CN114028483B

CN114028483B - Pharmaceutical composition and preparation for treating chronic soft tissue injury

Info

Publication number: CN114028483B
Application number: CN202111048481.XA
Authority: CN
Inventors: 郭承军; 张晓丽; 迟明锋; 包信通; 石刚
Original assignee: Shandong Sports Rehabilitation Research Center
Current assignee: Shandong Sports Rehabilitation Research Center
Priority date: 2021-09-08
Filing date: 2021-09-08
Publication date: 2022-12-13
Anticipated expiration: 2041-09-08
Also published as: CN114028483A

Abstract

The invention relates to a pharmaceutical composition for treating chronic soft tissue injury and a preparation thereof, wherein the pharmaceutical composition for treating chronic soft tissue injury comprises the following traditional Chinese medicine raw materials in parts by weight: 1-6 parts of safflower, 3-9 parts of unprocessed radix aconiti kusnezoffii, 1-6 parts of obscured homalomena rhizome, 1-6 parts of asarum, 3-9 parts of teasel root, 3-9 parts of rhizoma drynariae, 1-6 parts of ground beeltle, 1-6 parts of notopterygium root, 1-6 parts of radix angelicae pubescentis, 1-6 parts of pericarpium zanthoxyli and 1-3 parts of borneol. The pharmaceutical composition for treating chronic soft tissue injury can meet various clinical requirements, and is prepared into a traditional Chinese medicine compound external preparation with outstanding curative effect, convenient use and small side effect. Clinical observation data show that the product has good effects of promoting blood circulation, removing blood stasis, diminishing inflammation, relieving pain, softening hard masses and resolving hard mass.

Description

Pharmaceutical composition and preparation for treating chronic soft tissue injury

Technical Field

The invention belongs to the technical field of pharmacy, and particularly relates to a traditional Chinese medicine composition and a preparation for treating chronic soft tissue injury.

Background

Chronic soft tissue injury is a clinical frequently-occurring disease, and common parts comprise four limbs, waist and back, neck, shoulders and the like, such as tennis elbow, scapulohumeral periarthritis, cervical spondylosis, lumbar vertebra pathological changes, lumbar muscle strain, patella tip end disease, achilles tendon end disease, plantar fasciitis and the like. Because the disease belongs to chronic injury, the disease course is long, the recovery is slow, and the disease incidence rate of the general population and professional athletes accounts for the first of various sports injuries. Chronic soft tissue injury is hidden, initial symptoms are not obvious, but gradually worsen along with strain, once the chronic soft tissue injury exceeds the physiological bearable limit, the normal physiological functions of joint muscles are affected, and symptoms such as limited activity, local inflammatory reaction, continuous pain and the like appear, and the symptoms are lingering and difficult to cure after appearing and are difficult to eliminate. For professional athletes, the competitive state of the athletes can be influenced, the performance of the level is influenced, the training and competition plans of the athletes are disturbed, the athletic performances are finally influenced, and even the athletes are retired in advance.

Modern medicine considers that soft tissue injury diseases refer to diseases caused by soft tissue injuries such as muscles, tendons, ligaments, fascia and joint capsules. The clinical manifestations are local pain, swelling, tenderness or combined redness of skin, followed by bluish purple, pain, etc. Soft tissue injuries can be classified into sprain, contusion and fracture according to the cause of the soft tissue injury; it can be classified into acute injury and chronic injury according to the nature of injury. Acute injury of soft tissue is acute aseptic inflammation caused by trauma. After the tissue is damaged, the tissue destroys the cell inactivation, the muscle fiber is broken, the local small blood vessel is broken, the red blood cell infiltration, the plasma factor contacts the exposed basement membrane, collagen and the like, and then the changes of a kinin system, a complement system, a blood coagulation system, a fiber system and the like are carried out, various inflammatory mediators such as histamine, 5-hydroxytryptamine, bradykinin, prostaglandin E and the like are released to cause vascular reaction, the micro blood vessel expands and becomes congested after transient contraction, the permeability of the blood vessel wall is increased, water, electrolyte and plasma protein permeate into the tissue gap, meanwhile, neutrophils, monocytes and the like overflow from the blood vessel to enter the damaged tissue gap, and the local symptoms are swelling pain and dysfunction. Chronic injuries, including chronic fatigue soft tissue injuries and chronic injuries that result from an untimely conversion of therapy after acute soft tissue injury. Chronic injury is a soft tissue injury characterized by localized inflammatory pain, induration, clavicular nodules, decreased mobility, and limited motor function. Is the inevitable result of injury, healing, re-injury and re-healing caused by local long-term overload exercise and repeated stimulation. The athlete is generally closely related to sports speciality and is a type of injury which is accompanied with sports life and always needs to be intervened and treated. Most western medicine has the main effects of relieving pain and inflammation, and the like, for example, topical 'closed' therapy with glucocorticoid is very common in athletes, and has good short-term effect, but is not suitable for long-term application, and the side effect is obvious.

