CN1215595A - External use medicine for treating soft tissue injury and its producing method - Google Patents
External use medicine for treating soft tissue injury and its producing method Download PDFInfo
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- CN1215595A CN1215595A CN 96123078 CN96123078A CN1215595A CN 1215595 A CN1215595 A CN 1215595A CN 96123078 CN96123078 CN 96123078 CN 96123078 A CN96123078 A CN 96123078A CN 1215595 A CN1215595 A CN 1215595A
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Landscapes
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Abstract
An exterior-applied medicine in the form of liquid, ointment, filming agent and plaster for treating soft tissue injury is made of coptis root, phellodendron bark, capejasmine fruit and arnebia root through alcohol extraction and millipore filter sterilization, and features high safety, no toxicity, good moisture-holding nature, and quick and high curative effect (95.74% for effective rate).
Description
The present invention relates to a kind of pharmaceutical composition for the treatment of soft tissue injury, specifically is the external Chinese patent medicine of the treatment soft tissue injury made of raw material with the Chinese herbal medicine; The invention still further relates to this medicine production method.
Soft tissue injury is commonly encountered diseases, the frequently-occurring disease of traumatology, and fracture or dislocation equivalent damage often are associated with serious soft tissue injury.Modern medicine mainly adopts the operation debridement to open soft tissue injury, prevents traumatic infection with nitrofural, 75% ethanol, benzalkonium bromide, ethacridine etc. in early days; The protection of external vaseline oil yarn promotes the granulation tissue growth.To closed soft tissue injury then mainly with means such as braking, local freezing naturopathy.The traditional medicine external treatment many based on Chinese medicine loose, cream, tincture, be only applicable to closed soft tissue injury.Through the Chinese medicine documentation retrieval centre's update search of State Administration of Traditional Chinese Medicine China, domestic have the document that uses Chinese medicine water preparation and liniment treated soft tissue injury, but all be that treatment closed soft tissue injury or crude preparation by using are (as the freezing Cape jasmine acid solution of Zhang Shi [for water decoction] orthopedics and traumatology of Chinese medicine magazine 1987; (1): 38; The red Radix Et Rhizoma Rhei liniment of Shang Shi Cape jasmine [being tincture].The Shaanxi traditional Chinese medical science 1994; 15 (6): 256; The Young ichor [for tincture] that disappears. external treatment with Chinese medicine magazine 1995; (4): 11; Hou Shi damage liquefaction film [for containing pure liniment].China's traditional Chinese medical science bone injury magazine 1995; 3 (5): 1).
Chinese patent application 92112763 disclosed musk shuhuo essences are tincture, scientific and technological achievement Radix Angelicae Pubescentis liniment (serial number: 787) be external-use oil preparation, all only be applicable to closed soft tissue injury.Up to now, still do not have on the domestic and international market a kind of generally acknowledged, not only be suitable for open soft tissue injury but also be suitable for external Chinese medicine water preparation or ointment, the membrane etc. of closed soft tissue injury.
The shortcoming that the purpose of this invention is to provide the medicine that overcomes present treatment soft tissue injury provides a kind of open soft tissue injury that both can be used for, and is applicable to closed soft tissue injury again, has the medicine for external use of good curative effect.
Another object of the present invention provides the production method of this soft tissue injury curative.
The present invention realizes like this.
The employing medicine be Rhizoma Coptidis, Cortex Phellodendri, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi), Alumen, Mentholum as principal agent, the medicine for external use of making, preparation formulation are exterior-applied formulations such as water preparation, ointment, plaster, membrane.After increasing dosage again, also can adopt dosage forms for oral administration such as tablet, capsule, oral liquid, electuary.
When preparation of the present invention is the external water preparation, can adopt tween, arabic gum, tragakanta, glycerol etc. to make suspending agent (solubilizing agent), be good with glycerol, because glycerin preparation on spreading upon skin the time, has moisture-keeping function concurrently.
Water preparation of the present invention can also add antiseptic, as parabens, benzoic acids or phenols, is good with ethylparaben (being ethyl hydroxybenzoate) wherein.
Also can add Percutaneous absorption enhancer such as azone (azone) in the preparation of the present invention.
Medicine of the present invention is made (consumption is a weight ratio) by following component: 10～20 parts of Rhizoma Coptidis, 8～15 parts of Cortex Phellodendris, 8～15 parts of Fructus Gardeniaes, 8～15 parts of Radix Arnebiae (Radix Lithospermi)s, 2～5 parts of Alumens (Alumen), 0.05～0.1 part of Mentholum.
The preferential weight ratio scope of medicine of the present invention is: 12～18 parts of Rhizoma Coptidis, 10～12 parts of Cortex Phellodendris, 10～12 parts of Fructus Gardeniaes, 10～12 parts of Radix Arnebiae (Radix Lithospermi)s, 3～4 parts of Alumens (Alumen), 0.07～0.08 part of Mentholum.
The best proportioning of medicine external water preparation of the present invention is: Rhizoma Coptidis 15.96kg, Cortex Phellodendri 11.4kg, Fructus Gardeniae 11.4kg, Radix Arnebiae (Radix Lithospermi) 11.4kg, Alumen 3.42kg, Mentholum 0.09kg, glycerol 45.87kg, ethylparaben 0.46kg add water and are made into 230～920 premium on currency agent.
The production method of medicine external water preparation of the present invention is:
(1) get Rhizoma Coptidis, Cortex Phellodendri, Fructus Gardeniae pulverizing, add 10 times of amount 70% alcohol heating reflux 2 times,
Filter, filtering residue discards;
(2) get Radix Arnebiae (Radix Lithospermi) in addition and be cut into 1～2cm segment, add 10 times of amount 70% alcohol at normal temperature and soak 2 times,
Filter, filtering residue discards;
(3) Rhizoma Coptidis, Cortex Phellodendri, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi) filtrate are merged, 60～80 ℃ of decompression recycling ethanols add Alumen to the greatest extent;
(4) get Mentholum, ethylparaben and add after with a small amount of 95% dissolve with ethanol, capacity transfer fully stirs to 90～93% of capacity, leaves standstill 24 hours in 0～4 ℃, and filter press adds glycerol again, fully stirs;
(5) use the microporous filter membrane degerming, aseptic subpackaged, get product.
Pondage to capacity 90～93% after, regulating pH is between 3.7～4.0.
The aperture of microporous filter membrane is 0.45 μ m.
