Summary of the invention the objective of the invention is on the basis of collecting arrangement bone injury mongolian medicine proved recipe among the people, adopt modern technologies to analyze and research, propose a kind of bone injury to be had significant curative effect, and adapt to widely, usage is simple, and produce effects is fast, cost is low, treatment time is short, and the patient suffering is few, the mongolian medicine that therapeutic effect is good.
Above-mentioned purpose is realized by following technical scheme: the mongolian medicine of developing a kind of set a broken bone, be characterized in: this mongolian medicine is to be made by following bulk drugs: Echinops latifolius 15-62 part, Cortex Eucommiae 28-76 part, Margarita 0.5-8 part, Flos Carthami 15-50 part, Radix Notoginseng 5-27 part.
The mongolian medicine of said set a broken bone, its optimization prescription is: Echinops latifolius 35-42 part, Cortex Eucommiae 48-56 part, Margarita 1-6 part, Flos Carthami 22-30 part, Radix Notoginseng 9-17 part.
The mongolian medicine of said set a broken bone, its best prescription is: 39 parts of Echinops latifoliuss, 52 parts of the Cortexs Eucommiae, 3.25 parts of Margaritas, 26 parts on Flos Carthami, 13 parts of Radix Notoginseng.
The manufacture method of the mongolian medicine of said set a broken bone is: get crude drug Echinops latifolius 15-62 part, and Cortex Eucommiae 28-76 part, Margarita 0.5-8 part, Flos Carthami 15-50 part, Radix Notoginseng 5-27 part with the broken porphyrize of above-mentioned raw materials medicated powder, incapsulates.
The manufacture method of the mongolian medicine of said set a broken bone is: Margarita, Radix Notoginseng are pulverized standby; Echinops latifolius, the Cortex Eucommiae, Flos Carthami add ethanol extraction, and filtrate recycling ethanol gets thick paste; Medicinal residues decoct with water filtration, are concentrated into the thick paste shape; Two thick pastes merge, and concentrate; Mix with fine powder.
The dosage form of the mongolian medicine of said set a broken bone can be any dosage form on the pharmaceutics.
The mongolian medicine that adopts technique scheme to make, has promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain, effects such as reunion of fractured tendons and bones, through zoopery and clinical trial certificate, all have significant curative effect for multiple bone injurys such as the open wound due to soft tissue contusion, crush injury, articular sprain, wound and the operation, limb fractures, and it is simple to have usage, produce effects is fast, cost is low, characteristics such as treatment time is short, and the patient suffering is few, and therapeutic effect is good.This medicine is called the bluish red capsule in clinical experiment, owing to obtain the favorable comment of numerous triers and hospital, had certain popularity, now according to domestic well-known expert's suggestion, declares national new drug.
The specific embodiment
The present invention is on the basis of collecting a large amount of Mongolian medicine's mongolian medicine folk remedies, and the screening through a large amount of has formed the prescription scheme.Echinops latifolius is a monarch drug in the side, mainly contains alnulin acetas, 3.16-dihydroxy alnulin-3-monoacetate, cupreol, oleanolic acid, ursolic acid, daucosterol, compositions such as new sesquiterpene." mongolian medicine " (Mongolian edition teaching material) " Chinese medicine encyclopedia " (traditional Mongolian medicine volume) record: Echinops latifolius nature and flavor hardship, rare, gentle, light, blunt, cool; Has hard bone, synthetism, heat clearing away, analgesia function.The Cortex Eucommiae, Margarita are ministerial drug; Mainly contain 14 kinds of lignanoids and lignanoid's glucoside in the Cortex Eucommiae, also contain the iridoid constituents, and composition such as eucommoil, eucommoil glucoside-I.The Cortex Eucommiae " main blood, association's day (heat), synthetism "." mongolian medicine " (Mongolian edition teaching material) carries: " Cortex Eucommiae is synthetism, strong bone, heat clearing away ".The Four-Volume Medical Code (8th century Tibetan language version medical science monumental work) carries: " Cortex Eucommiae treatment fracture, bone splits and bone