CN108478567A - Novel pharmaceutical formulation - Google Patents
Novel pharmaceutical formulation Download PDFInfo
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- CN108478567A CN108478567A CN201810242037.3A CN201810242037A CN108478567A CN 108478567 A CN108478567 A CN 108478567A CN 201810242037 A CN201810242037 A CN 201810242037A CN 108478567 A CN108478567 A CN 108478567A
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- Prior art keywords
- bruceine
- gingko
- acid
- peltain
- migraine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
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- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Neurosurgery (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- General Chemical & Material Sciences (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to a kind of novel pharmaceutical formulations, specifically a kind of dosage form of drug that treating neurogenic disease, specifically, the drug include bruceine B, gingko eo-acid and peltain.The drug can effectively treat migraine.
Description
Technical field
The present invention relates to a kind of novel pharmaceutical formulation, specifically a kind of dosage form of drug that treating neurogenic disease, specifically
Ground, the drug include bruceine B, gingko eo-acid and peltain.The drug can effectively treat migraine.
Background technology
Migraine is a kind of symptom making one weakness, it is characterised in that the headache of moderate to severe and nausea, in women
It is more conventional, it is about 3 times of male.Typical migraine is Unilateral pain (influencing half head) and beating feature, continues 4 to 72
Hour；Symptom includes Nausea and vomiting, photophobia (sensitiveness to light increase), probably ring and (increase sound sensitive degree) and can be by daily
Activity aggravates.About 1/3 people by migraine discovers the abnormal vision of migraine aura-, smell or other feeling bodies
It tests, these experience are the signs that migraine will break out.First treatment is usually that antalgesic is used to have a headache, antiemetic is used for nausea,
And/or avoid trigger condition.The origin cause of formation of migraine is unclear；It is most common theoretical for the control system disorder of serotonin energy.
China's migraine epidemiological survey, by random or reconnaissance 3837597 people of sampling.Patient 37808 is found altogether, is suffered from
Sick rate is 98,52/,100,000, and incidence is 7,97/,100,000.Land plateau is the high illness area in China, Central-South coastal provinces and cities' illness rate
It is low.The ratio between men and women is 1：4.25~29 years old illness rate highests (1927.4/10 ten thousand), 10 years old or less minimum (42.6/10 ten thousand).The north
Hinterland is in summer Headache attacks frequency highest, and southern area is with spring highest.
The pathogenesis of migraine is not still fully aware of, and traditional blood vessel theory thinks, migraine is primary vascular diseases.
Intracranial vessel contraction causes migraine aura symptom, and subsequent cranium is outer, intracranial vessel is expanded, and tissues surrounding vascular generates vasoactive
Polypeptide causes aseptic inflammation to lead to the headache of pulsation.Neural theory thinks, when migraine the variation of nervous function be
Primary, the variation of blood flow is secondary.Serotonin (5-HT) participates in headache, and when Headache attacks, 5-HT is small from blood
It is disengaged in plate, directly acts on encephalic thin vessels and be allowed to shrink, and invest on vascular wall.When blood plasma 5-HT concentration declines, make
For the tension shrinkage event resolves of main artery, vascular wall expansion is had a headache.5-HT is both a kind of neurotransmitter and one
Kind circulatory mediator, has an impact nerve and blood vessel.Trigemino-vascular theory thinks that gasserian ganglion damage may be inclined head
The neural basal that pain generates.
Present inventor has found that the combination of bruceine B, gingko eo-acid and peltain can by the research of several years
For treating and/or preventing neurogenic disease especially migraine, and there is synergistic therapeutic effect.This achievement in research is current
It is not found in document report.
Invention content
One aspect of the present invention provides the pharmaceutical preparation comprising bruceine B, gingko eo-acid and peltain and exists
Prepare the purposes in the drug for the treatment of and/or prevention neurogenic disease.
Another aspect of the present invention provides a kind of pharmaceutical preparation treated and/or prevent neurogenic disease, wherein wrapping
Include the combination of bruceine B, gingko eo-acid and peltain.
Another aspect of the present invention, above-mentioned neurogenic disease refer to migraine.
