External medicine for burns and scalds and preparation method thereof

Abstract

The present invention relates to the technical field of external medicines for burns, and specifically to an external medicine for burns and burns and a preparation method thereof. The present invention uses Lithospermum officinale, Ampelopsis radix and Phellodendron chinense, which have the effects of promoting the healing of burns and burns, to prepare plant extracts, and adopts a composite bacteria fermentation method to enhance the efficacy of the extracts, while optimizing the collocation and ratio of the bacteria, and optimizing the process conditions so that the medicine can better promote the healing of burns; then ethanol is used for extraction and the concentration of ethanol in the extract is adjusted, and the active ingredients are enriched and purified, thereby further improving the efficacy of the extracts. Then the prepared extract is combined with clam shell powder and sesame oil to prepare an external medicine for burns and burns. The medicine of the present invention has a good effect on treating burns and burns, and is derived from plant components, does not use components such as organic solvents, has low side effects, and has little harm to the human body when used for a long time.

Description

Technical Field

[0001] The invention relates to the technical field of external medicines for burns, and in particular to an external medicine for burns and scalds and a preparation method thereof. Background Art

[0002] Burns are a type of skin injury caused by external factors, generally referring to the damage caused by hot water, soup, oil, or some high-temperature steam, flames, and high-temperature molten liquid metals that come into contact with the skin tissue, causing damage to the skin mucosa and even the deep muscle tissue. Severe thermal burns may damage the function of human bones and joints, cause systemic poisoning, and a large amount of body fluid loss will cause water and electrolyte imbalance in the body.

[0003] At present, the common treatment drugs for burns and scalds on the market are still mainly Western medicines such as "antibiotics" and "sulfonamides", which have potential adverse reactions or side effects, especially when they are used for a long time. Although traditional Chinese medicine for the treatment of burns and scalds is widely used in my country, there is still much room for improvement in its efficacy, process quality control and side effect monitoring.

[0004] Therefore, providing an external-use medicine for burns and scalds with small side effects and excellent efficacy is a technical problem that needs to be solved at present. Summary of the invention

[0005] In view of the above technical problems, the inventors have proposed the technical solution of the present invention, which includes an external medicine for burns and scalds and a preparation method thereof.

[0006] On the one hand, the present invention provides an external medicine for burns and scalds, and the raw materials for preparing the medicine include clam shell powder, sesame oil and plant extracts.

[0007] Furthermore, the plant extract is an extract of Lithospermum officinale, Ampelopsis pilosula and Phellodendron amurense.

[0008] Furthermore, the mass ratio of the clam shell powder, sesame oil and plant extract is 1:(8-15):(2-3).

[0009] Furthermore, the particle size of the clam shell powder is less than 15 μm.

[0010] Furthermore, the plant extract is obtained through a process comprising sequentially subjecting Lithospermum officinale, Ampelopsis pilosula and Phellodendron amurense to water extraction, fermentation, and adding ethanol to the fermentation liquid for extraction.

[0011] Furthermore, the mass ratio of the Bletilla striata and the Phellodendron chinense is 1.5-3:1.

[0012] Furthermore, the water extraction comprises crushing Lithospermum officinale, Ampelopsis pilosula and Phellodendron amurense, then mixing with water, and stirring at a temperature of 50-70° C. for 5-12 hours.

[0013] Furthermore, the fermentation includes co-fermentation using Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713.

[0014] Furthermore, the preparation of the plant extract comprises the following steps:

[0015] S1: by weight, 0.1-0.4 parts of Lithospermum officinale, 0.8-1.2 parts of Radix Ampelopsis and 0.2-0.5 parts of Cortex Phellodendri were crushed, mixed with water, and stirred at a temperature of 50-70° C. for 5-12 hours to obtain a stirred material; wherein the mass ratio of Radix Ampelopsis to Cortex Phellodendri was 1.5-3:1;

[0016] S2: Sterilize the stirred material, add fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713, and adjust the total amount of fermentation bacteria to 3×10 7 -8×10 7 cfu / mL, the ratio of the number of Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC 24713 is 1:2-4; aerobic fermentation is carried out at a temperature of 30-38°C for 15-30 hours to obtain a fermentation material;

[0017] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 30-42wt%, stir at 40-55°C for 4-8 hours, then cool and filter to obtain a filtrate;

[0018] S4: The filtrate is concentrated and dried to obtain the plant extract.

[0019] Further, the powder is crushed to a particle size of less than 0.2 mm.

