阅读说明：本技术 用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物及其制备方法 (Traditional Chinese medicine composition for treating early traumatic injury, acute soft tissue injury and fracture and preparation method thereof ) 是由 莫文 邬学群 夏月 许金海 林新艳 殷书梅 林丽 叶洁 范赵翔 周昕 于 2020-09-02 设计创作，主要内容包括：用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物及其制备方法。其中药组合物原料重量份包括大黄1000-5000份、栀子400-800份、乳香800-1600份、土鳖虫400-800份、木瓜800-1500份、蒲公英800-1500份。针对以上中药组合物所含有效成分采用现代提取、浓缩、减压干燥及粉碎等工艺制成粉末,加入一定比例的基质辅料如松香、石蜡等制成适宜的外用制剂。经临床验证,本发明具有行气活血、化瘀消肿、通络止痛之功效,患者易揭易贴,携带方便,具有皮肤刺激性小、致敏率低等优势,对跌打损伤初期、急性软组织损伤及骨折具有良好的镇痛效果,副作用少,上市后可实现有效成分均一、质量稳定可控。(A Chinese medicinal composition for treating early stage traumatic injury, acute soft tissue injury and fracture, and its preparation method are provided. Wherein the raw materials of the traditional Chinese medicine composition comprise 1000 portions of rhubarb minus 1000-plus 5000 portions, 400 portions of cape jasmine fruit minus 800 portions, 800 portions of frankincense minus 1600 portions, 400 portions of ground beetle minus 800 portions, 800 portions of pawpaw minus 1500 portions and 800 portions of dandelion minus 1500 portions. The effective components contained in the traditional Chinese medicine composition are prepared into powder by modern processes of extraction, concentration, reduced pressure drying, crushing and the like, and a proper external preparation is prepared by adding a certain proportion of matrix auxiliary materials such as rosin, paraffin and the like. Clinical verification shows that the traditional Chinese medicine composition has the effects of promoting qi and blood circulation, removing blood stasis and swelling, and dredging collaterals and relieving pain, is easy to remove and stick for patients, is convenient to carry, has the advantages of small skin irritation, low sensitization rate and the like, has a good analgesic effect on early traumatic injury, acute soft tissue injury and fracture, has few side effects, and can realize uniform active ingredients and stable and controllable quality after being marketed.)

1. A traditional Chinese medicine composition for treating early traumatic injury, acute soft tissue injury and fracture is characterized by comprising 1000 portions of rheum officinale, 400 portions of gardenia, 800 portions of frankincense, 400 portions of ground beetle, 800 portions of pawpaw and 800 portions of dandelion by weight.

2. The traditional Chinese medicine composition for treating early traumatic injury, acute soft tissue injury and fracture according to claim 1, which comprises the following matrix auxiliary materials in parts by weight: 1200 portions of paraffin wax, 800 portions of vaseline, 400 portions of liquid paraffin wax and 10 portions to 300 portions of rosin.

3. The traditional Chinese medicine composition for treating early traumatic injury, acute soft tissue injury and fracture as claimed in claim 2, wherein the composition comprises 1500-4500 parts by weight of rhubarb, 750 parts by weight of gardenia, 1500-900 parts by weight of frankincense, 750 parts by weight of ground beetle, 1500-900 parts by weight of pawpaw, 1500-900 parts by weight of dandelion, 1900-1300 parts by weight of paraffin, 1500-900 parts by weight of vaseline, 350-150 parts by weight of liquid paraffin and 30-250 parts by weight of rosin.

4. The Chinese medicinal composition for treating early traumatic injury, acute soft tissue injury and fracture as claimed in claim 3, wherein the composition comprises 1800 portions of rhubarb, 4000 portions of gardenia, 500 portions of frankincense, 1000 portions of ground beetle, 700 portions of pawpaw, 1000 portions of pawpaw, 1400 portions of dandelion, 1500 portions of paraffin, 1800 portions of vaseline, 1000 portions of vaseline, 320 portions of liquid paraffin, and 50 portions to 220 portions of rosin.

