CN103977001B - A kind of antidepressant composition and application thereof - Google Patents
A kind of antidepressant composition and application thereof Download PDFInfo
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Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention belongs to pharmaceutical field, disclose a kind of antidepressant composition and application thereof.Said composition contains the material of following weight portion: NAC 200 3000 parts, VB5 50 1500 parts and/or VB6 100 2000 parts；Further, possibly together with VB9 0.2 5 parts.Said composition has preferable antidepressant effect, can be used for preparing the medicine of depression, health product or food, and said composition few side effects, low cost, preparation method are simple, it is easy to industrial applications.
Description
Technical field
The invention belongs to pharmaceutical field, relate to a kind of antidepressant composition and application thereof.
Background technology
Depression is also known as depressive disorder, low as main clinical characteristics with notable and lasting mental state, is mood disorders
Main Types.Clinical visible mental state is low unbecoming with its situation, and the downhearted of emotion can be from depressed to extremely grieved, certainly
Inferior depression, the most pessimistic and worldweary, can there be suicidal attempt or behavior；Some cases it may also occur that the psychotic disease disease such as hallucination, vain hope
Shape.The patients with depression of China has reached 90,000,000, has 200,000 people to commit suiside because of severe depression every year.
The cause of disease of depression is the most unclear, and biological, psychology take part in sending out of depression with all many factors of social environment
Sick process.Drug therapy remains the Main Means of current various treating depression.In recent years depression mechanism is recognized
Go deep into, provide thinking for developing the antidepressant drug acting on novel targets.
N-acetylcystein, hereinafter referred to as NAC, be a kind of cystine analog.In recent years many document report NAC conducts
A kind of sulfydryl donor, or a kind of antioxidant, have the free radical disturbing free radical generation, removing to generate and regulation is thin
The metabolic activities of born of the same parents etc. act on, and have application in breathing, cardiovascular and neural Clinical and experimental study.
NAC can improve the content of body glutathion inside, and NAC is as small-molecule substance, it is easy to enters cell, deacetylated
Become the precursor of glutathione synthesis after base, promote the synthesis of glutathion, strengthen free radical resisting and antiradiation drug, the poisonous substance of tissue
The ability of damage.NAC has the effect of antibiooxidation, the sulfhydryl-group activity (-SH) in NAC molecule, can resist different reason institute
The tissue oxidizing damage caused.Internal oxygen-derived free radicals had obvious antagonism；Easily enter intracellular due to NAC, saturating to energy
Cell membrane and various kinds of cell composition react, causes hepatocyte and the downright bad oxygen-derived free radicals of neural cell injury to have suppression, clearly
Except effect.NAC is also by the protection of genotoxicity with safeguard DNA to preserve from and body is produced protective effect.
Vitamin B5 is also pantothenic acid, has the function manufacturing antibody, participates in the manufacture of energy i (in vivo), it is possible to control fat
Metabolism, be brain and the required nutrient substance of nerve.Also play the part of emphatically in terms of safeguarding hair, skin and blood health
Want role.It is the ingredient of coenzyme a and acyl carrier protein, the metabolism of coenzyme a involved in sugar, lipid and protein.Coenzyme a
The pantothenic acid of form is also by needed for acetyl and acetylation, and these conduction participating in internal signals and the activity of enzyme and degraded.?
There are some researches show that vitamin B5 can significantly improve the level of hungry rat brain glutathion inside, alleviate hungry to rat cerebral tissue
Response to oxidative stress.
Vitamin B6 is to refer to pyrrole to tremble the common name of class material, trembles because the material containing vitamin B6 activity is i.e. belonging to pyrrole
Alcohol.The constituent of vitamin B6 behaviour some coenzyme internal.Vitamin B6 participates in protein synthesis and catabolism, participates in institute
There is amino acid metabolism, as relevant in the metabolism with haemachrome, relevant with tryptophan synthesis nicotinic acid.Vitamin B6 participates in nucleic acid and DNA
Synthesizing, shortage can damage the synthesis of DNA, and this process is very important to maintaining suitable immunologic function.Rely on 2-methyl-3-hydroxy-4-formyl-5-hydroxymethylpyridine.
Phosphatic enzyme plays important role in the synthesis of 5 kinds of important neurotransmitteies: 5-hydroxy tryptamine, dopamine, adrenal gland
Element, norepinephrine and γ-aminobutyric acid.
FA, also known as folic acid, is water miscible vitamin.Coenzyme required when folic acid is nucleic acid, folic acid is not
Foot, affects nucleic acid synthesis and repairs.Folic acid is also the cofactor of the interior biological respinses of human body, and folic acid is quick at auxiliary cell
Divide and particularly important in growth, affect normal cell division and duplication.Folic acid also has anticancer effect, folic acid and nicotinic acid
Radical pair Chromosome breakage can be stoped together.
