CN106539834A - It is a kind of to treat pharmaceutical composition of climacteric syndrome and preparation method thereof - Google Patents

It is a kind of to treat pharmaceutical composition of climacteric syndrome and preparation method thereof Download PDF

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CN106539834A
CN106539834A CN201611132966.6A CN201611132966A CN106539834A CN 106539834 A CN106539834 A CN 106539834A CN 201611132966 A CN201611132966 A CN 201611132966A CN 106539834 A CN106539834 A CN 106539834A
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weight portion
weight
ethanol
pharmaceutical composition
percent concentration
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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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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
    • 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
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A61K36/12—Filicopsida or Pteridopsida
    • 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)
    • 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

The invention discloses a kind of treat pharmaceutical composition of climacteric syndrome and preparation method thereof, pharmaceutical composition of the present invention is with eupachlorin, Semen abelmoschi manihot, comb leaf, protocevine, capillarisin, acrifoline as crude drug, proportioning is formed, routinely various dosage forms can be made by preparation process, treatment climacteric syndrome is evident in efficacy.

Description

It is a kind of to treat pharmaceutical composition of climacteric syndrome and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, more particularly to a kind of pharmaceutical composition and its system for treating climacteric syndrome Preparation Method.
Background technology
Climacteric syndrome is the series of symptoms caused by decrease in estrogen.Along with change in menstrual cycle, Decrease in estrogen, hormonal system and neural blood vessel function it is all unstable, temporarily in disorderly period.Thus can cause Series of symptoms such as susceptible to lose temper due to restlessness, insomnia and dreamful sleep, dizziness and tinnitus, dysphoria with feverish sensation in the chest palms and soles are warmed sweating, edema loose stool, or cardiopalmus and are had palpitation, Soreness of the loins and bones, even mood disorderss etc., are referred to as climacteric syndrome.Climacteric syndrome has vasomotion by mechanism point Impairment property, Spirit nerve symptoms of disease, osteoporosis symptoms and urogenital symptoms.Although symptom is not quite similar, cause The root of these symptoms is mainly estrogen deficiency and causes, and complementing estrogen is come to treat climacteric syndrome be most directly to do Method.Hormone Replacement Therapy maintains determining female physiological periodicity by complementing estrogen, delays, deceleration hormone in vivo drastically reduces what is caused Various complication.But hormonal medicaments have many contraindications, and life-time service can be damaged to body.
The traditional Chinese medical science thinks that kidney deficiency is the principle pathological mechanism of menopause, climacteric syndrome, therefore climacteric syndrome is divided into Liver energy stagnation type, renal deficiency type, stagnation of liver-QI renal deficiency type, stagnation of liver-QI kidney deficiency hold stasis of blood type under the arm.Chinese traditional treatment more select Chinese crude drug prescription, with enriching yin and nourishing kidney, Based on liver-smoothing, qi-regulating, the Chinese patent medicine of Yi Huo State Food and Drug Administrations approval have female treasure pill, Yi mu Pill, climacteric it is peaceful, six Taste Dihuang Wan etc..But said medicine has specific dialectical for crowd, and not all patient is effective.Climacteric is each women In the physiology transition period being all subjected to, be a comparison special life change period.With the quickening pace of modern life, society The increase of pressure, Women’s climacteric morbidity's symptom are more and more obvious, also more and more early, need society, family in this stage Give women love more and support, while needing actively to seek medical advice, coordinate doctor's suggestion and treat, smoothly spend climacteric.
