CN1706463A - Medicine for treating women's habitual abortion and threatened abortion - Google Patents

Abstract

The present invention discloses one kind of medicine for treating women's habitual abortion and threatened abortion. The medicine is prepared with astragalus root, Dangshen, white atractylodes rhizome, teasel root, eucommia bark and other six kinds of Chinese medicinal materials and sugar in certain proportion. The preparation process includes the steps of pulverizing all the Chinese medicinal materials, thrice decoction, merging decocted liquid, filtering, concentrating at 60 deg.c to form dense paste of 1.05 density, cooling, mixing with alcohol through stirring, letting stand, filtering, concentrating the filtrate at 20 deg.c to obtain paste of 1.05-1.15 density, adding sugar and small amount of sodium benzoate as the additive, adding water through stirring, letting stand, filtering, packing and sterilizing.

Description

A kind of medicine for the treatment of women's habitual abortion and threatened abortion

Technical field

The present invention relates to a kind of medicine, particularly a kind of medicine for the treatment of women's habitual abortion and threatened abortion.

Background technology

Habitual abortion and threatened abortion are common clinically obstetrical and gynecological diseases, and the traditional Chinese medical science is called " habitual abortion, vaginal bleeding during pregnancy, frequent fetal movement ".The incidence rate of the two accounts for 10% of spontaneous abortion.Clinical manifestation is to have soreness of waist stomachache or lower abdomen weigh down trimester of pregnancy with miscarriage to expand, or is cardinal symptom with a small amount of vaginal hemorrhage.Basic pathology habitual, threatened abortion is that embryo and fetus elder generation are dead, and decidua basalis is hemorrhage, or retroplacental haemorrhage, forms hematoma of posteroplacenta, stimulates the uterus, makes it to shrink discharge embryo and fetus.Modern medicine thinks, generation habitual, threatened abortion influences with inherited genetic factors, extraneous noxious substance, the disease of parent, repulsion that immune factor causes and maternal-fetal blood group incompatibility etc. are relevant.General downern, Hormone Replacement Therapy or the vitimin supplement etc. of using in the treatment.Chinese medical theory is thought, and basic pathogenesis habitual, threatened abortion is the spleen kidney deficiency, finally causes dashing appointing qi and blood disorder, and fetus is not solid so that frequent fetal movement takes place, and answers the spleen reinforcing kidney, replenishing QI and blood in treatment.

Common medicine has tranquilizer, hormones, vitamin at present.Wherein comparatively the common chemical medicine has hypnotic and sedative as stable, estrogen such as Progesterone, vitamin E, but prolonged application produces very big untoward reaction.Continue during as early pregnancy to use tranquilizer, have the danger that can cause children's's harelip, the anemia of pregnant woman takes heavy dose of tranquilizer for a long time, can influence the intelligence development of fetus.If using estrogen, preceding 3 months women of trimester of pregnancy might make the fetus opposite sexization; Gestation was taken estrogen later in 3 months, can make the temporary increase of fetus genitals.A large amount of vitamin Es can make the hormone metabolism disorder, increase as amenorrhea or menorrhagia, breast and swell and ache, and blood cholesterol and triglyceride are raise, and immunologic function goes down.Chinese medicine commonly used then lacks generally acknowledges effective preparation, and general uncertain therapeutic efficacy is cut, and clinical observation on the therapeutic effect is many, and zoopery is few.And ignore this basic pathogenesis of spleen kidney deficiency in treatment, often simple tonify deficiency lacks the conditioning to QI and blood, and effect is bad.Therefore in the treatment of habituation, threatened abortion, still lack good effect, the little ideal medicament of side effect.

Summary of the invention

The objective of the invention is to, a kind of medicine for the treatment of women's habitual abortion and threatened abortion is provided, this medicine proves through animal experiment study and drug effect, pharmacology test, this medicine has strengthening spleen and nourishing blood, the tonifying kidney for preventing miscarriage effect has good therapeutical effect to habitual abortion and threatened abortion.

The medicine of treatment women's habitual abortion of the present invention and threatened abortion comprises the raw material of following weight ratio: the Radix Astragali 9%～13%, Radix Codonopsis 9%～13%, the Rhizoma Atractylodis Macrocephalae 5%～9%, Radix Dipsaci 5%～9%, the Cortex Eucommiae 9%～13%, the Radix Paeoniae Alba 3%～6%, Fructus Psoraleae 5%～9%, Radix Angelicae Sinensis 3%～5%, Rhizoma Dioscoreae 10%～17%, Fructus Jujubae 5%～9%, Fructus Amomi 5%～9%, sucrose 16%～20%, the summation of raw material are 100%, and add micro-sodium benzoate in addition as additive.

Manufacturing method for above mentioned medicine is that the raw material in the above-mentioned prescription except that sucrose, is ground into coarse powder, decoct with water three times, 2.5 hours for the first time, second, third time each 2 hours, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.05 (60 ℃), put cold, add ethanol and make and contain alcohol amount and reach 75%, stir evenly, left standstill 24 hours, filter, it is 1.05～1.15 clear paste that filtrate is concentrated into relative density at 20 ℃, with sucrose and micro-adjuvant sodium benzoate, adds water to ormal weight, stir evenly, leave standstill, filter embedding, sterilization, promptly.

The treatment women's habitual abortion of the present invention's preparation and the medicine of threatened abortion are tan liquid; Feeble QI, it is sweet to distinguish the flavor of, and has strengthening spleen and nourishing blood, and the tonifying kidney for preventing miscarriage effect is applicable to threatened abortion, habitual abortion symptom due to the asthenia of both the spleen and kidney.

The specific embodiment

Below in conjunction with embodiment and drug effect, the present invention is described in further detail for pharmacological testing.

Embodiment 1:

Prescription: Radix Astragali 112.5g, Radix Codonopsis 112.5g, Rhizoma Atractylodis Macrocephalae 75g, Radix Dipsaci 75g, Cortex Eucommiae 112.5g, Radix Paeoniae Alba 45g, Fructus Psoraleae 75g, Radix Angelicae Sinensis 37.5g, Rhizoma Dioscoreae 150g, Fructus Jujubae 75g, Fructus Amomi 37.5g, sucrose 200g, sodium benzoate 0.3g; Make 1000ml.

Method for making: the raw material in the above-mentioned prescription is ground into coarse powder except that sucrose, decocts with water 2.5 hours for the first time three times, second, third time each 2 hours, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.05 (60 ℃), put coldly, add ethanol and make and contain alcohol amount and reach 75%, stir evenly, left standstill 24 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.05～1.15 (20 ℃), adds adjuvant sodium benzoate and sucrose, adds water to ormal weight, stir evenly, leave standstill, filter, embedding, sterilization, promptly.

Character: this product is tan liquid; Feeble QI, it is sweet to distinguish the flavor of.

Discrimination method:

(1) get this product 30ml, extract 4 times with water saturated n-butyl alcohol jolting, each 30ml merges n-butyl alcohol liquid, and with ammonia solution washing 2 times, each 20ml merges n-butyl alcohol liquid, and evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets the astragaloside reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw above-mentioned need testing solution 10ul, reference substance solution 5 μ l, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water (13: 7: 2) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color; Put under the ultra-violet lamp (365nm) and inspect, show identical orange-yellow fluorescence speckle.

(2) get this product 30ml, extract 4 times with water saturated n-butyl alcohol jolting, each 30ml merges n-butyl alcohol liquid, and evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water (13: 7: 2) is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.

(3) get this product 30ml, extract 2 times with the ether jolting, each 30ml merges ether solution, volatilizes, and residue adds methanol 1ml makes dissolving, as need testing solution.Other gets the ferulic acid reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw above-mentioned need testing solution 5 μ l, reference substance solution 3 μ l, put respectively in same be on the silica gel g thin-layer plate of adhesive with the Carboxymethyl cellulose sodium, with benzene-ethyl acetate-formic acid (8: 2: 0.2) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.

Inspection item:

Relative density should be not less than 1.05 (an appendix VII of Chinese Pharmacopoeia version in 2000 A).

The PH value should be 4.0～6.5 (an appendix VII of Chinese Pharmacopoeia version in 2000 G).

