JP2009269904A - Herbal medicinal composition for curing external wound and bedsore and method of manufacturing medicine from the composition - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a herbal medicinal composition for curing a wound difficult to cure caused by a bedsore or an injury and a pasty preparation for external application. <P>SOLUTION: The herbal medicinal composition for curing an external wound and a bedsore contains herbal medicinal materials such as dried ginger root, dried aconiti tuber or dried aconiti tuber after soaked in bittern, and cinnamon bark as the effective ingredients. A more preferable preparation further contains nutlets of Z. piperitum DC, nutlets of Evodia rutaecarpa, roots of Chinese peony, bark of Magnolia obovata, frankincense, myrrh, and gambier. Another preferable preparation of the herbal medicine contains an extract from the freeze-dried mycelium of enoki mushroom in the preparation described above. The herbal medicine is an ointment obtained by pulverizing the medicinal materials of this formulation, and adding a fat (e.g. lard) to and mixing it with the pulverized materials to make them pasty. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a herbal medicine composition. The present invention also relates to an external paste-form preparation intended to treat pressure sores and other wounds that are difficult to heal due to injury or illness.

  Pressure sores are common clinical signs of medical care and are a common phenomenon in people who have difficulty in behavior or who have been sleeping for many years. As a cause of pressure ulcers, the local skin and the soft tissue under the skin are subjected to pressure for a long time, resulting in oxygen deprivation, resulting in necrosis of the cellular tissue.

The following explains the cause of pressure ulcers.
Local origin:
(1) Vertical pressure of the epidermis: When the external pressure is greater than the blood pressure of the microvessels in the local subcutaneous tissue, the circulation of the local blood is inhibited, so that the cells are oxygen deficient. If the deficiency continues for a long time, the cells die, causing ulcerations (chiran, destruction) in the skin, subcutaneous tissue and muscles.

The area to be pressed is always the most prominent part of the body, including the sacrum, hipbone, sciatic spine, throat, ankle, scapula, and elbow.
(2) Shear stress of the epidermis: When the patient lies down or sits down, the sacral skin is pulled, resulting in a horizontal pruning force, pressure is applied to the blood vessels that supply the skin, and the skin is oxygenated Causes deficiency and necrosis.

(3) Local trauma and infection: When infected by scratches or contusions, the tissue becomes less resistant to oxygen deficiency, and when bedridden for a long time, pressure ulcers occur due to pressure and shear stress.
(4) Local temperature: Since the temperature of the local tissue is lowered, the metabolic rate of the cells is lowered, and the resistance to oxygen deficiency is lowered.

(5) Local humidity: The skin becomes softer and more brittle due to excessive infiltration of the skin, and the local area is always warmed by wearing a paper diaper at all times because of poor ventilation and incontinence of large and small stools.

Systemic origin and cause:
(1) Age: Since the skin's elasticity is lost due to aging and blood circulation deteriorates, the tolerance to oxygen deficiency in tissues also decreases.

(2) Undernourishment: Due to long-term undernourishment, tissue repair stagnate, and resistance to oxygen deficiency and resistance to infection decreases.
(3) Anemia: When anemia occurs, the ability to carry oxygen in the blood is reduced, blood circulation is hindered, and oxygen deficiency is likely to occur in tissues.

(4) Psychological effects: Sleeping for long periods of time weakens the will to live and reduces immunity.
From the point of view of Chinese medicine, the turning point of the disease can be explained from Yellow Emperor's Inner Sutra Vol. 81 No. 81 (Non-patent Document 1).

“If a cold invades a meridian and stays, the blood circulation crawls out. If the blood circulation is interrupted, the operation of the airways is hindered, staying at the site where the blood circulation is interrupted and not circulating, resulting in an adenoma.

  The cold turns into heat, and when the heat builds up, the muscles rot, and when the muscles rot, suppuration occurs. If the pus is not drained, the muscles will be damaged, and if the muscles are damaged, the bones will be damaged.

If pyotoxin is not in the space of the bone segment, it is not excreted, causing blood loss.
If this happens, the musculoskeletal muscles will no longer be nourished, and the transspiratory vein will be damaged and damaged, and if the poisonous gas reaches the five organs, the five organs will be damaged and die. ]
Currently, in general, drugs used for wounds are iodine tincture, poultice, ointment for wounds and burns, and external medicines, and these effects are only sterilization and disinfection.

However, as mentioned above, the cause of pressure sores is very different from the cause of simple trauma.
And, for drugs that treat wounds that are difficult to heal like pressure ulcers, at the same time, it becomes a drug that simultaneously removes bacterial infection and regenerates necrotic tissue and has the ability to improve wound healing due to other diseases, etc. A compounding method with a certain effect has not been developed yet.

There are the following documents on Chinese medicine for treating pressure ulcers and trauma.
(1) Complete collection of surgical evidence (Non-Patent Document 2),
(2) Masamune Surgical (Non-Patent Document 3),
(3) Medical Buddhist gold book (Non-Patent Document 4).

In the above literature,
In (1), it is described that wrinkles and ulcers (causes), genital warts, and mosquitoes can be cured with a hydrating plaster.

  In (2), raw skin ball plasters form abscesses in ulcers such as wrinkles, swollen dorsum (back swelling, dorsum), various wrinkles / ulcers, stick poisons, etc. It is stated that it can be cured when you are doing.

In (3), it is described that it is possible to end corruption and generate new skin to cure all wrinkles.
The Kampo medicine prescription described in the above-mentioned literature has only a logical thinking, or actually has no therapeutic effect, and many patients have already used drugs such as external disinfectants such as iodine tincture in advance. Therefore, it has become difficult to cope with medical treatment.
Yellow Emperor's Inner Spirit 81 Surgical Seiji Life Collection Surgical Masamune Medical monarch

  As mentioned above, from the point of view of dialectical theory, it can be seen that cold sores are cold, proof, labor, illness, and blood clots. Warm it for the cold, make up for it, warm it for the labor, take the sun alone for the treatment of hemorrhoids, and assist it with the vitalized sputum method. This accords with the theory of “Internal law is a foreign law” described in “Lilong Ben Bun” written by Wu Shi-ki from Qing Dynasty.

  Based on the above principle, the present inventor has been dedicated to research and developed an effective salve for treating pressure ulcers.

The features of the traditional Chinese medicine composition for treating trauma and pressure ulcer and the traditional Chinese medicine for treating trauma and pressure ulcer according to the present invention are the following [1] to [32] and [33].
[1] A herbal medicine composition for the treatment of trauma and pressure ulcer characterized by containing as an active ingredient psoriasis (kankyo), bunshi (bushi), tsutsuji (bushi), and nikukei.

In addition, in this invention, it replaces with the samurai appendix (bushi) which detoxified the appendix (bushi) or the appendix (bushi), and a salt appendage (enbushi), a processed appendage (kakoubushi), etc. may be used.
[2] According to [1], the mixing weight ratio of kankyo, bunshi (bushi), tsutsuji (bushishi), and meat katsura (Nikukei) as active ingredients is 4: 2: 1. A herbal medicine composition for treating trauma or pressure ulcer as described.

[3] The herbal medicine composition for the treatment of trauma or pressure ulcer according to [1] or [2], wherein each active ingredient is in a powder form.
[4] A herbal medicine for treating trauma and pressure ulcer, comprising the herbal medicine composition according to any one of [1] to [3] and an appropriate amount of oils and fats.

  [5] Chinese herbal medicine composition for the treatment of trauma and pressure ulcer characterized by containing as an active ingredient psoriasis (kankyo), bunshi (bushi) or tsutsuji (bushishi), meat katsura (Nikukei), 蜀椒 (shokusho) object.

[6] The mixing weight ratio of the dry ingredients (bamboo), bunshi (bushi), tsutsuji (bushishi), meat katsura (Nikukei) and strawberry (shokusho) as active ingredients is 4: 1: 1: 1. A herbal medicine composition for the treatment of trauma or pressure ulcer as described in [5].
[7] The Chinese medicine composition for the treatment of trauma or pressure ulcer according to [5] or [6], wherein each active ingredient is in a powder form.
[8] A herbal medicine for treating trauma and pressure ulcer, comprising the herbal medicine composition according to any one of [5] to [7] and an appropriate amount of an oil and fat.
[9] A trauma characterized by containing, as an active ingredient, kankyo, bunshi (bushi) or tsutsuji (bushishi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu), A herbal medicine composition for treating pressure ulcers.
[10] The dry weight of kankyo, bunshi (bushi), tsutsuji (bushishi), meat katsura (Nikukei), shu (shokusho), and wushu (goshyu) as active ingredients is 4: 1. The Chinese medicine composition for the treatment of trauma and pressure ulcers according to [9], wherein the composition is 1: 1: 1.

[11] The Chinese medicine composition for the treatment of trauma or pressure ulcer according to [9] or [10], wherein each active ingredient is in a powder form.
[12] A Kampo medicine for treating trauma and pressure ulcer, comprising the Kampo medicine composition according to any one of [9] to [11] and an appropriate amount of oils and fats.
[13] Containing as an active ingredient kankyo, bunshi (bushi) or tsutsuji (bushi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu), glaze (peony) A herbal medicine composition for treating traumatic and pressure ulcers.
[14] Mixing weight ratio of kankyo, tsutsuji (bushi), tsutsuji (bushi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshuyu), and glaze (sakuyaku) as active ingredients Is a Chinese medicine composition for the treatment of trauma and pressure ulcer as described in [13], wherein the ratio is 4: 1: 1: 1: 1: 1.
[15] The herbal medicine composition for the treatment of trauma or pressure ulcer according to [13] or [14], wherein each active ingredient is in a powder form.
[16] A herbal medicine for treating trauma and pressure ulcer, comprising the herbal medicine composition according to any one of [13] to [15] and an appropriate amount of an oil and fat.
[17] Practical use of kankyo, bunshi (bushi) or tsutsuji (bushishi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu), glaze (peony), koboku A herbal medicine composition for the treatment of trauma and pressure sores characterized by containing as an ingredient.
[18] As an active ingredient, dried oysters, bunshi or tsutsuji (bushi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu), glaze (peony), magnolia ( The mixing weight ratio is 4: 1: 1: 1: 1: 1: 1: 1 [1
[7] A traditional Chinese medicine composition for treating trauma or pressure ulcer.
[19] The traditional Chinese medicine composition for the treatment of trauma or pressure ulcer according to [17] or [18], wherein each active ingredient is in a powder form.

