Traditional Chinese medicine composition for treating pressure sores, preparation method and application of traditional Chinese medicine composition and pressure sore ointment

Abstract

The invention relates to a traditional Chinese medicine composition for treating pressure sores, a preparation method and application of the traditional Chinese medicine composition and pressure sore ointment, and relates to the technical field of traditional Chinese medicine compositions.The traditional Chinese medicine composition for treating pressure sores is prepared from, by weight, 35-55 parts of derris eriocarpa, 20-30 parts of gerbera piloselloides, 10-18 parts of dandelion, 7-15 parts of astragalus membranaceus, 5-10 parts of rhizoma bletillae and 5-10 parts of borneol. The traditional Chinese medicine composition for treating the pressure sores is prepared by taking the derris eriocarpa and the gerbera piloselloides as monarch drugs, giving full play to the synergistic effect of the derris eriocarpa and the gerbera piloselloides, and matching with a proper amount of dandelion, astragalus membranaceus, rhizoma bletillae and borneol as minister, assistant and guide drugs. Animal experiments show that the traditional Chinese medicine composition is high in healing rate on the surface of pressure sores and quick in curative effect, can be further applied to preparation of external preparations such as pressure sore cream and the like, provides a new means for treatment of the pressure sores, and has a wide application prospect.

Description

Technical Field

[0001] The invention relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition for treating pressure sores, a preparation method and application thereof, and a pressure sore ointment. Background Art

[0002] Pressure sores, also known as pressure ulcers or bedsores in clinical practice, are a serious problem in the modern medical field that has attracted much attention and needs to be solved urgently. With the aging of the population and the increase in the number of patients with chronic diseases and disabilities, the incidence of pressure sores is on the rise, bringing heavy physical pain and economic burden to patients and their families.

[0003] The causes of pressure sores are complex and diverse, involving the interaction of multiple factors, including decreased skin elasticity due to aging, decreased mobility, malnutrition, and insufficient tissue perfusion. However, the core cause is prolonged bed rest or sitting, which causes continuous pressure on a certain part of the body, especially on bony protrusions such as the buttocks and heels, causing long-term ischemia and hypoxia of local tissues, leading to ulceration and necrosis. Studies have shown that when the pressure on local tissues reaches 9.33 kPa and lasts for more than 2 hours, irreversible damage may occur to the skin and subcutaneous tissues, leading to pressure sores.

[0004] Pressure sores often occur in the areas of pressure on bone protrusions, such as the sacrum, back, shoulders, elbows, heels, and medial and lateral ankles. These areas are prone to blood circulation disorders and tissue damage due to long-term bearing of body weight or external pressure. According to the occurrence and development process of pressure sores, they can be divided into four stages: Stage I (blood stasis and ruddy stage) is the initial stage of pressure sores, and the skin shows symptoms such as redness, swelling, heat, pain or numbness; Stage II (inflammatory infiltration stage), the epidermis, dermis or both of the skin are damaged or necrotic, the pressure site is purple-red, nodules are produced under the skin, and blisters are often formed; Stage III (shallow ulcer stage), the entire layer of skin is destroyed, the epidermal blisters rupture, and the dermis layer has yellow exudate. After infection, the surface will be covered with pus; and Stage IV (necrotizing ulcer stage) is the severe stage of pressure sores, necrotic tissue invades the subdermis and muscle layer, and the infection can spread to the periphery and deep, even to the bone surface, posing a serious threat to the patient's life safety.

[0005] In order to prevent the occurrence of pressure sores, some medical devices or instruments have been launched on the market. For example, specially designed pressure-reducing mattresses, air mattresses, turning machines, etc. These devices or instruments reduce the pressure time and pressure intensity of local body tissues to a certain extent by dispersing pressure, turning over at regular intervals, etc., thereby playing a role in preventing pressure sores. However, these devices or instruments are usually expensive and need to be matched with professional medical beds. For ordinary families, the economic cost and usage conditions are unaffordable. Therefore, they are not suitable for family popularization and have a large scope of application. More importantly, these devices can only play a preventive role when pressure sores have not yet occurred. Once pressure sores have formed, they cannot effectively treat pressure sores and cannot meet the needs of pressure sore treatment.

[0006] In the treatment of pressure sores, there is still a lack of specific drugs on the market. Existing treatment methods are mainly based on relief treatment, such as the use of surgical dressings and surgical operations. Surgical dressings are usually applied with a single antibiotic or other bactericide after conventional disinfection, but these drugs are highly irritating to the wound surface, and the antibacterial drugs stay on the wound surface for a short time, and cannot effectively remove corrupt necrotic tissue, which is not conducive to the growth of granulation tissue and wound healing. Therefore, the course of the disease is long and the overall efficacy is not ideal. Although surgical operations can remove necrotic tissue, they cannot cure the pressure sore affected area, but may bring greater pain and trauma to patients. In addition, traditional Chinese medicine also has a certain effect in the treatment of pressure sores. However, the existing traditional Chinese medicine formula is complex, the preparation is cumbersome, and the efficacy is unstable. The treatment cycle is long, the symptoms are prone to recurrence, and it is difficult to meet the clinical demand for rapid and effective treatment of pressure sores. Summary of the invention

[0007] In order to solve the above problems, the present invention provides a traditional Chinese medicine composition for treating pressure sores, a preparation method and application thereof, and a pressure sore ointment.

