CN105125799A - Medicine composition for treating bone fractures and preparing method of medicine composition - Google Patents

Medicine composition for treating bone fractures and preparing method of medicine composition Download PDF

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Publication number
CN105125799A
CN105125799A CN201510651443.1A CN201510651443A CN105125799A CN 105125799 A CN105125799 A CN 105125799A CN 201510651443 A CN201510651443 A CN 201510651443A CN 105125799 A CN105125799 A CN 105125799A
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parts
radix
pharmaceutical composition
fracture
medicine composition
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王翠江
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Linyi Caozhimei Pharmaceutical Technology Co Ltd
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Linyi Caozhimei Pharmaceutical Technology Co Ltd
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Priority to CN201610306340.6A priority patent/CN105943791A/en
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    • A61K36/185—Magnoliopsida (dicotyledons)
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Abstract

The invention discloses a medicine composition for treating bone fractures and a preparing method of the medicine composition and belongs to the technical field of traditional Chinese medicine. The medicine composition is prepared from circium japonicum, sangusis draconis, codonopsis pilosula, radix angelicae pubescentis, ligusticum wallichii, folium mori, cucumber seeds, sargentg loryvine stems, liquorice and other raw materials. The medicine composition has the obvious treating advantages of invigorating qi to nourish the blood, enriching the blood and qi, promoting the blood to remove stasis, supporting body resistance, strengthening tendons and bones and the like on the aspect of treating the bone fractures. In addition, the medicine composition has the advantages of being stable in preparation medicine effect, wide in application range, easy to apply and popularize and the like.

Description

A kind of pharmaceutical composition for the treatment of fracture and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of pharmaceutical composition for the treatment of fracture and preparation method thereof.
Background technology
Fracture is that the integrity of phalanges or seriality are damaged caused, the disease being main manifestations with pain, swelling, livid purple, dysfunction, deformity and bony crepitus etc.Its clinical main manifestations is: fractures has localized pain and tenderness, local swelling and occur ecchymosis, limb function position or completely lose, and completeness sclerotin still can occur cacomelia and abnormal movement.Fracture is a kind of commonly encountered diseases, is the clinical frequently-occurring disease of orthopaedic trauma, can damages social labor power, the health of the serious harm mankind.According to investigations, the prevalence of China's fracture is about 1.4%, and because China's population base is comparatively large, the fracture patient of existence is also more.Although the Chinese medicine of current treatment this respect disease is a lot, but majority also exists, and reducing swelling and alleviating pain is slow, the course for the treatment of is long, the dissatisfactory shortcoming of effect, doctor trained in Western medicine is when treating the comparatively serious bone injury of this respect and being sick, normally by the position of bone righting of patient part, then medical apparatus and instruments is used to be carried out internal fixtion, or carry out extenal fixation, resting slowly with Gypsum Fibrosum, binder, clamping plate etc.This western medicine therapy utilizing operation and medicine, weak point is that sufferer healing recovers comparatively slow, and treatment cycle is longer, and medical expense is high, and in process, patient is more painful.If meet the patient of unsuitable operative treatment, this Therapeutic Method just has certain limitation.
Chinese invention patent 201310238201.0 discloses a kind of Chinese medicine composition for the treatment of fracture, and the raw materials of this Chinese medicine composition comprises: Semen Strychni 10-30 part, Herba Artemisiae Anomalae 10-40 part, Radix Astragali 10-50 part, Cortex Eucommiae 10-20 part, Radix Lamiophlomidis Rotatae 5-10 part, Rhizoma Chuanxiong 5-15 part, Radix Rehmanniae Preparata 5-15 part, Radix Notoginseng 5-15 part, Eupolyphaga Seu Steleophaga 5-15 part, Olibanum 9-15 part, Myrrha 9-15 part, Rhizoma Drynariae 5-15 part, Fructus Chaenomelis 3-8 part and Radix Glycyrrhizae 1.5-9 part.This Chinese medicine composition has effect of kidney tonifying synthetism, expelling pus and promoting granulation, reducing swelling and alleviating pain and heat-clearing and toxic substances removing, but at benefiting QI for activating blood circulation, blood nourishing and calcium replenishing aspect effect is not very remarkable.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of pharmaceutical composition for the treatment of fracture, and this pharmaceutical composition can effective blood nourishing and calcium replenishing, QI invigorating QI invigorating, promoting blood circulation to restore menstrual flow, promoting blood circulation to remove blood stasis, the body resistance strengthening and constitution consolidating and bone and muscle strengthening.In addition, the present invention also provides corresponding manufacturing process to be made and facilitate easy-to-use finished product preparation under the prerequisite ensureing curative effect by this Chinese medicine.
