CN105816554A - Traditional Chinese medicine composition for treating depression - Google Patents
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- CN105816554A CN105816554A CN201610172260.6A CN201610172260A CN105816554A CN 105816554 A CN105816554 A CN 105816554A CN 201610172260 A CN201610172260 A CN 201610172260A CN 105816554 A CN105816554 A CN 105816554A
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Abstract
The invention discloses a traditional Chinese medicine composition for treating depression. The traditional Chinese medicine is prepared from, by weight, 1-5 parts of semen ziziphi spinosae, 1-5 parts of radix polygalae, 1-5 parts of flower buds of Japanese apricot, 5-10 parts of flos albiziae, 1-5 parts of flos magnoliae officinalis, 5-10 parts of tribulus terrestris, 5-10 parts of fructus citri sarcodactylis, 5-10 parts of radix et rhizoma nardostachyos, 5-10 parts of licorice roots, 1-5 parts of radix bupleuri, 1-5 parts of radix angelica sinensis, 5-10 parts of valerian roots, 1-5 parts of folium ginkgo, 5-10 parts of Chinese dates, 1-5 parts of fructus aurantii immaturus, 5-10 parts of fruits of fiverleaf akebia and 1-5 parts of dragon's teeth. The traditional Chinese medicine composition has the effects of clearing and soothing the liver qi, relieving depression with fragrance, and soothing the nerves by quieting the heart. All the medicinal materials are combined and cooperate to be mainly used for treating deprementia, low spirit and chest distress. The traditional Chinese medicine composition is high in safety and small in side effect and has high application value. It is proved by pharmacodynamic tests that by means of the composition, the immobile time of a mouse in a tail suspension test and a forced swimming test can be obviously shortened, the action strength of the composition is in positive correlation with the dosage of administration, and depression can be effectively treated; clinical research indicates that regarding HAMD as a curative effect level evaluation index, the composition is remarkable in curative effect, and the effective rate reaches 90%; compared with a fluoxertine hydrochloride control group, the clinical effects are equivalent, no adverse reaction is generated, and therefore the composition is worthy of clinical application and popularization.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, be specifically related to a kind of Chinese medicine composition treating depression.
Background technology
Depression is typically low with mental state, and retardation of thinking, Cognitive function damage, bulesis go down and body
Symptom is the disease of principal character.Along with the continuous quickening of rhythm of life, the stress of people is also continuously increased,
Depression has become as the commonly encountered diseases of modern society, high morbidity.
In recent years, the sickness rate of depression rises year by year, it was predicted that will become the most secondary to the year two thousand twenty depression
In the second largest illness of cardiovascular disease, the patient of about 80% will be recurred, and 10%-15% patient is eventually
Commit suiside.Depression can betide each age level, have become as society serious harm people healthy,
Quality of life and the great psychiatric physiological decease of social work's function.
At present chemical medicine treatment still has many weak points, and Chinese medicine compound has multipath, Mutiple Targets, many according to the study
The treatment advantage of level, gradually demonstrates certain curative effect and Prospect of R & D in terms of depression.Therefore, find
Antidepressant good effect, rapid-action, can improve patients ' life quality, reduce recurrence, side reaction is few, patient compliance
Property the advantage such as good Chinese medicine composition, have become as the focus of Recent study.
Summary of the invention
It is an object of the invention to provide a kind of Chinese medicine composition for treating depression.
The compositions that the present invention is provided to treat depression is made up of the raw material of following weight portion: Semen Ziziphi Spinosae
1-5 part, Radix Polygalae 1-5 part, flower bud of Japanese apricot 1-5 part, Flos Albiziae 5-10 part, Flos Magnoliae Officinalis 1-5 part, Fructus Atriplicis Sibiricae 5-10
Part, Fructus Citri Sarcodactylis 5-10 part, Radix Et Rhizoma Nardostachyos 5-10 part, Radix Glycyrrhizae 5-10 part, Radix Bupleuri 1-5 part, Radix Angelicae Sinensis 1-5 part, Rhizoma et radix valerianae
5-10 part, Folium Ginkgo 1-5 part, Fructus Jujubae 5-10 part, Fructus Aurantii Immaturus 1-5 part, Fructus Akebiae 5-10 part, Dens Draconis 1-5
Part.
Wherein, the described preferred parts by weight of each component are: Semen Ziziphi Spinosae 3 parts, Radix Polygalae 3 parts, flower bud of Japanese apricot 3
Part, Flos Albiziae 8 parts, Flos Magnoliae Officinalis 3 parts, Fructus Atriplicis Sibiricae 8 parts, Fructus Citri Sarcodactylis 8 parts, Radix Et Rhizoma Nardostachyos 8 parts, 8 parts of Radix Glycyrrhizae,
Radix Bupleuri 3 parts, Radix Angelicae Sinensis 3 parts, Rhizoma et radix valerianae 8 parts, Folium Ginkgo 3 parts, 8 parts of Fructus Jujubae, Fructus Aurantii Immaturus 3 parts, Fructus Akebiae 8
Part, Dens Draconis 3 parts.
