CN108295178B

CN108295178B - Traditional Chinese medicine composition and traditional Chinese medicine ointment for treating refractory wound and preparation method thereof

Info

Publication number: CN108295178B
Application number: CN201810308484.4A
Authority: CN
Inventors: 程红; 李彦杰; 周明丽; 张白云; 高红; 沈秀华; 马希佳; 屈帅勇; 刘亚南; 吕默晗; 徐伟玲; 冯保荣
Original assignee: Henan Hospital Traditional Chinese Medicine Second Affiliated Hospital of Henan University of Traditional Chinese Medicine TCM
Current assignee: Henan Hospital Traditional Chinese Medicine Second Affiliated Hospital of Henan University of Traditional Chinese Medicine TCM
Priority date: 2018-04-08
Filing date: 2018-04-08
Publication date: 2020-10-16
Anticipated expiration: 2038-04-08
Also published as: CN108295178A

Abstract

The invention provides a traditional Chinese medicine composition and a traditional Chinese medicine ointment for treating refractory wound surfaces and a preparation method thereof, and relates to the technical field of medicines. A traditional Chinese medicine ointment for treating refractory wound surfaces comprises the following raw materials in parts by weight: 50-70 parts of astragalus membranaceus, 20-40 parts of angelica sinensis, 20-40 parts of rheum officinale, 50-70 parts of lithospermum, 20-40 parts of honeysuckle, 30-50 parts of longhairy antenoron herb, 20-40 parts of paederia scandens, 90-110 parts of white sugar, 10-30 parts of rhizoma paridis powder, 40-60 parts of pearl powder and 480-520 parts of sesame oil. The Chinese medicinal ointment has effects of accelerating the removal of slough, promoting the growth of new granulation, convenient dressing change, relieving pain of patients, and reducing treatment cost.

Description

Traditional Chinese medicine composition and traditional Chinese medicine ointment for treating refractory wound and preparation method thereof

Technical Field

The invention relates to the technical field of medicines, and in particular relates to a traditional Chinese medicine composition and a traditional Chinese medicine ointment for treating refractory wounds and a preparation method thereof.

Background

The refractory wound surface refers to the disease of the wound surface which is difficult to heal or not heal due to long-term bed rest, malnutrition, partial lack of good blood supply of the organism, lack of new blood vessels, long-term repeated inflammation stimulation of peripheral tissues, fibrous tissue hyperplasia, scar tissue formation, skin and subcutaneous tissue atrophy and thinning, repeated inflammatory hyperplasia of sclerotin, callus ischemia sclerosis, or chemotherapy drug extravasation of chronic patients after spinal cord injury, malignant tumors, diabetes, fracture operation and the like. Including traumatic ulcer, pressure ulcer, radioactive ulcer, arterial ischemic ulcer, venous stasis ulcer, infectious ulcer, malignant ulcer, and chemotherapy drug-leakage skin ulcer. Some wounds can not be healed even after being treated for 2-3 months by conventional dressing change, and even can not be healed for a long time, and the wounds need to be treated for several months to several years by dressing change. The disease course is prolonged, the patients suffer from pain, the economic burden is heavy, the treatment is difficult, and the life quality of the patients is seriously affected. At present, the western medicine treatment methods mainly comprise hyperbaric oxygen therapy, negative pressure wound treatment technology, physical therapy, ozone therapy, silver ion dressing, growth factor gel and the like, but have the defects of increased wound, pain in dressing change of patients, high cost, easy rejection reaction and the like.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating difficult-to-heal wound surfaces, which can accelerate the removal of slough and promote the growth of new granulation.

The invention also aims to provide the traditional Chinese medicine ointment for treating the difficult-to-heal wound surface, which can accelerate the removal of slough, promote the growth of new granulation, facilitate dressing change, relieve the pain of patients and reduce the treatment cost.

The invention also aims to provide a preparation method of the traditional Chinese medicine ointment for treating the intractable wound, which is simple and easy to implement, has strong operability, retains the efficacy to the maximum extent and is easy for industrial production.

The technical problem to be solved by the invention is realized by adopting the following technical scheme.

The invention provides a traditional Chinese medicine composition for treating refractory wound surfaces, which comprises the following raw materials in parts by weight: 50-70 parts of astragalus membranaceus, 20-40 parts of angelica sinensis, 20-40 parts of rheum officinale, 50-70 parts of lithospermum, 20-40 parts of honeysuckle, 30-50 parts of longhairy antenoron herb, 20-40 parts of paederia scandens, 90-110 parts of white sugar, 10-30 parts of rhizoma paridis powder and 40-60 parts of pearl powder.

