CN109568392A - A kind of pharmaceutical composition and its preparation method and application for treating infertility - Google Patents

A kind of pharmaceutical composition and its preparation method and application for treating infertility Download PDF

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Publication number
CN109568392A
CN109568392A CN201710911026.5A CN201710911026A CN109568392A CN 109568392 A CN109568392 A CN 109568392A CN 201710911026 A CN201710911026 A CN 201710911026A CN 109568392 A CN109568392 A CN 109568392A
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parts
radix
preparation
pharmaceutical composition
added
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郭博信
黄云
沈晓洲
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Traditional Chinese Medicine Science And Technology (beijing) Ltd By Share Ltd Bosin
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Traditional Chinese Medicine Science And Technology (beijing) Ltd By Share Ltd Bosin
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    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481—Astragalus (milkvetch)
    • 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
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/235—Foeniculum (fennel)
    • 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)
    • A61K36/34—Campanulaceae (Bellflower family)
    • A61K36/344—Codonopsis
    • 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)
    • A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
    • 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)
    • A61K36/43—Cuscutaceae (Dodder family), e.g. Cuscuta epithymum or greater dodder
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537—Salvia (sage)
    • 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)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • 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)
    • A61K36/57—Magnoliaceae (Magnolia family)
    • 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)
    • A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
    • 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)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • 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)
    • A61K36/79—Schisandraceae (Schisandra family)

Abstract

The present invention provides a kind of pharmaceutical compositions for treating infertility, it is prepared by the bulk pharmaceutical chemicals of following weight proportion: 15-55 parts of Radix Astragali, 15-55 parts of Radix Codonopsis, 15-50 parts of Radix Paeoniae Alba, 15-50 parts of Radix Angelicae Sinensis, 8-35 parts of teasel root, 8-35 parts of Radix Salviae Miltiorrhizae, 8-35 parts of Semen Cuscutae, 8-35 parts of Schisandra chinensis, 2-12 parts of fennel seeds, 0.5-8 parts of cortex cinnamomi.The present invention also provides the preparation method of the pharmaceutical composition and purposes.Clinical test proves that drug of the present invention effectively treats infertility, and compatibility is precise and appropriate, curative for effect, has no toxic side effect, and clinical applicability is good, and preparation method is simple, and big technique is suitble to produce.

Description

A kind of pharmaceutical composition and its preparation method and application for treating infertility
Technical field
The present invention relates to a kind of pharmaceutical compositions for treating infertility.
Background technique
Infertility refers to that all Women of Childbearing Age are lived together 2 years after marriage, and syngamy function is normal, has normal sexuality not practise contraception And the person that do not become pregnant；Or once bred, it does not practise contraception and 2 years or more the persons that no longer do not become pregnant, the former claims primary infertility, and the latter claims secondary It is infertile.Cause the complicated multiplicity of the factor of female infertility, mainly by genetic defect, anatomic abnormalities, endocrine disturbance, it is immune because The a variety of causes such as element, infection, systemic disease and environmental factor cause.In recent years, in world wide in crowd infertility hair Sick rate has the tendency that rising year by year, and predicts according to the World Health Organization, and in 21 century, infertility, which will become, is only second to tumour and heart and brain 3rd big disease of angiosis.
The drug for the treatment of infertility has hundreds of at present, and Western medicine is mainly based on hormone drug, such as ethinyloestradiol, chromium Phenol, bromocriptine, progesterone etc..However these drugs, there are biggish toxic side effect, long-term use will bring liver, kidney function to women The consequences such as energy decline, be easy to cause female irregular menstruation, premature ovarian failure, ovarian hyperstimulation syndrome occur, a few peoples then can Suffer from ovarian neoplasm.
