CN105770671A - Medicine composition for treating recurrent abortion and method for preparing medicine composition - Google Patents

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a medicine composition for treating recurrent abortion and a method for preparing the medicine composition. The medicine composition comprises fructus lycii, semen cuscutae, fructus broussonetiae, dried radix rehmanniae, cortex moutan, viola japonica, fruits of herba melastomatis dodecandri, cortex eucommiae, semen plantaginis, fructus alpiniae oxyphyllae and rhizoma atractylodis macrocephalae according to certain weight proportions. The medicine composition and the method have the advantages that various medicines are compatible with one another, effects of tonifying kidneys, clearing livers, nourishing and activating blood, consolidating thoroughfare and conception channels and preventing miscarriage can be realized by the aid of meaning of ' same source of livers and kidneys and joint treatment on the livers and the kidneys', ACA (anticardiolipin antibodies) can become negative by means of immunological regulation, fetuses can continue developing, the blood viscosity can be obviously reduced, the circulation flow rates can be increased, platelet aggregation and thrombosis can be resisted, placental micro-circulation can be improved, traditional Chinese medicine symptoms of patients can be treated, and the shortcoming of adverse factors of simple western medicine therapy can be overcome.

Description

A kind of pharmaceutical composition treating recurrent abortion and preparation method thereof

Technical field

The invention belongs to technical field of Chinese medicine, relate to a kind of pharmaceutical composition treating recurrent abortion and preparation method thereof, especially a kind of pharmaceutical composition treating anticardiolipin antibody positive recurrent abortion and preparation method thereof.

Background technology

Recurrent abortion (recurrentspontaneousabortion, RSA) is a kind of common pregnancy complications, refers to the fetus spontaneous abortion before occurring 2 times or more than 2 times pregnant 28 weeks with same spouse.The factor of recurrent abortion is extremely complex to cause patient to occur, for instance congenital uterine anomalies, infection, inherited genetic factors, luteal phase defect, cryptorrhea etc., the influence factor of some patients with recurrent spontaneous abortions cannot be clear and definite.Along with the development of China's medical level, China extremely payes attention to for the relation between patient's autoimmune antibody and the recurrent abortion of unknown cause, and substantial amounts of research confirms that recurrent abortion is how closely related with the dysimmunity of patient self.According to the pathogenesis of patient's miscarriage, recurrent abortion is generally divided into two big classes: autoimmune type and alloimmunity type, and autoimmune type is general and anticardiolipin antibody (anticardiolipinantibody, the ACA) positive etc. is closely related.

ACA causes the exact mechanism of miscarriage still not fully aware of, Most scholars thinks that being probably ACA combines with the phospholipid on vascular endothelial cell, make impaired vascular endothelium, prostacyclin synthesis reduces, prostacyclin A2 is out of proportion with prostacyclin, causes that in local vascular, blood fastens formation, or the phospholipid on platelet membrane is combined, causing platelet aggregation, blood fastens formation.Owing to decidua Ink vessel transfusing blood fastens formation, fetal blood, for being obstructed, causes the generation of miscarriage.Foreign literature report adopts hormone or aspirin or heparin therapy, also has and above-mentioned several drugs combines application, and domestic also have similar report, but said medicine is in pregnant early stage, and application all has certain side effect, should reduce use as far as possible.

Though ACA positive RSA is defined by the traditional Chinese medical science without definite, but its treatment can refer to " vaginal bleeding during pregnancy ", " frequent fetal movement ", " induced abortion " etc., and its main clinical manifestation is suffer from abdominal pain after the gestation soreness of waist, fetal movement tenesmus, colporrhagia etc..Modern doctor thinks caused for ACA recurrent spontaneous abortion more and suffers from a deficiency of the kidney is that tire is unable, and dysfunction of the kidney in storing essence is relevant, or hold concurrently insufficiency of the spleen, heat in blood, blood stasis.We find clinically, in dysimmunity raised type recurrent abortion, except increasing except anticardiolipin antibody (ACA) titer, the symptom of common suffer from a deficiency of the kidney stagnation of liver-QI or liver-yang hyperactivity of suffering from a deficiency of the kidney, can inference, the sensitive body constitution of this easy generation anticardiolipin antibody (ACA) local immunity reaction belongs to the Liver Channel pathological changes person that suffers from a deficiency of the kidney mostly, so Liver Channel disease damage such as liver-yang hyperactivity, dampness-heat of the liver etc. are the mark of the immune recurrent abortion of secondary.

Summary of the invention

For overcoming the unfavorable factor of prior art, inventor is on the basis for the treatment of habitual abortion side handed down from one's ancestors, body constitution and modern medical theory in conjunction with modern, dialectical combine with differential diagnosis of diseases, provide a kind of pharmaceutical composition treating recurrent abortion, especially a kind of pharmaceutical composition treating anticardiolipin antibody positive recurrent abortion.