Solution of the present invention is based on understanding and the Therapeutic Principle of motherland's medical science to falling the etiology and pathogenesis of pouncing on wound, by the theory of Chinese medical science prescription, filter out one group of Chinese herbal medicine of heat-clearing and toxic substances removing, reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling, putrefaction-removing granulation-promoting effect, according to the modern pharmacological research achievement, adopt the preparation process of science and a kind of medicine for external use for the treatment of opening and closed soft tissue injury of developing.Said preparation is reused Rhizoma Coptidis with heat-clearing and toxic substances removing, the dampness detumescence; Help the merit of Rhizoma Coptidis heat-clearing and toxic substances removing, dampness detumescence with Cortex Phellodendri, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi), Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi) are held concurrently can removing heat from blood and promoting blood circulation, promotes blood circulation to change block up; Alumen detoxifcation putrefaction removing, the convergence granulation promoting; The hot cold of Herba Menthae is loose wind-expelling pain-stopping, and the energy that helps the Radix Arnebiaeization block up to promote blood circulation with light clear a surname.We's prescription is rigorous, makes a distinction between the important and the lesser one, and plays the merit of heat-clearing and toxic substances removing, reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling, putrefaction-removing granulation-promoting altogether.Cure mainly pain caused by ecchymoma that various traumatic injury cause, hemorrhage; And to because of invade in wind (heat) poison the rotten blood of (burn and scald) or stagnation of blood stasis and heat, meat lose the soft tissue that causes red, swollen, hot, bitterly in addition disease such as suppuration ideal curative effect is arranged.Through modern pharmacological research, this medicine has infection, antiinflammatory, analgesia, the growth of promotion wound surface granulation tissue, microcirculation disturbance is had a better role, no obvious toxic and side effects, and curative effect is fast.
Narrate embodiment below.
Embodiment 1
Take by weighing raw material by following proportioning: Rhizoma Coptidis 35kg, Cortex Phellodendri 25kg, Fructus Gardeniae 25kg, Radix Arnebiae (Radix Lithospermi) 25kg, Alumen 7.5kg, Mentholum 0.2kg, glycerol 100.55kg, ethylparaben 1kg, make 1000000ml.
Get the granule that Rhizoma Coptidis, Cortex Phellodendri, Fructus Gardeniae are ground into the Semen Glycines size, add 10 times of amount 70% alcohol heating reflux 2 times, each 1 hour, filter, filtering residue discards; Other gets Radix Arnebiae (Radix Lithospermi) is cut into 1～2cm segment, and add 10 times of amount 70% alcohol at normal temperature and soak 2 times, each 24 hours, filter, filtering residue discards; Merge above filtrate, 65 ℃ of decompression recycling ethanols are to most.Add Alumen; Getting Mentholum, ethylparaben adds after with a small amount of 95% dissolve with ethanol; Capacity transfer is to 92% of capacity, and transferring pH is 3.85, fully stirs, and leaves standstill 24 hours in 0～4 ℃, and filter press stirs behind the glycerol adding; After the microporous filter membrane degerming of 0.45 μ m, aseptic subpackaged, the aluminium lid press seal promptly.
Embodiment 2
Rhizoma Coptidis 16kg, Cortex Phellodendri 11kg, Fructus Gardeniae 11kg, Radix Arnebiae (Radix Lithospermi) 11kg, Alumen (Alumen) 3.5kg, Mentholum 0.09kg, preceding four liquid medicine are carried, and concentrate, and add back two medicines, add water solublity or emulsion-type ointment base, make ointment.
Embodiment 3
Rhizoma Coptidis 10kg, Cortex Phellodendri 8kg, Fructus Gardeniae 8kg, Radix Arnebiae (Radix Lithospermi) 15kg, Alumen 5kg, Mentholum 0.1kg, preceding four liquid medicine are carried, and concentrate, and add back two medicines, add plaster substrate, make black plaster or rubber ointment.
Embodiment 4
Rhizoma Coptidis 20kg, Cortex Phellodendri 8kg, Fructus Gardeniae 15kg, Radix Arnebiae (Radix Lithospermi) 8kg, Alumen 3kg, Mentholum 0.05 kg, preceding four liquid medicine are carried, and concentrate, and add back two medicines, mix with the filmogen serosity, make membrane according to a conventional method.
Embodiment 5
Rhizoma Coptidis 15.96kg, Cortex Phellodendri 11.4kg, Fructus Gardeniae 11.4kg, Radix Arnebiae (Radix Lithospermi) 11.4kg, Alumen 4.2kg, Mentholum 0.09kg, glycerol 45.87kg, ethylparaben 0.46kg are made into 460 premium on currency agent.
This production method is seen the production method that goes up the external water preparation.
Embodiment 6
Dosage and production method add water and are made into 920 premium on currency agent with embodiment 5.
Rhizoma Coptidis of the present invention, Cortex Phellodendri, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi) also available water are carried.
The administrated method of medicine of the present invention is that the drug ointment agent is applied to affected part (comprising wound surface and closure creation affected part), every day 1～3 time, as be plaster and membrane, then be affixed on the affected part.Every day 1 time.As be water preparation, soak into medicinal liquid with gauze, the external application affected part bandages, and changes dressings every day 1 time, and 20 days is a course of treatment.
An important feature of medicine of the present invention is that pharmacological action is extensive, has:
(1) anti-infectious function.Embodiment 5 and the pyogenic infection of 6 pairs of caused by Staphylococcus aureus mouse skins of embodiment have the obvious treatment effect, and the pathological changes index of infection is obviously reduced, and the necrosis that obviously reduces epidermis, corium, hypodermic necrosis and the appendages of skin destroys.Common traumatic infection pathogen and conditioned pathogen all there is in various degree antibacterial action, wherein stronger to staphylococcus aureus, staphylococcus epidermidis and beta hemolytic streptococcus effect, see Table 1～4, the experimental result prompting: this medical instrument has the effect of heat-clearing and toxic substances removing putrefaction removing.
Table 1. pair caused by Staphylococcus aureus mouse skin pyogenic infection pathological changes information slip (X ± S)
Annotate: 1. be number of animals in ().
| Group | Medicine | The index of infection lesion (score) | ||||
| Concentration (%) | The 3rd day | The 5th day | The 7th day | The 9th day | The 11st day | |
| Normal saline muscles relaxing essence embodiment 6 embodiment 5 | ?- 100 | ?2.53±0.64 ????(15) 2.00±0.53* ????(15) 2.33±0.49 ????(15) 1.47±0.52** ????(15) | 2.80±0.68 ????(15) 2.13±0.35** ????(15) 2.33±0.62 ????(15) 1.33±0.49** ????(15) | 2.77±0.73 ????(15) 2.13±0.35** ????(15) 2.07±0.27** ????(15) 0.73±0.59** ????(15) | 2.45±0.52 ????(15) 1.60±0.51** ????(15) 1.21±0.47** ????(15) 0.40±0.63** ????(15) | 1.55±0.52 ????(15) 0.93±0.73** ????(15) 0.89±0.41** ????(15) 0.27±0.64** ????(15) |
2. compare * P＜0.05, * * P＜0.01 with the normal saline group.