Said medicine preparation include capsule, tablet, pill, granule, powder, oral solution, injection, freeze-dried powder,
Spray, film, patch etc..
Above-mentioned pharmaceutically acceptable carrier includes filler, disintegrant, adhesive, lubricant, corrigent etc..
Another aspect of the present invention, the quality of bruceine B, gingko eo-acid and peltain in said medicine preparation
Ratio is 1-10:1-10:1-10.
Another aspect of the present invention, the quality of bruceine B, gingko eo-acid and peltain in said medicine preparation
Ratio is 5-10:1-5:5-10.
Another aspect of the present invention, the quality of bruceine B, gingko eo-acid and peltain in said medicine preparation
Ratio is 10:3:7.
Another aspect of the present invention, the quality of bruceine B, gingko eo-acid and peltain in said medicine preparation
Ratio is 1:1:1.
Another aspect of the present invention, the quality of bruceine B, gingko eo-acid and peltain in said medicine preparation
Ratio is 5:2:8.
Another aspect of the present invention, the combination of bruceine B, gingko eo-acid and peltain be " for simultaneously, point
Not or the joint agent used successively or pharmaceutical composition ", especially refer to a kind of " group subpackage ", mean component bruceine B,
Gingko eo-acid and peltain can be applied or be applied by the different fixed Combinations with different component content each independently,
In different time points or it is administered simultaneously.So, organizing the component of subpackage can for example be administered simultaneously or be spaced application in chronological order, i.e.,
In different time points and with the arbitrary component of identical or different time interval administration group subpackage.Preferably, between the selected time
Any individual obtained effect of component is used only every that should make to be used in combination component and be higher than to the effect of treated disease or illness.
Term " prevention " refer to healthy patients prophylactically using it is described combination with prevent disease described herein and
Illness occurs.In addition, term " prevention " may point to, the patient in disease early period to be treated is preventative to apply the combination.
Each component can be used simultaneously or successively, and the component with any in the present invention combination of therapeutically effective amount
It can apply or be applied as fixed Combination respectively.Single component in combination can respectively be applied in the different time during treatment
Or with separated or single combining form and application.In addition, term " use " further includes use can be converted into institute in vivo
The prodrug of any drug of the drug of selection.It therefore, should invention is construed as either simultaneously or alternately treated including all these
Scheme, and correspondingly term " use " should be explained.
The preferred route of administration of dosage form of the present invention is through enteral or preferred oral route.Since application is convenient, tablet
The best oral dosage unit form with Capsules representative, in this case, it is evident that solid pharmaceutical carriers need to be used.
The effective dose of each active constituent used in combined therapy can be with used specific pharmaceutical composition
Object, occupation mode or state of the illness and change.
Specific implementation mode
Embodiment 1：The preparation of tablet
Bruceine B 15g
Gingko eo-acid 15g
Peltain 15g
Above-mentioned active constituent is taken, the customary adjuvant that addition prepares tablet is appropriate, mixing, and conventional tablet presses are made 1500.
Embodiment 2：The preparation of tablet
Bruceine B 10g
Gingko eo-acid 3g
Peltain 7g
Above-mentioned active constituent is taken, the customary adjuvant that addition prepares tablet is appropriate, mixing, and conventional tablet presses are made 1000.
Embodiment 3：The preparation of capsule
Bruceine B 5g
Gingko eo-acid 2g
Peltain 8g
Above-mentioned active constituent is taken, the customary adjuvant that addition prepares capsule is appropriate, mixing, encapsulated to be made 1000.
It is as follows that experimental example 4. carries out animal experiment to the pharmaceutical composition for treating migraine：
230~260g male guinea pigs are randomly divided into blank group, model group, active compound treatment group of the present invention, control
Embodiment group, Gastrodin capsule for treating group (Kunming Medicine Group Stock Co., Ltd's production), every group 10.Before modeling every group it is pre-
5d is administered in anti-property, is gastric infusion；Composition of embodiment of the present invention group, comparative examples group and Rhizoma Gastrodiae cellulose capsule dosage
For 14mg/kg weight.For model group with blank group in addition to the physiological saline of injection equivalent, other processing are identical as each group.
