CN103285360A - Traditional Chinese medicinal preparation for treating thromboangiitis obliterans, and preparation method thereof - Google Patents

Traditional Chinese medicinal preparation for treating thromboangiitis obliterans, and preparation method thereof Download PDF

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CN103285360A
CN103285360A CN2013102455153A CN201310245515A CN103285360A CN 103285360 A CN103285360 A CN 103285360A CN 2013102455153 A CN2013102455153 A CN 2013102455153A CN 201310245515 A CN201310245515 A CN 201310245515A CN 103285360 A CN103285360 A CN 103285360A
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CN103285360B (en
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王京涛
柳春华
吕咸进
全淼
王永萍
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王京涛
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Abstract

The invention discloses a traditional Chinese medicinal preparation for treating thromboangiitis obliterans, and a preparation method thereof. The traditional Chinese medicinal preparation comprises Pangolin Scales, cassia twig, Salvia trijuga, Rhizoma Polygoni Cuspidati, Peach Seed, Lycium Chinense, dry ginger, hawthorn fruit, Chinese yam, coix seed, Achyranthes bidentata, Malaytea Scurfpea Fruit, Herba Lycopi, Rabdosia rubescens, Artemisia argyi, rhizome of Whiteback Greenbrier, honeysuckle flower and Herba Selaginellae. The traditional Chinese medicinal preparation utilizes the traditional Chinese medicinal theory in China, has the effects of channel warming, cold expelling, dampness removing, detoxifying, blood circulation promoting, blood stasis removing, and spleen, liver and kidney tonifying, and has the advantages of definite curative effect, fast effectiveness, high effective rate, and small side effects.

Description

A kind of Chinese medicine preparation for the treatment of thromboangiitis obliterans and preparation method thereof
Technical field
The present invention relates to pharmaceutical technology, particularly a kind of Chinese medicine preparation for the treatment of thromboangiitis obliterans and preparation method thereof.
Background technology
Thromboangiitis obliterans is called for short vasculitis.Refer to a kind of chronic persistence, the progressive vascular inflammation pathological changes of vascular on every side (in, small artery and vein), cause thrombosis to make the lumen of vessels obturation.Pathological changes mainly involve distal limbs in, small artery, accompanying vein and shallow table vein also often involve, based on lower limb.Ulcer and the gangrene of healing can take place to be difficult in the severe patient acra, may cause permanent disfunction or limbs to be lost, even dead.
Mainly based on antiinflammatory, analgesic Western medicine, Western medicine can improve the state of an illness to the western medical treatment vasculitis really, but antiphlogistic effects is poor, and side effect is big, can not thoroughly cure vasculitis.
Thromboangiitis obliterans belongs to Chinese medicine " necrosis " category, and its cause of disease is because temper is strong, and insufficiency of kidney-YANG adds outer catching cold again and freezes, and the heresy of cold-damp is invaded and fallen ill.Temper is strong, changes to give birth to not enoughly, and deficiency of qi and blood interiorly can not be strengthened foster internal organs; The extremity of can not supplementing nutrition outward.Spleen kidney yang QI-insufficiency can not the replenishing vital QI with drugs of warm nature extremity, are subjected to the heresy of cold-damp again, coagulation of QI-blood then, and meridians block, stagnation of QI and blood may bring about pain, the extremity QI and blood is not filled, and loses in moistening and supports that then skin and flesh is withered, and necrosis comes off.If the cold-evil accumulates for a long time, then strongly fragrant and heat-transformation, damp and hot contamination is then suffered from the red and swollen pus of bursting of toe (finger).YIN damaged by pathogenic heat, disease can cause deficiency of YIN-blood for a long time, and podomere loses supports, withered atrophy.The generation of primary disease is this with the deficiency of spleen and stomach, and the cold-damp wound is mark, and coagulation of QI-blood, meridian and vessels obstruction are its main pathogenesis.
Summary of the invention
Technical problem to be solved by this invention is, provides a kind of Chinese medicine preparation and preparation method that is used for the treatment of thromboangiitis obliterans, Chinese medicine preparation dispelling cold by warming the meridian of the present invention, eliminating damp, detoxifying, blood circulation promoting and blood stasis dispelling, tonification spleen, lung, liver, kidney, has determined curative effect, the advantage that side effect is little.
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of thromboangiitis obliterans, described Chinese medicine preparation comprises following raw medicinal material: Squama Manis, Ramulus Cinnamomi, Radix Rubiae Yunnanensis, Rhizoma Polygoni Cuspidati, Semen Persicae, Fructus Lycii, Rhizoma Zingiberis, Fructus Crataegi, Rhizoma Dioscoreae, Semen Coicis, Radix Achyranthis Bidentatae, Fructus Psoraleae, Herba Lycopi, Rabdosia rubescens, Folium Artemisiae Argyi, Herba Lycopodii, Flos Lonicerae and Herba Selaginellae.
Wherein, the ratio of weight and number of each raw medicinal material can be as follows in the described Chinese medicine preparation:
5~10 parts of Squama Manis, 15~20 parts of Ramulus Cinnamomi, 20~35 parts of Radix Rubiae Yunnanensis, 10~15 parts of Rhizoma Polygoni Cuspidati, 10~15 parts in Semen Persicae, 10~20 parts of Fructus Lyciis, 15~20 parts of Rhizoma Zingiberiss, 10~15 parts of Fructus Crataegis, 10~20 parts of Rhizoma Dioscoreaes, 10~15 parts of Semen Coiciss, 10~20 parts of Radix Achyranthis Bidentataes, 10~20 parts of Fructus Psoraleaes, 10~15 parts of Herba Lycopi, 10~15 parts of Rabdosia rubescens, 5~10 parts of Folium Artemisiae Argyis, 15~20 parts of Herba Lycopodiis, 10~15 parts of 10~15 parts of Flos Loniceraes and Herba Selaginellaes.
