CN105770291A - Medicine composition for treating recurrent abortion due to positive anticardiolipin antibodies - Google Patents
Medicine composition for treating recurrent abortion due to positive anticardiolipin antibodies Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
The invention belongs to the technical field of traditional Chinese medicines, and relates to a medicine composition for treating recurrent abortion due to positive anticardiolipin antibodies and a method for preparing the medicine composition. The medicine composition comprises semen cuscutae, herba epimedii, radix rehmanniae preparata, caragana rosea, herba cistanches, roots of polyalthia nemoralis, cortex eucommiae, cyperus michelianus, herba leonuri and clematis chrysocoma. The medicine composition and the method have the advantages that all components of the medicine composition are compatible with one another, accordingly, effects of nourishing kidneys, enriching qi and promoting blood circulation to remove blood stasis can be realized, congenital and postnatal attributes can be jointly nourished, yin and yang in the kidneys can be regulated and invigorated again to be in balance, and definite curative effects of reducing or eliminating the serum anticardiolipin antibodies can be realized; symptoms of kidney deficiency and blood stasis of patients who suffer from excessive maternal-fetal immune recognition type recurrent spontaneous abortion can be treated, the obvious curative effects can be realized, and the medicine composition is free of side effects.
Description
Technical field
The invention belongs to technical field of Chinese medicine, relate to a kind for the treatment of anticardiolipin antibody positive pharmaceutical composition causing 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 primary disease cause of disease and pathogenesis are considerably complicated, and immune factor is also one of major reason.Phospholipid is prevalent in human body, is the neccessary composition of Placenta Hominis and fine hair.Anti-phospholipid antibody (antiphospholipidantibodies, APA) is the antibody that can react with the multiple antigenic substance containing structure of phospholipid, and it mainly includes anticardiolipin antibody (anticardiolipinantibody, ACA).
Anticardiolipin antibody is that a class is closely related but affinity different, a hypotype of anti-electronegative phospholipid (such as cuorin, Phosphatidylserine, phosphatidylinositols) antibody, is a kind of autoantibody using cuorin electronegative in platelet and endothelial cell membrane as target antigen.ACA lasting masculin is the principal character of anticardiolipin syndrome, this autoimmune disease main manifestations is multiple thrombosis, sending out well with middle thin vessels, department of obstetrics and gynecology often result in threatened abortion, spontaneous abortion, habitual abortion, stillborn fetus, premature labor, fetal intrauterine growth retardation etc. clinically.The positive harmful effect to gestation of visible ACA through whole trimester of pregnancy, very harmful to pregnant and lying-in women and fetus.
At present, two aspects are generally divided to the treatment of ACA positive pregnant women, it is on the one hand for the purpose of suppressing and removing, adopt adrenocortical hormone or a large amount of immunoglobulin (such as β-glycoprotein), or employing therapeutic plasma exchange, but the untoward reaction such as blood glucose rising, osteoporosis, infection can be produced；Being the anticoagulation therapy for the purpose of antithrombotic on the other hand, frequently with heparin or aspirin, but after life-time service can produce bleeding tendency, thrombocytopenia, anaphylaxis and fetal birth, intracranial hemorrhage is likely to.So, the treatment to the miscarriage that the ACA positive causes, current doctor trained in Western medicine still lacks safely and effectively method.
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..Chinese medicine thinks that the kidney being the origin of congenital constitution, kidney storing essence, main reproduction, says in " Records of Tradition Chinese and Western Medicine in Combination ": " it is strong that men and women's fertility all relies kidney qi to make, the prosperous self energy stoppage of growth of the fetus of kidney, and it is solid that kidney qi contains then feotus vitality, from the worry without vaginal bleeding during pregnancy, frequent fetal movement." illustrating that kidney qi is healthy and vigorous, then tire has direct bearing, from the worry without induced abortion.And woman is with blood for this, if asthenia of renal qi, the deficiency of vital energy is so that blood stasis, stasis blocking collaterals of the uterus so that collaterals of the uterus loses supports, and being difficult is tire, habitual abortion will occurs.Therefore many doctors thinks that the recurrent abortion caused by the ACA positive surely belongs to kidney deficiency blood stasis type by Chinese medical discrimination.And the spleen being the foundation of acquired constitution, source of generating QI and blood, if insufficiency of the spleen, it is difficult transporting QI and blood, being that tire is unable also can cause habitual abortion；If blood system has heat, thermal burn punching is appointed, and damage feotus vitality also results in the generation of habitual abortion.So the generation of primary disease also with insufficiency of the spleen, heat in blood, blood stasis etc. because have substantial connection.Chinese medicine has the adjustment mass action of multisystem, too many levels, can significantly transfer allomeric function, and safely and effectively, untoward reaction is few, therefore, utilizes this disease of Chinese medicine gradually to be praised highly by people.
