CN105617295A - Traditional Chinese medicine preparation for treating heel pain by external application - Google Patents

Traditional Chinese medicine preparation for treating heel pain by external application Download PDF

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CN105617295A
CN105617295A CN201610217804.6A CN201610217804A CN105617295A CN 105617295 A CN105617295 A CN 105617295A CN 201610217804 A CN201610217804 A CN 201610217804A CN 105617295 A CN105617295 A CN 105617295A
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parts
chinese medicine
medicine preparation
root
chinese
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刘学键
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Yantai Lanyangzhicao Pharmaceutical Biotechnology Co Ltd
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Yantai Lanyangzhicao Pharmaceutical Biotechnology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/80Scrophulariaceae (Figwort family)
    • A61K36/804Rehmannia
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/19Carboxylic acids, e.g. valproic acid
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    • A61K35/63Arthropods
    • A61K35/646Arachnids, e.g. spiders, scorpions, ticks or mites
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/282Artemisia, e.g. wormwood or sagebrush
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/286Carthamus (distaff thistle)
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/47Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/708Rheum (rhubarb)
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/716Clematis (leather flower)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/74Rubiaceae (Madder family)
    • A61K36/744Gardenia
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/756Phellodendron, e.g. corktree
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/902Sparganiaceae (Bur-reed family)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9066Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The invention discloses a traditional Chinese medicine preparation for treating heel pain by external application, and belongs to the technical field of traditional Chinese medicines. The preparation is prepared from the following raw materials: radix rehmanniae praeparata, rheum officinale, scorpion, cortex phellodendri, parasitic loranthus, phryma leptostachya, flos carthami, radix clematidis, radix achyranthis bidentatae, rhizoma sparganii, curcuma zedoary, borneol, folium artemisiae argyi, mature vinegar, semen brassicae and cape jasmine. Compared with the prior art, the traditional Chinese medicine preparation for treating heel pain has the technical advantages of quick response, good curative effect, hard relapse after healing and the like; moreover, the preparation process is simple, convenient and feasible; and the preparation has a stable medical effect and good university, is suitable for industrial production, and is beneficial to more patients.

Description

The Chinese medicine preparation of a kind of external application for curing talalgia
Technical field
The present invention discloses the Chinese medicine preparation of a kind of external application for curing talalgia, belongs to technical field of Chinese medicine.
Background technology
Heel one or both sides pain, not red pneumonedema, inconvenient walking. Also known as relieving heel pain. It it is the disease that the sclerotin due to heel, joint, the sliding place such as capsule, manadesma pathology cause. Common is sole of the foot fascitis, often occurring in vertical for a long time or walking worker, slight wound long-term, chronic causes, and shows as sole of the foot manadesma fibre breakage and repair process, below calcaneum, the manadesma of inner side depends on place's hyperosteogeny and tenderness partially, position, side X-ray sheet display calcanean spur. But having spur not necessarily to have talalgia, sole of the foot fascitis not necessarily has spur.
Traditional Chinese medicine is thought, talalgia many genus hepatic and renal YIN deficiency, phlegm are wet, blood-head etc. because of caused by. The main muscle of liver, Shen controls bone, caused by liver and kidney deficiency, muscles and bones is lost and is supported, and sense wind-cold damp pathogen or chronic strain just cause meridian stasis stagnant again, and QI-blood circulation is obstructed, and muscles and bones muscle is lost and supports and fall ill. Main differentiation of symptoms and signs for classification of syndrome and treat as follows:
1, qi stagnation and blood stasis type: various reason cause local blood slowly, stagnation of blood stasis, train of thought is hindered, then QI-blood circulation is smooth and pain, and localized pain, and pain with tenderness, walks limited.
The rules for the treatment of: dispersing pathogen accumulation, heat-clearing and damp-drying drug, stimulate the menstrual flow by the stasis of blood.
2, deficiency of the liver and kidney: the other network of liver kidney and branch thereof is walked around heel, the main muscle of liver, main Tibetan blood, and Shen controls bone, main Tibetan essence, the raw marrow of essence. Old body, deficiency of the liver and kindey, blood and essence asthenia, passages through which vital energy circulates loses and fills, then muscle is become homeless foster, and bone is become homeless master, and the bone muscle that withers relaxes, therefore when standing or walk heel ache, secret anguish, weak, pain happiness is pressed, and touches pain and subtracts.
