Traditional Chinese medicine composition as well as application and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with the effects of promoting tissue regeneration, relieving pain, expelling pus and toxin, sterilizing and removing necrotic tissue. The traditional Chinese medicine composition is mainly prepared from the following raw materials in parts by weight: 1-55 parts of astragalus membranaceus, 1-50 parts of scutellaria baicalensis, 1-25 parts of coptis chinensis, 1-35 parts of golden cypress, 1-20 parts of rheum officinale, 1-25 parts of polygonum cuspidatum, 1-15 parts of borneol, 1-15 parts of dried alum and 50-350 parts of sesame oil. The traditional Chinese medicine composition disclosed by the invention can be used for effectively treating the phenomenon that the wound surface is not healed for a long time caused by various reasons, has disinfection and sterilization effects, and can replace alcohol, iodine tincture, iodophor, bromogeramine and other poisoning agents used for treating the wound surface clinically.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, which is a divisional application of patent application number 202011146141.6, filed on October 23, 2020, entitled "A Traditional Chinese Medicine Composition and Its Uses and Preparation Methods", and belongs to the field of traditional Chinese medicine technology. Background Technology

[0002] A wound is damage to normal skin (tissue) caused by external injury factors (such as surgery, external force, heat, electric current, chemicals, and low temperature) and internal factors (such as local blood supply disorders). A wound is a disease with characteristics of a single disease, including etiology, epidemiology, and symptoms, requiring diagnosis and treatment planning. The causes of wounds are numerous, including systemic chronic diseases such as diabetes, hypertension, gout, rheumatism, and lupus erythematosus; vascular diseases such as varicose veins of the great saphenous vein and arterial occlusion; skin diseases (such as eczema, sebaceous cysts, and neurological diseases); physical and mechanical injuries (such as crush injuries and avulsions); burns; scalds; frostbite; electric shocks; animal bites; chemical injuries; tumors; and iatrogenic injuries (such as surgery, radiotherapy, and medications).

[0003] The main clinical manifestations of wounds include skin ulceration, manifested as soft tissue defects, ulceration with bleeding or tissue fluid; subcutaneous tissue damage, such as subcutaneous nerve and blood vessel damage, muscle connective tissue necrosis, and osteoporosis and necrosis of bone cortex; infection, with local purulent discharge, redness, swelling, heat and pain; ischemic manifestations, such as tissue crusting, tissue shriveling, or necrosis of the extremities; and functional impairments, such as joint deformities and movement disorders, defecation disorders caused by perianal wounds, and mouth opening disorders caused by periocular wounds.

[0004] Differential diagnosis of wound diseases mainly involves etiological and pathological differentiation. These include ischemic wounds (such as distal arterial occlusion and diabetic foot) and inflammatory wounds (such as cutaneous phlebitis, lymphangitis, dog and snake bites, Vibrio vulnificus, carbuncles, cellulitis of the skin and soft tissues, necrotizing fasciitis, benign ulcers, malignant ulcers, penetrating fistulas, and blind fistulas).

[0005] With a wide variety of wound types, broad professional scope, complex mechanisms, and high treatment difficulty, how to ensure that wound patients receive effective treatment is an urgent issue for the medical community. Summary of the Invention

[0006] Traditional Chinese medicine has anti-inflammatory and swelling-reducing effects on wounds, especially complex wounds. Topical medications can promote granulation tissue and blood vessel growth, and promote wound healing.

[0007] One of the purposes of the present application is to provide a traditional Chinese medicine composition with the effects of promoting tissue regeneration, relieving swelling and pain, expelling pus, disinfecting and sterilizing, and removing corruption, which is mainly prepared from the following raw materials: Radix Astragali 1-55 parts by weight, Radix Scrophulariae 1-50 parts by weight, Rhizoma Coptidis 1-25 parts by weight, Cortex Phellodendri 1-35 parts by weight, Radix et Rhizoma Rhei 1-20 parts by weight, Rhizoma Polygoni Cuspidati 1-25 parts by weight, Borneolum Syntheticum 1-15 parts by weight, Ferula Semen 1-15 parts by weight, and Sesamum Indicum Oil 50-450 parts by weight.