5. The Chinese medicinal composition for treating early traumatic injury, acute soft tissue injury and fracture as claimed in claim 3, wherein the composition comprises (by weight parts) Rheum officinale 2000-3800 parts, Gardenia jasminoides fruit 550-650 parts, Olibanum 1100-1300 parts, Eupolyphaga Seu Steleophaga 550-650 parts, Chaenomeles lagenaria 1100-1200 parts, Taraxacum mongolicum 1100-1300 parts, Paraffin 1550-1750 parts, Vaseline 1100-1200 parts, liquid Paraffin 180-320 parts, and Colophonium 80-200 parts.

6. The Chinese medicinal composition for treating initial traumatic injury, acute soft tissue injury and fracture according to any one of claims 3, 4 or 5, wherein the rhubarb, the gardenia, the pawpaw, the frankincense, the ground beeltle and the dandelion can be raw medicinal materials, decoction pieces or processed products, and the vaseline can be white vaseline or yellow vaseline.

7. The Chinese medicinal composition for treating early traumatic injury, acute soft tissue injury and fracture according to claim 1, which comprises the following matrix auxiliary materials: is prepared from one or more of pressure-sensitive adhesive, sodium polyacrylate series, PAA-polyvinylpyrrolidone, polyethylene glycol, silicone rubber, silicone oil, lanolin, gelatin, carbomer and other adjuvants for external use.

8. The Chinese medicinal composition for treating initial stages of traumatic injury, acute soft tissue injury and bone fracture according to any one of claims 3 to 7, wherein the composition comprises transdermal penetration enhancer such as azone, borneol, methyl salicylate, menthol, propylene glycol and volatile oil or volatile component of Chinese medicinal materials which are obvious to those skilled in the art.

9. The preparation method of the Chinese medicinal composition for treating traumatic injury in the early stage, acute soft tissue injury and bone fracture as claimed in claim 6, comprising the following steps:

(1) pulverizing Olibanum into fine powder at low temperature, and sieving with 60-90 mesh sieve; pulverizing Eupolyphaga Seu Steleophaga into fine powder, oven drying at 50-70 deg.C for 2.5-4.5 hr, pulverizing into fine powder, and sieving with 60-90 mesh sieve;

(2) respectively coarsely pulverizing radix et rhizoma Rhei and fructus Gardeniae, sieving with 20-40 mesh sieve, mixing with fructus Chaenomelis and herba Taraxaci, reflux-extracting with 60-80% ethanol for 2 times, each for 2 hr, mixing extractive solutions, recovering ethanol, concentrating to obtain soft extract with relative density of 1.20-1.30, drying at 70-80 deg.C under vacuum degree of-0.05 MPa, pulverizing the obtained dry extract powder, sieving with 60-90 mesh sieve, and mixing;

(3) heating Colophonium, paraffin, vaseline, and liquid paraffin to 90-100 deg.C, melting, cooling to 65-75 deg.C, sequentially adding Eupolyphaga Seu Steleophaga powder, Olibanum powder, and dry extract powder, and stirring to obtain coating;

(4) coating paste, cutting, covering the lining and slicing to obtain the product.

10. The method for preparing a Chinese medicinal composition for treating initial stage of traumatic injury, acute soft tissue injury and fracture as claimed in claim 9, wherein the composition can be prepared into external preparations such as black plaster, ointment, rubber plaster, emplastrum, plastics, cataplasm, liniment, lotion, gel, etc.

Technical Field

The invention relates to the field of traditional Chinese medicine external paste, in particular to a traditional Chinese medicine composition for treating early traumatic injury, acute soft tissue injury and fracture and a preparation method thereof.

Background

With the improvement of living standard, the social demand for exercise and health care activities is increased year by year, which leads to the increase of the incidence of acute injury of soft tissues around joints caused by exercise on the basis of the prior common traumatic injury and fracture of the joints of human body such as ankle, knee, elbow, wrist and the like. The traditional Chinese medicine has a long history of treating the initial stage of traumatic injury and acute soft tissue injury, and forms a comprehensive treatment system of dynamic and static combination, repeated treatment of muscles and bones, internal and external combined treatment and staged application in long-term practice, and achieves certain progress. Developed to date, traditional Chinese medicine has produced a plurality of methods for relieving symptoms of early-stage traumatic injury and acute soft tissue injury, such as traditional Chinese medicine decoction and Chinese patent medicine containing the functions of promoting blood circulation to remove blood stasis, promoting qi circulation to remove meridian obstruction and relieving pain, acupuncture, moxibustion, massage and the like, which improve local meridian qi circulation, regulate qi and blood, and traditional Chinese medicine external treatment such as plaster application, blood circulation promotion, blood stasis removal, pain relief and swelling reduction, and has obvious curative effect.

