A Chinese medicine composition and medicine for promoting wound healing

Abstract

The present invention relates to a traditional Chinese medicine composition and a medicine for promoting wound healing. The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 30-50 parts of Centella asiatica, 10-20 parts of Lithospermum officinale, 5-20 parts of Bletilla striata, 5-20 parts of Chrysanthemum indica, 10-30 parts of Platycodon grandiflorum, 5-20 parts of Folium Isatidis, and 5-15 parts of Olibanum. The Chinese medicine composition of the present invention is composed of appropriate amounts of Centella asiatica, Lithospermum officinale, Bletilla striata, Chrysanthemum indica, Platycodon grandiflorum, Folium Isatidis and Olibanum. In the prescription, Centella asiatica can clear away heat and dampness, detoxify and reduce swelling, and Centella asiatica is used as the main medicine; Lithospermum officinale can cool blood and activate blood circulation, detoxify and cure rashes; Chrysanthemum indica can disperse wind-heat, reduce swelling and detoxify; Folium Isatidis can clear heat and detoxify, cool blood and eliminate spots, and assist the main medicine in clearing heat and detoxifying, and serves as the minister medicine; Platycodon grandiflorum is used to discharge pus, and Bletilla striata can astringe and stop bleeding, reduce swelling and promote tissue regeneration, and assist the main medicine and the minister medicine in reducing swelling and detoxifying; Olibanum can promote blood circulation and qi circulation, so that the drug effect can directly reach the diseased area; all the medicines can play the functions of clearing heat and detoxifying, reducing swelling and promoting tissue regeneration, and promote wound healing.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition and medicine for promoting wound healing. Background Art

[0002] Skin wound healing refers to the healing process after the skin tissue is severed or damaged due to some kind of effect, including the regeneration of various tissues, the proliferation of granulation tissue, and the complex combination of scar tissue formation. The mildest wound is limited to the epidermis of the skin. Slightly more serious wounds involve the rupture of the skin and subcutaneous tissue, and the appearance of wounds; more serious wounds may involve the rupture of muscles, tendons, nerves, and fractures.

[0003] When trauma occurs, there are different degrees of tissue necrosis and vascular rupture and bleeding in the local area. Tissue factor and intracellular calcium ions are released, which initiates the exogenous coagulation pathway, and finally fibrin clots are generated and entrain a large number of platelets. After thrombosis, it blocks the site of trauma, forming a barrier to prevent microbial invasion and providing a scaffold for the next step of cell infiltration. At this time, growth factors recruit neutrophils, monocytes, and fibroblasts into the wound. These constitute the beginning of the inflammatory phase. That is, in the early stage of trauma, neutrophils enter the wound surface, remove cell debris and bacteria entering the wound surface, and prevent the wound surface from being infected. Then, at the beginning of the proliferation phase, fibroblasts enter the wound surface, synthesize glycosaminoglycans, proteoglycans, and collagen, participate in the formation of a new extracellular matrix of granular tissue, and begin to form new blood vessels and granulation tissue. The remodeling phase overlaps with the proliferation phase. In the early stage, the matrix composed of fibrin, leukocytes, and fibronectin is decomposed and replaced by proteoglycans and collagen (types I and III), which are hinged together through enzymatic reactions, increasing the toughness and tensile strength of the wound. At the same time, fibroblasts also transform into myofibroblasts, and in the final stage, fibroblasts and endothelial cells undergo apoptosis, and ultimately, the wound heals.

[0004] In clinical observation, the symptoms are congestion, serous exudation, local redness and swelling in sequence; the blood and exudate from the wound then coagulate into lumps or scabs; then the entire layer of skin and subcutaneous tissue at the contraction edge moves toward the center, new granulation tissue and skin are generated, and the wound surface shrinks.

[0005] At present, the main drug treatments for wound repair include: antibiotics, wound dressings, chemical drugs such as cytokines, and some Chinese medicine combinations or Chinese medicine monomers. The role of antibiotics is to inhibit bacteria and prevent wound infection; wound dressings such as band-aids and gauze mainly provide a physical barrier to prevent wound infection; collagen excipients, interleukins, etc. accelerate the course of wound repair; Chinese medicine single volume asiaticoside tablets are for oral use; the mechanism of action of Chinese medicine combinations is more complicated, due to the complexity of the ingredients and the synergistic effects between the components. Summary of the invention

[0006] Based on this, the purpose of the present invention is to provide a Chinese medicine composition for promoting wound healing, which can effectively inhibit bacterial infection of wounds, reduce inflammatory reactions, accelerate skin wound repair, and promote wound healing.

[0007] The first aspect of the present invention is to provide a traditional Chinese medicine composition for promoting wound healing, wherein the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 30-50 parts of Centella asiatica, 10-20 parts of Lithospermum erythrorhizon, 5-20 parts of Bletilla striata, 5-20 parts of Chrysanthemum indica, 10-30 parts of Platycodon grandiflorum, 5-20 parts of Folium Isatidis, and 5-15 parts of Frankincense.

[0008] In some embodiments, the active ingredients of the Chinese medicine composition are prepared from the following raw materials in parts by weight: 30-50 parts of Centella asiatica, 10-20 parts of Lithospermum erythrorhizon, 10-20 parts of Bletilla striata, 10-15 parts of Chrysanthemum indica, 10-25 parts of Platycodon grandiflorum, 5-10 parts of Folium Isatidis, and 5-10 parts of Frankincense.

[0009] In some embodiments, the active ingredients of the Chinese medicine composition are prepared from the following raw materials in parts by weight: 35-40 parts of Centella asiatica, 15-20 parts of Lithospermum erythrorhizon, 15-20 parts of Bletilla striata, 12-15 parts of Chrysanthemum indica, 20-25 parts of Platycodon grandiflorum, 5-10 parts of Folium Isatidis, and 8-10 parts of Frankincense.

[0010] In some embodiments, the active ingredients of the Chinese medicine composition are prepared from the following raw materials in parts by weight: 40 parts of Centella asiatica, 15 parts of Lithospermum officinale, 15 parts of Bletilla striata, 12 parts of Chrysanthemum indica, 20 parts of Platycodon grandiflorum, 10 parts of Folium Isatidis, and 8 parts of Frankincense.

[0011] The second aspect of the present invention is to provide the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for promoting wound healing.

[0012] The third aspect of the present invention is to provide the use of the above-mentioned traditional Chinese medicine composition in the preparation of antibacterial and / or anti-inflammatory drugs.