Semen abelmoschi manihot：Kind of this product for malvaceae plant Abelmoschus manihot （L.） Medic Abelmoschus manihot (L.) Medic. Son.Harvest during autumn fruit maturation.【Nature and flavor】It is sweet, tremble with fear, it is sliding.【Indication】Diuretic, detumescence, lactogenesis.Control gonorrhea, edema, breast Juice is obstructed, carbuncle, injury from falling down, fracture.【Former phytomorph】Abelmoschus manihot （L.） Medic is annual or perennial herb, high 1-2m.Dredge and grown Bristle.Leaf alternate；The long 6-18cm of petiole, dredges by long bristle；Stipule lanceolar, long l-1.5cm.Leaf palmate 5-9 drastic crack, diameter 15-30cm, the long round shape lanceolar of sliver, long 8-18cm, wide 1-6cm, two sides are dredged by long bristle, and edge has thick crenation.Hua Dan It is born in an end axil；Squamella 4-5, ovum shape lanceolar, long 15-25mm, wide 4-5mm are dredged by long bristle；Calyx spathe shape, 5 Split, nearly full edge, longer than squamella, by pubescence, come off during fruit；Hua great, faint yellow, inner face base portion purple, diameter about 12cm；It is male Stamen column length 1.5-2cm, the nearly stockless of flower pesticide；Stigma atropurpureuss, spoon-shaped dish type.Capsule ovate-elliptic, long 4-5cm, diameter 2.5- 3cm, by bristle.Seed is most, kidney shape, and the striped constituted by pubescence is a plurality of.The month at florescence 8-10.Record in《Dictionary of medicinal plant》.
Comb leaf：This product is Athyriaceae Diplazium donianum (Mett.) Tard. Blet. platymiscium Diplazium donianum (Mett.) Tard. Blet. Diplazium donianum（Mett.）Tard- Blot. the herb of ［ Asplenium donianum Mett. ］.Whole year can harvest, and clean, dry.【Nature and flavor】Slight bitter；It is cold. 【Indication】Clearing away heat-damp and promoting diuresis；Removing pathogenic heat from blood and toxic substance from the body.Main jaundice due to damp-heat；Venom；Traumatic hemorrhage；Dysmenorrhea.【Chemical analysis】Containing sieve The Chinese pine sterone (makisterone) A, B and D.【Former phytomorph】The high 30-60cm of plant.Rhizome length and grow wild, sturdy, top It is close with petiole base by black, lanceolar scale, there is little tooth at edge.Ye Jinsheng；The long 15-30cm of petiole, straw color are hard；Leaf Piece ground paper matter, without hair, Long Circle or ovate Long Circle, long 20-40cm, wide 15-20cm, a pinniform；Accessory pinna 2-5 pair is given birth in side, Alternate, obliquely, has short handle, long round shape lanceolar or ovum shape lanceolar, long 10-16cm, wide 2.5-5cm, and top is tapering to be slightly in Shape of tail, base portion wealthy wedge shape, full edge or to top tool dredge sawtooth, basidixed accessory pinna and side life accessory pinna similar shape；Middle arteries substantially, have shallow above Longitudinal furrow, justifies below and swells, lateral vein pinniform bifurcated, slightly obliquely, have scun 3-5 bars per group, and go directly limb.Sporangioruses line Shape, the generally twin both sides up and down in scun, have 1-2 bars on every group of lateral vein, nearly middle arteries are stretched out, several up to limb；Indusium similar shape, Film quality.Record in dictionary of medicinal plant.
Eupachlorin（Eupachlorin）：CAS 20071-50-5, molecular formula C20H25ClO7, molecular weight 412.87. 【Biological activity】Antitumor；Cell toxicant (KB, ED50=0.21 μ g/ml).【Ingredient origin】Roundleaf Herba Lycopi Eupatorium rotundifolium。
Protocevine（Protocevine）：CAS 5876-23-3, molecular formula C27H43NO8, molecular weight 509.64.【Composition Source】Rhizoma et radix veratri (Radix Rhizoma Veratri) Veratrum nigrum.
Capillarisin（Capillarisin）：CAS 56365-38-9, molecular formula C16H12O7, molecular weight 316.26. 【Pharmacological action】Function of gallbladder promoting.【Ingredient origin】Feverfew Herba Artemisiae Scopariae aerial partss.