For achieving the above object, the technical solution used in the present invention is as follows:

A kind of pharmaceutical composition treating recurrent abortion, it is characterised in that by Fructus Lycii, Semen Cuscutae, Fructus Broussonetiae, Radix Rehmanniae, Cortex Moutan, Herba Violae japonicae, fruit, the Cortex Eucommiae, Semen Plantaginis, Fructus Alpiniae Oxyphyllae, the Rhizoma Atractylodis Macrocephalae be that medicinal raw material is made according to certain weight.

All medicines or dual-purpose simply in side of the present invention, or a medicine is multiplex, for making all medicines functionally complement each other, to heighten the effect of a treatment；Making mutually in the property of medicine and help mutually, to lower toxicity, inventor is it is preferred that go out below scheme:

A kind of pharmaceutical composition treating recurrent abortion, it is characterised in that be made up of the medicinal raw material of following weight: Fructus Lycii 20-26 part, Semen Cuscutae 10-15 part, Fructus Broussonetiae 7-12 part, Radix Rehmanniae 10-15 part, Cortex Moutan 7-12 part, Herba Violae japonicae 8-13 part, fruit 10-15 part, Cortex Eucommiae 5-8 part, Semen Plantaginis 7-12 part, Fructus Alpiniae Oxyphyllae 2-5 part, Rhizoma Atractylodis Macrocephalae 7-12 part.

Further preferably, a kind of pharmaceutical composition treating recurrent abortion, it is characterised in that be made up of the medicinal raw material of following weight: Fructus Lycii 25 parts, Semen Cuscutae 12 parts, Fructus Broussonetiae 10 parts, Radix Rehmanniae 10 parts, Cortex Moutan 8 parts, Herba Violae japonicae 12 parts, fruit 15 parts, the Cortex Eucommiae 6 parts, Semen Plantaginis 9 parts, Fructus Alpiniae Oxyphyllae 4 parts, the Rhizoma Atractylodis Macrocephalae 10 parts.

Though woman is with liver for congenital, right kidney is the yin aspect of yin, and liver is the yang aspect of yin, and sun person is actively.Kidney is the mother of liver, and kidney has nourishing the liver function, also has and assists irritability to rise the effect sending out catharsis；If pathogenic fire derived from stagnation of liver-QI, lower misfortune kidney yin, kidney yin is more empty, and stagnation of liver-QI is more puzzled；Yu Ze fire-transformation of a specified duration injures cloudy blood.Fructus Lycii profit in side and nourish, double can bring down a fever, and specially in the kidney invigorating, lung moistening, promote the production of body fluid, QI invigorating, for the key medicine of Liver and kidney kidney-YIN being deficient, tired interior-heat tonification；Semen Cuscutae tonifying kidney and nourishing liver, warming the spleen helps stomach, two medicines 5 with mending and not high, temperature and not dry, void can be mended, in fact can be in order to, cold can temperature, heat can be cool, wet can be dry, dry tonifying kidney and nourishing liver of can moistening is monarch drug.Fructus Broussonetiae is sweet cold, and the kidney invigorating tonifying YIN, purging liver-heat, Radix Rehmanniae nourishing YIN and clearing away heat, removing heat from blood is enriched blood；Cortex Moutan clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling；Herba Violae japonicae heat-clearing and toxic substances removing, removing stasis to stop bleeding, removing heat from blood liver heat removing, four medicine 5 nourishing YIN and supplementing blood, purging liver-heat, blood circulation promoting and blood stasis dispelling, removing pathogenic heat from blood and toxic substance from the body, for ministerial drug.The ground sweet temperature of fruit, kidney-replenishing blood-nourishing, arresting bleeding and miscarriage prevention；Benefit vital essence in the sweet temperature compensation of the Cortex Eucommiae, hard rigidity of soft tissues bone, mend solid feotus vitality；Semen Plantaginis is sweet to be slightly cold, and liver of manageing it dredges kidney, freely strongly fragrant and positive, with kidney-reinforcing drug use, makes reinforcing YIN-essence have son；Medicinal with regulating liver-QI, control conjunctival congestion blurred vision；With antipyretic use, dysentery relieving disease fire stagnation；Medicinal with relaxing muscles and tendons, energy promoting diuresis to eliminate dampness and promoting QI circulation, strong fortune foot knee joint；Fructus Alpiniae Oxyphyllae warming the spleen warming the kidney, reducing urination controlling nocturnal emission with astringent drugs；Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI, dampness diuretic, antiabortive, for adjuvant.All medicines close 5 meanings taking its " yi and Kui are derived from the same origin, Liver and kidney is ruled together ", kidney tonifying liver heat removing, nourshing blood and promoting blood circulation, admittedly appoint antiabortive, and treating both the principal and secondary aspects of a disease.

Further, the pharmacological property involved by medicinal raw material used by the present invention is as follows with present Research:

Fructus Lycii: [nature and flavor] are sweet is flat.[return through] returns liver, kidney channel.[function cures mainly] nourishing the liver and kidney, replenishing vital essence to improve eyesight.For asthenia damage of essence, soreness of waist and knee joint, vertigo and tinnitus, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, and blurred vision is failed to understand.