Other should meet every regulation relevant under the mixture item (an appendix I of Chinese Pharmacopoeia version in 2000 J)

N-butanol extract: precision is measured this product 20ml, extract 5 times with water saturated n-butyl alcohol jolting, each 30ml merges n-butyl alcohol liquid, put in the evaporating dish that is dried to constant weight, evaporate to dryness in 105 ℃ of dryings 3 hours, moves in the drying receptacle, cooled off 30 minutes, weight decided in accurate rapidly title, calculates, promptly.

This product contains n-butanol extract must not be less than 3.0%.

Assay is measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D).

Chromatographic condition and system suitability test octadecylsilane chemically bonded silica are filler; Methanol-water-acetic acid (25: 75: 0.2) is mobile phase; Detect the long 313nm of being of wave-wave.Number of theoretical plate calculates by the ferulic acid peak should be not less than 5000.

It is an amount of that the preparation precision of reference substance solution takes by weighing the ferulic acid reference substance, puts in the brown measuring bottle, adds methanol-glacial acetic acid (5: 1) mixed solution, makes the solution that every 1ml contains 0.2mg, promptly.

The preparation precision of need testing solution is measured this product 30ml under the loading amount item, and the jolting that adds diethyl ether is extracted 4 times, each 20ml, merge ether solution, the sodium carbonate liquor jolting with 5% is extracted 3 times, each 20ml, merge alkali liquor, regulate pH value to 1～2, extract 3 times with the ether jolting with hydrochloric acid, each 30ml merges ether solution, uses anhydrous sodium sulfate dehydration, filter, filtrate volatilizes, and residue adds the dissolving of methanol-glacial acetic acid (5: 1) mixed solution, be transferred in the brown measuring bottle of 5ml and be diluted to scale, shake up, promptly.

Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.

Every dress of specification 10ml, every contains Radix Angelicae Sinensis with ferulic acid (C ₁₀H ₁₀O ₄) meter, must not be less than 12 μ g.

Function cures mainly strengthening spleen and nourishing blood, and tonifying kidney for preventing miscarriage is used for threatened abortion, habitual abortion due to the asthenia of both the spleen and kidney.

Usage and dosage is oral, a 10ml, 3 times on the one.

Taboo difficult labour, ectopic pregnancy person forbidding.Period in a medicine prevents strenuous exercise.

Embodiment 2:

Prescription: Radix Astragali 100g, Radix Codonopsis 100g, Rhizoma Atractylodis Macrocephalae 70g, Radix Dipsaci 75g, Cortex Eucommiae 100g, Radix Paeoniae Alba 40g, Fructus Psoraleae 75g, Radix Angelicae Sinensis 40g, Rhizoma Dioscoreae 175g, Fructus Jujubae 85g, Fructus Amomi 37.5g, sucrose 210g, sodium benzoate 0.3g; Make 1000ml.

Other is all with embodiment 1.

Need to prove that the foregoing description can exemplify many, owing to the tonic that mostly is of the application's employing, therefore the scope at above-mentioned raw materials all can realize purpose of the present invention.Do not exemplify one by one at this.

Prescription is analyzed:

Prescription of the present invention is that applicant's scientific research forms in conjunction with theory of Chinese medical science basis and modern Chinese medicine theoretical research according to clinical experience for many years from the member.This side's reasonable recipe, evident in efficacy, have no side effect, be treatment women's habitual abortion and the comparatively ideal medicine of threatened abortion.This side by the Radix Astragali, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Radix Dipsaci etc. ten simply Chinese medicine form, be monarch drug wherein with the Radix Astragali, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, play invigorating the spleen and replenishing QI altogether, the merit of the spleen invigorating of nourishing blood, reaching blood circulation depending on qi flow, five tires peace and, towards the purpose of Ren Tongsheng; Radix Dipsaci is the key medicine of promoting flow of QI and blood muscles and bones, and tool tonify without causing stagnation, row and the characteristics of not letting out can invigorating the liver and kidney, benefit dashes and appoint; The Cortex Eucommiae, Fructus Psoraleae are the antiabortive medicine commonly used of gynecological, four ministerial drugs in the side of being altogether; Help simultaneously with Radix Angelicae Sinensis and invigorate blood circulation to enrich blood, Rhizoma Dioscoreae is with spleen benefiting and strengthen kidney, and then reaches the purpose of conditioning blood vessels, tonifying kidney for preventing miscarriage; With Fructus Jujubae, Fructus Amomi is messenger drug, the merit of playing invigorating the spleen and benefiting QI, nourishing YIN and benefiting blood altogether.

Fructus Amomi: be the dry mature fruit of zingiberaceous plant Fructus Amomi, green shell sand or SEMEN AMOMI LONGILIGULA.The Fructus Amomi main product in Guangdong, ground such as Guangxi, Yunnan, Fujian, the green shell sand main product is in Guangdong, Yunnan and other places; The SEMEN AMOMI LONGILIGULA main product is in the Hainan and the Lezhou Peninsula and other places.In between summer, autumn, gather during fruit maturation, dry or cold drying.Time spent smashes to give birth to and uses.Property of medicine suffering, temperature.Return spleen, stomach, kidney channel, its effect is the removing dampness circulation of qi promoting, and warming middle-JIAO to stop diarrhea is antiabortive.

1, retention of dampness in middle-JIAO and stagnation of QI in spleen and stomach card: the hot temperature of loosing of this product is logical, abnormal smells from the patient fragrance, and its removing dampness is amusing, and the effect of circulation of qi promoting warming middle-JIAO is all good, and ancients say it: " transfer the stomach key medicine for being amusing." so all cards of incoordination between the spleen and stomach such as abdominal distention due to all wet resistances or the stagnation of QI are commonly used, especially cold-damp stagnation of QI person is the most suitable.If the retention of dampness in middle-JIAO person, normal and Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae, Fructus Aurantii Immaturus are equal to usefulness.If stagnation of QI in spleen and stomach, can with the Radix Aucklandiae, the same usefulness of Fructus Aurantii Immaturus, as xiangsha zhizhu pill (Jing-Yue Complete Works); If the card of weakness of the spleen and stomach, can join the Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Poria of invigorating the spleen and benefiting QI etc.As Xiangsha Liujunzi decoction (" prescription of peaceful benevolent dispensary ").

2. Deficiency and coldness of spleen and stomach is vomited and diarrhoea: this product kind can the warming middle-JIAO warming the stomach reaching the merit that preventing or arresting vomiting rushes down, but it focuses on warming the spleen.Can singly swallow, or use together with medicines such as Rhizoma Zingiberis, Radix Aconiti Lateralis Preparatas with grinding into powder.

3. stagnation of QI pregnancy reactions and frequent fetal movement: this product can circulation of qi promoting and in and preventing or arresting vomiting is antiabortive.If pregnant vomiting anorexia, can singly use, as the sand that contracts looses (recipes for Saving Lives), or with compatibilities such as Caulis Perillae, the Rhizoma Atractylodis Macrocephalae with using; If insufficiency of vital energy and blood, frequent fetal movement person, can with compatibilities such as Radix Ginseng, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, antiabortive with benefiting QI and nourishing blood, as Taishan Panshi San (ancient and Modern Medicine).

The Radix Paeoniae Alba: be the root of ranunculaceae plant Radix Paeoniae.Main product in Zhejiang, ground such as Anhui, Sichuan.Excavate summer and autumn, removes clean mud and supporting root, peeling, and boiling water soaks or slightly boils to being heated evenly, and dries.Time spent runs through section.General give birth to or wine stir-fry or fry usefulness.Property of medicine hardship, acid are slightly cold.Return liver, spleen channel, its effect is the yin fluid astringing that nourishes blood, easing the affected liver to relieve pain, suppressing liver-YANG.

1. liver-blood deficiency, menoxenia: this product sour in the mouth, the convergence liver-yin often is equal to usefulness in Radix Rehmanniae Preparata, Radix Angelicae Sinensis to nourish blood, and with treating the liver anemia void, pale complexion, dizzy cardiopalmus, or menoxenia, metrorrhagia and metrostaxis is as SIWU TANG (" prescription of peaceful benevolent dispensary ").If blood deficiency has heat, menoxenia, but medicines such as compatibility Radix Scutellariae, Cortex Phellodendri, Radix Dipsaci, Ru Baoyin fries in shallow oil (Jing-Yue Complete Works); If metrorrhagia can be equal to usefulness with Colla Corii Asini, Folium Artemisiae Argyi.