[0008] Preferably, the traditional Chinese medicine composition is mainly prepared from the following raw materials: Radix Astragali 1-30 parts by weight, Radix Scrophulariae 1-15 parts by weight, Rhizoma Coptidis 1-30 parts by weight, Cortex Phellodendri 1-20 parts by weight, Radix et Rhizoma Rhei 1-25 parts by weight, Rhizoma Polygoni Cuspidati 1-20 parts by weight, Borneolum Syntheticum 1-15 parts by weight, Ferula Semen 1-10 parts by weight, and Sesamum Indicum Oil 50-200 parts by weight.

[0009] Further preferably, the traditional Chinese medicine composition is mainly prepared from the following raw materials: Radix Astragali 4-5 parts by weight, Radix Scrophulariae 4-6 parts by weight, Rhizoma Coptidis 3-5 parts by weight, Cortex Phellodendri 4-6 parts by weight, Radix et Rhizoma Rhei 2-3 parts by weight, Rhizoma Polygoni Cuspidati 2-4 parts by weight, Borneolum Syntheticum 1-2 parts by weight, Ferula Semen 2-4 parts by weight, and Sesamum Indicum Oil 90-190 parts by weight.

[0010] The second purpose of the present application is to provide a preparation method of the traditional Chinese medicine composition, which mainly comprises the following steps: Step A: powdering Borneolum Syntheticum and Ferula Semen, sieving through a 120-mesh sieve, and preparing fine powder for use; Step B: preparing coarse granules from Radix Scrophulariae, Cortex Phellodendri, Radix et Rhizoma Rhei, and Rhizoma Polygoni Cuspidati, soaking the mixture in Sesamum Indicum Oil, and preparing the mixture for use; Step C: preparing coarse granules from Radix Astragali and Rhizoma Coptidis, soaking the mixture in Sesamum Indicum Oil for 24 hours, heating under a strong fire until Radix Astragali and Rhizoma Coptidis turn yellow, adding the mixture obtained in Step B, heating, filtering, cooling, and preparing the liquid for use; Step D: adding the fine powder obtained in Step A to the liquid obtained in Step C.

[0011] Preferably, the preparation method mainly comprises the following steps: Step A: powdering Borneolum Syntheticum and Ferula Semen, sieving through a 120-mesh sieve, and preparing fine powder for use; Step B: preparing coarse granules from Radix Scrophulariae, Cortex Phellodendri, Radix et Rhizoma Rhei, and Rhizoma Polygoni Cuspidati, soaking the mixture in Sesamum Indicum Oil, and preparing the mixture for use; Step C: preparing coarse granules from Radix Astragali and Rhizoma Coptidis, soaking the mixture in Sesamum Indicum Oil for 24 hours, heating under a strong fire until Radix Astragali and Rhizoma Coptidis turn yellow, adding the mixture obtained in Step B, heating, filtering, cooling, and preparing the liquid for use; Step D: adding the fine powder obtained in Step A to the liquid obtained in Step C.

[0012] The third object of the present application is to provide the use of the above-mentioned traditional Chinese medicine composition, i.e. the use in preparing disinfectant, bactericide, putrefaction-removing and pus-discharging drugs and the use in preparing drugs for promoting wound healing.

[0013] The fourth object of the present application is to provide a traditional Chinese medicine preparation containing the above-mentioned traditional Chinese medicine composition; preferably, the traditional Chinese medicine preparation is in a clinically acceptable dosage form; further preferably, the clinically acceptable dosage form is an external ointment; more preferably, the external ointment is one or more of an ointment, a paste, a film-coating agent and a liniment.

[0014] Compared with the prior art, the present application has achieved remarkable technical effects: 1) The traditional Chinese medicine composition of the present application can effectively treat long-term non-healing wounds caused by various reasons, especially the problems of fresh tissue at the base of the treated wound, abundant granulation, obvious bleeding when touched, and non-spreading of the surrounding skin to the center.