[0008] In a first aspect, the present invention provides a Chinese medicine composition for treating pressure sores, wherein the Chinese medicine composition for treating pressure sores comprises the following raw materials in parts by weight:

[0009] 35-55 parts of Derris tricholoma, 20-30 parts of Gerbera pubescens, 10-18 parts of Taraxacum officinale, 7-15 parts of Astragalus, 5-10 parts of Bletilla striata and 5-10 parts of Borneol.

[0010] Furthermore, the Chinese medicine composition for treating pressure sores comprises the following raw materials in parts by weight:

[0011] 45 parts of Derris tricholoma, 24 parts of Gerbera tricholoma, 15 parts of Taraxacum officinale, 11.5 parts of Astragalus, 8 parts of Bletilla striata and 8 parts of Borneolum.

[0012] In a second aspect, the present invention provides a method for preparing the Chinese medicine composition for treating pressure sores according to any one of the first aspects, the preparation method comprising the following steps:

[0013] The mixture of Dermatocarpus tricholoma and Gerbera tricholoma is ground and then added into water for a first reflux extraction, and then the first extract obtained is combined and concentrated and dried to obtain an extract in the form of an extract;

[0014] The extract in the form of an extract is added into water for dispersion, and then extracted with ethyl acetate, and then the obtained ethyl acetate extracts are combined, concentrated and dried to obtain a first extract;

[0015] Mixing and grinding dandelion, astragalus and bletilla striata, adding into ethanol aqueous solution for second reflux extraction, and then combining the obtained second extracts for concentration and drying to obtain a second extract;

[0016] The first extract, the second extract and borneol are mixed, crushed and sieved to obtain the traditional Chinese medicine composition for treating bedsores.

[0017] Furthermore, the working condition parameters of the first reflux extraction include: pressure of 18 to 30 kPa, temperature of 66 to 74°C, time of 1 to 2 hours, number of times of 1 to 3 times, and a weight ratio of the total weight of the Derris trichocarpa and the Gerbera pubescens to the water of 1:(5 to 10).

[0018] Furthermore, the working condition parameters of the first reflux extraction include: pressure of 25 kPa, temperature of 71°C, time of 1.5 hours, number of times of 2 times, and a weight ratio of the total weight of the Derris trichocarpa and the Gerbera pubescens to the water of 1:8.

[0019] Furthermore, the working condition parameters of the second reflux extraction include: pressure is normal pressure, temperature is 95-105°C, time is 1-2 hours, number of times is 1-3 times, and the weight ratio of the dandelion, the astragalus, the white schizonepeta and the ethanol aqueous solution is 1:(5-10).

[0020] Furthermore, the volume fraction of ethanol in the ethanol aqueous solution is 40-50%.

[0021] In a third aspect, the present invention provides a Chinese medicine composition for treating pressure sores as described in any one of the first aspects or a Chinese medicine composition for treating pressure sores obtained by the preparation method of the Chinese medicine composition for treating pressure sores as described in any one of the second aspects, for use in preparing a drug for treating pressure sores.

[0022] In a fourth aspect, the present invention provides a pressure sore cream, the pressure sore cream comprising a medicinal efficacy component and a matrix;

[0023] The medicinal active ingredient is a Chinese medicinal composition for treating pressure sores as described in any one of the first aspects or a Chinese medicinal composition for treating pressure sores obtained by the preparation method of the Chinese medicinal composition for treating pressure sores as described in any one of the second aspects;

[0024] The matrix is ​​composed of lanolin and vaseline;

[0025] The weight ratio of the drug active ingredient to the matrix is ​​1:(3-6).

[0026] Furthermore, the weight ratio of the lanolin to the vaseline is (0.2-0.5):1, and the weight ratio of the medicinal active ingredient to the matrix is ​​1:4.5.

[0027] The above technical solution provided by the embodiment of the present invention has at least the following advantages compared with the prior art:

[0028] The embodiments of the present invention provide a traditional Chinese medicine composition for treating pressure sores, a preparation method and application thereof, and a pressure sore cream. The present invention uses Derris tricholoma and Gerbera pubescens as the main drugs to give full play to the synergistic pharmacodynamic effects of the two, and simultaneously uses appropriate amounts of Taraxacum officinale, Astragalus, Bletilla striata and Borneol as auxiliary drugs to prepare a traditional Chinese medicine composition for treating pressure sores. Animal experiments have shown that the traditional Chinese medicine composition has a high healing rate for the sore surface of pressure sores and a fast therapeutic effect. It can be further used in the preparation of external preparations such as pressure sore creams, providing a new means for the treatment of pressure sores and has broad application prospects. Specifically:

[0029] Main medicine: Dermatocarpus tricholoma and Gerbera tricholoma

[0030] Derris tricolor: It has the effects of detoxification, dispersing nodules, promoting blood circulation and unblocking collaterals. The formation of pressure sores is often related to local blood stasis, blocked meridians, and accumulation of toxic evil. Derris tricolor can promote the circulation of local blood and qi on the sore surface, dissipate stasis, and relieve the damage of toxic evil to the skin, creating conditions for the healing of the sore surface through its detoxification and blood circulation effects.

