CN107998246B - Traditional Chinese medicine composition for treating chronic soft tissue injury or osteoarthropathy caused by traumatic injury and application thereof - Google Patents
Traditional Chinese medicine composition for treating chronic soft tissue injury or osteoarthropathy caused by traumatic injury and application thereof Download PDFInfo
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- CN107998246B CN107998246B CN201810047782.2A CN201810047782A CN107998246B CN 107998246 B CN107998246 B CN 107998246B CN 201810047782 A CN201810047782 A CN 201810047782A CN 107998246 B CN107998246 B CN 107998246B
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- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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Abstract
The invention relates to a traditional Chinese medicine composition for treating chronic soft tissue injury or osteoarthropathy caused by traumatic injury and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12-15 parts of pine needle, 12-15 parts of radix zanthoxyli, 12-15 parts of radix periplocae, 12-15 parts of gardenia jasminoides, 12-15 parts of achyranthes aspera, 12-15 parts of common burreed herb, 12-15 parts of centipeda minima, 12-15 parts of cupressus sempervirens, 12-15 parts of radix polygoni multiflori, 25-30 parts of rhizoma drynariae, 20-30 parts of peach root, 20-30 parts of palm root, 12-15 parts of dioscorea nipponica, 12-15 parts of hypericum japonicum, 12-15 parts of lobelia chinensis, 25-30 parts of pseudo-ginseng and 25-30 parts of banyan root. Clinical tests show that the traditional Chinese medicine composition has obvious curative effect on chronic soft tissue injury or osteoarthropathy caused by intractable traumatic injury, and follow-up results show that the treatment is thorough and the relapse is not easy.
Description
Technical Field
The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating chronic soft tissue injury or osteoarthropathy caused by traumatic injury and application thereof.
Background
Traumatic injuries include knife gun, fall, blow, contusion, puncture, abrasion, sports injuries, and the like, and the injuries are often painful, swollen, bleeding or fracture, dislocation, and the like, and also include some visceral injuries. Chronic soft tissue injury or chronic osteoarticular pain can be caused frequently due to over-severe injury or untimely and incomplete treatment, and the life quality of patients is seriously influenced. The chronic soft tissue injury caused by traumatic injury refers to the symptoms that the injury causes more than two days, capillary vessels of superficial skin and subcutaneous tissues are broken to generate green and red lumps due to the injury, or deeper soft tissue injury has no surface abnormality but pressure pain. The chronic osteoarticular pain caused by traumatic injury refers to pain which is not resolved for a plurality of days and is caused by fracture, dislocation or joint sprain. The chronic soft tissue injury or chronic osteoarticular pain not only has the characteristic of long-term disunion, but also can develop long-term chronic diseases or relapse, and has larger treatment difficulty.
The traditional Chinese medicine for treating traumatic injury generally adopts the methods of activating blood circulation to dissipate blood stasis, relieving swelling and pain, relaxing tendons and activating collaterals. For example, patent document CN105920538A, published japanese 2016.09.07 discloses a traditional Chinese medicine composition for treating bone injury and acute and chronic soft tissue injury, which comprises the following components in parts by mass: radix aconiti preparata: 30-90 parts; preparing kusnezoff monkshood root: 30-90; rhizoma drynariae: 30-90 parts; psoralea fruit: 30-90 parts; frankincense: 30-90 parts; myrrh: 30-90; herba schizonepetae: 20-50 parts; preventing wind; 20-50 parts; b, common clubmoss herb: 25-60 parts; garden balsam stem: 25-60 parts; peach kernel: 15-45 parts; safflower: 15-45 parts; coptis chinensis: 10-30 parts; phellodendron bark: 10-30 parts; three-edge: 30-90 parts; zedoary turmeric: 30-90 parts; radix cyathulae: 25-60 parts; achyranthes bidentata: 25-60 parts; eucommia ulmoides: 25-60 parts of cortex acanthopanacis: 25-60 parts and the like. The pharmaceutical composition is prepared from pure traditional Chinese medicines, has no toxic or side effect, quick healing, short course of treatment and low price, and has remarkable curative effect on various bone injuries such as fracture, bone nonunion, muscle and bone contusion, joint injury, acute and chronic soft tissue injury, muscle strain, neck, shoulder, waist and leg pain and the like. Patent document CN105796806A, published japanese patent No. 2016.07.27, discloses a method for preparing a traditional Chinese medicine ointment for treating acute and chronic traumatic injuries, which is prepared by adding angelica sinensis, safflower, dragon's blood, frankincense, myrrh, catechu and water into a container according to a certain mass ratio, decocting for a certain time under a certain temperature condition, cooling and filtering