CN105796672A - Medicinal preparation for treating early threatened abortion complicated with SCH (sub-chorionic hematoma) - Google Patents
Medicinal preparation for treating early threatened abortion complicated with SCH (sub-chorionic hematoma) Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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)
- A61K36/27—Asclepiadaceae (Milkweed family), e.g. hoya
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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)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
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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)
- A61K36/57—Magnoliaceae (Magnolia family)
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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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/716—Clematis (leather flower)
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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)
- A61K36/79—Schisandraceae (Schisandra family)
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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
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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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention belongs to the field of traditional Chinese medicine, and relates to a medicinal preparation for treating early threatened abortion complicated with SCH (sub-chorionic hematoma) and a preparation method of the medicinal preparation. The medicinal preparation is prepared from the medicinal materials in parts by weight as follows: melastoma dodecandrum fruits, large-flowered triplostegia tubers, auriculate cynanchum tubers, Chinese taxillus herbs, all-grass of loureiro clematis, beauty-leaf roots, cantonese speranskia and Chinese magnoliavine fruits. The medicinal materials selected by the medicinal preparation are compatible appropriately, components are refined, and disease curing and miscarriage prevention are realized simultaneously; the medicinal preparation has the effects of tonifying the kidney, activating the blood circulation, dispersing blood stasis and preventing miscarriage, and has the functions of tonifying the spleen, nourishing blood, removing dampness and dredging collaterals; the medicine property is mild, qi and blood are not injured, and medication is stopped as soon as effects are achieved, so that the medicinal preparation is beneficial to the fetus and the pregnant woman, the purpose of curing the disease without disturbing the fetus is achieved, and particularly, the medicinal preparation is developed for the patients with the kidney deficiency and blood stasis type early threatened abortion complicated with SCH on the basis of traditional Chinese medicine differentiation, and the effect is remarkable.
Description
Technical field
The invention belongs to tcm field, relate to a kind of pharmaceutical preparation treating early stage Threatened Abortion with Subchorionic Hematoma and preparation method thereof.
Background technology
Early stage threatened abortion refers to occurred that vagina was bled on a small quantity before pregnant 12 weeks, with clinical manifestations such as lower abdomen pendant pain and soreness of waist and knee joint.Recently as the impact of society's fast development, environmental pollution, life and operating pressure and the factors such as irregular of working and resting, threatened abortion sickness rate raises year by year.Abroad being reported in early stage threatened abortion case, about 18% caused by Subchorionic hematoma (Sub-chorionichaematoma, SCH).Research shows, better less than the SCH prognosis of 25% pregnant capsule area, and the incidence rate of spontaneous abortion can be made to increase to 49% more than the SCH of 25% pregnant capsule area, and therefore more simple for threatened abortion merging SCH threatened abortion has more danger, adds the difficulty prevented miscarriage.
SCH is the special pathology of one of early pregnancy (in 12 weeks).Separated out blood by chorionic plate and decidua basalis part, make accumulation of blood at chorion and decidua basalis.The visible fetal membrane of ultrasound diagnosis and decidua are partially stripped, therebetween in echoless opaque dark area of fluid, visible point-like, wire or the cotton-shaped high briliancy picture of cloud in it when hematoma has more greatly a sludged blood, stripping place fetal membrane briliancy is higher, profile is more apparent, many in crescent, its hematoma lower edge often communicates with orificium internUm isthmi and colporrhagia occurs.
Early stage threatened abortion merges SCH and belongs to the traditional Chinese medical science " vaginal bleeding during pregnancy ", " frequent fetal movement " category, it is considered that the many blood stasis of holding concurrently with suffer from a deficiency of the kidney (spleen is suffered from a deficiency of the kidney), asthenia of qi and blood, heat in blood of its etiology and pathogenesis etc. are relevant.Determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs is TCM knowledge and the basic principle for the treatment of disease, is also the characteristic of Chinese traditional treatment threatened abortion, embodies the integrity of science, method, prescription, drugs；Therefore regard threatened abortion as systemic disease, and due to the difference of natural endowment, the state of an illness, the course of disease etc., give differentiation of symptoms and signs for classification of syndrome, recipe is prescribed after the establishment of the principle for the treatment of, carry out immunotherapy targeted autoantibody；Determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs to pay attention to the etiology and pathogenesis of different pattern of syndrome threatened abortion, distinguish suffer from a deficiency of the kidney, the hold concurrently stasis of blood, heat in blood blood stasis etc. of blood stasis, deficient qi and blood different and adopt different method for the treatment of, namely so-called " card rule together also with, demonstrate,prove different control also different ".Chinese medicine threatened abortion is with a long history, and determined curative effect is easy for patients to accept.