Wherein, the ratio of weight and number of each raw medicinal material can also be as follows in the described Chinese medicine preparation:
7~10 parts of Squama Manis, 15~18 parts of Ramulus Cinnamomi, 25~35 parts of Radix Rubiae Yunnanensis, 12~15 parts of Rhizoma Polygoni Cuspidati, 10~13 parts in Semen Persicae, 15~20 parts of Fructus Lyciis, 15~18 parts of Rhizoma Zingiberiss, 13~15 parts of Fructus Crataegis, 15~20 parts of Rhizoma Dioscoreaes, 10~13 parts of Semen Coiciss, 10~15 parts of Radix Achyranthis Bidentataes, 15~20 parts of Fructus Psoraleaes, 10~12 parts of Herba Lycopi, 13~15 parts of Rabdosia rubescens, 7~10 parts of Folium Artemisiae Argyis, 15~17 parts of Herba Lycopodiis, 13~15 parts of 13~15 parts of Flos Loniceraes and Herba Selaginellaes.
Wherein, the ratio of weight and number of each raw medicinal material again can be as follows in the described Chinese medicine preparation:
9 parts of Squama Manis, 16 parts of Ramulus Cinnamomi, 32 parts of Radix Rubiae Yunnanensis, 13 parts of Rhizoma Polygoni Cuspidati, 12 parts in Semen Persicae, 18 parts of Fructus Lyciis, 15 parts of Rhizoma Zingiberiss, 14 parts of Fructus Crataegis, 17 parts of Rhizoma Dioscoreaes, 12 parts of Semen Coiciss, 14 parts of Radix Achyranthis Bidentataes, 16 parts of Fructus Psoraleaes, 11 parts of Herba Lycopi, 15 parts of Rabdosia rubescens, 8 parts of Folium Artemisiae Argyis, 16 parts of Herba Lycopodiis, 15 parts of 14 parts of Flos Loniceraes and Herba Selaginellaes.
When the dosage form of described Chinese medicine preparation was tablet, its preparation method may further comprise the steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, adding is 80%~90% ethanol with respect to the determining alcohol of 5~8 times of mixture qualities, reflux 100~140 minutes, extract, filter and obtain first extracting solution, it is 75%~85% ethanol that the medicinal residues that filter to obtain add determining alcohol with respect to 3~6 times of medicinal residues quality again, reflux 80~120 minutes, extract, filter and obtain second extracting solution, first extracting solution and second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, drying obtains and gets dry extract;
Second step: the dried cream that the first step is obtained is placed on pulverizes 3~6 hours in the super micron mill, crushing screening obtains 200~400 purpose micropowders;
The 3rd step: in the micropowders of second step acquisition, add with respect to the microcrystalline Cellulose of 0.3~0.6 times of its quality, 0.15~0.25 times lactose and 0.2~0.4 times starch, sieve, mix homogeneously, granulate, drying adds the magnesium stearate with respect to 0.02~0.06 times of micropowders quality, granulate, tabletting is made.
When the dosage form of described Chinese medicine was capsule, its preparation method may further comprise the steps:
The first step, with Squama Manis, Ramulus Cinnamomi, Radix Rubiae Yunnanensis, Rhizoma Polygoni Cuspidati, Semen Persicae and Herba Selaginellae add the water extraction volatile oil with respect to 5~8 times in mixture by described mixed, with the volatile oil beta-cyclodextrin inclusion compound that obtains, the ratio of volatile oil and beta-schardinger dextrin-is 1: 4~8, stirs 45 ℃~65 ℃ of temperature 100 minutes~150 minutes, get volatile oil clathrate compound, standby; Relative density is 1.21~1.23 clear paste when in addition aqueous extract being concentrated into 60 ℃;
Second step, with Fructus Lycii, Rhizoma Zingiberis, Fructus Crataegi, Rhizoma Dioscoreae, Semen Coicis, Radix Achyranthis Bidentatae and Fructus Psoraleae are by described mixed, adding with respect to 3~6 times in mixture amount determining alcohol is 85%~90% alcohol reflux 3~5 times, each 2~3 hours, filters respectively, each time filtrate merges, reclaim ethanol, relative density is 1.27~1.29 clear paste when being concentrated into 60 ℃, and is standby;
The 3rd step will remain described raw medicinal material by described mixed, add with respect to 8~10 times of water gagings of mixture, boil 6~8 hours, filter, and relative density is 1.30~1.32 clear paste when being concentrated into 60 ℃;
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 60 ℃~70 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step, the described volatile oil clathrate compound of the first step and described dried cream powder of the 4th step are fully mixed, subsequently with respect to the mixture of the described volatile oil clathrate compound of 100 weight portions and dried cream powder, add 8~12 weight portion carboxymethyl starch sodium, 15~40 weight portion starch mix homogeneously, adding 250~400 weight portion determining alcohols then is 90%~95% alcohol granulation, dry, granulate, last mixture with respect to the described volatile oil clathrate compound of 100 weight portions and dried cream powder, add 6~10 weight portion magnesium stearate, in the gelatine capsule of packing into then.
Beneficial effect of the present invention:
Chinese medicine preparation provided by the invention utilizes the traditional theory of Chinese medical science of China, dispelling cold by warming the meridian, and eliminating damp, detoxifying, blood circulation promoting and blood stasis dispelling, tonification spleen, lung, liver, kidney have determined curative effect, instant effect, effective percentage height, the advantage that side effect is little.
The specific embodiment
The invention provides a kind of Chinese medicine preparation for the treatment of thromboangiitis obliterans, described Chinese medicine preparation comprises following raw medicinal material: Squama Manis, Ramulus Cinnamomi, Radix Rubiae Yunnanensis, Rhizoma Polygoni Cuspidati, Semen Persicae, Fructus Lycii, Rhizoma Zingiberis, Fructus Crataegi, Rhizoma Dioscoreae, Semen Coicis, Radix Achyranthis Bidentatae, Fructus Psoraleae, Herba Lycopi, Rabdosia rubescens, Folium Artemisiae Argyi, Herba Lycopodii, Flos Lonicerae and Herba Selaginellae.
