Traditional Chinese medicine external nursing medicine for treating burns and scalds

Abstract

The invention discloses a traditional Chinese medicine external nursing medicine for treating burns and scalds. The traditional Chinese medicine external nursing medicine comprises the following raw material medicines and auxiliary materials in parts by weight, raw material medicines: 8-12 parts of dandelion, 6-8 parts of oldenlandia diffusa, 8-10 parts of purpleflower holly leaf, 8-10 parts of Chinese elm bark, 10-12 parts of calcined dragon bone, 6-8 parts of aloe, 8-10 parts of safflower, 8-10 parts of radix angelicae, 8-10 parts of astragalus membranaceus, 3-5 parts of borneol, 2-4 parts of pearl powder, 1-3 parts of a salvia miltiorrhiza extract, 8-10 parts of golden cypress, 6-8 parts of sanguisorba officinalis and 4-6 parts of rheum officinale; auxiliary materials: 5-10 parts of chitosan, 3-6 parts of hyaluronic acid, 10-20 parts of olive oil and 1-2 parts of nano titanium dioxide; the pearl powder, the radix salviae miltiorrhizae extract, the cortex phellodendri, the radix sanguisorbae and the radix et rhizoma rhei are added to construct an anti-infection-healing promoting-scar inhibiting triple-effect synergistic system, and pharmacodynamic experiments prove that the deep II-degree wound healing time can be shortened by 3-5 days, and the scar hyperplasia degree can be reduced by 40%; the temperature-sensitive hydrogel realizes'gelation when being contacted with skin ', is uniformly coated and is not easy to fall off.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine for external use for treating burns and scalds. Background Art

[0002] Burns and scalds are common clinical emergencies, and their treatment faces three major challenges: wound infection, slow healing, and scar hyperplasia. Currently, Western medicine treatments primarily rely on anti-infection and surgical skin grafting, but these are limited by drug resistance, significant scarring, and significant patient pain. While external treatments in Traditional Chinese Medicine (TCM) have demonstrated advantages in wound repair, existing TCM preparations still have the following shortcomings:

[0003] (1) Single dosage form: mainly traditional ointments and tinctures, which have problems such as uneven coating, easy shedding, and uncontrollable penetration rate;

[0004] (2) Weak scar inhibition effect: The existing formula focuses on clearing heat and detoxifying, and the regulatory mechanism of fibroblast overproliferation and collagen deposition is unclear;

[0005] (3) Ambiguous quality standards: Lack of quantitative detection of active ingredients and safety evaluation system.

[0006] Therefore, there is an urgent need to develop a new type of external use Chinese medicine preparation that has efficient transdermal absorption, precise regulation of the healing process, and significant inhibition of scars. Summary of the Invention

[0007] In view of the deficiencies in the prior art, the present invention provides a traditional Chinese medicine for external use for treating burns and scalds, which solves the problems raised in the background art.

[0008] To achieve the above objectives, the present invention is implemented through the following technical scheme: a traditional Chinese medicine external nursing medicine for treating burns and scalds, comprising the following raw materials and excipients in parts by weight; raw materials: 8-12 parts of dandelion, 6-8 parts of oldenlandia diffusa, 8-10 parts of evergreen, 8-10 parts of elm bark, 10-12 parts of calcined dragon bone, 6-8 parts of aloe, 8-10 parts of safflower, 8-10 parts of angelica dahurica, 8-10 parts of astragalus, 3-5 parts of borneol, 2-4 parts of pearl powder, 1-3 parts of salvia miltiorrhiza extract, 8-10 parts of phellodendron, 6-8 parts of sanguisorba officinalis, and 4-6 parts of rhubarb; excipients: 5-10 parts of chitosan, 3-6 parts of hyaluronic acid, 10-20 parts of olive oil, and 1-2 parts of nano titanium dioxide.

[0009] Preferably, the invention comprises the following raw materials and excipients in parts by weight: raw materials: 8 parts of dandelion, 6 parts of oldenlandia diffusa, 10 parts of evergreen, 8 parts of elm bark, 10 parts of calcined dragon bone, 6 parts of aloe, 8 parts of safflower, 8 parts of angelica dahurica, 10 parts of astragalus, 3 parts of borneol, 2 parts of pearl powder, 1 part of salvia miltiorrhiza extract, 8 parts of phellodendron, 6 parts of sanguisorba officinalis, and 4 parts of rhubarb; excipients: 5 parts of chitosan, 3 parts of hyaluronic acid, 10 parts of olive oil, and 1 part of nano titanium dioxide.

