CN113398248A - External medicine for improving blood circulation of skin flap and preparation method thereof - Google Patents
External medicine for improving blood circulation of skin flap and preparation method thereof Download PDFInfo
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- CN113398248A CN113398248A CN202110853434.6A CN202110853434A CN113398248A CN 113398248 A CN113398248 A CN 113398248A CN 202110853434 A CN202110853434 A CN 202110853434A CN 113398248 A CN113398248 A CN 113398248A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1825—Fibroblast growth factor [FGF]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention relates to an external medicine for improving flap blood circulation and a preparation method thereof, which comprises 1000-5000IU/mL of basic fibroblast growth factor, 10-50 mg/mL of minoxidil and 100-300 mg/mL of urea. The invention provides an external medicine which is safe, convenient, efficient and quick, can prevent and treat related skin dilation complications and can improve blood circulation of dilated skin flaps. When the patient has dilated skin tissues and has early warning signs of poor dilatation, such as capillary hyperplasia, thinned skin, transparence and the like, the mode of locally smearing the dilated skin surface is adopted, and the external medicine can improve the poor skin state during the dilation, promote the regeneration of the dilated skin and effectively prevent and treat complications related to the dilated skin.
Description
Technical Field
The invention relates to the field of surgery, namely the plastic repair and reconstruction of skin soft tissue tissues, in particular to the development of a new drug applied to the treatment of a skin soft tissue expander, which can improve the expansion efficiency and reduce the expansion-related complications.
Background
Skin tissue defects are a common problem in plastic and reconstructive surgery, and soft tissue dilation is an ideal repair means for providing skin tissue with similar skin color, texture, etc. However, the complication rate of soft tissue dilation can reach 17.44%, which has a direct relationship with the limited ability of skin tissue regeneration. Clinically, telangiectasis of skin tissues, capillary hyperplasia, thinning and translucency of the skin are early warning signs of poor dilatation, and the progress of the signs can cause severe complications such as skin ulcer and even necrosis. When relevant pre-warning signs appear, halting or terminating dilation is the primary measure to avoid complications.
In order to improve the expansion efficiency and reduce expansion-related complications, the expansion process can be assisted by means of medicines, stem cell injection and the like. The currently known treatment means comprise botulinum toxin type A injection, CGF injection, gelatin sponge coating, stem cell injection, autologous fat transplantation and medicine smearing on the surface of the dilated skin, and the treatment methods have certain promotion effect on skin dilation, but the application value in practical clinical application is limited, and the treatment methods have limitations, specifically as follows:
botulinum toxin type a injection: intramuscular injection is needed, so that the pain is high, and the acceptance of patients is poor; trauma to the dilated area, increasing the risk of complications associated with the dilated skin; and the treatment effect is not exact.
Coating with gelatin sponge: some parts such as the head and the face, or dilators with larger volume are difficult to coat by gelatin sponge, and the use has limitation.
CGF injection: blood is required to be collected, and the blood quality of part of patients does not reach the standard; causing damage to the dilated area and increasing the risk of complications associated with the dilated skin.
Stem cell injection: the stem cells need to be obtained through invasive operation or surgery, and the preparation process is time-consuming and labor-consuming; (ii) a The ethical aspect is not yet clear; trauma to the dilated area increases the risk of complications associated with the dilated skin.
Autologous fat transplantation: the fat needs to be obtained through liposuction surgery, and many patients have less subcutaneous fat, so that the transplantation requirement cannot be met.
Expanding the skin surface and applying drugs, such as triamcinolone acetonide, sucralfate, papaverine, etc.: the medicament has side effects and limited clinical application
Disclosure of Invention
In order to solve the problems in the prior art, the invention develops the external medicine which is safe, convenient, efficient and quick, prevents and treats the skin-related complications on the surface of the skin flap and improves the blood circulation of the skin on the surface of the skin flap. When the skin tissue on the surface of the skin flap of a patient has unfavorable expansion warning signs such as capillary hyperplasia, skin thinning, transparency and the like, the external medicine can improve the unfavorable state of the skin during expansion or after the skin flap operation, promote the regeneration of the expanded skin and effectively prevent and treat the related complications of the expanded skin by adopting a mode of locally smearing the skin surface.
The technical scheme adopted by the invention is as follows:
an external medicine for improving the blood circulation of skin flaps comprises 1000-5000IU/mL of basic fibroblast growth factor, 10-50 mg/mL of minoxidil, 100-300 mg/mL of urea and the like.
Preferably: the external medicine also comprises an oil phase auxiliary material.
Preferably: the oil phase auxiliary materials comprise one or more of stearic acid, span 60, octadecanol, liquid paraffin, albolene and laurocapram.
Preferably: the external medicine also comprises water and oil phase auxiliary materials.
Preferably: the water phase auxiliary materials comprise one or more than one of polyacrylate 80, glycerol, sorbic acid, dimethyl sulfoxide and purified water.
