CN106729028A - A kind of pharmaceutical composition for treating climacteric metancholia - Google Patents

A kind of pharmaceutical composition for treating climacteric metancholia Download PDF

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CN106729028A
CN106729028A CN201611132964.7A CN201611132964A CN106729028A CN 106729028 A CN106729028 A CN 106729028A CN 201611132964 A CN201611132964 A CN 201611132964A CN 106729028 A CN106729028 A CN 106729028A
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ethanol
pharmaceutical composition
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不公告发明人
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/24—Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/55—Liquid-liquid separation; Phase separation

Abstract

Pharmaceutical composition of climacteric metancholia and preparation method thereof is treated the invention discloses a kind of, pharmaceutical composition of the present invention is with lady's-grass, Guangxi dog tartar, veratrosin, Qingyanshengenin as bulk drug, proportioning is formed, routinely various formulations can be made by preparation process, treatment climacteric metancholia is evident in efficacy.

Description

A kind of pharmaceutical composition for treating climacteric metancholia
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition and its system for treating climacteric metancholia Preparation Method.
Background technology
Climacteric metancholia (MPS) is the caused endocrinopathy due to perimenopausal women ovarian failure, then There are a series of vegetative nerve functional disturbance symptoms.Clinical signs are hectic fever night sweat, shortness of breath uncomfortable in chest, anxiety-depression, nervous head Dizzy, pain in low back and legs, insomnia forgetfulness etc., and anxiety, depression are the main clinic symptoms of MPS.Have a strong impact on the quality of life of patient. For a long time, hormone Replacement Therapy is the traditional remedies of MPS, can significantly alleviate clinical symptoms, but prolonged application hormone Replacement therapy then increased the risk that malignant tumour occurs.MPS is one group based on vegetative nerve functional disturbance and emotional handicap Want the comprehensive syndrome of symptom.Due to ovarian failure, decrease in estrogen, in brain in a period of time before and after postmenopausal women Catechol estrogen secretion is reduced, and influences catecholamine metabolism, vegetative nerve insufficiency of accommodation the clinical conditions such as anxiety-depression occur Shape.About 30% climacteric women can reach new hormonal balance by self-control, and no conscious sympton occurs, and about 70% women shows obvious clinical symptoms.Multinomial climacteric metancholia epidemiology survey shows, China's Woman climacteric Mental symptom incidence is higher in symptom, considerably beyond the classical menopausal symptom " hectic fever sweating " of Western women.As the whole nation is enclosed Menopausal women health survey cooperative groups have carried out the epidemiology survey of climacteric on Beijing, Shanghai, Jiangxi, Fujian and other places It was found that, Neurotoxicity symptom is the most common, average originating rate 75.2%.Therefore, improving patient mental's neurological symptom is Treat one of major way of MPS.Hormone replacement therapy and antidepressant therapy are the traditional therapeutic modalities of MPS.But it is female Hormone replacement therapy increased the risk of tumour, pernicious swollen including carcinoma of endometrium, oophoroma, cervical carcinoma, breast cancer etc. The occurrence probability of knurl is high compared with general population.And prolonged application antidepressants side effect is larger, therefore find that curative effect is good, side effect Small medicine is the matter of utmost importance of clinical workers.MPS belongs to the traditional Chinese medical science " strongly fragrant disease " category,《Interior warp》Cloud:The conception vessel of woman seventy-seven is empty, Taichong channel is declined and lacks, the menopause, menostasia, therefore shape is gone bad and s.m.p.MPS is that, with kidney asthenia as the principal aspect, liver depression is to mark, deficiency of kidney-essence, Kidney deficiency and liver, hyperactivity of heart-liver fire, breakdown of the normal physiological coordination between the heart and the kidney shows as Somatic discomfort, anxiety, depression.Control and answer soothing liver-qi stagnation, replenishing vital essence and blood, kidney tonifying Calm the nerves.
