CN105125988A - Traditional Chinese medicinal preparation for treating thromboangiitis obliterans and preparation method of traditional Chinese medicinal preparation - Google Patents
Traditional Chinese medicinal preparation for treating thromboangiitis obliterans and preparation method of traditional Chinese medicinal preparation Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicinal preparation for treating thromboangiitis obliterans and a preparation method of the traditional Chinese medicinal preparation. The traditional Chinese medicinal preparation comprises the following raw medicinal materials of hedychium coronarium koen, asarum caudigerum, bark of fragrant spicebush, caryopteris incana, semen litchi, root of mysorethorn, rhododendron thymifolium maxim, berchemia floribunda brongn, meconopsis horridula, hylotelephium verticillatum, latouchea fokiensis, davallia formosana, salvia evansiana and oxalis acetosella. The traditional Chinese medicinal preparation provided by the invention has a definite therapeutic effect for the thromboangiitis obliterans, and has small side effects.
Description
Technical field
The present invention relates to pharmaceutical technology, particularly relate to 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 persistent, the progressive vascular inflammation pathological changes of peripheral vascular (in, small artery and vein), cause thrombosis to make lumen of vessels inaccessible.Pathological changes is mainly involved in distal limbs, small artery, and accompanying vein and Superficial veins also often involve, based on lower limb.Can be there is the ulcer that not easily heals and gangrene in severe patient acra, permanent disfunction or limbs may be caused to lose, even dead.
Western medical treatment vasculitis is mainly based on antiinflammatory, analgesic Western medicine, and Western medicine can improve the state of an illness really, but antiphlogistic effects is poor, and side effect is large, thoroughly can not cure vasculitis.
Thromboangiitis obliterans belongs to " necrosis " category of Chinese medicine, and its cause of disease is because temper is not good for, insufficiency of kidney-YANG, and add again outer catching cold and freeze, the heresy of cold-damp is invaded and falls ill.Temper is not good for, and changes raw not enough, deficiency of qi and blood, interiorly can not strengthen foster internal organs; Can not to supplement nutrition outward extremity.Spleen kidney yang QI-insufficiency, can not replenishing vital QI with drugs of warm nature extremity, and again by the heresy of cold-damp, then coagulation of QI-blood, meridians block, stagnation of QI and blood may bring about pain, and extremity QI and blood is not filled, and lose and support that then skin and flesh is withered in moistening, necrosis comes off.If cold-evil accumulates for a long time, then strongly fragrant and heat-transformation, damp and hot contamination, then suffer from toe (finger) redness and to burst pus.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 take deficiency of spleen and stomach as this, and 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 for the treatment of thromboangiitis obliterans and preparation method thereof, and Chinese medicine preparation of the present invention is definitely effective in cure to thromboangiitis obliterans, and 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, its raw medicinal material comprises: Rhizoma Hedychii Coronarii, asarum caudigerum Hance, Cortex Linderae Fragrantis, Herba Caryopteridis Incanae, Semen Litchi, Radix Caesalpiniae Radicis, black fragrant bavin, Radix berchemiae floribundae, Herba Meconopsis Horridulae, Hylotelephium verticillatum (Linn.) H. Ohba, Radix limonii sinensis, great Ye Rhizoma Drynariae, Salvia salvia flava Forrest ex diels. and SANYE Hydrocotyle vulgaris L..