The traditional Chinese medicine considers that the chronic soft tissue injury belongs to the category of muscle injury and muscle strain in the traditional Chinese medicine, and belongs to the symptoms of qi stagnation and blood stasis, arthralgia due to cold, damp arthralgia and the like in the traditional Chinese medicine. The muscle and vessel fatigue, the unsmooth circulation of qi and blood and the malnutrition of the tendons due to the frequent local activity and overwork, and the local pain caused by the obstruction of the circulation of qi and blood due to the invasion of wind-cold-dampness pathogen caused by the damaged meridians and local overwork. Chronic soft tissue injury is an occupational chronic injury. Nearly 70% of professional people suffer from low back pain, and the prevalence rate of low back pain of general people is up to 15% -20%. Because the diseases are wide and the cure is difficult, the world health organization classifies the chronic soft tissue injury as one of three difficult and complicated diseases (cancer, cardiovascular and cerebrovascular diseases and chronic soft tissue injury) in the world at present.

Disclosure of Invention

The invention aims to solve the problems and provides a traditional Chinese medicine composition and a preparation for treating chronic soft tissue injury.

In order to achieve the aim, the invention provides a traditional Chinese medicine composition for treating chronic soft tissue injury, which comprises the following traditional Chinese medicine raw materials in parts by weight: 1-6 parts of safflower, 3-9 parts of unprocessed radix aconiti kusnezoffii, 1-6 parts of obscured homalomena rhizome, 1-6 parts of asarum, 3-9 parts of teasel root, 3-9 parts of rhizoma drynariae, 1-6 parts of ground beeltle, 1-6 parts of notopterygium root, 1-6 parts of radix angelicae pubescentis, 1-6 parts of pericarpium zanthoxyli and 1-3 parts of borneol.

According to one aspect of the invention, preferably, the traditional Chinese medicine raw materials are as follows: 3 parts of safflower, 6 parts of unprocessed radix aconiti kusnezoffii, 3 parts of homalomena rhizoma, 2 parts of asarum, 6 parts of teasel root, 6 parts of rhizoma drynariae, 2 parts of ground beeltle, 2 parts of notopterygium root, 2 parts of radix angelicae pubescentis, 2 parts of pericarpium zanthoxyli and 1 part of borneol.

The invention also provides a preparation prepared from the traditional Chinese medicine composition for treating chronic soft tissue injury.

According to one aspect of the invention, the formulation is a powder, tincture, medicated wine, spray, aerosol, patch, ointment, cream or gel.

The invention also provides a preparation method of the traditional Chinese medicine composition for treating chronic soft tissue injury, which comprises the steps of weighing the traditional Chinese medicine raw materials according to the proportion of the traditional Chinese medicine raw materials in the traditional Chinese medicine composition for treating chronic soft tissue injury, cleaning, crushing, processing, or adding a solvent for extraction, refining, concentrating, and then respectively adding corresponding pharmaceutical excipients according to different preparation formulations prepared according to requirements for preparation.

The invention is based on the traditional classical prescription and is obtained by grinding and simplifying on the basis of the clinical empirical prescription summarized for professional athletes treating chronic soft tissue injury for many years. The prescription medicinal ingredients and the preparation forming process are deeply researched, the external preparation which is suitable for various clinical requirements is developed, and the traditional Chinese medicine compound external preparation with outstanding curative effect, convenient use and small side effect is prepared. Clinical observation data show that the product has good effects of promoting blood circulation, removing blood stasis, diminishing inflammation, relieving pain, softening hard masses and resolving hard mass. If the traditional Chinese medicine is matched with massage manipulation for treatment, good synergistic effect can be generated, the clinical curative effect is improved, the treatment time is saved, and the rehabilitation process is accelerated.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention or technical solutions in the prior art, the present invention is described in detail below with reference to examples, which cannot be repeated herein, but the embodiments of the present invention are not limited to the following embodiments.

The invention aims to exert the advantages of a traditional Chinese medicine compound preparation and meet the clinical requirements, and invents a pharmaceutical composition for treating chronic soft tissue injury and a preparation thereof, wherein the prepared preparation comprises the following components: powders, tinctures, vinuses, sprays, aerosols, patches, plasters, ointments, creams, gels and any other clinically or pharmaceutically acceptable external preparation.

