CN103263657B - Pharmaceutical composition for fracture restoration as well as preparation method, preparation and application of pharmaceutical composition - Google Patents
Pharmaceutical composition for fracture restoration as well as preparation method, preparation and application of pharmaceutical composition Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition as well as a preparation method, preparation and application thereof. The pharmaceutical composition is prepared from the raw materials in parts by weight: 200-400 parts of luxuriantly green vegetables, 800-1200 parts of tinospora crispa, 800-1200 parts of blackberry lily, 100-300 parts of pepper, 200-400 parts of dried ginger and 400-1000 of dragon blood through the steps of classifying, extracting, concentrating and drying. The pharmaceutical composition is prepared into powder, tablets, capsules, granules, dripping pills or honey pills after being additionally provided with pharmaceutically-accepted accessories. The pharmaceutical composition is applied to the preparation of a fracture restoration drug. The luxuriantly green vegetables are used as principal drugs with the effects of supplementing fire and strengthening body, removing wind and promoting blood circulation to relieve pain as well as removing blood stasis and promoting the subsidence of swelling; the dried ginger and the pepper are used as adjuvant drugs and can be used for assisting the principal drugs in enhancing the treating effect; the dragon blood is placed into a water tower, and water and blood are derived from the same source, therefore the dragon blood has strong effects on activating blood and dissolving stasis; and the tinospora crispa and the blackberry lily have the effects on moisturizing and moistening as well as replenishing essence and supplementing marrow. All formulas are matched, and cold and heat are matched, thus the pharmaceutical composition can be used for the restoration after a fracture.
Description
Technical field
The invention belongs to Chinese drug preparation technique field, be specifically related to a kind of for restorative compositions and preparation method thereof, preparation and application after fracturing.
Background technology
It is caused that fracture is that the integrity of phalanges or seriality are damaged, and take the disease that pain, swelling, livid purple, dysfunction, deformity and bony crepitus etc. be main manifestations, comparatively common in daily life.Treatment fracture is mainly by reset, fixing, functional exercise, then with medicine partner treatment, to promote its healing.
The traditional Chinese medical science is thought, kidney storing essence, the raw marrow of main bone.That is, kidney has the effect of the skeleton of supplementing nutrition, and essence can be given birth to marrow, the nourishing bone of marrow energy, and kidney essense is filled Sheng, and skeleton could be fine and close healthy and strong, tough degree of having.When supplementing kidney essense, be aided with drug for invigorating blood circulation and eliminating stasis, further accelerating bone healing speed.
Summary of the invention
The first object of the present invention is to provide a kind of pharmaceutical composition, the second object is to provide the preparation method of this pharmaceutical composition, the 3rd object is to provide the preparation of this pharmaceutical composition, and the 4th object is to provide this pharmaceutical composition recovering the application in medicine for the preparation of fracture.
The first object of the present invention is to realize like this, described pharmaceutical composition comprises that the strongly fragrant vegetables of 200 ~ 400 parts of parts by weight, the Tinospora crispa of 800 ~ 1200 parts, the Rhizoma Belamcandae of 800 ~ 1200 parts, the Fructus Piperis of 100 ~ 300 parts, the Rhizoma Zingiberis of 200 ~ 400 parts, the Sanguis Draxonis of 400 ~ 1000 parts are raw material, the pharmaceutical composition of preparing after classification extraction, concentrate drying.
The second object of the present invention is achieved in that described preparation method comprises that raw material is prepared, classification is extracted, concentrate drying, is specially:
A, raw material are prepared: Tinospora crispa, Rhizoma Belamcandae, strongly fragrant vegetables, Fructus Piperis are carried out respectively to coarse pulverization, and Sanguis Draxonis powder is broken to 150 ~ 200 orders, standby after Rhizoma Zingiberis slicing treatment;
B, classification are extracted: get in Tinospora crispa, Rhizoma Belamcandae coarse powder and add 70 ~ 90% ethanol of 4 ~ 8 times of coarse powder weight to extract, reclaim ethanol, be concentrated into relative density and be 1.10 ~ 1.30 clear paste a; Get dried ginger slice and extract volatile oil with vapor distillation, obtain oil of ginger; Get strongly fragrant vegetables, Fructus Piperis coarse powder, mix, add 90 ~ 100% ethanol extraction 2 ~ 4 times, filter, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste b;
C, concentrate drying: clear paste a, clear paste b are merged and Sanguis Draxonis powder blend, at 60 ~ 80 ℃, be condensed into thick paste, after oil of ginger is mixed, at drying under reduced pressure below 85 ℃, obtain described pharmaceutical composition.