Along with going deep into for depression mechanism understanding, it is a kind of combining in fact that increasing scholar admits depression
Closing disease, its mechanism relates to that neurotransmitter and receptor, neuroendocrine, neuronal damage and cytokine etc. are many asks
Topic, pathogenesis is more complicated.But, existing antidepressants are generally directed to a certain mechanisms play effect, poor effect, mesh
Previous its cure rate of line antidepressant drug is also only 30%, and 60%-90% patient can be recurred in 1 year, and exists costly,
The shortcomings such as side effect is many.Currently without a kind of effective, treatment of low cost, few side effects or the compositions of prevention of depression.
Summary of the invention
It is an object of the invention to provide a kind of effective treatment or the compositions of prevention of depression for above-mentioned technical problem.
It is a further object to provide above-mentioned composition in preparing the medicine of depression, health product or food
Application.
It is an object of the invention to be realized by following technical proposal:
A kind of antidepressant composition, said composition contains the material of following weight portion:
NAC 200-3000 part, VB5 50-1500 part and/or VB6 100-2000 part.
Further, preferably NAC 500-1500 part, VB5 300-800 part and/or VB6 300-1000 part.
Further, preferably NAC 1000 parts, VB5 500 parts and/or VB6 500 parts.
Described compositions, said composition is possibly together with VB9 0.2-5 weight portion, and further, VB9 content is preferably 0.5-3
Weight portion；Further, VB9 content is preferably 1 weight portion.
The dosage form of described compositions is pharmacy or any dosage form of health product permission, preferably tablet, capsule, granule
Agent, powder, pill, oral liquid, injection, membrane.
The application in preparing the medicine of depression, health product or food of the described compositions.
A kind of method treating depression, the method is depressive patients to apply above-mentioned composition or by combinations thereof
The raw material of thing and consumption take each raw material respectively and jointly put on depressive patients.
Beneficial effects of the present invention:
NAC is combined by the present invention with vitamin B5, B6 and B9, forms the combination with antidepressant effect that a class is new
Thing, and find, between above-mentioned four kinds of compositions with different action target spot, there is the most collaborative antidepressant effect, said composition
Also having preferable antidepressant effect and safe and reliable in clinical trial, low cost, raw material is easy to get, it is easy to popularization and application.
The raw material of preparation said composition is used equally to food, and therefore, its few side effects, raw material sources are extensive, preparation method
Simple, it is simple to industrialized production.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is described, it should be noted that these embodiments are merely to illustrate this
Bright should not be construed as limitation of the present invention.
Any form not taking compositions but take respectively each raw material according to the present invention record consumption be provided commonly for treatment
The situation of depression falls within the content of present invention protection.
Being 1 part with 1mg in following preparation example, the preparation technology of various dosage forms and adjuvant select to be prior art.
Embodiment 1 (NB5 preparation example)
By NAC 200 parts, the ratio that VB5 is 50 parts takes each component, adds 2.5 parts of magnesium stearate, 5 parts of starch, suitable quantity of water,
Mix homogeneously, tabletting, obtain tablet.
Embodiment 2 (NB5 preparation example)
By NAC 1000 parts, the ratio that VB5 is 500 parts takes each component, adds 15 parts of carboxymethyl starch sodium (CMS-Na), suitable
Amount water, mix homogeneously, tabletting, obtain tablet.
Embodiment 3 (NB5 preparation example)
By NAC 3000 parts, the ratio that VB5 is 1500 parts takes each component, adds 30 parts of microcrystalline Cellulose, 40 parts of dextrin, suitable
Amount water, mix homogeneously, soft material processed, extrusion spheronization method is pelletized, is obtained granule.
Embodiment 4 (NB6 preparation example)
By NAC 200 parts, the ratio that VB6 is 100 parts takes each component, adds 10 parts of microcrystalline Cellulose, suitable quantity of water, and mixing is all
Even, tabletting, obtain tablet.
Embodiment 5 (NB6 preparation example)
By NAC 1000 parts, the ratio that VB6 is 500 parts takes each component, adds 20 parts of starch, 15 parts of magnesium stearate, in right amount
Water, mix homogeneously, tabletting, obtain tablet.
Embodiment 6 (NB6 preparation example)
By NAC 3000 parts, the ratio that VB6 is 2000 parts takes each component, adds 40 parts of microcrystalline Cellulose, 30 parts of stearic acid
Magnesium, 30 parts of polyvinylpolypyrrolidone, suitable quantity of water, mix homogeneously, mist projection granulating, fill capsule, obtain capsule.