Summary of the invention
Inventor is good at combining modern medical theory with traditional medical theory, dialectical combine with differential diagnosis of diseases, thinking that the anticardiolipin antibody positive causes the basic pathogenesis of recurrent spontaneous abortion is blood stasis due to renal deficiency, and woman is with blood for this, if asthenia of renal qi, the deficiency of vital energy is so that blood stasis, stasis blocking collaterals of the uterus so that collaterals of the uterus loses supports, and being difficult is tire, habitual abortion will occur, provide a kind of anticardiolipin antibody positive for the treatment of based on this and cause the pharmaceutical composition of recurrent abortion.
The technical solution used in the present invention is as follows:
A kind of anticardiolipin antibody positive for the treatment of causes the pharmaceutical composition of recurrent abortion, it is characterised in that be that medicinal raw material is made by Semen Cuscutae, Herba Epimedii, Radix Rehmanniae Preparata, Radix Caraganae Roseae, Herba Cistanches, Polyalthia nemoralis A. D C., the Cortex Eucommiae, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani), Herba Leonuri, Herba Clematidis loureirianae.
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 anticardiolipin antibody positive for the treatment of causes the pharmaceutical composition of recurrent abortion, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 18-24 part, Herba Epimedii 7-12 part, Radix Rehmanniae Preparata 14-20 part, Radix Caraganae Roseae 12-17 part, Herba Cistanches 5-8 part, Polyalthia nemoralis A. D C. 10-15 part, Cortex Eucommiae 4-7 part, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 10-15 part, Herba Leonuri 7-12 part, Herba Clematidis loureirianae 10-15 part.
Further preferably, a kind of anticardiolipin antibody positive for the treatment of causes the pharmaceutical composition of recurrent abortion, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 20 parts, Herba Epimedii 8 parts, Radix Rehmanniae Preparata 15 parts, Radix Caraganae Roseae 15 parts, Herba Cistanches 7 parts, Polyalthia nemoralis A. D C. 15 parts, the Cortex Eucommiae 6 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 12 parts, Herba Leonuri 10 parts, Herba Clematidis loureirianae 10 parts.
Fang Zhong: the sweet temperature of Semen Cuscutae can warming and recuperating the spleen and kidney, invigorating kidney qi；Herba Epimedii Xin Ganwen, pungent can eliminating stagnation, in Gan Nenghuan, temperature can be ventilated promoting the circulation of blood, can benefit vital essence, insufficiency of kidney-YANG, two medicine 5 use, the kidney invigorating gas helps kidney yang, and kidney qi is contained then punching and appointed and adjust, and the stasis of blood is stagnant dispels.Radix Rehmanniae Preparata nourishing YIN and supplementing blood, benefit essence fills out marrow；Herba Cistanches kidney-replenishing, nourishing kidney gas, benefiting essence-blood；Cortex Eucommiae energy invigorating middle warmer benefit vital essence, hard rigidity of soft tissues bone, the solid feotus vitality of temperature, three medicine 5 use, nourishing YIN and supplementing blood, life essence-filling, marrow-benefitting, treating YANG within YIN, nourishing YIN in sun, for ministerial drug.With monarch drug 5 use, nourish kidney yin kidney yang, Chong and Ren Meridians regulating, only under the self-restraint of kidney, the normal immunoloregulation function of immune system competence exertion.Radix Caraganae Roseae tonifying speen and tonifying kidney, diuresis of stimulating the menstrual flow；Polyalthia nemoralis A. D C. invigorating spleen and reinforcing stomach, tonifying the kidney to consolidate the essence；Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) circulation of qi promoting is nourished blood；Herba Leonuri promoting the circulation of blood is nourished blood, promoting blood flow to regulate menstruation, promoting the circulation of blood and do not hinder fresh blood, nourish blood and the not stagnant stasis of blood；Herba Clematidis loureirianae clearing away heat and promoting diuresis；Promoting blood circulation to restore menstrual flow；Expelling wind and removing dampness, for adjuvant.Full side closes 5, tonifies Qi of the kidney, the effect of blood circulation promoting and blood stasis dispelling, and the first day after tomorrow supports altogether, and negative and positive in readjustment the kidney invigorating, so as to balance, cultivate the source bred, and regulate healthy energy, improve body's immunity, prepare for becoming pregnant.
