CN101919924B - Pharmaceutical composition for curing tristimania and preparation method and application thereof - Google Patents
Pharmaceutical composition for curing tristimania and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for curing tristimania and a preparation method and an application thereof. The pharmaceutical composition comprises the following components in parts by mass: 3-60 parts of cassia twig, 3-60 parts of liquorice and 6-90 parts of Morinda officinalis. Based on different properties of drugs, the invention respectively adopts the modes of extracting by volatile oil, decocting by water, extracting by ethanol and the like to extract effective components so as to obtain the pharmaceutical composition in the invention. The pharmaceutical composition has the efficacies of regulating heart-yang, keep ying and weiqi balance, tonifying qi and calming heart, can be used for preparing drugs for curing tristimania and has obvious and safe curative effect on tristimania with small toxic or side effect.
Description
Technical field
The present invention relates to the preparation field of Chinese medicine composition, be specifically related to a kind of pharmaceutical composition of treating depression.
Background technology
Depression be meant with depressed, bradyphrenia and with interest lower, the sluggish symptom of degradation psychomotor serve as the one type of mood disorders syndrome that mainly shows under the initiative; Degree can from slight sorrow, dejected, feel oneself inferior, feel guilty, to severe from crime sense, despair, suicidal tendency etc.Along with the development and the rhythm of life of society are constantly accelerated, the sickness rate of depression increases year by year, has become the height morbidity of modern society, is called by psychosis and psychological professional " flu of psychiatric department ".Depression whole world sickness rate is 3～5%, and relapse rate is up to 85%, and is cultural and economically developed, and the fierce countries and regions sickness rate of social competition is about 5～10%, becomes the fourth-largest illness that threatens human health.
The definite cause of disease of depression is not thoroughly illustrated so far, but Most scholars is thought at present, and the generation of depression is biochemistry, heredity and social environment results of interaction.The main applied chemistry synthetic drug of clinical treatment of depression comprises the 1st generation (classics) antidepressants, oxidase inhibitor (MAOIs), tricyclic antidepressants (TCAs) and Fourth Ring class antidepressants (HCAs) etc. at present; The 2nd generation (novel) antidepressants, i.e. selectivity 5-HT reuptake inhibitor (SSRIs), 5-HT/NE reuptake depressant (SNRIs), 5-HT antagonism/picked-up depressant (SARIs) etc.There are shortcomings such as the antidepressant spectrum is narrow, side effect is big, the high and easy recurrence of medicine valency mostly in synthetic antidepressants.Modern pharmacology research shows: the depression pathogenesis is very complicated; For any antidepressant drug; All there is nearly 1/3 depressive patient can't obtain significant curative effect; Solution is generally drug combination or use has the machine-processed medicine of multiple action, but both have all increased the probability that adverse effect occurs, have influenced pill taker's toleration.
Depression belongs to " feelings will disease " in Chinese medicine, be equivalent to the category of diseases such as " demented, hysteria, Bulbus Lilii syndrome, melancholia ".Chinese traditional treatment depression advantage is " organic conception " and " determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs ", through the adjusting of each effect components in the compound recipe to body multisystem, many target spots, too many levels, reaches the purpose of treatment disease.Along with carrying out in a deep going way of Chinese medicine compound antidepressant research, the advantage of treatment by Chinese herbs depression manifests gradually.But tcm clinical practice medication at present mainly is to use the hospital preparation of conventional dosage forms such as decoctions, powder of some basic side plus-minuss and topical application, fails the industrialization and the marketization.Therefore, the invention good effect, toxic and side effects is low, price is low, and the Chinese patent medicine of treatment depression is very necessary and urgent.
Summary of the invention
The objective of the invention is to according to conventional dosage forms such as the decoction that mainly is to use some basic side plus-minuss in the existing treatment depression medicine, powders; Fail the industrialization and the marketization; And the problem of toxic side effect, a kind of good effect, pharmaceutical composition that toxic and side effects is low are provided.
Another purpose of the present invention is to provide the method for preparing of aforementioned pharmaceutical compositions.
A further object of the invention is to provide the application of aforementioned pharmaceutical compositions.
Above-mentioned purpose of the present invention is achieved through following technical scheme:
A kind of pharmaceutical composition comprises following components in part by mass: Ramulus Cinnamomi 3～60, Radix Glycyrrhizae 3～60, Radix Morindae Officinalis 6～90.
As a kind of preferred version, pharmaceutical composition of the present invention also can comprise following components in part by mass: the Radix Paeoniae Alba 3～60, Os Draconis 6～120, Semen Ziziphi Spinosae 6～120.
Crude drug recited above all refers to meet Chinese crude drug or the decoction pieces that Chinese Pharmacopoeia is stipulated, its concrete kind is:
(1) Ramulus Cinnamomi: be the dry twig of canella Cortex Cinnamomi Cinnamomum cassia Presl.
(2) Radix Paeoniae Alba: be the dry root of ranunculaceae plant Radix Paeoniae Paeonia lactiflora Pall..
(3) Radix Glycyrrhizae: be the dry root and rhizome of glycyrrhizic legume Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. Glycyrrhiza glabra L..
(4) Os Draconis: be the skeleton fossil of ancient times mammal such as Hippocampal cortex, rhinoceros class, deer class, bovine, type of elephant etc.
(5) Semen Ziziphi Spinosae: be the dry mature seed of Rhamnaceae plant Ziziphi Spinosae Ziziphus jujuba Mill.var.spinosa (Bunge) Hu ex H.F.Chou.
(6) Radix Morindae Officinalis: be the dry root of Maguireothamnus speciosus Radix Morindae Officinalis Morinda officinalis How.