[0013] The fourth aspect of the present invention is to provide a drug for promoting wound healing, antibacterial and / or anti-inflammatory effects, the drug comprising an active ingredient and a pharmaceutically acceptable carrier, wherein the active ingredient comprises the Chinese medicine composition as described above.

[0014] In some embodiments, the drug is in the form of an external administration dosage form, and the drug is in the form of an ointment, a gel, a solution, or a spray.

[0015] A fifth aspect of the present invention is to provide a method for preparing the above-mentioned drug, comprising the following steps:

[0016] (1) weighing the frankincense, and crushing it to obtain frankincense fine powder;

[0017] (2) weighing the Centella asiatica, Bletilla striata, Chrysanthemum indigofera, Platycodon grandiflorum and Folium Isatidis, adding an extraction solvent for extraction to obtain a filtrate 1;

[0018] (3) weighing the lithospermum officinale, frying and extracting it, filtering it, and obtaining filtrate 2;

[0019] (4) combining the filtrate 1 and the filtrate 2, concentrating them to obtain a drug solution;

[0020] (5) preparing a drug matrix, adding the drug solution and frankincense powder into the matrix, and stirring evenly to obtain the drug matrix.

[0021] In some embodiments, the extraction solvent in step (2) is water or ethanol.

[0022] In some embodiments, the extraction in step (2) is decoction extraction.

[0023] In some embodiments, the mass of the extraction solvent in step (2) is 5 to 15 times the total mass of the raw material.

[0024] In some embodiments, the mass of the oil in step (3) is 3 to 10 times the mass of Lithospermum officinale.

[0025] In some embodiments, step (2) is: weigh the Centella asiatica, Bletilla striata, Chrysanthemum indigofera, Platycodon grandiflorum and Folium Isatidis, add water and boil for extraction 1 to 3 times, concentrate the filtrate into an extract, add ethanol, filter, and obtain filtrate 1.

[0026] In some embodiments, the powder in step (1) is sieved through a 100-mesh sieve after being crushed.

[0027] The invention provides a traditional Chinese medicine composition for promoting wound healing. The traditional Chinese medicine composition is composed of appropriate amounts of centella asiatica, lithospermum erythrorhizon, bletilla striata, wild chrysanthemum, platycodon grandiflorum, isatis indigotica and frankincense. In the prescription, centella asiatica can clear away heat and dampness, detoxify and reduce swelling, and centella asiatica is used as a main medicine; lithospermum erythrorhizon can cool blood and activate blood circulation, detoxify and cure rashes; wild chrysanthemum can disperse wind-heat, reduce swelling and detoxify; isatis indigotica can clear heat and detoxify, cool blood and eliminate spots, and can assist the main medicine in clearing heat and detoxifying, and can serve as a minister medicine; platycodon grandiflorum is used to discharge pus, and bletilla striata can astringe and stop bleeding, reduce swelling and promote tissue regeneration, so as to assist the main medicine and the minister medicine in reducing swelling and detoxifying; frankincense can promote blood circulation and qi circulation, so that the drug effect can directly reach the diseased area; all the medicines can play the functions of clearing heat and detoxifying, reducing swelling and promoting tissue regeneration, and promote wound healing.

[0028] The Chinese medicine composition of the present invention has simple raw material composition, and has been proved by in vitro and in vivo tests to be able to significantly inhibit Staphylococcus aureus and Pseudomonas aeruginosa, significantly reduce inflammatory response, and increase wound healing rate. In addition, the raw materials in the Chinese medicine composition are all commonly used Chinese medicinal materials, which are safe and cheap, and have a simple preparation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1-1 , Figure 1-2 and Figure 1-3 The wound healing status of rats in each group after administration. DETAILED DESCRIPTION

[0030] In order to facilitate the understanding of the present invention, the present invention will be described more fully below. The present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present invention more thorough and comprehensive.

[0031] The experimental methods in the following examples without specifying specific conditions are usually carried out under conventional conditions or conditions recommended by the manufacturers. The various commonly used chemical reagents used in the examples are all commercially available products.

[0032] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those commonly understood by those skilled in the art to which the present invention belongs. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used in the present invention includes any and all combinations of one or more of the related listed items.

[0033] In addition, as used in the present invention, the term "or" is an inclusive "or" symbol and is equivalent to the term "and / or", unless the context clearly dictates otherwise. The term "based on" is not exclusive and allows for being based on other factors not described, unless the context clearly dictates otherwise. In addition, throughout the specification, the meanings of "a", "an", and "the" include plural referents. The meaning of "in..." includes "in..." and "on...".

[0034] Some embodiments of the present invention relate to a traditional Chinese medicine composition for promoting wound healing, wherein the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 30-50 parts of Centella asiatica, 10-20 parts of Lithospermum erythrorhizon, 5-20 parts of Bletilla striata, 5-20 parts of Chrysanthemum indica, 10-30 parts of Platycodon grandiflorum, 5-20 parts of Folium Isatidis, and 5-15 parts of Frankincense.

[0035] Centella asiatica: The dried whole herb of Centella asiatica (L.) Urb. of the Umbelliferae family. It tastes bitter, pungent, and cold, and enters the liver, spleen, and kidney meridians.

[0036] Lithospermum officinale: The dried root of Arnebia euchroma (Royle) Johnst or Arnebia guttata Bunge, Boraginaceae. Sweet, salty, cold. Enters the heart and liver meridians.

[0037] Bletilla striata: It is the dried tuber of Bletilla striata (Thunb.) Reichb.f. of the orchid family. It tastes bitter, sweet, astringent, and slightly cold. It enters the lung, liver, and stomach meridians.

[0038] Wild chrysanthemum: Dried inflorescence of Chrysanthemumindicum L., a plant of the Asteraceae family. Bitter, pungent, slightly cold. Enters the liver and heart meridians.

[0039] Platycodon grandiflorum: It is the dried root of Platycodon grandiflorum (Jacq.) A.DC. of the Campanulaceae family. It tastes bitter, pungent, and neutral. It enters the lung meridian.

[0040] Isatis indigotica: The dried leaves of the cruciferous plant Isatis indigotica Fort. Bitter and cold. Enters the heart and stomach meridians.

[0041] Frankincense: Resin exuded from the bark of Boswellia carterii Birdw. and Boswelliabhaw-dajiana Birdw., both of which are members of the same genus. Pungent, bitter, warm. Enters the heart, liver, and spleen meridians.

[0042] The present invention is further described in detail below with reference to specific embodiments.