The invention provides a traditional Chinese medicine ointment for treating refractory wound surfaces, which comprises the following raw materials in parts by weight: 50-70 parts of astragalus membranaceus, 20-40 parts of angelica sinensis, 20-40 parts of rheum officinale, 50-70 parts of lithospermum, 20-40 parts of honeysuckle, 30-50 parts of longhairy antenoron herb, 20-40 parts of paederia scandens, 90-110 parts of white sugar, 10-30 parts of rhizoma paridis powder, 40-60 parts of pearl powder and 480-520 parts of sesame oil.

The invention provides a preparation method of the traditional Chinese medicine ointment for treating refractory wound surfaces, which comprises the following steps: adding radix astragali, radix Angelicae sinensis, radix et rhizoma Rhei, flos Lonicerae, herba Lysimachiae Christinae and herba Paederiae into oleum Sesami, soaking, heating with strong fire until the oil is boiling, adding radix Arnebiae, heating with slow fire until the medicine is completely fried, filtering the medicinal oil to obtain filtrate, adding white sugar, rhizoma paridis powder and Margarita powder into the filtrate, and stirring to obtain ointment.

The traditional Chinese medicine composition and the traditional Chinese medicine ointment for treating the refractory wound surface and the preparation method thereof have the beneficial effects that:

the invention adopts astragalus, angelica, rhubarb, lithospermum, honeysuckle, longhairy antenoron herb, Chinese fevervine herb, rhizoma paridis powder and pearl powder, has the functions of invigorating qi and activating blood circulation, removing necrotic tissue and promoting granulation, clearing away heat and toxic material and diminishing inflammation, and is assisted by white sugar with hypertonic function, inhibits the growth of bacteria, eliminates granulation edema, and promotes the absorption and convergence of inflammation. The formula of the traditional Chinese medicine ointment is that sesame oil is added on the basis of the formula of the traditional Chinese medicine composition, the sesame oil has extremely strong lipophilicity and is easy to combine with the surface of a wound tissue to form a layer of protective barrier, pain sensation nerve endings of the wound can be effectively prevented from being stimulated, stimulation of drying injury is avoided, pain caused by dressing change is relieved, the environment in the wound surface is in an oiled and moist state, and the traditional Chinese medicine ointment is beneficial to growth of granulation tissues and healing of the wound surface. Meanwhile, when the dressing change is carried out, the traditional Chinese medicine ointment can reduce wound pain, reduce mechanical injury caused by auxiliary materials, reduce infection chances, relieve the pain of patients and accelerate the healing of affected parts.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required to be used in the embodiments will be briefly described below. It is appreciated that the following drawings depict only certain embodiments of the invention and are therefore not to be considered limiting of its scope. For a person skilled in the art, it is possible to derive other relevant figures from these figures without inventive effort.

FIG. 1 is a graph showing the therapeutic effect provided in typical case 1 of the present invention;

FIG. 2 is a graph showing the therapeutic effect provided by exemplary case 2 of the present invention;

fig. 3 is a graph showing the therapeutic effect provided by exemplary case 3 of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.

The following describes a Chinese medicinal composition and a Chinese medicinal ointment for treating intractable wounds and a preparation method thereof.

The embodiment of the invention provides a traditional Chinese medicine composition for treating refractory wound surfaces, which comprises the following raw materials in parts by weight: 50-70 parts of astragalus membranaceus, 20-40 parts of angelica sinensis, 20-40 parts of rheum officinale, 50-70 parts of lithospermum, 20-40 parts of honeysuckle, 30-50 parts of longhairy antenoron herb, 20-40 parts of paederia scandens, 90-110 parts of white sugar, 10-30 parts of rhizoma paridis powder and 40-60 parts of pearl powder.

Further, in a preferred embodiment of the present invention, the composition comprises, in parts by weight: 55-65 parts of astragalus membranaceus, 25-35 parts of angelica sinensis, 25-35 parts of rheum officinale, 55-65 parts of lithospermum, 25-35 parts of honeysuckle, 35-45 parts of longhairy antenoron herb, 25-35 parts of paederia scandens, 95-105 parts of white sugar, 15-25 parts of rhizoma paridis powder and 45-55 parts of pearl powder.