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: Rhizoma Hedychii Coronarii 5 ~ 15 parts, asarum caudigerum Hance 5 ~ 15 parts, Cortex Linderae Fragrantis 10 ~ 20 parts, Herba Caryopteridis Incanae 35 ~ 45 parts, Semen Litchi 35 ~ 45 parts, Radix Caesalpiniae Radicis 15 ~ 25 parts, black fragrant bavin 10 ~ 20 parts, Radix berchemiae floribundae 5 ~ 15 parts, Herba Meconopsis Horridulae 5 ~ 15 parts, Hylotelephium verticillatum (Linn.) H. Ohba 25 ~ 35 parts, Radix limonii sinensis 10 ~ 20 parts, great Ye Rhizoma Drynariae 15 ~ 25 parts, Salvia salvia flava Forrest ex diels. 25 ~ 35 parts and SANYE Hydrocotyle vulgaris L. 10 ~ 20 parts.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: Rhizoma Hedychii Coronarii 5 ~ 10 parts, asarum caudigerum Hance 5 ~ 10 parts, Cortex Linderae Fragrantis 10 ~ 15 parts, Herba Caryopteridis Incanae 35 ~ 40 parts, Semen Litchi 35 ~ 40 parts, Radix Caesalpiniae Radicis 15 ~ 20 parts, black fragrant bavin 10 ~ 15 parts, Radix berchemiae floribundae 5 ~ 10 parts, Herba Meconopsis Horridulae 5 ~ 10 parts, Hylotelephium verticillatum (Linn.) H. Ohba 25 ~ 30 parts, Radix limonii sinensis 10 ~ 15 parts, great Ye Rhizoma Drynariae 15 ~ 20 parts, Salvia salvia flava Forrest ex diels. 25 ~ 30 parts and SANYE Hydrocotyle vulgaris L. 10 ~ 15 parts.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: Rhizoma Hedychii Coronarii 6 parts, asarum caudigerum Hance 7 parts, Cortex Linderae Fragrantis 14 parts, Herba Caryopteridis Incanae 38 parts, Semen Litchi 36 parts, Radix Caesalpiniae Radicis 16 parts, black fragrant bavin 12 parts, Radix berchemiae floribundae 8 parts, Herba Meconopsis Horridulae 7 parts, Hylotelephium verticillatum (Linn.) H. Ohba 29 parts, Radix limonii sinensis 13 parts, great Ye Rhizoma Drynariae 18 parts, Salvia salvia flava Forrest ex diels. 26 parts and SANYE Hydrocotyle vulgaris L. 11 parts.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, the dosage form of described Chinese medicine preparation is capsule, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.3 ~ 0.6 times, the starch of 0.3 ~ 0.6 times, the magnesium stearate of 0.002 ~ 0.02 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is powder, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 4 times is the ethanol of 70 ~ 80%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 70 ~ 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 2 ~ 3 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize, sieve, obtain 100 order ~ 200 object micropowders;
3rd step: add the starch relative to its quality 2 ~ 4 times in the micropowders obtained by second step, mixing, obtains powder.
Beneficial effect of the present invention: Chinese medicine preparation of the present invention is definitely effective in cure to thromboangiitis obliterans, and side effect is little.
Detailed description of the invention
The invention provides a kind of Chinese medicine preparation for the treatment of thromboangiitis obliterans, its raw medicinal material comprises: Rhizoma Hedychii Coronarii, asarum caudigerum Hance, Cortex Linderae Fragrantis, Herba Caryopteridis Incanae, Semen Litchi, Radix Caesalpiniae Radicis, black fragrant bavin, Radix berchemiae floribundae, Herba Meconopsis Horridulae, Hylotelephium verticillatum (Linn.) H. Ohba, Radix limonii sinensis, great Ye Rhizoma Drynariae, Salvia salvia flava Forrest ex diels. and SANYE Hydrocotyle vulgaris L..
In described Chinese medicine preparation, the pharmacology of each raw medicinal material is as follows:
Rhizoma Hedychii Coronarii: [source] is the rhizome of zingiberaceous plant Hedychium coronarium Koenig.[nature and flavor] acrid in the mouth, warm in nature.[function cures mainly] expelling wind and cold, antalgic.Main exterior syndrome due to wind-cold, headache general pain, rheumatic arthralgia, coldness and pain in the epigastrium, traumatic injury.
