CN104510970A - Use of traditional Chinese medicine preparation in preparation of drug for treatment of habitual abortion - Google Patents
Use of traditional Chinese medicine preparation in preparation of drug for treatment of habitual abortion Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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Abstract
The invention discloses use of a traditional Chinese medicine preparation in preparation of a drug for treatment of habitual abortion. The traditional Chinese medicine preparation is prepared from astragalus membranaceus, Chinese yam, prepared rhizome of rehmannia, fructus lycii, semen cuscutae, bighead atractylodes rhizome, colla corii asini, eucommia ulmoides, pulp of dogwood fruit, folium artemisiae argyi, fructus amomi, pericarpium citri reticulatae, salvia miltiorrhiza, parasitic loranthus, cimicifugae foetidae, rubia cordifolia, herba cistanche, rhizoma cyperi, radix paeoniae alba, liquorice and other traditional chinese medicinal materials by a special preparation process. The traditional Chinese medicine preparation has significant therapeutic effects on habitual abortion, after the traditional Chinese medicine preparation is developed into a finished dosage form convenient to take, universal applicability is good, curative effect is still significant, production process is simple, and popularization and application are easy.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation for the preparation of the purposes in treatment habitual abortion medicine, belong to the field of Chinese medicines.
Background technology
So-called habitual abortion refers to continuous more than the 3 times persons of spontaneous abortion, and each miscarriage often occurs in same gestation month.In recent years conventional recurrent abortion replaces habitual abortion, changes the spontaneous abortion of 2 times and more than twice into.The injury of habitual abortion to women is very large, and not only health is inflicted heavy losses on because of habitual abortion, and bring huge mental pressure also can to conceived person, some even produces the feared state of mind to pregnancy, dare not undergo another pregnancy.
At present, the treatment meanss such as doctor trained in Western medicine many employings hormone, operation, weak curative effect, side effect is large, and it is even poorer that the body constitution of patient is not improved, and some patients causes permanent infertile.
Habitual abortion is called " habitual abortion " by the traditional Chinese medical science.As " collection of experiences of famous physicians in the Ming Dynasty ": " if previous three months and fall, then next time must be so multiple as scheduled, cover prior to now injured, thus after must answer to the phase, the phase void of taking advantage of is also." it is generally acknowledged generation and the congenital defect of " habitual abortion ", kidney qi is impaired; Or weakness of the spleen and stomach, biochemistry is had no right; Or the ferritic deficiency of YIN, the factors such as interior-heat void is prosperous are relevant.All have deficiency of kidney-QI, deficiency of qi and blood, the moon to hinder the pathological change persons such as interior-heat, all can coup injury nausea, makes it to be difficult for being, pregnantly repeatly falls repeatly.Therefore control suitable the kidney invigorating primordial QI reinforcing, invigorating the spleen and benefiting QI, nourish blood methods such as adjusting punching
The present invention just above on the dialectical cognitive basis of habitual abortion, through clinical practice repeatedly grope produce.
Summary of the invention
The technical problem to be solved in the present invention has two, and the first invents a kind of Chinese medicine preparation, makes it have good therapeutic effect to habitual abortion; It two is for this Chinese medicine preparation tailors a set of manufacturing process, can on the basis ensureing curative effect, Chinese medicine is made universality is strong, be easy to carry about with one the finished product preparation taken.
In order to solve first technical problem, inventor according to oneself from clinical experience for many years, traditional proved recipe and secret prescription handed down in the family from generation to generation are fully transformed and utilized, and according to the ill feature of contemporary people with adapt to industrial needs, carry out increase and decrease medical material and dose, again scientific compatibility medical material, and grope through clinical checking repeatedly, finally obtain a very significant Chinese prescription for the treatment of habitual abortion effect, the component of this Chinese medicine preparation is (with parts by weight):
Radix Astragali 10-26 part, RHIIZOMA DIOSCOREAE fr0m Henan of China 10-30 part, Radix Rehmanniae Preparata 11-25 part, Fructus Lycii 6-24 part, Semen Cuscutae 6-20 part, Rhizoma Atractylodis Macrocephalae 6-16 part, Colla Corii Asini 6-18 part, Cortex Eucommiae 7-23 part, Fructus Corni 15-29 part, Folium Artemisiae Argyi 11-25 part, Fructus Amomi 5-15 part, Pericarpium Citri Reticulatae 3-11 part, Radix Salviae Miltiorrhizae 7-21 part, Herba Taxilli 6-14 part, Rhizoma Cimicifugae 3-11 part, charred RADIX RUBIAE 13-27 part, Herba Cistanches 6-20 part, Rhizoma Cyperi 5-15 part, Radix Paeoniae Alba 7-17 part, Radix Glycyrrhizae 7-16 part.
