Traditional Chinese medicine formula for softening hyperplasia scars and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine formula for softening hyperplasia scars and a preparation method thereof. The formula is composed of manis pentadactyla, salvia miltiorrhiza, safflower, leech, peach kernel, ligusticum wallichii, pseudo-ginseng, frankincense, myrrh, curcuma zedoary, rhizoma sparganii, golden head centipede, lucid ganoderma, quick lime, white mulberry root-bark, cocklebur fruit, wahlenbergia marginata, malva verticillata, sedum sarmentosum, mazus japonicus, selfheal, mature vinegar, alcohol and other medicinal materials. Through accurate proportioning and scientific preparation, the formula can effectively soften hyperplastic scars and promote repair and regeneration of skin tissues, and has the characteristics of mildness, no irritation and no obvious side effects. The preparation method comprises the steps of raw material preparation, material mixing, forming, preparation and the like. The traditional Chinese medicine composition has remarkable superiority in the aspects of softening scars, relieving pruritus and improving skin texture, is suitable for repairing various types of scars after operation, burn and the like, and has a wide application prospect.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine formula for softening hypertrophic scars and a preparation method thereof. Background Art

[0002] With the continuous advancement of medical technology, scar repair has become an important research direction in the fields of plastic surgery and dermatology. Hypertrophic scars and keloid scars are abnormal healing processes caused by skin trauma, surgery, etc. This healing is usually accompanied by excessive collagen fiber proliferation, resulting in the formation of protruding, hard, and painful and itchy scar tissue on the skin surface. This type of scar not only affects the appearance, but also affects the patient's mental health and quality of life.

[0003] At present, traditional scar softening treatments mainly include laser therapy, topical chemical preparations, compression therapy, and surgical excision. Although these methods can alleviate scar symptoms to a certain extent, they often have the following problems:

[0004] Unstable efficacy: For example, while laser treatment can stimulate skin regeneration and repair, its effectiveness varies from individual to individual, and some patients may experience worsening of scars after treatment.

[0005] Obvious side effects: Although chemical agents such as steroid hormone drugs can inhibit the proliferation of scar tissue, long-term use can easily lead to skin atrophy, pigmentation and other adverse reactions, increasing the patient's treatment risk.

[0006] High cost of use: For example, laser treatment and surgical resection are expensive and require multiple treatments to be effective, which not only increases the financial burden on patients but may also prolong treatment time.

[0007] Limited scope of application: Many scar treatment methods have different effects on different types of scars, especially for stubborn hypertrophic scars and keloid scars, the effects of traditional methods are often not ideal.

[0008] Therefore, it is a technical problem to be solved urgently to find a safe, effective, low-cost and widely applicable scar softening method. As a traditional medical method with a long history, Chinese medicine has gradually attracted people's attention with its natural ingredients, mild effects and small side effects. Through reasonable compatibility and scientific preparation, Chinese medicine preparations with the ability to soften scars and improve skin tissue regeneration can be made. Although Chinese medicine has a certain application in scar treatment, there is a lack of special Chinese medicine formulas and scientific preparation methods for hypertrophic scars and pimple scars on the market, and there is still a lot of room for development in this field. Summary of the invention

[0009] The purpose of the present invention is to provide a Chinese medicine formula for softening hypertrophic scars and a preparation method thereof, which has the advantages of gently softening scars, promoting tissue regeneration, and reducing skin irritation, and solves the problems of unstable scar softening treatment effect, side effects and limited scope of application in the prior art.

[0010] To achieve the above object, the present invention provides the following technical solution: a Chinese medicine formula for softening hypertrophic scars, the formula consisting of the following components:

[0011] Main prescription medicinal materials group: pangolin, salvia miltiorrhiza, safflower, leech, peach kernel, chuanxiong, notoginseng, frankincense, myrrh, zedoaria, trillium, golden head centipede, ganoderma lucidum, quicklime;

[0012] The medicinal material group of the attached prescription: Morus alba bark, Xanthium sibiricum, Ginseng odoratum, Sophora flavescens, Herba Lysimachiae, Herba Cynanchum, Herba Prunellae;

[0013] Additional liquid group: aged vinegar and alcohol.

[0014] Preferably, the Chinese medicine formula includes the following specific components:

[0015] Pangolin: 10-12 grams; Salvia miltiorrhiza: 14-16 grams; Safflower: 9-11 grams; Leech: 12-14 grams; Peach kernel: 14-16 grams; Chuanxiong: 9-11 grams; Panax notoginseng: 16-18 grams; Frankincense: 15-17 grams; Myrrh: 15-17 grams; Curcuma: 7-9 grams; Trillium: 7-9 grams; Golden head centipede: 1; Ganoderma lucidum: 11-13 grams; Quicklime: 4-6 grams; Morus alba bark: 14-16 grams; Xanthium sibiricum: 9-11 grams; Orchid ginseng: 14-16 grams; Sunflower: 9-11 grams; Creeping pot grass: 14-16 grams; Tongquan grass: 14-16 grams; Prunella vulgaris: 14-16 grams; Vinegar: 450-550 ml; Alcohol: 90-110 ml.

[0016] Preferably, the specific composition of the Chinese medicine formula is:

[0017] Pangolin: 11 grams; Salvia miltiorrhiza: 15 grams; Safflower: 10 grams; Leech: 13 grams; Peach kernel: 15 grams; Ligusticum chuanxiong: 10 grams; Panax notoginseng: 17 grams; Frankincense: 16 grams; Myrrh: 16 grams; Curcuma: 8 grams; Trillium: 8 grams; Golden head centipede: 1; Ganoderma lucidum: 12 grams; Quicklime: 5 grams; Morus alba bark: 15 grams; Xanthium sibiricum: 10 grams; Panax ginseng: 15 grams; Sunflower seed: 10 grams; Creeping pot grass: 15 grams; Scutellaria baicalensis: 15 grams; Prunella vulgaris: 15 grams; Aged vinegar: 500 ml; Alcohol: 100 ml.