Traditional Chinese medicine theory thinks, the common interpretation of the cause, onset and process of an illness of female sterility has kidney deficiency, liver depression, phlegm wet, blood stasis, qi-blood deficiency It should be directed to the different interpretation of the cause, onset and process of an illness when Deng, treatment, formulate different treatment methods.The drug of existing treatment infertility uses prodrug complex, Treatment time is long, is not suitable for big technique production, and clinical applicability is bad；A kind of drug for treating infertility of existing patent report Composition, number of patent application: CN200410024568.3, patent name: a kind of ovulation promoting helps pregnant drug, it is by following The raw material of weight is made: radix rehmanniae preparata 9~30, Radix Angelicae Sinensis 6~15, Rhizoma Chuanxiong 6~10, Radix Paeoniae Alba 6~15, Poria cocos 9~15, Radix Codonopsis 6 ~15, Rhizoma Atractylodis Macrocephalae 9~15, Radix Astragali 15~30, keel 9~30, oyster 9~30, cornu cerve degelatinatum 10~20, Cortex Eucommiae 10~15, folium artemisiae argyi 6~ 12, HERBA EPIMEDII 10~20, Semen Cuscutae 6~20, thizoma curculiginis 6~15, Herba Cistanches 6~15, amethyst 6~30, Radix Salviae Miltiorrhizae 9~30, benefit are female Careless 10~30, radix paeoniae rubra 9~20, Semen Leonuri 6~30, rhizoma cyperi 6~15, Chinese yam 15~30, cortex cinnamomi 3~10, teasel root 9~15, donkey-hide gelatin 3 ~15, Cortex Phellodendri 6~20, the tuber of multiflower knotweed 6~20, Radix Glycyrrhizae 3~10.This side's prodrug complex, and wherein most price of medicinal material are high, are not suitable for big Industrial production.
It produces one kind and meets existing patient demand, medication is simplified, and it is very necessary for capable of effectively treating the drug of infertility 's.
Summary of the invention
The present invention provides a kind of pharmaceutical compositions for treating infertility, and the present invention also provides its of the pharmaceutical composition Preparation method and purposes.
A kind of pharmaceutical composition for treating infertility, it is prepared by the bulk pharmaceutical chemicals of following weight proportion: it be by The bulk pharmaceutical chemicals of following weight proportion are prepared: 15-55 parts of Radix Astragali, 15-55 parts of Radix Codonopsis, 15-50 parts of Radix Paeoniae Alba, 15-50 parts of Radix Angelicae Sinensis, 8-35 parts of teasel root, 8-35 parts of Radix Salviae Miltiorrhizae, 8-35 parts of Semen Cuscutae, 8-35 parts of Schisandra chinensis, 2-12 parts of fennel seeds, 0.5-8 parts of cortex cinnamomi.
Wherein, the pharmaceutical composition is prepared by the bulk pharmaceutical chemicals of following weight proportion: 23-51 parts of Radix Astragali, party Join 22-48 parts, 20-42 parts of Radix Paeoniae Alba, 18-40 parts of Radix Angelicae Sinensis, 12-30 parts of teasel root, 10-32 parts of Radix Salviae Miltiorrhizae, 15-30 parts of Semen Cuscutae, the five tastes 10-30 parts sub-, 3-11 parts of fennel seeds, 1-5 parts of cortex cinnamomi.
Wherein, the pharmaceutical composition is prepared by the bulk pharmaceutical chemicals of following weight proportion: 35 parts of Radix Astragali, Radix Codonopsis 35 Part, 30 parts of Radix Paeoniae Alba, 30 parts of Radix Angelicae Sinensis, 20 parts of teasel root, 20 parts of Radix Salviae Miltiorrhizae, 20 parts of Semen Cuscutae, 20 parts of Schisandra chinensis, 6 parts of fennel seeds, cortex cinnamomi 3 Part.
Wherein, it is work that described pharmaceutical composition, which is by the primary medicinal powder or water or extractive with organic solvent of the raw material, Property ingredient, in addition pharmaceutically acceptable auxiliary material or complementary ingredient are prepared into pharmaceutically common preparation.
