CN105709120A - Traditional Chinese medicine preparation for treating thrombophlebitis - Google Patents
Traditional Chinese medicine preparation for treating thrombophlebitis Download PDFInfo
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- CN105709120A CN105709120A CN201610269361.5A CN201610269361A CN105709120A CN 105709120 A CN105709120 A CN 105709120A CN 201610269361 A CN201610269361 A CN 201610269361A CN 105709120 A CN105709120 A CN 105709120A
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Abstract
The invention discloses a traditional Chinese medicine preparation for treating thrombophlebitis, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine preparation is prepared from motherwort, Chinese violet, red peony root, leech, scorpion, figwort root, oriental wormwood, coix seed, phellodendron bark, fiveleaf akebia, eupatorium, frankincense, myrrh, rhizoma pleionis, cape jasmine, stiff silkworm, rhizoma alismatis and licorice as raw materials. The traditional Chinese medicine preparation has obvious technical advantages of outstanding curative effect, high cure rate, very low side effect and the like in the aspect of treating thrombophlebitis; and the preparation method of the traditional Chinese medicine preparation is simple and easy, and the preparation is stable in medical effect. Therefore, the traditional Chinese medicine preparation is suitable for popularization and application to benefit more patients and create greater social values.
Description
Technical field
The invention belongs to technical field of Chinese medicines, relate to a kind of Chinese medicine preparation treating thrombophlebitis.
Background technology
Phlebitis (full name thrombophlebitis) refers to the acute aseptic inflammation of vein blood vessel, and different according to diseased region, phlebitis can be divided into superficial phlebitis and deep phlebitis.A few patients can have heating, total white blood cells to increase, and patient usually states pain and swelling.The cause of disease causing venous thrombosis is a lot, as wound, operation, gestation, childbirth, heart disease, malignant tumor, oral contraceptive and stand for a long time, squat down, sitting, lying on bed for a long time etc., more typically surgical site infections causes primary disease.
Vein input strong and stimulating, high concentration medicine or the time of use are longer, damage venous endothelial cell；Superficial veins varicose, blood stasis；Obesity, smoking, wound cause venous endothelial to damage；Antibacterial infection etc..After vein blood vessel inner film injury, forming thrombosis, rapidly result in the inflammatory reaction of whole piece superficial vein wall, even involve vein surrounding tissue, and have transudate, topical manifestations to have strand runner or the beading scleroma of pain, swelling and tenderness, general reaction is inconspicuous.
Phlebitis belongs to the disease categories such as traditional Chinese medical science BI-syndrome involved the blood vessels, arthralgia due to stagnation of blood, superficial obstructive phlebitis, swelling, muscular rheumatism, multiple abscess due to blood stasis, in being more common in, old people.Its clinical characters is affected part swelling, pain, stands or fatigue increases the weight of, and affected part color of the leather is deepened, skin temperature rise.Its pathogenesis is damp invasion of lower energizer, qi and blood stagnation and qi-blood disharmony and cause.Phlebitis can betide each position of health, is generally mainly in extremity, next to that chest and abdomen wall, minority is migrans outbreak.During unilateral morbidity, left side is more than right side.Thrombophlebitis, traditional Chinese medical science angle, is divided into three types according to the PD order of severity.
1, yang deficiency cold-condensing type (being equivalent to the first phase)
Suffering limb sends out cool, numb, local pallor, that touches is ice-cold, has paroxysmal ticpain.Light red tongue, tongue is white, deep-thready pulse.
The rule for the treatment of: warming YANG to expel cold, removing obstruction in the collateral to relieve pain.
2, blood stasis stagnated heat type (being equivalent to the second phase)
The blue dead color of suffering limb skin, severe pain of walking, or lie awake all night, eat anorexia.Red tongue or purple dark, the area on the wrist over the radial artery where the pulse is felt for diagnosis deep-thready pulse is puckery.
The rule for the treatment of: the suitable blood circulation promoting and blood stasis dispelling of blood stasis stagnated heat type, heat clearing away removing obstruction in the collateral to relieve pain.
3, deficiency of YIN noxious dampness type (being equivalent to the third phase)
Suffering limb severe pain or causalgia, profile is withered, and the rotten muscle of very then burned black necrosis, or meat is rotten, refers to that apotelus comes off, dim complexion or pale.Vexed poor appetite.Deep red tongue, yellow and greasy fur, the area on the wrist over the radial artery where the pulse is felt for diagnosis slippery and rapid pulse, loud or stringy and rapid pulse.
The rule for the treatment of: YIN nourishing is detoxified, putrefaction removing of invigorating blood circulation.
Summary of the invention
The technical problem to be solved in the present invention is to develop a kind of Chinese medicine preparation that thrombophlebitis has better therapeutic effect.