In each raw medicinal material of described Chinese medicine preparation, Ramulus Cinnamomi, Rhizoma Zingiberis, Folium Artemisiae Argyi, Herba Lycopodii dispelling cold by warming the meridian.Removing obstruction in the collateral to relieve pain; Squama Manis, Radix Rubiae Yunnanensis, Semen Persicae, Fructus Crataegi, Radix Achyranthis Bidentatae, Herba Lycopi, Herba Selaginellae blood circulation promoting and blood stasis dispelling; Rhizoma Polygoni Cuspidati, Semen Coicis, Rabdosia rubescens, Flos Lonicerae heat-clearing and toxic substances removing, the spleen invigorating eliminating dampness by diuresis; Fructus Lycii, Rhizoma Dioscoreae, Radix Achyranthis Bidentatae, Fructus Psoraleae nourishing the liver and kidney taste.All medicine compatibilities, energy dispelling cold by warming the meridian, blood circulation promoting and blood stasis dispelling, eliminating damp, detoxifying, while energy nourishing the liver and kidney taste, treating both the principal and secondary aspects of a disease.
The pharmacology of each raw medicinal material is as follows in the described Chinese medicine preparation:
Squama Manis: distinguish the flavor of into, cool in nature.Return Liver Channel, stomach warp.Energy blood circulation promoting and dispersing pathogen accumulation, the stimulating milk secretion of stimulating the menstrual flow, eliminating carbuncle are burst hard.Main blood stasis amenorrhea, lump in the abdomen, rheumatic arthralgia, agalactia, carbuncle, scrofula etc.
Ramulus Cinnamomi: suffering, sweet, warm in nature.Return liver, kidney, bladder three warps.The diaphoresis expelling pathogenic factors from muscles, warming the meridian and promoting blood circulation, supporing yang activating QI, dispersing cold for relieving pain.Be used for anemofrigid cold, coldness and pain in the epigastrium, cold in blood amenorrhea, arthralgia, phlegm retention, edema, cardiopalmus, renal mass.
Radix Rubiae Yunnanensis: sweet; Temperature.Return Liver Channel.Relaxing muscles and tendons to promote blood circulation; Promoting tissue regeneration by removing blood stasis; Take good care of QI and blood.The main air pain that wets; Traumatic injury, menoxenia; Amenorrhea; Leukorrhagia; Puerperal arthralgia; The pulmonary tuberculosis hemoptysis; Dizzy insomnia; Anemia." Kunming medical herbs commonly used among the people ": relaxing muscles and tendons to promote blood circulation, promoting tissue regeneration by removing blood stasis." Yunnan Chinese herbal medicine ": promoting the flow of QI in the collateral by warming the meridian, take good care of QI and blood." Red River Chinese herbal medicine ": cooling blood for hemostasis, the promoting the circulation of blood of stimulating the menstrual flow, stasis-dispelling and pain-killing.(" China's book on Chinese herbal medicine ")
Rhizoma Polygoni Cuspidati: little hardship is slightly cold.Return liver, gallbladder, lung meridian.Heat-clearing and toxic substances removing, promoting the function of the gallbladder to alleviate jaundice, expelling wind and removing dampness, dissipating blood stasis analgesic therapy, relieving cough and resolving phlegm.Be used for arthralgia, jaundice due to damp-heat, amenorrhea, postnatal blood stasis are not following, cough with copious phlegm, burn due to hot liquid or fire, traumatic injury, carbuncle sore tumefacting virus." the southern regions of the Yunnan Province book on Chinese herbal medicine ": attack all toxic swellings, only have sore throat, diuresis is walked meridians.Control the five types of stranguria nebulousurine, anal fistula, carbuncle sore, married woman's leucorrhea with red and white discharge.
Semen Persicae: bitter, sweet, flat.GUIXIN, liver, large intestine channel.Blood circulation promoting and blood stasis dispelling, loosening bowel to relieve constipation, relieving cough and asthma.Be used for amenorrhea, dysmenorrhea, injury from falling down, dryness of the intestine constipation.
Fructus Lycii: Fructus Lycii: sweet in the mouth, property is flat.Return liver, kidney, lung meridian.Nourishing the liver and kidney, replenishing vital essence to improve eyesight.Be used for the chronic consumptive disease damage of essence, soreness of waist and knee joint, vertigo and tinnitus, interior-heat Xiao is thirsty, blood deficiency and yellow complexion, blurred vision is not clear." detailed outline ": nourishing kidney, lung moistening makes eye bright.
Rhizoma Zingiberis: acrid in the mouth, hot in nature.Return spleen, stomach, the heart, lung meridian.Warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, dampness expectorant, warming the lung to resolve fluid-retention.
Fructus Crataegi: sour in the mouth, sweet, slightly warm in nature.Return spleen, stomach, Liver Channel.Appetite-stimulating indigestion-relieving, change stagnant removing food stagnancy, promoting blood circulation to remove blood stasis, the circulation of qi promoting of reducing phlegm.Be used for carnivorous stagnate long-pending, lump in the abdomen, abdominal distention feeling of fullness, the stasis of blood resistance stomachache, phlegm retention, have loose bowels, discharging fresh blood stool.
Rhizoma Dioscoreae: sweet in the mouth, property is flat.Return spleen, lung, kidney channel.The spleen reinforcing nourishing the stomach, the lung benefiting that promotes the production of body fluid, the kidney invigorating arresting seminal emission.Be used for insufficiency of the spleen lack of appetite, incessant chronic diarrhea, the deficiency of the lung is breathed with cough, emission due to deficiency of the kidney, leukorrhagia, frequent micturition, deficiency-heat is quenched one's thirst." book on Chinese herbal medicine just ": Rhizoma Dioscoreae, energy spleen invigorating tonify deficiency is grown essence and is reinforced the kidney, and controls weakness, treats five kinds of strain and seven kinds of impairment.
