CN105797081A - Pharmaceutical composition for treating amenorrhea - Google Patents

Pharmaceutical composition for treating amenorrhea Download PDF

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Publication number
CN105797081A
CN105797081A CN201610306338.9A CN201610306338A CN105797081A CN 105797081 A CN105797081 A CN 105797081A CN 201610306338 A CN201610306338 A CN 201610306338A CN 105797081 A CN105797081 A CN 105797081A
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parts
radix
pharmaceutical composition
caulis spatholobi
rhizoma
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李志杰
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Yantai Lanyangzhicao Pharmaceutical Biotechnology Co Ltd
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Yantai Lanyangzhicao Pharmaceutical Biotechnology Co Ltd
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    • A—HUMAN NECESSITIES
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    • 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)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
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    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/75—Rutaceae (Rue family)
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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Abstract

The invention discloses a pharmaceutical composition for treating amenorrhea, and belongs to the technical field of traditional Chinese medicines. The pharmaceutical composition is prepared from the raw materials of suberect spatholobus stem, argy wormwood leaf, rhizoma corydalis, safflower, Szechwan chinaberry fruit, combined spicebush root, tree peony bark, danshen root, mulberry fruit, cassia bark, green tangerine peel, rhubarb, white peony root, curcuma zedoary, oyster shell, desertliving cistanche, tuckahoe, fleece flower root, mussel and licorice root. The pharmaceutical composition has the effects of promoting blood circulation to remove blood stasis, regulating menstruation to relieve pain, nourishing yin and moistening lung, clearing heart and soothing nerves, and cooling blood and removing toxic materials, and has the advantages of scientific compatibility, rapid treatment effect, high cure rate, low cost and the like.

Description

A kind of pharmaceutical composition treating amenorrhea
The application be applicant Linyi Cao Zhimei Pharmaceutical Technology Co., Ltd propose application for a patent for invention (denomination of invention is: a kind of pharmaceutical composition preparation treatment amenorrhea medicine in purposes, application number is: 2015106516189, and the applying date is: on October 10th, 2015) divisional application.
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of pharmaceutical composition treating amenorrhea.
Background technology
Amenorrhea is symptom common in gynaecopathia, it is possible to caused by various different reasons.Generally amenorrhea is divided into constitutional and Secondary cases two kinds.All persons that do not pass through yet over 18 years old are called primary amenorrhea；After menarche, in any time before normal menopause (gestation or except age of sucking), menstruation apolipsis is called secondary amenorrhea more than 6 months persons.Menstruation is to be caused endometrical cycle to come off by the periodic adjustment of hypothalamic-pituitary-ovarian axis to be formed, therefore any organic or functional change occurred on the links in hypothalamus, hypophysis, ovary and reproductive tract particularly uterus, is all likely to cause amenorrhea.Organic and the functional exception of other endocrine gland, it is also possible to affect menstruation so that there is amenorrhea.
In recent years, along with the increase of life stress, a lot of women just occur in that the phenomenon of amenorrhea too early before menopause.Amenorrhea is very big on the impact of women physical and mental health.Amenorrhea is a kind of gynecological common disease, clinical manifestation: from ischomenia, association's abdominal distention and pain symptom is the most prominent, the traditional Chinese medical science is thought: the generation of amenorrhea, void is had to have reality, many with void person, reality person is few, void person is due to congenital defect or the fecund exhaustion due to sexual indulgence day after tomorrow, prolonged illness serious disease, improper diet and overtiredness, the factor such as worry too much of being worried causes kidney qi weakness, or deficient qi and blood, or deficiency of YIN blood is dry, depletion of blood can under, and cause amenorrhea due to blood depletion, reality person is due to internal injury caused by excess of seven emotions or experiences cold and heat damp or ferritic obesity, many abundant expectoration wet, cause qi depression to blood stasis, or stagnation of phlegm-damp, blockage of vessel, menses must not be descending and cause that blood is every amenorrhea.According to theory of Chinese medical science, for the pathogeny of amenorrhea, with depressed liver-energy dispersing and QI regulating, benefiting vital QI and blood, dispelling cold by warming the meridian, blood circulation promoting and blood stasis dispelling for the rule for the treatment of, carry out dialectical prescription compatibility, to reach the purpose for the treatment of both the principal and secondary aspects of a disease.At present, the medicine for the treatment of amenorrhea is also a lot, but there is the deficiencies such as curative effect instability, treatment time length, side effect are big.