Three that find the in practice proportionings with excellent therapeutic effect are respectively (with parts by weight):
1, the Radix Astragali 18 parts, RHIIZOMA DIOSCOREAE fr0m Henan of China 20 parts, 18 parts, Radix Rehmanniae Preparata, Fructus Lycii 15 parts, Semen Cuscutae 13 parts, the Rhizoma Atractylodis Macrocephalae 11 parts, 12 parts, Colla Corii Asini, the Cortex Eucommiae 15 parts, Fructus Corni 22 parts, Folium Artemisiae Argyi 18 parts, Fructus Amomi 10 parts, Pericarpium Citri Reticulatae 7 parts, Radix Salviae Miltiorrhizae 14 parts, Herba Taxilli 10 parts, Rhizoma Cimicifugae 7 parts, charred RADIX RUBIAE 19 parts, Herba Cistanches 13 parts, Rhizoma Cyperi 10 parts, the Radix Paeoniae Alba 12 parts, 12 parts, Radix Glycyrrhizae.
2, the Radix Astragali 20 parts, RHIIZOMA DIOSCOREAE fr0m Henan of China 22 parts, 17 parts, Radix Rehmanniae Preparata, Fructus Lycii 14 parts, Semen Cuscutae 15 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, 13 parts, Colla Corii Asini, the Cortex Eucommiae 15 parts, Fructus Corni 24 parts, Folium Artemisiae Argyi 16 parts, Fructus Amomi 11 parts, Pericarpium Citri Reticulatae 8 parts, Radix Salviae Miltiorrhizae 16 parts, Herba Taxilli 11 parts, Rhizoma Cimicifugae 8 parts, charred RADIX RUBIAE 21 parts, Herba Cistanches 12 parts, Rhizoma Cyperi 10 parts, the Radix Paeoniae Alba 13 parts, 13 parts, Radix Glycyrrhizae.
3, the Radix Astragali 19 parts, RHIIZOMA DIOSCOREAE fr0m Henan of China 23 parts, 18 parts, Radix Rehmanniae Preparata, Fructus Lycii 13 parts, Semen Cuscutae 14 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, 14 parts, Colla Corii Asini, the Cortex Eucommiae 13 parts, Fructus Corni 23 parts, Folium Artemisiae Argyi 17 parts, Fructus Amomi 12 parts, Pericarpium Citri Reticulatae 9 parts, Radix Salviae Miltiorrhizae 13 parts, Herba Taxilli 12 parts, Rhizoma Cimicifugae 9 parts, charred RADIX RUBIAE 20 parts, Herba Cistanches 14 parts, Rhizoma Cyperi 9 parts, the Radix Paeoniae Alba 13 parts, 12 parts, Radix Glycyrrhizae.
In order to solve second technical problem, inventor adjusts through prescription, the processing procedure of repetition test ingredients and extraction process, and in conjunction with modern pharmaceutical technological invention a set of preparation technology, this technological operation is easy, preparation stabilization, guarantee drug effect, be easy to apply.Said preparation technique is following steps:
Step 1, get Radix Astragali processed with honey method, fry to tack-free, for subsequent use; Get the Rhizoma Atractylodis Macrocephalae, Cortex Eucommiae parched with bran, for subsequent use;
Step 2, take the 8 taste medical materials such as the Radix Astragali, Radix Rehmanniae Preparata, Fructus Lycii, Semen Cuscutae, the Rhizoma Atractylodis Macrocephalae, the Cortex Eucommiae, Rhizoma Cimicifugae, the Radix Paeoniae Alba by Chinese prescription of the present invention, pulverize respectively, mixing, add the ethanol of the 50-65% of 6-10 times of weight, soak 12-24 hour, reflux 2-3 hour, filter; Filtering residue adds the ethanol of the 50-65% of 5-8 times of initial medical material weight, and reflux 1-2 hour filters; By twice filtrate mixing, distilling under reduced pressure removing ethanol, obtains extracting solution A, for subsequent use;
Step 3, take the 12 taste medical materials such as RHIIZOMA DIOSCOREAE fr0m Henan of China, Colla Corii Asini, Fructus Corni, Folium Artemisiae Argyi, Fructus Amomi, Pericarpium Citri Reticulatae, Radix Salviae Miltiorrhizae, Herba Taxilli, charred RADIX RUBIAE, Herba Cistanches, Rhizoma Cyperi, Radix Glycyrrhizae by Chinese prescription of the present invention, pulverize respectively, mixing, adds the purified water of 5-11 times of weight, backflow decocts 2-4 hour, filters; Filtering residue adds the purified water of 4-9 times of initial medical material weight, and backflow decocts 1-2 hour, filters, and twice filtrate mixed, 1/5 of simmer down to original volume, is extracting solution B;
Step 4, by extracting solution A, B mix, being concentrated into density is 1.25-1.36(70-80 DEG C of survey), be Chinese medical concrete;
Step 5, Chinese medical concrete is added adjuvant make finished product Chinese medicine preparation.
Chinese medicine preparation of the present invention can make the multiple dosage forms such as granule, tablet, capsule, pill, oral liquid, powder.
The source of Chinese Herbs Medicines raw material of the present invention, character and function:
The Radix Astragali: this product is the dry root of leguminous plant Radix Astagali or Radix Astragali.Sweet in the mouth, warm in nature; Return lung, spleen channel; Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.
RHIIZOMA DIOSCOREAE fr0m Henan of China: this product is the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae.Sweet in the mouth, property is put down; Return spleen, lung, kidney channel; Spleen reinforcing nourishing the stomach, promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.
Radix Rehmanniae Preparata: this product is the Preparation process product of Radix Rehmanniae.Sweet in the mouth, slightly warm in nature; Return liver, kidney channel; Nourishing YIN and supplementing blood, beneficial essence fills out marrow.