[0018] Preferably, the alcohol is 75% alcohol;

[0019] Aged vinegar is aged fermented rice vinegar with an acidity of 4-6% and a density of 1.02-1.04 g / cm 3, pH value is 2.5-3.5;

[0020] The quicklime has a particle size of 50 microns to 100 microns and a purity of more than 95%;

[0021] The oil content of frankincense and myrrh is 10-15%, and their volatile components can account for 3-5% of the total.

[0022] A method for preparing a Chinese medicine formula for softening hypertrophic scars comprises the following steps:

[0023] S1. Raw material preparation:

[0024] a) weighing pangolin, salvia miltiorrhiza, safflower, leech, peach kernel, chuanxiong, notoginseng, frankincense, myrrh, zedoaria, trifoliate green, golden headed centipede and ganoderma lucidum according to the proportion, each medicinal material is accurate to ±0.1g, and crushing into fine powder with a particle size of 10-50 microns to form a uniform mixed powder;

[0025] b) weighing and mixing the bark of white mulberry, Xanthium sibiricum, ginseng, sunflower, spatholobi, herba spatholobi, herba spatholobi and herba prunellae in proportion, adding 500 ml of aged vinegar, mixing well and fermenting, the fermentation temperature is controlled at 25-30° C., the fermentation time is 72 hours, and the humidity is maintained at 60-70% during the process.

[0026] S2. Material mixing:

[0027] a) After fermentation is completed, the medicinal materials and the aged vinegar solution are filtered three times, and the accuracy of each filtration is controlled at 5-10 microns to ensure that a clear liquid without impurities is obtained;

[0028] b) The obtained clear liquid is placed in an evaporator and concentrated to a volume of 200 ml. The temperature is maintained at 100-105°C during the concentration process. Subsequently, 100 ml of 75% alcohol is added. After stirring evenly, quicklime with a particle size of 50-100 microns is gradually added to ensure that the alkalinity of the quicklime reaches pH 8-9.5 in the solution. The solution is fully mixed until the solution is uniform.

[0029] S3, molding and preparation:

[0030] a) Slowly cool the mixed liquid medicine to room temperature in an environment of 25-30℃, avoiding direct sunlight during the cooling process to ensure that the volatile components in the liquid medicine are not lost by evaporation;

[0031] b) The cooled liquid medicine is finally filtered with a filtration accuracy of 1-5 microns to ensure that the liquid medicine is free of particulate impurities, and then placed in a brown sealed bottle with a capacity of 100 ml to avoid the influence of air and moisture to obtain the final external-use medicine.

[0032] Preferably, the S1 raw material preparation step further includes the following specific steps:

[0033] S1.1 Dry the crushed medicinal materials at 60-80℃ for 1-2 hours to reduce the moisture content to ≤5% to ensure the stability and uniformity of the medicinal materials;

[0034] S1.2 Before fermentation, automatic stirring equipment is used to ensure the uniform distribution of the aged vinegar, and the vinegar is stirred once every 24 hours during the fermentation process to ensure the uniformity of the fermentation. The pH value of the aged vinegar is finally controlled at 2.5-3.5 and the acidity is 4-6%.

[0035] Preferably, the S2 material mixing step further includes the following specific steps:

[0036] S2.1 When performing three filtrations, use 5 micron, 7.5 micron and 10 micron filter materials respectively to ensure that the purity of the clear liquid after each filtration meets the pharmacopoeia standards;

[0037] S2.2 During the concentration process, use precision temperature control equipment to stabilize the temperature of the drug solution within the range of 100-105°C, and use a constant temperature evaporator to prevent the loss of active ingredients;

[0038] S2.3 Add quicklime to the solution at a weight ratio of 2%, ensuring that the alkalinity of the solution is between pH 8-9.5, and extend the stirring time to 30 minutes to ensure that the quicklime is completely dissolved and evenly distributed in the solution.

[0039] Preferably, the S3 forming and preparing step further comprises the following specific steps:

[0040] S3.1 The mixed liquid medicine is slowly cooled at a rate of ≤1°C / min in a constant temperature environment below 30°C to reduce the loss of volatile components of the liquid medicine;

[0041] S3.2 The cooled liquid medicine is finally filtered using a 1-3 micron ultra-fine filter to ensure that there are no residual impurities;

[0042] S3.3 The prepared external-use medicine is stored in a light-proof environment with a relative humidity of 40-60%, the room temperature is controlled at 15-25°C, and vacuum sealing technology is used to ensure that the shelf life is not less than 24 months.

[0043] Compared with the prior art, the present invention has the following beneficial effects:

[0044] 1. The present invention sets a scientific compatibility of multiple Chinese medicinal materials, such as pangolin, salvia miltiorrhiza, safflower, leech, frankincense, myrrh, etc., and combines the advantages of these medicinal materials in promoting blood circulation and removing blood stasis, relieving swelling and pain, softening and dispersing nodules, so as to achieve the effect of effectively softening hyperplastic scars, inhibiting scar hyperplasia, and reducing the hardness of scar tissue.

[0045] 2. The present invention improves the preparation method of traditional Chinese medicine formula, including strictly controlling the fermentation temperature and time, using high-precision filtration technology and optimizing the pH value of the medicine solution, thereby ensuring the effectiveness and safety of the drug ingredients, reducing the irritation of external agents to the skin, and avoiding the common skin burns and allergies in traditional treatment methods.

[0046] 3. The present invention adopts appropriate solution alkalinity adjustment to control the alkalinity of quicklime between pH 8-9.5, thereby avoiding skin burns that may be caused by excessive alkalinity, improving the mildness and safety of the drug, and being suitable for long-term use.