2. incoordination between the liver and spleen, breast side of body epigastric pain, the anxious pain of extremity contraction: liver-yin is held back in this product acid, nourishing blood to suppress the hyperactive liver and Radix Bupleuri, Radix Angelicae Sinensis etc. are often joined in pain relieving, treatment blood deficiency stagnation of liver-QI, the pain over the hypochondriac region is as XIAOYAO POWDER (" prescription of peaceful benevolent dispensary "); Also can this product transfer liver reason spleen, easing the affected liver to relieve pain with the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the same usefulness of Pericarpium Citri Reticulatae, is treated insufficiency of the spleen liver-yang hyperactivity, and stomachache is had loose bowels, as tongxieyao formula (Jing-Yue Complete Works); And if the Radix Aucklandiae, Rhizoma Coptidis is equal to usefulness, can control dysentery stomachache, as Radix Paeoniae Decoction (" plain inquiring about disease machine gas should save one's life collection "); Cause brothers' contraction if cloudy blood deficiency muscle arteries and veins loses foster and suddenly have a pain, often join the Radix Glycyrrhizae relieving spasm to stop pain, i.e. peony and licorice decoction (treatise on Febrile Diseases).

3. liver-yin rising, it is dizzy to have a headache: with this product nourish blood yin fluid astringing, suppressing liver-YANG, often join Radix Achyranthis Bidentatae, Haematitum, Os Draconis, Concha Ostreae etc., as town's liver endogenous wind stopping soup, build water jar soup (" Records of Tradition Chinese and Western Medicine in Combination ").

Radix Angelicae Sinensis: be the root of umbelliferae angelica.Main product is in the Minxian County of the southeast, Gansu Province, and output is many, and quality is good.Secondly, also there is cultivation in provinces such as Shaanxi, Sichuan, Yunnan, Hubei.Autumn end excavates, and eliminates reed head, fibrous root, treat moisture slightly after the row evaporation by size thickness tie into wisp respectively, with low baking temperature slowly smoke-dried beancurd or sulfur, usefulness is given birth in the moth-proof and mould-proof section, or through wine mix, wine fries and uses.Property of medicine Gan Xinwen.Return liver, the heart, spleen channel.Effect is a tonifying blood and regulating menstruation, and promoting blood circulation and stopping pain is moistened just unimpeded.

1. all cards of blood deficiency: the sweet Wen Zhirun of this product, be longer than and enrich blood, be the panacea of enriching blood.If QI and blood deficiency is often joined the Radix Astragali, ginseng qi-tonifying hemopoietic, as Radix Angelicae Sinensis decoction for tonifying blood (" secret record of the orchid chamber "), RENSHEN YANGRONG TANG (" treatise on pestilence "); If blood deficiency and yellow complexion, palpitation and insomnia are often in Radix Rehmanniae Preparata, the Radix Paeoniae Alba, Rhizoma Chuanxiong compatibility, as SIWU TANG (" prescription of peaceful benevolent dispensary ").

2. blood deficiency and blood stasis, menoxenia, amenorrhea, dysmenorrhea: often enrich blood and invigorate blood circulation with this product, menstruction regulating and pain relieving, the normal and same usefulness of tonifying blood and regulating menstruation medicine, as " prescription of peaceful benevolent dispensary " SIWU TANG, both agent of wanting for enriching blood are again the basis side of gynecological's regulating menstruation; If hold concurrently deficiency of vital energy person, can join Radix Ginseng, the Radix Astragali; If hold concurrently stagnation of QI person, can join Rhizoma Cyperi, Rhizoma Corydalis; If hold concurrently heat in blood person, can join Radix Scutellariae, Rhizoma Coptidis or Cortex Moutan, Cortex Lycii; If the obstructed person of blood stasis amenorrhea can join Semen Persicae, Flos Carthami; If the cold person that stagnates of blood deficiency can join Colla Corii Asini, Folium Artemisiae Argyi etc.

3. deficiency and coldness stomachache, traumatic injury, ulcer sores, the wind and cold arthralgia pain: the hot row temperature of this product is logical, is the key medicine of blood-activating and qi-promoting.This product enrich blood lively atmosphere, dispersing cold for relieving pain are joined Ramulus Cinnamomi, Radix Paeoniae, Rhizoma Zingiberis Recens and are equal to usefulness, and the stomachache of treatment blood deficiency and blood stasis cold coagulation is as Chinese angelica, ginger mutton soup, Danggui Jianzhong Tang; This product promoting blood circulation and stopping pain is equal to usefulness with Olibanum, Myrrha Semen Persicae, Flos Carthami, and treatment traumatic injury blood stasis is had a pain,

4. blood deficiency dryness of the intestine constipation: this product is enriched blood with loosening bowel to relieve constipation, with controlling the constipation of blood deficiency dryness of the intestine.Normal and Herba Cistanches, Radix Achyranthis Bidentatae, Rhizoma Cimicifugae are equal to usefulness, as jichuan decoction.

Rhizoma Dioscoreae: be Dioscoreaceae plant Rhizoma Dioscoreae rhizome.Main product is in Henan Province, and ground such as Hunan, Jiangxi also produce.Being accustomed to thinking so there is the title of " RHIIZOMA DIOSCOREAE frOm Henan of China " to excavate after the Frost's Descent, scraping off rough bark by the product person of Henan institute performance optimal, drying the back oven dry, is " hair Rhizoma Dioscoreae "; Or reprocessing is " light yam ".Run through, cut sheet, give birth to and use or parched with bran usefulness.The property of medicine is sweet, flat.Return spleen, lung, kidney channel.Effect is the spleen reinforcing nourishing the stomach, the lung benefiting that promotes the production of body fluid, the kidney invigorating arresting seminal emission.

1. syndrome of spleen-deficiency: this product nature and flavor are sweet flat, can invigorating the spleen and replenishing QI, nourish spleen the moon.Be used for deficiency-weakness of spleen-QI or deficiency of both QI and YIN, it is weak to become thin more, lack of appetite, loose stool; Or spleen insufficiency, women's leukorrhagia that turbid damp is made a bet.

2. deficiency of the lung card: this product again can tonifying the lung gas, and holding concurrently can lung-yin nourishing.Though the power of its tonifying the lung is gentler, to the cloudy all empty persons of lung temper, mend soil and also help to give birth to gold, control cough and asthma due to lung deficiency, can with the same usefulness of product such as the Radix Pseudostellariae of spleen lung giving young employees remedial-courses in general knowledge and vocational skills, Radix Adenophorae, play the effect of tonifying the lung Dingchuan altogether.

3. body deficiency syndrome: this product can also the kidney invigorating gas, doublely can nourish kidney yin, and to all empty persons of kidney spleen, it is mended and will also help to supplement nutrition congenital the day after tomorrow.Be applicable to the soreness of the waist and knees of deficiency of kidney-QI, the nocturia or the enuresis, spermatorrhea premature ejaculation, the emaciated physique of the clear rare and deficiency of the kidney yin of woman's leukorrhagia, soreness of the waist and knees, diseases such as seminal emission.Successive dynasties many kidney invigorating name side is as all being furnished with this product in shenqi pill, the LIUWEI DIHUANG WAN.

Fructus Jujubae: be the mature fruit of Rhamnaceae plant Fructus Jujubae.Main product in Hebei, ground such as Henan, Shandong.Gather during fruit maturation autumn, dries, and gives birth to and use.The property of medicine is sweet, warm.Return spleen, stomach heart channel; Effect is invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind;

1. syndrome of spleen-deficiency: the sweet temperature of this product, can invigorating the spleen and replenishing QI, be applicable to deficiency-weakness of spleen-QI, become thin, diseases such as fatigue and weakness, loose stool.Single with effective.If the deficiency of vital energy is very weak, be suitable for invigorating the spleen and replenishing QI medicine compatibilities such as Radix Ginseng, the Rhizoma Atractylodis Macrocephalae.

2. hysteria, the insomnia card: this product can tranquilizing by nourishing the heart, supplements nutrition mind dereliction and dirty dry key medicine for the treatment heart loses.Single with effective, control the hysteria sorrow without reason from crying as " Standards of Diagnosis and Treatment " from laughing at, with the Fructus Jujubae charred medicinal herb with its property retained, rice drink accent is down.Because of the many and insufficiency of heart-YIN of its card, hyperactivity of heart-fire is relevant, and often the motive is also not enough, so often and Fructus Tritici Levis, Radix Glycyrrhizae compatibility, and as GANMAI DAZAO TANG (" Medical Treasures of the Golden Chamber ")." prescriptions worth thousand gold " is also with the unhappy insomnia person of this product treatment asthenia.

