CN107149641B

CN107149641B - Composition for treating burns and scalds

Info

Publication number: CN107149641B
Application number: CN201710373839.3A
Authority: CN
Inventors: 刘泽宇; 魏元刚; 钟慧; 左婧; 易铭; 杨永安
Original assignee: Nanjing Ziyuankang Pharmaceutical Technology Co ltd
Current assignee: Nanjing purple source Kang medicine technology Co., Ltd.
Priority date: 2017-05-24
Filing date: 2017-05-24
Publication date: 2020-07-21
Anticipated expiration: 2037-05-24
Also published as: CN107149641A

Abstract

The invention discloses a composition for treating burns and scalds. The active ingredients of the composition consist of alkannin, a burn and scald compound alcohol extract and a burn and scald compound water extract, wherein the burn and scald compound alcohol extract is an alcohol extract of frankincense, indigo naturalis and dragon's blood, and the burn and scald compound water extract is a water extract of coptis chinensis, rheum officinale, rhizoma corydalis, sanguisorba officinalis and golden larch bark. The alkannin accounts for 0.01-0.3% of the weight of the composition; the burn and scald alcohol extract accounts for 0.5-5% of the composition by weight; the weight percentage of the burn and scald compound water extract in the composition is 0.2-12%. The invention combines the modern production technology with the traditional secret recipe as the basis to extract and process the effective components of a plurality of Chinese medicinal materials. Under the condition of no side effect, the ointment can heal and eliminate scars and reduce infection to the maximum extent, has good treatment effect on burns and scalds, and avoids the irritation of modern chemical agents and the inconvenience in use of traditional Chinese medicine preparations.

Description

Composition for treating burns and scalds

Technical Field

The invention belongs to the technical field of biological medicines and therapeutic cosmetics, and particularly relates to a composition containing alkannin and a traditional Chinese medicine extract for treating burns and scalds and a preparation method of partial dosage forms.

Background

Burn and scald are common diseases, which troubles the patients for a long time. Burn and scald are the heat injury of skin, and heat toxin is the disease, so how to protect the wound surface, reduce exudation and prevent infection is the main problem to be solved. The principle of treating the burns and scalds is to clear away heat and toxic materials, cool blood and activate blood, promote diuresis and eliminate dampness, and supplement qi and nourish yin.

At present, the medicines for treating burns and scalds are various, can be basically divided into traditional Chinese medicines and western medicines, are passively treated in time after blistering, skin breaking and ulceration after being burnt, bring great pain to patients, cause economic loss and worry about fatigue to families, and even cause huge psychological pressure of waste and loss of beauty of appearance; in addition, the raw materials of the western medicines are mostly chemical substances, the efficacy is single, or the western medicines can irritate the skin of a human body, and some western medicines have dependence or side effects after long-term use. The traditional Chinese medicine has rich experience in the aspect of external treatment of burn, the theoretical level of the traditional Chinese medicine for external treatment of burn is continuously improved in recent years, the clinical experience is continuously rich, and the clinical advantages are more and more obvious.

The traditional Chinese medicine lithospermum has many advantages in the aspect of treating skin diseases, particularly, the application of a traditional Chinese medicine compound, and clinical and experimental researches prove that the lithospermum has the effects of resisting inflammation, inhibiting bacteria, relieving itching, repairing and the like, is mainly used for treating burns, eczema and various skin diseases, and particularly has good effect in healing large-area foot ulcer wounds caused by diabetes. Is often favored by patients and dermatologists. The main active ingredient of the lithospermum is shikonin (shikonin), also named 5, 8-dihydroxy-2- [ (1R) -1-hydroxy-4-methylpent-3-enyl ] naphthalene-1, 4-dione, which is a unique fat-soluble naphthoquinone pigment compound in the lithospermum, but the lithospermum contains chemical ingredients called pyrrolizidine alkaloids, PAs for short, the toxicity is concentrated in the liver, also called liver toxicity pyrrolizidine alkaloids, and hidden troubles are left for clinical application.