Lady's-grass：It is grass family knotgrass plant Digitaria sanguinalis Digitaria sanguinalis (L.) Scop. [Panicum Sangui-nale L.] herb.Summer, autumn tap herb, dry.【Nature and flavor】It is sweet；It is cold.【Indication】Improving eyesight moistening lung.It is main Mesh is secretly failed to understand；Cough with lung heat.【Proterties】Dry herb 40-100cm long.Stalk branch, takes root on the section of bottom.Intact leaf strip is draped over one's shoulders Aciculiform, 8-17cm long, 5-15mm wide, tip is tapering or short point.Base portion blunt circle, two sides is without hair or sparsely grow pubescence, loose armful of leaf sheath Stem, without hair or sparsely grow pubescence.【Former phytomorph】Lady's-grass, annual herb, culm base is often inclined, and is easily taken root after soil, high 40-100cm.Footpath 2-3mm.Leaf sheath Chang Shusheng has the fur of wart base, dilute without hair；Tip of a leaf 1-3mm long；Blade wire lanceolar is long 8-17cm, 5-15mm wide, two sides are dredged by fur or without hair, and edge is thickening and coarse.Raceme is thin and delicate, 3-10 pieces, 5- long 15cm, is generally arranged in stalk top into finger-like, and cob about 1mm wide, middle rib white accounts for the 1/3 of width；Small spike length 3-3.5mm, drapes over one's shoulders Aciculiform, twin cob is respectively saved, and one has long handle, and one has extremely short handle or a few stockless；1st clever obtuse triangle, is about 0.2mm, acrotism, The 1/2-3/4 of the 2nd clever a length of small ear, it is narrow, have between very unconspicuous 3 arteries and veins, arteries and veins and edge has short cilium mostly；1st lemma with Small ear is isometric, there is a 5-7 arteries and veins, and central 3 veinclearing shows, between arteries and veins distance it is wider and without hair, side form is very approached, sometimes not substantially, without hair or The adhesion pubescence between arteries and veins, the 2nd lemma nearly keratin, celadon is waited and is longer than the 1st lemma；Flower pesticide is about 1mm.Flower, the fruiting period 6-9 months.Receive It is loaded in dictionary of medicinal plant.
Guangxi dog tartar：It is Apocynaceae Ervatamia plant Guangxi dog tartar Ervatamia kwangsiensis The root skin of Tsiang, leaf.Root skin whole year can adopt, and clean, using fresh herb；Leaf using fresh herb.【Nature and flavor】It is bitter；It is pungent；It is mild-natured.【Indication】Promoting blood circulation Analgesic.Main traumatic injury；Fracture swells and ache.【Former phytomorph】Shrub, up to 5m.Without hair in addition to spending；Branch and sprig have hole skin, Internode reaches 2-3cm.Expand and symphysis, oval, up to 2mm on the pretext of leaf base.Leaf opposite；Petiole 5-12mm long；Blade heavily fortified point paper Matter, ellipticity oval, 5-15cm long, 3-6.5cm wide, tip is short tapering, base portion wedge shape, surface bottle green, back side light green； Middle arteries are recessed on blade face, overleaf raised；Lateral vein 12-14 pairs, arc rises.Cyme axillary, usual two discrimination, is born in sprig Top, there is colored 6-7；Total bennet 3-4cm long；Bract and squamella oval；Spend 5 numbers：Bud cylindrical shape；Calyx is wide bell, Base portion inner face Non-gland body, sepal has echinid；Corolla white, it is caducous；Tube top covers to the left to right rotation, sliver base portion, There is micro- pubescence on two sides；Stamen is born in nearly gorge portion；The nearly arrow-shaped of flower pesticide；Column cap 2 splits.Follicle radish is twin, 150 ° of forks, round shape long Lanceolar, has short beak；Carpopodium is about 1cm, fruit 5-6cm long.There is 5-6 in seed Mei Ge Follicle radish.The month at florescence 5-9, fruiting period 9- November.Record in dictionary of medicinal plant.
Qingyanshengenin（Qingyangshengenin）：CAS 84745-94-8, molecular formula C28H36O8, molecular weight 500.58.【Bioactivity】Anti-inflammatory, traumatic injury, it is anticonvulsion.【Ingredient origin】Asclepiadaceae Cynanchum plant wallich swallowwort root.
Veratrosin（Veratrosine）：CAS 475-00-3, molecular formula C33H49NO7, molecular weight 571.74.【Biology is living Property】Anti-hypertension.【Ingredient origin】American hellebore Veratrum viride, hair leaf black false hellebore Veratrum grandiflorum.