The 3rd object of the present invention is achieved in that and in described pharmaceutical composition, adds the adjuvant of pharmaceutically accepting to be prepared into powder, tablet, capsule, granule, drop pill or honey pill agent.
The 4th object of the present invention is achieved in that described pharmaceutical composition is recovering the application in medicine for the preparation of fracture.
Pharmaceutical composition of the present invention is according to Dai Nationality's medical knowledge opinion compatibility, and raw material comprises strongly fragrant vegetables, Tinospora crispa, Rhizoma Belamcandae, Fructus Piperis, Rhizoma Zingiberis, Sanguis Draxonis.Tower is thin (four towers of shelves all, i.e. soil, water, fire, wind) theory is the core of Dai Nationality's theory of medicine system, the doctor of the Dai Nationality thinks that " tower all shelves is thin " is present in human body and between universe, world's all things on earth and people's body all has the support of these four kinds of matter essential factor (also claim " four large life "), auxiliary being polymerized, and the breeding of human body, growth, growth all must rely on the delivery of moist, Tu Ta of warm, the water tower of the subsidy of wind tower, fiery tower.Fang Zhongyu vegetables are principal agent, and acrid in the mouth, micro-sweet, hot in nature enters fire, wind tower.There is the effect of mending the strong body of fire, removing the logical blood and relieving pain of wind, detumescence dissipating blood stasis.Rhizoma Zingiberis, Fructus Piperis are adjuvant, help principal agent to heighten the effect of a treatment; Rhizoma Zingiberis, Fructus Piperis be hot in nature also enters wind-fire tower, has and mends fire except the merit of cold, the logical pain relieving of temperature, the strong waist of increasing property, warm palace pain relieving, and the doctor of the Dai Nationality thinks: " strongly fragrant vegetables obtain helping of Rhizoma Zingiberis Recens, green pepper, its hot enhancing and can therefore can dispel cold, mend fire all over the row whole body, promoting flow of QI and blood, strengthening the loins and invigorating the kidney ".Sanguis Draxonis enters water tower, and water blood homology, has the effect of very strong blood circulation promoting and blood stasis dispelling, specially controls disorders of blood, is called as the panacea of invigorating blood circulation, and directly priming arrives in water tower blood and strengthens Removing Blood Stasis, detumescence pain, connects the power of muscles and bones; Tinospora crispa, Rhizoma Belamcandae is cold in nature and enter water tower, has moisturizing and moistens, and the merit of benefiting essence and marrow, makes water foot essence full, and the strong waist of bone is strong.Full side share, and cold and heat match, kidney tonifying, essence replenishing, and blood-activating and qi-promoting, eliminating stasis to stop pain, for recovering after fracturing.We prove to have the features such as curative effect is safe and reliable, toxic and side effects is low after deliberation.
Accompanying drawing explanation
Fig. 1 is the process chart of preparation method of the present invention.
The specific embodiment
Below in conjunction with accompanying drawing, the present invention is further illustrated, but never in any form the present invention is limited, and any conversion or the replacement based on training centre of the present invention, done, all belong to protection scope of the present invention.
Pharmaceutical composition of the present invention comprises that the strongly fragrant vegetables of 200 ~ 400 parts of parts by weight, the Tinospora crispa of 800 ~ 1200 parts, the Rhizoma Belamcandae of 800 ~ 1200 parts, the Fructus Piperis of 100 ~ 300 parts, the Rhizoma Zingiberis of 200 ~ 400 parts, the Sanguis Draxonis of 400 ~ 1000 parts are raw material, the pharmaceutical composition of preparing after classification extraction, concentrate drying.