However, the traditional Chinese medicine traumatic injury plaster has the defects of multiple medicinal components, toxic medicinal materials, national animal protection medicinal materials, excessive heavy metal caused by the traditional preparation process, serious loss of effective components of the medicinal materials after frying, skin irritation, inconvenience in use, difficult unification of product quality caused by the traditional preparation process and the like.

Disclosure of Invention

The invention aims to solve the problems in the prior art and provides a composition which has high transdermal absorption, less stimulation, rapid detumescence, pain relief, blood circulation promotion, blood stasis removal and the like.

The technical scheme for completing the invention task is as follows: a traditional Chinese medicine composition for treating early traumatic injury, acute soft tissue injury and fracture is characterized by comprising 1000 portions of rheum officinale, 400 portions of gardenia, 800 portions of frankincense, 400 portions of ground beetle, 800 portions of pawpaw and 800 portions of dandelion by weight.

Preferably, the composition comprises the following matrix auxiliary materials in parts by weight: 1200 portions of paraffin wax, 800 portions of vaseline, 400 portions of liquid paraffin wax and 10 portions to 300 portions of rosin.

Preferably, the composition comprises 1500-4500 parts of rhubarb, 750 parts of 450-750 parts of gardenia, 1500-900 parts of frankincense, 750 parts of ground beetle, 1500-900 parts of pawpaw, 1500-900 parts of dandelion, 1900 parts of paraffin, 1500-900 parts of vaseline, 350-150 parts of liquid paraffin and 30-250 parts of rosin by weight.

Preferably, the composition comprises 1800-4000 parts of rhubarb, 500-700 parts of cape jasmine, 1000-1400 parts of frankincense, 500-700 parts of ground beetle, 1000-1400 parts of pawpaw, 1000-1400 parts of dandelion, 1500-1800 parts of paraffin, 1000-1400 parts of vaseline, 170-320 parts of liquid paraffin and 50-220 parts of rosin by weight.

Preferably comprises 2000-3800 parts of rhubarb, 550-650 parts of gardenia, 1100-1300 parts of frankincense, 550-650 parts of ground beetle, 1100-1200 parts of pawpaw, 1100-1300 parts of dandelion, 1550-1750 parts of paraffin, 1100-1200 parts of vaseline, 180-320 parts of liquid paraffin and 80-200 parts of rosin by weight.

Preferably, the rhubarb, the gardenia, the pawpaw, the frankincense, the ground beeltle and the dandelion can be raw medicinal materials, and can also be decoction pieces or processed products, and the vaseline can be white vaseline or yellow vaseline.

Preferably, the following matrix auxiliary materials are included: is prepared from one or more of pressure-sensitive adhesive, sodium polyacrylate series, PAA-polyvinylpyrrolidone, polyethylene glycol, silicone rubber, silicone oil, lanolin, gelatin, carbomer and other adjuvants for external use.

Preferably, the composition comprises transdermal penetration enhancer such as azone, Borneolum Syntheticum, methyl salicylate, Mentholum, propylene glycol and volatile oil or volatile component of Chinese medicinal materials.

The invention also provides a preparation method of the traditional Chinese medicine composition for treating traumatic injury in the initial stage, acute soft tissue injury and fracture, which is characterized by comprising the following steps:

(1) pulverizing Olibanum into fine powder at low temperature, and sieving with 60-90 mesh sieve; pulverizing Eupolyphaga Seu Steleophaga into fine powder, oven drying at 50-70 deg.C for 2.5-4.5 hr, pulverizing into fine powder, and sieving with 60-90 mesh sieve;

(2) respectively coarsely pulverizing radix et rhizoma Rhei and fructus Gardeniae, sieving with 20-40 mesh sieve, mixing with fructus Chaenomelis and herba Taraxaci, reflux-extracting with 60-80% ethanol for 2 times, each for 2 hr, mixing extractive solutions, recovering ethanol, concentrating to obtain soft extract with relative density of 1.20-1.30 (45-65 deg.C), drying under reduced pressure (below 70-80 deg.C and vacuum degree of-0.05 MPa), pulverizing the obtained dry extract powder, sieving with 60-90 mesh sieve, and mixing.