[0010] The nursing medicine formula of the present invention is mainly developed based on the pathogenesis characteristics of patients with burns and scalds, and has the remarkable effects of clearing away heat and detoxicating, resisting infection, promoting blood circulation and dispersing blood stasis, reducing swelling, absorbing moisture and healing sores, and protecting wound surface. Among the prescriptions, dandelion, white flower hedyotis diffusa, evergreen, elm bark, and aloe clear away heat and detoxicating, reduce swelling and relieve pain, have strong antibacterial and anti-infective effects, and evergreen also has a significant scab-forming effect; calcined dragon bone and astragalus root can heal sores and promote tissue regeneration, discharge pus and astringe sweat, and have a significant effect of promoting wound healing and descabbing; safflower, angelica dahurica, and borneol can promote blood circulation and menstruation, dissipate blood stasis and relieve pain, and angelica dahurica has the effect of reducing wound surface fluid exudation. Pearl powder, salvia miltiorrhiza extract, phellodendron, sanguisorba officinalis, and rhubarb can cool blood and stop bleeding, and have antibacterial and anti-inflammatory effects. Among them, pearl powder can promote epidermal cell differentiation and proliferation, salvia miltiorrhiza extract can inhibit scar hyperplasia, and phellodendron and sanguisorba officinalis compatibility can enhance anti-exudation effect; the nursing medicine formula of the present invention is reasonable and has a very strong targeted therapeutic effect on burns and scalds. Clinical application has proved that the Chinese medicine preparation has definite efficacy, mild medicinal properties, no toxic side effects and adverse reactions, and a high safety factor. The Chinese medicine preparation of the present invention adopts advanced extraction equipment and technology to fully extract the effective ingredients and can be made into a convenient Chinese medicine preparation.

[0011] The functions and indications of each raw material medicine in the nursing medicine of the present invention are:

[0012] Dandelion is bitter, sweet, and cold. It enters the Liver and Stomach meridians. It clears heat and detoxifies, reduces swelling and resolves stagnation, and promotes diuresis and relieving stranguria. It is used to treat sores, breast abscesses, scrofula, conjunctivitis, sore throat, lung abscesses, intestinal abscesses, damp-heat jaundice, and painful stranguria caused by heat.

[0013] Hedyotis diffusa has a sweet, light, and cooling nature. It enters the stomach, large intestine, and small intestine meridians. It clears heat and detoxifies, promotes diuresis and reduces swelling, and promotes blood circulation and relieves pain. It is used for intestinal carbuncle (appendicitis), sores, boils, swelling, damp-heat jaundice, and dysuria. It can also be used externally to treat sores, boils, carbuncles, and snake bites.

[0014] Sijiqing (Evergreen) has a bitter, astringent, and cold taste. It enters the Heart and Lung meridians. It clears heat, detoxifies, and cools the blood. It is used to treat sores caused by heat and toxicity, burns, lower limb ulcers, eczema, and leprosy.

[0015] Ulmus pumila bark is sweet, slightly bitter, and cold in nature. It clears heat and promotes diuresis, detoxifies and reduces swelling, and cools the blood and stops bleeding. It is used to treat stranguria caused by heat, dysuria, sores and swelling, breast abscesses, burns caused by water or fire, dysentery, gastrointestinal bleeding, hematuria, hemorrhoids, back pain, and bleeding from trauma.

[0016] Calcined Dragon Bone (Longgu): sweet, astringent, and neutral. It has a sedative effect, astringes sweat and sperm, promotes tissue regeneration, and heals sores. It is used for neurasthenia, palpitations, insomnia, frequent dreams, spontaneous sweating, night sweats, nocturnal emission, enuresis, metrorrhagia, and leukorrhea; it can also be used externally to treat persistent sores.

[0017] Aloe, bitter, cold. Leaves: used externally to treat caries, carbuncle, burns, eczema.

[0018] Safflower is pungent and warm. It enters the Heart and Liver meridians. It promotes blood circulation and menstruation, dissipates blood stasis and relieves pain. It is used for amenorrhea, dysmenorrhea, lochia retention, lumps and masses, injuries from falls, and sores and swelling.

[0019] Angelica dahurica is pungent and warm. It enters the stomach, large intestine, and lung meridians. It dispels wind and dampness, clears the orifices and relieves pain, and reduces swelling and discharges pus. It is used for colds, headaches, supraorbital pain, nasal congestion, sinusitis, toothache, leucorrhea, and sores and swelling.

[0020] Astragalus root is sweet and warm. It enters the lung and spleen meridians. It tonifies qi and strengthens the exterior, promotes diuresis and expels toxins, drains pus, and heals sores and promotes tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of qi in the middle, chronic diarrhea and rectal prolapse, bloody stools and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, carbuncles that are difficult to heal, long-lasting sores that do not heal, anemia and jaundice, internal heat and thirst, as well as proteinuria due to chronic nephritis and diabetes.