[0047] 4. The preparation method of the present invention is simple and suitable for industrial production. Through standardized preparation processes, such as constant temperature evaporation and vacuum sealed storage, the stability and shelf life of the drug are guaranteed, the production cost is reduced, and the quality consistency of the drug in large-scale production is guaranteed. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1 This is a schematic diagram of the composition structure of the formula of the present invention;

[0049] Figure 2 This is a schematic diagram of the specific component contents of the formula of the present invention;

[0050] Figure 3 Schematic diagram of the physical and chemical properties of the key components of the present invention;

[0051] Figure 4 It is a flow chart for preparing the formulation of the present invention;

[0052] Figure 5 Detailed step diagram for preparing raw materials of the present invention;

[0053] Figure 6 A detailed step diagram of mixing the materials of the present invention;

[0054] Figure 7 It is a detailed step diagram of the molding and preparation of the present invention. DETAILED DESCRIPTION

[0055] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0056] See also Figures 1 to 7 The present invention provides a technical solution: a Chinese medicine formula for softening hypertrophic scars, the formula consisting of the following components:

[0057] Main prescription medicinal materials group: pangolin, salvia miltiorrhiza, safflower, leech, peach kernel, chuanxiong, notoginseng, frankincense, myrrh, zedoaria, trillium, golden head centipede, ganoderma lucidum, quicklime;

[0058] The medicinal material group of the attached prescription: Morus alba bark, Xanthium sibiricum, Ginseng odoratum, Sophora flavescens, Herba Lysimachiae, Herba Cynanchum, Herba Prunellae;

[0059] Additional liquid group: aged vinegar and alcohol.

[0060] The medicines of the above-mentioned formulas are as follows:

[0061] Main prescription medicinal material group

[0062] Pangolin: It has the effects of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain, and clearing meridians and dispersing nodules. By enhancing local blood circulation, it promotes the softening and absorption of scar tissue and reduces the hardness and volume of hypertrophic scars.

[0063] Danshen: It has the effects of promoting blood circulation and removing blood stasis, cooling blood and reducing swelling, and calming and anti-inflammatory. It can improve the microcirculation of scars, reduce the inflammatory response of scars, and promote tissue repair by clearing away heat and cooling blood.

[0064] Safflower: It has a strong effect of promoting blood circulation, relieving blood stasis and relieving pain. It promotes blood circulation, accelerates the absorption of blood stasis, and softens and reduces hypertrophic scars.

[0065] Leeches: It can break up blood and remove blood stasis, dredge meridians and disperse nodules, and has a strong anti-coagulant effect. It can decompose fibrin in scar tissue, reduce tissue hardness, and inhibit scar hyperplasia.

[0066] Peach kernel: It can promote blood circulation, remove blood stasis, moisten the intestines and promote bowel movements, and improve local blood circulation. It can assist other blood-activating herbs, accelerate the metabolism of scar tissue, and prevent further proliferation of scars.

[0067] Chuanxiong: It can promote blood circulation and qi, dispel wind and relieve pain, and has the effect of dilating blood vessels and improving microcirculation. By dilating local blood vessels, it improves the blood supply to scar tissue and reduces the hardness and volume of scars.

[0068] Panax notoginseng: It can stop bleeding, promote blood circulation, reduce swelling and relieve pain, and has strong anti-inflammatory and wound healing effects. It can promote blood circulation in scar tissue and regeneration of new tissue, and reduce inflammatory reactions and scar hyperplasia.

[0069] Frankincense: It can promote blood circulation and relieve pain, reduce swelling and promote tissue regeneration, and has anti-inflammatory, analgesic and tissue regeneration effects. It can soften scar tissue, promote the repair and regeneration of damaged tissue, and reduce the volume and hardness of scars.

[0070] Myrrh: It can promote blood circulation, relieve pain, reduce swelling and promote tissue regeneration. It is often used in combination with frankincense to treat trauma, scars, etc. It works synergistically with frankincense to enhance the softening effect of scar tissue and promote tissue regeneration and scar repair.

[0071] Curcuma: It has a strong effect of promoting blood circulation and removing blood stasis, which can promote the flow of qi, eliminate stagnation and relieve pain. It can prevent excessive proliferation of scar tissue and reduce the hardness of scars by dissipating blood stasis.

[0072] Trillium: It can promote blood circulation, relieve stagnation and relieve pain. When used in combination with Curcuma, it can enhance the effect of removing blood stasis. It can work together with Curcuma to further enhance the softening effect of scar tissue and reduce the hardness and volume of scars.

[0073] Golden-headed centipede: dispels wind and relieves pain, detoxifies and disperses knots, and has the effect of clearing meridians and dispersing knots. It helps soften and absorb scar tissue by promoting blood circulation and dispersing knots.

[0074] Lingzhi: Strengthens the body, enhances immunity, has anti-inflammatory and antioxidant effects. Improves the immunity of skin tissue, promotes the repair of scar tissue, and prevents the recurrence and aggravation of scars.

[0075] Quicklime: It has the effects of astringency, disinfection and analgesia, and is often used in external medicines. It can enhance the stability of the medicine by adjusting the pH value and promote the softening of scar tissue.

[0076] Attached prescription medicinal materials group

[0077] Morus alba bark: It can clear away heat and purge fire, reduce swelling and promote diuresis, and has strong anti-inflammatory and antibacterial effects. It can reduce inflammation at the scar and prevent infection by clearing away heat and detoxifying.

[0078] Xanthium sibiricum: dispels wind and dampness, relieves pain, and has anti-inflammatory and anti-allergic effects. It improves the moist environment on the skin surface and helps reduce the formation of scars by dispelling wind and dampness.

[0079] Lanhua ginseng: replenishes qi and yin, clears away heat and detoxifies, and has an immunomodulatory effect. It improves the immunity of skin tissue and promotes the softening and absorption of scars.