For solving above-mentioned technical problem, the technical scheme that inventor takes is: first from self clinical experience and theoretical knowledge, meticulous compatibility medical material, form a preliminary Chinese prescription, checking repeatedly and improvement through clinical experiment, then through exploitation and the adjustment of modern Chinese medicine preparation technique, finally invent a brand-new Chinese prescription and the preparation method of a set of adaptation modern industrialization production.Chinese prescription of the present invention is expressed as with weight portion: Herba Leonuri 15-45 part, Herba Violae 9-27 part, Radix Paeoniae Rubra 7-25 part, Hirudo 11-31 part, Scorpio 4-12 part, Radix Scrophulariae 12-35 part, Herba Artemisiae Scopariae 12-38 part, Semen Coicis 10-30 part, Cortex Phellodendri 8-24 part, Caulis Akebiae 8-32 part, Herba Eupatorii 7-19 part, Olibanum 6-18 part, Myrrha 6-20 part, Pseudobulbus cremastrae seu pleiones 7-24 part, Fructus Gardeniae 11-35 part, Bombyx Batryticatus 9-31 part, Rhizoma Alismatis 6-22 part, Radix Glycyrrhizae 8-15 part.
In R&D process, the preferred prescription proportioning with excellent curative effect out is expressed as with weight portion:
Herba Leonuri 30 parts, Herba Violae 18 parts, Radix Paeoniae Rubra 17 parts, Hirudo 21 parts, Scorpio 8 parts, Radix Scrophulariae 22 parts, Herba Artemisiae Scopariae 24 parts, Semen Coicis 20 parts, Cortex Phellodendri 16 parts, Caulis Akebiae 15 parts, Herba Eupatorii 13 parts, Olibanum 12 parts, Myrrha 13 parts, Pseudobulbus cremastrae seu pleiones 15 parts, Fructus Gardeniae 23 parts, Bombyx Batryticatus 20 parts, Rhizoma Alismatis 14 parts, 11 parts of Radix Glycyrrhizae.
The preparation method of Chinese medicine preparation of the present invention is following steps:
(1), ingredients is accurately weighed by Chinese prescription of the present invention；
(2), take Cortex Phellodendri, alcohol-pickled 4-24 hour of Radix Paeoniae Rubra 40-70%, drain, pulverize, parch, grind, cross 70-120 mesh sieve, obtain mixing fine powders, standby；
(3), Herba Leonuri, Herba Violae, Hirudo, Scorpio, Radix Scrophulariae, Herba Artemisiae Scopariae, Semen Coicis, Caulis Akebiae, Herba Eupatorii, Olibanum, Myrrha, Pseudobulbus cremastrae seu pleiones, Fructus Gardeniae, Bombyx Batryticatus, Rhizoma Alismatis, Radix Glycyrrhizae are pulverized and mixed respectively, add the purified water of initial 5-16 times of weight of medical material, soak 4-24 hour, backflow decocts 1-6 hour, filter, add the purified water of 4-12 times of weight of initial weight, backflow decocts 1-5 hour, filter and retain filtering residue, merging filtrate, is concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25 standby；
(4), the filtering residue of step (3) adding the ethanol of the concentration 65-85% of 5-14 times of weight, reflux, extract, 2 times, each 1-5 hour, filter, merging filtrate, decompression is distilled off ethanol, and it is standby to be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25；
(5), being merged by the concentrated solution of step (3) and (4) gained, add the mixing fine powders of step (2), mix homogeneously, continuing to be concentrated into 55 DEG C of relative densities is the traditional Chinese medicine thick paste of 1.42-1.47, standby；
(6), by the traditional Chinese medicine thick paste of step (5), add suitable adjuvant, utilize modern general Chinese medicine preparation technology, make the Chinese medicine finished product preparation required for clinic, such as dosage forms such as decoction, pill (containing the watered pill, honeyed pill, concentrated pill, drop pill, wax pill, paste pill), tablet, tincture, capsule (containing soft capsule), granule, powder, syrups.
The nature and flavor of the raw materials used medical material of Chinese medicine preparation of the present invention, return through and function effect:
Herba Leonuri: this product is the fresh of labiate Herba Leonuri or dry aerial parts.Bitter in the mouth, pungent, cold nature；Return liver, pericardium channel；Promoting blood flow to regulate menstruation, inducing diuresis to remove edema.
Herba Violae: this product is the dry herb of Violaceae Chinese violet.Bitter in the mouth, pungent, cold in nature；GUIXIN, Liver Channel；Heat-clearing and toxic substances removing, removing heat from blood is subsided a swelling.
Radix Paeoniae Rubra: this product is ranunculaceae plant Radix Paeoniae or the dry root of river Radix Paeoniae Rubra.Bitter in the mouth, cold nature；Return Liver Channel；Clearing away heat and cooling blood, eliminating stasis to stop pain.
Hirudo: this product is the dry body of Hirudinidae animal whitmania, Hirudo or Folium Salicis Babylonicae Hirudo.Salty in the mouth, hardship, property is put down；Return Liver Channel；Removing blood stasis, removing blood stasis, stimulates the menstrual flow.
Scorpio: this product is the dry body of Buthidae animal Scorpio.Acrid in the mouth, property is put down；Return Liver Channel；Endogenous wind stopping spasmolytic, dispersing pathogen accumulation, removing obstruction in the collateral to relieve pain.
Radix Scrophulariae: this product is the dry root of goatweed Radix Scrophulariae.Sweet in the mouth, hardship, salty, cold nature；Return lung, stomach, kidney channel；Removing heat from blood YIN nourishing, eliminating fire and detoxication.