Preferably, the astragalus root can be 56 parts, 58 parts, 61 parts and 63 parts, the angelica can be 27 parts, 29 parts, 31 parts and 32 parts, the rhubarb can be 28 parts, 29 parts, 31 parts and 32 parts, the lithospermum can be 56 parts, 57 parts, 59 parts and 63 parts, the honeysuckle can be 28 parts, 29 parts, 31 parts and 33 parts, the lysimachia can be 37 parts, 39 parts, 41 parts and 44 parts, the fevervine can be 26 parts, 27 parts, 28 parts and 32 parts, the white sugar can be 97 parts, 98 parts, 101 parts and 103 parts, the paris polyphylla powder can be 18 parts, 19 parts, 22 parts and 23 parts, and the pearl powder can be 47 parts, 49 parts, 51 parts and 54 parts.

Huang Qi is sweet and warm, entering lung and spleen meridians. Has the effects of invigorating qi, invigorating yang, consolidating superficial resistance, arresting sweating, inducing diuresis, relieving swelling, promoting fluid production, nourishing blood, removing stagnation, relieving arthralgia, removing toxic substance, expelling pus, healing sore, and promoting granulation. The book of Ben Jing records: huang Qi is mainly indicated for abscess, long-term decay and sore, discharging pus and alleviating pain. Tonify deficiency, all diseases of children. "

Dang Gui is sweet, pungent and warm. It enters liver, heart and spleen meridians. Has effects of promoting blood circulation, removing blood stasis, promoting granulation, astringing wound, and healing wound. Contains volatile oil, organic acid, amino acids, vitamins, trace elements, etc., and can promote hemopoiesis and increase the content of erythrocyte, leukocyte and hemoglobin. The angelica polysaccharide can activate macrophages, lymphocytes and the like in a hematopoietic microenvironment through direct and indirect ways to promote the macrophages, the lymphocytes and the like to generate hematopoietic regulatory factors, further promote the proliferation and differentiation of pluripotent hematopoietic stem cells, stimulate bone marrow granule hematopoiesis and increase peripheral blood leukocytes. The angelica can improve immunity, and the angelica can obviously improve the activity of cell lysosome enzyme. The Angelica polysaccharide and its separated components have analgesic effect.

Rhubarb, bitter and cold. It enters spleen, stomach, large intestine, liver and pericardium meridians. Has effects in clearing away heat and toxic materials, cooling blood, promoting blood circulation, relieving inflammation and pain, promoting pus discharge, promoting granulation, healing sore, inhibiting bacteria, inflammation and virus, eliminating exotoxin, enhancing cellular immunity, and stabilizing internal environment.

Zi Cao is sweet, salty and cold. It enters heart and liver meridians. Has the effects of clearing heat, cooling blood, promoting blood circulation, removing toxic substances, promoting eruption and eliminating macula. It can be used for treating epidemic febrile disease with purple and black macula, measles with purple and dark color, eruption difficulty, carbuncle, cellulitis, pyocutaneous disease, eczema, pruritus vulvae, and scald due to water or fire. Has remarkable effects of resisting tumor, protecting liver, resisting virus, resisting fertility, resisting inflammation, regulating immunity, etc. The radix Arnebiae contains naphthoquinone as main ingredient. It is easily dissolved in organic solvent such as petroleum ether, and has inhibitory effect on virus, Staphylococcus aureus, Escherichia coli, etc., and can accelerate epithelial growth and inhibit capillary permeability.

Honeysuckle flower, sweet and cold. It enters lung, heart and stomach meridians. Has effects of clearing away heat and toxic materials, and dispelling pathogenic wind and heat. The honeysuckle has obvious inhibition effect on staphylococcus aureus, hemolytic streptococcus, dysentery, typhoid fever, meningococcus, pneumococcus, pyocyanea, influenza virus and the like. The honeysuckle can promote the transformation of lymphocytes and enhance the phagocytic function of white blood cells. Promoting immunity, and improving immunity. The honeysuckle can promote the release of adrenocortical hormone and has obvious inhibition effect on inflammation.

Jin Qian Cao is sweet, salty and slightly cold. It enters liver, gallbladder, kidney and bladder meridians. Has effects of promoting diuresis, eliminating jaundice, promoting urination, treating stranguria, removing toxic substance and relieving swelling. It is indicated for abscess, swelling, sore, snake bite, sore, tinea and eczema. The herba Lysimachiae Christinae has antiinflammatory effect, and can inhibit humoral immunity and cellular immunity, and prolong the occurrence time of skin graft rejection.

Paederia scandens, sweet and sour in flavor and mild in nature. It enters heart, liver, spleen and kidney meridians. Has effects in nourishing liver and kidney, nourishing essence and blood, and moistening intestine. It is used together with jin Yin Hua to treat carbuncle, sore, furuncle and swelling. Has antibacterial and antiviral activities, and also has analgesic effect.