Ramulus Cinnamomi is hot sweet and warm in the side, GUIXIN, lung, urinary bladder channel, and effect diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI are good at declaring Tong Weiyang; Radix Paeoniae Alba bitter in the mouth, acid, cool in nature, return liver, spleen channel, effect nourishing blood to suppress the hyperactive liver, slow middle pain relieving, yin fluid astringing are received antiperspirant.The two compatibility is the key medicine of harmonizing yingfen and weifen.Radix Glycyrrhizae spleen reinforcing stomach function regulating, relieving spasm to stop pain, Yiqi and vein recovery can rouse oneself heart-yang with the Ramulus Cinnamomi compatibility, then defend and are so incensed that smooth to declare; With Radix Paeoniae compatibility sour and sweet drugs can transforme into YIN, then ying-qi must be filled, and battalion defends mediation, ataraxia, and sleep is expected to again normal.Os Draconis sweet in the mouth, puckery, cold nature, GUIXIN, Liver Channel, effect suppressing the hyperactive liver and subsiding YANG, tranquillizing and allaying excitement, convergence are astringent or styptic treatment for spontaneous sweating.Os Draconis and Ramulus Cinnamomi, Radix Paeoniae compatibility make among the harmonizing yingfen and weifen, the ability of holding concurrently tranquillizing and allaying excitement, and the disorder of internal organs residence is quiet, opposes each other and yet also complement each other, and becomes harmonizing yingfen and weifen altogether, and QI invigorating is calm, the merit of mind tranquilizing and the heart calming.Sweet, suffering, tepor.Return kidney, Liver Channel.The Radix Morindae Officinalis kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.Has the effect of declaring positive tonification.Battalion defends and becomes estranged, and malaise adds the Semen Ziziphi Spinosae mind tranquilizing and the heart calming.The sweet temperature of Semen Ziziphi Spinosae, tranquilizing by nourishing the heart, the nourishing YIN of being amusing, arresting sweating mind calming.Use the Semen Ziziphi Spinosae tranquilizing by nourishing the heart, stable the five internal organs are adjuvant drug.
Full side share, and has the logical heart-yang of a surname, harmonizing yingfen and weifen, the merit of QI invigorating mind calming.
With the above-mentioned raw materials medicine, according to the needs of clinical treatment, press the Chinese medicine preparation common process, add conventional adjuvant, process multiple peroral dosage form, comprise capsule, tablet, granule, powder, pill or oral liquid.
When preparation of drug combination capsule of the present invention, tablet, granule, powder or pill, can be following steps:
(1) get crude drug, Ramulus Cinnamomi is added the water of 3～7 times of volumes, soak 0～2h, vapor distillation extracts volatile oil 3～5h;
(2) volatile oil is added 1～3 times of volume of ethanol dilution back and beta-schardinger dextrin-and the water mixed with 1ml: 5～8g: 70～120ml, stir enclose down to not having volatile oil flavor, cold drying at 30～85 ℃; Make the Benexate Hydrochloride of volatile oil; Pulverize, sieve, subsequent use;
(3) Radix Glycyrrhizae, Radix Morindae Officinalis are added 30～90 volume % alcohol reflux 2～4 times, add 4～10 times of volume of ethanol at every turn, 1～2h refluxes; Alcohol liquid filters filtrate recycling ethanol, surplus liquid concentrate drying; Pulverize; Benexate Hydrochloride fine powder mix homogeneously with volatile oil adds required conventional adjuvant again, processes capsule, tablet, granule, powder or pill.
When comprising the Radix Paeoniae Alba, Os Draconis and Semen Ziziphi Spinosae in the present composition, method for preparing is following:
(1) get crude drug, Ramulus Cinnamomi is added the water of 3～7 times of volumes, soak 0～2h, vapor distillation extracts volatile oil 3～5h;
(2) volatile oil is added 1～3 times of volume of ethanol dilution back and beta-schardinger dextrin-and the water mixed with 1ml: 5～8g: 70～120ml, stir enclose down to not having volatile oil flavor, cold drying at 30～85 ℃; Make the Benexate Hydrochloride of volatile oil; Pulverize, sieve, subsequent use;
(3) Ramulus Cinnamomi medicinal residues and Radix Glycyrrhizae, Os Draconis merge, and decocte with water 2～3 times adds the water of 10～15 times of volumes at every turn, decocts 1～2h, the aqueous solution behind decoction liquor and the Ramulus Cinnamomi extraction volatile oil, the clear paste of relative density 1.05～1.10 when being concentrated into 50 ℃;
(4) Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Morindae Officinalis are added 30～90 volume % alcohol reflux 2～4 times, add 4～10 times of volume of ethanol at every turn, 1～2h refluxes; Alcohol liquid filters, filtrate recycling ethanol, and surplus liquid and above-mentioned clear paste merge; Concentrate drying is ground into fine powder, with the Benexate Hydrochloride fine powder mix homogeneously of volatile oil; Add required conventional adjuvant again, process capsule, tablet, granule, powder or pill.
As a kind of preferred version, above-mentioned method for preparing comprises the steps:
(1) get crude drug, 0.5h is steeped in the water logging that Ramulus Cinnamomi is added 5 times of volumes, and vapor distillation extracts volatile oil 4h;
(2) volatile oil is used isopyknic dissolve with ethanol, the water of the beta-schardinger dextrin-of 6 times of quality and 12 times of volumes carries out enclose to there not being the volatile oil flavor, and 40 ℃ of dryings of clathrate are pulverized, and cross 40 mesh sieves, and are subsequent use;
(3) Ramulus Cinnamomi medicinal residues and Radix Glycyrrhizae, Os Draconis merge, and decocte with water 2 times adds the water of 10 times of volumes at every turn, decocts 1.5h, decoction liquor and the aqueous solution of extracting behind the volatile oil, the clear paste of relative density 1.10 when being concentrated into 50 ℃;
(4) Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Morindae Officinalis are added 50 volume % alcohol reflux 2 times, add the alcohol of 8 times of volumes, backflow 1.5h at every turn; Merge pure liquid, decompression recycling ethanol, surplus liquid and above-mentioned clear paste merge; Concentrate drying is ground into fine powder, with volatile oil beta cyclodextrin inclusion complex fine powder mix homogeneously; Add required conventional adjuvant again, process capsule, tablet, granule, powder or pill.
