CN103933227B - Chinese herbal preparation for treating acute soft tissue injury and preparation method thereof - Google Patents

Abstract

The invention discloses a Chinese herbal preparation for treating acute soft tissue injury and a preparation method thereof. The Chinese herbal preparation is prepared from chicken, teasel root, Chinese birch root and bark, rhzizoma drynariae, earthworm, polygonum cuspidatum, cortex lycii radicis, cape jasmine fruit, semen strychni and musk. The Chinese herbal preparation disclosed by the invention has good effects of clearing heat for detumescence, dispersing blood stasis and relieving pain, is exact in curative effect for clinically treating the acute soft tissue injury, has total effective rate of 95.59% and good safety.

Description

It is a kind of to treat Chinese medicine preparation of acute soft tissue injury and preparation method thereof

Technical field

The present invention relates to technical field of Chinese medicines, more particularly to a kind of Chinese medicine preparation for treating acute soft tissue injury and its Preparation method.

Background technology

In recent years, with social industry, the development of communication, the generation of traumatic incidents is and acute also increasing year by year Soft tissue injury is one of its modal complication.Acute soft tissue injury is orthopedics department common clinical, frequently-occurring disease, is referred to A series of disease of pathological changes that various causative factors of injury act on body and cause soft tissue, cause muscle, ligament, fascia, The acute closed property at the positions such as stndon sheath, articular cartilage, joint capsule, synovial bursae is damaged.Its pathological change with topical acute inflammation with Repair as principal character.Clinic is mainly shown as local swelling, pain, dysfunction, livid purple stasis of blood class etc..Acute soft tissue injury Often generate heat because blood stasis are detained so that stagnation of blood stasis and heat, the pathogenesis for having " blood stasis heating ", therefore qi depression to blood stasis, venation is got along well, and tendon and vessel hinders Stagnant is the pathogenesis of the acute injury of tendon and muscle, therefore treats the acute injury of tendon and muscle, should directly act on local with clearing heat for detumescence, the medicine of blood-activating analgetic, Can make that blood stasis speed is gone, swelling pain is eliminated as early as possible.

Herbal pharmacology research shows that the swelling pain to damaging early stage appearance, activating blood and removing stasis drug can be controlled and slowed down Inflammatory reaction, absorbs oozing out caused by inflammatory reaction, congested and edema, mitigates the stimulation to terminationes nervorum liberae, while carrying High pain threshold, so as to play a part of reducing swelling and alleviating pain.There are some researches show that blood circulation promoting and blood stasis dispelling can reduce the permeability of blood capillary, subtract Few inflammatory seep and erythrocyte leakage, recover local blood circulation, improve the rheological characteristic and microcirculation disturbance of blood, so as to change Kind histanoxia state, enhances metabolism, and accelerates histiocyte reparation.

Modern medicine has to the primary treatments of acute soft tissue injury:Wrapping, partial closure, physical therapy etc., these Method curative effect is not good enough, and rehabilitation duration is longer.

The content of the invention

The technical problem to be solved is to provide a kind of highly concentrated, viscous, poly-, solidifying with soft tissue injury is significantly reduced State, suppresses platelet aggregation and antithrombotic effect, improves microcirculation, and the one kind for promoting the reparation of injury tissue is controlled Treat Chinese medicine preparation of acute soft tissue injury and preparation method thereof.

In order to solve above-mentioned technical problem, the present invention is adopted the following technical scheme that：It is young by chicken（Just go out shell, 21 It or so, Gallus Domesticuss kind is best）100~200g, 70~150g of Radix Dipsaci, Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. 70~150g of root bark, Rhizoma Drynariae 70~ 150g, 5~15g of Pheretima, 30~70g of Rhizoma Polygoni Cuspidati, 30~70g of Cortex Lycii, 30~70g of Fructus Gardeniae, 5~15g of Semen Strychni, Moschus 0.3~0.8g is prepared from.

Preferably：It is young by chicken（Shell is just gone out, 21 days or so, Gallus Domesticuss kind was best）150g, Radix Dipsaci 100g, water winter Melon root bark 100g, Rhizoma Drynariae 100g, Pheretima 10g, Rhizoma Polygoni Cuspidati 50g, Cortex Lycii 50g, Fructus Gardeniae 50g, Semen Strychni 10g, Moschus 0.5g It is prepared from.

A kind of preparation method of the Chinese medicine preparation for treating acute soft tissue injury of aforementioned therapies：By chicken son, Pheretima, Moschus 50~70 DEG C of crushed after being dried cross 120 mesh sieves, and it is standby outer to obtain fine powder, remaining Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark, Rhizoma Drynariae, Radix Dipsaci, Fructus Gardeniae, tiger The taste medicine of cane, Cortex Lycii, Semen Strychni etc. 7, plus 4 times of amount 50~75% alcohol reflux three times, 1.5~2 hours every time, filtration was closed And filtrate, reclaim ethanol and be evaporated to relative density for 1.35（60℃）Thick paste；Take above-mentioned thick paste and chicken it is young, Dragon, Moschus fine powder, sequentially add by sodium polyacrylate（200g）, gelatin（900 g）, glycerol（980 g）, dihydroxyaluminum aminoacetate（20 g）、 Ethyl hydroxybenzoate（20g）Made by substrate, after stirring, coating, lid lining, section is made 1000 patches and is obtained final product.