3. the normal saline group is overweight because of infecting in the experiment, 4 dead mouses, and embodiment is 1 death for 6 groups.
The influence of table 2. pair caused by Staphylococcus aureus pyogenic infection mice affected skin pathological change (X ± S)
Annotate: 1. dermal pathology changes standards of grading:
| Group | Medicine | Number of animals | Dermal pathology changes (score) | |||
| Concentration (%) | (only) | Epidermis is downright bad to suppurate | Corium is downright bad to suppurate | Subcutaneous downright bad the suppuration | Attached downright bad the destruction | |
| Normal saline muscles relaxing essence embodiment 6 embodiment 5 | ????- ????100 | ??11 ??15 ??14 ??15 | ?4.0±0 ?3.2±0.4** ?2.6±0.5** ?2.4±0.7** | 4.0±0 1.8±0.8** 1.4±0.5** 1.5±0.5** | ?1.6±0.8 ?1.2±0.4 ?1.1±0.4 ?1.0±0.4* | 4.0±0 1.2±0.4** 1.1±0.4** 1.0±0.2** |
"-" expression is normal, gets 0 fen;
"+" expression extent of disease got 1 fen in below 1/4 of the visual field;
" ++ " expression extent of disease accounts for about 2/4 of the visual field, gets 2 fens;
" +++" represent that extent of disease accounts for about 3/4 of the visual field, got 3 fens;
" ++ ++ " represent that extent of disease involves whole visual field, got 4 fens.
2. compare * P＜0.05, * * P＜0.01 with the normal saline group.
Table 3. pair caused by Staphylococcus aureus pyogenic infection mice affected skin fiber
The influence of hamartoplasia (X ± S)
Annotate: 1. fibroplasia is divided into level Four:
| Group | Drug level (%) | Number of animals (only) | Fibroplasia (score) |
| Normal saline muscles relaxing essence embodiment 6 embodiment 5 | ?????- ????100 | ????11 ????15 ????14 ????15 | ????0.1±0.3 ????1.0±0.5** ????1.1±0.6** ????1.3±0.5** |
"-" expression whole visual field is not seen hypertrophy, gets 0 fen;
"+" expression hypertrophy scope got 1 fen in below 1/4 of the visual field;
" ++ " expression hypertrophy scope accounts for about 2/4 of the visual field, gets 2 fens;
" +++" represent that the hypertrophy scope accounts for about 3/4 of the visual field, gets 3 fens;
" ++ ++ " represent that the hypertrophy scope involves whole visual field, gets 4 fens.
2. compare * P＜0.05, * * P＜0.01 with the normal saline group.
Table 4. traumatology yellow fluid is to the antibacterial evaluation of traumatic infection encountered pathogenic bacteria and conditioned pathogen
| Medicine | Inhibitory potency | |||||||
| Staphylococcus aureus | Staphylococcus epidermidis | Alpha streptococcus | Group B streptococcus | Micrococcus catarrhalis | Escherichia coli | Bacillus pyocyaneus | Candida albicans | |
| Embodiment 5,6 musk shuhuo essences | ?1∶80 ?1∶5 | ????1∶40 ????1∶5 | ?1∶20 ?1∶5 | ?1∶40 ?1∶5 | ?1∶10 ?1∶2.5 | ?1∶5 ?1∶2.5 | ?1∶5 ?1∶2.5 | ?1∶5 ?1∶2.5 |
(2) antiinflammatory action is arranged.5,6 pairs of histamines of embodiment induced mice capillary of skin permeability increases inhibitory action, and can suppress the mice ear due to the dimethylbenzene; Foot swelling due to embodiment 5,6 PARA FORMALDEHYDE PRILLS(91,95)s and the Ovum Gallus domesticus album has inhibitory action, and see Table 5～8, results suggest: embodiment has the detumescence effect.
The table 5. pair influence that histamine's induced mice capillary of skin permeability increases
| Group | Drug level (%) | Number of animals (only) | Fibroplasia (score) |
| Normal saline muscles relaxing essence WANHUAYOU embodiment 6 embodiment 5 | ?????- ????100 ????100 | ????10 ????10 ????10 ????10 ????10 | ?0.359±0.092 ?0.289±0.091 ?0.171±0.089** ?0.256±0.071* ?0.192±0.063** |
Annotate: compare * P＜0.05, * * P＜0.01 with the normal saline group.
The influence of table 6. xylol induced mice ear swelling
| Group | Drug level (%) | Number of animals (only) | Fibroplasia (score) |
| Normal saline muscles relaxing essence embodiment 6 embodiment 5 | ?????- ????100 | ????12 ????10 ????10 ????10 | ?39.6±13.2 ?25.7±13.1* ?22.1±14.6* ?22.4±10.9** |
Annotate: compare * P＜0.05, * * P＜0.01 with the normal saline group.
The influence of table 7. pair rat Ovum Gallus domesticus album foot swelling
| Group | Medicine | Number of animals | Cause scorching back foot swelling degree (X ± S) | ||
| Concentration (%) | (only) | 1 hour | 2 hours | 5 hours | |
| Normal saline muscles relaxing essence WANHUAYOU embodiment 6 embodiment 5 | ????- ????100 ????100 | ??11 ??10 ??10 ??10 ??10 | ?0.877±0.135 ?0.830±0.170 ?0.715±0.118** ?0.895±0.145 ?0.785±0.167 | ?0.759±0.167 ?0.695±0.110 ?0.610±0.120* ?0.735±0.143 ?0?635±0.143 | ?0.391±0.113 ?0?385±0.120 ?0.235±0.103** ?0.355±0.103 ?0.285±0.112 |
Annotate: compare * P＜0 05, * * P＜0.01 with normal saline.
The influence of table 8. pair rat formaldehyde foot swelling
| Group | Medicine | Number of animals | Cause scorching back foot swelling degree (X ± S) | |||
| Concentration (%) | (only) | The 2nd day | The 3rd day | The 4th day | The 5th day | |
| Normal saline muscles relaxing essence embodiment 6 embodiment 5 | ????- ???100 | ??10 ??10 ??10 ??10 | ?0.770±0.158 ?0.641±0.186 ?0.630±0.155 ?0.570±0.160** | ?0.530±0.140 ?0.310±0.097** ?0.450±0.108 ?0.330±0.059** | ?0.390±0.129 ?0.230±0.042** ?0.320±0.123 ?0.220±0.111** | ?0.351±0.101 ?0.180±0.092** ?0.330±0.123 ?0.160±0.117** |
Annotate: compare * * P＜0.01 with the normal saline group.
