CN105616827A - Traditional Chinese medicine for treating delayed fracture healing and preparation method thereof - Google Patents

Abstract

The invention provides a traditional Chinese medicine for treating delayed fracture healing and a preparation method thereof. The traditional Chinese medicine is prepared from the following medicinal raw materials: creeping mallotus root leaf, microsorium hymenodes, alysicarpus vaginalis, torricellia angulata, ophiophagus hannah, leonurus pseudomacranthus, carex siderosticta hance, large-flowered zephyranthes, aralia yunnanensis franch, root of flemingia macrophylla, ardisia maculosa mez, xylobalsamum, salvia scapiformis hance and radix argyreiae acutae. The traditional Chinese medicine can be matched with a western medical conventional method for treating delayed fracture healing, and can be used for effectively improving the healing ratio of fracture, remarkably shortening the healing time of fracture in clinical application, and quickly relieving the pain of patients.

Description

A kind of Chinese medicine and preparation method treating fracture delayed union

Technical field

The present invention relates to containing the medicinal preparation deriving from plant, animal or mineral component, particularly relate to a kind of Chinese medicine and the preparation method that treat fracture delayed union.

Background technology

Fracture delayed union (delayunion) is the common complication of bone fracture, is that phalangeal fracture passes through treatment, exceedes the time needed for usually healing (being generally 4-8 individual month) fracture site and does not occur yet fracturing and connect. Fracture delayed union is also not equal to disunion, as long as we find the reason causing fracture delayed union, positive symptomatic treatment, fracture still can heal. The time of the union of fracture of different sites is not identical, even if the fracture at same position, fracture situation is different, and healing time is also different. Such as simple closed fracture, if also not healing in 3 months, namely may be delayed union. And the open fracture of complexity, even if just healing half a year, also not necessarily delayed union. Such as care of fractured fingers healing time is generally 4-5 week, fracture of upper arm 5-8 week, thigh fracture 8-14 week, shank fracture 8-12 week, the 3-5 week but children's fractures.

Through clinical study, it is easy to cause the reason of fracture delayed union to mainly contain: (1) fracture has bony defect. (2) fracture soft tissue injury is serious. (3) fracture soft tissue infection. (4) repeatedly manual reduction roughly. (5) excessively draw. (6) periosteum is had extensively to peel off during operation. (7) fixing insecure or the set time is too short. (8) functional training is incorrect. (9) fracture site has soft tissue to embed. Once discovery delayed union, reason should be found in time, process rapidly. Such as infecting the delayed union caused, as long as controlling infection, fracture just likely heals. If improper causing because fixing, it is necessary to improve fixing, fracture just likely heals.

Affect the factor of union of fracture, mainly contain following several. 1, whole body factor: (1) age: children's is because of the regeneration of its tissue and to mould shape ability strong, and therefore, speed of fracture union is relatively grown up soon, and functional rehabilitation is good. Such as children's's Fracture of femur, within 1 month, can substantially heal, and adult thighbone fracture, often need 3-4 month ability substantially to heal; The Fracture of femur healing rate of the elderly and functional rehabilitation are then slower. (2) general medical condition: chronic wasting disease, such as patients such as diabetes, severe malnutrition, calcium metabolism disorder, osteomalacia, malignant tumours, as fractured, then union of fracture postpones. (3) individual difference: individual different, speed of fracture union can be variant. 2, local factor: (1) classification of fracture: volution and oblique fracture, because fracture face contact is big, has the newborn growth of spur of part, just easily clinical healing occurs, so union of fracture is fast. The contact of horizontal shape fractured bones fracture is little, though there being the newborn porosis of a great deal of, but the ripe poroma often needing more amount just can reach clinical healing, therefore clinical healing speed is relatively slow. Fracture end contact is tight, the healing of favourable fracture. As impaction fracture more easily heals, and having crack or separation between fracture end, therebetween has soft tissue, then not easily heal. Bone end asks that scissors stress or other forms of activity can affect the healing of fracture. (2) fracture segment blood supply situation: the tissue regeneration in fracture healing process, it is necessary to enough blood supplies. If fracture segment blood supply reduces, then speed of fracture union becomes slow; Fracture segment blood supply is subject to serious hindrance or loses completely, then union of fracture occurs to postpone to connect, even ischemic osteonecrosis. (3) soft tissue injury degree: the fracture that directly violence causes, soft tissue injury is serious, muscle, blood vessel, nerve, and periosteum all may have and damages in various degree, and the speed of union of fracture is it is possible to slower. And indirect closed fracture caused by violence, soft tissue injury is relatively light, and union of fracture is very fast. Union of fracture caused by radioactive combined injury is slow or disunion. (4) impact infected: open fracture infects, causes suppurative osteomyelitis, or sequestrum is formed, and the congested decalcification of fracture site, union of fracture is very slow. (5) quantity fractured: having several sections of fracture on multiple fracture or a bone, speed of fracture union is also slower.

Summary of the invention

Technical problem to be solved by this invention is, it is provided that a kind of Chinese medicine and preparation method treating fracture delayed union, and this Chinese medicine coordinates doctor trained in Western medicine fracture operation to use, it is possible to better treat fracture delayed union.