Raw material effect of the present composition is as follows:
Semen Ziziphi Spinosae: sweet, sour is flat.Return liver, gallbladder, heart channel.Nourish heart tonifying liver, mind tranquilizing and the heart calming, and arresting sweating promotes the production of body fluid.
For restlessness of asrhenia type and insomnia, dreaminess of palpitating with fear, body void hyperhidrosis, Tianjin wound is thirsty.Pharmacological research proves, Semen Ziziphi Spinosae has town
The effects such as quiet hypnosis, anxiety, antidepressant.
Radix Polygalae: bitter, pungent, temperature.GUIXIN, kidney, lung meridian.Calm the nerves Fructus Alpiniae Oxyphyllae, restoring normal coordination between the heart and kidney, eliminate the phlegm, detumescence.
The insomnia and dreamful sleep caused for disarmony between the heart and kidney, forgetful palpitation with fear, staring spells, expectoration is not well, sore swollen toxin, breast
Room swells and ache.Pharmacological research shows, Radix Polygalae is at aspects such as calmness, convulsion, antidepressant, dementia, brain protections
There is excellent activity.
Flower bud of Japanese apricot: micro-acid, puckery, flat.Return liver, stomach, lung meridian.Dissipating depression of QI and in, reduce phlegm, removing toxic substances.For strongly fragrant
Vexed vexed, stomachache due to hyperactive liver-QI attacking the stomach, expectorant heat is stopped up stagnant, inappetence, globus hystericus；Scrofula, furuncle are controlled in external.
Flos Albiziae: sweet, flat.GUIXIN, Liver Channel.Resolving stagnation for tranquilization.For irritability, melancholy insomnia.Pharmacology
Research shows, Flos Albiziae has the effects such as antidepressant, tranquilizing soporific, antibacterial, removing free radical.
Flos Magnoliae Officinalis: bitter, pungent, temperature.Return spleen, stomach, lung, large intestine channel.Dampness expectorant, the therapeutic method to keep the adverse QI flowing downwards is except full.For
Humidity hysteresis damaging the spleen and stomach, the vomiting and diarrhoea of gastral cavity painful abdominal mass, stagnation of QI due to dyspepsia, abdominal distention constipation, phlegm retention is breathed with cough.Pharmacological research proves, Flos Magnoliae Officinalis
There is antidepressant, antioxidation, antibacterial, antitumor, Gastrointestinal motility adjustment, liver protecting.
Fructus Atriplicis Sibiricae: pungent, bitter, tepor；Slightly poisonous.Return Liver Channel.Suppressing the hyperactive liver resolving depression, promoting blood circulation by removing wind, improving eyesight, only
Itch.For dizziness of having a headache, distending pain in the chest and hypochondrium, breast closes acute mastitis, cataract, rubella pruritus.Pharmacological research shows,
Fructus Atriplicis Sibiricae has and improves cardiovascular circulation, regulates lipid metabolism, and pharmacological action of waiting for a long time antibacterial, anti-ageing.
Fructus Citri Sarcodactylis: pungent, bitter, sour, warm.Return liver, spleen, stomach, lung meridian.Depressed liver-energy dispersing and QI regulating, and stomach and alleviating pain, dampness
Reduce phlegm.For stagnation of liver-QI and stomach-QI, distending pain in the chest and hypochondrium, gastral cavilty feeling of fullness, lack of appetite vomiting, cough with copious phlegm.Pharmacological research table
Bright, Fructus Citri Sarcodactylis have obvious antitussive, relieving asthma, phlegm-dispelling functions and antioxidation, antitumor, health invigorating and immunization machine
The effects such as energy.
Radix Et Rhizoma Nardostachyos: acrid, sweet, warm.Return spleen, stomach warp.Regulating QI to relieve pain, relieving stagnation and activating the spleen；External damp eliminating is subsided a swelling.With
In distension and fullness in the abdomen, inappetence, vomiting；Toothache, tinea pedis toxic swelling are controlled in external.Pharmacological research shows, Radix Et Rhizoma Nardostachyos has
There are calmness, epilepsy, antidepressant, rush nerve growth, improve the multiple medicine such as cognitive competence, protecting myocardial cell
Reason activity.