The rules for the treatment of: the strong bone that dispels the wind, soft heavily fortified point fall apart the stasis of blood, and disappear long-pending pain relieving.
3, cold blood stasis type: QI-blood circulation is slow, feels cold-evil again, cold main stagnates, main spasm, causes that channels and collaterals are hindered, coagulation of QI-blood is obstructed and pain, and pain with tenderness, happiness heat is afraid of cool.
The rules for the treatment of: warming spleen and stomach for dispelling cold, remove obstruction in channels to relieve pain.
Summary of the invention
The technical problem to be solved in the present invention is that invention is a kind of can the Chinese medicine preparation of external application for curing talalgia. In order to solve this technical problem, contriver according to self tcm clinical practice experience in conjunction with the ill feature of modern, meticulous composition of prescription, then through inspection repeatedly and the adjustment improvement of clinical practice, a final invention brand-new Chinese prescription, and develop a set of preparation method in conjunction with modern Chinese herbal medicine preparation technique. This Chinese prescription is (with parts by weight):
Cultivated land 6-22 part, rheum officinale 6-25 part, scorpio 4-13 part, golden cypress 7-26 part, loranthus parasiticus 7-30 part, Tuberculate Speranskia Herb 10-33 part, safflower 4-15 part, Root of Sixpetal Clematis 8-34 part, root of bidentate achyranthes 7-32 part, Rhizoma Sparganii 6-21 part, curcuma zedoary 6-23 part, borneol 7-20 part, tarragon 10-35 part, mature vinegar 80-280 part, White Mustard Seed 11-40 part, cape jasmine 6-19 part.
In practice, preferred two have the prescription proportioning of superior performance for (with parts by weight):
Proportioning 1: 16 parts, cultivated land, rheum officinale 15 parts, scorpio 8 parts, golden cypress 17 parts, loranthus parasiticus 18 parts, Tuberculate Speranskia Herb 22 parts, 9 parts, safflower, 20 parts, Root of Sixpetal Clematis, the root of bidentate achyranthes 19 parts, Rhizoma Sparganii 16 parts, curcuma zedoary 14 parts, borneol 15 parts, tarragon 21 parts, 120 parts, mature vinegar, White Mustard Seed 26 parts, cape jasmine 12 parts.
Proportioning 2: 18 parts, cultivated land, rheum officinale 16 parts, scorpio 9 parts, golden cypress 15 parts, loranthus parasiticus 17 parts, Tuberculate Speranskia Herb 24 parts, 8 parts, safflower, 22 parts, Root of Sixpetal Clematis, the root of bidentate achyranthes 22 parts, Rhizoma Sparganii 15 parts, curcuma zedoary 16 parts, borneol 14 parts, tarragon 24 parts, 140 parts, mature vinegar, White Mustard Seed 25 parts, cape jasmine 11 parts.
The present invention also discloses a kind of method of Chinese medicine preparation preparing external application for curing talalgia, comprises the following steps:
(1) each taste Chinese medicinal materials is taken by Chinese prescription of the present invention;
(2) by cultivated land, rheum officinale, golden cypress, root of bidentate achyranthes frying, pulverize respectively, levigate, cross 70-120 order sieve, it is mixed to get fine powder, for subsequent use;
(3) scorpio, safflower, Tuberculate Speranskia Herb, borneol is dry respectively, pulverize grinding, cross 70-120 order sieve, be mixed to get fine powder, for subsequent use;
(4) loranthus parasiticus, Root of Sixpetal Clematis, Rhizoma Sparganii, curcuma zedoary, tarragon, White Mustard Seed, cape jasmine being pulverized respectively, add the purified water of 5-14 times of weight after mixing, backflow is decocted and is boiled three times, each 1-6 hour, filter, merging filtrate, concentrate to 55 DEG C of relative densities be the concentrated solution of 1.42-1.46, for subsequent use;
(5) mixing fine powders that will be obtained in step (2) and (3), adds in the made concentrated solution of step (4), adds mature vinegar simultaneously, mix, continue to concentrate to 55 DEG C of relative densities be the thick cream of 1.35-1.40, for subsequent use;
(6) by the thick cream of step (5) gained, add suitable auxiliary material, utilize modern general Chinese medicine preparation technology, make the Chinese medicine finished product external preparation of clinical needs, such as paste (containing cream taste, ointment, plaster), extractum, lozenge, distillate medicinal water, glue agent, nail agent, rod agent, suppository, herbal leaven, paste, wash put agent, finish, line agent (medicated thread), medicated roll (fuse) on the skin, press agent, process agent, fumicants, medicine perfume, tincture, aerosol, enema, the formulation such as film agent (membrane agent).