Summary of the invention
Inventor, on the basis of recipe handed down from ancestors, learns wildly from other's strong points, in conjunction with body constitution and the modern medical theory of modern, doctor trained in Western medicine pathology is combined with Chinese medical discrimination, summary thinks that primary disease main pathogenesis should be blood stasis due to renal deficiency, suffers from a deficiency of the kidney, and occurs that tire is become homeless load, blood stasis and cause stagnation of blood stasis punching and appoint a uterus, make feotus vitality lose to support and do not consolidate, blood stasis is pathological product, is again new paathogenic factor, and blood stasis does not go, fresh blood is not given birth to, escape of blood from meridian.Provide accordingly a kind of curative effect determine, side effect little can treating both the principal and secondary aspects of a disease early stage Threatened Abortion with Subchorionic Hematoma pharmaceutical preparation.
The present invention adopts the following technical scheme that:
A kind of pharmaceutical preparation treating early stage Threatened Abortion with Subchorionic Hematoma, it is that medicinal raw material is made by ground fruit, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis.
Not single utilization blood circulation promoting and blood stasis dispelling in prescription of the present invention, a but medicine is dual-purpose or a medicine is multiplex, anemia of pregnant woman can without dying, and nausea is also without dying also.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 preparation treating early stage Threatened Abortion with Subchorionic Hematoma, it is made up of the medicinal raw material of following weight: ground fruit 20-26 part, Radix Triplostegiae Grandiflorae 30-35 part, Radix cynanchi wilfordii 15-20 part, Herba Taxilli 12-17 part, Herba Clematidis loureirianae 7-12 part, Radix calophylli membranacei 12-17 part, Herba speranskiae cantonensis 8-13 part, Fructus Schisandrae Chinensis 4-7 part.
Further preferably, a kind of pharmaceutical preparation treating early stage Threatened Abortion with Subchorionic Hematoma, it is made up of the medicinal raw material of following weight: ground fruit 25 parts, Radix Triplostegiae Grandiflorae 35 parts, Radix cynanchi wilfordii 18 parts, Herba Taxilli 15 parts, Herba Clematidis loureirianae 10 parts, Radix calophylli membranacei 15 parts, Herba speranskiae cantonensis 12 parts, Fructus Schisandrae Chinensis 5 parts.
Finding through our clinical observation, the present invention is evident in efficacy, not only can stop blooding, and alleviates the diseases such as the stomachache soreness of waist, and the growth promoter of fetus be may also function as good result, and Fang Zhong: the sweet temperature in ground, kidney-replenishing blood-nourishing, arresting bleeding and miscarriage prevention, for monarch drug.The sweet micro-hardship of Radix Triplostegiae Grandiflorae is put down, spleen invigorating invigorating qi and benefiting blood, and Yishen Huoxue stops blooding；Radix cynanchi wilfordii invigorating the liver and kidney, bone and muscle strengthening, strengthening the spleen and stomach；Herba Taxilli invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit, the source of the QI and blood day after tomorrow is mended in the spleen invigorating of three medicines 5, and blood yiqi, Gu Chong appoints, antiabortive unit, for ministerial drug.Herba Clematidis loureirianae clearing away heat and promoting diuresis, promoting blood circulation to restore menstrual flow, expelling wind and removing dampness, Herba speranskiae cantonensis expelling wind and removing dampness, the meridian dredging, disappear hard block；Two medicine 5 use, eliminating pathogenic factor for supporting vital QI, Radix calophylli membranacei hardship is put down, wind-damp dispelling, bone and muscle strengthening, promoting blood circulation and stopping pain；The sweet temperature of trimethyl gallic acid, restrains astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming, and four medicines are adjuvant.All medicine 5 use, interacts, is use mutually, has invigorating kidney, promoting blood circulation, the effect that dissipating blood stasis is antiabortive, have concurrently simultaneously spleen reinforcing nourish blood, the merit of dampness removing dredging collateral；The property of medicine is mild, and the not impairment of QI-blood, namely middle disease stops, and pacifies sub-Herba Leonuri, belongs to blood stasis due to renal deficiency disease type development especially for early stage Threatened Abortion with Subchorionic Hematoma patient differential diagnosis in tcm.