[0031] Gerbera pubescens: It has the effects of clearing away heat and dampness, detoxifying and reducing swelling. It can remove dampness and heat caused by poor blood circulation in the sore, reduce inflammation, and relieve symptoms such as redness, swelling, heat and pain. In combination with Derris pubescens, the two work together, one focusing on promoting blood circulation and unblocking collaterals, and the other focusing on clearing heat, removing dampness and detoxifying, and jointly targeting the main causes and pathogenesis of pressure sores, playing a leading role in treatment and laying the foundation for the healing of the sore.

[0032] Herbal medicine: Dandelion

[0033] Dandelion has the effects of clearing away heat and detoxifying, promoting dampness and relieving stranguria. As a ministerial drug in this prescription, it can assist the monarch drug to further enhance the effect of clearing heat and detoxifying. Pressure sores are prone to heat toxins. Dandelion can enhance the ability to clear heat toxins, reduce inflammation, prevent heat toxins from further damaging the skin and deep tissues, promote the disappearance of inflammation on the sore surface, and accelerate the healing process of the sore surface. At the same time, its effect of reducing swelling and dispersing nodules helps to eliminate swelling around the sore surface and improve local blood circulation.

[0034] Adjuvants: Astragalus, Bletilla

[0035] Astragalus: It has the effects of replenishing qi and raising yang, strengthening the body's defense system, and removing toxins and promoting muscle growth. In the treatment of pressure sores, patients often have insufficient vital energy and deficiency of qi and blood, which makes it difficult for the sores to heal. Astragalus can replenish the body's vital energy, enhance the body's resistance and repair ability, remove toxins, and promote the growth of new flesh on the sore surface. It can restrict the excessive detoxification and blood circulation effects of the main medicine, avoid excessive loss of vital energy, and play a supporting role. At the same time, it cooperates with the previous medicine to provide a material basis and driving force for the healing of the sore surface.

[0036] Bletilla striata: It has the effects of astringing and stopping bleeding, reducing swelling and promoting tissue regeneration. It can form a protective film on the sore surface, reduce exudation, and promote scab formation and healing of the sore surface. In the prescription, it can assist the main and auxiliary drugs in repairing damaged skin tissue, play a role in astringing and repairing the sore surface, prevent the sore surface from further expanding and infecting, and enhance the effect of the overall prescription in promoting the healing of the sore surface.

[0037] Drug: Borneol

[0038] Borneol has the effects of refreshing the mind, clearing away heat and relieving pain, and antiseptic and granulation, and has a good transdermal effect. As a guiding drug in this prescription, it can lead other drugs in the prescription directly to the affected area, enhance the penetration and absorption of drugs, increase the concentration of drugs on the local surface of the sore, and better exert the efficacy of the drugs. Its heat-clearing and analgesic effects can relieve the pain symptoms of patients with pressure sores and improve the comfort of patients. In addition, the antiseptic and granulation effects of borneol also help keep the sore surface clean and promote the healing of the sore surface. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0040] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0041] Figure 1A schematic flow chart of a method for preparing a traditional Chinese medicine composition for treating pressure sores provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0042] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0044] In a first aspect, the present invention provides a Chinese medicine composition for treating pressure sores, wherein the Chinese medicine composition for treating pressure sores comprises the following raw materials in parts by weight:

[0045] 35-55 parts of Derris tricholoma, 20-30 parts of Gerbera pubescens, 10-18 parts of Taraxacum officinale, 7-15 parts of Astragalus, 5-10 parts of Bletilla striata and 5-10 parts of Borneol.

[0046] The embodiment of the present invention provides a Chinese medicine composition for treating pressure sores. The present invention uses Derris tricholoma and Gerbera tricholoma as the main drugs, giving full play to the synergistic effect of the two, and simultaneously uses appropriate amounts of Taraxacum officinale, Astragalus, Bletilla striata and Borneol as the assistant drugs to prepare a Chinese medicine composition for treating pressure sores. Animal experiments show that the Chinese medicine composition has a high healing rate for the sore surface of pressure sores and a fast efficacy. It can be further used in the preparation of external preparations such as pressure sore cream, providing a new means for the treatment of pressure sores and having broad application prospects.

[0047] In the present invention, Brachypterum eriocarpum (FCHow) Adema & Sirich., also known as hairy fish vine, is a plant of the genus Brachypterum, Leguminosae, and a climbing shrub. The dried stems of Brachypterum eriocarpum are selected as the medicinal part.