In order to solve the problems of the technologies described above, inventor is by the checking repeatedly of clinical practice, and the amount of adjustment medical material and kind, finally invented a kind of brand-new pharmaceutical composition.This pharmaceutical composition is prepared from by the raw material of following parts by weight: Radix Cirsii Japonici 15-30 part, Sanguis Draxonis 15-30 part, Radix Codonopsis 14-28 part, Radix Angelicae Pubescentis 10-20 part, Rhizoma Chuanxiong 12-28 part, Folium Mori 15-20 part, Semen Cucumidis sativi 10-18 part, Caulis Sargentodoxae 10-20 part and Radix Glycyrrhizae 10-20 part.
Preferably, this pharmaceutical composition is prepared from by the raw material of following parts by weight: Radix Cirsii Japonici 15 parts, Sanguis Draxonis 15 parts, Radix Codonopsis 14 parts, Radix Angelicae Pubescentis 10 parts, Rhizoma Chuanxiong 12 parts, 15 parts, Folium Mori, Semen Cucumidis sativi 10 parts, Caulis Sargentodoxae 10 parts and 10 parts, Radix Glycyrrhizae.
Preferably, this pharmaceutical composition is prepared from by the raw material of following parts by weight: Radix Cirsii Japonici 30 parts, Sanguis Draxonis 30 parts, Radix Codonopsis 28 parts, Radix Angelicae Pubescentis 20 parts, Rhizoma Chuanxiong 28 parts, 20 parts, Folium Mori, Semen Cucumidis sativi 18 parts, Caulis Sargentodoxae 20 parts and 20 parts, Radix Glycyrrhizae.
Preferably, this pharmaceutical composition is prepared from by the raw material of following parts by weight: Radix Cirsii Japonici 28 parts, Sanguis Draxonis 28 parts, Radix Codonopsis 20 parts, Radix Angelicae Pubescentis 15 parts, Rhizoma Chuanxiong 16 parts, 18 parts, Folium Mori, Semen Cucumidis sativi 14 parts, Caulis Sargentodoxae 15 parts and 15 parts, Radix Glycyrrhizae.
Preferably, this pharmaceutical composition is made into Chinese medicine decoction, granule, powder, capsule, watered pill or tablet.
Accordingly, the preparation method of pharmaceutical composition of the present invention comprises following step:
(1): get Radix Cirsii Japonici, wash away impurity, 50 DEG C of hot air dryings 5 hours, control moisture is 3%-8%, pulverizes, and crosses 40-60 mesh sieve, obtains coarse powder; Coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, carries out micronizing respectively after drying, crosses 800 mesh sieves, obtains Ultra-fine Powder of Mulberry Leaves, for subsequent use;
(2): get Sanguis Draxonis, Radix Codonopsis, Radix Angelicae Pubescentis, Rhizoma Chuanxiong, Folium Mori, Semen Cucumidis sativi, Caulis Sargentodoxae and Radix Glycyrrhizae, clean, crushed after being dried, add the water soaking 0.5-1 hour of coarse powder total amount 8-13 times amount, then decoct 2-3 time, each 1-2 hour, filter, merging filtrate, filtrate is at 50-65 DEG C, vacuum is survey the clear paste that relative density is 1.10-1.20 under vacuum-concentrcted to 60 DEG C condition under the condition of 0.05-0.08MPa, cooling, slowly adds ethanol while stirring to alcohol content for reaching 40-60%, 4 DEG C of standing 12-24 hour, filter, obtain filtrate A and filtering residue;
(3): the filtering residue obtained in step (2) slowly being added while stirring its weight 4-6 times amount volume fraction is the ethanol of 40-60%, 4 DEG C of standing 3-5 hour, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 2-3 time of 40-60% again, collects and merges cleaning mixture;
(4): merge described filtrate A, liquor B and cleaning mixture, survey the thick paste that relative density is 1.10-1.20, drying under reduced pressure under mixing final vacuum is evaporated to 60 DEG C of conditions, pulverize, cross 100-200 mesh sieve, mix with described Ultra-fine Powder of Mulberry Leaves, to obtain final product.