Acrifoline（Acrifoline）：CAS 664-24-4, molecular formula C16H23NO2, molecular weight 261.36.【Into Divide source】Herba Lycopodii Selaginiies Huperzia selago [Syn. Lycopodium selago], 2 years Lycopodium clavatum Lycopodium annotinum var. acrifolium。
The chemical constitution of 4 crude drug：
Capillarisin（Capillarisin）Eupachlorin（Eupachlorin）
Protocevine（Protocevine）Acrifoline（Acrifoline）.
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 effectively treatment climacteric syndrome Compound and preparation method thereof.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for making the crude drug of the pharmaceutical composition of the treatment climacteric syndrome be：
Eupachlorin 23.5-24.5 weight portion Semen abelmoschi manihot 356-360 weight portion comb leaf 470-475 weight portion Rhizoma et radix veratri (Radix Rhizoma Veratri)s Cevine 18-19 weight portion capillarisin 14-16 weight portion acrifoline 1-3 weight portions.
The pharmaceutical composition for the treatment of climacteric syndrome is preferably used in, is made up of the crude drug of following weight portion：
24 weight portion Semen abelmoschi manihot of eupachlorin, 358 472 weight portion protocevine of weight portion comb leaf, 18.5 weight portion 15 weight portion acrifoline of capillarisin, 2 weight portion.
A kind of pharmaceutical composition for treating climacteric syndrome, it is characterised in that pharmaceutical composition can adopt galenic pharmacy Conventional method prepares piece agent or capsule or drop pill.
A kind of pharmaceutical composition for treating climacteric syndrome, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine group Into treatment climacteric syndrome medicine.
A kind of preparation method of the pharmaceutical composition for treating climacteric syndrome, it is characterised in that prepare as follows：
The composition and weight portion of crude drug be：Eupachlorin 23.5-24.5 weight portion Semen abelmoschi manihot 356-360 weight portions are combed Comb leaf 470-475 weight portion protocevine 18-19 weight portion capillarisin 14-16 weight portion acrifoline 1-3 weight Part；
Preparation method：
（1）Eupachlorin, Semen abelmoschi manihot, comb leaf, protocevine, capillarisin, sharp leaf Lycopodium clavatum are taken by crude drug proportioning Alkali, mixes, and with 34% ethanol of weight percent concentration as solvent, extracts in 27.5 DEG C of warm macerating, and extraction time is 10 times, every time Extraction time is 40 hours, and 36 times for crude drug gross weight of each solvent load, filtration obtain medicinal residues A and extracting solution A, extract Liquid A reclaims ethanol, is concentrated into relative density 1.14, filters, and medicinal liquid is first washed with water by DM131 macroporous adsorptive resins, then With 23% ethanol solution eluting DM131 macroporous adsorptive resins of weight percent concentration, 23% ethanol of weight percent concentration is collected Eluent, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Medicinal residues A, with 47% ethanol of weight percent concentration as solvent, heating and refluxing extraction 9 times, is carried every time The time is taken for 0.6 hour, 28 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 77% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 77% ethanol elution of weight percent concentration, Ethanol is reclaimed, 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 syndrome, it is characterised in that as follows Prepare：
The composition and weight portion of crude drug be：24 weight portion Semen abelmoschi manihot of eupachlorin, 358 weight portion comb leaf, 472 weight 15 weight portion acrifoline of part 18.5 weight portion capillarisin of protocevine, 2 weight portion；
Preparation method：
（1）Eupachlorin, Semen abelmoschi manihot, comb leaf, protocevine, capillarisin, sharp leaf Lycopodium clavatum are taken by crude drug proportioning Alkali, mixes, and with 34% ethanol of weight percent concentration as solvent, extracts in 27.5 DEG C of warm macerating, and extraction time is 10 times, every time Extraction time is 40 hours, and 36 times for crude drug gross weight of each solvent load, filtration obtain medicinal residues A and extracting solution A, extract Liquid A reclaims ethanol, is concentrated into relative density 1.14, filters, and medicinal liquid is first washed with water by DM131 macroporous adsorptive resins, then With 23% ethanol solution eluting DM131 macroporous adsorptive resins of weight percent concentration, 23% ethanol of weight percent concentration is collected Eluent, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Medicinal residues A, with 47% ethanol of weight percent concentration as solvent, heating and refluxing extraction 9 times, is carried every time The time is taken for 0.6 hour, 28 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 77% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 77% ethanol elution of weight percent concentration, Ethanol is reclaimed, 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 syndrome, it is characterised in that pharmaceutical composition can be adopted Piece agent or capsule or drop pill are prepared with the conventional method of galenic pharmacy.