[0048] The gerbera in the present invention is the dried whole herb of the gerbera Piloselloides hirsuta (Forsk.) G. Jeffrey of the Asteraceae family.

[0049] The dandelion in the present invention is the dried whole herb of the dandelion plant of the Asteraceae family.

[0050] The astragalus in the present invention is the root of the leguminous plant Astragalus mongolica or Astragalus membranaceus.

[0051] The bletilla striata in the present invention is the dried tuber of the orchidaceae plant bletilla striata.

[0052] The borneol in the present invention is a processed product of borneol resin of Dipterocarpaceae plant or synthetic borneol.

[0053] In some specific embodiments, the Chinese medicine composition for treating pressure sores comprises the following raw materials in parts by weight:

[0054] 45 parts of Derris tricholoma, 24 parts of Gerbera tricholoma, 15 parts of Taraxacum officinale, 11.5 parts of Astragalus, 8 parts of Bletilla striata and 8 parts of Borneolum.

[0055] In a second aspect, the present invention provides a method for preparing the Chinese medicine composition for treating pressure sores according to any one of the first aspects, such as Figure 1 As shown, the preparation method comprises the following steps:

[0056] The mixture of Dermatocarpus tricholoma and Gerbera tricholoma is ground and then added into water for a first reflux extraction, and then the first extract obtained is combined and concentrated and dried to obtain an extract in the form of an extract;

[0057] The extract in the form of an extract is added into water for dispersion, and then extracted with ethyl acetate, and then the obtained ethyl acetate extracts are combined, concentrated and dried to obtain a first extract;

[0058] Mixing and grinding dandelion, astragalus and bletilla striata, adding into ethanol aqueous solution for second reflux extraction, and then combining the obtained second extracts for concentration and drying to obtain a second extract;

[0059] The first extract, the second extract and borneol are mixed, crushed and sieved to obtain the traditional Chinese medicine composition for treating bedsores.

[0060] In some specific embodiments, when ethyl acetate is used for extraction, the solid-liquid ratio of the extract-like extract and the solvent is 1:12, and the weight ratio of water to ethyl acetate is 1:1.2.

[0061] In some specific embodiments, the working condition parameters of the first reflux extraction include: pressure of 18-30 kPa, temperature of 66-74°C, time of 1-2 hours, number of times of 1-3 times, and the weight ratio of the total weight of the Derris trichocarpa and the Gerbera tricholoma to the water is 1:(5-10).

[0062] In some specific embodiments, the working condition parameters of the first reflux extraction include: pressure of 25 kPa, temperature of 71°C, time of 1.5 hours, number of times of 2 times, and the weight ratio of the total weight of the Dermatocarpus trichocarpa and the Gerbera tricholoma to the water is 1:8.

[0063] In some specific embodiments, the working condition parameters of the second reflux extraction include: pressure is normal pressure, temperature is 95-105°C, time is 1-2 hours, number of times is 1-3 times, and the weight ratio of the dandelion, the astragalus, the white schizonepeta and the ethanol aqueous solution is 1:(5-10).

[0064] In some specific embodiments, the volume fraction of ethanol in the ethanol aqueous solution is 40-50%.

[0065] In a third aspect, the present invention provides a Chinese medicine composition for treating pressure sores as described in any one of the first aspects or a Chinese medicine composition for treating pressure sores obtained by the preparation method of the Chinese medicine composition for treating pressure sores as described in any one of the second aspects, for use in preparing a drug for treating pressure sores.

[0066] In a fourth aspect, the present invention provides a pressure sore cream, the pressure sore cream comprising a medicinal efficacy component and a matrix;

[0067] The medicinal active ingredient is a Chinese medicinal composition for treating pressure sores as described in any one of the first aspects or a Chinese medicinal composition for treating pressure sores obtained by the preparation method of the Chinese medicinal composition for treating pressure sores as described in any one of the second aspects;

[0068] The matrix is ​​composed of lanolin and vaseline;

[0069] The weight ratio of the drug active ingredient to the matrix is ​​1:(3-6).

[0070] In some specific embodiments, the weight ratio of the lanolin to the vaseline is (0.2-0.5):1, and the weight ratio of the medicinal active ingredient to the matrix is ​​1:4.5.

[0071] In some specific embodiments, the pressure sore ointment can be prepared according to the existing preparation process of traditional Chinese medicine ointment, which specifically includes the following process: heating the matrix to a molten state at a suitable temperature such as 85°C, then adding the traditional Chinese medicine composition and continuously stirring to room temperature, and then packaging and storing.

[0072] It should be noted that the Chinese medicine composition for treating pressure sores provided in the embodiments of the present invention, its preparation method and application, and the components and raw materials involved in the pressure sore ointment, unless otherwise specified or specified, can directly use commercially available products or use existing public preparation methods to make them themselves; at the same time, the steps and parameters involved, unless otherwise specified or specified, can be carried out according to the processing technology of existing Chinese medicine compositions and preparations or directly use existing equipment, and the present invention document will not describe them one by one.

[0073] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples that do not specify specific conditions are usually measured according to national standards. If there is no corresponding national standard, then the conditions recommended by the manufacturer are followed.