Coptis root, sanguisorba, rhubarb, and the like are all good medicines for treating burns and scalds in traditional Chinese medicines. According to records in Chinese pharmacopoeia, Chinese medicine dictionary and Chinese materia medica, the coptis has the functions of clearing heat, drying dampness, purging fire and detoxifying, is used for treating carbuncle-abscess sore toxin, eczema and scald caused by hot soup, berberine in the coptis can sterilize and inhibit bacteria and has the functions of mild sedation and the like, so that the berberine is an effective barrier for protecting a wound surface and preventing infection, and meanwhile, the sedation generated after the wound surface is absorbed by tissues can effectively relieve the pain of a patient; radix Sangusorbae contains abundant tannin, has strong astringency and blood vessel contraction effects, and can reduce capillary permeability, inflammatory exudation and tissue edema. It has effects in cooling blood, stopping bleeding, healing sore, and removing toxic substance, and can be used for preventing and controlling infection, relieving pain, and promoting wound healing; the rhubarb has the effects of clearing heat and purging fire, cooling blood and removing toxicity, and is particularly suitable for treating burns and scalds, the nature of the rhubarb is cold and cool, the toxic heat of the scalded part and excessive secretion generated by the body under the stimulation of the toxic heat can be quickly removed, and the skin can be quickly healed without scars.

The Chinese patent document with application number 201110249919.0 discloses a burn and scald liquid, a burn and scald ointment and a preparation method thereof, wherein the burn and scald liquid is prepared by pulverizing rhizoma Polygoni Cuspidati, radix Arnebiae, fructus Gardeniae, and cortex Phellodendri, soaking in ethanol for one or two months, filtering when in use, and adding a small amount of Moschus. The preparation of the burn and scald liquid needs a long time, the use method is not convenient enough, and the ethanol has great irritation to the injured skin, which can bring great pain to patients. The ointment for treating burn and scald is prepared by pulverizing radix Arnebiae, radix Angelicae Dahuricae, radix Angelicae sinensis, Glycyrrhrizae radix, radix et rhizoma Rhei, cortex Phellodendri, etc. into powder, using sesame oil as matrix, refrigerating for storage, and adding small amount of Moschus. The application method of the burn and scald ointment is still not convenient enough.

Disclosure of Invention

The purpose of the invention is as follows: in order to safely and effectively treat burns and scalds, the invention provides a composition containing alkannin and traditional Chinese medicine extracts, which has a novel formula and a remarkable curative effect. The invention also provides a preparation method of the partial dosage form.

The technical scheme is as follows: a composition for treating burn and scald comprises alkannin, a burn and scald compound alcohol extract and a burn and scald compound water extract as active ingredients, wherein the burn and scald compound alcohol extract is an alcohol extract of frankincense, indigo naturalis and dragon's blood, and the burn and scald compound water extract is a water extract of coptis chinensis, rheum officinale, rhizoma corydalis, sanguisorba officinalis and golden larch bark.

The coptis chinensis has the effects of clearing heat, eliminating dampness, purging fire and removing toxin, and is used for treating carbuncle, deep-rooted carbuncle, sore and toxin, eczema and soup fire scalds, and berberine in the coptis chinensis can kill bacteria and inhibit bacteria and has the effects of mild sedation and the like; the rhubarb has the effects of clearing heat, purging fire, cooling blood and removing toxicity, is particularly suitable for treating burns and scalds, and contains emodin with the functions of bacteriostasis, anti-inflammation and anti-inflammation; rhizoma corydalis is also called rhizoma corydalis, has the effects of promoting blood circulation, removing blood stasis, regulating qi-flowing and relieving pain, and extracts more than 10 kinds of alkaloids in the tuber of the plant, and the alkaloids have certain anti-inflammatory and antibacterial effects; sanguisorba contains a large amount of tannin, and sanguisorba contains a large amount of tannin, has strong astringency and blood vessel contraction effects, can reduce permeability of capillary vessels, reduce inflammatory exudation and relieve tissue edema, has the functions of cooling blood, stopping bleeding, healing sores and detoxifying, and can play roles in preventing and controlling infection, eliminating pain, promoting wound healing and the like; cortex pseudolaricis has effects of dispelling pathogenic wind, removing dampness, killing parasite and relieving itching, mainly contains cortex pseudolaricis acetic acid, and has antifungal, anti-tumor, anti-fertility, and anti-angiogenesis effects. The above components can be extracted with water to obtain effective components.