Asarum caudigerum Hance: the herb that [source] is aristolochiaceae plant asarum caudigerum Hance and floral leaf asarum caudigerum Hance.[warm in nature] is pungent, micro-hardship, temperature.[return through] returns lung, kidney channel.[function cures mainly] dispelling cold by warming the meridian, preventing phlegm from forming and stopping coughing, reducing swelling and alleviating pain.Main anemofrigid cold, headache, cough, asthma, rheumatic arthralgia, traumatic injury, aphtha of the mouth and tongue, venom, sore swollen toxin.
Cortex Linderae Fragrantis: the bark that [source] is canella Cortex Linderae Fragrantis or leaf.[nature and flavor] are pungent, temperature.[return through] returns stomach warp.[function cures mainly] warming middle-JIAO to promote flow of QI, expelling wind and cold.Main anemofrigid cold, stomachache with cool feeling, dyspepsia, rheumatic arthralgia.
Herba Caryopteridis Incanae: the herb that [source] is Verbenaceae Herba Caryopteridis Incanae or whole herb with root.[nature and flavor] are pungent, temperature.[function cures mainly] dispelling wind to relieve the exterior syndrome, dispelling cold and dehumidification, eliminating stasis to stop pain.Main anemofrigid cold, headache, cough, coldness and pain in the epigastrium, dyspeptic vomiting and diarrhea, cold stasis of blood dysmenorrhea, the stagnant stomachache of the stasis of blood in puerperal, anemofrigid-damp arthralgia, traumatic injury congestive edema, takes cellulitis and does not disappear, eczema, snakebite.
Semen Litchi: [source] is the seed of sapindaceous plant Fructus Litchi.[nature and flavor] are sweet, micro-hardship, warm in nature.[return through] returns liver, kidney, spleen channel.[function cures mainly] regulating QI to relieve pain, cold relieving is fallen apart stagnant.Main colicky, painful and swollen testis, gastric abscess, dysmenorrhea, puerperal abdonimal pain.
Radix Caesalpiniae Radicis: the root that [source] is leguminous plant Semen Caesalpiniae or root bark.[nature and flavor] are bitter, pungent, temperature.[function cures mainly] dispels the wind, cold expelling, dehumidifying.Main cold cough, general pain, lumbago, laryngalgia, toothache, traumatic injury, lymphogranuloma inguinale inguinal bubo.
Black fragrant bavin: the branch and leaf that [source] is ericad Radix Rhododendri thymifolii and flower.[nature and flavor] are bitter, pungent, warm in nature.[function cures mainly] relieving cough and resolving phlegm, warming the stomach cold relieving.Main cough with asthma abundant expectoration, cold syndrome of the stomach pain.
Radix berchemiae floribundae: [source] spends more the root of Radix Berchemiae Giraldianae for Rhamnaceae plant.[nature and flavor] are sweet, bitter, flat.[return through] returns spleen, kidney channel.[function cures mainly] invigorating spleen to remove dampness, dredge the meridian passage.Main weakness of the spleen and stomach, lack of appetite, stomachache, jaundice, edema, stranguria with turbid discharge, leukorrhagia, pathogenic wind toxic multiple abscess, articular rheumatic pain.
Herba Meconopsis Horridulae: [source] is the herb of bloodroot Herba Meconopsis Horridulae.[nature and flavor] tremble with fear, bitter.[return through] returns Liver Channel.[function cures mainly] blood circulation promoting and blood stasis dispelling, heat-clearing and toxic substances removing.Main traumatic injury, fracture, chest and back pain, wind heat pain, arthralgia.
Hylotelephium verticillatum (Linn.) H. Ohba: [source] is the herb of crassulaceae plants Hylotelephium verticillatum (Linn.) H. Ohba.[nature and flavor] are bitter, cool.[function cures mainly] blood circulation promoting and blood stasis dispelling, removing toxic substances and promoting subsidence of swelling.Main impairment caused by overstrain lumbago, gold creates blood, nameless gall, snake bite and insect sting.
Radix limonii sinensis: [source] is the herb of gentianaceae plant Radix limonii sinensis.[nature and flavor] are bitter, pungent, cold in nature.[return through] returns lung, liver, large intestine channel.[function cures mainly] blood circulation promoting and blood stasis dispelling, clearing and antitussive.Blood stasis mass in the abdomen in main abdomen, epersalgia cough.