Effect of the present invention：Clearing heat for detumescence, blood-activating analgetic.

Trade name of the present invention：Hu Shi Embryo Gallus domesticus Pheretima cream

The present invention main component be chicken son, Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark, Rhizoma Drynariae, Radix Dipsaci, Pheretima, Fructus Gardeniae, Rhizoma Polygoni Cuspidati, bone Skin, Semen Strychni, Moschus.Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark, Radix Dipsaci, Rhizoma Drynariae are bitter, tremble with fear, and belong to water medicine, with the effect of heat clearing away, promoting blood circulation to remove obstruction in the collateral with Clearing heat for detumescence pain relieving is principal agent；Pheretima, Fructus Gardeniae, Rhizoma Polygoni Cuspidati, Cortex Lycii are bitter, tremble with fear, and are ministerial drug with heat-clearing and toxic substances removing, and Pheretima assistant helps the water winter Melon root bark clearing heat for detumescence；Fructus Gardeniae, Rhizoma Polygoni Cuspidati, slight bitter is slightly cold, heat-clearing and toxic substances removing, eliminating stasis to stop pain；Cortex Lycii slight bitter, is slightly cold, and heat clearing away is cool Blood；All medicines play altogether clearing heat for detumescence in the assistant side of helping, and the work(of blood-activating analgetic, Semen Strychni is bitter, cold, severe toxicity, treating the poisonous disease with poisonous drugs, clearing away heat to alleviate pain； Moschus promoting blood circulation to remove obstruction in the collateral, dissipating blood stasis auxiliary water Fructus Benincasae root bark, Radix Dipsaci, Rhizoma Drynariae, Pheretima, Fructus Gardeniae, Rhizoma Polygoni Cuspidati, Cortex Lycii etc. are main, all medicines of minister To strengthen clearing heat for detumescence, the effect of blood-activating analgetic；The happiness in love product chicken son's righting qi-restoratives of flesh and blood.More than all medicines in accordance with master, Minister, auxiliary Shui nationality medicine combination principle, prescription is rigorous, and cautiously grasping pathogenesises are that evil side is attacked in external, and clearing heat for detumescence is played altogether, and blood stasis dispelling stops The effect of pain.

Prescription of the present invention is that Shui nationality doctor replaces according to life, day-night change based on the extreme misery theory of Shui nationality medicine And the fluctuation of river, sum up Yi Shui and the transaction attribute that fire is outline, it is believed that：It is every with flowing downward, liquid, quilt Dynamic, sombrely dark, static things is mostly aqueouss；Every rising, sunlight, bright, warm, changeable belong to fire Property, tentatively generate the concept of negative and positive.Hydrothermal coordination, all things on earth is gentle；Extreme misery is lacked of proper care, and all things on earth is mutually damaged；Extreme misery specific object is showed For extreme misery, clinic card marquis's performance extreme misery, rule for the treatment of Heibei provincial opera extreme misery, correction prosperity and decline.It is big that the Shui nationality people are divided into gunpowder, water medicine two medicine Class.Principle of medication is calentura water medicine, cold disease gunpowder.In medicinal flavor classification, i.e. acrid in the mouth, temperature, sweet, numb, fragrant, peppery Medicine belongs to gunpowder；All nature and flavor are cold, cool, sour, puckery, bitter, salty category water medicine.Shui nationality medicine bone injury diagnosis and treatment are unbalance as core theory with extreme misery, Card marquis's performance extreme misery, rule for the treatment of Heibei provincial opera extreme misery corrects prosperity and decline, regards the heart upper as sun, and kidney is lower for the moon.The state of water is cold and cool, fortune Line direction is descending, and pictograph is water, and it is kidney that internal organs are corresponding；The state of fire is hot, and traffic direction is up, and pictograph is Fire, it is heart that internal organs are corresponding.Acute soft tissue injury cures the category of category " muscle and tendon injury " in water, is that, due to qi depression to blood stasis, blood stasis is sent out Heat, venation discord, tendon and vessel retardance is that caused by the pathogenesis of the acute injury of tendon and muscle, many passivity of acute soft tissue injury or sharp sexual violence are caused injury, Wound or impact injury are flutterred including abrading, spraining, dampen, fall, the tear bleeding of human body local subcutaneous soft tissue is caused or is oozed out.Clinical table It is now pain, swelling, dysfunction.Shui nationality medicine thinks that acute soft tissue injury belongs to fiery disease（Calentura）, treatment employing mostly Water medicine.Therapeutic Principle is " controlling heat with water ".

