Composition for treating chronic wounds as well as preparation method and application thereof

Abstract

The invention provides a composition for treating chronic wounds and a preparation method and application thereof, and belongs to the technical field of chronic wound treatment. The composition for treating the chronic wound surface, provided by the invention, is prepared from the following raw materials in parts by weight: 8 to 12 parts of brown sugar, 8 to 12 parts of rhizoma coptidis, 8 to 12 parts of radix ampelopsis, 12 to 18 parts of cortex ilicis rotundae, 10 to 12 parts of radix sanguisorbae and 0.5 to 1.5 parts of resina draconis. The composition for treating chronic wounds provided by the invention is rigorous in compatibility and distinct in monarch, minister, assistant and guide. Brown sugar and coptis chinensis are used as monarch drugs; the ministerial drugs ampelopsis japonica and ovateleaf holly bark help the monarch drug to clear damp and promote tissue regeneration; sanguisorba officinalis and dragon's blood are used as adjuvant drugs for removing blood stasis and activating blood to promote wound healing. All the components are combined to jointly achieve the effects of clearing heat, eliminating dampness, promoting blood circulation and promoting tissue regeneration, and are exactly combined with the pathogenesis of damp-heat stasis resistance and difficulty in healing wounds, so that the traditional Chinese medicine composition is suitable for treating chronic refractory wounds, pressure sores, non-healing wounds after operations, chronic eczema, bedsores and other durable and unhealed symptoms, and also has the effect of inhibiting pathogenic bacteria.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of chronic wound treatment, and particularly relates to a composition for treating chronic wounds and a preparation method and application thereof. BACKGROUND

[0002] In the field of clinical medicine, chronic refractory wounds, pressure sores, postoperative wounds that do not heal for a long time, chronic eczema, bedsores and other chronic conditions that do not heal for a long time have always been a difficult problem for patients and medical workers. From the clinical classification, chronic wounds mainly include pressure sores (bedsores), diabetic foot ulcers, venous ulcer, postoperative wound non-healing, infected wounds and the like. These wounds have common characteristics such as long course, easy infection, repeated attacks, and poor effect of conventional treatment, and their pathophysiological processes involve multiple factors such as abnormal inflammatory response, cell function disorder, lack of growth factors, and local blood supply disorder. In the current medical practice, the treatment of chronic refractory wounds is still one of the major challenges faced by clinicians. The drugs commonly used in clinical treatment include traditional Chinese medicines and chemical drugs.

[0003] Traditional Chinese medicine has a long history and rich experience in treating chronic wounds. Many classic prescriptions and preparations are still widely used in clinical practice today. Here are some commonly used Chinese medicine preparations for chronic wound treatment and their characteristics: (1) Dragon's Blood Powder: composed of single dragon's blood, it has the effects of promoting blood circulation, stopping pain and bleeding, and astringing and promoting tissue regeneration. It is traditionally used for injuries, blood stasis, external bleeding, and chronic ulcers. However, as a single preparation, its efficacy is relatively single, and for chronic wounds caused by complex etiology, it often needs to be used in combination with other drugs. (2) Jingwanhong Ointment: composed of more than 30 kinds of Chinese herbs such as Coptis, Scutellaria, and Phellodendri, it has the effects of promoting blood circulation, detoxifying, relieving swelling and pain, and promoting tissue regeneration. It is mainly used for mild burns, sore and painful ulcers, and chronic wounds. However, due to its complex composition, it can cause allergic reactions, and pregnant women should use it with caution. It is also contraindicated for burn and infection, limiting its application in some patients. (3) Ruyi Golden Yellow Powder: composed of turmeric, rhubarb, phellodendri, atractylodes, and magnolia officinalis, it has the effects of clearing heat and detoxifying, and relieving swelling and pain. It is commonly used for sore and painful ulcers, and erysipelas. It has good effect on some acute inflammatory skin diseases. However, for chronic wounds and diseases, its continuous treatment effect is insufficient, and its powder form is not convenient to use, easy to fall off, and affects the treatment effect. (4) Shaolin Sore Ointment: as a pure Chinese medicine external preparation derived from Shaolin Huichun Ointment, it is composed of angelica, safflower, rhubarb, and scutellaria. It has the effects of clearing heat and relieving pain, relieving swelling and promoting tissue regeneration, and clearing heat and detoxifying. It is suitable for skin infections, boils, and bedsores. However, it is an oily preparation, which is not convenient to use, easy to contaminate clothes, and prohibited for oral use, limiting its application range. (5) Qinggu Powder: composed of clam shell, indigo, gypsum, light powder, and phellodendri, it has the effects of killing insects, relieving inflammation, and relieving itching. It is used for skin wetness, itching, yellowish water, and chronic pain. This prescription is effective for chronic eczema with exudation, but has limited effect on dry type chronic wounds or deep ulcers.