In order to solve the problems of the technologies described above, the present invention provides a kind of Chinese medicine treating fracture delayed union, and its raw medicinal material comprises: Root ot stem of Creeping Mallotus, the broken benefit of rattan, dog ant grass, beggar, cross mountain breeze, carve dish, Root of Broadleaf Sedge, Herba zephyranthis grandiflorae, grass levisticum, Root of Largeleaf Flemingia, Herba Ardisiae Maculosae, Cortex Seu Folium Actinodaphnes Pilosae, Herba Salviae Scapiformis and Root of Common Argyreia.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material is as follows: Root ot stem of Creeping Mallotus 10��20 parts, the broken benefit of rattan 20��30 parts, dog ant grass 35��45 parts, beggar 5��15 parts, cross mountain breeze 10��20 parts, carve dish 20��30 parts, Root of Broadleaf Sedge 55��65 parts, Herba zephyranthis grandiflorae 10��20 parts, grass levisticum 20��30 parts, Root of Largeleaf Flemingia 50��60 parts, Herba Ardisiae Maculosae 5��15 parts, Cortex Seu Folium Actinodaphnes Pilosae 5��15 parts, Herba Salviae Scapiformis 35��45 parts and Root of Common Argyreia 10��20 parts.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: Root ot stem of Creeping Mallotus 10��15 parts, the broken benefit of rattan 20��25 parts, dog ant grass 35��40 parts, beggar 5��10 parts, cross mountain breeze 10��15 parts, carve dish 20��25 parts, Root of Broadleaf Sedge 55��60 parts, Herba zephyranthis grandiflorae 10��15 parts, grass levisticum 20��25 parts, Root of Largeleaf Flemingia 50��55 parts, Herba Ardisiae Maculosae 5��10 parts, Cortex Seu Folium Actinodaphnes Pilosae 5��10 parts, Herba Salviae Scapiformis 35��40 parts and Root of Common Argyreia 10��15 parts.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material can also be preferably: Root ot stem of Creeping Mallotus 14 parts, the broken benefit of rattan 22 parts, dog ant grass 38 parts, beggar 6 parts, cross mountain breeze 11 parts, carve dish 24 parts, Root of Broadleaf Sedge 58 parts, Herba zephyranthis grandiflorae 13 parts, grass levisticum 23 parts, Root of Largeleaf Flemingia 53 parts, Herba Ardisiae Maculosae 9 parts, Cortex Seu Folium Actinodaphnes Pilosae 8 parts, Herba Salviae Scapiformis 36 parts and Root of Common Argyreia 12 parts.

Present invention also offers the preparation method of above-mentioned Chinese medicine, the formulation of described Chinese medicine is tablet, and its preparation method comprises the following steps:

The first step: each for described Chinese medicine preparation component is mixed in proportion, adding relative to the determining alcohol of mixture quality 3��5 times is the ethanol of 60��70%, reflux 2��3 hours, extract, filter and obtain the first extracting solution, it is the ethanol of 60��70% that the dregs of a decoction that filtration obtains add relative to the determining alcohol of dregs of a decoction quality 2��3 times again, reflux 1��2 hour, extract, filtering and obtain the 2nd extracting solution, the first extracting solution and the 2nd extracting solution are merged, concentrating under reduced pressure removes alcohol solvent, drying, obtains and gets dry extract;

2nd step: the dry cream that the first step obtains is placed in supper micron mill and pulverizes 1��2 hour, pulverize and sieve acquisition 150��250 object micropowders;

3rd step: add the Microcrystalline Cellulose relative to its quality 0.3��0.5 times, the lactose of 0.03��0.3 times, the starch of 0.3��0.5 times in the micropowders that the 2nd step obtains, sieve, mix, granulate, drying, adds the Magnesium Stearate relative to micropowders quality 0.003��0.03 times, whole grain, compressing tablet, makes.

Present invention also offers the preparation method of above-mentioned Chinese medicine, the formulation of described Chinese medicine is granule, and its preparation method comprises the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 4��6 times, mixture is the ethanol of 70��80%, it is heated to boiling reflux 2��3 hours, filter, adopt percolation slowly to ooze with the speed of every minute 1��2ml to filter, collect percolate, when being evaporated to 70��80 DEG C subsequently under vacuum tightness 0.01��0.05Mpa, relative density is the lotion of 1.03��1.05, spraying dry, the inlet temperature of spray-drier 165��185 DEG C, air outlet temperature 65��85 DEG C, pulverize into powder subsequently, make dried cream powder;

2nd step: the dextrin adding the cane sugar powder relative to dried cream powder quality 0.4��0.6 times and 0.4��0.6 times in the dried cream powder obtained, makes particle, in 65��75 DEG C of dryings, obtains granule.

The useful effect of the present invention: Chinese medicine of the present invention can coordinate doctor trained in Western medicine ordinary method treatment fracture delayed union, effectively improves the healing ratio of fracture, can obviously shorten the healing time of fracture, alleviate the pain of patient faster on simultaneously clinical.