Pharmaceutically acceptable auxiliary material of the present invention refers in addition to the active ingredient (s include substance in dosage form, packet Include but be not limited only to filler (diluent), lubricant (glidant or antitack agent), dispersing agent, wetting agent, adhesive, adjusting Agent, solubilizer, antioxidant, bacteriostatic agent, emulsifier, disintegrating agent etc..Adhesive include syrup, Arabic gum, gelatin, sorbierite, Tragacanth, cellulose and its derivates (such as microcrystalline cellulose, sodium carboxymethylcellulose, ethyl cellulose or hydroxypropyl methylcellulose Element etc.), gelatine size, syrup, starch slurry or polyvinylpyrrolidone etc.；Filler include lactose, Icing Sugar, dextrin, starch and its Derivative, cellulose and its derivates, inorganic calcium salt (such as calcium sulfate, calcium phosphate, calcium monohydrogen phosphate, precipitated calcium carbonate), sorb Alcohol or glycine etc.；Lubricant includes superfine silica gel powder, magnesium stearate, talcum powder, aluminium hydroxide, boric acid, hydrogenated vegetable oil, poly- second Glycol etc.；Disintegrating agent includes starch and its derivative (such as sodium carboxymethyl starch, Explotab, pregelatinized starch, improvement shallow lake Powder, hydroxypropul starch, cornstarch etc.), polyvinylpyrrolidone or microcrystalline cellulose etc.；Wetting agent includes dodecyl sulphate Sodium, water or alcohol etc.；Antioxidant packages are containing sodium sulfite, sodium hydrogensulfite, sodium pyrosulfite, dibutyl benzoic acid etc.；Bacteriostatic agent includes 0.5% phenol, 0.3% cresols, 0.5% anesin etc.；Regulator includes hydrochloric acid, citric acid, potassium hydroxide (sodium), citron Sour sodium and buffer (including sodium dihydrogen phosphate and disodium hydrogen phosphate) etc.；Emulsifier includes Tween-80, fatty acid sorb Smooth, pluronic gram F-68, lecithin, Fabaceous Lecithin etc.；Solubilizer includes Tween-80, bile, glycerol etc..
The pharmaceutically acceptable complementary ingredient, it has certain physiological activity, but the addition of the ingredient will not change Become the leading position of above compound or derivative in the course of disease treatment, and only plays auxiliary effect, these auxiliary function Effect is only the utilization to the ingredient known activity, is the usual adjuvant treatment modality of field of medicaments.If by it is above-mentioned it is complementary at Divide and be used cooperatively with the compounds of this invention, still should belong to the scope of protection of the invention.
Wherein, the preparation is oral preparation.
Wherein, the preparation is decoction, powder, granule, tablet, capsule, oral solution, pill；Preferably, the ball Agent is the water-bindered pill, honeyed bolus, dripping pill.
The present invention also provides the preparation methods of pharmaceutical composition above-mentioned, it is comprised the following steps:
(1) bulk pharmaceutical chemicals of each weight proportion are weighed；
(2) powder is beaten, or water or organic solvent is added to extract, pharmaceutically acceptable auxiliary material is added or complementary ingredient is prepared into Pharmaceutically common preparation.
Water extract is used as medicine with medicinal powder, is Chinese medicine tradition usage mode, after water mentions, since the soluble end of water is wide, and energy It is enough to dissolve out most of effective component, make drug be easier to be absorbed by the body, works faster, such as the form of medication such as decoction；With Original powder is used as medicine, and the surface area of medicinal powder is larger, is also beneficial to the absorption of effective component in vivo in medicinal material, but medicinal material is un-extracted, Effective component still needs to dissolve out re-absorption in vivo, and the opposite water extract that works is slower, but also weaken simultaneously in medicinal material nocuousness at Divide the toxicity caused by human body, is suitable for taking for a long time, such as original powder is prepared into pill form of medication.At present in pharmacy In the process, ethyl alcohol extracts drug as solvent and one of most commonly seen extracting mode, ethyl alcohol are that semi-polarity is molten Agent, solubility property circle can dissolve water-soluble certain ingredients between polarity and nonpolar solvent, and it is molten also to dissolve nonpolarity Some ingredients of agent dissolution, are usually extracted with ethyl alcohol and replace decocting, to avoid the dissolution of a large amount of invalid components, improve effectively at The concentration and extraction efficiency divided, but the price of ethyl alcohol is expensive compared with water, in modern pharmaceutical industry mass production, is produced into save This, usually or based on decocting.In the case where the water extract of known compositions of the present invention has physiological activity, in order to adapt to Various productions and demand when using, can optionally water mentions, original powder, alcohol extracting or their combination method prepare specific agent Type.
