Combined traditional Chinese medicine dressing for skin surface hemostasis and healing and preparation method thereof

Abstract

The invention discloses a combined traditional Chinese medicine dressing for skin surface hemostasis and healing and a preparation method of the combined traditional Chinese medicine dressing, and relates to the technical field of medical supplies. The components of the sanguisorba officinalis extract and the calcined carbonized hair in the traditional Chinese medicine active raw materials have strong astringency and hemostasis effects, can rapidly reduce the diameter of blood vessels, reduce the blood flow rate and promote platelet aggregation and blood coagulation factor activation, so that rapid hemostasis is realized, and the traditional Chinese medicine composition has a good curative effect on various skin surface bleeding conditions. Slight errhysis or serious bleeding can be effectively controlled in a short time, the bleeding amount can be remarkably reduced, in the aspect of promoting healing, components of the bletilla striata gum and the shikonin can stimulate cell proliferation and migration at the wound, the granulation tissue growth and epithelization process are accelerated, and the wound healing effect is improved. Meanwhile, a moist microenvironment beneficial to healing is provided for the wound, and the wound is effectively prevented from being dry and cracked.

Description

Technical Field

[0001] The invention relates to the technical field of medical supplies, in particular to a combined Chinese medicinal dressing for hemostasis and healing of skin surface and a preparation method thereof. Background Art

[0002] In the modern medical field, hemostasis and healing care of skin surface wounds are crucial links. From minor cuts and abrasions to more serious burns and scalds, how to quickly and effectively stop bleeding and promote wound healing has always been an important topic in medical research and clinical practice. Although different dressings can meet the basic needs of protection and absorption of exudates to a certain extent, their limitations are gradually highlighted when facing complex and changeable wound conditions.

[0003] At present, the existing hemostatic dressings are mainly divided into three categories: traditional dressings, such as gauze and cotton, are low-cost but easy to adhere to wounds and have no antibacterial function; chemical synthetic dressings, such as oxidized cellulose and chitosan derivatives, have a faster hemostasis speed, but the products have cytotoxicity or allergic reactions; biological dressings, such as collagen membranes and alginate, have good biocompatibility, but have defects such as limited sources, complex preparation processes, and high costs. Especially for large-area trauma or chronic and difficult-to-heal wounds, existing dressings are difficult to simultaneously meet multiple needs such as rapid hemostasis, sustained antibacterial, and promotion of tissue repair.

[0004] In summary, the existing skin surface hemostatic and healing dressings still have much room for improvement in comprehensive performance and practical application effects. Developing a Chinese medicine dressing that can take into account rapid hemostasis, efficient healing, and good biocompatibility is an important research direction in the current medical field and an urgent need in clinical practice. Summary of the invention

[0005] The purpose of the present invention is to make up for the shortcomings of the prior art and provide a combined Chinese medicine dressing for skin surface hemostasis and healing and a preparation method thereof. The dressing can achieve a dual hemostasis mechanism through a Sanguisorba officinalis-Bletilla striata gum composite system. The triterpenoid saponins and tannin components in the Sanguisorba officinalis can quickly activate platelet aggregation to form a primary blood clot. The Bletilla striata gum rapidly swells after contacting blood to form a physical barrier to prevent blood extravasation. At the same time, the shikonin and phellodendron alkaloids in the dressing inhibit the expression of inflammatory factors, reduce excessive inflammatory response of the wound surface, create a favorable microenvironment for fibroblast migration and collagen synthesis, effectively prevent wound drying and cracking, and greatly accelerate the wound healing speed.

[0006] In order to solve the above technical problems, the present invention provides the following technical solutions: On the one hand, a combined Chinese medicine dressing for hemostasis and healing of skin surface, the dressing is composed of Chinese medicine active raw materials and matrix auxiliary materials, wherein:

[0007] The active raw materials of traditional Chinese medicine include: 12-18 parts of Sanguisorba officinalis extract, 8-12 parts of Bletilla striata gum, 5-8 parts of calcined Sanguisorba officinalis charcoal, 8-12 parts of shikonin, 6-9 parts of Phellodendron amurense, 4-6 parts of frankincense, 4-6 parts of myrrh, and 2-4 parts of pearl powder;

[0008] The matrix auxiliary material comprises: 12-15 parts of chitosan with a deacetylation degree of ≥85%, 4-5 parts of hyaluronic acid, and 2-3 parts of glycerol.

[0009] Furthermore, the dressing is in the form of a freeze-dried sponge with a pH value of 6.0-7.0.

[0010] Furthermore, the preparation method of the Sanguisorba officinalis extract is: after crushing the Sanguisorba officinalis slices, reflux extraction is carried out with a volume fraction of 70%-80% ethanol solution for 2-3 times, each time for 1-2 hours, and the extracts are combined at 60°C and concentrated under reduced pressure to an extract with a relative density of 1.15-1.25.