[0074] Example 1

[0075] This example provides a Chinese medicine composition for treating pressure sores. The Chinese medicine composition for treating pressure sores includes the following raw materials in parts by weight:

[0076] 45 parts of Derris tricholoma, 24 parts of Gerbera tricholoma, 15 parts of Taraxacum officinale, 11.5 parts of Astragalus, 8 parts of Bletilla striata and 8 parts of Borneolum.

[0077] The preparation method of the above-mentioned Chinese medicine composition for treating pressure sores comprises the following steps:

[0078] The mixture of Dermatocarpus tricholoma and Gerbera tricholoma is ground and then added into water for a first reflux extraction, and then the first extract obtained is combined and concentrated and dried to obtain an extract in the form of an extract;

[0079] The extract in the form of an extract is added into water for dispersion, and then extracted with ethyl acetate for 3 times, and then the obtained ethyl acetate extracts are combined, concentrated and dried to obtain a first extract;

[0080] Mixing and grinding dandelion, astragalus and bletilla striata, adding into ethanol aqueous solution for second reflux extraction, and then combining the obtained second extracts for concentration and drying to obtain a second extract;

[0081] The first extract, the second extract and borneol are mixed, crushed and passed through a 200-mesh sieve to obtain the traditional Chinese medicine composition for treating pressure sores;

[0082] The working condition parameters of the first reflux extraction include: pressure of 25 kPa, temperature of 71°C, time of 1.5 hours, number of times of 2 times, and a weight ratio of the total weight of the Derris trichocarpa and the Gerbera pubescens to the water of 1:8;

[0083] When ethyl acetate is used for extraction, the solid-liquid ratio of the extract-like extract to the solvent is 1:12, and the volume ratio of the water to the ethyl acetate is 1:1.2;

[0084] The working condition parameters of the second reflux extraction include: pressure is normal pressure, temperature is 100°C, time is 1.5 hours, number of times is 2 times, the weight ratio of the dandelion, the astragalus, the white schizonepeta and the ethanol aqueous solution is 1:8; the volume fraction of ethanol in the ethanol aqueous solution is 45%.

[0085] Example 2

[0086] This example provides a Chinese medicine composition for treating pressure sores. The Chinese medicine composition for treating pressure sores includes the following raw materials in parts by weight:

[0087] 35 parts of Derris tricholoma, 20 parts of Gerbera pubescens, 10 parts of Taraxacum officinale, 7 parts of Astragalus, 5 parts of Bletilla striata and 5 parts of Borneolum.

[0088] The preparation method of the above-mentioned Chinese medicine composition for treating pressure sores comprises the following steps:

[0089] The mixture of Dermatocarpus tricholoma and Gerbera tricholoma is ground and then added into water for a first reflux extraction, and then the first extract obtained is combined and concentrated and dried to obtain an extract in the form of an extract;

[0090] The extract in the form of an extract is added into water for dispersion, and then extracted with ethyl acetate for 3 times, and then the obtained ethyl acetate extracts are combined, concentrated and dried to obtain a first extract;

[0091] Mixing and grinding dandelion, astragalus and bletilla striata, adding into ethanol aqueous solution for second reflux extraction, and then combining the obtained second extracts for concentration and drying to obtain a second extract;

[0092] The first extract, the second extract and borneol are mixed, crushed and passed through a 200-mesh sieve to obtain the traditional Chinese medicine composition for treating pressure sores;

[0093] The working condition parameters of the first reflux extraction include: pressure of 18 kPa, temperature of 66°C, time of 1.5 hours, number of times of 2 times, and a weight ratio of the total weight of the Derris trichocarpa and the Gerbera pubescens to the water of 1:8;

[0094] When ethyl acetate is used for extraction, the solid-liquid ratio of the extract-like extract to the solvent is 1:12, and the volume ratio of the water to the ethyl acetate is 1:1.2;

[0095] The working condition parameters of the second reflux extraction include: pressure is normal pressure, temperature is 100°C, time is 1.5 hours, number of times is 2 times, the weight ratio of the dandelion, the astragalus, the white schizonepeta and the ethanol aqueous solution is 1:8; the volume fraction of ethanol in the ethanol aqueous solution is 40%.

[0096] Example 3

[0097] This example provides a Chinese medicine composition for treating pressure sores. The Chinese medicine composition for treating pressure sores includes the following raw materials in parts by weight:

[0098] 55 parts of Derris tricholoma, 30 parts of Gerbera pubescens, 18 parts of Taraxacum officinale, 15 parts of Astragalus, 10 parts of Bletilla striata and 10 parts of Borneolum.