The frankincense has the effects of activating blood circulation, promoting qi circulation, relieving pain, reducing swelling and promoting tissue regeneration, and the extract and the contained triterpenoid component, namely the frankincense acid compound have anti-inflammatory activity on various acute and chronic inflammation models; indigo naturalis has effects of clearing heat, cooling blood, and removing toxic substance, and mainly contains indigo blue, indirubin, tryptanthrin, etc., wherein tryptanthrin has strong antibacterial effect on 7 kinds of dermatogic fungi such as Microsporum lanosum, Trichophyton Menispermis, Microsporum gypseum, Trichophyton purpureum, etc.; dragon's blood has the functions of promoting blood circulation to disperse blood clots, stopping pain, stopping bleeding, healing sore and promoting granulation, and contains flavone compounds, pterostilbene, resveratrol, Longxuening A, etc. and has certain inhibiting effect on staphylococcus aureus, white staphylococcus, staphylococcus limonum, Neisseria, diphtheria bacillus and Shigella flexneri. The three medicinal materials can be extracted with alcohol to obtain effective components.

The above medicinal materials have synergistic effect in treating burn and scald. The coptis root, the rhubarb, and the like can inhibit bacteria, resist inflammation and prevent wound infection; sanguisorba root, frankincense and the like can relieve inflammation, reduce swelling, relieve pain and promote wound healing. Therefore, after the ethanol extraction and the water extraction are respectively carried out, the treatment effect can be better exerted by adding the ethanol extract and the water extract simultaneously.

The compound alcohol extract for burns and scalds comprises the following raw materials in percentage by weight:

10-12 parts of frankincense

15-20 parts of indigo naturalis

4-6 parts of dragon blood.

The preparation method of the burn and scald compound alcohol extract comprises the following steps:

mixing the frankincense, the indigo naturalis and the dragon's blood, extracting for 2-4 times by using ethanol with the volume ratio of 5-10 times, wherein the purity of the ethanol is 80-100%, the extraction temperature is 70-90 ℃, the extraction time is 1-3 hours, merging filtrate after extraction is finished, concentrating and drying to obtain the burn and scald compound alcohol extract.

The compound aqueous extract for burns and scalds comprises the following raw materials in percentage by weight:

the preparation method of the compound aqueous extract for burns and scalds comprises the following steps:

mixing the coptis chinensis, the rheum officinale, the rhizoma corydalis, the garden burnet and the golden larch bark, then extracting with water of which the volume ratio is 5-10 times for 2-4 times, wherein the extraction temperature is 70-90 ℃, the extraction time is 1-3 hours, merging filtrate after the extraction is finished, concentrating and drying to obtain the burn and scald compound water extract.

Preferably, in the extraction process of the burn and scald compound alcohol extract and the burn and scald compound water extract, the purity of the ethanol is 90%, the temperature of the alcohol extraction and the water extraction is 85 ℃, the extraction time is 2 hours each time, the extraction is carried out twice respectively, and then the effective components can be fully extracted.

The composition of the invention contains acceptable base materials and auxiliary materials in pharmacy or cosmetics besides active ingredients, and can be prepared into products such as gel, cream, suspension, emulsion and the like.

Optionally, the alkannin accounts for 0.01-0.3% of the weight of the composition; the burn and scald alcohol extract accounts for 0.5-5% of the composition by weight, and is equivalent to 0.1-2% of frankincense, 0.2-3% of natural indigo and 0.05-1% of dragon's blood; the weight percentage of the burn and scald compound aqueous extract is 0.2-12% of the composition, which is equivalent to 0.02-3% of coptis chinensis, 0.04-4.5% of rheum officinale, 0.03-3.5% of rhizoma corydalis, 0.02-3.5% of sanguisorba officinalis and 0.02-3.5% of golden larch bark.

Preferably, the alkannin accounts for 0.02-0.1% of the weight of the composition; the weight percentage of the burn and scald compound alcohol extract in the composition is 0.5-2%, and the weight percentage of the burn and scald compound water extract in the composition is 0.5-2%.

Optionally, the matrix is one or more of a gel framework material, an oil phase matrix and an emulsifier; the auxiliary materials comprise one or more of solubilizer, humectant, pH regulator, skin penetration enhancer and water; the auxiliary materials also comprise one or more of disinfectant, preservative, antioxidant and essence.