Semen Cuscutae: [nature and flavor] are sweet, temperature.[return through] returns liver,kidney,spleen warp.[function cures mainly] nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.For impotence and seminal emission, dripping urination, enuresis frequent micturition, soreness of the waist and knees, blurred vision tinnitus, vaginal bleeding due to deficiency of the kidney during pregnancy, frequent fetal movement, spleen is suffered from a deficiency of the kidney and is rushed down；Externally treating leucoderma.[usage and dosage] 6～12g；Suitable amount used externally.

Fructus Broussonetiae: [nature and flavor] are sweet, cold.[return through] returns liver, kidney channel.[function cures mainly] the kidney invigorating liver heat removing, improving eyesight, diuresis.For soreness of the waist and knees, asthenia hectic fever due to YIN-deficiency, dizzy blurred vision, the raw nebula film of order, edema distension.[usage and dosage] 6～12g.

Radix Rehmanniae: [nature and flavor] sweet in the mouth；Bitter；It is slightly cold.[return through] GUIXIN；Liver；Kidney channel.[function cures mainly] nourishing YIN and clearing away heat；Removing heat from blood is enriched blood.Main calentura excessive thirst；Interior-heat is quenched one's thirst；Hectic fever due to YIN-deficiency consumptive fever；Epidemic febrile disease sends out speckle；Haematemesis caused by heat in blood；Metrorrhagia；Hematuria；Have blood in stool；Blood deficiency and yellow complexion；Dizziness cardiopalmus；Insufficiency of blood amenorrhea.[usage and dosage] takes orally: decocting soup, 10-15g, heavy dose can use to 30g；Also can endure cream or enter ball, dissipate；Or after infiltration, smash strand juice drink.External: appropriate, smashes deposited.

Ground fruit: [nature and flavor] sweet in the mouth；Warm in nature.[return through] returns kidney；Liver；Spleen channel.[function cures mainly] kidney-replenishing blood-nourishing；Arresting bleeding and miscarriage prevention.Main essence of suffering from a deficiency of the kidney is special；Soreness of the waist and knees；Blood deficiency and yellow complexion；The deficiency of vital energy is weak；Through many；Metrorrhagia；Frequent fetal movement；The prolapse of the uterus；Proctoptosis.[usage and dosage] takes orally: decoct soup, 10-30g；Or infusing drugs in wine.

The Cortex Eucommiae: [nature and flavor] are sweet, temperature.[return through] returns liver, kidney channel.[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, antiabortive.For lumbago due to renal deficiency, muscles and bones is unable, blood leaking in gestation, frequent fetal movement；Hypertension.[usage and dosage] 6～9g.

Semen Plantaginis: [nature and flavor] are sweet, are slightly cold.[return through] returns liver, kidney, lung, small intestine meridian.[function cures mainly] clearing away heat and promoting diuresis, eliminating dampness by diuresis is treating stranguria, improving eyesight, eliminates the phlegm.For edema distension, the puckery pain of pyretic stranguria, diarrhea due to summer heat and dampness, conjunctival congestion and swelling pain, phlegm-heat cough.[usage and dosage] 9～15g, entering decoct should decoct a drug wrapped.

Cortex Moutan: [nature and flavor] are bitter, pungent, are slightly cold.[return through] GUIXIN, liver, kidney channel.[function cures mainly] clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling.For maculae caused by violent heat pathogen, hematemesis and epistaxis, night fever abating at dawn, lossless hectic fever due to YIN-deficiency, amenorrhea dysmenorrhea, carbuncle sore tumefacting virus, fall and flutter the pain of injury.[usage and dosage] 6～12g.

Herba Violae japonicae: [nature and flavor] bitter in the mouth；Micro-pungent；Cold in nature.[return through] liver；Spleen channel.[function cures mainly] heat-clearing and toxic substances removing；Blood stasis dispelling evacuation of pus；Removing heat from blood liver heat removing.Main swollen ulcer drug；Acute mastitis；Acute appendicitis hematochezia；Suppurative osteomyelitis；Jaundice；Conjunctival congestion and swelling pain；Scrofula；Traumatic hemorrhage；Snakebite.[usage and dosage] takes orally: decoct soup, 9-15g, fresh goods 30-60g；Or smash juice clothes.External: appropriate, smashes deposited.

Fructus Alpiniae Oxyphyllae: [nature and flavor] acrid in the mouth；Warm in nature.[return through] spleen；Kidney channel.[function cures mainly] is warming spleen and stopping diarrha takes the photograph saliva；Warming the kidney reducing urination controlling nocturnal emission with astringent drugs.Main Deficiency and coldness of spleen and stomach；Vomiting；Have loose bowels；Cold in abdomen educate；The many salivas of mouth；Enuresis due to deficiency of the kidney；Frequent micturition；Seminal emission；Nebulousurine.[usage and dosage] takes orally: decoct soup, 3-9g；Or enter ball, dissipate.