[0099] The preparation method of the above-mentioned Chinese medicine composition for treating pressure sores comprises the following steps:

[0100] The mixture of Dermatocarpus tricholoma and Gerbera tricholoma is ground and then added into water for a first reflux extraction, and then the first extract obtained is combined and concentrated and dried to obtain an extract in the form of an extract;

[0101] The extract in the form of an extract is added into water for dispersion, and then extracted with ethyl acetate for 3 times, and then the obtained ethyl acetate extracts are combined, concentrated and dried to obtain a first extract;

[0102] Mixing and grinding dandelion, astragalus and bletilla striata, adding into ethanol aqueous solution for second reflux extraction, and then combining the obtained second extracts for concentration and drying to obtain a second extract;

[0103] The first extract, the second extract and borneol are mixed, crushed and passed through a 200-mesh sieve to obtain the traditional Chinese medicine composition for treating pressure sores;

[0104] The working condition parameters of the first reflux extraction include: pressure of 30 kPa, temperature of 74°C, time of 1.5 hours, number of times of 2 times, and a weight ratio of the total weight of the Derris trichocarpa and the Gerbera pubescens to the water of 1:8;

[0105] When ethyl acetate is used for extraction, the solid-liquid ratio of the extract-like extract to the solvent is 1:12, and the volume ratio of the water to the ethyl acetate is 1:1.2;

[0106] The working condition parameters of the second reflux extraction include: pressure is normal pressure, temperature is 100°C, time is 1.5 hours, number of times is 2 times, the weight ratio of the dandelion, the astragalus, the white schizonepeta and the ethanol aqueous solution is 1:8; the volume fraction of ethanol in the ethanol aqueous solution is 50%.

[0107] Comparative Example 1

[0108] This example provides a Chinese medicine composition for treating pressure sores and a preparation method thereof. The only difference from Example 1 is that the amount of Derris trichocarpa used is adjusted to 0 parts (i.e., Derris trichocarpa is not added); the remaining steps and parameters are the same.

[0109] Comparative Example 2

[0110] This example provides a Chinese medicine composition for treating pressure sores and a preparation method thereof, which is different from Example 1 only in that the amount of gerbera is adjusted to 0 (ie, no gerbera is added); the remaining steps and parameters are the same.

[0111] Comparative Example 3

[0112] This example provides a Chinese medicine composition for treating pressure sores and a preparation method thereof. The only difference from Example 1 is that the dosage of Derris trichocarpa and Gerbera pubescens is adjusted to 0 parts (i.e., Derris trichocarpa and Gerbera pubescens are not added); the remaining steps and parameters are the same.

[0113] Comparative Example 4

[0114] This example provides a Chinese medicine composition for treating pressure sores and a preparation method thereof. The only difference from Example 1 is that the dosage of Derris trichocarpa is adjusted to 24 parts and the dosage of Gerbera pubescens is adjusted to 45 parts (i.e., the dosage ratio of Derris trichocarpa and Gerbera pubescens is adjusted); the remaining steps and parameters are the same.

[0115] Test Example 1

[0116] In this example, the therapeutic effect of the Chinese medicine ointment prepared from the Chinese medicine composition obtained in Examples 1 to 3 and Comparative Examples 1 to 4 on pressure sores was investigated according to the test method disclosed in the prior art.

[0117] The test method is as follows:

[0118] 1. Preparation of Ointment

[0119] Matrix preparation: Mix lanolin and vaseline in a weight ratio of 0.4:1 and heat at 85°C until completely melted.

[0120] Preparation of ointment: According to the weight ratio of the Chinese medicine composition to the matrix of 1:4.5, the Chinese medicine composition is slowly added into the molten matrix, and stirring is continued to room temperature to ensure uniform mixing, and finally the Chinese medicine ointment is obtained.

[0121] 2. Establishment of pressure ulcer model

[0122] Experimental animals: Healthy Kunming male mice were selected, and the body weight was controlled within the range of 20.5±0.12g.

[0123] Modeling method: Gently pull up the back skin at a distance of 5 mm on both sides of the midline of the mouse's back. Strong neodymium magnets with a diameter of 12 mm and a thickness of 5 mm are placed symmetrically on both sides to implement compression. Each cycle includes 12 hours of magnet compression (causing ischemia) and 12 hours of magnet removal (allowing perfusion), and a total of 3 cycles are performed.

[0124] Model verification: After 3 cycles, two wounds will form on the back of each mouse. To avoid mutual interference between magnets, mice need to be fed in single cages, and the cage cover is made of stainless steel. During the experiment, mice were fed and drank water normally. After the ischemia-reperfusion cycle, the epidermis or dermis of the back skin of the mice was partially damaged or edematous, and dry superficial ulcers appeared through naked eye observation, which was consistent with the characteristics of the stage of pressure sores, confirming that the early pressure sore model (stage II) was successfully prepared.

[0125] 3. Grouping and drug intervention

[0126] Group setting: a model group (1 group, 10 mice, not given any drug treatment) and a drug intervention group (7 groups, each group was given external application intervention with the Chinese medicine ointment made from the Chinese medicine composition prepared in Examples 1 to 3 and Comparative Examples 1 to 4) were set up.

[0127] Dosage method: The patients in the group underwent topical ointment application once a day to ensure that the ointment completely covered the sore surface, and the sore surface was covered and protected with medical absorbent gauze dressings; the model group received no other special treatment.