Herba Artemisiae Scopariae: this product is the dry aerial parts of feverfew Artemisia scoparia Waldst. et Kit. or Herba Artemisiae Scopariae.Bitter in the mouth, pungent, cold nature；Return spleen, stomach, liver, gallbladder meridian；Clearing away damp-heat, jaundice eliminating subcutaneous ulcer.
Semen Coicis: this product is the dry mature kernal of grass Semen Coicis.Sweet in the mouth, light, cool in nature；Return spleen, stomach, lung meridian；Spleen invigorating eliminating dampness by diuresis, eliminating impediment antidiarrheal, row is dense in heat clearing away.
Cortex Phellodendri: this product is the dry bark of rutaceae wampee or Cortex Phellodendri.Bitter in the mouth, cold in nature；Return kidney, bladder warp；Heat clearing and damp drying, pathogenic fire purging is except steaming, detoxification sore treatment.
Caulis Akebiae: for the woody stems of plants of Lardizabalaceae Caulis Akebiae or threeleaf akebia, Caulis Akebiae.Bitter in the mouth, cool in nature；Enter the heart, small intestinal, bladder warp；Pathogenic fire purging row water, promoting blood circulation.
Herba Eupatorii: this product is the dry aerial parts of feverfew Herba Eupatorii.Summer, Qiu Erji tap at twice, remove impurity, dry.Acrid in the mouth, property is put down.Return spleen, stomach, lung meridian.Removing dampness by means of aromatics, appetizing of being amusing, deliver expelling summer-heat.For turbid damp obstructing in middle-JIAO, gastral cavity painful abdominal mass vomiting and nausea, sweet greasy in mouth, halitosis, sialism, heat-damp in summer table disease, feeling of fullness in the head is uncomfortable in chest.
Olibanum: Burseraceae Boswellia carterii platymiscium Boswellia carterii, medicine glue XIANGSHU and wild Boswellia carterii etc., is used as medicine with the oleo-gum-resin that its trunk skin zone wound oozes out.Acrid in the mouth is bitter, warm in nature；Enter the heart, liver, spleen channel；Regulating qi and activating blood, analgesic therapy, chase after poison.
Myrrha: Burseraceae bdellium plant myrrh and belong to the oleo-gum-resin that the trunk skin zone of his kind of plant oozes out together.Bitter in the mouth, property is put down；Enter Liver Channel；Eliminating stasis to stop pain, externally used detumescence granulation promoting.
Pseudobulbus cremastrae seu pleiones: this product is the dry pseudobulb of orchid Cremastra appendiculata, pleione bulbocodioides or Pleione yunnanensis.Sweet in the mouth, micro-pungent, cool in nature；Return liver, spleen channel；Heat-clearing and toxic substances removing, dissipating phlegm and resolving masses.
Fructus Gardeniae: this product is the dry mature fruit of Maguireothamnus speciosus Fructus Gardeniae.Bitter in the mouth, cold in nature；GUIXIN, lung, tri-jiao channel；Fruit: pathogenic fire purging relieving restlessness, clearing away heat and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body.
Bombyx Batryticatus: this product is that the larva in Bombycidae insecticide silkworm 4-5 age infects (or artificial vaccination) muscardine and lethal larva dry body.Salty in the mouth, pungent, property is put down；Return liver, lung, stomach warp；Expelling wind for relieving convulsion, dissipating phlegm and resolving masses.
Rhizoma Alismatis: this product is the dry tuber of Notes On Alism At Aceae Rhizoma Alismatis.Sweet in the mouth, cold in nature；Return kidney, bladder warp；Diuresis, clearing away damp-heat.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down；GUIXIN, lung, spleen, stomach warp；Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The side of Chinese prescription of the present invention solves:
This Chinese prescription is with Herba Leonuri, Herba Artemisiae Scopariae, Fructus Gardeniae, Hirudo, Bombyx Batryticatus, Radix Scrophulariae for monarch drug, promoting blood flow to regulate menstruation, clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body, removing blood stasis, dissipating phlegm and resolving masses, removing heat from blood YIN nourishing；With Semen Coicis, Herba Violae, Radix Paeoniae Rubra, Cortex Phellodendri for ministerial drug, heat clearing away dense, the removing heat from blood detumescence of row, eliminating stasis to stop pain, detoxification sore treatment；With Scorpio, Pseudobulbus cremastrae seu pleiones, Caulis Akebiae, Myrrha for adjuvant drug, removing obstruction in the collateral to relieve pain, dissipating phlegm and resolving masses, promoting blood circulation, eliminating stasis to stop pain；With Herba Eupatorii, Rhizoma Alismatis, Olibanum for making medicine, removing dampness by means of aromatics, diuretic heat clearing away, regulating qi and activating blood；With the Radix Glycyrrhizae mediation all property of medicine matter of monarch, make all medicine YIN and YANG balancing, the exterior and the interior is mutually auxiliary, synergism, thus reaching the effects such as promoting blood flow to regulate menstruation, clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body, removing blood stasis, dissipating phlegm and resolving masses, removing heat from blood YIN nourishing, eliminating stasis to stop pain, detoxification sore treatment, dissipating phlegm and resolving masses, promoting blood circulation, thrombophlebitis is had very significant therapeutic effect.