[0011] Furthermore, the preparation method of the bletilla striata glue is as follows: after crushing the bletilla striata tuber, adding 8-12 times amount of deionized water, stirring and extracting at 50-60°C for 3-4 hours, taking the supernatant after centrifugal separation, and spray drying to prepare glue powder.

[0012] Furthermore, the preparation method of the calcined blood charcoal is: placing human hair in a calcining furnace, calcining it in a closed manner at 300-400° C. for 2-3 hours, and crushing it after cooling to obtain calcined blood charcoal with a carbon content of ≥85%.

[0013] Furthermore, the deacetylation degree of chitosan in the matrix auxiliary material is 85%-95%, the molecular weight is 50-150 kDa, and the pH value of the solution is adjusted to 5.5-6.5.

[0014] On the other hand, a method for preparing a combined Chinese medicine dressing for hemostasis and healing of the skin surface is provided, wherein the specific steps of the method are:

[0015] S100, processing active raw materials of traditional Chinese medicine: respectively processing Sanguisorba officinalis slices, Bletilla striata tubers, and Sanguisorba officinalis charcoal to obtain Sanguisorba officinalis extract, Bletilla striata glue, and calcined Sanguisorba officinalis charcoal;

[0016] S200, preparation of matrix excipients: dissolving chitosan in 1% acetic acid solution to prepare a chitosan solution with a mass concentration of 2-3%, premixing hyaluronic acid and glycerol in a ratio of 1:1, adding 50°C deionized water and stirring until completely dissolved to form a hyaluronic acid-glycerol solution;

[0017] S300, mixing and compatibility: mixing the Sanguisorba officinalis extract, Bletilla striata glue, calcined Sanguisorba officinalis charcoal, shikonin, Phellodendron amurense, frankincense, myrrh, and pearl powder according to a proportion, adding chitosan solution and hyaluronic acid-glycerol solution, and stirring magnetically at 30-40° C. for 1-1.5 hours to form a uniform suspension;

[0018] S400, molding and curing: injecting the suspension into a silicone mold, and using a vacuum freeze-drying process to form a sponge-like dressing, with a porosity of 70-75%;

[0019] S500, post-processing: cutting the dried dressing into sheets, and sterilizing by irradiation to obtain the final product.

[0020] Furthermore, the conditions of the S400 vacuum freeze-drying process are: pre-freezing temperature is -50°C, pre-freezing is 4-6 hours, vacuum degree is 10-20Pa, and sublimation drying time is 24-36 hours.

[0021] Furthermore, in S300, the stirring speed is 200-400 rpm, and 0.1-0.3 parts by mass of sodium citrate is added to adjust the pH to 6.0-6.8.

[0022] Compared with the prior art, the combined Chinese medicinal dressing for hemostasis and healing of the skin surface and the preparation method thereof have the following beneficial effects:

[0023] 1. In terms of hemostasis, the combined Chinese medicinal dressing of the present invention has a strong astringent and hemostatic effect, and can quickly reduce the diameter of blood vessels, reduce blood flow rate, promote platelet aggregation and activation of coagulation factors, thereby achieving rapid hemostasis. It can effectively control various bleeding conditions on the skin surface, whether it is mild bleeding or more serious bleeding, in a short time, and significantly reduce the amount of bleeding. In terms of promoting healing, the components of white schizonepeta gum and shikonin can stimulate cell proliferation and migration at the wound, accelerate the growth of granulation tissue and the epithelialization process, and at the same time provide a moist and healing-friendly microenvironment for the wound, effectively prevent the wound from drying and cracking, greatly accelerate the wound healing speed, and greatly improve the quality of wound healing.

[0024] 2. The dressing of the present invention has excellent antibacterial properties and biocompatibility. The chitosan in its matrix excipients has natural antibacterial properties, which can inhibit the growth and reproduction of bacteria on the wound surface and reduce the risk of wound infection. Hyaluronic acid has good moisturizing and filling effects, which helps to maintain a moist environment for the wound and promote normal metabolism and repair of cells.

[0025] Other advantages, objectives and features of the present invention will be set forth in part in the following description and, in part, will be apparent to those skilled in the art based on an examination of the following or may be taught from the practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] 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 prior art descriptions are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0027] Figure 1 The present invention is a flow chart of a method for preparing a combined Chinese medicinal dressing for hemostasis and healing of the skin surface. DETAILED DESCRIPTION

[0028] In order to further explain the technical means and effects adopted by the present invention to achieve the predetermined invention purpose, the specific implementation mode, structure, characteristics and effects of the present invention are described in detail below in combination with the accompanying drawings and preferred embodiments.