[0021] Borneol (Borneolum Syntheticum) is bitter and pungent, with a cooling effect. It enters the heart and lung meridians. It clears all orifices, dispels stagnant internal heat, removes cataracts, improves eyesight, and reduces swelling and relieves pain. It treats lockjaw caused by stroke, coma caused by febrile illness, epilepsy, phlegm-induced confusion, qi stagnation, deafness, laryngeal congestion, mouth ulcers, otitis media, carbuncles, hemorrhoids, pannus, and pinworms.

[0022] Pearl powder is sweet, salty, and cold. It enters the Heart and Liver meridians. It calms the mind, relieves convulsions, brightens the eyes, dispels cataracts, and promotes tissue regeneration. It is used for palpitations, insomnia, convulsions, epilepsy, cloudiness of the eyes, persistent sores, and skin pigmentation.

[0023] Salvia miltiorrhiza extract is bitter and slightly cold. It enters the Heart and Liver meridians. It promotes blood circulation, dispels blood stasis, promotes menstruation and relieves pain, and clears the heart and relieves restlessness. It is used for chest pain, abdominal pain, and flank pain, accumulation of masses, pain due to heat rheumatic arthritis, restlessness and insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0024] Phellodendron chinense is bitter and cold. It enters the kidney and bladder meridians. It clears heat and dampness, purges fire and eliminates steam, detoxifies and treats sores. It is used for damp-heat diarrhea, jaundice, dark urine, leucorrhea and vaginal itching, painful stranguria due to heat, beriberi and paralysis, bone steaming and fatigue fever, night sweats and spermatorrhea, sores and swelling, and eczema.

[0025] Sanguisorba officinalis is bitter, sour, astringent, and slightly cold. It enters the Liver and Large Intestine meridians. It cools blood and stops bleeding, detoxifies and heals sores. It is used for bloody stools, hemorrhoids, bloody diarrhea, metrorrhagia, burns caused by water or fire, carbuncles, sores, eczema, and skin ulcers.

[0026] Rhubarb is bitter and cold. It enters the spleen, stomach, large intestine, liver, and pericardium meridians. It has a purgative and dispelling effect, clears heat and purges fire, cools the blood and detoxifies, and removes blood stasis and promotes menstruation. It is used for constipation due to excess heat, vomiting and bleeding due to blood heat, red eyes and swollen throat, carbuncles and furuncles, abdominal pain due to intestinal carbuncles, amenorrhea due to blood stasis, postpartum stasis, traumatic injuries, damp-heat dysentery, jaundice and dark urine, and edema due to stranguria.

[0027] Preferably, the nursing medicine is a temperature-sensitive hydrogel ointment or a nanoemulsion tincture.

[0028] Preferably, the preparation method of the temperature-sensitive hydrogel ointment comprises the following steps:

[0029] Extraction of raw materials: Using water extraction and alcohol precipitation, dandelion, Hedyotis diffusa, Evergreen, Ulmus pumila bark, calcined dragon bone, aloe, safflower, angelica dahurica, astragalus, borneol, pearl powder, salvia miltiorrhiza extract, Phellodendron amurense, Sanguisorba officinalis, and rhubarb are mixed in proportion, and then 8 times the amount of purified water is added. The mixture is decocted twice, the first time for 1.5 hours and the second time for 1 hour. The filtrates are combined and concentrated under vacuum to an extract with a relative density of 1.25-1.30. 95% ethanol is added to make the alcohol content reach 70%. After standing for 24 hours, the supernatant is collected and the ethanol is recovered to obtain a drug fluid extract.

[0030] Excipient preparation: Chitosan was dissolved in 2% acetic acid solution to form a 3% colloidal solution. Hyaluronic acid was swelled with water for injection for 12 hours and then sterilized by filtration. Olive oil was dry-heat sterilized at 180°C for 30 minutes and then pre-dispersed with nano-titanium dioxide in a high-speed shear emulsifier to control the particle size to ≤100nm.

[0031] Preparation molding: The drug fluid extract and chitosan colloid are isothermally mixed at 4°C, hyaluronic acid solution is added, and the pH adjuster is slowly added dropwise until neutral. Finally, the nano-titanium dioxide-olive oil dispersion system is added under sterile conditions. After being processed by a three-stage homogenizer, it is packaged into pre-sterilized light-proof aluminum tubes to form a temperature-sensitive hydrogel ointment with a phase transition temperature of 37°C.