The raw materials used involved pharmacological property present Research of the present invention is as follows:
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.
Herba Epimedii: [nature and flavor] acrid, sweet, warm.[return through] returns liver, kidney channel.[function cures mainly] kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.For impotence and seminal emission, muscles and bones flaccidity is soft, rheumatic arthralgia, numbness contracture；Climacteric hypertension.[usage and dosage] 3～9g.
Radix Rehmanniae Preparata: [nature and flavor] are sweet, tepor.[return through] returns liver, kidney channel.[function cures mainly] nourishing YIN and supplementing blood, benefit essence fills out marrow.For the hepatic and renal YIN deficiency, soreness of the waist and knees, osteopyrexia and fever, night sweat is passed out semen, and interior-heat is quenched one's thirst, blood deficiency and yellow complexion, severe palpitation, menoxenia, metrostaxis, dizziness, tinnitus, early whitening of beard and hair.[usage and dosage] 9～15g.
Radix Caraganae Roseae: [nature and flavor] are sweet；Micro-pungent；Flat.[return through] liver；Spleen channel.[function cures mainly] spleen invigorating, kidney tonifying, stimulate the menstrual flow, diuresis.Main deficient consumptive fever, cough, stranguria with turbid discharge, sexual impotence, metrorrhagia, leucorrhea, breast is few, and uterine prolapse [usage and dosage] is taken orally: decoct soup, 6-24g.
Herba Cistanches: [nature and flavor] are sweet, salty, temperature.[return through] returns kidney, large intestine channel.[function cures mainly] kidney-replenishing, benefiting essence-blood, loosening bowel to relieve constipation.For sexual impotence, infertile, soreness of the waist and knees, muscles and bones is unable, dryness of the intestine constipation.[usage and dosage] 6～9g.
Polyalthia nemoralis A. D C.: [nature and flavor] are sweet is flat.[function cures mainly] invigorating spleen and reinforcing stomach, tonifying the kidney to consolidate the essence.Controlling chronic gastritis, taste lose, inappetence, myasthenia of limbs, seminal emission.[usage and dosage] takes orally: decoct soup, 0.5～1 liang.
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.
Cyperus michelianus(L.) Link (Herba Cyperi Micheliani): [nature and flavor] acrid in the mouth；Light；Property is put down.[return through] liver；Spleen channel.[function cures mainly] circulation of qi promoting is nourished blood；Regulating menstruation.Main menoxenia；Dysmenorrhea.[usage and dosage] takes orally: decoct soup, 9-15g；Or grind into powder.
Herba Leonuri: [nature and flavor] are bitter, pungent, are slightly cold.[return through] returns liver, pericardium channel.[function cures mainly] promoting blood flow to regulate menstruation, inducing diuresis to remove edema.For menoxenia, dysmenorrhea, amenorrhea, lochiorrhea, edema oliguria；Acute nephritis edema.[usage and dosage] 9～30g；Fresh goods 12～40g.
Herba Clematidis loureirianae: [nature and flavor] sweet in the mouth；Light；Property is put down.[return through] returns liver；Kidney；Bladder warp.[function cures mainly] clearing away heat and promoting diuresis；Promoting blood circulation to restore menstrual flow；Expelling wind and removing dampness.Main dysuria；Edema；Damp-heat gonorrhoea；Rheumatic arthralgia；Traumatic injury；Inflammation on wind-fire；Eye red pain；Amenorrhea；Mange.[usage and dosage] takes orally: decoct soup, 10-15g；Or infusing drugs in wine.External: appropriate, decocts washing；Or fresh goods mashes deposited.