Wherein, the preparation of the preparation specific the preparation method is as follows:
Decoction: weighing bulk pharmaceutical chemicals, decoct, filtering to get；
Powder: weighing bulk pharmaceutical chemicals, beats powder, sieving to get；
Granule: weighing bulk pharmaceutical chemicals, and water or organic solvent is added to extract, filtering, filtrate concentration, dry, addition auxiliary material or auxiliary Helping property ingredient, mix, granulation, whole grain, dry to get；
Tablet: weighing bulk pharmaceutical chemicals, and water or organic solvent is added to extract, filtering, filtrate concentration, be added auxiliary material or it is complementary at Point, granulation, whole grain, tabletting to get；
Capsule: weighing bulk pharmaceutical chemicals, and water or organic solvent is added to extract, and filtering, filtrate is concentrated and dried, and auxiliary material or auxiliary is added Property ingredient, mix, it is encapsulated to get；
The water-bindered pill: weighing bulk pharmaceutical chemicals, beats powder, sieving, is added excipient, water pill, it is dry to get；
Honeyed bolus: weighing bulk pharmaceutical chemicals, beats powder, sieving, is added honey, pill, it is dry to get；
Dripping pill: weighing bulk pharmaceutical chemicals, and water or organic solvent is added to extract, filtering, and matrix is added in filtrate, mixes heating and melting, Instill in not miscible condensate liquid condensation to get.
The organic solvent is the ethyl alcohol of various concentration, such as the ethyl alcohol of 25%-95%.
The present invention provides purposes of the pharmaceutical composition in the drug of preparation treatment infertility.
Pharmaceutical composition of the present invention by Radix Astragali, Radix Codonopsis, Radix Paeoniae Alba, Radix Angelicae Sinensis, teasel root, Radix Salviae Miltiorrhizae, Semen Cuscutae, Schisandra chinensis, fennel seeds, Cortex cinnamomi Ten Herbs material composition, Radix Astragali tonifying Qi in side, invigorating qi for consolidating superficies, it is altogether monarch drug in a prescription that Radix Codonopsis, which reinforces the spleen to benefit the lung, enriching blood and promoting secretion of body fluid；Radix Paeoniae Alba It enriches blood, suppressing liver-YANG restrains hidroschesis, and Chinese angelica blood supplementing promoting blood circulation, menstruation regulating is altogether ministerial drug；Teasel nourishing liver and kidney, strengthening the bones and muscles, promoting blood circulation stop Bitterly, arresting bleeding and miscarriage prevention, Radix Salviae Miltiorrhizae activating microcirculation and removing stasis medicinal, relieving restlessness are calmed the nerves, and Semen Cuscutae is nourishing liver and kidney, astringent sperm contracting urine, miscarriage prevention, and Schisandra chinensis convergence is solid It is puckery, it is altogether adjutant；Fennel seeds, cortex cinnamomi Wen Yang relax and are promoted blood circulation, and are altogether to make medicine.Compatibility of drugs, plays temperature male wind-supplying kidney altogether, activating microcirculation and removing stasis medicinal, The effect of warming meridians and promoting circulation of qi.
Clinical test proves that drug of the present invention can effectively treat infertility, and compatibility is precise and appropriate, curative for effect, has no toxic side effect, Clinical applicability is good.
Obviously, above content according to the present invention is not being departed from according to the ordinary technical knowledge and customary means of this field Under the premise of the above-mentioned basic fundamental thought of the present invention, the modification, replacement or change of other diversified forms can also be made.