to obtain a filtrate, and uniformly mixing the filtrate, a high molecular substance solution, a humectant, a natural freshener and a moistening penetrant according to a certain mass ratio. Patent document CN101327265A, published japanese patent No. 2008.12.24, discloses an external use medicine for treating chronic soft tissue injury, which is prepared by mixing dried alum, rhubarb, old towel gourd (with a burning property), pepper, cinnamon, pine nodular branch, eucommia bark and achyranthes root according to a certain proportion, grinding into powder and placing into a prepared bottle for later use. The injury eliminating powder can thoroughly treat chronic soft tissue injury, directly acts on the injured soft tissue through the medicine, can directly permeate skin and the soft tissue, has the effects of dredging channels and collaterals, promoting blood circulation and removing blood stasis, dispersing stagnation, relieving swelling, eliminating pain and diminishing inflammation, has the function of gradually repairing the injured soft tissue, is quick to treat, good in curative effect, free of any toxic and side effects on a human body, widely applicable to various crowds, low in cost and convenient to operate. Patent document CN101284088A, published japanese patent No. 2008.10.15, discloses a traditional Chinese medicine preparation for effectively relieving pain caused by acute and chronic soft tissue injuries, which is prepared by combining sticktight, sabia japonica, rheum officinale, pseudo-ginseng, rhizoma paridis and other medicinal herbs, the preparation comprises ointment, external gel and other dosage forms, has the efficacies of promoting blood circulation to remove blood stasis, clearing away heat and toxic materials, relieving spasm and pain, reducing swelling and promoting granulation, and is suitable for pain caused by acute and chronic soft tissue injuries, and clinically treating pain caused by acute and chronic soft tissue injuries, and the total effective rate is 85%.
However, the soft tissue injury or osteoarticular pain which is not healed for a long time or has repeated attacks due to traumatic injury is a difficult problem in the prior art, but most of the traditional Chinese medicines in the field aim at pain caused by acute or chronic traumatic injury, and the effect on the long-lasting soft tissue injury or osteoarticular pain caused by traumatic injury is not obvious, so that the research and development of the medicines are urgently needed.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating chronic soft tissue injury or osteoarthropathy caused by traumatic injury aiming at the defects in the prior art.
The invention also aims to provide the application of the traditional Chinese medicine composition.
The other purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition.
In order to achieve the first purpose, the invention adopts the technical scheme that:
a traditional Chinese medicine composition for treating chronic soft tissue injury or osteoarthropathy caused by traumatic injury is prepared from the following raw material medicines in parts by weight: 12-15 parts of pine needle, 12-15 parts of radix zanthoxyli, 12-15 parts of radix periplocae, 12-15 parts of gardenia jasminoides, 12-15 parts of achyranthes aspera, 12-15 parts of common burreed herb, 12-15 parts of centipeda minima, 12-15 parts of cupressus sempervirens, 12-15 parts of radix polygoni multiflori, 25-30 parts of rhizoma drynariae, 20-30 parts of peach root, 20-30 parts of palm root, 12-15 parts of dioscorea nipponica, 12-15 parts of hypericum japonicum, 12-15 parts of lobelia chinensis, 25-30 parts of pseudo-ginseng and 25-30 parts of banyan root.
Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 13-14 parts of pine needle, 13-14 parts of radix zanthoxyli, 13-14 parts of radix periplocae, 13-14 parts of gardenia jasminoides, 13-14 parts of achyranthes aspera, 13-14 parts of common burreed herb, 13-14 parts of centipeda minima, 13-14 parts of cupressus sempervirens, 13-14 parts of radix polygoni multiflori, 27-29 parts of rhizoma drynariae, 24-26 parts of peach root, 24-26 parts of palm root, 13-14 parts of dioscorea nipponica, 13-14 parts of hypericum japonicum, 13-14 parts of Chinese lobelia, 27-29 parts of pseudo-ginseng and 27-29 parts of banyan root.
More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 14 parts of pine needle, 14 parts of radix zanthoxyli, 14 parts of rhizoctonia, 14 parts of gardenia jasminoides, 14 parts of achyranthes aspera, 14 parts of Chinese silvergrass, 14 parts of centipeda minima, 14 parts of cupressus sempervirens, 14 parts of radix stemonae, 14 parts of tasselflower lysimachia, 28 parts of rhizoma drynariae, 25 parts of peach root, 25 parts of palm root, 14 parts of dioscorea nipponica, 14 parts of hypericum japonicum, 14 parts of Chinese lobelia, 28 parts of madder and 28 parts of banyan root.
As a specific embodiment of the invention, the dosage form of the traditional Chinese medicine composition is an external dosage form.
The external preparation is an external liquid medicament, an ointment, a gel, a paste or a transdermal patch.