Fructus Lycii: this product is the dry mature fruit of plant of Solanaceae lycium barbarum.Sweet in the mouth, property is put down; Return liver, kidney channel; Nourishing the liver and kidney, replenishing vital essence to improve eyesight.
Semen Cuscutae: this product is the dry mature seed of convolvulus cuscuta plant.Sweet in the mouth, warm in nature; Return liver,kidney,spleen warp; Nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.
The Rhizoma Atractylodis Macrocephalae: this product is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae.Bitter in the mouth, sweet, warm in nature; Return spleen, stomach warp; Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.
Colla Corii Asini: this product is that the skin of equine species donkey is through decocting, concentrating the solid gum made.Sweet in the mouth, property is put down; Return lung, liver, kidney channel; To enrich blood YIN nourishing, moisturize, hemostasis.
The Cortex Eucommiae: this product is the dry bark of the Eucommiaceae plant Cortex Eucommiae.Sweet in the mouth, warm in nature; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, antiabortive.
Fructus Corni: this product is the drying and ripening sarcocarp of Cornaceae plant Fructus Corni.Sour in the mouth, puckery, slightly warm in nature; Return liver, kidney channel; Liver and kidney tonifying, essence astringing and desertion stemming.
Folium Artemisiae Argyi: for
compositaethe dried leaves of plant Chinese mugwort.Bitter in the mouth, pungent, warm in nature; Return liver,spleen,kidney warp.Warming the meridian for stopping bleeding, antiabortive, blood of regulating the flow of vital energy, only metrorrhagia, menoxenia.
Fructus Amomi: this product is the dry mature fruit of zingiberaceous plant Fructus Amomi, green shell sand or SEMEN AMOMI LONGILIGULA.Acrid in the mouth, warm in nature; Return spleen, stomach, kidney channel; Removing dampness is whetted the appetite, warming spleen and stopping diarrha, regulates the flow of vital energy antiabortive.
Pericarpium Citri Reticulatae: be the mature peel of rutaceae orange and variety thereof.Bitter in the mouth, pungent, warm in nature; Return lung, spleen channel; Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.
Radix Salviae Miltiorrhizae: this product is the root that dicotyledon Lamiaceae Salvia belongs to perennial vertical herbage plant.Sweet in the mouth, sweet, property is put down.Strengthening the spleen and tonifying the lung, supplementing QI for promoting the production of body fluid, enriches blood and invigorates blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.
Herba Taxilli: this product is the dry stem and branch with leaf of Loranthaceae plant Herba Taxilli.Taste, sweet, property is put down; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.
Rhizoma Cimicifugae: this product is the dry rhizome of ranunculaceae plant C.heracleifolia, Cimicifuga Dahurica or Rhizoma Cimicifugae.Acrid in the mouth, micro-sweet, cold nature; Return lung, spleen, stomach, large intestine channel; Deliver rash, heat-clearing and toxic substances removing, elevate a turnable ladder yang-energy.
Charred RADIX RUBIAE: this product is
radix Rubiaethe root of the perennial climbing herb plant of section.Bitter in the mouth, cold nature; Return liver, heart channel, promoting blood flow to regulate menstruation, inducing diuresis to remove edema, blood circulation promoting and blood stasis dispelling, cooling blood for hemostasis.
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; Return kidney, large intestine channel.Kidney-replenishing, benefiting essence-blood, loosening bowel to relieve constipation.
Rhizoma Cyperi: this product is the dry rhizome of sedge dried tuber.Acrid in the mouth, micro-hardship, micro-sweet, property is put down; Return liver, spleen, tri-jiao channel; Promoting QI circulation for relieving depression, menstruction regulating and pain relieving.
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.
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.
The prescription analysis of Chinese medicine preparation of the present invention:
According to the compatibility theory of the traditional Chinese medical science to the dialectical of habitual abortion and Chinese crude drug, in conjunction with the body constitution of modern and the feature of modern pharmaceutical technology, the collocation ingredients of reasonable science, form Chinese prescription of the present invention, this prescription is that with the Radix Astragali, RHIIZOMA DIOSCOREAE fr0m Henan of China, Fructus Corni, Radix Rehmanniae Preparata, charred RADIX RUBIAE, Folium Artemisiae Argyi for monarch drug, invigorating QI to consolidate the body surface resistance, the kidney invigorating only collapse, liver nourishing is promoted the production of body fluid, promoting blood flow to regulate menstruation; With Fructus Lycii, Semen Cuscutae, Herba Cistanches, the Cortex Eucommiae, Colla Corii Asini, for ministerial drug, YIN nourishing of enriching blood, antiabortive improving eyesight, the kidney invigorating and essence nourishing; With the Rhizoma Atractylodis Macrocephalae, Radix Salviae Miltiorrhizae, the Radix Paeoniae Alba, Herba Taxilli for adjuvant drug, invigorating the spleen and benefiting QI, enrich blood invigorate blood circulation, nourishing blood for regulating menstruation, damp eliminating be antiabortive; With Fructus Amomi, Pericarpium Citri Reticulatae, Rhizoma Cimicifugae, Rhizoma Cyperi for making medicine, removing dampness appetizing, regulating qi-flowing for strengthening spleen, elevate a turnable ladder yang-energy, promoting QI circulation for relieving depression; With Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, all medicine of monarch is coordinated, collaboratively to promote, complement each other, finally reach that the kidney invigorating is only collapsed, antiabortive benefit essence, enrich blood invigorate blood circulation, the effect such as promoting QI circulation for relieving depression, thus to habitual abortion, there is very significant therapeutic effect.