[0032] Preferably, the preparation method of the nanoemulsion tincture comprises the following steps:

[0033] Preparation of nanoemulsion tincture base: Mix polysorbate 80 and propylene glycol in a ratio of 1:3 as the oil phase, add glycerol as a cosolvent, and preheat to 45°C for use;

[0034] Raw material processing: Take dandelion, Hedyotis diffusa, Evergreen, Elm bark, calcined dragon bone, aloe, safflower, Angelica dahurica, Astragalus, borneol, pearl powder, Salvia miltiorrhiza extract, Phellodendron amurense, Sanguisorba officinalis, and Rhubarb, use alcohol extraction and water precipitation method, soak in 70% ethanol for 24 hours, reflux extraction at 70℃ for 3 times, combine the extracts, refine through ceramic membrane filtration system, and concentrate under reduced pressure to a thick paste with a relative density of 1.10-1.15;

[0035] Emulsification and dispersion: slowly add the thick drug paste into the preheated oil phase system, and use a high-pressure homogenizer to cycle the process for 5 times, controlling the droplet size to ≤200nm and maintaining the Zeta potential at -20mV to -30mV;

[0036] Sterilization and packaging: Add 0.05% ethylparaben as a preservative, filter through a 0.22 μm microporous filter membrane, fill into brown pharmaceutical glass bottles in a Class 100 clean environment, and sterilize by cobalt-60 irradiation to finally produce a nanoemulsion tincture with a transdermal absorption rate of 85% or more.

[0037] Preferably, the pH regulator is 0.1M NaOH; and the pressure of the three-stage homogenizing emulsifier is 20MPa / 40MPa / 60MPa.

[0038] Preferably, the time for the three reflux extractions is 2 h, 1.5 h and 1 h respectively; the pore size of the ceramic membrane filtration system is 0.22 μm, the pressure of the high-pressure homogenizer is 50 MPa; and the dose of cobalt-60 irradiation sterilization is 8 kGy.

[0039] The invention discloses a drug for preparing a drug for treating deep second-degree burns and scalds or below. The drug has the effects of promoting wound healing and inhibiting scar hyperplasia.

[0040] Compared with the prior art, the present invention has the following beneficial effects:

[0041] The added pearl powder, salvia miltiorrhiza extract, phellodendron amurense, sanguisorba officinalis and rhubarb construct a three-effect synergistic system of "anti-infection-promoting healing-inhibiting scars". Pharmacological experiments have confirmed that it can shorten the healing time of deep second-degree wounds by 3-5 days and reduce the degree of scar hyperplasia by 40%; the thermosensitive hydrogel achieves "gelation upon contact with the skin", is evenly applied and not easy to fall off, the drug loading capacity is increased by 20%, and the drug transdermal penetration rate is 1.5 times higher than that of traditional ointments; it is not only suitable for deep second-degree burns and below, but can also be used for pigmentation repair after chemical burns and softening superficial scars. DETAILED DESCRIPTION

[0042] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described 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 making creative efforts are within the scope of protection of the present invention.

[0043] The invention provides a technical solution: a traditional Chinese medicine external nursing medicine for treating burns and scalds, comprising the following raw materials and auxiliary materials in parts by weight: the raw materials: 8-12 parts of dandelion, 6-8 parts of oldenlandia diffusa, 8-10 parts of evergreen, 8-10 parts of elm bark, 10-12 parts of calcined dragon bone, 6-8 parts of aloe, 8-10 parts of safflower, 8-10 parts of angelica dahurica, 8-10 parts of astragalus, 3-5 parts of borneol, 2-4 parts of pearl powder, 1-3 parts of salvia miltiorrhiza extract, 8-10 parts of phellodendron, 6-8 parts of sanguisorba officinalis, and 4-6 parts of rhubarb; and auxiliary materials: 5-10 parts of chitosan, 3-6 parts of hyaluronic acid, 10-20 parts of olive oil, and 1-2 parts of nano titanium dioxide.

[0044] The nursing medicine formula of the present invention is mainly developed based on the pathogenesis characteristics of patients with burns and scalds, and has the remarkable effects of clearing away heat and detoxicating, resisting infection, promoting blood circulation and dispersing blood stasis, reducing swelling, absorbing moisture and healing sores, and protecting wound surface. Among the prescriptions, dandelion, white flower hedyotis diffusa, evergreen, elm bark, and aloe clear away heat and detoxicating, reduce swelling and relieve pain, have strong antibacterial and anti-infective effects, and evergreen also has a significant scab-forming effect; calcined dragon bone and astragalus root can heal sores and promote tissue regeneration, discharge pus and astringe sweat, and have a significant effect of promoting wound healing and descabbing; safflower, angelica dahurica, and borneol can promote blood circulation and menstruation, dissipate blood stasis and relieve pain, and angelica dahurica has the effect of reducing wound surface fluid exudation. Pearl powder, salvia miltiorrhiza extract, phellodendron, sanguisorba officinalis, and rhubarb can cool blood and stop bleeding, and have antibacterial and anti-inflammatory effects. Among them, pearl powder can promote epidermal cell differentiation and proliferation, salvia miltiorrhiza extract can inhibit scar hyperplasia, and phellodendron and sanguisorba officinalis compatibility can enhance anti-exudation effect; the nursing medicine formula of the present invention is reasonable and has a very strong targeted therapeutic effect on burns and scalds. Clinical application has proved that the Chinese medicine preparation has definite efficacy, mild medicinal properties, no toxic side effects and adverse reactions, and a high safety factor. The Chinese medicine preparation of the present invention adopts advanced extraction equipment and technology to fully extract the effective ingredients and can be made into a convenient Chinese medicine preparation.