A kind of preparation method of the pharmaceutical composition for treating climacteric syndrome, it is characterised in that pharmaceutical composition and chemistry Medicine or Chinese medicine composition treatment climacteric syndrome medicine.
Medicine composite for curing climacteric syndrome is evident in efficacy.
Specific embodiment
Embodiment 1：Pharmaceutical composition for the treatment of climacteric syndrome and preparation method thereof
Treatment climacteric syndrome pharmaceutical composition crude drug composition and weight portion be：Eupachlorin 24g Abelmoschus manihot （L.） Medic Sub- 358g combs leaf 472g protocevines 18.5g capillarisin 15g acrifoline 2g；
Preparation method：
（1）Eupachlorin, Semen abelmoschi manihot, comb leaf, protocevine, capillarisin, sharp leaf Lycopodium clavatum are taken by crude drug proportioning Alkali, mixes, and with 34% ethanol of weight percent concentration as solvent, extracts in 27.5 DEG C of warm macerating, and extraction time is 10 times, every time Extraction time is 40 hours, and 36 times for crude drug gross weight of each solvent load, filtration obtain medicinal residues A and extracting solution A, extract Liquid A reclaims ethanol, is concentrated into relative density 1.14, filters, and medicinal liquid is first washed with water by DM131 macroporous adsorptive resins, then With 23% ethanol solution eluting DM131 macroporous adsorptive resins of weight percent concentration, 23% ethanol of weight percent concentration is collected Eluent, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Medicinal residues A, with 47% ethanol of weight percent concentration as solvent, heating and refluxing extraction 9 times, is carried every time The time is taken for 0.6 hour, 28 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 77% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 77% ethanol elution of weight percent concentration, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2：Pharmaceutical composition for the treatment of climacteric syndrome and preparation method thereof
Treatment climacteric syndrome pharmaceutical composition crude drug composition and weight portion be：Eupachlorin 23.5g Huangs another name for Sichuan Province Certain herbaceous plants with big flowers 360g comb leaf 470g protocevine 19g capillarisin 14g acrifoline 3g；
Preparation method：
（1）Eupachlorin, Semen abelmoschi manihot, comb leaf, protocevine, capillarisin, sharp leaf Lycopodium clavatum are taken by crude drug proportioning Alkali, mixes, and with 34% ethanol of weight percent concentration as solvent, extracts in 27.5 DEG C of warm macerating, and extraction time is 10 times, every time Extraction time is 40 hours, and 36 times for crude drug gross weight of each solvent load, filtration obtain medicinal residues A and extracting solution A, extract Liquid A reclaims ethanol, is concentrated into relative density 1.14, filters, and medicinal liquid is first washed with water by DM131 macroporous adsorptive resins, then With 23% ethanol solution eluting DM131 macroporous adsorptive resins of weight percent concentration, 23% ethanol of weight percent concentration is collected Eluent, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Medicinal residues A, with 47% ethanol of weight percent concentration as solvent, heating and refluxing extraction 9 times, is carried every time The time is taken for 0.6 hour, 28 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 77% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 77% ethanol elution of weight percent concentration, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3：Pharmaceutical composition for the treatment of climacteric syndrome and preparation method thereof
Treatment climacteric syndrome pharmaceutical composition crude drug composition and weight portion be：Eupachlorin 24.5g Huangs another name for Sichuan Province Certain herbaceous plants with big flowers 356g comb leaf 475g protocevine 18g capillarisin 16g acrifoline 1g；