[20] A herbal medicine for treating trauma and pressure ulcer, comprising the herbal medicine composition according to any one of [17] to [19] and an appropriate amount of fats and oils.
[21] Ingredients (Kankyo), Tsuji (Bushi) or Tsukutsu (Husushi), Miku Katsura (Nikukei), Tsuku (Shokusho), Wu Shu (Gushyu), Shakuyaku (Peonies), Koboku (Nyukou), a traditional Chinese medicine composition for the treatment of trauma and pressure ulcers, characterized in that it contains as an active ingredient numb.
[22] Ingredients as dry ingredients, kanshiki, bunshi (bushi) or tsutsuji (bushishi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu), glaze (peony), magnolia ( The mixing weight ratio of Koboku), frankincense (Nyuko), and pills (Motsuyaku) is 4: 1: 1
: The composition of the traditional Chinese medicine for the treatment of trauma and pressure ulcer according to [21], wherein the composition is 1: 1: 1: 1: 1: 1: 1.
[23] The herbal medicine composition for the treatment of trauma or pressure ulcer according to [21] or [22], wherein each active ingredient is in a powder form.
[24] A Kampo medicine for treating trauma and pressure ulcer, comprising the Kampo medicine composition according to any one of [21] to [23] and an appropriate amount of oil and fat.
[25] Ingredients (Kankyo), Tsuji (Bushi) or Tsukuda (Hushibushi), Meat Katsura (Nikukei), Kite (Shokusho), Wu Zhi (Gushyu), Shakuyaku (Peonies), Koboku A herbal medicine composition for the treatment of trauma and pressure ulcer characterized by comprising (Nyukou), pills (motsuyaku), and asenyaku (asenyaku, kocha) as active ingredients.
[26] Ingredients as dry ingredients, kanshiki, bunshi or tsutsuji (bushishi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu), glaze (peony), magnolia ( It is characterized in that the mixing weight ratio of Koboku), frankincense (Nyuko), pills (motsuyaku), and asenyaku (asenyaku, kocha) is 4: 1: 1: 1: 1: 1: 1: 1: 1: 1: 1 And the herbal medicine composition for the treatment of trauma or pressure ulcer according to [25].

[27] The traditional Chinese medicine composition for treating trauma or pressure ulcer according to [25] or [26], wherein each active ingredient is in a powder form.
[28] A Kampo medicine for treating trauma and pressure ulcer, comprising the Kampo medicine composition according to [27] and an appropriate amount of oil and fat.
[29] [1] to [3], [5] to [7], [9] to [11], [13], further comprising an enokitake fungus mycelium extract as an active ingredient -[15], [17]-[19], [21]-[23], [25]-[27] The Chinese medicine composition for the treatment of trauma and pressure ulcers.
[30] Enokitake mushroom mycelium extract is another active ingredient, kankyo, bunshi (bushi), tsutsuji (hobushi), meat katsura (Nikukei), 蜀椒 (shokusho)
, 0.01% to 1 part by weight of the total content of Gushyu, Peonies, Koboku, Nuka, Nutsuyaku, Asenyaku
The herbal medicine composition for the treatment of trauma and pressure ulcers according to [29], characterized in that it is ˜0.27 parts by weight, preferably 0.02 to 0.1 parts by weight.
[31] The herbal medicine composition for the treatment of trauma or pressure ulcer according to [29] or [30], wherein the active ingredient is powdery.
[32] A Chinese herbal medicine for treating trauma and pressure ulcer, comprising the Chinese medicine composition according to any one of [29] to [31] and an appropriate amount of oil and fat.
[33] For the treatment of trauma or pressure ulcer according to any of [4], [8], [12], [16], [20], [24], [28], wherein the oil or fat is lard Chinese medicine composition or salve.

  Its main utility is to not only enhance the patient's immunity, ie “sane” and effectively control the infection, but also remove the spoiled muscle, ie “get rid of the evil” and remove the old ones It is also compatible with wounds, and can rapidly absorb exudate and keep it moist.

Therefore, the present invention provides an externally used Chinese medicine plaster that is applied when a wound is not easily cured.
The externally used Chinese medicine plaster according to the present invention is most effective for treating pressure ulcer in particular.

  The above-mentioned Chinese herbal medicines are dried citrus, bunshi or bunshi, nikukei, nikukei, shu (shokusho, yam), wushu, peony , Chinese medicine such as Koboku, Nuka, Nyaku, Mochiyaku, and Asen (Asenyaku, Chinese: Kocha). Furthermore, a better effect can be obtained by preparing an enokitake fungus mycelium extract.

  Pepper is a dried ginger of Zingiber officinale Roscoe. It works on cold chills, has hemostasis and circulation, and has pharmacological effects such as analgesic action, antagonism of oxygen deficiency, and anti-inflammatory action.

Bushi is the lateral root of Aconitum carmichaeli Debeaux. It has effects of rejuvenation and cold dehumidification, reducing blood flow, antagonizing and antithrombotic action, anti-inflammatory action, T cell (lymphocyte) of heart muscle deficiency There is a pharmacological action such as improving immune function to increase the conversion rate.炮 Bushi is a deodorized version of Bushi.

  Nikukei (cinnamon) is a bark of the cinnamon Cinnamomum cassia Presl, which has been peeled off and dried. It has effects of supplementary fire assistance, cold soreness, warm transpulmonary, and pharmacological actions such as anti-ulcer action, anti-inflammatory action, antibacterial action, and aging prevention action. A young branch, Keishi, can be substituted.

The following is a preferred prescription selected from the above-mentioned Chinese herbal medicines, and the numerical values represent parts by weight.
The prescription 1 is composed of 4 pieces of kankyo, a bunshi or a bun, 2 and a nikukei.

Prescription 1 'consists of the composition of kankyo (4), bunshi (bushi) or tsutsuji (bushishi) 2, nikkei (1), and mycelium extract 0.27.
The prescription 2 is composed of 4 types of dry rice (kankyo), bunshi (bushi) or bonito (bushishi) 1, meat katsura (Nikukei) 1, 蜀椒 (shokusho, yam).

  Prescription 2 'is composed of 4 pieces of kankyo, bunshi or bunshibushi, 1, katsura 1, 1 of shochu, and 0.27 enokitake fungus mycelium extract It is.

Prescription 3 is composed of 4 kinds of kankyo, 1 bunshi or 1 bun, 1 nikukei, 1 shu, 1 goshuyu .
Prescription 3 'is extracted from kankyo (4), bunshi (bushi) or tsutsuji (bushi) 1, nikukei 1, shokusho 1, goshuyu 1 and enokitake fungus mycelium It consists of the structure of object 0.27.

Prescription 4 consists of 4 varieties, 1 Bushi or 1 Bushi, 1 Nikukei, 1 Shaku, 1 Goshuyu, 1 Peony It consists of a structure.

  The prescription 4 'is: Pepper 4 、 Bushi or Bushi 1 、 Niku Kei 1 、 Sho 1 、 Gush Yu 1 、 Shaku Yaku 1 And enokitake mushroom mycelium extract 0.27.

The prescription 5 is: Pepper 4, Bushi or Bushi 1, Nikukei 1, 1 シ ョ 1, 1 シ ュ 1, 1 peony 1, It is composed of Kokaku 1.

  The prescription 5 'is: Pepper 4, Bushi or Bushi 1, Nikukei 1, 1 シ ョ 1, 1 シ ュ 1, 1 peonies 1 , And composed of Kobaku 1 and Enokitake fungus mycelium extract 0.27.

Formula 6 consists of 4 varieties, 1 Bushi or 1 Bushi, 1 Nikukei, 1 Shaku 1, 1 Gushyu 1, 1 Peony It consists of Kokaku 1, Nuka 1 and Mochiyaku 1.

The prescription 6 'is: Pepper 4 、 Bushi or Bushi 1 、 Niku Kei 1 、 Sho 1 、 Gush Yu 1 、 Shaku Yaku 1 , Kobaku 1, Nyuka, Nyaku 1 and Enokitake fungus mycelium extract 0.27.

The Chinese herbal medicine of the present invention comprises the above-mentioned Chinese herbal medicine based on the above-mentioned prescription ratio, mixed and pulverized into a powder form, added with an auxiliary agent, and stirred. .
The Chinese herbal medicine may be either a fresh type or a dry type. However, a dry type is preferable in order to avoid contamination with impurities.

There is no particular limitation on the degree of drying, but if it is too dry, quality will be affected.
The auxiliary agent may be a mineral fat or oil or an animal or vegetable fat. Furthermore, wax or the like may be used.

Examples of the mineral fats and oils include ceresin and petrolatum, as well as paraffinic ones obtained from petroleum resources and C15 or higher.
Examples of animal fats include, for example, animal oils such as egg yolk oil, mink oil, cod liver oil, and squalane.
Animal fats include het (beef tallow), lard (pig tallow), and sheep fat.

Examples of vegetable oils include, in vegetable oils, dry oils such as sunflower oil; semi-dry oils such as sesame oil; non-drying oils such as olive oil and persimmon oil;
Examples of vegetable fats include cocoa butter, coconut oil, and mole.

In the present invention, these auxiliaries are preferably pasty at high temperatures.
Mineral oils and fats are relatively good. The animal and vegetable fats and oils are preferably het (beef tallow) and lard (pig tallow).