The present invention also discloses the purposes of above-mentioned Chinese medicine preparation in the medicine preparing external application for curing talalgia.
The character Characteristic of the raw materials used medicinal material of the present invention:
Cultivated land: this product is the Preparation process product of Radix Rehmanniae. Taste is sweet, slightly warm in nature; Return liver, kidney channel; Nourishing YIN and supplementing blood, benefit essence fills out marrow.
Rheum officinale: this product is the dry root and rhizome of polygonum rheum palmatum, Rheum tanguticum or Rheum officinale. Bitter, cold in nature; Return spleen, stomach, large intestine, liver, pericardium warp; Purge heat logical intestines, and removing pattogenic heat from the blood and toxic material from the body, stimulates the menstrual flow by the stasis of blood.
Scorpio: this product is the dry body of Qian Xie section animal buthus martensii Karscs. Taste is pungent, and property is put down; Return Liver Channel; Breath wind antispastic, dispersing pathogen accumulation, removes obstruction in channels to relieve pain.
Golden cypress: this product is the dry bark of rutaceae wampee or cork tree. Bitter, cold in nature; Return kidney, bladder warp; Heat-clearing and damp-drying drug, purging intense heat removes steams, detoxification sore treatment.
Loranthus parasiticus: this product is the dry stem and branch with leaf of Loranthaceae plant loranthus parasiticus. Bitter, sweet, property is put down; Return liver, kidney channel; Invigorating the liver and kidney, strengthening the bones and muscles, wind-damp dispelling, antiabortive unit.
Tuberculate Speranskia Herb: Euphorbiaceae Speranskia plant speranskia tuberculata, Balsaminaceae herbaceous plant Flower of Garden Balsam, Bignoniaceae Incarvillea AJuss plant angle wormwood artemisia, the full grass of pulse family Vetch plant Herba Viciae Amoenae and the complete stool of Ericaceae Gaultheria plant Caulis et folium gaultheriae yunnanensis. Taste is pungent, bitter, warm in nature; Return liver, kidney channel; Dispel rheumatism, removing toxic substances pain relieving.
Safflower: call red indigo plant flower, thorn safflower, composite family, safflower platymiscium. Taste is pungent, warm in nature; Enter the heart, Liver Channel; Promoting blood circulation to restore menstrual flow, goes stasis of blood pain relieving.
Root of Sixpetal Clematis: this product is the dry root and rhizome of ranunculaceae plant Root of Sixpetal Clematis, Clematis hexapetala (mountain knotweed) or northeast clematis (black common vetch). Taste is pungent, salty, warm in nature; Return bladder warp; Dispel rheumatism, remove obstruction in channels to relieve pain.
The root of bidentate achyranthes: this product is the dry root of the amaranthaceous plant root of bidentate achyranthes. Bitter, acid, property is put down; Return liver, kidney channel; Invigorating the liver and kidney, strengthening the bones and muscles, stimulates the menstrual flow by the stasis of blood, ensurings proper downward flow of the blood.
Rhizoma Sparganii: this product is the dry tuber of the black Rhizoma Sparganii of Sparganiaceae plant. Taste is pungent, bitter, and property is put down; Return liver, the spleen channel; Broken blood gas, disappear long-pending pain relieving.
Curcuma zedoary: this product is the dry rhizome of zingiberaceous plant zddoary, Guangxi zedoary or RADIX CURCUMAE. Taste is pungent, bitter, warm in nature; Return liver, the spleen channel; Blood is broken in promoting the circulation of qi, and disappear long-pending pain relieving.