Be further that described pharmaceutical composition comprises the strongly fragrant vegetables of 250 ~ 350 parts of parts by weight, the Tinospora crispa of 900 ~ 1100 parts, the Rhizoma Belamcandae of 900 ~ 1100 parts, the Fructus Piperis of 150 ~ 250 parts, the Rhizoma Zingiberis of 250 ~ 350 parts, the Sanguis Draxonis of 550 ~ 850 parts.
Described pharmaceutical composition comprises the strongly fragrant vegetables of 300 parts of parts by weight, the Tinospora crispa of 1000 parts, the Rhizoma Belamcandae of 1000 parts, the Fructus Piperis of 200 parts, the Rhizoma Zingiberis of 300 parts, the Sanguis Draxonis of 700 parts.
The preparation method of pharmaceutical composition of the present invention comprises that raw material is prepared, classification is extracted, concentrate drying, is specially:
A, raw material are prepared: Tinospora crispa, Rhizoma Belamcandae, strongly fragrant vegetables, Fructus Piperis are carried out respectively to coarse pulverization, and Sanguis Draxonis powder is broken to 150 ~ 200 orders, standby after Rhizoma Zingiberis slicing treatment;
B, classification are extracted: get in Tinospora crispa, Rhizoma Belamcandae coarse powder and add 70 ~ 90% ethanol of 4 ~ 8 times of coarse powder weight to extract, reclaim ethanol, be concentrated into relative density and be 1.10 ~ 1.30 clear paste a; Get dried ginger slice and extract volatile oil with vapor distillation, obtain oil of ginger; Get strongly fragrant vegetables, Fructus Piperis coarse powder, mix, add 90 ~ 100% ethanol extraction 2 ~ 4 times, filter, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste b;
C, concentrate drying: clear paste a, clear paste b are merged and Sanguis Draxonis powder blend, at 60 ~ 80 ℃, be condensed into thick paste, after oil of ginger is mixed, at drying under reduced pressure below 85 ℃, obtain described pharmaceutical composition.
Clear paste a described in B step is 70 ~ 90% soak with ethanol 24 ~ 48h that add 6 times of coarse powder weight in Tinospora crispa, Rhizoma Belamcandae coarse powder, extracts 3 ~ 5 times, and filtration, merging filtrate, reclaim ethanol and be also condensed into clear paste a.
Described Tinospora crispa, 80% soak with ethanol 36h for Rhizoma Belamcandae coarse powder, extract 4 times, filters, merging filtrate, reclaims ethanol and be also condensed into clear paste a.
Clear paste a described in B step adds 70 ~ 90% ethanol of 6 times of coarse powder weight in Tinospora crispa, Rhizoma Belamcandae coarse powder, dipping 48 ~ 72h, and the speed percolation with 70 ~ 90% ethanol with 2 ~ 4ml/min, collects the liquid of filtering, and reclaims ethanol and is condensed into clear paste a.
Described Tinospora crispa, 80% alcohol dipping 60h for Rhizoma Belamcandae coarse powder, the speed percolation with 80% ethanol with 3ml/min, collects the liquid of filtering, and reclaims ethanol and is also condensed into clear paste a.
The preparation of pharmaceutical composition of the present invention is in described pharmaceutical composition, to add the adjuvant of pharmaceutically accepting to be prepared into powder, tablet, capsule, granule, drop pill or honey pill agent.
Pharmaceutical composition of the present invention is recovering the application in medicine for the preparation of fracture.
Embodiment 1
Prepare strongly fragrant vegetables 200g, Tinospora crispa 800g, Rhizoma Belamcandae 800g, Fructus Piperis 100g, Rhizoma Zingiberis 200g, Sanguis Draxonis 400g; Tinospora crispa, Rhizoma Belamcandae, strongly fragrant vegetables, Fructus Piperis are carried out respectively to coarse pulverization, and Sanguis Draxonis powder is broken to 150 orders, standby after Rhizoma Zingiberis slicing treatment.The 70% soak with ethanol 24h that adds 4 times in Tinospora crispa, Rhizoma Belamcandae coarse powder, extracts 5 times, filters, merging filtrate, is concentrated into relative density and is 1.10 ~ 1.30 clear paste a; Get dried ginger slice and extract volatile oil with vapor distillation, obtain oil of ginger; Get strongly fragrant vegetables, Fructus Piperis coarse powder, mix, add 90% ethanol extraction 4 times, filter, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste b; Clear paste a, clear paste b are merged and Sanguis Draxonis powder blend, at 60 ℃, be condensed into thick paste, after oil of ginger is mixed, at drying under reduced pressure below 85 ℃, obtain described pharmaceutical composition.