However, according to the use of the traditional Chinese medicine external preparation of the present invention, other pharmaceutical fats and oils and emulsion materials can be selected and used.
The inventor has proved by experiments that the effect of lard is the best.

  If the above-mentioned auxiliary agent (example: lard) and the powdered Chinese medicine preparation are mixed and stirred, a preparation such as an ointment is completed. In order to adjust the viscosity of the ointment, a viscosity modifier may be appropriately mixed. Further, a deodorant and a fragrance may be mixed as appropriate so that the user can easily accept them.

  The enokitake mushroom mycelium extract may be mixed with the auxiliary agent after stirring the Chinese herbal medicine into a powder, followed by stirring and mixing. Alternatively, after the paste-form preparation is completed, the enokitake mushroom mycelium extract may be added thereto and stirred and mixed.

The range of action of the salve of the present invention includes skin (skin), pulse (nerve, blood vessel, transvenous), meat (subcutaneous fat), muscle (muscle), bone (bone marrow) and the like.
The pasty preparation of the present invention has the following advantages.

・ Action on deep ulcers of defects:
The most difficult treatment for decubitus is the removal of necrotic tissue (this is the “cold” in Chinese medicine), but the salve of the present invention has the effect of relieving coagulation, thus removing dead skin. And you can end the ulcer.
This is a key point for the presence or absence of a therapeutic effect.

・ Promoting the renewal of granulation tissue:
The salve of the present invention has the effect of promoting the formation of new skin.

・ Control of exudate:
The large amount of exudate that is common in pressure ulcers is also infectious impetigo (densensei nokacin, flying squirt), and the pathogen is mostly Staphylococcus aureus.
The active ingredient contained in the salve of the present invention has a function of enhancing the phagocytosis of macrophages and enhancing the immunity of the living body, and has an inhibitory action against various pathogens.

-Keep wet:
The salve of the present invention has an inhibitory action against excessive infiltrates of the exudate,
At the same time, the tissue after removal of the exudate is kept infiltrated so as to help recover the wound.

The salve of the present invention can be applied at any stage of the pressure ulcer.
Next, the manufacturing method of said enokitake mushroom mycelium extract is demonstrated.
First, water, preferably pure water, is appropriately mixed in a solid medium composed of Bacasu, sterilized, cooled, and inoculated with Enokitake.

In addition to rice bran, minerals such as phosphorus and iron, peanut epidermis, brown rice, etc. may be added to this bacus medium if necessary.
In addition, the sugarcane squeezed rice cake contains sugars and proteins that serve as nutrients for the mycelium, and can remain a solid medium as it is, but when adding the rice bran to the bacus, Rice bran is usually used in an amount of about 10 to 20 parts by weight with respect to 80 parts by weight of bacus.

As the enokitake mushroom, conventionally known ones can be used.
Next, the medium inoculated with the enokitake mushroom is placed in a culture chamber in which the temperature and humidity are adjusted and the illuminance is also adjusted to grow the mycelium.

  When the enokitake mushroom mycelium is grown in this manner, after inoculating the enokitake fungus as described above, the temperature and humidity are preferably 75 to 99 under the conditions of a temperature exceeding 14 to 25 ° C. and a humidity of 70%. In a culture chamber adjusted to the above temperature and humidity conditions of 80 to 95%, and usually maintained (cultured) for 2 to 6 months, preferably 2 to 3 months, and the mycelium It is desirable to grow.

  In addition, due to the action of Enokitake fungi, the medium components are decomposed during the cultivation and finally become water and carbon dioxide, and the water inside the medium becomes about 80%. For this reason, when the humidity is set to 70% or less, the evaporation of moisture to the outside of the medium increases, and as a result, the medium shrinks and the original object cannot be obtained.

  In the present invention, the mycelium spreads in the solid medium and immediately before the fruit body is generated. It is desirable that the fiber element of the bacus base material is unbundled at a time immediately after that so that the passage through 12 mesh is 30% by weight or less. In addition, the bundling of the bacus base medium is performed immediately before the fruit body is generated as described above. Although it is preferable to carry out at the time immediately after, it may be done at a time after the fruiting body has grown considerably.

To the solid medium thus unwound, water and one or more enzymes selected from cellulase, protease, glucosidase, hemicellulase, chitinase, amylase and pectinase are added while keeping the solid medium at 30 to 50 ° C. .

Cellulase is preferable as the enzyme to be added.
The added amount of the enzyme is 0.5 to 5 g, preferably 1 to 3 g, per 1 kg of the solid medium.

The water is preferably pure water that does not contain ions such as metal ions, and 1 kg of pure water, preferably 3 to 5 kg, is added to 1 kg of the unbundled medium to obtain a mixture containing bacus.
Next, the enokitake mushroom mycelium extract is extracted from this bacas-containing mixture.To extract the enokitake mushroom mycelium extract in this way, the medium-containing mixture is circulated using, for example, a gear pump with a transmission, etc. It is desirable to add pulverization and crushing (Laikai) action to the solid medium so that about 70% by weight or more of the bacus fiber can be passed through 12 mesh.

  If the 12 mesh passage is less than 70% by weight, the extraction of the active ingredient in the solid medium becomes insufficient, the part where the fiber is not sufficiently softened increases, and the resulting solid residue is used as feed, food or fertilizer. As a result, it may become impossible to effectively use.

Crushing and crushing (Laikai) of the mixture containing Bacus may be performed while maintaining the temperature of the mixture at 30 to 50 ° C., and may be performed while gradually increasing the temperature from the above temperature. However, it is preferable to carry out.

  When air at room temperature is injected into a mixture containing bacus when the water temperature is 30 ° C or higher, preferably 35 ° C or higher, the air bubbles are rapidly heated and burst, impacting the bacus fibers and the active ingredient Can be extracted more efficiently.

  Next, the bacass-containing mixture thus treated is further heated to a temperature of up to 95 ° C., preferably about 75 to 90 ° C., and kept at this temperature for several tens of minutes, so that the enzyme in the mixture is When the mixture is inactivated and the mixture is sterilized, enokitake mushroom mycelium extract is obtained.

When the enzyme in the mixture is inactivated by heating and sterilized in this manner, the alteration of the enokitake mushroom mycelium extract can be prevented.
In addition, you may filter the obtained enokitake mushroom mycelium extract using the filter cloth of 50-120 mesh, Preferably about 60-100 mesh as needed.

The enokitake mushroom mycelium extract thus obtained contains proflamin.
Such an extract can be concentrated and used, or can be freeze-dried and used as a powder. Further, it can be diluted with purified water, alcohol, etc. It can be used by adding it to a flame remedy, athlete's foot treatment, comedone remedy, immune activator, AIDS remedy, anticancer agent, etc.) cosmetics (skin moisturizing cosmetics, etc.).
Hereinafter, the Kampo medicine composition for the treatment of trauma and pressure ulcer and the Kampo medicine for the treatment of trauma and pressure ulcer according to the present invention will be described more specifically with reference to production examples and examples.

[Production Example 1]:
The following herbal medicines were blended based on the following prescription ratio, mixed, pulverized, and stirred.

150 g of dried rice cake, 37.5 g of Bushi or Hushishi, 37.5 g of Nikukei, 37.5 g of Shakusho, 37.5 g of Goshuyu, 37.5 g of Peonies , 37.5 g of Kobak, 37.5 g of incense (Nyuko), 37.5 g of pills (Motsuyaku), and 37.5 g of Asenyaku (487.5 g in total).

The pulverization is performed using an air flow type ultra-fine pulverizer (manufactured by Wuzhen Enterprise Company; Taiwan Patent No. 121630) so as to pass about 120 mesh (fine pulverization). After pulverization, the mixture was further mixed with 2400 g of lard and stirred to obtain a paste to obtain an ointment-like preparation (Chinese medicine ointment 1: 2887.5 g).

[Production Example 2]:
Chinese herbal medicine manufactured based on the same formulation as in Production Example 1 (487.5 g in total) was mixed and pulverized to add powder, 10 g of freeze-dried Enokitake fungus mycelium extract powder was added, stirred well, It was mixed with 2400 g of lard and stirred to make a paste to obtain an ointment-like preparation (Chinese medicine ointment 2: 2897.5 g).

Preparation method of Enokitake fungus mycelium culture extract (FVM):
After adding pure water to a solid medium consisting of 90 parts by weight of bacus and 10 parts by weight of rice bran, inoculated with enokitake mushrooms and allowed to stand in a culture chamber with controlled temperature and humidity to grow mycelium. .

After the mycelium was spread on the solid medium, the filaments of the bacus base material were unbound so that the amount passed through the 12 mesh was 24% by weight or less. To 1.0 kg of the unbundled medium, 3.5 kg of pure water was added, and 2.0 g of purified cellulase was added while maintaining the temperature at 40 ° C. to obtain a medium-containing mixture.

  Next, while the medium-containing mixture was circulated by a gear pump with a transmission, the solid medium was crushed and ground at the gear portion for about 200 minutes, so that about 80% by weight of the bacus fiber was passed through 12 mesh.

The medium-containing mixture was pulverized and ground while gradually raising the temperature of the mixture.
Thereafter, the medium-containing mixture was further heated and left at 90 ° C. for 30 minutes. By heating to 90 ° C., the enzyme was inactivated and sterilized.
The obtained medium-containing mixture was filtered using a 60-mesh filter cloth to obtain an enokitake mycelium extract. After concentration, a freeze-dried powder that was an enokitake mycelium extract was obtained.

Example of combined use of pressure ulcer ointment preparation of the present invention and enokitake fungus mycelium culture extract (FVM):
(1) As a result of studying the therapeutic effect using pressure buds containing enokitake mushroom mycelium culture extract (FVM), it generally takes several days to regenerate. The patients used were promoted to regenerate compared to that.

This is thought to be due to the synergistic addition of the antitumor action, immunostimulatory action and fatigue recovery action inherent to the enokitake mushroom mycelium culture extract (FVM) to increase the resistance to the body.
In particular, it is suggested that the enokitake mycelium culture extract stimulates sympathetic nerves and recovers from fatigue at low concentrations.