Embodiment

The present invention provides a kind of Chinese medicine treating fracture delayed union, and its raw medicinal material comprises: Root ot stem of Creeping Mallotus, the broken benefit of rattan, dog ant grass, beggar, cross mountain breeze, carve dish, Root of Broadleaf Sedge, Herba zephyranthis grandiflorae, grass levisticum, Root of Largeleaf Flemingia, Herba Ardisiae Maculosae, Cortex Seu Folium Actinodaphnes Pilosae, Herba Salviae Scapiformis and Root of Common Argyreia.

In described Chinese medicine, the pharmacology of each raw medicinal material is as follows:

Root ot stem of Creeping Mallotus: [another name] reversal of the natural order of things gold hook, scouring rush maple rattan, ten thousand thorn rattans, colter maple, gold hook, dry fragrant rattan, rock paulownia fiber crops, soya bean tree, blue or green barb, colter bavin, Shu Liqi, Wan Ziteng, barb bavin, little Jin thick stick rattan, green grass or young crops yncaria stem with hooks, noisy hook, energetically king, bucket are handed over rattan, added and hang rattan, mad dog rattan, black scraper grass, woody water spinach Huang, wood stalk Typhonium divaricatum, great Ye milk perfume, hexagonal maple rattan. [source] comes from Jinhua " conventional herbal medicine folk prescription proved recipe a collection of selected materials ". [source] medicinal material Ji Yuan: be the root of euphorbia plant stone rock maple, stem, leaf. [nature and flavor] bitter; Pungent; Warm in nature. [return through] heart; Liver; The spleen channel. [function cures mainly] dispels rheumatism; Promoting blood circulation and removing obstruction in channels; Detoxify and promote the subsdence of swelling; Expelling insect and relieving itching. Main rheumatism bi Zheng; Lumbago and skelalgia; Facial hemiparalysis; Wound; Carbuncle swells sore; Teniasis; Eczema; Stubborn dermatitis; Snake lyssodexis.

The broken benefit of rattan: [source] is the rhizome of Polypodiaceae plant Yunnan star fern. [nature and flavor] micro-hardship, cool. [function cures mainly] clearing and antitussive, promoting blood circulation and removing obstruction in channels, removing damp and stopping pain. Main cough, fracture, wound, internal lesion caused by overexertion pain, rheumatic arthralgia.

Dog ant grass: [source] is the full grass of leguminous plants dog ant grass. [nature and flavor] are sweet, bitter, flat. [function cures mainly] is promoting blood circulation and removing obstruction in channels, clearing away heat and eliminating dampness, refutes bone detumescence, removes necrosis and promote granulation. Controlling hemiplegia, femur is ached, chronic hepatitis, snakebite, wound, traumatic hemorrhage.

Beggar: root, leaf and the seed that [source] is pittosporum tobira section plant Taiwan circle fruit pittosporum tobira. [nature and flavor] are bitter, tepor. [function cures mainly] detoxifies, and profit is wet, invigorates blood circulation, detumescence. Controlling snakebite, arthralgia, general edema with yellowish tinge of the skin swells, and ulcer sore scabies, falls folding of injuring, skin eczema.

Cross mountain breeze: root that [source] is canella wheel blade Litsea pungens, leaf, bark. [nature and flavor] are pungent, temperature. [function cures mainly] dispelling wind and removing obstruction in the collateral, activating blood circulation and reducing swelling, pain relieving. Main rheumatic arthritis, pain in the waist and lower extremities, tetraplegia, dysmenorrhoea, treating swelling and pain by traumatic injury.

Carve dish: [another name] tower grass, beautiful Rong grass, spend Motherwort Herb, DUIYUECAO in vain, spend motherwort in vain, Yushan rice careless. [source] is come from " A Supplement to the Compendium of Materia Medica ". " Bencao Shiyi " carves Lay, raw south of the River swale. Female like benefit, square-stem, to joint, is spent in vain, sweet juice in spending, drink such as honey. [source] medicinal material Ji Yuan: carve dish or the full grass of great Hua engraving tool dish for labiate. [nature and flavor] taste abnormal pigmentary deposit on the skin; Property is put down. [function cures mainly] promoting blood flow to regulate menstruation; Detoxify and promote the subsdence of swelling. Main menoxenia; Amenorrhoea; Dysmenorrhoea; Postpartum blood stasis is suffered from abdominal pain; Uterine bleeding; Traumatic pain; Sore carbuncle. [each discussion] 1. " Bencao Shiyi ": main broken blood. Puerperal abdonimal pain, liquor takes it; Also dressing treatment sore is smashed to pieces. 2. " the southern regions of the Yunnan Province book on Chinese herbal medicine ": cure mainly all muscles and bones chilly soft, the exhaustion of yang exhaustion of yin, night many night sweat, wound, married woman's metrorrhagia, synthetism.

Root of Broadleaf Sedge: [source] is the root of sedge sesame leaf sedge. [nature and flavor] taste is sweet, pungent, warm in nature. [return through] returns lung, liver, kidney channel. [function cures mainly] replenishing qi and blood, promoting blood flow to regulate menstruation. Main deficient qi and blood, lassitude, palpitation and insomnia, menoxenia, through closing.