[0004] With the development of molecular biology and tissue engineering, modern medicine has gradually developed a variety of biological agents and new drugs for chronic wounds. However, these drugs still have various limitations: (1) Growth factor drugs: such as epidermal growth factor (EGF), fibroblast growth factor (FGF), etc., have been widely used in the treatment of chronic wounds. These growth factors can directly promote cell proliferation, migration and differentiation, and accelerate the healing process of the wound. However, the cost of purification of these growth factor proteins is very high, and they cannot persist in the injury site for a long time, resulting in high treatment costs and unstable efficacy. (2) Antibacterial drugs: for chronic wounds with infection, antibacterial drugs are the conventional treatment choice. For example, Japanese researchers have developed SR-0379 drugs that can suppress the proliferation of various bacteria such as Pseudomonas aeruginosa and Acinetobacter. However, long-term use of a single antibacterial drug can easily lead to bacterial drug resistance, and simple antibacterial drugs without promoting tissue regeneration are difficult to fundamentally solve the problem of wound healing. (3) Nanometer drugs: Israeli scientists have developed a low-cost nanometer drug for treating chronic wounds. The drug uses genetic engineering to produce "robot" growth factor proteins that respond to temperature. Raising the temperature will cause these proteins to fold into nanoparticles. This method greatly simplifies the protein purification process, making the production cost very low, and also allows the growth factor to be localized and retained in the burn or wound site. Japanese researchers have developed a new drug called "SR-0379" that can effectively suppress bacterial infection while reducing the area of skin ulcers. However, these new drugs are still in the experimental or clinical trial stage and have not been widely used in clinical practice. Their long-term safety and effectiveness still need to be further verified.

[0005] Although the above drugs have played a certain role in their respective application ranges, there are still many shortcomings in the treatment of chronic refractory wounds, pressure sores, long-term non-healing postoperative wounds, chronic eczema, and bedsores. The adverse reactions of some drugs are not clear, and some drugs have the risk of allergy. In addition, some drugs have a long treatment period, but the effect is not significant, which not only prolongs the pain time of patients, but also increases the economic burden of patients.

[0006] In this context, it is crucial to develop a new type of traditional Chinese medicine ointment with Chinese medicine characteristics. Traditional Chinese medicine emphasizes the holism and balance of the human body, and believes that chronic wounds and skin disorders are closely related to factors such as poor blood circulation and internal accumulation of dampness and heat. At the same time, the applicant's research and development team has deeply realized the limitations of existing drugs in the treatment of chronic refractory wounds, pressure sores, long-term non-healing postoperative wounds, chronic eczema, and bedsores in long-term clinical practice. These clinical cases have made the applicant's research and development team realize that a more targeted, more effective, and safer drug for treating chronic refractory wounds is needed. SUMMARY

[0007] Therefore, the present application aims to provide a composition for treating chronic wounds, which has the effects of clearing heat and removing dampness, promoting blood circulation and promoting tissue regeneration, and is suitable for treating chronic wounds, pressure sores, or chronic eczema, bedsores, and other chronic wounds.

[0008] In order to achieve the above-mentioned application purposes, the present application provides the following technical solutions. The present application provides a composition for treating chronic wounds, which comprises the following raw materials in terms of weight fraction: 8-12 parts of brown sugar, 8-12 parts of Coptis chinensis, 8-12 parts of Radix Ampelopsis, 12-18 parts of Radix Potentillae, 10-12 parts of Radix Sanguis Draxonis, and 0.5-1.5 parts of Dragon's Blood.

[0009] The present application also provides a preparation method of the above-mentioned composition, which comprises the following steps: mixing Coptis chinensis with water, decocting and extracting, taking the medicinal liquid to concentrate to obtain Coptis chinensis thick paste; mixing Radix Ampelopsis, Radix Potentillae, and Radix Sanguis Draxonis to obtain a mixture, mixing the mixture with water, decocting and extracting, and taking the medicinal liquid to concentrate to obtain a mixture thick paste; crushing Dragon's Blood to obtain fine powder; dividing the brown sugar into two parts, mixing one part with the Coptis chinensis thick paste to obtain thick paste one, and mixing the other part with the mixture thick paste to obtain thick paste two; heating the soft paste medicinal adjuvant, adding the fine powder, and then adding thick paste one and thick paste two respectively to obtain the soft paste.

[0010] Preferably, the soaking time is 0.5-1.5 h, and the weight of water is 12-16 times the weight of Coptis chinensis during soaking; when preparing the Coptis chinensis thick paste, the decocting and extracting is performed 1-3 times, the weight of water is 10-14 times the weight of Coptis chinensis during the second or third decocting and extracting, and the decocting and extracting time is 1-2 h each time.

[0011] Preferably, when preparing the mixture thick paste, the decocting and extracting is performed 1-3 times; the weight of water is 12-16 times the weight of the mixture during the first decocting and extracting, and the decocting and extracting time is 1.5-2.5 h; the weight of water is 10-14 times the weight of the mixture during the second or third decocting and extracting, and the decocting and extracting time is 1-2 h.

[0012] Preferably, the relative density of the Coptis chinensis thick paste under the condition of 60-65℃ is 1.20-1.30, and the relative density of the mixture thick paste under the condition of 60-65℃ is 1.20-1.30.

[0013] Preferably, the fine powder is the fine powder after being sieved through a 100-120 mesh sieve.

[0014] Preferably, the weight of the brown sugar mixed with the Coptis chinensis thick paste is 17%-20% of the total weight of the brown sugar, and the weight of the brown sugar mixed with the mixture thick paste is 80%-83% of the total weight of the brown sugar.

[0015] Preferably, the total weight of thick paste one and thick paste two is 100:80~100 of the weight of the ointment-making auxiliary material; the ointment-making auxiliary material comprises polyethylene glycol 4000 and glycerol, the weight-volume ratio of the polyethylene glycol 4000 and glycerol is 6g:1mL; the heating temperature is 65~70℃.