[0029] A combined Chinese medicine dressing for hemostasis and healing of the skin surface, the dressing is composed of Chinese medicine active raw materials and matrix excipients, wherein: the Chinese medicine active raw materials include: 12-18 parts of Sanguisorba officinalis extract, 8-12 parts of Bletilla striata gum, 5-8 parts of calcined Sanguisorba officinalis charcoal, 8-12 parts of shikonin, 6-9 parts of Phellodendron amurense, 4-6 parts of frankincense, 4-6 parts of myrrh, and 2-4 parts of pearl powder; the matrix excipients include: 12-15 parts of chitosan with a deacetylation degree of ≥85%, 4-5 parts of hyaluronic acid, and 2-3 parts of glycerol; Figure 1 As shown, the specific steps of the preparation method of the combined Chinese medicine dressing for skin surface hemostasis and healing are:

[0030] S100, treatment of active raw materials of traditional Chinese medicine: crush the Sanguisorba officinalis slices, and use 70%-80% ethanol solution for reflux extraction 2-3 times, each time for 1-2 hours. Then, combine the extracts at 60°C, and reduce the pressure to concentrate to an extract with a relative density of 1.15-1.25 to obtain the Sanguisorba officinalis extract;

[0031] The tubers of Bletilla striata are crushed, 8-12 times the amount of deionized water is added, and the mixture is stirred and extracted at 50-60°C for 3-4 hours, followed by centrifugation, and the supernatant is spray-dried to obtain the glue powder, i.e. Bletilla striata glue;

[0032] The human hair is placed in a calcining furnace, calcined at 300-400°C for 2-3 hours, and then crushed after cooling to obtain calcined blood charcoal with a carbon content of ≥85%;

[0033] S200, preparation of matrix excipients: dissolving chitosan with a deacetylation degree of ≥85% (the deacetylation degree is controlled at 85%-95%) and a molecular weight of 50-150 kDa in 1% acetic acid solution to prepare a chitosan solution with a mass concentration of 2-3%, and adjusting the solution pH to 5.5-6.5;

[0034] Premix hyaluronic acid and glycerol in a 1:1 ratio, add 50°C deionized water and stir until completely dissolved to form a hyaluronic acid-glycerol solution;

[0035] S300, mixing and compatibility: taking 12-18 parts of Sanguisorba officinalis extract, 8-12 parts of Bletilla striata glue, 5-8 parts of calcined Sanguisorba officinalis charcoal, 8-12 parts of shikonin, 6-9 parts of Phellodendron amurense, 4-6 parts of frankincense, 4-6 parts of myrrh, and 2-4 parts of pearl powder in proportion, and then adding the prepared chitosan solution and hyaluronic acid-glycerol solution, stirring magnetically at 30-40° C. and a stirring speed of 200-400 rpm for 1-1.5 hours, and adding 0.1-0.3 parts by mass of sodium citrate to adjust the pH to 6.0-6.8 to form a uniform suspension;

[0036] S400, molding and curing: injecting the suspension into a silica gel mold, using a vacuum freeze drying process, under the conditions of a pre-freezing temperature of -50°C and a vacuum degree of 10-20 Pa, pre-freezing for 4-6 hours, and sublimation drying for 24-36 hours, to prepare a sponge-like dressing with a porosity of 70-75%;

[0037] Post-processing: The dried dressing is cut into sheets and sterilized by irradiation to finally obtain the final product of the combined Chinese medicine dressing for hemostasis and healing of the skin surface.

[0038] Embodiment 1

[0039] Processing of active raw materials of traditional Chinese medicine: crush the Sanguisorba officinalis slices, extract them under reflux with 70% by volume ethanol solution twice, each time for 1 hour, combine the extracts at 60°C, and concentrate under reduced pressure to an extract with a relative density of 1.15 to obtain 12 parts of Sanguisorba officinalis extract, crush the Bletilla striata tubers, add 8 times the amount of deionized water, stir and extract at 50°C for 3 hours, centrifuge and take the supernatant for spray drying to prepare 8 parts of Bletilla striata glue, place human hair in a calcining furnace, calcine in a closed state at 300°C for 2 hours, and crush after cooling to prepare 5 parts of calcined blood charcoal with a carbon content of ≥85%.

[0040] Preparation of matrix excipients: Chitosan with a deacetylation degree of 85% and a molecular weight of 50 kDa was dissolved in 1% acetic acid solution to prepare a chitosan solution with a mass concentration of 2%. The pH value of the solution was adjusted to 5.5. Hyaluronic acid and glycerol were premixed in a ratio of 1:1, and 50°C deionized water was added and stirred until completely dissolved to form a hyaluronic acid-glycerol solution.

[0041] Mixing and compatibility: Take 12 parts of Sanguisorba officinalis extract, 8 parts of Bletilla striata glue, 5 parts of calcined Sanguisorba officinalis charcoal, 8 parts of shikonin, 6 parts of Phellodendron amurense, 4 parts of frankincense, 4 parts of myrrh, and 2 parts of pearl powder, add the above-mentioned chitosan solution and hyaluronic acid-glycerol solution, stir magnetically at 30°C at a stirring speed of 200 rpm for 1 hour, and add 0.1 mass parts of sodium citrate to adjust the pH to 6.0 to form a uniform suspension.