2 bulk drug chemical constitutions：
Veratrosin（Veratrosine）Qingyanshengenin（Qingyangshengenin）.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided a kind of medicine group of effective treatment climacteric metancholia Compound and preparation method thereof.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for being made the bulk drug of the pharmaceutical composition of the treatment climacteric metancholia be：
Lady's-grass 7060-7080 weight portions Guangxi dog tartar 400-410 weight portion veratrosin 30-34 weight portion Cynanchum otophyllum Schneid glycosides First 50-52 weight portions.
The pharmaceutical composition for the treatment of climacteric metancholia is preferably used in, is made up of the bulk drug of following weight portion：
The weight portion of 7,070 32 weight portion Qingyanshengenin of weight portion Guangxi dog 405 weight portion veratrosin of tartar of lady's-grass 51.
A kind of pharmaceutical composition for treating climacteric metancholia, it is characterised in that pharmaceutical composition can be using galenic pharmacy Conventional method prepares piece agent or capsule or dripping pill.
A kind of pharmaceutical composition for treating climacteric metancholia, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine group Into treatment climacteric metancholia medicine.
A kind of preparation method of the pharmaceutical composition for treating climacteric metancholia, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Lady's-grass 7060-7080 weight portions Guangxi dog tartar 400-410 weight portion black false hellebore supports Plain 30-34 weight portions Qingyanshengenin 50-52 weight portions；
Preparation method：
（1）Lady's-grass, Guangxi dog tartar, veratrosin, Qingyanshengenin are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 17% ethanol being spent as solvent, being taken in 28 DEG C of temperature extractions, extraction time is 24 times, and each extraction time is 77 hours, each solvent Consumption is 47 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.17, filtration, liquid is first washed with water by HP20 large pore resin absorption columns, then with the ethanol solution of weight percent concentration 43% Wash-out HP20 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 43%, reclaim ethanol, and concentrate drying is obtained final product Extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 10 times is carried every time The time is taken for 0.4 hour, each solvent load is 63 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.04 is concentrated into, filtered, liquid is first washed with water by LKS02 large pore resin absorption columns, then with again Amount percent concentration 79% ethanol solution wash-out LKS02 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 79% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Preferred a kind of preparation method of the pharmaceutical composition for treating climacteric metancholia, it is characterised in that as follows Prepare：
The composition and weight portion of bulk drug be：The weight of 7,070 405 weight portion veratrosin of weight portion Guangxi dog tartar of lady's-grass 32 Part weight portion of Qingyanshengenin 51；
Preparation method：
（1）Lady's-grass, Guangxi dog tartar, veratrosin, Qingyanshengenin are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 17% ethanol being spent as solvent, being taken in 28 DEG C of temperature extractions, extraction time is 24 times, and each extraction time is 77 hours, each solvent Consumption is 47 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.17, filtration, liquid is first washed with water by HP20 large pore resin absorption columns, then with the ethanol solution of weight percent concentration 43% Wash-out HP20 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 43%, reclaim ethanol, and concentrate drying is obtained final product Extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 10 times is carried every time The time is taken for 0.4 hour, each solvent load is 63 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.04 is concentrated into, filtered, liquid is first washed with water by LKS02 large pore resin absorption columns, then with again Amount percent concentration 79% ethanol solution wash-out LKS02 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 79% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
A kind of preparation method of the pharmaceutical composition for treating climacteric metancholia, it is characterised in that pharmaceutical composition can be adopted Piece agent or capsule or dripping pill are prepared with the conventional method of galenic pharmacy.
A kind of preparation method of the pharmaceutical composition for treating climacteric metancholia, it is characterised in that pharmaceutical composition and chemistry Medicine or Chinese medicine composition treatment climacteric metancholia medicine.
Medicine composite for curing climacteric metancholia is evident in efficacy.