[0043] The sources of the reference substances in the following examples are as follows:

[0044] Centella asiatica reference substance (China Food and Drug Inspection Institute, 110892-202006);

[0045] Madecassoside reference substance (China Food and Drug Inspection Institute, 110893-202105);

[0046] L-shikonin reference substance (China Food and Drug Control Institute, 110769-200506);

[0047] 1,4-Di[4-(glucose oxygen)benzyl]-2-isobutylmalate reference substance (China Food and Drug Inspection Institute, 112061-202102);

[0048] Menghua glycoside reference substance (China Food and Drug Inspection Institute, 111528-202213);

[0049] Platycodon saponin D reference substance (China Food and Drug Inspection Institute, 111851-202209);

[0050] Indigo carmine reference substance (China Food and Drug Inspection Institute, 110717-202407).

[0051] Example 1 Ointment

[0052] According to the weight ratio, weigh frankincense and grind it into fine powder, pass through a 100-mesh sieve, and set aside; add water (6 times the total weight of the original medicinal materials) to 40g of Centella asiatica, 10g of Bletilla striata, 12g of Chrysanthemum indica, 10g of Platycodon grandiflorum, and 10g of Folium Isatidis, and boil twice, the first time for 2 hours, the second time for 1 hour, filter the decoction, concentrate the filtrate to a clear paste with a relative density of about 1.20 (25°C), add ethanol to make the alcohol content reach 75%, refrigerate for 10 hours, filter, recover the filtrate until there is no alcohol taste, and refrigerate for use; take 15g of Lithospermum officinale, chop it, moisten it with water (covered, about 4 times the total weight of the original medicinal materials), fry it in a pot with sesame oil (4 times the total weight of the original medicinal materials) until it becomes purple-red, remove the residue, and filter it. All filtrates are combined and concentrated to 42g to obtain a medicinal solution.

[0053] Separately heat the oil phase of stearic acid, lanolin, liquid paraffin (mass ratio 50:7:75) and the water phase of triethanolamine, glycerol, distilled water (mass ratio 7:10:300) to 70°C, add the water phase to the oil phase under stirring (water-oil mass ratio 5:2), cool to 40°C, add 1g of ethyl p-hydroxybenzoate, stir well, and make a matrix. Take the above liquid, heat it to 40-50°C, add it to the matrix, and stir. Add 8g of frankincense powder, stir well, and you will get 500g of ointment. Each 1g of ointment contains no less than 0.32mg of hydroxy-madecassoside and asiaticoside in total; no less than 0.32mg of levorotatory shikonin; no less than 0.20mg of 1,4-di[4-(glucose oxygen) benzyl]-2-isobutyl malate, no less than 0.08mg of montanol, and no less than 0.0006mL of Somali frankincense. The content of Platycodon grandiflorum in terms of platycodon saponin D shall not be less than 0.05 mg, and the content of Isatis indigotica in terms of indigo red shall not be less than 0.002 mg.

[0054] Example 2 Gel

[0055] Weigh frankincense according to the weight ratio and crush it into fine powder, pass through a 100-mesh sieve, and set aside; add water (6 times the total weight of the original medicinal materials) to 40g of Centella asiatica, 10g of Bletilla striata, 12g of Chrysanthemum indica, 10g of Platycodon grandiflorum, and 10g of Folium Isatidis, and decoct twice, the first time for 2 hours, the second time for 1 hour, filter the decoction, concentrate the filtrate to a clear paste with a relative density of about 1.20 (25°C), add ethanol to make the alcohol content reach 75%, refrigerate for 10 hours, filter, recover the filtrate until there is no alcohol taste, and refrigerate for use; take 15g of Lithospermum officinale, chop it, moisten it with water (covered, about 4 times the total weight of the original medicinal materials), fry it in a pot with sesame oil (4 times the total weight of the original medicinal materials) until it becomes purple-red, remove the residue, and filter it. All filtrates are combined. Concentrate to 42g to obtain a medicinal solution.

[0056] Separately, 14.7g of 3% carbomer, 24.5g of triethanolamine, 43.8g of propylene glycol, and 367g of water are mixed and stirred to obtain a gel matrix. Take the above-mentioned liquid medicine, heat it to 50-60°C, add it to an appropriate amount of the matrix, and stir it. Add 8g of frankincense powder, stir it well, and then 500g of gel is obtained. Each 1g of gel contains no less than 0.32mg of hydroxy-madecassoside and asiaticoside in total; no less than 0.32mg of levorotatory shikonin; no less than 0.20mg of 1,4-di[4-(glucose oxygen) benzyl]-2-isobutyl malate; no less than 0.08mg of montanolide; and no less than 0.0006mL of Somali frankincense. Platycodon grandiflorum contains no less than 0.05mg of platycodon saponin D, and Folium isatidis contains no less than 0.002mg of indigo red.

[0057] Example 3

[0058] Study on the antibacterial effect of Staphylococcus aureus and Pseudomonas aeruginosa

[0059] Experimental Materials

[0060] Test product:

[0061] Composition 1: 40 parts of Centella asiatica, 15 parts of Lithospermum officinale, 15 parts of Bletilla striata, 12 parts of Chrysanthemum indica, 20 parts of Platycodon grandiflorum, 10 parts of Isatis indigotica, 8 parts of Frankincense, extract content: 0.24 g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology.

[0062] Centella asiatica extract, content: 0.24g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0063] Lithospermum officinale extract, content: 0.24g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0064] Bletilla striata extract, content: 0.24g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0065] Wild chrysanthemum extract, content: 0.24g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0066] Platycodon grandiflorum extract, dosage calculated at 0.24g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0067] Folium Isatidis extract, dosage is calculated at 0.24g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0068] Frankincense powder, dosage is calculated at 0.24g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0069] Positive control: Kangfuxin liquid, a light brown liquid, for external use in appropriate amounts, 10mL / time for internal use, 3 times a day. Specification: 50mL per bottle, batch number: 240207, valid until February 3, 2027, indications: promote blood circulation, nourish yin and promote muscle growth. Internal use: used for blood stasis, stomach pain and bleeding, gastric and duodenal ulcers; and auxiliary treatment of yin deficiency pulmonary tuberculosis. External use: used for wounds of wounds, trauma, ulcers, fistulas, burns, scalds, and bedsores. Provided by Sichuan Good Doctor Panxi Pharmaceutical Co., Ltd.

[0070] Negative control: blank gel matrix.

[0071] Test bacteria: Staphylococcus aureus, Pseudomonas aeruginosa.

[0072] Experimental methods

[0073] 1. Preparation of bacterial culture

[0074] Take an appropriate amount of nutrient broth culture of Staphylococcus aureus and Pseudomonas aeruginosa cultured at 30-35°C for 24 hours, dilute to 100-200 cfu / mL with sterile sodium chloride-peptone buffer with a pH of 7.0, and store at 2-8°C for use. The storage time shall not exceed 24 hours.