Herba zephyranthis grandiflorae: [another name] calamus lotus, carbuncle curtain, wind and rain flower, non-irrigated narcissus, hollow leek, solely garlic. [source] is come from " Guizhou herbal medicine ". [source] medicinal material Ji Yuan: be the full grass of amrallid Jiu Lian. [nature and flavor] are bitter; Cold. [function cures mainly] promoting blood circulation and cooling blood; Detoxify and promote the subsdence of swelling. Main haematemesis; Have blood in stool; Uterine bleeding; Get injured by a fall redness; Sore carbuncle is red and swollen; Venomous snake bite.

Grass levisticum: [source] is the root of Araliaceae Yunnan root of araliae. [nature and flavor] bitter, pungent, slightly warm in nature. [function cures mainly] expelling cold, eliminating, strong spleen Li Shui, relaxes the muscles and stimulate the blood circulation, preventing malaria. Main common cold caused by wind-cold, cough, edema due to deficiency of the spleen, infantile malnutrition, chest side of body pain, treating swelling and pain by traumatic injury, rheumatalgia, pain in the back, fracture, menoxenia, traumatic hemorrhage, malaria.

Root of Largeleaf Flemingia: [source] is the root of leguminous plants Flemingia macrophylla. [nature and flavor] are warm in nature, and taste is sweet. [function cures mainly] wind-damp dispelling, arteries and veins of invigorating blood circulation, strengthening the bones and muscles. Dispelling the wind and dampness pathogens ostalgia, lumbar muscle strain, hemiplegia, impotence.

Herba Ardisiae Maculosae: [source] is the complete stool of Myrsinacea tabasheer umbrella. [nature and flavor] are pungent, bitter, slightly warm in nature. [return through] returns liver, kidney, lung channel. [function cures mainly] promoting blood circulation and stopping pain, throat clearing and benefiting. Main wound, fracture, rheumatic arthralgia, diphtheria, swelling and pain in the throat, stomach ulcer.

Cortex Seu Folium Actinodaphnes Pilosae: [another name] tea Jiao Shu, wood shavings, tea bakelite, bakelite, the ears of an ox or cow glue, wooden dipper flowers and trees, Lao Renmu, hair camphor tree. [source] is come from " Luchuan book on Chinese herbal medicine ". [source] medicinal material Ji Yuan: be the bark of canella actinodaphne obovata. Gather and store: spring, summer gather. Root, removes fibrous root, earth; Bark and leaf, remove impurity and dry. [nature and flavor] are pungent; Bitter; Property is put down. [return through] lung channel. [function cures mainly] promoting blood circulation and stopping pain; Detoxify and promote the subsdence of swelling. Main traumatic pain; Sciatica, stomachache, the swollen poison of sore furuncle. [function cures mainly] be " Luchuan book on Chinese herbal medicine " 1.: " skin, leaf: drive wind, detumescence, broken long-pending, removing toxic substances. Control wound, the swollen poison of sore furuncle ". 2. " register planted by Guangxi medicine ": " leaf: cough-relieving ".

Herba Salviae Scapiformis: [source] is the full grass of labiate bristle field bund Salvia japonica Thunb.. [nature and flavor] taste is pungent, sweet, and property is put down. [function cures mainly] qi-restoratives benefit is damaged, and strengthens muscles and bones. Main tuberculosis, weak skinny and wizened, vertigo, internal lesion caused by overexertion.

Root of Common Argyreia: [source] is the root of convolvulaceous plant Stem and leaf of Common Argyreia. [nature and flavor] are puckery, sweet, flat. [return through] returns kidney channel. [function cures mainly] wind-damp dispelling, relaxing muscles and tendons network. Main rheumatic arthralgia, wound.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material is as follows: Root ot stem of Creeping Mallotus 10��20 parts, the broken benefit of rattan 20��30 parts, dog ant grass 35��45 parts, beggar 5��15 parts, cross mountain breeze 10��20 parts, carve dish 20��30 parts, Root of Broadleaf Sedge 55��65 parts, Herba zephyranthis grandiflorae 10��20 parts, grass levisticum 20��30 parts, Root of Largeleaf Flemingia 50��60 parts, Herba Ardisiae Maculosae 5��15 parts, Cortex Seu Folium Actinodaphnes Pilosae 5��15 parts, Herba Salviae Scapiformis 35��45 parts and Root of Common Argyreia 10��20 parts.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: Root ot stem of Creeping Mallotus 10��15 parts, the broken benefit of rattan 20��25 parts, dog ant grass 35��40 parts, beggar 5��10 parts, cross mountain breeze 10��15 parts, carve dish 20��25 parts, Root of Broadleaf Sedge 55��60 parts, Herba zephyranthis grandiflorae 10��15 parts, grass levisticum 20��25 parts, Root of Largeleaf Flemingia 50��55 parts, Herba Ardisiae Maculosae 5��10 parts, Cortex Seu Folium Actinodaphnes Pilosae 5��10 parts, Herba Salviae Scapiformis 35��40 parts and Root of Common Argyreia 10��15 parts.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material can also be preferably: Root ot stem of Creeping Mallotus 14 parts, the broken benefit of rattan 22 parts, dog ant grass 38 parts, beggar 6 parts, cross mountain breeze 11 parts, carve dish 24 parts, Root of Broadleaf Sedge 58 parts, Herba zephyranthis grandiflorae 13 parts, grass levisticum 23 parts, Root of Largeleaf Flemingia 53 parts, Herba Ardisiae Maculosae 9 parts, Cortex Seu Folium Actinodaphnes Pilosae 8 parts, Herba Salviae Scapiformis 36 parts and Root of Common Argyreia 12 parts.