Specific embodiment
Embodiment 1：Treat pharmaceutical composition of climacteric metancholia and preparation method thereof
Treat climacteric metancholia pharmaceutical composition bulk drug composition and weight portion be：Lady's-grass 7070g Guangxi dog tartar 405g veratrosin 32g Qingyanshengenins 51g；
Preparation method：
（1）Lady's-grass, Guangxi dog tartar, veratrosin, Qingyanshengenin are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 17% ethanol being spent as solvent, being taken in 28 DEG C of temperature extractions, extraction time is 24 times, and each extraction time is 77 hours, each solvent Consumption is 47 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.17, filtration, liquid is first washed with water by HP20 large pore resin absorption columns, then with the ethanol solution of weight percent concentration 43% Wash-out HP20 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 43%, reclaim ethanol, and concentrate drying is obtained final product Extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 10 times is carried every time The time is taken for 0.4 hour, each solvent load is 63 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.04 is concentrated into, filtered, liquid is first washed with water by LKS02 large pore resin absorption columns, then with again Amount percent concentration 79% ethanol solution wash-out LKS02 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 79% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2：Treat pharmaceutical composition of climacteric metancholia and preparation method thereof
Treat climacteric metancholia pharmaceutical composition bulk drug composition and weight portion be：Lady's-grass 7060g Guangxi dog tartar 410g veratrosin 30g Qingyanshengenins 52g；
Preparation method：
（1）Lady's-grass, Guangxi dog tartar, veratrosin, Qingyanshengenin are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 17% ethanol being spent as solvent, being taken in 28 DEG C of temperature extractions, extraction time is 24 times, and each extraction time is 77 hours, each solvent Consumption is 47 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.17, filtration, liquid is first washed with water by HP20 large pore resin absorption columns, then with the ethanol solution of weight percent concentration 43% Wash-out HP20 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 43%, reclaim ethanol, and concentrate drying is obtained final product Extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 10 times is carried every time The time is taken for 0.4 hour, each solvent load is 63 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.04 is concentrated into, filtered, liquid is first washed with water by LKS02 large pore resin absorption columns, then with again Amount percent concentration 79% ethanol solution wash-out LKS02 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 79% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3：Treat pharmaceutical composition of climacteric metancholia and preparation method thereof
Treat climacteric metancholia pharmaceutical composition bulk drug composition and weight portion be：Lady's-grass 7080g Guangxi dog tartar 400g veratrosin 34g Qingyanshengenins 50g；
Preparation method：
（1）Lady's-grass, Guangxi dog tartar, veratrosin, Qingyanshengenin are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 17% ethanol being spent as solvent, being taken in 28 DEG C of temperature extractions, extraction time is 24 times, and each extraction time is 77 hours, each solvent Consumption is 47 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.17, filtration, liquid is first washed with water by HP20 large pore resin absorption columns, then with the ethanol solution of weight percent concentration 43% Wash-out HP20 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 43%, reclaim ethanol, and concentrate drying is obtained final product Extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 10 times is carried every time The time is taken for 0.4 hour, each solvent load is 63 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.04 is concentrated into, filtered, liquid is first washed with water by LKS02 large pore resin absorption columns, then with again Amount percent concentration 79% ethanol solution wash-out LKS02 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 79% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 4：The preparation of tablet
The pharmaceutical composition 770g of Example 1, adds starch 926g, mixes, and granulation is dried, plus microcrystalline cellulose 520g, stearic Sour magnesium 40g, mixes, and is pressed into 7000, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 870g of Example 2, adds starch 1240g, mixes, and granulation is dried, whole grain, adds appropriate stearic acid Magnesium, mixes, and encapsulated 5000, obtains final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 181g water-baths and boil molten, add the pharmaceutical composition 9.7g of embodiment 3, fully stir Mix uniform, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is 3 DEG C, and drip internal-and external diameter is 7.0/ 1.5 (mm/mm), drip is 1.8cm away from liquid level, and drop speed is optimum condition with every point 65 drop, and the cold of dripping pill surface is blotted with cotton Solidifying agent, obtains final product medicament composition dropping pills.
Experimental example 1：The Experiment on Function research for the treatment of climacteric metancholia
1 data and method
1.1 clinical datas
1.1.1 inclusive criteria
The diagnostic criteria reference of MPS《Gynecotokology》The diagnostic criteria of the 7th edition；Age ＞ 40 years old, ＜ 60 years old；Naturally absolutely Through menopause more than 3 months；15 points of ＞ of Kupperman scorings；Understand the content of application form, energy is autonomous or at least can Filling in for questionnaire and Self-assessment Scale, the medical history that is a cup too low and personality disorder are completed under help；Participate in patient requests certainly It is willing to, signs Informed Consent Form.
