CN105748717A - Pharmaceutical composition for treating renal deficiency and blood stasis type recurrent spontaneous abortion - Google Patents
Pharmaceutical composition for treating renal deficiency and blood stasis type recurrent spontaneous abortion Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/37—Celastraceae (Staff-tree or Bittersweet family), e.g. tripterygium or spindletree
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/486—Millettia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/487—Psoralea
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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
- A61K2236/33—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 medicine, and in particular discloses a pharmaceutical composition for treating renal deficiency and blood stasis type recurrent spontaneous abortion and a preparation method thereof. The pharmaceutical composition is prepared from the raw medicinal materials including barbary wolfberry fruits, malaytea scurfpea fruits, largehead atractylodes rhizome, stems or leaves of fortune euonymus, root of ford metalleaf, root of denseflower euonymus, eucommia bark, and suberect spatholobus stem. All the raw medicinal medicines are compatible, so that the pharmaceutical composition has the effects of tonifying kidney to prevent miscarriage, reinforcing qi and nourishing blood, promoting blood circulation to remove blood stasis, and clearing and activating channels and collaterals, can ensure that the kidney qi is sufficient, the Chong and Conception Channels are solidified and stasis is removed, can improve the clinical cure rate of patients with renal deficiency and blood stasis type recurrent spontaneous abortion, is relatively small in side effect and relatively good in patient compliance, and is convenient to take.
Description
Technical field
The invention belongs to technical field of Chinese medicine, specifically disclose a kind of pharmaceutical composition treating kidney deficiency blood stasis type recurrent abortion and preparation method thereof.
Background technology
Recurrent abortion refers to occur being the spontaneous abortion of continuous 2 times or more than 2 times pregnancy complications clinically more typically, account for the 1%～5% of the women of child-bearing age with homogeneity companion.Its cause of disease is complicated, and risk of recurrence increases along with the increase of abortion times, and research also confirms that, double post-abortion, and the probability again miscarried is more than 20%；Continuous three miscarriages, the probability again miscarried is more than 30%, is one of the pertinacious disease of gynecological.
Modern medicine is thought, repulsion that recurrent abortion and inherited genetic factors, extraneous noxious substance impact, the disease of parent, immune factor cause and maternal-fetal blood group incompatibility etc. are relevant.But the definite cause of disease of its generation still suffers from a lot of dispute, but the immunity that research finds between parent and fetus is two-way, to maintaining, gestation is fairly heavy to be wanted Immune Recognition System, the generation of RSA is relevant to immune factor, and the counting for much of anti-phospholipid antibody and RSA in immune factor, wherein anticardiolipin antibody (ACA) is relevant with the RSA of significant proportion, is key factor, it can cause the situation such as Placenta Hominis blood vessel and uterine artery thrombosis, and then affects embryo and fetus growth.Doctor trained in Western medicine mainly adopts Low molecular heparin and aspirin to carry out anticoagulant therapy, but there is anaphylaxis, thrombocytopenia, the untoward reaction such as hemorrhage.
Recurrent abortion belongs to " habitual abortion " category in motherland's medical science, Chinese medicine is long-standing to the understanding of recurrent abortion, primary disease first appeared in " the 41 of General Treatise on the Cause and Symptoms of Diseases volume ", its medium cloud: " gestation number induced abortion is waited: the deficient person of vim and vigour, and son is dirty to be occupied by air-cooled; then vim and vigour are not enough; therefore not fetus nourishing, and institute, so that tire number is fallen, waits its gestation; and permanent lumbago person, and happiness induced abortion is also." think that insufficiency of vital energy and blood can cause that tire number is fallen.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.
Development along with China's Chinese medicine, on treatment recurrent abortion, it is little that people appreciate treatment by Chinese herbs recurrent abortion side effect gradually, bear painful little advantage, and organic conception is paid attention in Chinese traditional treatment, pay attention to comprehensive control, pay attention to determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, therapeutic effect demonstrates the advantage for the treatment of by Chinese herbs habitual abortion more.
Summary of the invention
It is an object of the invention to provide a kind of pharmaceutical composition treating kidney deficiency blood stasis type recurrent abortion, its advantages of perfect compatibility, hit pathogenesis, and therapeutic effect is good, cure rate is high, without any side effects.