[0045] The nursing medicine is a thermosensitive hydrogel ointment or nanoemulsion tincture.

[0046] The preparation method of the temperature-sensitive hydrogel ointment comprises the following steps:

[0047] Extraction of raw materials: Using water extraction and alcohol precipitation, dandelion, Hedyotis diffusa, Evergreen, Ulmus pumila bark, calcined dragon bone, aloe, safflower, angelica dahurica, astragalus, borneol, pearl powder, salvia miltiorrhiza extract, Phellodendron amurense, Sanguisorba officinalis, and rhubarb are mixed in proportion, and then 8 times the amount of purified water is added. The mixture is decocted twice, the first time for 1.5 hours and the second time for 1 hour. The filtrates are combined and concentrated under vacuum to an extract with a relative density of 1.25-1.30. 95% ethanol is added to make the alcohol content reach 70%. After standing for 24 hours, the supernatant is collected and the ethanol is recovered to obtain a drug fluid extract.

[0048] Excipient preparation: Chitosan was dissolved in 2% acetic acid solution to form a 3% colloidal solution. Hyaluronic acid was swelled with water for injection for 12 hours and then sterilized by filtration. Olive oil was dry-heat sterilized at 180°C for 30 minutes and then pre-dispersed with nano-titanium dioxide in a high-speed shear emulsifier to control the particle size to ≤100nm.

[0049] Preparation molding: The drug fluid extract and chitosan colloid are isothermally mixed at 4°C, hyaluronic acid solution is added, and the pH adjuster is slowly added dropwise until neutral. Finally, the nano-titanium dioxide-olive oil dispersion system is added under sterile conditions. After being processed by a three-stage homogenizer, it is packaged into pre-sterilized light-proof aluminum tubes to form a temperature-sensitive hydrogel ointment with a phase transition temperature of 37°C.

[0050] The preparation method of the nanoemulsion tincture comprises the following steps:

[0051] Preparation of nanoemulsion tincture base: Mix polysorbate 80 and propylene glycol in a ratio of 1:3 as the oil phase, add glycerol as a cosolvent, and preheat to 45°C for use;

[0052] Raw material processing: Take dandelion, Hedyotis diffusa, Evergreen, Elm bark, calcined dragon bone, aloe, safflower, Angelica dahurica, Astragalus, borneol, pearl powder, Salvia miltiorrhiza extract, Phellodendron amurense, Sanguisorba officinalis, and Rhubarb, use alcohol extraction and water precipitation method, soak in 70% ethanol for 24 hours, reflux extraction at 70℃ for 3 times, combine the extracts, refine through ceramic membrane filtration system, and concentrate under reduced pressure to a thick paste with a relative density of 1.10-1.15;

[0053] Emulsification and dispersion: slowly add the thick drug paste into the preheated oil phase system, and use a high-pressure homogenizer to cycle the process for 5 times, controlling the droplet size to ≤200nm and maintaining the Zeta potential at -20mV to -30mV;

[0054] Sterilization and packaging: Add 0.05% ethylparaben as a preservative, filter through a 0.22 μm microporous filter membrane, fill into brown pharmaceutical glass bottles in a Class 100 clean environment, and sterilize by cobalt-60 irradiation to finally produce a nanoemulsion tincture with a transdermal absorption rate of 85% or more.

[0055] The pH regulator is 0.1M NaOH; the pressure of the three-stage homogenizing emulsifier is 20MPa / 40MPa / 60MPa.

[0056] The reflux extraction times were 2 h, 1.5 h, and 1 h, respectively. The pore size of the ceramic membrane filtration system was 0.22 μm, the pressure of the high-pressure homogenizer was 50 MPa, and the dose of cobalt-60 irradiation sterilization was 8 kGy.

[0057] The invention discloses a drug for preparing a drug for treating deep second-degree burns and scalds or below. The drug has the effects of promoting wound healing and inhibiting scar hyperplasia.

[0058] Example 1:

[0059] The preparation method of the temperature-sensitive hydrogel ointment comprises the following steps:

[0060] Extraction of raw materials: using water extraction and alcohol precipitation method, 8 parts of dandelion, 6 parts of oldenlandia diffusa, 10 parts of evergreen, 8 parts of elm bark, 10 parts of calcined dragon bone, 6 parts of aloe, 8 parts of safflower, 8 parts of angelica dahurica, 10 parts of astragalus, 3 parts of borneol, 2 parts of pearl powder, 1 part of salvia miltiorrhiza extract, 8 parts of phellodendron, 6 parts of sanguisorba officinalis, and 4 parts of rhubarb are mixed in proportion, and then 8 times the amount of purified water is added. The mixture is decocted twice, the first time for 1.5 hours and the second time for 1 hour. The filtrates are combined and concentrated under vacuum to an extract with a relative density of 1.25-1.30. 95% ethanol is added to make the alcohol content reach 70%. After standing for 24 hours, the supernatant is collected and the ethanol is recovered to obtain a drug fluid extract.

