CN105726868A - Pharmaceutical preparation for treating first-trimester threatened abortion with anticardiolipin antibody positive - Google Patents

Pharmaceutical preparation for treating first-trimester threatened abortion with anticardiolipin antibody positive Download PDF

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CN105726868A
CN105726868A CN201610172993.XA CN201610172993A CN105726868A CN 105726868 A CN105726868 A CN 105726868A CN 201610172993 A CN201610172993 A CN 201610172993A CN 105726868 A CN105726868 A CN 105726868A
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pharmaceutical preparation
salviae miltiorrhizae
schum
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王盛梅
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/41Crassulaceae (Stonecrop family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention belongs to the field of traditional Chinese medicines, and relates to a pharmaceutical preparation for treating first-trimester threatened abortion with anticardiolipin antibody positive. The pharmaceutical preparation is prepared from the following medicinal raw materials: fructus psoraleae, acanthopanax roots, roots of shrubberry rhodiola, fruits of Chinese wolfberry, roots of wilford swallowwort, taxillus delavayi, annular holostemma, salviae miltiorrhizae, winged yam rhizome and rubia cordifolia. The pharmaceutical preparation is less in medicinal odor, is fine and reasonable in compatibility of medicines, is safe and reliable in curative effect, is free of obvious toxic and side effect on the mother and baby, has effects of tonifying kidneys and strengthening the spleen, nourishing the fetus with qi and blood and preventing miscarriage, shows great advantages in treating the first-trimester threatened abortion with the traditional Chinese medicines, and is worthy of being further researched and applied.

Description

A kind of pharmaceutical preparation treating the early stage threatened abortion companion anticardiolipin antibody positive
Technical field
The invention belongs to tcm field, relate to a kind of pharmaceutical preparation treating the early stage threatened abortion companion anticardiolipin antibody positive and preparation method thereof.
Background technology
Before threatened abortion refers to forepart pregnant women 28 weeks, a small amount of colporrhagia occurs, be often kermesinus or sanguinous leukorrhea, no passage of pregnancy tissue, paroxysmal lower abdominal pain or lumbago and backache occur subsequently.Gynecologial examination cervix uteri mouth is not opened, and fetal membrane does not break, and uterus size is consistent with menolipsis week number.Through having a rest and transference cure after treatment, gestation can be continued;If vaginal bleeding volume increases or lower abdominal pain aggravation, inevitable abortion can be developed into.There are about the anemia of pregnant woman of 20% and there will be threatened abortion, and wherein half patient can be further development of artificial abortion.This disease is included in the category of " vaginal bleeding during pregnancy ", " frequent fetal movement " by motherland's medical science.Occur to be called early stage threatened abortion at pregnant 12 weeks with the former.If " inevitable abortion ", " missed abortion " etc. can not can be developed into by effective treatment clinically, have a strong impact on the physical and mental health of anemia of pregnant woman.
In recent years, domestic and international substantial amounts of active immunity and passive immunity animal model prove, anticardiolipin antibody (Anticardiolipinantibody, ACA) early stage threatened abortion patient being had direct pathogenic effects, anticardiolipin antibody is cuorin electronegative in platelet and the endothelial cell membrane autoantibody as target antigen.It is generally acknowledged at present, ACA mono-aspect energy interference body phospholipid dependency coagulation function, thus injured blood vessel endothelium and trigger endogenous blood coagulation system, change thromboxane/prostaglandin level, promote platelet aggregation, thrombosis, causes Placental ischemia, causes fetal intrauterine growth retardation, stillborn fetus so that miscarrying.On the other hand, pregnant early stage ACA may interfere with the growth promoter of the cytotrophoblast fusion with syncytiotrophoblast and amniotic membrane, thus causing miscarriage.
The treatment of the threatened abortion that current ACA causes, adopt immunosuppressant (prednisone or prednisone etc.) United anticoagulation medicine (aspirin or heparin etc.) to treat more both at home and abroad, but prolonged application can cause blood glucose rising, osteoporosis, infection, thrombocytopenia, the side reaction such as hemorrhage.Chinese medicine is prevented miscarriage the curative effect of its uniqueness and advantage, especially motherland's medical science two-way immunoregulation effect to immune function of human body too many levels, Mutiple Targets, determined curative effect.Furthermore, repeatedly practise through clinic in several thousand, Chinese medicine prevent miscarriage treatment higher in clinical practice safety, easy for patients to accept.