[0128] Observation and recording: Observe the healing of the ulcer surface at regular times and locations every day. Place a steel ruler at the edge of the ulcer when taking photos to accurately measure the size of the ulcer surface. Use Image J software to record the remaining ulcer surface area in the ulcer photos at each time point.

[0129] Calculation of healing rate: The healing rate of wound surface was calculated according to the formula "wound surface healing rate (%) = (original wound area - unhealed wound area) / original wound surface area × 100%".

[0130] 4. Results Statistics and Analysis

[0131] Data collection: After 7 days of intervention treatment, the wound healing rate of each group was statistically analyzed and the results were expressed as mean ± standard deviation, as shown in Table 1.

[0132] Data analysis: Statistical analysis was performed on the collected data to evaluate the differences in the therapeutic effects of ointments made from different Chinese herbal compositions on pressure ulcers.

[0133] Table 1

[0134]

[0135]

[0136] From Table 1, we can see that:

[0137] 1) Compared with the model group, the treatment groups treated with the Chinese medicine ointment prepared by the Chinese medicine composition prepared in Examples 1 to 3 and Comparative Examples 1 to 4 for external application intervention had different degrees of improvement in the healing of the ulcer surface of the pressure sores, and there were significant differences; however, the treatment effect of the Chinese medicine ointment prepared by the Chinese medicine composition provided by Examples 1 to 3 of the present invention for external application intervention was better, and the 7-day ulcer surface healing rate of the intervention treatment group of Example 1 could reach 90.2%, with a fast therapeutic effect.

[0138] 2) By comparing the test results of the intervention treatment group of Example 1, the intervention treatment group of Comparative Example 1, the intervention treatment group of Comparative Example 2 and the intervention treatment group of Comparative Example 3, it can be seen that when either Derris tricholoma or Gerbera pubescens in the Chinese medicine composition of the present invention is omitted, the therapeutic effect of the obtained Chinese medicine composition on bedsores will be significantly reduced; at the same time, the two show a significant positive synergistic effect, indicating that Derris tricholoma and Gerbera pubescens are both monarch drugs, and the two work together to give full play to the synergistic pharmacodynamic effect of the two.

[0139] 3) By comparing the test results of the intervention treatment group of Example 1 and the intervention treatment group of Comparative Example 4, it can be seen that when the dosage ratio of Derris tricholoma and Gerbera pubescens in the present invention is adjusted, the therapeutic effect of the obtained Chinese medicine composition on pressure sores will be adjusted up and down to a certain extent.

[0140] Test Example 2

[0141] On the basis of the above-mentioned test example 1, the present invention applies the Chinese medicine ointment prepared by the Chinese medicine composition provided in Example 1 to the treatment of patients with pressure sores, and the curative effect is significant, and the treatment efficiency is greater than 90%. Some typical cases are as follows:

[0142] Typical Case 1

[0143] Patient Wang, male, 57 years old, had a spinal cord injury caused by a traffic accident, was bedridden for a long time, and had a pressure sore below the left shoulder blade, with a sore size of about 2.5 cm × 3.7 cm. In the early stage of treatment, the wound was disinfected with iodine tincture, and then the Chinese medicine ointment made from the Chinese medicine composition provided in Example 1 was applied, and the dressing was changed once a day. On the second day after treatment, the exudate on the sore surface decreased, and the local redness and swelling subsided; on the fourth day, the sore surface began to heal until the tenth day, the sore surface was basically healed.

[0144] Typical Case 2

[0145] Patient Li, female, 72 years old, had a condition of: long-term bed rest due to stroke sequelae, and the right buttocks were continuously compressed, causing damage to the subcutaneous tissue and forming a pressure sore, with a sore surface of about 4.3 cm × 6.7 cm. During treatment, the wound surface was disinfected with iodine tincture, and then the Chinese medicine ointment made from the Chinese medicine composition provided in Example 1 was applied. The dressing was changed once a day, and it was observed that on the third day after using the Chinese medicine ointment of the present invention, a thin scab began to form on the surface of the sore surface, and on the seventh day, the sore surface was significantly reduced, and the granulation tissue grew well. The treatment was continued until the twelfth day, and the sore surface was completely healed.

[0146] Typical Case 3

[0147] The patient, Zhang, male, 68 years old, had a condition of: long-term bed rest due to sequelae of cerebral infarction, and a pressure sore formed on the right hip. The size of the sore was about 3.1 cm × 6.5 cm, and the sore surface was deep into the muscle layer, with a small amount of purulent secretions. At the beginning of the treatment, the doctor used hydrogen peroxide and normal saline to alternately rinse the wound surface, thoroughly remove necrotic tissue and pus, and then applied the Chinese medicine ointment made from the Chinese medicine composition provided in Example 1. The dressing was changed twice a day to keep the sore surface clean and the ointment effective. On the second day after treatment, the purulent secretions on the sore surface decreased and the odor was reduced; on the fifth day, granulation tissue began to grow on the sore surface, and the depth of the sore surface became shallower; on the sixteenth day, the sore surface healed, and the skin regained elasticity. The patient and his family were very satisfied with the treatment effect.