White sugar, which in the present invention is understood to be white sugar. The white granulated sugar has sweet taste and mild nature, has the functions of clearing heat and diminishing inflammation, effectively reduces secretion and inhibits the growth of bacteria. The white sugar forms a hypertonic state on the wound surface after melting, so that bacteria are dehydrated, denatured and necrotic, the pH value in the wound surface can be reduced by the high sugar, an acid environment is formed, the growth of the bacteria is inhibited, and granuloma edema is eliminated, so that the inflammation absorption and convergence are promoted, and the purpose of wound surface healing is achieved.

Paris polyphylla powder is bitter, slightly cold and slightly toxic. It enters liver meridian. Has the effects of clearing away heat and toxic materials, and relieving swelling and pain. Has antibacterial, tranquilizing, and analgesic effects, and is generally powder.

Pearl powder is sweet, salty and cold. It enters heart and liver meridians. Has effects of tranquilizing, arresting convulsion, removing toxic substance, promoting granulation, caring skin, and removing speckle. Animal experiments show that the pearl hydrolysate can dredge microcirculation, increase the blood flow speed of the bulboconjunctival membrane of the rabbit eye, improve the microcirculation disturbance of the bulboconjunctival membrane of the rabbit eye and prevent the formation of the microcirculation disturbance. Therefore, the pearl has the function of dredging microcirculation. Promoting blood circulation of the wound is of great importance in the process of wound healing.

The astragalus, the angelica, the rhubarb, the lithospermum, the honeysuckle, the desmodium, the paederia scandens, the rhizoma paridis powder and the pearl powder are used together, so that the effects of tonifying qi and activating blood, removing necrotic tissues and promoting granulation, clearing away heat and toxic materials and diminishing inflammation are achieved, and the white sugar with the hypertonic effect is used as an auxiliary material to inhibit the growth of bacteria and eliminate granuloma edema, so that the absorption and the convergence of inflammation are promoted, and the purpose of wound healing is achieved. In order to enlarge the application range of the traditional Chinese medicine composition, the raw materials also comprise pharmaceutically acceptable auxiliary materials to support different formulations.

Further, in a preferred embodiment of the present invention, the composition comprises, in parts by weight: 55-65 parts of astragalus membranaceus, 25-35 parts of angelica sinensis, 25-35 parts of rheum officinale, 55-65 parts of lithospermum, 25-35 parts of honeysuckle, 35-45 parts of longhairy antenoron herb, 25-35 parts of paederia scandens, 95-105 parts of white sugar, 15-25 parts of rhizoma paridis powder, 45-55 parts of pearl powder and 490-510 parts of sesame oil.

The formula of the traditional Chinese medicine ointment is based on the formula of the traditional Chinese medicine composition and added with sesame oil. It should be noted that the sesame oil according to the embodiment of the present invention is sesame oil, and in other embodiments of the present invention, other sesame oil having the same function may be used. The sesame oil has extremely strong lipophilicity, is easy to combine with the surface of a wound surface tissue to form a layer of protective barrier, can effectively avoid stimulating pain nerve endings of the wound surface, avoid stimulation of dry injury, relieve pain caused by dressing change, enable the environment in the wound surface to be in an oily and moist state, and is beneficial to growth of granulation tissue and healing of the wound surface. The moist environment can retain the exudate in the wound surface, can effectively maintain the activity of cells, can increase the migration speed of epithelial cells, stimulate the development of capillary vessels, and promote the keratinization of the epithelial cells and the generation of endothelial cells. The moist environment can effectively inhibit the growth of bacteria and improve the local immunity. When the dressing change is carried out, the traditional Chinese medicine ointment can reduce wound pain, reduce mechanical injury caused by auxiliary materials, reduce infection chances, relieve the pain of patients and accelerate the healing of affected parts.

The invention also provides a preparation method of the traditional Chinese medicine ointment for treating the intractable wound, which comprises the following steps:

weighing raw materials in proportion, cleaning and drying radix astragali, radix Angelicae sinensis, radix et rhizoma Rhei, radix Arnebiae, flos Lonicerae, herba Lysimachiae Christinae and herba Paederiae, and crushing. Preferably, the particle size of the crushed traditional Chinese medicine is 1-10 meshes. The traditional Chinese medicine with the particle size can enable active ingredients in medicinal materials to rapidly overflow, and meanwhile, the phenomenon that the medicinal materials are rapidly fried to be scorched in the heating process to influence the property of the traditional Chinese medicine ointment due to the excessively small particle size is avoided.