Preparation method：
（1）Eupachlorin, Semen abelmoschi manihot, comb leaf, protocevine, capillarisin, sharp leaf Lycopodium clavatum are taken by crude drug proportioning Alkali, mixes, and with 34% ethanol of weight percent concentration as solvent, extracts in 27.5 DEG C of warm macerating, and extraction time is 10 times, every time Extraction time is 40 hours, and 36 times for crude drug gross weight of each solvent load, filtration obtain medicinal residues A and extracting solution A, extract Liquid A reclaims ethanol, is concentrated into relative density 1.14, filters, and medicinal liquid is first washed with water by DM131 macroporous adsorptive resins, then With 23% ethanol solution eluting DM131 macroporous adsorptive resins of weight percent concentration, 23% ethanol of weight percent concentration is collected Eluent, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Medicinal residues A, with 47% ethanol of weight percent concentration as solvent, heating and refluxing extraction 9 times, is carried every time The time is taken for 0.6 hour, 28 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 77% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 77% ethanol elution of weight percent concentration, Ethanol is reclaimed, 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
1 pharmaceutical composition 244g of Example, adds starch 500g, mixes, and granulation is dried, plus Microcrystalline Cellulose 148g, Hard Fat Sour magnesium 4g, mixes, is pressed into 2000, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
2 pharmaceutical composition 190g of Example, adds starch 210g, mixes, and granulation is dried, granulate, adds appropriate stearic acid Magnesium, mixes, encapsulated 1200, obtains final product medicament composition capsule.
Embodiment 6：The preparation of drop pill
Weigh (80 DEG C) heating of polyethylene glycol 6000 360g water-baths and boil molten, add 3 pharmaceutical composition 17.6g of embodiment, fully Stir, with liquid paraffin as coolant, put glass tubing（4*80cm）In, chilling temperature is -3 DEG C, and drip internal-and external diameter is 7.0/2.0 (mm/mm), drip is 2.5cm away from liquid level, and drop speed is per dividing 53 drops as optimum condition, to blot drop pill surface with cotton Condensing agent, obtain final product medicament composition dropping pills.
Embodiment 7：The pharmaceutical composition for the treatment of climacteric syndrome
Treatment climacteric syndrome pharmaceutical composition crude drug composition and weight portion be：
84 weight portion acrifoline of eupachlorin 20 weight portion protocevine, 50 weight portion capillarisin, 15 weight Part.
Embodiment 8：The pharmaceutical composition for the treatment of climacteric syndrome
Treatment climacteric syndrome pharmaceutical composition crude drug composition and weight portion be：
35 weight portion acrifoline of eupachlorin 40 weight portion protocevine, 20 weight portion capillarisin, 10 weight Part.
Embodiment 9：The pharmaceutical composition for the treatment of climacteric syndrome
Treatment climacteric syndrome pharmaceutical composition crude drug composition and weight portion be：
50 weight portion acrifoline of eupachlorin 28 weight portion protocevine, 60 weight portion capillarisin, 20 weight Part.
Experimental example 1：The experimental study for the treatment of climacteric syndrome
1 data and method
1.1 physical data
In June, 2013 in July, 2014 this city hospital-based outpatient obstetrical clinic go to a doctor perimenopausal women, occur hectic fever, perspiration, The menopause syndrome such as emotional instability, hypomnesis, affect life actively to seek treatment, and Jing gynecological endocrine inspections are made a definite diagnosis Patient and without Hormone Replacement Therapy contraindication, the age is 40～56 years old, 50 years old mean age, totally 29.