A preparation method of an external medicine for improving skin flap blood circulation comprises the following steps:
(1) dissolving minoxidil in dimethyl sulfoxide, and dissolving alkaline fibroblast growth factor in purified water;
(2) heating and melting the oil-phase auxiliary materials, and controlling the temperature to be 75-80 ℃;
(3) heating the water phase auxiliary materials except the dimethyl sulfoxide to 75-80 ℃ and filtering;
(4) adding the water-phase auxiliary materials into the oil-phase auxiliary materials while the mixture is hot with stirring, and stirring until the mixture is completely emulsified;
(5) adding minoxidil solution when the mixture is completely emulsified and the temperature is reduced to below 50 ℃, and continuously stirring;
(6) when the mixture is stirred to be solidified and the temperature is reduced to below 37 ℃, adding an alkaline fibroblast growth factor solution, and stirring until the mixture is solidified;
(7) packaging under sterile condition, and reserving.
Preferably: and (7) sealing and storing at 4 ℃ after packaging.
The invention has the beneficial effects that:
compared with the prior art, the invention has the beneficial effects that:
the basic fibroblast growth factor (bFGF) has the biological activity of promoting the proliferation of blood vessels and mitosis of various cells, and is suitable for promoting the healing of skin wound surfaces; the minoxidil has a strong arteriolar dilation effect, and influences the regeneration of skin fibroblasts and promotes the growth of skin by enhancing blood supply; the urea can increase the water content of the skin stratum corneum, soften hyperkeratotic skin, and has good moistening and moisturizing effects, so as to enhance the penetration of other medicines.
The invention provides an external medicine which is safe, convenient, efficient and quick, can prevent and treat related skin dilation complications and can improve blood circulation of dilated skin flaps. When the patient has dilated skin tissues and has early warning signs of poor dilatation, such as capillary hyperplasia, thinned skin, transparence and the like, the mode of locally smearing the dilated skin surface is adopted, and the external medicine can improve the poor skin state during the dilation, promote the regeneration of the dilated skin and effectively prevent and treat complications related to the dilated skin.
The invention can effectively avoid the problems in the prior art and effectively improve the blood transportation function of the expansion flap; no local skin irritation and no systemic toxic and side effects; the preparation is simple, the performance is stable, and the product is colorless and free from peculiar smell and is suitable for long-term external use; the patient has high acceptance of the external preparation and does not cause trauma to the dilated area, thereby reducing the risk of complications related to the dilated skin.
The invention can be used for treating clinically common skin expansion related complications, expands the indications of main component medicaments, and can create certain economic value. Meanwhile, the mode of smearing the external medicine can effectively prevent and treat related complications of skin expansion, so that the skin soft tissue expansion process is smoothly carried out, sufficient skin tissues with similar skin color, texture and the like are provided, the treatment of more patients with congenital malformation and acquired injury is guaranteed, and the external medicine has certain social value.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is an effect diagram of a typical case 1;
fig. 2 is an effect diagram of typical case 2.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
An external medicine for improving the blood circulation of skin flaps comprises 1000-5000IU/mL of basic fibroblast growth factor, 10-50 mg/mL of minoxidil and 100-300 mg/mL of urea. The external medicine of the invention can be prepared into different formulations according to the requirements and the medicine properties, such as solution, powder, oil, ointment and the like, and different auxiliary materials are selected according to different formulations. The addition amount of the auxiliary materials can be added according to the properties of the auxiliary materials.
The following examples are based on the selection of the excipients in the form of ointments, although the type and amount of excipients can be adjusted and will not be described in detail.
Example 1
An external medicine for improving the blood circulation of skin flaps and a preparation method thereof,
accurately weighing the following raw material medicines:
50 ten thousand IU (about 5g) of freeze-dried powder of the basic fibroblast growth factor, 5g of freeze-dried minoxidil powder, 20g of urea, 5mL of dimethyl sulfoxide, 3mL of lauryl nitrogen, 3mL of ketone, 4.5g of stearic acid, 601.25 g of span, 4.5g of octadecanol, 7g of liquid paraffin, 4.5g of albolerin, 803.5 g of polysorbate, 8g of glycerol, 0.2g of sorbic acid and a proper amount of purified water, and the total amount is 100 g.
Dissolving the minoxidil freeze-dried powder in dimethyl sulfoxide for later use, and dissolving the alkaline fibroblast growth factor freeze-dried powder in purified water for later use.
Thirdly, taking oil phase components of stearic acid, span 60, octadecanol, liquid paraffin, albolene, lauryl nitrogen and ketone, heating and melting the components in a water bath, and controlling the temperature to be 75-80 ℃;
heating the water phase components of urea, poly acid ester 80, glycerin, sorbic acid and purified water to 75-80 ℃ and filtering;
adding the water phase component into the oil phase component with stirring when the oil phase component and the water phase component are the same, and continuously stirring in one direction until the emulsification is complete;
sixthly, when the mixture is completely emulsified and the temperature is reduced to below 50 ℃, adding minoxidil solution and continuing stirring;
seventhly, when the mixture is stirred to be solidified soon and the temperature is reduced to be below 37 ℃, adding the basic fibroblast growth factor solution, and stirring until the mixture is solidified.
And sealing and storing at 4 ℃ in a sterile manner for later use.