Compared with prior art, the technical advantage such as Chinese medicine preparation of the present invention has good effect, has no side effect, conditioning effect is remarkable, and after being developed to the finished product preparation conveniently taken, general applicability is good, curative effect is still remarkable, and production technology is simple, is easy to apply.
Detailed description of the invention
Embodiment 1 and embodiment 2 are the minimax scope of Chinese medicine preparation of the present invention, and embodiment 3 is any amount within the scope of preparation, and embodiment 4-6 is respectively 3 optimal proportions of Chinese medicine preparation of the present invention.Embodiment 7 is the animal acute and chronic toxicity test of Chinese medicine granules of the present invention, and embodiment 8 is the clinical trial that the granule produced by the present invention's 3 optimum proportioning carries out.
embodiment 1
Operate 1, get Radix Astragali processed with honey method, fry to tack-free, for subsequent use; Get the Rhizoma Atractylodis Macrocephalae, Cortex Eucommiae parched with bran, for subsequent use;
Operate 2, take Radix Astragali 1100g, Radix Rehmanniae Preparata 1200g, Fructus Lycii 700g, Semen Cuscutae 700g, Rhizoma Atractylodis Macrocephalae 700g, Cortex Eucommiae 800g, Rhizoma Cimicifugae 400g, Radix Paeoniae Alba 800g by Chinese prescription of the present invention, pulverize respectively, mixing, add the ethanol of 60% of 8 times of weight, soak 18 hours, reflux 2.5 hours, filters; Filtering residue adds the ethanol of 60% of 6 times of initial medical material weight, reflux 1.5 hours, filters; By twice filtrate mixing, distilling under reduced pressure removing ethanol, obtains extracting solution A, for subsequent use;
Operate 3, take RHIIZOMA DIOSCOREAE fr0m Henan of China 1100g, Colla Corii Asini 700g, Fructus Corni 1600g, Folium Artemisiae Argyi 1200g, Fructus Amomi 600g, Pericarpium Citri Reticulatae 400g, Radix Salviae Miltiorrhizae 800g, Herba Taxilli 700g, charred RADIX RUBIAE 1200g, Herba Cistanches 700g, Rhizoma Cyperi 600g, Radix Glycyrrhizae 800g by Chinese prescription of the present invention, pulverize respectively, mixing, add the purified water of 9 times of weight, backflow decoction 3 hours, filters; Filtering residue adds the purified water of 7 times of initial medical material weight, and backflow decoction 1.5 hours, filters, and by twice filtrate mixing, 1/5 of simmer down to original volume, is extracting solution B;
Operate 4, extracting solution A, B are mixed, being concentrated into density is 1.29(78 DEG C of survey), be Chinese medical concrete;
Operation 5, Chinese medical concrete is added adjuvant make granule, amounting to crude drug content is 0.2g crude drug/g granule.
embodiment 2
Operate 1, get Radix Astragali processed with honey method, fry to tack-free, for subsequent use; Get the Rhizoma Atractylodis Macrocephalae, Cortex Eucommiae parched with bran, for subsequent use;
Operate 2, take Radix Astragali 2500g, Radix Rehmanniae Preparata 2400g, Fructus Lycii 2300g, Semen Cuscutae 1900g, Rhizoma Atractylodis Macrocephalae 1500g, Cortex Eucommiae 2200g, Rhizoma Cimicifugae 1000g, Radix Paeoniae Alba 1600g by Chinese prescription of the present invention, pulverize respectively, mixing, add the ethanol of 60% of 8 times of weight, soak 18 hours, reflux 2.5 hours, filters; Filtering residue adds the ethanol of 60% of 6 times of initial medical material weight, reflux 1.5 hours, filters; By twice filtrate mixing, distilling under reduced pressure removing ethanol, obtains extracting solution A, for subsequent use;
Operate 3, take RHIIZOMA DIOSCOREAE fr0m Henan of China 2900g, Colla Corii Asini 1700g, Fructus Corni 2800g, Folium Artemisiae Argyi 2400g, Fructus Amomi 1400g, Pericarpium Citri Reticulatae 1000g, Radix Salviae Miltiorrhizae 2000g, Herba Taxilli 1300g, charred RADIX RUBIAE 2600g, Herba Cistanches 1900g, Rhizoma Cyperi 1400g, Radix Glycyrrhizae 1500g by Chinese prescription of the present invention, pulverize respectively, mixing, add the purified water of 9 times of weight, backflow decoction 3 hours, filters; Filtering residue adds the purified water of 7 times of initial medical material weight, and backflow decoction 1.5 hours, filters, and by twice filtrate mixing, 1/5 of simmer down to original volume, is extracting solution B;
Operate 4, extracting solution A, B are mixed, being concentrated into density is 1.29(78 DEG C of survey), be Chinese medical concrete;
Operation 5, Chinese medical concrete is added adjuvant make granule, amounting to crude drug content is 0.2g crude drug/g granule.