Summary of the invention
Inventor sums up and thinks: patient's natural endowment is not enough, and kidney qi is weak, or deficiency of the kidney, taste will lose strong the day after tomorrow, biochemical weary source, and QI and blood is not filled, asthenia of both the spleen and kidney, tire is become homeless foster, and born of the same parents become homeless and are, caused by liability to abortion, meanwhile, in conjunction with the pathomechanism of primary disease: based on thrombosis, Gu Zuo is with the product of blood circulation promoting and blood stasis dispelling, trimester of pregnancy drug for invigorating blood circulation and eliminating stasis is originally for disabling, and herein with it, also takes the meaning of it " having therefore lossless ".Accordingly, it is provided that the pharmaceutical preparation for the treatment of early stage threatened abortion companion's anticardiolipin antibody positive that a kind of curative effect is determined, side effect is little, it is particularly suited for early stage threatened abortion companion anticardiolipin antibody sun patient's asthenia of both the spleen and kidney pattern of syndrome.
Technical scheme is as follows:
A kind of treat the pharmaceutical preparation that early stage threatened abortion companion anticardiolipin antibody is positive, it is characterised in that be that medicinal raw material is made by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow parasitism, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae.
Further preferably, a kind of pharmaceutical preparation treating the early stage threatened abortion companion anticardiolipin antibody positive, it is characterised in that be made up of the medicinal raw material of following weight: Fructus Psoraleae 13-18 part, Radix Et Caulis Acanthopanacis Senticosi 11-16 part, Radix Rhodiolae Dumulosae 6-11 part, Fructus Lycii 15-20 part, Radix cynanchi wilfordii 10-15 part, willow parasitism 5-9 part, Holostemma annulare (Roxb.) K. Schum 10-15 part, Radix Salviae Miltiorrhizae 7-12 part, Rhizoma Dioscoreae Alatae 15-20 part, Radix Rubiae 6-11 part.
Further preferably, a kind of pharmaceutical preparation treating the early stage threatened abortion companion anticardiolipin antibody positive, it is characterised in that be made up of the medicinal raw material of following weight: Fructus Psoraleae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Rhodiolae Dumulosae 8 parts, Fructus Lycii 20 parts, Radix cynanchi wilfordii 12 parts, parasitic 8 parts of willow, Holostemma annulare (Roxb.) K. Schum 12 parts, Radix Salviae Miltiorrhizae 10 parts, Rhizoma Dioscoreae Alatae 15 parts, 8 parts of Radix Rubiae.
Fang Zhong: the arduous temperature of Fructus Psoraleae, energy temperature compensation kidney spleen, with kidney-replenishing, spleen invigorating sun, with the foster the five internal organs of honor, therefore the labor of main the five internal organs, the pungent micro-bitter temperature of Radix Et Caulis Acanthopanacis Senticosi, kidney and spleen invigorating, benefiting vital QI for tranquillizing, and have the merit of promoting blood circulation to remove obstruction in the collateral, and two medicines 5 kidney-replenishing spleen invigorating sun, tire mat temper is with length, mat kidney qi is to lift, this two medicines warming and recuperating the spleen and kidney, has greatly the merit of solid tire, for monarch drug.The flat profit of Fructus Lycii and nourish benefit essence, double can bring down a fever;Radix cynanchi wilfordii nourishing YIN and benefiting blood, spleen invigorating is pleasant, sedation-analgesia, two medicine 5 nourishing YIN and clearing away heat, spleen invigorating of nourishing blood, kidney tonifying, essence replenishing, principal drug assistance equilibrium between yin and yang, Rhizoma Dioscoreae Alatae invigorating the spleen to arrest diarrhea, and lung benefiting nourishing kidney, three medicines are ministerial drug.Willow parasitism invigorating the liver and kidney, wind-damp dispelling, hemostasis, antiabortive;Radix Rhodiolae Dumulosae kidney tonifying nourishing the liver, regulating menstruation and activating blood;Holostemma annulare (Roxb.) K. Schum benefiting QI and nourishing blood, dredge the meridian passage;Radix Salviae Miltiorrhizae stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness;Radix Rubiae cooling blood for hemostasis, blood stasis dispelling stimulates the menstrual flow, for adjuvant.All medicine 5 use, interacts, is use mutually, has kidney and spleen invigorating, reinforcing fundamental and preventing miscarriage, supports QI invigorating, the effect of promoting blood circulation to remove blood stasis, kidney qi fills Sheng, and temper is healthy and vigorous, and punching is appointed solid, blood is unobstructed, and QI and blood is harmonious, with foster born of the same parents' tire, full side both tonified Qi of the kidney, nourishing blood and hemoslasis is antiabortive, can increase again immunity of organisms, removes and reduces anticardiolipin antibody, evident in efficacy, non-evident effect, clinic further genralrlization.
