CN103315989A - Pharmaceutical composition - Google Patents
Pharmaceutical composition Download PDFInfo
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- CN103315989A CN103315989A CN2013102546504A CN201310254650A CN103315989A CN 103315989 A CN103315989 A CN 103315989A CN 2013102546504 A CN2013102546504 A CN 2013102546504A CN 201310254650 A CN201310254650 A CN 201310254650A CN 103315989 A CN103315989 A CN 103315989A
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- chlocibutamine
- ammonia ester
- epilepsy
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- pharmaceutical composition
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Abstract
The invention relates to a composition for treating epilepsy, belongs to the technical field of medicine and provides a compound pharmaceutical composition for treating epilepsy. The pharmaceutical composition is characterized in that DCPB and felbamate are combined, and an unexpected synergistic action is obtained in the aspect of epilepsy treatment. The composition provided by the invention has the advantages that the aim of controlling epileptic seizure is achieved through improving the medication compliance of patients, and meanwhile, the side effects of felbamate in clinical medication are reduced. A safe and effective clinical drug is provided for the epileptic.
Description
Technical field: the present invention relates to a kind of compositions for the treatment of epilepsy, belong to medical technical field.
Background technology: epilepsy is the chronic brain diseases that causes owing to Different types of etiopathogenises, thereby causes the transience central nervous system function unusually as feature take the cerebral neuron paradoxical discharge.Document announcement is arranged, domestic Epidemiological study demonstration, the sickness rate of domestic epilepsy is near 1 ‰, and prevalence is about 4 ‰～9 ‰.The existing epileptic of China is nearly more than 5,000,000, and it is main that the best approach of controlling at present epilepsy remains Drug therapy, and its medication purpose is to reduce or stop outbreak.At present, there is no the method for effective prevention and healing, so the treatment of epilepsy is lifelong often, and because there is untoward reaction in most drug, and some side effect or irreversible, life-time service make the patient be difficult to accept, therefore cause the interruption for the treatment of and the state of an illness repeatedly.
Non-ammonia ester is a kind of antiepileptic of extensive use, but single application or share the treatment partial seizures with other antuepileptic.The common side effect of this product is that gastrointestinal reaction is felt sick, vomiting, anorexia etc., and nervous system reaction dizziness, insomnia, sleepy, diplopia etc.
The purpose of this invention is to provide a kind of compositions, improve patient's compliance, reach the purpose of control epilepsy, reduce simultaneously the generation of side effect.For the epileptic provides a kind of safe and effective clinical application.
The applicant finds through overtesting, and chlocibutamine and non-ammonia ester compatibility are being obtained beyond thought synergism aspect the treatment epilepsy.
Technical scheme:
A kind of compound medicament composition for the treatment of epilepsy is characterized in that, contains chlocibutamine and non-ammonia ester.
The preferred technical scheme of the present invention is: contain non-ammonia ester 900～1800mg in the compositions of unit dose, chlocibutamine 75～200mg.
The preferred technical scheme of the present invention is: contain non-ammonia ester 1000～1600mg in the compositions of unit dose, chlocibutamine 85～180mg.
The preferred technical scheme of the present invention is: contain non-ammonia ester 1200～1500mg in the compositions of unit dose, chlocibutamine 100～150mg.
The preferred technical scheme of the present invention is: contain non-ammonia ester 1300mg in the compositions of unit dose, chlocibutamine 100mg.
The conventional amount used of the present composition is oral 1,2 times on the 1st.
Present composition pharmaceutical preparation preparation method preparation routinely.
The present composition can also be prepared as slow releasing preparation.
The present composition can be prepared as controlled release preparation.According to the drug release situation selection unit dosage in the body.
The invention has the beneficial effects as follows provides a kind of compositions, by the reasonable compatibility of chlocibutamine and non-ammonia ester, under the prerequisite that guarantees therapeutic effect, has reduced the side effect of the clinical application of non-ammonia ester, has improved clinical therapeutic efficacy.
Embodiment 1, chlocibutamine 200g, non-ammonia ester 900g prepares 1000 according to a conventional method.
Embodiment 2, chlocibutamine 75g, non-ammonia ester 1800g prepares 1000 according to a conventional method.
Embodiment 3, chlocibutamine 160g, non-ammonia ester 1000g prepares 1000 according to a conventional method.
Embodiment 4, chlocibutamine 100g, non-ammonia ester 1600g prepares 1000 according to a conventional method.
Embodiment 5, chlocibutamine 100g, non-ammonia ester 1300g prepares 1000 according to a conventional method.
Embodiment 6, chlocibutamine 75g, non-ammonia ester 900g prepares 1000 according to a conventional method.
Test example 1:
Enter the group standard: the age met epilepsy partial seizure class definition (1985) more than 18 years old; Do not treat history, the epilepsy frequency per month 2 times or more than; Confirm to have epileptiform discharge through EEG (electrocardiogram) examination; Be ready to participate in test and preferably compliance is arranged.