(2) The anti-tumor and immunostimulatory effects inherent to the enokitake mushroom mycelium culture extract (FVM) are included in the enamel mushroom mycelium culture extract (FVM) -containing pressure ulcer (eg, Chinese medicine ointment 2 in Production Example 2). And has a fatigue recovery effect.

Furthermore, the enokitake mushroom mycelium culture extract (FVM) has a moisturizing action on the skin, and treatment with this acne agent promoted skin regeneration, and the regenerated skin was fastened by moisturizing action.

The enokitake mushroom mycelium culture extract (FVM) -containing pressure ulcer (= also referred to as Chinese herbal ointment or Chinese herbal ointment 2) (b) is (i) no treatment (skin Compared to the case of no treatment for the cut wound), it shows a significantly high value in terms of wound tension, and has a healing promoting effect.

In addition, the traditional Chinese medicine ointment 2 of the present invention is more compared to “b-FGF” (decubitus treatment agent, general name “trafermin” manufactured by Kaken Pharmaceutical Co., Ltd.), which is commercially available as a general treatment agent for acne. It exhibits a strong healing promoting action and has excellent effectiveness in the healing effect of skin cuts (Test Example 11).

Moreover, as a result of applying the Chinese herbal medicine ointment 2 of the present invention to a defect site prepared on the back of a genetically diabetic mouse (db / db mouse) and measuring the area of the defect, the healing promotion effect of the Chinese medicine ointment 2 was recognized. It was. Moreover, the area under the time course curve (AUC) of the defect area also shows a significantly low value, and a healing promoting action is observed (Test Example 12).

The salve of the present invention is used according to the following explanation.
First, the pressure ulcer is washed with sterile physiological saline, and an appropriate amount of salve is applied onto the non-woven fabric with a sterilized cotton swab and covered with gauze, which is applied to the pressure ulcer.

If the pressure ulcer is deep, apply a plaster (adjusted depending on the size and depth of the lip) to the pressure lip and cover with gauze. Replace several times a day depending on the condition of the wound.
When exchanging, be careful not to break the wound's new thin film and keep it moist, and do not disinfect with iodine tincture.

  How to Save: Place in a cool, dark place away from direct sunlight. When storing for a long time, place in a refrigerator and refrigerate. The shelf life is one year.

(Test Example 1)
"Medical history number 1": Mr. Chen
A 52-year-old patient with cerebral dysemia who was bedridden for a long time and developed a pressure sore on the sacral region on September 28, 2007. The wound (area) is about 10 cm x 5 cm, and it is an ulcer extending to the dermis of a second-degree pressure ulcer (joxou).

The wound was completely healed on October 10 of the same year by reapplying once a day using the pressure ulcer made in Production Example 1.
This is shown in FIGS. 1 (A) to (D).

(Test Example 2)
"Medical history number 2": Mr. Tsuji
A 66-year-old patient with cerebral dysemia who is bedridden for a long time and has pressure ulcers in the sacrum. The wound is about 3cm
× 2cm, it reaches the subcutaneous fat layer and is a third degree pressure ulcer. He had a history of 1 month and was a wound that was difficult to heal. The wound was completely healed on October 10 of the same year by treatment using the pressure ulcer made from Production Example 1 on September 29, 2007.
This is shown in FIGS.

(Test Example 3)
"Medical history number 3": Mr. Tsuji
A 34-year-old patient with hypertension and venous thrombosis in the lower limbs, visited on May 5, 2007. He suffered cellulitis due to injury of the left foot heel. There is a history of one month, the wound is about 10cm x 4cm, and it reaches the subcutaneous fat layer.

By reapplying the pressure ulcer made from Production Example 1 once a day, the wound was fully healed on July 20 of the same year.
This is shown in FIGS. 3 (A) to 3 (B).

(Test Example 4)
"History number 4": 21-year-old Wang
Around the beginning of March 2007, a car accident injured his right shin and sewed it, but the wound did not heal easily and suffered cellulitis.

The wound is about 6cm x 4cm, and it reaches the muscle layer and is an IV degree pressure ulcer.
The wound was completely healed on June 29 of the same year by reapplying the pressure ulcer made from Production Example 1 on April 12 of the same year.
This is shown in FIG.

(Test Example 5)
"Medical history number 5": Mr. Tsuji
A 54-year-old patient with cerebral dysemia and diabetes who is bedridden for a long time, has a pressure ulcer on his buttock, has a wound of about 10 cm x 5 cm, reaches the muscle layer, and has an IV degree pressure ulcer.

A pressure ulcer also develops on the back, the wound is about 5cm x 3cm, and it reaches the subcutaneous fat. There is a history of 2 months.
The wound was completely healed on July 17 of the same year by reapplying the pressure ulcer made from Production Example 1 once a day from around June 2007.
This is shown in FIGS.

(Test Example 6)
“History No. 6”: 76-year-old Xu Jiang is a handicapped person who has developed a pressure sore on the back with a wheelchair and a bed for a long period of time, and the skin becomes red and swollen, and finally the skin is torn I have. It is a first-degree pressure ulcer whose wound extends to the epidermis layer. There is one month of medical history. From October 1, 2007, the wound was completely healed on October 7, 2007, by reapplying the pressure ulcer made from Production Example 1 once a day.
This is shown in FIGS. 6 (A) to (E).

(Test Example 7)
"Medical history number 7": Mr. Liu
A 64-year-old patient with breast and rectal cancer who underwent surgery to rebuild the small intestine colostomy. Some wounds did not heal in the abdomen and suppurated.

It is a type II acne that has many wounds (area) of 1-2 cm x 1-2 cm and extends to the dermis layer. There are several months of medical history.
By using and treating the pressure ulcer made in Production Example 1 from around September 2007, suppuration stopped on October 5 of the same year and the wound was completely healed.
This is shown in FIGS. 7 (A) to (F).

(Test Example 8)
"Medical history number 8": Mr. Zhang
A 79-year-old diabetic patient with black left thumb and necrosis, swollen second hip joint, suppuration and pain. There are several months of medical history.

The condition of suppuration and swelling improved on August 3 of the same year by applying the pressure ulcer made from Production Example 1 from around July 2007 and repainting it once or twice a day.
This is shown in FIG.

(Test Example 9)
"Medical history number 9": Mr. Tsuji
A 76-year-old patient with cerebral dysemia, who was bedridden for a long time and developed pressure ulcers in the sciatic region. It is a pressure sore that has a wound of about 2cm x 2cm and extends to the dermis layer.
There is one month of medical history. The wound was completely healed on September 21, 2007 by using and treating the pressure ulcer made from Production Example 1 on August 10, 2007.

(Test Example 10)
"Medical history number 10": Mr. Tsuji
A 77-year-old patient with pulmonary tuberculosis who was bedridden for a long time and developed a pressure ulcer in his left scapula. The skin turned red and swollen and eventually the skin broke.

This is a pressure ulcer with a wound area of about 2cm x 2cm that extends to the epidermis. There is a history of 2 months.
The wound was completely healed around the beginning of August of the same year by treating and using the pressure ulcer made from Production Example 1 from July 13, 2007.

(Test Example 11)
<< Treatment Test of Traditional Chinese Ointment 2 by Rat Skin Incision Model >>
1. <Summary>
A 12-week-old Cr1: CD (SD type) rat skin incision model was treated with the Chinese medicine ointment (also referred to as “Chinese medicine ointment 2”) obtained in Production Example 2 to test the healing promotion effect. As a result, as shown in Table 1 and FIG. 9 below, (a) no treatment group, (b) Chinese medicine ointment 2 treatment group of the present invention, and (c) “b-FGF” (decubitus therapeutic agent, Kaken Pharmaceutical Co., Ltd.) The average and standard error of wound strength of the treatment group were (b) 143 ± 8 g, (b) 289 ± 31 g, and (c) 205 ± 19 g, respectively.

In addition, (b) the rate of increase in wound tension in the Chinese medicine ointment 2 treatment group and (c) b-FGF treatment group of the present invention was 102.1% and 43.4%, respectively. .
The wound tension of the treatment group of the Chinese herbal medicine ointment 2 of the present invention and the treatment group of “b-FGF” (acne therapeutic agent, Kaken Pharmaceutical Co., Ltd., generic name “trafermin”) was significantly higher than that of the non-treatment group. A high value was indicated, suggesting a healing promoting effect. It can also be seen that the Chinese herbal ointment 2 treatment group of the present invention further promoted the healing of the skin incision than the b-FGF treatment group (see Table 1 and FIG. 9).

From the above results, the traditional Chinese medicine ointment (Chinese medicine ointment 2) obtained in Production Example 2 shows a healing promoting action that exceeds the b-FGF marketed as a pressure ulcer, and the traditional Chinese medicine ointment 2 of the present invention is skin. It has been demonstrated that it has excellent effectiveness in healing the wound.
The following is a detailed description of the test process.

2. <Summary>
(i) (ia) Test substance: Chinese medicine ointment of the present invention obtained in Production Example 2 (Chinese medicine ointment 2).
(ib) Control substance: “Fiblast (registered trademark) spray 250” (abbreviated as “b-FGF”)
, Treatment for pressure ulcer, Kaken Pharmaceutical Co., Ltd., generic name “trafermin”)).
(ii) Test system: rat (SPF), Crl: CD (SD).
(iii) Test: The effect of promoting the wound healing of the Chinese herbal ointment (Chinese herbal ointment 2) of the present invention obtained in Production Example 2 was tested using a rat skin incision model.
(iv) Exam period: February 26, 2008 to June 11, 2008
(v) Date of study: Obtaining test animals (rats), dividing into groups, making cuts (March 17, 2008), and starting drug administration on March 17, 2008. Administration was terminated on the 20th of May.
Tension measurements were taken on March 21, 2008.
(vi-1) The body weight range on the 1st day after obtaining the test animal (rat) was: 325 to 403 g. The obtained animals showed no abnormalities in the general state and weight transition during the quarantine / acclimation breeding period.
(vi-2) Humidity: Raised at 40.0-70.0%. (Temporarily out of this humidity range for a very short time, but the test results are not affected.)