[0075] 2. Preparation of test solution: accurately weigh 5g of the above test substance (5*0.21g for frankincense) and control substance (if necessary, heat and melt appropriately, the temperature does not exceed 45℃) in a conical flask containing 5g Span 80 and 10g polysorbate 80, stir to form a mass, add sterile sodium chloride-peptone buffer with pH 7.0 in portions to 100mL, stir to fully disperse the test substance, add appropriate amount of glass beads and shake to obtain (1:20 dilution), place at 2-8℃ for use, and the storage time does not exceed 1h. All test substances and control substances, reagents, and consumables are sterile or sterilized.

[0076] 3. Inoculation and dilution

[0077] Take the test solution in a culture dish, immediately inject sterile tryptic soy agar medium, place at room temperature for about 1 hour until solidified, then incubate at 30-35℃ for 48 hours, use the pouring method to count the colonies, and use the MTT analysis method to calculate the inhibition rate. Each experimental group was processed in parallel for six times and the average value was taken.

[0078] The experimental groups included: test group (test solution + test bacterial solution), test sample control group (test solution + diluent), and bacterial solution control group (diluent + test bacterial solution).

[0079] Experimental group: Take the prepared test solution and add the bacterial solution at a volume ratio of 1:1 and mix well.

[0080] Test sample control group: replace the bacterial solution with diluent, and other operations are the same as the experimental group.

[0081] Bacterial solution control group: The test solution was replaced by the diluent, and the rest of the operations were the same as those of the experimental group.

[0082] Dilution control group: The test solution and bacterial solution were replaced by diluent, and the rest of the operations were the same as those of the experimental group.

[0083] Experimental Results

[0084] The results are shown in Table 1 below.

[0085] Table 1 In vitro antibacterial rates against Staphylococcus aureus and Pseudomonas aeruginosa

[0086]

[0087] The results show that the inhibition rate of the Chinese medicine composition 1 of the present invention on Staphylococcus aureus and Pseudomonas aeruginosa is higher than that of the raw material extracts in the prescription, and is higher than that of the commercially available Kangfuxin solution with the same total mass.

[0088] Study on the antibacterial effect of Staphylococcus aureus and Pseudomonas aeruginosa

[0089] Experimental Materials

[0090] Test product:

[0091] Composition 1: 40 parts of Centella asiatica, 15 parts of Lithospermum officinale, 15 parts of Bletilla striata, 12 parts of Chrysanthemum indica, 20 parts of Platycodon grandiflorum, 10 parts of Isatis indigotica, 8 parts of Frankincense, extract content: 0.24 g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology.

[0092] Composition 2: 50 parts of Centella asiatica, 20 parts of Lithospermum erythrorhizon, 10 parts of Bletilla striata, 10 parts of Chrysanthemum indigofera, 10 parts of Platycodon grandiflorum, 5 parts of Isatis indigotica, 5 parts of Frankincense, extract content: 0.24 g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0093] Composition 3: 30 parts of Centella asiatica, 10 parts of Lithospermum erythrorhizon, 20 parts of Bletilla striata, 15 parts of Chrysanthemum indigofera, 25 parts of Platycodon grandiflorum, 10 parts of Folium Isatidis, 10 parts of Frankincense, extract content: 0.24 g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology.

[0094] Control composition 1: 20 parts of Centella asiatica, 15 parts of Lithospermum officinale, 15 parts of Bletilla striata, 20 parts of Chrysanthemum indigofera, 20 parts of Platycodon grandiflorum, 15 parts of Isatis indigotica, 15 parts of Frankincense, extract content: 0.24g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0095] Control composition 2: 40 parts of Centella asiatica, 15 parts of Lithospermum officinale, 15 parts of Bletilla striata, 12 parts of Chrysanthemum indica, 20 parts of Platycodon grandiflorum, 10 parts of Folium Isatidis, 8 parts of Olibanum, 10 parts of Angelica dahurica, 10 parts of Rehmannia glutinosa, 10 parts of Saposhnikovia divaricata. The extraction process of Angelica dahurica, Rehmannia glutinosa and Saposhnikovia divaricata is the same as that of Centella asiatica, Bletilla striata and Chrysanthemum indica. Extract content: 0.24 g crude drug / g. Batch number: 240601. Valid until September 2024. It is provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology.

[0096] Control composition 3: 40 parts of Centella asiatica, 15 parts of Lithospermum officinale, 15 parts of Bletilla striata, 12 parts of Chrysanthemum indigofera, and 10 parts of Folium Isatidis, extract content: 0.24 g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology.

[0097] Control composition 4: 40 parts of Centella asiatica, 15 parts of Lithospermum officinale, 15 parts of Bletilla striata, 12 parts of Chrysanthemum indigofera, 10 parts of Folium Isatidis, 20 parts of Angelica dahurica, 8 parts of Myrrha, extract content: 0.24 g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology.

[0098] Centella asiatica extract, content: 0.24g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0099] Wild chrysanthemum extract, content: 0.24g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0100] Angelica dahurica extract, content: 0.24g crude drug / g, batch number: 240601, valid until September 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0101] Rehmannia root extract, content: 0.24g crude drug / g, batch number: 240601, valid until September 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0102] Saposhnikovia divaricata extract, content: 0.24g crude drug / g, batch number: 240601, valid until September 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0103] Angelica dahurica extract, content: 0.24g crude drug / g, batch number: 240601, valid until September 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0104] Myrrh extract, content: 0.24g crude drug / g, batch number: 240601, valid until September 2024, provided by the Natural Pharmacology Laboratory of Hunan Science and Technology Vocational College.

[0105] Negative control: blank gel matrix.

[0106] Positive control: Kangfuxin liquid, a light brown liquid, for external use in appropriate amounts, 10mL / time for internal use, 3 times a day. Specification: 50mL per bottle, batch number: 240207, valid until February 3, 2027, indications: promote blood circulation, nourish yin and promote muscle growth. Internal use: used for blood stasis, stomach pain and bleeding, gastric and duodenal ulcers; and auxiliary treatment of yin deficiency pulmonary tuberculosis. External use: used for wounds of wounds, trauma, ulcers, fistulas, burns, scalds, and bedsores. Provided by Sichuan Good Doctor Panxi Pharmaceutical Co., Ltd.

[0107] Test bacteria: Staphylococcus aureus, Pseudomonas aeruginosa.

[0108] Experimental methods

[0109] Same as above.

[0110] Experimental Results

[0111] The results are shown in Table 2 below.