Further, the pharmacological activity present Research of each medicine used by the present invention is as follows:
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.
Radix Et Caulis Acanthopanacis Senticosi: [nature and flavor] hardship pungent, micro-, temperature.[return through] returns spleen, kidney, heart channel.[function cures mainly] replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization.For deficiency of spleen-YANG and kidneyYANG, body void is weak, inappetence, soreness of waist and knee joint, insomnia and dreamful sleep.[usage and dosage] 9~27g.
Radix Rhodiolae Dumulosae: [nature and flavor] sweet in the mouth;Micro-hardship;Property is put down.[return through] kidney;Liver Channel.[function cures mainly] kidney tonifying nourishing the liver;Regulating menstruation and activating blood.Main consumptive fever hectic fever due to YIN-deficiency;An emaciation due to blood disorder;Have a dizzy spell;Menoxenia.[usage and dosage] takes orally: decoct soup, 6-12g.
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.
Radix cynanchi wilfordii: Radix cynanchi wilfordii, heat-insulating mechanism, Radix Cynanchi Auriculati, white Radix Polygoni Multiflori, mountain Fructus Trichosanthis.[nature and flavor] sweet in the mouth;Micro-hardship;Slightly warm in nature;[return through] spleen;Stomach;Kidney channel.[function cures mainly] invigorating the liver and kidney;Bone and muscle strengthening;Strengthening the spleen and stomach;Removing toxic substances.Main liver and kidney deficiency;Feel dizzy;Insomnia forgetfulness;Early whitening of beard and hair;Sexual impotence;Seminal emission;Waist knee joint acid is climbed;Spleen insufficiency;Distension and fullness in the abdomen;Ren is intended to depressed;Have loose bowels;Puerperal, breast was few;Lymphogranuloma inguinale sore.[usage and dosage] takes orally: decoct soup, 9-15g external: fresh goods is appropriate, smashes deposited.
Willow is parasitic: [nature and flavor] micro-hardship;Sweet;Property is put down.[return through] liver;Kidney channel.[function cures mainly] invigorating the liver and kidney;Wind-damp dispelling;Hemostasis;Antiabortive.Master has a dizzy spell;Lumbocrural pain;Rheumatic numbness;Metrorrhagia;Frequent fetal movement.[usage and dosage] takes orally: decoct soup, 10-15g;Or infusing drugs in wine;Or smash juice;Or fricassee.External: appropriate, decocts washing.
Holostemma annulare (Roxb.) K. Schum: [nature and flavor] are sweet;Flat.[return through] liver;Spleen channel.[function cures mainly] benefiting QI and nourishing blood;Stimulate the menstrual flow stimulating milk secretion.Main puerperal asthenia;Puerperal hypogalactia.[usage and dosage] takes orally: decoct soup, 3-9g.
Radix Salviae Miltiorrhizae: [nature and flavor] are bitter, are slightly cold.[return through] GUIXIN, Liver Channel.[function cures mainly] stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, chest and abdomen twinge, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia;Hepatosplenomegaly, angina pectoris.
Rhizoma Dioscoreae Alatae: [nature and flavor] are sweet;Micro-puckery;Flat.[return through] spleen;Lung;Kidney channel.[function cures mainly] invigorating the spleen to arrest diarrhea;Lung benefiting nourishing kidney;Removing toxic substances sore.Main diarrhea due to hypofunction of the spleen;Emission due to deficiency of the kidney;Leukorrhagia;Frequent micturition;Cough due to consumptive disease;Quench one's thirst;Skin infection festers;Burn.[usage and dosage] takes orally: decoct soup, 9-15g;Or enter ball, dissipate.External: appropriate, grinds into powder deposited.
Radix Rubiae: [nature and flavor] are bitter, cold.[return through] returns Liver Channel.[function cures mainly] removing heat from blood, hemostasis, blood stasis dispelling, stimulates the menstrual flow.For spitting blood, epistaxis, metrorrhagia, traumatic hemorrhage, amenorrhea stasis blocking, arthralgia, tumbling and swelling.[usage and dosage] 6~9g.