Great Ye Rhizoma Drynariae: [source] is the rhizome of Davalliaceae plant great Ye Rhizoma Drynariae.[nature and flavor] are bitter, temperature.[function cures mainly] blood circulation promoting and blood stasis dispelling, invigorating the kidney and strengthening the bones, wind-expelling pain-stopping.Main traumatic injury, lumbago due to renal deficiency, rheumatic ostalgia.
Salvia salvia flava Forrest ex diels.: [source] is the root of labiate Salvia salvia flava Forrest ex diels..[nature and flavor] bitter in the mouth, cold nature.[function cures mainly] blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain.Main menoxenia, dysmenorrhea, amenorrhea, abdominal pain due to blood stasis, metrorrhagia, lump in the abdomen, scrofula, erythema, traumatic injury, dermatitis rhus.
SANYE Hydrocotyle vulgaris L.: [source] is the herb of Oxalidaceae plant Herba Oxalis acetosellae.[nature and flavor] sour in the mouth, micro-pungent, property is put down.[return through] GUIXIN, liver, urinary bladder channel.[function cures mainly] blood circulation promoting and blood stasis dispelling, heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome, main impairment caused by overstrain pain, traumatic injury, leprosy, innominate toxic swelling, scabies, oral aphthae in children, burn and scald, stranguria with turbid discharge leukorrhagia, urine retention.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: Rhizoma Hedychii Coronarii 5 ~ 15 parts, asarum caudigerum Hance 5 ~ 15 parts, Cortex Linderae Fragrantis 10 ~ 20 parts, Herba Caryopteridis Incanae 35 ~ 45 parts, Semen Litchi 35 ~ 45 parts, Radix Caesalpiniae Radicis 15 ~ 25 parts, black fragrant bavin 10 ~ 20 parts, Radix berchemiae floribundae 5 ~ 15 parts, Herba Meconopsis Horridulae 5 ~ 15 parts, Hylotelephium verticillatum (Linn.) H. Ohba 25 ~ 35 parts, Radix limonii sinensis 10 ~ 20 parts, great Ye Rhizoma Drynariae 15 ~ 25 parts, Salvia salvia flava Forrest ex diels. 25 ~ 35 parts and SANYE Hydrocotyle vulgaris L. 10 ~ 20 parts.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: Rhizoma Hedychii Coronarii 5 ~ 10 parts, asarum caudigerum Hance 5 ~ 10 parts, Cortex Linderae Fragrantis 10 ~ 15 parts, Herba Caryopteridis Incanae 35 ~ 40 parts, Semen Litchi 35 ~ 40 parts, Radix Caesalpiniae Radicis 15 ~ 20 parts, black fragrant bavin 10 ~ 15 parts, Radix berchemiae floribundae 5 ~ 10 parts, Herba Meconopsis Horridulae 5 ~ 10 parts, Hylotelephium verticillatum (Linn.) H. Ohba 25 ~ 30 parts, Radix limonii sinensis 10 ~ 15 parts, great Ye Rhizoma Drynariae 15 ~ 20 parts, Salvia salvia flava Forrest ex diels. 25 ~ 30 parts and SANYE Hydrocotyle vulgaris L. 10 ~ 15 parts.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: Rhizoma Hedychii Coronarii 6 parts, asarum caudigerum Hance 7 parts, Cortex Linderae Fragrantis 14 parts, Herba Caryopteridis Incanae 38 parts, Semen Litchi 36 parts, Radix Caesalpiniae Radicis 16 parts, black fragrant bavin 12 parts, Radix berchemiae floribundae 8 parts, Herba Meconopsis Horridulae 7 parts, Hylotelephium verticillatum (Linn.) H. Ohba 29 parts, Radix limonii sinensis 13 parts, great Ye Rhizoma Drynariae 18 parts, Salvia salvia flava Forrest ex diels. 26 parts and SANYE Hydrocotyle vulgaris L. 11 parts.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, the dosage form of described Chinese medicine preparation is capsule, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.3 ~ 0.6 times, the starch of 0.3 ~ 0.6 times, the magnesium stearate of 0.002 ~ 0.02 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is powder, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 4 times is the ethanol of 70 ~ 80%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 70 ~ 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 2 ~ 3 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize, sieve, obtain 100 order ~ 200 object micropowders;
3rd step: add the starch relative to its quality 2 ~ 4 times in the micropowders obtained by second step, mixing, obtains powder.