[0148] In summary, the embodiments of the present invention provide a Chinese medicine composition for treating pressure sores, a preparation method and application thereof, and a pressure sore cream. The present invention uses Derris trichocarpa and Gerbera pubescens as the main drugs, giving full play to the synergistic pharmacodynamic effects of the two, and simultaneously uses appropriate amounts of Taraxacum officinale, Astragalus, Bletilla striata and Borneol as the assistant drugs to prepare a Chinese medicine composition for treating pressure sores. Animal experiments have shown that the Chinese medicine composition has a high healing rate for the sore surface of pressure sores and a fast therapeutic effect. It can be further used in the preparation of external preparations such as pressure sore creams, providing a new means for the treatment of pressure sores and having broad application prospects.

[0149] Various embodiments of the present invention may be presented in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present invention; therefore, the range description should be considered to have specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, the range description from 1 to 6 should be considered to have specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6, which apply regardless of the range. In addition, whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range.

[0150] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A Chinese medicine composition for treating pressure sores, characterized in that: The Chinese medicine composition for treating pressure sores comprises the following raw materials in parts by weight: 35-55 parts of Derris tricholoma, 20-30 parts of Gerbera pubescens, 10-18 parts of Taraxacum officinale, 7-15 parts of Astragalus, 5-10 parts of Bletilla striata and 5-10 parts of Borneol.

2. The Chinese medicine composition for treating pressure sores according to claim 1, characterized in that: The Chinese medicine composition for treating pressure sores comprises the following raw materials in parts by weight: 45 parts of Derris tricholoma, 24 parts of Gerbera tricholoma, 15 parts of Taraxacum officinale, 11.5 parts of Astragalus, 8 parts of Bletilla striata and 8 parts of Borneolum.

3. A method for preparing the Chinese medicine composition for treating pressure sores according to claim 1 or 2, characterized in that: The preparation method comprises the following steps: The mixture of Dermatocarpus tricholoma and Gerbera tricholoma is ground and then added into water for a first reflux extraction, and then the first extract obtained is combined and concentrated and dried to obtain an extract in the form of an extract; The extract in the form of an extract is added into water for dispersion, and then extracted with ethyl acetate, and then the obtained ethyl acetate extracts are combined, concentrated and dried to obtain a first extract; Mixing and grinding dandelion, astragalus and bletilla striata, adding into ethanol aqueous solution for second reflux extraction, and then combining the obtained second extracts for concentration and drying to obtain a second extract; The first extract, the second extract and borneol are mixed, crushed and sieved to obtain the traditional Chinese medicine composition for treating bedsores.

4. The method for preparing the Chinese medicine composition for treating pressure sores according to claim 3, characterized in that: The working condition parameters of the first reflux extraction include: pressure of 18-30 kPa, temperature of 66-74°C, time of 1-2 hours, number of times of 1-3 times, and the weight ratio of the total weight of the Derris trichocarpa and the Gerbera pubescens to the water is 1:(5-10).

5. The method for preparing the Chinese medicine composition for treating pressure sores according to claim 3, characterized in that: The working condition parameters of the first reflux extraction include: pressure of 25 kPa, temperature of 71°C, time of 1.5 hours, number of times of 2 times, and the weight ratio of the total weight of the Derris trichocarpa and the Gerbera pubescens to the water is 1:

8.

6. The method for preparing the Chinese medicine composition for treating pressure sores according to claim 3, characterized in that: The working condition parameters of the second reflux extraction include: pressure is normal pressure, temperature is 95-105°C, time is 1-2 hours, number of times is 1-3 times, and the weight ratio of the dandelion, the astragalus, the white schizonepeta and the ethanol aqueous solution is 1:(5-10).

7. The method for preparing the Chinese medicine composition for treating pressure sores according to claim 3, characterized in that: The volume fraction of ethanol in the ethanol aqueous solution is 40-50%.

8. Use of a Chinese medicinal composition for treating pressure sores as claimed in claim 1 or 2, or a Chinese medicinal composition for treating pressure sores obtained by the preparation method of a Chinese medicinal composition for treating pressure sores as claimed in any one of claims 3 to 7 in the preparation of a drug for treating pressure sores.

9. A pressure sore ointment, characterized in that: The pressure sore cream comprises a medicinal efficacy component and a matrix; The medicinal active ingredient is the Chinese medicinal composition for treating pressure sores according to claim 1 or 2, or the Chinese medicinal composition for treating pressure sores obtained by the preparation method of the Chinese medicinal composition for treating pressure sores according to any one of claims 3 to 7; The matrix is ​​composed of lanolin and vaseline; The weight ratio of the drug active ingredient to the matrix is ​​1:(3-6).

10. The pressure sore ointment according to claim 9, characterized in that: The weight ratio of the lanolin to the vaseline is (0.2-0.5):1, and the weight ratio of the medicinal active ingredient to the matrix is ​​1:4.5.

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