embodiment 3
Operate 1, get Radix Astragali processed with honey method, fry to tack-free, for subsequent use; Get the Rhizoma Atractylodis Macrocephalae, Cortex Eucommiae parched with bran, for subsequent use;
Operate 2, take Radix Astragali 2400g, Radix Rehmanniae Preparata 1300g, Fructus Lycii 2200g, Semen Cuscutae 800g, Rhizoma Atractylodis Macrocephalae 1400g, Cortex Eucommiae 900g, Rhizoma Cimicifugae 900g, Radix Paeoniae Alba 900g by Chinese prescription of the present invention, pulverize respectively, mixing, add the ethanol of 60% of 8 times of weight, soak 18 hours, reflux 2.5 hours, filters; Filtering residue adds the ethanol of 60% of 6 times of initial medical material weight, reflux 1.5 hours, filters; By twice filtrate mixing, distilling under reduced pressure removing ethanol, obtains extracting solution A, for subsequent use;
Operate 3, take RHIIZOMA DIOSCOREAE fr0m Henan of China 2800g, Colla Corii Asini 800g, Fructus Corni 2700g, Folium Artemisiae Argyi 1300g, Fructus Amomi 1300g, Pericarpium Citri Reticulatae 500g, Radix Salviae Miltiorrhizae 1900g, Herba Taxilli 800g, charred RADIX RUBIAE 2500g, Herba Cistanches 800g, Rhizoma Cyperi 1300g, Radix Glycyrrhizae 900g by Chinese prescription of the present invention, pulverize respectively, mixing, add the purified water of 9 times of weight, backflow decoction 3 hours, filters; Filtering residue adds the purified water of 7 times of initial medical material weight, and backflow decoction 1.5 hours, filters, and by twice filtrate mixing, 1/5 of simmer down to original volume, is extracting solution B;
Operate 4, extracting solution A, B are mixed, being concentrated into density is 1.29(78 DEG C of survey), be Chinese medical concrete;
Operation 5, Chinese medical concrete is added adjuvant make granule, amounting to crude drug content is 0.2g crude drug/g granule.
embodiment 4
Operate 1, get Radix Astragali processed with honey method, fry to tack-free, for subsequent use; Get the Rhizoma Atractylodis Macrocephalae, Cortex Eucommiae parched with bran, for subsequent use;
Operate 2, take Radix Astragali 1800g, Radix Rehmanniae Preparata 1800g, Fructus Lycii 1500g, Semen Cuscutae 1300g, Rhizoma Atractylodis Macrocephalae 1100g, Cortex Eucommiae 1500g, Rhizoma Cimicifugae 700g, Radix Paeoniae Alba 1200g by Chinese prescription of the present invention, pulverize respectively, mixing, add the ethanol of 60% of 8 times of weight, soak 18 hours, reflux 2.5 hours, filters; Filtering residue adds the ethanol of 60% of 6 times of initial medical material weight, reflux 1.5 hours, filters; By twice filtrate mixing, distilling under reduced pressure removing ethanol, obtains extracting solution A, for subsequent use;
Operate 3, take RHIIZOMA DIOSCOREAE fr0m Henan of China 2000g, Colla Corii Asini 1200g, Fructus Corni 2200g, Folium Artemisiae Argyi 1800g, Fructus Amomi 1000g, Pericarpium Citri Reticulatae 700g, Radix Salviae Miltiorrhizae 1400g, Herba Taxilli 1000g, charred RADIX RUBIAE 1900g, Herba Cistanches 1300g, Rhizoma Cyperi 1000g, Radix Glycyrrhizae 1200g by Chinese prescription of the present invention, pulverize respectively, mixing, add the purified water of 9 times of weight, backflow decoction 3 hours, filters; Filtering residue adds the purified water of 7 times of initial medical material weight, and backflow decoction 1.5 hours, filters, and by twice filtrate mixing, 1/5 of simmer down to original volume, is extracting solution B;
Operate 4, extracting solution A, B are mixed, being concentrated into density is 1.29(78 DEG C of survey), be Chinese medical concrete;
Operation 5, Chinese medical concrete is added adjuvant make granule, amounting to crude drug content is 0.2g crude drug/g granule.