Optionally, when the dosage form is a gel, the gel matrix material is at least one of carbomer series, cellulose derivatives, chitosan-based matrices; when the dosage form is cream, the selected oil phase matrix is at least one of vegetable oil, higher fatty alcohol, beeswax, and stearic acid; the emulsifier is at least one of fatty acid ester of polyhydric alcohol, fatty alcohol, and polyoxyethylene ether.

Preferably, when the dosage form is a gel, the gel matrix material selected is at least one of carbomer U10, carbomer U20, hydroxyethyl cellulose.

Optionally, the solubilizer is at least one of poloxamer series and tween series, and the poloxamer series comprises poloxamer 188 and poloxamer 407; the humectant is at least one of glycerol, propylene glycol, 1, 3-butanediol, sorbitol, sodium pyrrolidone carboxylate, hyaluronic acid, lactic acid and sodium lactate; the disinfectant is at least one of triclosan, parachlorometaxylenol, chlorhexidine acetate and polyhexamethylene biguanide.

Optionally, the humectant accounts for 5-20% of the total weight, the skin penetration enhancer accounts for 0.3-5% of the total weight, the preservative accounts for 0.05-0.5% of the total weight, the antioxidant accounts for 0.2-1% of the total weight, the essence accounts for 0.02-2% of the total weight, the pH regulator accounts for 0.1-2% of the total weight, and the disinfectant accounts for 0.05-1% of the total weight; when the dosage form is gel, the gel framework material accounts for 0.25-2% of the total weight; when the dosage form is cream or emulsion, the emulsifier accounts for 0.5-10% of the total weight.

When the formulation is cream, the composition comprises the following components in percentage by weight: 0.01-0.3% of alkannin; 2-4% of propylene glycol; chlorhexidine acetate, 0.1-0.3%; 2-10% of M-68 emulsifier, 1-3% of peregal O-25; 0.5-3% of octadecanol; 5-10% of PEG-60 hydrogenated castor oil; 2-10% of isopropyl myristate; 0.1-0.3% of oil-soluble VE; 2-6% of squalane; 2-10% of olive oil; 0.5-5% of a compound alcohol extract for burns and scalds; 0.5-5% of ethanol; 0.1-0.5% of dipotassium glycyrrhizinate; 0.1-0.3% of hyaluronic acid; 0.01-0.05% of EDTA-2 Na; 0.01-0.05% of citric acid; 0.2-12% of a compound water extract for burns and scalds; the balance of water; wherein the mass concentration of hyaluronic acid is 1-2%;

when the dosage form is a gel, the composition comprises the following components in percentage by weight: 0.01-0.3% of alkannin; 2-4% of propylene glycol; 2-6% of poloxamer 188; 0.1-0.3% of triclosan; 10-30% of glycerol; 0.2-0.8% of carbomer U20; 0.1-0.5% of xanthan gum; 0.2-12% of burn and scald aqueous extract; 0.5-5% of alcohol extract of burns and scalds; 2-10% of triethanolamine; the balance of water; wherein the mass concentration of the triethanolamine is 8-10%.

Preferably, when the formulation is a cream, the composition comprises, in weight percent: alkannin, 0.02%; 4% of propylene glycol; chlorhexidine acetate, 0.3%; 10% of M-68 emulsifier, 2% of peregal O-25; 1% of octadecanol; PEG-60 hydrogenated castor oil, 10%; isopropyl myristate, 9.5%; oil-soluble VE, 0.2%; 5% of squalane; olive oil, 5%; 0.5-2% of a compound alcohol extract for burns and scalds; 2% of ethanol; 0.2% of dipotassium glycyrrhizinate; hyaluronic acid, 0.15%; EDTA-2Na, 0.025%; 0.025% of citric acid; 0.5-2% of a compound water extract for burns and scalds; the balance being water.

Preferably, when the dosage form is a gel, the composition comprises, in weight percent: alkannin, 0.02%; 2% of propylene glycol; poloxamer 188, 4%; 0.15 percent of triclosan; 20% of glycerol; carbomer U20, 0.6%; 0.25 percent of xanthan gum; 0.5-2% of burn and scald aqueous extract; 0.5-2% of alcohol extract of burns and scalds; triethanolamine, 3%; the balance being water.