In order to express the pharmaceutical preparation of the present invention better, pharmaceutical preparation of the present invention is to be active component by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow parasitism, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae or its water or its extractive with organic solvent, adds pharmaceutically acceptable carrier and is prepared from.
The pharmaceutical preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms include: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, sucks agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.The preparation of the present invention, preferably peroral dosage form, such as soft capsule, capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum, it is most preferred that be pharmaceutical preparation preparation of the present invention is preferably tablet, capsule or granule, it is most preferred that for capsule.
nullThe pharmaceutical preparation of the present invention,Applicable pharmaceutically acceptable carrier is optionally added when preparing into medicament,Described pharmaceutically acceptable carrier is selected from: mannitol、Sorbitol、Sodium pyrosulfite、Sodium sulfite、Sodium thiosulfate、Cysteine hydrochloride、TGA、Methionine、Vitamin C、EDETATE SODIUM、Ethylenediaminetetraacetic Acid Calcium Salt,The alkali-metal carbonate of monovalence、Acetate、Phosphate or its aqueous solution、Hydrochloric acid、Acetic acid、Sulphuric acid、Phosphoric acid、Aminoacid、Sodium chloride、Potassium chloride、Sodium lactate、Xylitol、Maltose、Glucose、Fructose、Dextran、Glycine、Starch、Sucrose、Lactose、Mannitol、Silicon derivative、Cellulose and its derivates、Alginate、Gelatin、Polyvinylpyrrolidone、Glycerol、POLYSORBATE 80、Agar、Calcium carbonate、Calcium bicarbonate、Surfactant、Polyethylene Glycol、Cyclodextrin、Beta-schardinger dextrin-、Phospholipid material、Kaolin、Pulvis Talci、Calcium stearate、Magnesium stearate etc..
Present invention also offers a kind of method preparing the positive pharmaceutical preparation for the treatment of early stage threatened abortion companion's anticardiolipin antibody, the method comprises the following steps:
By Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow parasitism, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 3-9 times for the first time, decoct 1.0-1.5 hour, add water as medical material weight portion 3-6 times of second time decocts 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.05-1.10 (recording when 65 DEG C), adds ethanol and makes alcohol content reach 35%, stirs evenly, in-5-0 DEG C of cold preservation 8-12 hour, filtering, filtrate recycling ethanol, concentration obtains active constituents of medicine;Individually or mix with pharmaceutically acceptable carrier with this active component, make according to galenic pharmacy routine techniques.
The pharmaceutical preparation of present invention situation according to patient in use determines usage and dosage.The preparation of present invention situation according to patient in use determines usage and dosage, can take 1-3 time every day, each 1-20 agent, such as: 1-20 bag or grain or sheet.
The present invention is also claimed said medicine preparation purposes in the medicine that preparation treatment early stage threatened abortion companion's anticardiolipin antibody is positive, particularly in the purposes in the medicine of preparation treatment early stage threatened abortion companion's anticardiolipin antibody positive asthenia of both the spleen and kidney card.By clinical observation test example 9: the comparison of (1) two group of clinic total effects: treatment group and matched group total effective rate respectively 92.5% and 72.5%, 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;(2) two groups of ACA turn out cloudy comparitive study: treatment group and matched group total effective rate respectively 87.5% and 55.0%, 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;Before and after (3) 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 treatment, with comparing difference statistically significant (P < 0.01) before treatment, matched group compares with before treatment, difference statistically significant (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 is relatively and prior art, have following clear superiority: compatibility of drugs of the present invention is precise and appropriate rationally, treatment threatened abortion class ACA positive patient can the kidney invigorating spleen invigorating again, congenital to support the day after tomorrow, gas is to carry tire, blood is with fetus nourishing, and the first day after tomorrow, with mending, has therefore lossless, strengthen antiabortive merit, curative effect is safe and reliable, and mother and baby is found no obvious toxic-side effects, it is shown that Chinese medicine huge advantage in treatment early stage threatened abortion.
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 Psoraleae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Rhodiolae Dumulosae 8 parts, Fructus Lycii 20 parts, Radix cynanchi wilfordii 12 parts, parasitic 8 parts of willow, Holostemma annulare (Roxb.) K. Schum 12 parts, Radix Salviae Miltiorrhizae 10 parts, Rhizoma Dioscoreae Alatae 15 parts, 8 parts of Radix Rubiae.