3. <Introduction>
The effect of the Chinese herbal ointment obtained in Production Example 2 on the healing promoting effect was tested using a skin incision model of 12-week-old Crl: CD (SD system) rat.

4). <Test substances, etc.>
4.1. (A) Test substance and comparative control substance Test substance: Chinese herb ointment of the present invention (Chinese medicine ointment 2) obtained in Production Example 2.
Comparative control substance: “Fiblast (registered trademark) spray 250” (abbreviation “b-FGF”, (treatment for pressure ulcer, Kaken Pharmaceutical Co., Ltd., general name “trafermin”, lot number: G71183).
5. <Administration sample>
5.1 (a) Preparation method (Comparative substance)
The test substance was used for the test as it was.
The comparative control substance was used by adding the entire amount of the attached dissolution liquid (2.5 mL / tube) to one vial (250 μg) and dissolving it to a concentration of 0.01 w / v /%.

6). <Test system>
(6-1) Test animals and their rearing conditions In the test, male Crl: CD (SD) (SPF, Japan Charles River Corporation) was used.

As test animals, 42 animals aged 10 weeks were obtained on March 5, 2008. The body weight range for one day after acquisition was 325 to 403 g. Among them, a quarantine period of 5 days and an acclimatization period of 7 days are provided, and during this period, body weight measurement (electronic balance: PM2000, PG2002-S, manufactured by METTLER TOLEDO) is used three times in general. Observation of the condition was performed once a day, and animals in which no abnormality was observed were used for the test.

  Animals are set temperature: 23 ° C (actual value: 20.5-24.7 ° C), set humidity 55% (actual value: 29.4-74.9%), light and darkness 12 hours each, ventilation rate 12 times / hour (freshly sterilized by filter) Breeding in a breeding room maintained in air). The tray and the water bottle were changed at least twice a week.

As the feed, a solid feed (CRF-1, lot number: 071105, manufactured by Oriental Yeast Co., Ltd.) was placed in a feeder and allowed to freely ingest.
Drinking water was taken freely by putting tap water in a water bottle.

(6-2) Grouping method and individual identification method Grouping is performed on the start date of administration, and after dividing the body weight into layers using a computer, the average body weight and variance of the animals in each group are approximately equal by random sampling. The group was divided into 3 groups of 10 animals per group. (Remaining animals after grouping were killed under anesthesia.)

(6-3) Administration The administration route was transdermal administration according to the clinical application route.
Administration is in accordance with the usual method used in the test facility, and the test substance (Group 2) is cut into 200 mg (0.2 mL) by the volume obtained from the specific gravity measured in advance using a polypropylene syringe. It was applied to. A comparative control substance (Group 3) was prepared by dropping 0.2 mL of the control substance into the cut site using a micropipette.
The administration frequency was once a day for 4 days.
The administration was performed in the morning, and the cut creation date and the Miher removal date were performed immediately after completion of the work for each individual.

(6-4) Group composition, dose, and number of animals used In the first group (no treatment, 10 animals), no application (treatment) was performed.
In the second group (treatment of the Chinese herbal medicine ointment 2 of the present invention, 10 animals), 200 mg (0.2 mL) was applied (site).
In the third group (b-FGF treatment, 10 animals), 0.2 mL was applied.

7). <Test method>
(7-1) Preparation of skin incision wound After anesthesia with sodium pentobarbital ("Nembutal" (registered trademark) injection, 40 mg / 0.8 mL / kg, ip) on the day of administration, the back of the animal with an electric clipper I shaved. The back skin was disinfected with alcohol cotton, and a 3.4 cm cut was made on the midline with a scalpel (this day was designated as cut creation day 1). 1 cm position meter 3 at the center of the incision and from the center to the head and tail
The site was sutured with Miher (Michel's suture hook: large 3.0 × 14 mm, manufactured by Natsume Seisakusho Co., Ltd.).

(7-2) Evaluation of wound healing effect Miher was removed under diethyl ether anesthesia 4 days before administration of the cut wound. On the 5th day of cut preparation, the body weight was measured (electronic balance: PG-2002-G, METTLER TOLEDO Co., Ltd.) and lethal by diethyl ether overanesthesia, and the skin around the wound was peeled off. Create a strip-shaped skin piece (about 2cm x about 3cm) with the wound at the center, fix one side at a position of about 0.5cm from the end, and the wound strength (load required to cut the wound) Was measured with a tensile tester for wound healing measurement (TK-251, Unicom).
The general condition was observed once a day in the morning from the 2nd day to the 5th day.

8). <Summary of statistical methods and results>
The average tension ± standard error was calculated for the wound tension and body weight of each group. The increase rate from the untreated group was also calculated based on the average wound tension value of each group.
Statistical analysis was performed on wound tension and compared between the two groups. That is, the equidispersity test by the F test was performed, and the Aspin-Welch t test was performed because of the unequal dispersion. In addition, between groups (1 group vs 2-3 groups) to compare is described below. The significance level was expressed as being less than 5%, and divided into less than 5% (p <0.05) and less than 1% (p <0.01).
(Comparison between groups)
Comparison was made between group 1 and groups 2-3.

9. <Test results>
Table 1 and FIG. 9 show the results of examining the healing promoting effect on the skin incision model prepared in the rat.

The untreated wound strength was 143 ± 8 g.
The wound tension when the skin incision model was treated using the Chinese herbal ointment (Chinese herbal ointment 2) obtained in Production Example 2 was 289 ± 31 g, which was significant compared with the untreated group. An increase in tensile strength was observed. The rate of increase in wound tension from the untreated group was 102.1%.
The wound tension of the b-FGF group was 205 ± 19 g, and a significant increase in wound tension was observed compared to the untreated group. The rate of increase in wound tension from the untreated group was 43.4%.

10. <Conclusion>
As a result of testing the healing promotion effect of the Chinese herbal ointment 2 of the present invention using a skin incision model of a 12-week-old Crl: CD (SD system) rat, the results of the treatment-free group (I) and the Chinese herbal ointment 2 of the present invention The average and standard error of wound tension of treatment group (b) and b-FGF treatment group (c) are (
A) 143 ± 8 g, (b) 239 ± 31 g, and (c) 205 ± 19 g.
In addition, the rate of increase in wound strength from the untreated group (A) was (B) 102.1% and (C) 43.4 in the Chinese medicine ointment group (B) and b-FGF group (C) obtained in Production Example 2, respectively. %Met.
The wound tension of the Chinese herbal ointment treatment group (b) and b-FGF treatment group (c) obtained in Production Example 2 was significantly higher than that of the non-treatment group (a), indicating a healing promoting effect. It was done. In addition, the Chinese herbal ointment treatment group (b) obtained in Production Example 2 further promoted the healing of the skin incision than the b-FGF treatment group (c).

From the above results, the Chinese herbal ointment of the present invention obtained in Production Example 2 shows a healing promoting action that exceeds the b-FGF marketed as a pressure ulcer, and the Chinese herbal ointment of the present invention obtained in Production Example 2 The effectiveness was shown.

(Test Example 12)
<< Healing effect test of the herbal medicine ointment 2 of the present invention for a model of skin damage in genetically diabetic mice (db / db mice) >>
1. <Summary>
(1-1) Test substance name: Chinese medicine ointment of the present invention obtained in Production Example 2 (Chinese medicine ointment 2).
(1-2) Test system: mouse (SPF), BKS.Cg ₋ + Lepr ^db / + Lepr ^db / Jcl.
(1-3) Test purpose: The herbal ointment obtained in Production Example 2 was tested for the presence or absence of a wound healing promotion effect in a genetically diabetic mouse (db / db mouse) by preparing a skin defect.
(1-4) Test period: February 26, 2008 (start) to July 7, 2008 (end).
(1-5) Study implementation date: Obtain test animals (genetic diabetic mice, db / db mice), group them, and create a defect (April 9, 2008). Administration was started on April 9, 2008, and administration was completed on April 29, 2007.
(1-6) The body weight range on the first day after obtaining the test animal (on the day of acquisition) was 42.0 to 45.4 g. The obtained animals showed no abnormalities in the general state and weight transition during the quarantine / acclimation breeding period.
(1-7) 3-methyl-1-butanol (lot number: WKG6715).

2. <Summary>
Apply the Chinese medicine ointment (Chinese medicine ointment 2) of the present invention obtained in Production Example 2 once a day to the deficient part prepared on the back of 12-week-old genetically diabetic mice (db / db mice). The defect area was measured once a day, and the healing promoting action of Chinese herbal medicine ointment 2 was examined.

As a result, although the Chinese herbal medicine ointment 2 of the present invention showed a significant high value on the 3rd day of administration, a significant low value was observed on the 11th, 13th, 15th, 17th and 19th days of administration, and a healing promoting effect was observed. .
Moreover, the area under the time course curve (AUC) of the defect part area also showed a significantly low value, and the healing promotion effect was recognized.

In addition, “b-FGF” (decubitus treatment, manufactured by Kaken Pharmaceutical Co., Ltd.)
The general name “trafermin”) showed a significant low value on administrations 9, 11, 13, 15, 17, 19 and 21 and AUC also showed a significant low value, indicating a healing promoting effect.
From the above, the Chinese medicine ointment 2 of the present invention was found to promote wound healing in the absence of damage in db / db mice.

3. <Introduction>
In the rat back incision test shown in Test Example 11 (therapeutic test of the Chinese herbal medicine ointment 2 of the present invention using a rat skin incision model), it was shown that the Chinese herbal medicine ointment 2 of the present invention has an effect of promoting wound healing.