Through years of clinical practice, based on the understanding of traditional Chinese medicine on chronic soft tissue injury, the inventor screens out a composition consisting of twelve traditional Chinese medicines such as safflower, unprocessed radix aconiti kusnezoffii, obscured homalomena rhizome, asarum, teasel root, rhizoma drynariae, ground beeltle, notopterygium root, radix angelicae pubescentis, pericarpium zanthoxyli, borneol and the like on the basis of a classical prescription, and prepares a proper external preparation which has the functions of promoting blood circulation, dredging collaterals, dispelling cold, relieving pain, softening hardness, dissipating stagnation, dispelling rheumatism and the like, and is mainly used for treating chronic soft tissue injury which is caused by incomplete treatment after acute soft tissue injury or is caused by long-term overload exercise and is characterized by local inflammatory pain, nodule, activity reduction and movement function limitation. Wherein the safflower is the monarch drug in the prescription for promoting blood circulation, removing blood stasis and relieving pain; radix Aconiti, radix Aconiti Kusnezoffii, herba asari, radix Dipsaci, rhizoma Drynariae, eupolyphaga Seu Steleophaga, radix Aconiti Kusnezoffii, herba asari with effects of dispelling pathogenic wind, eliminating dampness, warming channels, relieving pain, and promoting blood circulation; the notopterygium root, the pubescent angelica root and the pericarpium zanthoxyli are adjuvant medicaments for expelling wind-damp, dispelling cold and relieving pain; borneol is used as a guiding drug when guiding the drugs into the interior. The combination of the medicines achieves the effects of clearing and activating the channels and collaterals, dispelling cold and relieving pain, warming meridians and eliminating dampness.

Through years of clinical application of the inventor, the invention has better clinical curative effect within the following range of the mass ratio of the medicines:

1 to 6 parts of safflower, 3 to 9 parts of unprocessed radix aconiti agrestis, 1 to 6 parts of obscured homalomena rhizome, 1 to 6 parts of asarum, 3 to 9 parts of teasel root, 3 to 9 parts of rhizoma drynariae, 1 to 6 parts of ground beetle, 1 to 6 parts of notopterygium root, 1 to 6 parts of radix angelicae pubescentis, 1 to 6 parts of pericarpium zanthoxyli and 1 to 3 parts of borneol.

The medicine of the invention can obtain the best clinical curative effect when the medicine is prepared by the following components in percentage by mass:

3 parts of safflower, 6 parts of unprocessed radix aconiti kusnezoffii, 3 parts of obscured homalomena rhizome, 2 parts of asarum, 6 parts of teasel root, 6 parts of rhizoma drynariae, 2 parts of ground beeltle, 2 parts of notopterygium root, 2 parts of radix angelicae pubescentis, 2 parts of pericarpium zanthoxyli and 1 part of borneol.

The invention can be obtained by the following method, but is not to be understood as being limited to the following preparation method:

the first process comprises the following steps: mixing Carthami flos, radix Aconiti Kusnezoffii, rhizoma homalomenae, herba asari, radix Dipsaci, rhizoma Drynariae, eupolyphaga Seu Steleophaga, notopterygii rhizoma, radix Angelicae Pubescentis, fructus Zanthoxyli, and Borneolum Syntheticum, pulverizing into fine powder, and packaging. (powder agent)

And a second process: mixing Carthami flos, radix Aconiti Kusnezoffii, rhizoma homalomenae, herba asari, radix Dipsaci, rhizoma Drynariae, eupolyphaga Seu Steleophaga, notopterygii rhizoma, radix Angelicae Pubescentis, fructus Zanthoxyli, and Borneolum, pulverizing into coarse powder, grinding into superfine powder with ball mill, and packaging. (micronized powder)

And a third process: taking eleven medicinal materials of safflower, unprocessed radix aconiti kusnezoffii, homalomena occulta, asarum, teasel root, rhizoma drynariae, ground beeltle, notopterygium root, radix angelicae pubescentis, pericarpium zanthoxyli and the like, adding water for decocting for 1-3 times, combining decoctions, filtering, concentrating into thick paste, drying to obtain dry extract, and crushing to obtain the traditional Chinese medicine extract.

And a fourth process: taking eleven medicinal materials of safflower, raw radix aconiti kusnezoffii, obscured homalomena rhizome, asarum, teasel root, drynaria rhizome, ground beeltle, notopterygium root, radix angelicae pubescentis, pericarpium zanthoxyli and the like, adding water for decocting for 1-3 times, combining decoction, filtering, concentrating to obtain thick paste with the relative density of 1.05-1.30, adding ethanol to ensure that the alcohol content is 60-80%, precipitating with ethanol, refrigerating overnight, filtering, recovering ethanol from filtrate, concentrating to obtain thick paste, drying and crushing to obtain the traditional Chinese medicine extract.