【Medical material standard】

1. chicken son has just gone out shell, and 21 days or so, Gallus Domesticuss kind was best.

2. Radix Dipsaci this product is the dry root of Dipsacaceae plant Radix Dipsaci Dipszcus asper Wall.ex.Quality Standard referring to《Pharmacopoeia of People's Republic of China》Specify under " Radix Dipsaci " item in 2010 editions.

3. Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark this product is Cornaceae plant torricellia angulata Toricellia angulata Oliv. Var. the dry root skin of intermedia (Harms) Hu.Quality standard referring to《Guizhou Province's Chinese crude drug. Ethnic crude drugs quality mark It is accurate》Specify under 2003 editions " Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. skin " items.

4. Rhizoma Drynariae this product is Plants of Polypodiaceae Mongolian oak Herba pteridii latiusculi Drynaria fortunei（Kunze）J.Sm. dry root Stem.Quality standard referring to《Pharmacopoeia of People's Republic of China》Specify under " Rhizoma Drynariae " item in 2010 editions.

5. Pheretima this product is Ju Yin sections animal Pheretima aspergillum Pheretima aspergillum (E.Perrier), leads to Popular Pheretimatschiliensis Pheretim, a vuLgaris Chen, power simulation Pheretima guillelmi (Michaelsen) or The dry body of the blind Pheretimatschiliensis Pheretimapectini fera Michaelsen of comb.Quality standard referring to《Chinese people's republicanism State's pharmacopeia》Specify under " Pheretima " item in 2010 editions.

6. Rhizoma Polygoni Cuspidati this product is the dry root of polygonaceae plant Rhizoma Polygoni Cuspidati Polygonum CU3pidatum Sieb. etZucc. Stem and root.Quality standard referring to《Pharmacopoeia of People's Republic of China》Specify under " Rhizoma Polygoni Cuspidati " item in 2010 editions.

7. Cortex Lycii this product is the root bark of Fructus Lycii Lycium chinense Mill..Quality standard referring to《Middle Chinese People republic pharmacopeia》Specify under " Cortex Lycii " item in 2010 editions.

8. Fructus Gardeniae this product is the drying and ripening fruit of Maguireothamnus speciosus Fructus Gardeniae Gardenia jasminoides Ellis It is real.Quality standard referring to《Pharmacopoeia of People's Republic of China》Specify under " Fructus Gardeniae " item in 2010 editions.

9. Semen Strychni this product is Semen Strychni Strychnos nux-vomica L. seeds.Quality standard referring to《Middle Chinese People republic pharmacopeia》Specify under " Semen Strychni " item in 2010 editions.

10. Moschus this product Moschus moschiferouss section animal, is such as dried secretion in the ripe male body note capsule of woods Moschus moschiferouss, horse Moschus moschiferouss or former Moschus moschiferouss Thing.Quality standard referring to《Pharmacopoeia of People's Republic of China》Specify under " Moschus " item in 2010 editions.

Present invention treatment acute soft tissue injury experimentation

1 materials and methods

1.1 medicine

1. Hu Shi Embryo Gallus domesticus Pheretima cream：By chicken son, Radix Dipsaci, Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark, Rhizoma Drynariae, Pheretima, Rhizoma Polygoni Cuspidati, Cortex Lycii, mountain Cape jasmine, Semen Strychni, Moschus Chinese medicine composition.Specification:7.0cm × 7.0cm, is provided by the In Qiannan hospital of traditional Chinese hospital of Guizhou Province Drug Manufacturing Room.② The strange pain cream that just disappearing:Mainly it is made up of Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensiss, Rhizoma Curcumae Longae, Cacumen Myricariae Germanicae etc., by Qizheng Tibetan Medicine, group provides, Chinese medicines quasi-word Z54020113。

Modeling and packet take rat 240, male and female half and half, and 8% sodium sulfide depilatory of 24h is sloughed left back before test Calf hair, is then divided at random 2 big groups, and per big group 6 groups, 20 per group are divided at random again.Matched group, model group, Positive control drug is very just disappearing pain cream group (0.65g/kg crude drugs are 3.7 times of clinical equivalent dosage) and Hu Shi Embryo Gallus domesticus Pheretima cream 0.50g/kg crude drugs, be clinical equivalent dosage, 3 times of dose,equivalent.In addition to matched group, remaining each group rat, difference side position It is fixed on soft tissue beating device, selects soft tissue on the outside of left back mid calf to carry out labelling, 200g is beaten into acute soft tissue The duplication of damage model, hammer is pulled to 30cm height, peening hammer is unclamped at alignment mark and freely falls strike soft tissue by its, Continuous strike 5 times, causes topical acute soft tissue injury.Each group carries out being externally applied to affected part using relative medicine.Treatment time is 7 days.