Radix Glycyrrhizae: sweet, flat.GUIXIN, lung, spleen, stomach warp.Invigorating the spleen and replenishing QI, thermal detoxification, expelling phlegm for arresting cough, slow
Anxious pain relieving, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, four
Limb contraction urgency pain, carbuncle sore tumefacting virus, cushion toxicity, strong.Modern pharmacological research shows, Radix Glycyrrhizae has anti-
Depression, antiinflammatory, spasmolytic, antioxidation, protect the liver, the multiple pharmacologically active such as immunomodulating and memory reinforcing.
Radix Bupleuri: pungent, bitter, is slightly cold.Return liver, gallbladder, lung meridian.Evacuation is brought down a fever, dispersing the stagnated live-QI to relieve the stagnation of QI, rises and lifts yang-energy.
For cold, fever, alternate attack of chill and fever, distending pain in the chest and hypochondrium, menoxenia, uterine prolapse, proctoptosis.Modern pharmacology grinds
Study carefully and show, Radix Bupleuri have antipyretic, antiinflammatory, protect the liver, antibacterial, antiviral, rush enzyme secretion, antitumor, antioxygen
All multiactions such as change, antidepressant, regulation immunity, convulsion, anti-platelet aggregation, promotion cell growth.
Radix Angelicae Sinensis: sweet, pungent, temperature.Return liver, the heart, spleen channel.Replenishing and activating blood, menstruction regulating and pain relieving, loosening bowel to relieve constipation.With
In blood deficiency and yellow complexion, dizziness cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, rheumatic arthralgia, injury from falling down,
Ulcer sores, dryness of the intestine constipation.Radix Angelicae Sinensis (processed with wine) promoting blood circulation to restore menstrual flow.Modern pharmacological research shows, Radix Angelicae Sinensis has hemopoietic, resists
Platelet aggregation, arrhythmia, radioprotective, antitumor, antidepressant, ease pain, regulate smooth muscle and right
The protective effect of internal organs.
Rhizoma et radix valerianae: micro-sweet, bitter, flat, GUIXIN warp.Mind tranquilizing and the heart calming, for neurasthenia, insomnia, subjectively disease, is tired of
Hot-tempered.Pharmacological research proves, Rhizoma et radix valerianae has calmness, hypnosis, anxiety, convulsion, regulation blood circulation, resists
The pharmacological actions such as tumor, organ protection and spasmolytic.
Folium Ginkgo: sweet, bitter, puckery is flat.GUIXIN, lung meridian.Blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain, astringe the lung and relieving asthma,
Change turbid blood fat reducing.For obstruction of collaterals by blood stasis, obstruction of qi in the chest and cardialgia, apoplectic hemiplegia, cough and asthma due to lung deficiency, hyperlipemia.Pharmacology is ground
Study carefully proof, Folium Ginkgo have expansion blood vessel, Adjust-blood lipid, antagonism platelet activating factor, protection ischemic injuries,
The multiple pharmacological effect such as antiinflammatory and antitumor.
Fructus Jujubae: sweet, temperature.Return spleen, stomach, heart channel.Invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.For insufficiency of the spleen lack of appetite, weary
Power loose stool, woman hysteria.Pharmacological research proves, it is calm that Fructus Jujubae has blood pressure lowering, antioxidation, and defying age is enriched blood,
Protect the liver, antitumor, the pharmacological action such as immunomodulating.
Fructus Aurantii Immaturus: bitter, pungent, sour, is slightly cold.Return spleen, stomach warp.Dispelling the stagnated QI removing food stagnancy, scattered painful abdominal mass of reducing phlegm.In stagnant
Stop, feeling of fullness distending pain, weight, constipation, the stagnant vapour lock of expectorant, the thoracic obstruction, blocked-up chest, visceroptosis after dysentery.Pharmacology
Research proves, Fructus Aurantii Immaturus has the effect such as anxiety, anticancer, antioxidation, antibacterial, antiinflammatory.
Fructus Akebiae: sweet, cold.Return liver,spleen,kidney warp.Dispersing the stagnated liver-QI for regulating the stomach, regulating QI to relieve pain, relieving restlessness diuresis.For
Stomachache due to hyperactive liver-QI attacking the stomach, gastric heat food is slow-witted, excessive thirst, also Hakuri, lumbago, hypochondriac pain, hernia, menopause, and uterus drops.
Pharmacological research proves, Fructus Akebiae has the effects such as antiinflammatory, antibacterial, diuresis, anticancer, antithrombotic.
Dens Draconis: sweet, puckery is cool.GUIXIN, Liver Channel.Tranquillizing and allaying excitement.For demented infantile convulsion, palpitation and insomnia.Forge
Dens Draconis is used for insomnia and dreamful sleep.Pharmacological research proves, Dens Draconis has tranquillizing and allaying excitement, convulsion, the effect such as have one's ideas straightened out.