(3) this medicine has certain analgesic activity.Embodiment 5,6 can reduce because of injection due to the formaldehyde little damaged by rats or lick sufficient accumulated time, the trend that the hot plate method proof has the threshold of pain that makes mice to improve, see Table 9～10, results suggest: embodiment has analgesic effect.
The influence of table 9. pair thermostimulation induced mice pain
| Group | Drug level (%) | Number of animals (only) | Threshold of pain percentage rate behind the medicine (%, X ± S) |
| Normal saline muscles relaxing essence WANHUAYOU embodiment 6 embodiment 5 | ?????- ????100 | ????12 ????10 ????10 ????10 ????10 | ????89.6±23.6 ????104.1±17.3 ????121.8±14.5** ????102.7±20.4 ????107.3±17.5 |
Annotate: compare * * P＜0.01 with the normal saline group.
The influence of table 10. PARA FORMALDEHYDE PRILLS(91,95) induced mice foot pain (X ± S)
| Group | Drug level (%) | Number of animals (only) | Lick or sting sufficient accumulated time (second, X ± S) |
| Normal saline muscles relaxing essence embodiment 6 embodiment 5 | ?????- ????100 | ????11 ????10 ????10 ????10 | ????72.4±11.7 ????58.0±11.5* ????66.3±14.7 ????60.5±11.5* |
Annotate: compare * P＜0.05 with the normal saline group.
(2) has the outgrowth effect of the local organization of promotion.Embodiment 5,6 can obviously promote the partial proliferation of fibrous tissue of pyogenic infection mice affected skin of caused by Staphylococcus aureus, 5 pairs of rat cotton balls of embodiment granuloma hypertrophy has the tendency of promotion, see Table 11, results suggest: embodiment has promoting muscle growth functions.
The table 11. pair granulomatous influence of rat cotton balls (X ± S)
| Group | Drug level (%) | Number of animals (only) | Granuloma heavy (mg/100g body weight) |
| Normal saline muscles relaxing essence hydrocortisone embodiment 6 embodiment 5 | ????100 ????100 ????50 ????100 | ????10 ????9 ????9 ????9 ????9 | ????191.2±36.1 ????201.3±36.0 ????101.0±27.9** ????201.4±14.6 ????221.2±31.5 |
Annotate: compare * * P＜0.01 with the normal saline group.
(5) have the growth of the wound surface of promotion granulation tissue, accelerate the effect of wound repair.By dynamic observing of experimental wound granulation tissue model shown: it is totally smooth that embodiment 5,6 forms mouthful outward appearance, and color and luster is fresh and tender, and the part wound has the yellowish-brown crust to cover; See under the Electronic Speculum that fibroblast quantity is many in the granulation tissue, mitochondrion increases, rough endoplasmic reticulum is abundant, poly and free ribosome increase, tangible Golgi body occurs, collagen fiber are synthetic vigorous, and hydroxyproline content is apparently higher than the normal saline group in the granulation tissue, see Table 12～13, results suggest: embodiment 5,6 has the into function of wound granulation tissue reparation.
Table 12. embodiment, nitrofural and normal saline are to rat implementation granulation group
Knit the influence (3,4 weeks of postoperative) of outward appearance
| The wound outward appearance | Embodiment 5 | Nitrofural | Normal saline |
| Surface color quality abnormal flavour purulent secretion crust | Clean smooth fresh and tender real nothing has | Clean smooth fresh and tender soft nothing or a little do not have | Filth is whole, and sallow is soft obviously has or not |
Table 13. embodiment 5, nitrofural and normal saline are to the influence of hydroxyproline content in the granulation tissue
(mg/g,X±S)
| Group | The 1st week | The 2nd week | The 3rd week | The 4th week |
| Embodiment 5 nitrofural normal saline | 10.20±1.58** 7.03±0.89## 3.45±0.46 | ?19.51±1.18** ?15.84±1.16## ?5.16±0.83 | ?23.88±1.21 ?23.50±1.37## ?11.01±0.92 | ?23.96±0.82**## ?26.37±1.18 ?12.66±0.84 |
Compare with same time nitrofural group * P＜0.01;
Compare with same time normal saline group ##P＜0.01.
(6) this medicine has a better role to experimental microcirculation disturbance, due to 5,6 pairs of epinephrines of embodiment in the lagophthalmos bulbar conjunctiva blood capillary flow velocity of blood flow slow down and the minimizing of flow all improves significantly, and can increase the opening of capillary network, see Table 14～15.Results suggest: embodiment 5,6 has the effect of blood circulation promoting and blood stasis dispelling.
The influence of 5,6 pairs of point of intersect of the capillary network countings of table 14. embodiment
| Group | Number of animals (only) | Point of intersect of the capillary network (bar, X ± S) | |
| Before the medicine | Behind the medicine | ||
| Distilled water 654-2 embodiment 6 embodiment 5 | ????7 ????7 ????7 ????7 | ?5.867±1.958 ?6.428±2.718 ?6.000±1.603 ?4.142±0.833 | ????5.857±1.355 ????10.428±3.659* ????9.000±1.603** ????7.143±0.833** |
Annotate: self compare * P＜0.05, * * P＜0.01 before and after each organizes administration.
Microcirculation change situation before the table 15-1. administration (X ± S, n=7)
| Group | Before the administration | |||
| V(mm/s) | ????D(μm) | ????S(μm 2) | Q(×103μm 3/s) | |
| Distilled water 654-2 embodiment 6 embodiment 5 | ?0.23±0.06 ?0.21±0.05 ?0.20±0.03 ?0.19±0.08 | ?9.00±3.92 ?8.17±1.48 ?9.57±2.26 ?10.14±3.48 | ?81.43±56.21 ?60.71±19.39 ?75.34±36.87 ?97.51±46.39 | ?19.00±14.27 ?13.57±7.12 ?14.29±5.44 ?18.00±8.28 |
Microcirculation change situation after the table 15-2. administration (X ± S, n=7)
| Group | Before the administration | |||
| V(mm/s) | ????D(μm) | ????S(μm 2) | Q(×103μm 3/s) | |
| Distilled water 654-2 embodiment 6 embodiment 5 | ?0.22±0.08 ?0.27±0.05* 0.32±0.06** 0.31±0.09** | ?8.86±3.98 ?10.71±2.21 ?9.43±2.66 ?11.86±1.73 | ?79.71±57.31 ?93.29±38.71 ?74.86±39.91 ?111.14±42.27 | ?16.86±13.72 ?24.30±8.90* ?22.43±9.98 ?34.71±19.10* |
Annotate: self compare * P＜0.05, * * P＜0.01 before and after each organizes administration.
Another important feature of medicine of the present invention is no obvious toxic and side effects.