The specific embodiment of form by the following examples remakes further specifically above content of the invention It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to example below.It is all to be based on above content of the present invention The technology realized all belongs to the scope of the present invention.
Specific embodiment
The preparation of the medicinal tablet of the present invention of embodiment 1
Weigh following raw materials: Radix Astragali 35g, Radix Codonopsis 35g, Radix Paeoniae Alba 30g, Radix Angelicae Sinensis 30g, teasel root 20g, Radix Salviae Miltiorrhizae 20g, Semen Cuscutae 20g, Schisandra chinensis 20g, fennel seeds 6g, cortex cinnamomi 3g；Powder is beaten, direct powder compression is to get tablet.
The preparation of the medicinal tablet of the present invention of embodiment 2
Weigh following raw materials: Radix Astragali 15g, Radix Codonopsis 15g, Radix Paeoniae Alba 15g, Radix Angelicae Sinensis 15g, teasel root 8g, Radix Salviae Miltiorrhizae 8g, Semen Cuscutae 8g, Schisandra chinensis 8g, fennel seeds 2g, cortex cinnamomi 0.5g；It adds water to cook extraction, be condensed into medicinal extract, starch granulation, whole grain, tabletting is added, i.e., Obtain tablet.
The preparation of the medicine capsule of the present invention of embodiment 3
Weigh following raw materials: Radix Astragali 23g, Radix Codonopsis 22g, Radix Paeoniae Alba 20g, Radix Angelicae Sinensis 18g, teasel root 12g, Radix Salviae Miltiorrhizae 10g, Semen Cuscutae 15g, Schisandra chinensis 10g, fennel seeds 3g, cortex cinnamomi 1g；Add water to cook extraction, be condensed into medicinal extract, be added auxiliary material, mix, packing to get Capsule.
The preparation of the drug water-bindered pill of the present invention of embodiment 4
Weigh following raw materials: Radix Astragali 51g, Radix Codonopsis 48g, Radix Paeoniae Alba 42g, Radix Angelicae Sinensis 40g, teasel root 30g, Radix Salviae Miltiorrhizae 32g, Semen Cuscutae 30g, Schisandra chinensis 30g, fennel seeds 11g, cortex cinnamomi 5g；Powder is beaten, excipient is added in sieving, and water pill is dry to get the water-bindered pill.
The preparation of the drug honeyed bolus of the present invention of embodiment 5
Weigh following raw materials: Radix Astragali 41g, Radix Codonopsis 48g, Radix Paeoniae Alba 32g, Radix Angelicae Sinensis 24g, teasel root 18g, Radix Salviae Miltiorrhizae 12g, Semen Cuscutae 20g, Schisandra chinensis 28g, fennel seeds 7g, cortex cinnamomi 6；Powder is beaten, honey is added in sieving, and pill is dry to get honeyed bolus.
The preparation of the drug decoction of the present invention of embodiment 6
Weigh following raw materials: Radix Astragali 30g, Radix Codonopsis 25g, Radix Paeoniae Alba 20g, Radix Angelicae Sinensis 30g, teasel root 10g, Radix Salviae Miltiorrhizae 25g, Semen Cuscutae 20g, Schisandra chinensis 15g, fennel seeds 8g, cortex cinnamomi 1g；Decoction is soaked in water, merging filtrate filters to get decoction.
The preparation of the drug decoction of the present invention of embodiment 7
Weigh following raw materials: Radix Astragali 28g, Radix Codonopsis 35g, Radix Paeoniae Alba 30g, Radix Angelicae Sinensis 20g, teasel root 15g, Radix Salviae Miltiorrhizae 20g, Semen Cuscutae 18g, Schisandra chinensis 15g, fennel seeds 7g, cortex cinnamomi 4g；Decoction is soaked in water, merging filtrate filters to get decoction.