The Rhizoma Atractylodis Macrocephalae: [nature and flavor] are bitter, sweet, temperature.[return through] returns spleen, stomach warp.[function cures mainly] invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, frequent fetal movement.

The pharmaceutical composition for the treatment of recurrent abortion provided by the present invention, it is possible to directly by Fructus Lycii, Semen Cuscutae, Fructus Broussonetiae, Radix Rehmanniae, Cortex Moutan, Herba Violae japonicae, fruit, the Cortex Eucommiae, Semen Plantaginis, Fructus Alpiniae Oxyphyllae, the Rhizoma Atractylodis Macrocephalae pulverize, prepare into pulvis oral；Each component directly can also be mixed and made into coarse powder, the effective ingredient extracted in coarse powder makes extractum, extractum is utilized to prepare into peroral dosage form, one or more in tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, granule, honey pill agent, powder, sublimed preparation, solution etc.；Other dosage form being suitable to treatment recurrent abortion can also be prepared into.

Inventor considers the factors such as recipe quantity, pharmaceutical properties, medication object, easy to use, cost of manufacture, it is preferable that make capsule, tablet or granule；Most preferably making capsule, be directly mixed and made into coarse powder by each component, extract the effective ingredient system in coarse powder, this effective ingredient individually or mixes with pharmaceutically acceptable carrier, is prepared from according to galenic pharmacy routine techniques.

The preparation method that present invention also offers a kind of pharmaceutical composition described above, the present inventor finds under study for action, by optimized fabrication method, when keeping active drug, impurity or the part without drug effect can be removed, reduce the impurity interference to therapeutic effect, make this pharmaceutical composition more efficient, and thus reducing the consumption of medicine, the preparation method of this pharmaceutical composition provided by the invention, it comprises the steps:

Take Cortex Moutan, Herba Violae japonicae, Semen Plantaginis 70% alcohol reflux by prescription, collect alcohol reflux liquid and filtering residue；Fructus Lycii, Semen Cuscutae, Fructus Broussonetiae, Radix Rehmanniae, fruit, the Cortex Eucommiae, Fructus Alpiniae Oxyphyllae, the Rhizoma Atractylodis Macrocephalae together with Cortex Moutan, Herba Violae japonicae, Semen Plantaginis filtering residue, the soak by water of 4-10 times of weight portion of addition 2 times, each 1.0-2.0 hour, merge decoction liquor, adding ethanol to concentration is 40%, place 8-12 hour, filter to obtain alcohol deposit fluid, alcohol deposit fluid merges with alcohol reflux liquid, decompression recycling ethanol, is concentrated into extractum, and extract dry becomes fine powder, add the mixing of medicine acceptable carrier, make clinical receptible dosage form by conventional formulation method.

Pharmaceutically acceptable carrier described above is optional freely: starch, Icing Sugar, dextrin, microcrystalline cellulose, amylum pregelatinisatum, magnesium stearate, micropowder silica gel, fructose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, vegetable oil, lecithin, Polyethylene Glycol, propylene glycol, ethyl hydroxybenzoate etc..

The present invention is also claimed aforementioned pharmaceutical compositions purposes in the medicine of preparation treatment recurrent abortion, especially causes the purposes in the medicine of recurrent abortion in the preparation treatment anticardiolipin antibody positive.Known by the known clinical trial of embodiment 9, the comparison of two groups of Comprehensive Clinical curative effects: the obvious effective rate for the treatment of group and matched group and total effective rate respectively 66.67%, 90.48% and 45.32%, 76.19%, two groups of obvious effective rates, total effective rate comparing differences statistically significant (P < 0.05), the curative effect for the treatment of group is substantially better than matched group；Two groups of ACA change comparing difference not statistically significant (P > 0.05), two groups of therapeutic equivalences；In before and after two groups of treatments, TCM symptom score compares: after the treatment for the treatment of group, TCM symptom score is all substantially more less than before treating, with comparing difference statistically significant (P < 0.01) before treatment, matched group compares with before treatment, no significant difference (P > 0.05)；Comparing between two groups after treatment, treatment group is better than matched group in improving tcm symptom, and the minimizing for the treatment of group symptom integral becomes apparent from, difference statistically significant (P < 0.01).

The present invention relatively and prior art, has following clear superiority:

First, the pathogenic characteristic that pharmaceutical composition prescription of the present invention mainly belongs to, according to recurrent abortion especially differential diagnosis in tcm, heat in blood of suffering from a deficiency of the kidney develops, and full side plays kidney tonifying liver heat removing, nourshing blood and promoting blood circulation altogether, admittedly appoint antiabortive effect, it is likely to make ACA turn out cloudy by immunomodulating, fetus continues to grow, and blood viscosity also can be made substantially to reduce simultaneously, increases circular flow, energy antiplatelet aggregation and thrombosis, improve Placenta Hominis microcirculation, improve patient's TCM syndrome, overcome the unfavorable factor that simple western medicine is treated.