Preparation method: by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow is parasitic, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 6 times for the first time, decoct 1.0-1.5 hour, second time adds water and decocts 1.5-2.0 hour into 5 times of medical material weight portion, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.07 (recording when 65 DEG C), adding ethanol makes alcohol content reach 35%, stir evenly, in-5-0 DEG C of cold preservation 8-12 hour, filter, filtrate recycling ethanol, concentration obtains active constituents of medicine, capsule is made according to galenic pharmacy routine techniques, every contains crude drug 0.9g.
Embodiment 2 capsule
Prescription: Fructus Psoraleae 13 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Radix Rhodiolae Dumulosae 11 parts, Fructus Lycii 15 parts, Radix cynanchi wilfordii 15 parts, parasitic 8 parts of willow, Holostemma annulare (Roxb.) K. Schum 10 parts, Radix Salviae Miltiorrhizae 8 parts, Rhizoma Dioscoreae Alatae 15 parts, 8 parts of Radix Rubiae.
Preparation method: by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow is parasitic, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 4 times for the first time, decoct 1.0-1.5 hour, second time adds water and decocts 1.5-2.0 hour into 5 times of medical material weight portion, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.05 (recording when 65 DEG C), adding ethanol makes alcohol content reach 35%, stir evenly, in-5-0 DEG C of cold preservation 8-12 hour, filter, filtrate recycling ethanol, concentration obtains active constituents of medicine, make according to galenic pharmacy routine techniques.
Embodiment 3 capsule
Prescription: Fructus Psoraleae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Radix Rhodiolae Dumulosae 8 parts, Fructus Lycii 20 parts, Radix cynanchi wilfordii 10 parts, parasitic 5 parts of willow, Holostemma annulare (Roxb.) K. Schum 15 parts, Radix Salviae Miltiorrhizae 7 parts, Rhizoma Dioscoreae Alatae 18 parts, 10 parts of Radix Rubiae.
Preparation method: by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow is parasitic, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 8 times for the first time, decoct 1.0-1.5 hour, second time adds water and decocts 1.5-2.0 hour into 3 times of medical material weight portion, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.08 (recording when 65 DEG C), adding ethanol makes alcohol content reach 35%, stir evenly, in-5-0 DEG C of cold preservation 8-12 hour, filter, filtrate recycling ethanol, concentration obtains active constituents of medicine, make according to galenic pharmacy routine techniques.
Embodiment 4 capsule
Prescription: Fructus Psoraleae 18 parts, Radix Et Caulis Acanthopanacis Senticosi 11 parts, Radix Rhodiolae Dumulosae 10 parts, Fructus Lycii 18 parts, Radix cynanchi wilfordii 14 parts, parasitic 9 parts of willow, Holostemma annulare (Roxb.) K. Schum 10 parts, Radix Salviae Miltiorrhizae 12 parts, Rhizoma Dioscoreae Alatae 18 parts, 10 parts of Radix Rubiae.
Preparation method: by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow is parasitic, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 6 times for the first time, decoct 1.0-1.5 hour, second time adds water and decocts 1.5-2.0 hour into 6 times of medical material weight portion, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.07 (recording when 65 DEG C), adding ethanol makes alcohol content reach 35%, stir evenly, in-5-0 DEG C of cold preservation 8-12 hour, filter, filtrate recycling ethanol, concentration obtains active constituents of medicine, make according to galenic pharmacy routine techniques.
Embodiment 5 capsule
Prescription: Fructus Psoraleae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Rhodiolae Dumulosae 10 parts, Fructus Lycii 18 parts, Radix cynanchi wilfordii 15 parts, parasitic 5 parts of willow, Holostemma annulare (Roxb.) K. Schum 15 parts, Radix Salviae Miltiorrhizae 12 parts, Rhizoma Dioscoreae Alatae 15 parts, 6 parts of Radix Rubiae.
Preparation method: by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow is parasitic, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 3 times for the first time, decoct 1.0-1.5 hour, second time adds water and decocts 1.5-2.0 hour into 6 times of medical material weight portion, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.05 (recording when 65 DEG C), adding ethanol makes alcohol content reach 35%, stir evenly, in-5-0 DEG C of cold preservation 8-12 hour, filter, filtrate recycling ethanol, concentration obtains active constituents of medicine, make according to galenic pharmacy routine techniques.
Embodiment 6 capsule
Prescription: Fructus Psoraleae 16 parts, Radix Et Caulis Acanthopanacis Senticosi 16 parts, Radix Rhodiolae Dumulosae 10 parts, Fructus Lycii 16 parts, Radix cynanchi wilfordii 15 parts, parasitic 9 parts of willow, Holostemma annulare (Roxb.) K. Schum 10 parts, Radix Salviae Miltiorrhizae 12 parts, Rhizoma Dioscoreae Alatae 20 parts, 8 parts of Radix Rubiae.