[0016] The application also provides application of the composition or the preparation method in preparation of a chronic wound treatment product or in preparation of a pathogenic bacteria inhibiting product.

[0017] Preferably, the chronic wound comprises pressure sores, diabetic foot ulcers, varicose ulcers, postoperative wound non-healing and / or infectious wounds; the pathogenic bacteria comprises Staphylococcus aureus, Pseudomonas aeruginosa and / or Streptococcus pyogenes.

[0018] Advantages of the application: The composition for treating chronic wounds provided by the application has strict compatibility, and the monarch, minister and assistant drugs are clearly classified. The monarch drug, brown sugar and Coptis chinensis, take both the symptoms and the root causes into account; the minister drugs, white yam and Sargentodoxa, help the monarch drug to remove dampness and promote skin regeneration; and the assistant drugs, Burnet and dragon's blood, remove blood stasis to promote wound healing. The combination of all the drugs has the effects of removing dampness and promoting blood circulation and skin regeneration, which is suitable for the treatment of chronic refractory wounds, pressure sores, or postoperative wounds that do not heal for a long time, or chronic eczema, bedsores and other symptoms that do not heal for a long time, and also has the effect of inhibiting pathogenic bacteria. DETAILED DESCRIPTION

[0019] The application provides a composition for treating chronic wounds, which comprises the following raw materials in terms of weight fractions: 8~12 parts of brown sugar, 8~12 parts of Coptis chinensis, 8~12 parts of white yam, 12~18 parts of Sargentodoxa, 10~12 parts of Burnet and 0.5~1.5 parts of dragon's blood.

[0020] The present application does not have special limitations for the specific source of each raw material, and the conventional commercially available products in the art can be used. In the present application, the composition is also referred to as Hongtang Yuyang Ointment, and the amount of brown sugar is preferably 9-11 parts, more preferably 10 parts; the amount of Coptis chinensis is preferably 9-11 parts, more preferably 10 parts; the amount of Radix Anisidi is preferably 9-11 parts, more preferably 10 parts; the amount of Ilex asprella is preferably 14-16 parts, more preferably 15 parts; the amount of Radix Sanguisorbae is preferably 11 parts; and the amount of Dragon's Blood is preferably 0.7-1.2 parts, more preferably 0.9-1.1 parts. In the present application, brown sugar and Coptis chinensis are used as the monarch drugs: brown sugar is warm and sweet, which can moisten dryness, promote tissue regeneration, nourish blood and tonify deficiency; Coptis chinensis is bitter and cold, which can clear heat and resolve toxicity, dry dampness and eliminate evil; the combination of the two drugs, one warm and one cold, one tonifying and one purgative, can treat the root cause by moistening dryness, nourishing blood and tonifying deficiency with brown sugar, and treat the symptoms by clearing heat and resolving toxicity with Coptis chinensis, and achieve the effect of treating both the root cause and the symptoms. Radix Anisidi and Ilex asprella are used as the ministerial drugs: Radix Anisidi can astringe and promote tissue regeneration, and Ilex asprella can clear heat and resolve toxicity, relieve dampness and stop pain; the combination of the two drugs can enhance the heat-clearing and toxicity-resolving effect of the monarch drugs, and assist the monarch drugs in promoting tissue regeneration, astringing and promoting tissue regeneration, and achieve the effect of the ministerial drugs.

[0021] Radix Sanguisorbae and Dragon's Blood are used as the auxiliary drugs: Radix Sanguisorbae can clear heat and cool blood, and also can stop bleeding and activate blood; Dragon's Blood can eliminate stasis and stop bleeding, and is good at promoting tissue regeneration and astringing; the combination of the two drugs can activate blood and eliminate stasis, dredge blood vessels, make the gas and blood of the sore reach and be nourished adequately, assist the monarch and ministerial drugs in promoting tissue regeneration and astringing, and conform to the academic concept of "eliminating stasis and resolving dampness" of Deng's dampness school, so they are also auxiliary drugs.

[0022] The present application also provides a preparation method of the above-mentioned composition, which comprises the following steps: mixing Coptis chinensis with water, decocting and extracting, taking the medicinal liquid to concentrate to obtain Coptis chinensis thick paste; mixing Radix Anisidi, Ilex asprella and Radix Sanguisorbae to obtain a mixture, mixing the mixture with water, decocting and extracting, taking the medicinal liquid to concentrate to obtain a mixture thick paste; crushing Dragon's Blood into fine powder; dividing brown sugar into two parts, mixing one part with the Coptis chinensis thick paste to obtain thick paste one, and mixing the other part with the mixture thick paste to obtain thick paste two; heating the soft ointment preparation aid, adding the fine powder, and then adding thick paste one and thick paste two respectively to mix, to obtain the soft ointment.

[0023] In the present application, the soaking time is preferably 0.5-1.5 h, more preferably 0.8-1.2 h, and the weight of water is preferably 12-16 times the weight of Coptis chinensis, more preferably 13-15 times the weight of Coptis chinensis; when preparing Coptis chinensis thick paste, the number of decocting and extracting is preferably 1-3 times, more preferably 2 times, and the weight of water is preferably 10-14 times the weight of Coptis chinensis, more preferably 11-13 times the weight of Coptis chinensis; and the time of each decocting and extracting is preferably 1-2 h.