And a fifth process: taking eleven medicinal materials of safflower, unprocessed radix aconiti kusnezoffii, homalomena occulta, asarum, teasel root, rhizoma drynariae, ground beeltle, notopterygium root, radix angelicae pubescentis, pericarpium zanthoxyli and the like, adding 60-80% of ethanol for reflux extraction for 1-3 times, combining extracting solutions, recovering ethanol, concentrating into thick paste, drying and crushing to obtain the traditional Chinese medicine extract.

And a sixth process: taking eleven medicinal materials such as safflower, unprocessed radix aconiti kusnezoffii, obscured homalomena rhizome, asarum, teasel root, drynaria rhizome, ground beeltle, notopterygium root, radix angelicae pubescentis, pericarpium zanthoxyli and the like, adding 60-80% of ethanol into the eleven medicinal materials such as the safflower, the asarum, the notopterygium root, the radix angelicae pubescentis and the pericarpium zanthoxyli for reflux extraction for 1-3 times, combining extracting solutions, recovering the ethanol and concentrating into thick paste for later use; decocting the rest raw materials in water for 1-3 times, mixing decoctions, filtering, concentrating into thick paste, mixing with the above thick paste, drying, and pulverizing to obtain the Chinese medicinal extract.

The present invention can be prepared into the following clinically usual external preparations, but cannot be understood as being prepared into only the following preparations.

Preparation of powder: and (4) directly taking the crushed fine powder or superfine powder and subpackaging to obtain the compound preparation as described in the first process to the second process.

Preparing a tincture: pulverizing Carthami flos, radix Aconiti Kusnezoffii, rhizoma homalomenae, herba asari, radix Dipsaci, rhizoma Drynariae, eupolyphaga Seu Steleophaga, notopterygii rhizoma, radix Angelicae Pubescentis, and fructus Zanthoxyli into coarse powder except Borneolum, placing into a percolation barrel, adding 70% ethanol, soaking for a certain time, slowly percolating, collecting percolate, adding Borneolum and appropriate amount of adjuvants, stirring to dissolve completely, mixing, filtering, and bottling. Or adding 70% ethanol solution into the Chinese medicinal extract prepared by the third to sixth processes, adding Borneolum Syntheticum and appropriate adjuvants, stirring to dissolve, filtering, and packaging.

Preparing a wine agent: taking eleven medicinal materials of safflower, unprocessed radix aconiti kusnezoffii, homalomena occulta, asarum, teasel root, rhizoma drynariae, ground beeltle, notopterygium root, radix angelicae pubescentis, pericarpium zanthoxyli and the like, pulverizing all the materials except borneol into coarse powder, putting the coarse powder into a percolation barrel, adding 50-60 degrees of white spirit, soaking for a proper time, slowly percolating, collecting percolate, adding borneol and a proper amount of auxiliary materials, stirring to completely dissolve, uniformly mixing, filtering and filling to obtain the traditional Chinese medicine composition. Adding 50-60 degree Chinese liquor into the Chinese medicinal extract prepared by the third process to the sixth process, adding borneol, stirring to dissolve, filtering and subpackaging to obtain the Chinese medicinal composition.

Preparing a spray: taking the traditional Chinese medicine extract prepared by the third to sixth processes, adding a specified amount of water or ethanol with proper concentration to completely dissolve, adding polysorbate 80, borneol and a proper amount of preservative, filtering, sterilizing and filling to obtain the traditional Chinese medicine extract.

Preparing an aerosol: adding water or ethanol with proper concentration into the Chinese medicinal extract prepared by the third to sixth processes, heating to dissolve completely, adding Borneolum Syntheticum and antiseptic, filtering, sterilizing, bottling, and injecting propellant.

Preparing a emplastrum: dissolving the Chinese medicinal extract prepared by the third to sixth processes with appropriate amount of water or ethanol to obtain soft extract, adding matrix prepared from rubber, zinc oxide, colophonium, lanoline, vaseline, methyl salicylate, and Borneolum Syntheticum, mixing, making into coating, cutting, and covering with liner.

Preparing cataplasm: adding appropriate amount of gelatin or acrylic ester, swelling completely, slowly adding the Chinese medicinal extract and Borneolum Syntheticum into the matrix, stirring, coating, and covering with lining.