Adding the cut medicinal materials into oleum Sesami, soaking for 1 week, placing in a container, and heating with strong fire until the oil is boiled. Adding radix Arnebiae, and heating with slow fire. Stirring the materials until the materials are fried to dry. Preferably, the surface of the medicine is black, the interior is dark brown, and the medicinal oil is dark red. The purple red color of the medicinal oil shows that the frying time is short, and the medicinal components can not be effectively separated out; the color change to dark brown indicates that the frying time is too long and the medicine is dry and scorched. And (3) filtering to remove residues when the temperature of the oil is reduced to 75-85 ℃, taking the filtrate, and adding edible white sugar, rhizoma paridis powder and pearl powder into the filtrate. Stirring to obtain paste, sterilizing the ointment with high pressure steam, and sealing in a clean container.

The preparation method adopts a sesame oil heating extraction method, and the effective components in the medicinal materials are directly extracted into the sesame oil, so that the content of the effective components in the sesame oil is high, the effective components are uniformly distributed, and the drug property of the sesame oil is improved.

The traditional Chinese medicine ointment for treating the difficult-to-heal wound surface can be used for treating II and III degree pressure sores caused by long-term lying in bed after stroke, and has a treatment effect on the wound surfaces of III and IV stage and non-stage pressure sores, diabetic feet and large-area burns.

The features and properties of the present invention are described in further detail below with reference to examples.

Example 1

The embodiment provides a traditional Chinese medicine ointment for treating refractory wounds, which is prepared by the following preparation method:

weighing the raw materials in proportion, comprising: 50 parts of astragalus membranaceus, 20 parts of angelica sinensis, 20 parts of rheum officinale, 50 parts of lithospermum, 20 parts of honeysuckle, 30 parts of desmodium, 20 parts of paederia scandens, 90 parts of white sugar, 10 parts of rhizoma paridis powder, 40 parts of pearl powder and 480 parts of sesame oil.

Cleaning radix astragali, radix Angelicae sinensis, radix et rhizoma Rhei, radix Arnebiae, flos Lonicerae, herba Lysimachiae Christinae, and herba Paederiae, drying, and crushing. Adding the cut medicinal materials into oleum Sesami, soaking for 1 week, placing in a container, and heating with strong fire until the oil is boiled. Adding radix Arnebiae, and heating with slow fire. Stirring the materials until the materials are fried to dry. The surface of the medicine is black, the interior is dark brown, and the color of the medicinal oil is dark red. And (3) filtering to remove residues when the temperature of the oil is reduced to 75-85 ℃, taking the filtrate, and adding edible white sugar, rhizoma paridis powder and pearl powder into the filtrate. Stirring to obtain paste, sterilizing the ointment with high pressure steam, and sealing in a clean container.

Example 2

weighing the raw materials in proportion, comprising: 70 parts of astragalus membranaceus, 40 parts of angelica sinensis, 40 parts of rheum officinale, 70 parts of lithospermum, 40 parts of honeysuckle, 50 parts of desmodium, 40 parts of paederia scandens, 110 parts of white sugar, 30 parts of rhizoma paridis powder, 60 parts of pearl powder and 520 parts of sesame oil.

Example 3

weighing the raw materials in proportion, comprising: 60 parts of astragalus membranaceus, 30 parts of angelica sinensis, 30 parts of rheum officinale, 60 parts of lithospermum, 30 parts of honeysuckle, 40 parts of desmodium, 30 parts of paederia scandens, 100 parts of white sugar, 20 parts of rhizoma paridis powder, 50 parts of pearl powder and 500 parts of sesame oil.

Example 4

weighing the raw materials in proportion, comprising: 65 parts of astragalus membranaceus, 25 parts of angelica sinensis, 25 parts of rheum officinale, 65 parts of lithospermum, 35 parts of honeysuckle, 35 parts of desmodium, 25 parts of paederia scandens, 110 parts of white sugar, 30 parts of rhizoma paridis powder, 50 parts of pearl powder and 520 parts of sesame oil.

Comparative example 1

This comparative example provides a common complexed iodine for wound disinfection.

Comparative example 2

This comparative example provides recombinant human basic fibroblast growth factor for external use (35000 IU/vial, Beijing Erlu pharmaceutical Co., Ltd.).