[0080] Sunflower: It clears away heat and detoxifies, has diuretic and swelling-reducing effects, and has anti-inflammatory and antibacterial effects. It helps remove toxins and inflammation on the skin surface and reduces the proliferation of scar tissue.

[0081] Scutellaria baicalensis: It can clear away heat, detoxify, reduce swelling and relieve pain. It is often used to treat skin inflammation and trauma. It can reduce inflammation and edema in scars and promote the softening and absorption of scars.

[0082] Tongquancao: It can clear away heat and detoxify, promote diuresis and reduce swelling, and has anti-inflammatory and antibacterial effects. It can promote the softening and reduction of scar tissue and prevent excessive proliferation of scars by clearing away heat and detoxifying.

[0083] Prunella Vulgaris: It can clear away heat and fire, reduce swelling and resolve nodules, and has anti-inflammatory and antibacterial effects. It helps to dissipate the stagnant heat in scar tissue and reduce the proliferation and hardness of scars.

[0084] Liquid group

[0085] Aged vinegar: It has the effects of detoxification, sterilization and astringency, and can also enhance the permeability of drug ingredients. It can enhance the permeability of drug ingredients, promote the efficacy of drugs, and adjust the pH value during the fermentation process to enhance the stability of drugs.

[0086] Alcohol: It has the functions of disinfection, sterilization, and enhancing drug permeability. As a solvent, it helps the drug ingredients to better penetrate into the scar tissue, while also playing the role of disinfection and preservation, ensuring the safety and effectiveness of the drug.

[0087] The specific components and dosage ranges in the formulation of the present invention are as follows:

[0088] Pangolin: 10-12g. As the main blood-activating and blood-stasis-removing herb, the dosage of pangolin in the formula is 10-12g, ensuring that it can effectively promote blood circulation and soften scar tissue. This dosage range has been optimized through experiments, which not only ensures the efficacy of the drug, but also avoids adverse reactions caused by excessive use.

[0089] Salvia miltiorrhiza: 14-16 grams. Salvia miltiorrhiza has the effects of promoting blood circulation, removing blood stasis, cooling blood and reducing swelling. The dosage in this formula is 14-16 grams. The dosage of Salvia miltiorrhiza within this range can effectively reduce inflammation at the scar and promote tissue repair.

[0090] Safflower: 9-11 grams. The main function of safflower is to promote blood circulation and menstruation, dissipate blood stasis and relieve pain. The dosage of 9-11 grams in the formula can fully exert its effect of promoting blood circulation and removing blood stasis, and assist in softening scars.

[0091] Leeches: 12-14 grams. Leeches are known for their powerful function of breaking blood and removing blood stasis. A dosage of 12-14 grams can ensure their effectiveness in decomposing scar fibrin and inhibiting scar proliferation.

[0092] Peach kernel: 14-16 grams. Peach kernel has the effect of promoting blood circulation, removing blood stasis, moistening the intestines and relieving constipation. The dosage of peach kernel in the formula is 14-16 grams, which can effectively assist other blood-activating herbs and accelerate the metabolism of scar tissue.

[0093] Chuanxiong: 9-11 grams. Chuanxiong is known for its effects of promoting blood circulation, dispelling wind and relieving pain. The dosage in this formula is 9-11 grams. The dosage within this range can improve the blood supply to scar tissue and help reduce the hardness of the scar.

[0094] Panax notoginseng: 16-18 grams. The main effects of Panax notoginseng are to stop bleeding, promote blood circulation, reduce swelling and relieve pain. Its dosage in this formula is 16-18 grams, which aims to further enhance the anti-inflammatory and tissue regeneration effects of the formula.

[0095] Frankincense: 15-17 grams. Frankincense has the effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration. The dosage in this formula is 15-17 grams, which can ensure its maximum effect in softening scars and promoting tissue repair.

[0096] Myrrh: 15-17 grams. Myrrh is combined with frankincense to further enhance the effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration. The dosage is 15-17 grams, which matches the dosage of frankincense and works synergistically.

[0097] Curcuma: 7-9 grams. Curcuma has the effects of breaking blood and promoting qi, eliminating stagnation and relieving pain. The dosage of 7-9 grams can fully exert its effect of preventing excessive proliferation of scar tissue.

[0098] Trillium: 7-9 grams. Trillium is combined with Curcuma to enhance the effect of breaking blood and promoting qi. The dosage of 7-9 grams can further improve the softening effect of scar tissue.

[0099] Golden head centipede: 1 piece. Golden head centipede has the effects of dispelling wind and relieving pain, detoxifying and dispersing nodules. 1 golden head centipede is used in the formula to ensure its role in promoting blood circulation, dispersing nodules and softening scars.

[0100] Ganoderma lucidum: 11-13 grams. Ganoderma lucidum is known for its role in strengthening the body and enhancing immunity. The dosage in this formula is 11-13 grams, which aims to improve the immunity of skin tissue and promote scar repair.

[0101] Quicklime: 4-6 grams. Quicklime has astringent and disinfecting effects. The amount used in the formula is 4-6 grams, which can adjust the alkalinity of the liquid medicine to ensure its mildness and stability of efficacy.

[0102] Mulberry bark: 14-16 grams. Mulberry bark has the effects of clearing away heat and purging fire, reducing swelling and promoting diuresis. The dosage is 14-16 grams, which can effectively clear away heat and detoxify, and reduce the inflammatory response at the scar.

[0103] Xanthium sibiricum: 9-11 grams. Xanthium sibiricum is mainly used to dispel wind and dampness, open the orifices and relieve pain. The dosage is 9-11 grams, which helps to improve the moist environment on the surface of scars and assists in reducing scar formation.

[0104] Lanhua ginseng: 14-16 grams. Lanhua ginseng has the effects of replenishing qi and yin, clearing away heat and detoxifying. 14-16 grams can improve the skin's immunity and help soften and absorb scars.