Compared with prior art, Chinese medicine preparation of the present invention has the significant technical advantages such as curative effect is prominent, cure rate is high, side effect is extremely low；Further, the preparation method of the present invention is simple and easy to do, gained preparation efficacy stability, therefore, is suitable for popularization and application to benefit more patient, creates bigger social value.
Detailed description of the invention
Embodiment 1
Granule is produced with the maximum of Chinese prescription scope of the present invention and the technological parameter that it is considered herein that optimum:
(1), Herba Leonuri 4500g, Herba Violae 2700g, Radix Paeoniae Rubra 2500g, Hirudo 3100g, Scorpio 1200g, Radix Scrophulariae 3500g, Herba Artemisiae Scopariae 3800g, Semen Coicis 3000g, Cortex Phellodendri 2400g, Caulis Akebiae 3200g, Herba Eupatorii 1900g, Olibanum 1800g, Myrrha 2000g, Pseudobulbus cremastrae seu pleiones 2400g, Fructus Gardeniae 3500g, Bombyx Batryticatus 3100g, Rhizoma Alismatis 2200g, Radix Glycyrrhizae 1500g are accurately weighed by Chinese prescription of the present invention；
(2), take Cortex Phellodendri, Radix Paeoniae Rubra with alcohol-pickled 8 hours of 60%, drain, pulverize, parch, grind, cross 80 mesh sieves, obtain mixing fine powders, standby；
(3), Herba Leonuri, Herba Violae, Hirudo, Scorpio, Radix Scrophulariae, Herba Artemisiae Scopariae, Semen Coicis, Caulis Akebiae, Herba Eupatorii, Olibanum, Myrrha, Pseudobulbus cremastrae seu pleiones, Fructus Gardeniae, Bombyx Batryticatus, Rhizoma Alismatis, Radix Glycyrrhizae are pulverized and mixed respectively, add the purified water of initial 12 times of weight of medical material, soak 10 hours, backflow decocts 2 hours, filters, adds the purified water of 8 times of weight of initial weight, backflow decocts 2 hours, filter and retain filtering residue, merging filtrate, be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25 standby；
(4), the filtering residue of step (3) adding the ethanol of the concentration 70% of 11 times of weight, reflux, extract, 2 times, each 2 hours, filter, merging filtrate, decompression is distilled off ethanol, and it is standby to be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25；
(5), being merged by the concentrated solution of step (3) and (4) gained, add the mixing fine powders of step (2), mix homogeneously, continuing to be concentrated into 55 DEG C of relative densities is the traditional Chinese medicine thick paste of 1.42-1.47, standby；
(6), by the traditional Chinese medicine thick paste of step (5), adding suitable adjuvant, utilize modern general Chinese medicine preparation technology, make granule, specification is: 0.56g crude drug/g granule.
Embodiment 2
Granule is produced with the minima of Chinese prescription scope of the present invention and the technological parameter that it is considered herein that optimum:
(1), Herba Leonuri 1500g, Herba Violae 900g, Radix Paeoniae Rubra 700g, Hirudo 1100g, Scorpio 400g, Radix Scrophulariae 1200g, Herba Artemisiae Scopariae 1200g, Semen Coicis 1000g, Cortex Phellodendri 800g, Caulis Akebiae 800g, Herba Eupatorii 700g, Olibanum 600g, Myrrha 600g, Pseudobulbus cremastrae seu pleiones 700g, Fructus Gardeniae 1100g, Bombyx Batryticatus 900g, Rhizoma Alismatis 600g, Radix Glycyrrhizae 800g are accurately weighed by Chinese prescription of the present invention；
(2), take Cortex Phellodendri, Radix Paeoniae Rubra with alcohol-pickled 8 hours of 60%, drain, pulverize, parch, grind, cross 80 mesh sieves, obtain mixing fine powders, standby；
(3), Herba Leonuri, Herba Violae, Hirudo, Scorpio, Radix Scrophulariae, Herba Artemisiae Scopariae, Semen Coicis, Caulis Akebiae, Herba Eupatorii, Olibanum, Myrrha, Pseudobulbus cremastrae seu pleiones, Fructus Gardeniae, Bombyx Batryticatus, Rhizoma Alismatis, Radix Glycyrrhizae are pulverized and mixed respectively, add the purified water of initial 12 times of weight of medical material, soak 10 hours, backflow decocts 2 hours, filters, adds the purified water of 8 times of weight of initial weight, backflow decocts 2 hours, filter and retain filtering residue, merging filtrate, be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25 standby；
(4), the filtering residue of step (3) adding the ethanol of the concentration 70% of 11 times of weight, reflux, extract, 2 times, each 2 hours, filter, merging filtrate, decompression is distilled off ethanol, and it is standby to be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25；
(5), being merged by the concentrated solution of step (3) and (4) gained, add the mixing fine powders of step (2), mix homogeneously, continuing to be concentrated into 55 DEG C of relative densities is the traditional Chinese medicine thick paste of 1.42-1.47, standby；
(6), by the traditional Chinese medicine thick paste of step (5), adding suitable adjuvant, utilize modern general Chinese medicine preparation technology, make granule, specification is: 0.56g crude drug/g granule.