Embodiment 2
Prepare strongly fragrant vegetables 400g, Tinospora crispa 1200g, Rhizoma Belamcandae 1200g, Fructus Piperis 300g, Rhizoma Zingiberis 400g, Sanguis Draxonis 1000g; Tinospora crispa, Rhizoma Belamcandae, strongly fragrant vegetables, Fructus Piperis are carried out respectively to coarse pulverization, and Sanguis Draxonis powder is broken to 170 orders, standby after Rhizoma Zingiberis slicing treatment.90% ethanol that adds 8 times of coarse powder weight in Tinospora crispa, Rhizoma Belamcandae coarse powder, dipping 48h, the speed percolation with 90% ethanol with 2ml/min, collects the liquid of filtering, and recovery ethanol is concentrated into relative density and is 1.10 ~ 1.30 clear paste a; Get dried ginger slice and extract volatile oil with vapor distillation, obtain oil of ginger; Get strongly fragrant vegetables, Fructus Piperis coarse powder, mix, add 100% ethanol extraction 2 times, filter, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste b; Clear paste a, clear paste b are merged and Sanguis Draxonis powder blend, at 80 ℃, be condensed into thick paste, after oil of ginger is mixed, at drying under reduced pressure below 85 ℃, obtain described pharmaceutical composition.
Embodiment 3
Prepare strongly fragrant vegetables 300g, Tinospora crispa 1000g, Rhizoma Belamcandae 1000g, Fructus Piperis 200g, Rhizoma Zingiberis 300g, Sanguis Draxonis 700g; Tinospora crispa, Rhizoma Belamcandae, strongly fragrant vegetables, Fructus Piperis are carried out respectively to coarse pulverization, and Sanguis Draxonis powder is broken to 150 orders, standby after Rhizoma Zingiberis slicing treatment.The 80% soak with ethanol 36h that adds 6 times of coarse powder weight in Tinospora crispa, Rhizoma Belamcandae coarse powder, extracts 4 times, filters, merging filtrate, is concentrated into relative density and is 1.10 ~ 1.30 clear paste a; Get dried ginger slice and extract volatile oil with vapor distillation, obtain oil of ginger; Get strongly fragrant vegetables, Fructus Piperis coarse powder, mix, add 95% ethanol extraction 3 times, filter, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste b; Clear paste a, clear paste b are merged and Sanguis Draxonis powder blend, at 70 ℃, be condensed into thick paste, after oil of ginger is mixed, at drying under reduced pressure below 85 ℃, obtain described pharmaceutical composition.
Embodiment 4
Prepare strongly fragrant vegetables 250g, Tinospora crispa 900g, Rhizoma Belamcandae 900g, Fructus Piperis 150g, Rhizoma Zingiberis 250g, Sanguis Draxonis 550g; Tinospora crispa, Rhizoma Belamcandae, strongly fragrant vegetables, Fructus Piperis are carried out respectively to coarse pulverization, and Sanguis Draxonis powder is broken to 180 orders, standby after Rhizoma Zingiberis slicing treatment.80% ethanol that adds 6 times of coarse powder weight in Tinospora crispa, Rhizoma Belamcandae coarse powder, dipping 60h, the speed percolation with 80% ethanol with 3ml/min, collects the liquid of filtering, and recovery ethanol is concentrated into relative density and is 1.10 ~ 1.30 clear paste a; Get dried ginger slice and extract volatile oil with vapor distillation, obtain oil of ginger; Get strongly fragrant vegetables, Fructus Piperis coarse powder, mix, add 95% ethanol extraction 3 times, filter, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste b; Clear paste a, clear paste b are merged and Sanguis Draxonis powder blend, at 60 ℃, be condensed into thick paste, after oil of ginger is mixed, at drying under reduced pressure below 85 ℃, obtain described pharmaceutical composition.