heat "; " onlooker's happiness " (16th century Tibetan language version medical science monumental work) carries: " Cortex Eucommiae is synthetism, cure the wound, heat clearing away, also can treat waist and leg ache "; " Chinese medicine encyclopedia " (traditional Mongolian medicine volume) carries: " Cortex Eucommiae sweet in the mouth, little suffering, property are flat, dry, blunt, heavy, gentle, soft, heat clearing away are arranged, the effect of synthetism ".Margarita contains a large amount of calcium carbonate, and compositions such as aminoacid, taurine, ornithine have detoxifcation, cure the wound, granulation promoting and treatment effects such as " aortic arch syndromes ", and " mongolian medicine " (Mongolian edition teaching material) carries: " Margarita is concocted with milk; Control aortic arch syndrome, granulation promoting, cure the wound "." aortic arch syndrome " is the clinical name of disease of traditional Mongolian medicine, and the general reference nervous system disease can comprise fracture back local nerve blood vessel injury, Margarita with the principal drug assistance synthetism, cure the wound and granulation promoting outside, can also promote the healing of injured nerve blood vessel and the recovery of function.Flos Carthami, Radix Notoginseng make for assistant, and Flos Carthami contains carthamin (C
21H
22O
11) and Flos Carthami flavochrome (C
24H
30O
5), have the effect of removing blood stasis with potent drugs promoting blood circulation to restore menstrual flow.Radix Notoginseng contains arasaponin first (C
30H
22O
16) arasaponin second (C
23H
32O
16) and flavonoid glycoside.Have hemostasis, blood stasis dispelling, detumescence, pain relieving, antiviral, antifungal effect.Full side's five kinds of Chinese medicine is auxilliary mutually for usefulness, has promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain, the function of reunion of fractured tendons and bones.It also is higher, the representative crude drug of the frequency of occurrences in the middle of the mongolian medicine proved recipe.The concocting method and the dosage form of this prescription are a lot, only lift two examples:
First kind of embodiment: get 39 parts of Echinops latifoliuss by touchstone, 52 parts of the Cortexs Eucommiae, 3.25 parts of Margaritas, 26 parts on Flos Carthami, 13 parts of Radix Notoginseng.Said medicine is pulverized porphyrize, incapsulate.
Instructions of taking: mixing in water for oral taking, each 10-15g, day clothes 3 times.
Second kind of embodiment: get crude drug Echinops latifolius 390g, Cortex Eucommiae 520g, Margarita 32.5g, Flos Carthami 260g, Radix Notoginseng 130g.Margarita, Radix Notoginseng powder are broken into fine powder, and facing-up method mix homogeneously is standby.Echinops latifolius, the Cortex Eucommiae, Flos Carthami add 12 times of amount 60% alcohol reflux three times, each 2 hours.Filter, filtrate recycling ethanol gets thick paste.Medicinal residues add 14 times of water gagings and decoct secondary, and each 1.5 hours, filter, filtrate is concentrated into the thick paste shape, and two thick pastes merge, and are concentrated into relative density 1.35 (80 ℃ of surveys).Add above-mentioned fine powder and an amount of dextrin and receive cream, 60 ℃ of oven dry are ground into fine powder, add an amount of wetting agent, and 14 mesh sieves are granulated, 60 ℃ of oven dry, and 16 mesh sieve granulate incapsulate and make 1000.
Instructions of taking: be grown up one day three times, one time 3.
The experiment situation:
One. zoopery:
1. toxicity test
(1) anxious poison test.According to the pertinent regulations of study of tcm new drug, to the median lethal dose(LD 50) (LD of bluish red capsule mouse stomach administration
50) carried out test determination, but do not measure LD
50, therefore carried out mtd test.Result: with Cmax (60%), maximum dosage-feeding (60ml/kg, dividing secondary to give in one day) 36g/Kg irritates stomach, be equivalent to crude drug amount 104g/kg, 522 times (pressing 60kg) of the daily dosage of clinical plan are equivalent to be grown up, none death of mice in seven days is put to death each internal organs of mice anatomic observation and is not found toxic reaction, and administration group and control group mice do not have any difference.