Embodiment 3
Granule is produced with the arbitrary value of Chinese prescription scope of the present invention and the technological parameter that it is considered herein that optimum:
(1), Herba Leonuri 4500g, Herba Violae 900g, Radix Paeoniae Rubra 2400g, Hirudo 1200g, Scorpio 500g, Radix Scrophulariae 3400g, Herba Artemisiae Scopariae 1300g, Semen Coicis 3000g, Cortex Phellodendri 2400g, Caulis Akebiae 900g, Herba Eupatorii 1800g, Olibanum 800g, Myrrha 1000g, Pseudobulbus cremastrae seu pleiones 2200g, Fructus Gardeniae 1300g, Bombyx Batryticatus 3000g, Rhizoma Alismatis 700g, Radix Glycyrrhizae 1400g are accurately weighed by Chinese prescription of the present invention；
(2), take Cortex Phellodendri, Radix Paeoniae Rubra with alcohol-pickled 8 hours of 60%, drain, pulverize, parch, grind, cross 80 mesh sieves, obtain mixing fine powders, standby；
(3), Herba Leonuri, Herba Violae, Hirudo, Scorpio, Radix Scrophulariae, Herba Artemisiae Scopariae, Semen Coicis, Caulis Akebiae, Herba Eupatorii, Olibanum, Myrrha, Pseudobulbus cremastrae seu pleiones, Fructus Gardeniae, Bombyx Batryticatus, Rhizoma Alismatis, Radix Glycyrrhizae are pulverized and mixed respectively, add the purified water of initial 12 times of weight of medical material, soak 10 hours, backflow decocts 2 hours, filters, adds the purified water of 8 times of weight of initial weight, backflow decocts 2 hours, filter and retain filtering residue, merging filtrate, be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25 standby；
(4), the filtering residue of step (3) adding the ethanol of the concentration 70% of 11 times of weight, reflux, extract, 2 times, each 2 hours, filter, merging filtrate, decompression is distilled off ethanol, and it is standby to be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25；
(5), being merged by the concentrated solution of step (3) and (4) gained, add the mixing fine powders of step (2), mix homogeneously, continuing to be concentrated into 55 DEG C of relative densities is the traditional Chinese medicine thick paste of 1.42-1.47, standby；
(6), by the traditional Chinese medicine thick paste of step (5), adding suitable adjuvant, utilize modern general Chinese medicine preparation technology, make granule, specification is: 0.56g crude drug/g granule.
Embodiment 4
Granule is produced with the optimum ratio value of Chinese prescription of the present invention and the technological parameter that it is considered herein that optimum:
(1), Herba Leonuri 3000g, Herba Violae 1800g, Radix Paeoniae Rubra 1700g, Hirudo 2100g, Scorpio 800g, Radix Scrophulariae 2200g, Herba Artemisiae Scopariae 2400g, Semen Coicis 2000g, Cortex Phellodendri 1600g, Caulis Akebiae 1500g, Herba Eupatorii 1300g, Olibanum 1200g, Myrrha 1300g, Pseudobulbus cremastrae seu pleiones 1500g, Fructus Gardeniae 2300g, Bombyx Batryticatus 2000g, Rhizoma Alismatis 1400g, Radix Glycyrrhizae 1100g are accurately weighed by Chinese prescription of the present invention；
(2), take Cortex Phellodendri, Radix Paeoniae Rubra with alcohol-pickled 8 hours of 60%, drain, pulverize, parch, grind, cross 80 mesh sieves, obtain mixing fine powders, standby；
(3), Herba Leonuri, Herba Violae, Hirudo, Scorpio, Radix Scrophulariae, Herba Artemisiae Scopariae, Semen Coicis, Caulis Akebiae, Herba Eupatorii, Olibanum, Myrrha, Pseudobulbus cremastrae seu pleiones, Fructus Gardeniae, Bombyx Batryticatus, Rhizoma Alismatis, Radix Glycyrrhizae are pulverized and mixed respectively, add the purified water of initial 12 times of weight of medical material, soak 10 hours, backflow decocts 2 hours, filters, adds the purified water of 8 times of weight of initial weight, backflow decocts 2 hours, filter and retain filtering residue, merging filtrate, be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25 standby；
(4), the filtering residue of step (3) adding the ethanol of the concentration 70% of 11 times of weight, reflux, extract, 2 times, each 2 hours, filter, merging filtrate, decompression is distilled off ethanol, and it is standby to be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25；
(5), being merged by the concentrated solution of step (3) and (4) gained, add the mixing fine powders of step (2), mix homogeneously, continuing to be concentrated into 55 DEG C of relative densities is the traditional Chinese medicine thick paste of 1.42-1.47, standby；
(6), by the traditional Chinese medicine thick paste of step (5), adding suitable adjuvant, utilize modern general Chinese medicine preparation technology, make granule, specification is: 0.56g crude drug/g granule.