Borneol: extension set ice making sheet and L-Borneol two class. The borneol that mechanism borneol synthesizes by raw material of turps, camphor etc. through chemical process; L-Borneol be composite family Herba Blumeae Balsamiferae platymiscium Balsamiferou Blumea Herb fresh leaf through steam distillation, cooling gained crystallization, also known as " Chinese mugwort powder " or " sheeting ". Taste is pungent, bitter, cold nature; The thoughts of returning home, spleen, lung channel; Have one's ideas straightened out inducing resuscitation, clearing away heat to and alleviating pain.
Tarragon: this product is the dry leave of feverfew Chinese mugwort. Taste is pungent, bitter, warm in nature; Return liver, spleen, kidney channel; Dispersing cold for relieving pain, warming the meridian for stopping bleeding.
Mature vinegar: be taking Chinese sorghum, wheat bran, cavings and water as main raw material, taking barley, the made Daqu of pea as saccharifying ferment, after zymamsis, then becomes through solid-state acetic fermentation, the smoked operation brew such as unstrained spirits, ageing. The ageing phase is 9-15 month, and total acid is at 8-12 degree.
White Mustard Seed: be the seed of cress sinapsis alba. Taste is pungent, warm in nature; Enter lung, stomach warp; The open-minded phlegm of profit gas, warming spleen and stomach for dispelling cold, removes obstruction in channels to relieve pain.
Cape jasmine: this product is the dry mature fruit of madder wort cape jasmine. Bitter, cold in nature; The thoughts of returning home, lung, three burnt warps; Fruit: purging intense heat relieving restlessness, clearing away heat and promoting diuresis, removing pattogenic heat from the blood and toxic material from the body.
The prescription analysis of Chinese prescription of the present invention:
This prescription is taking Tuberculate Speranskia Herb, White Mustard Seed, Root of Sixpetal Clematis, tarragon as monarch's medicine, removing toxic substances pain relieving, warming spleen and stomach for dispelling cold, remove obstruction in channels to relieve pain, warming the meridian for stopping bleeding; Taking loranthus parasiticus, the root of bidentate achyranthes, golden cypress, Rhizoma Sparganii as ministerial drug, the strong bone that dispels the wind, stimulate the menstrual flow by the stasis of blood, heat-clearing and damp-drying drug, disappear long-pending pain relieving; Taking cape jasmine, rheum officinale, curcuma zedoary, scorpio, safflower as adjutant, removing pattogenic heat from the blood and toxic material from the body, stimulate the menstrual flow by the stasis of blood, promoting the circulation of qi broken blood, dispersing pathogen accumulation, go stasis of blood pain relieving; Taking cultivated land, borneol as making medicine, benefit essence fills out marrow, clearing away heat to and alleviating pain; With the mature vinegar mediation all property of medicine matter of monarch, and strengthen the property of medicine. All medicines act synergistically, thus reach warming spleen and stomach for dispelling cold, remove obstruction in channels to relieve pain, the strong bone that dispels the wind, stimulate the menstrual flow by the stasis of blood, heat-clearing and damp-drying drug, the long-pending pain relieving that disappears, dispersing pathogen accumulation, benefit essence fill out the effects such as marrow, talalgia is had very significant curative effect.
Compared with prior art, Chinese medicine preparation of the present invention has following significant technical superiority:
1, instant effect, good effect, not easily recurs after more;
2, preparation process is simple and easy to do, preparation efficacy stability, and general adaptability is good, is applicable to suitability for industrialized production, it is possible to benefit more patients.
Embodiment
Embodiment 1
In order to prove the feasibility of Chinese medicine preparation preparation method of the present invention and Chinese prescription, contriver have chosen 5 groups of representative prescription proportioning values, the practice carrying out ointment with the processing parameter of the best is produced, this a few assembly is than being respectively the cut off value of prescription scope, arbitrary value and two optimum ratios, they are numbered as A, B, C, D, E successively, and each prescription proportioning value is as shown in table 1.