In the above-mentioned method for preparing, said drying is conventional drying, drying under reduced pressure or spray drying.
When using preparation of pharmaceutical compositions oral liquid of the present invention, can be following steps:
(1) get crude drug, Ramulus Cinnamomi is added the water of 3～7 times of volumes, soak 0～2h, vapor distillation extracts volatile oil 3～5h;
(2) volatile oil is dissolved in the dehydrated alcohol of 10～40 times of volumes, makes the alcoholic solution of volatile oil;
(3) get a medicinal residues and Radix Morindae Officinalis, Radix Glycyrrhizae, Os Draconis, decocte with water 2～3 times adds the water of 5～15 times of volumes at every turn, decocts 1～3h, collecting decoction, the clear paste of relative density 1.05～1.10 when being concentrated into 50 ℃;
(4) Radix Paeoniae Alba, Semen Ziziphi Spinosae are added 30～90 volume % alcohol reflux 2～4 times, add the alcohol of 4～10 times of volumes at every turn, the 1～2h that refluxes merges ethanol liquid; Filter decompression filtrate recycling ethanol, the clear paste of relative density 1.05～1.10 during to 50 ℃; Merge with above-mentioned clear paste, add ethanol and make pure content reach 70～90 volume %, filter; Decompression filtrate recycling ethanol, adds required conventional adjuvant again and processes oral liquid with Ramulus Cinnamomi Volatile oil alcoholic solution mix homogeneously to there not being the alcohol flavor.
As a kind of preferred version, above-mentioned method for preparing comprises the steps:
(1) get crude drug, Ramulus Cinnamomi is added the water of 4 times of volumes, soak 1h, vapor distillation extracts volatile oil 4h;
(2) volatile oil is dissolved in the dehydrated alcohol of 10 times of volumes, makes the alcoholic solution of volatile oil;
(3) get Ramulus Cinnamomi medicinal residues and Radix Morindae Officinalis, Radix Glycyrrhizae, Os Draconis, decocte with water 2 times adds the water of 10 times of volumes at every turn, decocts 1.5h, collecting decoction, the clear paste of relative density 1.10 when being concentrated into 50 ℃;
(4) Radix Paeoniae Alba, Semen Ziziphi Spinosae are added 50 volume % alcohol reflux 2 times, add the alcohol of 8 times of volumes at every turn, backflow 1.5h merges ethanol liquid; Filter decompression filtrate recycling ethanol, the clear paste of relative density 1.10 during to 50 ℃; Merge with above-mentioned clear paste, add ethanol and make pure content reach 85 volume %, filter; Decompression filtrate recycling ethanol, adds required conventional adjuvant again and processes oral liquid with Ramulus Cinnamomi Volatile oil alcoholic solution mix homogeneously to there not being the alcohol flavor.
Pharmaceutical composition of the present invention can be used for preparation treatment depression medicine.
Compared with prior art, the present invention has following beneficial effect:
Pharmaceutical composition of the present invention has the logical heart-yang of a surname, harmonizing yingfen and weifen, and the effect of QI invigorating mind calming is used for depression and has the obvious treatment effect.A large amount of zooperies show that also pharmaceutical composition of the present invention has antidepressant effect, do not see that obvious toxic and side effects is arranged simultaneously.It is thus clear that drug regimen of the present invention has clear and definite, safe therapeutic effect to depression.
The specific embodiment
Come further to explain the present invention below in conjunction with embodiment, but embodiment does not do any type of qualification to the present invention.
Embodiment 1 acquired desperate animal model experiment
Method: 60 of Kunming mouses, male and female half and half, body weight 18～20g.At normal diet, natural lighting, light dark period is 12h, room temperature (23 ± 1) ℃ was raised 3 days under the quiet environment, made it to conform.Be divided into 4 groups at random according to body weight immediately, 15 every group, i.e. blank group, amitriptyline hydrochloride group, antidepressant Chinese medicine (Ramulus Cinnamomi, Radix Morindae Officinalis, Radix Glycyrrhizae, the Radix Paeoniae Alba, Os Draconis, Semen Ziziphi Spinosae) high dose group, antidepressant Chinese medicine low dose group.The blank group gives normal saline, presses the 0.2ml/10g gastric infusion, once a day, and successive administration 10 days; The amitriptyline hydrochloride group begins 7 days normal diets, does not give any medicine, tests to give amitriptyline hydrochloride in preceding 3 days, and dosage is 50mg/Kg, the 0.2ml/10g gastric infusion, once a day, successive administration 3 days; Give antidepressant Chinese medicine high dose group (15g/kg) and antidepressant Chinese medicine low dose group (3.75g/kg) respectively, press the 0.2ml/10g gastric infusion, once a day, successive administration 10 days, each group was all prohibited the water fasting in preceding 12 hours in experiment.
1, to hanging the influence of tail mice depression model
Each group all behind last administration 1h, with Kunming mouse from the position of the most advanced and sophisticated 2cm of tail with transparent sticker on a horizontal plank, plank makes animal present the reversal of the natural order of things state apart from ground 20cm, mouse head is apart from ground 10cm.The suspension both sides separate the animal sight line with plank, and animal is for overcoming abnormal position struggle activity, but behind the movable certain hour, discontinuity " motionless " occurs, show " disappointment " state.During experiment, let animal on plank, adapt to 2min, add up the dead time of mice in the 5min then, and observe mice struggle amplitude.
2, forced swimming is caused the influence of mice depression model
Each group is put into high 28.5cm with mice all behind last administration 1h, diameter 13.5cm, and in the cylindrical glass preparation jar of the depth of water (10 ± 2) cm, one in every cylinder, water temperature (18 ± 1) ℃.Mice struggles in water for overcoming abnormal sensation during swimming; But behind the struggle certain hour, discontinuity " motionless " occurs, show as and in water, stop to struggle, being floating state; Or only have tiny limb motion to keep afloat to keep head, show disappointed state.During experiment, the mice 2min that in cylinder, swims adapts to, and adds up the dead time of mice in the 5min then.