[0112] Table 2 In vitro inhibition rate against Staphylococcus aureus and Pseudomonas aeruginosa

[0113]

[0114]

[0115] The results show that the inhibition rates of the Chinese medicine compositions 1-3 of the present invention against Staphylococcus aureus and Pseudomonas aeruginosa are higher than those of the Centella asiatica extract and Chrysanthemum indica extract, which have the best antibacterial effects among the ingredients, and are higher than those of the commercially available Kangfuxin liquid at the same total mass, among which composition 1 has the best antibacterial effect.

[0116] Compared with the Chinese medicine composition 1 of the present invention, the control composition 1 has the same types of raw materials but different ratios of raw materials, which leads to a decrease in the inhibition rate of Staphylococcus aureus and Pseudomonas aeruginosa, indicating that the ratio of raw materials in the prescription will significantly affect the synergistic effect between the raw materials, thereby affecting the antibacterial effect of the Chinese medicine composition.

[0117] Compared with the Chinese medicine composition 1 of the present invention, the control composition 2 adds 10 parts of Angelica dahurica, 10 parts of Rehmannia glutinosa, and 10 parts of Saposhnikovia divaricata on the basis of the formula of the Chinese medicine composition 1 of the present invention. As shown in Table 2, the addition of other raw materials does not increase the antibacterial rate of the Chinese medicine composition.

[0118] Compared with the Chinese medicine composition 1 of the present invention, the control composition 3 deleted Platycodon grandiflorum and frankincense from the prescription, and its inhibition rate on Staphylococcus aureus and Pseudomonas aeruginosa was significantly reduced, even lower than that of Centella asiatica extract and Chrysanthemum indici extract.

[0119] Compared with the Chinese medicine composition 1 of the present invention, the control composition 4 uses Angelica dahurica which also has the effect of reducing swelling and draining pus to replace Platycodon grandiflorum, and Myrrh which has the effect of promoting blood circulation and relieving pain to replace Frankincense to compound with Centella asiatica, Lithospermum officinale, Bletilla striata, Chrysanthemum indica and Folium Isatidis. As shown in Table 2, the inhibition rate of the control composition 4 on Staphylococcus aureus and Pseudomonas aeruginosa is significantly lower than that of the present invention composition 1. This indicates that Platycodon grandiflorum, Frankincense, Centella asiatica, Lithospermum officinale, Bletilla striata, Chrysanthemum indica and Folium Isatidis can better cooperate with each other to improve the antibacterial rate of the Chinese medicine composition.

[0120] Example 4

[0121] Study on the efficacy of drugs in wound repair and healing after surgery in rats.

[0122] Experimental Materials

[0123] Test sample: Low-concentration composition 1, content: 0.12g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology. Medium-concentration composition 1, content: 0.24g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology. High-concentration composition 1, content: 0.48g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology.

[0124] Centella asiatica extract, content: 0.48g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology. Lithospermum officinale extract, content: 0.48g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology. Bletilla striata extract, content: 0.48g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology. Chrysanthemum officinale extract, content: 0.48g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology. Platycodon grandiflorum extract, the dosage is converted to 0.48g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology. Isatis indigotica extract, the dosage is converted to 0.48g crude drug / g, batch number: 240507, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology. Frankincense powder, the dosage is converted to 0.48g crude drug / g, batch number: 240508, valid until August 2024, provided by the Natural Pharmacology Laboratory of Hunan Vocational College of Science and Technology.

[0125] Positive control: Kangfuxin liquid, a light brown liquid, for external use in appropriate amounts, 10mL / time for internal use, 3 times a day. Specification: 50mL per bottle, batch number: 240207, valid until February 3, 2027, indications: promote blood circulation, nourish yin and promote muscle growth. Internal use: used for blood stasis, stomach pain and bleeding, gastric and duodenal ulcers; and auxiliary treatment of yin deficiency pulmonary tuberculosis. External use: used for wounds of wounds, trauma, ulcers, fistulas, burns, scalds, and bedsores. Provided by Sichuan Good Doctor Panxi Pharmaceutical Co., Ltd.

[0126] Negative control: blank gel matrix.

[0127] The experimental animals are shown in Table 3:

[0128] Table 3 Experimental animals

[0129]

[0130] Main experimental reagents and instruments

[0131] It mainly includes skin samplers, scalpels, surgical scissors, etc.

[0132] Test sample preparation

[0133] Use a balance to weigh an appropriate amount of the test sample and reference sample and apply them evenly to the wound, and fix them with a bandage. Kangfuxin solution can be absorbed with a medical sponge / bandage.

[0134] Experimental methods

[0135] Modeling and grouping

[0136] Thirty-nine SPF SD rats that passed quarantine were selected, and the acute trauma model was established by removing the full-thickness skin of the rats. Before modeling, the hair on the back of the rats was removed with a shaver or depilatory cream, and the shaved area was 3.0cm*3.0cm. The hairless skin was checked for damage due to hair removal. If it was damaged, it was not suitable for the experiment. After shaving, the animals were anesthetized with isoflurane. After anesthesia, a circular skin defect with a diameter of about 7mm-10mm was made on the back of the rat with a skin sampler, and then the fascia layer was bluntly destroyed with a scalpel or surgical scissors and tweezers. After modeling, the wound was hemostatic and disinfected with iodine. The modeling day was 0d.

[0137] After the postoperative wound model was prepared, the animals were randomly divided into 13 groups, each with 3 animals: low-dose group of composition 1 of the present invention, medium-dose group of composition 1 of the present invention, high-dose group of composition 1 of the present invention, extract groups of each component, positive control group, blank control group (blank matrix), model control group (no treatment). When making animal models, prototype skin defect wounds need to be made on both sides of the spine of the rats. In addition, the shaved area on the back without wound treatment can be used as a control for clinical observation.

[0138] The dosage setting and administration are shown in Table 4:

[0139] Table 4 Experimental measurement and group design

[0140]

[0141] Centella asiatica extract, Lithospermum officinale extract, Bletilla striata extract, Chrysanthemum indici extract, and Frankincense powder extract are only used in the present invention for comparison to verify the synergistic effect of the composition of the present invention, so a high dose of the composition of the present invention is used.

[0142] Detection

[0143] Observation of physical signs and body weight of rats.

[0144] The rats' physical signs were observed after administration every day. The observation indicators included: animal appearance, behavioral activities, secretions, excretions, diet, death (number of deaths, time of death, pre-mortem reaction), etc. The body weight was measured once a week before administration and during continuous administration and recorded in the corresponding table.