[0024] In the present application, the number of times of decocting extraction for preparing the mixture thick paste is preferably 1-3, more preferably 2; the weight of water added for the first time is preferably 12-16 times the weight of the mixture, more preferably 13-15 times the weight of the mixture; the time of the first decocting extraction is preferably 1.5-2.5 h, more preferably 1.8-2.2 h; the weight of water added for the second or third time is preferably 10-14 times the weight of the mixture, more preferably 11-13 times the weight of the mixture; the time of the second or third decocting extraction is preferably 1-2 h, more preferably 1.2-1.8 h.

[0025] The present application is not particularly limited in the specific way of concentration, and a conventional concentration method in the art can be used. In the present application, the relative density of the Coptis thick paste under the condition of 60-65℃ is preferably 1.20-1.30; the relative density of the mixture thick paste under the condition of 60-65℃ is preferably 1.20-1.30.

[0026] The present application is not particularly limited in the specific way of crushing of dragon's blood, and a conventional crushing method in the art can be used. In the present application, the crushed product is preferably sieved, and the mesh number of the sieving is preferably 100-120.

[0027] In the present application, the brown sugar is preferably divided into two parts according to weight, one part is 17-20% of the total weight of the brown sugar, and the other part is the remaining amount of the brown sugar, wherein the weight of the brown sugar mixed with the Coptis thick paste is 17-20% of the total weight of the brown sugar, and the brown sugar mixed with the mixture thick paste is the remaining amount of the brown sugar.

[0028] In the present application, the weight ratio of the total weight of the thick paste one and the thick paste two to the weight of the ointment-making medicinal adjuvant is preferably 100:80-100, more preferably 100:85-95; the ointment-making medicinal adjuvant preferably comprises polyethylene glycol 4000 and glycerol, and the weight-volume ratio of the polyethylene glycol 4000 and the glycerol is preferably 6 g:1 mL; the heating method is preferably water bath heating, and the heating temperature is preferably 65-70℃. The present application is not particularly limited in the order of adding the thick paste one and the thick paste two, and the thick paste one can be added first, or the thick paste two can be added first.

[0029] The composition ointment provided by the application contains brown sugar, Coptis chinensis, Radix Ampelopsis, Rhizoma Polygoni Cuspidati, Sanguis Draconis and polyethylene glycol as a base, is an innovative design based on traditional Chinese medicine compatibility essence and combined with the clinical needs of modern chronic wound treatment. The composition ointment provided by the application has the dual effects of clearing heat and removing dampness (Coptis chinensis, Rhizoma Polygoni Cuspidati and Sanguis Draconis) and promoting blood circulation and generating muscle (brown sugar, Sanguis Draconis and Radix Ampelopsis). Meanwhile, polyethylene glycol is used as a base and modern production technology (melt method) is used for production. The ointment provided by the application maintains the advantages of multi-target and overall regulation of traditional Chinese medicine, overcomes some inherent limitations of traditional Chinese medicine preparations by simplifying the formula and clearly defining the indications, and provides a safer and more effective treatment option with controllable quality for patients with chronic refractory wounds.

[0030] The application also provides application of the composition or the preparation method in preparation of a chronic wound treatment product or in preparation of a product for inhibiting pathogenic bacteria.

[0031] In the application, the chronic wound preferably includes pressure ulcers, diabetic foot ulcers, varicose ulcers, postoperative wound non-healing and / or infected wounds; and the pathogenic bacteria preferably include Staphylococcus aureus, Pseudomonas aeruginosa and / or Streptococcus pyogenes. In the application, the product preferably includes a drug.

[0032] The technical solutions provided by the application are described in detail below in combination with examples, but they should not be understood as limitations to the protection scope of the application.

[0033] In the following examples, all are conventional methods unless otherwise specified.

[0034] In the following examples, the materials and reagents used are commercially available unless otherwise specified.

[0035] Example 1 A composition for treating chronic wounds is prepared from the following raw materials: 10g of brown sugar, 10g of Coptis chinensis, 10g of Radix Ampelopsis, 15g of Rhizoma Polygoni Cuspidati, 12g of Sanguis Draconis and 1g of Radix Ampelopsis.

[0036] The preparation method is as follows: Coptis chinensis is mixed with water 14 times the weight of Coptis chinensis, soaked for 1h, decocted and extracted for 1h, filtered, and the medicinal liquid and dregs are separated; water 12 times the weight of Coptis chinensis is added to the dregs, decocted and extracted for 1h, filtered, and the medicinal liquid and dregs are separated; the medicinal liquids obtained in the two times are combined and concentrated to a relative density of 1.25 (measured at 60℃) to obtain Coptis chinensis thick paste; Mixing white yam, radix mori and hawthorn to get a mixture, mixing the mixture with water whose weight is 14 times of the mixture, decocting and extracting for 2 hours, filtering, separating the medicinal liquid and the residue; adding water whose weight is 12 times of the mixture to the residue, decocting and extracting for 1 hour, filtering, separating the medicinal liquid and the residue; combining the medicinal liquids obtained in the two times, concentrating to get a mixture thick paste with a relative density of 1.25 (measured at 60℃); Grinding dragon's blood, passing through a 100-mesh sieve to get fine powder; Dividing brown sugar into two parts, one part of brown sugar whose weight is 20% of the total weight of brown sugar, and the other part of brown sugar whose weight is 80% of the total weight of brown sugar, mixing the part of brown sugar whose weight is 20% of the total weight of brown sugar with the thick paste of Coptis to get thick paste one, and mixing the other part with the mixture thick paste to get thick paste two; Heating the soft paste medicinal adjuvant whose weight is 90% of the total weight of thick paste one and thick paste two at 65℃ in a water bath, stirring uniformly, the soft paste medicinal adjuvant is composed of polyethylene glycol 4000 and glycerol, the weight-volume ratio of polyethylene glycol 4000 and glycerol is 6g:1mL; then adding fine powder and stirring uniformly until no particles, mixing thick paste two uniformly, finally adding thick paste one and mixing uniformly until no particles, to get ointment.