Preparation method: by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow is parasitic, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 6 times for the first time, decoct 1.0-1.5 hour, second time adds water and decocts 1.5-2.0 hour into 4 times of medical material weight portion, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.07 (recording when 65 DEG C), adding ethanol makes alcohol content reach 35%, stir evenly, in-5-0 DEG C of cold preservation 8-12 hour, filter, filtrate recycling ethanol, concentration obtains active constituents of medicine, make according to galenic pharmacy routine techniques.
Embodiment 7 granule
Prescription: Fructus Psoraleae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Rhodiolae Dumulosae 8 parts, Fructus Lycii 20 parts, Radix cynanchi wilfordii 12 parts, parasitic 8 parts of willow, Holostemma annulare (Roxb.) K. Schum 12 parts, Radix Salviae Miltiorrhizae 10 parts, Rhizoma Dioscoreae Alatae 15 parts, 8 parts of Radix Rubiae.
Preparation method: by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow is parasitic, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 3-8 times for the first time, decoct 1.0-1.5 hour, add water as medical material weight portion 3-6 times of second time decocts 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.05-1.10 (recording when 65 DEG C), adding ethanol makes alcohol content reach 35%, stir evenly, in-5-0 DEG C of cold preservation 8-12 hour, filter, filtrate recycling ethanol, concentration obtains active constituents of medicine, make according to galenic pharmacy routine techniques.
Embodiment 8 tablet
Prescription: Fructus Psoraleae 18 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Rhodiolae Dumulosae 8 parts, Fructus Lycii 20 parts, Radix cynanchi wilfordii 12 parts, parasitic 8 parts of willow, Holostemma annulare (Roxb.) K. Schum 15 parts, Radix Salviae Miltiorrhizae 12 parts, Rhizoma Dioscoreae Alatae 15 parts, 8 parts of Radix Rubiae.
Preparation method: by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow is parasitic, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 3-8 times for the first time, decoct 1.0-1.5 hour, add water as medical material weight portion 3-6 times of second time decocts 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.05-1.10 (recording when 65 DEG C), adding ethanol makes alcohol content reach 35%, stir evenly, in-5-0 DEG C of cold preservation 8-12 hour, filter, filtrate recycling ethanol, concentration obtains active constituents of medicine, make according to galenic pharmacy routine techniques.
Embodiment 9 clinical observation is tested
1 clinical data and method
1.1 physical data: be in hospital in the court in March, 2013~2014 year March and patient diagnosis for early stage threatened abortion and looks into anticardiolipin antibody positive patient 80 example, 23~38 years old age, menopause 35~85 days, parity 0~3 time, abortion times 0~3 time, dripping hemorrhage 3~25 days of vagina.Adopt random treatment group and the matched group of being divided into by digits table with 1:1, wherein treatment group 40 example, the mean age (30.3 ± 3.7) year, average menopause (46.5 ± 5.7) sky.Matched group 40 example, year mean age (29.8 ± 3.4), average menopause (44.7 ± 6.3) sky.Two groups of patient ages, menopause, parity, abortion times, vagina dripping bleeding times compare, and no significant difference (P > 0.05) has comparability.
1.2 diagnosis marks
1.2.1 Western medicine diagnose standard: as follows with reference to Zhang Yuzhen the 7th edition " Gynecology of Chinese Medicine " early stage threatened abortion diagnostic criteria: 1. medical history: have menolipsis history and morning sickness;2. symptom: vagina is hemorrhage on a small quantity, or with lower abdomen pendant pain or soreness of waist pain;3. pregnancy tests: urine pregnancy test is positive;4. gynecologial examination: cervical orifice is not opened, body of uterus is soft, size and pregnant Zhou Xiangfu;5. ultrasound investigation: Type B sound wave checks that uterus size, pregnant capsule or embryo (fetus) grow and pregnant Zhou Xiangfu;6. examination of basal body temperature: keep level luteal phase (maintaining high temperature curve);7. Serum HCG (β-HCG), progesterone (P) level are consistent substantially with pregnant week and B ultrasonic result (pregnant capsule size, fetal development);8. the serum ACA detection positive.