[0020] Furthermore, in S1, the mass ratio of the total material after crushing Lithospermum officinale, Bletilla striata and Phellodendron chinense to water is 1:20-60.

[0021] Furthermore, in S1, the stirring speed is 50-2000 rpm.

[0022] Furthermore, in S3, the stirring speed is 50-2000 rpm.

[0023] Further, in S3, cooling to room temperature.

[0024] Furthermore, in S3, filtering is performed using a filter membrane with a pore size of less than 5 μm.

[0025] Further, in S4, the filtrate is concentrated to 5-12% of the mass of the filtrate.

[0026] Furthermore, in S4, the drying is freeze-drying, and the drying is performed until the water content is less than 7.5%.

[0027] Furthermore, in S4, the drying is followed by a crushing and sieving process, wherein the sieving process selects a particle size of less than 15 μm.

[0028] On the other hand, the present invention also provides a method for preparing the external medicine for burns and scalds, comprising the steps of weighing raw materials and stirring and mixing the raw materials. Further, the stirring speed can be selected to be 50-600 rpm.

[0029] On the other hand, the present invention also provides a method for using the external medicine for burns and scalds, comprising the steps of shaking well before use and applying to the burned and scalded skin.

[0030] Beneficial effects of the present invention:

[0031] The present invention uses lithospermum officinale, white scutellaria and phellodendron chinense to prepare plant extracts that promote the healing of burns and scalds, uses a composite bacteria fermentation method to enhance the efficacy of the extract, optimizes the bacteria collocation and ratio, and optimizes the process conditions so that the drug can better promote the healing of burns; then uses ethanol for extraction and adjusts the concentration of ethanol in the extract, enriches and purifies the active ingredients, thereby further improving the efficacy of the extract. Then the prepared extract is combined with clam shell powder and sesame oil to prepare an external medicine for burns and scalds.

[0032] When the drug of the present invention is applied to a rat scald wound healing experiment, it is shown that the healing rate of the rat scald wound on the 13th day reaches (39.73±4.56)%, and the healing rate on the 20th day reaches (66.38±7.47)%, and the wound healing can be well promoted; the drug of the present invention can effectively promote the increase of the content of epidermal growth factor EGF and vascular endothelial growth factor VEGF in the rat scald wound tissue, so that the content of epidermal growth factor EGF and vascular endothelial growth factor VEGF in the rat wound tissue on the 13th day is 544.37±55.92 ng / mL and 410.29±49.31 ng / mL respectively; the drug of the present invention has a good effect of treating burns and scalds, is derived from plant components, does not use components such as organic solvents, has low side effects, and is less harmful to the human body when used for a long time.

[0033] The present invention ferments the drugs, which can greatly increase the effect of external drugs on promoting the healing of burns and scalds. In particular, the combination of the fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC 24713 of the present invention has better drug efficacy than fermentation with other bacteria.

[0034] When the amount of Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713 is matched in the fermentation material of the present invention, the two can mutually promote each other to increase the drug activity to a certain extent, so that the wound healing effect is better. When the ratio of the two fermentation bacteria is selected to be 1:2-4, the obtained drug has the best effect.

[0035] After fermentation, the present invention adds ethanol and adjusts the ethanol solution of appropriate concentration for further extraction, which can increase the effect of the medicine of the present invention. When the ethanol concentration in the extract is adjusted to 30-42wt%, the obtained medicine has a better effect of promoting the healing of burns and scalds. When the mass ratio of white ampel and phellodendron is selected to be 1.5-3:1, the prepared external medicine can better heal wounds. DETAILED DESCRIPTION

[0036] The present invention will be described below in conjunction with specific embodiments, and various effects of the present invention will be more clearly presented. It should be understood by those skilled in the art that these specific embodiments are used to illustrate the present invention, rather than to limit the present invention.

[0037] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0038] 1. Preparation of plant extracts

[0039] Extract 1:

[0040] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0041] S2: Sterilize the stirred material, add fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL, the ratio of Bacillus licheniformis CICC 21738 to Bacillus subtilis CICC24713 was 1:3; aerobic fermentation was carried out at a temperature of 35°C for 20 hours to obtain a fermentation material;

[0042] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 38wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0043] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0044] Extract 2:

[0045] The preparation steps are as follows: S1: by mass, 0.4 parts of Lithospermum officinale, 1.1 parts of Bletilla striata and 0.5 parts of Phellodendron chinense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:45, and stirred at a temperature of 60° C. and a rotation speed of 80 rpm for 8 hours to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron chinense is 2.2:1;