nullChinese patent 201310308011.1 discloses a kind of Chinese medicine composition treating amenorrhea，This Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Codonopsis 20-30 part、Radix Rehmanniae Preparata 20-30 part、Herba Epimedii 20-30 part、Folium Photiniae (Folium Photiniae serrulatae) 20-30 part、Flos Carthami 20-30 part、Radix Paeoniae Alba 20-30 part、Herba Leonuri 10-20 part、Radix Astragali 10-15 part、Cornu Cervi Degelatinatum 10-15 part、Rhizoma Atractylodis Macrocephalae 5-15 part、Poria 5-15 part、Radix Rhapontici 5-15 part、Fructus Liquidambaris 5-15 part、Fructus Leonuri 5-15 part、Rhizoma Cyperi 5-15 part、Ramulus Cinnamomi 5-15 part、Fructus Lycii 5-15 part、Fructus Ligustri Lucidi 5-15 part、Semen Cuscutae 5-15 part、Fructus Rubi 5-15 part、Herba Ephedrae 5-15 part、Cortex Mori 5-15 part、Radix Achyranthis Bidentatae 5-15 part、Flos Carthami 5-15 part、Radix Bupleuri 5-15 part、Herba Lycopi's 5-15 part、Radix Curcumae 5-15 part、Radix Glycyrrhizae 5-15 part、Eupolyphaga Seu Steleophaga 3-9 part、Hirudo 3-9 part、Radix Platycodonis 3-9 part、Rhizoma Chuanxiong 3-9 part.Effect that this Chinese medicine composition has stable curative effect, treatment time is short, side effect is little, but in dispersing cold for relieving pain, effect is not very notable.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of pharmaceutical composition treating amenorrhea, this pharmaceutical composition has effect of blood circulation promoting and blood stasis dispelling, menstruction regulating and pain relieving, nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization and removing pathogenic heat from blood and toxic substance from the body, also has compatibility science, and curative effect is rapid, cure rate is high, low cost and other advantages.Additionally, the present invention also provides for corresponding manufacturing process, this pharmaceutical composition is made and facilitated easy-to-use preparation under the premise ensureing curative effect.
The technical solution used in the present invention is:
A kind of pharmaceutical composition treating amenorrhea, this pharmaceutical composition is prepared from by the raw material of following parts by weight: Caulis Spatholobi 4-16 part, Folium Artemisiae Argyi 6-29 part, Rhizoma Corydalis 4-8 part, Flos Carthami 7-11 part, Fructus Toosendan 5-7 part, Radix Linderae 4-8 part, Cortex Moutan 7-11 part, Radix Salviae Miltiorrhizae 10-14 part, Fructus Mori 6-11 part, Cortex Cinnamomi 2-4 part, Pericarpium Citri Reticulatae Viride 4-8 part, Radix Et Rhizoma Rhei 4-29 part, Radix Paeoniae Alba 7-14 part, Rhizoma Curcumae 7-8 part, Concha Ostreae 10-29 part, Herba Cistanches 3-9 part, Poria 10-14 part, Radix Polygoni Multiflori 6-12 part, Mytilus 6-19 part and Radix Glycyrrhizae 2-9 part.
Preferably, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Caulis Spatholobi 4 parts, Folium Artemisiae Argyi 6 parts, Rhizoma Corydalis 4 parts, 7 parts of Flos Carthami, Fructus Toosendan 5 parts, the Radix Linderae 4 parts, Cortex Moutan 7 parts, Radix Salviae Miltiorrhizae 10 parts, Fructus Mori 6 parts, Cortex Cinnamomi 2 parts, 4 parts of Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei 4 parts, the Radix Paeoniae Alba 7 parts, Rhizoma Curcumae 7 parts, Concha Ostreae 10 parts, Herba Cistanches 3 parts, 10 parts of Poria, Radix Polygoni Multiflori 6 parts, Mytilus 6 parts and 2 parts of Radix Glycyrrhizae.
Preferably, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Caulis Spatholobi 16 parts, Folium Artemisiae Argyi 29 parts, Rhizoma Corydalis 8 parts, 11 parts of Flos Carthami, Fructus Toosendan 7 parts, the Radix Linderae 8 parts, Cortex Moutan 11 parts, Radix Salviae Miltiorrhizae 14 parts, Fructus Mori 11 parts, Cortex Cinnamomi 4 parts, 8 parts of Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei 29 parts, the Radix Paeoniae Alba 14 parts, Rhizoma Curcumae 8 parts, Concha Ostreae 29 parts, Herba Cistanches 9 parts, 14 parts of Poria, Radix Polygoni Multiflori 12 parts, Mytilus 19 parts and 9 parts of Radix Glycyrrhizae.
Preferably, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Caulis Spatholobi 12 parts, Folium Artemisiae Argyi 20 parts, Rhizoma Corydalis 6 parts, 8 parts of Flos Carthami, Fructus Toosendan 6 parts, the Radix Linderae 6 parts, Cortex Moutan 8 parts, Radix Salviae Miltiorrhizae 12 parts, Fructus Mori 7 parts, Cortex Cinnamomi 3 parts, 6 parts of Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei 22 parts, the Radix Paeoniae Alba 10 parts, Rhizoma Curcumae 7 parts, Concha Ostreae 23 parts, Herba Cistanches 6 parts, 12 parts of Poria, Radix Polygoni Multiflori 8 parts, Mytilus 10 parts and 6 parts of Radix Glycyrrhizae.
