mg/ pieces 23
A month, the moon attack times do not improve.Through soliciting patient and family members' opinion, the composition of the embodiment of the present invention 5, day medication are taken
2 times, 1 time 1.Second month plays record number of incidences and breaks out 3 times for the moon.Patient is substantially eliminated because taking other medicines at the same time
Nausea, dizziness, the insomnia phenomenon of thing appearance, readme can feel good.
Above test example proves that the present composition has prominent synergy to treatment epileptic condition.Illustrate chlorine osmanthus fourth
Amine and the combination of non-urethane have unexpected Clinical practice effect.
Claims (4)
1. a kind of compound medicament composition for treating epilepsy, contains chlocibutamine and non-urethane, it is characterised in that unit dose
Contain non-900~1800mg of urethane, 75~200mg of chlocibutamine in composition.
2. according to composition described in claim 1, it is characterised in that in the composition of unit dose containing non-urethane 1000~
1600mg, 85~180mg of chlocibutamine.
3. according to composition described in claim 1, it is characterised in that in the composition of unit dose containing non-urethane 1200~
1500mg, 100~150mg of chlocibutamine.
4. according to composition described in claim 1, it is characterised in that contain non-urethane 1300mg, chlorine in the composition of unit dose
Osmanthus butylamine 100mg.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310254650.4A CN103315989B (en) | 2013-06-15 | 2013-06-15 | A kind of pharmaceutical composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310254650.4A CN103315989B (en) | 2013-06-15 | 2013-06-15 | A kind of pharmaceutical composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103315989A CN103315989A (en) | 2013-09-25 |
| CN103315989B true CN103315989B (en) | 2018-05-11 |
Family
ID=49185225
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310254650.4A Expired - Fee Related CN103315989B (en) | 2013-06-15 | 2013-06-15 | A kind of pharmaceutical composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103315989B (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 CN201310254650.4A patent/CN103315989B/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 (2)
| Title |
|---|
| A Review of Pharmacology and Clinical Use of Piperine and Its Derivatives;Yin Quan Pei;《Epilepsia》;19830430;第24卷;177-182 * |
| 丹参对癫痫大鼠脑电图及脑内Fos、GFAP表达的影响;刘玲;《中国优秀博硕士学位论文全文数据库（硕士）医药卫生科技辑》;20050915(第5期);E057-125,10 * |
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| Publication number | Publication date |
|---|---|
| CN103315989A (en) | 2013-09-25 |
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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 |