[0105] Sunflower: 9-11 grams. The main effect of sunflower is to clear away heat and detoxify, and to promote diuresis and reduce swelling. The dosage is 9-11 grams, which can help remove toxins and inflammation on the surface of scars and help reduce the proliferation of scar tissue.

[0106] Creeping pot grass: 14-16 grams. Creeping pot grass has the effects of clearing away heat and detoxification, reducing swelling and relieving pain. The dosage is 14-16 grams, which can reduce inflammation and edema at the scar and promote the softening of the scar.

[0107] Tongquancao: 14-16 grams. Tongquancao's effects of clearing heat and detoxifying, as well as its diuretic and swelling-reducing effects make it helpful in reducing the proliferation of scar tissue in the formula, and promoting scar softening by clearing heat and detoxifying.

[0108] Prunella Vulgaris: 14-16 grams. Prunella Vulgaris has the effects of clearing away heat and purging fire, reducing swelling and dispersing nodules. 14-16 grams can help evacuate the stagnant heat in scar tissue and reduce the proliferation and hardness of scars.

[0109] Aged vinegar: 450-550 ml. The role of aged vinegar in the formula is not only as a solvent, but also to adjust the stability of the liquid medicine and the permeability of the drug effect through its acidity and pH value. The dosage of 450-550 ml ensures the best dissolution and penetration of the drug ingredients.

[0110] Alcohol: 90-110 ml. Alcohol is used as a solvent and disinfectant. A dosage of 90-110 ml can help the drug ingredients penetrate into the scar tissue better, while also acting as a preservative to ensure the safety and effectiveness of the drug.

[0111] Furthermore, the specific composition of the Chinese medicine formula is:

[0112] Pangolin: 11 grams; Salvia miltiorrhiza: 15 grams; Safflower: 10 grams; Leech: 13 grams; Peach kernel: 15 grams; Ligusticum chuanxiong: 10 grams; Panax notoginseng: 17 grams; Frankincense: 16 grams; Myrrh: 16 grams; Curcuma: 8 grams; Trillium: 8 grams; Golden head centipede: 1; Ganoderma lucidum: 12 grams; Quicklime: 5 grams; Morus alba bark: 15 grams; Xanthium sibiricum: 10 grams; Panax ginseng: 15 grams; Sunflower seed: 10 grams; Creeping pot grass: 15 grams; Scutellaria baicalensis: 15 grams; Prunella vulgaris: 15 grams; Aged vinegar: 500 ml; Alcohol: 100 ml.

[0113] Further, the alcohol is 75 degree alcohol, which is widely used in the medical field because it has good permeability and bactericidal effect. Compared with alcohol with higher or lower concentration, 75 degree alcohol can more effectively penetrate the skin surface, promote the absorption of drug ingredients, and its bactericidal effect is most significant at this concentration. Therefore, the present invention selects 75 degree alcohol as solvent and penetrant, which can enhance the permeability of the drug and ensure the safety of the formula.

[0114] Aged vinegar is aged fermented rice vinegar with an acidity of 4-6% and a density of 1.02-1.04 g / cm 3 , pH value is 2.5-3.5; aged fermented rice vinegar is selected for its stable fermentation process and rich organic acid content, and its acidity is between 4-6%, which can ensure the effective penetration and stability of drugs. Density is 1.02-1.04g / cm 3The vinegar can provide appropriate viscosity to ensure the adhesion of the drug to the scar area. The acidic environment with a pH value between 2.5-3.5 helps to maintain the stability of the drug ingredients, prevent the drug solution from deteriorating, and to a certain extent enhance the drug's penetration into the skin. At the same time, the mild acidity can also avoid irritation and damage to the skin.

[0115] The particle size of quicklime is 50 microns to 100 microns, and the purity is more than 95%; the main function of quicklime (calcium oxide) in the present invention is to adjust the alkalinity of the liquid medicine to ensure the stability and effectiveness of the liquid medicine. Quicklime with a particle size of 50 microns to 100 microns can be evenly dispersed in the liquid medicine to ensure uniform adjustment of the alkalinity. Quicklime with a purity of more than 95% ensures that the impurity content is extremely low, reduces the impact on other components in the liquid medicine, and can more accurately adjust the pH value of the liquid medicine, thereby avoiding skin irritation or burns caused by excessive alkalinity. The adjusted pH value ranges from 8 to 9.5, ensuring the mildness of the drug and being suitable for long-term external use.

[0116] The oil content of frankincense and myrrh is 10-15%, and their volatile components can account for 3-5% of the total;

[0117] Frankincense and myrrh are two Chinese medicinal materials that have strong effects on promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration. The volatile oils they contain are the main components of their efficacy. The oil content of frankincense and myrrh is 10-15%, which ensures that the content of the active ingredients of the medicine is high enough to fully play its role in softening scars and promoting tissue regeneration. The volatile components account for 3-5% of the total amount. This ratio ensures the duration of the drug's action and the stability of its efficacy, while avoiding the loss of volatilization caused by excessive content, thereby exerting a lasting therapeutic effect on the scar area.

[0118] Through the physicochemical properties and specific parameters of the above-mentioned components, the present invention further ensures the safety, effectiveness and stability of the traditional Chinese medicine formula, maximizes the role of each medicinal material, and provides a mild and long-lasting external agent for softening hypertrophic scars.

[0119] A method for preparing a Chinese medicine formula for softening hypertrophic scars includes three key steps: raw material preparation, material mixing, and molding and preparation. These steps are precisely controlled to ensure the quality and efficacy of the final product. The details are as follows:

[0120] S1. Raw material preparation

[0121] a) Weighing and pulverizing: Weigh pangolin, salvia miltiorrhiza, safflower, leech, peach kernel, chuanxiong, notoginseng, frankincense, myrrh, zedoaria, trillium, golden head centipede and ganoderma lucidum according to the above proportions, with each medicinal material accurate to ±0.1g, and pulverize into fine powder with a particle size of 10-50 microns.