The invention also provides a preparation method of the composition partial dosage form, which comprises the following steps:

cream preparation: mixing M-68 emulsifier, peregal O-25, octadecanol, PEG-60 hydrogenated castor oil, isopropyl myristate, oil-soluble VE, squalane and olive oil according to a weight ratio, heating in a water bath kettle at about 75-80 ℃, melting, uniformly stirring, and adding a burn and scald compound alcohol extract heated and dissolved by ethanol and chlorhexidine acetate heated and dissolved by propylene glycol to form an oil phase A; dissolving dipotassium glycyrrhizinate, hyaluronic acid, EDTA-2Na, citric acid and the compound water extract for burns and scalds in purified water, heating in a water bath kettle at the temperature of about 75-85 ℃, and uniformly stirring to form an aqueous phase B. Pumping the A and the B into a homogenizing pot, keeping the temperature of 70-80 ℃, homogenizing, stirring and gradually cooling to 40-45 ℃ after full emulsification, adding the alkannin ultrasonically dissolved in the propylene glycol at room temperature, continuously stirring, cooling to room temperature after uniformity, and filling;

gelling agent: according to the weight ratio, taking carbomer U20, dispersing with water, heating to 75-85 ℃, uniformly stirring, adding poloxamer 188, triclosan, glycerol, xanthan gum, a compound water extract for burns and scalds and a compound alcohol extract for burns and scalds, continuously stirring until the materials are uniformly dissolved, cooling to room temperature, adding alkannin ultrasonically dissolved in propylene glycol at room temperature, slowly stirring, adding triethanolamine, uniformly stirring and filling.

The composition of the invention is used as a medicine or a cosmetic with a percutaneous effect, and can be used for treating burns and scalds.

Compared with the prior art, the invention has the beneficial effects that:

the active ingredients contained in the composition are derived from natural plants, are extracted by a reasonable process and added into a medicinal or cosmetic substrate, inherit the stable quality of modern medicinal preparations or cosmetic products and the mild and effective treatment method of traditional Chinese medicines, and provide a medicament or cosmetic with convenient use and novel formula in the field of treating burns and scalds.

The invention combines the modern production technology with the traditional secret recipe as the basis to extract and process the effective components of a plurality of Chinese medicinal materials. Under the condition of no side effect, the ointment can heal and eliminate scars and reduce infection to the maximum extent, has good treatment effect on burns and scalds, and avoids the irritation of modern chemical agents and the inconvenience in use of traditional Chinese medicine preparations.

The preparation process of the composition has short period, and the use method is simple and convenient.

In conclusion, the invention realizes the low-cost, few-step, low-loss and environment-friendly production of extracting effective components from traditional Chinese medicines and applying the effective components to modern pharmaceutical preparations or cosmetics by effectively integrating the technologies, and has the advantages of good treatment effect, strong market competitiveness and wide application prospect.

Detailed Description

The present invention is further illustrated by the following examples, which are intended to be purely exemplary and are not intended to limit the scope of the invention, as various equivalent modifications of the invention will occur to those skilled in the art upon reading the present disclosure and fall within the scope of the appended claims.

In a particular embodiment of the present invention, the substrate is,

weighing 12 parts of frankincense, 20 parts of indigo naturalis and 6 parts of dragon's blood in parts by weight, mixing, extracting for 2 times by using 8 times of ethanol in volume ratio, wherein the purity of the ethanol is 90%, the extraction temperature is 85 ℃, the extraction time is 2 hours, merging filtrate after the extraction is finished, concentrating and drying to obtain the burn and scald compound alcohol extract.

The preparation method of the burn and scald compound aqueous extract comprises the following steps:

weighing 16 parts of coptis chinensis, 20 parts of rheum officinale, 20 parts of rhizoma corydalis, 20 parts of garden burnet and 20 parts of golden larch bark according to parts by weight, mixing, extracting for 2 times by using purified water with volume ratio of 8 times, wherein the extraction temperature is 85 ℃, the extraction time is 2 hours, merging the filtrate after the extraction is finished, concentrating and drying to obtain the burn and scald compound water extract.