In addition, the same usefulness of all strong or deleterious medicine of this product and the part property of medicine has the protection gastric qi, relaxes the effect of the strong property of medicine of gas poison, as Shizao Tang (treatise on Febrile Diseases), promptly in order to relax the strong and toxicity of Radix Kansui, the Radix Euphorbiae Pekinensis, Flos Genkwa.

Fructus Psoraleae: be the mature fruit of legumes psoraleae.Main product in Shaanxi, ground such as Henan, Shanxi, Jiangxi, Anhui, Guangdong, Sichuan, Yunnan.Cultivation or wild, more with Henan, Sichuan and other places.Gather during fruit maturation autumn, dries.Give birth to usefulness, fry or saline stir-fry usefulness.Property of medicine hardship, suffering, temperature.Return kidney, spleen channel.Effect is a kidney invigorating and YANG supporting, controlling nocturnal emission with astringent drugs reducing urination, warming the spleen stopping leak, helping inspiration to relieve asthma.

1. impotence due to deficiency of the kidney, soreness of the waist and knees: this product toil flavor is dry, kind invigorating kidney-YANG, warming the kidney, normal and Semen Cuscutae, Semen Juglandis, Lignum Aquilariae Resinatum are equal to usefulness, control impotence due to deficiency of the kidney, as Fructus Psoraleae ball (" prescription of peaceful benevolent dispensary "); With the Cortex Eucommiae, the same usefulness of Semen Juglandis, control kidney yang deficiency, the chills and pain of the waist and kness of air-cooled invasion and attack etc. are as blue or green moth ball (" prescription of peaceful benevolent dispensary ").

2. emission due to deficiency of the kidney, the enuresis, frequent micturition: this product has adstringency concurrently, kind reinforcing the kidney and supporting YANG, the controlling nocturnal emission with astringent drugs reducing urination, single with effectively, also can be with its medicine of card compatibility.As control spermatorrhea, serve as end clothes (" three categories of etiologic factors side ") with Fructus Psoraleae, Halitum five equilibrium with frying; Single fry,, control bed-wetting, as Fructus Psoraleae loose (" mend and want pocket children's side opinion ") for the end clothes with this product; Be divided into ball with Fructus Foeniculi, control the kidney qi cold caused by deficiency, it is immoderate to urinate, as Fructus Psoraleae ball (" Wei Shi family Tibetan side ").

3. deficiency of spleen-YANG and kidneyYANG, have loose bowels just before dawn: this product can invigorating kidney-YANG, warm spleen sun is with stopping leak, with Semen Myristicae, Rhizoma Zingiberis Recens, Fructus Jujubae be ball, as two refreshing balls (" ability side "); Or the top adds Fructus Evodiae, Fructus Schisandrae Chinensis, controls diarrhea before dawn, as SISHEN WAN (" political criterion ").

4. failure of the kidney in receiving QI, deficiency and coldness is breathed with cough: this product reinforcing the kidney and supporting YANG, helping inspiration to relieve asthma, polygamy 5 Semen Juglandis, Mel etc. can be controlled deficiency and coldness to breath with cough, as control side's of breathing heavily (" hospital's opinion ").Or join usefulness such as Radix Ginseng, the Radix Aucklandiae and control the dyspnea due to deficiency consumptive disease and cough, as chronic cough side (" being vegetarian hospital ").

The Radix Astragali: be the root of leguminous plant Radix Astagali or Radix Astragali.Main product in the Inner Mongol, ground such as Shanxi, Heilungkiang.Two seasons of spring and autumn excavate.Remove fibrous root and root head, dry, section is given birth to and is used or processed with honey usefulness.The property of medicine is sweet, tepor.Return spleen, lung meridian.Effect is the spleen invigorating invigorating middle warmer, ascending up spleen-Qi and Yang, and benefit is defended consolidating superficial resistance, diuresis, promoting pus discharge and tissue regeneration strengthening.

1. syndrome of deficiency of spleen qi: the sweet temperature of this product, be apt to into taste, be the invigorating the spleen and replenishing QI key medicine.Deficiency-weakness of spleen-QI, fatigue and weakness, the anorexia and loose stool person, can be singly with enduring the cream clothes, or with air making-up and spleen enlivening medicine compatibilities such as Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae.Because of its energy ascending up spleen-Qi and Yang, so be longer than the chronic diarrhea proctoptosis for the treatment of insufficiency of the spleen sinking of QI of middle-JIAO, visceroptosis.The same usefulness of product such as normal and Radix Ginseng, Rhizoma Cimicifugae, Radix Bupleuri are as BUZHONG YIQI TANG (" Treatise on the spleen and stomach ").Lose fortune if insufficiency of the spleen water is wet, so that swelling of the breast oliguria person, this product can invigorating the spleen and replenishing QI, again can inducing diuresis to remove edema, and treating both the principal and secondary aspects of a disease, for controlling the key medicine of deficiency of vital energy edema, the product compatibility of inducing diuresis to remove edema such as the normal and Rhizoma Atractylodis Macrocephalae, Poria.This product again can qi-supplementing, blood-engendering, control syndrome of deficiency of blood also normal with the hematonic compatibility, as Radix Angelicae Sinensis decoction for tonifying blood (" secret record of the orchid chamber ") with Radix Angelicae Sinensis with usefulness.To the card of losing blood due to the insufficiency of the spleen blood of can not uniting, but still QI invigorating is taking the photograph blood for this product, and the same usefulness of product such as normal and Radix Ginseng, the Rhizoma Atractylodis Macrocephalae are as GUIPI TANG (recipes for Saving Lives).To insufficiency of the spleen can not cloth Tianjin quench one's thirst, this product can tonifying QI to produce body fluid, promotes the generation of body fluid with defeated cloth the effect of quenching the thirst to be arranged, often and the same usefulness of product such as Radix Trichosanthis, Radix Puerariae, as good wine soup (" Records of Tradition Chinese and Western Medicine in Combination ").

2. syndrome of deficiency of lung qi: this product is gone into lung again can replenishing and restoring lung-QI, can be used for insufficiency of lung-QI, cough with asthma with the passing of time, shortness of breath and tired spirit person, the product compatibility that expelling phlegm for arresting cough such as normal and Radix Asteris, Flos Farfarae, Semen Armeniacae Amarum are relievingd asthma.

1, spontaneous sweating due to deficiency of QI: the people of deficiency of both the splenic and pulmonary QI is failure of defensive QI to protect the body against pathogen often, the exterior deficiency spontaneous perspiration.This product can spleen reinforcing the gas of lung, benefit is defended consolidating superficial resistance, the same usefulness of product of hidroschesis such as normal and Concha Ostreae, Radix Ephedrae is as Muli San (" mixture office side ").If because of failure of defensive QI to protect the body against pathogen, exterior deficiency spontaneous perspiration and susceptible phoenix heresy person is suitable for the same usefulness of product such as the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae is as YUPINGFENG SAN (" danxi's experiential therapy ").

Radix Codonopsis: the property of medicine is sweet, bitter, temperature.Return spleen, stomach warp.Effect is invigorating the spleen and benefiting QI, the bath diuresis of wetting, and hidroschesis, antiabortive.

1, syndrome of deficiency of lung qi: this product nature and flavor are sweet flat, and main spleen lung two warps of returning serve as mainly to act on the gas of spleen reinforcing lung.The empty asthenia of body that is used for deficiency of QI in middle-JIAO, diseases such as anorexia and loose stool, the Rhizoma Atractylodis Macrocephalae, Poria normal and the air making-up and spleen enlivening dehumidifying are equal to usefulness;

2, QI and blood two must card: this product can QI invigorating, can enrich blood again, and being usually used in the deficiency of vital energy can not hemopoietic, or blood deficiency is difficult activating QI, and sees the deficiency of both QI and blood of pale or sallow complexion, weak, dizzy, cardiopalmus.Product such as the Chang Peiwu Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Rehmanniae Preparata are to strengthen its QI invigorating effect of enriching blood.