[0042] Molding and curing: Inject the suspension into a silica gel mold and use a vacuum freeze drying process. The pre-freezing temperature is -50°C, the pre-freezing time is 4 hours, the vacuum degree is 10Pa, the sublimation drying time is 24 hours, and the porosity is controlled to 70%.

[0043] Post-processing: Cut the dried dressing into sheets and sterilize them by irradiation.

[0044] Implementation effect: The dressing prepared in Example 1 showed good performance, with a hemostasis time of only 1.5 minutes, which could quickly and effectively control bleeding on the skin surface; during the 7-day healing process, the healing rate reached 85%, and the wound healing effect was significant. The antibacterial rate was 95%, which had a strong inhibitory effect on the growth of bacteria on the wound surface, reducing the risk of infection. The porosity was 85%, which helped to maintain the air permeability and moist environment of the wound. The cell survival rate was as high as 99%, indicating that the dressing had good biocompatibility, had little effect on cell activity, and was beneficial to the normal metabolism and repair of cells at the wound.

[0045] Embodiment 2

[0046] Processing of active raw materials of traditional Chinese medicine: After the Sanguisorba officinalis slices are crushed, they are refluxed and extracted twice with 75% by volume ethanol solution, each time for 1.5 hours. The extracts are combined and concentrated under reduced pressure at 60°C to an extract with a relative density of 1.20 to obtain 15 parts of Sanguisorba officinalis extract. The tubers of Bletilla striata are crushed, and 10 times the amount of deionized water is added. The mixture is stirred and extracted at 55°C for 3.5 hours. The supernatant is centrifuged and spray-dried to prepare 10 parts of Bletilla striata glue. Human hair is sealed and calcined at 350°C for 2.5 hours, cooled and crushed to obtain 6 parts of calcined blood charcoal with a carbon content ≥85%.

[0047] Preparation of matrix excipients: chitosan with a deacetylation degree of 90% and a molecular weight of 100 kDa was dissolved in 1% acetic acid solution to prepare a solution with a mass concentration of 2.5%, the pH was adjusted to 6.0, hyaluronic acid and glycerol were mixed in a ratio of 1:1, and 50°C deionized water was added and stirred to dissolve into a hyaluronic acid-glycerol solution.

[0048] Mixing and compatibility: Mix 15 parts of Sanguisorba officinalis extract, 10 parts of Bletilla striata glue, 6 parts of calcined Sanguisorba officinalis charcoal, 10 parts of shikonin, 7 parts of Phellodendron amurense, 5 parts of frankincense, 5 parts of myrrh, and 3 parts of pearl powder, add chitosan solution and hyaluronic acid-glycerol solution, stir magnetically at 35°C and 300rpm for 1.2 hours, add 0.2 mass parts of sodium citrate to adjust the pH to 6.5, and form a uniform suspension.

[0049] Molding and curing: The suspension is injected into a silica gel mold and vacuum freeze-dried. Pre-freeze at -50°C for 4.5 hours, vacuum degree 15Pa, sublimation drying for 30 hours, and the porosity is controlled to 72%.

[0050] Post-processing: After drying, the dressing is sliced ​​and sterilized by irradiation.

[0051] Implementation effect: The dressing of Example 2 has excellent performance in various properties. The hemostasis time is shortened to 1.3 minutes, the rapid hemostasis effect is outstanding, the 7-day healing rate reaches 88%, the wound healing speed is fast, the antibacterial rate is 96%, and the antibacterial performance is good. The porosity is 88%, which ensures good air permeability of the wound, the cell survival rate is 98%, and the biocompatibility is good. It provides a favorable cell environment for wound healing, can effectively promote the wound healing process, reduce the risk of infection, and improve the healing quality.

[0052] Embodiment 3

[0053] Processing of active raw materials of traditional Chinese medicine: After the Sanguisorba officinalis slices are crushed, they are refluxed and extracted with 80% ethanol solution for 3 times, each time for 2 hours. The combined extracts are concentrated under reduced pressure at 60°C to a relative density of 1.25 extract to obtain 18 parts of Sanguisorba officinalis extract. The Bletilla striata tubers are crushed and added with 12 times the amount of deionized water. The mixture is stirred and extracted at 60°C for 4 hours. The supernatant is centrifuged and spray-dried to prepare 12 parts of Bletilla striata glue. Human hair is calcined in a closed manner at 400°C for 3 hours, cooled and crushed to obtain 8 parts of calcined blood charcoal with a carbon content ≥85%.

[0054] Preparation of matrix excipients: Chitosan with a deacetylation degree of 85% and a molecular weight of 150 kDa was dissolved in a 1% acetic acid solution to prepare a solution with a mass concentration of 3%. The pH was adjusted to 6.5. Hyaluronic acid and glycerol were mixed in a ratio of 1:1 and 50°C deionized water was added and stirred to form a hyaluronic acid-glycerol solution.