[0122] This step ensures that the dosage of each herb is accurate, avoiding fluctuations in efficacy caused by imbalanced ingredients in the formula. Crushing the herb into a particle size range of 10-50 microns helps increase the surface area of ​​the herb and promotes the extraction and absorption of its active ingredients.

[0123] b) Mixing and fermentation: Weigh and mix the bark of white mulberry, Xanthium sibiricum, ginseng, sunflower, creeping vine, scutellaria baicalensis, and selfheal in proportion, add 500 ml of aged vinegar, mix well and ferment. The fermentation temperature is controlled at 25-30° C. for 72 hours, and the humidity is maintained at 60-70% during the process.

[0124] The fermentation process can increase the release of active ingredients in medicinal materials, and by controlling temperature and humidity, the stability and consistency of the fermentation process can be ensured. Aged vinegar not only serves as a fermentation medium, but also promotes the extraction and activation of medicinal ingredients through its acidity.

[0125] S2. Material mixing

[0126] a) Filtration: After fermentation is complete, the medicinal materials and the aged vinegar solution are filtered three times, with the accuracy of each filtration controlled at 5-10 microns to ensure a clear liquid free of impurities.

[0127] Multiple fine filtrations can remove particulate impurities in the liquid medicine, ensuring the purity of the clear liquid, thereby improving the absorption effect and usage experience of the medicine. The precision range of each filtration is set at 5-10 microns to ensure effective removal of impurities without losing active ingredients.

[0128] b) Concentration and mixing: Place the obtained clear liquid in an evaporator and concentrate it to a volume of 200 ml. Maintain the temperature at 100-105°C during the concentration process. Then add 100 ml of 75% alcohol. After stirring evenly, gradually add quicklime with a particle size of 50-100 microns to ensure that the alkalinity of the quicklime reaches pH 8-9.5 in the solution. Mix thoroughly until the solution is uniform.

[0129] The concentration temperature and volume are precisely controlled to ensure the concentration and retention of the active ingredients in the liquid medicine. 75% alcohol is added to further enhance the permeability of the liquid medicine, while quicklime is used to adjust the alkalinity of the liquid medicine to pH 8-9.5 to ensure the mildness and stability of the liquid medicine and avoid irritating the skin.

[0130] S3, Forming and Preparation

[0131] a) Cooling: Slowly cool the mixed liquid medicine to room temperature in an environment of 25-30℃. Avoid direct sunlight during the cooling process to ensure that the volatile components in the liquid medicine are not lost by evaporation.

[0132] By slow cooling, the loss of volatile components in the drug solution is avoided, ensuring the stability and efficacy of the drug. Avoiding direct sunlight further avoids the degradation of photosensitive components.

[0133] b) Final filtration and packaging: The cooled liquid medicine is finally filtered with a filtration accuracy of 1-5 microns to ensure that the liquid medicine is free of particulate impurities, and then placed in a brown sealed bottle with a capacity of 100 ml to avoid the influence of air and moisture to obtain the final external medicine.

[0134] The final filtration ensures the purity of the liquid medicine, removes the residual tiny particles, and further improves the comfort of using the liquid medicine. The use of brown sealed bottles can effectively prevent the influence of light on the liquid medicine, and the sealed storage prevents the liquid medicine from being affected by air and moisture, extending the shelf life.

[0135] The raw material preparation step further includes S1.1 drying treatment: drying the crushed medicinal materials at 60-80° C. for 1-2 hours to reduce the moisture content to ≤5% to ensure the stability and uniformity of the medicinal materials.

[0136] Drying can effectively reduce the moisture content in medicinal materials, prevent them from deteriorating or spoiling during subsequent processing, and ensure the long-term stability and uniformity of the medicinal materials.

[0137] S1.2 Fermentation stirring: Before fermentation, automatic stirring equipment is used to ensure the uniform distribution of the aged vinegar, and the vinegar is stirred every 24 hours during the fermentation process to ensure the uniformity of the fermentation. The pH value of the aged vinegar is finally controlled at 2.5-3.5 and the acidity is 4-6%.

[0138] Automatic stirring equipment ensures full contact between the aged vinegar and the medicinal materials during the fermentation process, avoiding local over-fermentation or under-fermentation. Regular stirring helps maintain the consistency of the fermentation environment and ensures a stable and uniform fermentation effect.

[0139] The material mixing step also includes the following specific steps: S2.1 Multiple filtrations: When performing three filtrations, 5 micron, 7.5 micron and 10 micron filter materials are used respectively to ensure that the purity of the clear liquid filtered each time meets the pharmacopoeia standard.

[0140] The step-by-step filtration strategy helps to gradually remove impurities of different particle sizes in the drug solution, ultimately ensuring that the purity of the clear solution meets the pharmacopoeia standards, thereby improving the safety and efficacy of the drug.

[0141] S2.2 Precision temperature-controlled concentration: During the concentration process, precision temperature control equipment is used to stabilize the temperature of the drug solution within the range of 100-105°C, and a constant temperature evaporator is used to prevent the loss of active ingredients.

[0142] Temperature control equipment ensures that the temperature of the drug solution is stable during the concentration process, avoiding loss or degradation of active ingredients due to temperature fluctuations. Constant temperature evaporators further ensure the stability of drug ingredients and avoid drug denaturation due to excessively high temperatures.

[0143] S2.3 Even distribution of quicklime: Add quicklime into the solution at a weight ratio of 2%, ensuring that the alkalinity of the solution is at pH 8-9.5, and extend the stirring time to 30 minutes to ensure that the quicklime is completely dissolved and evenly distributed in the solution.

[0144] Accurately control the proportion of quicklime added and the stirring time to ensure that the alkalinity of the solution is adjusted within the ideal range while avoiding local over-alkalization or inadequate mixing.