Prescription of the present invention is simplified, and dialectical combines with differential diagnosis of diseases, and compatibility is reasonable, with low cost, verifies by clinic application, its determined curative effect, mild in medicine property and, toxic and side effects and obvious adverse reaction do not occur, safety coefficient is high.

Detailed description of the invention

Further describing the present invention below by way of specific embodiment, the present invention is not limited only to following example.Within the scope of the invention or without departing from present disclosure, spirit and scope, change, combination or the replacement that the present invention is carried out, will be apparent to the person skilled in the art, and be included within the scope of the present invention.

Embodiment 1 capsule

Prescription: Fructus Lycii 25 parts, Semen Cuscutae 12 parts, Fructus Broussonetiae 10 parts, Radix Rehmanniae 10 parts, Cortex Moutan 8 parts, Herba Violae japonicae 12 parts, fruit 15 parts, the Cortex Eucommiae 6 parts, Semen Plantaginis 9 parts, Fructus Alpiniae Oxyphyllae 4 parts, the Rhizoma Atractylodis Macrocephalae 10 parts.

Preparation method: take Cortex Moutan, Herba Violae japonicae, Semen Plantaginis 70% alcohol reflux by prescription, collects alcohol reflux liquid and filtering residue；Fructus Lycii, Semen Cuscutae, Fructus Broussonetiae, Radix Rehmanniae, fruit, the Cortex Eucommiae, Fructus Alpiniae Oxyphyllae, the Rhizoma Atractylodis Macrocephalae together with Cortex Moutan, Herba Violae japonicae, Semen Plantaginis filtering residue, add the soak by water 2 times of 4-10 times of weight portion, each 1.0-2.0 hour, merge decoction liquor, adding ethanol to concentration is 40%, places 8-12 hour, filters to obtain alcohol deposit fluid, alcohol deposit fluid merges with alcohol reflux liquid, decompression recycling ethanol, is concentrated into extractum, and extract dry is ground into fine powder, making capsule by conventional formulation method, every contains crude drug 1.2g.

Embodiment 2 capsule

Prescription: Fructus Lycii 20 parts, Semen Cuscutae 15 parts, Fructus Broussonetiae 8 parts, Radix Rehmanniae 12 parts, Cortex Moutan 10 parts, Herba Violae japonicae 12 parts, fruit 10 parts, the Cortex Eucommiae 8 parts, Semen Plantaginis 12 parts, Fructus Alpiniae Oxyphyllae 4 parts, the Rhizoma Atractylodis Macrocephalae 10 parts.

Preparation method: the operation with reference to embodiment 1 carries out.

Embodiment 3 capsule

Prescription: Fructus Lycii 25 parts, Semen Cuscutae 10 parts, Fructus Broussonetiae 8 parts, Radix Rehmanniae 12 parts, Cortex Moutan 8 parts, Herba Violae japonicae 10 parts, fruit 12 parts, the Cortex Eucommiae 6 parts, Semen Plantaginis 10 parts, Fructus Alpiniae Oxyphyllae 5 parts, the Rhizoma Atractylodis Macrocephalae 7 parts.

Preparation method: the operation with reference to embodiment 1 carries out.

Embodiment 4 capsule

Prescription: Fructus Lycii 26 parts, Semen Cuscutae 15 parts, Fructus Broussonetiae 10 parts, Radix Rehmanniae 15 parts, Cortex Moutan 8 parts, Herba Violae japonicae 13 parts, fruit 10 parts, the Cortex Eucommiae 8 parts, Semen Plantaginis 12 parts, Fructus Alpiniae Oxyphyllae 3 parts, the Rhizoma Atractylodis Macrocephalae 12 parts.

Preparation method: the operation with reference to embodiment 1 carries out.

Embodiment 5 capsule

Prescription: Fructus Lycii 24 parts, Semen Cuscutae 12 parts, Fructus Broussonetiae 12 parts, Radix Rehmanniae 15 parts, Cortex Moutan 10 parts, Herba Violae japonicae 8 parts, fruit 15 parts, the Cortex Eucommiae 8 parts, Semen Plantaginis 10 parts, Fructus Alpiniae Oxyphyllae 3 parts, the Rhizoma Atractylodis Macrocephalae 10 parts.

Preparation method: the operation with reference to embodiment 1 carries out.

Embodiment 6 capsule

Prescription: Fructus Lycii 25 parts, Semen Cuscutae 12 parts, Fructus Broussonetiae 12 parts, Radix Rehmanniae 12 parts, Cortex Moutan 12 parts, Herba Violae japonicae 8 parts, fruit 12 parts, the Cortex Eucommiae 6 parts, Semen Plantaginis 8 parts, Fructus Alpiniae Oxyphyllae 4 parts, the Rhizoma Atractylodis Macrocephalae 10 parts.

Preparation method: the operation with reference to embodiment 1 carries out.