Comparative example 3

The comparative example provides a traditional Chinese medicine ointment for treating refractory wound surfaces, which is prepared by the following preparation method:

weighing the raw materials in proportion, comprising: 30 parts of angelica sinensis, 30 parts of honeysuckle, 40 parts of desmodium, 30 parts of paederia scandens and 400 parts of sesame oil.

Cleaning radix Angelicae sinensis, flos Lonicerae, herba Lysimachiae Christinae, and herba Paederiae, drying, and crushing. Adding the cut medicinal materials into oleum Sesami, soaking for 1 week, placing in a container, and heating with strong fire until the oil is boiled. Then heating with slow fire. Stirring the materials until the materials are fried to dry. The surface of the medicine is black, the interior is dark brown, and the color of the medicinal oil is dark red. Filtering to remove residue when the temperature of the oil is reduced to 80 deg.C, collecting filtrate, and adding Margarita powder. Stirring to obtain paste, sterilizing the ointment with high pressure steam, and sealing in a clean container.

Test example 1 animal test

1. Establishment of animal model

80 adult rats weighing 18-22 g were randomly divided into 8 groups of 10 rats each, namely a blank group, corresponding groups of examples 1-4 and comparative examples 1-3. 150mg/kg of ketamine hydrochloride is injected into the abdominal cavity of each group of rats, the molding area (the middle upper part of the lumbar vertebra) is sheared after anesthesia, the molding area is marked by a plastic bottle cap with the diameter of 20mm, and the benzalkonium bromide tincture is used. The cotton ball skin is disinfected, the skin of the rat is cut along a marking line, the tissue is peeled to reach a muscle fascia, the bleeding is stopped, and a disinfected gauze dressing covers the wound to form a rat full-layer skin defect open wound model (a common wound). Injecting 8mg/100g of hydrocortisone sodium succinate into muscle after molding to prepare a wound surface model difficult to heal. From 1d before the operation, each group was intramuscularly injected with penicillin sodium salt (4000U/mouse) for 4d in series to prevent infection. The breeding is carried out separately in cages, and water and diet are fed freely.

2. Method of administration

The dressing change of each group is started on the day of the molding, 1 time per day, and the wounds are cleaned by 1/5000 furacilin before dressing change. The medicaments provided in examples 1-4 and comparative examples 1-3 are respectively smeared on the wound surface of each group of rats every day, physiological saline smeared on a blank group is covered by external sterile gauze and fixed by medical adhesive plaster, and the healing condition of the wound surface of the mouse is regularly observed.

3. Results and analysis

TABLE 1 healing results

As can be seen from table 1, the traditional Chinese medicine ointment for treating the refractory wound provided in embodiments 1 to 4 has a good treatment effect on the scald wound, and the scald wound is cured within one month. Compared with comparative example 1, the traditional Chinese medicine ointment provided in examples 1-4 has obvious drug effect and faster action, and the drug effect of the medicaments provided in comparative examples 2 and 3 is poorer than that of the medicaments provided in the examples.

Test example 2 clinical test

1. Case selection

Collecting data: 200 patients with intractable sore surfaces admitted to the rehabilitation department of the first subsidiary hospital of the traditional Chinese medicine college of Henan, second and third colleges and the first subsidiary hospital of Zhengzhou university from 1 month to 2017 in 2012 were selected, wherein 44 patients with cerebral apoplexy and hemiplegia, 32 patients with spinal cord injury and paraplegia, 14 patients with diabetic gangrene, 76 patients with scald, and 34 patients with unfavorable limb activities after cerebral trauma surgery or due to other reasons. All the patients lie in bed for a long time and cannot take care of themselves, the age is 18-75 years, and the average age is 45 years. The depth of the wound surface reaches three or four degrees, and the wound surface does not heal for more than one month. Patients were randomly divided into treatment groups of 100 patients each, with 58 male patients, 42 female patients, 58 male in the control group, and 42 female in the control group. The clinical data of two groups of patients have no significant difference and are comparably prominent.

And (4) judging the standard: (1) meets the clinical staging of the modern clinical medical diagnosis standard series surgical disease diagnosis standard: and (3) three degrees: the pathological tissue is swollen, hard to brown or black, rotten and necrotic to form ulcer which is round, the edge is raised and hard, the lacuna is like a funnel, the granulation tissue is loose, and the secretion is rare; the surrounding skin was infiltrated and bluish purple. Lesions involve the entire layer of skin and have extensive potential damage. Fourthly: the necrosis involves deep tissues including deep sarcolemma, ligament and bone tissue, and the secretion has bad odor. The wound surface size is 2.0 × 2.0cm to 5.0 × 4.0 cm. (2) There is a history of long-term bed-rest disease such as trauma or infection, tumor, spinal cord injury, etc.: (3) the course of disease is more than 1 month.