Embodiment 7 (NB56 preparation example)
By NAC 200 parts, VB5 50 parts, the ratio that VB6 is 100 parts takes each component, adds 20 parts of microcrystalline Cellulose, in right amount
Water, mix homogeneously, tabletting, obtain tablet.
Embodiment 8 (NB56 preparation example)
By NAC 1000 parts, VB5 500 parts, the ratio that VB6 is 500 parts takes each component, adds 30 parts of dextrin, 15 parts of tristearin
Acid magnesium, suitable quantity of water, mix homogeneously, tabletting, obtain tablet.
Embodiment 9 (NB56 preparation example)
By NAC 3000 parts, VB5 1500 parts, the ratio that VB6 is 2000 parts takes each component, adds 50 parts of lactose, and 40 parts micro-
Crystalline cellulose, suitable quantity of water, mix homogeneously, pelletize, be dried, encapsulated, obtain capsule.
Embodiment 10 (NB569 preparation example)
By NAC 200 parts, VB5 50 parts, VB6 100 parts, the ratio that VB9 is 0.2 part takes each component, is dissolved in water, and sweetens
Leaf echinacoside seasoning, adds water to 500ml, filters, fill (5ml/ props up), sealing, and 105 DEG C of flowing steam sterilizings obtain oral liquid.
Embodiment 11 (NB569 preparation example)
By NAC 1000 parts, VB5 500 parts, VB6 500 parts, the ratio that VB9 is 1 part takes each component, adds 40 parts of crystallite fibres
Dimension element, suitable quantity of water, mix homogeneously, tabletting, obtain tablet.
Embodiment 12 (NB569 preparation example)
By NAC 3000 parts, VB5 1500 parts, VB6 2000 parts, the ratio that VB9 is 5 parts takes each component, adds 60 parts of tristearin
Acid magnesium, suitable quantity of water, mix homogeneously, tabletting, obtain tablet.
Embodiment 13 (NB569 food preparation example)
By NAC 1000 parts, VB5 500 parts, VB6 500 parts, the ratio that VB9 is 1 part takes each component, add 100 parts of flour,
50 portions of sucrose, suitable quantity of water, mix homogeneously, dry, make cookies.
Embodiment 14 (effect example) present composition antidepressant effect in mouse forced swimming test
1, experimental technique: forced swim test is by being placed in mice in the environment of a limitation (in water), and animal exists
Struggle of risking one's life in this environment makes an attempt at escaping and cannot escape, thus provides one without avoidable compressing environment, a period of time
Experiment after, animal i.e. shows typically " motionless state ", reflects one and is referred to as " behavioral despair state ".Work as animal
After receiving antidepressant drug before the test, the time of this desperate behavior can be reduced.
2, animal: male Kunming kind mouse, body weight 26 ± 2g, random packet.Respectively at experiment first 24 hours, 2 hours and 1
Hour per os fills medicine feed thing, and then mice is placed in depth of water 12cm, and water temperature 21-23 DEG C, in the glass of 21 × 12cm.Maintain trip
Swim 6 minutes, and record the time that latter four minutes mices of statistics are motionless.
3, each group medicine code name explanation:
NB569: take NAC, VB5, VB6 and VB9 and mix with the ratio of 1000mg:500mg:500mg:1mg and get final product；NB569
Basic, normal, high dosage group i.e. weighs with the weight of this compositions.
NBC: take NAC, VB5, VB6 and VC and mix with the ratio of 1000mg:500mg:500mg:500mg and get final product；NBC is low,
Middle and high dosage group i.e. weighs with the weight of this compositions.
NB56: take NAC, VB5 and VB6 and mix with the ratio of 1000mg:500mg:500mg and get final product；Basic, normal, high dose of NB56
Amount group i.e. weighs with the weight of this compositions.
NB5: take NAC and VB5 and mix with the ratio of 1000mg:500mg and get final product；NB5 basic, normal, high dosage group is i.e. with this group
The weight of compound weighs.
NB6: take NAC and VB6 and mix with the ratio of 1000mg:500mg and get final product；NB6 basic, normal, high dosage group is i.e. with this group
The weight of compound weighs.
VB569: take VB5, VB6 and B9 and mix with the ratio of 500mg:500mg:1mg and get final product；The basic, normal, high dosage of VB569
Group i.e. weighs with the weight of this compositions.
NC: take NAC and VC and mix with the ratio of 1000mg:500mg and get final product；NC basic, normal, high dosage group is i.e. with this compositions
Weight weigh.