1.1.2 exclusion standard
Receiving the drug therapy mutually disturbed with this research in the recent period；Receive HRT treatments in the recent period, or just carry out psychotherapy；Dislike Property tumour tendency；Severe hypertension, diabetes, patients with coronary heart disease；Allergy and dysnoesia, psychiatric patient.
1.1.3 physical data
In May, 2013~2014 year July hospital outpatients MPS patient 50 is chosen, divides patient at random by random digits table Into control group and treatment group, each 25.Wherein 44~56 years old control group age, average 52 years old；4 months climacteric~5 year, averagely 2.1 years.45~57 years old treatment group's age, average 51 years old；4 months climacteric~5 year, average 2.2 years.Two groups of patients with Vexed, anxiety, depression are main clinical manifestation.It is more not statistically significant (P ＞ 0.05) at aspects such as age, climacteric, tool There is comparativity.
1.2 treatment methods
Two groups give correct cognitive guidance, and the conditioning on Psychological support and diet, treatment group's combination of oral medication (is implemented The pharmaceutical composition of example 1), each 1g, daily 3 times；The oral Deanxit of control group (Lundbeck pharmaceutical Co. Ltd of Denmark, approval text Number:Chinese medicines quasi-word H20080175), 1 every time, every 1~2 time, treat 3 months altogether.
1.3 evaluation methods
1.3.1 Kupperman scores and efficacy determination
0,1,2,3 points of four grades are remembered respectively by there is asymptomatic and symptom the order of severity.Total mark=items weighting point is (thick Point × base point) sum curative effect determinate standard:It is effective:Symptom is clearly better, and scoring declines 3 grades or minimizes；Have Effect:Symptom takes a turn for the better, and scoring declines 1 grade；It is invalid:Symptom is without change or aggravates.
1.3.2 SCL-90 scorings
SCL-90 includes 10 factors, each factor reflection body different situations, fraction index reflection symptom characteristic distributions. When individuality is more than 2 in the score of certain Graph One factor, i.e., divide equally beyond normal, then individuality just probably has psychology in this aspect Problem in terms of health.
1.3.3 antidepressants sub-anti-symmetrical matrix
Antidepressants sub-anti-symmetrical matrix (SERS) 14 projects of the scale score, using 0~3 point of 4 grades of point system, all standard is: No；Slightly；Moderate；Severe.
1.4 statistical procedures
Data analysis is carried out using the statistical softwares of SPPS 17.0, enumeration data is used and compared between Chi-square Test, measurement data group Checked using t, ranked data are analyzed using Ridit, P ＜ 0.05 have statistical significance for difference.
2 results
Kupperman scorings are compared before and after 2.1 two groups of patient's treatments
The results are shown in Table 1.
Kupperman scorings are compared (x ± s) before and after 1 two groups of patient's treatments of table
Group n Before treatment After treatment
Treatment group 25 21.77±4.32 15.09±3.12
Control group 25 21.85±4.46 17.11±3.26
After treatment, two groups of patient Kupperman scorings have declined (P ＜ 0.05) before relatively treating, but treatment group declines more Substantially, compare with control group, difference is statistically significant (P ＜ 0.05),
2.2 two groups of patient's comparitive studies
Result sees table 2.
The effect of 2 two groups of patient's anti depressant therapies of table compares
Group n It is effective Effectively It is invalid Total effective rate (%)
Treatment group 25 13 10 2 92.00
Control group 25 13 7 5 80.00
After treatment, treatment group's total effective rate is 92.00%, and control group 80.00% shows through statistics Ridit analysis results, Test group curative effect is substantially better than control group, and difference is statistically significant
SCL-90 scoring comparative results before and after 2.3 two groups of patient's treatments
After treatment, each factor of test group has declined (P ＜ 0.05) before relatively treating, in interpersonal relation sensitivity, bigoted, mental disease Property aspect be decreased obviously (P ＜ 0.05) compared with control group.