In order to achieve the second object, the invention adopts the technical scheme that:
the traditional Chinese medicine composition is applied to the preparation of medicines for treating chronic soft tissue injury or osteoarthropathy caused by traumatic injury.
As a specific embodiment of the invention, the duration of the chronic soft tissue injury or the bone joint pain caused by the traumatic injury is more than ten days, or the chronic soft tissue injury or the bone joint pain has the characteristic of repeated attack.
In order to achieve the third object, the invention adopts the technical scheme that:
the preparation method of the traditional Chinese medicine composition comprises the following steps: adding water into the raw materials, soaking the raw materials in water, and decocting.
As a specific embodiment of the invention, the preparation method comprises the following steps: adding water into the above materials, soaking the above materials, decocting for 1-3 times (each time for 1-3 hr), mixing decoctions, filtering, and concentrating the filtrate.
As a specific embodiment of the invention, the traditional Chinese medicine composition is prepared into a liquid medicament, an ointment, a gel, a paste or a transdermal patch for external use.
The invention has the advantages that:
1. the traditional Chinese medicine composition is prepared by combining proper raw material medicines according to research experience and a large number of experiments of traditional Chinese medicine prescriptions based on the inventor's deepening understanding of the pathogenesis of intractable traumatic injury pain for many years in clinical treatment. In the prescription, radix zanthoxyli and the radix cynanchi wilfordii have the functions of promoting blood circulation, removing blood stasis, relieving swelling and pain; fructus Gardeniae, radix Achyranthis, radix seu caulis Parthenocissi Tricuspidatae, herba Duchesneae Indicae, herba Lobeliae chinensis, and rhizoma Tupistrae chinensis for clearing away heat and toxic materials, cooling blood, and removing blood stasis; the clinical tests prove that the curative effect on chronic soft tissue injury or osteoarticular pain caused by traumatic injury which has long lasting time or repeated attack and can not be cured for a long time is obvious, the follow-up results also show that the treatment is thorough, and the problem of clinical pain treatment is solved.
2. The traditional Chinese medicine composition is an external preparation, and has small side effect.
Detailed Description
The following provides a detailed description of specific embodiments of the present invention.
EXAMPLE 1 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention
12 parts of pine needle, 15 parts of radix zanthoxyli, 12 parts of rhizoctonia solani, 15 parts of gardenia jasminoides, 12 parts of achyranthes aspera, 15 parts of common burreed herb, 12 parts of centipeda minima, 15 parts of cupressus sempervirens, 12 parts of road-blocking tiger, 15 parts of tasselflower lysimachia, 25 parts of rhizoma drynariae, 30 parts of peach root, 20 parts of palm root, 15 parts of dioscorea nipponica, 12 parts of hypericum japonicum, 15 parts of Chinese lobelia, 30 parts of madder and 25 parts of ficus microcarpa root, soaking the above medicines in water, decocting for 2 times, 2 hours each time, combining the decoctions, filtering, and concentrating the filtrate to obtain the traditional.
EXAMPLE 2 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention
15 parts of pine needle, 12 parts of radix zanthoxyli, 15 parts of rhizoctonia, 12 parts of gardenia jasminoides, 15 parts of achyranthes aspera, 12 parts of common clubmoss herb, 15 parts of centipeda minima, 12 parts of cupressus sempervirens, 15 parts of road-blocking tiger, 12 parts of tasselflower lysimachia, 30 parts of rhizoma drynariae, 20 parts of peach root, 30 parts of palm root, 12 parts of dioscorea nipponica makino, 15 parts of hypericum japonicum, 12 parts of Chinese lobelia, 30 parts of madder and 25 parts of ficus microcarpa root, soaking the above medicines in water, decocting for 2 times, 1 hour each time, combining the decoctions, filtering, and concentrating the filtrate to obtain.
EXAMPLE 3 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention
12 parts of pine needle, 12 parts of radix zanthoxyli, 15 parts of rhizoctonia solani, 15 parts of gardenia jasminoides, 12 parts of achyranthes aspera, 12 parts of common clubmoss herb, 15 parts of centipeda minima, 15 parts of cupressus sempervirens, 12 parts of radix polygoni multiflori, 30 parts of rhizoma drynariae, 30 parts of peach root, 20 parts of palm root, 12 parts of dioscorea nipponica, 15 parts of hypericum japonicum, 15 parts of lobelia chinensis, 25 parts of madder and 25 parts of ficus microcarpa root, soaking the above medicines in water for 3 times, decocting for 1 hour each time, combining the decoctions, filtering, and concentrating the filtrate to obtain the traditional Chinese medicine.