Present invention also offers the preparation method of above-mentioned Chinese medicine, the formulation of described Chinese medicine is tablet, and its preparation method comprises the following steps:

The first step: each for described Chinese medicine preparation component is mixed in proportion, adding relative to the determining alcohol of mixture quality 3��5 times is the ethanol of 60��70%, reflux 2��3 hours, extract, filter and obtain the first extracting solution, it is the ethanol of 60��70% that the dregs of a decoction that filtration obtains add relative to the determining alcohol of dregs of a decoction quality 2��3 times again, reflux 1��2 hour, extract, filtering and obtain the 2nd extracting solution, the first extracting solution and the 2nd extracting solution are merged, concentrating under reduced pressure removes alcohol solvent, drying, obtains and gets dry extract;

2nd step: the dry cream that the first step obtains is placed in supper micron mill and pulverizes 1��2 hour, pulverize and sieve acquisition 150��250 object micropowders;

3rd step: add the Microcrystalline Cellulose relative to its quality 0.3��0.5 times, the lactose of 0.03��0.3 times, the starch of 0.3��0.5 times in the micropowders that the 2nd step obtains, sieve, mix, granulate, drying, adds the Magnesium Stearate relative to micropowders quality 0.003��0.03 times, whole grain, compressing tablet, makes.

Present invention also offers the preparation method of above-mentioned Chinese medicine, the formulation of described Chinese medicine is granule, and its preparation method comprises the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 4��6 times, mixture is the ethanol of 70��80%, it is heated to boiling reflux 2��3 hours, filter, adopt percolation slowly to ooze with the speed of every minute 1��2ml to filter, collect percolate, when being evaporated to 70��80 DEG C subsequently under vacuum tightness 0.01��0.05Mpa, relative density is the lotion of 1.03��1.05, spraying dry, the inlet temperature of spray-drier 165��185 DEG C, air outlet temperature 65��85 DEG C, pulverize into powder subsequently, make dried cream powder;

2nd step: the dextrin adding the cane sugar powder relative to dried cream powder quality 0.4��0.6 times and 0.4��0.6 times in the dried cream powder obtained, makes particle, in 65��75 DEG C of dryings, obtains granule.

Hereinafter adopt embodiment that embodiments of the present invention are described in detail, fully understand that how utilisation technology means carry out technical solution problem in the present invention, reach technique effect and implement according to this whereby.

Embodiment 1: tablet

Getting Root ot stem of Creeping Mallotus 140g, rattan broken benefit 220g, dog ant grass 380g, beggar 60g, cross mountain breeze 110g, carve dish 240g, Root of Broadleaf Sedge 580g, Herba zephyranthis grandiflorae 130g, grass levisticum 230g, Root of Largeleaf Flemingia 530g, Herba Ardisiae Maculosae 90g, Cortex Seu Folium Actinodaphnes Pilosae 80g, Herba Salviae Scapiformis 360g and Root of Common Argyreia 120g;

Prepare according to the following steps:

The first step: each for described Chinese medicine preparation component is mixed in proportion, adding relative to the determining alcohol of mixture quality 5 times is the ethanol of 70%, reflux 3 hours, extract, filtering and obtain the first extracting solution, it is the ethanol of 70% that the dregs of a decoction that filtration obtains add relative to the determining alcohol of dregs of a decoction quality 3 times again, reflux 1 hour, extract, filtering and obtain the 2nd extracting solution, the first extracting solution and the 2nd extracting solution are merged, concentrating under reduced pressure removes alcohol solvent, drying, obtains and gets dry extract;

2nd step: be placed in supper micron mill by the dry cream that the first step obtains and pulverize 1 hour, pulverizes and sieves and obtains 200 object micropowders;

3rd step: add the Microcrystalline Cellulose relative to its quality 0.35, the lactose of 0.18 times, the starch of 0.42 times in the micropowders that the 2nd step obtains, sieve, mix, granulate, dry, add the Magnesium Stearate relative to micropowders quality 0.014 times, whole grain, compressing tablet, makes.