The present composition can make the peroral dosage form of clinical needs, can make oral liquid, tablet, capsule
Agent, granule, preferably tablet.
It is a further object of the present invention to provide a kind of preparation method treating depression Chinese medicine composition, the method bag
Include following steps:
(1) take Dens Draconis, be ground into fine powder, standby；
(2) taking Fructus Citri Sarcodactylis, water vapour distillation volatile oil to the greatest extent, collects volatile oil, the aqueous solution after distillation,
Filter, standby；
(3) Semen Ziziphi Spinosae, Radix Polygalae, Fructus Atriplicis Sibiricae, Radix Et Rhizoma Nardostachyos, Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma et radix valerianae, Folium Ginkgo eight in the side of taking
Taste, adds 75% ethanol, heating and refluxing extraction 2 times, united extraction liquid, filters, and decompression filtrate recycling ethanol is extremely
Taste without alcohol, and it is condensed into thick paste；
(4) flower bud of Japanese apricot in the side of taking, Flos Albiziae, Flos Magnoliae Officinalis, Radix Glycyrrhizae, Fructus Jujubae, Fructus Aurantii Immaturus, Fructus Akebiae seven taste with
Above-mentioned alcohol extraction medicinal residues mix, boiling 2 times, collecting decoction, filter, water-soluble after the distillation of filtrate and Fructus Citri Sarcodactylis
Liquid mixes, and is condensed into thick paste；
(5) take alcohol extraction thick paste to merge with decocting thick paste, add the mixing of Dens Draconis fine powder, dry, pulverize into fine powder,
Add dextrin and lactose is appropriate, granule processed, be dried, spray into Fructus Citri Sarcodactylis volatile oil, mixing, tabletted, to obtain final product.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is described in further detail, but present disclosure does not limits
The embodiment of Yu Suoju.
Embodiment 1: present composition granule
Take Semen Ziziphi Spinosae 3 parts, Radix Polygalae 3 parts, flower bud of Japanese apricot 3 parts, Flos Albiziae 8 parts, Flos Magnoliae Officinalis 3 parts, Fructus Atriplicis Sibiricae
8 parts, Fructus Citri Sarcodactylis 8 parts, Radix Et Rhizoma Nardostachyos 8 parts, 8 parts of Radix Glycyrrhizae, Radix Bupleuri 3 parts, Radix Angelicae Sinensis 3 parts, Rhizoma et radix valerianae 8 parts, Semen Ginkgo
3 parts of leaf, 8 parts of Fructus Jujubae, Fructus Aurantii Immaturus 3 parts, Fructus Akebiae 8 parts, Dens Draconis 3 parts.
Its preparation method is:
(1) take Dens Draconis, be ground into fine powder, standby；
(2) taking Fructus Citri Sarcodactylis, water vapour distillation volatile oil to the greatest extent, collects volatile oil, the aqueous solution after distillation,
Filter, standby；
(3) Semen Ziziphi Spinosae, Radix Polygalae, Fructus Atriplicis Sibiricae, Radix Et Rhizoma Nardostachyos, Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma et radix valerianae, Folium Ginkgo eight in the side of taking
Taste, adds 75% ethanol, heating and refluxing extraction 2 times, united extraction liquid, filters, and decompression filtrate recycling ethanol is extremely
Taste without alcohol, and it is condensed into thick paste；
(4) flower bud of Japanese apricot in the side of taking, Flos Albiziae, Flos Magnoliae Officinalis, Radix Glycyrrhizae, Fructus Jujubae, Fructus Aurantii Immaturus, Fructus Akebiae seven taste with
Above-mentioned alcohol extraction medicinal residues mix, boiling 2 times, collecting decoction, filter, water-soluble after the distillation of filtrate and Fructus Citri Sarcodactylis
Liquid mixes, and is condensed into thick paste；
(5) take alcohol extraction thick paste to merge with decocting thick paste, add the mixing of Dens Draconis fine powder, dry, pulverize into fine powder,
Add dextrin and lactose is appropriate, granule processed, be dried, spray into Fructus Citri Sarcodactylis volatile oil, mixing, make granule, to obtain final product.
Embodiment 2: present composition capsule
Take Semen Ziziphi Spinosae 3 parts, Radix Polygalae 3 parts, flower bud of Japanese apricot 3 parts, Flos Albiziae 8 parts, Flos Magnoliae Officinalis 3 parts, Fructus Atriplicis Sibiricae
8 parts, Fructus Citri Sarcodactylis 8 parts, Radix Et Rhizoma Nardostachyos 8 parts, 8 parts of Radix Glycyrrhizae, Radix Bupleuri 3 parts, Radix Angelicae Sinensis 3 parts, Rhizoma et radix valerianae 8 parts, Semen Ginkgo
3 parts of leaf, 8 parts of Fructus Jujubae, Fructus Aurantii Immaturus 3 parts, Fructus Akebiae 8 parts, Dens Draconis 3 parts.