.3 Plasma Viscosity detection randomly selects rat 4 in the 1st, 2,3,5,7 days each groups respectively, carries out blood preparation Plasma Viscosity inspection is made in collection.Blood drawing injection anticoagulant heparin centrifuge tube.It is centrifuged 15 minutes with 3,000r.Using R28A type blood Viscosity test instrument is tested.

Tectology is checked after the completion of every group of animal blood taking, each group animal carried out respectively apparent outside soft tissue injury Examine and histological observation scoring, scoring finishes quick execution, takes 10% formaldehyde of centre of percussion area skin and muscular tissue and consolidates It is fixed, specimens paraffin embedding slices, HE dyeing, om observation wound local subcutaneous tissue, muscular tissue and traumatic aseptic are scorching The pathological manifestations such as disease reaction.

The all numerical value that determine of statistical method represent that each group mean difference is using side with means standard deviation (x ± s) Difference analytic process.

As a result

Impact of the 2.1 Hu Shi Embryo Gallus domesticus Pheretima cream to rat soft tissue histological scores

Hu Shi Embryo Gallus domesticus Pheretima cream group rat soft tissue histological scores compare with model group, difference it is statistically significant (P <0.01)；Pain cream group compares with very just disappearing, and difference is also statistically significant（P＜ 0.01）.It is shown in Table 1.

Impact of the Hu Shi Embryo Gallus domesticus Pheretima cream to acute soft tissue injury hemorheology of rat

Compare with matched group, model group items hemorheology index is significantly raised, and erythrocyte electrophoretic time extends (P<0.01), point out after acute soft tissue injury, blood is in high viscous, dense, poly-, solidifying state.

Compare with model group, the Hu Shi Embryo Gallus domesticus Pheretima cream and positive control medicine pain cream items hemorheology that very just disappearing refers to Mark compare with model group, difference it is statistically significant (P<0.01)；Show Hu Shi Embryo Gallus domesticus Pheretima cream and very just disappearing pain cream can Different degrees of reduction rat whole blood, plasma viscosity, fibrinogen content, packed cell volume, slows down erythrocyte sedimentation rate, reduces Erythrocyte sedimentation rate K values, shortening erythrocyte electrophoretic time (P<0.01), point out：Hu Shi Embryo Gallus domesticus Pheretimas cream can substantially reduce acute soft tissue Damage rat blood is highly concentrated, viscous, poly-, solidifying state, improves its hemorheological property.Hu Shi Embryo Gallus domesticus Pheretimas cream reduction rat whole blood, Plasma viscosity, fibrinogen content, packed cell volume, slow down erythrocyte sedimentation rate, reduce erythrocyte sedimentation rate K values, shorten erythrocyte electrophoresises Time compares respectively with the pain cream group that very just disappearing, it is different it is statistically significant (P<0.01)；The effect of Hu Shi Embryo Gallus domesticus Pheretima cream groups is excellent In the pain cream group that very just disappearing (P<0.01).Table 2.

Impact of the Hu Shi Embryo Gallus domesticus Pheretima cream to acute soft tissue injury rat platelet aggregation activity

Hu Shi Embryo Gallus domesticus Pheretima cream group and very just disappearing pain cream group adenosine diphosphate (ADP) and thrombin maximum agglutination rate and model group ratio Statistically significant compared with, difference (P<0.01)；Hu Shi Embryo Gallus domesticus Pheretima cream group and the pain cream group that very just disappearing can be different degrees of make Maximum platelet aggregation rate be decreased obviously (P<0.01) ；The effect of Hu Shi Embryo Gallus domesticus Pheretima cream groups better than the pain cream group that very just disappearing (P< 0.01).Table 3.

Hu Shi Embryo Gallus domesticus Pheretima cream is on the thrombotic impact of acute soft tissue injury rats in vitro

Compare with matched group, model group thrombus length, wet weight of thrombus and dry weight all substantially increase (P<0.05 orP <0.01) .Compare with model group, what Hu Shi Embryo Gallus domesticus Pheretima cream and positive control drug were very just disappearing that pain cream can be different degrees of makes body Outer thrombosis length, wet weight of thrombus and dry weight substantially reduce (P<0.05 orP<0.01) .Table 4.

Conclusion：

With significantly reducing, soft tissue injury rat blood is highly concentrated, viscous, poly-, coagulate state for Hu Shi Embryo Gallus domesticus Pheretimas cream side, suppresses Platelet aggregation and antithrombotic effect, improve microcirculation, promote the reparation of injury tissue.

Clinical data

First, case selection standard

1. diagnostic criteria

Reference《New Chinese medicine treats the guideline of clinical investigations of soft tissue injury》Acute soft tissue injury diagnostic criteria: There are obvious trauma history, sharp ache, the rapid swelling in local, limb activity dysfunction；Injury tenderness substantially, may occur in which local Livid purple ecchymosis, severe patient may occur in which ecchymosiss, and the positive is levied in fluctuation；Articular sprain person has significantly sprain history, pain after wound Acutely, locally there is different degrees of swelling, ecchymosis, joint movement function obstacle；The main exclusion fracture of Assisting X-ray piece inspection, Dislocation and osteopathia etc.；MRI checks that impurities removal merges the ligament rapture for needing operative repair to treat and damages.