The medicinal part that medicinal raw material of the present invention is all recorded in the ancient books and records such as " Chinese Pharmacopoeia ", " China's book on Chinese herbal medicine " is for standard, and pharmacological activity present Research is as described below.
Ground fruit: [nature and flavor] sweet in the mouth；Warm in nature.[return through] returns kidney；Liver；Spleen channel.[function cures mainly] kidney-replenishing blood-nourishing；Arresting bleeding and miscarriage prevention.Main essence of suffering from a deficiency of the kidney is special；Soreness of the waist and knees；Blood deficiency and yellow complexion；The deficiency of vital energy is weak；Through many；Metrorrhagia；Frequent fetal movement；The prolapse of the uterus；Proctoptosis.[usage and dosage] takes orally: decoct soup, 10-30g；Or infusing drugs in wine.
Radix Triplostegiae Grandiflorae: [nature and flavor] hardship sweet, micro-is flat.[function cures mainly] tonifying speen and tonifying kidney, promoting blood flow to regulate menstruation, only metrorrhagia, removing toxic substances.For lumbago due to renal deficiency, anemia, cough, seminal emission, sexual impotence, rheumatic arthritis, menoxenia, vicarious menstruation, metrorrhagia, leukorrhagia, infertility.External is stopped blooding.[usage and dosage] 0.5～1 liang.
Radix cynanchi wilfordii: [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；External: fresh goods is appropriate, smashes deposited.
Herba Taxilli: [nature and flavor] bitter, sweet, flat.[return through] returns liver, kidney channel.[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.For rheumatic arthralgia, soreness of the waist and knees, muscles and bones is unable, metrorrhagia through many, blood leaking in gestation, frequent fetal movement；Hypertension.
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.
Radix calophylli membranacei: for the root of Garcinia maingayii slender lobule poon.[nature and flavor] micro-hardship；Flat.[return through] liver；Kidney channel.[function cures mainly] wind-damp dispelling, bone and muscle strengthening；Promoting blood circulation and stopping pain.Main air arthralgia chiefly caused by damp pathogen is demonstrate,proved；Lumbago due to renal deficiency；Menoxenia；Dysmenorrhea；Traumatic injury.[usage and dosage] takes orally: decoct soup, 15-30g.
Herba speranskiae cantonensis: [nature and flavor] are bitter；Flat.[return through] lung；Liver；Large intestine channel.[function cures mainly] wind-damp dispelling；The meridian dredging；Removing blood stasis with potent drugs pain relieving.Main air pain of dampness syndrome；Lump in the abdomen；Scrofula；Furuncle swelling toxin；Traumatic injury.[usage and dosage] takes orally: decoct soup, 15-30g.External: appropriate, smashes deposited；Or decoct washing.
Fructus Schisandrae Chinensis: [nature and flavor] are sour, sweet, temperature.[return through] returns lung, the heart, kidney channel.[function cures mainly] restrains astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.For chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, and deficient pulse of losing heart, interior-heat is quenched one's thirst, palpitation and insomnia.[usage and dosage] 1.5～6g.
In order to express the pharmaceutical preparation of the present invention better, pharmaceutical preparation of the present invention can be active component by ground fruit, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis or its water or its extractive with organic solvent, adds pharmaceutically acceptable carrier and is prepared from.