Inclusion criteria were: the diagnostic standard is met; the patient or family member voluntarily takes care of the treatment after the age of 18-75 years, and the treatment can be actively matched.

Exclusion criteria: bleeding tendency or recent anticoagulation; for patients allergic to the traditional Chinese medicines; severe anemia, hypoproteinemia, infected; severe multiple organ diseases of heart, liver and kidney.

Shedding standard: the subjects who meet the inclusion standard and are qualified in screening, enter a random test by informed consent and complete the first evaluation do not complete the items and observation periods specified by the scheme for the reason, and are taken as the cases of the abscission.

According to the 'diagnosis standard of surgical diseases', a wound surface measuring ruler is used for evaluating the area, depth, color, necrotic tissue condition, wound surface secretion and the like of the wound surface. The wound healing condition is evaluated by checking every day from the first treatment day, and the evaluation contents comprise the area and the stage of the wound surface, secretion of the wound surface, exudate, granulation growth and epithelial crawling condition. The wound surface observation surface is filled every day, and the wound surface healing treatment effect is observed. The two treatment courses are the same, and 30 days is 1 treatment course. After 3 treatment courses, wound surface examination and curative effect judgment are carried out.

2. Method of treatment

According to the nutritional status and the disease condition, reasonable nutrition regulation and care are given, and protein, heat, vitamins, trace elements and the like in the diet are properly increased; strengthening the morning and evening care, keeping the bed unit clean, dry and chipless; the air cushion bed is used, and the soft pillow is used for cushioning the local part to avoid being pressed again; and establishing a turnover card, ensuring that the turnover is carried out for 1 time at least every 2 hours and recording.

Treatment groups: the wound surface is cleaned by a cotton ball with 0.9% sodium chloride solution, then disinfected by 3% hydrogen peroxide and povidone iodine solution, and removed necrotic tissues or crusts by aseptic scissors, the traditional Chinese medicine ointment provided in example 3 is smeared on the affected part, covered with three layers of aseptic dressings (for preventing the medicine oil from polluting clothes and bedding), and fixed by breathable hypoallergenic adhesive plaster, and changed 1 time after 2-3 days until the wound surface is healed.

Control group: the patient is treated by conventional surgical debridement and dressing change on the same day of admission, the wound surface is cleaned by a 0.9% sodium chloride solution cotton ball, then the wound surface is disinfected by 3% hydrogen peroxide and povidone iodine solution, necrotic tissues or crusts are removed by aseptic scissors, external recombinant human basic fibroblast growth factor (35000 IU/bottle) is uniformly and fully sprayed on the wound surface after debridement, three layers of aseptic dressing are covered on the wound surface, the wound surface is fixed by breathable low-sensitivity adhesive plaster, and dressing change is carried out for 1 time in 2-3 days until the wound surface is healed.

3. The observation and method of the curative effect are as follows:

4. And (3) judging standard: the evaluation is carried out by referring to the standard of curative effect of diagnosis of traditional Chinese medicine diseases issued by the State administration of traditional Chinese medicine.

And (3) curing: the new granulation tissue grows out completely, and the wound surface is healed completely.

The method has the following advantages: the wound surface is reduced, part of the wound surface is ruddy, the new granulation tissue is partially grown, and inflammatory effusion is reduced.

And (4) invalidation: the wound surface has no obvious change or deterioration before and after the application.

5. Treatment results and analysis

TABLE 2 therapeutic results

Note: compared with the effective rates of 10 days, 20 days and 30 days, the p is less than 0.05, and the difference is obvious.

TABLE 3 comparison of wound surface conditions

Note: p is < 0.05 compared with the control group.

As can be seen from tables 2 and 3, the effective rate of the treatment group using the traditional Chinese medicine ointment for treating intractable wounds provided in example 3 was 98% after 30 days, while the effective rate of the control group was 87%. And the slough shedding time, the new granulation emergence time and the wound healing time of the healing group are all smaller than those of the control group. The traditional Chinese medicine ointment provided by the invention has a good treatment effect on wound surfaces which are difficult to heal and are caused by various reasons, and the ointment is convenient to change the dressing in the treatment process, so that the pain of a patient is effectively relieved.

Typical case 1

Certain of plum: for men 72 years old and suffering from apoplexy for more than ten years, the skin ulceration is caused by long-term lying in bed, and the skin is healed after changing the medicine by the alternate-day dampness of the traditional Chinese medicine ointment provided by the invention for more than one month. For details, refer to fig. 1.