The traditional Chinese medical science is syndrome of qi stagnation and blood stasis：

Primary symptom：There is livid purple tired speckle or has larger hematoma in local swelling, twinge, localized pain, local skin temperature liter Height, suffering limb functional activity is limited.

Secondary disease：Purplish tongue has ecchymosis, stringy and hesitant pulse.

Diagnosis：Trauma history；Possess 2 primary symptoms；Or possess a primary symptom and any one time disease；Comprehensive picture of the tongue pulse condition can do Go out diagnosis.

2. inclusive criteria

1. above-mentioned diagnostic criteria person is met；

2. patient age 18~65 years old；

3. consultation time is apart from disease time≤48 hour；

4. damage location nonjoinder fracture, nonjoinder other visceral organ injuries.

3. exclusion standard

1. above-mentioned diagnostic criteria person is not met；

2. allergic constitution or to ingredient allergy sufferers；

3. injury region is with open wound person；

4. major injury, there is ecchymosiss fluctuation person；

5. other blood circulation promoting medicines and associated treatment person have been used；

6. puerpera or anemia of pregnant woman and with the disease patient such as liver, kidney, disease of hematopoietic system, psychosiss, tuberculosis；

7. exclude patients with fractures, joint dislocation and tendon, ligament to rupture completely or open injury person；

8. not by regulation medication, it is impossible to judge curative effect, or data is not congruent affects the treatment or safety judgement person.

4. research standard is terminated

1. (voluntarily exit and do not come in time institute further consultation person including patient) lost to follow-up;

2. occurs the local skin discomfort person that is unable to continual cure in testing;

3. occurs serious other complications person during clinical trial;

4. lack curative effect or primary symptom deteriorate, must the person of taking urgent measure

5. testing program person (poor including compliance) is run counter to.

2nd, therapeutic scheme

1. it is grouped

Go to a doctor in the orthopedics department outpatient service of the In Qiannan hospital of traditional Chinese hospital and ward during selection 09 month~in March, 2014 in 2012 acute Meet the patient of syndrome of qi stagnation and blood stasis in soft tissue injury, totally 660, using the method for scale trials, be randomly divided into Treatment group 240, wherein man 150, female 90；18~63 years old age, average 35.88 ± 13.27 years old；Disease classification：Ankle Articular sprain 32, sprain of knee joint 26, sprain of shoulder joint 28, elbow joint sprain 17, sprain of carpal joint 19 Example, lumbar sprain 35, contusion of upper limb 21, contusion of lower limb 20, waist dampens 19, and chest dampens 23；Medicine Matched group 220, man 135, female 85;18~64 years old age, average 35.47 ± 12.88 years old;Disease classification:Ankle is closed Section sprains 21, sprain of knee joint 28, sprain of shoulder joint 22, elbow joint sprain 20, sprain of carpal joint 18 Example, lumbar sprain 28, contusion of upper limb 18, contusion of lower limb 26, waist dampens 19, and chest and back dampens 20； Blank control group 200, man 126, female 74;18~64 years old age, average 35.42 ± 13.89 years old;Disease classification: Sprained ankle 16, sprain of knee joint 22, sprain of shoulder joint 21, elbow joint sprain 19, sprain of carpal joint 17, lumbar sprain 25, contusion of upper limb 16, contusion of lower limb 25, waist dampens 20, and chest and back dampens 19.Three Sex between group, the age, the course of disease, disease, degree of injury there are no significant difference (P >0.05), with comparability.

2. treat

（1）Treatment group：Hu Shi Embryo Gallus domesticus Pheretima cream main component be Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark, Rhizoma Drynariae, Radix Dipsaci, Fructus Gardeniae, Rhizoma Polygoni Cuspidati, Cortex Lycii, Semen Strychni, chicken son, Pheretima, Moschus etc. are constituted, and are taken Hu Shi Embryo Gallus domesticus Pheretimas cream and are persistently externally applied in right amount at patient's swelling, and 1 Times/day；（2）Drug control group：Treated using SHEXIANG ZHUIFENG GAO（Authentication code：Suizhou Pharmaceutical Co., Ltd., Jianmin Group, Wuhan City There is provided）1 times/day；（3）Blank control group：Any external application reducing swelling and alleviating pain medicine is not used.Simultaneously three groups use identical physical therapy Treat Deng based on.Drug therapy is prohibitted the use of during three groups of treatments.Treatment course is 14 days.Observe and record before treatment, control Treat clinical symptoms change situation and the skin irritation situation of the 1st, 5,7,14 day；If there is local untoward reaction, phase is given immediately Should process or discontinue medication, and give record.