3. card is hindered in gas Tianjin two: this product is thirsty to breathing hard of heat impairing vital QI Tianjin, and the tonifying QI to produce body fluid effect is also arranged, and is applicable to gas Tianjin mild case on the face, and the product that are suitable for YIN nourishing and the production of body fluid promoting such as Radix Ophiopogonis, Fructus Schisandrae Chinensis are with using.In addition, the medicine compatibilities of getting rid of evils such as the also normal and diaphoretic medicine of this product, cathartic drug are used for deficiency of vital energy diseases caused by exogenous pathogenic factor or interior-excess heat and the weakened body resistance card of the dominations of pathogen such as deficiency of qi and blood, with strengthening vital QI to eliminate pathogenic factors, make the merit heresy and healthy energy is not hindered.

The Rhizoma Atractylodis Macrocephalae: property of medicine hardship, suffering, return liver, kidney channel.Effect is a liver and kidney tonifying, strengthening the tendons and bones, arresting bleeding and miscarriage prevention, the continuous folding of curing the wound.

1, syndrome of deficiency of spleen qi: this product sweetness and bitterness is warm in nature, the main taste warp of returning, and wetting with spleen invigorating, bath is main effect, by forefathers' reputation is " spleen air making-up and spleen enlivening first key medicine ".The spleen has the function to transport and transform nutrients because of deficiency of spleen-QI, and the fortuneization mistake is strong, and often water is given birth in wet, cause lack of appetite, loose stool or have loose bowels, phlegm retention, edema, all cards of leukorrhagia.This product can be longer than QI invigorating with multiple spleen fortune, and again can bath wet, diuresis is to remove damp.Control the insufficiency of the spleen same usefulness of product such as wet, anorexia and loose stool or have loose bowels, normal and Radix Ginseng, Poria that have, as decoction of four noble drugs (" prescription of peaceful benevolent dispensary ").Control insufficiency of the spleen hypoactivity of YANG in middle-JIAO, the phlegm retention inner stopper is suitable for the product compatibility of warming YANG activating QI, promoting diuresis to eliminate damp pathogen, as Siberian cocklebur osmanthus art soup (" Medical Treasures of the Golden Chamber ").Control edema due to deficiency of the spleen, can be with Poria, medicine such as put in order with using.Control insufficiency of the spleen turbid damp and make a bet, the clear rare person of leukorrhagia can use together with the product that the spleen invigorating bath is wet.

2, spontaneous sweating due to deficiency of QI: this product is kind controls deficiency-weakness of spleen-QI, failure of defensive QI to protect the body against pathogen, and exterior deficiency spontaneous perspiration person, power is inferior slightly to the Radix Astragali is similar in its effect, also can invigorating the spleen and replenishing QI, strengthening superficial resistance to stop perspiration." prescriptions worth thousand gold " is single controls continuous perspiration with this product.Deficiency of both the splenic and pulmonary QI, failure of defensive QI to protect the body against pathogen, the exterior deficiency spontaneous perspiration, susceptible phoenix heresy person, the product compatibility that be suitable for benefit strengthening spleen and lungs such as the Radix Astragali, Radix Saposhnikoviae, dispels the wind is driven heresy with consolidating superficial resistance, as YUPINGFENG SAN (" danxi's experiential therapy ")

3, frequent fetal movement: this product is can also QI invigorating antiabortive.Be used for insufficiency of the spleen fetus and lose foster person, but this product air making-up and spleen enlivening promotes transportation and transformation of water and food with fetus nourishing, is suitable for the product compatibility of benefiting vital QI and blood such as Radix Ginseng, Colla Corii Asini; Control insufficiency of the spleen mistake fortune, the pregnancy reactions of turbid damp obstructing in middle-JIAO, vomiting and nausea is not eaten, the heavy person of extremity, but the bath of this product air making-up and spleen enlivening is wet, is suitable for the product compatibility of air making-up and spleen enlivening dehumidifying such as Radix Ginseng, Poria, Pericarpium Citri Reticulatae; Control insufficiency of the spleen edema during pregnancy, this product can air making-up and spleen enlivening, again can inducing diuresis to remove edema, and the product compatibility use of also normal and invigorating spleen for diuresis.

1. sexual impotence erectile problem, the seminal emission enuresis: the sweet temperature of this product is supporing yang, and hot temperature cold expelling is with controlling insufficiency of kidney-YANG, the sexual impotence erectile problem of below element deficiency and cold, the diseases such as lingering diarrhea, enuresis frequent micturition of passing out semen.Normal and tonifying YANGs such as Cornu Cervi Pantotrichum, Herba Cistanches, Semen Cuscutae play the product compatibility of flaccidity, as Cornu Cervi Pantotrichum Radix Dipsaci diffusing (" chicken peak Prescriptions for Universal Relief ") or with tonifying YANG Yi Yin such as Radix Polygalae, Fructus Cnidii, Rhizoma Dioscoreae, the same usefulness of the product of restoring normal coordination between the heart and kidney is as Radix Polygalae ball (" medical secrets of official "); Also can with Os Draconis, the same usefulness of Poria, with controlling the disease that lingering diarrhea be can't help, as lock smart ball (" prescription of peaceful benevolent dispensary ").

2. soreness of waist and knee joint, arthralgia due to cold-dampnes: the sweet temperature of this product is supporing yang, hotly has liver and kidney tonifying concurrently with dissipating blood stasis, bone and muscle strengthening, the merit of promoting blood circulation can be equal to usefulness with Bi , the Cortex Eucommiae, Radix Achyranthis Bidentatae, the treating the liver kidney deficiency, soreness of waist and knee joint is as Radix Dipsaci pellet (" Standards of Diagnosis and Treatment "); Also can with compatibilities such as Radix Saposhnikoviae, Radix Aconiti, with the treating the liver kidney deficiency arthralgia due to cold-dampnes of holding concurrently, as Radix Dipsaci ball (" prescription of peaceful benevolent dispensary ").

3. metrostaxis, frequent fetal movement: this product liver and kidney tonifying, Chong and Ren Meridians regulating has to consolidate antiabortive merit.The metrostaxis that can be used for deficiency of the liver and kindey, diseases such as frequent fetal movement.The compatibility Cacumen Platycladi preparata, Radix Angelicae Sinensis, hemostasis such as Folium Artemisiae Argyi are invigorated blood circulation, and the product of channel warming and blood nourishing are with controlling the more than person of metrorrhagia hematochezia (" class official seal side forever ").

The Cortex Eucommiae: the property of medicine is sweet, temperature.Return liver, kidney channel.Effect is invigorating the liver and kidney, and bone and muscle strengthening is antiabortive.

1. lumbago due to renal deficiency and various lumbago: with its invigorating the liver and kidney, bone and muscle strengthening, lumbago due to renal deficiency is suitable especially.Other lumbago is used it, and the effect of strengthening the body resistance is all arranged.Normal and Semen Juglandis, the same usefulness of Fructus Psoraleae are controlled lumbago due to renal deficiency or foot and knee flaccidity, as blue or green pretty young woman's ball (" prescription of peaceful benevolent dispensary "); Be equal to usefulness with Radix Angelicae Pubescentis, Herba Taxilli, Herba Asari, the dispelling the wind and dampness pathogens lumbago is cold heavy, as Radix Angelicae Pubescentis et Herba Taxilli Decoction (" prescriptions worth thousand gold "); With Rhizoma Chuanxiong, Cortex Cinnamomi, the unmarried usefulness that is equal to, control the gynecologic menstrual lumbago; Be equal to usefulness with Cornu Cervi Pantotrichum, Fructus Corni, Semen Cuscutae, treatment impotence due to deficiency of the kidney, cold sperm are not solid, and frequent micturition is mended ball (" Bao Shi proved recipe ") as ten.

2. frequent fetal movement, habitual induced abortion: often appoint antiabortively, single, also can be equal to usefulness with Herba Taxilli, Radix Dipsaci, Colla Corii Asini, Semen Cuscutae with effectively with this product invigorating the liver and kidney, Gu Chong.As " Shengji Zonglu " Cortex Eucommiae ball, single is the end with this product, and jujube pulp is a ball, controls frequent fetal movement; " easy folk prescription " with Radix Dipsaci, the same usefulness of Rhizoma Dioscoreae, control habitual induced abortion.

Pharmacodynamic test of active extract

Specify:, all refer to the medicine of treatment women's habitual abortion of the present invention and threatened abortion with the pregnant peaceful oral liquid of pleasure that hereinafter occurs.

1, to the preventive and therapeutic effect of zoopery miscarriage

80 of SD rat (60 of female Mus, 20 of male Mus).Body weight 220 ± 20g.Adaptability was raised and is begun experiment 1 week after animal was bought.Select proestrus with 1: 1 ratio, with the single cage copulation of male Mus.To see sperm in the smear is gestation the 1st day.And with male Mus taking-up.Gestation is divided to model control group, high dose group, middle dosage group, low dose group, Chinese medicine matched group and blank group by female Mus at random.