Further, a kind of method of the pharmaceutical preparation preparing treatment early stage Threatened Abortion with Subchorionic Hematoma, the method comprises the steps: to take ground fruit by prescription, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis adds 2-10 times amount water, decoct and extract 1-3 time, each 1-3 hour, merging filtrate, filter, it is concentrated into relative density 1.10-1.15 (60 DEG C of surveys), place to room temperature, adding ethanol makes alcohol content reach 30%, stir evenly,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is to without after alcohol taste, it is concentrated into dry, it is ground into fine powder；Make according to galenic pharmacy routine techniques.
Pharmaceutical preparation described above is preferably made 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 etc..It is further preferred that pharmaceutical preparation described above is preferably made as tablet, capsule or granule, it is most preferred that for capsule.
The present invention is also claimed said medicine preparation purposes in preparation treatment early stage threatened abortion medicine.Pharmaceutical preparation of the present invention is when treatment early stage threatened abortion, and particularly early stage Threatened Abortion with Subchorionic Hematoma, when differential diagnosis in tcm is blood stasis due to renal deficiency, it is shown that significant curative effect.Clinical observation experiment embodiment 9 of the present invention shows, compared with routine of western medicine therapy, the present invention antiabortive effective percentage, promote Subchorionic hematoma to absorb, shorten the colporrhagia time, reduce TCM symptom score etc. in all relatively Western medicine group have a clear superiority in, there is unexpected technique effect.
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, cures the disease and develops simultaneously with antiabortive, has invigorating kidney, promoting blood circulation, the effect that dissipating blood stasis is antiabortive, have concurrently simultaneously spleen reinforcing nourish blood, the merit of dampness removing dredging collateral；The property of medicine is mild, the not impairment of QI-blood, and namely middle disease stops, and pacifies sub-Herba Leonuri, thus reaching to cure the disease and the purpose of the fraud of the dynamic tire of nothing, belongs to blood stasis due to renal deficiency disease type development especially for early stage Threatened Abortion with Subchorionic Hematoma patient differential diagnosis in tcm.
The present invention is gentle product selecting activating blood and removing stasis drug, avoid injuring feotus vitality, and dose is lighter, the state of blood stasis of trimester of pregnancy appearance can be treated on the one hand, promote that decidua is grown, keep uterus static situation, it is suppressed that the parent repulsion to embryo, can promote on the other hand after Placenta Hominis or under decidua basalis, the absorption value of hematoma obtains, be worthy of popularization clinically.
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: ground fruit 25 parts, Radix Triplostegiae Grandiflorae 35 parts, Radix cynanchi wilfordii 18 parts, Herba Taxilli 15 parts, Herba Clematidis loureirianae 10 parts, Radix calophylli membranacei 15 parts, Herba speranskiae cantonensis 12 parts, Fructus Schisandrae Chinensis 5 parts.
Preparation method: take ground fruit, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis by prescription, add 7 times amount water, decoct and extract 2 times, each 1.5 hours, merging filtrate, filter, it is concentrated into relative density 1.12 (60 DEG C of surveys), place to room temperature, add ethanol and make alcohol content reach 30%, stir evenly, it is placed in-5-0 DEG C of cold preservation 12 hours, filtering, decompression filtrate recycling ethanol is to without, after alcohol taste, being concentrated into dry, it is ground into fine powder, capsule is made according to galenic pharmacy routine techniques, every 0.3g, be equivalent to there is crude drug 1.4g.
Embodiment 2 capsule
Prescription: ground fruit 20 parts, Radix Triplostegiae Grandiflorae 32 parts, Radix cynanchi wilfordii 15 parts, Herba Taxilli 13 parts, Herba Clematidis loureirianae 8 parts, Radix calophylli membranacei 12 parts, Herba speranskiae cantonensis 10 parts, Fructus Schisandrae Chinensis 5 parts.
Preparation method: take ground fruit, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis by prescription, add 4 times amount water, decoct and extract 3 times, each 1.5 hours, merging filtrate, filter, be concentrated into relative density 1.10 (60 DEG C of surveys), place to room temperature, adding ethanol makes alcohol content reach 30%, stir evenly, be placed in-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is to without after alcohol taste, it is concentrated into dry, is ground into fine powder, make capsule according to galenic pharmacy routine techniques.
