CN105748997A - Pharmaceutical composition for treating early threatened abortion with subchorionic hematoma - Google Patents
Pharmaceutical composition for treating early threatened abortion with subchorionic hematoma Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicine, and relates to a pharmaceutical composition for treating early threatened abortion with subchorionic hematoma and a preparation method thereof.The pharmaceutical composition is elaborately prepared by taking Chinese holly leaves, colla corii asini, semen cuscutae, radix dipsaci, sunflower discs, herb of lagopsis supina (Steph.)IK.-Gal., tuber fleeceflower stems, herb of euphorbia prostrata Ait.and herba lycopi as pharmaceutical raw materials according to a certain weight proportion.The pharmaceutical composition is reasonable in prescription and considerate in medication, has the effects of enriching yin and nourishing the kidney, nourishing the blood and clearing the liver and eliminating heat and harmonizing ying qi, has the obvious advantages on increasing the miscarriage prevention effective rate, promoting subchorionic hematoma absorption, shortening the vaginal bleeding time and the like compared a Western medicine group, achieves syndrome differentiation medication for traditional Chinese medicine symptoms and has the unexpected technical effects.
Description
Technical field
The invention belongs to tcm field, relate to a kind of pharmaceutical composition treating early stage Threatened Abortion with Subchorionic Hematoma and preparation method thereof.
Background technology
Early stage threatened abortion is the commonly encountered diseases of department of obstetrics and gynecology, account for the 15% of gestation, refer to that gestation occurred before 12 weeks hemorrhage on a small quantity with vagina, companion's lower abdomen pendant pain or soreness of waist pain etc. are the disease of main clinical manifestation, early stage threatened abortion wishes to continue to gestation through having a rest and still having after treatment, if but do not give attention, then it would be likely to develop into inevitable abortion.
Subchorionic hematoma (SCH) is the special pathology of one of early pregnancy, refer to that chorionic plate separates with decidua basalis hemorrhage, make accumulation of blood between chorion and decidua basalis, B ultrasonic display echoless or hypoechoic opaque dark area of fluid, often in crescent, surround part gestation sac, its many communicating with internal cervical orifice of hematoma lower edge and colporrhagia occurs, the appearance of Subchorionic hematoma adds rate of spontaneous abortion, increases difficulty of preventing miscarriage.Owing to SCH mechanism is still unclear, adopt is lain up more clinically, gives the Drug therapys such as progestogen, and curative effect is not satisfied.
Early stage threatened abortion merges SCH and belongs to the category of traditional Chinese medical science vaginal bleeding during pregnancy, frequent fetal movement, it is generally acknowledged that the many blood stasis etc. 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 are relevant, as correctly treated not in time, often can develop into induced abortion, abortion or concurrent diapause, directly affect the normal development of fetus and the physical and mental health of anemia of pregnant woman.Therefore, find preventing and treating early stage threatened abortion merging SCH safely and effectively method to be particularly important.
Summary of the invention
ZHU Dan-xi was once called: " it is many for thinking the tire void person that falls in interior-heat.Saying heat and say void, when a point weight, cover pregnant to March, upper symbolic animal of the birth year fire, so easily falling." its overabundant heat is because of " married woman has pregnant, hinders spleen, and transporting is late raw wet, humidogene heat " (" female section is through opinion ").Simultaneously sprouting tire because pregnant rear blood is poly-, liver is become homeless use, and edema with the liver involved presses down and do not reach, and liver is without being hidden, if in love will is not relaxed or flares up, then and fire movability mutually, fire of suffering from a deficiency of the kidney is dynamic, and the vaginal bleeding during pregnancy that arrives, frequent fetal movement, even have an abortion."Fu Qingzhu works on obstetric" is cloud also: " bosom of married woman is pregnant also generally, relies kidney water to sprout tire, insufficient water sources, then fire easily boiling ... extreme misery two is sick, and tire can not be consolidated and falls." inventor sums up and thinks: if tire loses, kidney water is supports, then raw in deficiency-heat, so-called having a surplus of fire is deficiency of kidney-YIN, yin deficiency heat in blood; kidney yin is by burning, and heat is disturbed punching and appointed, and disease causes the stasis of blood for a long time, forms kidney asthenia as the principal aspect; the pathomechanism that the punching of yin asthenia generating intrinsic heat, blood stasis is appointed, and youngster's tire is forced, must also uneasiness.