For achieving the above object, the present invention adopts the following technical scheme that:
A kind of pharmaceutical composition treating kidney deficiency blood stasis type recurrent abortion, it is that medicinal raw material is made by Fructus Lycii, Fructus Psoraleae, the Rhizoma Atractylodis Macrocephalae, Caulis Seu Folium Euonymi Fortunei, Radix Phyllagathis fordii, Radix Euonymi myrianthi, the Cortex Eucommiae, Caulis Spatholobi.
Modern many doctors think that the easy damaging fetus unit of drug for invigorating blood circulation and eliminating stasis is so being classified as contraindications during pregnancy, in fact, under accurately dialectical premise, vaginal bleeding during pregnancy caused by blood stasis, frequent fetal movement etc. are courageously adopted to blood-activating and stasis-removing treatment, not only do not result in any damage, satisfied therapeutic effect can be received on the contrary, as Zhang Jingyue institute's cloud in Systematic Compilation of Internal Classic: " have is so with being medicine; so-called ill then sick by it; therefore anemia of pregnant woman can without dying; and nausea is also without dying also ", this just to "Nei Jing" " have therefore without dying. also without dying also " the best annotate.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 kidney deficiency blood stasis type recurrent abortion, it is made up of the medicinal raw material of following weight: Fructus Lycii 25-30 part, Fructus Psoraleae 11-16 part, Rhizoma Atractylodis Macrocephalae 7-11 part, Caulis Seu Folium Euonymi Fortunei 15-20 part, Radix Phyllagathis fordii 10-15 part, Radix Euonymi myrianthi 20-25 part, Cortex Eucommiae 8-13 part, Caulis Spatholobi 10-15 part.
Further preferably, a kind of pharmaceutical composition treating kidney deficiency blood stasis type recurrent abortion, it is made up of the medicinal raw material of following weight: Fructus Lycii 28 parts, Fructus Psoraleae 12 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Caulis Seu Folium Euonymi Fortunei 18 parts, Radix Phyllagathis fordii 12 parts, Radix Euonymi myrianthi 20 parts, the Cortex Eucommiae 10 parts, Caulis Spatholobi 12 parts.
Fang Zhong: Fructus Lycii is sweet flat, profit and nourish, can 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；Fructus Psoraleae warming and recuperating the spleen and kidney, in kidney kidney-Yang be so incensed that mend, spleen is positive must be mended, can digesting food, steam waste matter and change precise and tiny, two medicine 5 use, mend Kidney-Yin kidney-Yang, for monarch drug.Caulis Seu Folium Euonymi Fortunei is bitter sweet micro-pungent, tepor, relaxing muscles and tendons and activating QI and blood in the collateral, and stop blooding repercussive, has the effect of the strong waist of kidney tonifying concurrently；The micro-hardship of Radix Phyllagathis fordii is sweet cool, and blood stasis dispelling is active, nourishing blood and hemoslasis；Two medicines 5 are with nourishing blood and not stagnant, and blood stasis dispelling is not just being hindered, for ministerial drug.Radix Euonymi myrianthi kidney tonifying strengthens waist, blood stasis dispelling dampness removing；Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI, dampness diuretic, antiabortive；Cortex Eucommiae invigorating the liver and kidney, bone and muscle strengthening, Gu feotus vitality；Caulis Spatholobi is enriched blood, and invigorates blood circulation as adjuvant drug.All medicines close 5, have tonifying kidney for preventing miscarriage, benefiting QI and nourishing blood, blood circulation promoting and blood stasis dispelling, the effect of dredge the meridian passage, make kidney qi contain, and punching is appointed solid, and the stasis of blood is stagnant to disappear, and can improve the clinical cure rate of kidney deficiency blood stasis type patients with recurrent spontaneous abortion.
The raw materials used involved pharmacological property present Research of the present invention is as follows:
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.
Fructus Psoraleae: [nature and flavor] are pungent, bitter, temperature.[return through] returns kidney, spleen channel.[function cures mainly] warming the kidney to activate YANG, improving inspiration by invigorating kidney-QI, antidiarrheal.For impotence and seminal emission, enuresis frequent micturition, chills and pain of the waist and kness, suffer from a deficiency of the kidney and breathe heavily, Diarrhoea；External curing vitiligo, alopecia areata.