1.2.2 TCM Syndrome Type typing standard: formulate with reference to " new Chinese medicine guideline of clinical investigations " and the 7th edition " Gynecology of Chinese Medicine " vaginal bleeding during pregnancy of Zhang Yuzhen of the revision in 2002 of national drug food surveillance authority, frequent fetal movement chapters and sections: primary symptom: vagina is hemorrhage on a small quantity, color is light dim, matter is thin, the soreness of waist, stomachache, tenesmus, two knees soreness.Secondary disease: Mental fatigue limb is soft, dizziness and tinnitus or shortness of breath and palpitation;Be off one's feed, shallow complexion or pale;Nocturia.Pale tongue tongue is white, and deep pulse is fine and smooth.The a small amount of hemorrhage indispensability of primary symptom vagina, separately should possess 1~2, and secondary disease possesses 2 in conjunction with tongue arteries and veins, namely diagnosable.
1.3 case inclusive criterias: with reference to " the new Chinese medicine guideline of clinical investigations " of the revision in 2002 of national drug food surveillance authority: during (1) meets, Western medicine diagnose standard.(2) this researcher is accepted voluntarily.(3) age is between 22~40 years old.
1.4 case exclusion standards: " new Chinese medicine guideline of clinical investigations " (1) age > 40 years old or < of reference national drug food surveillance authority revision in 2002 22 years old;(2) primary disease Western medicine diagnose standard and TCM syndrome diagnostic criteria are not met;(3) merge intentionally, brain, liver, the serious disease patient such as kidney and hemopoietic system;(4) cannot partner, as being associated with nerve, mental disease, or be reluctant partner;(5) eliminating and chromosomal abnormality, genitals anatomical factors, endocrine factors, genital infection, blocking antibody exception, extraneous undesirable element etc. cause the patient of early stage threatened abortion.
1.5 Therapeutic Method: two groups of patients all advise absolute bed rest, forbid sexual life and various ass work are dynamic or work, keep happy.
Treatment group: on secondary 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, prednisone 5mg, 2 times/d;Body ketone soft gelatin capsule 200mg, 1 time every night.
It is 1 course for the treatment of that two groups of patients treat 7 days all continuously, within 7 days, checks ACA1 time;2 courses for the treatment of of treatment altogether.
1.6 observation index: TCM syndrome observes (symptom, picture of the tongue, pulse condition etc.), by degree without, light, in, heavily classification, its corresponding score value respectively 0,1,2,3 points, every symptom score sum is total score, total score has 24 points, and score is more high, then symptom is more heavy.The observation of vaginal hemorrhage dwell time;Detection blood ACA turns out cloudy situation;B ultrasonic monitoring fetal development situation, if there being in utero hematocele person, monitors hematocele absorbing state.
1.7 efficacy assessment standards:
1.7.1 total effects criterion: according to " Chinese medical disease Standardization of diagnosis and curative effect " and " new Chinese medicine guideline of clinical investigations " threatened abortion criterion of therapeutical effect: clinical cure: after treatment, vaginal hemorrhage stops, stomachache soreness of waist transference cure, uterus size and pregnant Zhou Xiangfu, ultrasound diagnosis fetal development is normal.Effective: after treatment, vaginal hemorrhage stops, stomachache soreness of waist symptom is obviously improved, and syndrome integral reduces >=70%, uterus size and pregnant Zhou Xiangfu, and ultrasound diagnosis fetal development is normal.Effective: after treatment, vaginal hemorrhage stops, stomachache soreness of waist symptom makes moderate progress, and syndrome integral reduces >=30%, uterus size and pregnant Zhou Xiangfu, and ultrasound diagnosis fetal development is normal.Invalid: colporrhagia after treatment, stomachache soreness of waist symptom ditto or increase the weight of, final inevitable abortion.
1.7.2 blood ACA turns out cloudy curative effect determinate standard: cure: after treatment, the various antibody of blood ACA is all turned out cloudy.Effective: the equal positive of blood ACA-IgG and ACA-IgM after treatment, any of which item is turned out cloudy.Invalid: after treatment, blood ACA is still positive.
2 results
The comparison of 2.1 liang of clinical total effectses of group: treatment group cures 21 examples, effective 11 examples, effective 5 examples, invalid 3 examples, matched group cures 8 examples, effective 8 examples, effective 13 examples, invalid 11 examples, treatment group and matched group total effective rate respectively 92.5% and 72.5%, 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 the clinical total effects of 1 liang of table group
Note: compare with matched group, * P < 0.05.