[0015] 2) The traditional Chinese medicine composition of the present application can also dissolve the secretions around and inside the ulcer, making it easy to clean the ulcer surface and shorten the healing time of normal wounds.

[0016] 3) The traditional Chinese medicine composition of the present application has definite curative effect and no irritation, and can replace disinfectants and bactericides such as alcohol, iodine, iodophor and new jieerdu used in clinical treatment of wounds. BRIEF DESCRIPTION OF DRAWINGS

[0017] APPENDIX Figure 1 Typical case 1 of the present application: appearance of perianal skin (July 04, 2013) APPENDIX Figure 2 Typical case 1 of the present application: appearance of perianal skin (July 12, 2013) APPENDIX Figure 3 Typical case 1 of the present application: appearance of perianal skin (July 16, 2013) APPENDIX Figure 4 Typical case 2 of the present application: perianal infection of acute myeloid leukemia-M2 (July 18, 2013) APPENDIX Figure 5 Typical case 2 of the present application: perianal infection of acute myeloid leukemia-M2 (July 22, 2013) DETAILED DESCRIPTION The inventor would like to point out that the following examples are only representative of some of the formulations and preparation methods of the present application, but those skilled in the art should know that the examples described do not limit the present application in any way. In addition, those skilled in the art can make many possible changes and modifications to the technical solutions of the present application, or modify equivalent examples with equivalent changes, without departing from the scope of the technical solutions of the present application, by utilizing the disclosed technical content. Therefore, any simple modification, equivalent change and modification made to the following examples in accordance with the technical essence of the present application should fall within the scope of protection of the technical solutions of the present application.

[0018] Example 1 Preparation of ointment Prescription: Radix Astragali 1 g, Radix Scrophulariae 1 g, Rhizoma Coptidis 1 g, Cortex Phellodendri 1 g, Radix et Rhizoma Rhei 20 g, Rhizoma Polygoni Cuspidati 25 g, Borneolum Syntheticum 1 g, Calcined Alum 1 g, Sesamum Indicum Oil 50 g; Preparation method: Step A: Mix Borneolum Syntheticum and Calcined Alum, crush, pass through a 120-mesh sieve, and reserve the fine powder; Step B: Mix Radix Scrophulariae, Cortex Phellodendri, Radix et Rhizoma Rhei, and Rhizoma Polygoni Cuspidati, crush, and make coarse granules. Soak the mixture in an appropriate amount of Sesamum Indicum Oil for 24 hours, and reserve the mixture; Step C: Mix Radix Astragali and Rhizoma Coptidis, crush, and make coarse granules. Soak the mixture in an appropriate amount of Sesamum Indicum Oil for 24 hours. Heat over high heat until Radix Astragali and Rhizoma Coptidis turn yellow. Add the mixture obtained in Step B, and continue heating until all the medicines turn dark brown. Immediately filter, cool to room temperature, and reserve the medicinal liquid; Step D: Slowly add the fine powder obtained in Step A to the medicinal liquid obtained in Step C, stir to dissolve, and obtain the traditional Chinese medicine composition.

[0019] Prepare the traditional Chinese medicine composition into an ointment according to the conventional process.

[0020] Example 2 Preparation of film coating agent Prescription: Radix Astragali 55 g, Radix Scrophulariae 50 g, Rhizoma Coptidis 25 g, Cortex Phellodendri 35 g, Radix et Rhizoma Rhei 1 g, Rhizoma Polygoni Cuspidati 1 g, Borneolum Syntheticum 15 g, Calcined Alum 15 g, Sesamum Indicum Oil 250 g The preparation method of the traditional Chinese medicine composition is the same as that in Example 1. Prepare the traditional Chinese medicine composition into a film coating agent according to the conventional process.

[0021] Example 3 Preparation of liniment Prescription: Radix Astragali 10 g, Radix Scrophulariae 10 g, Rhizoma Coptidis 10 g, Cortex Phellodendri 10 g, Radix et Rhizoma Rhei 5 g, Rhizoma Polygoni Cuspidati 5 g, Borneolum Syntheticum 5 g, Calcined Alum 5 g, Sesamum Indicum Oil 200 g; The preparation method of the traditional Chinese medicine composition is the same as that in Example 1. Prepare the traditional Chinese medicine composition into a liniment according to the conventional process.