[0046] S2: Sterilize the stirred material, add fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713, and adjust the total amount of fermentation bacteria to 7.2×10 7 cfu / mL, the ratio of Bacillus licheniformis CICC 21738 to Bacillus subtilis CICC24713 was 1:2; aerobic fermentation was carried out at a temperature of 32°C for 25 hours to obtain a fermentation material;

[0047] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 30wt%, stir at 48°C and 70rpm for 4.5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0048] S4: the filtrate is concentrated under reduced pressure at 58° C. to 8% by mass of the filtrate, freeze-dried at -30° C. to a water content of about 5.67% by mass, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0049] Extract 3:

[0050] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0051] S2: Sterilize the stirred material, add the fermentation bacteria Pichia pastoris GS115, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL; aerobically ferment at 35°C for 20 hours to obtain a fermentation material;

[0052] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 38wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0053] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0054] Extract 4:

[0055] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0056] S2: Sterilize the stirred material, add fermentation bacteria Lactobacillus, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL; anaerobically ferment at 35°C for 20 hours to obtain a fermentation material;

[0057] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 38wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0058] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0059] Extract 5:

[0060] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0061] S2: Sterilize the stirred material, add water, and stir at 35°C and 50 rpm for 20 hours to obtain material S2;

[0062] S3: sterilize material S2, add ethanol to adjust the ethanol concentration to 38wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0063] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0064] Extract 6:

[0065] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0066] S2: Sterilize the stirred material, add the fermentation bacteria Bacillus licheniformis CICC 21738, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL; aerobically ferment at 35°C for 20 hours to obtain a fermentation material;

[0067] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 38wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0068] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0069] Extract 7:

[0070] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0071] S2: Sterilize the stirred material, add the fermentation bacteria Bacillus subtilis CICC 24713, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL; aerobically ferment at 35°C for 20 hours to obtain a fermentation material;

[0072] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 38wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0073] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0074] Extract 8:

[0075] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0076] S2: Sterilize the stirred material, add fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL, the bacterial count ratio of Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713 was 1:0.5; aerobic fermentation was performed at a temperature of 35°C for 20 hours to obtain a fermentation material;

[0077] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 38wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0078] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0079] Extract 9:

[0080] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0081] S2: Sterilize the stirred material, add fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL, the ratio of Bacillus licheniformis CICC 21738 to Bacillus subtilis CICC24713 was 1:6; aerobic fermentation was carried out at a temperature of 35°C for 20 hours to obtain a fermentation material;

[0082] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 38wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0083] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0084] Extract 10:

[0085] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0086] S2: Sterilize the stirred material, add fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL, the ratio of Bacillus licheniformis CICC 21738 to Bacillus subtilis CICC24713 was 1:3; aerobic fermentation was carried out at a temperature of 35°C for 20 hours to obtain a fermentation material;

[0087] S3: sterilize the fermentation material, add 0.594 times the mass of water of the fermentation material, stir for 5 hours at a temperature of 52°C and a rotation speed of 70 rpm, then cool to room temperature, filter through a filter membrane with a pore size of 0.22 μm to obtain a filtrate;

[0088] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0089] Extract 11:

[0090] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 1 part of Bletilla striata and 0.4 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5°C and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 2.5:1;

[0091] S2: Sterilize the stirred material, add fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL, the ratio of Bacillus licheniformis CICC 21738 to Bacillus subtilis CICC24713 was 1:3; aerobic fermentation was carried out at a temperature of 35°C for 20 hours to obtain a fermentation material;

[0092] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 65wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0093] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0094] Extract 12:

[0095] The preparation steps are as follows: S1: by mass, 0.3 parts of Lithospermum officinale, 0.5 parts of Bletilla striata and 0.9 parts of Phellodendron amurense are crushed to a particle size of less than 0.2 mm to obtain a mixed powder, which is then mixed with water at a mass ratio of 1:40, and stirred for 10 hours at a temperature of 65.5° C. and a rotation speed of 80 rpm to obtain a stirred material; wherein the mass ratio of Bletilla striata to Phellodendron amurense is 0.56:1;

[0096] S2: Sterilize the stirred material, add fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713, and adjust the total amount of fermentation bacteria to 6×10 7 cfu / mL, the ratio of Bacillus licheniformis CICC 21738 to Bacillus subtilis CICC24713 was 1:3; aerobic fermentation was carried out at a temperature of 35°C for 20 hours to obtain a fermentation material;

[0097] S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 38wt%, stir at 52°C and 70rpm for 5 hours, then cool to room temperature, filter through a 0.22μm filter membrane to obtain a filtrate;

[0098] S4: the filtrate is concentrated under reduced pressure at 58° C. to 10% by mass of the filtrate, freeze-dried at -30° C. to about 5.72% by mass of water, crushed, and sieved to select powder with a particle size of less than 1 μm to obtain the plant extract.