Result: 1, to hanging the influence of tail mice depression model
The dead time of amitriptyline hydrochloride group obviously is less than the blank group, and significant differences (P＜0.01) is arranged; The dead time of medicinal liquid-1 group is compared with the blank group, and notable difference (P＜0.05) is arranged, and lacks than the dead time of medicinal liquid-2 group; Medicinal liquid-2 group is compared with the blank group, and difference does not have significance.The result sees table 1.
Table 1 antidepressant Chinese patent medicine is to the influence
of suspension dead time of Mus tail
Annotate: compare with the blank group: * * P＜0.01, * P＜0.05 (t check).
2, forced swimming is caused the influence of mice depression model
The dead time of amitriptyline hydrochloride group obviously is less than the blank group, and significant difference (P＜0.01) is arranged; The dead time of the dead time of medicinal liquid-1 group than medicinal liquid-2 group significantly reduces, and compares with the blank group, and difference has significance (P＜0.01), and medicinal liquid-2 group is compared with the blank group, and difference is significantly (P＞0.05) not.The result sees table 2.
Table 2 antidepressant Chinese patent medicine is to the influence
of mice forced swimming dead time
Annotate: compare with the blank group: * * P＜0.01 (t check).
Embodiment 2 chronic unpredictable Stress model experiments
Method: select SD adult healthy rat for use, body weight 180g～200g, at normal diet, natural lighting, light dark period is 12h, room temperature (23 ± 1) ℃ is raised under the quiet environment, makes it to conform 3 days.In quiet room, carry out the scoring of autonomic activities test carrying out behavioristics immediately; From eligible (50＜horizontal movement score＜220), select the rat that score is on close level; Be divided into 4 groups at random; Every group 8, i.e. blank group, model group, antidepressant Chinese medicine high dose group, antidepressant Chinese medicine low dose group.The blank group does not give any stimulation, and normal the raising gives normal saline, presses the 10ml/Kg gastric infusion, once a day, and successive administration 43 days.The single cage of depression model group is raised, and gives normal saline, presses the 10ml/Kg gastric infusion, once a day, and successive administration 43 days.The single cage of medicinal liquid high dose group is raised, and after stimulating 16 days, gives the high dose medicinal liquid, and dosage is that (adult is in 60Kg for 6.4g crude drug/Kg; Dosage is 20 times of the clinical maximum dosage of adult); Press the 1ml/10g gastric infusion, once a day, successive administration 35 days.The single cage of medicinal liquid low dose group is raised, and after stimulating 16 days, gives the low dosage medicinal liquid, and dosage is that (adult is in 60Kg for 1.6g crude drug/Kg; Dosage is 5 times of the clinical maximum dosage of adult); Press the 0.5ml/10g gastric infusion, once a day, successive administration 35 days.The all 12h taboo water fasting before experiment of each group.
Each is organized rat and after the 1h 1wt% sucrose solution preference of carrying out 4 days is tested, formally begins to give unpredictable chronic stress sexual stimulus; Every day is a kind of; Stimulating factor comprises single cage raising, fasting 24h, taboo water (empty bottle) 24h, 2h behavior restriction, wet cage, rocks 5 minutes (water bath with thermostatic control beds; Rotating speed 160rpm, 5min), the 2h light and shade puts upside down, continue the bright 24h of lamp, 5min swims in 4 ℃ of frozen water; Stimulate one to two kind every day, average every kind of stimulation is used 5 times, and the homologous stimulus factor is discontinuous carries out, and makes animal can not expect the generation that stimulates.Blank group normal diet does not give any stimulation.Blank group, depression model group, medicinal liquid high dose group and medicinal liquid low dose group behavioristics score, weight increase amount, sucrose solution preference, forced swimming experimental index are compared.
1, body weight is observed
Every day, 8:00～12:00 irritated stomach, and afternoon, 4:00 gave equivalent food, observed body weight change.Before setting up depression model, experimentize respectively with stimulating after 16 days, 32 days, 43 days.
2,1h 1wt% sucrose solution preference test
Before the test, in noise, quiet room, animal training adapts to and contains sugar drinking-water, and every cage is placed 2 water bottles simultaneously, first 24h, and two bottles all are equipped with 1wt% sucrose water, 24h subsequently, a bottled 1wt% sucrose solution, a bottled pure water.Basic sucrose solution/pure water the consumption test of the laggard action thing of water is prohibited in the fasting of 2h, gives quantitative in advance and load weighted two bottles of water with every rat simultaneously: one bottle of 1wt% sucrose solution, one bottle of pure water.Behind the 60min, take two bottles and weigh away.Calculate always liquid-consumed, sucrose solution consumption, pure water consumption, the sucrose solution preference (sucrose solution preference %=sucrose solution consumption/always liquid-consumed * 100%) of animal.
This experiment experimentizes with stimulating after 16 days, 32 days, 43 days before setting up depression model respectively.
3, autonomic activities (Open-field text) experiment
Spacious case apparatus is become by the cardboard leather, and the bottom surface is the square of 100cm * 100cm, and is divided into the grid that 10 * 10 areas equate with the nondiscoloration stroke, installs high 40cm.Carry out this experimental observation in the quiet room between 8:00～18:00.With in the rat centering grid, let its 2min that conforms during experiment, adding up the lattice number (get in the grid three-jaw more than and can be designated as 1 fen) that rat passes through in 5min then is horizontal movement score (crossing); Upright number of times (two pawls leave the bottom surface and are sign, and how long no matter animal can be designated as 1 fen until putting down two pawls if being stood) is the score that moves both vertically (rearing).
After stimulating 16 days, 32 days, 43 days, experimentize.