Pharmaceutical composition of the present invention can add one or more pharmaceutically acceptable carriers, is applied to the patient needing this treatment in the way of oral administration.During for being administered orally, the solid preparation of routine can be made into, such as tablet, capsule, soft capsule, dispersible tablet, oral liquid, granule, chewable tablet, oral cavity disintegration tablet, drop pill, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule, make liquid preparation such as water or oil-suspending agent or other liquid preparation such as syrup etc..
Pharmaceutical composition of the present invention can adopt the conventional method in existing pharmaceutical field to produce, and adds various pharmaceutically acceptable carrier.Described carrier includes the conventional excipient of pharmaceutical field, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier, lubricant etc..
Pharmaceutical composition of the present invention is when making oral formulations, and selectable filler has: starch, Icing Sugar, calcium phosphate, calcium sulfate two water thing, dextrin, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol etc.；Selectable binding agent has: sodium carboxymethyl cellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methylcellulose, ethyl cellulose, hypromellose, gelling starch etc.；Selectable disintegrating agent has: dried starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.；Selectable lubricant has；Magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel etc..
Preferably, the preparation of pharmaceutical composition described above is preferably tablet, capsule or granule, it is most preferred that for capsule.
The preparation method that it is a further object of the present invention to provide a kind of pharmaceutical composition described above.
The preparation method of pharmaceutical composition provided by the invention comprises the steps of and takes the Polyalthia nemoralis A. D C. of recipe quantity, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) adds ethanol extraction secondary, each 1-2 hour, united extraction liquid, filtering, filtrate recycling ethanol, concentrating under reduced pressure becomes thick paste, dry, pulverizing, it is thus achieved that dried cream powder, standby；Take the Semen Cuscutae of recipe quantity, Herba Epimedii, Radix Rehmanniae Preparata, Radix Caraganae Roseae, Herba Cistanches, the Cortex Eucommiae, Herba Leonuri, Herba Clematidis loureirianae, boiling twice, first time amount of water is 5-8 times of the got it filled material total amount of this step, decoct 2-3 hour, 3-4 times that second time amount of water is the got it filled material total amount of this step decocts 1-2 hour, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 45%, place 12 hours, filter, filtrate recycling ethanol, continue concentrating under reduced pressure and become thick paste, dry, obtain dried cream powder, merge, add one or more pharmaceutically acceptable carriers, adopt the conventional method in existing pharmaceutical field to produce and prepare conventional Chinese medicine pharmaceutical dosage form clinically.
The present invention is also claimed aforementioned pharmaceutical compositions and causes the purposes in the medicine of recurrent abortion in the preparation treatment anticardiolipin antibody positive, and causes recurrent abortion differential diagnosis in tcm in the preparation treatment anticardiolipin antibody positive and belong to the purposes in the medicine of blood stasis due to renal deficiency disease.Known by the known clinical trial of embodiment 9, medicine of the present invention has definite curative effect to reducing or eliminating ACA in Serum, after 1st course of therapy terminates, treatment group, matched group patient ACA turn out cloudy respectively 23,10 example, ACA negative conversion rate respectively 47.92%, 20.83%, treatment group ACA negative conversion rate apparently higher than matched group, difference statistically significant (P < 0.05)；After 2nd course of therapy terminates, treatment group, matched group patient ACA turn out cloudy respectively 47,26 example, ACA negative conversion rate respectively 97.92%, 54.17%, treatment group ACA negative conversion rate apparently higher than matched group, difference statistically significant (P < 0.05).Simultaneously, Maternal-fetal immunity identification can be improved and cross the symptom of degree type recurrent spontaneous abortion blood stasis due to renal deficiency, after 2 courses for the treatment of, 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).
The present invention relatively and prior art, has following clear superiority:
Selected by invention medicine, medical material compatibility is suitable, refining formula, meets Chinese medicine and pharmacy and modern medicine theory, and comprehensively, medication is thoughtful in legislation, plays special effect, has and tonify Qi of the kidney, the effect of blood circulation promoting and blood stasis dispelling；The first day after tomorrow supports altogether, and negative and positive in readjustment the kidney invigorating, so as to balance, cultivate the source bred, and regulate healthy energy, improve body's immunity, prepare for becoming pregnant, can significantly improve the anticardiolipin antibody positive and cause the symptom of patients with recurrent spontaneous abortion.