Semen Coicis: cool in nature, sweet in the mouth.The spleen invigorating eliminating dampness by diuresis, eliminating impediment antidiarrheal.Semen Coicis can be used for treating edema, beriberi, dysuria, arthralgia chiefly caused by damp pathogen contracture, diarrhea due to hypofunction of the spleen.Be the product of the clearing heat and expelling damp of mitigation.
Radix Achyranthis Bidentatae: hardship, acid, property is flat.Invigorating the liver and kidney, bone and muscle strengthening, promoting blood circulation to restore menstrual flow, ignite (blood) is descending, inducing diuresis for treating stranguria syndrome.Cure mainly soreness of waist and knee joint, flaccidity and weakness of the lower limbs, amenorrhea due to stagnation of blood, dysmenorrhea, puerperal abdominal pain due to blood stasis, lump in the abdomen, retention of placenta, pyretic stranguria, stranguria with blood, traumatic injury, carbuncle malignant boil, laryngopharynx swelling and pain.
Fructus Psoraleae: acrid in the mouth, hardship, warm in nature.Reinforcing the kidney and supporting YANG, helping inspiration to relieve asthma, warming spleen and stopping diarrha.Main insufficiency of kidney-YANG, below element deficiency and cold, chills and pain of the waist and kness, impotence and seminal emission, frequent micturition, the enuresis.Compendium of Material Medica: control diarrhea due to kidney-dificiency, the logical gate of vitality, spirit is held back at warm public region.
Herba Lycopi: tepor, bitter in the mouth, suffering.Return liver, spleen channel.Blood circulation promoting and blood stasis dispelling, line water detumescence.Be used for menoxenia, amenorrhea, dysmenorrhea, postnatal blood stasis stomachache, edema.
Rabdosia rubescens: bitter in the mouth, sweet, be slightly cold.Heat-clearing and toxic substances removing, promoting blood circulation and stopping pain.Cure mainly laryngopharynx swelling and pain, headache due to common cold, tracheitis, chronic hepatitis, rheumatic arthritis, snake bite and insect sting.
Folium Artemisiae Argyi: hot, bitter, temperature.Return the liver,spleen,kidney warp.Dispersing cold for relieving pain, warming the meridian for stopping bleeding.Be used for few abdomen cold type of pain, coldness and unbalance in meridians, cold womb is infertile, spits blood, epistaxis, the metrorrhagia warp is many, gestation hemorrhage; The external treatment skin pruritus, decortication." detailed outline ": warming middle-JIAO, by cold, dehumidifying.
Herba Lycopodii: hardship, suffering, temperature is returned Liver Channel.Expelling wind and cold, dehumidifying detumescence, relaxing muscles and tendons and activating QI and blood in the collateral.Be used for anemofrigid-damp arthralgia, carbuncle is ached in the contracture of muscle arteries and veins.External is controlled osteopatia sprain and is swollen and ache." Hunan medicine will ": relaxing muscles and tendons to promote blood circulation, invigorating qi and dredging collateral.Control lumbago, arthralgia.
Flos Lonicerae: suffering, cold.Return lung, stomach, the heart, large intestine channel.Dispelling wind-heat, removing summer-heat blood poison is used for various febrile diseases.
Herba Selaginellae: suffering, flat.Return liver, heart channel.Promoting blood circulation to restore menstrual flow.Be used for the amenorrhea dysmenorrhea, injury from falling down.
Wherein, the ratio of weight and number of each raw medicinal material can be as follows in the described Chinese medicine preparation:
5~10 parts of Squama Manis, 15~20 parts of Ramulus Cinnamomi, 20~35 parts of Radix Rubiae Yunnanensis, 10~15 parts of Rhizoma Polygoni Cuspidati, 10~15 parts in Semen Persicae, 10~20 parts of Fructus Lyciis, 15~20 parts of Rhizoma Zingiberiss, 10~15 parts of Fructus Crataegis, 10~20 parts of Rhizoma Dioscoreaes, 10~15 parts of Semen Coiciss, 10~20 parts of Radix Achyranthis Bidentataes, 10~20 parts of Fructus Psoraleaes, 10~15 parts of Herba Lycopi, 10~15 parts of Rabdosia rubescens, 5~10 parts of Folium Artemisiae Argyis, 15~20 parts of Herba Lycopodiis, 10~15 parts of 10~15 parts of Flos Loniceraes and Herba Selaginellaes.
Wherein, the ratio of weight and number of each raw medicinal material can also be as follows in the described Chinese medicine preparation:
7~10 parts of Squama Manis, 15~18 parts of Ramulus Cinnamomi, 25~35 parts of Radix Rubiae Yunnanensis, 12~15 parts of Rhizoma Polygoni Cuspidati, 10~13 parts in Semen Persicae, 15~20 parts of Fructus Lyciis, 15~18 parts of Rhizoma Zingiberiss, 13~15 parts of Fructus Crataegis, 15~20 parts of Rhizoma Dioscoreaes, 10~13 parts of Semen Coiciss, 10~15 parts of Radix Achyranthis Bidentataes, 15~20 parts of Fructus Psoraleaes, 10~12 parts of Herba Lycopi, 13~15 parts of Rabdosia rubescens, 7~10 parts of Folium Artemisiae Argyis, 15~17 parts of Herba Lycopodiis, 13~15 parts of 13~15 parts of Flos Loniceraes and Herba Selaginellaes.
Wherein, the ratio of weight and number of each raw medicinal material again can be as follows in the described Chinese medicine preparation:
9 parts of Squama Manis, 16 parts of Ramulus Cinnamomi, 32 parts of Radix Rubiae Yunnanensis, 13 parts of Rhizoma Polygoni Cuspidati, 12 parts in Semen Persicae, 18 parts of Fructus Lyciis, 15 parts of Rhizoma Zingiberiss, 14 parts of Fructus Crataegis, 17 parts of Rhizoma Dioscoreaes, 12 parts of Semen Coiciss, 14 parts of Radix Achyranthis Bidentataes, 16 parts of Fructus Psoraleaes, 11 parts of Herba Lycopi, 15 parts of Rabdosia rubescens, 8 parts of Folium Artemisiae Argyis, 16 parts of Herba Lycopodiis, 15 parts of 14 parts of Flos Loniceraes and Herba Selaginellaes.