Its preparation method is:
(1) take Dens Draconis, be ground into fine powder, standby；
(2) taking Fructus Citri Sarcodactylis, water vapour distillation volatile oil to the greatest extent, collects volatile oil, the aqueous solution after distillation,
Filter, standby；
(3) Semen Ziziphi Spinosae, Radix Polygalae, Fructus Atriplicis Sibiricae, Radix Et Rhizoma Nardostachyos, Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma et radix valerianae, Folium Ginkgo eight in the side of taking
Taste, adds 75% ethanol, heating and refluxing extraction 2 times, united extraction liquid, filters, and decompression filtrate recycling ethanol is extremely
Taste without alcohol, and it is condensed into thick paste；
(4) flower bud of Japanese apricot in the side of taking, Flos Albiziae, Flos Magnoliae Officinalis, Radix Glycyrrhizae, Fructus Jujubae, Fructus Aurantii Immaturus, Fructus Akebiae seven taste with
Above-mentioned alcohol extraction medicinal residues mix, boiling 2 times, collecting decoction, filter, water-soluble after the distillation of filtrate and Fructus Citri Sarcodactylis
Liquid mixes, and is condensed into thick paste；
(5) take alcohol extraction thick paste to merge with decocting thick paste, add the mixing of Dens Draconis fine powder, dry, pulverize into fine powder,
Add dextrin and lactose is appropriate, granule processed, be dried, spray into Fructus Citri Sarcodactylis volatile oil, mixing, load capsule, to obtain final product.
Embodiment 3: present composition tablet
Take Semen Ziziphi Spinosae 3 parts, Radix Polygalae 3 parts, flower bud of Japanese apricot 3 parts, Flos Albiziae 8 parts, Flos Magnoliae Officinalis 3 parts, Fructus Atriplicis Sibiricae
8 parts, Fructus Citri Sarcodactylis 8 parts, Radix Et Rhizoma Nardostachyos 8 parts, 8 parts of Radix Glycyrrhizae, Radix Bupleuri 3 parts, Radix Angelicae Sinensis 3 parts, Rhizoma et radix valerianae 8 parts, Semen Ginkgo
3 parts of leaf, 8 parts of Fructus Jujubae, Fructus Aurantii Immaturus 3 parts, Fructus Akebiae 8 parts, Dens Draconis 3 parts.
Its preparation method is:
(1) take Dens Draconis, be ground into fine powder, standby；
(2) taking Fructus Citri Sarcodactylis, water vapour distillation volatile oil to the greatest extent, collects volatile oil, the aqueous solution after distillation,
Filter, standby；
(3) Semen Ziziphi Spinosae, Radix Polygalae, Fructus Atriplicis Sibiricae, Radix Et Rhizoma Nardostachyos, Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma et radix valerianae, Folium Ginkgo eight in the side of taking
Taste, adds 75% ethanol, heating and refluxing extraction 2 times, united extraction liquid, filters, and decompression filtrate recycling ethanol is extremely
Taste without alcohol, and it is condensed into thick paste；
(4) flower bud of Japanese apricot in the side of taking, Flos Albiziae, Flos Magnoliae Officinalis, Radix Glycyrrhizae, Fructus Jujubae, Fructus Aurantii Immaturus, Fructus Akebiae seven taste with
Above-mentioned alcohol extraction medicinal residues mix, boiling 2 times, collecting decoction, filter, water-soluble after the distillation of filtrate and Fructus Citri Sarcodactylis
Liquid mixes, and is condensed into thick paste；
(5) take alcohol extraction thick paste to merge with decocting thick paste, add the mixing of Dens Draconis fine powder, dry, pulverize into fine powder,
Add dextrin and lactose is appropriate, granule processed, be dried, spray into Fructus Citri Sarcodactylis volatile oil, mixing, tabletted, to obtain final product.
Embodiment 4: the present composition test of pesticide effectiveness
The therapeutical effect of pharmacology index of being correlated with for the checking present composition, we set up animal from following several respects
Model, and observe drug action using fluoxetine Hydrochloride as positive control drug.
1. the impact on behavioral despair mice
Laboratory animal: test point two expansion, each tests and respectively takes 50 ICR mices, body weight 18-22g,
Male, it is purchased from Beijing Vital River Experimental Animals Technology Co., Ltd..
Trial drug: example of formulations 3 gained tablet
Test method:
Tail suspension test
Mice is randomly divided into 5 groups, i.e. blank group (equal-volume normal saline), the fluoxetine Hydrochloride positive
Matched group (fluoxetine Hydrochloride suspension) and the present composition high, medium and low dosage group, often group 10,
Every day gavage once, successive administration 7d, administration volume is 10mL/kg.