Preferably, described pharmaceutical composition is made into capsule, tablet, powder, granule or pill.
Accordingly, the preparation method of described pharmaceutical composition comprises following step:
(1): take Caulis Spatholobi, wash away impurity, crushed after being dried, crosses 100-140 mesh sieve, and adding Caulis Spatholobi coarse powder gross weight 6-8 times amount volume fraction is the ethanol of 75-85%, add the cellulase of Caulis Spatholobi coarse powder total amount 0.9%-1.1%, lixiviate 1-2 hour at 45-55 DEG C, then 70-80 DEG C reflux, extract, 1-2 hour, filter, filtrate reduced in volume is the extractum of 1.10-1.25 to relative density at 65 DEG C, obtains Caulis Spatholobi extract；
(2): take Folium Artemisiae Argyi, Rhizoma Corydalis, Flos Carthami, Fructus Toosendan, the Radix Linderae, Cortex Moutan, Radix Salviae Miltiorrhizae, Fructus Mori, Cortex Cinnamomi, Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei, the Radix Paeoniae Alba, Rhizoma Curcumae, Concha Ostreae, Herba Cistanches, Poria, Radix Polygoni Multiflori, Mytilus and Radix Glycyrrhizae, wash away impurity, crushed after being dried, the Caulis Spatholobi medicinal residues obtained with step (1) mix, add the water of above-mentioned coarse powder total amount 12-14 times amount, soak 20-30 minute, reflux, extract, 2-3 time, each 1-3 hour, filter, merging filtrate, filtrate reduced in volume is the extractum of 1.10-1.25 to surveying relative density at 65 DEG C, cooling, it is slowly added to ethanol while stirring to alcohol content for reaching 75-85%, 4 DEG C stand 12-24 hour, filter, obtain filtrate；
(3): it is the extractum of 1.20-1.25 that filtrate reduced in volume step (2) obtained surveys relative density to 65 DEG C of conditions；
(4): the extractum that Caulis Spatholobi extract step (1) obtained obtains with step (3) mixes, and carries out spray drying, inlet temperature 85-110 DEG C, outlet temperature 50-80 DEG C, wind speed 6-8m/s, pressure 0.05-0.1kPa；Dried powder is crossed 100-200 mesh sieve, to obtain final product.
The source of component used by the present invention, nature and flavor, return through and effect:
Caulis Spatholobi: this product is the plant of pulse family Millettia, bitter in the mouth, sweet, warm in nature；Return liver, kidney channel；Enrich blood, invigorate blood circulation, dredging collateral；Relaxing muscles and tendons to promote blood circulation, nourishing blood for regulating menstruation.
Folium Artemisiae Argyi: for the dried leaves of feverfew Chinese mugwort；Its nature and flavor acrid, bitter, warm, returns liver,spleen,kidney warp；Folium Artemisiae Argyi has the effects such as warming the meridian for stopping bleeding, dispersing cold for relieving pain, regulating menstruation be antiabortive, removing damp to relieve itching, dredge the meridian passage.
Rhizoma Corydalis: this product is the dry tuber of papaveraceae plant corydalis；Acrid in the mouth, hardship, warm in nature；Return liver, spleen channel；Invigorate blood circulation, promoting the circulation of QI, pain relieving.
Flos Carthami: this product is the tubular flower of Compositae；Promoting blood circulation to restore menstrual flow, blood stasis removing pain relieving.Controlling amenorrhea, lump in the abdomen, difficult labour, stillborn fetus, disease that postpartum lochia can't go, blood stasis are had a pain, carbuncle, injury from falling down..
Fructus Toosendan: this product is the dry mature fruit of Meliaceae plant Fructus Toosendan；Bitter in the mouth, cold in nature；Return liver, small intestinal, bladder warp；Soothing liver-QI promoting the circulation of QI to relieve pain.
The Radix Linderae: this product is the dried root of the canella Radix Linderae；Acrid in the mouth, warm in nature；Return lung, spleen, kidney, bladder warp；Pleasant pain relieving, warming kidney for dispelling cold.
Cortex Moutan: this product is the dry root bark of ranunculaceae peony；Bitter in the mouth, pungent, cold nature；GUIXIN, liver, kidney channel；Clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling.
Radix Salviae Miltiorrhizae: this product is the root for labiate Radix Salviae Miltiorrhizae and Salvia przewalskii；Bitter in the mouth, tepor；Enter the heart, Liver Channel.Stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea, abdominal mass is gathered, chest and abdomen twinge, pyretic arthralgia pain, and skin infection swells and ache, dysphoria and insomnia；Hepatosplenomegaly, angina pectoris.