Model control group prepares the rat abortion model of suffering from a deficiency of the kidney.The 3rd day beginning of gestation gavaged the hydroxyurea distilled water solution to the 12nd day.Gestation gavaged mifepristone 1 time on the 12nd day.(hydroxyurea: Jinan pharmaceutical factory produces.The animals administer amount is every hectogram body weight 20mg every day.Levigation is dissolved in the distilled water standby.Mifepristone: Beijing the 3rd pharmaceutical factory produces.Every 25mg.The animals administer amount is every hectogram body weight 3.75mg every day.Levigation is dissolved in the distilled water standby.)

High, medium and low dosage group is except that with the administration of model matched group, find pleasure in simultaneously in addition that dosage 5.83g/kg, low dosage 2.92g/kg irritate stomach (dividing the filling stomach 2 times) among pregnant peaceful oral liquid (every milliliter contains crude drug 0.9 gram) the high dose 11.67g/kg.

SHOUTAI WAN matched group SHOUTAI WAN is a prescription among the Zhang Xichun " Records of Tradition Chinese and Western Medicine in Combination ".The side is made up of Semen Cuscutae, Herba Taxilli, Radix Dipsaci, Colla Corii Asini.Take by weighing each medicine in proportion, decocting, filtration contain crude drug 0.17 to every ml soln.The animals administer amount is every hectogram body weight 2.4ml every day, divides and irritates stomach 2 times.

The blank group gavages with the volume distilled water every day.

Observation index is observed the ordinary circumstance of all modeling rats, as body weight, by hair, active situation etc.All female Mus were put to death in gestation on the 15th day.The variation of tire number, abortion number, the abortion ratio of observe living and to (anti-trophocyte antibody kit are available from the scientific and technological biotech firm in last sea cowry west, and the IL-2 test kit is available from east, Beijing refined biotechnology research institute) such as effects of anti-trophocyte antibody of serum and IL-2.

The similar syndromes of suffering from a deficiency of the kidney such as weight increase is slow, fluffy by hair, hogback is moving less appear in ordinary circumstance hydroxyurea administration 1 all left and right sides rat of rat as a result; Model control group also see lose weight, disease such as aversion to cold and cold limbs; After giving mifepristone in pregnant 12 days, all saw the vaginal hemorrhage phenomenon in pregnant 12 or 14 days; When dissected finds that each treated animal miscarriage situation of modeling differs.

Tire number, abortion number, abortion ratio situation of change see Table 1 1.1 each group is lived

Each group of table 1 is lived tire number, abortion number, abortion ratio variation relatively

Group	Sample number (n)	Tire number (n) alive	Abortion number (n)	Abortion ratio (%)
					The happy pregnant peaceful low dose group SHOUTAI WAN matched group of the happy pregnant peaceful middle dosage group of the happy pregnant peaceful high dose group of blank group model matched group	??7 ??7 ??7 ??7 ??7 ??7	??6.581±1.521 ??0.867±0.910** ??1.867±1.355# ??4.724±1.37## ??3.867±2.025## ??2.581±1.262#	??0.141±0.368 ??5.153±1.763** ??3.581±0.786# ??2.153±0.68## ??2.581±0.786## ??3±1#	??0.023±0.054 ??85.924±14.231** ??57.324±15.857## ??32.481±14.131## ??43.2±17.890## ??62.062±13.625##

*: compare P＜0.01 with the blank group.*: compare P＜0.05 with the blank group.

##: compare P＜0.01 with model control group.#: compare P＜0.05 with model control group.

Table 1 result shows that model control group decline, P＜0.01 than blank group tire digital display alive.Each treatment group all has tangible effect of fetus care in middle, relatively is respectively P＜0.05, P＜0.01, P＜0.01, P＜0.05 with model control group.Happy pregnant peaceful middle dosage group obviously is better than high dose group and matched group, P＜0.05.Model control group miscarriage digital display and is higher than the blank group, P＜0.01.Each treatment group and model control group more all have apparent difference, are respectively P＜0.05, P＜0.01, P＜0.01, P＜0.05.Happy pregnant peaceful in, the low dose group curative effect is higher than matched group, is respectively P＜0.01 and P＜0.05, is higher than high dose group, all P＜0.05.With the blank group relatively, the model control group abortion ratio is showing and is rising P＜0.01.Happy pregnant peaceful each group treatment back is showing than the model control group abortion ratio and is descending, and statistical result is P＜0.01.Happy pregnant peaceful in, the low dose group effect of fetus care in middle is better than high dose group and matched group, is respectively P＜0.01, P＜0.05.

1.2 the anti-trophocyte antibody test of serum the results are shown in Table 2.

Table 2 is respectively organized the anti-trophocyte antibody test of serum result relatively

Group	Sample number (n)	Anti-trophocyte antibody (ng/m)
			The happy pregnant peaceful low dose group SHOUTAI WAN matched group of the happy pregnant peaceful middle dosage group of the happy pregnant peaceful high dose group of blank group model matched group	????6 ????6 ????7 ????8 ????7 ????8	??????0.728±0.542 ??????1.496±0.926* ??????1.364±0.868 ??????0.851±0.644 ??????1.338±1.164 ??????0.849±0.543

*: compare P＜0.05 with the blank group

The anti-trophocyte antibody content of model control group serum obviously raises P＜0.05.Happy pregnant peaceful high, medium and low dosage group is treated the anti-trophocyte antibody of back serum and is normal level, with blank group zero difference, P＞0.05.Equal no difference of science of statistics between all the other each groups.

1.3 serum il-2 testing result sees Table 3.

Table 3 is respectively organized serum il-2 testing result relatively

Group	Sample number (n)	????IL-2(ng/ml)
			The happy pregnant peaceful low dose group SHOUTAI WAN matched group of the happy pregnant peaceful middle dosage group of the happy pregnant peaceful high dose group of blank group model matched group	????7 ????8 ????6 ????8 ????7 ????9	????1.77±0.734 ????2.561±0.467* ????1.894±0.582# ????1.986±0.595# ????1.982±0.455# ????1.984±0.579#

*: compare P＜0.05 with the blank group.#: compare P＜0.05 with model control group.

Table 3 shows, with the blank group relatively, model control group IL-2 level is showing and is raising P＜0.05.The IL-2 content that after the happy pregnant peaceful high, medium and low dosage treatment model is raise drops to normally, compares P＞0.05 with the blank group.

2, to the morphologic influence of miscarriage rat tissue

Administration and modeling method are the same.Laboratory animal is taken off ovary, gravid uterus, liver, kidney, immediately with 10% formalin fixed after putting to death.The series dehydration of alcohol, transparent, paraffin embedding, section, HE dyeing.Light microscopic is observed the morphological change of each tissue down.

2.1 uterus, ovary perusal: 1. normal non-gravid uterus: the uterus is tiny.2. normal pregnancy uterus: thick as beading, see after the dissection that the embryo is intact.3. part miscarriage: see in the uterine cavity that the embryo is imperfect.4. artificial abortion: do not see embryo or obvious blood stasis sign in the uterine cavity.Om observation: 1. uterus: the normal control group shows that decidua organizes completely, does not see hemorrhagely, and fetal development is normal; The model control group performance embryo disappear, the decidual cell regression, and as seen hemorrhage and inflammatory cell oozes out; The decidua of Chinese medicine high dose group is complete, local decidual cell regression, fetal development maturation; The decidua of dosage group is complete in the Chinese medicine, the regression of part cell; The decidual cell part regression of low dose group, the embryo of as seen surviving; The regression of SHOUTAI WAN group decidual cell part, local stasis of blood.2. ovary: the normal control group shows that the corpus luteum volume is bigger, and cell cytosol is abundant, engrain, part regression; Model control group then shows part atrophy of corpus iuteum, regression; The corpus luteum volume of happy pregnant peaceful high dose group is bigger, and cell cytosol is abundant; Middle dosage group corpus luteum volume is bigger, and endochylema is abundant, engrain; Low dose group corpus luteum volume is bigger, the local cells regression; SHOUTAI WAN group corpus luteum volume is not of uniform size, the regression of part corpus luteum.