[0022] Example 4 Preparation of paste Prescription: Radix Astragali 4 g, Radix Scrophulariae 6 g, Rhizoma Coptidis 3 g, Cortex Phellodendri 6 g, Radix et Rhizoma Rhei 2 g, Polygonum cuspidatum 4 g, Borneolum Syntheticum 1 g, Ferula assa-foetida 4 g, and Camellia oil 90 g.

[0023] The Chinese medicinal composition is prepared into a paste according to a conventional process.

[0024] Example 5 Preparation of paste Prescription: Radix Astragali 5 g, Radix Scrophulariae 4 g, Rhizoma Coptidis 5 g, Cortex Phellodendri 4 g, Radix et Rhizoma Rhei 3 g, Polygonum cuspidatum 2 g, Borneolum Syntheticum 2 g, Ferula assa-foetida 2 g, and Camellia oil 190 g.

[0025] The Chinese medicinal composition is prepared into a paste according to a conventional process.

[0026] I. Effect of the Chinese medicinal composition of the present application on wound healing after operation in rats To verify the effects of the Chinese medicinal composition of the present application in promoting tissue regeneration, relieving pain, expelling pus, killing bacteria, removing decay, and promoting wound healing, the inventors carried out pharmacodynamic test research and drug clinical research. It should be noted that the following only takes the most representative formula of the present application as an example to illustrate part of the pharmacodynamic experiments; the other formulas and effects included in the present application have also been subjected to pharmacodynamic experiments, and all have the same or similar effects, but due to the limitation of the length, they are not listed one by one here.

[0027] The inventors would like to point out that the following experimental researches are carried out on the basis of the safety of acute toxicity test and long-term toxicity test, and the dosages in the experimental researches are within the safe dosage range.

[0028] 1 Material 1.1 Animal: SD rats, 180~220 g, experimental animal license number: SYXK(Lu)2018 0008, adaptive feeding for one week before experiment.

[0029] 1.2 Test substance 1.2.1 Drug The Chinese medicinal composition prepared according to the prescription and preparation method described in Example 5 (concentrated to 1 mL of liquid containing 0.5 g, 1 g, and 1.5 g of original medicinal materials, respectively, as low, medium, and high doses of the present application).

[0030] 1.2.2 Method of use External use. Apply to the wound (thickness is thinner than 1mm), replace new drug every 4-6 hours. Before dressing change, wipe off the drug and liquefaction on the wound, and expose the wound to the drug.

[0031] 2. Modeling and grouping, administration 2.1 Modeling The perianal local injection of glacial acetic acid method is used to establish the postoperative wound infection model, and the specific operation is as follows: iodophor cotton ball is used to disinfect the perianal skin of the rat, and 75% glacial acetic acid is injected in a fan shape under the skin of the perianal part of the rat, and after injection, the perianal part is massaged to make the liquid fully disperse. 24 hours after injection, the perianal part is observed for ulcer, redness, inflammatory exudation, etc.

[0032] The success criteria of modeling are as follows: the perianal part is red and swollen, the swelling is greater than 1mm, exceeds the ulcer surface, the inflammatory exudation is much, and the ulcer surface is greater than or equal to 0.3cm 2 .

[0033] 2.2 Grouping and administration On the second day after successful modeling, 40 successfully modeled rats are taken out, and are randomly divided into a model group, an (high, medium and low) dose group of the present application, and each group has 10 rats.

[0034] Another 10 normal rats are taken out as a blank group.

[0035] The three dose groups of the present application are respectively smeared with the corresponding drugs in the wound area according to the above-mentioned “1.2.2 method of use”, and the blank group and the model group are smeared with 0.9% normal saline.

[0036] The administration is continuously performed for 7 days.

[0037] 3. Inspection items 3.1 Inspection of the perianal edema degree and wound area of the rat After the last administration, the ulcer area size and the edema degree of the perianal wound are measured, and a standard score is made. No edema is 0 points, barely visible is 1 point, the edge is higher than the skin is 2 points, and obvious swelling is 3 points.