Exclusion standard: non-Epileptic fits; Be associated with the serious diseases such as cardiovascular, liver, kidney and hemopoietic system; Medicine and alcohol abuse history are arranged; Prepare gestation or women breast-feeding their children; Affect the treatment or safety judgement person with activeness psychotic etc.
70 examples, male 32 examples, women 38 examples.Be divided at random 7 groups, every group of 10 people are respectively 1 group to 5 groups of the non-ammonia ester of chlocibutamine group group, embodiment.Continuous use 2 months, during the medication, previous month as the phase of adjustment, get rear one month outbreak situation as the judgement of therapeutic effect.
Observation index: the total inspection phase was 8 weeks.The rehabilitation diary is observed once and checked to per 2 weeks, carry out routine blood test, routine urinalysis, liver, renal function and Electrocardioscopy around every, and EEG (electrocardiogram) examination after the treatment before the treatment, and with regard to epilepsy number of times, drug dose, untoward reaction extremely degree record and curative effect evaluation be once.
The chlocibutamine group is taken the chlocibutamine sheet, 200mg/ sheet, every day 2 times, each 1.
Non-ammonia ester group is taken non-ammonia ester, 400mg/ sheet, each 3, every day three times.
1 group-5 groups of embodiment take the tablet 2 times of corresponding embodiment, each 1 every day.
Judgment criteria: outbreak control, nothing outbreak in the observation period; Produce effects, attack times reduces 75%-99% in the observation period; Effectively, the observation period attack times reduces between 74%-50%; Heterodyne, observation period attack times reduce below the 26%-49%; Invalid, the observation period attack times reduces below 25%; Worsen, attack times increases more than 25%.
Digital proof in the table: the successful of present composition treatment epilepsy is higher than the folk prescription medicine of matched group, illustrates that synergism has occured the reasonable compatibility of chlocibutamine and non-ammonia ester.
Test example 2, Lee, the woman, 46 years old, clinical definite was partial epilepsy, and medical history 6 years was once taken barbital, O'Casey equality medicine, can not effectively control outbreak, and patient and family are subjected to the torment of this disease deeply.Before this on-test, the patient takes non-ammonia ester 400mg/ sheet, and each 3, every day three times, month outbreak about 8 times.Take chlocibutamine every day 2 times, 2 of each 200mg/ sheets 3 months, month attack times is not improved.Through soliciting patient and family members' suggestion, have the phychology of trying in arms, take the compositions of the embodiment of the invention 6, day take medicine 2 times, 1 time 1.Second month plays record morbidity number of times and is month outbreak 5 times.The patient has eliminated nauseating, the dizzy phenomenon that occurs because taking other drug basically simultaneously, and readme can be felt good.
Test example 3, high certain, the man, 48 years old, clinical definite was partial epilepsy, medical history 7 years was once taken multiple antiepileptic, can not effectively control outbreak, patient and family are subjected to the torment of this disease deeply.Before this on-test, the patient takes non-ammonia ester 400mg/ sheet, and each 3, every day three times, month outbreak about 8 times.Take chlocibutamine every day 2 times, 2 of each 200mg/ sheets 3 months, month attack times is not improved.Through soliciting patient and family members' suggestion, take the compositions of the embodiment of the invention 5, day take medicine 2 times, 1 time 1.Second month plays record morbidity number of times and is month outbreak 3 times.The patient has eliminated nauseating, dizzy, the insomnia phenomenon that occurs because taking other drug basically simultaneously, and readme can be felt good.
The above test example proof present composition has outstanding synergy to the treatment epileptic condition.The combination that chlocibutamine and non-ammonia ester are described has beyond thought clinical result of use.
Claims (5)
1. a compound medicament composition for the treatment of epilepsy is characterized in that, contains chlocibutamine and non-ammonia ester.
2. according to the described compositions of claim 1, it is characterized in that, contain non-ammonia ester 900～1800mg in the compositions of unit dose, chlocibutamine 75～200mg.
3. according to the described compositions of claim 1, it is characterized in that, contain non-ammonia ester 1000～1600mg in the compositions of unit dose, chlocibutamine 85～180mg.
4. according to the described compositions of claim 1, it is characterized in that, contain non-ammonia ester 1200～1500mg in the compositions of unit dose, chlocibutamine 100～150mg.
5. according to the described compositions of claim 1, it is characterized in that, contain non-ammonia ester 1300mg in the compositions of unit dose, chlocibutamine 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 true CN103315989A (en) | 2013-09-25 |
| CN103315989B CN103315989B (en) | 2018-05-11 |
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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 |
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| 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 |
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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 |
|---|
| YIN QUAN PEI: "A Review of Pharmacology and Clinical Use of Piperine and Its Derivatives", 《EPILEPSIA》 * |
| 刘玲: "丹参对癫痫大鼠脑电图及脑内Fos、GFAP表达的影响", 《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》 * |
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| Publication number | Publication date |
|---|---|
| CN103315989B (en) | 2018-05-11 |
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| CF01 | Termination of patent right due to non-payment of annual fee |