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.
Caulis Seu Folium Euonymi Fortunei: [nature and flavor] are bitter；Sweet；Micro-pungent；Tepor.[return through] liver；Spleen；Kidney channel.[function cures mainly] relaxing muscles and tendons and activating QI and blood in the collateral；Kidney tonifying strengthens waist；Hemostasis repercussive.Main soreness of waist and knee joint of suffering from a deficiency of the kidney；Hemiplegia；Rheumatic arthralgia；Infantile convulsion；Spitting of blood；Spit blood；Metrorrhagia；Have through uncomfortable；Uterine prolapse；Injury and bone fracture；Wound hemorrhage.[usage and dosage] takes orally: decoct soup, 15-30g；Or infusing drugs in wine, or enter ball, dissipate.External: appropriate, levigation dresses, or smashes deposited, or pan-fried water smoking is washed.
Radix Phyllagathis fordii: [nature and flavor] micro-hardship；Sweet；Cool in nature.[return through] returns liver；The heart；Bladder warp.[function cures mainly] nourishing blood for regulating menstruation.Main blood deficiency and yellow complexion；Menoxenia；Amenorrhea；Dysmenorrhea；Leukorrhagia.[usage and dosage] takes orally: decoct soup, 15-30g.External: appropriate, smashes deposited；Or pan-fried soup washes.
Radix Euonymi myrianthi: [nature and flavor] are sweet；Micro-hardship；Flat.[return through] liver；Spleen；Kidney channel.[function cures mainly] kidney tonifying strengthens waist；Blood stasis dispelling dampness removing.Main lumbago due to renal deficiency；Frequent fetal movement；Chronic nephritis；Prolonged lochia；Injury and bone fracture；Rheumatic arthralgia；Leukorrhagia.[usage and dosage] takes orally: decoct soup, 10-60g.External: appropriate, decocts soup fumigation and wash method.
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.
Caulis Spatholobi: [nature and flavor] are bitter, sweet, temperature.[return through] returns liver, kidney channel.[function cures mainly] enriches blood, and invigorates blood circulation, dredging collateral.For menoxenia, blood deficiency and yellow complexion, paralysis and numbness, rheumatic arthralgia.[usage and dosage] 9～15g.
The preparation method that present invention also offers this pharmaceutical composition, it comprises the steps: to mix described Fructus Lycii, Fructus Psoraleae, the Rhizoma Atractylodis Macrocephalae, Caulis Seu Folium Euonymi Fortunei, Radix Phyllagathis fordii, Radix Euonymi myrianthi, the Cortex Eucommiae, Caulis Spatholobi in prescription ratio, add the water relative to mixture quality 4～6 times, decoct 2～3 hours, filter and obtain the first extracting solution；Filter the medicinal residues obtained and add the water relative to described medicinal residues quality 2～4 times, decoct 1～2 hour, filter and obtain the second extracting solution；First extracting solution and the second extracting solution are merged, concentrating under reduced pressure, dry, it is thus achieved that dry cream, add pharmaceutically acceptable adjuvant or complementary composition prepares according to Chinese medicine preparation common process.
Described pharmaceutically acceptable carrier or complementary composition, such as 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 dosage form of described pharmaceutical composition is peroral dosage form, such as, and tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, granule, honey pill agent, powder, sublimed preparation, solution or plaster etc..Preferably, the dosage form of described pharmaceutical composition is tablet, capsule or granule, it is most preferred that for capsule.
The present invention is also claimed aforementioned pharmaceutical compositions and is particularly preparing for the purposes in the medicine of kidney deficiency blood stasis type Patients on Recurrence stream at preparation treatment recurrent abortion.By clinical trial it can be seen that two groups of patient treatment total effectses compare, treatment group total effective rate is 91.7%, and matched group total effective rate is 75.0%, and total effective rate compares, and treatment group is apparently higher than matched group；The comparison of two groups of tcm syndrome curative effects: treatment group total effective rate 93.75%, matched group total effective rate 70.83%, treatment group compares with matched group total effective rate, difference statistically significant (P < 0.05)；Treatment group is substantially better than matched group in the plasma D-Dimer improving patient, difference statistically significant (P < 0.05).