Example 4 preparation of liquid preparation for external use of the Chinese medicinal composition of the present Invention (IV)
15 parts of pine needle, 15 parts of zanthoxylum nitidum, 12 parts of chuangen stem, 12 parts of gardenia jasminoides, 15 parts of achyranthes aspera, 15 parts of common burreed herb, 12 parts of centipeda minima, 15 parts of gecko, 15 parts of tasselflower herb, 15 parts of tasselflower lysimachia, 25 parts of rhizoma drynariae, 20 parts of peach root, 30 parts of palm root, 15 parts of dioscorea nipponica, 12 parts of tremella, 12 parts of Chinese lobelia, 30 parts of madder and 30 parts of ficus microcarpa root, soaking the medicines with water for 1 time for 3 hours, combining the decoctions, filtering, and concentrating the filtrate to obtain the traditional Chinese medicine.
EXAMPLE 5 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention (V)
15 parts of pine needle, 15 parts of zanthoxylum nitidum, 15 parts of chuangen, 12 parts of gardenia jasminoides, 12 parts of achyranthes aspera, 12 parts of common clubmoss herb, 15 parts of centipeda minima, 15 parts of cupressus sempervirens, 15 parts of gecko, 12 parts of tasselflower lysimachia herb, 25 parts of rhizoma drynariae, 20 parts of peach root, 30 parts of palm root, 15 parts of dioscorea nipponica makino, 15 parts of hypericum japonicum, 12 parts of Chinese lobelia, 25 parts of madder and 25 parts of ficus microcarpa root, soaking the medicines with water, decocting for 2 times, 2 hours each time, combining the decoctions, filtering, and concentrating the filtrate to.
EXAMPLE 6 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention (VI)
12 parts of pine needle, 12 parts of radix zanthoxyli, 12 parts of rhizomes of chuanteng, 12 parts of gardenia jasminoides, 15 parts of achyranthes aspera, 15 parts of common burreed herb, 15 parts of common clubmoss herb, 12 parts of road-blocking tiger, 12 parts of tassel, 25 parts of rhizoma drynariae, 20 parts of peach root, 30 parts of palm root, 15 parts of dioscorea nipponica, 15 parts of hypericum japonicum, 15 parts of lobelia chinensis, 25 parts of madder and 25 parts of ficus microcarpa root, soaking the above medicines in water for 3 times, decocting for 1 hour each time, combining the decoctions, filtering, and concentrating the filtrate to obtain the traditional Chinese medicine.
EXAMPLE 7 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention
14 parts of pine needle, 14 parts of radix zanthoxyli, 14 parts of rhizoctonia solani, 12 parts of gardenia jasminoides, 15 parts of achyranthes aspera, 14 parts of common burreed herb, 14 parts of common centipeda herb, 14 parts of cupramma herb, 14 parts of road-blocking tiger, 14 parts of common cephalanoplos herb, 28 parts of rhizoma drynariae, 25 parts of peach root, 25 parts of palm root, 14 parts of dioscorea nipponica makino, 14 parts of hypericum japonicum, 14 parts of Chinese lobelia, 28 parts of madder and 28 parts of ficus microcarpa root, soaking the medicines with water on the medicine surface, decocting for 2 times, 2 hours each time, combining the decoctions, filtering, and concentrating the filtrate.
EXAMPLE 8 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention (eight)
14 parts of pine needle, 14 parts of radix zanthoxyli, 14 parts of rhizoctonia solani, 14 parts of gardenia jasminoides, 14 parts of achyranthes aspera, 14 parts of common burreed herb, 14 parts of common clubmoss herb, 14 parts of common lopseed, 14 parts of common cephalanoplos herb, 28 parts of rhizoma drynariae, 25 parts of peach root, 25 parts of palm root, 14 parts of dioscorea nipponica, 14 parts of hypericum japonicum, 14 parts of Chinese lobelia, 28 parts of madder and 28 parts of ficus microcarpa root, soaking the above medicines in water for 2 times, decocting for 2 hours each time, combining the decoctions, filtering, and concentrating the filtrate to obtain the traditional Chinese medicine.
Example 9 preparation of a liquid preparation for external use of the Chinese medicinal composition of the present invention (nine)
13 parts of pine needle, 14 parts of radix zanthoxyli, 13 parts of rhizoctonia solani, 14 parts of gardenia jasminoides, 13 parts of achyranthes aspera, 14 parts of common clubmoss herb, 13 parts of centipeda minima, 14 parts of cupressus sempervirens, 13 parts of road-blocking tiger, 14 parts of tasselflower herb, 27 parts of rhizoma drynariae, 26 parts of peach root, 24 parts of palm root, 14 parts of dioscorea nipponica makino, 13 parts of hypericum japonicum, 14 parts of Chinese lobelia, 27 parts of madder root and 29 parts of ficus microcarpa root, soaking the medicines in water for 3 times, decocting for 1 hour each time, combining the decoctions, filtering, and concentrating the.