(2) long term toxication. for clinical drug safety, according to the pertinent regulations of country to new drug research, application Wistar rat will be tested medicine and will be set at high, medium and low three dosage, be respectively bluish red capsule particle 4.8g/kg, 2.4g/kg, 1.2g/kg (being equivalent to crude drug 13.9g/kg, 7.0g/kg, 3.5g/kg). press human dosage (70kg) and be capsule particle calculating in 0.06g/kg/ days, be 80 times, 40 times of the human effective dose and 20 times (press 60kg, be 70 times, 35 times and 17.5 times of human effective dose); Other establishes a matched group. and gastric infusion 90 days, 180 days and the drug withdrawal of part animal are after 10 days continuously, observe of the influence of bluish red capsule to the every physiology of rat, biochemical indicator. experimental result shows: give rat continuous oral 180 days with bluish red capsule various dose, food-intake and growth promoter (body weight gain) to rat all do not have influence. liver function and renal function are not all found the overt toxicity effect. and routine blood test, blood biochemistry, urine biochemistry and bone marrow sheet etc. be there is no obvious influence, compare no significant difference with matched group between each group.
2. pharmacodynamic experiment
(1) the bluish red capsule is to the influence of rabbit union of fracture
Cause the fracture of radius model with rabbit, use bluish red basic, normal, high three dosage of capsule (0.138g/kg, 0.276g/kg, 0.552g/kg) oral administration gavage drug treatment 38 days,, take the photograph the X-ray film histopathological examination under the same conditions in different time.Dynamic observe the fracture site callus formation, union of fracture situation and optical microscope undertissue morphological change.Observe fracture rabbit active situation, food-intake, fracture site swelling degree simultaneously.And the content of mensuration fracture site fracture resistence force, callus dry weight, serum Ca, P, alkali phosphatase, creatine phosphokinase and lactic acid dehydrogenase and serum calcitonin, Bone Gla protein and growth hormone.Experimental result shows that the bluish red capsule has dose dependent ground and promotes fracture and bone defect healing.Can alleviate fracture site swelling degree and improve symptom, promote callus formation, healing place is comparatively firm.X line and pathomorphism are quantitatively marked and the fracture resistence force index all obviously is better than model control group and positive control drug pill for traumatic injuries group (P<0.05 or P<0.01).The bluish red capsule also has the hemorheology of improvement, reduces whole blood viscosity, increases the effect of growth hormone content in the blood.
(2) experimentation of bluish red capsule anti-inflammatory and antalgic
Adopt rat paw edema and mice ear method to carry out the antiinflammatory experiment, adopt mice hot plate method and writhing method to carry out analgesic experiment, observe of the influence of oral bluish red capsule various dose swelling and pain.The result shows: the bluish red capsule can obviously suppress the foot swelling that carrageenin brings out, and dimethylbenzene induced mice ear swelling obviously prolongs the mice hot plate method and causes the incubation period of pain and reduce the glacial acetic acid induced mice and turn round the body number of times.Prove that each dosage bluish red capsule has anti-inflammatory and analgesic effect, effect of high dosage is more obvious.
(3) the bluish red capsule is to the influence of rat soft tissue injury
Adopt the blunt nosed ferrum pestle device of self-control, (30cm) freely falls from top to down at certain altitude, causes the non-open soft tissue injury model of rat left lower extremity.With the positive matched group of pill for traumatic injuries, be provided with the blank group simultaneously, with basic, normal, high three dosage treatment of bluish red capsule 6 days, carry out perusal and pathological tissue sxemiquantitative and observe, get the detection that blood carries out serum calcium, phosphorus, alkali phosphatase, creatine phosphokinase, lactic acid dehydrogenase and whole blood viscosity simultaneously.The result: behind the bluish red capsule for treating, perusal strike position and pathological tissue observation swelling ecchymosis disappear obviously Zao than blank group, and particularly the high dose group damage location organizes majority to recover normal.Serum Ca, P and alkali phosphatase are not had influence, the influence of creatine phosphokinase and lactic acid dehydrogenase is had reduction trend with the increase of dosage, but not statistically significant.Each dosage bluish red capsule and positive control drug pill for traumatic injuries all can obviously reduce soft tissue injury rat whole blood viscosity.Illustrate that the bluish red capsule has facilitation to the healing of soft tissue injury.
Two, clinical experiment: since 2002,, received satisfied clinical efficacy in Affiliated Hospital of National University of the Inner Mongol treatment clavicular fracture 33 examples.In the Huhehaote City, ground such as Baotou, Chifeng City, Wuhai City, Ordos City, Erenhot City, Manzhouli City, Ulan Cha Bushi, Hinggan League, cylinder Ge Le alliance, Hulunbeier City, Bayan nur city, Alashan League carried out the clinical experiment of other bone injurys respectively, all obtained curative effect preferably.