(1) embodiment acute toxicity test
This experimental observation 5 pairs of animal intact skins of embodiment and damaged skin short time or repeat to smear toxicity, skin irritation and the anaphylaxis situation that administration produces.Result of the test as seen, 5 pairs of white rabbit intact skins of embodiment and damaged skin irritant reaction and matched group relatively, difference is not obvious, does not see that also abnormal change appears in animal; White guinea pig skin repeat administration was not met quick reaction.Seeing Table 16～17 shows normal and damaged skin nonirritant; Normal and the damaged skin administration to animal, no acute toxic reaction; Repeat to smear administration and do not see the generation sensitization.
5 pairs of skin irritant average response values of table 16. embodiment
| Group | Number of animals | The integration summation | The average response value | |||||
| (only) | 1 | ?24 | ?48(h) | ????1 | ?24 | ?48(h) | ||
| Contrast is low dose of heavy dose of | The intact skin injury skin of the intact skin injury skin of intact skin injury skin | ????4 ????4 ????4 ????4 ????4 ????4 | ?0 ?4 ?0 ?4 ?0 ?4 | ?0 ?4 ?0 ?4 ?0 ?4 | ????0 ????0 ????0 ????0 ????0 ????0 | ????0 ????1 ????0 ????1 ????0 ????1 | ????0 ????1 ????0 ????1 ????0 ????1 | ????0 ????0 ????0 ????0 ????0 ????0 |
5 pairs of guinea pig skin influences hypersensitive of table 17. embodiment
| Group | The Mus number | The average response value | The sensitization rate | |||
| (only) | ????6 | ????24 | ????48 | ?72(h) | ????(％) | |
| Contrast positive embodiment 5 | ????10 ????10 ????10 | ????0 ????1 ????0 | ????0 ????0.95 ????0 | ????0 ????0.80 ????0 | ????0 ????0 ????0 | ????0 ????100 ????0 |
(2) embodiment long term toxicity test
Heavy dose of administration 42 days is not seen and is caused animal appearance, behavioral activity, and food ingestion, just large and small, the hematology, blood biochemical is learned and the pathologic of important organ changes, and sees Table 18～23, shows traumatology yellow fluid safety non-toxic, can use for clinical trial.
Respectively organized the variation (X ± S) of rat body weight after table 18. embodiment administration 42 days and the drug withdrawal in 14 days
| Group | Sex 0d | ????20d | ????42d | 14d after the drug withdrawal | |
| Intact skin | Contrast low dosage high dose | ♀174.00±8.43 ♂184.50±7.97 ♀171.50±7.09 ♂182.00±7.98 ♀170.28±10.16 ♂185.02±6.32 | ?230.50±16.06 ?276.50±17.48 ?233.00±19.46 ?269.50±21.46 ?220.50±19.01 ?264.50±17.67 | ?256.50±14.30 ?327.00±30.65 ?253.88±15.76 ?316.50±36.43 ?246.00±20.81 ?312.00±26.26 | ?281.20±17.43 ?359.43±25.41 ?279.76±18.36 ?352.31±35.10 ?272.63±24.21 ?346.82±31.32 |
| Damaged skin | Contrast low dosage high dose | ♀172.10±7.24 ♂180.42±8.32 ♀170.92±6.82 ♂183.24±9.21 ♀174.25±6.42 ♂179.41±8.24 | ?228.46±15.46 ?274.40±16.21 ?228.12±17.12 ?265.50±18.21 ?218.42±17.43 ?260.82±18.58 | ?252.80±16.40 ?317.21±28.26 ?250.21±16.49 ?310.43±19.21 ?240.19±18.41 ?300.12±24.81 | ?276.19±16.41 ?351.26±19.93 ?270.42±20.41 ?348.21±16.40 ?286.45±24.31 ?342.92±20.45 |
The variation of table 19-1 percutaneous drug delivery rat blood index after 42 days (X ± S)
| Group | ????RBC (×10 12/L) | ????HGB ????(g/L) | ????RRBC ????(％) | ????PLT ????(×10 8/L) | |
| The intact skin damaged skin | Contrast low dosage high dose contrast low dosage high dose | ?7.83±0.58 ?7.25±0.74 ?7.24±0.61 ?7.42±0.64 ?7.01±0.72 ?7.31±0.45 | ?145.30±5.80 ?141.30±8.51 ?140.10±4.38 ?140.41±6.62 ?138.49±7.21 ?142.24±5.42 | ?2.03±0.53 ?2.10±0.40 ?1.87±0.51 ?2.23±0.72 ?2.43±0.49 ?2.51±0.81 | ?833.20±89.36 ?881.21±98.24 ?876.38±94.53 ?902.24±100.43 ?892.41±98.92 ?884.00±112.41 |
Table 19-2
| Group | ????WBC (×10 8/L) | ????LYMPH ????(％) | ????MO+GR ????(％) | ????CT ????(min) | |
| The intact skin damaged skin | Contrast low dosage high dose contrast low dosage high dose | 13.81±4.21 ?13.48±3.21 ?13.59±2.93 ?13.60±5.10 ?13.76±5.92 ?13.90±4.12 | ?75.40±6.70 ?77.85±5.21 ?74.20±6.80 ?78.20±5.10 ?76.80±4.20 ?80.00±8.28 | ?24.60±5.70 ?22.15±4.30 ?25.80±2.40 ?21.80±3.10 ?23.20±3.21 ?20.00±4.00 | ????3.20±1.20 ????3.41±1.41 ????3.01±1.50 ????3.43±1.82 ????3.61±1.96 ????3.21±1.63 |
The variation of table 20-1 administration rat blood biochemical indexes after 42 days (X ± S)
| Group | ????ALT ????(u/L) | ????AST ????(u/L) | ????ALP ????(u/L) | ????TP ????(g/L) | ALB (g/L) | |
| The intact skin damaged skin | Contrast low dosage high dose contrast low dosage high dose | ?41.21±10.24 ?38.42±12.41 ?39.21±9.24 ?42.46±12.64 ?39.21±10.41 ?39.81±8.14 | ?159.21±19.29 ?153.10±17.50 ?142.30±18.94 ?151.43±18.43 ?144.26±16.72 ?154.27±10.12 | ?147.30±26.27 ?130.82±48.49 ?132.00±63.14 ?138.62±52.21 ?131.24±38.42 ?140.08±40.01 | ?67.20±2.79 ?66.20±3.53 ?64.90±4.34 ?65.20±3.45 ?62.92±4.21 ?61.90±4.82 | ?35.80±4.48 ?40.61±3.01 ?39.20±3.40 ?34.21±3.28 ?32.48±4.01 ?31.82±2.31 |
Table 20-2
| Group | ????GLU (mmol/L) | ????T-CHO (mmol/L) | ????T-BIL (μmol/L) | BUN (mmol/L) | ????Cr (μmol/L) | |