When the dosage form of described Chinese medicine preparation was tablet, its preparation method may further comprise the steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, adding is 80%~90% ethanol with respect to the determining alcohol of 5~8 times of mixture qualities, reflux 100~140 minutes, extract, filter and obtain first extracting solution, it is 75%~85% ethanol that the medicinal residues that filter to obtain add determining alcohol with respect to 3~6 times of medicinal residues quality again, reflux 80~120 minutes, extract, filter and obtain second extracting solution, first extracting solution and second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, drying obtains and gets dry extract;
Second step: the dried cream that the first step is obtained is placed on pulverizes 3~6 hours in the super micron mill, crushing screening obtains 200~400 purpose micropowders;
The 3rd step: in the micropowders of second step acquisition, add with respect to the microcrystalline Cellulose of 0.3~0.6 times of its quality, 0.15~0.25 times lactose and 0.2~0.4 times starch, sieve, mix homogeneously, granulate, drying adds the magnesium stearate with respect to 0.02~0.06 times of micropowders quality, granulate, tabletting is made.
When the dosage form of described Chinese medicine was capsule, its preparation method may further comprise the steps:
The first step, with Squama Manis, Ramulus Cinnamomi, Radix Rubiae Yunnanensis, Rhizoma Polygoni Cuspidati, Semen Persicae and Herba Selaginellae add the water extraction volatile oil with respect to 5~8 times in mixture by described mixed, with the volatile oil beta-cyclodextrin inclusion compound that obtains, the ratio of volatile oil and beta-schardinger dextrin-is 1: 4~8, stirs 45 ℃~65 ℃ of temperature 100 minutes~150 minutes, get volatile oil clathrate compound, standby; Relative density is 1.21~1.23 clear paste when in addition aqueous extract being concentrated into 60 ℃;
Second step, with Fructus Lycii, Rhizoma Zingiberis, Fructus Crataegi, Rhizoma Dioscoreae, Semen Coicis, Radix Achyranthis Bidentatae and Fructus Psoraleae are by described mixed, adding with respect to 3~6 times in mixture amount determining alcohol is 85%~90% alcohol reflux 3~5 times, each 2~3 hours, filters respectively, each time filtrate merges, reclaim ethanol, relative density is 1.27~1.29 clear paste when being concentrated into 60 ℃, and is standby;
The 3rd step will remain described raw medicinal material by described mixed, add with respect to 8~10 times of water gagings of mixture, boil 6~8 hours, filter, and relative density is 1.30~1.32 clear paste when being concentrated into 60 ℃;
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 60 ℃~70 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step, the described volatile oil clathrate compound of the first step and described dried cream powder of the 4th step are fully mixed, subsequently with respect to the mixture of the described volatile oil clathrate compound of 100 weight portions and dried cream powder, add 8~12 weight portion carboxymethyl starch sodium, 15~40 weight portion starch mix homogeneously, adding 250~400 weight portion determining alcohols then is 90%~95% alcohol granulation, dry, granulate, last mixture with respect to the described volatile oil clathrate compound of 100 weight portions and dried cream powder, add 6~10 weight portion magnesium stearate, in the gelatine capsule of packing into then.
Below adopt example to describe embodiments of the present invention in detail, how the application technology means solve technical problem to the present invention whereby, and the implementation procedure of reaching technique effect can fully understand and implements according to this.
The tablet of embodiment 1 the present invention preparation
Get Squama Manis 90g, Ramulus Cinnamomi 160g, Radix Rubiae Yunnanensis 320g, Rhizoma Polygoni Cuspidati 130g, Semen Persicae 120g, Fructus Lycii 180g, Rhizoma Zingiberis 150g, Fructus Crataegi 140g, Rhizoma Dioscoreae 170g, Semen Coicis 120g, Radix Achyranthis Bidentatae 140g, Fructus Psoraleae 160g, Herba Lycopi 110g, Rabdosia rubescens 150g, Folium Artemisiae Argyi 80g, Herba Lycopodii 160g, Flos Lonicerae 140g and Herba Selaginellae 150g;
Its preparation method may further comprise the steps:
The first step: each raw medicinal material of Chinese medicine preparation is mixed in proportion, adds determining alcohol with respect to 7 times of mixture qualities and be 85% ethanol, reflux 120 minutes, extract, filter to obtain first extracting solution, filtering the medicinal residues that obtain, to add determining alcohol with respect to 5 times of medicinal residues quality again be 85% ethanol, reflux 90 minutes, extract, filter and obtain second extracting solution, first extracting solution and second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, drying obtains and gets dry extract;
Second step: the dried cream that the first step is obtained is placed in the super micron mill to be pulverized 5 hours, and crushing screening obtains 300 purpose micropowders;
The 3rd step: in the micropowders of second step acquisition, add with respect to the microcrystalline Cellulose of 0.5 times of its quality, 0.25 times lactose and 0.35 times starch, sieve mix homogeneously, granulate, drying adds the magnesium stearate with respect to 0.05 times of micropowders quality, granulate, tabletting is made.