Proportioning raw materials table look-up respectively organized by table 1
(1) each taste Chinese medicinal materials is taken by the proportion speed of Chinese medicinal materials shown in table 1;
(2) by cultivated land, rheum officinale, golden cypress, root of bidentate achyranthes frying, pulverize respectively, levigate, cross 80 order sieves, it is mixed to get fine powder, for subsequent use;
(3) scorpio, safflower, Tuberculate Speranskia Herb, borneol is dry respectively, pulverize grinding, cross 80 order sieves, be mixed to get fine powder, for subsequent use;
(4) loranthus parasiticus, Root of Sixpetal Clematis, Rhizoma Sparganii, curcuma zedoary, tarragon, White Mustard Seed, cape jasmine being pulverized respectively, add the purified water of 10 times of weight after mixing, backflow is decocted and is boiled three times, each 2 hours, filter, merging filtrate, concentrate to 55 DEG C of relative densities be the concentrated solution of 1.42-1.46, for subsequent use;
(5) mixing fine powders that will be obtained in step (2) and (3), adds in the made concentrated solution of step (4), adds mature vinegar simultaneously, mix, continue to concentrate to 55 DEG C of relative densities be the thick cream of 1.35-1.40, for subsequent use;
(6) by the thick cream of step (5) gained, adding suitable auxiliary material, utilize modern general Chinese medicine preparation technology, make ointment, specification is: 1.26g crude drug/g ointment.
Experimental example 1: the toxicity test of Chinese medicine preparation of the present invention
1, skin irritation test
(1) Experimental agents: the ointment of the numbering A-E that the embodiment of the present invention 1 is produced, specification is 1.26g crude drug/g ointment.
(2) experimental technique:
Get healthy guinea pig 36, it is divided into 6 groups at random, often organize 6, trichogen is evenly coated by guinea pig back backbone both sides, makes mao scope about 20 square centimeters. Clean trichogen returns cage to observe 24 hours, 5 groups of cavys are coated with A-E traditional Chinese herb medicine 2g, 4g and 6g prepared by the present invention respectively, respectively containing crude drug 2.52g, 5.04g and 7.56g, control group is coated with the every twice-daily of solvent 0.8ml, continuous one week, after experiment terminates, being put to death by cavy, the heart, liver, kidney and depilation skin do pathological examination.
(3) result:
Above-mentioned 5 groups of medication cavy trunks depilation district, having no local skin has oedema, hyperemia, erythema, blutpunkte and ulcer. Medication group cavy chroma of hair, ingest, the control group no significant difference such as four limbs are movable, histopathologic examination, the administration group heart, liver, kidney and depilation skin compare also no significant difference with control group. Result is pointed out, and Chinese medicine preparation of the present invention, without local irritant effect, also has no general toxicity performance. Show traditional Chinese medicine for external application use safety of the present invention.
2, animal acute toxicity test research
Ointment of the present invention, through trial test, can not measure LD50, therefore measure maximum dosage-feeding. Adopting rectal delivery, the maximum dosage-feeding on the one recording mouse is that 89.4g/kg(is in crude drug), it is about 470.5 times (people is in 60kg) intending clinical people's consumption (clinical people's consumption is 0.19g crude drug/kg/d). Laboratory animal is observed one week all continuously, and its outward appearance sign, the mental status, diet, drinking-water, ight soil etc. are showed no obvious abnormalities. At the end of experiment, all healthy survival of animal, body weight increases.
3, long-term toxicity test for animals research
Experimental design medicine height of the present invention, in, low dose group, matrix control group and blank group, rectal delivery is adopted to give rat, dosage is respectively 75.6g/kg, 50.4g/kg and 25.2g/kg(is in crude drug), be equivalent to intend the 60 of clinical patient consumption, 40 and 20 times, successive administration 3 months, in administration process, the body weight of each administration group and matrix group rat, dietary amount, outward appearance sign, behavioral activity, the mental status, hair look, ight soil proterties compares with blank group, no significant difference (P > 0.05), the weight of animals increasing value and main organs coefficient and blank group comparing difference are not significantly (P > 0.05), hematology and blood parameters check result administration group compare without significant difference (P > 0.05) with blank group, but decubation terminates rear variant hematology and blood parameters has recovered normal all, other indexs and blank comparing difference are not significantly (P > 0.05), administration phase and decubation histological examination high dose group animal main organs compare with blank group and have no notable difference, have no slowness toxicity to occur.
By above experiment, illustrate that Chinese medicine ointment clinical application of the present invention is safe.