Chinese medicine Chinese medicine preparation of the present invention has Mutiple Targets, too many levels, multi-level comprehensive regulation effect, and side effect is less, and patient compliance is better, and taking convenience can alleviate patient's burden and misery, wide popularization and application on clinic effectively.
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: Semen Cuscutae 20 parts, Herba Epimedii 8 parts, Radix Rehmanniae Preparata 15 parts, Radix Caraganae Roseae 15 parts, Herba Cistanches 7 parts, Polyalthia nemoralis A. D C. 15 parts, the Cortex Eucommiae 6 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 12 parts, Herba Leonuri 10 parts, Herba Clematidis loureirianae 10 parts.
Preparation method: take the Polyalthia nemoralis A. D C. of recipe quantity, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) adds ethanol extraction secondary, each 1-2 hour, united extraction liquid, filters, filtrate recycling ethanol, and concentrating under reduced pressure becomes thick paste, dry, pulverizing, it is thus achieved that dried cream powder, standby.Take the Semen Cuscutae of recipe quantity, Herba Epimedii, Radix Rehmanniae Preparata, Radix Caraganae Roseae, Herba Cistanches, the Cortex Eucommiae, Herba Leonuri, Herba Clematidis loureirianae, boiling twice, first time amount of water is 5-8 times of the got it filled material total amount of this step, decoct 2-3 hour, 3-4 times that second time amount of water is the got it filled material total amount of this step decocts 1-2 hour, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 45%, place 12 hours, filter, filtrate recycling ethanol, continue concentrating under reduced pressure and become thick paste, dry, obtain dried cream powder, merge, adopt the conventional method in existing pharmaceutical field to produce to prepare.The present embodiment capsule every contains crude drug 0.9g.
Embodiment 2 capsule
Prescription: Semen Cuscutae 20 parts, Herba Epimedii 10 parts, Radix Rehmanniae Preparata 18 parts, Radix Caraganae Roseae 12 parts, Herba Cistanches 5 parts, Polyalthia nemoralis A. D C. 10 parts, the Cortex Eucommiae 7 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 15 parts, Herba Leonuri 8 parts, Herba Clematidis loureirianae 12 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 3 capsule
Prescription: Semen Cuscutae 18 parts, Herba Epimedii 10 parts, Radix Rehmanniae Preparata 15 parts, Radix Caraganae Roseae 15 parts, Herba Cistanches 8 parts, Polyalthia nemoralis A. D C. 10 parts, the Cortex Eucommiae 5 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 10 parts, Herba Leonuri 7 parts, Herba Clematidis loureirianae 12 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 4 capsule
Prescription: Semen Cuscutae 24 parts, Herba Epimedii 10 parts, Radix Rehmanniae Preparata 20 parts, Radix Caraganae Roseae 12 parts, Herba Cistanches 8 parts, Polyalthia nemoralis A. D C. 12 parts, the Cortex Eucommiae 5 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 15 parts, Herba Leonuri 12 parts, Herba Clematidis loureirianae 12 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 5 capsule
Prescription: Semen Cuscutae 20 parts, Herba Epimedii 8 parts, Radix Rehmanniae Preparata 20 parts, Radix Caraganae Roseae 17 parts, Herba Cistanches 6 parts, Polyalthia nemoralis A. D C. 10 parts, the Cortex Eucommiae 7 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 15 parts, Herba Leonuri 10 parts, Herba Clematidis loureirianae 15 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 6 capsule
Prescription: Semen Cuscutae 22 parts, Herba Epimedii 9 parts, Radix Rehmanniae Preparata 18 parts, Radix Caraganae Roseae 16 parts, Herba Cistanches 8 parts, Polyalthia nemoralis A. D C. 12 parts, the Cortex Eucommiae 6 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 12 parts, Herba Leonuri 12 parts, Herba Clematidis loureirianae 10 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 7 tablet
Prescription: Semen Cuscutae 20 parts, Herba Epimedii 10 parts, Radix Rehmanniae Preparata 15 parts, Radix Caraganae Roseae 12 parts, Herba Cistanches 6 parts, Polyalthia nemoralis A. D C. 12 parts, the Cortex Eucommiae 6 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 12 parts, Herba Leonuri 10 parts, Herba Clematidis loureirianae 10 parts.