The capsule of embodiment 2 the present invention preparation
Get Squama Manis 100g, Ramulus Cinnamomi 170g, Radix Rubiae Yunnanensis 280g, Rhizoma Polygoni Cuspidati 150g, Semen Persicae 100g, Fructus Lycii 160g, Rhizoma Zingiberis 170g, Fructus Crataegi 150g, Rhizoma Dioscoreae 200g, Semen Coicis 100g, Radix Achyranthis Bidentatae 120g, Fructus Psoraleae 190g, Herba Lycopi 100g, Rabdosia rubescens 140g, Folium Artemisiae Argyi 90g, Herba Lycopodii 170g, Flos Lonicerae 130g and Herba Selaginellae 140g;
Its preparation method may further comprise the steps:
The first step, with Squama Manis, Ramulus Cinnamomi, Radix Rubiae Yunnanensis, Rhizoma Polygoni Cuspidati, Semen Persicae and Herba Selaginellae are mixed in proportion, and add the water extraction volatile oil with respect to 6 times in mixture, with the volatile oil beta-cyclodextrin inclusion compound that obtains, the ratio of volatile oil and beta-schardinger dextrin-is 1: 6, stirs 50 ℃ of temperature 130 minutes, get volatile oil clathrate compound, standby; Relative density is 1.22 clear paste when in addition aqueous extract being concentrated into 60 ℃;
Second step, with Fructus Lycii, Rhizoma Zingiberis, Fructus Crataegi, Rhizoma Dioscoreae, Semen Coicis, Radix Achyranthis Bidentatae and Fructus Psoraleae are mixed in proportion, adding with respect to 5 times in mixture amount determining alcohol is 90% alcohol reflux 4 times, each 2 hours, filters respectively, each time filtrate merges, reclaim ethanol, relative density is 1.28 clear paste when being concentrated into 60 ℃, and is standby;
The 3rd step was mixed in proportion the surplus stock medical material, added with respect to 9 times of water gagings of mixture, boiled 7 hours, filtered, and relative density is 1.31 clear paste when being concentrated into 60 ℃;
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 70 ℃ of reduced vacuum dryings, powder gets dry extract;
The 5th step, first step volatile oil clathrate compound and the 4th step dried cream powder are fully mixed, subsequently with respect to the mixture of 100 weight portion volatile oil clathrate compounds and dried cream powder, add 11 weight portion carboxymethyl starch sodium, 35 weight portion starch mix homogeneously, adding 350 weight portion determining alcohols then is 90%~95% alcohol granulation, drying, granulate, with respect to the mixture of 100 weight portion volatile oil clathrate compounds and dried cream powder, add 8 weight portion magnesium stearate, in the gelatine capsule of packing into then at last.
Toxicity test:
Acute toxicity testing:
Use 60 of mices, male and female half and half, body weight 17~24g carries out acute toxicity test.Mice is divided into two groups at random, be matched group and administration group, fasting 12 hours before the experiment, with the tablet dissolved of embodiments of the invention 1 preparation in water, (concentration is 4.86g crude drug/ml, maximum concentration) irritate stomach, irritating the stomach volume is that 5ml/kg (is that single-dose dosage is that 24.3 crude drugs/kg), matched group gives the equivalent normal saline, administration in one day 2 times, delivery time 6 hours was observed 14 days continuously after the administration, and the record mice toxic reaction and death toll.Experimental result shows: compare with matched group, mice does not see notable difference after the administration, and experiment was observed 14 days continuously, and mice overall health of patients, diet, drinking-water, body weight gain are all normal.Mice oral administration gavage tablet of the present invention is LD50>24.3 crude drugs/kg, and every day, maximum dosage-feeding was 48.6 crude drugs/kg.Chinese medicine clinical application amount of the present invention is 2.5g crude drug/day/people, becomes body weight for humans in 60KG, and average dosage is 0.042g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 20g) oral administration gavage Chinese medicine of the present invention is 972 times of clinical consumption.Therefore Chinese medicine acute toxicity of the present invention is low, clinical drug safety.
Long term toxicity test:
The tablet dissolved of the embodiment of the invention 1 is in water, to mice by 9.64,21.43 and 36.87g crude drug/16 weeks of kg continuous use (10ml/kg) and 4 weeks of drug withdrawal after, the result shows: Chinese medicine preparation of the present invention does not all have obvious influence to indexs such as the hair of rat, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat, the internal organs naked eyes do not find that difference changes and the histological examination result shows, after 16 weeks of medication and 4 weeks of drug withdrawal, each internal organs of rat all do not have obvious change.Illustrate that toxicity is little after Chinese medicine preparation of the present invention is to the rat long-term prescription, also do not have the difference reaction after the drug withdrawal, application safety.
Clinical data:
Case is selected: whole 40 routine cases are my patient of institute, all are the male, and at 25~40 years old age, 39 examples have smoking history. and thromboangiitis obliterans divided for three phases: the first phase is the ischemia phase, and the second phase is the malnutrition phase, and the third phase is the tissue necrosis phase.13 examples belong to the first phase among the 40 routine patients, and 20 examples belong to the second phase, and 7 examples belong to the third phase.
Diagnostic criteria: 1, male person between twenty and fifty (20~45 years old) have smoking history more or catch cold and freeze history.2, acra be afraid of cold, numb, pain, skin colour changes, intermittent claudication, limbs malnutrition.3,40~60% have migration superficial thrombophlebitis medical history and sign.4, trouble main drive arteriopalmus obviously weakens or disappears.
Therapeutic Method: take 1 tablet every day of the embodiment of the invention 3 times, each 3,15 days is a course for the treatment of.
Curative effect judging standard:
Cure: cardinal symptom disappears, and wound surface heals fully, and pain disappears, and it is normal that skin temperature and color and luster recover, and suffers from the limb disturbance of blood circulation and obviously improves, and resumes work and does not have recurrence in 1 year.
Produce effects: the clinical symptoms major part disappears or obviously alleviates, and pain disappears, and skin temperature and color and luster are clearly better, and wound surface approaches healing, and the slight obstacle of blood circulation can be worked.
Effectively: condition of illness alleviates, and wound surface before dwindles, and suffers from the limb blood circulation and makes moderate progress, and still can not be engaged in work.
Invalid: clinical symptoms and sign all do not have improvement.
Therapeutic outcome:
Take 1 course for the treatment of of tablet of Chinese medicine preparation embodiment 1 of the present invention, cure 10 examples, produce effects 22 examples, effective 5 examples, invalid 3 examples; Cure rate reaches 25%, and total effective rate reaches 92.5%.
Take 2 courses for the treatment of of tablet of Chinese medicine preparation embodiment 1 of the present invention, cure 21 examples, produce effects 15 examples, effective 4 examples, invalid 0 example; Cure rate reaches 52.5%, and total effective rate reaches 100%.