Experimental example 2: the pharmacodynamic experiment of Chinese medicine preparation of the present invention
1, this product is on the impact (turbidimetry) of the maximum aggregation rate of rat platelet
Get Wistar rat 80, it is divided into control group at random; Positive controls: QIZHENG XIAOTONG TIE cream 5g crude drug/kg/d; What the embodiment of the present invention 1 was produced be numbered D, be numbered the height of E (7.6g crude drug/kg), in (3.8g crude drug/kg), low (1.9g crude drug/kg) each three dosage groups, totally 8 groups, often organize 10. Test medicine distilled water is mixed with suspension, rat ig administration 20ml/kg, and control group gives same volume distilled water, administration every day 1 time, continuous 5 days, 1h after last administration, the apparatus oily sherwood oil silication in 2% osmanthus, vetanarcol are anaesthetized, and aorta gets blood, Sodium Citrate 9:1 anti-freezing, 1500 turns of centrifugal 20min supernatants are platelet rich plasma (PRP), 4000 turns of centrifugal 20min supernatants are platelet poor plasma (PRP), and correction platelet aggregation instrument, surveys maximum platelet aggregation rate. Result with�� SD represents, t inspection between statistical procedures method employing group. After each treated animal last administration, 1h maximum platelet aggregation rate is as shown in table 2.
Table 2 Chinese medicine preparation of the present invention on the impact of the maximum aggregation rate of rat platelet (�� SD, n=10)
From the experimental data listed by table 2 it may be seen that the maximum platelet aggregation rate of Chinese medicine preparation 7.6g/kg and 3.8g/kg two dosage treated animals of the present invention is all significantly lower than control group (P < 0.05). Above-mentioned test-results shows, the maximum aggregation rate of rat platelet is had obvious restraining effect by Chinese medicine preparation of the present invention, shows that Chinese medicine preparation of the present invention has stronger function of promoting blood circulation to disperse blood clots, and wherein the action effect of dosage is slightly better than QIZHENG XIAOTONG TIE cream.
2, to the restraining effect of the synthesis of PGE2 in rat inflammation tissue
Get rat 80, male and female are regardless of and are divided into 8 groups at random, what the embodiment of the present invention 1 was produced be numbered D, each three dosage groups that are numbered the high, medium and low dosage of the traditional Chinese herb medicine of E, and amoxicillin and clavulanate potassium (is called for short A Ke) control group and blank group, often organize 10. Dosage: this product is high, normal, basic is respectively 7.6g crude drug/kg, 3.8g crude drug/kg, 1.9g crude drug/kg; A Ke group is 0.00625g/kg; Successive administration three days, after last medicine 1 hour, right back sufficient subcutaneous injection 1% carrageenin 0.1ml, cause scorching latter 4 hours, putting to death rat, on ankle joint, 0.5cm place cuts swelling foot, peeling, shred, physiological saline 5ml soaks 1 hour, soak solution centrifugal (1500rpm) 10 minutes, Aspirate supernatant 0.1ml, add the KOH-MeOH solution 2.0ml of 0.5mol/L, 50 DEG C of different structures of constant temperature 20 minutes, are diluted to 20.0ml with methyl alcohol, at wavelength 278nm place, measure its absorbancy (A) value with UV-2100 ultraviolet spectrophotometer, result with�� SD represents, t inspection between statistical procedures method employing group, result is as shown in table 3.
Table 3 traditional Chinese medicine oral liquid of the present invention on the impact of PGE2 content in inflammatory tissue (�� SD, n=10)
Note: compare with blank group*P < 0.05,**P < 0.01,***P < 0.001;
Table 3 result shows, and the high, medium and low dosage of traditional Chinese herb medicine of the present invention can suppress the synthesis of PGE2 in rat inflammation tissue respectively to some extent, and high, medium and low dosage compares with blank group very significant and significant difference respectively; Point out through statistical procedures: wherein dosage action intensity is poorer than A Ke.
3,0.6%HAC is caused the analgesic activity of mouse pain reaction
Getting male and healthy mouse 80, be divided into 8 groups at random, what the embodiment of the present invention 1 was produced be numbered D, each three dosage groups that are numbered the high, medium and low dosage of the traditional Chinese herb medicine of E, is very just organizing and blank group, QIZHENG XIAOTONG TIE cream 5g crude drug/kg/d group; This product 7.6g crude drug/kg, 3.8g crude drug/kg, 1.9g crude drug/kg, all by the volume gastric infusion of 0.25ml/10g body weight, blank group gives isopyknic water gastric infusion, continuous 3 days, 1 hour abdominal injection 0.6%HAC after mensuration last medicine respectively, 0.1ml/10g mouse is heavy, the writhing number of times in latent period and 15 minutes that writhing response occurs in record, by formulae discovery pain inhibiting rate (%), result with�� SD represents, t inspection between statistical procedures method employing group, result is as shown in table 4.