Embodiment 3 capsule
Prescription: ground fruit 22 parts, Radix Triplostegiae Grandiflorae 33 parts, Radix cynanchi wilfordii 15 parts, Herba Taxilli 15 parts, Herba Clematidis loureirianae 8 parts, Radix calophylli membranacei 17 parts, Herba speranskiae cantonensis 10 parts, Fructus Schisandrae Chinensis 4 parts.
Preparation method: take ground fruit, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis by prescription, add 8 times amount water, decoct and extract 2 times, each 2 hours, merging filtrate, filter, it is concentrated into relative density 1.15 (60 DEG C of surveys), places to room temperature, add ethanol and make alcohol content reach 30%, stir evenly, being placed in-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is to without after alcohol taste, it is concentrated into dry, is ground into fine powder；Capsule is made according to galenic pharmacy routine techniques.
Embodiment 4 capsule
Prescription: ground fruit 26 parts, Radix Triplostegiae Grandiflorae 305 parts, Radix cynanchi wilfordii 20 parts, Herba Taxilli 13 parts, Herba Clematidis loureirianae 12 parts, Radix calophylli membranacei 12 parts, Herba speranskiae cantonensis 13 parts, Fructus Schisandrae Chinensis 5 parts.
Preparation method: take ground fruit, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis by prescription, add 10 times amount water, decoct and extract 2 times, each 2.5 hours, merging filtrate, filter, be concentrated into relative density 1.13 (60 DEG C of surveys), place to room temperature, adding ethanol makes alcohol content reach 30%, stir evenly, be placed in-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is to without after alcohol taste, it is concentrated into dry, is ground into fine powder, make capsule according to galenic pharmacy routine techniques.
Embodiment 5 capsule
Prescription: ground fruit 25 parts, Radix Triplostegiae Grandiflorae 30 parts, Radix cynanchi wilfordii 20 parts, Herba Taxilli 12 parts, Herba Clematidis loureirianae 12 parts, Radix calophylli membranacei 15 parts, Herba speranskiae cantonensis 13 parts, Fructus Schisandrae Chinensis 6 parts.
Preparation method: take ground fruit, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis by prescription, add 6 times amount water, decoct and extract 2 times, each 2 hours, merging filtrate, filter, be concentrated into relative density 1.12 (60 DEG C of surveys), place to room temperature, adding ethanol makes alcohol content reach 30%, stir evenly, be placed in-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is to without after alcohol taste, it is concentrated into dry, is ground into fine powder, make capsule according to galenic pharmacy routine techniques.
Embodiment 6 capsule
Prescription: ground fruit 26 parts, Radix Triplostegiae Grandiflorae 30 parts, Radix cynanchi wilfordii 18 parts, Herba Taxilli 17 parts, Herba Clematidis loureirianae 7 parts, Radix calophylli membranacei 17 parts, Herba speranskiae cantonensis 10 parts, Fructus Schisandrae Chinensis 7 parts.
Preparation method: take ground fruit by prescription, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis add 8 times amount water, decoct extraction 2 times, when each 1, merging filtrate, filters, is concentrated into relative density 1.12 (60 DEG C of surveys), place to room temperature, add ethanol and make alcohol content reach 30%, stir evenly, it is placed in-5-0 DEG C of cold preservation 12 hours, filtering, decompression filtrate recycling ethanol is to without, after alcohol taste, being concentrated into dry, it is ground into fine powder, makes capsule according to galenic pharmacy routine techniques.
Embodiment 7 granule
Prescription: ground fruit 25 parts, Radix Triplostegiae Grandiflorae 35 parts, Radix cynanchi wilfordii 18 parts, Herba Taxilli 15 parts, Herba Clematidis loureirianae 10 parts, Radix calophylli membranacei 15 parts, Herba speranskiae cantonensis 12 parts, Fructus Schisandrae Chinensis 5 parts.