The present invention relatively and prior art, has following clear superiority:
Selected by medicine of the present invention, medical material compatibility is suitable, refining formula, meets Chinese medicine and pharmacy and modern medicine theory, comprehensively, medication is thoughtful in legislation, plays special effect, there is tonifying kidney for preventing miscarriage, benefiting QI and nourishing blood, blood circulation promoting and blood stasis dispelling, the effect of dredge the meridian passage, kidney qi is made to contain, punching is appointed solid, and the stasis of blood is stagnant to disappear, and can improve the clinical cure rate of kidney deficiency blood stasis type patients with recurrent spontaneous abortion.
Drug for invigorating blood circulation and eliminating stasis used by prescription of the present invention, does not only result in any damage for the vaginal bleeding during pregnancy caused by blood stasis, frequent fetal movement, can receive satisfied therapeutic effect on the contrary.
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: Fructus Lycii 28 parts, Fructus Psoraleae 12 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Caulis Seu Folium Euonymi Fortunei 18 parts, Radix Phyllagathis fordii 12 parts, Radix Euonymi myrianthi 20 parts, the Cortex Eucommiae 10 parts, Caulis Spatholobi 12 parts.
Preparation method: described Fructus Lycii, Fructus Psoraleae, the Rhizoma Atractylodis Macrocephalae, Caulis Seu Folium Euonymi Fortunei, Radix Phyllagathis fordii, Radix Euonymi myrianthi, the Cortex Eucommiae, Caulis Spatholobi are mixed in prescription ratio, adds the water relative to mixture quality 4～6 times, decoct 2～3 hours, filter and obtain the first extracting solution；Filter the medicinal residues obtained and add the water relative to described medicinal residues quality 2～4 times, decoct 1～2 hour, filter and obtain the second extracting solution；First extracting solution and the second extracting solution are merged, concentrating under reduced pressure, dry, it is thus achieved that dry cream, prepare according to Chinese medicine preparation common process.The present embodiment capsule every contains crude drug 1.1g.
Embodiment 2 capsule
Prescription: Fructus Lycii 25 parts, Fructus Psoraleae 12 parts, the Rhizoma Atractylodis Macrocephalae 8 parts, Caulis Seu Folium Euonymi Fortunei 15 parts, Radix Phyllagathis fordii 15 parts, Radix Euonymi myrianthi 25 parts, the Cortex Eucommiae 10 parts, Caulis Spatholobi 10 parts.
Preparation method: with reference to embodiment 1.
Embodiment 3 capsule
Prescription: Fructus Lycii 28 parts, Fructus Psoraleae 15 parts, the Rhizoma Atractylodis Macrocephalae 7 parts, Caulis Seu Folium Euonymi Fortunei 15 parts, Radix Phyllagathis fordii 10 parts, Radix Euonymi myrianthi 25 parts, the Cortex Eucommiae 12 parts, Caulis Spatholobi 15 parts.
Preparation method: with reference to embodiment 1.
Embodiment 4 capsule
Prescription: Fructus Lycii 30 parts, Fructus Psoraleae 15 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Caulis Seu Folium Euonymi Fortunei 15 parts, Radix Phyllagathis fordii 12 parts, Radix Euonymi myrianthi 23 parts, the Cortex Eucommiae 8 parts, Caulis Spatholobi 10 parts.
Preparation method: with reference to embodiment 1.
Embodiment 5 capsule
Prescription: Fructus Lycii 28 parts, Fructus Psoraleae 16 parts, the Rhizoma Atractylodis Macrocephalae 11 parts, Caulis Seu Folium Euonymi Fortunei 15 parts, Radix Phyllagathis fordii 10 parts, Radix Euonymi myrianthi 25 parts, the Cortex Eucommiae 13 parts, Caulis Spatholobi 10 parts.
Preparation method: with reference to embodiment 1.
Embodiment 6 capsule
Prescription: Fructus Lycii 25 parts, Fructus Psoraleae 15 parts, the Rhizoma Atractylodis Macrocephalae 7 parts, Caulis Seu Folium Euonymi Fortunei 15 parts, Radix Phyllagathis fordii 10 parts, Radix Euonymi myrianthi 25 parts, the Cortex Eucommiae 12 parts, Caulis Spatholobi 12 parts.