Example 1: composition and cream for burns and scalds

The formula comprises the following components (100g) in percentage by mass: alkannin, 0.02%; 4% of propylene glycol; chlorhexidine acetate, 0.3%; 10% of M-68 emulsifier, 2% of peregal O-25; 1% of octadecanol; PEG-60 hydrogenated castor oil, 10%; isopropyl myristate, 9.5%; oil-soluble VE, 0.2%; 5% of squalane; olive oil, 5%; 0.5 percent of burn and scald compound alcohol extract; 2% of ethanol; 0.2% of dipotassium glycyrrhizinate; hyaluronic acid (1%, mass concentration), 0.15%; EDTA-2Na, 0.025%; 0.025% of citric acid; 0.5 percent of burn and scald compound aqueous extract; purified water was added to 100 g.

The preparation method comprises the following steps: mixing M-68 emulsifier, peregal O-25, octadecanol, PEG-60 hydrogenated castor oil, isopropyl myristate, oil-soluble VE, squalane and olive oil, heating in a water bath at about 80 deg.C, melting, stirring, adding burn and scald compound alcohol extract (heated and dissolved with ethanol) and chlorhexidine acetate (heated and dissolved with 2g propylene glycol) to obtain oil phase A; dissolving dipotassium glycyrrhizinate, hyaluronic acid, EDTA-2Na, citric acid and the compound water extract for burn and scald in purified water, heating in a water bath kettle at about 80 ℃, and stirring uniformly to obtain an aqueous phase B. Pumping the A and the B into a homogenizing pot, keeping the temperature of 70-80 ℃, homogenizing, stirring and gradually cooling to 40 ℃ after full emulsification, adding alkannin (2 g of propylene glycol dissolved by ultrasonic at room temperature), continuously stirring, cooling to room temperature after uniform stirring, and filling to obtain the cream.

Example 2: composition and cream for burns and scalds

The formula comprises the following components (100g) in percentage by mass: alkannin, 0.02%; 4% of propylene glycol; chlorhexidine acetate, 0.3%; 10% of M-68 emulsifier, 2% of peregal O-25; 1% of octadecanol; PEG-60 hydrogenated castor oil, 10%; isopropyl myristate, 9.5%; oil-soluble VE, 0.2%; 5% of squalane; olive oil, 5%; 1% of burn and scald compound alcohol extract; 2% of ethanol; 0.2% of dipotassium glycyrrhizinate; hyaluronic acid (1%, mass concentration), 0.15%; EDTA-2Na, 0.025%; 0.025% of citric acid; 1% of burn and scald compound aqueous extract; purified water was added to 100 g.

Example 3: composition and cream for burns and scalds

The formula comprises the following components (100g) in percentage by mass: alkannin, 0.02%; 4% of propylene glycol; chlorhexidine acetate, 0.3%; 10% of M-68 emulsifier, 2% of peregal O-25; 1% of octadecanol; PEG-60 hydrogenated castor oil, 10%; isopropyl myristate, 9.5%; oil-soluble VE, 0.2%; 5% of squalane; olive oil, 5%; 2% of burn and scald compound alcohol extract; 2% of ethanol; 0.2% of dipotassium glycyrrhizinate; hyaluronic acid (1%, mass concentration), 0.15%; EDTA-2Na, 0.025%; 0.025% of citric acid; 2% of burn and scald compound aqueous extract; purified water was added to 100 g.

Example 4: composition and gel for burns and scalds

The formula comprises the following components (100g) in percentage by mass: alkannin, 0.02%; 2% of propylene glycol; poloxamer 188, 4%; 0.15 percent of triclosan; 20% of glycerol; carbomer U20, 0.6%; 0.25 percent of xanthan gum; 0.5 percent of burn and scald compound aqueous extract; 0.5 percent of burn and scald compound alcohol extract; triethanolamine (10%, mass concentration), 3%; purified water, added to 100 g.

The preparation method comprises the following steps: dispersing carbomer U20 with purified water, heating to about 80 deg.C, stirring, adding poloxamer 188, triclosan, glycerol, xanthan gum, water extract of burn and scald, and ethanol extract of burn and scald, and stirring. Cooling to room temperature, adding alkannin (propylene glycol dissolved by ultrasonic wave at room temperature), slowly stirring, and adding triethanolamine. Stirring, and packaging to obtain gel.

Example 5: composition and gel for burns and scalds

The formula comprises the following components (100g) in percentage by mass: alkannin, 0.02%; 2% of propylene glycol; poloxamer 188, 4%; 0.15 percent of triclosan; 20% of glycerol; carbomer U20, 0.6%; 0.25 percent of xanthan gum; 1% of burn and scald compound aqueous extract; 1% of burn and scald compound alcohol extract; triethanolamine (10%, mass concentration), 3%; purified water, added to 100 g.