[0099] The information of raw materials used in the above extracts is as follows:

[0100] Bacillus licheniformis CICC 21738: Bacillus licheniformis, number: CICC 21738, China Industrial Microbiology Culture Collection Center.

[0101] Bacillus subtilis CICC 24713: Bacillus subtilis, number: CI CC 24713, China Industrial Microorganism Culture Collection Management Center.

[0102] Pichia pastoris GS115: Pichia pastoris, number: CCTCC AY 207028, China Center for Type Culture Collection.

[0103] Lactobacillus: Lactobacillus sp, number: CCTCC AB 200050, China Center for Type Culture Collection.

[0104] 2. Preparation of external medicines

[0105] The plant extracts (abbreviated as extracts 1-12) are used to prepare external medicines for burns and scalds.

[0106] 1. External use medicine A1:

[0107] The raw material composition is: 1kg of clam shell powder, 10kg of sesame oil and 2kg of the above extract 1.

[0108] Preparation method: (1) Crush the mussel shells using a crusher, and screen the powder with a particle size less than 1 μm for later use;

[0109] (2) Weigh the raw materials according to the amount;

[0110] (3) Put sesame oil into a container, add clam shell powder and extract 1, and then stir at 200 rpm for 0.5 hour to obtain the external medicine A1.

[0111] 2. External medicine A2: The only difference from external medicine A1 is that extract 2 is used to replace extract 1.

[0112] The external medicine A3-12 is different from the external medicine A1 only in that the extract 1 is replaced by the extract 3-12.

[0113] 3. External use medicine A13:

[0114] The raw material composition is: 1kg clam shell powder, 10kg sesame oil.

[0115] Preparation method: (1) Crush the mussel shells using a crusher, and screen the powder with a particle size less than 1 μm for later use;

[0116] (2) Weigh the raw materials according to the amount;

[0117] (3) Put sesame oil into a container, add clam shell powder, and then stir at 200 rpm for 0.5 hours to obtain the external medicine A13.

[0118] 3. Effect Test

[0119] The above-mentioned external medicines A1 to A13 were tested for their effects.

[0120] A number of female SD rats weighing 320±20g were selected and randomly divided into A1-13 group, positive control group and model group, a total of 15 groups, 20 rats in each group. After anesthesia, the rats in each group were fixed on a wooden board, and a 4cm×4cm area was shaved on the same part of the back, and then the hair was removed and the shaved area was disinfected. The iron block was placed in boiling water for 20 minutes and then placed on the rat hair removal area for 20 seconds to create an area of ​​about 10cm 2 The wound of deep II degree burns of about 100%. Then the drugs were administered, and the administration method was as follows: the A1-13 groups were administered with the above-mentioned topical drugs A1-A13 in turn, specifically, the corresponding topical drugs were evenly applied to the burn wounds of rats, and the dosage of each rat burn wound was 0.4g, and the drugs were administered once a day in the morning and evening; the positive control group used the mupirocin ointment of Sino-US SmithKline (brand) to be evenly applied to the burn wounds of rats, and the dosage of each rat burn wound was 0.28g, and the drugs were administered once a day in the morning and evening; the model group used 0.4g of normal saline to replace the drugs, and the drugs were treated in the same way. Each group cleaned the wound with normal saline before applying the drugs each time. The drugs were administered continuously for 20 days.

[0121] 6 hours after administration on the 13th day, 10 rats from each group were randomly selected, the wound conditions of the rats were scanned and collected, and the wound healing rate of the rats on the 13th day was analyzed and calculated, wherein the wound healing rate = (initial scald area - scald area at different times after administration) / initial scald area × 100%; the test results are shown in Table 1. After the wound healing rate on the 13th day was tested, about 120 mg of the full-thickness skin tissue of the scald wound of the rat was taken, and the active blood and body fluids were absorbed by filter paper and weighed. The homogenate was made into 10wt% tissue homogenate in an ice water bath, centrifuged at 2°C and 7500rpm for 20min, and the supernatant was taken and stored at -75°C. The content of epidermal growth factor EGF and vascular endothelial growth factor VEGF was determined by ELISA; the results are shown in Table 2.