Inventor is on the basis of recipe handed down from ancestors, learn 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, it is provided that a kind of curative effect is determined, side effect little can treating both the principal and secondary aspects of a disease early stage Threatened Abortion with Subchorionic Hematoma pharmaceutical composition.
The present invention adopts the following technical scheme that:
A kind of pharmaceutical composition treating early stage Threatened Abortion with Subchorionic Hematoma, it is that medicinal raw material is made by Folium Mahoniae, Colla Corii Asini, Semen Cuscutae, Radix Dipsaci, floral disc of sunflower, Herba lagopsis supinae, Caulis Polygoni Multiflori, Herba euphorbiae prostratae, Herba Lycopi.
Inventor is it is preferred that go out below scheme: a kind of pharmaceutical composition treating early stage Threatened Abortion with Subchorionic Hematoma, it is made up of the medicinal raw material of following weight: Folium Mahoniae 15-20 part, Colla Corii Asini 25-30 part, Semen Cuscutae 10-15 part, Radix Dipsaci 10-15 part, floral disc of sunflower 20-25 part, Herba lagopsis supinae 13-18 part, Caulis Polygoni Multiflori 8-13 part, Herba euphorbiae prostratae 15-20 part, Herba Lycopi's 7-12 part.
Further,: a kind of pharmaceutical composition treating early stage Threatened Abortion with Subchorionic Hematoma, it is made up of the medicinal raw material of following weight: Folium Mahoniae 18 parts, 25 parts of Colla Corii Asini, Semen Cuscutae 12 parts, Radix Dipsaci 10 parts, floral disc of sunflower 25 parts, Herba lagopsis supinae 15 parts, Caulis Polygoni Multiflori 12 parts, Herba euphorbiae prostratae 15 parts, Herba Lycopi 10 parts.
Modern pharmacological research shows, some removing heat from blood, blood stasis dispelling, dredging collateral Chinese medicine can stop thrombosis, improve Placenta Hominis microcirculation, but the pregnancy period use blood circulation promoting medicine probably to cause miscarriage.Inventor sum up think relatively suffer from a deficiency of the kidney and asthenia of both the spleen and kidney etc. suffer from a deficiency of the kidney be the congenital of master or the first day after tomorrow all deficient person, this type is the card of simulataneous insufficiency and excessive, and not as the first day after tomorrow deficient person's disease very, so-called " mother-qi is strong to be contained, and the stoppage of growth of the fetus is had a surplus ", therefore tire damages and easily helps, fetal movement is easily pacified；Therefore for the early stage Threatened Abortion with Subchorionic Hematoma that YinXuXueRe blood stasis causes, should with enriching yin and nourishing kidney, liver heat removing of nourishing blood, expel the heat-evil and flourish for the main method for the treatment of rule for the treatment of, blood circulation promoting medicine can less with even without, also can obtain significant effect.Fang Zhong: Folium Mahoniae hardship is cool, kind tonic cloudy gas, clearing away heat and nourishing YIN, suppressing the hyperactive liver kidney tonifying；Colla Corii Asini is sweet flat, replenishing blood and nourishing liver, and tonifying YIN grows water, heat clearing away, hemostasis, and two medicine 5 tonifying kidney-yins, kidney nourishing water, nourishing the liver blood, removing heat from the liver, for monarch drug.Floral disc of sunflower is apt to heat clearing away suppressing the hyperactive liver, it is intended that protect the moon, pain relieving, and hemostasis is cold and moistens；Herba lagopsis supinae nourshing blood and promoting blood circulation, clearing away heat-damp and promoting diuresis, two medicine 5 use, nourshing blood and promoting blood circulation, clearing away heat-damp and promoting diuresis, make stagnant heat go with water, righting of getting rid of evils, for ministerial drug.The sweet temperature of Semen Cuscutae, tonifying kidney and nourishing liver, warming the spleen helps stomach, flat nourishing YIN sun, with monarch drug 5 with can conditioning human body equilibrium between yin and yang, make monarch drug mend and not stagnant, Radix Dipsaci toil tepor, can invigorating the liver and kidney, bone and muscle strengthening, continuous injured, Gu Chong appoints, and Caulis Polygoni Multiflori is apt to tranquilizing by nourishing the heart, dispels the wind, network of passing through, promoting blood circulation；Herba euphorbiae prostratae clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body；Herba Lycopi's toil tepor, enters spleen row water, enters liver and controls blood, and row water repercussive, for adjuvant.