Inhibiting rate (%)=(blank group writhing number of times-administration group writhing number of times)/blank group writhing number of times �� 100%
Table 4 traditional Chinese medicine oral liquid of the present invention 0.6%HAC is caused mouse pain reaction effect (�� SD, n=10)
Note: compare with blank group*P < 0.05,**P < 0.01.
From table 4 result, the high, medium and low dosage of traditional Chinese herb medicine of the present invention all can obviously suppress the writhing latent period of mouse. The significant difference having in various degree is compared with blank group; The high, medium and low dosage of traditional Chinese herb medicine of the present invention all can significantly reduce the writhing number of times of mouse, compares, with blank group, the significant difference having in various degree, points out Chinese medicine preparation ointment of the present invention to have good analgesic activity. In terms of pain inhibiting rate result: Chinese medicine preparation of the present invention, dosage group is slightly better than strange just group.
Experimental example 3: the clinical trial of Chinese medicine preparation of the present invention
1, physical data
Talalgia patient 360 example is collected in this clinical trial altogether, wherein man 150 example, female 210 example, the age 24-64 year, the factors such as age-based for all patients, sex, the course of disease are divided into three groups, control group, test 1 group and test 2 groups.
2, medication is tested
Control group: QIZHENG XIAOTONG TIE cream, the accurate word Z54020113 of traditional Chinese medicines, manufacturer: XiZang QiZheng Tibetan pharmaceuticals Co., Ltd.
Testing 1 group: the embodiment of the present invention 1 is produced the ointment being numbered D, specification is: 1.26g crude drug/g ointment.
Testing 2 groups: the embodiment of the present invention 1 is produced the ointment being numbered E, specification is: 1.26g crude drug/g ointment.
3, test method
Control group patient uses comparison medicine, and every day one pastes; Test 1 group, test 2 and group use respectively the embodiment of the present invention 1 and produce be numbered D, be numbered the investigational agent of E, often daily about 5g smears affected part, sooner or later each once; All patients treat 3 weeks all continuously, stop administration after 6 months, healing person are paid a return visit, record recurrent cases; Treatment result is carried out statistical study after all terminating by treatment.
4, therapeutic evaluation
Cure: stop pain completely dissolve after medicine, normally walk;
Effective: pain obviously alleviates;
Invalid: pain does not have considerable change even more serious;
Recurrence: stopping administration in 6 months, former position suffers from talalgia again.
5, test-results statistics
After test all terminates, by as shown in table 5 for test-results statistical study.
6, conclusion
Test-results shows, and the curative ratio compared with control group, test 1 group, testing 2 group improves 22.5,21.6 percentage points respectively, always has efficiency to improve 13.3,12.5 percentage points respectively, and recurrence rate control group is 6.7 times of test group. Therefore, compared with prior art, Chinese medicine preparation of the present invention has advantage for the treatment of very significantly, obtains breakthrough technology progress in the treatment field of talalgia, and its creativeness is fairly obvious.

Claims (5)

1. the Chinese medicine preparation of an external application for curing talalgia, it is characterized in that, the Chinese prescription of described Chinese medicine preparation is made up of the Chinese medicinal materials of following weight part: cultivated land 6-22 part, rheum officinale 6-25 part, scorpio 4-13 part, golden cypress 7-26 part, loranthus parasiticus 7-30 part, Tuberculate Speranskia Herb 10-33 part, safflower 4-15 part, Root of Sixpetal Clematis 8-34 part, root of bidentate achyranthes 7-32 part, Rhizoma Sparganii 6-21 part, curcuma zedoary 6-23 part, borneol 7-20 part, tarragon 10-35 part, mature vinegar 80-280 part, White Mustard Seed 11-40 part, cape jasmine 6-19 part.