Below adopt embodiment to describe embodiments of the present invention in detail, fully understand how application technology means solve technical problem in the present invention whereby, reach technique effect and implement according to this.
Embodiment 1: capsule
Get Rhizoma Hedychii Coronarii 60g, asarum caudigerum Hance 70g, Cortex Linderae Fragrantis 140g, Herba Caryopteridis Incanae 380g, Semen Litchi 360g, Radix Caesalpiniae Radicis 160g, black fragrant bavin 120g, Radix berchemiae floribundae 80g, Herba Meconopsis Horridulae 70g, Hylotelephium verticillatum (Linn.) H. Ohba 290g, Radix limonii sinensis 130g, great Ye Rhizoma Drynariae 180g, Salvia salvia flava Forrest ex diels. 260g and SANYE Hydrocotyle vulgaris L. 110g;
Prepare according to the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 times is the ethanol of 85%, reflux 2 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 times again, reflux 1 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 hour, pulverize and sieve acquisition 100 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.3 times, the starch of 0.3 times, the magnesium stearate of 0.002 times, carry out mixing process, namely obtain capsule 's content, described Capsule content is incapsulated in housing, namely obtain capsule finished product.
Embodiment 2: powder
Get Rhizoma Hedychii Coronarii 80g, asarum caudigerum Hance 80g, Cortex Linderae Fragrantis 120g, Herba Caryopteridis Incanae 360g, Semen Litchi 390g, Radix Caesalpiniae Radicis 180g, black fragrant bavin 140g, Radix berchemiae floribundae 60g, Herba Meconopsis Horridulae 90g, Hylotelephium verticillatum (Linn.) H. Ohba 270g, Radix limonii sinensis 110g, great Ye Rhizoma Drynariae 170g, Salvia salvia flava Forrest ex diels. 280g and SANYE Hydrocotyle vulgaris L. 150g;
Prepare according to the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 times is the ethanol of 80%, reflux 2 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 2 times again, reflux 1 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 hour, pulverize, sieve, obtain 200 object micropowders;
3rd step: add the starch relative to its quality 4 times in the micropowders obtained by second step, mixing, obtains powder.
Toxicity test:
Acute toxicity testing: application mice 50, male and female half and half, body weight 20 ~ 26g, carries out acute toxicity test.Mice is divided into two groups at random, i.e. matched group and administration group, before experiment, fasting 12 hours, is dissolved in water by Chinese medicine capsules prepared by embodiments of the invention 1, (concentration is 8.18g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg (namely unit dosage form is 40.9 crude drugs/kg), and matched group gives normal saline, administration in one day 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and record mice toxic reaction and death toll.Experimental result shows: compare with matched group, and after administration, mice has no notable difference, and experiment Continuous Observation 14 days, mouse systemic situation, diet, drinking-water, body weight increase all normal.Mouse oral gavage capsule LD50>40.9 crude drug/kg of the present invention, every day, maximum dosage-feeding was 81.8 crude drugs/kg/ day.Chinese medicine preparation clinical application amount of the present invention be 7.2g crude drug/day/people, adult body weight in 60KG, average dosage is 0.12g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 23g) oral administration gavage Chinese medicine preparation of the present invention is 682 times of quantity.Therefore Chinese medicine preparation acute toxicity of the present invention is extremely low, clinical drug safety.