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.
Folium Mahoniae: [nature and flavor] are bitter；Cool.[return through] liver；Kidney channel.[function cures mainly] clearind deficient heat；Liver and kidney tonifying；Wind-damp dispelling.Main hectic fever due to deficiency of YIN；Cough spitting of blood；Have a dizzy spell；Soreness of the waist and knees；Rheumatic arthralgia；Vitiligo.[usage and dosage] takes orally: decoct soup, 9-15g.External: appropriate, smashes juice or endures cream coating.
Semen Cuscutae: [nature and flavor] are sweet, temperature.[return through] returns liver,kidney,spleen warp.[function cures mainly] nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.For impotence and seminal emission, dripping urination, enuresis frequent micturition, soreness of the waist and knees, blurred vision tinnitus, vaginal bleeding due to deficiency of the kidney during pregnancy, frequent fetal movement, spleen is suffered from a deficiency of the kidney and is rushed down；Externally treating leucoderma.[usage and dosage] 6～12g；Suitable amount used externally.
Colla Corii Asini: [nature and flavor] are sweet is flat.[return through] returns lung, liver, kidney channel.[function cures mainly] is enriched blood YIN nourishing, is moisturized, hemostasis.For blood deficiency and yellow complexion, dizziness cardiopalmus, flesh flaccidity is unable, dysphoria and insomnia, stirring-up of pathogenic wind in the interior resulting from deficiency, xeropulmonary cough, and chronic cough is spat blood, haematemesis hematuria, metrorrhagia of having blood in stool, vaginal bleeding during pregnancy.[usage and dosage] molten takes, 3～9g.
Floral disc of sunflower: [nature and flavor] sweet in the mouth；Cold in nature.[return through] returns Liver Channel.[function cures mainly] heat clearing away；Suppressing the hyperactive liver；Pain relieving；Hemostasis.Main hypertension；Headache；Dizzy；Tinnitus；Abdominal pain；Dysmenorrhea；Metrorrhagia；Skin ulcer rash.[usage and dosage] takes orally: decoct soup, 15-60g.External: appropriate, smashes deposited；Or levigation applies.
Herba lagopsis supinae: [nature and flavor] acrid in the mouth；Micro-hardship；Cold in nature.[return through] returns Liver Channel.[function cures mainly] nourshing blood and promoting blood circulation；Clearing away heat-damp and promoting diuresis.Main menoxenia；Puerperal the stagnant stomachache of the stasis of blood；Blood deficiency is dizzy；It is unsuccessful partly to penetrate；Traumatic injury；Edema；Dysuria；Conjunctival congestion and swelling pain；Carbuncle sore；Chilblain；Toothache；Erythra pruritus.[usage and dosage] takes orally: decoct soup, 9-12g；Or endure cream.
Caulis Polygoni Multiflori: [nature and flavor] hardship sweet, micro-, property is put down.[return through] heart, Liver Channel.[function cures mainly] tranquilizing by nourishing the heart, dispels the wind, dredging collateral.Main insomnia, dreaminess, blood deficiency general pain, numbness of the skin, rheumatic arthralgia, rubella pruritus.[usage and dosage] takes orally: decoct soup, 10～20g.External: appropriate, decocts washing；Or mash deposited.