1.2 method
Combination of oral medication（1 pharmaceutical composition of embodiment）, once a day, each 0.6g continuously takes.Follow-up 6 months, Observation index:Climacteric syndrome symptom treatment effect adopts Kumpperman point systems；Blood lipid level:Index includes TC, TG, HDL-C, LDL-C, before treatment with treatment each detection in 6 months once；29 climacteric patients for receiving treatment simultaneously exist Other hormone medicines are not taken during using Hormone Replacement Therapy and hypolipidemic medicine is affected.
1.3 statistical method
All data are analyzed using 0 statistics softwares of SPSS17., and quantitative data result represents employing (x ± s), difference Analysis is checked using t, and inspection level is a=0. 05.
2 results
In 29 patients, 1 patient does not survey blood fat by process lost to follow-up after treating 6 months.28 patient on medication's compositionss half After individual month to one month, menopause syndrome is particularly nervous, a large amount of perspiration and Urogenital symptoms are relieved, and has 1 trouble Person occurs a small amount of vaginal hemorrhage over the course for the treatment of, and the persistent period is about 0. 5～1d, on the compliance treated without impact, 1 There is distending pain of the breast and/or headache in example, and symptom is lighter；Body weight before 28 patients treatment and after treatment 6 months without substantially plus Weight, 3 weight in patients averagely increase about 2.1kg.Treat front 29 patients menopause syndrome Kupperman scoring be (6.78 ± 2.58) divide, Kupperman scorings after treating 6 months are (1.59 ± 1.99) point.
Table 1 treat before and treatment 6 months after menopause syndrome Kupperman scoring compare
Time Number of cases Kupperman scores
Before treatment 29 6.78±2.58
After treatment 6 months 28 1.59±1.99*
Note：Compare with before treatment, * P<0. 05.
Table 2 treatment climacteric syndrome treatment before and treatment 6 months after blood lipid level compare (mmol/L)
Time Number of cases TC TG HDL-C LDL-C
Before treatment 29 5.51±0.71 1.54±0.44 1.85±0.45 2.22±0.72
After treatment 6 months 28 4.32±0.52 1.44±0.43 1.65±0.74 2.17±0.62
Blood lipid level before all patients treatment and after treatment 6 months compares discoverys, after treating 6 months, T-CHOL (TC) water It is flat relatively treat before level be remarkably decreased, difference is statistically significant, triglyceride (TG) and low density lipoprotein, LDL (LDL-C) compared with Slightly decline before treatment, no significant difference, high density lipoprotein (HDL-C) relatively treats front without significant change, and difference is without system Meter learns meaning.

Claims (8)

1. a kind of pharmaceutical composition for treating climacteric syndrome, it is characterised in that make the group of the crude drug of the pharmaceutical composition Into with weight portion it is：
Eupachlorin 23.5-24.5 weight portion Semen abelmoschi manihot 356-360 weight portion comb leaf 470-475 weight portion Rhizoma et radix veratri (Radix Rhizoma Veratri)s Cevine 18-19 weight portion capillarisin 14-16 weight portion acrifoline 1-3 weight portions.
2. a kind of pharmaceutical composition for treating climacteric syndrome according to claim 1, it is characterised in that make the medicine The composition and weight portion of the crude drug of compositionss be：
24 weight portion Semen abelmoschi manihot of eupachlorin, 358 472 weight portion protocevine of weight portion comb leaf, 18.5 weight portion 15 weight portion acrifoline of capillarisin, 2 weight portion.
3. a kind of pharmaceutical composition for treating climacteric syndrome according to claim 1, it is characterised in that pharmaceutical composition The conventional method of galenic pharmacy can be adopted to prepare piece agent or capsule or drop pill.
4. a kind of pharmaceutical composition for treating climacteric syndrome according to claim 1, it is characterised in that pharmaceutical composition The treatment climacteric syndrome medicine constituted with chemical drugs or Chinese medicine.