Preparation method: with reference to embodiment 1.
Embodiment 7 tablet
Prescription: Fructus Lycii 28 parts, Fructus Psoraleae 12 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Caulis Seu Folium Euonymi Fortunei 18 parts, Radix Phyllagathis fordii 12 parts, Radix Euonymi myrianthi 20 parts, the Cortex Eucommiae 10 parts, Caulis Spatholobi 12 parts.
Preparation method: described Fructus Lycii, Fructus Psoraleae, the Rhizoma Atractylodis Macrocephalae, Caulis Seu Folium Euonymi Fortunei, Radix Phyllagathis fordii, Radix Euonymi myrianthi, the Cortex Eucommiae, Caulis Spatholobi are mixed in prescription ratio, adds the water relative to mixture quality 4～6 times, decoct 2～3 hours, filter and obtain the first extracting solution；Filter the medicinal residues obtained and add the water relative to described medicinal residues quality 2～4 times, decoct 1～2 hour, filter and obtain the second extracting solution；First extracting solution and the second extracting solution are merged, concentrating under reduced pressure, dry, it is thus achieved that dry cream, prepare according to Chinese medicine preparation common process.
Every, the present embodiment tablet contains crude drug 0.6g.
Embodiment 8 granule
Prescription: Fructus Lycii 28 parts, Fructus Psoraleae 12 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Caulis Seu Folium Euonymi Fortunei 18 parts, Radix Phyllagathis fordii 12 parts, Radix Euonymi myrianthi 20 parts, the Cortex Eucommiae 10 parts, Caulis Spatholobi 12 parts.
Preparation method: described Fructus Lycii, Fructus Psoraleae, the Rhizoma Atractylodis Macrocephalae, Caulis Seu Folium Euonymi Fortunei, Radix Phyllagathis fordii, Radix Euonymi myrianthi, the Cortex Eucommiae, Caulis Spatholobi are mixed in prescription ratio, adds the water relative to mixture quality 4～6 times, decoct 2～3 hours, filter and obtain the first extracting solution；Filter the medicinal residues obtained and add the water relative to described medicinal residues quality 2～4 times, decoct 1～2 hour, filter and obtain the second extracting solution；First extracting solution and the second extracting solution are merged, concentrating under reduced pressure, dry, it is thus achieved that dry cream, prepare according to Chinese medicine preparation common process.
The present embodiment granule every bag contains crude drug 2.5g.
The clinical observation test of embodiment 9 pharmaceutical composition of the present invention
1 data and method
1.1 physical data: 96 example cases are the patients with recurrent spontaneous abortion that in January, 2013, in March, 2014, this Out-patient Department was accepted for medical treatment to, adopt random digits table to be divided into treatment group and matched group.Treatment group 48 example, the mean age (34.7 ± 3.58) year, miscarriage frequency (2.4 ± 1.1) secondary, menopause (35.8 ± 10.2) sky；Matched group 48 example, the mean age (29.6 ± 3.86) year, miscarriage frequency (2.2 ± 0.9) secondary, menopause (33.2 ± 8.5) sky.Two groups of ages, abortion times, menopause isobase data compare, and no significant difference (P > 0.05) has comparability.
1.2 diagnostic criterias
1.2.1 Western medicine diagnose standard: the diagnostic criteria of " obstetrics and gynecology " of recurrent spontaneous reference Le Jie chief editor the 7th edition: the spontaneous abortion of continuous 2 times and more than 2 times, before showing as pregnant 28 weeks, a small amount of vaginal hemorrhage first occurs, no passage of pregnancy tissue, occurs paroxysmal lower abdominal pain or lumbago and backache subsequently；Gynecologial examination cervix uteri mouth is not opened, and uterus size is consistent with menolipsis week number；Ultrasound diagnosis uterus size, pregnant capsule or embryo and pregnant Zhou Xiangfu.
1.2.2 Syndrome Differentiation of Traditional Chinese Medicine standard: with reference to " new Chinese medicine guideline of clinical investigations " in conjunction with clinical symptoms: repeatly pregnant fall repeatly or should the phase and fall, the soreness of waist, dizziness and tinnitus, nocturia, dim complexion, there are petechia or ecchymosis in pale tongue limit, thready and rolling pulse chi pulse sinks, dialectical for kidney deficiency blood stasis type.