Example 2
Basically the same as example 1, except that: accurately weighing the following raw material medicines:
10 ten thousand IU (about 1g) of freeze-dried powder of the basic fibroblast growth factor, 2g of freeze-dried powder of minoxidil, 27g of urea, 5mL of dimethyl sulfoxide, 3mL of lauryl nitrogen, 3mL of ketone, 4.5g of stearic acid, 601.25 g of span, 4.5g of octadecanol, 7g of liquid paraffin, 4.5g of albolerin, 803.5 g of polysorbate, 8g of glycerol, 0.2g of sorbic acid and a proper amount of purified water, and the total amount is 100 g.
Example 3
Basically the same as example 1, except that: accurately weighing the following raw material medicines:
20 ten thousand IU (about 2g) of freeze-dried powder of the basic fibroblast growth factor, 4g of freeze-dried minoxidil powder, 24g of urea, 5mL of dimethyl sulfoxide, 3mL of lauryl nitrogen, 3mL of ketone, 4.5g of stearic acid, 601.25 g of span, 4.5g of octadecanol, 7g of liquid paraffin, 4.5g of albolerin, 803.5 g of polysorbate, 8g of glycerol, 0.2g of sorbic acid and a proper amount of purified water, and the total amount is 100 g.
Example 4
Basically the same as example 1, except that: accurately weighing the following raw material medicines:
the composition comprises basic fibroblast growth factor freeze-dried powder 40 ten thousand IU (about 4g), minoxidil freeze-dried powder 6g, urea 20g, dimethyl sulfoxide 5mL, lauryl nitrogen, ketone 3mL, stearic acid 4.5g, span 601.25 g, octadecanol 4.5g, liquid paraffin 7g, albolerin 4.5g, polysorbate 803.5 g, glycerin 8g, sorbic acid 0.2g and a proper amount of purified water, and the total amount is 100 g.
Effect test
By adopting the ointment prepared in the embodiment 1, when the patient has the early warning signs of poor dilatation such as capillary hyperplasia, thinned and transparent skin and the like when the skin tissues are dilated, the mode of local smearing on the dilated skin surface is adopted, and the external medicine is smeared once in the morning and at night after the local skin is cleaned. Pre-use symptoms: dilate skin tissue to cause capillary vessel hyperplasia and thin and transparent skin. Symptoms after use: the dilated skin tissue has reduced capillary vessel hyperplasia and increased skin thickness.
Typical case 1: as shown in fig. 1, in fig. 1: a is before treatment; and B is 1 week after the medicine is used. It can be seen that the dilated skin has reduced blood vessels, improved skin texture, and improved complications related to dilation.
Typical case 2: as shown in fig. 2, in fig. 2: a is before treatment; b is more than 1 month after the medicine is used; c is more than 2 months after using the medicine of the invention. It can be seen that the dilated skin has reduced blood vessels, improved skin texture, and improved complications related to dilation.
Although embodiments of the present invention have been described above, it would be appreciated by those skilled in the art that changes may be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the claims.
Claims (7)
1. An external medicine for improving the blood circulation of skin flaps is characterized in that: comprises 1000-5000IU/mL of basic fibroblast growth factor, 10-50 mg/mL of minoxidil and 100-300 mg/mL of urea.
2. The external use medicine for improving skin flap blood circulation as claimed in claim 1, wherein: the external medicine also comprises an oil phase auxiliary material.
3. The external use medicine for improving skin flap blood circulation as claimed in claim 1, wherein: the oil phase auxiliary materials comprise one or more of stearic acid, span 60, octadecanol, liquid paraffin, albolene and laurocapram.
4. The external use medicine for improving skin flap blood circulation according to any one of claims 1 to 3, characterized in that: the external medicine also comprises water and oil phase auxiliary materials.
5. The external use medicine for improving skin flap blood circulation as claimed in claim 4, wherein: the water phase auxiliary materials comprise one or more than one of polyacrylate 80, glycerol, sorbic acid, dimethyl sulfoxide and purified water.
6. The method for preparing the external medicine for improving skin flap blood circulation as claimed in claim 4, wherein: the method comprises the following steps:
(1) dissolving minoxidil in dimethyl sulfoxide, and dissolving alkaline fibroblast growth factor in purified water;
(2) heating and melting the oil-phase auxiliary materials, and controlling the temperature to be 75-80 ℃;
(3) heating the water phase auxiliary materials except the dimethyl sulfoxide to 75-80 ℃ and filtering;
(4) adding the water-phase auxiliary materials into the oil-phase auxiliary materials while the mixture is hot with stirring, and stirring until the mixture is completely emulsified;
(5) adding minoxidil solution when the mixture is completely emulsified and the temperature is reduced to below 50 ℃, and continuously stirring;
(6) when the mixture is stirred to be solidified and the temperature is reduced to below 37 ℃, adding an alkaline fibroblast growth factor solution, and stirring until the mixture is solidified;
(7) packaging under sterile condition, and reserving.
7. The method of claim 6, wherein: and (7) sealing and storing at 4 ℃ after packaging.
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