Embodiment 5
The toxicity test of Chinese medicine preparation of the present invention
(1), test material
Experimental animal: SPF level KM mice, body weight 20 ± 4g, SD rat, body weight 226 ± 13g, equal male and female half and half, from Shanghai, raw prosperous laboratory animal cultivates company limited's purchase.
The granule that trial drug: embodiment of the present invention 1-4 produces, specification is 0.56g crude drug/g granule.
(2), acute toxicity test
Mice is pressed 0.7g/ml, 50ml/kg dosage gavage and gives Chinese medicine granules of the present invention, one day 3 times, interval 4h.Continuous Observation 14d after administration, all test mice skins, hair color are normal, and nose, eye, oral cavity be normal and secretions without exception, and without vomiting phenomenon, body weight increases, movable, diet drinking-water and two is just normal, and unfavorable condition and death does not occur in animal.Within 15th day, putting to death and dissect animal, perusal main organs is no abnormal.Rat presses 0.7g/ml, 50ml/kg dosage gavage gives Chinese medicine granules of the present invention, one day 3 times, Continuous Observation 14d after medicine, all tested rat skins, hair color are normal, and nose, eye, oral cavity be normal and secretions without exception, without vomiting phenomenon, body weight increases, movable, diet drinking-water and two is just normal, and unfavorable condition and death does not occur in animal.Within 15th day, putting to death and dissect animal, perusal main organs is no abnormal.This product mice, one day of rat administration total amount are 250 times of adult (0.42g crude drug/kg/d), point out Chinese medicine granules drug safety of the present invention significantly high.
(3), long term toxicity test
Select SD rat, male and female half and half, random packet: blank group and the high, medium and low dosage group of Chinese medicine granules of the present invention, the high, medium and low dosage of Chinese medicine granules of the present invention: 100.8g crude drug/kg/d, 33.6g crude drug/kg/d, 11.2g crude drug/kg/d, respectively Coming-of-Age Day clinic intends the 180 of consumption, 60,20 times, adopts gastric infusion, once a day, successive administration 6 months, and drug withdrawal does restorative observation for 1 month.Observe the outward appearance of animal, general behavior, body weight, the change of diet amount of drinking water during test, each group is carried out hemanalysis, blood biochemical analysis and organ coefficient, blank group and high dose group and carries out histopathology index checking.
Result of the test shows: blank group and in Chinese medicine composition of the present invention, low dose group animal general state good, outward appearance sign, behavioral activity, glandular secretion, breathing, two just, body weight increase, administration reaction and the change all without exception of drinking water diet amount.Reducing occurs in high dose group the weight of animals, accidental soft stool, but recovers after drug withdrawal.In hemanalysis, having indivedual index to compare with matched group variant, blood biochemical analysis indexes no abnormality seen changes.Be administered 3 months, each administration group organ coefficient compares with blank group without substantially poor after drug withdrawal 1 month.Be administered 3 months, administration 6 months, the color and luster of each treated animal main organs after drug withdrawal 1 month, quality normal, naked eyes are there are no obvious change.Pathological examination, blank group has no the Pathologic changes relevant with medicine to high dose group main organs tissue.Result shows that rat oral gavage administration is had no significant effect by Chinese medicine granules of the present invention administration in continuous 6 months, without clear and definite toxicity target organ and sensitive indicator, convalescent period observation also has no retardance toxic reaction, and the dose safety pointing out Chinese medicine granules clinical practice of the present invention is significantly high.
Embodiment 6
The pharmacodynamic experiment of Chinese medicine preparation of the present invention
1, this product impact (turbidimetry) on rat platelet maximum agglutination rate
Take Wistar rat 80, be randomly divided into matched group；Positive control drug thrombus-resisting capsules (the quasi-word Z20003274 of traditional Chinese medicines, Shaanxi Huaxi Pharmaceutical Co., Ltd.) 12.4g/kg group；Granule (specification is: 0.56g crude drug/g granule) 16.8g/kg, 8.4g/kg, 4.2g/kg group (clinical the 40 of consumption per day, 20,10 times) manufactured by the embodiment of the present invention 3, granule (specification is: 0.56g crude drug/g granule) 16.8g/kg, 8.4g/kg, 4.2g/kg group (clinical the 40 of consumption per day, 20,10 times) manufactured by the embodiment of the present invention 4, totally 8 groups, often group 10.Test medicine distilled water is configured to suspension, and rat ig is administered 15ml/kg, and matched group gives same volume distilled water, it is administered every day 1 time, continuous 5 days, lh after last is administered, apparatus is with 2% cassia oil one petroleum ether silication, pentobarbital sodium is anaesthetized, and aorta takes blood, sodium citrate 9:1 anticoagulant, 1500 to leave heart 20min supernatant be platelet rich plasma (PRP), 4000 to leave heart 20min supernatant be platelet poor plasma (PRP), corrects platelet aggregation instrument, surveys maximum platelet aggregation rate.Result withRepresent, t inspection between statistical procedures method employing group.After the administration of each treated animal last, 1h maximum platelet aggregation rate is as shown in table 1.