In addition to blank control group, nitroglycerin injection 10mg/ is subcutaneously injected after treatment in the 5th day in remaining each group animal
Kg, to experimental migraine animal model.The hints models such as increase to occur that ears are rubescent, forelimb is frequently scratched one's head, climb cage number
The symptom of animal head discomfort is the successful index of modeling.
The time of the red appearing and subsiding of ear after observation rat modeling；In per a period of time after rat modeling from from the modeling
Between the difficult to tackle number of section；There is continuous number difficult to tackle up to 5 times or more for mark with rat in time of occurrence difficult to tackle, and extinction time is with one
Rat scratches one's head number less than 5 times and burnout occurs, tired show as indicating in a period.
After observing rat behavior evaluation, by animal sacrificed by decapitation, brain is taken, is rapidly separated brain stem, is weighed, is put into advance
In the cryopreservation tube of number, it is quickly placed into liquid helium and stores, it is spare.5- hydroxyls in rat brain are measured using efficient liquid phase (electrochemical process)
The monoamine neurotransmitters such as tryptamines (5-HT), 5-hydroxyindoleacetic acid (5-HIAA), dopamine (DA) and norepinephrine (NE)
Content.Experimental result is shown in Table 1~table 3.
Comparative examples 1：Bruceine B
Comparative examples 2：Gingko eo-acid
Comparative examples 3：Peltain
1. present composition of table is to the red appearance of each group experiment rat ears and the influence of extinction time
2. present composition of table is difficult to tackle to each group experiment rat 3h and gets rid of the influence of a number
| Group | n | Number difficult to tackle | Get rid of a number |
| Blank group | 10 | 15 | 2 |
| Model group | 10 | 42 | 13 |
| Embodiment 1 | 10 | 19 | 5 |
| Embodiment 2 | 10 | 21 | 5 |
| Embodiment 3 | 10 | 17 | 4 |
| Gastrodin Capsules group | 10 | 23 | 6 |
| Comparative examples 1 | 10 | 25 | 8 |
| Comparative examples 2 | 10 | 29 | 10 |
| Comparative examples 3 | 10 | 37 | 11 |
3. present composition of table tests each group the influence of 5-HT, 5-HIAA, DA and NE in rat cerebral tissue
Experiment find, composition of embodiment of the present invention treatment group and Gastrodin capsule for treating group it is red to Migraine Rats ear,
It scratches first-class behavior and all has intervention effect, it can serotonin, dopamine and norepinephrine in significantly raised rat cerebral tissue
Content.Model group intracerebral neurotransmitter NE, 5-HT content is decreased obviously, and DA changes of contents is little, illustrate migraine with
The certain nerve cell secreting functions of brain stem decline related.Present composition treatment group obviously changes levels of monoamine neurotransmitters
It is kind, hence it is evident that increase brain tissue 5-HT, NE, DA, illustrate the related neuron of present composition energy nutrition body, it is promoted to control
Transmitter substance generation increases, so as to improve cephalagra.
In conclusion the present composition has shortsightedness therapeutic action to the Migraine Rats caused by nitroglycerin,
Mechanism of action and intracerebral neurotransmitter 5-HT, DA, NE are closely related.
Embodiment 5：
It will illustrate therapeutic effect of the pharmaceutical composition of the present invention to migraine by human body pharmacodynamic experiment below.
Clinical 100 migraine patients, age 20-60 Sui.The course of disease of selected case was answered at least a year, and to nearly 3 months
Headache attacks history it is clearer.Selected case is in nearly 1 month medicine that migraine need to be not used, to avoid other medicines
Influence of the object to this experiment.The breaking-out situation of selected case at least should monthly break out 2 times, usually monthly break out 2-6 times.
Diagnostic criteria：According to [International Headache association (International Headache Society, IHS) is formulated
《Migraine diagnostic criteria》.
Therapy：By 100 migraine patients, 5 groups are divided into using randomized, wherein negative control group takes peace
Console agent；Positive controls take 100mg Topiramates/day；Experimental group takes 100mg embodiments 1-3/ days.