Fructus Mori: this product is the mature fruit of mulberry；Sweet in the mouth acid, cold in nature；Enter lung, liver, kidney, large intestine channel；The liver and the kidney tonifying, intestine moistening of promoting the production of body fluid, black hair improving eyesight, quench the thirst removing toxic substances, looks improving and the skin nourishing.
Cortex Cinnamomi: this product is the dry bark of canella Cortex Cinnamomi；Acrid in the mouth, sweet, extremely hot in nature；Return kidney, spleen, the heart, Liver Channel；Mend fire supporing yang, let the fire back to its origin, dispersing cold for relieving pain, promoting blood circulation to restore menstrual flow.
Pericarpium Citri Reticulatae Viride: this product is the peel of the dry young fruit of rutaceae orange and variety thereof or immature fruit；Bitter in the mouth, pungent, warm in nature；Return liver, gallbladder, stomach warp；Soothing the liver dispelling the stagnated QI, removing food stagnancyization is stagnant.
Radix Et Rhizoma Rhei: this product is the dry root and rhizome of polygonaceae plant Radix Et Rhizoma Rhei；Bitter in the mouth, cold in nature；Return spleen, stomach, large intestine, liver, pericardium channel；Purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, eliminating blood stasis and inducing menstruation.
The Radix Paeoniae Alba: this product is the dry root of ranunculaceae plant Radix Paeoniae；Bitter in the mouth, acid, cold nature；Return liver, spleen channel；Suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.
Rhizoma Curcumae: this product is the dry rhizome of zingiberaceous plant Rhizoma Curcumae；Acrid in the mouth, hardship, warm in nature；Return liver, spleen channel；Circulation of qi promoting removing blood stasis, removing food stagnancy pain relieving.
Concha Ostreae: this product is the shell of Ostreidae animal Concha Ostreae；Salty in the mouth, cold nature；Return liver, gallbladder, kidney channel；Tranquillization with heavy prescription, YANG hyperactivity suppressing nourishing YIN, hard masses softening and resolving.
Herba Cistanches: this product is the fleshy stem of the dry zone scale leaf of orobanchaceae plant cistanche；Sweet in the mouth, salty, warm in nature；Enter kidney, large intestine channel, kidney-replenishing；Benefiting essence-blood；Intestine moistening road.Main kidney yang deficiency；The sexual impotence of asthenia of essence and blood；Seminal emission；Nebulousurine；The frequent micturition heeltap；Lumbago flaccidity of the lower limbs；Tinnitus order flower；Menstruation is spread out the phase；Infertility；Dryness of the intestine constipation.For sexual impotence, infertile, soreness of the waist and knees, muscles and bones is unable, dryness of the intestine constipation.
Poria: this product is the dry sclerotia of On Polyporaceae Poria；Sweet in the mouth, light, property is put down；GUIXIN, lung, spleen, kidney channel；Promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.
Radix Polygoni Multiflori: this product is the dried root of polygonum multiflorum thunb；Bitter in the mouth, sweet, puckery, warm in nature；Return liver, the heart, kidney channel；Removing toxic substances, eliminating carbuncle, loosening bowel to relieve constipation.
Mytilus: this product is the shellfish meat of Mytilidae animal；Salty in the mouth, warm in nature；Enter liver, kidney channel；Invigorating the liver and kidney, benefiting essence-blood, disappear goiter.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down；GUIXIN, lung, spleen, stomach warp；Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
Compared with prior art, the present invention has following technical advantage:
1, pharmaceutical composition of the present invention is compared with the medicine of other treatment amenorrhea, in blood circulation promoting and blood stasis dispelling, menstruction regulating and pain relieving, nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization and removing pathogenic heat from blood and toxic substance from the body, has significant effect.
2, compared with the chemotherapeutic agent of Current therapeutic amenorrhea, pharmaceutical composition of the present invention is natural pure Chinese medicinal preparation, untoward reaction and side effect significantly reduce, and pharmaceutical composition effect of the present invention is comprehensive, medication effect is more preferably, efficiently solve the morbidity root of amenorrhea, and improve the quality of life of patient.
3, pharmaceutical composition of the present invention also has compatibility science, and curative effect is rapid, and cure rate is high, low cost and other advantages.
Detailed description of the invention
It will be understood by those skilled in the art that technology disclosed in following example represents the technology playing good action in the practice of the invention that the inventors discovered that.But, disclosed specific embodiments can be made many changes, and still obtain same or analogous result, without deviating from the spirit and scope of the present invention.
Embodiment 1:
Raw material is weighed: Caulis Spatholobi 4 parts, Folium Artemisiae Argyi 6 parts, Rhizoma Corydalis 4 parts, 7 parts of Flos Carthami, Fructus Toosendan 5 parts, the Radix Linderae 4 parts, Cortex Moutan 7 parts, Radix Salviae Miltiorrhizae 10 parts, Fructus Mori 6 parts, Cortex Cinnamomi 2 parts, 4 parts of Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei 4 parts, the Radix Paeoniae Alba 7 parts, Rhizoma Curcumae 7 parts, Concha Ostreae 10 parts, Herba Cistanches 3 parts, 10 parts of Poria, Radix Polygoni Multiflori 6 parts, Mytilus 6 parts and 2 parts of Radix Glycyrrhizae by following weight portion.