Concrete case:
Case 1: Zhao, male, 34 years old, when coming my institute to go to a doctor as follows limb send out cold, be afraid of cold, numb, pain, the sense of foot underbed has intermittent claudication, shank is suppressed and is risen, light red tongue, tongue is white, deep-thready pulse, be diagnosed as the asthenic cold type thromboangiitis obliterans, take Chinese medicine preparation embodiment 1 tablet of the present invention, every day 3 times, each 3,1 course for the treatment of, the symptom complete obiteration is followed up a case by regular visits to and is not recurred half a year.
Case 2: Chen, the male, 25 years old, the trouble limb was afraid of cold, pain, normal be migration, during walking lower limb aching and tired, suppress rise, heavy weak, lump or tuberosity often appear in lower limb, red and swollen heat pain, suffer from limb edema sometimes, red tongue, yellow and greasy fur, wiry and frequent pulse is diagnosed as the damp-heat type thromboangiitis obliterans, takes the capsule of Chinese medicine preparation embodiment 2 of the present invention, every day 3 times, each 2, took for 1 course for the treatment of, symptom disappears substantially, takes course for the treatment of recovery from illness again, follows up a case by regular visits to not recurrence in 1 year.
The above only is preferred embodiment of the present invention, is not to be the restriction of the present invention being made other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away to any simple modification, equivalent variations and remodeling that above embodiment does, still belongs to the protection domain of technical solution of the present invention according to technical spirit of the present invention.

Claims (8)

1. a Chinese medicine preparation for the treatment of thromboangiitis obliterans is characterized in that, described Chinese medicine preparation comprises following raw medicinal material: Squama Manis, Ramulus Cinnamomi, Radix Rubiae Yunnanensis, Rhizoma Polygoni Cuspidati, Semen Persicae, Fructus Lycii, Rhizoma Zingiberis, Fructus Crataegi, Rhizoma Dioscoreae, Semen Coicis, Radix Achyranthis Bidentatae, Fructus Psoraleae, Herba Lycopi, Rabdosia rubescens, Folium Artemisiae Argyi, Herba Lycopodii, Flos Lonicerae and Herba Selaginellae.
2. Chinese medicine preparation as claimed in claim 1 is characterized in that, the ratio of weight and number of each raw medicinal material is as follows in the described Chinese medicine preparation:
5~10 parts of Squama Manis, 15~20 parts of Ramulus Cinnamomi, 20~35 parts of Radix Rubiae Yunnanensis, 10~15 parts of Rhizoma Polygoni Cuspidati, 10~15 parts in Semen Persicae, 10~20 parts of Fructus Lyciis, 15~20 parts of Rhizoma Zingiberiss, 10~15 parts of Fructus Crataegis, 10~20 parts of Rhizoma Dioscoreaes, 10~15 parts of Semen Coiciss, 10~20 parts of Radix Achyranthis Bidentataes, 10~20 parts of Fructus Psoraleaes, 10~15 parts of Herba Lycopi, 10~15 parts of Rabdosia rubescens, 5~10 parts of Folium Artemisiae Argyis, 15~20 parts of Herba Lycopodiis, 10~15 parts of 10~15 parts of Flos Loniceraes and Herba Selaginellaes.
3. Chinese medicine preparation as claimed in claim 1 or 2 is characterized in that, the ratio of weight and number of each raw medicinal material is as follows in the described Chinese medicine preparation:
7~10 parts of Squama Manis, 15~18 parts of Ramulus Cinnamomi, 25~35 parts of Radix Rubiae Yunnanensis, 12~15 parts of Rhizoma Polygoni Cuspidati, 10~13 parts in Semen Persicae, 15~20 parts of Fructus Lyciis, 15~18 parts of Rhizoma Zingiberiss, 13~15 parts of Fructus Crataegis, 15~20 parts of Rhizoma Dioscoreaes, 10~13 parts of Semen Coiciss, 10~15 parts of Radix Achyranthis Bidentataes, 15~20 parts of Fructus Psoraleaes, 10~12 parts of Herba Lycopi, 13~15 parts of Rabdosia rubescens, 7~10 parts of Folium Artemisiae Argyis, 15~17 parts of Herba Lycopodiis, 13~15 parts of 13~15 parts of Flos Loniceraes and Herba Selaginellaes.
4. as the described Chinese medicine preparation of claim 1 to 3, it is characterized in that the ratio of weight and number of each raw medicinal material is as follows in the described Chinese medicine preparation:
9 parts of Squama Manis, 16 parts of Ramulus Cinnamomi, 32 parts of Radix Rubiae Yunnanensis, 13 parts of Rhizoma Polygoni Cuspidati, 12 parts in Semen Persicae, 18 parts of Fructus Lyciis, 15 parts of Rhizoma Zingiberiss, 14 parts of Fructus Crataegis, 17 parts of Rhizoma Dioscoreaes, 12 parts of Semen Coiciss, 14 parts of Radix Achyranthis Bidentataes, 16 parts of Fructus Psoraleaes, 11 parts of Herba Lycopi, 15 parts of Rabdosia rubescens, 8 parts of Folium Artemisiae Argyis, 16 parts of Herba Lycopodiis, 15 parts of 14 parts of Flos Loniceraes and Herba Selaginellaes.
5. as the described Chinese medicine preparation of claim 1 to 4, it is characterized in that when the dosage form of described Chinese medicine preparation was tablet, its preparation method may further comprise the steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, adding is 80%~90% ethanol with respect to the determining alcohol of 5~8 times of mixture qualities, reflux 100~140 minutes, extract, filter and obtain first extracting solution, it is 75%~85% ethanol that the medicinal residues that filter to obtain add determining alcohol with respect to 3~6 times of medicinal residues quality again, reflux 80~120 minutes, extract, filter and obtain second extracting solution, first extracting solution and second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, drying obtains and gets dry extract;
Second step: the dried cream that the first step is obtained is placed on pulverizes 3~6 hours in the super micron mill, crushing screening obtains 200~400 purpose micropowders;
The 3rd step: in the micropowders of second step acquisition, add with respect to the microcrystalline Cellulose of 0.3~0.6 times of its quality, 0.15~0.25 times lactose and 0.2~0.4 times starch, sieve, mix homogeneously, granulate, drying adds the magnesium stearate with respect to 0.02~0.06 times of micropowders quality, granulate, tabletting is made.