Radix Dipsaci: [nature and flavor] are bitter, pungent, tepor.[return through] returns liver, kidney channel.[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, continuous injured, only metrorrhagia.For soreness of the waist and knees, rheumatic arthralgia, metrorrhagia, vaginal bleeding during pregnancy, injury from falling down.Prepared RADIX DIPSACI with yellow rice wine is used for rheumatic arthralgia, injury from falling down.Prepared RADIX DIPSACI with salt solution is used for soreness of the waist and knees.[usage and dosage] 9～15g.
Herba euphorbiae prostratae: [nature and flavor] are lightly seasoned；Cool in nature.[return through] enters Liver Channel.[function cures mainly] clearing away heat-damp and promoting diuresis；Removing pathogenic heat from blood and toxic substance from the body；Lactogenic.Main dysentery；Have loose bowels；Diphtheria；Milk is rare；Bleeding from the gum；Have blood in stool；Nebulousurine；Hematuria；Herpes zoster；Carbuncle furuncle；Eczema.[usage and dosage] takes orally: decoct soup, fresh goods 30-60g；Or smash juice.External: appropriate, fresh goods is smash deposited.
Herba Lycopi: [nature and flavor] are bitter, pungent, tepor.[return through] returns liver, spleen channel.[function cures mainly] blood circulation promoting and blood stasis dispelling, line water detumescence.For menoxenia, amenorrhea, dysmenorrhea, postnatal blood stasis is suffered from abdominal pain, edema.
In order to express the pharmaceutical composition of the present invention better, pharmaceutical composition of the present invention can be active component by Folium Mahoniae, Colla Corii Asini, Semen Cuscutae, Radix Dipsaci, floral disc of sunflower, Herba lagopsis supinae, Caulis Polygoni Multiflori, Herba euphorbiae prostratae, Herba Lycopi or its water or its extractive with organic solvent, adds pharmaceutically acceptable carrier and is prepared from.
Further, a kind of method of pharmaceutical composition preparing treatment early stage Threatened Abortion with Subchorionic Hematoma, the method comprises the steps:
(1) take Herba lagopsis supinae by prescription, Caulis Polygoni Multiflori adds 2-10 times amount 75% ethanol, reflux, extract, twice, each 1-3 hour, filters, merges twice filtrate, and decompression recycling ethanol is to obtaining ethanol extraction without alcohol taste, standby；
(2) Folium Mahoniae, Semen Cuscutae, Radix Dipsaci, floral disc of sunflower, Herba euphorbiae prostratae, Herba Lycopi are taken by prescription, merge with filtering residue after Herba lagopsis supinae, Caulis Polygoni Multiflori ethanol extraction, add 2-10 times amount water, decoct and extract 1-3 time, each 1-3 hour, merging filtrate, filters, 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%, stirs evenly ,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol to merging with step (1) ethanol extraction without after alcohol taste, continues to be evaporated to dry, is ground into fine powder；
(3) take Colla Corii Asini by prescription, be ground into fine powder, mix homogeneously with the fine powder of step (2), make according to galenic pharmacy routine techniques.
Pharmaceutical composition 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 composition described above is preferably made as tablet, capsule or granule, it is most preferred that for capsule.
The present invention is also claimed aforementioned pharmaceutical compositions purposes in preparation treatment early stage threatened abortion medicine.Pharmaceutical composition 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 YinXuXueRe blood stasis, 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, meeting Chinese medicine and pharmacy and modern medicine theory, comprehensively, medication is thoughtful in legislation, play special effect, there are enriching yin and nourishing kidney, liver heat removing of nourishing blood, expel the heat-evil and Rong Zhixiao, in antiabortive effective percentage, promotion Subchorionic hematoma absorption, shortening colporrhagia time etc., all relatively Western medicine group has a clear superiority in, and has unexpected technique effect.
Drug for invigorating blood circulation and eliminating stasis used by a prescription of the present invention or medicine is dual-purpose or a medicine is multiplex, consumption is few, and can receive satisfied therapeutic effect, wide popularization and application on clinic.