Preparation method: take ground fruit by prescription, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis add 7 times amount water, decoct and extract 2 times, each 1.5 hours, merging filtrate, filter, be concentrated into relative density 1.13 (60 DEG C of surveys), place to room temperature, adding ethanol makes alcohol content reach 30%, stir evenly, be placed in-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is to without after alcohol taste, it is concentrated into dry, is ground into fine powder, make tablet according to galenic pharmacy routine techniques, every tablet weight 0.4g, is equivalent to crude drug 1.0g.
Embodiment 8 granule
Prescription: ground fruit 23 parts, Radix Triplostegiae Grandiflorae 30 parts, Radix cynanchi wilfordii 17 parts, Herba Taxilli 12 parts, Herba Clematidis loureirianae 10 parts, Radix calophylli membranacei 15 parts, Herba speranskiae cantonensis 12 parts, Fructus Schisandrae Chinensis 5 parts.
Preparation method: take ground fruit by prescription, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis add 6 times amount water, decoct and extract 3 times, each 2 hours, merging filtrate, filter, be concentrated into relative density 1.10-1.15 (60 DEG C of surveys), place to room temperature, adding ethanol makes alcohol content reach 30%, stir evenly, be placed in-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is to without after alcohol taste, it is concentrated into dry, is ground into fine powder, make granule according to galenic pharmacy routine techniques, every bag of weight 10g, is equivalent to crude drug 6.0g.
Embodiment 9 clinical observation is tested
1 clinical data and method
1.1 physical data: choose in December ,-2014 in January, 2014 the court early stage Threatened Abortion with Subchorionic Hematoma patient, totally 94 example, 22～40 years old age, 29.5 years old mean age, previously miscarriage (including drug induced abortion, artificial abortion and inevitable abortion) is up to 5 times, equal abortion times is 1.56 times, 6～12 weeks pregnant ages, average pregnant week (9.5 ± 1.4) week, employing is random is divided into treatment group and matched group by digits table with 1:1, the treatment group mean age (29.3 ± 3.58) year, pregnant week (9.2 ± 1.3) week；The matched group mean age (29.8 ± 3.86) year, pregnant week (9.7 ± 1.6) week, 2 groups of equal not statistically significants of physical data comparing difference (P > 0.05), there is comparability.
1.2 diagnosis marks,
1.2.1 early stage threatened abortion standard: " new Chinese medicine guideline of clinical investigations " and happy outstanding 6th edition " obstetrics and gynecology " the early stage threatened abortion diagnostic criteria with reference to the revision in 2002 of national drug food surveillance authority is as follows: 1. have menolipsis history and morning sickness；2. vagina is hemorrhage on a small quantity, or with lower abdomen pendant pain or soreness of waist pain；3. urine pregnancy test is positive；4. cervical orifice is not opened, and body of uterus is soft, size and pregnant Zhou Xiangfu；5. B ultrasonic shows there is opaque dark area of fluid around pregnant capsule, and form is not fixed, and pregnant capsule or fetus are consistent in month with gestation.
1.2.2SCH diagnostic criteria is with reference to " the ultrasonic collection of illustrative plates of department of obstetrics and gynecology " (version in 2005, TIANJINKEJIFANYICHUBANGONGSI publishes PeterM.Doubilet&CarolBBenson and writes, Chen Tiefu, Sun Qian, and Liu Diwen translates).
1.2.3 Syndrome Differentiation of Traditional Chinese Medicine standard: " new Chinese medicine guideline of clinical investigations " and Zhang Yuzhen " Gynecology of Chinese Medicine " with reference to the revision in 2002 of national drug food surveillance authority formulate YinXuXueRe folder Blood stasis: primary symptom: just a small amount of colporrhagia, color is light dim；Abdomen pendant pain, the soreness of waist is stranded；Secondary card: soreness of the waist and knees, mental weariness；Dizziness and tinnitus, frequent urination at night；Complexion is intensely dark, and eye socket is dark；There are ecchymosis, stringy and rolling pulse or fine and smooth, CHI-pulse being weak in tongue dimness or limit.Symptom score standard according to symptom degree without, light, in, heavily classification, its corresponding score value respectively 0,1,2,3 points, every symptom score sum is total score, and total score has 18 points, and score is more high, then symptom is more heavy.