embodiment 5
Operate 1, get Radix Astragali processed with honey method, fry to tack-free, for subsequent use; Get the Rhizoma Atractylodis Macrocephalae, Cortex Eucommiae parched with bran, for subsequent use;
Operate 2, take Radix Astragali 2000g, Radix Rehmanniae Preparata 1700g, Fructus Lycii 1400g, Semen Cuscutae 1500g, Rhizoma Atractylodis Macrocephalae 1000g, Cortex Eucommiae 1500g, Rhizoma Cimicifugae 800g, Radix Paeoniae Alba 1300g by Chinese prescription of the present invention, pulverize respectively, mixing, add the ethanol of 60% of 8 times of weight, soak 18 hours, reflux 2.5 hours, filters; Filtering residue adds the ethanol of 60% of 6 times of initial medical material weight, reflux 1.5 hours, filters; By twice filtrate mixing, distilling under reduced pressure removing ethanol, obtains extracting solution A, for subsequent use;
Operate 3, take RHIIZOMA DIOSCOREAE fr0m Henan of China 2200g, Colla Corii Asini 1300g, Fructus Corni 2400g, Folium Artemisiae Argyi 1600g, Fructus Amomi 1100g, Pericarpium Citri Reticulatae 800g, Radix Salviae Miltiorrhizae 1600g, Herba Taxilli 1100g, charred RADIX RUBIAE 2100g, Herba Cistanches 1200g, Rhizoma Cyperi 1000g, Radix Glycyrrhizae 1300g by Chinese prescription of the present invention, pulverize respectively, mixing, add the purified water of 9 times of weight, backflow decoction 3 hours, filters; Filtering residue adds the purified water of 7 times of initial medical material weight, and backflow decoction 1.5 hours, filters, and by twice filtrate mixing, 1/5 of simmer down to original volume, is extracting solution B;
Operate 4, extracting solution A, B are mixed, being concentrated into density is 1.29(78 DEG C of survey), be Chinese medical concrete;
Operation 5, Chinese medical concrete is added adjuvant make granule, amounting to crude drug content is 0.2g crude drug/g granule.
embodiment 6
Operate 1, get Radix Astragali processed with honey method, fry to tack-free, for subsequent use; Get the Rhizoma Atractylodis Macrocephalae, Cortex Eucommiae parched with bran, for subsequent use;
Operate 2, take Radix Astragali 1900g, Radix Rehmanniae Preparata 1800g, Fructus Lycii 1300g, Semen Cuscutae 1400g, Rhizoma Atractylodis Macrocephalae 1200g, Cortex Eucommiae 1300g, Rhizoma Cimicifugae 900g, Radix Paeoniae Alba 1300g by Chinese prescription of the present invention, pulverize respectively, mixing, add the ethanol of 60% of 8 times of weight, soak 18 hours, reflux 2.5 hours, filters; Filtering residue adds the ethanol of 60% of 6 times of initial medical material weight, reflux 1.5 hours, filters; By twice filtrate mixing, distilling under reduced pressure removing ethanol, obtains extracting solution A, for subsequent use;
Operate 3, take RHIIZOMA DIOSCOREAE fr0m Henan of China 2300g, Colla Corii Asini 1400g, Fructus Corni 2300g, Folium Artemisiae Argyi 1700g, Fructus Amomi 1200g, Pericarpium Citri Reticulatae 900g, Radix Salviae Miltiorrhizae 1300g, Herba Taxilli 1200g, charred RADIX RUBIAE 2000g, Herba Cistanches 1400g, Rhizoma Cyperi 900g, Radix Glycyrrhizae 1200g by Chinese prescription of the present invention, pulverize respectively, mixing, add the purified water of 9 times of weight, backflow decoction 3 hours, filters; Filtering residue adds the purified water of 7 times of initial medical material weight, and backflow decoction 1.5 hours, filters, and by twice filtrate mixing, 1/5 of simmer down to original volume, is extracting solution B;
Operate 4, extracting solution A, B are mixed, being concentrated into density is 1.29(78 DEG C of survey), be Chinese medical concrete;
Operation 5, Chinese medical concrete is added adjuvant make granule, amounting to crude drug content is 0.2g crude drug/g granule.
the animal toxicity test of embodiment 7, Chinese medicine granules of the present invention
1, acute toxicity test
(1), tested Chinese medicine preparation: the granule manufactured by embodiment of the present invention 1-6, adds purified water by 1:2, makes solution, for subsequent use.
(2), experimental animal: regular grade NIH mice, body weight 20g ± 5g, male and female half and half, female mice is all without pregnant.
(3), the solution of mouse stomach Chinese medicine granules preparation of the present invention, when given low reaches 735.5g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal.
(4), result of the test shows: the maximum dosage-feeding of the granule manufactured by mouse stomach embodiment 1-6 is 735.5g crude drug/kg/d(LD
50> 735.5g crude drug/kg).Chinese medicine powder clinical application every day total amount of the present invention is 0.15g crude drug/kg/d to the maximum; By weighing machine, the dosis tolerata of mouse stomach A-F granule is 4903.3 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.
2, long-term toxicity test for animals
(1), tested Chinese medicine preparation: embodiment of the present invention 1-6 gained Chinese medicine granules, adds purified water by 1:2, make solution, for subsequent use.
(2), experimental animal: regular grade SD rat, body weight 210g ± 14g, male and female half and half, female rats is all without pregnant.
(3), method and result:
6 kinds of Chinese medicine granules: be divided into high, medium and low three dosage groups, per weight dosage is respectively 180,60,20 times of patient's dose;
Experimental mouse is divided into 20 groups at random, and wherein the granule solution of 19 groups of difference gavages, 6 kinds of three dosage, remains one group of gavage normal saline (40 times of patient's dose); All 20 groups of all continuous gavages 180 days, observe animal general toxic reaction and the order of severity, check each position, and carry out hematology, the pathological examination of the main organs such as ALT, BUN and the heart, liver, spleen, lung, kidney, stomach after execution by rule of operation;
Through long-term feeding, all there is not toxic reaction in 20 groups of rats.Physically well develop.Macroscopic appearance and main organs no abnormality seen.Peripheral hemogram and Serum ALT, BUN compare with matched group and change without pathologic.The all not significant changes such as the pathological replacement heart, liver, spleen, lung, kidney, stomach, therefore, think through proved by pathology, 6 kinds of Chinese medicine granules show without chronic toxicity animal.