Long term toxicity test: invention Chinese medicine preparation to three groups of mices (often organize 20) by 13.86,21.25 and 41.38g crude drug/kg continuous use 15 weeks (1.0ml/100g body weight, every day 2 times) and drug withdrawal after 3 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of Chinese medicine preparation of the present invention to mice all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 15 weeks and drug withdrawal are after 3 weeks, and Organs of Mice is all without obviously changing.Illustrate that Chinese medicine preparation of the present invention is little to toxicity after mice long-term prescription, also there is no difference reaction after drug withdrawal, application safety.
Clinical data:
Case selection: whole 92 routine cases are my Out-patient Department patient of in JIUYUE, 2012 ~ 2014 year June.Patient is divided into treatment group and matched group at random, wherein treatment group 48 people, male 40 people, women 8 people, 22 ~ 58 years old age, average (36 ± 7.6) year, the course of disease 3 months ~ 8 years, on average (16.2 ± 7.8) individual month, site of pathological change: one-sided 42 examples, bilateral 6 example; Severity Scaling: I phase 8 example, II phase 25 example, III phase 15 example; Matched group 44 people, male 38 people, women 6 people, 23 ~ 60 years old age, average (37 ± 8.2) year, the course of disease 3 months ~ 8 years, average (15.6 ± 6.4) individual month, site of pathological change: one-sided 39 examples, bilateral 5 example; Severity Scaling: I phase 7 example, II phase 23 example, III phase 14 example.Two groups in age, the course of disease, symptom and coincident with severity degree of condition etc. through statistical analysis there was no significant difference (p>0.05).
Diagnostic criteria: 1, common male is between twenty and fifty, has smoking history more or catches cold and freeze history or history of making moist.2, acra be afraid of cold, numb, pain, skin colour changes, intermittent claudication, limbs malnutrition.3,40 ~ 60% have migrans superficial thrombophlebitis medical history and sign.4, suffering limb arteriopalmus obviously weakens or disappears.
The differentiation of the course of disease, according to the degree of limb ischemia, can be divided into for three phases:
I phase (ischemia phase): be the primary stage of pathological changes.Main manifestations be suffering limb numb, send out cool, be afraid of cold, acid is swollen, fatiguability, heavy and mild intermittent limping.The latter is current period typical case sign.After patient walks 1 ~ 2 li journey, there is distending pain or take out pain in shank or muscle of foot, if walked on, then pain increases the weight of, and is finally forced to halt.After rest, pain is alleviated immediately.After walking, symptom occurs again again, is called as intermittent claudication.Along with the development of the state of an illness, travel distance shortens gradually.This is because of caused by muscle oxygen demand after walking increases.Check that suffering limb skin temperature drop is low, color of the leather is paler, dorsal artery of foot or (with) posterior tibial artery beats and weakens.Often there is migratory thrombophlebitis.
II phase (malnutrition phase): the exacerbation of symptoms such as suffering limb is numb, send out cool, be afraid of cold, acid is swollen, intermittent claudication is day by day obvious, and travel distance shortens, time of having a rest prolongation, and pain transfers persistence to.Under limbs are in resting state, pain is still more than, is called rest pain.Night is more obvious.Suffering limb skin temperature obviously reduces, and color of the leather is paler, or occurs purpura, flushing, xerosis cutis, and fine hair comes off.Toe (finger) first thickens distortion, Calf muscle atrophy, and beat disappearance ， popliteal tremulous pulse, femoral pulse of dorsal artery of foot, posterior tibial artery also can weaken.
III phase (tissue necrosis phase): except above-mentioned symptom continues to increase the weight of, suffering limb severe ischemic, rest pain more increases the weight of, sharp ache, prolonged, and patient day and night goes down on one's knees and embraces foot and sit, steady night sleeplessness.Appetite reduces, and muscle power declines day, obviously becomes thin.If concurrent local infection, the whole body toxemic symptomses such as fever, fear of cold, agitation can be there is.Extremity anatomy ischemia is even more serious, produces ulcer or gangrene.Be mostly dry gangrene, the withered blackout of toe (finger) end, can proximally extend.After slough comes off, form the prolonged ulcer do not healed.If secondary infection, then in wet gangrene.According to the scope of gangrene, can be divided into three grades: I grade, gangrene is confined to toe (finger) portion; II grade, gangrene is prolonged and toe Plantar (fingers and palms) joint and Plantar (palm) portion; III grade, gangrene is prolonged and more than heel, ankle joint or ankle joint.