Table 1 Chinese medicine preparation of the present invention on the impact of rat platelet maximum agglutination rate (, n=10)
Note: compare with matched group, * P < 0.05, * * P < 0.01, * * * P < 0.001；&P < 0.05 ， &&P < 0.01 is compared with thrombus-resisting capsules group.
From the experimental data listed by table 1 it can be seen that the maximum platelet aggregation rate of Chinese medicine preparation group of the present invention and thrombus-resisting capsules treated animal is all significantly lower than matched group.Above-mentioned result of the test shows, rat platelet maximum agglutination rate is had obvious inhibitory action by Chinese medicine preparation of the present invention, and this inhibitory action dosage group highly significant high, middle is better than thrombus-resisting capsules, and low dose group is significantly better than thrombus-resisting capsules；Point out Chinese medicine preparation of the present invention to have obvious anti thrombotic action, phlebitis is had good curative effect, and it evident in efficacy is better than thrombus-resisting capsules.
2, the Chinese medicine preparation of the present invention impact on mouse peritoneal capillary permeability
Take Kunming mouse 80, male and female half and half, be divided into 8 groups, often group 10.Administration: blank group (isometric(al) distilled water), aspirin group (0.2g/kg), embodiment 3 experimental group gives the granule of high, medium and low 3 dosage of granule manufactured by the embodiment of the present invention 3 respectively, embodiment 4 experimental group gives the granule of high, medium and low 3 dosage of granule manufactured by the embodiment of the present invention 4 respectively, and dosage is ibid.Each group mice is with 20mL/kg gastric infusion, after administration, 1h is injected intravenously 0.5% azovan blue normal saline solution 0.1ml/10g body weight, the acetic acid of lumbar injection 0.7% immediately, 0.2ml/ is only, after 20min, de-for mice cervical vertebra is put to death, abdominal cut integumentary musculature, with 10ml normal saline mark time washing abdominal cavity, draw cleaning mixture and be incorporated into 10ml, 3000 revs/min of centrifugal 15min；Taking supernatant 752 type spectrophotometers in its absorbance of 590nm place colorimetric determination, carry out statistical procedures with t inspection, result is in Table 2.
Table 2 Chinese medicine preparation on the impact (n=10) of mouse peritoneal capillary permeability ()
Note: compare with blank group, * P < 0.05, * * P < 0.01；， &P < 0.05 compared with aspirin group.
Table 2 result shows, embodiment 3, the made granule of embodiment 4 and aspirin all can significantly reduce mouse peritoneal capillary permeability in pole, show that embodiment 3, the made granule of embodiment 4 and aspirin all have certain antiinflammatory action, further, 3 dosage of this action intensity are all significantly better than aspirin.
3,0.6%HAC is caused the analgesic activity of mice pain reaction:
Take male and healthy mice 80, it is randomly divided into 8 groups, the Chinese medicine granules of the embodiment of the present invention 3 preparation is high, in, low dose group, the Chinese medicine granules of the embodiment of the present invention 4 preparation is high, in, low dose group, thrombus-resisting capsules group and blank group, dosage is ibid, all by the volume gastric infusion of 0.25ml/10g body weight, blank group gives isopyknic water gastric infusion, for three days on end, 1 hour lumbar injection 0.6%HAC after mensuration last medicine respectively, 0.1ml/10g Mus weight, there is interior writhing number of times incubation period and 15 minutes of writhing response in record, pain suppression ratio (%) is calculated by formula, result withRepresenting, t inspection between statistical procedures method employing group, result is as shown in table 3.
Table 3 Chinese medicine granules of the present invention 0.6%HAC is caused mice pain reaction effect (, n=10)
Note: compare * P < 0.05, * * P < 0.01 with blank group；&P < 0.05 compared with thrombus-resisting capsules group.
From table 3 result, Chinese medicine granules of the present invention dosage high, middle all can substantially suppress the writhing incubation period of mice.The significant difference having in various degree is compared with blank group；The high, medium and low dosage of Chinese medicine granules of the present invention and thrombus-resisting capsules all can significantly reduce the writhing number of times of mice, compare, with blank group, the significant difference having in various degree, point out Chinese medicine granules of the present invention to have good analgesic activity.From pain suppression ratio result: the high, medium and low dosage of Chinese medicine granules of the present invention is superior to thrombus-resisting capsules, and dosage high, middle has significant difference.
In sum, pharmacodynamic experiment shows, Chinese medicine granules of the present invention has good antithrombotic, antiinflammatory and analgesic activity, points out Chinese medicine preparation of the present invention that thrombophlebitis there may be significant curative effect.