2.2 liang of group ACA turn out cloudy comparitive study: treatment group cures 26 examples, effective 9 examples, invalid 5 examples, matched group group cures 9 examples, effective 13 examples, invalid 18 examples, treatment group and matched group total effective rate respectively 87.5% and 55.0%, 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 2.
2 liang of table group ACA turns out cloudy comparitive study
Note: compare 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, difference statistically significant (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 < 0.05, * * 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.
In a word, compatibility of drugs of the present invention is precise and appropriate rationally, and treatment threatened abortion class ACA positive patient can the kidney invigorating spleen invigorating again, congenital to support the day after tomorrow, gas is to carry tire, and blood is with fetus nourishing, and the first day after tomorrow is with mending, have therefore lossless, strengthening antiabortive merit, curative effect is safe and reliable, and mother and baby is found no obvious toxic-side effects, show Chinese medicine huge advantage in treatment early stage threatened abortion, be worth studying application further.

Claims (10)

1. treat the pharmaceutical preparation that early stage threatened abortion companion anticardiolipin antibody is positive for one kind, it is characterised in that be that medicinal raw material is made by Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow parasitism, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae.
2. pharmaceutical preparation as claimed in claim 1, it is characterised in that be made up of the medicinal raw material of following weight: Fructus Psoraleae 13-18 part, Radix Et Caulis Acanthopanacis Senticosi 11-16 part, Radix Rhodiolae Dumulosae 6-11 part, Fructus Lycii 15-20 part, Radix cynanchi wilfordii 10-15 part, willow parasitism 5-9 part, Holostemma annulare (Roxb.) K. Schum 10-15 part, Radix Salviae Miltiorrhizae 7-12 part, Rhizoma Dioscoreae Alatae 15-20 part, Radix Rubiae 6-11 part.
3. pharmaceutical preparation as claimed in claim 2, it is characterised in that be made up of the medicinal raw material of following weight: Fructus Psoraleae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Rhodiolae Dumulosae 8 parts, Fructus Lycii 20 parts, Radix cynanchi wilfordii 12 parts, parasitic 8 parts of willow, Holostemma annulare (Roxb.) K. Schum 12 parts, Radix Salviae Miltiorrhizae 10 parts, Rhizoma Dioscoreae Alatae 15 parts, 8 parts of Radix Rubiae.
4. the pharmaceutical preparation as described in as arbitrary in claim 1-3, it is characterised in that preparation method comprises the following steps:
By Fructus Psoraleae, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae Dumulosae, Fructus Lycii, Radix cynanchi wilfordii, willow parasitism, Holostemma annulare (Roxb.) K. Schum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae Alatae, Radix Rubiae boiling secondary, add water into medical material weight portion 3-8 times for the first time, decoct 1.0-1.5 hour, add water as medical material weight portion 3-6 times of second time decocts 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume obtains thick paste, relative density is 1.05-1.10 (recording when 65 DEG C), adds ethanol and makes alcohol content reach 35%, stirs evenly, in-5-0 DEG C of cold preservation 8-12 hour, filtering, filtrate recycling ethanol, concentration obtains active constituents of medicine;Individually or mix with pharmaceutically acceptable carrier with this active component, make according to galenic pharmacy routine techniques.
5. the pharmaceutical preparation as described in as arbitrary in claim 1-4, it is characterised in that described pharmaceutical preparation may be made in any pharmaceutically useful dosage form.
6. pharmaceutical preparation as claimed in claim 5, it is characterised in that described pharmaceutical preparation is preferably made as peroral dosage form.
7. pharmaceutical preparation as claimed in claim 6, it is characterised in that described peroral dosage form is one or more in soft capsule, capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum.
8. pharmaceutical preparation as claimed in claim 7, it is characterised in that described peroral dosage form is preferably tablet, capsule or granule.
9. pharmaceutical preparation as claimed in claim 8, it is characterised in that described peroral dosage form is preferably capsule.
10. the purposes in the medicine that preparation treatment early stage threatened abortion companion's anticardiolipin antibody is positive of the pharmaceutical preparation as described in as arbitrary in claim 1-3.
CN201610172993.XA 2016-03-24 2016-03-24 Pharmaceutical preparation for treating first-trimester threatened abortion with anticardiolipin antibody positive Pending CN105726868A (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115290805A (en) * 2022-08-23 2022-11-04 陕西省中医药研究院 Finger print method and content detection method for radix Pteris Multifidae medicinal material

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115290805A (en) * 2022-08-23 2022-11-04 陕西省中医药研究院 Finger print method and content detection method for radix Pteris Multifidae medicinal material

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