[0122] On the 20th day of administration, the wound conditions of the remaining 10 rats in each group were scanned and collected, and the wound healing rate of each group of rats on the 20th day was analyzed and calculated, wherein the wound healing rate = (initial scald area - scald area at different times after administration) / initial scald area × 100%. The results are shown in Table 1.

[0123] Table 1 Healing rate of burn wounds in rats at different time

[0124]

[0125]

[0126] Table 2 EGF and VEGF levels in rats on day 30

[0127]

[0128]

[0129] It can be seen from the test results of Table 1-2 that the rat scald wound test showed that the healing rate on the 13th day reached (39.73±4.56)%, and the healing rate on the 20th day reached (66.38±7.47)%, which can promote wound healing well; the drug of the present invention can effectively promote the increase of the content of epidermal growth factor EGF and vascular endothelial growth factor VEGF in the scald wound tissue of rats, so that the content of epidermal growth factor EGF and vascular endothelial growth factor VEGF in the wound tissue of rats on the 13th day were 544.37±55.92ng / mL and 410.29±49.31ng / mL respectively; it can be seen that the drug of the present invention has a good effect on treating burns and scalds, and is derived from plant ingredients, does not use ingredients such as organic solvents, has low side effects, and is less harmful to the human body when used for a long time.

[0130] By comparing the effects of external medicines A1 and 3-5 in Table 1-2, it can be seen that the fermentation of the drugs in the present invention can greatly increase the effect of the external medicines in promoting the healing of burns and scalds, especially the combination of the fermentation bacteria Bacillus licheniformis CI CC 21738 and Bacillus subtilis CI CC 24713 of the present invention, which has better efficacy than fermentation with other bacteria.

[0131] By comparing the external medicines A1 and 6-7, it can be seen that when the number of Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC 24713 bacteria are matched in the fermentation material, the two can promote each other to a certain extent to increase the drug activity, so that the wound healing effect is better. And when the ratio of the two fermentation bacteria is selected to be 1:2-4, the obtained drug has the best effect.

[0132] After fermentation, the present invention adds ethanol and adjusts the ethanol solution of appropriate concentration for further extraction, which can increase the effect of the drug of the present invention, and when the ethanol concentration in the extract is adjusted to 30-42wt%, the obtained drug has a better effect of promoting the healing of burns and scalds. The above content can be known by comparing the external medicines A1, 10, and 11. When the mass ratio of white mulberry and phellodendron is selected to be 1.5-3:1 in the present invention, the prepared external medicine can better heal wounds, which can be obtained by comparing the external medicines A1, 2, and 12.

[0133] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. An external medicine for burns and scalds, characterized in that: The preparation raw materials consist of clam shell powder, sesame oil and plant extracts; The plant extracts are extracts of Lithospermum officinale, Ampelopsis pilosula and Phellodendron amurense; The mass ratio of the clam shell powder, sesame oil and plant extract is 1:(8-15):(2-3); The preparation of the plant extract comprises the following steps: S1: by weight, 0.1-0.4 parts of Lithospermum officinale, 0.8-1.2 parts of Radix Ampelopsis and 0.2-0.5 parts of Cortex Phellodendri were crushed, mixed with water, and stirred at a temperature of 50-70° C. for 5-12 hours to obtain a stirred material; S2: Sterilize the stirred material, add fermentation bacteria Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC24713, and adjust the total amount of fermentation bacteria to 3×10 7 -8×10 7 cfu / mL, the ratio of the number of Bacillus licheniformis CICC 21738 and Bacillus subtilis CICC 24713 is 1:2-4; aerobic fermentation is carried out at a temperature of 30-38°C for 15-30 hours to obtain a fermentation material; S3: sterilize the fermentation material, add ethanol to adjust the ethanol concentration to 30-42wt%, stir at 40-55°C for 4-8 hours, then cool and filter to obtain a filtrate; S4: concentrating the filtrate and drying it to obtain the plant extract; The particle size of the clam shell powder is less than 15 μm; The mass ratio of the white ampelopsis and the phellodendron amurense is 1.5-3:

1.

2. An external-use medicine for burns and scalds according to claim 1, characterized in that: In S4, the mixture is dried until the water content is less than 7.5%.

3. A method for preparing the external medicine for burns and scalds according to any one of claims 1-2, characterized in that: The method comprises the steps of weighing raw materials and stirring and mixing the raw materials.

4. A preparation method according to claim 3, characterized in that: The stirring speed is 50-600 rpm.

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