Embodiment 5
Prepare strongly fragrant vegetables 350g, Tinospora crispa 1100g, Rhizoma Belamcandae 1100g, Fructus Piperis 250g, Rhizoma Zingiberis 350g, Sanguis Draxonis 850g; Tinospora crispa, Rhizoma Belamcandae, strongly fragrant vegetables, Fructus Piperis are carried out respectively to coarse pulverization, and Sanguis Draxonis powder is broken to 150 orders, standby after Rhizoma Zingiberis slicing treatment.The 70% soak with ethanol 48h that adds 4 times of coarse powder weight in Tinospora crispa, Rhizoma Belamcandae coarse powder, extracts 3 times, filters, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste a; Get dried ginger slice and extract volatile oil with vapor distillation, obtain oil of ginger; Get strongly fragrant vegetables, Fructus Piperis coarse powder, mix, add 90% ethanol extraction 4 times, filter, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste b; Clear paste a and clear paste b are merged and Sanguis Draxonis powder blend,, at 80 ℃, be condensed into thick paste, after being mixed, oil of ginger at drying under reduced pressure below 85 ℃, obtains described pharmaceutical composition.
Embodiment 6
Prepare strongly fragrant vegetables 200g, Tinospora crispa 1200g, Rhizoma Belamcandae 900g, Fructus Piperis 250g, Rhizoma Zingiberis 300g, Sanguis Draxonis 600g; Tinospora crispa, Rhizoma Belamcandae, strongly fragrant vegetables, Fructus Piperis are carried out respectively to coarse pulverization, and Sanguis Draxonis powder is broken to 200 orders, standby after Rhizoma Zingiberis slicing treatment.70% ethanol that adds 8 times of coarse powder weight in Tinospora crispa, Rhizoma Belamcandae coarse powder, dipping 72h, the speed percolation with 70% ethanol with 4ml/min, collects the liquid of filtering, and recovery ethanol is concentrated into relative density and is 1.10 ~ 1.30 clear paste a; Get dried ginger slice and extract volatile oil with vapor distillation, obtain oil of ginger; Get strongly fragrant vegetables, Fructus Piperis coarse powder, mix, add 100% ethanol extraction 2 times, filter, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste b; Clear paste a, clear paste b are merged and Sanguis Draxonis powder blend, at 70 ℃, be condensed into thick paste, after oil of ginger is mixed, at drying under reduced pressure below 85 ℃, obtain described pharmaceutical composition.
Embodiment 7
The pharmaceutical composition pack of getting embodiment 1 preparation becomes powder.
Embodiment 8
The pharmaceutical composition of getting embodiment 2 preparations adds pharmaceutically acceptable adjuvant to make tablet.
Embodiment 9
The pharmaceutical composition of getting embodiment 3 preparations adds pharmaceutically acceptable adjuvant to make capsule.
Embodiment 10
The pharmaceutical composition of getting embodiment 4 preparations adds pharmaceutically acceptable adjuvant granulation agent.
Embodiment 11
The pharmaceutical composition of getting embodiment 5 preparations adds pharmaceutically acceptable adjuvant to make drop pill.
Embodiment 12
The pharmaceutical composition of getting embodiment 5 preparations adds pharmaceutically acceptable adjuvant to make honey pill agent.
Embodiment 13
The capsule being prepared into the pharmaceutical composition of embodiment 3 carries out toxicological test and clinical practice test, and result is as follows:
1, toxicological test:
Test is prepared: get test specimen and be mixed with every 1ml containing the suspendible mother solution of 200 mg compositionss with 0.5% sodium carboxymethyl cellulose solution, after fully mixing, with coubling dilution, separately get partial mother liquid and be mixed with 100,50 mg/ml concentration.Experimental animal is 48 of kunming mices, male and female half and half.
Test method: 48 kunming mices, 7 week age, body weight l8 ~ 22 g, male and female half and half, standard Animal House is raised, and adapts to after 1 day, and fasting 12 h, can freely drink water.