[0061] Excipient preparation: Chitosan was dissolved in 2% acetic acid solution to form a 3% colloidal solution. Hyaluronic acid was swelled with water for injection for 12 hours and then sterilized by filtration. Olive oil was dry-heat sterilized at 180°C for 30 minutes and then pre-dispersed with nano-titanium dioxide in a high-speed shear emulsifier to control the particle size to ≤100nm.

[0062] Preparation molding: The drug fluid extract and chitosan colloid are isothermally mixed at 4°C, hyaluronic acid solution is added, and the pH adjuster is slowly added dropwise until neutral. Finally, the nano-titanium dioxide-olive oil dispersion system is added under sterile conditions. After being processed by a three-stage homogenizer, it is packaged into pre-sterilized light-proof aluminum tubes to form a temperature-sensitive hydrogel ointment with a phase transition temperature of 37°C.

[0063] The preparation method of the nanoemulsion tincture comprises the following steps:

[0064] Preparation of nanoemulsion tincture base: Mix polysorbate 80 and propylene glycol in a ratio of 1:3 as the oil phase, add glycerol as a cosolvent, and preheat to 45°C for use;

[0065] Raw material processing: take 8 parts of dandelion, 6 parts of oldenlandia diffusa, 10 parts of evergreen, 8 parts of elm bark, 10 parts of calcined dragon bone, 6 parts of aloe, 8 parts of safflower, 8 parts of angelica dahurica, 10 parts of astragalus, 3 parts of borneol, 2 parts of pearl powder, 1 part of salvia miltiorrhiza extract, 8 parts of phellodendron, 6 parts of sanguisorba officinalis, and 4 parts of rhubarb, adopt alcohol extraction and water precipitation method, soak in 70% ethanol for 24 hours, reflux extraction at 70°C for 3 times, refine the combined extracts through ceramic membrane filtration system, and concentrate under reduced pressure to a thick paste with a relative density of 1.10-1.15;

[0066] Emulsification and dispersion: slowly add the thick drug paste into the preheated oil phase system, and use a high-pressure homogenizer to cycle the process for 5 times, controlling the droplet size to ≤200nm and maintaining the Zeta potential at -20mV to -30mV;

[0067] Sterilization and packaging: Add 0.05% ethylparaben as a preservative, filter through a 0.22 μm microporous filter membrane, fill into brown pharmaceutical glass bottles in a Class 100 clean environment, and sterilize by cobalt-60 irradiation to finally produce a nanoemulsion tincture with a transdermal absorption rate of 85% or more.

[0068] Example 2:

[0069] The preparation method of the temperature-sensitive hydrogel ointment comprises the following steps:

[0070] Extraction of raw materials: using water extraction and alcohol precipitation method, 10 parts of dandelion, 8 parts of white flower oldenlandia, 9 parts of evergreen, 9 parts of elm bark, 11 parts of calcined dragon bone, 7 parts of aloe, 9 parts of safflower, 9 parts of angelica dahurica, 8 parts of astragalus, 4 parts of borneol, 3 parts of pearl powder, 2 parts of salvia miltiorrhiza extract, 9 parts of phellodendron, 7 parts of sanguisorba officinalis, and 5 parts of rhubarb are mixed in proportion, and then 8 times the amount of purified water is added. The mixture is decocted twice, the first time for 1.5 hours and the second time for 1 hour. The filtrates are combined and concentrated under vacuum to an extract with a relative density of 1.25-1.30. 95% ethanol is added to make the alcohol content reach 70%. After standing for 24 hours, the supernatant is collected and the ethanol is recovered to obtain a drug fluid extract;

[0071] Excipient preparation: Chitosan was dissolved in 2% acetic acid solution to form a 3% colloidal solution. Hyaluronic acid was swelled with water for injection for 12 hours and then sterilized by filtration. Olive oil was dry-heat sterilized at 180°C for 30 minutes and then pre-dispersed with nano-titanium dioxide in a high-speed shear emulsifier to control the particle size to ≤100nm.

[0072] Preparation molding: The drug fluid extract and chitosan colloid are isothermally mixed at 4°C, hyaluronic acid solution is added, and the pH adjuster is slowly added dropwise until neutral. Finally, the nano-titanium dioxide-olive oil dispersion system is added under sterile conditions. After being processed by a three-stage homogenizer, it is packaged into pre-sterilized light-proof aluminum tubes to form a temperature-sensitive hydrogel ointment with a phase transition temperature of 37°C.