Example 6: composition and gel for burns and scalds

The formula comprises the following components (100g) in percentage by mass: alkannin, 0.02%; 2% of propylene glycol; poloxamer 188, 4%; 0.15 percent of triclosan; 20% of glycerol; carbomer U20, 0.6%; 0.25 percent of xanthan gum; 2% of burn and scald compound aqueous extract; 2% of burn and scald compound alcohol extract; triethanolamine (10%, mass concentration), 3%; purified water, added to 100 g.

Example 7: the invention relates to a test of the bacteriostatic effect of the pharmaceutical composition

The detection method comprises the following steps: the bacteria to be tested and the quantitative sample are coated on the culture medium, and the culture medium without the sample is used as a control. And obtaining the bacteriostasis rate according to the number difference of the detected bacteria after culturing for 48 hours. The specific results are as follows:

TABLE 1 bacteriostatic effect test of the pharmaceutical composition of the present invention

Group of	Inhibiting rate of colibacillus	Inhibiting rate to staphylococcus aureus
			Example 1	73％	76％
Example 2	95％	93％
			Example 3	100％	100％
Example 4	83％	81％
			Example 5	96％	95％
Example 6	100％	100％

Example 8: clinical test of the pharmaceutical composition for treating patients with superficial II-degree burn and deep II-degree burn

Case selection: 163 cases of burn and scald patients from 2017 to 2017, 5 months, are taken in Nanjing City. 87 male, 76 female, 4-71 years old, and 35 years old on average; the method is divided into the following steps according to the burn and scald reasons: scald 85 cases with boiling water, burn 78 cases with fire; the method comprises the following steps of: 74 cases of superficial II degree burn and 89 cases of deep II degree burn and scald.

The treatment method comprises the following steps: 74 patients with superficial II degree burn are divided into 7 groups; 89 cases of deep II degree burn and scald are divided into 7 groups. Treatment groups 1-3 were treated with the creams of examples 1-3 of the present invention, respectively; the treatment groups 4-6 were treated with the gels of the invention of examples 4-6, respectively, and conventional western medicine ointment (boric acid zinc oxide borneol ointment) was used as the control group. The dosage of patients in each administration group is determined according to the area of burn and scald, and the condition that the patients can completely cover the wound surface is taken as the standard. The treatment is carried out 3 times daily, 7 days and 1 treatment course, and 3 treatment courses are continued. The total effective rate is calculated according to the percentage of cure, obvious effect and effective. The wound surface is recovered to be treated as recovery, the wound surface is not infected to be treated as obvious effect, and the wound surface is treated as effective for reducing the effusion and swelling of the wound surface.

The cure rate [% of the area to be cured ] +0.6 [% of the area to be effective ] +0.3 [% of the area to be effective ].

The curative effect evaluation is carried out after 3 courses of treatment. The results are shown in table 1, and from the treatment condition of different pharmaceutical dosage forms of the pharmaceutical composition of the invention on burn and scald patients, the different dosage forms of the pharmaceutical composition have obvious effect on the cure rate.

TABLE 2 clinical trial of the composition of the present invention for treating superficial II degree burn and deep II degree burn

Note: compared with a control group: p <0.05, P < 0.01.

Claims

1. A composition for treating burns and scalds is characterized in that active ingredients comprise alkannin, a burn and scald compound alcohol extract and a burn and scald compound water extract, wherein the burn and scald compound alcohol extract is an alcohol extract of frankincense, natural indigo and dragon's blood, and the burn and scald compound water extract is a water extract of coptis chinensis, rhubarb, rhizoma corydalis, sanguisorba officinalis and golden larch bark; the compound alcohol extract for burns and scalds comprises the following raw materials in parts by weight:

10-12 parts of frankincense

15-20 parts of indigo naturalis

4-6 parts of dragon blood;

the compound aqueous extract for burns and scalds comprises the following raw materials in parts by weight:

12-16 parts of coptis chinensis

20-25 parts of rheum officinale

15-20 parts of rhizoma corydalis

10-20 parts of garden burnet

10-20 parts of golden larch bark;

the alkannin accounts for 0.01-0.3% of the weight of the composition; the burn and scald compound alcohol extract accounts for 0.5-5% of the composition by weight; the weight percentage of the burn and scald compound water extract in the composition is 0.2-12%.