Example 10 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention (ten)
14 parts of pine needle, 13 parts of radix zanthoxyli, 14 parts of rhizoctonia solani, 13 parts of gardenia jasminoides, 14 parts of achyranthes aspera, 13 parts of common clubmoss herb, 14 parts of centipeda minima, 13 parts of cupressus sempervirens, 14 parts of road-blocking tiger, 13 parts of tasselflower herb, 29 parts of rhizoma drynariae, 24 parts of peach root, 26 parts of palm root, 13 parts of dioscorea nipponica makino, 14 parts of hypericum japonicum, 13 parts of Chinese lobelia, 29 parts of madder root and 27 parts of ficus microcarpa root, soaking the medicines in water for 2 times, decocting for 2 hours each time, combining the decoctions, filtering, and concentrating the.
EXAMPLE 11 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention (eleven)
13 parts of pine needle, 13 parts of radix zanthoxyli, 14 parts of rhizoctonia solani, 13 parts of gardenia jasminoides, 14 parts of achyranthes aspera, 13 parts of common clubmoss herb, 14 parts of centipeda minima, 13 parts of cupressus sempervirens, 14 parts of road-blocking tiger, 13 parts of tasselflower herb, 29 parts of rhizoma drynariae, 24 parts of peach root, 26 parts of palm root, 13 parts of dioscorea nipponica makino, 14 parts of hypericum japonicum, 13 parts of Chinese lobelia, 29 parts of madder root and 27 parts of ficus microcarpa root, soaking the medicines in water for 2 times, decocting for 2 hours each time, combining the decoctions, filtering, and concentrating the.
EXAMPLE 12 preparation of liquid preparation for external use of the Chinese medicinal composition of the present invention (twelve)
14 parts of pine needle, 14 parts of radix zanthoxyli, 14 parts of rhizoctonia solani, 13 parts of gardenia jasminoides, 14 parts of achyranthes aspera, 13 parts of common clubmoss herb, 14 parts of centipeda minima, 13 parts of cupressus sempervirens, 14 parts of road-blocking tiger, 13 parts of tasselflower herb, 29 parts of rhizoma drynariae, 24 parts of peach root, 26 parts of palm root, 13 parts of dioscorea nipponica makino, 14 parts of hypericum japonicum, 13 parts of Chinese lobelia, 30 parts of madder root and 27 parts of ficus microcarpa root, soaking the medicines in water for 2 times, decocting for 2 hours each time, combining the decoctions, filtering, and concentrating the.
EXAMPLE 13 preparation of the Chinese medicinal composition paste of the present invention
The raw materials are taken according to the weight part ratio in any one of the embodiments 1 to 12, water is added to soak the medicine surface, the decoction is carried out for 2 times and 2 hours each time, the decoction liquid is merged, the filtration is carried out, and the filtrate is concentrated. Adding the filtrate 1/5 volume of beeswax and yellow Vaseline, decocting with slow fire, stirring, and cooling to obtain paste.
EXAMPLE 14 preparation of gel of the Chinese medicinal composition of the present invention
The raw materials are taken according to the weight part ratio in any one of the embodiments 1 to 12, water is added to soak the medicine surface, the decoction is carried out for 2 times and 2 hours each time, the decoction liquid is merged, the filtration is carried out, and the filtrate is concentrated. Adding carbomer into glycerol, grinding to moisten, adding small amount of distilled water, grinding, transferring into a measuring cup, dissolving triethanolamine, ethylparaben and distilled water in appropriate amount, stirring to obtain gel, adding distilled water, stirring, adding the above filtrate concentrate, and grinding.
EXAMPLE 15 preparation of transdermal Patches of the Chinese medicinal composition of the present invention
The raw materials are taken according to the weight part ratio in any one of embodiments 1-12, water is added to the raw materials to soak the raw materials, the raw materials are decocted for 3 times, 5 hours each time, decoction liquid is combined, filtered, and filtrate is concentrated. Adding conventional matrix such as kaolin and glycerol into the filtrate, stirring, coating on the back lining layer, and adding protective layer.
Example 16 clinical trial of the Chinese medicinal composition of the present invention for treating chronic soft tissue injury and osteoarthropathy due to traumatic injury
1. General data
200 patients with chronic soft tissue injury and/or osteoarticular pain caused by traumatic injury treated in hospital from 9 months to 2 months in 2013, 119 men and 81 women are selected. Patients were randomly divided into four groups including the traditional Chinese medicine of the invention, a traditional Chinese medicine one control group, a traditional Chinese medicine two control group and a detumescence and acesodyne tincture group. The data of each group of cases are shown in table 1 and table 2.