[0073] The preparation method of the nanoemulsion tincture comprises the following steps:

[0074] Preparation of nanoemulsion tincture base: Mix polysorbate 80 and propylene glycol in a ratio of 1:3 as the oil phase, add glycerol as a cosolvent, and preheat to 45°C for use;

[0075] Raw material processing: take 10 parts of dandelion, 8 parts of oldenlandia diffusa, 9 parts of evergreen, 9 parts of elm bark, 11 parts of calcined dragon bone, 7 parts of aloe, 9 parts of safflower, 9 parts of angelica dahurica, 8 parts of astragalus, 4 parts of borneol, 3 parts of pearl powder, 2 parts of salvia miltiorrhiza extract, 9 parts of phellodendron, 7 parts of sanguisorba officinalis, and 5 parts of rhubarb, use alcohol extraction and water precipitation method, soak in 70% ethanol for 24 hours, reflux extraction at 70°C for 3 times, refine the combined extracts through ceramic membrane filtration system, and concentrate under reduced pressure to a thick paste with a relative density of 1.10-1.15;

[0076] Emulsification and dispersion: slowly add the thick drug paste into the preheated oil phase system, and use a high-pressure homogenizer to cycle the process for 5 times, controlling the droplet size to ≤200nm and maintaining the Zeta potential at -20mV to -30mV;

[0077] Sterilization and packaging: Add 0.05% ethylparaben as a preservative, filter through a 0.22 μm microporous filter membrane, fill into brown pharmaceutical glass bottles in a Class 100 clean environment, and sterilize by cobalt-60 irradiation to finally produce a nanoemulsion tincture with a transdermal absorption rate of 85% or more.

[0078] Specific implementation:

[0079] 1. Pharmacodynamics experiments

[0080] Scar inhibition experiment: Using a rat deep second-degree burn model, the gel of the present invention (Group A), commercially available sulfadiazine silver ointment (Group B), and a blank control group (Group C) were compared. After 28 days of treatment, the scar thickness of Group A (0.32±0.05mm) was significantly lower than that of Group B (0.58±0.08mm) and Group C (0.75±0.10mm), and the hydroxyproline content decreased by 35% (P<0.01), indicating a decrease in collagen deposition. Transdermal absorption experiment: Using a Franz diffusion cell and taking chlorogenic acid as an indicator, the 24-hour cumulative transdermal amount of the thermosensitive gel of the present invention (12.5±1.2μg / cm 2 ) is a traditional ointment (7.8±0.9μg / cm 2 ) was 1.6 times that of the control group, and the difference was significant (P<0.05).

[0081] 2. Clinical observation

[0082] A multicenter clinical trial enrolled 300 patients with deep second-degree burns and scalds and randomly divided them into a treatment group (150 patients, using the gel of the present invention) and a control group (150 patients, using Jingwanhong ointment). The results are as follows:

[0083] Healing time: average (18.5±2.3) days in the treatment group and (23.7±3.1) days in the control group, P<0.01;

[0084] Scar score (VSS scale): treatment group (3.2±1.1) points, control group (5.8±1.5 points), P<0.01;

[0085] Safety: There was no abnormal liver and kidney function in both groups. The adverse reaction rate in the treatment group (1.3%) was lower than that in the control group (4.7%).

[0086] Typical case: A 35-year-old male patient suffered from deep second-degree burns on the right upper limb (area 10%). After 7 days of treatment with the gel of the present invention, exudation stopped, the scab fell off after 14 days, the new skin became smooth after 28 days, and the scar was mild after 6 months, with a VSS score of 2 points.

[0087] While 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 these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese herbal external-use nursing medicine for treating burns and scalds, characterized in that: The invention comprises the following raw materials and auxiliary materials in parts by weight; raw materials: 8-12 parts of dandelion, 6-8 parts of oldenlandia diffusa, 8-10 parts of evergreen, 8-10 parts of elm bark, 10-12 parts of calcined dragon bone, 6-8 parts of aloe, 8-10 parts of safflower, 8-10 parts of angelica dahurica, 8-10 parts of astragalus, 3-5 parts of borneol, 2-4 parts of pearl powder, 1-3 parts of salvia miltiorrhiza extract, 8-10 parts of phellodendron, 6-8 parts of sanguisorba officinalis, and 4-6 parts of rhubarb; Auxiliary materials: 5-10 parts of chitosan, 3-6 parts of hyaluronic acid, 10-20 parts of olive oil, and 1-2 parts of nano titanium dioxide.