[0037] Example 2 A composition for treating chronic wounds, made of the following raw materials: brown sugar 8g, Coptis 8g, white yam 8g, radix mori 12g, hawthorn 10g, dragon's blood 0.5g.

[0038] The preparation method is as follows: Mixing Coptis with water whose weight is 12 times of Coptis, soaking for 0.5h, decocting and extracting for 1.5h, filtering, separating the medicinal liquid and the residue; adding water whose weight is 10 times of Coptis to the residue, decocting and extracting for 1.5h, filtering, separating the medicinal liquid and the residue; combining the medicinal liquids obtained in the two times, concentrating to get Coptis thick paste with a relative density of 1.30 (measured at 65℃); Mixing white yam, radix mori and hawthorn to get a mixture, mixing the mixture with water whose weight is 12 times of the mixture, decocting and extracting for 1.5h, filtering, separating the medicinal liquid and the residue; adding water whose weight is 10 times of the mixture to the residue, decocting and extracting for 1.5h, filtering, separating the medicinal liquid and the residue; combining the medicinal liquids obtained in the two times, concentrating to get a mixture thick paste with a relative density of 1.30 (measured at 65℃); Grinding dragon's blood, passing through a 120-mesh sieve to get fine powder; Dividing brown sugar into two parts, one part of brown sugar whose weight is 17% of the total weight of brown sugar, and the other part of brown sugar whose weight is 83% of the total weight of brown sugar, mixing the part of brown sugar whose weight is 17% of the total weight of brown sugar with the thick paste of Coptis to get thick paste one, and mixing the other part with the mixture thick paste to get thick paste two; The ointment-making auxiliary material is heated in a 70℃ water bath, and stirred uniformly, the ointment-making auxiliary material is composed of polyethylene glycol 4000 and glycerol, the weight-volume ratio of polyethylene glycol 4000 and glycerol is 6g:1mL; then the fine powder is added and stirred uniformly until no particles are left, thick paste one is added and stirred uniformly, finally thick paste two is added and stirred uniformly until no particles are left, to obtain the ointment.

[0039] Example 3 A composition for treating chronic wounds is prepared from the following raw materials: brown sugar 12g, Coptis 12g, Radix Ampelopsis 12g, Rhizoma Polygoni 18g, Radix Sanguisorba 12g, Dragon's Blood 1.5g.

[0040] The preparation method is as follows: Coptis is mixed with water 16 times the weight of Coptis, soaked for 1.5h, decocted and extracted for 2h, filtered, and the medicinal liquid and residue are separated; water 14 times the weight of Coptis is added to the residue, decocted and extracted for 2h, filtered, and the medicinal liquid and residue are separated; the medicinal liquids obtained in the two times are combined, and concentrated to a relative density of 1.20 (measured at 65℃) to obtain Coptis thick paste; Radix Ampelopsis, Rhizoma Polygoni and Rhizoma Polygoni are mixed to obtain a mixture, the mixture is mixed with water 16 times the weight of the mixture, decocted and extracted for 2.5h, filtered, and the medicinal liquid and residue are separated; water 14 times the weight of the mixture is added to the residue, decocted and extracted for 2h, filtered, and the medicinal liquid and residue are separated; the medicinal liquids obtained in the two times are combined, and concentrated to a relative density of 1.20 (measured at 65℃) to obtain the mixture thick paste; Dragon's Blood is crushed and passed through a 120 mesh sieve to obtain fine powder; The brown sugar is divided into two parts, one part of brown sugar is 18% of the total weight of brown sugar, and the other part of brown sugar is 82% of the total weight of brown sugar, the part of brown sugar which is 18% of the total weight of brown sugar is mixed with Coptis thick paste to obtain thick paste one, and the other part is mixed with the mixture thick paste to obtain thick paste two; The ointment-making auxiliary material is heated in a 70℃ water bath, and stirred uniformly, the ointment-making auxiliary material is composed of polyethylene glycol 4000 and glycerol, the weight-volume ratio of polyethylene glycol 4000 and glycerol is 6g:1mL; then the fine powder is added and stirred uniformly until no particles are left, thick paste one is added and stirred uniformly, finally thick paste two is added and stirred uniformly until no particles are left, to obtain the ointment.

[0041] Example 4 The extraction process (soaking time, extraction time, water addition multiple, decoction times) of Coptis and three medicinal herbs (Radix Ampelopsis, Rhizoma Polygoni and Rhizoma Polygoni) is investigated respectively, and the content of index components and the medicinal herb dry paste rate are evaluated.