Embodiment 2: granule

Getting Root ot stem of Creeping Mallotus 120g, rattan broken benefit 250g, dog ant grass 360g, beggar 80g, cross mountain breeze 140g, carve dish 210g, Root of Broadleaf Sedge 570g, Herba zephyranthis grandiflorae 140g, grass levisticum 210g, Root of Largeleaf Flemingia 550g, Herba Ardisiae Maculosae 70g, Cortex Seu Folium Actinodaphnes Pilosae 60g, Herba Salviae Scapiformis 380g and Root of Common Argyreia 150g;

Prepare according to the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 3 times, mixture is the ethanol of 90%, it is heated to boiling reflux 2 hours, filters, adopt percolation slowly to ooze with the speed of every minute 2ml and filter, collect percolate, when being evaporated to 75 DEG C subsequently under vacuum tightness 0.01Mpa, relative density is the lotion of 1.05, spraying dry, the inlet temperature of spray-drier 180 DEG C, air outlet temperature 80 DEG C, pulverize into powder subsequently, make dried cream powder;

2nd step: the dextrin adding the cane sugar powder relative to dried cream powder quality 0.5 times and 0.5 times in the dried cream powder obtained, makes particle, in 70 DEG C of dryings, obtains granule.

Toxicity test:

Acute toxicity test: application mouse 60, male and female half and half, body weight 22��36g, carries out acute toxicity test. Mouse is divided into two groups at random, i.e. control group and administration group, before experiment, fasting 12 hours, is dissolved in water by Chinese medicinal tablet prepared by embodiments of the invention 1, (concentration is 8.48g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg (namely single-dose dosage is 42.4 crude drugs/kg), and control group gives equivalent physiological saline, administration in one day 2 times, delivery time 6 hours, observes 14 days continuously after administration, and record mouse toxic reaction and death toll. Experimental result shows: compare with control group, and after administration, mouse has no notable difference, and experiment is observed 14 days continuously, and mouse systemic situation, diet, drinking-water, body weight increase all normal. Tablet LD50 > 42.4 crude drugs/the kg of Mouse oral gavage the present invention, every day, maximum dosage-feeding was 84.8 crude drugs/kg/ day. The Chinese medicine clinical application amount of the present invention be 8.4g crude drug/day/people, adult body weight in 60KG, average dosage is 0.14g crude drug/kg/ day. By batheroom scale: the tolerance amount of the Chinese medicine of mouse (mean body weight is taking 29g) oral administration gavage the present invention is as 606 times of clinical consumption. Therefore the Chinese medicine acute toxicity of the present invention is extremely low, clinical drug safety.

Long term toxicity test: Chinese medicine embodiment 1 tablet of the present invention to three groups of mouse (often organize 20) by 13.88,22.32 and 43.56g crude drug/kg continuous use 15 weeks (1.0ml/100g body weight, every day 2 times) and stop medicine after 3 weeks, result shows: the indexs such as the hair of mouse, behavior, stool and urine, body weight, organ weights, blood picture, hepatic and renal function, blood sugar, blood fat are all had no significant effect by Chinese medicine of the present invention, internal organs naked eyes do not find that difference change and histological indications show, medication 15 weeks and stop medicine after 3 weeks, each internal organs of mouse are all without obviously changing. Illustrate that Chinese medicine of the present invention is little to toxicity after mouse long-term prescription, also there is no difference reaction after stopping medicine, application safety.

Clinical data:

Case selection: whole 90 example cases are the fracture delayed union patient that my institute sees and treat patients. Patient is divided at random treatment group and control group. Wherein, treatment group 45 example, the male sex 26 example, women 19 example, 19��61 years old age; Fracture site: shin bone 16 example, femur 12 example, humerus 9 example, radius 6 example, ulna 2 example. Control group 45 example, the male sex 28 example, women 17 example, 20��63 years old age; Fracture site: shin bone 17 example, femur 12 example, humerus 8 example, radius 6 example, ulna 2 example. Two groups in sex, age, fracture site and state of an illness severity etc. through statistical analysis there was no significant difference, there is comparability.

Case definition: 1, fracture end has abnormal movable, and bone end easily produces pain when mobile or when examination does and bears a heavy burden, and fracture can have angulation, shortens and rotate deformity, can occur that articular contracture is lopsided and myatrophy. Heavy burden afunction. 2, imaging examination: X line shows that fracture end has gap, and poroma is few, fracture line is still obvious, mostly is the pungency poroma of cloud arrangement disorder. Fracture end hardens, and fracture face is smooth clear. Medullary space is closed. Osteoporosis. Formed without bone trabecula between poroma. Pseudarthrosis occurs.

Methods for the treatment of

Control group: adopt doctor trained in Western medicine internal fixation treatment. By the treatment of surgical menopause again, if fixing for steel plate and screw before, after removing, change screw, again fixing by fracture line pressurization, eliminate gap. If need not reset, then unnecessary excision disunion Interface Microstructure, can be converted into bone voluntarily after fixing-stable. Retaining and grown poroma, sclerotic bone and hyperplasia scar around cleaning fracture site, spongy bone arrangement fracture fills defect sclerotin. Patient's rehabilitation is instructed to take exercise after art. Having the infected, according to the drug sensitivity tests of patient's whole body situation or merocrine secretion's thing, give one or more suitable microbiotic and carry out anti-inflammatory anti-infective therapy, the course for the treatment of is 4-6 week; Treatment result is added up after 4 months after art.