Embodiment 7 tablet

Prescription: Fructus Lycii 25 parts, Semen Cuscutae 15 parts, Fructus Broussonetiae 7 parts, Radix Rehmanniae 12 parts, Cortex Moutan 10 parts, Herba Violae japonicae 12 parts, fruit 15 parts, the Cortex Eucommiae 6 parts, Semen Plantaginis 9 parts, Fructus Alpiniae Oxyphyllae 4 parts, the Rhizoma Atractylodis Macrocephalae 10 parts.

Preparation method: take Cortex Moutan, Herba Violae japonicae, Semen Plantaginis 70% alcohol reflux by prescription, collects alcohol reflux liquid and filtering residue；Fructus Lycii, Semen Cuscutae, Fructus Broussonetiae, Radix Rehmanniae, fruit, the Cortex Eucommiae, Fructus Alpiniae Oxyphyllae, the Rhizoma Atractylodis Macrocephalae together with Cortex Moutan, Herba Violae japonicae, Semen Plantaginis filtering residue, add the soak by water 2 times of 4-10 times of weight portion, each 1.0-2.0 hour, merge decoction liquor, adding ethanol to concentration is 40%, places 8-12 hour, filters to obtain alcohol deposit fluid, alcohol deposit fluid merges with alcohol reflux liquid, decompression recycling ethanol, is concentrated into extractum, and extract dry is ground into fine powder, making tablet by conventional formulation method, every contains crude drug 1.0g.

Embodiment 8 granule

Prescription: Fructus Lycii 25 parts, Semen Cuscutae 12 parts, Fructus Broussonetiae 10 parts, Radix Rehmanniae 15 parts, Cortex Moutan 8 parts, Herba Violae japonicae 10 parts, fruit 10 parts, the Cortex Eucommiae 6 parts, Semen Plantaginis 12 parts, Fructus Alpiniae Oxyphyllae 5 parts, the Rhizoma Atractylodis Macrocephalae 12 parts.

Preparation method: take Cortex Moutan, Herba Violae japonicae, Semen Plantaginis 70% alcohol reflux by prescription, collects alcohol reflux liquid and filtering residue；Fructus Lycii, Semen Cuscutae, Fructus Broussonetiae, Radix Rehmanniae, fruit, the Cortex Eucommiae, Fructus Alpiniae Oxyphyllae, the Rhizoma Atractylodis Macrocephalae together with Cortex Moutan, Herba Violae japonicae, Semen Plantaginis filtering residue, add the soak by water 2 times of 4-10 times of weight portion, each 1.0-2.0 hour, merge decoction liquor, adding ethanol to concentration is 40%, places 8-12 hour, filters to obtain alcohol deposit fluid, alcohol deposit fluid merges with alcohol reflux liquid, decompression recycling ethanol, is concentrated into extractum, and extract dry is ground into fine powder, making granule by conventional formulation method, every bag contains crude drug 4.0g.

The observation of curative effect of patients with recurrent spontaneous abortion is tested by embodiment 9 pharmaceutical composition medicine of the present invention

1 data and method

1.1 physical data: in March, 2013～2014 year March is just controlled at Hospital Attached to Shandong Chinese Medical Univ.'s Out-patient Clinic of Department of Gynecology and meets 84 example female patients of inclusive criteria be randomly divided into two groups.Wherein treatment group 42 example.24～39 years old age, average 27.6 years old；Miscarry 3 times or more than 3 times person 22 examples, 2 person 20 examples of miscarrying；Dripping hemorrhage 3～25 days of vagina；Pregnant time 7～14 weeks；B ultrasonic report early pregnancy, fetal survival, wherein 28 examples are reported in utero or hematocele under Placenta Hominis.Matched group 42 example, 23～40 years old age, average 28.1 years old；Miscarry less than 3 times person 19 examples, habitual abortion 21 example, dripping hemorrhage 2～21 days of vagina；Pregnant time 7～13.2 weeks, B ultrasonic report early pregnancy, fetal survival, wherein 26 examples are reported in utero or hematocele under Placenta Hominis.Two groups of physical data comparing differences are without significant (P > 0.05).

1.2 diagnostic criterias:

1.2.1 Western medicine diagnose standard: according to recurrent stream in Le Jie chief editor " obstetrics and gynecology (the 7th edition) "

Product diagnostic criteria is drafted: (1) medical history: Women of Childbearing Age, menolipsis 4～12 weeks, has >=spontaneous abortion the medical history of 2 times；(2) clinical symptoms: have menolipsis history and (or) with morning sicknesss such as nausea and vomiting in various degree, lassitude and weak, dizzinesses, there are a small amount of colporrhagia and (or) lower abdominal distention pain, falling inflation sense and (or) the soreness of waist back of the body swollen, discharge without decidua sample tissue；(3) urine pregnancy test is positive；(4) conventional gynecological inspection: cervical orifice is not opened, body of uterus is soft, and uterus size meets early pregnancy week number；(5) Gynaecological B ultrasound inspection: body of uterus size, pregnant capsule or embryo (fetus) grow and be consistent with pregnant all numbers, and fetal rhythm reaction is normal；(6) anticardiolipin antibody (ACA) is positive.