Preparation method is as follows:
(1): take Caulis Spatholobi, wash away impurity, crushed after being dried, crosses 100 mesh sieves, and adding Caulis Spatholobi coarse powder gross weight 6 times amount volume fraction is the ethanol of 75%, add the cellulase of Caulis Spatholobi coarse powder total amount 0.9%, lixiviate 1 hour at 45 DEG C, then 70 DEG C of reflux, extract, 1 hour, filters, filtrate reduced in volume is the extractum of 1.10 to relative density at 65 DEG C, obtains Caulis Spatholobi extract；
(2): take Folium Artemisiae Argyi, Rhizoma Corydalis, Flos Carthami, Fructus Toosendan, the Radix Linderae, Cortex Moutan, Radix Salviae Miltiorrhizae, Fructus Mori, Cortex Cinnamomi, Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei, the Radix Paeoniae Alba, Rhizoma Curcumae, Concha Ostreae, Herba Cistanches, Poria, Radix Polygoni Multiflori, Mytilus and Radix Glycyrrhizae, wash away impurity, crushed after being dried, the Caulis Spatholobi medicinal residues obtained with step (1) mix, add the water of above-mentioned coarse powder total amount 12 times amount, soak 20 minutes, reflux, extract, 2 times, each 1 hour, filter, merging filtrate, filtrate reduced in volume is the extractum of 1.10 to surveying relative density at 65 DEG C, cooling, it is slowly added to ethanol while stirring to alcohol content for reaching 75%, 4 DEG C stand 12 hours, filter, obtain filtrate；
(3): it is the extractum of 1.20-1.25 that filtrate reduced in volume step (2) obtained surveys relative density to 65 DEG C of conditions；
(4): the extractum mixing that the Caulis Spatholobi extract obtain step (1) and step (3) obtain, spray drying, inlet temperature 85 DEG C, outlet temperature 50 DEG C, wind speed 6m/s, pressure 0.05kPa are carried out；Dried powder is crossed 100 mesh sieves, adds corresponding adjuvant, make capsule.
Embodiment 2:
Raw material is weighed: Caulis Spatholobi 16 parts, Folium Artemisiae Argyi 29 parts, Rhizoma Corydalis 8 parts, 11 parts of Flos Carthami, Fructus Toosendan 7 parts, the Radix Linderae 8 parts, Cortex Moutan 11 parts, Radix Salviae Miltiorrhizae 14 parts, Fructus Mori 11 parts, Cortex Cinnamomi 4 parts, 8 parts of Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei 29 parts, the Radix Paeoniae Alba 14 parts, Rhizoma Curcumae 8 parts, Concha Ostreae 29 parts, Herba Cistanches 9 parts, 14 parts of Poria, Radix Polygoni Multiflori 12 parts, Mytilus 19 parts and 9 parts of Radix Glycyrrhizae by following weight portion.
Preparation method is as follows:
(1): take Caulis Spatholobi, wash away impurity, crushed after being dried, crosses 120 mesh sieves, and adding Caulis Spatholobi coarse powder gross weight 7 times amount volume fraction is the ethanol of 80%, add the cellulase of Caulis Spatholobi coarse powder total amount 1.0%, lixiviate 1 hour at 50 DEG C, then 75 DEG C of reflux, extract, 1 hour, filters, filtrate reduced in volume is the extractum of 1.20 to relative density at 65 DEG C, obtains Caulis Spatholobi extract；
(2): take Folium Artemisiae Argyi, Rhizoma Corydalis, Flos Carthami, Fructus Toosendan, the Radix Linderae, Cortex Moutan, Radix Salviae Miltiorrhizae, Fructus Mori, Cortex Cinnamomi, Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei, the Radix Paeoniae Alba, Rhizoma Curcumae, Concha Ostreae, Herba Cistanches, Poria, Radix Polygoni Multiflori, Mytilus and Radix Glycyrrhizae, wash away impurity, crushed after being dried, the Caulis Spatholobi medicinal residues obtained with step (1) mix, add the water of above-mentioned coarse powder total amount 13 times amount, soak 25 minutes, reflux, extract, 2 times, each 2 hours, filter, merging filtrate, filtrate reduced in volume is the extractum of 1.20 to surveying relative density at 65 DEG C, cooling, it is slowly added to ethanol while stirring to alcohol content for reaching 80%, 4 DEG C stand 18 hours, filter, obtain filtrate；
(3): it is the extractum of 1.23 that filtrate reduced in volume step (2) obtained surveys relative density to 65 DEG C of conditions；
(4): the extractum that Caulis Spatholobi extract step (1) obtained obtains with step (3) mixes, spray drying, inlet temperature 100 DEG C, outlet temperature 65 DEG C, wind speed 7m/s, pressure 0.08kPa are carried out；Dried powder is crossed 140 mesh sieves, adds corresponding adjuvant, make tablet.