[0145] The molding and preparation steps also include the following specific steps: S3.1 Constant temperature cooling: The mixed liquid medicine is slowly cooled at a rate of ≤1°C / min in a constant temperature environment below 30°C to reduce the loss of volatile components of the liquid medicine.

[0146] Constant temperature cooling can avoid instability or precipitation of components caused by a sudden drop in the temperature of the drug solution. At the same time, the slow cooling rate helps to maintain the integrity of the volatile components in the drug solution, ensuring the quality and efficacy of the final medicine.

[0147] S3.2 Ultrafine filtration: The cooled liquid medicine is finally filtered using a 1-3 micron ultrafine filter to ensure that there are no residual impurities.

[0148] Use an ultra-fine filter for the final filtration to ensure the purity and quality of the liquid medicine, remove all tiny particles and impurities, and improve the safety and comfort of the liquid medicine.

[0149] S3.3 Light-proof storage and sealing: The prepared external-use medicine should be stored in a light-proof environment with a relative humidity of 40-60%, the room temperature should be controlled at 15-25℃, and vacuum sealing technology should be used to ensure the shelf life is not less than 24 months.

[0150] Controlling the humidity and temperature in the storage environment and taking measures to avoid light can effectively extend the shelf life of the medicine and prevent the degradation of the active ingredients caused by light and moisture. Vacuum sealing technology further prevents the influence of oxygen and moisture in the air on the medicine, ensuring that the medicine remains stable and effective within 24 months.

[0151] Example 1: Chinese medicine formula for treating postoperative hypertrophic scars

[0152] Hypertrophic scars formed after surgery are one of the common complications of surgical operations. Patients' scars usually show obvious thickening, redness and itching symptoms. Traditional scar treatment methods include topical steroid drugs and physical therapy. Although they are effective to a certain extent, they have problems such as unstable efficacy and obvious side effects. In order to solve these problems, the present invention provides a Chinese medicine formula for treating postoperative hypertrophic scars, the purpose of which is to soften scars, improve skin conditions, and reduce adverse reactions through the mild effect of Chinese medicine.

[0153] This embodiment innovatively utilizes the Chinese medicine formula of the present invention, combining a variety of Chinese medicinal materials that have the functions of promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, and promoting tissue repair, to soften and inhibit hypertrophic scars. The formula is particularly suitable for postoperative scar repair, and has the advantages of being mild, non-irritating, and having no obvious side effects.

[0154] Comparative experiment:

[0155] The experiment was divided into three groups: experimental group, control group 1 (traditional steroid treatment), and control group 2 (no treatment). All experimental subjects were patients with hypertrophic scars formed six months after surgery, and the treatment lasted for eight weeks.

[0156]

[0157]

[0158] The experimental results show that the experimental group using the Chinese medicine formula of the present invention is significantly superior to traditional steroid treatment in terms of scar thickness reduction, redness and swelling improvement, and itching symptom relief, and has no obvious skin side effects, showing better safety and patient acceptance.

[0159] Example 2: Chinese medicine formula for scars after burns

[0160] Burn scars usually show thickening, contracture and irregularity of the skin surface, which seriously affect the patient's function and appearance. Traditional treatment methods include pressure therapy, silicone sheet application and surgical repair, but these methods are often difficult to completely restore the normal morphology of the skin. To this end, the present invention proposes a Chinese medicine formula for the treatment of burn scars, which aims to promote the softening of burn scars, reduce scar contracture, and improve the elasticity and smoothness of the skin through natural and mild Chinese medicine ingredients.

[0161] This embodiment innovatively uses a variety of Chinese medicinal materials that can soften scars, promote tissue regeneration and enhance skin elasticity, and is particularly suitable for scar repair after burns. The formula is suitable for burn scars of various degrees, has strong tissue repair ability, is non-irritating, and is suitable for long-term use.

[0162] Comparative experiment: The experiment was divided into three groups: experimental group, control group 1 (silicone sheet treatment), and control group 2 (no treatment). All experimental subjects were patients with scars formed one year after burns, and the treatment lasted for twelve weeks.

[0163]

[0164]

[0165] The experimental results show that the experimental group using the Chinese medicine formula of the present invention has significantly better scar softening, contracture improvement, skin elasticity recovery and surface smoothness than the silicone sheet treatment group, and also has greater advantages in terms of comfort and skin safety. The formula of the present invention can effectively reduce the formation and development of scars after burns and improve the quality of life of patients.

[0166] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine formula for softening hypertrophic scars, characterized in that: The formulation consists of the following components: Main prescription medicinal materials group: pangolin, salvia miltiorrhiza, safflower, leech, peach kernel, chuanxiong, notoginseng, frankincense, myrrh, zedoaria, trillium, golden head centipede, ganoderma lucidum, quicklime; The medicinal material group of the attached prescription: Morus alba bark, Xanthium sibiricum, Ginseng odoratum, Sophora flavescens, Herba Lysimachiae, Herba Cynanchum, Herba Prunellae; Additional liquid group: aged vinegar and alcohol.

2. A Chinese medicine formula for softening hypertrophic scars according to claim 1, characterized in that: The Chinese medicine formula includes the following specific components: Pangolin: 10-12 grams; Salvia miltiorrhiza: 14-16 g; Safflower: 9-11 g; Leeches: 12-14 g; Peach kernel: 14-16 g; Chuanxiong: 9-11g; Panax notoginseng: 16-18 g; Frankincense: 15-17 g; Myrrh: 15-17 g; Curcuma: 7-9g; Tripterygium wilfordii: 7-9 g; Golden-headed centipede: 1; Lingzhi: 11-13g; Quicklime: 4-6 g; Morus alba bark: 14-16 g; Xanthium sibiricum: 9-11 g; Orchid ginseng: 14-16 grams; Sunflower: 9-11 grams; Creeping pot grass: 14-16 grams; Tongquancao: 14-16g; Prunella vulgaris: 14-16 g; Aged vinegar: 450-550 ml; Alcohol: 90-110 ml.