Source, the nature and flavor of the present invention's component used, return through and effect:
Sanguis Draxonis: the resin oozed out for babassu Sanguis Draxonis fruit is through being processed into, sweet, salty is flat; GUIXIN, Liver Channel; To invigorate blood circulation analgesic therapy, removing stasis to stop bleeding, expelling pus and promoting granulation; For traumatic injury, trusted subordinate's stasis of blood pain, traumatic hemorrhage, skin infection is not held back.
Radix Angelicae Pubescentis :this product is the dry root of samphire Angelica pubescens, acrid in the mouth, hardship, slightly warm in nature; Return kidney, urinary bladder channel; Expelling wind and removing dampness, arthralgia aggravated by cold pain relieving; For anemofrigid-damp arthralgia, wash pain, few cloudy volt wind headache, wind and cold holds wet headache under the arm.
Rhizoma Chuanxiong: this product is the dry rhizome of samphire Rhizoma Chuanxiong; Acrid in the mouth, warm in nature; Return liver, gallbladder, pericardium channel; Blood-activating and qi-promoting, wind-expelling pain-stopping.
Folium Mori: this product is be the dried leaves of moraceae plants Mulberry; Bitter in the mouth, sweet, cold nature; Return lung, Liver Channel; Wind and heat dispersing, clearing away lung-heat to relieve cough, liver heat removing and eyesight improving.
Caulis Sargentodoxae: this product is the dry stem of fallen leaves, bejuco; Nature and flavor are bitter, flat; There is heat-clearing and toxic substances removing, promoting blood circulation to remove obstruction in the collateral, the effect of expellingging wind and relieving convulsion; Rheumatic arthralgia, bloody dysentery, stranguria with blood, menoxenia, infantile malnutrition, worm pain, injury from falling down.
Radix Cirsii Japonici: this product is dry aerial parts or the root of Radix Cirsii Japonici plant; Sweet, bitter, cool; GUIXIN, Liver Channel; Cooling blood for hemostasis, removing blood stasis to reduce swelling.
Radix Codonopsis: this product is the dry root of Campanulaceae Radix Codonopsis; Sweet in the mouth, property is put down; Return spleen, lung meridian; Invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The prescription analysis of Chinese prescription of the present invention:
Chinese prescription of the present invention is with Sanguis Draxonis, Radix Codonopsis for monarch drug, spirit keeping and blood activating, blood nourishing and calcium replenishing; With Radix Cirsii Japonici, Folium Mori, Rhizoma Chuanxiong for ministerial drug, invigorating QI to consolidate the body surface resistance, promoting blood circulation to restore menstrual flow, stasis-dispelling and pain-killing, with Caulis Sargentodoxae, Semen Cucumidis sativi, Radix Angelicae Pubescentis for adjuvant drug, removing pathogenic heat from blood and toxic substance from the body, replenishes the calcium and keeps fit, wind-expelling pain-stopping, detumescence and promoting granulation; With Radix Glycyrrhizae for making medicine, coordinating the actions of various ingredients in a prescription, makes all medicines arrange in pairs or groups, synergism, jointly reaches the effects such as blood nourishing and calcium replenishing, QI invigorating QI invigorating, promoting blood circulation to restore menstrual flow, promoting blood circulation to remove blood stasis, the body resistance strengthening and constitution consolidating and bone and muscle strengthening, has very significant effect to treatment fracture.