Treatment group: on the conventional internal fixation treatment basis of control group doctor trained in Western medicine, the tablet of the oral embodiment of the present invention 1 preparation simultaneously, every day 3 times, each 3; It within 1 month, it is a course for the treatment of; Treatment result is added up after 4 months after art.

Criterion of therapeutical effect: cure: fracture end heals completely, without pain when fracture bears a heavy burden, functional rehabilitation, X line shows that fracture end gap disappears, and has a large amount of poroma to cover, and fracture line is completely dissolve. Effective: fracture end is close to healing, and when fracture bears a heavy burden, pain disappears or obviously alleviates, and function is recovered substantially, and X line shows that fracture end gap disappears, and has a large amount of or middle amount poroma to cover, fracture line is fuzzy but fracture end without hardening phenomenon. Invalid: when fracture bears a heavy burden, pain without obviously alleviating or increases the weight of, and X line shows that fracture line is not improved or disunion.

Treatment result: two groups treat 4 months respectively after, statistics is see table 1 and table 2.

Clinical efficacy comparison after treating 4 months respectively (unit: example) organized by table 1 liang

Group	Number of cases	Cure	Effectively	Invalid	Always there is efficiency
						Treatment group	45	40	5	0	45 (100%)
Control group	45	28	10	7	38 (84.4%)

As can be seen from Table 1, treatment group adopts the Chinese medicine of the present invention, coordinates western medical treatment fracture delayed union, relative to control group, in result for the treatment of, has significant improvement.

Table 2 liang is organized healing number and time after treating 4 months respectively and is compared (unit: example/%)

Group	Number of cases	Medication 2 months	Medication 3 months	Medication 4 months
					Treatment group	40	19 (42.2%)	31 (68.9%)	40 (88.9%)
Control group	28	12 (26.7%)	20 (44.4%)	28 (62.2%)

As can be seen from Table 2, treatment group adopts the Chinese medicine of the present invention, coordinates western medical treatment fracture delayed union, and relative to control group, not only better efficacy, takes effect also faster.

Untoward reaction: treatment group over the course for the treatment of, the liver and kidney dysfunction relevant to medicine or other untoward reactions does not all occur.

Concrete case: Lee, man, 52 years old, because traffic accident causes right middle humerus fracture, open reduction, intramedullary needle was fixed, and fractures and do not heal after 7 months, is diagnosed as fracture delayed union through checking, row is performed the operation again, uses steel plate screw instead and fixes. Retaining and grown poroma, sclerotic bone and hyperplasia scar around cleaning fracture site, spongy bone arrangement fracture fills defect sclerotin. Patient's rehabilitation is instructed to take exercise after art. The tablet of the oral embodiment of the present invention 1 preparation after art, every day 3 times, each 3; After art 2 months, fracture end healed completely, and without pain when fracture bears a heavy burden, functional rehabilitation, X line shows that fracture end gap disappears, has a large amount of poroma to cover, and fracture line is completely dissolve, healing.

The above is only the better embodiment of the present invention, is not the restriction that the present invention does 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 not departing from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling above embodiment done according to the technical spirit of the present invention, still belongs to the protection domain of technical solution of the present invention.

Claims (8)

1. treat the Chinese medicine of fracture delayed union for one kind, it is characterised in that, each raw medicinal material of described Chinese medicine comprises: Root ot stem of Creeping Mallotus, the broken benefit of rattan, dog ant grass, beggar, crosses mountain breeze, carves dish, Root of Broadleaf Sedge, Herba zephyranthis grandiflorae, grass levisticum, Root of Largeleaf Flemingia, Herba Ardisiae Maculosae, Cortex Seu Folium Actinodaphnes Pilosae, Herba Salviae Scapiformis and Root of Common Argyreia.

2. Chinese medicine as claimed in claim 1, it is characterised in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine is as follows: Root ot stem of Creeping Mallotus 10��20 parts, the broken benefit of rattan 20��30 parts, dog ant grass 35��45 parts, beggar 5��15 parts, cross mountain breeze 10��20 parts, carve dish 20��30 parts, Root of Broadleaf Sedge 55��65 parts, Herba zephyranthis grandiflorae 10��20 parts, grass levisticum 20��30 parts, Root of Largeleaf Flemingia 50��60 parts, Herba Ardisiae Maculosae 5��15 parts, Cortex Seu Folium Actinodaphnes Pilosae 5��15 parts, Herba Salviae Scapiformis 35��45 parts and Root of Common Argyreia 10��20 parts.

3. Chinese medicine as claimed in claim 1 or 2, it is characterised in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine is as follows: Root ot stem of Creeping Mallotus 10��15 parts, the broken benefit of rattan 20��25 parts, dog ant grass 35��40 parts, beggar 5��10 parts, cross mountain breeze 10��15 parts, carve dish 20��25 parts, Root of Broadleaf Sedge 55��60 parts, Herba zephyranthis grandiflorae 10��15 parts, grass levisticum 20��25 parts, Root of Largeleaf Flemingia 50��55 parts, Herba Ardisiae Maculosae 5��10 parts, Cortex Seu Folium Actinodaphnes Pilosae 5��10 parts, Herba Salviae Scapiformis 35��40 parts and Root of Common Argyreia 10��15 parts.