Preparation method: take the Polyalthia nemoralis A. D C. of recipe quantity, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) adds ethanol extraction secondary, each 1-2 hour, united extraction liquid, filters, filtrate recycling ethanol, and concentrating under reduced pressure becomes thick paste, dry, pulverizing, it is thus achieved that dried cream powder, standby.Take the Semen Cuscutae of recipe quantity, Herba Epimedii, Radix Rehmanniae Preparata, Radix Caraganae Roseae, Herba Cistanches, the Cortex Eucommiae, Herba Leonuri, Herba Clematidis loureirianae, boiling twice, first time amount of water is 5-8 times of the got it filled material total amount of this step, decoct 2-3 hour, 3-4 times that second time amount of water is the got it filled material total amount of this step decocts 1-2 hour, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 45%, place 12 hours, filter, filtrate recycling ethanol, continue concentrating under reduced pressure and become thick paste, dry, obtain dried cream powder, merge, adopt the conventional method in existing pharmaceutical field to produce to prepare.Every, the present embodiment tablet contains crude drug 0.6g.
Embodiment 8 granule
Prescription: Semen Cuscutae 20 parts, Herba Epimedii 8 parts, Radix Rehmanniae Preparata 15 parts, Radix Caraganae Roseae 15 parts, Herba Cistanches 7 parts, Polyalthia nemoralis A. D C. 15 parts, the Cortex Eucommiae 6 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 12 parts, Herba Leonuri 10 parts, Herba Clematidis loureirianae 10 parts.
Preparation method: take the Polyalthia nemoralis A. D C. of recipe quantity, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) adds ethanol extraction secondary, each 1-2 hour, united extraction liquid, filters, filtrate recycling ethanol, and concentrating under reduced pressure becomes thick paste, dry, pulverizing, it is thus achieved that dried cream powder, standby.Take the Semen Cuscutae of recipe quantity, Herba Epimedii, Radix Rehmanniae Preparata, Radix Caraganae Roseae, Herba Cistanches, the Cortex Eucommiae, Herba Leonuri, Herba Clematidis loureirianae, boiling twice, first time amount of water is 5-8 times of the got it filled material total amount of this step, decoct 2-3 hour, 3-4 times that second time amount of water is the got it filled material total amount of this step decocts 1-2 hour, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 45%, place 12 hours, filter, filtrate recycling ethanol, continue concentrating under reduced pressure and become thick paste, dry, obtain dried cream powder, merge, adopt the conventional method in existing pharmaceutical field to produce to prepare.The present embodiment capsule every contains crude drug 2.5g.
The anticardiolipin antibody positive is caused the observation of curative effect test of recurrent abortion by embodiment 9 medicine of the present invention
1 data and method
1.1 physical data: include institute of traditional Chinese medicine of Jinan City in August, 2013 in December ,-2014 diagnosis and treatment 96 example anticardiolipin antibody positive altogether in and cause patients with recurrent spontaneous abortion as object of study, employing is random is divided into treatment group and matched group by digits table with 1:1, wherein treatment group 48 example, 24～35 years old age, year mean age (28.8 ± 3.5)；Abortion times 2～6 times, average (2.8 ± 1.2) are secondary；Matched group 48 example, 23～36 years old age, year mean age (29.3 ± 3.8)；Abortion times 2～6 times, average (2.4 ± 0.9) are secondary, and two groups of patient ages, abortion times compare, no significant difference (P > 0.05), have comparability.
1.2 diagnostic criterias:
1.2.1 the diagnostic criteria of recurrent abortion: with reference to " Gynecology of Chinese Medicine " (Zhang Yuzhen) relevant criterion: suffer fetal loss person before the gestation 28 weeks of 2 times or more than 2 times with homogeneity companion continuously；2. anticardiolipin antibody (ACA) is positive.