2. The composition for treating burns and scalds according to claim 1, wherein the preparation method of the compound alcohol extract for treating burns and scalds comprises the following steps: mixing the frankincense, the indigo naturalis and the dragon's blood, extracting for 2-4 times by using ethanol with the volume ratio of 5-10 times, wherein the purity of the ethanol is 80-100%, the extraction temperature is 70-90 ℃, the extraction time is 1-3 hours, merging filtrate after extraction is finished, concentrating and drying to obtain the burn and scald compound alcohol extract;

the preparation method of the compound aqueous extract for burns and scalds comprises the following steps: mixing the coptis chinensis, the rheum officinale, the rhizoma corydalis, the garden burnet and the golden larch bark, then extracting with water of which the volume ratio is 5-10 times for 2-4 times, wherein the extraction temperature is 70-90 ℃, the extraction time is 1-3 hours, merging filtrate after the extraction is finished, concentrating and drying to obtain the burn and scald compound water extract.

3. The composition for treating burns and scalds according to claim 1, further comprising pharmaceutically or cosmetically acceptable excipients.

4. The composition for treating burns and scalds according to claim 3, wherein the formulation is a gel, cream, suspension or emulsion.

5. The composition for treating burns and scalds according to claim 3, wherein the auxiliary material is one or more of a gel matrix material, an oil phase matrix, an emulsifier, a solubilizer, a humectant, a pH regulator, a skin penetration enhancer, deionized water, a disinfectant, a preservative, an antioxidant and an essence.

6. The composition for treating burns and scalds according to claim 5, wherein when the dosage form is a gel, the gel matrix material is selected from at least one of carbomer series, cellulose derivatives, chitosan-based matrices; when the dosage form is cream, the selected oil phase matrix is at least one of vegetable oil, higher fatty alcohol, beeswax, and stearic acid; the emulsifier is at least one of fatty acid ester of polyhydric alcohol, fatty alcohol, and polyoxyethylene ether.

7. The composition for treating burns and scalds according to claim 3,

when the dosage form is a gel, the composition comprises the following components in percentage by weight: 0.01-0.3% of alkannin; 2-4% of propylene glycol; 2-6% of poloxamer 188; 0.1-0.3% of triclosan; 10-30% of glycerol; 0.2-0.8% of carbomer U20; 0.1-0.5% of xanthan gum; 0.2-12% of a compound water extract for burns and scalds; 0.5-5% of a compound alcohol extract for burns and scalds; 2-10% of triethanolamine; the balance of water; wherein the mass concentration of the triethanolamine is 8-10%.

8. The composition for treating burns and scalds according to claim 7, wherein the cream is prepared by a method comprising: mixing M-68 emulsifier, peregal O-25, octadecanol, PEG-60 hydrogenated castor oil, isopropyl myristate, oil-soluble VE, squalane and olive oil according to weight percentage, heating at 75-80 ℃, melting, uniformly stirring, and adding the burn and scald compound alcohol extract heated and dissolved by ethanol and chlorhexidine acetate heated and dissolved by propylene glycol to form an oil phase A; dissolving dipotassium glycyrrhizinate, hyaluronic acid, EDTA-2Na, citric acid and the compound water extract for burns and scalds in water, heating at 75-85 ℃, and uniformly stirring to form an aqueous phase B; keeping the temperature of the oil phase A and the water phase B at 70-80 ℃ and homogenizing, stirring and gradually cooling to 40-45 ℃ after full emulsification, adding the alkannin ultrasonically dissolved in propylene glycol at room temperature, continuously stirring, cooling to room temperature after uniformity, and filling;

the preparation method of the gel comprises the following steps: according to the weight percentage, carbomer U20 is taken and dispersed with water, the mixture is heated to 75-85 ℃, after the uniform stirring, poloxamer 188, triclosan, glycerol, xanthan gum, a compound water extract of burns and scalds and a compound alcohol extract of burns and scalds are added, the mixture is continuously stirred until the mixture is uniformly dissolved, the temperature is reduced to the room temperature, propylene glycol alkannin which is ultrasonically dissolved at the room temperature is added, the mixture is stirred, triethanolamine is added, and the mixture is filled after the uniform stirring.