By above two toxicity tests, prove that the present invention is safe by the Chinese medicine granules that embodiment 1-6 makes, have no side effect, can be taken by patient.
the clinical effectiveness test of embodiment 8, Chinese medicine granules of the present invention
1, subjects data
Experimenter is all from certain maternity & child care center of city, for this hospital female patient suffering from habitual abortion that year December is accepted for medical treatment in April, 2010 to 2013, therefrom select the patient 90 of applicable clinical trial, age 25-40 year, all be diagnosed as habitual abortion by hospital, and prepare conceived person.All patients are divided into 3 groups, are numbered A, B, C group respectively, and often organize 30, the mean age is respectively 30 years old, 30.5 years old, 31 years old.
2, Chinese medicine preparation is tested
Test Chinese medicine preparation is the Chinese medicine granules that the embodiment of the present invention 4,5,6 obtains by three optimal proportions, specification: amounting to crude drug amount is 0.2g crude drug/g granule.
3, test method
The Chinese medicine granules of A, B, C tri-group respectively obtained by oral embodiment 4,5,6,15g/ time, every day 3 times, surrounding is a course for the treatment of, treats 5 courses for the treatment of continuously.Record patient take medicine after health, unpregnancy person records official holiday situation, the person's of becoming pregnant record patient pregnancy period response situation, the inspection of anemia of pregnant woman's associated hormone in therapeutic process.All patients are paid a return visit in treatment end after 6 months, statistics motherhood situation.
4, test evaluation standard
(1), cure: patient's habitual abortion related symptoms disappears completely, spends the habitual abortion phase smoothly, and gives birth to healthy babies.
(2), effective: habitual abortion related symptoms partial disappearance, health takes a turn for the better, but still needs treatment further.
(3), invalid: habitual abortion related symptoms is without any improvement, even more serious.
5, result of the test statistical analysis
(1), physical attributes record: untoward reaction symptom does not all appear in all experimenters, and medication person's health all take a favorable turn, and bleeding disappears, lower abdomen pendant pain takes a turn for the better, middle gas foot, and gather colour, pays a return visit display, the healthy baby that had patient over half to give birth to.
(2), result of the test statistical analysis
After all case tests, statistical analysis calculating is carried out to result, as shown in table 1:
Table 1 result of the test statistical analysis table
6, conclusion (of pressure testing)
For this disease of habitual abortion, the not good method treatment of current doctor trained in Western medicine, the hormone that adopts is prevented miscarriage more, and often side effect is large, poor effect, and allows patient body make the matter worse sometimes, and the state of an illness is difficult to control more.In this case, granule of the present invention, the average cure rate of 3 test group is 72.5%, and total effective rate is 100%, and this therapeutic effect is very significant, and technical advantage clearly, obtains beyond thought technique effect.
Claims (6)
1. Chinese medicine preparation is for the preparation of the purposes in treatment habitual abortion medicine, and it is characterized in that, described Chinese medicine preparation is made up of the crude drug of following weight portion:
Radix Astragali 10-26 part, RHIIZOMA DIOSCOREAE fr0m Henan of China 10-30 part, Radix Rehmanniae Preparata 11-25 part, Fructus Lycii 6-24 part, Semen Cuscutae 6-20 part, Rhizoma Atractylodis Macrocephalae 6-16 part, Colla Corii Asini 6-18 part, Cortex Eucommiae 7-23 part, Fructus Corni 15-29 part, Folium Artemisiae Argyi 11-25 part, Fructus Amomi 5-15 part, Pericarpium Citri Reticulatae 3-11 part, Radix Salviae Miltiorrhizae 7-21 part, Herba Taxilli 6-14 part, Rhizoma Cimicifugae 3-11 part, charred RADIX RUBIAE 13-27 part, Herba Cistanches 6-20 part, Rhizoma Cyperi 5-15 part, Radix Paeoniae Alba 7-17 part, Radix Glycyrrhizae 7-16 part.
2. purposes as claimed in claim 1, it is characterized in that, described Chinese medicine preparation is made up of the crude drug of following weight portion:
The Radix Astragali 18 parts, RHIIZOMA DIOSCOREAE fr0m Henan of China 20 parts, 18 parts, Radix Rehmanniae Preparata, Fructus Lycii 15 parts, Semen Cuscutae 13 parts, the Rhizoma Atractylodis Macrocephalae 11 parts, 12 parts, Colla Corii Asini, the Cortex Eucommiae 15 parts, Fructus Corni 22 parts, Folium Artemisiae Argyi 18 parts, Fructus Amomi 10 parts, Pericarpium Citri Reticulatae 7 parts, Radix Salviae Miltiorrhizae 14 parts, Herba Taxilli 10 parts, Rhizoma Cimicifugae 7 parts, charred RADIX RUBIAE 19 parts, Herba Cistanches 13 parts, Rhizoma Cyperi 10 parts, the Radix Paeoniae Alba 12 parts, 12 parts, Radix Glycyrrhizae.