[0042] 1. Soaking time investigation (1) Huanglian soaking time investigation: 10 portions of Huanglian, each 10 g, were soaked for 0, 0.5, 1.0, 1.5, and 2.0 h, respectively, each level was tested twice, the first time the amount of water added was 12 times the weight of Huanglian, and the second time the amount of water added was 10 times the weight of Huanglian, each time the heating extraction time was 1.0 h, the medicinal liquid obtained by combining the two extractions was measured for volume, and the contents of berberine hydrochloride, epiberberine, coptisine, and palmatine under each condition were determined, and the dry extract rate of Huanglian under each condition was calculated: dry extract rate = dry extract weight x extraction liquid volume / (medicinal material weight x sample volume), and the results are shown in Table 1.

[0043] Table 1 Huanglian soaking time investigation results (n = 2)

[0044] As shown in Table 1, the change in soaking time has a great influence on the contents of the four indicators and the dry extract rate of Huanglian, the total amount is the largest when the soaking time is 0.5 h, and the dry extract rate increases with the increase of the soaking time.

[0045] (2) Three medicinal materials soaking time investigation: 10 portions of the mixture of Baiyan, Jiubiyang, and Diyi were taken, each portion consisting of 10 g of Baiyan, 12 g of Diyu, and 15 g of Jiubiyang, and were soaked for 0, 0.5, 1.0, 1.5, and 2.0 h, respectively, each level was tested twice, the first time the amount of water added was 12 times the weight of the mixture, and the second time the amount of water added was 10 times the weight of the mixture, each time the heating extraction time was 1.0 h, the medicinal liquid obtained by combining the two extractions was measured for volume, and the content of gallic acid under each condition was determined, and the dry extract rate of the three medicinal materials under each condition was calculated: dry extract rate = dry extract weight x extraction liquid volume / (medicinal material weight x sample volume), and the results are shown in Table 2.

[0046] Table 2 Three medicinal materials soaking time investigation results (n = 2)

[0047] As shown in Table 2, the change in soaking time has a great influence on the content of gallic acid and the dry extract rate of the three medicinal materials, the content is the largest when the soaking time is 0.5 h, and the content has a decreasing trend after 0.5 h, while the dry extract rate is the largest when the soaking time is 0 h, and the dry extract rate changes little with the increase of the amount of water added, so the technical scheme of soaking for 0 h is finally selected.

[0048] 2. Water addition multiple investigation (1) Huanglian water multiple investigation: 10 portions of Huanglian, each 10 g, were taken, and 8+6 (the first time was 8 times the weight of Huanglian, and the second time was 6 times the weight of Huanglian), 10+8 (the first time was 10 times the weight of Huanglian, and the second time was 8 times the weight of Huanglian), 12+10 (the first time was 12 times the weight of Huanglian, and the second time was 10 times the weight of Huanglian), 14+12 (the first time was 14 times the weight of Huanglian, and the second time was 12 times the weight of Huanglian), and 16+14 (the first time was 16 times the weight of Huanglian, and the second time was 14 times the weight of Huanglian) amounts of water were added, each level was carried out twice, and the soaking time was 0 h. The heating and decocting time was 1.0 h each time. The obtained medicinal liquid was combined, the filtrate volume was measured, the contents of berberine hydrochloride, epiberberine, coptisine, and palmatine under each condition were determined, and the dry extract rate of Huanglian under each condition was calculated: dry extract rate = dry extract weight x extract liquid volume / (medicinal material weight x sample volume). The results are shown in Table 3.

[0049] Table 3 Huanglian water multiple investigation results (n=2)

[0050] As shown in Table 3, the change of water amount has a great influence on the four index contents and the dry extract rate of Huanglian. With the increase of water amount, the contents and the dry extract rate also increase.

[0051] (2) Three medicinal herbs water multiple investigation: 10 portions of the mixture of Baijian, Jiubiyang, and Diyi were taken, each portion consisting of 10 g of Baijian, 12 g of Diyi, and 15 g of Jiubiyang, and 8+6, 10+8, 12+10, 14+12, and 16+14 amounts of water were added, each level was carried out twice, and the soaking time was 0 h. The heating and decocting time was 1.0 h each time. The obtained medicinal liquid was combined, the medicinal liquid volume was measured, the content of gallic acid under each condition was determined, and the dry extract rate of the three medicinal herbs under each condition was calculated: dry extract rate = dry extract weight x extract liquid volume / (medicinal material weight x sample volume). The results are shown in Table 4.

[0052] Table 4 Three medicinal herbs water multiple investigation results (n=2)

[0053] As shown in Table 4, the change of water amount has a great influence on the content of gallic acid and the dry extract rate of the three medicinal herbs. With the increase of water multiple, the content of gallic acid and the dry extract rate also increase, and the content and the dry extract rate reach the maximum at the water multiple of 14+12.

[0054] 3. Decoction times investigation (1) The decoction times of Coptidis Rhizoma were investigated. Two samples of Coptidis Rhizoma were taken, each of 10 g, soaked for 0 h, decocted for three times, 12 times the amount of water was added in the first time, 10 times the amount of water was added in the second time, and 10 times the amount of water was added in the third time. The heating decoction time was 1.0 h each time. The extract was filtered each time. The liquid obtained by combining the three decoctions was measured in volume. The contents of berberine hydrochloride, epiberberine, coptisine and palmatine under each condition were determined. The dry extract rate of Coptidis Rhizoma under each condition was calculated: dry extract rate = dry extract weight x extract volume / (sample weight x sample volume). The results are shown in Table 5.