Safety evaluatio during 2.4 two groups of patients treat and after treatment
There is adverse reaction significantly lower than control group in test group patient, and difference is statistically significant (P ＜ 0.05)；SERS scores Also it is significantly lower than control group (P ＜ 0.05).

Claims (8)

1. a kind of pharmaceutical composition for treating climacteric metancholia, it is characterised in that be made the group of the bulk drug of the pharmaceutical composition It is into weight portion：
Lady's-grass 7060-7080 weight portions Guangxi dog tartar 400-410 weight portion veratrosin 30-34 weight portion Cynanchum otophyllum Schneid glycosides First 50-52 weight portions.
2. a kind of pharmaceutical composition for treating climacteric metancholia according to claim 1, it is characterised in that be made the medicine The composition and weight portion of the bulk drug of composition be：
The weight portion of 7,070 32 weight portion Qingyanshengenin of weight portion Guangxi dog 405 weight portion veratrosin of tartar of lady's-grass 51.
3. a kind of pharmaceutical composition for treating climacteric metancholia according to claim 1, it is characterised in that pharmaceutical composition Piece agent or capsule or dripping pill can be prepared using the conventional method of galenic pharmacy.
4. a kind of pharmaceutical composition for treating climacteric metancholia according to claim 1, it is characterised in that pharmaceutical composition The treatment climacteric metancholia medicine constituted with chemical drugs or Chinese medicine.
5. a kind of preparation method of the pharmaceutical composition for treating climacteric metancholia, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Lady's-grass 7060-7080 weight portions Guangxi dog tartar 400-410 weight portion black false hellebore supports Plain 30-34 weight portions Qingyanshengenin 50-52 weight portions；
Preparation method：
（1）Lady's-grass, Guangxi dog tartar, veratrosin, Qingyanshengenin are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 17% ethanol being spent as solvent, being taken in 28 DEG C of temperature extractions, extraction time is 24 times, and each extraction time is 77 hours, each solvent Consumption is 47 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.17, filtration, liquid is first washed with water by HP20 large pore resin absorption columns, then with the ethanol solution of weight percent concentration 43% Wash-out HP20 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 43%, reclaim ethanol, and concentrate drying is obtained final product Extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 10 times is carried every time The time is taken for 0.4 hour, each solvent load is 63 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.04 is concentrated into, filtered, liquid is first washed with water by LKS02 large pore resin absorption columns, then with again Amount percent concentration 79% ethanol solution wash-out LKS02 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 79% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. a kind of preparation method of the pharmaceutical composition for treating climacteric metancholia according to claim 5, it is characterised in that Prepare as follows：
The composition and weight portion of bulk drug be：The weight of 7,070 405 weight portion veratrosin of weight portion Guangxi dog tartar of lady's-grass 32 Part weight portion of Qingyanshengenin 51；
Preparation method：
（1）Lady's-grass, Guangxi dog tartar, veratrosin, Qingyanshengenin are taken by bulk drug proportioning, is mixed, it is dense with percentage by weight 17% ethanol being spent as solvent, being taken in 28 DEG C of temperature extractions, extraction time is 24 times, and each extraction time is 77 hours, each solvent Consumption is 47 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.17, filtration, liquid is first washed with water by HP20 large pore resin absorption columns, then with the ethanol solution of weight percent concentration 43% Wash-out HP20 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 43%, reclaim ethanol, and concentrate drying is obtained final product Extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 10 times is carried every time The time is taken for 0.4 hour, each solvent load is 63 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.04 is concentrated into, filtered, liquid is first washed with water by LKS02 large pore resin absorption columns, then with again Amount percent concentration 79% ethanol solution wash-out LKS02 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 79% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. a kind of preparation method of the pharmaceutical composition for treating climacteric metancholia according to claim 5, it is characterised in that Pharmaceutical composition can prepare piece agent or capsule or dripping pill using the conventional method of galenic pharmacy.
8. a kind of preparation method of the pharmaceutical composition for treating climacteric metancholia according to claim 5, it is characterised in that Pharmaceutical composition and chemical drugs or Chinese medicine composition treatment climacteric metancholia medicine.
CN201611132964.7A 2016-12-10 2016-12-10 A kind of pharmaceutical composition for treating climacteric metancholia Withdrawn CN106729028A (en)

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