The preparation of the medicine oral liquid of the present invention of embodiment 8
Weigh following raw materials: Radix Astragali 55g, Radix Codonopsis 55g, Radix Paeoniae Alba 50g, Radix Angelicae Sinensis 50g, teasel root 35g, Radix Salviae Miltiorrhizae 35g, Semen Cuscutae 35g, Schisandra chinensis 35g, fennel seeds 12g, cortex cinnamomi 8g；Decoction is soaked in water, merging filtrate, concentration, encapsulating, sterilizing is to get oral Liquid.
Beneficial effects of the present invention are proved below by way of specific clinical test:
The clinical efficacy of the medicine composite for curing infertility of the present invention of test example 1
1 experimental material
1.1 experimental drugs pharmaceutical composition of the present invention, is prepared by embodiment 1.
1.2 patient datas observe case totally 43.
2 experimental methods
2.1 are included in case standard: 1. Women of Childbearing Age has normal sexual life after marriage, and bridegroom's or husband's side reproductive function is normal, does not keep away Pregnant live together 2 years and fail to become pregnant.2. ovulatory dysfunction is infertile.3. infertile caused by endometriosis.4. fallopian tubal It is infertile caused by inflammation.5. infertile caused by endometriosis interna.6. infertile caused by Asherman's syndrom.
2.2 exclusion criterias: 1. infertile caused by congenital physiological defect or deformity.2. infertile caused by inherent cause.③ It is infertile etc. caused by immunity.4. bridegroom's or husband's side reproductive function is abnormal.5. it is serious former to be associated with angiocarpy, liver, kidney and hemopoietic system etc. Hair property disease and mental patient.6. to drug allergy person used.
The judgement of 2.3 curative effects
It is effective: the person of becoming pregnant in 2 years.
It is invalid: without significant change after treatment.
2.4 medication
Oral administration, daily 3 times, it is early, middle and late respectively take it is primary, each taking when need to be separated with the meal time it is super In half an hour, each taking the weight of drug be equivalent to 3 grams of crude drugs.
3 experimental results
Experimental result: 1-3 month visible positive effects are taken；Illustrate that pharmaceutical composition of the present invention can treat infertility, Total effective rate is up to 95.3%.
The typical case of the medicine composite for curing infertility of the present invention of test example 2
Case 1: Xing X, female, 31 years old.4 years unpregnancies after marriage, throughout the year life at abroad, drink daily ice water, eat it is cold and cool Food causes its underbelly is long to feel ice-cold, feels with pendant.It is successfully pregnant after taking this medicine 1 month within 2013, it is rear smoothly to produce Next female.
Case 2: Lee XX, female, 36 years old.Many years unpregnancy after marriage, rear check is salpingemphraxis, and length feels waist soreness, weary Power lazyness speech.After take this medicine 1 month after feel that spirit takes a favorable turn, waist soreness also greatly improves, then after taking this medicine 1 month Smoothly pregnancy.
To sum up, drug of the present invention can effectively treat infertility, and compatibility is precise and appropriate, curative for effect, have no toxic side effect, and clinic is applicable in Property good, simple production process, be suitble to big technique to produce.

Claims (10)

1. a kind of pharmaceutical composition for treating infertility, it is characterised in that: it be by following weight proportion bulk pharmaceutical chemicals preparation and At: 15-55 parts of Radix Astragali, 15-55 parts of Radix Codonopsis, 15-50 parts of Radix Paeoniae Alba, 15-50 parts of Radix Angelicae Sinensis, 8-35 parts of teasel root, 8-35 parts, Tu of Radix Salviae Miltiorrhizae 8-35 parts sub-, 8-35 parts of Schisandra chinensis, 2-12 parts of fennel seeds, 0.5-8 parts of cortex cinnamomi.
2. pharmaceutical composition according to claim 1, it is characterised in that: it is prepared by the bulk pharmaceutical chemicals of following weight proportion Form: 23-51 parts of Radix Astragali, 22-48 parts of Radix Codonopsis, 20-42 parts of Radix Paeoniae Alba, 18-40 parts of Radix Angelicae Sinensis, 12-30 parts of teasel root, 10-32 parts of Radix Salviae Miltiorrhizae, 15-30 parts of Semen Cuscutae, 10-30 parts of Schisandra chinensis, 3-11 parts of fennel seeds, 1-5 parts of cortex cinnamomi.