1.3 inclusive criterias: recur 2 times or more than 2 times spontaneous abortions；DDi (D-Dimer) is abnormal；(3) the differentiation of symptoms and signs for classification of syndrome standard person of traditional Chinese medical science kidney deficiency blood stasis type is met.
1.4 exclusion standards: merge genitals's anatomical structure exception or Mr. and Mrs one or both peripheral blood chromosome karyotyping exception person；Merge endocrinopathy or suffer from the systemic disease persons such as severe infections, thrombotic disease, nephropathy；Within nearly 2 months, use anticoagulant or fibrinolysis enhancing medicine, and the person that takes contraceptive；Husband's semen exception person；To drugs allergy sufferers.
1.5 Therapeutic Method:
Matched group: give aspirin (Aspirin Enteric-coated Tablets (25mg/ sheet), oral, each 1, every day 2 times) associating Low molecular heparin (low molecular heparin calcium injection (4100AXa unit: 0.4mL/ /) 0.4mL subcutaneous injection, every day 1 time.) anticoagulant therapy；Treatment group: the capsule of the oral embodiment of the present invention 1 preparation, every day 2 times, each 2-4 grain on the basis of matched group western medicine, takes after meal half an hour.All treating to arbortive time January the past for two groups, patient's pregnancy period prohibits sexual life, it is to avoid overworked, and special vaginal hemorrhage person lies up.Follow up a case by regular visits to normal labor and carry out efficacy evaluation.
1.6 observation index and method:
1.6.1 general index: observe the change of related symptoms, sign and tongue arteries and veins before and after treatment, and carry out tcm symptom scoring, symptom score standard is formulated with reference to " new Chinese medicine guideline of clinical investigations " 2002 editions related content amendments, 1/3 ratio according to comprehensive syndrome integral letter lid total score carries out severity Scaling: slight, 0～9 point；Moderate, 10～18 points；Severe, 19～27 points.
1.6.2 check blood coagulation 6 (PT, APTI', TT, AT-III, D-Dimer, FIB-C) in every 24 weeks after medication.
1.7 efficacy assessment standards:
1.7.1 clinical efficacy evaluation criteria: formulate with the amendment of " new Chinese medicine guideline of clinical investigations " related content with reference to " obstetrics and gynecology ".Cure: gestation was more than 20 weeks, and when pregnant 20 weeks, ultrasound diagnosis shows that fetal development is normal, and adjoint clinical symptoms and sign disappear or be obviously improved；Take a turn for the better: gestation exceedes miscarried the longest pregnant week in the past, but miscarried not less than 20 weeks, and adjoint clinical symptoms and sign make moderate progress；Not healing: namely gestation miscarry not less than miscarriage in the past in the longest pregnant week, adjoint clinical symptoms and sign increase the weight of without improving or having.
1.7.2 tcm syndrome efficacy assessment standard: formulate with reference to the amendment of " new Chinese medicine guideline of clinical investigations " related content.Therapeutic index (n) calculating adopts Buddhist nun's not group's method: n=(before treatment integration after integration-treatment) front integration × 100% of/treatment；Recovery from illness: each transference cure or substantially alleviate, n >=70% after treatment；Take a turn for the better: after treatment, each symptom alleviates to some extent, 70% > n >=30%；Invalid: after treatment, each disease is increased the weight of without alleviating or having, n < 30%.
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.
Without rejecting and coming off and terminate case in therapeutic process, all complete clinical observation.
The comparisons of 2.1 liang of group Comprehensive Clinical curative effects: treatment group and matched group total effective rate respectively 91.7% and 75.0%, two groups of 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.
The comparisons of 2.2 liang of group tcm syndrome curative effects: after treatment, treatment group is fully recovered 35 examples, and take a turn for the better 10 examples, invalid 3 examples, total effective rate 93.75%；Matched group is fully recovered 10 examples, and take a turn for the better 24 examples, invalid 14 examples, total effective rate 70.83%, treatment group compares with matched group total effective rate, difference statistically significant (P < 0.05), illustrates that treatment group Chinese medicine syndrome integral improves and is substantially better than matched group.In Table 2.
2 liang of table group patient's tcm syndrome comparitive study
Note: compare with matched group, * P < 0.05.