6. as the described Chinese medicine preparation of claim 1 to 4, it is characterized in that when the dosage form of described Chinese medicine was capsule, its preparation method may further comprise the steps:
The first step, with Squama Manis, Ramulus Cinnamomi, Radix Rubiae Yunnanensis, Rhizoma Polygoni Cuspidati, Semen Persicae and Herba Selaginellae add the water extraction volatile oil with respect to 5~8 times in mixture by described mixed, with the volatile oil beta-cyclodextrin inclusion compound that obtains, the ratio of volatile oil and beta-schardinger dextrin-is 1: 4~8, stirs 45 ℃~65 ℃ of temperature 100 minutes~150 minutes, get volatile oil clathrate compound, standby; Relative density is 1.21~1.23 clear paste when in addition aqueous extract being concentrated into 60 ℃;
Second step, with Fructus Lycii, Rhizoma Zingiberis, Fructus Crataegi, Rhizoma Dioscoreae, Semen Coicis, Radix Achyranthis Bidentatae and Fructus Psoraleae are by described mixed, adding with respect to 3~6 times in mixture amount determining alcohol is 85%~90% alcohol reflux 3~5 times, each 2~3 hours, filters respectively, each time filtrate merges, reclaim ethanol, relative density is 1.27~1.29 clear paste when being concentrated into 60 ℃, and is standby;
The 3rd step will remain described raw medicinal material by described mixed, add with respect to 8~10 times of water gagings of mixture, boil 6~8 hours, filter, and relative density is 1.30~1.32 clear paste when being concentrated into 60 ℃;
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 60 ℃~70 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step, the described volatile oil clathrate compound of the first step and described dried cream powder of the 4th step are fully mixed, subsequently with respect to the mixture of the described volatile oil clathrate compound of 100 weight portions and dried cream powder, add 8~12 weight portion carboxymethyl starch sodium, 15~40 weight portion starch mix homogeneously, adding 250~400 weight portion determining alcohols then is 90%~95% alcohol granulation, dry, granulate, last mixture with respect to the described volatile oil clathrate compound of 100 weight portions and dried cream powder, add 6~10 weight portion magnesium stearate, in the gelatine capsule of packing into then.
7. the preparation method of the described Chinese medicine preparation of claim 1 to 4 is characterized in that, the dosage form of described Chinese medicine preparation is tablet, and its preparation method may further comprise the steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, adding is 80%~90% ethanol with respect to the determining alcohol of 5~8 times of mixture qualities, reflux 100~140 minutes, extract, filter and obtain first extracting solution, it is 75%~85% ethanol that the medicinal residues that filter to obtain add determining alcohol with respect to 3~6 times of medicinal residues quality again, reflux 80~120 minutes, extract, filter and obtain second extracting solution, first extracting solution and second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, drying obtains and gets dry extract;
Second step: the dried cream that the first step is obtained is placed on pulverizes 3~6 hours in the super micron mill, crushing screening obtains 200~400 purpose micropowders;
The 3rd step: in the micropowders of second step acquisition, add with respect to the microcrystalline Cellulose of 0.3~0.6 times of its quality, 0.15~0.25 times lactose and 0.2~0.4 times starch, sieve, mix homogeneously, granulate, drying adds the magnesium stearate with respect to 0.02~0.06 times of micropowders quality, granulate, tabletting is made.
8. the preparation method of the described Chinese medicine preparation of claim 1 to 4 is characterized in that, the dosage form of described Chinese medicine is capsule, and its preparation method may further comprise the steps:
The first step, with Squama Manis, Ramulus Cinnamomi, Radix Rubiae Yunnanensis, Rhizoma Polygoni Cuspidati, Semen Persicae and Herba Selaginellae add the water extraction volatile oil with respect to 5~8 times in mixture by described mixed, with the volatile oil beta-cyclodextrin inclusion compound that obtains, the ratio of volatile oil and beta-schardinger dextrin-is 1: 4~8, stirs 45 ℃~65 ℃ of temperature 100 minutes~150 minutes, get volatile oil clathrate compound, standby; Relative density is 1.21~1.23 clear paste when in addition aqueous extract being concentrated into 60 ℃;
Second step, with Fructus Lycii, Rhizoma Zingiberis, Fructus Crataegi, Rhizoma Dioscoreae, Semen Coicis, Radix Achyranthis Bidentatae and Fructus Psoraleae are by described mixed, adding with respect to 3~6 times in mixture amount determining alcohol is 85%~90% alcohol reflux 3~5 times, each 2~3 hours, filters respectively, each time filtrate merges, reclaim ethanol, relative density is 1.27~1.29 clear paste when being concentrated into 60 ℃, and is standby;
The 3rd step will remain described raw medicinal material by described mixed, add with respect to 8~10 times of water gagings of mixture, boil 6~8 hours, filter, and relative density is 1.30~1.32 clear paste when being concentrated into 60 ℃;
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 60 ℃~70 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step, the described volatile oil clathrate compound of the first step and described dried cream powder of the 4th step are fully mixed, subsequently with respect to the mixture of the described volatile oil clathrate compound of 100 weight portions and dried cream powder, add 8~12 weight portion carboxymethyl starch sodium, 15~40 weight portion starch mix homogeneously, adding 250~400 weight portion determining alcohols then is 90%~95% alcohol granulation, dry, granulate, last mixture with respect to the described volatile oil clathrate compound of 100 weight portions and dried cream powder, add 6~10 weight portion magnesium stearate, in the gelatine capsule of packing into then.
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