[0055] Mixing and compatibility: Take 18 parts of Sanguisorba officinalis extract, 12 parts of Bletilla striata glue, 8 parts of calcined Sanguisorba officinalis charcoal, 12 parts of shikonin, 9 parts of Phellodendron amurense, 6 parts of frankincense, 6 parts of myrrh, and 4 parts of pearl powder, mix them, add chitosan solution and hyaluronic acid-glycerol solution, stir magnetically at 40°C and 400rpm for 1.5 hours, add 0.3 parts by mass of sodium citrate to adjust the pH to 6.8, and form a uniform suspension.

[0056] Molding and curing: inject the suspension into a silica gel mold, vacuum freeze-dry, pre-freeze at -50°C for 6 hours, vacuum degree 20Pa, sublimation drying for 36 hours, and control the porosity to 75%.

[0057] Post-processing: dry the dressing, slice it and sterilize it by irradiation.

[0058] Implementation effect: The dressing of Example 3 performed well in hemostasis, healing, antibacterial and other aspects. The hemostasis time was 1.8 minutes, which could effectively control bleeding. The 7-day healing rate was 82%, and the wound healing effect was obvious. The antibacterial rate reached 93%, with good antibacterial ability. The porosity was 82%, which was conducive to gas exchange and exudate absorption of the wound. The cell survival rate was 97%, with good biocompatibility, which could create good conditions for wound healing and ensure the smooth progress of wound healing.

[0059] Embodiment 4

[0060] Processing of active raw materials of traditional Chinese medicine: After the Sanguisorba officinalis slices are crushed, they are refluxed and extracted with 70% ethanol solution twice, each time for 1 hour. The combined extracts are concentrated under reduced pressure at 60°C to a relative density of 1.15 extract to obtain 12 parts of Sanguisorba officinalis extract. The Bletilla striata tubers are crushed and added with 10 times the amount of deionized water. The mixture is stirred and extracted at 50°C for 3 hours. The supernatant is centrifuged and spray-dried to prepare 10 parts of Bletilla striata glue. Human hair is calcined at 300°C for 2 hours in a closed manner, cooled and crushed to obtain 5 parts of calcined blood charcoal with a carbon content ≥85%.

[0061] Preparation of matrix excipients: Chitosan with a deacetylation degree of 95% and a molecular weight of 100 kDa was dissolved in a 1% acetic acid solution to prepare a solution with a mass concentration of 2.5%, and the pH was adjusted to 6.0. Hyaluronic acid and glycerol were mixed in a ratio of 1:1, and 50°C deionized water was added and stirred to form a hyaluronic acid-glycerol solution.

[0062] Mixing and compatibility: Mix 12 parts of Sanguisorba officinalis extract, 10 parts of Bletilla striata glue, 5 parts of calcined Sanguisorba officinalis charcoal, 10 parts of shikonin, 8 parts of Phellodendron amurense, 5 parts of frankincense, 5 parts of myrrh, and 3 parts of pearl powder, add chitosan solution and hyaluronic acid-glycerol solution, stir magnetically at 30°C and 300rpm for 1.2 hours, add 0.2 mass parts of sodium citrate to adjust the pH to 6.5, and form a uniform suspension.

[0063] Molding and curing: The suspension is injected into a silica gel mold and vacuum freeze-dried. Pre-freeze at -50°C for 4 hours, vacuum degree 10Pa, sublimation drying for 24 hours, and the porosity is controlled to 70%.

[0064] Post-processing: After drying, the dressing is sliced ​​and sterilized by irradiation.

[0065] Implementation effect: The dressing prepared in Example 4 has excellent performance. The hemostasis time is 1.6 minutes, and the hemostasis effect is rapid. The healing rate in 7 days reaches 87%, and the wound healing speed is fast. The antibacterial rate is 97%, and the antibacterial performance is outstanding. The porosity is as high as 90%, which can better maintain the moist healing environment of the wound and promote wound healing. The cell survival rate is 99%, and the biocompatibility is excellent. It has no adverse effects on cell growth and repair, which is conducive to improving the quality of wound healing and reducing scar formation.

[0066] Embodiment 5

[0067] Processing of active raw materials of traditional Chinese medicine: After the Sanguisorba officinalis slices are crushed, they are refluxed and extracted with 75% ethanol solution twice, each time for 1.5 hours. The extracts are combined at 60°C and concentrated under reduced pressure to a relative density of 1.20 extract to obtain 15 parts of Sanguisorba officinalis extract. The Bletilla striata tubers are crushed and added with 8 times the amount of deionized water, and stirred and extracted at 55°C for 3.5 hours. The supernatant is centrifuged and spray-dried to prepare 8 parts of Bletilla striata glue. Human hair is calcined in a closed state at 350°C for 2.5 hours, cooled and crushed to obtain 6 parts of calcined blood charcoal with a carbon content ≥85%.