[0038] 3.2 Statistical method SPSS22.0 software is used for data processing. The obtained data is represented by mean ± standard deviation (x±s) ), normal distribution test and variance homogeneity test are performed on the data of each group, and single factor variance analysis is used for comparison between groups. P<0.05 is considered to have statistical significance.

[0039] 4. Results and conclusions The perianal edema degree score and the wound area of the model group of rats are significantly higher than those of the blank group (P<0.01), the perianal edema degree score of the high and medium dose groups of the present application has no difference with that of the blank group (P>0.05), and the wound area is higher than that of the blank group (P<0.01).

[0040] Table 1 Comparison of perianal edema degree score and wound area of rats in each group n=10 Note: compared with the blank group, @ P <0.05, # P <0.01; compared with the model group, & P <0.01; II. Clinical typical cases Clinical indications: suitable for various types of long-term non-healing wounds of unknown causes. Solve long-term non-healing wounds caused by various reasons, especially the base of the treated wound is fresh, the granulation is rich, the touch is obvious, and the surrounding skin does not spread to the center. The invention can also dissolve the secretions around and inside the ulcer, making it easy to clean the ulcer surface and shorten the healing time of normal wounds.

[0041] Usage and dosage: various types of long-term non-healing wounds of unknown causes (thickness less than 1mm), replace new medicine every 4-6 hours. Before dressing change, the remaining medicine and liquefied material on the wound surface should be wiped off and the wound surface should be exposed to the medicine.

[0042] The inventor wants to explain that wound diseases involve a wide range of aspects and types. Since 2012, the First Affiliated Hospital of Zhengzhou University has collected part of the patients of 40 cases of various types of long-term non-healing wounds (surgical wounds, burn and scald wounds, and non-healing wounds caused by genetic diseases). The following are only some typical cases in the clinical treatment process, which are used for explanation.

[0043] 1. Wei, male, 18 years old. The patient found a hard lump around the anus with pain for more than 1 year, accompanied by dry stool, difficult defecation, abdominal distension, and a sense of incomplete defecation. There was no fever, abdominal pain, nausea and vomiting, hematochezia, and pyocyanic stool. He underwent surgical ligation at the local hospital, but the effect was not good. One year after the operation, the patient had bleeding and pus from the broken part of the sacrococcygeal region every time he defecated. After entering our hospital, he was diagnosed with sacrococcygeal pilonidal sinus and underwent "sacrococcygeal pilonidal sinus resection + wound expansion". After the operation, anti-inflammatory and continuous negative pressure suction were given. After 1 month of local wound application of Wound Healing I, the sacrococcygeal wound grew well after the fresh granulation, and the wound healed. The apparent phenomenon is shown in the attached Figure 1 (2013-07-04), attached Figure 2 (2013-07-12), attached Figure 3 (2013-07-16).

[0044] 2. Zhu, male, 16 years old. The patient was admitted to hospital with "intermittent loss of consciousness for more than 10 months". After examination such as bone puncture, the patient was diagnosed as acute myeloid leukemia-M2, and was successively given "DA" scheme, "MEA, high-dose cytarabine, TA" scheme chemotherapy. The patient had perianal infection, and the effect was poor after being given strong antibiotics and perianal debridement. Later, the patient was given Wound Healing No. I for external use, and the perianal wound gradually recovered. The apparent phenomenon is shown in the attached Figure 4 (2013.07.18), and the attached Figure 5 (2013.07.22).

Claims

1. A traditional Chinese medicine composition for promoting wound healing, characterized in that, The traditional Chinese medicine composition is mainly prepared from the following raw materials: 1-55 parts by weight of Radix Astragali, 1-50 parts by weight of Radix Scutellariae, 1-25 parts by weight of Rhizoma Coptidis, 1-35 parts by weight of Cortex Phellodendri, 1-20 parts by weight of Radix et Rhizoma Rhei, 1-25 parts by weight of Rhizoma Polygoni Cuspidati, 1-15 parts by weight of Borneolum Syntheticum, 1-15 parts by weight of Ferula Gummosa, and 50-450 parts by weight of Sesamum Indicum Oil.