1h after last gastric infusion, uses medical proof fabric by single mice tail end (at the about 2cm of tail tip)
Sticking in outstanding boot (40cm × 40cm × 35cm) upper bracket, make into reversal of the natural order of things state, head is from bottom about
15cm.Mice is in order to overcome abnormal position and struggle activity, but occurs that discontinuity is not after movable a period of time
Dynamic state, be mice stop struggling, motionless or without any activity, display despair.The suspension time is 6min,
After record, in 4min, mouse tail suspension adds up the dead time.
Mouse forced swimming test
Ibid, after last gastric infusion, 1h tests for packet and dosage regimen.24h before official testing, will
Mice is individually placed in the glass infuser of depth of water 10cm, water temperature (24 ± 1) DEG C, forces swimming instruction 15min.
During official testing, mice is swum 6min under conditions of identical with training, and after record, in 4min, swimming is accumulative
The time of motionless state.The judgment criteria of the motionless behavior of mice is that mice stops struggling in water, floats on the water surface,
Or only keep head to surface and do required experiencing small oscillating movements.
Result of the test:
Comparing with blank group, the present composition each dosage group substantially shortens tail-suspention test and forced swimming is real
Test the dead time of small mouse, its action intensity and dosage positive correlation (P < 0.05 or P < 0.01)；Equally
Under experiment condition, positive control drug fluoxetine Hydrochloride group, shortens tail-suspention test and forced swim test small mouse
Dead time is substantially less than model control group (P < 0.01).Show that the present composition has good antidepressant to make
With.The results are shown in Table 1.
Table 1 present composition on the impact of tail-suspention test and forced swim test small mouse dead time (N=10)
Compare with blank group, * P < 0.05, * * P < 0.01
2. the impact on reserpine antagonism
Laboratory animal: take 50 ICR mices, body weight 18-22g, male, it is purchased from the experiment of Beijing dimension tonneau China dynamic
Thing Technology Co., Ltd..
Trial drug: example of formulations 3 gained tablet
Test method:
Mice is randomly divided into 5 groups, i.e. blank group (equal-volume normal saline), the fluoxetine Hydrochloride positive is right
According to group (fluoxetine Hydrochloride suspension) and the present composition high, medium and low dosage group, often group 10, often
Once, successive administration 7d, administration volume is 10mL/kg to it gavage.After last is administered 1h, measure mice
Basal body temperature, lumbar injection reserpine 2.5mg/kg, observes after 1h:
(1) ptosis: put by mice and observe 15s on the top of the shelf, observes whether animal blepharoptosis occurs
And blepharoptosis degree marking.0 point, eyelid is not turned off；1 point, eyelid closes 1/4；2 points,
Eyelid closes 1/2；3 points, eyelid closes 3/4；4 points, eyelid Close All.
(2) motion can not: animal is placed on diameter 18cm circular blank sheet of paper central authorities, observe 15s, compare
Each group mice still stays in the number in circle.
(3) impact on body temperature: after 4h, dips a small amount of vaseline with rectal thermometer and inserts animal gently
At anus 1～2cm, stop 15s, measure animal heat, respectively group body temperature value.
Result of the test:
Present composition dosage group high, middle all can be obviously improved reserpine induction temperature decline (P < 0.05,
P < 0.01), present composition high dose group substantially stops the blepharoptosis (P < 0.05) of reserpine induction,
Motion to reserpine induction can not have certain improvement result.In the present composition, low dose group is to reserpine
The motion of induction can not have certain antagonism with blepharoptosis, but not statistically significant (P > 0.05), see
Table 3 and table 4.
Table 3 present composition on the impact of reserpine antagonism mouse temperature (N=10)
Compare with blank group, * P < 0.05, * * P < 0.01
Table 4 present composition on reserpine antagonism mice blepharoptosis and akinetic impact (N=10)
Compare with blank group, * P < 0.05, * * P < 0.01
Embodiment 5: present composition acute toxicity test in mice
Laboratory animal: ICR mice, female 20, male 20.Body weight 18-20g, ties up tonneau purchased from Beijing
Laboratory animal Technology Co., Ltd. of China.
Trial drug: example of formulations 3 gained tablet
Test method:
By qualified mice after quarantine, fasting, can't help water 12 hours.It is randomly divided into 2 by body weight after fasting
Group, i.e. Normal group and administration group, often group 20, male and female half and half.Normal group Mouse oral gavage
Giving purified water, administration group Mouse oral gavage gives the present composition, is administered volume and is
0.4ml/10gBW, is administered once on the 1st.Mice is observed once before administration, Continuous Observation 6 hours after administration
And observe animal general status, toxic reaction and death condition etc. in continuous 7 days；Observation period terminate after little to each group
Mus carries out cuing open inspection, and the change of internal organs is respectively organized in perusal.