48 experiment mices are divided into 4 groups at random, every group 12, be respectively solvent group, basic, normal, high dosage group (2000,4000,8000 mg/kg), every group of each administration 0.4 ml/10g of mice, once a day, matched group is to wait dosage 0.5% sodium carboxymethyl cellulose gavage.
Each group is tight body weight change, diet drinking-water, spiritual autonomic activities, hair, secretions, death condition and the toxic reaction etc. of observing animal subject in 24 h after first day gavage, observe 3 times every day later, continuous 14 days, record body weight, feed, flooded condition and behavioral activity, the mental status and the animals survived situation of each treated animal.In the 15th day, mouse orbit blood sampling, centrifugalize upper serum ,-80 ℃ of freezing preservations, liver to be tested (ALT, AST) renal function (Cr, BUN).Weigh internal organs weight in wet base and calculate organ index.Dissect the pathological change of the main organs such as rear its heart of perusal, liver, spleen, lung, kidney, brain, stomach, intestinal.
Result of the test: each is organized, and mice 4 h internal nares after administration are dry without secretions, mouthful peritricha, respiratory frequency and the degree of depth evenly, reaction is normal.Compare with solvent matched group, administration group only autonomic activities slightly increases.In 24 h, respectively organize mice feed drinking-water all normal, high dose group mice stool has a little loose stool, and recover next day.In 14 day observation period, hair color is pure white smooth, does not occur any spirit, dyskinesia, does not occur obvious poisoning symptom and death condition.The weight of animals, main organs index are respectively in Table 1 ~ 2, and each dosage group compares not statistically significant with solvent matched group.After putting to death animal, dissect macroscopy, the main organs such as liver, the heart, spleen, lung, kidney, thymus are not found pathological change.Hepatic and renal function index is in Table 3 ~ 4, and each administration group mice ALT, AST, BUN, Cr compare not statistically significant with normal group mice.
Conclusion (of pressure testing): the day maximum dosage-feeding of this experimental observation mice is 8000 mg/kg dosage, be equivalent to 160 times of every daily dose 50 mg/kg of people, Mouse Weight, main metabolic, immune organ index, hepatic and renal function are not all made significant difference, do not occur obvious poisoning symptom and death condition.Show that under maximum dosage-feeding 8000 mg/kg dosage, drug toxicity is very little.
Mouse Weight situation is respectively organized in table 1 compositions administration of the present invention for 14 days afterwards
| Group | Dosage (mg/kg) | Sample number (only) | Body weight (g) |
| Solvent matched group | - | 12 | 35.23±1.74 |
| Low dose group | 2000 | 12 | 34.61±2.01 |
| Middle dosage group | 4000 | 12 | 35.77±1.81 |
| High dose group | 8000 | 12 | 34.28±1.90 |
Mice important organ index is respectively organized in table 2 compositions administration of the present invention for 14 days afterwards
| Group | Dosage (mg/kg) | Sample number (only) | Liver index (%) | Index and spleen index (%) | Thymus index (%) |
| Solvent matched group | - | 12 | 4.92±0.32 | 0.3425±0.0409 | 0.3168±0.0478 |
| Low dose group | 2000 | 12 | 4.87±0.30 | 0.3292±0.0315 | 0.3334±0.0605 |
| Middle dosage group | 4000 | 12 | 4.79±0.32 | 0.3375±0.0249 | 0.3227±0.0376 |
| High dose group | 8000 | 12 | 4.85±0.27 | 0.3458±0.0514 | 0.3348±0.0318 |
The serum levels of mice glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT is respectively organized in table 3 compositions administration of the present invention for 14 days afterwards
| Group | Dosage (mg/kg) | Sample number (only) | ALT（U/L） | AST（U/L） |
| Solvent matched group | - | 12 | 37.50±9.30 | 163.92±35.44 |
| Low dose group | 2000 | 12 | 39.08±8.83 | 170.17±37.70 |
| Middle dosage group | 4000 | 12 | 38.33±10.74 | 167.83±33.28 |
| High dose group | 8000 | 12 | 40.25±10.04 | 168.17±27.42 |
The serum levels of mice blood urea nitrogen, creatinine is respectively organized in table 4 compositions administration of the present invention for 14 days afterwards
| Group | Dosage (mg/kg) | Sample number (only) | BUN（mmol/L） | Cr（μmol/L） |
| Solvent matched group | - | 12 | 7.48±1.12 | 12.17±3.51 |
| Low dose group | 2000 | 12 | 7.51±1.37 | 11.42±3.96 |
| Middle dosage group | 4000 | 12 | 7.60±1.25 | 11.75±2.99 |
| High dose group | 8000 | 12 | 7.56±1.36 | 11.83±3.41 |
Two, after fracture, recover patient clinical test:
1, case selection
Choose 186 routine closed fracture patients, diagnosis has bony crepitus or bone rubbing feeling, separately clap x-ray inspection and make a definite diagnosis, and get rid of pathologisch Bruch or with other as diabetes etc., and injure peripheral vessels nerve injury without compound, without infection complication.Male's 105 examples, women's 81 examples, 37～65 years old age.Two groups of subject age, sex, type of impairment etc., all without significant difference, have comparability.