Compared with prior art, the present invention has following technical advantage:
1, each Chinese medicinal components of pharmaceutical composition of the present invention is worked in coordination with, better in the effect in strong bone of fostering the spirit of nobility and replenish the calcium of enriching blood;
2, pharmaceutical composition of the present invention is natural pure Chinese medicinal preparation, and toxic and side effects is little;
3, pharmaceutical composition of the present invention is in treatment fracture, there is the remarkable result of blood nourishing and calcium replenishing, QI invigorating QI invigorating, promoting blood circulation to restore menstrual flow, promoting blood circulation to remove blood stasis, the body resistance strengthening and constitution consolidating and bone and muscle strengthening, in addition, also have preparation efficacy stability, applied widely, be easy to advantages such as applying.
Detailed description of the invention
It will be understood by those skilled in the art that technology disclosed in following examples represents the technology playing good action in the practice of the invention of the present inventor's discovery.But, many changes can be made in disclosed specific embodiments, and still obtain same or analogous result, and not depart from the spirit and scope of the present invention.
embodiment 1:
Raw material is taken: Radix Cirsii Japonici 15 parts, Sanguis Draxonis 15 parts, Radix Codonopsis 14 parts, Radix Angelicae Pubescentis 10 parts, Rhizoma Chuanxiong 12 parts, 15 parts, Folium Mori, Semen Cucumidis sativi 10 parts, Caulis Sargentodoxae 10 parts and 10 parts, Radix Glycyrrhizae by following parts by weight.
Preparation method:
(1): get Radix Cirsii Japonici, wash away impurity, 50 DEG C of hot air dryings 5 hours, controlling moisture is 5%, pulverizes, and crosses 40 mesh sieves, obtains coarse powder; Coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, carries out micronizing respectively after drying, crosses 800 mesh sieves, obtains Ultra-fine Powder of Mulberry Leaves, for subsequent use;
(2): get Sanguis Draxonis, Radix Codonopsis, Radix Angelicae Pubescentis, Rhizoma Chuanxiong, Folium Mori, Semen Cucumidis sativi, Caulis Sargentodoxae and Radix Glycyrrhizae, pulverize after cleaning, drying, add the water soaking 1 hour of coarse powder total amount 8 times amount, then decoct 2 times, each 2 hours, filter, merging filtrate, filtrate is at 50 DEG C, vacuum is survey the clear paste that relative density is 1.10 under vacuum-concentrcted to 60 DEG C condition under the condition of 0.05MPa, cooling, slowly adds ethanol while stirring to alcohol content for reaching 60%, and 4 DEG C leave standstill 24 hours, filter, obtain filtrate A and filtering residue;
(3): the filtering residue obtained in (2) slowly being added while stirring its weight 4 times amount volume fraction is the ethanol of 60%, 4 DEG C leave standstill 3 hours, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 3 times of 60% again, collects and merges cleaning mixture;
(4): merge described filtrate A, liquor B and cleaning mixture, survey the thick paste that relative density is 1.10, drying under reduced pressure under mixing final vacuum is evaporated to 60 DEG C of conditions, pulverize, cross 100 mesh sieves, mix with described Ultra-fine Powder of Mulberry Leaves, to obtain final product.
embodiment 2:
Raw material is taken: Radix Cirsii Japonici 30 parts, Sanguis Draxonis 30 parts, Radix Codonopsis 28 parts, Radix Angelicae Pubescentis 20 parts, Rhizoma Chuanxiong 28 parts, 20 parts, Folium Mori, Semen Cucumidis sativi 18 parts, Caulis Sargentodoxae 20 parts and 20 parts, Radix Glycyrrhizae by following parts by weight.