(3) Heating Colophonium, paraffin, vaseline, and liquid paraffin to 90-100 deg.C, melting, cooling to 65-75 deg.C, sequentially adding Eupolyphaga Seu Steleophaga powder, Olibanum powder, and dry extract powder, and stirring to obtain coating.

(4) Coating paste, cutting, covering the lining and slicing to obtain the product.

Preferably, the composition can also be prepared into external preparations such as black plaster, ointment, rubber paste, emplastrum, coating agent, paste, liniment, lotion, gel and the like.

The invention has the beneficial effects that:

acute soft tissue injury refers to a series of pathological changes of soft tissue caused by various injury-causing factors acting on the body, and the pathological changes are mainly characterized by local acute inflammation and repair. The clinical manifestations are local swelling, pain, dysfunction, and ecchymosis, which are common and frequently encountered diseases in orthopedics and traumatology. With the progress of society and the change of life style, trauma diseases are relatively increased, and the disease is more in an absolute increasing trend due to the increasingly developed vehicles. The modern medicine has been used for a long time for treating acute soft tissue injury by mainly using wrapping, local sealing, physical therapy, inflammation diminishing and pain easing and the like, and the methods have poor curative effect, long recovery time, old injury, chronic pain and joint dysfunction, and influence the physical and psychological health of patients. The composition of the invention consists of the Chinese polyphaga, rhubarb, papaya and dandelion, which can promote blood circulation, relieve pain and dissipate blood stasis. The Chinese medicinal composition is prepared by taking rhubarb and gardenia as monarch medicaments in a prescription, taking the rhubarb as an essential medicament for traumatology, activating blood circulation to dissipate blood stasis, relieving swelling and pain, and taking the gardenia as an essential medicament for traumatology. Frankincense and Chinese polyphaga are used as ministerial drugs, the frankincense has the effects of dissipating blood stasis, eliminating swelling and relieving pain, and the Chinese polyphaga has the effects of removing blood stasis and treating fracture and wound, and the frankincense, the Chinese polyphaga and the Chinese polyphaga are used for removing blood stasis, relieving pain and eliminating swelling. The pawpaw and the dandelion are used as adjuvant drugs, the pawpaw is used for dissipating blood stasis and activating blood circulation, relaxing meridians and collaterals and activating muscles and bones, the dandelion is used for clearing heat and removing toxicity, eliminating swelling and dissipating stagnation, and the two drugs are combined to coordinate nutritive, diuretic and collateral-activating. The combination of the medicines has the effects of promoting qi and blood circulation, removing blood stasis and detumescence, and dredging collaterals and relieving pain, and accords with the treatment general method of regulating qi and blood and regulating the qi and blood to peace the mind (plain questions, essential essentiality treatise).

With the development of society and the improvement of living standard, the traditional black plaster preparation has the defects of large application area, high possibility of exceeding the standard of microorganisms, short effective storage period, difficult production and the like, can not meet the requirements of patients on convenience, cleanness and hypoallergenic property, and restricts the inheritance and development of traditional medicines. The medicine composition is improved on the basis of a clinical effective empirical formula, and is inconvenient to feed back and apply after being used by a patient, poor in comfortable sensation and easy to pollute clothes. The composition of the invention adopts modern extraction and purification technology of traditional Chinese medicine, enriches effective components for clearing heat, relieving swelling and easing pain from raw medicinal materials, and uses modern auxiliary materials to combine transdermal drug delivery technology to truly play the therapeutic effect of the medicine. The inventor adopts the traditional process and the process of the invention to carry out pilot-scale production of a plurality of batches of pilot-scale samples respectively, and through accelerated and 3-month long-term stability test investigation, the appearance, the character, the application comfort level, the convenience and the clinical curative effect of the product are obviously improved after the traditional process is improved, the quality is stable and reliable, the microorganism detection indexes are qualified, and the use safety of patients is ensured. Compared with the oral preparation on the market, the external preparation achieves the purpose of quick response through local targeted treatment, avoids the first pass effect of the liver, and reduces the toxic and side effects caused by oral administration of the medicine; compared with the traditional plaster, the plaster is comfortable and convenient to apply, low in sensitization and easy to accept by patients.

Detailed Description