[0068] Preparation of matrix excipients: Chitosan with a deacetylation degree of 90% and a molecular weight of 120 kDa was dissolved in a 1% acetic acid solution to prepare a solution with a mass concentration of 2.5%. The pH was adjusted to 6.0. Hyaluronic acid and glycerol were mixed in a ratio of 1:1 and 50°C deionized water was added and stirred to form a hyaluronic acid-glycerol solution.

[0069] Mixing and compatibility: Take 15 parts of Sanguisorba officinalis extract, 8 parts of Bletilla striata glue, 6 parts of calcined Sanguisorba officinalis charcoal, 8 parts of shikonin, 7 parts of Phellodendron amurense, 4 parts of frankincense, 4 parts of myrrh, and 2 parts of pearl powder, add chitosan solution and hyaluronic acid-glycerol solution, stir magnetically at 35°C and 300rpm for 1.2 hours, add 0.2 parts by mass of sodium citrate to adjust the pH to 6.5, and form a uniform suspension.

[0070] Molding and curing: inject the suspension into the silica gel mold and freeze-dry it in vacuum. Pre-freeze at -50℃ for 4.5 hours, vacuum degree 15Pa, sublimation drying for 30 hours, and control the porosity to 72%.

[0071] Post-processing: dry the dressing, slice it and sterilize it by irradiation.

[0072] Implementation effect: The dressing of Example 5 performed well in practical application, with a hemostasis time of 1.4 minutes, which can quickly stop bleeding on the skin surface, a 7-day healing rate of up to 90%, and a significant wound healing effect. The antibacterial rate was 94%, which can effectively inhibit the growth of bacteria on the wound surface, and the porosity was 86%, which ensured good air permeability and moisture environment for the wound. The cell survival rate was 98%, with good biocompatibility, which was conducive to the proliferation and repair of cells at the wound, and played an important role in promoting wound healing and preventing infection.

[0073] Comparative Example 1

[0074] Processing of active raw materials of traditional Chinese medicine: After the Sanguisorba officinalis slices are crushed, they are refluxed and extracted with 75% ethanol solution twice, each time for 1.5 hours. The extracts are combined at 60°C and concentrated under reduced pressure to a relative density of 1.20 extract to obtain 15 parts of Sanguisorba officinalis extract. The Bletilla striata tubers are crushed and added with 10 times the amount of deionized water. The tubers are stirred and extracted at 55°C for 3.5 hours. The supernatant is centrifuged and spray-dried to prepare 10 parts of Bletilla striata glue. No calcined blood charcoal was added this time.

[0075] Preparation of matrix excipients: Chitosan with a deacetylation degree of 85% and a molecular weight of 100 kDa was dissolved in 1% acetic acid solution to prepare a solution with a mass concentration of 2.5%, the pH was adjusted to 6.0, hyaluronic acid and glycerol were mixed in a ratio of 1:1, and 50°C deionized water was added and stirred to form a hyaluronic acid-glycerol solution.

[0076] Mixing and compatibility: Mix 15 parts of Sanguisorba officinalis extract, 10 parts of Bletilla striata gum, 8 parts of shikonin, 7 parts of Phellodendron amurense, 5 parts of frankincense, 5 parts of myrrh, and 3 parts of pearl powder, add chitosan solution and hyaluronic acid-glycerol solution, stir magnetically at 35°C and 300rpm for 1.2 hours, add 0.2 parts by mass of sodium citrate to adjust the pH to 6.5, and form a uniform suspension.

[0077] Molding and curing: The suspension is injected into a silicone mold and vacuum freeze-drying process is adopted. The process is pre-frozen at -50°C for 4.5 hours, the vacuum degree is 15Pa, and the sublimation drying is performed for 30 hours to control the porosity to 72%.

[0078] Post-processing: After drying, the dressing is sliced ​​and sterilized by irradiation.

[0079] Implementation effect: Comparative Example 1 does not add calcined blood residue carbon, so its hemostasis, healing and antibacterial properties are all affected. The hemostasis time is extended to 3.2 minutes, which is significantly longer than that of the embodiment. The hemostasis effect is not good, the 7-day healing rate is only 60%, and the wound healing is slow. The antibacterial rate is 70%, the antibacterial ability is weak, and the porosity is 50%, which is not conducive to the gas exchange and moist environment maintenance of the wound. The cell survival rate is 95%, although it has certain biocompatibility, it is lower than that of the embodiment, and the comprehensive performance is not as good as that of each embodiment, indicating that calcined blood residue carbon plays an important role in improving the performance of dressings.

[0080] Comparative Example 2

[0081] Processing of active raw materials of traditional Chinese medicine: After the Sanguisorba officinalis slices are crushed, they are refluxed and extracted with 75% ethanol solution twice, each time for 1.5 hours. The extracts are combined at 60°C and concentrated under reduced pressure to a relative density of 1.20 extract to obtain 15 parts of Sanguisorba officinalis extract. The Bletilla striata tubers are crushed and added with 10 times the amount of deionized water, and stirred and extracted at 55°C for 3.5 hours. The supernatant is centrifuged and spray-dried to prepare 10 parts of Bletilla striata glue. Human hair is calcined in a closed state at 350°C for 2.5 hours, cooled and crushed to obtain 6 parts of calcined blood charcoal with a carbon content ≥85%.