Preparation method:
(1): get Radix Cirsii Japonici, wash away impurity, 50 DEG C of hot air dryings 5 hours, controlling moisture is 8%, pulverizes, and crosses 60 mesh sieves, obtains coarse powder; Coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, carries out micronizing respectively after drying, crosses 800 mesh sieves, obtains Ultra-fine Powder of Mulberry Leaves, for subsequent use;
(2): get Sanguis Draxonis, Radix Codonopsis, Radix Angelicae Pubescentis, Rhizoma Chuanxiong, Folium Mori, Semen Cucumidis sativi, Caulis Sargentodoxae and Radix Glycyrrhizae, clean, crushed after being dried, add the water soaking 0.5 hour of coarse powder total amount 13 times amount, then decoct 3 times, each 1 hour, filter, merging filtrate, filtrate is at 65 DEG C, vacuum is survey the clear paste that relative density is 1.20 under vacuum-concentrcted to 60 DEG C condition under the condition of 0.08MPa, cooling, slowly adds ethanol while stirring to alcohol content for reaching 60%, and 4 DEG C leave standstill 12 hours, filter, obtain filtrate A and filtering residue;
(3): the filtering residue obtained in (2) slowly being added while stirring its weight 6 times amount volume fraction is the ethanol of 40%, 4 DEG C leave standstill 5 hours, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 2 times of 60% again, collects and merges cleaning mixture;
(4): merge described filtrate A, liquor B and cleaning mixture, survey the thick paste that relative density is 1.20, drying under reduced pressure under mixing final vacuum is evaporated to 60 DEG C of conditions, pulverize, cross 200 mesh sieves, mix with described Ultra-fine Powder of Mulberry Leaves, to obtain final product.
embodiment 3:
Raw material is taken: Radix Cirsii Japonici 28 parts, Sanguis Draxonis 28 parts, Radix Codonopsis 20 parts, Radix Angelicae Pubescentis 15 parts, Rhizoma Chuanxiong 16 parts, 18 parts, Folium Mori, Semen Cucumidis sativi 14 parts, Caulis Sargentodoxae 15 parts and 15 parts, Radix Glycyrrhizae by following parts by weight.
Preparation method:
(1): get Radix Cirsii Japonici, wash away impurity, 50 DEG C of hot air dryings 5 hours, controlling moisture is 5%, pulverizes, and crosses 50 mesh sieves, obtains coarse powder; Coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, carries out micronizing respectively after drying, crosses 800 mesh sieves, obtains Ultra-fine Powder of Mulberry Leaves, for subsequent use;
(2): get Sanguis Draxonis, Radix Codonopsis, Radix Angelicae Pubescentis, Rhizoma Chuanxiong, Folium Mori, Semen Cucumidis sativi, Caulis Sargentodoxae and Radix Glycyrrhizae, clean, crushed after being dried, add the water soaking 0.5 hour of coarse powder total amount 10 times amount, then decoct 2 times, each 2 hours, filter, merging filtrate, filtrate is at 60 DEG C, vacuum is survey the clear paste that relative density is 1.20 under vacuum-concentrcted to 60 DEG C condition under the condition of 0.06MPa, cooling, slowly adds ethanol while stirring to alcohol content for reaching 50%, and 4 DEG C leave standstill 24 hours, filter, obtain filtrate A and filtering residue;
(3): the filtering residue obtained in (2) slowly being added while stirring its weight 5 times amount volume fraction is the ethanol of 50%, 4 DEG C leave standstill 4 hours, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 3 times of 50% again, collects and merges cleaning mixture;
(4): merge described filtrate A, liquor B and cleaning mixture, survey the thick paste that relative density is 1.20, drying under reduced pressure under mixing final vacuum is evaporated to 60 DEG C of conditions, pulverize, cross 200 mesh sieves, mix with described Ultra-fine Powder of Mulberry Leaves, to obtain final product.
The pharmaceutical composition of embodiment of the present invention 1-3 can be prepared as tablet, and concrete technology is as follows:
Take the pharmaceutical composition obtained in embodiment, add adjuvant mixing, described adjuvant comprises: the gelatin solution of starch, lactose, 5-20%, dried starch and distilled water, lubricant is added after combination drying, described lubricant is micropowder silica gel, tabletting, coating, obtains the tablet of embodiment of the present invention 1-3 pharmaceutical composition.
pharmaceutical composition pharmacodynamic study of the present invention
test example 1pharmaceutical composition of the present invention is on the impact of White Rabbit fracture model bone density
1, test material
(1) experimental animal: White Rabbit, male and female half and half, 1.5-2.5kg, are provided by Zhongshan University center; Get White Rabbit 50, be divided into 5 groups at random, often organize 10, be respectively model group (equal-volume normal saline), Radix Lamiophlomidis Rotatae group (1.0g/kg ﹒ d), pharmaceutical composition A of the present invention, B and C group;
(2) instrument: Hitachi 7020 automatic clinical chemistry analyzer, Japanese Hitachi company; Absorptiometry (Piximusbonedensito-meter, LUNAR company of the U.S.)