2. The traditional Chinese medicine composition of claim 1, wherein, The traditional Chinese medicine composition is mainly prepared from the following raw materials: 1-30 parts by weight of Radix Astragali, 1-15 parts by weight of Radix Scutellariae, 1-30 parts by weight of Rhizoma Coptidis, 1-20 parts by weight of Cortex Phellodendri, 1-25 parts by weight of Radix et Rhizoma Rhei, 1-20 parts by weight of Rhizoma Polygoni Cuspidati, 1-15 parts by weight of Borneolum Syntheticum, 1-10 parts by weight of Ferula Gummosa, and 50-200 parts by weight of Sesamum Indicum Oil.

3. The traditional Chinese medicine composition of claim 2, wherein, The traditional Chinese medicine composition is mainly prepared from the following raw materials: 4-5 parts by weight of Radix Astragali, 4-6 parts by weight of Radix Scutellariae, 3-5 parts by weight of Rhizoma Coptidis, 4-6 parts by weight of Cortex Phellodendri, 2-3 parts by weight of Radix et Rhizoma Rhei, 2-4 parts by weight of Rhizoma Polygoni Cuspidati, 1-2 parts by weight of Borneolum Syntheticum, 2-4 parts by weight of Ferula Gummosa, and 90-190 parts by weight of Sesamum Indicum Oil.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The preparation method of the traditional Chinese medicine composition mainly comprises the following steps: Step A: the Borneolum Syntheticum and Ferula Gummosa are crushed and passed through a 120-mesh sieve, and the fine powder is prepared for use; Step B: the Radix Scutellariae, Cortex Phellodendri, Radix et Rhizoma Rhei, and Rhizoma Polygoni Cuspidati are prepared into coarse granules, and then soaked in Sesamum Indicum Oil for 24 hours, and the mixture is prepared for use; Step C: the Radix Astragali and Rhizoma Coptidis are prepared into coarse granules, and then soaked in Sesamum Indicum Oil for 24 hours, and then heated with a strong fire until the Radix Astragali and Rhizoma Coptidis turn yellow, and then the mixture obtained in step B is added, and heated until all the medicinal materials turn dark, and then filtered, cooled, and the medicinal liquid is prepared for use; Step D: the fine powder obtained in step A is added to the medicinal liquid obtained in step C, and then stirred and dissolved, and the traditional Chinese medicine composition is obtained.

5. The preparation method according to claim 4, characterized in that, The preparation method mainly comprises the following steps: Step A: the Borneolum Syntheticum and Ferula Gummosa are crushed and passed through a 120-mesh sieve, and the fine powder is prepared for use; Step B: the Radix Scutellariae, Cortex Phellodendri, Radix et Rhizoma Rhei, and Rhizoma Polygoni Cuspidati are prepared into coarse granules, and then soaked in Sesamum Indicum Oil, and the mixture is prepared for use; Step C: the Radix Astragali and Rhizoma Coptidis are prepared into coarse granules, and then soaked in Sesamum Indicum Oil for 24 hours, and then heated with a strong fire until the Radix Astragali and Rhizoma Coptidis turn yellow, and then the mixture obtained in step B is added, and heated until all the medicinal materials turn dark, and then filtered, cooled, and the medicinal liquid is prepared for use; Step D: the fine powder obtained in step A is added to the medicinal liquid obtained in step C, and then stirred and dissolved, and the traditional Chinese medicine composition is obtained.

6. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The promotion of wound healing refers to the wound of the perianal part.

7. A traditional Chinese medicine preparation containing the traditional Chinese medicine composition of any one of claims 1-3.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The traditional Chinese medicine preparation is in a clinically acceptable dosage form; preferably, the clinically acceptable dosage form is an external ointment.

9. The traditional Chinese medicine preparation according to claim 8, characterized in that, The external ointment is one or more of an ointment, a paste, a coating agent, and a liniment.

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