2. the Chinese medicine preparation of external application for curing talalgia as claimed in claim 1, it is characterized in that, the Chinese prescription of described Chinese medicine preparation is made up of the Chinese medicinal materials of following weight part: 16 parts, cultivated land, rheum officinale 15 parts, scorpio 8 parts, golden cypress 17 parts, loranthus parasiticus 18 parts, Tuberculate Speranskia Herb 22 parts, 9 parts, safflower, 20 parts, Root of Sixpetal Clematis, the root of bidentate achyranthes 19 parts, Rhizoma Sparganii 16 parts, curcuma zedoary 14 parts, borneol 15 parts, tarragon 21 parts, 120 parts, mature vinegar, White Mustard Seed 26 parts, cape jasmine 12 parts.
3. the Chinese medicine preparation of external application for curing talalgia as claimed in claim 1, it is characterized in that, the Chinese prescription of described Chinese medicine preparation is made up of the Chinese medicinal materials of following weight part: 18 parts, cultivated land, rheum officinale 16 parts, scorpio 9 parts, golden cypress 15 parts, loranthus parasiticus 17 parts, Tuberculate Speranskia Herb 24 parts, 8 parts, safflower, 22 parts, Root of Sixpetal Clematis, the root of bidentate achyranthes 22 parts, Rhizoma Sparganii 15 parts, curcuma zedoary 16 parts, borneol 14 parts, tarragon 24 parts, 140 parts, mature vinegar, White Mustard Seed 25 parts, cape jasmine 11 parts.
4. the Chinese medicine preparation of external application for curing talalgia as described in item as arbitrary in claim 1-3, it is characterised in that, described Chinese medicine preparation is prepared from by following method:
(1) each taste Chinese medicinal materials is taken by Chinese prescription of the present invention;
(2) by cultivated land, rheum officinale, golden cypress, root of bidentate achyranthes frying, pulverize respectively, levigate, cross 70-120 order sieve, it is mixed to get fine powder, for subsequent use;
(3) scorpio, safflower, Tuberculate Speranskia Herb, borneol is dry respectively, pulverize grinding, cross 70-120 order sieve, be mixed to get fine powder, for subsequent use;
(4) loranthus parasiticus, Root of Sixpetal Clematis, Rhizoma Sparganii, curcuma zedoary, tarragon, White Mustard Seed, cape jasmine being pulverized respectively, add the purified water of 5-14 times of weight after mixing, backflow is decocted and is boiled three times, each 1-6 hour, filter, merging filtrate, concentrate to 55 DEG C of relative densities be the concentrated solution of 1.42-1.46, for subsequent use;
(5) mixing fine powders that will be obtained in step (2) and (3), adds in the made concentrated solution of step (4), adds mature vinegar simultaneously, mix, continue to concentrate to 55 DEG C of relative densities be the thick cream of 1.35-1.40, for subsequent use;
(6) by the thick cream of step (5) gained, add suitable auxiliary material, utilize modern general Chinese medicine preparation technology, make the Chinese medicine finished product external preparation of clinical needs.
5. the Chinese medicine preparation of external application for curing talalgia as described in item as arbitrary in claim 1-3, it is characterised in that: the formulation of described Chinese medicine preparation is paste, extractum, lozenge, distillate medicinal water, glue agent, nail agent, rod agent, suppository, herbal leaven, paste, wash put agent, finish, line agent, medicated roll on the skin, press agent, process agent, fumicants, medicine perfume, tincture, aerosol, enema or film agent.
CN201610217804.6A 2016-04-11 2016-04-11 Traditional Chinese medicine preparation for treating heel pain by external application Withdrawn CN105617295A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102949476A (en) * 2012-10-17 2013-03-06 王萍 Health traditional Chinese medicine composition for heel pain
CN103830402A (en) * 2014-02-17 2014-06-04 马青 Traditional Chinese medicine lotion for treating painful heel
CN104825591A (en) * 2015-05-25 2015-08-12 苗怡文 Traditional Chinese medicine preparation for treating cervical vertebra diseases and preparation method of traditional Chinese medicine preparation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102949476A (en) * 2012-10-17 2013-03-06 王萍 Health traditional Chinese medicine composition for heel pain
CN103830402A (en) * 2014-02-17 2014-06-04 马青 Traditional Chinese medicine lotion for treating painful heel
CN104825591A (en) * 2015-05-25 2015-08-12 苗怡文 Traditional Chinese medicine preparation for treating cervical vertebra diseases and preparation method of traditional Chinese medicine preparation

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Application publication date: 20160601