Furthermore, in order to investigate the presence or absence of wound healing effect, the herbal medicine of the present invention was used once a day for the injured part prepared on the back using a deficient model of 12-year-old genetically diabetic mice (db / db mice). The ointment 2 was closedly administered with Tegaderm (Note 1), and the defect area was measured once every two days to examine whether the herbal medicine ointment 2 had a healing promoting effect.
(Note 1) “Closed administration of traditional Chinese medicine ointment 2 with tegaderm” means that, as will be described later, a breathable sealing material “Tegaderm” is used to cover the missing part of the back of the mouse. A polyurethane film that can prevent water and bacteria from entering the damaged area, has water vapor and oxygen permeability, can maintain skin respiration, and can be applied for a long period of time. This means that a syringe filled with 2 (injection needle for b-FGF administration) is pressed against the film and pierced to administer Kampo ointment 2 (b-FGF for b-FGF administration) to the injured part. .

4). <Test substances, etc.>
4.1 Test substance, control substance and medium
(1-a) Test substance: The traditional Chinese medicine ointment (Chinese medicine ointment 2) obtained in “Production Example 2”.
(1-b) Control substance: “Fiblast (registered trademark) spray 250” (intractable skin ulcer drug, manufactured by Kaken Pharmaceutical Co., Ltd., lot number: G71183).
(1-c) Saline solution of medium (lot number: K7E83, manufactured by Otsuka Pharmaceutical Factory).
4.2 Reagents: 3-methyl-1-butanol (lot number: WKG6715, Wako Pure Chemical Industries, Ltd.), 2,2,2-tribromoethanol (lot number: DPH7940, Wako Pure Chemical Industries, Ltd.).
Water for injection (lot number: 7C75N, Otsuka Pharmaceutical Factory).

5. <Dosage sample>
5.1 Preparation method 5.1.1 Preparation of comparison control substance Comparison control substance: Add the total amount of the attached dissolution solution (2.5 mL / tube) per vial as the preparation control solution and dissolve to a concentration of 0.01 w / v% And used.
5.1.2 Test substance and comparative control substance Test substance: The Chinese medicine ointment 2 of the test substance is used as it is.
Comparative control substance: A physiological saline solution was added to the prepared stock solution, and diluted 5-fold to a concentration of 0.002 w / v%.
5.1.3 Anesthesia (avatin)
To 2 mL of 3-methyl-1-butanol, 3 g of 2,2,2-tribromoethanol was added and dissolved in a warm bath at around 37 ° C. for about 30 minutes. After complete dissolution, 0.5 mL of the solution was added to 40 mL of water for injection and mixed by inversion.

6). <Test system>
6.1 Test animals and rearing conditions In the test, female BKS.Cg- + Lepr ^db / + Lepr ^db / Jcl (SPF, Japan Claire), which is an animal species generally used in pharmacological studies and whose lineage is clearly maintained. Co., Ltd.) was used.
For this test animal, 40 animals aged 10 weeks were obtained on March 27, 2008. The body weight range on the first day after acquisition (on the day of acquisition) was 42.0 to 45.4 g. The obtained animal was quarantined for 5 days and then acclimated for 8 days. During this period, body weight measurement (electronic balance: PG2002-S, PB3002, manufactured by METTLER TOLEDO Co., Ltd.) was performed three times in a general state. Were observed once a day, and those in which no abnormality was observed were used in the test.

  Animals were set temperature: 23 ° C (actual value: 22.9-23.7 ° C), set humidity: 55% (actual value: 51.3-57.5%), light and darkness for 12 hours each, ventilation rate 12 times / hour (sterilized by filter It was raised in a breeding room maintained in fresh air.

Plastic cages and water bottles were changed at least twice a week, and feeders were changed at least once every two weeks.
As the feed, a solid feed (CRF-1, lot numbers: 071105, 080107, manufactured by Oriental Yeast Co., Ltd.) was placed in a feeder and allowed to freely ingest.
Drinking water was taken freely by putting tap water in a water bottle.

6.2 Grouping method and individual identification method Grouping should be performed on the start date of administration, and after dividing the body weight into layers using a computer, the average body weight and variance of each group of animals should be approximately equal by random sampling. The group was divided into 3 groups of 10 animals per group on the administration start day. (The remaining animals in the group were killed.)

6.3 Administration For administration of the drug, a 26G injection needle (manufactured by Terumo Corp.) is used for b-FGF administration of the third group,
For the administration of the second group Chinese herbal ointment 2 as a plaster, a disposable syringe made of polypropylene (1 mL, manufactured by Terumo Corp.) equipped with a 21G injection needle was used. After filling each injection drug (specimen) into these injection needles (or syringes), piercing from above the polyurethane film material (trade name “Tegaderm”, manufactured by 3M) covering the missing part, Drug 100μ
l (0.1 mL) was applied to the missing part.
The administration frequency was once a day for 21 days.
The administration was performed between 9 am and 2 pm, and the defect creation date, trace, and photography date were performed immediately after the completion of the work for each individual.

6.4 Group composition, dose, and number of animals used In the first group (no treatment, 10 animals), no application (treatment) was performed.
In the second group (treatment of Chinese medicine ointment 2 (decubitus) of the present invention, 10 animals), 100 μL was applied.
In the third group (b-FGF treatment, 10 animals), 100 μL was applied.

7). <Test method>
7.1 Production of skin defect In 3 days before the grouping, the hair on the back of the test animal was shaved with an electric clipper and then removed with a hair removal cream. After grouping, remove 1.5 cm square skin centered on the back midline with scissors for ophthalmology under “avatin” anesthesia [administration volume: body weight (g) × 0.02 + 0.05 mL, administration route: intraperitoneal] Then, a skin defect was created (: defect creation one day).
Thereafter, the damaged part of the skin was covered with a polyurethane film material “Tegaderm” (trade name, manufactured by 3M) having excellent oxygen and water vapor permeability.

7.2 Measurement of the area of the skin defect The contour of the defect was traced on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21 of defect creation. Area line meter (Super PLANIX β, Tamaya Measurement System Co., Ltd.)
Measurement).

No further tracing was performed on animals in which the skin defect was judged to be “healed”, and the area of the defect was zero.
Further, the area ratio of each administration day was calculated with the area on the first administration day (: same day) as 100%, and the area under the time course curve (AUC) of the defect area was calculated from the administration day according to the following formula.
AUC = (a + k) +2 (b + c + d + e + f + g + h + i + j)
a: Area ratio of 1 day of administration, b: Area ratio of 3 days of administration, c: Area ratio of 5 days of administration, d: Area ratio of 7 days of administration, e: Area ratio of 9 days of administration, f: 11 days of administration Area ratio, g: area ratio of administration 13 days, h: administration 15
Area ratio on day, i: Area ratio on day 17 of administration, j: Area ratio on day 19 of administration, k: Area ratio on day 21 of administration.

7.3 General Conditions General conditions including the presence or absence of death were observed once daily before administration in the morning.

7.4 Body weight measurement The body weight was measured on days 1, 7, 14 and 21 (measured before administration on the day of administration) (Electric balance: PG2002-S, manufactured by METTLER TOLEDO) was used.

7.5 Photographing Photographs were taken for all cases on days 1, 7, 13, and 21 of preparation of missing lesions (the day of administration was photographed before administration).

8). Statistical method The body weight, the defect area from the first day of defect creation to the first day of defect creation and the area under the time course curve (AUC) of the defect area were calculated as mean ± standard error for each group.
The significant difference test was performed between the untreated control group and each administration group. The significance was less than 5%, and was divided into less than 5% (p <0.05) and less than 1% (p <0.01). As the test method, after Bartlett test, Dunnett test was used in the case of equal variance, and nonparametric Steel test was used in the case of unequal variance. SAS preclinical package Version 5.0 (SAS Institute Japan Co., Ltd.) was used for the test.

9. Test Results 9.1 General Conditions No abnormalities were observed in the general condition during the administration period in any group.

9.2 Body weight The results are shown in FIG.
In the untreated group, the average body weight value on the first day of administration (: first day) was 45.4 ± 0.5 g, but gradually decreased throughout the administration period, and became 38.5 ± 1.5 g on the 21st day of administration.
In the Kampo ointment administration group of the present invention obtained in Production Example 2, the average daily weight value was 45.4 g ± 0.4 g, but gradually decreased over the administration period. It became ± 0.8g. Compared to the untreated group, the measurement value was lower on the measurement days after the 14th day of administration, but no significant difference was observed on any measurement day.
In the b-FGF administration group, the average body weight value on the day of administration was 45.3 ± 0.4 g, but gradually decreased throughout the administration period and became 38.3 ± 0.9 g on the 21st day of administration. Compared to the untreated group, the body weight changes were almost the same, and no significant difference was observed.

9.3 Area of skin defect and area under time-lapse curve of defect area (AUC)
The results are shown in FIGS.
In the untreated group, the average area of the missing damage 1 day (the day when the missing damage was created) was 255.3 ± 6.7 mm ² . This area remained almost constant until the 15th day of defect creation, and after 15 days it was smaller with the passage of days, but the area rate on the 21st defect creation was 62.4 ± 5.8%. . In all cases, no cure was observed. The average of this AUC was 1885.1 ± 44.1 mm ² .

In the Chinese medicine ointment treatment group of the present invention obtained in Production Example 2, the average area of the missing damage one day was 258.8 ± 9.1 mm ² .
This area ratio increased from the time of creation until the 7th day of missing damage creation (7 days from the first day), and the area around the missing damage was inflamed after 14 days of missing damage creation.

However, the defect area decreased with the passage of days, and the area rate of the defect creation 21 days was 43.7 ± 5.5%.
In addition, in the Chinese medicine ointment 2 treatment group of the present invention, “(healing of skin defect)” was not observed in all cases. The average of this AUC was 1472.9 ± 55.1 mm ² .