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: Folium Mahoniae 18 parts, 25 parts of Colla Corii Asini, Semen Cuscutae 12 parts, Radix Dipsaci 10 parts, floral disc of sunflower 25 parts, Herba lagopsis supinae 15 parts, Caulis Polygoni Multiflori 12 parts, Herba euphorbiae prostratae 15 parts, Herba Lycopi 10 parts.
Preparation method: (1) takes Herba lagopsis supinae by prescription, Caulis Polygoni Multiflori adds 2-10 times amount 75% ethanol, reflux, extract, twice, each 1-3 hour, filters, merges twice filtrate, and decompression recycling ethanol is to obtaining ethanol extraction without alcohol taste, standby；
(2) Folium Mahoniae, Semen Cuscutae, Radix Dipsaci, floral disc of sunflower, Herba euphorbiae prostratae, Herba Lycopi are taken by prescription, merge with filtering residue after Herba lagopsis supinae, Caulis Polygoni Multiflori ethanol extraction, add 2-10 times amount water, decoct and extract 1-3 time, each 1-3 hour, merging filtrate, filters, 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%, stirs evenly ,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol to merging with step (1) ethanol extraction without after alcohol taste, continues to be evaporated to dry, is ground into fine powder；
(3) take Colla Corii Asini by prescription, be ground into fine powder, mix homogeneously with the fine powder of step (2), make capsule according to galenic pharmacy routine techniques.Every weight 0.40g, is equivalent to crude drug 1.2g.
Embodiment 2 capsule
Prescription: Folium Mahoniae 15 parts, 25 parts of Colla Corii Asini, Semen Cuscutae 10 parts, Radix Dipsaci 12 parts, floral disc of sunflower 20 parts, Herba lagopsis supinae 15 parts, Caulis Polygoni Multiflori 10 parts, Herba euphorbiae prostratae 15 parts, Herba Lycopi 8 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 3 capsule
Prescription: Folium Mahoniae 18 parts, 28 parts of Colla Corii Asini, Semen Cuscutae 15 parts, Radix Dipsaci 10 parts, floral disc of sunflower 20 parts, Herba lagopsis supinae 13 parts, Caulis Polygoni Multiflori 13 parts, Herba euphorbiae prostratae 15 parts, Herba Lycopi 10 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 4 capsule
Prescription: Folium Mahoniae 20 parts, 25 parts of Colla Corii Asini, Semen Cuscutae 10 parts, Radix Dipsaci 12 parts, floral disc of sunflower 20 parts, Herba lagopsis supinae 15 parts, Caulis Polygoni Multiflori 10 parts, Herba euphorbiae prostratae 18 parts, Herba Lycopi 10 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 5 capsule
Prescription: Folium Mahoniae 20 parts, 30 parts of Colla Corii Asini, Semen Cuscutae 15 parts, Radix Dipsaci 10 parts, floral disc of sunflower 25 parts, Herba lagopsis supinae 16 parts, Caulis Polygoni Multiflori 13 parts, Herba euphorbiae prostratae 15 parts, Herba Lycopi 12 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 6 capsule
Prescription: Folium Mahoniae 16 parts, 26 parts of Colla Corii Asini, Semen Cuscutae 15 parts, Radix Dipsaci 15 parts, floral disc of sunflower 22 parts, Herba lagopsis supinae 15 parts, Caulis Polygoni Multiflori 10 parts, Herba euphorbiae prostratae 18 parts, Herba Lycopi 10 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 7 granule
Prescription: Folium Mahoniae 18 parts, 25 parts of Colla Corii Asini, Semen Cuscutae 12 parts, Radix Dipsaci 10 parts, floral disc of sunflower 25 parts, Herba lagopsis supinae 15 parts, Caulis Polygoni Multiflori 12 parts, Herba euphorbiae prostratae 15 parts, Herba Lycopi 10 parts.