[0145] Observation of the appearance of rat back wounds and determination of wound healing rate.

[0146] During the modeling and drug administration period, the wound was observed with the naked eye every day to see if there were inflammatory symptoms such as blood, inflammatory pus, and swelling. The scab of the wound was observed and the relevant conditions were recorded. The wound healing of rats in each group was observed on the day of modeling D0, the day of drug administration (D1), D3, D7, D11, and D14 after drug administration. The wound healing of the back wound of the rats was photographed and recorded. The JPEG format image data was obtained using Image-J image processing and analysis software to evaluate the wound healing. After using color and contrast filters to enhance the image, the red wound was selected as the measurement area based on the difference between the red wound and the background skin color, the wound area was measured, and the wound healing rate was calculated. Wound healing rate = (total area of ​​the original wound-unhealed wound area) / total area of ​​the original wound * 100%.

[0147] Animal treatment

[0148] Gross dissection: At the end of the experiment, the experimental animals shall be dissected grossly in accordance with relevant regulations, and the surface color, shape, size and texture of major organs such as the heart, liver, spleen, lungs, kidneys, gastrointestinal tract, brain, and drug administration site shall be observed with the naked eye to see if there are obvious toxic pathological changes, which shall be recorded on the animal disposal record sheet. If there are obvious lesions in the organs visible to the naked eye during the gross dissection, a comprehensive analysis shall be conducted based on the degree of the lesion to determine whether a histopathological examination shall be performed.

[0149] If an animal is found dead or dying during the experiment, a gross dissection should be performed on the animal in a timely manner in accordance with relevant regulations, and the surface color, shape, size, and texture of major organs such as the heart, liver, spleen, lungs, kidneys, gastrointestinal tract, brain, and administration site should be observed for obvious toxic and pathological changes, and the information should be recorded in the animal disposal record sheet.

[0150] Experimental Results

[0151] 1. Observation of rat physical signs and weight monitoring

[0152] After modeling, rats in each group showed symptoms such as decreased movement, but no other obvious abnormalities were observed. The body weights are shown in Table 5 below.

[0153] Table 5. Body weight of rats (g, n=3)

[0154]

[0155]

[0156] 2. Observation of the appearance of rat back wounds and determination of wound healing rate

[0157] The back skin of rats in each group was taken to the fascia using a skin harvester, a scalpel and surgical scissors, and the entire layer of skin was destroyed to create a circular wound. The original wound area of ​​the animals in each group is shown in Table 6 below.

[0158] Table 6 Original wound area of ​​rats in disease model group (cm 2 )

[0159]

[0160] As shown in Figure 1, on the first day of administration, the ulcer wounds of the animals in each group were red, with blood and inflammatory pus oozing out, and swelling was observed in some animals.

[0161] On the third day of continuous administration, exudation was observed on the wound surface of the blank control group animals given blank matrix, the wound edge shrank, and some animals had black-red blood exudation and thin white purulent secretions when pressed; exudation was observed on the wound surface of the untreated model control group animals, the wound edge shrank, and some animals had red-black blood and thin white purulent secretions when pressed; the wound surface of some animals in the low-dose group of the composition of the present invention was dry without exudation, the wound surface shrank, and some animals had bleeding and a thin layer of white purulent secretions; the wound surface of the animals in the medium-dose group of the composition of the present invention was dry without exudation, the wound surface shrank, and some animals had slight bleeding and thin white purulent secretions; the wound surface of the animals in the low- and high-dose groups of the composition of the present invention was dry without exudation, the wound surface shrank, and some animals had thin white purulent secretions; the wound surface of the animals in the Centella asiatica extract group, the Lithospermum officinale extract group, the Bletilla striata extract group, the Chrysanthemum indica extract group, the Platycodon grandiflorum extract group, the Isatis indigotica extract group, the Frankincense powder group, and the Kangfuxin liquid group was dry without exudation, the wound surface shrank, and some animals had bleeding and a thin layer of white purulent secretions;

[0162] On the 7th day of continuous administration, the wounds of the animals in the blank control group given the blank matrix formed reddish brown and black scabs, the wounds contracted, and exudation was still visible on the wounds of some animals; the wounds of the animals in the untreated model control group formed black and red scabs, the wounds contracted, and white dandruff was visible on the edges of the wounds of some animals; the wounds of the animals in the low-dose group of the composition of the present invention formed reddish brown and black scabs, the wounds contracted, and exudation was visible on the wounds of some animals when pressed; the wounds of the animals in the medium-dose group of the composition of the present invention formed reddish brown and black scabs, the wounds contracted, and exudation was visible on the wounds of some animals when pressed; the wounds of the animals in the low- and high-dose groups of the composition of the present invention formed reddish brown and black scabs, the wounds contracted, and exudation was visible on the wounds of some animals when pressed; the wounds of the animals in the Centella asiatica extract group formed thin reddish brown scabs, the wounds contracted, and exudation was visible on the wounds of some animals The wounds of the animals in the Lithospermum officinale extract group formed a thin reddish brown scab, the wound surface contracted, and exudation was still visible on the wounds of some animals; the wounds of the animals in the Bletilla striata extract group formed a thin reddish brown scab, the wound surface contracted, and exudation was still visible on the wounds of some animals; the wounds of the animals in the Chrysanthemum odoratum extract group formed a thin reddish brown scab, the wound surface contracted, and exudation was still visible on the wounds of some animals; the wounds of the animals in the Platycodon grandiflorum extract group formed a thin reddish brown scab, the wound surface contracted, and exudation was still visible on the wounds of some animals; the wounds of the animals in the Isatis indigotica extract group formed a thin reddish brown scab, the wound surface contracted, and exudation was still visible on the wounds of some animals; the wounds of the animals in the frankincense powder extract group formed a thin reddish brown scab, the wound surface contracted, and exudation was still visible on the wounds of some animals; the wounds of the animals in the Kangfuxin liquid group formed a thin reddish brown scab, the wound surface contracted, and exudation was still visible on the wounds of some animals.