4, forced swimming experiment
Carrying out body weight weighing, the test of 1h 1wt% sucrose solution preference and autonomic activities experiment, the depression model group is compared with the blank group, and notable difference is arranged, and shows and sets up the model success.After stimulating 43 days, carry out forced swimming experiment, rat is put into high 28.5cm, diameter 13.5cm, in the cylindrical glass preparation jar of the depth of water (18 ± 2) cm, one in every cylinder, water temperature (4 ± 1) ℃.Rat struggles in water for overcoming abnormal sensation during swimming; But behind the struggle certain hour, discontinuity " motionless " occurs, show as and in water, stop to struggle, being floating state; Or only have tiny limb motion to keep afloat to keep head, show disappointed state.During experiment, the rat 2min that in cylinder, swims adapts to, and adds up the dead time of rat in the 5min then.
The result: 1, stress before body weight observation, autonomic activities and the experiment of 1h 1wt% sucrose solution preference
Each treated animal each item index measurement before modeling is close, compares there was no significant difference between group.The result sees table 3.
Table 3 stress before body weight, autonomic activities and the liquid-consumed amount (n=8
) of animal
2, stimulate each item index after 16 days
As shown in table 4: giving each item stimulated after 16 days, and each item index of depression model group all descends to some extent, and each item index of medicinal liquid high dose group shows tentatively that near normal group the high dose of antidepressant Chinese patent medicine has antidepressant effect.
Table 4 stimulated the influence (n=8
) of back medicinal liquid to body weight, autonomic activities and liquid-consumed amount in 16 days
Annotate: compare with blank control group:, △ △ P＜0.01, △ P＜0.05; Compare with the depression model group: * * P＜0.01, * P＜0.05 (t check).
3, stimulate each item index after 32 days
Giving each item stimulated after 32 days, observed and horizontal movement gets score value and can find out from body weight, and the medicinal liquid high dose group is apparently higher than depression model group (P＜0.01), and more approaching with the value of normal group, showed that the high dose of this antidepressant Chinese medicinal liquid has antidepressant effect.The result sees table 5.
Table 5 stimulated the influence (n=8
) of retarded depression spirit to body weight, autonomic activities and liquid-consumed amount in 32 days
Annotate: compare with blank control group: △ △ P＜0.01, △ P＜0.05; Compare with the depression model group: * * P＜0.01, * P＜0.05 (t check).
4, give 43 days stimulation back each item indexs
Giving each item stimulated after 43 days; In body weight observation and behavioristics, the medication group is compared all variant with the depression model group, especially medicinal liquid high dose group (body weight P＜0.01; Horizontal movement score P＜0.01; Vertical score P＜0.01), near the value of normal group, proves that the high dose of antidepressant Chinese patent medicine medicinal liquid has antidepressant effect to depression model.The result sees table 6.
Table 6 stimulated the influence (n=8
) of retarded depression spirit to body weight, autonomic activities and liquid-consumed amount in 43 days
Annotate: compare with blank control group: △ △ P＜0.01, △ P＜0.05; Compare with the depression model group: * * P＜0.01, * P＜0.05 (t check).
5, forced swimming experiment
Giving each item stimulated after 43 days, carried out the forced swimming experiment.With the contrast of depression model group, medicinal liquid low dose group and medicinal liquid high dose group all can obviously shorten the dead time (P＜0.05), explain that low, the high dose of depressed medicine liquid has certain antidepressant effect to depression model.The result sees table 7.
Table 7 stimulated the influence (n=8
) of retarded depression spirit to the forced swimming dead time in 43 days
Annotate: compare with model group: * P＜0.05 (t check)
Can know that by table 3-table 7 after a plurality of factors stimulated, the rat body weight of depression model group descended, all significantly descend in the horizontal movement and the score that moves both vertically.The rat of antidepressant Chinese patent medicine medicinal liquid treatment group is then near normal level, the high dose group of antidepressant Chinese patent medicine medicinal liquid especially, and it can improve body weight, horizontal movement score, the score that moves both vertically of rats with depression, shortens the forced swimming dead time.
Experiment conclusion: the antidepressant experiment shows this antidepressant Chinese patent medicine ability significant prolongation mice swimming time, shortens the outstanding tail mice dead time; Improve the body weight of rats with depression, level, the score that moves both vertically, no sucrose solution preference, and be obvious dose-effect relationship.
The preparation of embodiment 3 capsules
Ramulus Cinnamomi 10kg Radix Morindae Officinalis 15kg Radix Glycyrrhizae 10kg
Get the above-mentioned raw materials medicine, Ramulus Cinnamomi is added the water of 4 times of volumes, vapor distillation extracts volatile oil 3h; Volatile oil is added behind the equivalent ethanol dilution and beta-schardinger dextrin-and the water mixed with 1ml: 5g: 70ml, at room temperature stir enclose to there being the volatile oil flavor, cold drying makes the Benexate Hydrochloride of volatile oil, pulverizes, and sieves, and is subsequent use; Radix Morindae Officinalis, Radix Glycyrrhizae add 30～90 volume % alcohol reflux 2 times, add the alcohol of 6 times of volumes at every turn, backflow 2h, and pure liquid filters; Filtrate recycling ethanol, concentrating under reduced pressure, drying are pulverized; With volatile oil beta cyclodextrin inclusion complex fine powder mix homogeneously, add the 15wt% microcrystalline Cellulose, 40 volume % alcohol granulations; Cold drying, granulate incapsulates.
The preparation of embodiment 4 tablets
Ramulus Cinnamomi 10kg Radix Morindae Officinalis 20kg Radix Glycyrrhizae 10kg
Get the above-mentioned raw materials medicine, Ramulus Cinnamomi is added the water of 4 times of volumes, vapor distillation extracts volatile oil 3h; Volatile oil is added behind the equivalent ethanol dilution and beta-schardinger dextrin-and the water mixed with 1ml: 5g: 70ml, at room temperature stir enclose to there being the volatile oil flavor, cold drying makes the Benexate Hydrochloride of volatile oil, pulverizes, and sieves, and is subsequent use; Radix Morindae Officinalis, Radix Glycyrrhizae add 30～90 volume % alcohol reflux 2 times, add the alcohol of 6 times of volumes at every turn, backflow 2h, and pure liquid filters; Filtrate recycling ethanol, concentrating under reduced pressure, drying are pulverized; With volatile oil beta cyclodextrin inclusion complex fine powder mix homogeneously, add an amount of microcrystalline Cellulose, micropowder silica gel, 50 volume % alcohol granulations; Cold drying, granulate is pressed into tablet.