[0055] Table 5 Investigation results of decoction times of Coptidis Rhizoma (n = 2)

[0056] As shown in Table 5, the decoction times have a great influence on the four index contents and the dry extract rate of Coptidis Rhizoma. The contents and dry extract rate of the first and second extractions account for more than 90% of the total amount of the three extractions. Considering the actual production, the decoction is selected for two times.

[0057] (2) The decoction times of the mixture of three herbs were investigated. Two samples of the mixture of three herbs were taken, each of which was composed of 10 g of Radix Ampelopsis, 12 g of Radix Astragali and 15 g of Radix Angelicae Dahuricae. The mixture was soaked for 0 h, decocted for three times, 12 times the amount of water was added in the first time, 10 times the amount of water was added in the second time, and 10 times the amount of water was added in the third time. The heating decoction time was 1.0 h each time. The extract was filtered each time. The liquid obtained by combining the three decoctions was measured in volume. The content of gallic acid under each condition was determined. The dry extract rate of the mixture of three herbs under each condition was calculated: dry extract rate = dry extract weight x extract volume / (sample weight x sample volume). The results are shown in Table 6.

[0058] Table 6 Investigation results of decoction times of the mixture of three herbs (n = 2)

[0059] As shown in Table 6, the decoction times have a great influence on the four index contents and the dry extract rate of the mixture of three herbs. The contents and dry extract rate of the first and second extractions account for more than 80% of the total amount of the three extractions. Considering the actual production, the decoction is selected for two times.

[0060] 4. Decoction time investigation (1) Huanglian decoction time investigation: 8 portions of Huanglian, each 10 g, were taken, soaked for 0 h, the first water added was 12 times the weight of Huanglian, the second water added was 10 times the weight of Huanglian, the two heating decoction times were the same, each heating decoction time was 0.5, 1.0, 1.5, 2.0 h, heating decoction was twice, the two extraction liquids were filtered and combined, the filtrate volume was measured, the contents of berberine hydrochloride, epiberberine, coptisine and palmatine under each condition were determined, and the dry extract rate of Huanglian under each condition was calculated: dry extract rate = dry extract weight x extraction liquid volume / (medicinal material weight x sample volume), the results are shown in Table 7.

[0061] Table 7 Huanglian decoction time investigation results (n = 2)

[0062] From Table 7, it can be seen that the increase of decoction time has a great influence on the contents of the four indicators and the dry extract rate of Huanglian, the total amount decreases after the decoction time reaches 1.5 h, and the dry extract rate grows slowly after the decoction time reaches 1.5 h.

[0063] (2) Three medicine decoction time investigation: 12 portions of Baiyan, Jiubiyang and Diyu mixture were taken, each portion consisting of Baiyan 10 g, Diyu 12 g and Jiubiyang 15 g, soaked for 0 h, added 12+10 times water, each decoction time was 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 h, heating decoction was twice, each decoction time was the same, the two extraction liquids were filtered and combined, the filtrate volume was measured, the content of gallic acid under each condition was determined, and the dry extract rate of the three medicines under each condition was calculated: dry extract rate = dry extract weight x extraction liquid volume / (medicinal material weight x sample volume), the results are shown in Table 8.

[0064] Table 8 Three medicine decoction time investigation results (n = 2)

[0065] From Table 8, it can be seen that the increase of decoction time has a great influence on the contents of gallic acid and the dry extract rate of the three medicines, the content and dry extract rate grow slowly after the decoction time reaches 2 h.

[0066] Example 5 Example 1 The composition (red sugar Yuyang paste) obtained was subjected to in vitro antibacterial test on common surgical pathogenic bacteria Experimental Method: Brown sugar wound healing ointment was diluted with physiological saline at ratios of 1:2, 1:4, 1:8, 1:16…1:1024 to prepare different concentrations of the drug solution. Double-strength culture medium was then added to the drug solution at a 1:1 ratio and mixed thoroughly. The solutions were then poured onto plates for use. After 12 hours of incubation, a loopful (approximately 0.05 mL) of bacterial culture from a 24-hour enrichment cycle was streaked onto the plates using an inoculation stick. The plates were incubated at 37°C for 24 hours, and bacterial growth was observed. The highest drug dilution at which no bacterial growth occurred was defined as the minimum inhibitory concentration (MIC) of the drug. The MIC was calculated using a regression equation based on the MICs of different culture dishes for each bacterial species. 50 MIC 90 .

[0067] The results are shown in Table 9. The MICs of brown sugar wound healing ointment against Staphylococcus aureus, Pseudomonas aeruginosa, and Streptococcus were also discussed. 50 The concentrations were 8.7, 9.5, and 18.3 mg / mL, respectively. This indicates that the brown sugar wound healing ointment of the present invention has a good antibacterial effect against common surgical pathogens.

[0068] Table 9. Inhibitory effect of brown sugar wound healing ointment on common surgical pathogens (10 culture dishes for each bacterial species).