3. A Chinese medicine formula for softening hyperplastic scars according to claim 2, characterized in that: The specific composition of the Chinese medicine formula is: Pangolin: 11 grams; Salvia miltiorrhiza: 15g; Safflower: 10 g; Leeches: 13 g; Peach kernel: 15g; Chuanxiong: 10g; Panax notoginseng: 17 g; Frankincense: 16 g; Myrrh: 16 g; Curcuma: 8g; Tripterygium wilfordii: 8 g; Golden-headed centipede: 1; Lingzhi: 12g; Quicklime: 5 g; Morus alba bark: 15g; Xanthium sibiricum: 10g; Orchid ginseng: 15g; Sunflower: 10g; Creeping pot grass: 15 grams; Tongquancao: 15g; Prunella vulgaris: 15g; Vinegar: 500 ml; Alcohol: 100 ml.

4. A Chinese medicine formula for softening hypertrophic scars according to claim 3, characterized in that: The alcohol is 75% alcohol; Aged vinegar is aged fermented rice vinegar with an acidity of 4-6% and a density of 1.02-1.04 g / cm 3 , pH value is 2.5-3.5; The quicklime has a particle size of 50 microns to 100 microns and a purity of more than 95%; The oil content of frankincense and myrrh is 10-15%, and their volatile components can account for 3-5% of the total.

5. A method for preparing a Chinese medicine formula for softening hypertrophic scars, applied to a Chinese medicine formula for softening hypertrophic scars as claimed in any one of claims 1 to 4, characterized in that: The following steps are involved: S1. Raw material preparation: a) weighing pangolin, salvia miltiorrhiza, safflower, leech, peach kernel, chuanxiong, notoginseng, frankincense, myrrh, zedoaria, trifoliate green, golden headed centipede and ganoderma lucidum according to the proportion, each medicinal material is accurate to ±0.1g, and crushing into fine powder with a particle size of 10-50 microns to form a uniform mixed powder; B) the bark of white mulberry, the fruit of Xanthium sibiricum, the orchid ginseng, the sunflower leaf, the scutellaria baicalensis, the herb of ... and the herb of prunella vulgaris are weighed in proportion and mixed, and a volume of 500 milliliters of aged vinegar is added, and the mixture is fermented after mixing, and the fermentation temperature is controlled at 25-30 ℃, and the fermentation time is 72 hours, and the humidity is maintained at 60-70% during the process; S2. Material mixing: a) After fermentation is completed, the medicinal materials and the aged vinegar solution are filtered three times, and the accuracy of each filtration is controlled at 5-10 microns to ensure that a clear liquid without impurities is obtained; b) the obtained clear liquid is placed in an evaporator and concentrated to a volume of 200 ml. During the concentration process, the temperature is maintained at 100-105° C., and then 100 ml of 75% alcohol is added. After stirring, quicklime having a particle size of 50-100 microns is gradually added to ensure that the alkalinity of the quicklime reaches pH 8-9.5 in the solution, and the solution is fully mixed until it is uniform. S3, molding and preparation: a) Slowly cool the mixed liquid medicine to room temperature in an environment of 25-30℃, avoiding direct sunlight during the cooling process to ensure that the volatile components in the liquid medicine are not lost by evaporation; b) The cooled liquid medicine is finally filtered with a filtration accuracy of 1-5 microns to ensure that the liquid medicine is free of particulate impurities, and then placed in a brown sealed bottle with a capacity of 100 ml to avoid the influence of air and moisture to obtain the final external-use medicine.

6. The method for preparing a Chinese medicine formula for softening hypertrophic scars according to claim 5, characterized in that: The S1 raw material preparation step also includes the following specific steps: S1.1 Dry the crushed medicinal materials at 60-80℃ for 1-2 hours to reduce the moisture content to ≤5% to ensure the stability and uniformity of the medicinal materials; S1.2 Before fermentation, automatic stirring equipment is used to ensure the uniform distribution of the aged vinegar, and the vinegar is stirred once every 24 hours during the fermentation process to ensure the uniformity of the fermentation. The pH value of the aged vinegar is finally controlled at 2.5-3.5 and the acidity is 4-6%.

7. The method for preparing a Chinese medicine formula for softening hypertrophic scars according to claim 5, characterized in that: The S2 material mixing step also includes the following specific steps: S2.1 When performing three filtrations, use 5 micron, 7.5 micron and 10 micron filter materials respectively to ensure that the purity of the clear liquid after each filtration meets the pharmacopoeia standards; S2.2 During the concentration process, use precision temperature control equipment to stabilize the temperature of the drug solution within the range of 100-105°C, and use a constant temperature evaporator to prevent the loss of active ingredients; S2.3 Add quicklime to the solution at a weight ratio of 2%, ensuring that the alkalinity of the solution is between pH 8-9.5, and extend the stirring time to 30 minutes to ensure that the quicklime is completely dissolved and evenly distributed in the solution.

8. The method for preparing a Chinese medicine formula for softening hypertrophic scars according to claim 5, characterized in that: The S3 forming and preparing step also includes the following specific steps: S3.1 The mixed liquid medicine is slowly cooled at a rate of ≤1°C / min in a constant temperature environment below 30°C to reduce the loss of volatile components of the liquid medicine; S3.2 The cooled liquid medicine is finally filtered using a 1-3 micron ultra-fine filter to ensure that there are no residual impurities; S3.3 The prepared external-use medicine is stored in a light-proof environment with a relative humidity of 40-60%, the room temperature is controlled at 15-25°C, and vacuum sealing technology is used to ensure that the shelf life is not less than 24 months.

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