Efficacy assessment standard：
According to [International Headache association (International Headache Society, IHS) is formulated《Migraine is examined
Disconnected standard》It drafts.Headache disappears in 1 hour after patient on medication's treatment or the patient of headache relief has been accordingly to be regarded as in 2 hours
Effect.After 2 hours cannot the person of alleviation be considered as in vain.
Treatment results：Record is 2 small after patient records headache severity and medication when breaking out after treatment in the form of diary
When interior pain relief degree, statistical result is as shown in the table：
Statistical result
| Group | n | Recovery from illness | Effectively | In vain | Total effective rate |
| 1 group of embodiment | 20 | 12 | 8 | 0 | 100% |
| 2 groups of embodiment | 20 | 8 | 11 | 1 | 95% |
| 3 groups of embodiment | 20 | 15 | 5 | 0 | 100% |
| Positive controls | 20 | 8 | 8 | 4 | 80% |
| Negative control group | 20 | 0 | 1 | 19 | 5% |
As can be seen from the above table, the effect of the effect of embodiment 1-3 treatment groups patient, is substantially better than control group patient.
Claims (10)
1. the pharmaceutical preparation comprising bruceine B, gingko eo-acid and peltain is preparing treatment and/or is preventing nerve disease
Purposes in the drug of disease, wherein the pharmaceutical preparation is capsule, tablet, pill, granule, powder, oral solution, injection
Liquid, freeze-dried powder, spray, film or patch.
2. purposes as described in claim 1, wherein neurogenic disease are migraine.
3. the mass ratio of purposes as claimed in claim 1 or 2, wherein bruceine B, gingko eo-acid and peltain is
1-10:1-10:1-10。
4. the quality of purposes as described in any one of claims 1-3, wherein bruceine B, gingko eo-acid and peltain
Ratio is 5-10:1-5:5-10.
5. the quality of purposes as described in any one of claims 1-3, wherein bruceine B, gingko eo-acid and peltain
Ratio is 10:3:7、1:1:1 or 5:2:8.
6. the pharmaceutical preparation of a kind for the treatment of and/or prevention neurogenic disease, including bruceine B, gingko eo-acid and/or shield
Leaf podophyllotoxin, wherein the pharmaceutical preparation is capsule, tablet, pill, granule, powder, oral solution, injection, freeze-dried powder
Needle, spray, film or patch.
7. pharmaceutical preparation as claimed in claim 6, wherein neurogenic disease are migraine.
8. the mass ratio of pharmaceutical preparation as claimed in claims 6 or 7, wherein bruceine B, gingko eo-acid and peltain
Example is 1-10:1-10:1-10.
9. such as claim 6-8 any one of them pharmaceutical preparations, wherein bruceine B, gingko eo-acid and peltain
Mass ratio is 5-10:1-5:5-10.
10. such as claim 6-8 any one of them pharmaceutical preparations, wherein bruceine B, gingko eo-acid and peltain
Mass ratio is 10:3:7、1:1:1 or 5:2:8.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810242037.3A CN108478567A (en) | 2018-03-22 | 2018-03-22 | Novel pharmaceutical formulation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810242037.3A CN108478567A (en) | 2018-03-22 | 2018-03-22 | Novel pharmaceutical formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108478567A true CN108478567A (en) | 2018-09-04 |
Family
ID=63319426
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810242037.3A Withdrawn CN108478567A (en) | 2018-03-22 | 2018-03-22 | Novel pharmaceutical formulation |
Country Status (1)
| Country | Link |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111494439A (en) * | 2020-04-21 | 2020-08-07 | 南通大学 | Application of brucea javanica fat-soluble extract in preparation of medicine for promoting peripheral nerve regeneration |
-
2018
- 2018-03-22 CN CN201810242037.3A patent/CN108478567A/en not_active Withdrawn
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111494439A (en) * | 2020-04-21 | 2020-08-07 | 南通大学 | Application of brucea javanica fat-soluble extract in preparation of medicine for promoting peripheral nerve regeneration |
| CN111494439B (en) * | 2020-04-21 | 2021-04-27 | 南通大学 | Application of brucea javanica fat-soluble extract in preparation of medicine for promoting peripheral nerve regeneration |
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| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20180904 |
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| WW01 | Invention patent application withdrawn after publication |