Compared with the untreated group, in the group treated with the Chinese herbal medicine ointment 2 of the present invention, the area ratio showed a significant high value on the 3rd day of administration, and a significantly low value on the 11th, 13th, 15th, 17th and 19th day of administration. Was recognized. AUC showed a significantly low value.

In the b-FGF treatment group, the average area of missing damage creation 1 day (: day of missing damage creation) is 245.7 ± 6.4 mm ²
Met. This area ratio became smaller with the passage of days after the production of the defect, and the area ratio on the day 21 of the production of the defect was 1.2 ± 0.6%. In 6 of 10 cases, (complete cure) healing was observed. The average of this AUC was 1135.5 ± 33.3 mm ² . Compared to the untreated group, the area ratio in the b-FGF treated group was significantly lower at the administration days 9, 11, 13, 15, 17, 19, and 21. AUC also showed a significant low value.

10. <Conclusion>
Using a 12-week-old genetically diabetic mouse (db / db mouse), apply the Chinese herb ointment (Chinese herb ointment 2) of the present invention obtained in Production Example 2 to the deficient part produced once a day on the back. Then, the defect area was measured once every two days, and the healing promotion effect of this Chinese herb ointment 2 was examined.

As a result, the Chinese herbal ointment (Chinese herbal ointment 2) of the present invention obtained in Production Example 2 showed a significant high value on the 3rd day of administration, but a significantly low value on the 11th, 13th, 15th, 17th and 19th days of the administration. Was observed, and a healing promoting effect was observed.

Moreover, the area under the time course curve (AUC) of the defect part area also showed a significantly low value, and the healing promotion effect was recognized. However, in the Chinese medicine ointment (Chinese medicine ointment 2) of the present invention obtained in Production Example 2 used this time, the body weight was lower than that in the untreated group after 14 days of administration, and the back skin was around the injured part. Due to inflammation, the contraction of the defect area after 17 days of administration was stagnant.

  The cause of this is not clear, but since this specimen (drug) is a plaster, the closed administration, which is the current administration method, was hardly absorbed from the skin, and the specimen remained in the tegaderm. For this reason, it is considered that the daily administration puts a burden on the animal, loads stress, and has affected the decrease in body weight and the stagnation of the defect area.

However, in the rat skin incision test shown in Test Example 11, the effectiveness of the Chinese herbal medicine ointment of the present invention obtained in Production Example 2 is shown, which has a healing promoting effect that exceeds that of b-FGF marketed as a pressure ulcer. It was done.

Moreover, the healing promotion effect | action was recognized also by the healing effect of the skin defect | deletion damage in the diabetes genetic mouse (db / db mouse) performed this time.
From the above, although the Chinese herbal ointment (Chinese herbal ointment 2) of the present invention obtained in Production Example 2 is difficult to be absorbed from the skin by daily closed administration, it has the effect of promoting the healing of skin defect in db / db mice. It became clear to have.

In general treatment methods such as pressure ulcers, when rotting muscles appear in the wound, necrotic tissue that affects the healing of the wound must be removed.
This is called debridement (the surgeon removes it with a machine or softens the necrotic tissue with a specific poultice), and the wound necrotic tissue is wiped off and the new tissue is removed from the patient only under normal circumstances. Can be generated.

However, the pain and mental burden of patients associated with wound treatment are often unbearable, and psychological therapeutic exclusion can even affect wound healing.
The salve of the present invention is applied to the salve of the present invention without using any drugs that cause side effects, such as antibiotics that suppress pathogenic bacteria, in the entire process from the beginning of application to recovery. Only by implementing the means (changing and applying gauze several times) can effectively remove necrotic tissue and promote the generation of new skin.

In addition, the salve of the present invention has an action of suppressing exudate, and at the same time, keeps the wound in a moist state and is useful for the recovery of the wound.
Therefore, there is no physical distress or mental burden on the patient, and an economic burden due to surgery or the like can be avoided, and the time until recovery is shortened.

Therefore, for the patient himself and his family, the salve of the present invention is an excellent prescription in terms of recovery, mental, physical, economic and time aspects.
The present invention relates to kankyo, bunshi (bushi) or tsutsuji (bushi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu), glaze (peony), magnolia, nymph (nyuko) 10 kinds of Chinese herbal medicines such as pills (motsuyaku), Asen medicine (Kocha) and enokitake mushroom mycelium extract are the active ingredients. In these prescriptions, they are adjusted and adjusted appropriately according to actual symptoms. can do.

  According to the logic of the Chinese medicine, the present inventor said that the above 10 kinds of Chinese medicines have the ingredients of the present invention as indispensable ingredients such as kankyo, bunshi or bushi, and nikukei. Obtained the knowledge that it is the fundamental combination of the two, and further earnestly researched to complete the Kampo medicine composition for the treatment of trauma and pressure ulcer according to the present invention and the Kampo medicine for the treatment of trauma and pressure ulcer. It is.

A more preferable prescription is “a combination of kansui, bunshi (bushi) or bonito (bushi), meat katsura (Nikukei), 蜀椒 (shokusho)”, or “kansui, bunshi (bushi)” Alternatively, it may be a “combination of rooster, nikukei, shokusho and enokitake fungus mycelium extract”.

Better prescriptions are “Kankyo, Bushi, or Hushishi, Nikukei, Shokusho, Goshuyu” or “Kankyo” ), Bushi or Bushi or Hobushi, Nikukei, Shokusho, Goshuyu,
“Combination with Enokitake fungus mycelium extract” may be used.

In addition, the better prescription is “Kankyo, Bushi, or Hushishi, Nikukei, Shokusho, Goshyu, Peonies”, Or “Kankyo, Bushi or Bushibushi, Nikukei, Shokusho, Goshuyu, Peonies,
“Combination with Enokitake fungus mycelium extract” may be used.

Better prescriptions include: “Kankyo, Bushi or Bushibushi, Nikukei, Nikukei, Kushoku, Goshuyu, Peonies, Pak ”, Or“ Kankyo, Bushi or Bushibushi, Nikkei, Shokusho, Goshuyu, Peonies, Koboku and Or a combination with Enokitake mushroom mycelium extract ”.

Further preferred prescriptions are: “Kankyo, Bushi or Bushibushi, Nikukei, Shakusho, Goshuyu, Shakuyaku, Kokaku, Nakkou (Nyuko), pills (motsuyaku) combination ”, or“ Kankyo, Bushi or Tsukubushi, meat katsura, shokusho, goshuyu, glaze (Combination of Peonies), Kobaku, Nyuka, Nyaku (Motsuyaku), and Enokitake fungus mycelium extract.

The most preferred prescriptions are: “Kankyo, Bushi or Bushibushi, Nikukei, Shakusho, Goshuyu, Peonies, Pak, Nuts (Nyuko), pills (motsuyaku), Asen medicine (kocha) combination ", or" Kankyo, Bushi or Bushi, Hokkushi, Nikukei, Shousho, “Combination of Goshuyu, Peonies, Kobaku, Nyukkou, Mochiyaku, Asen-yaku (Kocha) and Enokitake fungus mycelium extract”.

FIG. 1 (A) is a first photograph showing the progress until the wound of the sacral region pressure ulcer shown in Test Example 1 is fully healed. FIG. 1 (B) is a second photograph following FIG. 1 (A), showing the process until the wound of the sacral decubitus pressure ulcer shown in Test Example 1 is fully healed. FIG. 1 (C) is a third photograph following FIG. 1 (B), showing the progress until the sacral pressure ulcer shown in Test Example 1 is fully healed. FIG. 1 (D) is a fourth photograph following FIG. 1 (C), showing the progress until the wound of the sacral region pressure ulcer shown in Test Example 1 is fully healed. FIG. 2 (A) is a first photograph showing the progress until the wound of the sacral decubitus ulcer shown in Test Example 2 is fully healed. FIG. 2 (B) is a second photograph following FIG. 2 (A), showing the progress until the wound of the sacral region pressure ulcer shown in Test Example 2 is fully healed. FIG. 2 (C) is a third photograph following FIG. 2 (B), showing the progress until the wound of the sacral region pressure ulcer shown in Test Example 2 is fully healed. FIG. 2 (D) is a fourth photograph following FIG. 2 (C), showing the progress until the wound of the sacral region pressure ulcer shown in Test Example 2 is fully healed. FIG. 3 (A) is a first photograph showing the process until the wound of cellulitis that occurred in the heel of the left foot shown in Test Example 3 is fully healed. FIG. 3 (B) is a second photograph following FIG. 3 (A), showing the progress until the wound of cellulitis that occurred in the heel of the left foot shown in Test Example 3 was healed. FIG. 4 is a photograph showing a state in which the wounds of cellulitis on the shin of the right foot shown in Test Example 4 are completely healed. FIG. 5 (A) is a photograph showing a state in which the wound of the pressure ulcer of the buttocks shown in Test Example 5 has healed completely. FIG. 5 (B) is a photograph showing a state in which the wound of the pressure sore on the back shown in Test Example 5 has been completely healed. FIG. 6 (A) is a first photograph showing the course until the wound of the pressure sore on the back shown in Test Example 6 is fully healed. FIG. 6 (B) is a second photograph following FIG. 6 (A), showing the progress until the wound of the pressure sore on the back shown in Test Example 6 is fully healed. FIG. 6 (C) is a third photograph following FIG. 6 (B), showing the progress until the wound of the pressure sore on the back shown in Test Example 6 is fully healed. FIG. 6 (D) is a fourth photograph following FIG. 6 (C), showing the process until the wound of the pressure sore on the back shown in Test Example 6 is fully healed. FIG. 6 (E) is a fifth photograph following FIG. 6 (D), showing the process until the wound of the pressure sore on the back shown in Test Example 6 is fully healed. FIG. 7 (A) is a first photograph showing the progress until the wound of the abdominal pressure ulcer shown in Test Example 7 is fully healed. FIG. 7 (B) is a second photograph following FIG. 7 (A), showing the process until the wound of the abdominal pressure ulcer (joxou) shown in Test Example 7 is fully healed. FIG. 7 (C) is a third photograph following FIG. 7 (B), showing the progress until the wound of the abdominal pressure ulcer (joxou) shown in Test Example 7 is fully healed. FIG. 7 (D) is a fourth photograph following FIG. 7 (C), showing the process until the wound of the abdominal pressure ulcer (joxou) shown in Test Example 7 is fully healed. FIG. 7 (E) is a fifth photograph following FIG. 7 (D), showing the process until the wound of the abdominal pressure ulcer (joxou) shown in Test Example 7 is fully healed. FIG. 7 (F) is a sixth photograph following FIG. 7 (E), showing the progress until the wound of the abdominal pressure ulcer (joxou) shown in Test Example 7 is fully healed. FIG. 8 is a photograph showing a state in which the wound of the second hip joint portion of the left thumb of the foot shown in Test Example 8 has been improved. FIG. 9 shows the tension strength when the treatment with the rat skin incision model of Chinese medicine ointment (Chinese medicine of bedsore-2) obtained in Production Example 2 shown in Test Example 11 is performed. (tensile strength (g)).