2.3 liang of group treatment Plasma Before And After D-Dimer Indexes Comparison: treat front two groups of group patient's Indexes Comparison, the equal not statistically significant of difference (P > 0.05).After treatment, two groups of D-Dimer all have improvement, compare with before treatment, difference all statistically significant (P < 0.05), treatment group is substantially better than matched group in the plasma D-Dimer improving patient, difference statistically significant (P < 0.05).In Table 3.
3 liang of table group treatment Plasma Before And After D-Dimer Indexes Comparisonng/mL
Note: compare with before treatment, * P < 0.05, compare with Western medicine group after treatment,#P < 0.05.
2.4 during treating, and 2 groups of patients all occur without Drug untoward reaction.
From result of study, kidney deficiency blood stasis type patients with recurrent spontaneous abortion is had significant clinical efficacy by the application present invention medication combined Western medicine anticoagulant therapy, and the treatment for recurrent abortion provides new thinking.
Claims (10)
1. the pharmaceutical composition treating kidney deficiency blood stasis type recurrent abortion, it is characterised in that be that medicinal raw material is made by Fructus Lycii, Fructus Psoraleae, the Rhizoma Atractylodis Macrocephalae, Caulis Seu Folium Euonymi Fortunei, Radix Phyllagathis fordii, Radix Euonymi myrianthi, the Cortex Eucommiae, Caulis Spatholobi.
2. pharmaceutical composition as claimed in claim 1, it is characterised in that be made up of the medicinal raw material of following weight: Fructus Lycii 25-30 part, Fructus Psoraleae 11-16 part, Rhizoma Atractylodis Macrocephalae 7-11 part, Caulis Seu Folium Euonymi Fortunei 15-20 part, Radix Phyllagathis fordii 10-15 part, Radix Euonymi myrianthi 20-25 part, Cortex Eucommiae 8-13 part, Caulis Spatholobi 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: Fructus Lycii 28 parts, Fructus Psoraleae 12 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Caulis Seu Folium Euonymi Fortunei 18 parts, Radix Phyllagathis fordii 12 parts, Radix Euonymi myrianthi 20 parts, the Cortex Eucommiae 10 parts, Caulis Spatholobi 12 parts.
4. the pharmaceutical composition as described in as arbitrary in claim 1-3, it is characterized in that the preparation method of described pharmaceutical composition comprises the steps: to mix described Fructus Lycii, Fructus Psoraleae, the Rhizoma Atractylodis Macrocephalae, Caulis Seu Folium Euonymi Fortunei, Radix Phyllagathis fordii, Radix Euonymi myrianthi, the Cortex Eucommiae, Caulis Spatholobi in prescription ratio, add the water relative to mixture quality 4～6 times, decoct 2～3 hours, filter and obtain the first extracting solution；Filter the medicinal residues obtained and add the water relative to described medicinal residues quality 2～4 times, decoct 1～2 hour, filter and obtain the second extracting solution；First extracting solution and the second extracting solution are merged, concentrating under reduced pressure, dry, it is thus achieved that dry cream, add pharmaceutically acceptable adjuvant or complementary composition prepares according to Chinese medicine preparation common process.
5. the pharmaceutical composition as described in as arbitrary in claim 1-4, it is characterised in that described pharmaceutical composition be preferably made as peroral dosage form.
6. pharmaceutical composition as claimed in claim 5, it is characterised in that described be preferably tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, granule, honey pill agent, powder, sublimed preparation, solution or plaster etc. for peroral dosage form.
7. pharmaceutical composition as claimed in claim 6, it is characterised in that described be preferably tablet, capsule or granule for peroral dosage form.
8. pharmaceutical composition as claimed in claim 7, it is characterised in that described be preferably capsule for peroral dosage form.
9. the purposes in the medicine of preparation treatment kidney deficiency blood stasis type recurrent abortion of the pharmaceutical composition as described in as arbitrary in claim 1-3.
10. the purposes in the medicine of preparation treatment recurrent abortion of the pharmaceutical composition as described in as arbitrary in claim 1-3.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Non-Patent Citations (1)
| Title |
|---|
| 李国辉，等。: ""补肾安胎饮治疗早期先兆流产112例临床观察"", 《河北中医》 * |
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