(3) trial drug: pharmaceutical composition A group of the present invention is pharmaceutical composition (0.81g/kg ﹒ d) prepared by embodiment 3; Pharmaceutical composition B group is pharmaceutical composition (0.81g/kg ﹒ d) prepared by embodiment 1; Pharmaceutical composition C group is pharmaceutical composition (0.81g/kg ﹒ d) prepared by embodiment 2; Radix Lamiophlomidis Rotatae capsule, Gansu Duyiwei Biological Pharmaceutical Co., Ltd, 0.3g*50 grain/bottle;
2, test method:
After White Rabbit adaptability raises one week, with 3% Nembutal sodium solution according to after the anesthesia of 1ml/kg dose intravenous, both sides forelimb cropping, 75% alcohol disinfecting, is aseptically widely about 3mm with horizontal being drilled to of medical operation dental burr epimere 1/3 intersection in the radius of both sides, go deep into medullary cavity and form bone injury, skin suture, Post operation starts gastric infusion, successive administration next day, within after administration one week, to get 7 in each group of rabbit to surrounding, measure indices; And intercepting both sides radius respectively at second week after administration, 4th week, its length comprises damage and each normal reach sclerotin up and down, measures bone density, observe union of fracture situation with U.S. LUNAR company Piximusbonedensito-meter analyzer.
3, result of the test
Table 1 pharmaceutical composition of the present invention is on the impact of White Rabbit fracture model bone density
▲compared with model group, p < 0.05; ▲ ▲compared with model group, p < 0.01.
4, conclusion
As shown in Table 1, successive administration is after two weeks, and the bone density of Radix Lamiophlomidis Rotatae group and pharmaceutical composition A of the present invention, B and C group increases all to some extent, and has significant difference (p < 0.05 or p < 0.01) compared with model group; After successive administration surrounding, Radix Lamiophlomidis Rotatae group and pharmaceutical composition A of the present invention, the amplitude that the bone density of B and C group increases are larger, much larger than the bone density after two weeks, and there is pole significant difference (p < 0.05 or p < 0.01) compared with model group; As can be seen here, pharmaceutical composition of the present invention has accelerates bone ore deposit sedimentation rate, improves bone density, promotes the function of fracture site healing.
test example 2pharmaceutical composition of the present invention is to the clinical observation on the therapeutic effect of fracture clinical volunteers patient
(1) diagnostic criteria
Determine that the diagnostic criteria of this test is as follows with reference to " new Chinese medicine guideline of clinical investigations " 2002 " guideline of clinical investigations of new Chinese medicine treatment traumatic fracture ":
1, Western medicine diagnose standard:
Traumatic fracture diagnostic criteria:
(1) trauma history of direct or indirect violence is had;
(2) General Symptoms: uncomplicated simple fracture, General Symptoms is not obvious or not serious; Shock can be there is or merge visceral organ injury in serious wound, combined injury; Open fracture can concurrent infection or and go crazy, blood vessel injury, there is corresponding General Symptoms;
(3) local symptom: pain pain and tenderness, swelling, dysfunction, deformity, abnormal movement, bony crepitus;
(4) x-ray inspection: the diagnosis that can clearly fracture, can confirm the localized variation such as classification of fracture, moving direction, fracture end form, and get rid of pathologisch Bruch.
2, tcm diagnosis standard:
(1) syndrome of qi stagnation and blood stasis: primary symptom: fracture, pain, swelling, ecchymosis; Secondary disease: thirsty, dark coloured urine, constipation, red tongue or have ecchymosis, yellow fur, floating and rapid pulse or stringy and tense pulse;
(2) the sluggish card of congestion: primary symptom: fracture does not connect or bone connects hard, and alleviation of pain, swells and disappear to the greatest extent; Secondary disease: dimly red tongue, yellow and thin fur, stringy pulse.