Embodiment 3:
Raw material is weighed: Caulis Spatholobi 12 parts, Folium Artemisiae Argyi 20 parts, Rhizoma Corydalis 6 parts, 8 parts of Flos Carthami, Fructus Toosendan 6 parts, the Radix Linderae 6 parts, Cortex Moutan 8 parts, Radix Salviae Miltiorrhizae 12 parts, Fructus Mori 7 parts, Cortex Cinnamomi 3 parts, 6 parts of Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei 22 parts, the Radix Paeoniae Alba 10 parts, Rhizoma Curcumae 7 parts, Concha Ostreae 23 parts, Herba Cistanches 6 parts, 12 parts of Poria, Radix Polygoni Multiflori 8 parts, Mytilus 10 parts and 6 parts of Radix Glycyrrhizae by following weight portion.
Preparation method is as follows:
(1): take Caulis Spatholobi, wash away impurity, crushed after being dried, crosses 140 mesh sieves, and adding Caulis Spatholobi coarse powder gross weight 8 times amount volume fraction is the ethanol of 85%, add the cellulase of Caulis Spatholobi coarse powder total amount 1.1%, lixiviate 2 hours at 55 DEG C, then 80 DEG C of reflux, extract, 2 hours, filter, filtrate reduced in volume is the extractum of 1.25 to relative density at 65 DEG C, obtains Caulis Spatholobi extract；
(2): take Folium Artemisiae Argyi, Rhizoma Corydalis, Flos Carthami, Fructus Toosendan, the Radix Linderae, Cortex Moutan, Radix Salviae Miltiorrhizae, Fructus Mori, Cortex Cinnamomi, Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei, the Radix Paeoniae Alba, Rhizoma Curcumae, Concha Ostreae, Herba Cistanches, Poria, Radix Polygoni Multiflori, Mytilus and Radix Glycyrrhizae, wash away impurity, crushed after being dried, the Caulis Spatholobi medicinal residues obtained with step (1) mix, add the water of above-mentioned coarse powder total amount 14 times amount, soak 30 minutes, reflux, extract, 3 times, each 3 hours, filter, merging filtrate, filtrate reduced in volume is the extractum of 1.25 to surveying relative density at 65 DEG C, cooling, it is slowly added to ethanol while stirring to alcohol content for reaching 85%, 4 DEG C stand 24 hours, filter, obtain filtrate；
(3): it is the extractum of 1.25 that filtrate reduced in volume step (2) obtained surveys relative density to 65 DEG C of conditions；
(4): the extractum that Caulis Spatholobi extract step (1) obtained obtains with step (3) mixes, spray drying, inlet temperature 110 DEG C, outlet temperature 80 DEG C, wind speed 8m/s, pressure 0.1kPa are carried out；Dried powder is crossed 200 mesh sieves, adds corresponding adjuvant, make pill.
Pharmaceutical composition of the present invention is on the impact experiment of rat estrogen level
1, experimental technique: take 50 female sd inbred rats, it is randomly divided into 5 groups, often group 10, respectively matched group, model group, low dose group, middle dosage group and high dose group, except matched group, other are respectively organized rat and does bilateral oophorectomy, 3 months after operation, it is administered to each group of rat oral gavage, the normal saline of matched group and model group gavage equivalent, low dose group, middle dosage group and the corresponding medicine of high dose group gavage, medicine used is the pill that embodiment 3 prepares, once a day, successive administration 30 days.After last is administered 2 hours, abdomen arterial blood extracting prepares serum, detects serum estradiol (E2) and follicle stimulating hormone (FSH) content with test kit, compares between organizing.
2, experimental result: as shown in table 1.
Rat experiment result respectively organized by table 1
Note: compared with model group,▲P < 0.05, compared with matched group,★★P < 0.01.
As shown in Table 1, compared with matched group, model group follicle stimulating hormone and serum estradiol significantly reduce, and have extremely significant difference；Compared with model group, the follicle stimulating hormone of high, medium and low dosage group and serum estradiol have and improve more significantly, have the difference of significance, it is seen that, pharmaceutical composition of the present invention can significantly raised rat blood serum estradiol and follicle stimulating hormone content, rat estrogen is had certain rising effect.
Owing to whether estrogen and menstruation are normally closely connected, therefore estrogen number all can on amenorrhea produce impact, by this experiment impact on rat estrogen, it is appreciated that pharmaceutical composition of the present invention has in controlling estrogen to have certain effect, experimental result shows, rat estrogen is had certain rising effect by pharmaceutical composition of the present invention, it is seen then that pharmaceutical composition of the present invention has corresponding curative effect in treatment amenorrhea.