5. a kind of preparation method of the pharmaceutical composition for treating climacteric syndrome, it is characterised in that prepare as follows：
The composition and weight portion of crude drug be：Eupachlorin 23.5-24.5 weight portion Semen abelmoschi manihot 356-360 weight portions are combed Comb leaf 470-475 weight portion protocevine 18-19 weight portion capillarisin 14-16 weight portion acrifoline 1-3 weight Part；
Preparation method：
（1）Eupachlorin, Semen abelmoschi manihot, comb leaf, protocevine, capillarisin, sharp leaf Lycopodium clavatum are taken by crude drug proportioning Alkali, mixes, and with 34% ethanol of weight percent concentration as solvent, extracts in 27.5 DEG C of warm macerating, and extraction time is 10 times, every time Extraction time is 40 hours, and 36 times for crude drug gross weight of each solvent load, filtration obtain medicinal residues A and extracting solution A, extract Liquid A reclaims ethanol, is concentrated into relative density 1.14, filters, and medicinal liquid is first washed with water by DM131 macroporous adsorptive resins, then With 23% ethanol solution eluting DM131 macroporous adsorptive resins of weight percent concentration, 23% ethanol of weight percent concentration is collected Eluent, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Medicinal residues A, with 47% ethanol of weight percent concentration as solvent, heating and refluxing extraction 9 times, is carried every time The time is taken for 0.6 hour, 28 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 77% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 77% ethanol elution of weight percent concentration, Ethanol is reclaimed, 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 syndrome according to claim 5, it is characterised in that Prepare as follows：
The composition and weight portion of crude drug be：24 weight portion Semen abelmoschi manihot of eupachlorin, 358 weight portion comb leaf, 472 weight 15 weight portion acrifoline of part 18.5 weight portion capillarisin of protocevine, 2 weight portion；
Preparation method：
（1）Eupachlorin, Semen abelmoschi manihot, comb leaf, protocevine, capillarisin, sharp leaf Lycopodium clavatum are taken by crude drug proportioning Alkali, mixes, and with 34% ethanol of weight percent concentration as solvent, extracts in 27.5 DEG C of warm macerating, and extraction time is 10 times, every time Extraction time is 40 hours, and 36 times for crude drug gross weight of each solvent load, filtration obtain medicinal residues A and extracting solution A, extract Liquid A reclaims ethanol, is concentrated into relative density 1.14, filters, and medicinal liquid is first washed with water by DM131 macroporous adsorptive resins, then With 23% ethanol solution eluting DM131 macroporous adsorptive resins of weight percent concentration, 23% ethanol of weight percent concentration is collected Eluent, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Medicinal residues A, with 47% ethanol of weight percent concentration as solvent, heating and refluxing extraction 9 times, is carried every time The time is taken for 0.6 hour, 28 times for medicinal residues A weight of each solvent load, filtration obtain medicinal residues B and extracting solution B, and extracting solution B is returned Ethanol is received, relative density 1.03 is concentrated into, is filtered, medicinal liquid is first washed with water, then uses weight by LK06 macroporous adsorptive resins 77% ethanol solution eluting LK06 macroporous adsorptive resins of percent concentration, collect 77% ethanol elution of weight percent concentration, Ethanol is reclaimed, 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 syndrome according to claim 5, it is characterised in that Pharmaceutical composition can adopt the conventional method of galenic pharmacy to prepare piece agent or capsule or drop pill.
8. a kind of preparation method of the pharmaceutical composition for treating climacteric syndrome according to claim 5, it is characterised in that Pharmaceutical composition and chemical drugs or Chinese medicine composition treatment climacteric syndrome medicine.
CN201611132966.6A 2016-12-10 2016-12-10 It is a kind of to treat pharmaceutical composition of climacteric syndrome and preparation method thereof Withdrawn CN106539834A (en)

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