Preparing a gel agent: adding appropriate amount of water into carbomer or sodium alginate, swelling completely, adjusting pH, adding appropriate amount of surfactant to obtain matrix, slowly adding the above Chinese medicinal extract and Borneolum Syntheticum into the matrix, stirring, making into gel, and packaging.

Preparing the cream: dissolving the above Chinese medicinal extract and Borneolum Syntheticum in water, filtering, adding the filtrate into water-soluble matrix composed of glycerol and propylene glycol, heating for dissolving, adding into fat-soluble solution composed of stearic acid, cera flava, white vaseline and surfactant, mixing, grinding with colloid mill, and packaging.

In order to facilitate a better understanding of the medicinal value of the invention in treating soft tissue, part of the pharmacological and clinical trial data of the invention are disclosed.

Test example 1 pharmacological tests for anti-inflammatory and analgesic effects in connection with the present invention

Pharmacological test for anti-inflammation

Experimental Material

The instrument comprises: XLS-7A foot sole volume measuring instrument (Shandong province medical science institute)

Medicine preparation: the tincture prepared by the prescription of the invention; compound dexamethasone acetate cream (specification: 20g, 15mg, huarun sanjiu medicine, ltd., lot No. 2003024X); yunnan Baiyao tincture (30 ml/bottle, yunnan Baiyao group GmbH, batch number: 20180401)

Experimental animals: wistar rats: males, weighing 140-180 g, were provided by the experimental animals center of Shandong university of traditional Chinese medicine. The experimental animal produced the license SCXK (lu) 20190004 and the experimental animal used the license SYXK (lu) 20190015. Mouse, kunming species, female, body weight: 18-22 g, and the production license of the experimental animal is SCXK (Lu) 20190006, and the use license of the experimental animal is SYXK (Lu) 20190019.

The administration method comprises the following steps: blank control group (70% ethanol solution; 4 press/time); positive control group (compound dexamethasone acetate cream, appropriate amount, coating uniformly); the tincture of the invention is prepared by taking one press as a unit, uniformly coating each press, absorbing and drying the upper press, and spraying the lower press, and comprises a high dose group (6 presses), a medium dose group (4 presses) and a low dose group (2 presses).

The experimental method comprises the following steps: 50 male rats were randomly divided into 5 groups and were first shaved on their backs by a conventional method under light anesthesia with ether, and the area was about 8cm2. The following day was divided into groups for 3 days in the depilatory area 1 time per day. After 0.5h of the last application of the medicine, a mark is drawn around the ankle joint of the right hind limb of the rat by a marking pen, and the normal value is measured by a foot sole volume measuring instrument. After completion, 0.1 ml/piece of 5% formaldehyde was injected subcutaneously into the right hind foot sole, and then the volume of the foot was measured at 1, 2, 3, 4, 5, 6h after the onset of inflammation. The results are shown in Table 1.

TABLE 1 Effect of the invention on Formaldehyde-induced inflammatory paw volume in rats: (

n＝10)

*P<0.05；**P<0.01

Pharmacological test of analgesia

The administration method comprises the following steps: blank control group (70% ethanol solution; 4 press/time); the tincture of the invention is prepared by taking one press as a unit, uniformly coating each press, absorbing and drying the upper press, and spraying the lower press, and comprises three dosage groups, namely a high dosage group (3 presses), a medium dosage group (2 presses) and a low dosage group (1 press). Positive control group (Yunnan white drug powder tincture, take one press as unit, apply, totally 4 press);

the experimental method comprises the following steps: the test mice were randomly divided into 5 groups, and the abdomen of the rat was shaved by a conventional method under light anesthesia with ether, and the area was about 4cm2. The following day in the depilation region, the above-mentioned method was applied in groups 1 time per day for 3 days. After 0.5h of the last application, i.p.0.6% acetic acid (0.1 ml/10 g) per mouse, the number of wriggling within 15min was observed immediately, and the results are shown in Table 2.

TABLE 2 Effect of the invention on mouse writhing response: (

n＝10)

**P<0.01

Pharmacological test results show that the traditional Chinese medicine composition has an obvious anti-inflammatory effect, the high, medium and low dose groups have an obvious effect after 3 hours, and the traditional Chinese medicine composition has an obvious pharmacological activity in the aspect of analgesic effect, the analgesic effect of the three dose groups is obvious, and the analgesic effect of the high dose group is more obvious than that of Yunnan white drug.