The preparation of embodiment 5 granules
Ramulus Cinnamomi 10kg Radix Morindae Officinalis 20kg Radix Glycyrrhizae 10kg
Get crude drug, Ramulus Cinnamomi is added the water of 4 times of volumes, soak 1h, vapor distillation extracts volatile oil 4h;
Subsequent use; Radix Morindae Officinalis, Radix Glycyrrhizae add 60 volume % alcohol reflux 3 times, add the alcohol of 6 times of volumes at every turn, backflow 2h, and pure liquid filters; Decompression filtrate recycling ethanol, the concentrated solution spray drying adds an amount of lactose, Aspartane, 60 volume % alcohol granulations; Cold drying, granulate is got volatile oil with 10 times of volume ethanol dilutions; Spray in the granule, volatilize ethanol, promptly get.
The preparation of embodiment 6 pills
Ramulus Cinnamomi 15kg Radix Morindae Officinalis 15kg Radix Glycyrrhizae 10kg
Get the above-mentioned raw materials medicine, Ramulus Cinnamomi is added the water of 5 times of volumes, soak 1h, vapor distillation extracts volatile oil 5h; Volatile oil is added 2 times of volume of ethanol dilution back and beta-schardinger dextrin-and the mixed of water with 1ml: 7g: 100ml, stir enclose down to there being the volatile oil flavor at 40 ℃, cold drying makes the Benexate Hydrochloride of volatile oil, and pulverizing is sieved, and is subsequent use; Radix Morindae Officinalis, Radix Glycyrrhizae add 60 volume % alcohol reflux 3 times, add the alcohol of 6 times of volumes, backflow 2h at every turn; Alcohol liquid filters decompression filtrate recycling ethanol, the thick paste of relative density 1.35 when continuing to be condensed into 50 ℃; Drying under reduced pressure; Be ground into fine powder and volatile oil beta cyclodextrin inclusion complex mix homogeneously, the general ball of processing.
The preparation of embodiment 7 capsules
Ramulus Cinnamomi 10kg Radix Paeoniae Alba 20kg Radix Glycyrrhizae 10kg
Os Draconis 15kg Semen Ziziphi Spinosae 20kg Radix Morindae Officinalis 5kg
Get the above-mentioned raw materials medicine, Ramulus Cinnamomi is added the water of 4 times of volumes, vapor distillation extracts volatile oil 3h; Volatile oil is added behind the equivalent ethanol dilution and beta-schardinger dextrin-and the water mixed with 1ml: 5g: 70ml, at room temperature stir enclose to there being the volatile oil flavor, cold drying makes the Benexate Hydrochloride of volatile oil, pulverizes, and sieves, and is subsequent use; Ramulus Cinnamomi medicinal residues and Radix Glycyrrhizae, Os Draconis merge, and decocte with water 2 times adds the water of 10 times of volumes at every turn, decocts 1h, the aqueous solution behind decoction liquor and the Ramulus Cinnamomi extraction volatile oil, the clear paste of relative density 1.05 when being concentrated into 50 ℃; The Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Morindae Officinalis are added 30 volume % alcohol reflux 2 times, add the alcohol of 6 times of volumes at every turn, backflow 1h, pure liquid filters; Filtrate recycling ethanol, surplus liquid and above-mentioned clear paste merge, and concentrate; Drying under reduced pressure is ground into fine powder, with volatile oil beta cyclodextrin inclusion complex fine powder mix homogeneously; Add the 15wt% microcrystalline Cellulose, 40 volume % alcohol granulations incapsulate.
The preparation of embodiment 8 tablets
Ramulus Cinnamomi 15kg Radix Paeoniae Alba 25kg Radix Glycyrrhizae 15kg
Os Draconis 20kg Semen Ziziphi Spinosae 25kg Radix Morindae Officinalis 10kg
Get the above-mentioned raw materials medicine, Ramulus Cinnamomi is added the water of 7 times of volumes, soak 2h, vapor distillation extracts volatile oil 5h; Volatile oil is added behind 3 times of amount ethanol dilutions and beta-schardinger dextrin-and the water mixed with 1ml: 8g: 120ml, stir enclose down to there being the volatile oil flavor at 85 ℃, cold drying makes the Benexate Hydrochloride of volatile oil, and pulverizing is sieved, and is subsequent use; Ramulus Cinnamomi medicinal residues and Radix Glycyrrhizae, Os Draconis merge, and decocte with water 3 times adds 15 times of volumes of water at every turn, decoct 2h, and decoction liquor and Ramulus Cinnamomi extract the aqueous solution behind the volatile oil, the clear paste of relative density 1.10 when being concentrated into 50 ℃; The Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Morindae Officinalis are added 90 volume % alcohol reflux 4 times, add the alcohol of 6 times of volumes at every turn, backflow 2h, pure liquid filters; Filtrate recycling ethanol, surplus liquid and above-mentioned clear paste merge, and concentrate drying; Be ground into fine powder,, add an amount of microcrystalline Cellulose, micropowder silica gel, 50 volume % alcohol granulations with the volatile oil clathrate compound mix homogeneously; Cold drying, granulate is pressed into tablet.