NB9: take NAC and VB9 and mix with the ratio of 1000mg:1mg and get final product；NB9 basic, normal, high dosage group i.e. combines with this
The weight of thing weighs.
VB56: take VB5 and VB6 and mix with the ratio of 500mg:500mg and get final product；VB56 basic, normal, high dosage group is i.e. with this group
The weight of compound weighs.
The each basic, normal, high dosage group of NAC, VB5, VB6, VB9 is i.e. weighed by the weight of respective substance.
4, packet:
In test, 410 mices are divided into blank group, medicine NB569 low (200mg/kg), in (400mg/kg),
High (800mg/kg) dosage group, NBC low (250mg/kg), in (500mg/kg), high (1000mg/kg) dosage group, NB56 is low
(200mg/kg), in (400mg/kg), high (800mg/kg) dosage group, NB5 low (150mg/kg), in (300mg/kg), high
(600mg/kg) group dosage, NB6 low (150mg/kg), in (300mg/kg), high (600mg/kg) group dosage, VB569 is low
(100mg/kg), in (200mg/kg), high (400mg/kg) dosage group, NC low (150mg/kg), in (300mg/kg), high
(600mg/kg) dosage group, NB9 low (100mg/kg), in (200mg/kg), high (400mg/kg) dosage group, VB56 is low
(100mg/kg), in (200mg/kg), high (400mg/kg) dosage group, NAC low (100mg/kg), in (200mg/kg), high
(400mg/kg) dosage group, VB5 low (50mg/kg), in (100mg/kg), high (200mg/kg) dosage group, the low (50mg/ of VB6
Kg), in (100mg/kg), high (200mg/kg) dosage group, VB9 low (0.1mg/kg), in (0.2mg/kg), high (0.4mg/kg)
Dosage group and sertraline spirit (20mg/kg) group, totally 41 groups, often 10 mices of group, dosage is each dosage.
5, experimental result: blank group, the compositions group of various dose and sertraline spirit group are real at forced swimming to mice
In testing, the absolutely motionless time is as shown in table 1.Result shows: it is real that NB569 low middle height each dosage group all can significantly reduce forced swimming
Testing the absolutely motionless time of small mouse, its effect is significantly better than NB5, NB6, NB9, NB56 and VB569 each dosage group, wherein
In NB569, the effect of dosage group (30.43 ± 5.28) is even better than sertraline spirit group (38.56 ± 6.31)；NBC、NB56、NB5、
In NB6, dosage and NB6 high dose group can significantly reduce the absolutely motionless time of forced swim test small mouse, and its effect is the most obvious
Be better than VB56, NAC, VB5, VB6, VB9 each dosage group, and between NB56 and NB6, NB9, NBC each dosage group effect almost without
Difference.Illustrate that this compositions of NB569 has significant antidepressant effect, middle dosage group best results in this depression model；NAC
Also certain antidepressant effect, middle dosage group best results is had with combination NB5 and NB6 of B5 or B6；NAC, VB5, VB6 and VB9
Between there is the synergism of medicine, in especially NB569 dosage group than NB5, NB6, NB9, NB56 respectively organize effective very
Many, synergism is obvious.
Table 1: the impact of compositions time absolutely motionless on forced swim test small mouse
Data acquisition mean ± SEM represents, * P < 0.05, * * P < 0.01, * * * P < 0.001 vs matched group
Embodiment 15 (effect example) present composition antidepressant effect in Tail suspension test
1, experimental technique: tail-suspention test is a kind of classics and the method for energy Fast Evaluation antidepressant drug.Its principle is
Attempting after utilizing mouse tail suspension to escape but cannot escape, after the experiment of a period of time, animal is abandoned struggling, and enters distinctive pressing down
Yu Budong state.After animal receives antidepressant drug before the test, the time of this this kind motionless behavior can be reduced.
2, animal: male Kunming kind mouse, body weight 26 ± 2g, random packet.Respectively at experiment first 24 hours, 2 hours and 1
Hour per os fills medicine feed thing, and then mousetail tip be fixed on liftoff 60cm high-altitude suspension, and it is little to record latter 6 minutes of statistics
The time that Mus is motionless.