[0163] On the 11th day of continuous administration, black scabs were observed on the wounds of the animals in the blank control group given blank matrix, and some animals had white dandruff attached; black scabs were observed on the wounds of the animals in the untreated model control group, and some animals had white dandruff attached; the wounds of the animals in the low, medium and high dose groups of the composition of the present invention healed, and small black or red scabs were observed at the healed wounds of the low dose group; the wounds of the animals in the Centella asiatica extract group healed, and small black star scabs were observed at the healed wounds; the wounds of some animals in the Lithospermum officinale extract group healed, and small black star scabs were observed at the healed wounds; black and red scabs were observed on the wounds of the animals in the Bletilla striata extract group, and some animals had The wounds of the animals in the wild chrysanthemum extract group were basically healed, with a few small scabs with black stars; black scabs were seen on the wounds of the animals in the platycodon extract group, and the wounds of some animals were healed, with a few small scabs with black stars; black scabs were seen on the wounds of the animals in the isatis indigotica extract group, and the wounds of some animals were healed, with a few small scabs with black stars; black scabs were seen on the wounds of the animals in the frankincense powder extract group, and the wounds of some animals were healed, with a few small scabs with black stars, and some animals had white dandruff attached; the wounds of the animals in the Kangfuxin liquid group were basically healed, with small scabs with black stars.

[0164] The wound healing rates and healing conditions of rats in each group are shown in Table 7. Figure 1-1 , Figure 1-2 and Figure 1-3 shown.

[0165] Table 7 Wound healing rate of rats after administration (%, n=3)

[0166]

[0167]

[0168] Note: Compared with the model control group, each dose group + P≤0.05.

[0169] The results showed that the wounds on the backs of animals in each group of animals during the dosing cycle were contracted, scabbed and healed, and the healing rates of each group were different on different days of dosing. During the test, the healing rate of the high-dose group of the composition of the present invention was higher than that of the control groups, and the wound healing progress was faster and the appearance was more beautiful. During the dosing period, the inflammatory reaction of the composition of the present invention was lighter than that of the blank control and the extracts of each component. In summary, the composition of the present invention has a promoting effect on the repair and healing of the back wounds of rats, and its pharmacodynamic effect is better than that of the extracts of each component, with obvious synergistic effect.

[0170] Example 5

[0171] The invention discloses a quality control and detection method for the content of Centella asiatica (calculated as the total amount of asiatica glycoside and madecassoside) in the cream / gel.

[0172] This detection method is a high performance liquid chromatography method. The chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as the filler (column length is 25cm, inner diameter is 4.6mm, particle size is 5μm); the mobile phase is: acetonitrile-2mmol / L beta-cyclodextrin solution (24:76); isocratic elution, the mobile phase ratio is fixed; the detection wavelength is 205nm. The theoretical plate number calculated based on the asiaticoside peak should be no less than 4000.

[0173] Preparation of reference solution: Accurately weigh appropriate amount of asiaticaoside reference substance and hydroxymadecassoside reference substance, add methanol to make 1 ml of solution containing 0.2 mg of each.

[0174] Preparation of test solution: Accurately weigh about 5 g of cream / gel, place in a stoppered conical flask, accurately add 20 mL of 80% methanol, seal, weigh, ultrasonic (power 180 W, frequency 42 kHz) for 30 minutes, cool, weigh again, make up the lost weight with 80% methanol, shake well, centrifuge and take the supernatant.

[0175] Determination method: Accurately pipette 10 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0176] Results: The total amount of Centella asiatica in terms of asiatica glycoside and madecassoside contained in the cream / gel of the present invention per 1 g is not less than 0.32 mg.

[0177] Example 6

[0178] The invention discloses a quality control and detection method for the content of lithospermum officinale (calculated as L-shikonin) in a cream / gel.

[0179] The detection method is UV-Vis spectrophotometry.

[0180] Preparation of test solution: accurately weigh about 6g of cream / gel, place in a 100ml volumetric flask, add ethanol to dissolve and dilute to scale, plug tightly, shake for 4 hours, and filter. Accurately measure 5ml of the filtrate, place in a 25ml volumetric flask, add ethanol to scale, shake well, and obtain.

[0181] Detection: Measure the absorbance at 516 nm. 1％ 1cm) is calculated as 242.

[0182] Results: The cream / gel of the present invention contains no less than 0.28 mg of lithospermum in terms of L-shikonin per 1 g.

[0183] Example 7

[0184] Quality control and detection method of Bletilla striata content (calculated as 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate) in cream / gel of the present invention

[0185] The detection method is high performance liquid chromatography.

[0186] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; the mobile phase was acetonitrile-0.1% phosphoric acid solution (22:78); isocratic elution, the mobile phase ratio was fixed; the detection wavelength was 223nm. The theoretical plate number calculated based on 1,4-di[4-(glucose oxygen) benzyl]-2-isobutyl malate should not be less than 2000.

[0187] Preparation of reference solution: Accurately weigh 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate reference substance, add dilute ethanol (50%) to make a 1 ml solution containing 0.15 mg of each.

[0188] Preparation of test solution: Accurately weigh about 5 g of cream / gel and place it in a 50 ml conical flask with a stopper. Accurately add 25 ml of dilute ethanol (50%) and weigh it. Ultrasonicate (power 300 W, frequency 37 kHz) for 30 minutes. Let cool and weigh it again. Make up the lost weight with ethanol. Shake well and filter the supernatant.

[0189] Determination method: Accurately pipette 10 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0190] Results: The content of Bletilla striata in the form of 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate per 1 g of the cream / gel of the present invention is not less than 0.20 mg.

[0191] Example 8

[0192] Quality control and detection method of wild chrysanthemum content (calculated as chrysantheminin) in cream / gel of the present invention

[0193] The detection method is high performance liquid chromatography.

[0194] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; the mobile phase was methanol-water-glacial acetic acid (26:23:1); isocratic elution, the mobile phase ratio was fixed; the detection wavelength was 334nm. The theoretical plate number calculated based on mongoside should be no less than 3000.

[0195] Preparation of reference solution: Accurately weigh the montmorillonine reference substance, dissolve it in methanol (heat if necessary) to make a 1 ml solution containing 25 μg.

[0196] Preparation of test solution: Accurately weigh about 5 g of cream / gel and place it in a stoppered conical flask of appropriate specifications. Accurately add 100 ml of methanol, weigh the weight, heat and reflux for 3 hours, cool, weigh again, make up the lost weight with methanol, shake well, filter, and take the filtrate to obtain the test solution.

[0197] Determination method: Accurately pipette 20μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0198] Results: Every 1 g of the cream / gel of the present invention contains no less than 0.08 mg of wild chrysanthemum in the form of chrysanthemoside.

[0199] Example 9

[0200] The quality control and detection method of the platycodon content (calculated as platycodon saponin D) in the cream / gel of the present invention is a high performance liquid chromatography method.

[0201] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; the mobile phase was acetonitrile-water (25:75); isocratic elution, the mobile phase ratio was fixed; evaporative light scattering detector was used for detection. The theoretical plate number calculated based on platycodon saponin D should not be less than 3000.