The preparation of embodiment 9 granules
Ramulus Cinnamomi 20kg Radix Paeoniae Alba 30kg Radix Glycyrrhizae 20kg
Os Draconis 25kg Semen Ziziphi Spinosae 30kg Radix Morindae Officinalis 15kg
Get crude drug, Ramulus Cinnamomi is added the water of 4 times of volumes, soak 1h, vapor distillation extracts volatile oil 4h; Subsequent use; Ramulus Cinnamomi medicinal residues and Radix Glycyrrhizae, Os Draconis merge, and decocte with water 2 times adds the water of 12 times of volumes at every turn, decocts 1.5h, the aqueous solution behind decoction liquor and the Ramulus Cinnamomi extraction volatile oil, the clear paste of relative density 1.08 when being concentrated into 50 ℃; The Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Morindae Officinalis are added 60 volume % alcohol reflux 3 times, add the alcohol of 6 times of volumes at every turn, backflow 2h, pure liquid filters; Filtrate recycling ethanol, surplus liquid and above-mentioned clear paste merge, and spray drying adds an amount of lactose, Aspartane; 60 volume % alcohol granulations, cold drying, granulate is got volatile oil with 10 times of volume ethanol dilutions; Spray in the granule, volatilize ethanol, both.
The preparation of embodiment 10 powders
Ramulus Cinnamomi 10kg Radix Paeoniae Alba 30kg Radix Glycyrrhizae 20kg
Os Draconis 15kg Semen Ziziphi Spinosae 20kg Radix Morindae Officinalis 15kg
Get the above-mentioned raw materials medicine, mix pulverizing, cross sieve No. 5, obtain fine powder and be distributed into powder.
The preparation of embodiment 11 oral liquids
Ramulus Cinnamomi 20kg Radix Paeoniae Alba 20kg Radix Glycyrrhizae 10kg
Os Draconis 25kg Semen Ziziphi Spinosae 20kg Radix Morindae Officinalis 15kg
Get the above-mentioned raw materials medicine, Ramulus Cinnamomi is added the water of 4 times of volumes, soak 1h, vapor distillation extracts volatile oil 4h; Volatile oil is dissolved in the dehydrated alcohol of 10 times of volumes, makes the alcoholic solution of volatile oil; Get Ramulus Cinnamomi medicinal residues and Radix Morindae Officinalis, Radix Glycyrrhizae, Os Draconis, decocte with water 2 times adds the water of 10 times of volumes at every turn, decocts 1.5h, collecting decoction, the clear paste of relative density 1.10 when being concentrated into 50 ℃; The Radix Paeoniae Alba, Semen Ziziphi Spinosae are added 50 volume % alcohol reflux 2 times, add the alcohol of 8 times of volumes at every turn, backflow 1.5h merges ethanol liquid; Filter, decompression filtrate recycling ethanol, the clear paste of relative density 1.10 during to 50 ℃ merges with above-mentioned clear paste; Add ethanol and make pure content reach 85%, filter, decompression filtrate recycling ethanol is to there not being the alcohol flavor, with Ramulus Cinnamomi Volatile oil alcoholic solution mix homogeneously; Add water to required total amount, sterilization is distributed into oral liquid.
The preparation of embodiment 12 pills
Ramulus Cinnamomi 15kg Radix Paeoniae Alba 30kg Radix Glycyrrhizae 10kg
Os Draconis 25kg Semen Ziziphi Spinosae 25kg Radix Morindae Officinalis 15kg
Get the above-mentioned raw materials medicine, Ramulus Cinnamomi is added the water of 5 times of volumes, soak 1h, vapor distillation extracts volatile oil 5h; Volatile oil is added 2 times of volume of ethanol dilution back and beta-schardinger dextrin-and the mixed of water with 1ml: 7g: 100ml, stir enclose down to there being the volatile oil flavor at 40 ℃, cold drying makes the Benexate Hydrochloride of volatile oil, and pulverizing is sieved, and is subsequent use; Ramulus Cinnamomi medicinal residues and Radix Glycyrrhizae, Os Draconis merge, and decocte with water 2 times adds the water of 10 times of volumes at every turn, decocts 1h, the aqueous solution behind decoction liquor and the Ramulus Cinnamomi extraction volatile oil, the clear paste of relative density 1.10 when being concentrated into 50 ℃; The Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Morindae Officinalis are added 50 volume % alcohol reflux 2 times, add the alcohol of 8 times of volumes, backflow 2h at every turn; Alcohol liquid filters, filtrate recycling ethanol, and surplus liquid and above-mentioned clear paste merge; The thick paste of relative density 1.35 when continuing to be condensed into 50 ℃, drying under reduced pressure is ground into fine powder; With the volatile oil beta cyclodextrin inclusion complex mix homogeneously, the general ball of processing.
Claims (6)
1. a pharmaceutical composition is made up of following components in part by mass: Ramulus Cinnamomi 3～60, Radix Glycyrrhizae 3～60; Radix Morindae Officinalis 6～90; The Radix Paeoniae Alba 3～60, Os Draconis 6～120, Semen Ziziphi Spinosae 6～120; It is characterized in that said pharmaceutical composition is used for preparation treatment depression medicine, this preparation of drug combination method comprises the steps:
(1) get crude drug, Ramulus Cinnamomi is added the water of 3～7 times of volumes, soak 0～2h, vapor distillation extracts volatile oil 3～5h;
(2) volatile oil is added 1～3 times of volume of ethanol dilution back and beta-schardinger dextrin-and the water mixed with 1ml: 5～8g: 70～120ml, stir enclose down to not having volatile oil flavor, cold drying at 30～85 ℃; Make the Benexate Hydrochloride of volatile oil; Pulverize, sieve, subsequent use;
(3) Radix Glycyrrhizae, Radix Morindae Officinalis are added 30～90 volume % alcohol reflux 2～4 times, add 4～10 times of volume of ethanol at every turn, 1～2h refluxes; Alcohol liquid filters filtrate recycling ethanol, surplus liquid concentrate drying; Pulverize; Benexate Hydrochloride fine powder mix homogeneously with volatile oil adds required conventional adjuvant again, processes capsule, tablet, granule, powder or pill.