Therapeutic Method:
Matched group: give low-dose urokinase 300,000 U and add normal saline 100ml iv drip, every day 1 time, intravenous applications antibiotic infection control.30 days courses for the treatment of.
Treatment group: take Chinese medicine preparation embodiment 1 capsule of the present invention, every day 3 times, each 3.It within 30 days, is a course for the treatment of.
Curative effect judging standard: cure: cardinal symptom disappears, and wound surface heals completely, pain disappears, and skin temperature and color and luster recover normal, and suffering limb disturbance of blood circulation obviously improves, and resumes work in 1 year without recurrence.Effective: clinical symptoms major part disappears or obviously alleviates, and pain disappears, and skin temperature and color and luster are clearly better, wound surface is close to healing, and blood circulation is slight obstacle, can work.Effective: condition of illness alleviates, wound surface comparatively before reduces, and suffering limb blood circulation makes moderate progress, and still can not be engaged in work.Invalid: clinical symptoms and sign are all without improvement.
Therapeutic outcome: see the following form.
| Group | n | Cure | Effective | Effectively | Invalid | Effectively total |
| Treatment group | 48 | 18 | 20 | 6 | 4 | 44(91.67％) |
| Matched group | 44 | 10 | 15 | 10 | 9 | 35(79.55％) |
Treatment group compares with matched group, and treatment group curative effect is better than matched group.
Concrete case: Zhao, male, 43 years old, the course of disease 4 years, once at other hospital therapies, effect is undesirable, sees a doctor to my institute, on inspection, is diagnosed as II phase thromboangiitis obliterans, take Chinese medicine preparation embodiment 1 capsule 1 of the present invention course for the treatment of, symptom disappears completely, and recovery from illness, follows up a case by regular visits to and do not recur for 1 year.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (8)
1. treat a Chinese medicine preparation for thromboangiitis obliterans, it is characterized in that, each raw medicinal material of described Chinese medicine preparation comprises: Rhizoma Hedychii Coronarii, asarum caudigerum Hance, Cortex Linderae Fragrantis, Herba Caryopteridis Incanae, Semen Litchi, Radix Caesalpiniae Radicis, black fragrant bavin, Radix berchemiae floribundae, Herba Meconopsis Horridulae, Hylotelephium verticillatum (Linn.) H. Ohba, Radix limonii sinensis, great Ye Rhizoma Drynariae, Salvia salvia flava Forrest ex diels. and SANYE Hydrocotyle vulgaris L..
2. Chinese medicine preparation as claimed in claim 1, it is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: Rhizoma Hedychii Coronarii 5 ~ 15 parts, asarum caudigerum Hance 5 ~ 15 parts, Cortex Linderae Fragrantis 10 ~ 20 parts, Herba Caryopteridis Incanae 35 ~ 45 parts, Semen Litchi 35 ~ 45 parts, Radix Caesalpiniae Radicis 15 ~ 25 parts, black fragrant bavin 10 ~ 20 parts, Radix berchemiae floribundae 5 ~ 15 parts, Herba Meconopsis Horridulae 5 ~ 15 parts, Hylotelephium verticillatum (Linn.) H. Ohba 25 ~ 35 parts, Radix limonii sinensis 10 ~ 20 parts, great Ye Rhizoma Drynariae 15 ~ 25 parts, Salvia salvia flava Forrest ex diels. 25 ~ 35 parts and SANYE Hydrocotyle vulgaris L. 10 ~ 20 parts.