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: in meeting, Western medicine diagnose standard；Accept this researcher voluntarily；Age is between 20～40 years old.
1.4 case exclusion standards: with reference to " the new Chinese medicine guideline of clinical investigations " of the revision in 2002 of national drug food surveillance authority: (1) age > 40 years old or < 20 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: treatment group: the capsule of the oral embodiment of the present invention 1 preparation, every day 2 times, each 3-6 grain, take after meal, serve on 7 days half an hour, if the 8th day detection SCH does not disappear, then continue to serve on 7 days.
Matched group: oral dydrogesterone sheet, each 10mg, every day 2 times, is used in conjunction 14 days.
Two groups of patients, during treating, certainly treat the 1st, 8,15 days respectively 1 both transvaginal ultrasonography of detection, β-HCG and P values, understand embryo and hematoma situation of change, advise it to lie up, forbid sexual life, and bleeding can out-of-bed activity after stopping 1 week.In monitoring process, if according to B ultrasonic or blood HCG, P numerical value prompting embryo diapause, then processing by spontaneous abortion.
1.6 observation index:
1.6.1 clinical symptoms: the symptoms such as colporrhagia, stomachache, the soreness of waist, sagging distention in the smaller abdomen；Calculate symptom score before and after treatment；
1.6.2 the maximum cross section area change of SCH before and after treatment, adopts my institute's same type color Doppler ultrasound per vaginam by same people；
1.6.3 the change of blood HCG, P value；
1.6.4 safety observations: have no adverse reaction during observing each group of medication, each group after before the treatment all carries out hepatic and renal function, hematuria routine examination；
1.7 efficacy assessment standards: 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: recovery from illness: colporrhagia is only, the transference cures such as stomachache, the soreness of waist, ultrasonic prompting SCH disappears, fetal development is normal, and progesterone value reaches the gestation range of normal value same period；Taking a turn for the better: colporrhagia reduces, the symptom such as stomachache, the soreness of waist is improved, and ultrasonic prompting SCH area reduces, and normally, progesterone value reaches the gestation range of normal value same period to fetal development；Invalid: colporrhagia has no minimizing, the symptom such as stomachache, the soreness of waist has no improvement, and ultrasonic monitoring is for having miscarried or embryo diapause, opaque dark area of fluid enlarged areas around pregnant capsule.??
1.8 statistical methods: adopt SPSS15.0 statistical software to be calculated.Each numerical value withRepresenting, measurement data adopts t inspection, and enumeration data adopts χ2Inspection, statistically significant for difference with P < 0.05.
2 results
The comparisons of 2.1 liang of clinical total effectses of group: treatment group is fully recovered 30 examples, take a turn for the better 15 examples, invalid 2 examples, matched group is fully recovered 13 examples, take a turn for the better 25 examples, no effect 9, treatment group and matched group total effective rate respectively 95.7% and 80.9%, 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.
SCH Area comparison before and after 2.2 liang of group patient treatments: treat front two groups of patients's SCH area discrepancy not statistically significant (P > 0.05) and there is comparability.Before after treatment, treatment group patient SCH area is significantly smaller than treatment, difference statistically significant (P < 0.01), comparing difference statistically significant (P < 0.05) before and after treatment of control group, comparing difference statistically significant (P < 0.01) between two groups after treatment, treatment group patient's SCH area is significantly smaller than matched group.In Table 2.
SCH Area comparison (cm before and after 2 liang of table group patient treatment2,)
Note: compare with before treatment, * P < 0.05, * * P < 0.05；Compare the same period with matched group,#P < 0.01.
2.3 liang of group patients compare the colporrhagia time: result is as shown in table 3, and treatment group patient is considerably shorter than matched group, different statistically significant (P < 0.05) the colporrhagia time.
3 liang of table group patient compare the colporrhagia time
Note: compare with matched group, * P < 0.05.
Before and after 2.4 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 4.
4 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.