3. purposes as claimed in claim 1, it is characterized in that, described Chinese medicine preparation is made up of the crude drug of following weight portion:
The Radix Astragali 20 parts, RHIIZOMA DIOSCOREAE fr0m Henan of China 22 parts, 17 parts, Radix Rehmanniae Preparata, Fructus Lycii 14 parts, Semen Cuscutae 15 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, 13 parts, Colla Corii Asini, the Cortex Eucommiae 15 parts, Fructus Corni 24 parts, Folium Artemisiae Argyi 16 parts, Fructus Amomi 11 parts, Pericarpium Citri Reticulatae 8 parts, Radix Salviae Miltiorrhizae 16 parts, Herba Taxilli 11 parts, Rhizoma Cimicifugae 8 parts, charred RADIX RUBIAE 21 parts, Herba Cistanches 12 parts, Rhizoma Cyperi 10 parts, the Radix Paeoniae Alba 13 parts, 13 parts, Radix Glycyrrhizae.
4. purposes as claimed in claim 1, it is characterized in that, described Chinese medicine preparation is made up of the crude drug of following weight portion:
The Radix Astragali 19 parts, RHIIZOMA DIOSCOREAE fr0m Henan of China 23 parts, 18 parts, Radix Rehmanniae Preparata, Fructus Lycii 13 parts, Semen Cuscutae 14 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, 14 parts, Colla Corii Asini, the Cortex Eucommiae 13 parts, Fructus Corni 23 parts, Folium Artemisiae Argyi 17 parts, Fructus Amomi 12 parts, Pericarpium Citri Reticulatae 9 parts, Radix Salviae Miltiorrhizae 13 parts, Herba Taxilli 12 parts, Rhizoma Cimicifugae 9 parts, charred RADIX RUBIAE 20 parts, Herba Cistanches 14 parts, Rhizoma Cyperi 9 parts, the Radix Paeoniae Alba 13 parts, 12 parts, Radix Glycyrrhizae.
5. the purposes as described in as arbitrary in claim 1-4, it is characterized in that, described Chinese medicine preparation is processed into by following processing step:
Step 1, get Radix Astragali processed with honey method, fry to tack-free, for subsequent use; Get the Rhizoma Atractylodis Macrocephalae, Cortex Eucommiae parched with bran, for subsequent use;
Step 2, take the 8 taste medical materials such as the Radix Astragali, Radix Rehmanniae Preparata, Fructus Lycii, Semen Cuscutae, the Rhizoma Atractylodis Macrocephalae, the Cortex Eucommiae, Rhizoma Cimicifugae, the Radix Paeoniae Alba by Chinese prescription of the present invention, pulverize respectively, mixing, add the ethanol of the 50-65% of 6-10 times of weight, soak 12-24 hour, reflux 2-3 hour, filter; Filtering residue adds the ethanol of the 50-65% of 5-8 times of initial medical material weight, and reflux 1-2 hour filters; By twice filtrate mixing, distilling under reduced pressure removing ethanol, obtains extracting solution A, for subsequent use;
Step 3, take the 12 taste medical materials such as RHIIZOMA DIOSCOREAE fr0m Henan of China, Colla Corii Asini, Fructus Corni, Folium Artemisiae Argyi, Fructus Amomi, Pericarpium Citri Reticulatae, Radix Salviae Miltiorrhizae, Herba Taxilli, charred RADIX RUBIAE, Herba Cistanches, Rhizoma Cyperi, Radix Glycyrrhizae by Chinese prescription of the present invention, pulverize respectively, mixing, adds the purified water of 5-11 times of weight, backflow decocts 2-4 hour, filters; Filtering residue adds the purified water of 4-9 times of initial medical material weight, and backflow decocts 1-2 hour, filters, and twice filtrate mixed, 1/5 of simmer down to original volume, is extracting solution B;
Step 4, by extracting solution A, B mix, being concentrated into density is 1.25-1.36(70-80 DEG C of survey), be Chinese medical concrete;
Step 5, Chinese medical concrete is added adjuvant make finished product Chinese medicine preparation.
6. the purposes as described in as arbitrary in claim 1-4, it is characterized in that, described Chinese medicine preparation can make granule, tablet, capsule, pill, oral liquid and powder.
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| CN104740467A (en) * | 2015-04-20 | 2015-07-01 | 王雪雁 | Traditional Chinese medicine preparation for treating functional uterine bleeding and production process of traditional Chinese medicine preparation |
| CN105727146A (en) * | 2016-04-11 | 2016-07-06 | 王华荣 | Traditional Chinese medicine for treating embryonic diapause |
| CN105749121A (en) * | 2016-03-29 | 2016-07-13 | 广州暨南生物医药研究开发基地有限公司 | Folium-artemisiae-argyi-containing traditional Chinese medicine preparation for treating habitual abortion and preparation method thereof |
| CN105796944A (en) * | 2016-03-15 | 2016-07-27 | 张艳娟 | Pharmaceutical preparation for treating recurrent abortion |
| CN108771747A (en) * | 2018-09-10 | 2018-11-09 | 刘佳璐 | It is a kind of to be used for the Chinese medicine composition and preparation method thereof prevented miscarriage that reinforces the kidney |
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