1.2.2 TCM syndrome diagnostic criteria: be blood-heat syndrome of suffering from a deficiency of the kidney according to the standard of vaginal bleeding during pregnancy and " new Chinese medicine guideline of clinical investigations " Syndrome Diagnostic in Zhang Yuzhen chief editor " Gynecology of Chinese Medicine ": primary symptom: during gestation, pregnant repeatly falls repeatly, even fall as scheduled, vagina is irregular on a small quantity bleeds, and color depth is red or scarlet, and matter is thick, secondary disease: dizziness and tinnitus, soreness of waist and knee, vexed sleep less, thirsty drink is cold, yellow urine is just tied, and flushing lip is red, red tongue, yellow fur, slippery and rapid pulse.

1.3 inclusive criterias: meet the diagnosis of above-mentioned recurrent abortion Chinese and western medicine and tcm syndrome standard；20～40 years old age；Gestational period 4～12 weeks；Have neither part nor lot in similar curative effect Drug therapy in the recent period；Compliance is good, signs Informed Consent Form.

1.4 exclusion standards: do not meet above-mentioned Chinese and western medicine diagnostic criteria person；There are disease of hematopoietic system or serious hepatic and kidney function obstacle or general malignant tumor person；Age < 20 years old or > 40 years old；Thoughts emit medicine or other have teratogenecity drug administration history or radioactive substance contact history person before pregnant or during early pregnancy；Spiritedness disease patient, compliance is poor, drop by the wayside, be unfavorable for follower；For allergic constitution or the similar effect medicine person of recent use.

1.5 Therapeutic Method

Primary Care: two groups of patients all advise absolute bed rest, forbids that sexual life and various ass work be dynamic or work, keeps happy, two groups all give chorionic-gonadotropin hormone (HCG) 3000～5000U intramuscular injection simultaneously, the next day of per 1 time.

Treatment group: on Primary Care basis, the capsule of the oral embodiment of the present invention 1 preparation, every day 2 times, each 2-4 grain, take half an hour after meal.

Matched group: on Primary Care basis, matched group oral aspirin, 75mg/d, intramuscular injection human normal immunoglobulin, every 4 weeks 1 time, each 300mg.

It is 1 course for the treatment of that two groups of patients treat 20 days all continuously, within 20 days, checks ACA1 time；Said medicine extremely drug withdrawal in pregnant 90 days.

1.6 observation index:

1.6.1 two groups of patient ACA turn out cloudy situation；

1.6.2 two groups of tcm symptoms scoring improvement situation (by degree without, light, in, heavily classification, its corresponding score value respectively 0,1,2,3 points).

1.7 efficacy assessment standards: after treatment, vaginal hemorrhage stops, gestation is to term labor (Pregnancy Success), and ACA normal (continuous more than 2 times) is recovery from illness therebetween；After taking medicine vaginal hemorrhage stop, gestation reaches more than 28 weeks, therebetween ACA turn sun after through treatment turn out cloudy, after turn again sun, super display in utero live tire be effective；After taking medicine, vaginal hemorrhage stops, and gestation reaches more than 20 weeks, and ACA turns yang channel treatment and do not turn out cloudy therebetween, and B ultrasonic show that in utero tire alive is effective；Vaginal hemorrhage is more than or measures increase, and pregnant less than 18 weeks, ACA turned yang channel and fails to respond to any medical treatment, and B ultrasonic display FDIU is invalid.

1.8 statistical methods: adopt SPSS15.0 statistical software to be calculated.Each numerical value withRepresenting, measurement data adopts t inspection, and enumeration data adopts χ²Inspection, statistically significant for difference with P < 0.05.

2 results

The comparison of 2.1 liang of group Comprehensive Clinical curative effects: treatment group cures 12 examples, effective 16 examples, effective 10 examples, invalid 4 examples, matched group group cures 7 examples, effective 12 examples, effective 13 examples, invalid 10 examples, treatment group and matched group obvious effective rate and total effective rate respectively 66.67%, 90.48% and 45.32%, 76.19%, two groups of obvious effective rates, total effective rate comparing differences statistically significant (P < 0.05), the curative effect for the treatment of group is substantially better than matched group.In Table 1.

The comparison of 1 liang of table group Comprehensive Clinical curative effect

Note: compare with matched group, * P < 0.05.

2.2 liang of group ACA changes: treatment group the 1st is turned out cloudy 11 examples the course for the treatment of, 21 examples of turning out cloudy for the 2nd course for the treatment of, 10 examples of turning out cloudy for the 3rd course for the treatment of；Matched group respectively 5 examples, 26 examples, 11 examples.Two groups of comparing difference not statistically significants (P > 0.05).In Table 2.