TABLE 1 number of samples of each group of cases
| Group of | Group entry case | Exclusion | Effective case |
| The Chinese medicine of the invention | 50 | 2 | 48 |
| Chinese medicine contrast group | 50 | 3 | 47 |
| Two groups of traditional Chinese medicine contrast | 50 | 1 | 49 |
| Swelling-dispersing pain-relieving tincture set | 50 | 2 | 48 |
TABLE 2 comparison of age, disease progression, pain score for each group of cases
| Group of | Example number (example) | Age (year of old) | Course of disease (Tian) | VAS score (points) |
| The Chinese medicine of the invention | 48 | 41.8±3.2 | 23.2±2.1 | 7.33±1.14 |
| Chinese medicine contrast group | 47 | 43.2±5.4 | 22.5±1.7 | 7.25±1.57 |
| Two groups of traditional Chinese medicine contrast | 49 | 41.5±4.7 | 23.7±3.0 | 7.03±2.08 |
| Swelling-dispersing pain-relieving tincture set | 48 | 42.9±3.9 | 22.4±1.9 | 7.35±1.66 |
The results of the statistical analysis show that the grading difference of the sex, the age, the disease course and the pain degree before treatment of each group of patients has no statistical significance (P is more than 0.05) and is comparable.
2. Diagnostic criteria
2.1 Western diagnostic standards
2.1.1 Chronic Soft tissue contusion
Firstly, the traditional Chinese medicine has history of traumatic injury, severe pain in acute stage, rapid local swelling and limb dysfunction;
secondly, when in examination, the injured part is obviously pressed and painful, or is accompanied by skin purple ecchymosis, or subcutaneous hematoma appears, or wave sign is positive;
③ the course of disease lasts more than 10 days;
x-ray inspection: to assist in diagnosing whether or not a fracture, dislocation, bone disease, etc. is present at the injured part.
2.1.2 articular sprain
Firstly, the traditional Chinese medicine has history of traumatic injury, acute pain and local swelling, ecchymosis and joint movement disorder rapidly appear;
② after 10 days of joint sprain, the bruise is resolved, the ecchymosis turns into yellow brown, the pain is relieved but still exists, and the function is partially recovered;
③ the course of disease lasts more than 10 days;
x-ray inspection: to assist in diagnosing whether or not a fracture, dislocation, bone disease, etc. is present at the injured part.
2.2 Chinese medicine diagnostic Standard
The disease course lasts for more than 10 days;
② pricking pain, fixed pain and tenderness;
③ wiry or unsmooth pulse;
fourthly, the medicine has more than one of bruise and purpura, subcutaneous hematoma fluctuation, irritability, dry mouth, bitter taste and unsmooth stool.
3. Case inclusion criteria
The medicine accords with the Western medicine diagnosis standard and the traditional Chinese medicine syndrome differentiation standard of the chronic soft tissue injury and the joint sprain, and the disease course is more than 10 days and is brought into a test case;
② 18-65 years old.
4. Criteria for excluding cases
Not meeting the above-mentioned western medicine diagnosis and Chinese medicine syndrome differentiation;
② under 18 years old or over 65 years old;
③ pregnant or nursing women and people with allergic constitution;
fourthly, the soft tissues such as muscles, tendons, ligaments and the like are completely broken; local tissue damage with skin avulsion or open fractures;
patients with symptoms of pain, red swelling, bluish purple and the like caused by inflammatory infection;
sixthly, patients with serious primary diseases and psychoses such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems are combined;
seventhly, the medicine is not applied according to the regulation and is not matched with the treatment.
5. Test method
Treatment groups: the ointment prepared in example 13 of the present invention (the raw material drug is prepared as described in example 8), the crude drug content is 0.2kg/g, the ointment is applied to the skin of an affected part, and the ointment is massaged until no excess ointment is left on the surface of the skin, and the dosage depends on the pain range, 3 times per day, and 1 time respectively in the morning, at noon and at night.
Traditional Chinese medicine I control group: the paste is prepared by the following method: 14 parts of pine needle, 14 parts of radix zanthoxyli, 14 parts of rhizomae peruviae, 14 parts of gardenia jasminoides, 14 parts of achyranthes aspera, 14 parts of common clubmoss herb, 14 parts of cupramma herb, 14 parts of gecko, 14 parts of tasselflower herb, 28 parts of rhizoma drynariae, 25 parts of peach root, 25 parts of palm root, 14 parts of dioscorea nipponica, 14 parts of hypericum japonicum, 14 parts of Chinese lobelia, 28 parts of pseudo-ginseng and 28 parts of ficus microcarpa root, adding water to soak the medicinal powder, decocting for 2 times, decocting for 2 hours each time, combining the decoctions, filtering, concentrating the filtrate, adding 1/5 volumes of beeswax and yellow vaseline into the filtrate, decocting with slow fire, stirring, and cooling to obtain the paste, wherein the crude drug content is 0.2. Is applied to the affected skin, and massaged until no excess ointment is on the skin surface, with the dosage depending on the pain range, 3 times per day, 1 time each in the morning, noon and evening.