| The intact skin damaged skin | Contrast low dosage high dose contrast low dosage high dose | 8.06±0.54 ?7.86±0.96 ?7.64±0.84 ?7.81±0.68 ?7.59±0.48 ?7.21±0.62 | ?4.07±0.81 ?3.97±0.54 ?3.92±0.85 ?3.06±0.19 ?3.12±0.22 ?3.01±0.24 | ?0.89±0.61 ?1.95±0.92＊＊ ?2.79±0.69＊＊ ?0.95±0.69 ?2.06±0.98＊＊ ?2.72±1.21＊＊ | ?7.89±2.20 ?7.71±1.08 ?6.96±1.76 ?6.21±0.73 ?6.51±0.64 ?6.25±0.76 | ?65.50±8.24 ?68.50±8.27 ?72.80±11.25 ?54.34±7.57 ?52.52±7.79 ?56.48±9.14 |
Annotate: compare * p＜0.05, * * p＜0.01 (down together) with matched group
The variation of table 21-1 percutaneous drug delivery each main organs coefficient of rat after 42 days (X ± S)
| Group | Organ coefficient (g/100g body weight) | |||||
| The heart | Liver | Spleen | Lung | Kidney | ||
| The intact skin damaged skin | Contrast low dosage high dose contrast low dosage high dose | 0.31±0.04 0.32±0.04 0.31±0.03 0.30±0.03 0.29±0.04 0.29±0.03 | ?3.49±0.41 ?3.75±0.42 ?3.85±0.43 ?3.31±0.45 ?3.26±0.38 ?3.43±0.40 | ?0.37±0.15 ?0.37±0.10 ?0.37±0.08 ?0.36±0.10 ?0.34±0.07 ?0.35±0.07 | ?0.59±0.09 ?0.54±0.07 ?0.53±0.06 ?0.58±0.08 ?0.59±0.09 ?0.56±0.10 | ?0.69±0.08 ?0.68±0.08 ?0.74±0.07 ?0.62±0.08 ?0.80±0.07 0.58±0.06 |
Table 21-2
| Group | Organ coefficient (g/100g body weight) | ||||
| Thymus | The adrenal gland | The prostate seminal vesicle | The uterus ovary | ||
| The intact skin damaged skin | Contrast low dosage high dose contrast low dosage high dose | ?0.14±0.04 ?0.13±0.03 ?0.13±0.04 ?0.11±0.03 ?0.10±0.03 ?0.10±0.03 | ????0.021±0.008 ????0.023±0.009 ????0.021±0.008 ????0.020±0.007 ????0.019±0.008 ????0.021±0.09 | ????0.45±0.10 ????0.47±0.11 ????0.45±0.06 ????0.52±0.10 ????0.50±0.11 ????0.48±0.12 | ?0.21±0.04 ?0.24±0.03 ?0.24±0.05 ?0.26±0.09 ?0.27±0.12 ?0.25±0.11 |
Table 22. embodiment percutaneous drug delivery is rat liver tissue slice check result after 42 days
| Group | ?n | Downright bad companion's cell infiltration | Degeneration (endochylema is loose) | |||||||
| ?- | ????+ | ???++ | ???+++ | ????- | ?+ | ++ | +++ | |||
| The intact skin damaged skin | Contrast high dose contrast high dose | 10 10 10 10 | ?3 ?4 ?2 ?3 | ????5 ????4 ????5 ????6 | ????1 ????2 ????2 ????1 | ????1 ????0 ????1 ????0 | ????6 ????5 ????5 ????5 | ?0 ?1 ?2 ?1 | ?3 ?2 ?1 ?3 | ?1 ?2 ?2 ?1 |
Annotate: (1) necrosis: "+" is dispersed in point-like or little focal necrosis for minority;
"+" is light starlike distribution all over the sky for spotty necrosis;
" ++ " is that downright bad Caulis et folium pavettae hongkongensis distributes.
(2) degeneration: 1/3 of every lobule is involved for the endochylema puffing in "+";
" ++ " be every lobule 1/3～1/2 for the endochylema puffing involves;
" +++" endochylema puffing involves more than 1/2 of every lobule.
(3) low dosage is 20 times of clinical consumption, and high dose is 60 times of clinical consumption.
Acute and sub-acute toxicity test shows that this medicine of short-term or life-time service is not seen and caused animal appearance, behavioral activity, food ingestion, just large and small, the hematology, blood biochemical is learned and the pathologic of important organ changes, and shows the embodiment safety non-toxic, can use for clinical trial.
(4) clinical adverse is observed
Show that by the inspection to blood pressure, routine blood test, Cr, BUN, GPT, bilirubin metabolism before and after 60 routine patient's medications the human physiological functions of 5 pairs of above-mentioned projects of embodiment is harmless, sees Table 23, the clinical practice that shows embodiment is safe.
Table 23. embodiment is to the influence of indexs such as patient's blood pressure, hepatic and renal function
| Check before the experiment | Group | Before the medication | After the medication |
| Systolic pressure (KPa) diastolic pressure (KPa) creatinine (μ mol/L) urea nitrogen (mmol/L) glutamic-pyruvic transaminase (total bilirubin (μ mol/L) bilirubin direct (μ mol/L) indirect bilirubin (μ mol/L) of μ/L) | Treatment group (32) control group (28) treatment group (32) control group (28) treatment group (32) control group (28) treatment group (32) control group (28) treatment group (32) control group (28) treatment group (32) control group (28) treatment group (32) control group (28) treatment group (32) control group (28) | ?14.54±1.40 ?14.54±1.58 ?9.79±0.93 ?9.34±0.71 ?81.97±8.17 ?84.89±11.30 ?4.66±1.19 ?5.24±1.38 ?11.40±3.55 ?9.68±3.50 ?12.77±3.77 ?12.80±4.95 ?4.54±1.20 ?4.32±1.18 ?7.89±2.57 ?7.98±3.76 | ?14.06±1.12# ?14.09±1.16 ?9.03±0.77## ?9.13+0.67 ?82.52±7.28 ?81.84±6.32 ?4.60±1.06# ?5.24±1.12 ?10.75±5.30 ?13.22±5.81 ?13.16±4.15 ?11.70±2.32 ?4.35±1.27 ?4.44±0.73 ?8.29±2.87 ?7.40±2.15 |
Annotate: between two groups of * relatively;
#: compare before and after the medication;
*#:P＜0.05,##:P＜0.01
The clinical efficacy of medicine of the present invention has the following advantage that has:
(1) all can use many sick patients that plant the merging soft tissue injury, adapt to wide.