3, each group medicine code name explanation (with embodiment 14)
4, packet:
In test, 410 mices are divided into blank group, medicine NB569 low (200mg/kg), in (400mg/kg),
High (800mg/kg) dosage group, NBC low (250mg/kg), in (500mg/kg), high (1000mg/kg) dosage group, NB56 is low
(200mg/kg), in (400mg/kg), high (800mg/kg) dosage group, NB5 low (150mg/kg), in (300mg/kg), high
(600mg/kg) group dosage, NB6 low (150mg/kg), in (300mg/kg), high (600mg/kg) group dosage, VB569 is low
(100mg/kg), in (200mg/kg), high (400mg/kg) dosage group, NC low (150mg/kg), in (300mg/kg), high
(600mg/kg) dosage group, NB9 low (100mg/kg), in (200mg/kg), high (400mg/kg) dosage group, VB56 is low
(100mg/kg), in (200mg/kg), high (400mg/kg) dosage group, NAC low (100mg/kg), in (200mg/kg), high
(400mg/kg) dosage group, VB5 low (50mg/kg), in (100mg/kg), high (200mg/kg) dosage group, the low (50mg/ of VB6
Kg), in (100mg/kg), high (200mg/kg) dosage group, VB9 low (0.1mg/kg), in (0.2mg/kg), high (0.4mg/kg)
Dosage group and sertraline spirit (20mg/kg) group, totally 41 groups, often 10 mices of group, dosage is each dosage.
5, experimental result: blank group, the compositions group of various dose and sertraline spirit group to mice in tail-suspention test
The absolutely motionless time is as shown in table 2.Result shows: NB569 low middle height each dosage group all can significantly reduce tail-suspention test small mouse
The absolutely motionless time, its effect be significantly better than NB5, NB6, NB9, NB56 and VB569 each dosage group, wherein dosage in NB569
The effect of group (90.43 ± 9.83) is even better than sertraline spirit group (110.56 ± 10.87)；Dosage in NBC, NB5, NB6, NB56,
And the high dose group of NB56 and NB6 can significantly reduce the absolutely motionless time of tail-suspention test small mouse, its effect is the best
In VB56, NAC, VB5, VB6, VB9 each dosage group, and between NB56 and NB6, NB9, NBC each dosage group, effect is almost without difference
Different.Illustrate that this compositions of NB569 has significant antidepressant effect, middle dosage group best results in this depression model；NAC with
Combination NB5 and NB6 of B5 or B6 also has certain antidepressant effect, middle dosage group best results；NAC, VB5, VB6 and VB9 it
Between there is the synergism of medicine, in especially NB569 dosage group than NB5, NB6, NB9, NB56 respectively organize effective a lot,
Synergism is obvious.
Table 2: the impact of compositions time absolutely motionless on tail-suspention test small mouse
Data acquisition mean ± SEM represents, * P < 0.05, * * P < 0.01, * * * P < 0.001 vs matched group
Embodiment 16 (effect example) present composition curative effect in depressive patients
Experimental technique: object of study is to live in adolescents in China mental growth base in December, 2013 from January, 2012
The patient of institute's treatment, totally 120 example.In age 13-25 year, it is male, meets the diagnostic criteria of depression in CCMD-3, Chinese Mill
Depressed 17 scale (HAMD-17) scores > 17 points, without severe physical disease, ethanol or drug dependence, without other severe psychiatric
Disease.
Application area group randomized grouping method, the patient that the course of disease is close is randomized into seminar and matched group.Seminar's (clothes
With the present composition, prepare by the combination of NAC1000mg, VB5500mg, VB6500mg and VB91mg, i.e. NB569, dose
For 2001mg/ day) and matched group (normally taking the spirit of antidepressants sertraline, dose is 50mg/ day) each 60 examples.Once a day,
Breakfast half an hour after is administered orally.Two groups of equal not statistically significants of the difference such as patient age, the course of disease (P > 0.05).All patients all sign
Informed Consent Form.Before the treatment and treatment 4th week, the 8th week and the 12nd week evaluate the depressed water of patient respectively with HAMD-17
Flat.
Experimental result: the HAMD-17 scoring of seminar and matched group is shown in Table 3.In treatment the 8th week and the 12nd
The difference of week, seminar and experimental group is the most statistically significant, P < 0.05 and P < 0.01.Illustrate that this compositions has the most anti-
Depressed effect, effect is even better than sertraline spirit.
HAMD-17 scoring before and after the group treatment of 3. liang of table
Data acquisition mean ± SEM represents, * P < 0.05, * * P < 0.01 vs matched group.
Claims (4)
1. an antidepressant composition, it is characterised in that said composition contains the material of following weight portion:
N-acetylcystein 1000 parts, VB5500 parts, VB6500 parts, VB91 part.
Compositions the most according to claim 1, it is characterised in that its dosage form is any dosage form that pharmacy allows.
Compositions the most according to claim 2, it is characterised in that its dosage form is tablet, capsule, granule, powder, ball
Agent, oral liquid, injection, membrane.
4. the application in the medicine preparing depression of the compositions described in claim 1.
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