[0202] Preparation of reference solution: Accurately weigh platycodon saponin D reference substance, dissolve it in methanol to make a 1 ml solution containing 0.5 mg.

[0203] Preparation of test solution: Accurately weigh about 3g of cream / gel, place it in a stoppered conical flask of appropriate specifications, accurately add 50ml of 50% methanol, weigh the weight, ultrasonicate for 30 minutes (power 250W, frequency 40kHz), cool, weigh the weight again, make up the lost weight with 50% methanol, shake well, filter, take 25ml of the filtrate, evaporate to dryness, add 20ml of water to the residue, dissolve it with slight heat, shake and extract 3 times with water-saturated n-butanol, 20ml each time, combine the n-butanol solution, wash with 50ml of ammonia test solution, discard the ammonia solution, and then wash with 50ml of water saturated with n-butanol, discard the water solution, recover the solvent with the n-butanol solution until dry, add an appropriate amount of methanol to the residue to dissolve it, transfer it to a 5ml volumetric flask, add methanol to the scale, shake well, filter, take the filtrate, and obtain it.

[0204] Determination method: Accurately pipette 10 and 20 μl of reference solution and 10-15 μl of test solution respectively, inject into liquid chromatograph and determine.

[0205] Results: The content of Platycodon grandiflorum in terms of platycodon saponin D per 1 g of the cream / gel of the present invention is not less than 0.05 mg.

[0206] Example 10

[0207] Quality control and detection method of the content of Folium Isatidis (in indigo carmine) in the cream / gel of the present invention

[0208] The detection method is high performance liquid chromatography.

[0209] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; the mobile phase was methanol-water (75:25); isocratic elution, the mobile phase ratio was fixed; the detection wavelength was 289 nm. The theoretical plate number calculated by indigo red should not be less than 4000.

[0210] Preparation of reference solution: Accurately weigh the indigo red reference substance, dissolve it in methanol to make a 1 ml solution containing 2 μg.

[0211] Preparation of test solution: accurately weigh about 3g of cream / gel, place in a Soxhlet extractor, add chloroform, soak for 15h, heat and reflux until the extract is colorless. Recover the solvent to dryness, add methanol to dissolve the residue and transfer to a 100ml volumetric flask, add methanol to the scale, shake well, filter, and take the filtrate to obtain the solution.

[0212] Determination method: Accurately pipette 20μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0213] Results: Each 1 g of the cream / gel of the present invention contains not less than 0.002 mg of Folium Isatidis calculated as indirubin.

[0214] Embodiment 11

[0215] Quality control and detection method of frankincense content (measured in Somali frankincense volatile oil) in cream / gel of the present invention

[0216] This detection method is the volatile oil determination method A.

[0217] Weigh about 20g of cream / gel accurately, place in a flask, add 500ml of water and several glass beads, shake and mix, and connect the volatile oil analyzer and reflux condenser. Add water from the upper end of the condenser until it fills the scale part of the volatile oil analyzer and overflows into the flask. Place in an electric heating jacket or use other appropriate methods to slowly heat to boiling, and keep it boiling for 5 hours until the amount of oil in the analyzer no longer increases, stop heating, leave it for a while, open the piston at the lower end of the analyzer, and slowly release the water until the upper end of the oil layer reaches 5mm above the scale 0 line. Leave it for more than 1 hour, then open the piston to let the oil layer drop until its upper end is just flush with the scale 0 line, read the amount of volatile oil, and calculate the content of volatile oil in the test sample.

[0218] Results: Every 1g of the present invention contains no less than 0.0006mL of Somali frankincense volatile oil.

[0219] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A Chinese medicine composition for promoting wound healing, characterized in that: The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 30-50 parts of Centella asiatica, 10-20 parts of Lithospermum officinale, 5-20 parts of Bletilla striata, 5-20 parts of Chrysanthemum indica, 10-30 parts of Platycodon grandiflorum, 5-20 parts of Folium Isatidis, and 5-15 parts of Olibanum.

2. The Chinese medicine composition according to claim 1, characterized in that The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 30-50 parts of Centella asiatica, 10-20 parts of Lithospermum officinale, 10-20 parts of Bletilla striata, 10-15 parts of Chrysanthemum indica, 10-25 parts of Platycodon grandiflorum, 5-10 parts of Folium Isatidis, and 5-10 parts of Olibanum.

3. The Chinese medicine composition according to claim 2, characterized in that: The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 35-40 parts of Centella asiatica, 15-20 parts of Lithospermum officinale, 15-20 parts of Bletilla striata, 12-15 parts of Chrysanthemum indica, 20-25 parts of Platycodon grandiflorum, 5-10 parts of Folium Isatidis, and 8-10 parts of Olibanum.

4. Use of the Chinese medicine composition as described in any one of claims 1 to 3 in the preparation of a medicament for promoting wound healing.

5. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of antibacterial drugs.

6. A drug for promoting wound healing, characterized in that: The medicine comprises an active ingredient and a pharmaceutically acceptable carrier, and the active ingredient is the Chinese medicine composition according to any one of claims 1 to 3.

7. The drug according to claim 6, characterized in that The dosage form of the medicine is an external administration dosage form.

8. The drug according to claim 7, characterized in that The dosage form of the medicine is ointment, gel, solution and spray.

9. The method for preparing the drug according to any one of claims 6 to 8, characterized in that: The dosage form of the drug is an ointment or a gel, and the preparation method comprises the following steps: (1) weighing the frankincense, and crushing it to obtain frankincense fine powder; (2) Weigh the Centella asiatica, Bletilla striata, Chrysanthemum indigofera, Platycodon grandiflorum and Folium Isatidis, extract with water, then add ethanol, filter and obtain filtrate 1; (3) weighing the lithospermum officinale, frying and extracting it, filtering it, and obtaining filtrate 2; (4) combining the filtrate 1 and the filtrate 2, and concentrating them to obtain a drug solution; (5) Prepare a drug matrix, add the drug solution and frankincense powder into the matrix, and stir evenly to obtain the drug matrix.

10. The preparation method according to claim 9, characterized in that: The extraction in step (2) is decoction extraction; The mass of the water in step (2) is 5 to 15 times the total mass of the raw materials; The mass of the oil in step (3) is 3 to 10 times the mass of Lithospermum officinale.

11. The preparation method according to claim 10, characterized in that: Step (2) is: weigh the Centella asiatica, Bletilla striata, Chrysanthemum indigofera, Platycodon grandiflorum and Folium Isatidis, add water and boil for extraction 1 to 3 times, concentrate the filtrate into a clear paste, add ethanol, filter, and obtain filtrate 1.

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