[0069] Example 6 Effect of the composition obtained in Example 1 (brown sugar wound healing ointment) on wound healing in rats Experimental Methods: Several rats, half male and half female, were acclimatized for 5 days. Hair was removed from the right side of the back, and skin defect surgery was performed under anesthesia. After surgery, hemostasis and disinfection were carried out. Five hours later, the diameter of the defect was measured with calipers. The rats were randomly divided into 5 groups according to the severity of the wound (wound diameter): normal control group, positive drug group (Centella asiatica ointment, 0.02 g / kg), and large (2.14 g / kg), medium (1.07 g / kg), and small (0.53 g / kg) dose groups of brown sugar healing ointment. Each group consisted of 10 rats. The corresponding drug was applied to the wound and surrounding area of ​​each group, and the wound was bandaged. The treatment was carried out once a day. The wound diameter was measured and the wound healing time was recorded on the 4th and 11th days after drug administration. The mean and variance were calculated and compared with the normal control group. The significance of the differences between the groups was tested by t-test.

[0070] The results are shown in Table 10. The normal control group of rats had slower wound healing and longer healing time; the Hongtang Yuyang Ointment at the dosages of 0.53, 1.07 and 2.14 g / kg applied to the wound and the surrounding skin of the rats can promote wound healing and shorten the wound healing time. Compared with the normal control group, the wound diameters of the 0.53, 1.07 and 2.14 g / kg dosage groups on the 4th and 11th days after administration had significant differences (p<0.05 or p<0.01), and the wound healing time of the 1.07 and 2.14 g / kg dosage groups had significant differences (p<0.05). The results show that the Hongtang Yuyang Ointment has the effect of promoting wound healing.

[0071] Table 10 Effect of Hongtang Yuyang Ointment on wound healing of rats

[0072] Note: Compared with the normal control group, p<0.05; p<0.01.

[0073] The above only describes the preferred embodiments of the present application, and it should be noted that for those skilled in the art, without departing from the principles of the present application, a number of improvements and refinements can be made, and these improvements and refinements should also be considered as the protection scope of the present application.

Claims

1. A composition for the treatment of chronic wounds, characterized in that, The composition comprises the following raw materials by weight: brown sugar 8-12 parts, Coptis 8-12 parts, Cortex phellodendri 8-12 parts, Lonicera 12-18 parts, Radix harmi 10-12 parts, and dragon's blood 0.5-1.5 parts.

2. A process for the preparation of the composition of claim 1, characterized in that, The method comprises the following steps: mixing Coptis with water to soak, decocting and extracting, taking the liquid to concentrate to obtain Coptis thick paste; mixing Cortex phellodendri, Lonicera and Radix harmi to obtain a mixture, mixing the mixture with water, decocting and extracting, taking the liquid to concentrate to obtain mixture thick paste; crushing dragon's blood to obtain fine powder; dividing brown sugar into two parts, one part is mixed with Coptis thick paste to obtain thick paste one, and the other part is mixed with mixture thick paste to obtain thick paste two; heating soft paste pharmaceutical excipients, adding fine powder, and then adding thick paste one and thick paste two respectively to obtain soft paste.

3. The production method according to claim 2, characterized by, The soaking time is 0.5-1.5 h, and the weight of water is 12-16 times the weight of Coptis during soaking; when preparing Coptis thick paste, the decocting and extracting is performed 1-3 times, the weight of water is 10-14 times the weight of Coptis during the second or third decocting and extracting, and the decocting and extracting time is 1-2 h each time.

4. The production method according to claim 2, characterized by, When preparing mixture thick paste, the decocting and extracting is performed 1-3 times; the weight of water is 12-16 times the weight of the mixture during the first decocting and extracting, and the first decocting and extracting time is 1.5-2.5 h; the weight of water is 10-14 times the weight of the mixture during the second or third decocting and extracting, and the second or third decocting and extracting time is 1-2 h.

5. The preparation method according to claim 2, characterized in that, The relative density of Coptis thick paste under the condition of 60-65℃ is 1.20-1.30, and the relative density of mixture thick paste under the condition of 60-65℃ is 1.20-1.

30.

6. The preparation method according to claim 2, characterized in that, The fine powder is a fine powder after being sieved through a 100-120 mesh sieve.

7. The preparation method according to claim 2, characterized in that, The weight of brown sugar mixed with Coptis thick paste is 17%-20% of the total weight of brown sugar, and the weight of brown sugar mixed with mixture thick paste is 80%-83% of the total weight of brown sugar.

8. The preparation method according to claim 2, characterized in that, The weight ratio of the total weight of thick paste one and thick paste two to the weight of soft paste pharmaceutical excipients is 100:80-100; the soft paste pharmaceutical excipients comprise polyethylene glycol 4000 and glycerol, and the weight-volume ratio of polyethylene glycol 4000 to glycerol is 6g:1mL; the heating temperature is 65-70℃.

9. Use of the composition of claim 1 or the preparation method of any one of claims 2-8 in the preparation of a chronic wound treatment product or in the preparation of a product for inhibiting pathogenic bacteria.

10. Use according to claim 9, characterized in that, The chronic wound comprises pressure sores, diabetic foot ulcers, varicose ulcers, postoperative wound non-healing and / or infected wounds; and the pathogenic bacteria comprise Staphylococcus aureus, Pseudomonas aeruginosa and / or Streptococcus pyogenes.

9. Use of the composition of claim 1 or the preparation method of any one of claims 2-8 in the preparation of a chronic wound treatment product or in the preparation of a product for inhibiting pathogenic bacteria. The chronic wound comprises pressure sores, diabetic foot ulcers, varicose ulcers, postoperative wound non-healing and / or infected wounds; and the pathogenic bacteria comprise Staphylococcus aureus, Pseudomonas aeruginosa and / or Streptococcus pyogenes.

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