Serum ACA change before and after the group treatment of 2 liang of table

Note: compare the same period with matched group, * P < 0.05.

Before and after 2.3 liang of group treatments, TCM symptom score compares: after the treatment for the treatment of group, TCM symptom score is all substantially more less than before treatment, with comparing difference statistically significant (P < 0.01) before treatment, matched group compares with before treatment, no significant difference (P > 0.05)；Comparing between two groups after treatment, treatment group is better than matched group in improving tcm symptom, and the minimizing for the treatment of group symptom integral becomes apparent from, difference statistically significant (P < 0.01).In Table 3.

3 liang of table group treatment before and after TCM symptom score compare (Point)

Note: compare with before treatment, * P < 0.01, compare the same period with matched group,^#P < 0.01.

2.4 safety conditions: routine blood test, routine urinalysis, electrocardiogram change without exception before and after treatment group patient treatment, in therapeutic process, vital sign is steadily and without the untoward reaction such as nausea and vomiting, allergy, illustrates that our clinical application is safe and reliable.

Medicine of the present invention has the effect regulating immunologic function in a word, it is likely to make ACA turn out cloudy by immunomodulating, fetus continues to grow, and blood viscosity also can be made substantially to reduce simultaneously, increases circular flow, energy antiplatelet aggregation and thrombosis, improve Placenta Hominis microcirculation, improve patient's TCM syndrome, and evident in efficacy, have no side effect, overcome the unfavorable factor that simple western medicine is treated.

Claims (10)

1. the pharmaceutical composition treating recurrent abortion, it is characterised in that by Fructus Lycii, Semen Cuscutae, Fructus Broussonetiae, Radix Rehmanniae, Cortex Moutan, Herba Violae japonicae, fruit, the Cortex Eucommiae, Semen Plantaginis, Fructus Alpiniae Oxyphyllae, the Rhizoma Atractylodis Macrocephalae be that medicinal raw material is made.

2. pharmaceutical composition as claimed in claim 1, it is characterised in that the medicinal raw material of following weight is made: Fructus Lycii 20-26 part, Semen Cuscutae 10-15 part, Fructus Broussonetiae 7-12 part, Radix Rehmanniae 10-15 part, Cortex Moutan 7-12 part, Herba Violae japonicae 8-13 part, fruit 10-15 part, Cortex Eucommiae 5-8 part, Semen Plantaginis 7-12 part, Fructus Alpiniae Oxyphyllae 2-5 part, Rhizoma Atractylodis Macrocephalae 7-12 part.

3. pharmaceutical composition as claimed in claim 2, it is characterised in that the medicinal raw material of following weight is made: Fructus Lycii 25 parts, Semen Cuscutae 12 parts, Fructus Broussonetiae 10 parts, Radix Rehmanniae 10 parts, Cortex Moutan 8 parts, Herba Violae japonicae 12 parts, fruit 15 parts, the Cortex Eucommiae 6 parts, Semen Plantaginis 9 parts, Fructus Alpiniae Oxyphyllae 4 parts, the Rhizoma Atractylodis Macrocephalae 10 parts.

4. the pharmaceutical composition as described in as arbitrary in claim 1-3, it is characterised in that preparation method comprises the steps:

Take Cortex Moutan, Herba Violae japonicae, Semen Plantaginis 70% alcohol reflux by prescription, collect alcohol reflux liquid and filtering residue；Fructus Lycii, Semen Cuscutae, Fructus Broussonetiae, Radix Rehmanniae, fruit, the Cortex Eucommiae, Fructus Alpiniae Oxyphyllae, the Rhizoma Atractylodis Macrocephalae together with Cortex Moutan, Herba Violae japonicae, Semen Plantaginis filtering residue, the soak by water of 4-10 times of weight portion of addition 2 times, each 1.0-2.0 hour, merges decoction liquor, adding ethanol to concentration is 40%, placing 8-12 hour, filter to obtain alcohol deposit fluid, alcohol deposit fluid merges with alcohol reflux liquid, decompression recycling ethanol, being concentrated into extractum, extract dry is ground into fine powder, makes clinical receptible dosage form by conventional formulation method.

5. pharmaceutical composition as claimed in claim 4, it is characterised in that described pharmaceutical composition is preferably made as peroral dosage form.

6. pharmaceutical composition as claimed in claim 5, it is characterised in that described peroral dosage form is preferably one or more in tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, granule, honey pill agent, powder, sublimed preparation, solution.

7. pharmaceutical composition as claimed in claim 6, it is characterised in that described peroral dosage form is preferably tablet, capsule or granule.

8. pharmaceutical composition as claimed in claim 7, it is characterised in that described peroral dosage form is preferably capsule.

9. claim 1-3 arbitrary described pharmaceutical composition purposes in the medicine of preparation treatment recurrent abortion.

10. the arbitrary described pharmaceutical composition of claim 1-3 causes the purposes in the medicine of recurrent abortion in the preparation treatment anticardiolipin antibody positive.