2, Therapeutic Method
186 routine patients carry out conventional treatment when being admitted to hospital, complete the coherence checks such as CT and X sheet, and carry out the Primary Care of normal operation, postoperatively by operation sequencing, at random patient is divided into treatment group (compositions of the present invention) 93 example and matched group (placebo) 93 examples, oral capsule (0.35g/ grain), 3 tablets/time, every day 3 times, within 4 weeks, be 1 course for the treatment of, observe altogether 3 courses for the treatment of.During treatment, stop using and treat relevant medicine with this.
3, observation index
3.1 growth of spur situations
Respectively at treatment, within the 4th week, the 8th week, the 10th week, under identical conditions, take the photograph the growing state that fracture site anterioposterior and lateral film is observed callus.Evaluation criteria: (1) fracture line is high-visible is 0 minute without obvious growth of spur; (2) have a small amount of growth of spur, density is low is 1 minute; (3) fracture line is fuzzy, and middle amount growth of spur is 2 minutes; (4) fracture line disappears, and having seriality growth of spur is 3 minutes.
3.2 healing time
Observe each patient's healing time, criterion of therapeutical effect: effective: the clinical union of bone time, more similar fracture the average healing shortened >=1/3; Effective: the clinical union of bone time, more similar fracture the average healing shortened >=1/5, <1/3; Invalid: not reach above standard person.Similar healing time calculates by the average healing.Standard of fracture healing is with reference to the clinical union of bone standard of < < surgery > > and < < new Chinese medicine guideline of clinical investigations > >: (1) local standard: local without unusual movable, without tenderness and longitudinal percussion pain; (2) iconography standard: X-ray film shows that fracture line is fuzzy, has seriality callus to pass through fracture line; (3) profile: outer fixed solution is hindered limb after removing can meet following requirement: upper limb can reach 1 min to front raise 1 kg weight; Lower limb can not held up and turn on level land continuous walking 3 min and be no less than 30 steps, and 2 weeks fractures of Continuous Observation are indeformable.
4, result of the test
2 groups of closed fracture patients, after 3 course of therapy of compositions of the present invention, x-ray observation growth of spur situation, treatment group will obviously be better than matched group (as table 5, p<0.05).Each patient's healing time, there were significant differences (as table 6, p<0.05) for two groups of statistics for the treatment of group.To sum up result, recovers to have good therapeutic effect after compositions of the present invention is used for fracturing.