3. pharmaceutical composition according to claim 1 or 2, it is characterised in that: it is by the bulk pharmaceutical chemicals of following weight proportion It is prepared: 35 parts of Radix Astragali, 35 parts of Radix Codonopsis, 30 parts of Radix Paeoniae Alba, 30 parts of Radix Angelicae Sinensis, 20 parts of teasel root, 20 parts of Radix Salviae Miltiorrhizae, 20 parts of Semen Cuscutae, five 20 parts of taste, 6 parts of fennel seeds, 3 parts of cortex cinnamomi.
4. pharmaceutical composition according to claim 1 to 3, it is characterised in that: described pharmaceutical composition is by institute State the primary medicinal powder of raw material perhaps water or extractive with organic solvent be active constituent plus pharmaceutically acceptable auxiliary material or Complementary ingredient is prepared into pharmaceutically common preparation.
5. pharmaceutical composition according to claim 4, it is characterised in that: the preparation is oral preparation.
6. pharmaceutical composition according to claim 5, it is characterised in that: the preparation is decoction, powder, granule, piece Agent, capsule, oral solution, pill；Preferably, the pill is the water-bindered pill, honeyed bolus, dripping pill.
7. a kind of method for preparing pharmaceutical composition as claimed in any one of claims 1 to 6, it is characterised in that: it includes as follows Step:
(1) bulk pharmaceutical chemicals of each weight proportion are weighed；
(2) powder is beaten, or water or organic solvent is added to extract, pharmaceutically acceptable auxiliary material is added or complementary ingredient is prepared into pharmacy Upper common preparation.
8. preparation method according to claim 7, it is characterised in that: it is specific the preparation method is as follows:
Decoction: weighing bulk pharmaceutical chemicals, decoct, filtering to get；
Powder: weighing bulk pharmaceutical chemicals, beats powder, sieving to get；
Granule: weighing bulk pharmaceutical chemicals, and water or organic solvent is added to extract, filtering, filtrate concentration, dry, addition auxiliary material or complementary Ingredient, mix, granulation, whole grain, dry to get；
Tablet: weighing bulk pharmaceutical chemicals, and water or organic solvent is added to extract, filtering, and auxiliary material or complementary ingredient, system is added in filtrate concentration Grain, whole grain, tabletting to get；
Capsule: weighing bulk pharmaceutical chemicals, and water or organic solvent is added to extract, and filtering, filtrate is concentrated and dried, be added auxiliary material or it is complementary at Point, mix, it is encapsulated to get；
The water-bindered pill: weighing bulk pharmaceutical chemicals, beats powder, sieving, is added excipient, water pill, it is dry to get；
Honeyed bolus: weighing bulk pharmaceutical chemicals, beats powder, sieving, is added honey, pill, it is dry to get；
Dripping pill: weighing bulk pharmaceutical chemicals, and water or organic solvent is added to extract, filtering, and matrix is added in filtrate, mixes heating and melting, instills In not miscible condensate liquid condense to get.
9. purposes of the pharmaceutical composition as claimed in any one of claims 1 to 6 in the drug of preparation treatment infertility.
10. pharmaceutical composition as claimed in any one of claims 1 to 6 has temperature male wind-supplying kidney, activating microcirculation and removing stasis medicinal, Wen Jingtong in preparation Purposes in the drug of arteries and veins effect.
CN201710911026.5A 2017-09-29 2017-09-29 A kind of pharmaceutical composition and its preparation method and application for treating infertility Pending CN109568392A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101584832A (en) * 2008-05-21 2009-11-25 江中泉 Chinese medicament for treating female infertility

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101584832A (en) * 2008-05-21 2009-11-25 江中泉 Chinese medicament for treating female infertility

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