3rd, observation index：

1. safety observation

Once, such as there is the exception of test index in each detection before medication and at the end of the course for the treatment of in process of the test, should check To normal.

（1）General physical examination；

（2）Three is big conventional；

（3）Renal function (blood urea nitrogen, creatinine), liver function (glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT), blood pressure, electrocardiogram；

（4）The untoward reaction being likely to occur：Patient's private prosecution untoward reaction（It is such as dizzy, uncomfortable in chest）And dermoreaction observation （It is rubescent, itch, pimpling）.

2. clinical symptoms are integrated：

（1）Pain scores：Clinically the method that the main body of pain is evaluated and tested and quantified there are into many kinds, and visual simulation is commented VAS methods (visual analogue scale) are divided to be the most commonly used and simple and easy to do in current clinical research, VAS methods can Change procedure that is relatively more directly perceived, delicately reflecting pain and its degree alleviated or increase.In domestic clinically usual employing The VAS cards that magnificent medical association supervises, the card is a line diagram, is divided into 10 grades, and numeral is bigger, represents that pain intensity is bigger, Card two ends indicate respectively " without pain " (0) and " most violent pain " (10).Pain mechanism, table are explained using front to patient Method and using method are stated, tells that patient assesses exactly the pain of oneself.VAS evaluation criterias：0 point is without pain, counts 0 point； 1-4 point is mild pain, counts 2 points；5-7 point is moderate pain, counts 4 points；8-10 point is severe pain, counts 6 points；10 points is violent Pain.Primary data, and the 1st, 5,7,14 day difference record data after the treatment are recorded when being equally admitted to hospital from patient.

（2）Swelling scores：Using chi mark method, and make comparisons with strong side, surveyed centered on the most obvious place of injured limb swelling Two groups of suffering limbs are measured every time by amount limb circumference, calculate the swelling situation of different time sections, and record score value.1. receive Injury is without swelling (0 point)；2. tissue slightly swelling, skin texture is slightly shallow, and limb circumference is more than strong side 0.5-1cm (2 points)；3. swell Swollen substantially skin texture substantially shoals, and limb circumference is more than strong side 1.1-2.0cm (4 points)；4. serious swelling, epidermis is shinny, Skin texture disappears, or even Tension blister occurs, and limb circumference is more than strong more than side 2.1cm (6 points).Record when being admitted to hospital from patient Initial data, and in instant, the 1st, 5,7,14 day difference record data of being admitted to hospital.

（3）Tenderness:1. injury counts 0 point without tenderness;2. injury local counts 2 points by pain is pressed with;3. it is injured Pressing pain in place local substantially, counts 4 points;4. the obvious tenderness of injury local tenderness, counts 6 points.Record when being admitted to hospital from patient former Beginning data, and in instant, the 1st, 5,7,14 day difference record data of being admitted to hospital.

(4) ecchymosis:1. injury counts 0 point without ecchymosis;2. injury local is dispersed in ecchymosis, counts 2 points;3. it is injured The livid purple ecchymosis of place's small pieces, counts 4 points;4. the large stretch of purple dark ecchymosis of injury, counts 6 points.Initial data is recorded when being admitted to hospital from patient, And in instant, the 1st, 5,7,14 day difference record data of being admitted to hospital.

(5) dysfunction:1. nonfunctional obstacle, counts 0 point;2. dysfunction or joint are limited less than 30%, meter 2 Point;3. dysfunction or joint are limited in 30% -50%, count 4 points;4. dysfunction or limited more than more than 50%, counts 6 points. Initial data is recorded when being admitted to hospital from patient, and in instant, the 1st, 5,7,14 day difference record data of being admitted to hospital.

（6）Total effective rate=clinical cure case load+effective case load+effective case load/total case load × 100%.

4th, evaluation criteria

Reference《New Chinese medicine guideline of clinical investigations》：It is divided into clinical recovery, effective, effective, invalid.Product before and after treatment The difference of score value shows that sings and symptoms improves degree, and improvement degree is calculated with improvement rate.Improved using nimodipine method Rate=（Integrate after integration-treatment before treatment）Integration × 100% before/treatment.

（1）Clinical recovery standard：The symptoms such as pain, swelling, somatic feature score reduce >=95%, and functional activity is normal, can make each Plant activity；

（2）Effective standard:The symptoms such as pain, swelling, somatic feature score reduce >=70%,<95%, functional activity light restraint, It is dumb, can be engaged in vairious activities;

（3）Effective standard:The symptoms such as pain, swelling, somatic feature score reduce >=30%,<70%, functional activity is substantially movable It is limited, but take care of oneself, general activity can be engaged in;

（4）Null criterion:The symptoms such as pain, swelling, somatic feature score are reduced<30%, functional activity is unchanged, and severe is limited, Movable function is lost, and can't take care of oneself.