The patient who merges soft tissue injury by embodiment 5 treatments 200 routine fracture, dislocation, trauma infection contamination, soft tissue strain and contusion etc., male's 146 examples wherein, women's 54 examples, the oldest 77 years old, minimum 1.5 years old, damage location was the trunk extremity, wherein closed fracture or 122 examples of dislocating (accounting for 55.45%), soft tissue strain and contusion 19 examples (accounting for 8.6%), open fracture 44 examples (accounting for 20%), trauma infection contamination 35 examples (accounting for 15.91%).Therapeutic outcome sees the following form 24～25:
Each sick therapeutic evaluation of planting of table 24. embodiment 5 treatments
| Classification | Fracture dislocation | Compound fracture | Trauma infection contamination | Soft tissue strain and contusion | Add up to |
| The produce effects enabledisable adds up to the obvious effective rate total effective rate | ????107 ????15 ????0 ????122 ????87.71％ ????100％ | ????39 ????2 ????3 ????44 ????88.64％ ????93.18％ | ????22 ????12 ????1 ????35 ????62.86％ ????97.14％ | ????10 ????8 ????1 ????19 ????52.63％ ????94.74％ | ???107 ???37 ???5 ???220 ???80.91％ ???97.72％ |
The various damage individual event therapeutic evaluatioies of table 25. embodiment 5 treatments
| Produce effects | Effectively | Invalid | Total effective rate | |||||
| The example number | ????％ | The example number | ????％ | The example number | ????％ | The example number | ％ | |
| The red and swollen heat of swelling pain ecchymosis wound surface | ?150 ?166 ?86 ?57 ?680 | ?71.43 ?79.05 ?78.90 ?72.15 ?70.83 | ????50 ????40 ????20 ????16 ????25 | ?23.81 ?19.05 ?18.35 ?20.25 ?26.04 | ????10 ????4 ????3 ????6 ????3 | ?4.76 ?1.91 ?2.75 ?7.60 ?3.13 | ????210 ????210 ????109 ????79 ????96 | ?95.24 ?98.10 ?97.25 ?92.41 ?96.88 |
Above-mentioned clinical observation shows: this medicine has definite curative effect to soft group of thin,tough silk swelling, pain, ecchymosis, local red and swollen heat pain and the wound healing that fracture, dislocation, open fracture, trauma infection contamination, soft tissue strain and contusion etc. cause.
(2) it is fast that embodiment has reducing swelling and alleviating pain, obviously reduces the advantage of traumatic infection chance, and its therapeutical effect is comprehensive.
Observe by contrast treatment with acute open soft tissue injury, external embodiment 5, acute open soft tissue injury 60 examples of 6 treatments, wherein 32 examples are organized in the embodiment treatment, medication 15～20 days, its total effective rate is 93.75%, nitrofural matched group 28 examples, its total effective rate is 85.71%, see Table 26～29, the treatment group is directly poor to reducing strong Ipsilateral week, the skin temperature difference and the partial stasis of blood of wound mouth (red) speckle, the wound surface scope, WBC all obviously is better than nitrofural group (P＜0.05), embodiment is in detumescence, pain relieving, blood stasis dispelling, recover local skin temperature, reducing wound surface suppurates, promptly occur obviously effect after 3 days in medication, and nitrofural in medication obviously effect (P＜0.05) appearred just after 7 days.The effect that shows embodiment is many-sided, it is further developing at wound early stage energy inflammation-inhibiting not only, and the middle and advanced stage in wound can promote disappearing of inflammation, quicken the absorption of local stasis of blood, improve the damaged tissue local blood circulation effectively, quicken pyrogenicity, cause the moving commentaries on classics of the pain factor, thereby reach pain relieving, the local skin temperature of reduction, promote tissue repair, the appearance that the opposing local woanded surface infects, advance wound repair.Thereby proved the merit of embodiment heat-clearing and toxic substances removing, reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling, putrefaction-removing granulation-promoting objectively.Two groups to the curative effect of acute open soft tissue injury by contrast, and embodiment is that to have a reducing swelling and alleviating pain fast, obviously reduces the advantage of traumatic infection chance, and its therapeutical effect is comprehensive.
The comparison of table 26. liang group curative effect
| Group | n | Curative effect | Total effective rate | ||
| Recovery from illness | Produce effects | Invalid | ????(％) | ||
| Embodiment treatment group nitrofural matched group | 32 28 | 24(75.00) 19(67.85) | 8(18.75) 5(17.86) | 2(6.25) 4(14.29) | ????93.75 ????85.71 |
The table 27. liang open symptoms of soft tissue injuries that group is common, sign and lab testing are relatively
| Observation index | Group | Before the medication | After the medication | ||
| 3 days | 7 days | 15 days | |||
| Week footpath poor (cm) stasis of blood (red) speckle (cm 2) wound surface (cm 2) the skin temperature difference (℃) WBC (* 10 9/ L) DC (%) (℃) P (inferior/minute) | Treatment group treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group control group | 0.84±0.47(31) 0.80±0.61(27) 28.44±18.11(29) 30.64±19.40(28) 8.11±6.38(28) 6.68±4.01(24) -0.60±0.81(32) -0.76±1.02(27) 8.47±2.57(31) 8.15±1.98(28) 70.62±10.52(32) 72.43±8.37(28) 36.77±0.50(32) 36.98±0.34(28) 79.16±12.10(32) 79.48±8.23(27) | 1.18±0.91(32) 1.37±0.70(25)## 17.35±18.16(30)## 26.10±22.57(26) 2.62±1.92(29)* 4.35±3.48(28) 0.47±0.89(31)## 0.11±1.06(27)## 7.27±1.52(31)# 7.82±2.03(27) 68.97±6.97(32) 71.64±7.38(28) 36.49±0.44(31)## 36.59±0.40(28)## 80.94±9.30(32) 78.18±7.91(28) | 0.54±0.71(30)#* 0.95±0.80(27) 6.59±6.14(28)##* 13.92±12.27(26)## 1.45±1.10(27)##* 2.63±1.97(26)## 0.29±0.52(30)## 0.29±1.00(27)## 6.57±1.10(30)##* 7.48±1.78(28) 68.94±7.21(32) 68.39±6.96(28)# 36.43±0.44(32)## 36.61±0.50(28)## 81.03±9.23(32) 77.70±6.09(27) | 0(29)##* 0.16±0.31(25)# 0(26)##* 0.42±0.80(21)## 0(23)## 0(19)## 0.21±0.44(31)*## -0.07±0.51(25)# 7.69±1.99(30)# 7.58±1.74(25) 67.97±7.82(30) 66.16±8.02(25)# 36.46±0.43(32)## 36.55±0.49(28)## 81.81±10.47(32) 77.50±4.87(26) |
Annotate: *: treatment group matched group compares, #: compare * #:P＜0.05, ##:P＜0.01 before and after the group innerlich anwenden
Table 28. liang group is to the influence of pain
| Pain degree | Before the medication | After the medication 3 days | After the medication 7 days | After the medication 15 days | ||||
| Treatment group (32) | Matched group (28) | Treatment group # (32) | Matched group (28) | Treatment group # (32) | Matched group (28) | Treatment group ## (32) | Matched group * # (28) | |
| The severe moderate does not slightly have antiinflammatory rate (%) | ????1 ???22 ????9 ????0 ????0 | ????1 ????18 ????10 ????0 ????0 | ????1 ????2 ????27 ????2 ????6.25 | ????0 ????5 ????22 ????1 ????3.75 | ????0 ????2 ????22 ????8 ????25.00 | ????1 ????1 ????21 ????5 ????17.86 | ????0 ????0 ????6 ????26 ????81.25#* | ????0 ????0 ????9 ????19 ????67.86#* |
Annotate: compare P＜0.05 before and after the # group innerlich anwenden;
* after the medication 15 days with medication after 3,7 days relatively, *: P＜0.05
Table 29. wound secretions situation and positive rate of bacteria
| Index | Group | Before the medication | After the medication (my god) | ||
| ????3 | ????7 | ????15 | |||
| Purulent secretion positive rate (%) secretions positive rate of bacteria (%) | Treatment group (32) matched group (28) treatment group (32) matched group (28) | 3.12(1) 3.57(1) 18.75(6) 21.43(63) | 9.38(3)* 28.57(8) 25.00(8) 35.71(10) | 28.12(9)* 50.00(14)# 40.63(13) 42.86(12) | 25.00(8) 25.00(7) 28.12(9) 21.43(6) |
Annotate: *: two form face purulent secretion positive rate X relatively
2Value is respectively 3.68 and 3.02,
The α value is near significant level;
#: compare #P＜0.05, positive routine number in the bracket before and after the medication.