3. Chinese medicine preparation as claimed in claim 1 or 2, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Rhizoma Hedychii Coronarii 5 ~ 10 parts, asarum caudigerum Hance 5 ~ 10 parts, Cortex Linderae Fragrantis 10 ~ 15 parts, Herba Caryopteridis Incanae 35 ~ 40 parts, Semen Litchi 35 ~ 40 parts, Radix Caesalpiniae Radicis 15 ~ 20 parts, black fragrant bavin 10 ~ 15 parts, Radix berchemiae floribundae 5 ~ 10 parts, Herba Meconopsis Horridulae 5 ~ 10 parts, Hylotelephium verticillatum (Linn.) H. Ohba 25 ~ 30 parts, Radix limonii sinensis 10 ~ 15 parts, great Ye Rhizoma Drynariae 15 ~ 20 parts, Salvia salvia flava Forrest ex diels. 25 ~ 30 parts and SANYE Hydrocotyle vulgaris L. 10 ~ 15 parts.
4. the Chinese medicine preparation as described in claims 1 to 3, is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Rhizoma Hedychii Coronarii 6 parts, asarum caudigerum Hance 7 parts, Cortex Linderae Fragrantis 14 parts, Herba Caryopteridis Incanae 38 parts, Semen Litchi 36 parts, Radix Caesalpiniae Radicis 16 parts, black fragrant bavin 12 parts, Radix berchemiae floribundae 8 parts, Herba Meconopsis Horridulae 7 parts, Hylotelephium verticillatum (Linn.) H. Ohba 29 parts, Radix limonii sinensis 13 parts, great Ye Rhizoma Drynariae 18 parts, Salvia salvia flava Forrest ex diels. 26 parts and SANYE Hydrocotyle vulgaris L. 11 parts.
5. the Chinese medicine preparation described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine preparation is capsule, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.3 ~ 0.6 times, the starch of 0.3 ~ 0.6 times, the magnesium stearate of 0.002 ~ 0.02 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
6. the Chinese medicine preparation described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine preparation is powder, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 4 times is the ethanol of 70 ~ 80%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 70 ~ 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 2 ~ 3 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize, sieve, obtain 100 order ~ 200 object micropowders;
3rd step: add the starch relative to its quality 2 ~ 4 times in the micropowders obtained by second step, mixing, obtains powder.
7. a preparation method for Chinese medicine preparation described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine preparation is capsule, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.3 ~ 0.6 times, the starch of 0.3 ~ 0.6 times, the magnesium stearate of 0.002 ~ 0.02 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
8. a preparation method for Chinese medicine preparation described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine preparation is powder, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 ~ 4 times is the ethanol of 70 ~ 80%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 70 ~ 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 2 ~ 3 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize, sieve, obtain 100 order ~ 200 object micropowders;
3rd step: add the starch relative to its quality 2 ~ 4 times in the micropowders obtained by second step, mixing, obtains powder.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111514054A (en) * | 2020-06-08 | 2020-08-11 | 云南菊开生物科技有限公司 | Composition for inhibiting tyrosinase activity, preparation method thereof and cosmetic |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1116547A (en) * | 1995-07-08 | 1996-02-14 | 刘威 | "Xuemaitong"-biologic enhancing agent for treating thromboangiitis obliterans |
| CN1240145A (en) * | 1999-05-12 | 2000-01-05 | 姜延仲 | Medicine for treating thromboangitis obliterans |
-
2015
- 2015-09-15 CN CN201510585067.0A patent/CN105125988A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1116547A (en) * | 1995-07-08 | 1996-02-14 | 刘威 | "Xuemaitong"-biologic enhancing agent for treating thromboangiitis obliterans |
| CN1240145A (en) * | 1999-05-12 | 2000-01-05 | 姜延仲 | Medicine for treating thromboangitis obliterans |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111514054A (en) * | 2020-06-08 | 2020-08-11 | 云南菊开生物科技有限公司 | Composition for inhibiting tyrosinase activity, preparation method thereof and cosmetic |
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