Test example 2 partial clinical observations relating to the invention

1 diagnostic criteria

1.1 Western diagnostic standard. The method is formulated according to the clinical research guiding principle of the new traditional Chinese medicine and the soft tissue science of the Xuanzhe:

(1) History of chronic injury and good development age;

(2) Pain, tenderness, and induration of cords in strain parts;

(3) Limited movement at or adjacent to the joint;

(4) The relevant test checks positive signs;

(5) X-ray inspection: mainly eliminates fracture, dislocation, osteopathia and the like.

1.2 Chinese medicine syndrome diagnostic standard

(1) Meets the traditional Chinese medicine diagnosis standard of blood deficiency and cold coagulation type chronic soft tissue injury. The main symptoms are: the pain is mainly caused by local cold pain, and mild swelling and tenderness are caused; the secondary symptoms are as follows: spasm of tendons and collaterals, aggravated pain due to cold-dampness, pale red tongue, deep, thready and weak pulse.

(2) And (4) grading and quantifying symptoms. The score and weight for each relevant symptom are shown in table 3.

2 inclusion criteria

(1) Those who meet the above-mentioned Western diagnosis standards;

(2) Those who meet the above-mentioned criteria for diagnosis of syndrome in TCM;

(3) VAS score > 4;

(4) No other medications have been used within two weeks.

3 exclusion criteria

(1) Those who do not meet the criteria for diagnosing chronic soft tissue injury;

(2) The VAS score is less than or equal to 4;

(3) Completely broken soft tissues such as muscle, tendon and ligament;

(4) Those with skin damage;

(5) Patients with fracture, joint dislocation, and bone diseases;

(6) Those with obvious concurrent or concurrent symptoms;

(7) Allergic constitution or person who is allergic to the present preparation;

(8) Those not within the scope of action of the drug;

(9) Patients with serious primary diseases such as cardiovascular diseases, liver diseases, kidney diseases, hemopoietic diseases, endocrine diseases and the like and psychoses are combined.

4 observation index

4.1 Security Observation

(1) Inquiring the prior medication history and allergy history;

(2) General physical examination items;

(3) Adverse reactions may occur.

4.2 evaluation of therapeutic Effect

And (3) performing clinical evaluation on the soft tissue injury by adopting a visual simulation scoring method and a soft tissue injury symptom sign scoring standard, and respectively recording scoring results of 3d, 7d and 14d before treatment and after treatment.

(1) Visual Analogue Scoring (VAS)

Namely a VAS scale with the length of 10cm, a moving scale which can move between 0 and 10 is arranged on the front surface, and 11 figures are arranged on the back surface with 0 to 10. The 0 end represents no pain and the 10 end represents the most severe pain. The patient was asked to mark his pain between the floating scales and the observer read the number on the back immediately.

(2) Symptom sign score

The subjective pain feeling, tenderness, dysfunction and induration are scored uniformly and standardly according to the scoring standard of soft tissue injury symptom in the clinical guideline of new Chinese medicine, and the scores are divided into five grades of none, light, middle and heavy, and the scores are respectively scored as 0, 1, 2, 3 and 4. The scoring criteria are shown in table 3.

TABLE 3 Soft tissue injury symptom Scoring criteria

(3) Criteria for efficacy assessment

According to the 2002 clinical research guide principles of new Chinese medicines (trial) formulated by the State administration of traditional Chinese medicine, the changes of symptoms and sign integrals of patients before and after treatment are compared and used as the basis for judging the curative effect.

(1) And (3) healing: the pain and induration are completely disappeared, no pain point is left, the muscle tension and spasm are disappeared, the local function is recovered to be normal, the activity reaches the normal range, and the score after treatment is reduced by more than 95 percent compared with that before treatment.

(2) The effect is shown: the pain and induration basically disappear, the affected part has slight tenderness, the functional activity is recovered or close to normal, and the score after treatment is reduced by more than 70 percent but less than 95 percent compared with that before treatment.

(3) Improvement: the pain is obviously relieved, the affected part still has pressure pain, the function is improved to some extent compared with the prior art, and the integral is reduced by 30 percent but less than 70 percent compared with the prior art.

(4) And (4) invalidation: there was no significant improvement in signs of each symptom, and the score was reduced by <30% compared to before treatment.

Note: the calculation formula (nimodipine method) is: [ (pre-treatment score-post-treatment score) ÷ pre-treatment score ] x100%.

5 methods of treatment

Because the treatment of chronic soft tissue injury requires a long time, the number of patients that can be tracked is limited, and in addition, the source of the patients is special (athletes are the main in the early stage, and the product is only applied to the general population because WADA increases higenamine to enter the forbidden substance list of athletes in the later stage). The subject is only compared in effectiveness before and after the product is applied independently.