2.2 liver, kidney are respectively organized the light microscopic of rat liver and renal tissue and are observed down and show does not all have obviously change.Point out this experimental model and happy pregnant peaceful various dose to irritate the stomach treatment and all rat liver and renal tissue are not produced obviously influence.

2.3 the gross examination of skeletal muscle of pregnant rat and filial generation thereof

Each Chinese drug-treated group keeps 1 pregnant rat at random to producing, and tracing study pregnant rat and filial generation thereof (to 2 monthly ages): pregnant rat is no abnormal; The filial generation gross examination of skeletal muscle does not have deformity, body weight, quilt hair, activity etc. and normal product Mus zero difference.Shown that tentatively happy pregnant peaceful oral liquid does not have obvious toxic-side effects.

3, to the influence of laboratory animal isolated uterine smooth muscle

To the female unpregnancy Wistar of the effect in isolated rat uterus rat, body weight 200 ± 20g, preparation isolated uterine specimen places in the isolated organ analyzer bath, after stablizing, adds the happy pregnant body lotion concentration that rather makes and is respectively 5.65 * 10 ^-3, 11.3 * 10 ^-3, 22.6 * 10 ^-3G/ml, the uterus all is the obvious suppression effect, and the numerical value before and after the administration sees Table 3, and drug effect and dosage have obvious dependence.

The happy pregnant peaceful influence of table 4 to the isolated rat uterine contraction activity

Group	Uterus specimen (bar)	Amplitude (cm)	Tension force (cm)	Frequency (inferior/min)
					????I ????II ????III	Behind preceding 8 medicines of medicine behind preceding 10 medicines of 8 medicines behind preceding 10 medicines of 10 medicines 10	??2.28±0.84 ??1.31±1.09** ??2.90±1.13 ??0.38±0.43** ??3.16±0.35** ??0.35±0.35**	??0.78±0.58 ??0.38±0.26* ??0.40±0.28 ??0.23±0.09* ??1.12±1.07 ??0.27±0.34*	????0.99±0.21 ????0.76±0.33 ????0.84±0.31 ????0.39±0.33** ????0.97±0.31 ????0.43±0.33**

Annotate: the I group: NYN5.65 (* 10 ^-3G/ml), II group: NYN11.3, III group: NYN22.6; With comparison before the administration, * P＜0.05; * P＜0.01

In addition, finding pleasure in pregnant peaceful oral liquid can also show oxytocin short of money (Oxy) and acetylcholine (Ach) excitation to the uterus that lands very much.Happy pregnant peaceful 5.65 * 10 ^-3, 11.3 * 10 ^-3, 22.6 * 10 ^-3The body lotion of g/ml is to Oxy (2.5 * 10 ^-3U/ml) inhibitory action in excited uterus is respectively amplitude difference 1.58 ± 0.22cm, 2.12 ± 37cm, and 4.01 ± 0.52cm (P＜0.01) is less than normal uterine contraction amplitude; Tension Difference is 1.90 ± 0.51cm, 2.32 ± 0.47cm, 30.01 ± 0.52cm (P＜0.01). happy pregnant peaceful 11.3 * 10 ^-3The g/ml body lotion is to Ach (5 * 10 ^-5G/ml) antagonism amplitude difference 4.24 ± 1.20cm; Tension Difference 4.79 ± 0.76cm (P＜0.05).

Two, find pleasure in pregnant peaceful oral liquid toxicity test

1, acute toxicity test

40 of Kunming mouses, 18～22g, male and female half and half are irritated stomach (0.2mL/10g, maximum dose level are 23.24g/kg) with equal-volume, and 2 filling stomaches observed for 2 weeks, record poisoning manifestations and death condition continuously in the 24h.

40 of SD rats, 180～220g, male and female half and half, equal-volume is irritated stomach, and maximum dose level is 23.24g/kg, and expert 2 equal-volumes of 24h are irritated stomach (2mL/10g), observe for 2 weeks continuously, record poisoning manifestations and death condition.

The result: equal-volume is irritated stomach and is given 2 pregnant peaceful oral liquids of pleasure in 24h, observes for 2 weeks continuously, and it is good that each organizes rat, mice growing state during acute toxicity testing, there is no abnormal response, does not have dead the generation.Animal subject rat, its mouse oral LD ₅₀Female, male all greater than 23.24g/kg, according to acute toxicity grading criteria, happy pregnant peaceful oral liquid belongs to non-poisonous material.

2, long term toxicity test

Get 80 of SD kind rat, body weight 188 ± 15g, male and female half and half, be divided into four groups at random, 20 every group, heavy dose of group (11.67g/kg), 30 times of clinical consumption are equivalent to be grown up, in dosage group (5.83g/kg), 15 times of the clinical consumption that is equivalent to be grown up, small dose group (2.92g/kg) and water matched group (10mlk/kg).Every day gastric infusion once, successive administration one month.Weigh weekly once, observe every day such as its appetite, outward appearance, behavior, secretions, feces etc.After one month, sacrificed by decapitation is got blood and is carried out relevant check, claims weight in wet base to main organs, asks dirty body ratio and carries out pathological examination.

(1) observation of general situation:

After giving the rat oral gavage administration, large, medium and small dosage group rat, hair is glossy, activity freely, the figure is normal, ingest, feces etc. there is no unusually, body weight increases gradually, compares no significant change (P＞0.05) with matched group.

(2) hematological examination:

Erythrocyte (RBC) was checked in blood sampling immediately with the rat broken end in one month, leukocyte (WBC) counting, and hemoglobin (HB) is measured and the leukocyte classification.The result shows that the large, medium and small dosage of every index is compared with matched group, Non Apparent Abnormality (all P＞0.05).

(3) to the influence of blood parameters:

A. the mensuration of liver function: bag SGPT, SGOT, total protein, albumin.Result of the test sees Table 5.

Table 5 couple rat SGPT influences X ± SD

Group

Number of animals

??SGPT(U)

??SGOT(U)

Total protein (g/L)

Albumin (g/L)

Matched group	????20	????84±15	????65±24	????69±24	????37±16
						Small dose group	????20	????89±17	????77±19	????73±13	????33±13
Middle dosage group	????20	????97±23	????69±17	????78±15	????41±11
						Heavy dose of group	????20	????98±24	????73±25	????63±19	????43±23

Experimental result shows: large, medium and small dosage group is compared with matched group, and liver function is not had obvious influence (all P＞0.05).

B. renal function is measured: comprise that blood urea nitrogen, creatinine, experimental result see Table 6.

The influence of table 6 pair plasma urea nitrogen and creatinine content

Group	Number of animals	Plasma urea nitrogen content mg%	Creatinine content mg %
				Matched group	????20	????12.5±3.6	??1.3±0.7
Small dose group	????20	????9.5±2.5	??1.5±0.5
				Middle dosage group	????20	????9.8±3.3	??1.1±0.4
Heavy dose of group	????20	????9.8±3.3	??1.0±0.5

Experimental result shows: large, medium and small dosage group is compared with matched group, and blood urea nitrogen and creatinine have no significant change (all P＞0.05), and renal function is not had obvious influence.

(4) dirty body is than observing:

Behind the sacrificed by decapitation rat, take out the heart, liver, spleen, lung, kidney, adrenal gland, thymus, ovary, testis rapidly, remove blood on the filter paper, claim its weight in wet base, ask its dirty body ratio.

Experimental result shows: each organizes the rat heart, liver, spleen, lung, kidney, adrenal gland, thymus, ovary, testis body ratio, compares religion with matched group, and have no significant change (all P＞0.05) does not have obvious influence to the main organs coefficient.

(5) pathological examination:

After experiment finishes, when handling animal, the row gross necropsy, the result respectively organizes the heart, liver, spleen, lung, kidney, adrenal gland, thymus, ovary, testis, uterus, stomach, intestinal, thoracic cavity and the abdominal cavity of rat, there is no color, paramophia, NAD.Then core, liver, spleen, lung, kidney, stomach, intestinal, small intestinal, mesenteric lymph node, bone marrow of sternum, adrenal gland, thymus, parathyroid tissue, use 10% formaldehyde fixed, paraffin embedding, pathological observation is carried out in section HE dyeing under the mirror.As a result, with matched group relatively, the above histiocyte clear in structure of each administration treated animal is not found the pathological change relevant with administration.