Embodiment 7
The clinical trial of Chinese medicine preparation of the present invention
The experimenter of this time clinical trial has 342 examples, is all from certain the People's Hospital of city, age 43-68 year, all patients are randomly divided into three groups, respectively matched group, test 1 group and test 2 groups, often organize 114 examples.The age of three groups of patients, sex, symptom, the equal not statistically significant of course of disease difference (P > 0.05), have comparability.Matched group patient is administered orally thrombus-resisting capsules (the quasi-word Z20003274 of traditional Chinese medicines, Shaanxi Huaxi Pharmaceutical Co., Ltd.), every day 3 times, and each 8,3 weeks be a course for the treatment of, continuously 4 courses for the treatment of of treatment.Testing 1 group of oral granule (specification is: 0.56g crude drug/g granule) manufactured by the embodiment of the present invention 3, every day 3 times, each 15g, 3 weeks is a course for the treatment of, continuously 4 courses for the treatment of of treatment.Testing 2 groups of oral granules (specification is: 0.56g crude drug/g granule) manufactured by the embodiment of the present invention 4, instructions of taking is with test 1 group.After all patient treatments terminate, by as shown in table 4 for therapeutic outcome statistical analysis.
Table 4 result of the test statistical table
Table 4 result of the test shows, compared with matched group, test group evident in efficacy, the cure rate particularly testing 2 groups reaches 52.6%, is 3.15 times of matched group, and total effective rate 86.8% exceeds 20.1 percentage points than matched group；Therefore, compared with prior art Chinese medicine preparation of the present invention has very prominent treatment advantage, so the present invention has very significant technical advantage in its field, it is thus achieved that the technological achievement attracted people's attention, its creativeness is apparent from.
Claims (4)
1. the Chinese medicine preparation treating thrombophlebitis, it is characterized in that, with parts by weight, the Chinese prescription of described Chinese medicine preparation is: Herba Leonuri 15-45 part, Herba Violae 9-27 part, Radix Paeoniae Rubra 7-25 part, Hirudo 11-31 part, Scorpio 4-12 part, Radix Scrophulariae 12-35 part, Herba Artemisiae Scopariae 12-38 part, Semen Coicis 10-30 part, Cortex Phellodendri 8-24 part, Caulis Akebiae 8-32 part, Herba Eupatorii 7-19 part, Olibanum 6-18 part, Myrrha 6-20 part, Pseudobulbus cremastrae seu pleiones 7-24 part, Fructus Gardeniae 11-35 part, Bombyx Batryticatus 9-31 part, Rhizoma Alismatis 6-22 part, Radix Glycyrrhizae 8-15 part.
2. the Chinese medicine preparation for the treatment of thrombophlebitis according to claim 1, it is characterized in that, with parts by weight, the Chinese prescription of described Chinese medicine preparation is: Herba Leonuri 30 parts, Herba Violae 18 parts, Radix Paeoniae Rubra 17 parts, Hirudo 21 parts, Scorpio 8 parts, Radix Scrophulariae 22 parts, Herba Artemisiae Scopariae 24 parts, Semen Coicis 20 parts, Cortex Phellodendri 16 parts, Caulis Akebiae 15 parts, Herba Eupatorii 13 parts, Olibanum 12 parts, Myrrha 13 parts, Pseudobulbus cremastrae seu pleiones 15 parts, Fructus Gardeniae 23 parts, Bombyx Batryticatus 20 parts, Rhizoma Alismatis 14 parts, 11 parts of Radix Glycyrrhizae.
3. the Chinese medicine preparation for the treatment of thrombophlebitis according to claim 1 and 2, it is characterised in that the preparation method of described Chinese medicine preparation is following steps:
(1), ingredients is accurately weighed by Chinese prescription；
(2), take Cortex Phellodendri, alcohol-pickled 4-24 hour of Radix Paeoniae Rubra 40-70%, drain, pulverize, parch, grind, cross 70-120 mesh sieve, obtain mixing fine powders, standby；
(3), Herba Leonuri, Herba Violae, Hirudo, Scorpio, Radix Scrophulariae, Herba Artemisiae Scopariae, Semen Coicis, Caulis Akebiae, Herba Eupatorii, Olibanum, Myrrha, Pseudobulbus cremastrae seu pleiones, Fructus Gardeniae, Bombyx Batryticatus, Rhizoma Alismatis, Radix Glycyrrhizae are pulverized and mixed respectively, add the purified water of initial 5-16 times of weight of medical material, soak 4-24 hour, backflow decocts 1-6 hour, filter, add the purified water of 4-12 times of weight of initial weight, backflow decocts 1-5 hour, filter and retain filtering residue, merging filtrate, is concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25 standby；
(4), the filtering residue of step (3) adding the ethanol of the concentration 65-85% of 5-14 times of weight, reflux, extract, 2 times, each 1-5 hour, filter, merging filtrate, decompression is distilled off ethanol, and it is standby to be concentrated into the concentrated solution that 55 DEG C of relative densities are 1.22-1.25；
(5), being merged by the concentrated solution of step (3) and (4) gained, add the mixing fine powders of step (2), mix homogeneously, continuing to be concentrated into 55 DEG C of relative densities is the traditional Chinese medicine thick paste of 1.42-1.47, standby；
(6), by the traditional Chinese medicine thick paste of step (5), add suitable adjuvant, utilize modern general Chinese medicine preparation technology, make the Chinese medicine finished product preparation of clinical needs.
4. the Chinese medicine preparation for the treatment of thrombophlebitis according to claim 3, it is characterised in that: described Chinese medicine preparation is made into decoction, pill, tablet, tincture, capsule, granule, powder or syrup.
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