2. A Chinese medicine for external use nursing medicine for treating burns and scalds according to claim 1, characterized in that: The invention comprises the following raw materials and auxiliary materials in parts by weight; raw materials: 8 parts of dandelion, 6 parts of white flower oldenlandia, 10 parts of evergreen, 8 parts of elm bark, 10 parts of calcined dragon bone, 6 parts of aloe, 8 parts of safflower, 8 parts of angelica, 10 parts of astragalus, 3 parts of borneol, 2 parts of pearl powder, 1 part of salvia miltiorrhiza extract, 8 parts of phellodendron, 6 parts of sanguisorba officinalis, and 4 parts of rhubarb; Excipients: 5 parts of chitosan, 3 parts of hyaluronic acid, 10 parts of olive oil, and 1 part of nano-titanium dioxide.

3. A Chinese medicine for external use nursing medicine for treating burns and scalds according to claim 1, characterized in that: The nursing medicine is a temperature-sensitive hydrogel ointment or a nanoemulsion tincture.

4. A Chinese medicinal external-use nursing medicine for treating burns and scalds according to claim 3, characterized in that: The preparation method of the temperature-sensitive hydrogel ointment comprises the following steps: Extraction of raw materials: Using water extraction and alcohol precipitation, dandelion, Hedyotis diffusa, Evergreen, Ulmus pumila bark, calcined dragon bone, aloe, safflower, angelica dahurica, astragalus, borneol, pearl powder, salvia miltiorrhiza extract, Phellodendron amurense, Sanguisorba officinalis, and rhubarb are mixed in proportion, and then 8 times the amount of purified water is added. The mixture is decocted twice, the first time for 1.5 hours and the second time for 1 hour. The filtrates are combined and concentrated under vacuum to an extract with a relative density of 1.25-1.

30. 95% ethanol is added to make the alcohol content reach 70%. After standing for 24 hours, the supernatant is collected and the ethanol is recovered to obtain a drug fluid extract. Excipient preparation: Chitosan was dissolved in 2% acetic acid solution to form a 3% colloidal solution. Hyaluronic acid was swelled with water for injection for 12 hours and then sterilized by filtration. Olive oil was dry-heat sterilized at 180°C for 30 minutes and then pre-dispersed with nano-titanium dioxide in a high-speed shear emulsifier to control the particle size to ≤100nm. Preparation molding: The drug fluid extract and chitosan colloid are isothermally mixed at 4°C, hyaluronic acid solution is added, and the pH adjuster is slowly added dropwise until neutral. Finally, the nano-titanium dioxide-olive oil dispersion system is added under sterile conditions. After being processed by a three-stage homogenizer, it is packaged into pre-sterilized light-proof aluminum tubes to form a temperature-sensitive hydrogel ointment with a phase transition temperature of 37°C.

5. A Chinese medicinal external-use nursing medicine for treating burns and scalds according to claim 3, characterized in that: The preparation method of the nanoemulsion tincture comprises the following steps: Preparation of nanoemulsion tincture base: Mix polysorbate 80 and propylene glycol in a ratio of 1:3 as the oil phase, add glycerol as a cosolvent, and preheat to 45°C for use; Raw material processing: Take dandelion, Hedyotis diffusa, Evergreen, Elm bark, calcined dragon bone, aloe, safflower, Angelica dahurica, Astragalus, borneol, pearl powder, Salvia miltiorrhiza extract, Phellodendron amurense, Sanguisorba officinalis, and Rhubarb, use alcohol extraction and water precipitation method, soak in 70% ethanol for 24 hours, reflux extraction at 70℃ for 3 times, combine the extracts, refine through ceramic membrane filtration system, and concentrate under reduced pressure to a thick paste with a relative density of 1.10-1.15; Emulsification and dispersion: slowly add the thick drug paste into the preheated oil phase system, and use a high-pressure homogenizer to cycle the process for 5 times, controlling the droplet size to ≤200nm and maintaining the Zeta potential at -20mV to -30mV; Sterilization and packaging: Add 0.05% ethylparaben as a preservative, filter through a 0.22 μm microporous filter membrane, fill into brown pharmaceutical glass bottles in a Class 100 clean environment, and sterilize by cobalt-60 irradiation to finally produce a nanoemulsion tincture with a transdermal absorption rate of 85% or more.

6. A Chinese medicinal external-use nursing medicine for treating burns and scalds according to claim 4, characterized in that: The pH regulator is 0.1M NaOH; the pressure of the three-stage homogenizing emulsifier is 20MPa / 40MPa / 60MPa.

7. A Chinese medicinal external-use nursing medicine for treating burns and scalds according to claim 5, characterized in that: The reflux extraction times for the three times were 2 h, 1.5 h and 1 h respectively; the pore size of the ceramic membrane filtration system was 0.22 μm, the pressure of the high-pressure homogenizer was 50 MPa; and the dose of cobalt-60 irradiation sterilization was 8 kGy.

8. Use of the drug according to claim 1 in preparing a drug for treating deep second degree burns and scalds or below, characterized in that: The medicine has the effects of promoting wound healing and inhibiting scar hyperplasia.