(3) deficiency of qi and blood card: primary symptom: bone connects not hard, dizziness and blurred vision, pale white complexion; Secondary disease: deficiency of QI with disinclination to talk, spiritlessness and weakness, light red tongue, thready pulse;
(4) caused by liver and kidney deficiency card: primary symptom: bone connects not hard, soreness of waist and knee joint, and limbs wither soft; Secondary disease: spiritlessness and weakness, light red tongue, thin fur, thready pulse.
(2) exclusion standard:
(1) pathologisch Bruch caused by osteopathia; (2) open fracture has soft tissue defects or the infected; (3) suckling gestation or preparing gestation women; (4) allergic constitution or to multi-medicament allergy sufferers; (5) severe primary disease and the psychotics such as the heart, brain, liver, kidney, hemopoietic system, hormonal system is merged; (6) state of an illness is critical, is difficult to make definite estimator to the effectiveness of new drug and safety.
(3) clinical trial
1, physical data: all selected fracture clinical volunteers patients are divided into two groups at random, treatment group 100 example, wherein male patient 56 example, female patient 44 example; Matched group 100 example, wherein male patient 55 example, female patient 45 example.Age is 20-80 year, 50.5 years old mean age.Two groups of influence factors such as age, symptom, through statistical procedures, there was no significant difference, meets a point set condition.
2, test method
Treatment group: take tablet (0.3g*100 sheet/bottle) prepared by the embodiment of the present invention 3, every day 3 times, each 3, serve on 3 months;
Matched group: take bone setting tablet (Pan Shoude, accurate word Z21021461, the 0.33g*36 sheet/box of traditional Chinese medicines), every day 3 times, each 4, serve on 3 months.
3, curative effect determinate standard
Effective: pain is eased substantially, fracture site is red, swollen, heat all obviously alleviates,
Effective: pain obtains larger alleviation, and fracture site is red, swollen, heat all alleviates;
Invalid: pain does not have alleviation, fracture site is red, swollen, heat does not all obtain and obviously alleviates.
4, therapeutic outcome, as shown in table 2.
Table 2 therapeutic effect
5, conclusion
This test adopts bone setting tablet as a control group, bone setting tablet has blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, effect of relaxing muscles and tendons bone strengthening, for traumatic injury, lumbar sprain and QI divergeny, injured in the sinews or bones, swelling and pain due to blood stasis, damage is red and swollen waits disease, by with the comparing of medicine composite for curing effect of the present invention, highlight the effect of pharmaceutical composition of the present invention in treatment fracture.Unexpectedly, pharmaceutical composition of the present invention reaches more than 80% for the obvious effective rate for the treatment of fracture, total effective rate is up to 95%, far above obvious effective rate and the total effective rate of matched group, visible, pharmaceutical composition of the present invention particularly the embodiment of the present invention 3 prepare tablet evident in efficacy, total effective rate is high, can be used as treatment fracture drug use.

Claims (6)

1. treat the pharmaceutical composition of fracture for one kind, it is characterized in that, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Radix Cirsii Japonici 15-30 part, Sanguis Draxonis 15-30 part, Radix Codonopsis 14-28 part, Radix Angelicae Pubescentis 10-20 part, Rhizoma Chuanxiong 12-28 part, Folium Mori 15-20 part, Semen Cucumidis sativi 10-18 part, Caulis Sargentodoxae 10-20 part and Radix Glycyrrhizae 10-20 part.
2. the pharmaceutical composition for the treatment of fracture as claimed in claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Radix Cirsii Japonici 15 parts, Sanguis Draxonis 15 parts, Radix Codonopsis 14 parts, Radix Angelicae Pubescentis 10 parts, Rhizoma Chuanxiong 12 parts, 15 parts, Folium Mori, Semen Cucumidis sativi 10 parts, Caulis Sargentodoxae 10 parts and 10 parts, Radix Glycyrrhizae.
3. the pharmaceutical composition for the treatment of fracture as claimed in claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Radix Cirsii Japonici 30 parts, Sanguis Draxonis 30 parts, Radix Codonopsis 28 parts, Radix Angelicae Pubescentis 20 parts, Rhizoma Chuanxiong 28 parts, 20 parts, Folium Mori, Semen Cucumidis sativi 18 parts, Caulis Sargentodoxae 20 parts and 20 parts, Radix Glycyrrhizae.