The pharmaceutical composition of the present invention improvement result to rat blood stasis models
1, test method: take 72 healthy SD rats, body weight 0.18kg-0.2kg, male and female half and half, are randomly divided into 6 groups by body weight, often group 12, it is respectively as follows: matched group, model group, nutagrass flatsedge rhizome bolus by seven processes group, low dose group, middle dosage group and high dose group, gastric infusion, successive administration 14 days, matched group and model group gastric infusion 0.5%CMC respectively, all the other give the pill that the corresponding embodiment of the present invention 3 prepares, and dosage is as shown in table 2.Being administered the 13rd day, 14 days, except Normal group, all the other treated animals press 1mg/Kg subcutaneous injection adrenalin hydrochloride, 2 times/day, interval 4h, and after first time injection, animal is put into 15min in 4 DEG C of frozen water by 2h.It is administered the 15th day and takes 4-5ml blood anticoagulant heparin and measure blood rheology parameter, take liver and weigh conversion organ coefficient.
2, result of the test: as shown in table 2, table 3
The medicine impact on rat blood stasis models liver coefficient respectively organized by table 2
Note: compare with matched group, ▲▲ P < 0.01；Compared with model group★P < 0.05,★★P < 0.01.
The result statistics display of liver coefficient, model group compares with matched group, and liver coefficient significantly increases.And compare with model group, pharmaceutical composition of the present invention each dosage group basic, normal, high significantly reduce liver coefficient (P< 0.01), nutagrass flatsedge rhizome bolus by seven processes group is compared with model group, it is possible to significant reduction liver coefficient (P< 0.05), but effect is not as good as pharmaceutical composition of the present invention.
The medicine impact on rat blood stasis models lectin from hemolymph respectively organized by table 3
Note: compare with Normal group, ▲ P < 0.05, ▲▲ P < 0.01；Compared with model group★P < 0.05,★★P < 0.01.
As shown in Table 3, model group compares with matched group, the low cut index of whole blood, erythrocyte aggregation index, Casson viscosity and plasma viscosity all have and significantly increase (P< 0.05).Compare with model group, pharmaceutical composition of the present invention each dosage group basic, normal, high is all notable or pole significantly reduces the low cut index of whole blood, erythrocyte aggregation index, Casson viscosity and plasma viscosity, reduction amplitude amount effect relationship, wherein high dose group there were significant differences (P< 0.05).Under same experiment condition, nutagrass flatsedge rhizome bolus by seven processes group also reduces whole blood height cut index, the low cut index of whole blood, erythrocyte aggregation index, but its to the improvement effect of hemorheology index all not as good as pharmaceutical composition of the present invention.
Visible, pharmaceutical composition of the present invention in blood stasis removing with reduce in liver coefficient compared with existing medicine more excellent.Due to amenorrhea often because blockage of vessel, menses must not be descending and cause that blood is every amenorrhea, is therefore one of primary treatment principle according to theory of Chinese medical science blood circulation promoting and blood stasis dispelling.This experiment is by studying the pharmaceutical composition of the present invention improvement result to rat blood stasis models, and simulates the symptom of blood stasis after women amenorrhea, draws its effect in blood stasis dispelling.Finding by studying, pharmaceutical composition of the present invention has good therapeutical effect for the blood stasis situation of rat, it is seen then that the pharmaceutical composition of the present invention medicament that particularly embodiment 3 prepares has significant effect in treatment women amenorrhea.
Owing to describing the present invention already by above preferred embodiment, in the spirit and/or scope of the present invention, the present invention is implemented in any replacement/for the present invention or combination, will be apparent from for a person skilled in the art, and is included among the present invention.

Claims (6)

1. the pharmaceutical composition treating amenorrhea, it is characterized in that, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Caulis Spatholobi 4-16 part, Folium Artemisiae Argyi 6-29 part, Rhizoma Corydalis 4-8 part, Flos Carthami 7-11 part, Fructus Toosendan 5-7 part, Radix Linderae 4-8 part, Cortex Moutan 7-11 part, Radix Salviae Miltiorrhizae 10-14 part, Fructus Mori 6-11 part, Cortex Cinnamomi 2-4 part, Pericarpium Citri Reticulatae Viride 4-8 part, Radix Et Rhizoma Rhei 4-29 part, Radix Paeoniae Alba 7-14 part, Rhizoma Curcumae 7-8 part, Concha Ostreae 10-29 part, Herba Cistanches 3-9 part, Poria 10-14 part, Radix Polygoni Multiflori 6-12 part, Mytilus 6-19 part and Radix Glycyrrhizae 2-9 part.