1.2.2 TCM Syndrome Type standard: draft " blood stasis due to renal deficiency " pattern of syndrome standard with reference to " new Chinese medicine guideline of clinical investigations ", " Gynecology of Chinese Medicine " (Zhang Yuzhen) and " disease of tcm Standardization of diagnosis and curative effect ", repeatly pregnant fall repeatly or should the phase and fall, soreness of the waist and knees, dizziness and tinnitus, spiritlessness and weakness, dim complexion, menstruation or before or after, more or less mensis in amount, light coloured menses matter is rare accompanies clot, body of the tongue is dull, white and thin fur, thready and hesitant pulse.
1.3 include in, exclusion standard:
1.3.1 inclusive criteria: meet above-mentioned diagnostic criteria；The women of child-bearing age at 20～40 years old age；Couple's chromosome examination is normal；Bridegroom's or husband's side semen efamination is normal；Signature Informed Consent Form also can adhere to therapist according to plan.
1.3.2 exclusion standard: genitals organic disease except gynecologial examination, Visual quality；Reproductive Endocrine Hormones measures gets rid of endocrine factors；Salpingography gets rid of obstruction of fallopian tube person；Genital system infection is got rid of in cervical secretions detection；Except merge severe cardiac, cerebrovascular, primary disease and the psychotic such as liver, kidney and hemopoietic system；Except not by regulation medication, compliance is poor, it is impossible to judge that curative effect or data entirely affect the treatment person.
1.4 Therapeutic Method
Treatment group: the capsule of the oral embodiment of the present invention 1 preparation, every day 2 times, each 2-4 grain, takes after meal half an hour；Matched group: Aspirin, 50mg, 1 time every night.
Above 2 groups of equal drug withdrawals in menstrual period, period strict application condom contraception of taking medicine, 2 months is 1 course for the treatment of, 2 courses for the treatment of of Continuous Observation.All detect ACA antibody after terminating each course for the treatment of, and 2 groups of testing results are compareed.
1.5 observation index:
1.5.1 the curative effect of turning out cloudy of ACA after two groups of patient treatments；
1.5.2 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).
1.6 efficacy assessment standards are evaluated with reference to " new Chinese medicine guideline of clinical investigations ".Recovery from illness: detection blood ACA is negative, and subjective symptoms disappears；Invalid: blood test ACA is positive.
1.7 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
Serum ACA change before and after 2.1 liang of group treatments: after the 1st course of therapy terminates, treatment group, matched group patient ACA turn out cloudy respectively 23,10 example, ACA negative conversion rate respectively 47.92%, 20.83%, treatment group ACA negative conversion rate apparently higher than matched group, difference statistically significant (P < 0.05)；After 2nd course of therapy terminates, treatment group, matched group patient ACA turn out cloudy respectively 47,26 example, ACA negative conversion rate respectively 97.92%, 54.17%, treatment group ACA negative conversion rate apparently higher than matched group, difference statistically significant (P < 0.05).In Table 1.
Serum ACA change before and after the group treatment of 1 liang of table
Note: compare the same period with matched group, * P < 0.05.
Before and after 2.2 liang of group treatments, TCM symptom score compares: after 2 courses for the treatment of, 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 2.
2 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.
2.3 safety conditions: after treating 2 courses for the treatment of, 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 definite curative effect to reducing or eliminating ACA in Serum.Simultaneously, Maternal-fetal immunity identification can be improved and cross the symptom of degree type recurrent spontaneous abortion blood stasis due to renal deficiency, and evident in efficacy, have no side effect, the curative effect of mechanism and raising Chinese medicine immunity recurrent spontaneous abortion for studying Chinese medicine immunity recurrent spontaneous abortion have found new breakthrough point.
Claims (10)
1. treat the anticardiolipin antibody positive and cause the pharmaceutical composition of recurrent abortion for one kind, it is characterised in that be that medicinal raw material is made by Semen Cuscutae, Herba Epimedii, Radix Rehmanniae Preparata, Radix Caraganae Roseae, Herba Cistanches, Polyalthia nemoralis A. D C., the Cortex Eucommiae, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani), Herba Leonuri, Herba Clematidis loureirianae.