4. the pharmaceutical composition for the treatment of fracture according to claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the raw material of following parts by weight: Radix Cirsii Japonici 28 parts, Sanguis Draxonis 28 parts, Radix Codonopsis 20 parts, Radix Angelicae Pubescentis 15 parts, Rhizoma Chuanxiong 16 parts, 18 parts, Folium Mori, Semen Cucumidis sativi 14 parts, Caulis Sargentodoxae 15 parts and 15 parts, Radix Glycyrrhizae.
5. the pharmaceutical composition of the treatment fracture as described in any one of claim 1-4, is characterized in that: described pharmaceutical composition is made into Chinese medicine decoction, granule, powder, capsule, watered pill or tablet.
6. a preparation method for the pharmaceutical composition of the treatment fracture as described in any one of claim 1-4, is characterized in that, comprise the steps:
(1): get Folium Mori, wash away impurity, 50 DEG C of hot air dryings 5 hours, control moisture is 3-8%, pulverizes, and crosses 40-60 mesh sieve, obtains coarse powder; Coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, carries out micronizing respectively after drying, crosses 800 mesh sieves, obtains Ultra-fine Powder of Mulberry Leaves, for subsequent use;
(2): get Sanguis Draxonis, Radix Codonopsis, Radix Angelicae Pubescentis, Rhizoma Chuanxiong, Folium Mori, Semen Cucumidis sativi, Caulis Sargentodoxae and Radix Glycyrrhizae, clean, crushed after being dried, add the water soaking 0.5-1 hour of coarse powder total amount 8-13 times amount, then decoct 2-3 time, each 1-2 hour, filter, merging filtrate, filtrate is at 50-65 DEG C, vacuum is survey the clear paste that relative density is 1.10-1.20 under vacuum-concentrcted to 60 DEG C condition under the condition of 0.05-0.08MPa, cooling, slowly adds ethanol while stirring to alcohol content for reaching 40-60%, 4 DEG C of standing 12-24 hour, filter, obtain filtrate A and filtering residue;
(3): the filtering residue obtained in (2) slowly being added while stirring its weight 4-6 times amount volume fraction is the ethanol of 40-60%, 4 DEG C of standing 3-5 hour, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 2-3 time of 40-60% again, collects and merges cleaning mixture;
(4): merge described filtrate A, liquor B and cleaning mixture, survey the thick paste that relative density is 1.10-1.20, drying under reduced pressure under mixing final vacuum is evaporated to 60 DEG C of conditions, pulverize, cross 100-200 mesh sieve, mix with described Ultra-fine Powder of Mulberry Leaves, to obtain final product.
CN201510651443.1A 2015-10-10 2015-10-10 Medicine composition for treating bone fractures and preparing method of medicine composition Withdrawn CN105125799A (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103055197A (en) * 2012-12-26 2013-04-24 柳州市中医院 Traditional Chinese medicine for treating lumbar compression fracture and preparation method thereof
CN104547489A (en) * 2014-12-31 2015-04-29 曾子维 Use of traditional Chinese medicine composition in preparation of medicine for treating comminuted fracture
CN104958416A (en) * 2015-07-28 2015-10-07 青岛蓝盛洋医药生物科技有限责任公司 Chinese medicinal preparation for treating sciatica and preparation method thereof
CN104958429A (en) * 2015-08-04 2015-10-07 青岛蓝盛洋医药生物科技有限责任公司 Traditional Chinese medicinal composition for treating geriatric fracture and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103055197A (en) * 2012-12-26 2013-04-24 柳州市中医院 Traditional Chinese medicine for treating lumbar compression fracture and preparation method thereof
CN104547489A (en) * 2014-12-31 2015-04-29 曾子维 Use of traditional Chinese medicine composition in preparation of medicine for treating comminuted fracture
CN104958416A (en) * 2015-07-28 2015-10-07 青岛蓝盛洋医药生物科技有限责任公司 Chinese medicinal preparation for treating sciatica and preparation method thereof
CN104958429A (en) * 2015-08-04 2015-10-07 青岛蓝盛洋医药生物科技有限责任公司 Traditional Chinese medicinal composition for treating geriatric fracture and preparation method thereof

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