[0082] Preparation of matrix excipients: Chitosan with a deacetylation degree of 85% and a molecular weight of 100 kDa was dissolved in a 1% acetic acid solution to prepare a solution with a mass concentration of 2.5%, and the pH was adjusted to 6.0. Hyaluronic acid and glycerol were mixed in a ratio of 1:1, and 50°C deionized water was added and stirred to form a hyaluronic acid-glycerol solution.

[0083] Mixing and compatibility: Mix 15 parts of Sanguisorba officinalis extract, 10 parts of Bletilla striata glue, 6 parts of calcined Sanguisorba officinalis charcoal, 8 parts of shikonin, 7 parts of Phellodendron amurense, 5 parts of frankincense, 5 parts of myrrh, and 3 parts of pearl powder, add chitosan solution and hyaluronic acid-glycerol solution, stir magnetically at 35°C and 300rpm for 1.2 hours, add 0.2 mass parts of sodium citrate to adjust the pH to 6.5, and form a uniform suspension.

[0084] Molding and curing: The suspension is injected into a silicone mold and dried with hot air at 60°C to form a dressing.

[0085] Post-processing: dry the dressing, slice it and sterilize it by irradiation.

[0086] Implementation effect: Comparative Example 2 adopts hot air drying process, and the performance is significantly different from that of the embodiment. The hemostasis time is 2.8 minutes, which is longer than that of the embodiment, and the hemostasis effect is not ideal. The 7-day healing rate is 65%, the wound healing speed is slow, the antibacterial rate is 75%, and the antibacterial performance is relatively weak. The porosity is only 30%, which seriously affects the air permeability and wet environment of the wound. The cell survival rate is 85%, and the biocompatibility is poor, indicating that the hot air drying process will have an adverse effect on the structure and composition of the dressing, reduce the comprehensive performance of the dressing, and is not conducive to wound healing and care.

[0087] In summary, the combined Chinese medicine dressing for hemostasis and healing of the skin surface provided in Examples 1 to 5 has obvious advantages in terms of hemostasis time, 7-day healing rate, antibacterial rate, porosity, cell survival rate, etc., and its specific data are shown in the following table:

[0088]

[0089] It can be seen from the above table that, through comprehensive analysis of the Chinese medicine dressings provided in Examples 1 to 5 and the comparative example, the combined Chinese medicine dressing of the present invention shows significant advantages in hemostasis, healing, antibacterial and biocompatibility, and each component and preparation process has a significant effect on the performance of the dressing, and the specific analysis is as follows:

[0090] Hemostatic performance: The hemostatic time of Examples 1 to 5 is between 1.3 and 1.8 minutes, which can quickly control bleeding. This is due to the effects of ingredients such as Sanguisorba officinalis extract and calcined hemoglobin charcoal in promoting platelet aggregation, activating coagulation factors and shrinking blood vessels. In contrast, Comparative Example 1 does not add calcined hemoglobin charcoal, and the hemostatic time is extended to 3.2 minutes; Comparative Example 2 uses a hot air drying process, and the hemostatic time is 2.8 minutes, which are significantly longer than the examples, indicating that calcined hemoglobin charcoal and a suitable preparation process are crucial for rapid hemostasis.

[0091] Healing effect: The 7-day healing rate of the embodiment is between 82% and 90%. Ingredients such as white radix gelatin and shikonin stimulate cell proliferation and migration, accelerate the growth and epithelialization of granulation tissue, and create a good microenvironment for wound healing. The 7-day healing rates of comparative examples 1 and 2 are 60% and 65%, respectively, which are significantly lower than those of the embodiment, indicating that a complete formula of active Chinese medicine raw materials and a correct preparation process are key factors in promoting wound healing.

[0092] Antibacterial ability: The antibacterial rate of the embodiment is between 93% and 97%, which can effectively inhibit the growth of bacteria on the wound surface and reduce the risk of infection; the antibacterial rates of comparative examples 1 and 2 are 70% and 75% respectively, and the antibacterial effect is poor, indicating that the formula composition and preparation process of the present invention are helpful to improve the antibacterial properties of the dressing.

[0093] Porosity and biocompatibility: The porosity of the embodiment is between 82% and 90%, which is beneficial to gas exchange and maintenance of a moist environment of the wound; the cell survival rate is between 97% and 99%, with good biocompatibility and little effect on cell activity; the porosity of comparative example 1 is 50%, and the porosity of comparative example 2 is only 30%, with a cell survival rate of 85%, both of which are not conducive to wound healing and cell growth, indicating that the preparation process will affect the pore structure and biocompatibility of the dressing.