5th, statistical analysis technique

All of statistical test adopts two-sided test,PValue has statistics less than 0. 05 by checked difference is considered as Meaning.Measurement data will carry out statistics description using mean scholar standard deviation, when meeting homogeneity of variance, be checked using t;Such as it is unsatisfactory for During homogeneity of variance, then using nonparametric autumn and inspection.Enumeration data adopts χ²Test, Ridit is analyzed.To be united using SPSS12. 0 Meter software is calculated.

6th, result judges

1. the total Clinical efficacy comparison treatment group clinical cure of three groups of treatments, effective, effective, Ineffective Cases number and it is total effectively Rate compares respectively with blank control group, and difference is statistically significant（P＜ 0.01）；Drug control group clinical cure, it is effective, have Effect, Ineffective Cases number and total effective rate compare respectively with blank control group, and difference is statistically significant（P＜ 0.01）；Treatment Group clinical cure, effective case load compare with drug control group, and difference is statistically significant（P＜ 0.01）, treatment group always has Efficiency compares with drug control group, no significant difference（P＞ 0.05）, treatment group's clinical cure case is more than drug control Group and blank control group.

2. when the Relationship Comparison treatment group of three groups for the treatment of times and curative effect is with drug control group and identical blank control group Between compare, have significant difference（P＜ 0.01）, illustrate treatment group's effect better than drug control group and blank control group.It is shown in Table 2.

3. total effective rate is poor without significance between three groups of different diseases disease different from the Relationship Comparison treatment group of curative effect It is different, illustrate that Hu Shi Embryo Gallus domesticus Pheretima cream cream is suitable to extremity injury, lumbar sprain and contusion clinical efficacy.

4. three groups of different time point symptoms, three groups of patients of comparison of sign total mark before the treatment always accumulate by symptom, sign Divide and compare, no significant difference（P＞ 0.05）；When treating the 1st, 5,7,14 day, treatment group's symptom, sign total mark point Do not compare with drug control group and blank control group, difference is statistically significant（P＜ 0.01）, illustrate that treatment group's treatment improves Clinical symptoms effect is better than drug control group and blank control group.It is shown in Table 4.

5. in treatment clinical course, there are not adverse events in Hu Shi Embryo Gallus domesticus Pheretima cream groups, and three is big after treatment for untoward reaction There are not abnormal resulties in conventional, hepatic and renal function and Electrocardioscopy, and Hu Shi Embryo Gallus domesticus Pheretima cream clinical application safeties are good.

7th, conclusion

Treatment group 240, clinical cure 156, effective 36, effective 35, invalid 13, total effective rate is 95.59%；Drug control group 220, clinical cure 87, effective 47, effective 66, invalid 20, total effective rate is 90.91%；Blank control group 200, clinical cure 17, effective 39, effective 58, invalid 86, total effective rate is 57.00%；Treatment group's clinical cure, effective case load compare with drug control group, and difference is statistically significant（P＜ 0.01）, Treatment group's total effective rate compares with drug control group, no significant difference（P＞ 0.05）, treatment group's clinical cure case is more In drug control group and blank control group.Treatment group's clinic total effectses are suitable with drug control group.Whole therapeutic process does not occur There are not abnormal resulties in adverse events, three big conventional, biochemical analysis and Electrocardioscopy after treatment.

The effect of Hu Shi Embryo Gallus domesticus Pheretimas cream side has good clearing heat for detumescence, blood-activating analgetic.Clinical treatment is acute soft group Damage determined curative effect is knitted, and safety is good.

Specific embodiment：

Embodiment 1：Raw material：Chicken is young（Shell is just gone out, 21 days or so, Gallus Domesticuss kind was best）150g, Radix Dipsaci 100g, water winter Melon root bark 100g, Rhizoma Drynariae 100g, Pheretima 10g, Rhizoma Polygoni Cuspidati 50g, Cortex Lycii 50g, Fructus Gardeniae 50g, Semen Strychni 10g, Moschus 0.5g

Preparation method：Chicken son, Pheretima, 50~70 DEG C of crushed after being dried of Moschus are crossed into 120 mesh sieves, it is standby outer to obtain fine powder, The taste medicine of remaining Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark, Rhizoma Drynariae, Radix Dipsaci, Fructus Gardeniae, Rhizoma Polygoni Cuspidati, Cortex Lycii, Semen Strychni etc. 7, adds every time 4 times of amounts 50~75% Alcohol reflux three times, 1.5~2 hours every time, filtration, merging filtrate reclaimed ethanol and is evaporated to relative density and is 1.35（60℃）Thick paste；Above-mentioned thick paste and chicken son, Pheretima, Moschus fine powder are taken, is sequentially added by sodium polyacrylate（200g）、 Gelatin（900 g）, glycerol（980 g）, dihydroxyaluminum aminoacetate（20 g）, ethyl hydroxybenzoate（20g）Made by substrate, after stirring, Coating, lid lining, section is made 1000 patches and is obtained final product.