3, tertogenicity test

Get satisfactory Wister rat, press evening 8 every day female, mated copulation in male 2: 1, take out male Mus morning next day, female Mus vaginal smear examination sperm.With pregnant Mus by the time order and function of becoming pregnant, be divided into 5 groups at random, every group of 12～15 of Mus of becoming pregnant, 3 are tried agent amount group and are respectively 31.1,15.6 and 7.8 g/ (kgd), maximum dose level is equivalent to 80 times of clinical plan consumption, and other establishes solvent control group (distilled water) and positive controls (vitamin A).The pregnant Mus of each test group detects the same day of sperm as becoming pregnant the 0th day, pregnant Mus is at the 6th～15 day (histo-differentiation and period of organogenesis) 1 time/d per os gastric infusion of gestation, every 3d weighs 1 time, and adjusts dosage by body weight change, simultaneously the observed and recorded animal activity and the situation of ingesting.Happy each dosage group of pregnant peaceful oral liquid is with the aqueous solution of distilled water preparation desired concn, and vitamin A is prepared with salad oil.Pregnant Mus is in the 20th day pregnancy period sacrificed by decapitation, laparotomy inspection, and it is heavy to claim that the uterus connects tire, record implantation number, litter size, the tire of living, stillborn fetus, early stage and absorb tire number, corpus luteum number late period; Claim that each internal organs of pregnant Mus are heavy, calculate organ coefficient (heavy (the g)/body weight (g) * 100 of internal organs); Take out tire son and Placenta Hominis and weigh, check the young outward appearance deformity of tire, measure the long and chest measurement of height, tail of every tire Mus, check the outward appearance of the tire of living.It is fixing that every nest 50% tire son alive is put into Bouin liquid, makes freehand section, checks internal organs deformities (palate, nose, eye, brain, the heart, lung, liver, spleen, gastrointestinal, kidney, genitals); In addition the 50% tire son that lives is that 95% ethanol is fixed through volume fraction, after the transparent and alizarin red dyeing, does the skeleton deformity inspection.

The gained data are set up the data base with EXCEL, calculate the arithmetic mean and the standard deviation of each index, carry out the group difference that body weight, organ coefficient are analyzed in the variance inspection, x with SPSS software ²Unusual rate of check analysis and abnormal rate.

3.1 happy pregnant peaceful oral liquid influences the negative group of height, the pregnant Mus body weight gain of middle dosage group slowly to pregnant Mus body weight and organ coefficient, and the trend that alleviates with the dosage weight increase is arranged, all do not have apparent property (P＞0.05) but respectively organize pregnant Mus body weight gain difference, gestation was respectively organized each organ coefficient difference of pregnant Mus on the 20th day does not also have apparent property (P＞0.05).

3.2 the influence that happy pregnant peaceful oral liquid is grown pregnant mouse embryo is by table 1 as seen, each dosage group and negative control group relatively, the tire rate of living, absorption tire rate difference all do not have apparent property (P＞0.05).

The influence that the happy pregnant peaceful oral liquid of table 7 is grown pregnant mouse embryo

Group	Physicopsychic training techniques	The corpus luteum number	Nest tire number on average alive	The tire of living is counted %		Stillborn fetus is counted %		Absorb tire and count %
										High dose group	??70	??75	??14	??70	??100.00	??0	??0.00	??0	??0.00
Middle dosage group	??129	??141	??14	??124	??96.12	??0	??0.00	??5	??3.88
										Low dose group	??133	??150	??12	??128	??96.24	??0	??0.00	??5	??3.76
Negative group	??104	??135	??10	??100	??96.15	??2	??1.92	??2	??1.92
										Positive group	??144	??170	??14	??135	??93.75	??7	??4.86	??2	??1.39

3.3 happy pregnant peaceful oral liquid is to the influence of the general development condition of tire Mus by table 2 as seen, each dosage group tire Mus average weight, Placenta Hominis weight, height, tail grow and chest measurement all low than negative control group, but credit is analysed by statistics, difference does not all have apparent property (P＞0.05).

Table 8 tire Mus organizes respectively that average weight, Placenta Hominis weight, height, tail are long, chest measurement (x ± s)

Group	Tire Mus number	Average weight (g)	Placenta Hominis heavy (g)	Height (cm)	Tail long (cm)	Chest measurement (cm)
							High dose group	??70	??4.01±1.31	??0.55±0.07	?3.69±0.58	?1.39±0.11	?3.62±0.48

The positive group of the negative group of middle dosage group low dose group

129 133 104 144

????3.99±0.35 ????3.68±0.98 ????4.55±1.06 ????3.90±0.99

??0.56±0.11 ??0.54±0.14 ??0.58±0.16 ??0.51±0.09

?3.60±0.12 ?3.43±0.49 ?3.75±0.42 ?3.49±0.28

??1.35±0.03 ??1.33±0.13 ??1.42±0.13 ??1.36±0.14

?3.57±0.12 ?3.44±0.39 ?3.75±0.41 ?3.78±0.43

3.4 happy pregnant peaceful oral liquid is checked with free-hand slicing method the tire Mus internal organs that influence of tire Mus outward appearance and internal organs, the administration group is except that 1 routine ventricles of the brain increase appears in high dose, other each dosage group there is no obvious deformity, but multiple deformity appears in positive controls, total abnormal rate is 60%, the deformity type is mainly ventricles of the brain increase, eye is unusual and cardiac enlargement, is respectively 12.7%, 14.3% and 14.3%, secondly is liver expansion, huge stomach, polycystic kidney and tongue bifurcated etc.

3.5 happy pregnant peaceful oral liquid influences all visible breastbone disappearance of test group or ossified slow to what tire Os Mus bone was grown, except that the full disappearance of 1 routine breastbone appears in positive controls, other all shows as the disappearance of the 2nd, 5 breastbones or ossified slow, each dosage group and negative control group are relatively, difference does not all have apparent property, and positive controls and negative control group are relatively, and difference then has extremely showing property (P＜0.01), and each group is not all seen other skeleton deformity.

Conclusion: the result shows each dosage group and negative control group relatively, and tire Mus average weight, height, tail is long and chest measurement difference does not all have apparent property, illustrates that this medicine does not have development toxicity.Outward appearance, skeleton and the internal organs teratogenesis difference of tire Mus all do not have apparent property (P＞0.05) between 3 dosage groups, illustrate that this medicine do not see obvious teratogenesis under this experimental condition.

Claims (2)

1. medicine for the treatment of women's habitual abortion and threatened abortion, it is characterized in that, the raw material that comprises following weight ratio in this medicine: the Radix Astragali 9%～13%, Radix Codonopsis 9%～13%, the Rhizoma Atractylodis Macrocephalae 5%～9%, Radix Dipsaci 5%～9%, the Cortex Eucommiae 9%～13%, the Radix Paeoniae Alba 3%～6%, Fructus Psoraleae 5%～9%, Radix Angelicae Sinensis 3%～5%, Rhizoma Dioscoreae 10%～17%, Fructus Jujubae 5%～9%, Fructus Amomi 5%～9%, sucrose 16%～20%, the summation of raw material are 100%, and add micro-sodium benzoate in addition as additive.

2. the preparation method of the medicine of treatment women's habitual abortion and threatened abortion is characterized in that, follows these steps to preparation:

1) prescription comprises the raw material of following weight ratio:

The Radix Astragali 9%～13%, Radix Codonopsis 9%～13%, the Rhizoma Atractylodis Macrocephalae 5%～9%, Radix Dipsaci 5%～9%, the Cortex Eucommiae 9%～13%, the Radix Paeoniae Alba 3%～6%, Fructus Psoraleae 5%～9%, Radix Angelicae Sinensis 3%～5%, Rhizoma Dioscoreae 10%～17%, Fructus Jujubae 5%～9%, Fructus Amomi 5%～9%, sucrose 16%～20%, the summation of raw material is 100%, and add micro-sodium benzoate in addition as additive

2) with the raw material in the above-mentioned prescription except that sucrose, be ground into coarse powder, decoct with water three times, 2.5 hours for the first time, second, third time each 2 hours, collecting decoction, filter, filtrate is concentrated into relative density under 60 ℃ of temperature be 1.05 clear paste, puts coldly, adds ethanol and make and contain the alcohol amount and reach 75%, stir evenly, left standstill 24 hours, and filtered, it is 1.05～1.15 clear paste that filtrate is concentrated into relative density at 20 ℃, with sucrose and micro-adjuvant sodium benzoate, add water to ormal weight, stir evenly, leave standstill, filter, embedding, sterilization, promptly.