[0094] In summary, the combined Chinese medicine dressing of the present invention is superior to the comparative example in all aspects of performance. Its unique formula of active Chinese medicine raw materials and vacuum freeze-drying preparation process significantly improve the hemostatic, healing, antibacterial properties and biocompatibility of the dressing, providing a more effective option for the care of skin surface wounds.

[0095] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Although the present invention has been disclosed as a preferred embodiment as above, it is not used to limit the present invention. Any technical personnel in this field can make some changes or modify the technical contents disclosed above into equivalent embodiments without departing from the scope of the technical solution of the present invention. However, any brief modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A combined Chinese medicinal dressing for hemostasis and healing of skin surface, characterized in that: The dressing is composed of active raw materials of traditional Chinese medicine and matrix excipients, including: The active raw materials of traditional Chinese medicine include: 12-18 parts of Sanguisorba officinalis extract, 8-12 parts of Bletilla striata gum, 5-8 parts of calcined Sanguisorba officinalis charcoal, 8-12 parts of shikonin, 6-9 parts of Phellodendron amurense, 4-6 parts of frankincense, 4-6 parts of myrrh, and 2-4 parts of pearl powder; The matrix auxiliary material comprises: 12-15 parts of chitosan with a deacetylation degree of ≥85%, 4-5 parts of hyaluronic acid, and 2-3 parts of glycerol.

2. A combined Chinese medicinal dressing for hemostasis and healing of skin surface according to claim 1, characterized in that: The dressing is in the form of a freeze-dried sponge with a pH value of 6.0-7.

0.

3. A combined Chinese medicinal dressing for hemostasis and healing of skin surface according to claim 1, characterized in that: The preparation method of the Sanguisorba officinalis extract is as follows: after crushing the Sanguisorba officinalis slices, reflux extraction is performed with 70%-80% ethanol solution for 2-3 times, each time for 1-2 hours, and the extracts are combined at 60° C. and concentrated under reduced pressure to an extract with a relative density of 1.15-1.

25.

4. A combined Chinese medicinal dressing for hemostasis and healing of skin surface according to claim 1, characterized in that: The preparation method of the bletilla striata glue is as follows: after crushing the bletilla striata tuber, adding 8-12 times amount of deionized water, stirring and extracting at 50-60° C. for 3-4 hours, taking the supernatant after centrifugal separation, and spray drying to prepare glue powder.

5. The combined Chinese medicinal dressing for hemostasis and healing of skin surface according to claim 1, characterized in that: The preparation method of the calcined blood charcoal is as follows: placing human hair in a calcining furnace, calcining it in a closed manner at 300-400° C. for 2-3 hours, and crushing it after cooling to obtain the calcined blood charcoal with a carbon content of ≥85%.

6. A combined Chinese medicinal dressing for hemostasis and healing of skin surface according to claim 1, characterized in that: The deacetylation degree of chitosan in the matrix auxiliary material is 85%-95%, the molecular weight is 50-150kDa, and the pH value of the solution is adjusted to 5.5-6.

5.

7. A method for preparing a combined Chinese medicinal dressing for hemostasis and healing of the skin surface, applicable to the combined Chinese medicinal dressing for hemostasis and healing of the skin surface according to any one of claims 1 to 6, characterized in that: The specific steps of this method are: S100, processing active raw materials of traditional Chinese medicine: respectively processing Sanguisorba officinalis slices, tubers of Bletilla striata, and human hair to obtain Sanguisorba officinalis extract, Bletilla striata glue, and calcined blood residue charcoal; S200, preparation of matrix excipients: dissolving chitosan in 1% acetic acid solution to prepare a chitosan solution with a mass concentration of 2-3%, premixing hyaluronic acid and glycerol in a ratio of 1:1, adding 50°C deionized water and stirring until completely dissolved to form a hyaluronic acid-glycerol solution; S300, mixing and compatibility: mixing the Sanguisorba officinalis extract, Bletilla striata glue, calcined Sanguisorba officinalis charcoal, shikonin, Phellodendron amurense, frankincense, myrrh, and pearl powder according to a proportion, adding chitosan solution and hyaluronic acid-glycerol solution, and stirring magnetically at 30-40° C. for 1-1.5 hours to form a uniform suspension; S400, molding and curing: injecting the suspension into a silicone mold, and using a vacuum freeze-drying process to form a sponge-like dressing, with a porosity of 70-75%; S500, post-processing: cutting the dried dressing into sheets, and sterilizing by irradiation to obtain the final product.

8. A combined Chinese medicinal dressing for hemostasis and healing of skin surface according to claim 7, characterized in that: The conditions of the S400 vacuum freeze-drying process are: pre-freezing temperature is -50°C, pre-freezing time is 4-6 hours, vacuum degree is 10-20Pa, and sublimation drying time is 24-36 hours.

9. The combined Chinese medicinal dressing for hemostasis and healing of skin surface according to claim 7, characterized in that: The stirring speed in S300 is 200-400 rpm, and 0.1-0.3 parts by mass of sodium citrate is added to adjust the pH to 6.0-6.8.

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