Result of the test:
Within 7 day observation period, each treated animal outward appearance sign, behavioral activity, to irritant reaction, secretions, row
Let out thing etc. to show no obvious abnormalities, the poison of the dying death of mice caused because giving the present composition does not also occur
Property reaction.Mice all survives, body weight increases, and the observation period terminates, and cuts open and examines each group of mice, the perusal heart,
The tissue internal organs such as liver, spleen, lung, kidney, stomach and thymus have no pathological change.Result shows combination of the present invention
Thing safety is high.
Embodiment 6: present composition rat chronic toxicity test
Laboratory animal: SD rat, male and female half and half, it is randomly divided into 4 groups, body weight 160-200g, purchased from Beijing
Laboratory animal Technology Co., Ltd. of dimension tonneau China.
Trial drug: example of formulations 3 gained tablet
Test method:
If high, medium and low three the dosage groups of the present composition and Normal group.Often group male and female select 20
Rat, high, medium and low dosage is respectively equivalent to draft clinical 80 times of people's dosage, 50 times, 30 times.
Test uses the mode of gastric infusion, and Normal group gavage gives 1ml/100gBW purified water, high,
In, low dose group gavage give the present composition of 1ml/100gBW variable concentrations.Successive administration 3 months,
Observe the general toxic reaction of animal and the order of severity, be administered terminate the blood sampling of rear ventral aorta carry out hematological examination,
Serum bichemisbry.Cut open inspection heart, liver, spleen, kidney, adrenal gland, brain, cerebellum, brain stem, stomach etc.
Main organs carries out histopathologic examination.
Experimental result:
Under this experiment condition, SD rat gives the present composition in continuous 3 months, to hematological indices,
Serological biochemical markers content does not all cause the significance on toxicological significance to change.Inspection is cutd open all at the end of administration
The animal of dosage group, perusal is also cutd open the main organs examining animal, is had no and present composition toxic action
Relevant Pathologic changes.Thus prove that present composition long-term taking is also safe.
Embodiment 7: present composition treatment depression clinical observation
1. data and method:
Case selection
Inclusive criteria: light, moderate depressive patients patient, diagnosis meets " Chinese Spirit Obstacles classification and diagnostic criteria "
(the 3rd edition) about the paralepsy diagnostic criteria of unipolar depression episode or bipolar affective disorder, not by the age,
The impact of race, sex, includes patient's Hamilton depressive scale (HAMD 17) in and marks >=17 points and≤28
Point.
Exclusion standard: schizophrenia；Bipolar affective disorder；Medicine or Mental Disorder Caused by Alcohol；Spirit is sent out
Educate sluggishness；Serious suicidal tendency；Other mentally disturbeds；Severe physical disease；Pregnant and lactant women.
Rejecting standard: non-curative effect reason and untoward reaction and midway stopping person；Add the person that uses other drug；Data is not
Entirely can not the person of statistics；All cases not meeting inclusive criteria and by mistake included in, though and meeting inclusive criteria and receive
Not by the case of this programme treatment after entering, must reject.
Come off standard: patient dependence is poor, serious adverse reaction occurs, severe complication or special physiological occur
Change etc. should not continue reception test, is rejecting case.During statistical analysis, as charged to not for untoward reaction
The statistics of good reaction, has completed 1/2, should add up curative effect the course for the treatment of.
Choosing patient 80 example of the light moderate depressive patients meeting inclusive criteria, wherein male 40 example, women 40
Example；Object of study the range of age be 18-65 year, the course of disease is 2-36 month.Divide above-mentioned by table of random numbers method
For matched group and treatment group, often organize each 40 example patients.
2. Therapeutic Method:
Matched group gives oral hydrochloride fluoxetine, 2 pieces/times, 1 time/d, oral；It is real that treatment group takes the present invention
Execute example 3 tablet, 2 pieces/times, 1 time/d, oral.Two groups of courses for the treatment of are 8 weeks, are not combined other during treatment
Associated treatment medicine.
3. criterion of therapeutical effect
Recovery from illness: symptom is wholly absent, and Working Life is unaffected, HAMD deduction rate >=75%；Effective: disease
Shape disappears substantially, can work, but Working Life ability does not reaches level before disease, HAMD deduction rate >=50%；
Effective: symptom alleviates or partial disappearance, but Working Life ability, HAMD deduction rate >=25%；Invalid:
Symptom is without improvement or improves inconspicuous, HAMD deduction rate ＜ 25%.