Preparation method: (1) takes Herba lagopsis supinae by prescription, Caulis Polygoni Multiflori adds 2-10 times amount 75% ethanol, reflux, extract, twice, each 1-3 hour, filters, merges twice filtrate, and decompression recycling ethanol is to obtaining ethanol extraction without alcohol taste, standby；
(2) Folium Mahoniae, Semen Cuscutae, Radix Dipsaci, floral disc of sunflower, Herba euphorbiae prostratae, Herba Lycopi are taken by prescription, merge with filtering residue after Herba lagopsis supinae, Caulis Polygoni Multiflori ethanol extraction, add 2-10 times amount water, decoct and extract 1-3 time, each 1-3 hour, merging filtrate, filters, 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%, stirs evenly ,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol to merging with step (1) ethanol extraction without after alcohol taste, continues to be evaporated to dry, is ground into fine powder；
(3) take Colla Corii Asini by prescription, be ground into fine powder, mix homogeneously with the fine powder of step (2), make granule according to galenic pharmacy routine techniques.Every bag of weight 5.0g, is equivalent to crude drug 5.0g.
Embodiment 8 tablet
Prescription: Folium Mahoniae 18 parts, 25 parts of Colla Corii Asini, Semen Cuscutae 12 parts, Radix Dipsaci 10 parts, floral disc of sunflower 25 parts, Herba lagopsis supinae 15 parts, Caulis Polygoni Multiflori 12 parts, Herba euphorbiae prostratae 15 parts, Herba Lycopi 10 parts.
Preparation method: (1) takes Herba lagopsis supinae by prescription, Caulis Polygoni Multiflori adds 2-10 times amount 75% ethanol, reflux, extract, twice, each 1-3 hour, filters, merges twice filtrate, and decompression recycling ethanol is to obtaining ethanol extraction without alcohol taste, standby；
(2) Folium Mahoniae, Semen Cuscutae, Radix Dipsaci, floral disc of sunflower, Herba euphorbiae prostratae, Herba Lycopi are taken by prescription, merge with filtering residue after Herba lagopsis supinae, Caulis Polygoni Multiflori ethanol extraction, add 2-10 times amount water, decoct and extract 1-3 time, each 1-3 hour, merging filtrate, filters, 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%, stirs evenly ,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol to merging with step (1) ethanol extraction without after alcohol taste, continues to be evaporated to dry, is ground into fine powder；
(3) take Colla Corii Asini by prescription, be ground into fine powder, mix homogeneously with the fine powder of step (2), make tablet according to galenic pharmacy routine techniques.Every tablet weight 0.40g, is equivalent to crude drug 1.0g.
Embodiment 9 clinical observation is tested
1 clinical data and method
1.1 physical data: choose the court's in June ,-2014 in January, 2013 early stage Threatened Abortion with Subchorionic Hematoma patient, totally 104 example, 22～40 years old age, 30.5 years old mean age, previously miscarriage (including drug induced abortion, artificial abortion and inevitable abortion) is up to 5 times, equal abortion times is 1.34 times, 6～12 weeks pregnant ages, average pregnant week (8.8 ± 1.3) week, employing is random is divided into treatment group and matched group by digits table with 1:1, the treatment group mean age (30.3 ± 3.58) year, pregnant week (8.6 ± 1.2) week；The matched group mean age (30.8 ± 3.86) year, pregnant week (9.1 ± 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 Western medicine diagnose 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.
1.2.2 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: vagina on a small quantity hemorrhage, color is scarlet, matter is thick, stomachache, lower abdomen pendant pain, the soreness of waist；Secondary card: with vexed uneasiness, the palm of the hand is scorching hot, dry mouth and throat, constipation；Red tongue, yellow fur and do, stringy and rolling pulse or sliding number.Note: above syndrome main symptom is indispensable, one of adds item or two cards and namely tongue fur pulse condition is made a definite diagnosis.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 21 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 22～40 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 < 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: treatment group: the capsule of the oral embodiment of the present invention 1 preparation, every day 2 times, each 2-4 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.From treating the 1st, 8,15 days respectively 1 both transvaginal ultrasonography of detection, β-HCG and P values.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 33 examples, take a turn for the better 17 examples, invalid 2 examples, matched group is fully recovered 13 examples, take a turn for the better 29 examples, invalid 10 examples, treatment group and matched group total effective rate respectively 96.2% and 80.8%, 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).After treatment, treatment group patient SCH area is significantly smaller than matched group, and difference statistically significant (P < 0.05), in Table 2.