Note that the wound tension in the untreated group (control, control) and the wound tension in the case of treatment with “b-FGF” are also shown in FIG.
FIG. 10 is a graph showing the relationship between days of administration and body weight (g) to db / db mice in Test Example 12.

In FIG. 10, “◯ and solid line” indicates the control (control), “● and dotted line” indicates the case where the Chinese herbal medicine ointment 2 of the present invention is administered, and “Δ and solid line” indicates that “b-FGF” is administered. Show the case.
FIG. 11 is a graph showing the relationship between the days of administration to the db / db mice and the rate of change in wound lesion area (change of wound lesion area (%)) in Test Example 12 of the present invention.

The relationship between the number of days of administration to db / db mice and the rate of change in the non-damaged area in the untreated group (control, control), and the number of days of administration to db / db mice in the drug “b-FGF” administration group FIG. 11 also shows the relationship between the defect rate and the change rate of the damaged area.

In FIG. 11, “◯ and solid line” indicates the control (control), “● and dotted line” indicates the case where the Chinese herbal medicine ointment 2 of the present invention is administered, and “Δ and solid line” indicates that “b-FGF” is administered. Show the case.
Figure 12 shows the test example 12, the healing effect of the administration of the db / db mice herbal medicine ointment of the present invention obtained in Production Example 2 (Chinese medicine ointment 2, Chinese medicine of bedsore-2 ) AUC (mm 2 ).

  The case of administration of control (control) and “b-FGF” is also shown.

Claims (32)

  A herbal medicine composition for the treatment of trauma or pressure ulcer characterized by containing as an active ingredient kankyo, bunshi (bushi), tsutsuji (bushi), and nikukei.   The trauma according to claim 1, characterized in that the mixing weight ratio of kankyo, bunshi (bushi), tsutsuji (bushishi), and cinnamon (Nikukei) as active ingredients is 4: 2: 1. , Chinese medicine composition for the treatment of pressure ulcer.   3. The herbal medicine composition for the treatment of trauma and pressure ulcer according to claim 1, wherein each active ingredient is in a powder form. A herbal medicine for treating trauma or pressure ulcer, comprising the herbal medicine composition according to any one of claims 1 to 3 and an appropriate amount of an oil and fat.   A herbal medicine composition for the treatment of trauma and pressure ulcer, characterized by containing as an active ingredient psoriasis, bunshi (bushi), or tsutsuji (bushi), meat katsura (Nikukei), and shochu (shokusho).   It is characterized by the mixing weight ratio of 4: 1: 1: 1 as dry ingredients (bushi), tsutsuji (bushi), tsutsuji (bushi), meat katsura (Nikukei), and shrimp (shokusho) as active ingredients. A herbal medicine composition for the treatment of trauma or pressure ulcer according to claim 5.   Each active ingredient is powdery, The Chinese medicine composition for the treatment of the trauma and pressure ulcer of Claim 5 or Claim 6 characterized by the above-mentioned.   A herbal medicine for treating trauma and pressure ulcer, comprising the herbal medicine composition according to any one of claims 5 to 7 and an appropriate amount of oils and fats.   Treatment of trauma and pressure ulcers characterized by containing psoriasis, bunshi (bushi), or tsutsuji (bushi), meat katsura (Nikukei), shu (shokusho), wushu (goshyu) as active ingredients Chinese herbal medicine composition. Mixing weight ratio of 4: 1: 1: 1 as dry ingredients (bushi), tsutsuji (bushi), tsutsuji (bushishi), meat katsura (Nikukei), shrimp (shokusho), and wushu (goshyu) as active ingredients : 1
The herbal medicine composition for the treatment of trauma and pressure ulcer according to claim 9.   Each active ingredient is a powder form, The Chinese medicine composition for the treatment of the trauma and pressure ulcer of Claim 9 or Claim 10 characterized by the above-mentioned.   A herbal medicine for treating trauma and pressure ulcer, comprising the herbal medicine composition according to any one of claims 9 to 11 and an appropriate amount of oil and fat.   It is characterized by containing as an active ingredient dry citrus, bunshi (bushi) or tsutsuji (bushi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu), glaze (peony). A herbal medicine composition for the treatment of trauma and pressure ulcers. Ingredients for dry meal (kankyo), bunshi (bushi) or bonito (hobushi), meat katsura (
14. The trauma according to claim 13, wherein the mixing weight ratio of Nikkei), 蜀椒 (shokusho), wushu (goshuyu), and peony (peony) is 4: 1: 1: 1: 1: 1. A herbal medicine composition for treating pressure ulcers.   The herbal medicine composition for the treatment of trauma or pressure ulcer according to claim 13 or 14, wherein each active ingredient is in a powder form.   A herbal medicine for treating trauma and pressure ulcer, comprising the herbal medicine composition according to any one of claims 13 to 15 and an appropriate amount of an oil and fat.   Contains dried citrus, bunshi (bushi), or tsutsuji (bushi), meat katsura (Nikukei), 蜀椒 (Shokusho), wushu (Gushyu), glaze (Yakuyaku), Koboku (Kokuboku) as active ingredients A herbal medicine composition for the treatment of trauma and pressure ulcers. As an active ingredient of kankyo, bunshi (bushi) or tsutsuji (bushi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu), glaze (peony), koboku The herbal medicine composition for the treatment of trauma and pressure ulcer according to claim 17, wherein the mixing weight ratio is 4: 1: 1: 1: 1: 1: 1: 1.   The Chinese medicine composition for the treatment of trauma and pressure ulcer according to claim 17 or 18, wherein each active ingredient is in a powder form.   A herbal medicine for treating trauma and pressure ulcer, comprising the herbal medicine composition according to any one of claims 17 to 19 and an appropriate amount of an oil and fat.   Insect (Bangkok), Bushi (Bushi) or Bushi (Bushibushi), Nikukei, Shokusho, Goshuyu, Peonies, Koboku, Nakkou (Nyuko) A herbal medicine composition for the treatment of trauma and pressure ulcer, characterized by containing an pill (motsuyaku) as an active ingredient.   Ingredients as dry ingredients (kankyo), bunshi (bushi) or bonito (bushi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshuyu), glaze (peony), koboku, The treatment for trauma and pressure ulcer according to claim 21, wherein the mixture weight ratio of frankincense (incense) and pill (motsuyaku) is 4: 1: 1: 1: 1: 1: 1: 1: 1: 1. Herbal medicine composition.   23. The traditional Chinese medicine composition for the treatment of trauma and pressure ulcer according to claim 21, wherein each active ingredient is in a powder form.   A herbal medicine for treating trauma and pressure ulcer comprising the herbal medicine composition according to any one of claims 21 to 23 and an appropriate amount of an oil and fat agent.   Insect (Bangkok), Bushi (Bushi) or Bushi (Bushibushi), Nikukei, Shokusho, Goshuyu, Peonies, Koboku, Nakkou (Nyuko) A herbal medicine composition for the treatment of trauma and pressure ulcer, characterized by containing, as an active ingredient, pills (motsuyaku) and asenyaku (asenyaku, kocha). Ingredients as dry ingredients (kankyo), bunshi (bushi) or bonito (bushi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshuyu), glaze (peony), koboku, The mixing weight ratio of frankincense (Nyuko), pill (motsuyaku), and asenyaku (asenyaku, kocha) is 4: 1: 1: 1: 1: 1: 1: 1: 1: 1: 1 Item 26. A traditional Chinese medicine composition for treating trauma or pressure ulcer.   27. The herbal medicine composition for the treatment of trauma and pressure ulcer according to claim 25 or 26, wherein each active ingredient is in a powder form.   A herbal medicine for treating trauma and pressure ulcer, comprising the herbal medicine composition according to claim 27 and an appropriate amount of oil and fat.   Furthermore, the enokitake mushroom mycelium extract is contained as an active ingredient of Claims 1-3, 5-7, 9-11, 13-15, 17-19, 21-23, 25-27 A herbal medicine composition for the treatment of trauma or pressure ulcer according to any one of the above. Enokitake mushroom mycelium extract content is other active ingredient, kankyo, bunshi (bushi) or tsutsuji (hobushi), meat katsura (Nikukei), 蜀椒 (shokusho), wushu (goshyu) , 0.01 to 0.27 per 1 part by weight of the total amount of peony, peony, nectar, numb, and asen
30. The traditional Chinese medicine composition for the treatment of trauma and pressure ulcer according to claim 29, wherein the composition is part by weight.   31. The traditional Chinese medicine composition for the treatment of trauma and pressure ulcer according to claim 29 or 30, wherein the active ingredient is in powder form.   32. A traditional Chinese medicine for treating trauma and pressure ulcer, comprising the traditional Chinese medicine composition according to any one of claims 29 to 31 and an appropriate amount of an oil and fat.