2. the pharmaceutical composition treating amenorrhea as claimed in claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Caulis Spatholobi 4 parts, Folium Artemisiae Argyi 6 parts, Rhizoma Corydalis 4 parts, 7 parts of Flos Carthami, Fructus Toosendan 5 parts, the Radix Linderae 4 parts, Cortex Moutan 7 parts, Radix Salviae Miltiorrhizae 10 parts, Fructus Mori 6 parts, Cortex Cinnamomi 2 parts, 4 parts of Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei 4 parts, the Radix Paeoniae Alba 7 parts, Rhizoma Curcumae 7 parts, Concha Ostreae 10 parts, Herba Cistanches 3 parts, 10 parts of Poria, Radix Polygoni Multiflori 6 parts, Mytilus 6 parts and 2 parts of Radix Glycyrrhizae.
3. the pharmaceutical composition treating amenorrhea as claimed in claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Caulis Spatholobi 16 parts, Folium Artemisiae Argyi 29 parts, Rhizoma Corydalis 8 parts, 11 parts of Flos Carthami, Fructus Toosendan 7 parts, the Radix Linderae 8 parts, Cortex Moutan 11 parts, Radix Salviae Miltiorrhizae 14 parts, Fructus Mori 11 parts, Cortex Cinnamomi 4 parts, 8 parts of Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei 29 parts, the Radix Paeoniae Alba 14 parts, Rhizoma Curcumae 8 parts, Concha Ostreae 29 parts, Herba Cistanches 9 parts, 14 parts of Poria, Radix Polygoni Multiflori 12 parts, Mytilus 19 parts and 9 parts of Radix Glycyrrhizae.
4. the pharmaceutical composition treating amenorrhea as claimed in claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Caulis Spatholobi 12 parts, Folium Artemisiae Argyi 20 parts, Rhizoma Corydalis 6 parts, 8 parts of Flos Carthami, Fructus Toosendan 6 parts, the Radix Linderae 6 parts, Cortex Moutan 8 parts, Radix Salviae Miltiorrhizae 12 parts, Fructus Mori 7 parts, Cortex Cinnamomi 3 parts, 6 parts of Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei 22 parts, the Radix Paeoniae Alba 10 parts, Rhizoma Curcumae 7 parts, Concha Ostreae 23 parts, Herba Cistanches 6 parts, 12 parts of Poria, Radix Polygoni Multiflori 8 parts, Mytilus 10 parts and 6 parts of Radix Glycyrrhizae.
5. the pharmaceutical composition of the treatment amenorrhea as described in as arbitrary in claim 1-4, it is characterised in that: described pharmaceutical composition is made into capsule, tablet, powder, granule or pill.
6. the pharmaceutical composition of the treatment amenorrhea as described in as arbitrary in claim 1-4, it is characterised in that the preparation method of described pharmaceutical composition comprises following step:
(1) Caulis Spatholobi is taken, wash away impurity, crushed after being dried, crosses 100-140 mesh sieve, and adding Caulis Spatholobi coarse powder gross weight 6-8 times amount volume fraction is the ethanol of 75-85%, add the cellulase of Caulis Spatholobi coarse powder total amount 0.9%-1.1%, lixiviate 1-2 hour at 45-55 DEG C, then 70-80 DEG C reflux, extract, 1-2 hour, filter, filtrate reduced in volume is the extractum of 1.10-1.25 to relative density at 65 DEG C, obtains Caulis Spatholobi extract；
(2) Folium Artemisiae Argyi is taken, Rhizoma Corydalis, Flos Carthami, Fructus Toosendan, the Radix Linderae, Cortex Moutan, Radix Salviae Miltiorrhizae, Fructus Mori, Cortex Cinnamomi, Pericarpium Citri Reticulatae Viride, Radix Et Rhizoma Rhei, the Radix Paeoniae Alba, Rhizoma Curcumae, Concha Ostreae, Herba Cistanches, Poria, Radix Polygoni Multiflori, Mytilus and Radix Glycyrrhizae, wash away impurity, crushed after being dried, the Caulis Spatholobi medicinal residues obtained with step (1) mix, add the water of above-mentioned coarse powder total amount 12-14 times amount, soak 20-30 minute, reflux, extract, 2-3 time, each 1-3 hour, filter, merging filtrate, filtrate reduced in volume is the extractum of 1.10-1.25 to surveying relative density at 65 DEG C, cooling, it is slowly added to ethanol while stirring to alcohol content for reaching 75-85%, 4 DEG C stand 12-24 hour, filter, obtain filtrate；
(3) filtrate reduced in volume step (2) obtained surveys relative density to 65 DEG C of conditions is the extractum of 1.20-1.25；
(4) extractum that Caulis Spatholobi extract step (1) obtained obtains with step (3) mixes, and carries out spray drying, inlet temperature 85-110 DEG C, outlet temperature 50-80 DEG C, wind speed 6-8m/s, pressure 0.05-0.1kPa；Dried powder is crossed 100-200 mesh sieve, to obtain final product.
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