SCH Area comparison (cm before and after 2 liang of table group patient treatment2,)
Note: compare with before treatment, * P < 0.01, 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 50 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 composition treating early stage Threatened Abortion with Subchorionic Hematoma, it is characterised in that be that medicinal raw material is made by Folium Mahoniae, Colla Corii Asini, Semen Cuscutae, Radix Dipsaci, floral disc of sunflower, Herba lagopsis supinae, Caulis Polygoni Multiflori, Herba euphorbiae prostratae, Herba Lycopi.
2. pharmaceutical composition as claimed in claim 1, it is characterised in that be made up of the medicinal raw material of following weight: Folium Mahoniae 15-20 part, Colla Corii Asini 25-30 part, Semen Cuscutae 10-15 part, Radix Dipsaci 10-15 part, floral disc of sunflower 20-25 part, Herba lagopsis supinae 13-18 part, Caulis Polygoni Multiflori 8-13 part, Herba euphorbiae prostratae 15-20 part, Herba Lycopi's 7-12 part.
3. pharmaceutical composition as claimed in claim 2, it is characterised in that be made up of the medicinal raw material of following weight: Folium Mahoniae 18 parts, 25 parts of Colla Corii Asini, Semen Cuscutae 12 parts, Radix Dipsaci 10 parts, floral disc of sunflower 25 parts, Herba lagopsis supinae 15 parts, Caulis Polygoni Multiflori 12 parts, Herba euphorbiae prostratae 15 parts, Herba Lycopi 10 parts.
4. one kind prepare as arbitrary in claim 1-3 as described in the method for pharmaceutical composition, it is characterised in that comprise the steps:
(1) take Herba lagopsis supinae by prescription, Caulis Polygoni Multiflori adds 2-10 times amount 75% ethanol, reflux, extract, twice, each 1-3 hour, filters, merges twice filtrate, and decompression recycling ethanol is to obtaining ethanol extraction without alcohol taste, standby；
(2) Folium Mahoniae, Semen Cuscutae, Radix Dipsaci, floral disc of sunflower, Herba euphorbiae prostratae, Herba Lycopi are taken by prescription, merge with filtering residue after Herba lagopsis supinae, Caulis Polygoni Multiflori ethanol extraction, add 2-10 times amount water, decoct and extract 1-3 time, each 1-3 hour, merging filtrate, filters, 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%, stirs evenly ,-5-0 DEG C of cold preservation 12 hours, filter, decompression filtrate recycling ethanol to merging with step (1) ethanol extraction without after alcohol taste, continues to be evaporated to dry, is ground into fine powder；
(3) take Colla Corii Asini by prescription, be ground into fine powder, mix homogeneously with the fine powder of step (2), make according to galenic pharmacy routine techniques.
5. the pharmaceutical composition as described in as arbitrary in claim 1-3, it is characterised in that described pharmaceutical composition is preferably made peroral dosage form.
6. pharmaceutical composition as claimed in claim 5, it is characterised in that described peroral dosage form is tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, granule, honey pill agent, powder, sublimed preparation, solution etc..
7. pharmaceutical composition as claimed in claim 6, it is characterised in that described peroral dosage form is preferably tablet, capsule or granule.
8. pharmaceutical composition as claimed in claim 7, it is characterised in that described peroral dosage form is preferably capsule.
9. claim 1-3 arbitrary described pharmaceutical composition purposes in preparation treatment early stage Threatened Abortion with Subchorionic Hematoma medicine.
10. claim 1-3 arbitrary described pharmaceutical composition purposes in preparation treatment early stage Threatened Abortion with Subchorionic Hematoma YinXuXueRe Blood stasis medicine.
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| 徐涟: "益气养血助冲培元法妇科临证运用", 《新中医》 * |
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Application publication date: 20160713 |