And (3) a traditional Chinese medicine two control group: the paste is prepared by the following method: 14 parts of pine needle, 14 parts of radix zanthoxyli, 14 parts of rhizomae peruviae, 14 parts of gardenia jasminoides, 14 parts of achyranthes aspera, 14 parts of common burreed herb, 14 parts of common centipeda herb, 14 parts of cupramma herb, 14 parts of road-blocking tiger, 14 parts of tassel flower, 28 parts of callicarpa bodinieri, 25 parts of peach root, 25 parts of palm root, 14 parts of dioscorea nipponica makino, 14 parts of tremella aurantialba, 14 parts of Chinese lobelia, 28 parts of panax notoginseng and 28 parts of ficus microcarpa root, adding water to the mixture to be soaked on the medicine surface, decocting for 2 times, 2 hours each time, combining the decoction, filtering, concentrating the filtrate, adding 1/5 volumes of beewax and yellow vaseline into the filtrate, decocting and stirring the mixture with slow fire, and cooling the mixture. Is applied to the affected skin, and massaged until no excess ointment is on the skin surface, with the dosage depending on the pain range, 3 times per day, 1 time each in the morning, noon and evening.
The swelling-reducing pain-relieving tincture group comprises: the safflower tincture for detumescence and acesodyne, the Chinese medicine standard Z45021991, is applied to the skin of the affected part according to the instruction method, and is applied once again twice a day after being naturally dried.
The above groups are taken as a treatment course for 7 days.
6. Observation index
6.1 assessment of pain relief
Pain assessment was performed by Visual Analogue Scale (VAS) (Wewers ME, Lowe NK. academic review of visual analogue scales in the clinical phenol [ J ] Res Nuals Health,1990,13(4): 227-. Patient VAS scores were collected before and after treatment, respectively.
6.2 relapse conditions
At follow-up 1 month after treatment, the recurrence of patients with complete pain relief after treatment was recorded.
6.3 Observation of adverse reactions
Any adverse reactions that occurred after dosing were faithfully recorded.
7. Statistical treatment
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The data obtained by SPSS 17.0 statistical software processing are measured and expressed by x +/-S, and the difference of P less than 0.05 is statistically significant by adopting t test.
8. Test results
8.1 relieving effects on pain
The post-treatment, post-treatment VAS score statistics for each group of patients are presented in Table 3. The results show that the chronic pain of each group of patients after treatment is effectively relieved, and the VAS value difference before and after treatment of each group has statistical significance (P is less than 0.05); comparing the VAS scores after treatment among groups, wherein the VAS scores of the traditional Chinese medicine one control group, the traditional Chinese medicine two control group and the swelling and pain relieving tincture group have statistical significance (P is less than 0.05).
TABLE 3 pain scores (points) before and after treatment for each group of patients
| Group of | Total number of cases | Before treatment | After treatment |
| The Chinese medicine of the invention | 54 | 6.33±1.14 | 0.53±0.12* |
| Control Chinese medicine group | 56 | 6.25±1.57 | 1.97±0.68*# |
| Two groups of contrast traditional Chinese medicines | 49 | 6.03±2.08 | 2.54±0.76*# |
| Swelling-dispersing pain-relieving tincture set | 53 | 6.35±1.66 | 1.52±0.39*# |
Note: p < 0.05 for each group pre-treatment versus post-treatment; #, after treatment, P is less than 0.05 compared with the traditional Chinese medicine.
8.2 relapse conditions
Statistical results of the recurrence rate of each group at follow-up 1 month after treatment are shown in table 4. The results show that the relapse rate of the traditional Chinese medicine is obviously lower than that of other groups, and the difference of the relapse rate of the traditional Chinese medicine and the relapse rate of other groups has statistical significance (P is less than 0.05).
TABLE 4 group recurrence Rate statistics
| Group of | Total number of cases | Relapse number (case) | Recurrence Rate (%) |
| The Chinese medicine of the invention | 48 | 0 | 0 |
| Control Chinese medicine group | 28 | 6 | 21.4 |
| Two groups of contrast traditional Chinese medicines | 23 | 5 | 21.7 |
| Swelling-dispersing pain-relieving tincture set | 31 | 5 | 16.1 |
8.3 adverse reactions
No obvious adverse reaction is seen in each group.
The test results show that the traditional Chinese medicine composition disclosed by the invention can be used for treating chronic soft tissue injury or osteoarticular pain caused by traumatic injury, can effectively relieve chronic pain which is not healed for a long time or is easy to recur for patients, treats both principal and secondary aspect of disease, is not easy to recur, solves the clinical treatment problem of chronic pain, and benefits patients.