The drug treatment group sprays the drug on the injured part and the pressure pain point. The palm is repeatedly rubbed to make absorption complete, and the medicine is administered once, 1 time daily, 14 days as a treatment course, and the treatment effect is evaluated on 3 rd day, 7 th day and 14 th day of treatment. The sign score is recorded.

6 results and statistical analysis

According to the established clinical observation scheme of the product, 30 cases are included in total, and the detailed record of the clinical test data includes 28 effective cases, 12 males and 16 females. All are from patients of the general population.

The recorded curative effect scoring results are summarized, statistical analysis is carried out by using SPSS19.0 software, and all parameters are calculated according to the average number plus or minus standard deviation

The method is characterized in that the measurement data adopts t test, the curative effect data adopts x2 test, and the difference P < 0.05 has statistical significance.

(3) Criteria for efficacy assessment

(3) Improvement: the pain is obviously relieved, the affected part still has tenderness, the function is improved to some extent compared with the prior treatment, and the integral is reduced by 30 percent but less than 70 percent compared with the prior treatment.

Note: the calculation formula (nimodipine method) is: [ (before treatment score-after treatment score) ÷ before treatment score ] x100%.

TABLE 4 score data sheet of relevant signs of therapeutic effect before and after drug treatment

(3) And (3) importing all groups of data into SPSS19.0 statistical software, and carrying out t test on main efficacy indexes of the medicine group among matched sample groups. The results are shown in tables 5-1, 5-2, 5-3 and 5-4.

TABLE 5-1 paired group t test results for pain scores

TABLE 5-2 paired group t test results for tenderness scores

Table 5-3 paired group t test results for dysfunction scores

TABLE 5-4 paired group t test results for grading of induration cords

The total curative effect score shows that after 3 days of treatment, only 2 people achieve improvement, the improvement rate is 7.14%, and the effect is basically not effective; after 7 days of treatment, the remission rate reaches 75 percent; the clinical curative effect is shown; after 14 days of treatment, the curative effect is 53.6 percent, the improvement is 46.4 percent, and the total improvement rate is 100 percent.

7 conclusion

From the results of statistical analysis of the above clinical observations: (1) The invention has obvious functions of resisting inflammation, relieving pain, promoting blood circulation, dissipating blood stasis, softening hardness and dissipating stagnation and has definite clinical curative effect. Clinical data show that the anti-inflammatory and analgesic effects in a short time are obvious, the effects of promoting blood circulation to remove meridian obstruction and softening and resolving hard mass are gradually displayed after 14 days, and limited local functions are effectively recovered. (2) The invention does not find allergic cases in the clinical observation process, and has higher safety.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

Example 1

Prescription: safflower 30g raw Sichuan aconite root 60 raw wild aconite root 60 homalomena rhizome 30

Radix Dipsaci 60 rhizoma Drynariae 60 Eupolyphaga Seu Steleophaga 20 Notopterygii rhizoma 20

Pubescent angelica root, 20 zanthoxylum husk, 20 asarum herb, 20 borneol and 10g

The preparation method comprises the following steps: weighing the above materials according to a prescription, drying at 60 deg.C for 6 hr, cooling, pulverizing, sieving with 200 mesh sieve, and packaging.

Example 2

Prescription: safflower 30g, unprocessed radix aconiti 60, unprocessed radix aconiti kusnezoffii 60 homalomena rhizome 30

Pubescent angelica root, radix angelicae pubescentis, 20 zanthoxylum piperitum, 20 asarum herb and 10g borneol

The preparation method comprises the following steps:

weighing the above materials according to a prescription, baking at 60 deg.C for 6 hr, cooling, pulverizing into coarse powder, micronizing into superfine powder (larger than or equal to 500 mesh), and packaging.

Example 3

Dipsacus asperoides 60 rhizoma Drynariae 60 Eupolyphaga Seu Steleophaga 20 Notopterygii rhizoma 20

Preparation of Chinese medicinal extract

The first preparation method comprises the following steps: decocting the eleven medicinal materials except the borneol in water for 1-3 times, combining the decoctions, filtering, concentrating into thick paste, drying to obtain dry extract, and crushing to obtain the traditional Chinese medicine extract.

The second preparation method comprises the following steps: decocting the eleven medicinal materials except the borneol in water for 1-3 times, mixing decoctions, filtering, concentrating to obtain thick paste with the relative density of 1.05-1.30, adding ethanol until the ethanol content reaches 60-80%, precipitating with ethanol, refrigerating overnight, filtering, recovering ethanol from the filtrate, concentrating to obtain thick paste, drying and crushing to obtain the traditional Chinese medicine extract.