Table 5 compositions of the present invention on closed fracture operation in patients after the impact of the 10th week growth of spur situation
The impact of table 6 compositions of the present invention on closed fracture patient healing time
| Group | Sample number | Effective | Effectively | Invalid |
| Treatment group | 93 | 19 | 45 | 29 |
| Matched group | 93 | 8 | 37 | 48 |
Claims (9)
1. the pharmaceutical composition recovering for fracturing, it is characterized in that: take the strongly fragrant vegetables of 200 ~ 400 parts of parts by weight, the Tinospora crispa of 800 ~ 1200 parts, the Rhizoma Belamcandae of 800 ~ 1200 parts, the Fructus Piperis of 100 ~ 300 parts, the Rhizoma Zingiberis of 200 ~ 400 parts, the Sanguis Draxonis of 400 ~ 1000 parts is raw material the pharmaceutical composition that extracts, prepares after concentrate drying through classification; Its preparation method is specially:
A, raw material are prepared: Tinospora crispa, Rhizoma Belamcandae, strongly fragrant vegetables, Fructus Piperis are carried out respectively to coarse pulverization, and Sanguis Draxonis powder is broken to 150 ~ 200 orders, standby after Rhizoma Zingiberis slicing treatment;
B, classification are extracted: get in Tinospora crispa, Rhizoma Belamcandae coarse powder and add 70 ~ 90% ethanol of 4 ~ 8 times of coarse powder weight to extract, reclaim ethanol, be concentrated into relative density and be 1.10 ~ 1.30 clear paste a; Get dried ginger slice and extract volatile oil with vapor distillation, obtain oil of ginger; Get strongly fragrant vegetables, Fructus Piperis coarse powder, mix, add 90 ~ 100% ethanol extraction 2 ~ 4 times, filter, merging filtrate, reclaims ethanol, is concentrated into relative density and is 1.10 ~ 1.30 clear paste b;
C, concentrate drying: clear paste a, clear paste b are merged and Sanguis Draxonis powder blend, at 60 ~ 80 ℃, be condensed into thick paste, after oil of ginger is mixed, at drying under reduced pressure below 85 ℃, obtain described pharmaceutical composition.
2. pharmaceutical composition according to claim 1, is characterized in that: take the strongly fragrant vegetables of 250 ~ 350 parts of parts by weight, the Tinospora crispa of 900 ~ 1100 parts, the Rhizoma Belamcandae of 900 ~ 1100 parts, the Fructus Piperis of 150 ~ 250 parts, the Rhizoma Zingiberis of 250 ~ 350 parts, the Sanguis Draxonis of 550 ~ 850 parts is raw material.
3. pharmaceutical composition according to claim 1, is characterized in that: take the strongly fragrant vegetables of 300 parts of parts by weight, the Tinospora crispa of 1000 parts, the Rhizoma Belamcandae of 1000 parts, the Fructus Piperis of 200 parts, the Rhizoma Zingiberis of 300 parts, the Sanguis Draxonis of 700 parts is raw material.
4. pharmaceutical composition according to claim 1, it is characterized in that: the clear paste a described in B step is 70 ~ 90% soak with ethanol 24 ~ 48h that add 6 times of coarse powder weight in Tinospora crispa, Rhizoma Belamcandae coarse powder, extract 3 ~ 5 times, filtration, merging filtrate, reclaim ethanol and be also condensed into clear paste a.
5. pharmaceutical composition according to claim 4, is characterized in that: described Tinospora crispa, 80% soak with ethanol 36h for Rhizoma Belamcandae coarse powder, extract 4 times, and filter, merging filtrate, reclaim ethanol and be also condensed into clear paste a.
6. pharmaceutical composition according to claim 1, it is characterized in that: the clear paste a described in B step adds 70 ~ 90% ethanol of 6 times of coarse powder weight in Tinospora crispa, Rhizoma Belamcandae coarse powder, dipping 48 ~ 72h, speed percolation with 70 ~ 90% ethanol with 2 ~ 4ml/min, the collection liquid of filtering, reclaims ethanol and is also condensed into clear paste a.
7. pharmaceutical composition according to claim 6, is characterized in that: described Tinospora crispa, 80% alcohol dipping 60h for Rhizoma Belamcandae coarse powder, the speed percolation with 80% ethanol with 3ml/min, collects the liquid of filtering, and reclaims ethanol and is also condensed into clear paste a.
8. a preparation for pharmaceutical composition described in claim 1, is characterized in that: in described pharmaceutical composition, add the adjuvant of pharmaceutically accepting to be prepared into powder, tablet, capsule, granule, drop pill or honey pill agent.
9. described in a claim 1, pharmaceutical composition is recovering the application in medicine for the preparation of fracture.
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