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.
Claims (10)
1. The traditional Chinese medicine composition for treating chronic soft tissue injury or osteoarthropathy caused by traumatic injury is characterized by being prepared from the following raw material medicines in parts by weight: 12-15 parts of pine needle, 12-15 parts of radix zanthoxyli, 12-15 parts of radix periplocae, 12-15 parts of gardenia jasminoides, 12-15 parts of achyranthes aspera, 12-15 parts of common burreed herb, 12-15 parts of centipeda minima, 12-15 parts of cupressus sempervirens, 12-15 parts of radix polygoni multiflori, 25-30 parts of rhizoma drynariae, 20-30 parts of peach root, 20-30 parts of palm root, 12-15 parts of dioscorea nipponica, 12-15 parts of hypericum japonicum, 12-15 parts of lobelia chinensis, 25-30 parts of pseudo-ginseng and 25-30 parts of banyan root.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 13-14 parts of pine needle, 13-14 parts of radix zanthoxyli, 13-14 parts of radix periplocae, 13-14 parts of gardenia jasminoides, 13-14 parts of achyranthes aspera, 13-14 parts of common burreed herb, 13-14 parts of centipeda minima, 13-14 parts of cupressus sempervirens, 13-14 parts of radix polygoni multiflori, 27-29 parts of rhizoma drynariae, 24-26 parts of peach root, 24-26 parts of palm root, 13-14 parts of dioscorea nipponica, 13-14 parts of hypericum japonicum, 13-14 parts of Chinese lobelia, 27-29 parts of pseudo-ginseng and 27-29 parts of banyan root.
3. The traditional Chinese medicine composition according to claim 2, which is prepared from the following raw materials in parts by weight: 14 parts of pine needle, 14 parts of radix zanthoxyli, 14 parts of rhizoctonia, 14 parts of gardenia jasminoides, 14 parts of achyranthes aspera, 14 parts of Chinese silvergrass, 14 parts of centipeda minima, 14 parts of cupressus sempervirens, 14 parts of radix stemonae, 14 parts of tasselflower lysimachia, 28 parts of rhizoma drynariae, 25 parts of peach root, 25 parts of palm root, 14 parts of dioscorea nipponica, 14 parts of hypericum japonicum, 14 parts of Chinese lobelia, 28 parts of madder and 28 parts of banyan root.
4. The Chinese medicinal composition according to any one of claims 1 to 3, wherein the Chinese medicinal composition is in the form of an external preparation.
5. The composition of claim 4, wherein the topical formulation is a topical liquid, ointment, gel, paste, or transdermal patch.
6. Use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for treating chronic soft tissue injury or osteoarticular pain caused by traumatic injury.
7. The use of claim 6, wherein the chronic soft tissue injury or osteoarticular pain from traumatic injury lasts for more than ten days or is characterized by recurrent attacks.
8. A method for preparing the Chinese medicinal composition of any one of claims 1 to 3, which comprises the following steps: adding water into the raw materials, soaking the raw materials in water, and decocting.
9. The method of claim 8, comprising the steps of: adding water into the above materials, soaking the above materials, decocting for 1-3 times (each time for 1-3 hr), mixing decoctions, filtering, and concentrating the filtrate.
10. The method of claim 9, wherein the Chinese medicinal composition is formulated as a liquid preparation for external use, an ointment, a gel, a paste or a transdermal patch.
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| CN102626477A (en) * | 2012-04-10 | 2012-08-08 | 李国宣 | Externally used traditional Chinese medicine combination for treating long-time traumatic injury |
| CN104107368A (en) * | 2014-07-29 | 2014-10-22 | 侯明岳 | Traditional Chinese medicinal formula and preparation method thereof |
| CN105920538A (en) * | 2016-06-20 | 2016-09-07 | 葛林璞 | Traditional Chinese medicinal composition for treating bone injuries and acute and chronic soft tissue injuries |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102626477A (en) * | 2012-04-10 | 2012-08-08 | 李国宣 | Externally used traditional Chinese medicine combination for treating long-time traumatic injury |
| CN104107368A (en) * | 2014-07-29 | 2014-10-22 | 侯明岳 | Traditional Chinese medicinal formula and preparation method thereof |
| CN105920538A (en) * | 2016-06-20 | 2016-09-07 | 葛林璞 | Traditional Chinese medicinal composition for treating bone injuries and acute and chronic soft tissue injuries |
Non-Patent Citations (1)
| Title |
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| 自拟补肾壮骨方口服治疗膝关节骨性关节炎临床研究;王秀珍等;《河北医学》;20131031;第19卷(第10期);1584-1585 * |
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