2. pharmaceutical composition as claimed in claim 1, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 18-24 part, Herba Epimedii 7-12 part, Radix Rehmanniae Preparata 14-20 part, Radix Caraganae Roseae 12-17 part, Herba Cistanches 5-8 part, Polyalthia nemoralis A. D C. 10-15 part, Cortex Eucommiae 4-7 part, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 10-15 part, Herba Leonuri 7-12 part, Herba Clematidis loureirianae 10-15 part.
3. pharmaceutical composition as claimed in claim 2, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 20 parts, Herba Epimedii 8 parts, Radix Rehmanniae Preparata 15 parts, Radix Caraganae Roseae 15 parts, Herba Cistanches 7 parts, Polyalthia nemoralis A. D C. 15 parts, the Cortex Eucommiae 6 parts, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) 12 parts, Herba Leonuri 10 parts, Herba Clematidis loureirianae 10 parts.
4. the pharmaceutical composition as described in as arbitrary in claim 1-3, it is characterised in that described pharmaceutical composition is peroral dosage form.
5. pharmaceutical composition as claimed in claim 4, it is characterised in that described peroral dosage form is tablet, capsule, soft capsule, dispersible tablet, oral liquid, granule, chewable tablet, oral cavity disintegration tablet, drop pill, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule, syrup etc..
6. pharmaceutical composition as claimed in claim 5, it is characterised in that described peroral dosage form is preferably tablet, capsule or granule.
7. pharmaceutical composition as claimed in claim 6, it is characterised in that described peroral dosage form is preferably capsule.
8. the pharmaceutical composition as described in as arbitrary in claim 1-3, it is characterized in that the preparation method of described pharmaceutical composition comprise the steps of take the Polyalthia nemoralis A. D C. of recipe quantity, Cyperus michelianus(L.) Link (Herba Cyperi Micheliani) adds ethanol extraction secondary, each 1-2 hour, united extraction liquid, filters, filtrate recycling ethanol, concentrating under reduced pressure becomes thick paste, dry, pulverizing, it is thus achieved that dried cream powder, standby；Take the Semen Cuscutae of recipe quantity, Herba Epimedii, Radix Rehmanniae Preparata, Radix Caraganae Roseae, Herba Cistanches, the Cortex Eucommiae, Herba Leonuri, Herba Clematidis loureirianae, boiling twice, first time amount of water is 5-8 times of the got it filled material total amount of this step, decoct 2-3 hour, 3-4 times that second time amount of water is the got it filled material total amount of this step decocts 1-2 hour, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 45%, place 12 hours, filter, filtrate recycling ethanol, continue concentrating under reduced pressure and become thick paste, dry, obtain dried cream powder, merge, add one or more pharmaceutically acceptable carriers, adopt the conventional method in existing pharmaceutical field to produce to prepare.
9. 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.
10. the arbitrary described pharmaceutical composition of claim 1-3 causes the purposes in the medicine of recurrent abortion blood stasis due to renal deficiency card in the preparation treatment anticardiolipin antibody positive.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101040963A (en) * | 2007-04-02 | 2007-09-26 | 侯雪云 | Chinese medicinal herb composition for treating habitual miscarry |
| CN101112456A (en) * | 2007-08-29 | 2008-01-30 | 北京艺信堂医药研究所 | Chinese traditional medicine preparation for treating habitual abortion |
| CN101249240A (en) * | 2008-03-18 | 2008-08-27 | 陈永哲 | Body-building anti-abortion liquid for curing habitual abortion and method of preparing the same |
| CN104274588A (en) * | 2014-09-09 | 2015-01-14 | 宋永花 | Traditional Chinese medicine for treating habitual abortion |
-
2016
- 2016-03-21 CN CN201610160911.XA patent/CN105770291A/en not_active Withdrawn
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101040963A (en) * | 2007-04-02 | 2007-09-26 | 侯雪云 | Chinese medicinal herb composition for treating habitual miscarry |
| CN101112456A (en) * | 2007-08-29 | 2008-01-30 | 北京艺信堂医药研究所 | Chinese traditional medicine preparation for treating habitual abortion |
| CN101249240A (en) * | 2008-03-18 | 2008-08-27 | 陈永哲 | Body-building anti-abortion liquid for curing habitual abortion and method of preparing the same |
| CN104274588A (en) * | 2014-09-09 | 2015-01-14 | 宋永花 | Traditional Chinese medicine for treating habitual abortion |
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