4. Chinese medicine as described in claims 1 to 3, it is characterised in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine is as follows: Root ot stem of Creeping Mallotus 14 parts, the broken benefit of rattan 22 parts, dog ant grass 38 parts, beggar 6 parts, cross mountain breeze 11 parts, carve dish 24 parts, Root of Broadleaf Sedge 58 parts, Herba zephyranthis grandiflorae 13 parts, grass levisticum 23 parts, Root of Largeleaf Flemingia 53 parts, Herba Ardisiae Maculosae 9 parts, Cortex Seu Folium Actinodaphnes Pilosae 8 parts, Herba Salviae Scapiformis 36 parts and Root of Common Argyreia 12 parts.

5. Chinese medicine as described in Claims 1-4, it is characterised in that, the formulation of described Chinese medicine is tablet, and its preparation method comprises the following steps:

The first step: each for described Chinese medicine preparation component is mixed in proportion, adding relative to the determining alcohol of mixture quality 3��5 times is the ethanol of 60��70%, reflux 2��3 hours, extract, filter and obtain the first extracting solution, it is the ethanol of 60��70% that the dregs of a decoction that filtration obtains add relative to the determining alcohol of dregs of a decoction quality 2��3 times again, reflux 1��2 hour, extract, filtering and obtain the 2nd extracting solution, the first extracting solution and the 2nd extracting solution are merged, concentrating under reduced pressure removes alcohol solvent, drying, obtains and gets dry extract;

2nd step: the dry cream that the first step obtains is placed in supper micron mill and pulverizes 1��2 hour, pulverize and sieve acquisition 150��250 object micropowders;

3rd step: add the Microcrystalline Cellulose relative to its quality 0.3��0.5 times, the lactose of 0.03��0.3 times, the starch of 0.3��0.5 times in the micropowders that the 2nd step obtains, sieve, mix, granulate, drying, adds the Magnesium Stearate relative to micropowders quality 0.003��0.03 times, whole grain, compressing tablet, makes.

6. Chinese medicine as described in Claims 1-4, it is characterised in that, the formulation of described Chinese medicine is granule, and its preparation method comprises the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 4��6 times, mixture is the ethanol of 70��80%, it is heated to boiling reflux 2��3 hours, filter, adopt percolation slowly to ooze with the speed of every minute 1��2ml to filter, collect percolate, when being evaporated to 70��80 DEG C subsequently under vacuum tightness 0.01��0.05Mpa, relative density is the lotion of 1.03��1.05, spraying dry, the inlet temperature of spray-drier 165��185 DEG C, air outlet temperature 65��85 DEG C, pulverize into powder subsequently, make dried cream powder;

2nd step: the dextrin adding the cane sugar powder relative to dried cream powder quality 0.4��0.6 times and 0.4��0.6 times in the dried cream powder obtained, makes particle, in 65��75 DEG C of dryings, obtains granule.

7. the preparation method of Chinese medicine described in a Claims 1-4, it is characterised in that, the formulation of described Chinese medicine is tablet, and its preparation method comprises the following steps:

The first step: each for described Chinese medicine preparation component is mixed in proportion, adding relative to the determining alcohol of mixture quality 3��5 times is the ethanol of 60��70%, reflux 2��3 hours, extract, filter and obtain the first extracting solution, it is the ethanol of 60��70% that the dregs of a decoction that filtration obtains add relative to the determining alcohol of dregs of a decoction quality 2��3 times again, reflux 1��2 hour, extract, filtering and obtain the 2nd extracting solution, the first extracting solution and the 2nd extracting solution are merged, concentrating under reduced pressure removes alcohol solvent, drying, obtains and gets dry extract;

2nd step: the dry cream that the first step obtains is placed in supper micron mill and pulverizes 1��2 hour, pulverize and sieve acquisition 150��250 object micropowders;

3rd step: add the Microcrystalline Cellulose relative to its quality 0.3��0.5 times, the lactose of 0.03��0.3 times, the starch of 0.3��0.5 times in the micropowders that the 2nd step obtains, sieve, mix, granulate, drying, adds the Magnesium Stearate relative to micropowders quality 0.003��0.03 times, whole grain, compressing tablet, makes.

8. the preparation method of Chinese medicine described in a Claims 1-4, it is characterised in that, the formulation of described Chinese medicine is granule, and its preparation method comprises the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 4��6 times, mixture is the ethanol of 70��80%, it is heated to boiling reflux 2��3 hours, filter, adopt percolation slowly to ooze with the speed of every minute 1��2ml to filter, collect percolate, when being evaporated to 70��80 DEG C subsequently under vacuum tightness 0.01��0.05Mpa, relative density is the lotion of 1.03��1.05, spraying dry, the inlet temperature of spray-drier 165��185 DEG C, air outlet temperature 65��85 DEG C, pulverize into powder subsequently, make dried cream powder;

2nd step: the dextrin adding the cane sugar powder relative to dried cream powder quality 0.4��0.6 times and 0.4��0.6 times in the dried cream powder obtained, makes particle, in 65��75 DEG C of dryings, obtains granule.