Typical case 2

Certain Liu: for a male, the male is 53 years old, a spinal cord injury patient is lack of family care knowledge, the wound surface is black scab and ulcerated due to lack of nutrition, the traditional Chinese medicine ointment provided in the example 3 is applied after debridement, the dressing change is performed every other day, the wound surface grows flat after two months, then the traditional Chinese medicine ointment provided in the example 3 is applied externally, and the wound surface is completely healed for three months. For details, refer to fig. 2.

Typical case 3

Zhao a certain one: for a male, 36 years old, with spinal cord injury, the patient should be carelessly scalded, deep second degree, injured muscle layer, go to a plurality of third-level hospitals to consult and inform that skin grafting is needed, and the patient should be cured by changing the medicine with the traditional Chinese medicine ointment provided in example 3 for five months. For details, refer to fig. 3.

The embodiments described above are some, but not all embodiments of the invention. The detailed description of the embodiments of the present invention is not intended to limit the scope of the invention as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating the difficult-to-heal wound surface is characterized by comprising the following raw materials in parts by weight: 50-70 parts of astragalus membranaceus, 20-40 parts of angelica sinensis, 20-40 parts of rheum officinale, 50-70 parts of lithospermum, 20-40 parts of honeysuckle, 30-50 parts of longhairy antenoron herb, 20-40 parts of paederia scandens, 90-110 parts of white sugar, 10-30 parts of rhizoma paridis powder and 40-60 parts of pearl powder.

2. The traditional Chinese medicine composition for treating refractory wounds as claimed in claim 1, wherein the raw materials are, in parts by weight: 55-65 parts of astragalus membranaceus, 25-35 parts of angelica sinensis, 25-35 parts of rheum officinale, 55-65 parts of lithospermum, 25-35 parts of honeysuckle, 35-45 parts of longhairy antenoron herb, 25-35 parts of paederia scandens, 95-105 parts of white sugar, 15-25 parts of rhizoma paridis powder and 45-55 parts of pearl powder.

3. The traditional Chinese medicine ointment for treating the difficult-to-heal wound surface is characterized by comprising the following raw materials in parts by weight: 50-70 parts of astragalus membranaceus, 20-40 parts of angelica sinensis, 20-40 parts of rheum officinale, 50-70 parts of lithospermum, 20-40 parts of honeysuckle, 30-50 parts of longhairy antenoron herb, 20-40 parts of paederia scandens, 90-110 parts of white sugar, 10-30 parts of rhizoma paridis powder, 40-60 parts of pearl powder and 480-520 parts of sesame oil.

4. A traditional Chinese medicine ointment for treating refractory wounds according to claim 3, characterized in that the raw materials are: 55-65 parts of astragalus membranaceus, 25-35 parts of angelica sinensis, 25-35 parts of rheum officinale, 55-65 parts of lithospermum, 25-35 parts of honeysuckle, 35-45 parts of longhairy antenoron herb, 25-35 parts of paederia scandens, 95-105 parts of white sugar, 15-25 parts of rhizoma paridis powder, 45-55 parts of pearl powder and 490-510 parts of sesame oil.

5. A method of preparing a traditional Chinese medicine ointment for treating refractory wounds as claimed in claim 4 or 3, comprising: adding radix astragali, radix Angelicae sinensis, radix et rhizoma Rhei, flos Lonicerae, herba Lysimachiae Christinae and herba Paederiae into oleum Sesami, soaking, heating with strong fire until the oil is boiling, adding radix Arnebiae, heating with slow fire until the medicine is completely fried, filtering the medicinal oil to obtain filtrate, adding white sugar, rhizoma paridis powder and Margarita powder into the filtrate, and stirring to obtain ointment.

6. A method of preparing a Chinese medicinal ointment for treating intractable wound according to claim 5 wherein said medicine is dark brown on its surface and dark red on its interior when it is fried to dryness.

7. The method of claim 5, wherein radix astragali, radix Angelicae sinensis, radix Et rhizoma Rhei, flos Lonicerae, herba Lysimachiae, and herba Paederiae are chopped into 1-10 mesh before adding oleum Sesami.

8. The method for preparing a traditional Chinese medicine ointment for treating intractable wound according to claim 5, wherein the medicinal oil is filtered when the medicinal oil is cooled to 75-85 ℃.

9. A method of preparing a Chinese medicinal ointment for the treatment of intractable wound according to claim 5 wherein said ointment is autoclaved after it is prepared.