Other embodiment of the present invention shows that having identical and akin curative effect to reach with embodiment 5, embodiment 6 does not all have obvious toxic and side effects.
The invention is not restricted to the foregoing description.
Medicine of the present invention dosage form for oral administration is also done investigation, showed akin curative effect.
Claims (14)
1. medicine for external use for the treatment of soft tissue injury comprises following medicine: Rhizoma Coptidis, Cortex Phellodendri, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi), Alumen, Mentholum, make dosage forms such as water preparation, ointment, plaster or membrane.
2. the medicine for external use of treatment soft tissue injury according to claim 1 is characterized in that the weight ratio of each medicine is: 10～20 parts of Rhizoma Coptidis, 8～15 parts of Cortex Phellodendris, 8～15 parts of Fructus Gardeniaes, 8～15 parts of Radix Arnebiae (Radix Lithospermi)s, 2～5 parts of Alumens, 0.05～0.1 part of Mentholum.
3. the medicine for external use of treatment soft tissue injury according to claim 1 is characterized in that the preferential weight ratio of each medicine is: 12～18 parts of Rhizoma Coptidis, 10～12 parts of Cortex Phellodendris, 10～12 parts of Fructus Gardeniaes, 10～12 parts of Radix Arnebiae (Radix Lithospermi)s, 3～4 parts of Alumens, 0.07～0.08 part of Mentholum.
4. the medicine for external use of treatment soft tissue injury according to claim 1 is characterized in that medicine of the present invention is the external water preparation.
5. according to the medicine for external use of claim 1 or 4 described treatment soft tissue injurys, it is characterized in that adding solubilizing agent in the external water preparation of the present invention.
6. treat the medicine for external use of soft tissue injury according to claim 1 or 5, the solubilizing agent that it is characterized in that external water preparation of the present invention is a glycerol.
7. the medicine for external use of treatment soft tissue injury according to claim 1 is characterized in that adding antiseptic in the external water preparation of the present invention.
8. according to the medicine for external use of claim 1 or 7 described treatment soft tissue injurys, the antiseptic that it is characterized in that external water preparation of the present invention is an ethylparaben.
9. according to the medicine for external use of claim 1 or 4 described treatment soft tissue injurys, the best proportioning that it is characterized in that external water preparation of the present invention is: Rhizoma Coptidis 15.96kg, Cortex Phellodendri 11.4kg, Fructus Gardeniae 11.4 kg, Radix Arnebiae (Radix Lithospermi) 11.4kg, Alumen 3.42kg, Mentholum 0.09kg, glycerol 45.87kg, ethylparaben 0.46kg add water and are made into 230～920 premium on currency agent.
10. according to the medicine for external use of claim 1 or 4 described treatment soft tissue injurys, it is characterized in that external water preparation of the present invention also adds Percutaneous absorption enhancer.
11. the production method as the external water preparation of claim 1 treatment soft tissue injury may further comprise the steps:
A. get Rhizoma Coptidis, Cortex Phellodendri, Fructus Gardeniae pulverizing, add 10 times of amount 70% alcohol heating reflux 2 times, filter, filtering residue discards;
B. get Radix Arnebiae (Radix Lithospermi) in addition and be cut into 1～2cm segment, add 10 times of amount 70% alcohol at normal temperature and soak 2 times, filter, filtering residue discards;
C. Rhizoma Coptidis, Cortex Phellodendri, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi) filtrate are merged, reclaim ethanol, add Alumen to the greatest extent;
D. get Mentholum, ethylparaben and add after with a small amount of 95% dissolve with ethanol, capacity transfer fully stirs to 90～93% of capacity, leaves standstill 24 hours in 0～4 ℃, and filter press adds glycerol again, fully stirs;
E. use the microporous filter membrane degerming, aseptic subpackaged, get product.
12. the production method of the external water preparation of treatment soft tissue injury according to claim 11, the aperture that it is characterized in that microporous filter membrane are 0.45 μ m.
13. the production method of the external water preparation of treatment soft tissue injury according to claim 11, it is characterized in that pondage to 90～93% after, regulating pH is between 3.7～4.0.
14. the production method of the external water preparation of treatment soft tissue injury according to claim 11 is characterized in that Rhizoma Coptidis of the present invention, Cortex Phellodendri, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi) use water extraction.
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| CN101195010B (en) * | 2007-12-11 | 2011-09-21 | 徐欢欢 | Powder medicament for treating acute soft tissue injury |
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Family Cites Families (2)
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| NZ225473A (en) * | 1987-08-10 | 1990-02-26 | Ishihara Sangyo Kaisha | Herbicidal compositions containing sulphonylurea derivatives and known herbicides |
| CN1127129A (en) * | 1995-01-16 | 1996-07-24 | 徐永林 | External application medicine for burn and scald and preparing method |
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