CN103315987A - Pharmaceutical composition for treating epilepsy - Google Patents
Pharmaceutical composition for treating epilepsy Download PDFInfo
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- CN103315987A CN103315987A CN201310254723XA CN201310254723A CN103315987A CN 103315987 A CN103315987 A CN 103315987A CN 201310254723X A CN201310254723X A CN 201310254723XA CN 201310254723 A CN201310254723 A CN 201310254723A CN 103315987 A CN103315987 A CN 103315987A
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- vigabatrin
- chlocibutamine
- epilepsy
- pharmaceutical composition
- treating epilepsy
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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 by containing DCPB and vigabatrin. 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 central nervous system depressants 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 because the chronic brain diseases that Different types of etiopathogenises causes is feature thereby cause the transience central nervous system function with the cerebral neuron paradoxical discharge unusually.Document announcement is arranged, and domestic Epidemiological study shows that 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 epilepsy at present remains Drug therapy, and its medication purpose is to reduce or stop outbreak.At present, the method for still not having effectively prevention and curing, so treatment of epilepsy is lifelong often, and because there is untoward reaction in most drug, and some side effect still is irreversible, and life-time service makes the patient be difficult to accept, so cause the interruption for the treatment of and the state of an illness repeatedly.
Vigabatrin is the depressant of the main digestive enzyme GABA of GABA medium enzyme, and it can make cerebrospinal fluid GABA level improve.This medicine has safety, characteristics effective and that use easily in European extensive use, and is all effective to all types of epilepsy, to the partial seizure better effects if.But vigabatrin should not be used for petit mal, myoclonic seizure.
The purpose of this invention is to provide a kind of compositions, improve patient's compliance, reach the purpose of control epilepsy, reduce the generation of side effect simultaneously.For the epileptic provides a kind of safe, effective and inexpensive clinical application.
The applicant finds through overtesting, and chlocibutamine and vigabatrin 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 vigabatrin.
Optimized technical scheme of the present invention is: in the compositions of unit dose, contain vigabatrin 300～1500mg, chlocibutamine 75～200mg.
Optimized technical scheme of the present invention is: in the compositions of unit dose, contain vigabatrin 400～1200mg, chlocibutamine 80～180mg.
Optimized technical scheme of the present invention is: in the compositions of unit dose, contain vigabatrin 500～1000mg, chlocibutamine 80～150mg.
Optimized technical scheme of the present invention is: in the compositions of unit dose, contain vigabatrin 700～900mg, chlocibutamine 100～150mg.
The conventional amount used of the present composition is oral 1,2 times on the 1st.
Present composition preparation of pharmaceutical formulations 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 compatibility of chlocibutamine and vigabatrin, is obtaining beyond thought synergism aspect the treatment epilepsy.Under the prerequisite that guarantees therapeutic effect, the side effect of energy vigabatrin clinical application has improved clinical therapeutic efficacy.
Embodiment 1, chlocibutamine 200g, vigabatrin 300g prepares 1000 according to a conventional method.
Embodiment 2, chlocibutamine 75g, vigabatrin 1500g prepares 1000 according to a conventional method.
Embodiment 3, chlocibutamine 90g, vigabatrin 500g prepares 1000 according to a conventional method.
Embodiment 4, chlocibutamine 100g, vigabatrin 600g prepares 1000 according to a conventional method.
Embodiment 5, chlocibutamine 100g, vigabatrin 800g prepares 1000 according to a conventional method.
Embodiment 6, chlocibutamine 75g, vigabatrin 300g prepares 1000 according to a conventional method.
Test example 1:
Go into the group standard: the age met partial seizure class definition (1985) more than 18 years old; Do not treat history, epilepsy frequency 2 times every month or more than; Confirm to have epileptiform discharge through EEG (electrocardiogram) examination; Be ready to participate in test and compliance is preferably arranged.
Exclusion standard: non-Epileptic fits; Be associated with 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 34 examples, women 36 examples.Be divided into 7 groups at random, every group of 10 people are respectively 1 group to 6 groups of chlocibutamine group, vigabatrin group, embodiment.Continuous use 2 months, during the medication, previous month as the phase of adjustment, get back 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 treatment back EEG (electrocardiogram) examination before the treatment, and with regard to epilepsy number of times, drug dose, untoward reaction extremely degree record and curative effect assessment be once.
The chlocibutamine group is taken the chlocibutamine sheet, 200mg/ sheet, every day 2 times, each 1.
The vigabatrin group: the 500mg/ sheet, each 1, every day 2 times, but increase later on by 0.5 gram every day, to every day 3 times, each 2.
1 group-5 groups of embodiment take the tablet 2 times of corresponding embodiment, each 1 every day.
Judgment criteria: outbreak control, there is not 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 effect of present composition treatment epilepsy illustrates that apparently higher than the folk prescription medicine of matched group synergism has taken place for chlocibutamine and vigabatrin compatibility.
Test example 2, the Wang, the woman, 62 years old, clinical definite was epilepsy partial seizure patient, and medical history 6 years was once taken phenobarbital, 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 valproic acid 200mg/ grain, and each 1, every day three times, month outbreak about 9 times.After change into and take vigabatrin 500mg/ sheet every day 3 times, each 2, took month attack times 7 times 3 months.Through soliciting patient and family members' suggestion, have the phychology of trying in arms, take the embodiment of the invention 6 compositionss, day take medicine 2 times, 1 time 1.Play record morbidity number of times in the second month and be month outbreak 4 times.
More than the bright present composition of test illustration has outstanding synergy to the treatment epileptic condition.The combination that chlocibutamine and vigabatrin 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 vigabatrin.
2. according to the described compositions of claim 1, it is characterized in that, in the compositions of unit dose, contain vigabatrin 300～1500mg, chlocibutamine 75～200mg.
3. according to the described compositions of claim 1, it is characterized in that, in the compositions of unit dose, contain vigabatrin 400～1200mg, chlocibutamine 80～180mg.
4. according to the described compositions of claim 1, it is characterized in that, in the compositions of unit dose, contain vigabatrin 500～1000mg, chlocibutamine 80～150mg.
5. according to the described compositions of claim 1, it is characterized in that, in the compositions of unit dose, contain vigabatrin 700～900mg, chlocibutamine 100～150mg.
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 true CN103315987A (en) | 2013-09-25 |
| CN103315987B CN103315987B (en) | 2018-05-11 |
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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 |
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| 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 |
|---|
| YIN QUAN PEI: "A Review of Pharmacology and Clinical Use of Piperine and Its Derivatives", 《EPILEPSIA 》 * |
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| CN103315987B (en) | 2018-05-11 |
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| C06 | Publication | ||
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| 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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| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20180511 Termination date: 20200615 |
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| CF01 | Termination of patent right due to non-payment of annual fee |