4. result:
Matched group and treatment group (present composition group) total effective rate are respectively 85% and 90%, and two groups are faced
Bed comparitive study, difference no statistical significance (P > 0.05).It is shown in Table 5.
Table 5 treatment group and matched group patient clinical comparitive study
Treating for the 5th weekend, matched group has 5 examples dizziness occur over the course for the treatment of, and 3 examples appearance are drowsiness, give
After symptomatic treatment, not affecting successive treatment, there is not untoward reaction in treatment group.
Result of the test shows, the present composition treats light moderate depressive patients, and clinical efficacy is suitable with fluoxetine,
And do not have untoward reaction to occur, it is worth promoting the use of clinically.
Claims (4)
1. the Chinese medicine composition treating depression, it is characterised in that be made up of the raw material of following weight portion:
Semen Ziziphi Spinosae 1-5 part, Radix Polygalae 1-5 part, flower bud of Japanese apricot 1-5 part, Flos Albiziae 5-10 part, Flos Magnoliae Officinalis 1-5 part, white
Fructus Tribuli 5-10 part, Fructus Citri Sarcodactylis 5-10 part, Radix Et Rhizoma Nardostachyos 5-10 part, Radix Glycyrrhizae 5-10 part, Radix Bupleuri 1-5 part, Radix Angelicae Sinensis 1-5
Part, Rhizoma et radix valerianae 5-10 part, Folium Ginkgo 1-5 part, Fructus Jujubae 5-10 part, Fructus Aurantii Immaturus 1-5 part, Fructus Akebiae 5-10 part,
Dens Draconis 1-5 part.
A kind of Chinese medicine composition treating depression the most according to claim 1, it is characterised in that by with
The raw material of lower weight portion is made: Semen Ziziphi Spinosae 3 parts, Radix Polygalae 3 parts, flower bud of Japanese apricot 3 parts, Flos Albiziae 8 parts, Cortex Magnoliae Officinalis
Spend 3 parts, Fructus Atriplicis Sibiricae 8 parts, Fructus Citri Sarcodactylis 8 parts, Radix Et Rhizoma Nardostachyos 8 parts, 8 parts of Radix Glycyrrhizae, Radix Bupleuri 3 parts, Radix Angelicae Sinensis 3 parts,
Rhizoma et radix valerianae 8 parts, Folium Ginkgo 3 parts, 8 parts of Fructus Jujubae, Fructus Aurantii Immaturus 3 parts, Fructus Akebiae 8 parts, Dens Draconis 3 parts.
3. according to claim 1-2 any one, treat the Chinese medicine composition of depression, it is characterised in that institute
State compositions and can make the most acceptable peroral dosage form, preferably tablet.
4. according to the Chinese medicine composition of the treatment depression described in claim 1-3 any one, it is characterised in that
Its preparation method comprises the following steps:
(1) take Dens Draconis, be ground into fine powder, standby；
(2) taking Fructus Citri Sarcodactylis, water vapour distillation volatile oil to the greatest extent, collects volatile oil, the aqueous solution after distillation,
Filter, standby；
(3) Semen Ziziphi Spinosae, Radix Polygalae, Fructus Atriplicis Sibiricae, Radix Et Rhizoma Nardostachyos, Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma et radix valerianae, Folium Ginkgo eight in the side of taking
Taste, adds 75% ethanol, heating and refluxing extraction 2 times, united extraction liquid, filters, and decompression filtrate recycling ethanol is extremely
Taste without alcohol, and it is condensed into thick paste；
(4) flower bud of Japanese apricot in the side of taking, Flos Albiziae, Flos Magnoliae Officinalis, Radix Glycyrrhizae, Fructus Jujubae, Fructus Aurantii Immaturus, Fructus Akebiae seven taste with
Above-mentioned alcohol extraction medicinal residues mix, boiling 2 times, collecting decoction, filter, water-soluble after the distillation of filtrate and Fructus Citri Sarcodactylis
Liquid mixes, and is condensed into thick paste；
(5) take alcohol extraction thick paste to merge with decocting thick paste, add the mixing of Dens Draconis fine powder, dry, pulverize into fine powder, add
Dextrin and lactose are appropriate, and granule processed is dried, sprays into Fructus Citri Sarcodactylis volatile oil, mixing, and tabletted to obtain final product.
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| CN116999533A (en) * | 2023-08-16 | 2023-11-07 | 秦皇岛市山海关药业有限责任公司 | Heart-nourishing and pulse-activating granule, preparation method thereof and application thereof in antidepressant product |
| CN116999533B (en) * | 2023-08-16 | 2024-06-07 | 秦皇岛市山海关药业有限责任公司 | Heart-nourishing and pulse-activating granule, preparation method thereof and application thereof in antidepressant product |
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