2. according to the said pharmaceutical composition of claim 1, it is characterized in that said preparation of drug combination method comprises the steps:
(1) get crude drug, Ramulus Cinnamomi is added the water of 3～7 times of volumes, soak 0～2h, vapor distillation extracts volatile oil 3～5h;
(2) volatile oil is added 1～3 times of volume of ethanol dilution back and beta-schardinger dextrin-and the water mixed with 1ml: 5～8g: 70～120ml, stir enclose down to not having volatile oil flavor, cold drying at 30～85 ℃; Make the Benexate Hydrochloride of volatile oil; Pulverize, sieve, subsequent use;
(3) Ramulus Cinnamomi medicinal residues and Radix Glycyrrhizae, Os Draconis merge, and decocte with water 2～3 times adds the water of 10～15 times of volumes at every turn, decocts 1～2h, the aqueous solution behind decoction liquor and the Ramulus Cinnamomi extraction volatile oil, the clear paste of relative density 1.05～1.10 when being concentrated into 50 ℃;
(4) Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Morindae Officinalis are added 30～90 volume % alcohol reflux 2～4 times, add 4～10 times of volume of ethanol at every turn, 1～2h refluxes; Alcohol liquid filters, filtrate recycling ethanol, and surplus liquid and above-mentioned clear paste merge; Concentrate drying is ground into fine powder, with the Benexate Hydrochloride fine powder mix homogeneously of volatile oil; Add required conventional adjuvant again, process capsule, tablet, granule, powder or pill.
3. according to the said pharmaceutical composition of claim 2, it is characterized in that said preparation of drug combination method comprises the steps:
(1) get crude drug, 0.5h is steeped in the water logging that Ramulus Cinnamomi is added 5 times of volumes, and vapor distillation extracts volatile oil 4h;
(2) volatile oil is used isopyknic dissolve with ethanol, the water of the beta-schardinger dextrin-of 6 times of quality and 12 times of volumes carries out enclose to there not being the volatile oil flavor, and 40 ℃ of dryings of clathrate are pulverized, and cross 40 mesh sieves, and are subsequent use;
(3) Ramulus Cinnamomi medicinal residues and Radix Glycyrrhizae, Os Draconis merge, and decocte with water 2 times adds the water of 10 times of volumes at every turn, decocts 1.5h, decoction liquor and the aqueous solution of extracting behind the volatile oil, the clear paste of relative density 1.10 when being concentrated into 50 ℃;
(4) Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Morindae Officinalis are added 50 volume % alcohol reflux 2 times, add the alcohol of 8 times of volumes, backflow 1.5h at every turn; Merge pure liquid, decompression recycling ethanol, surplus liquid and above-mentioned clear paste merge; Concentrate drying is ground into fine powder, with volatile oil beta cyclodextrin inclusion complex fine powder mix homogeneously; Add required conventional adjuvant again, process capsule, tablet, granule, powder or pill.
4. according to said 3 pharmaceutical compositions of claim, it is characterized in that said drying is conventional drying, drying under reduced pressure or spray drying.
5. according to the said pharmaceutical composition of claim 1, it is characterized in that comprising the steps:
(1) get crude drug, Ramulus Cinnamomi is added the water of 3～7 times of volumes, soak 0～2h, vapor distillation extracts volatile oil 3～5h;
(2) volatile oil is dissolved in the dehydrated alcohol of 10～40 times of volumes, makes the alcoholic solution of volatile oil;
(3) get a medicinal residues and Radix Morindae Officinalis, Radix Glycyrrhizae, Os Draconis, decocte with water 2～3 times adds the water of 5～15 times of volumes at every turn, decocts 1～3h, collecting decoction, the clear paste of relative density 1.05～1.10 when being concentrated into 50 ℃;
(4) Radix Paeoniae Alba, Semen Ziziphi Spinosae are added 30～90 volume % alcohol reflux 2～4 times, add the alcohol of 4～10 times of volumes at every turn, the 1～2h that refluxes merges ethanol liquid; Filter decompression filtrate recycling ethanol, the clear paste of relative density 1.05～1.10 during to 50 ℃; Merge with above-mentioned clear paste, add ethanol and make pure content reach 70～90 volume %, filter; Decompression filtrate recycling ethanol, adds required conventional adjuvant again and processes oral liquid with Ramulus Cinnamomi Volatile oil alcoholic solution mix homogeneously to there not being the alcohol flavor.
6. according to the said pharmaceutical composition of claim 5, it is characterized in that comprising the steps:
(1) get crude drug, Ramulus Cinnamomi is added the water of 4 times of volumes, soak 1h, vapor distillation extracts volatile oil 4h;
(2) volatile oil is dissolved in the dehydrated alcohol of 10 times of volumes, makes the alcoholic solution of volatile oil;
(3) get Ramulus Cinnamomi medicinal residues and Radix Morindae Officinalis, Radix Glycyrrhizae, Os Draconis, decocte with water 2 times adds the water of 10 times of volumes at every turn, decocts 1.5h, collecting decoction, the clear paste of relative density 1.10 when being concentrated into 50 ℃;
(4) Radix Paeoniae Alba, Semen Ziziphi Spinosae are added 50 volume % alcohol reflux 2 times, add the alcohol of 8 times of volumes at every turn, backflow 1.5h merges ethanol liquid; Filter decompression filtrate recycling ethanol, the clear paste of relative density 1.10 during to 50 ℃; Merge with above-mentioned clear paste, add ethanol and make pure content reach 85 volume %, filter; Decompression filtrate recycling ethanol, adds required conventional adjuvant again and processes oral liquid with Ramulus Cinnamomi Volatile oil alcoholic solution mix homogeneously to there not being the alcohol flavor.
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| CN105477126A (en) * | 2015-12-30 | 2016-04-13 | 广东药学院 | Traditional Chinese medicine extract composition used for treating depression and preparation method and application thereof |
| CN107927107A (en) * | 2018-01-09 | 2018-04-20 | 广州聚澜健康产业研究院有限公司 | A kind of pineapple shortcake and preparation method thereof |
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