2.5 safeties and follow up a case by regular visits to situation: patient carries out hepatic and renal function to each group before the treatment afterwards, hematuria routine examination is showed no obvious abnormalities, and also has no obvious adverse reaction.In the 45 example patients that treatment group is therapeutically effective, 1 example is lost to follow-up, 1 example premature labor, all mature production of all the other patients, healthy without deformity, does not occur that placental abruption, Placenta Hominis are adhered and the related complication such as postpartum hemorrhage.Illustrate that our clinical application is safe and reliable, and be better than routine of western medicine therapy.
Claims (10)
1. the pharmaceutical preparation treating early stage Threatened Abortion with Subchorionic Hematoma, it is characterised in that be that medicinal raw material is made by ground fruit, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis.
2. pharmaceutical preparation as claimed in claim 1, it is characterised in that be made up of the medicinal raw material of following weight: ground fruit 20-26 part, Radix Triplostegiae Grandiflorae 30-35 part, Radix cynanchi wilfordii 15-20 part, Herba Taxilli 12-17 part, Herba Clematidis loureirianae 7-12 part, Radix calophylli membranacei 12-17 part, Herba speranskiae cantonensis 8-13 part, Fructus Schisandrae Chinensis 4-7 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: ground fruit 25 parts, Radix Triplostegiae Grandiflorae 35 parts, Radix cynanchi wilfordii 18 parts, Herba Taxilli 15 parts, Herba Clematidis loureirianae 10 parts, Radix calophylli membranacei 15 parts, Herba speranskiae cantonensis 12 parts, Fructus Schisandrae Chinensis 5 parts.
4. the pharmaceutical preparation as described in as arbitrary in claim 1-3, it is characterized in that preparation method comprises the steps: to take ground fruit by prescription, Radix Triplostegiae Grandiflorae, Radix cynanchi wilfordii, Herba Taxilli, Herba Clematidis loureirianae, Radix calophylli membranacei, Herba speranskiae cantonensis, Fructus Schisandrae Chinensis add 2-10 times amount water, decoct and extract 1-3 time, each 1-3 hour, merging filtrate, filter, it is concentrated into relative density 1.10-1.15 (60 DEG C of surveys), places to room temperature, add ethanol and make alcohol content reach 30%, stir evenly, being placed in-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol is to without after alcohol taste, it is concentrated into dry, is ground into fine powder；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 is preferably made peroral dosage form.
6. pharmaceutical preparation as claimed in claim 5, it is characterised in that described peroral dosage form is preferably tablet, film coated tablet, capsule, hard capsule, oral liquid, granule, honey pill agent, powder, sublimed preparation, solution.
7. pharmaceutical preparation as claimed in claim 6, it is characterised in that described peroral dosage form is preferably tablet, capsule or granule.
8. pharmaceutical preparation as claimed in claim 7, it is characterised in that described peroral dosage form is preferably capsule.
9. claim 1-3 arbitrary described pharmaceutical preparation purposes in preparation treatment early stage Threatened Abortion with Subchorionic Hematoma medicine.
10. claim 1-3 arbitrary described pharmaceutical preparation purposes in preparation treatment early stage Threatened Abortion with Subchorionic Hematoma blood stasis due to renal deficiency disease drug.
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| Application Number | Priority Date | Filing Date | Title |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610204311.9A CN105796672A (en) | 2016-04-05 | 2016-04-05 | Medicinal preparation for treating early threatened abortion complicated with SCH (sub-chorionic hematoma) |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102697949A (en) * | 2012-06-05 | 2012-10-03 | 李承平 | Qi-blood replenishing tablet |
| CN104436121A (en) * | 2014-11-24 | 2015-03-25 | 夏静 | Medicine for treating irregular menstruation, lower abdominal distension and persistent failure to conceive |
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2016
- 2016-04-05 CN CN201610204311.9A patent/CN105796672A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102697949A (en) * | 2012-06-05 | 2012-10-03 | 李承平 | Qi-blood replenishing tablet |
| CN104436121A (en) * | 2014-11-24 | 2015-03-25 | 夏静 | Medicine for treating irregular menstruation, lower abdominal distension and persistent failure to conceive |
Non-Patent Citations (1)
| Title |
|---|
| 南京中医药大学: "《中药大辞典 上册 第二版》", 31 March 2006, 上海科学技术出版社 * |
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