Embodiment 2：Raw material：Chicken is young（Shell is just gone out, 21 days or so, Gallus Domesticuss kind was best）100g, Radix Dipsaci 70g, water winter Melon root bark 70g, Rhizoma Drynariae 70g, Pheretima 5g, Rhizoma Polygoni Cuspidati 30g, Cortex Lycii 30g, Fructus Gardeniae 30g, Semen Strychni 5g, Moschus 0.3g

Preparation method：Chicken son, Pheretima, 50~70 DEG C of crushed after being dried of Moschus are crossed into 120 mesh sieves, it is standby outer to obtain fine powder, The taste medicine of remaining Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark, Rhizoma Drynariae, Radix Dipsaci, Fructus Gardeniae, Rhizoma Polygoni Cuspidati, Cortex Lycii, Semen Strychni etc. 7, adds every time 4 times of amounts 50~75% Alcohol reflux three times, 1.5~2 hours every time, filtration, merging filtrate reclaimed ethanol and is evaporated to relative density and is 1.35（60℃）Thick paste；Above-mentioned thick paste and chicken son, Pheretima, Moschus fine powder are taken, is sequentially added by sodium polyacrylate（200g）、 Gelatin（900 g）, glycerol（980 g）, dihydroxyaluminum aminoacetate（20 g）, ethyl hydroxybenzoate（20g）Made by substrate, after stirring, Coating, lid lining, section is made patch and is obtained final product.

Embodiment 3：Raw material：Chicken is young（Shell is just gone out, 21 days or so, Gallus Domesticuss kind was best）200g, Radix Dipsaci 150g, water winter Melon root bark 150g, Rhizoma Drynariae 150g, Pheretima 15g, Rhizoma Polygoni Cuspidati 70g, Cortex Lycii 70g, Fructus Gardeniae 70g, Semen Strychni 15g, Moschus 0.8g

Preparation method：Chicken son, Pheretima, 50~70 DEG C of crushed after being dried of Moschus are crossed into 120 mesh sieves, it is standby outer to obtain fine powder, The taste medicine of remaining Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark, Rhizoma Drynariae, Radix Dipsaci, Fructus Gardeniae, Rhizoma Polygoni Cuspidati, Cortex Lycii, Semen Strychni etc. 7, adds every time 4 times of amounts 50~75% Alcohol reflux three times, 1.5~2 hours every time, filtration, merging filtrate reclaimed ethanol and is evaporated to relative density and is 1.35（60℃）Thick paste；Above-mentioned thick paste and chicken son, Pheretima, Moschus fine powder are taken, is sequentially added by sodium polyacrylate（200g）、 Gelatin（900 g）, glycerol（980 g）, dihydroxyaluminum aminoacetate（20 g）, ethyl hydroxybenzoate（20g）Made by substrate, after stirring, Coating, lid lining, section is made patch and is obtained final product.

Claims (3)

1. a kind of Chinese medicine preparation for treating acute soft tissue injury, it is characterised in that：It is by chicken 100~200g of son, Radix Dipsaci 70~150g, Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. 70~150g of root bark, 70~150g of Rhizoma Drynariae, 5~15g of Pheretima, 30~70g of Rhizoma Polygoni Cuspidati, Cortex Lycii 30 ~70g, 30~70g of Fructus Gardeniae, 5~15g of Semen Strychni, 0.3~0.8g of Moschus are prepared from.

2. the Chinese medicine preparation of acute soft tissue injury is treated according to claim 1, it is characterised in that：It is young by chicken 150g, Radix Dipsaci 100g, Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark 100g, Rhizoma Drynariae 100g, Pheretima 10g, Rhizoma Polygoni Cuspidati 50g, Cortex Lycii 50g, Fructus Gardeniae 50g, Semen Strychni 10g, Moschus 0.5g are prepared from.

3. the preparation method of the Chinese medicine preparation of acute soft tissue injury is treated described in claim 1 or 2, it is characterised in that：Will be little Chicken son, Pheretima, 50~70 DEG C of crushed after being dried of Moschus cross 120 mesh sieves, and it is standby outer to obtain fine powder, remaining Saurauia tristyla DC. var. oldhamii (Hemsl.) Finet ＆ Gagncp. root bark, Rhizoma Drynariae, The taste medicine of Radix Dipsaci, Fructus Gardeniae, Rhizoma Polygoni Cuspidati, Cortex Lycii, Semen Strychni etc. 7, every time plus 4 times of 50~75% alcohol reflux of amount three times, every time 1.5~2 hours, filtration, merging filtrate, relative density is 1.35 thick paste when reclaiming ethanol and being evaporated to 60 DEG C；Take Thick paste and chicken son, Pheretima, Moschus fine powder are stated, is sequentially added by sodium polyacrylate 200g, gelatin 900g, glycerol 980g, sweet hydroxyl In the g of aluminum 20, substrate made by ethyl hydroxybenzoate 20g, after stirring, coating, lid lining, section is made patch and is obtained final product.