The preparation method comprises the following steps: taking the eleven medicinal materials except the borneol, adding 60-80% of ethanol for reflux extraction for 1-3 times, combining the extracting solutions, recovering the ethanol, concentrating into thick paste, drying and crushing to obtain the traditional Chinese medicine extract.

The preparation method comprises the following steps: taking the eleven medicinal materials except the borneol, wherein the safflower, the asarum, the notopterygium root, the radix angelicae pubescentis and the pericarpium zanthoxyli are added with 60-80% of ethanol for reflux extraction for 1-3 times, merging the extracting solutions, recovering the ethanol and concentrating to thick paste for later use; decocting the rest raw materials in water for 1-3 times, mixing decoctions, filtering, concentrating into thick paste, mixing with the above thick paste, drying, and pulverizing to obtain the Chinese medicinal extract.

Preparation and forming process

Preparing a tincture:

prescription:

the preparation process comprises the following steps:

1) Weighing the traditional Chinese medicine extract according to the prescription amount, adding 70% ethanol solution, and dissolving;

2) Weighing borneol according to the prescription amount, and adding the borneol into the ethanol solution for dissolving;

3) Filtering, and packaging the filtrate.

Preparation of aerosol:

prescription:

the preparation process comprises the following steps:

1) Weighing the traditional Chinese medicine extract according to the prescription amount, adding a proper amount of water, and heating to dissolve;

2) Weighing borneol according to the prescription amount, and adding the borneol into the solution to dissolve;

3) Filtering, packaging the filtrate, and injecting propellant.

Preparing cataplasm:

prescription:

the preparation process comprises the following steps:

1) Adding aluminum hydroxide and Borneolum Syntheticum into glycerol, mixing, adding NP-700, methyl hydroxybenzoate and propyl hydroxybenzoate, and mixing;

2) Adding water into the Chinese medicinal extract, heating to dissolve, cooling, filtering, and adding tartaric acid to dissolve;

3) Slowly adding the water phase into the glycerin organic phase under stirring, and continuously stirring for 20 minutes;

4) Transferring the mixture into a cataplasm coating machine, coating and cutting;

5) Naturally crosslinking and reacting the cataplasm in a clean environment with proper humidity for 24 hours;

6) Sealing and packaging to obtain the product.

Preparing a gel:

prescription:

the preparation process comprises the following steps:

taking the traditional Chinese medicine extract powder according to the prescription amount, adding a proper amount of water, heating to dissolve, cooling, and filtering;

adding carbomer P934 into the solution to fully swell;

regulating the pH value of the solution to 6 by using 5% triethanolamine solution, and uniformly stirring;

adding appropriate amount of glycerol into polysorbate-80, mixing, adding Borneolum Syntheticum, azone, methyl hydroxybenzoate, and propyl hydroxybenzoate, and stirring to dissolve;

mixing with above solution and matrix, grinding with colloid mill, and packaging.

The above description is only one embodiment of the present invention, and is not intended to limit the present invention, and it is apparent to those skilled in the art that various modifications and variations can be made in the present invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. The pharmaceutical composition for treating chronic soft tissue injury is characterized by comprising the following traditional Chinese medicine raw materials in parts by weight: 1-6 parts of safflower, 3-9 parts of unprocessed radix aconiti kusnezoffii, 1-6 parts of obscured homalomena rhizome, 1-6 parts of asarum, 3-9 parts of teasel root, 3-9 parts of rhizoma drynariae, 1-6 parts of ground beeltle, 1-6 parts of notopterygium root, 1-6 parts of radix angelicae pubescentis, 1-6 parts of pericarpium zanthoxyli and 1-3 parts of borneol.

2. The pharmaceutical composition for treating chronic soft tissue injury according to claim 1, wherein the traditional Chinese medicine is preferably prepared from the following raw materials: 3 parts of safflower, 6 parts of unprocessed radix aconiti kusnezoffii, 3 parts of obscured homalomena rhizome, 2 parts of asarum, 6 parts of teasel root, 6 parts of rhizoma drynariae, 2 parts of ground beeltle, 2 parts of notopterygium root, 2 parts of radix angelicae pubescentis, 2 parts of pericarpium zanthoxyli and 1 part of borneol.

3. A formulation prepared from the pharmaceutical composition for the treatment of chronic soft tissue injury of any one of claims 1-2.

4. The formulation of claim 3, wherein the formulation is a powder, tincture, wine, spray, patch, ointment, or gel.

5. The formulation of claim 3, wherein the formulation is an aerosol, patch, cream.